bioihbjkbjnl/mcl2 huggingface dataset:
A Study Comparing The Bioequivalence Of Ciclesonide Nasal Spray (Apotex, Inc.) To That Of Omnaris™ Nasal Spray (Sepracor, Inc.) In The Treatment Of Seasonal Allergic Rhinitis
Condition: Seasonal Allergic Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Seasonal
Study type: Interventional
Phase: Phase 3

Summary: 
      This study is to evaluate the equivalence of generic ciclesonide nasal spray with that of the
      marketed drug, Omnaris™ nasal spray, in the treatment of seasonal allergic rhinitis, and to
      evaluate the safety and tolerability of generic ciclesonide nasal spray compared with
      Omnaris™ nasal spray.
    


Intervention name(s): Ciclesonide nasal spray, 50 μg per actuation.
Intervention type(s): Drug
Intervention description(s): During placebo lead-in period: patients received placebo nasal spray, two actuations in each nostril once daily for 7 days.
During treatment period: subjects were then assigned to one of the following three treatments according to the randomization scheme:
Ciclesonide nasal spray: 50 μg per actuation, two actuations in each nostril once daily (200 μg per day) for 14 days.
Omnaris™ nasal spray: 50 μg per actuation, two actuations in each nostril once daily (200 μg per day) for 14 days.
Placebo nasal spray: 0 μg per actuation, two actuations in each nostril once daily for 14 days.
Intervention MeSH terms: Ciclesonide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Influence of Valproic Acid on Extinction-based Therapy in Patients With Fear of Spiders.
Condition: Phobia, Specific
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate whether valproic acid in combination with fear
      memory reactivation is useful to enhance treatment stability of exposure therapy for specific
      phobia.
    

Detailed description: 
      -  There will be one screening visit (visit 1), one intervention visit (visit 2) and one
           follow-up visit (90 days after visit 2) (visit 3).

        -  On visit 2 all participants will undergo 30 min exposure therapy in virtual reality with
           pre-defined spider situations.

        -  Duration for an individual participant will be at most 15 weeks depending on the time
           passing between screening (visit 1) and intervention visit (visit 2).

        -  Change in phobic fear to baseline (visit 1) will be assessed on 90 day follow-up (visit
           3).

        -  Documentation of all study relevant source data of every study participant will be done
           by completing the study specific electronic case report forms (eCRF, SoSci Survey) and
           study specific case report forms on paper (Adverse Events, Serious Adverse Events and
           concomitant medication). Data in the eCRF can be validated for completeness and
           discrepancies automatically. An audit trail system maintains a record of initial entries
           and changes (reasons for changes, time and date of changes, user identification of entry
           and changes).

        -  Quality insurance will be done by an external site monitoring (including study progress,
           accuracy and completeness of eCRF, fulfillment of protocol requirements, applicable
           local authority regulations and investigator's obligations).

        -  Monitoring includes 100% of safety parameters, primary endpoints, informed consent
           documents and the Trial Master File on the Initiation Visit and on Close Out.

        -  Standard Operating Procedures to address study activities such as patient recruitment,
           informed consent, study interventions, data collection, data management, data analysis,
           and reporting for adverse events exist.
    

Intervention name(s): Valproic Acid; Placebo; Fear reactivation; No fear reactivation
Intervention type(s): Drug; Drug; Behavioral; Behavioral
Intervention description(s): Once oral administration of 500mg before exposure therapy.; Once oral administration of 500mg before exposure therapy.; Fear reactivation before exposure therapy.; No fear reactivation before exposure therapy.
Other intervention name(s): Orfiril®
Intervention MeSH terms: Valproic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Subfoveal Choroidal Thickness and Visual Acuity After Intravitreal Injection of Ranibizumab in Diabetic Retinopathy
Condition: Subfoveal Choroidal Thickness; Intravitreal; Ranibizumab; Visual Acuity; Diabetic Retinopathy
MeSH terms: Retinal Diseases; Diabetic Retinopathy
Study type: Interventional

Summary: 
      The aim of this study is to compare subfoveal choroidal thickness (SFCT) and the visual
      status before and after intravitreal injection of ranibizumab in diabetic macular edema (DME)
      with the use of 3D-OCT by enhanced depth spectral-domain imaging (EDI-OCT) with fixating
      other factors.
    

Detailed description: 
      Diabetes is a metabolic disorder affecting the ocular vasculature. Although the principal
      posterior segment changes in diabetes usually occur in the retinal vasculature, additional
      changes are also observed in the choroid which provides an important blood supply to the
      outer retina. Diabetic choroidopathy involves choroidal abnormalities occurring in diabetic
      patients and may participate in mechanisms that lead to the decrease of visual acuity.

      Several studies demonstrated the possibility of imaging of the choroid using spectral-domain
      OCT. Many studies investigated variation in the choroidal thickness (CT) occurring with
      changes in age and axial length, or in different ocular diseases, Diabetic macular edema
      (DME) is a major cause of visual loss in diabetic patients.

      OCT (Optical coherence tomography) is a non-invasive imaging technique, that was used to
      obtain a high definition segments of retina. Lately, EDI (enhanced depth imaging)
      spectral-domain OCT has been explained. (EDI) program routinely captures a cross sectional
      picture with the choroid near the zero delay line to enhance sensitivity on the external edge
      of the choroid.

      Functional imaging findings also presented a decrease in choroidal flow of the blood in eyes
      with diabetic retinopathy.

      The current purpose of (EDI-OCT), which employing the enhanced depth of field from the
      inverted picture by locating the OCT device near to the eye, has helped the researchers to
      study the anatomic variations in the choroid in diabetic eyes.
    

Intervention name(s): Intravitreal injection of ranibizumab
Intervention type(s): Procedure
Intervention description(s): These patients were received three intravitreal injection of ranibizumab with one month interval. 3D-OCT by enhanced depth spectral-domain imaging (EDI-OCT) was done preoperative and a month after every injection.
All patients recieved topical anesthesia as 0.5 mg/0.05 ml , ranibizumab is injected 4 mm (3.5 mm in Pseudophakia) from the limbus intravitreally (in the lower temporal quadrant) by a needle (27gauge).
Intervention MeSH terms: Ranibizumab
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Safety, Tolerability, Pharmacokinetics (PK) and Pharmacodynamics (PD) Assessment of LIK066 in Healthy Subjects and in Patients With Type 2 Diabetes Mellitus (T2DM)
Condition: Type 2 Diabetes Mellitus (T2DM)
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This study will assess safety, tolerability, and effect of LIK066 on blood glucose in healthy
      subjects and in patients with T2DM.
    


Intervention name(s): LIK066; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Participants will receive a single or multiple doses of LIK066; Participants will receive a single or multiple doses of a matching placebo
Intervention MeSH terms: Licogliflozin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Other
Keywords: T2DM, blood glucose, OGTT, LIK066
Corifollitropin Alfa in Participants Undergoing Repeated Controlled Ovarian Stimulation (COS) Cycles Using a Multiple Dose Gonadatropin Releasing Hormone (GnRH) Antagonist Protocol (Study 38825)(P05714)
Condition: In Vitro Fertilization
Study type: Interventional
Phase: Phase 3

Summary: 
      The objective of the trial is to assess the non-immunogenicity and safety of corifollitropin
      alfa (also known as Org 36286, SCH 900962 and MK-8962) in participants undergoing repeated
      COS cycles using a multiple dose GnRH antagonist protocol.
    

Detailed description: 
      This trial is designed as an open-label, uncontrolled, repeated cycle trial to assess the
      non-immunogenicity and safety of corifollitropin alfa in participants undergoing repeated COS
      cycles for in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI) using a
      multiple dose GnRH antagonist protocol. The trial period per participant will cover 1, 2 or 3
      COS treatment cycles and no more than three (in-between two stimulation cycles) Frozen-Thawed
      Embryo Transfer (FTET) cycles following either or both of the first two treatment cycles. In
      each stimulation cycle, participants receive a single injection of corifollitropin alfa and
      one week later, treatment is continued with a daily dose of any FSH-containing preparation up
      to the day of (rec)hCG administration for final oocyte maturation. Assessment of
      anti-corifollitropin alfa antibodies and local tolerance after corifollitropin alfa injection
      are important safety endpoints in this trial.
    

Intervention name(s): Corifollitropin alfa; FSH; GnRH antagonist; (rec)hCG; Progesterone
Intervention type(s): Drug; Biological; Biological; Biological; Drug
Intervention description(s): Corifollitropin alfa 150 µg administered as a single subcutaneous dose.; FSH administerd subcutaneously at a dose not to exceed 225 IU/day.; GnRH antagonist administered subcutaneously at a dose of 0.25 mg/day.; (rec)hCG administered subcutaneously at a dose of 5,000-10,000 IU/250 µg.; Progesterone administered vaginally at a dose of at least 600 mg/day.
Other intervention name(s): Org 36286; SCH 900962; MK-8962
Intervention MeSH terms: Progesterone
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Infertility; Pharmacological effects of drugs; Hormones, Hormone Substitutes and Hormone Antagonists; Pharmacological Actions; Multi-center
QST-Pupillometry in Sickle Cell Disease Patients
Condition: SCD With Severe Phenotype (HbSS, HbSβ0 Thalassemia, HbSOARab)
MeSH terms: Anemia, Sickle Cell; Thalassemia
Study type: Observational

Summary: 
      There has been little progress for effective treatment of pain in sickle cell disease (SCD)
      patients. Many organizations have recognized that understanding the causes and reducing the
      burden of pain in SCD is critical in order to improve the quality of life in SCD patients. As
      patients with SCD face the challenge of living with both acute and chronic pain which is
      often improperly treated, our translational and interdisciplinary project aims to identify
      objective measures of pain sensitivity and its biochemical and genetic correlates. We
      hypothesize that SCD patients will have decreased tolerance to thermal and electrical
      stimuli.
    


Intervention name(s): Quantitative sensory testing
Intervention type(s): Other
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        SCD patients referred to the Pain Medicine clinic, either outpatient or inpatient.
      
Biospecimen description: 
      Collection of blood samples at baseline to be stored in the Pain Neurobiology laboratory for
      future biochemical studies.
A Study to Test How Well Men Tolerate Different Doses of BI 3006337
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The main objectives of this trial are to investigate safety, tolerability and
      pharmacokinetics of BI 3006337 in healthy male subjects following subcutaneous administration
      of single-rising doses.
    


Intervention name(s): BI 3006337; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): BI 3006337; Placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Longitudinal Multimodal Neuroimaging Studies in Patients With First Episode Psychosis
Condition: Psychotic Disorders
MeSH terms: Psychotic Disorders
Study type: Observational

Summary: 
      The purpose of this study is to investigate the structural, functional and chemical brain
      abnormalities in patients with first episode psychosis and assess the evolution of these
      abnormalities during the course of the disease.
    

Detailed description: 
      The purpose of this study is to investigate the structural, functional and chemical brain
      abnormalities in patients with first episode psychosis and assess the evolution of these
      abnormalities during the course of the disease.

      The study design is case-control, there are no interventions.
    

Intervention name(s): Observational
Intervention type(s): Other
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        First episode psychosis patients Healthy controls
      
Keywords: Schizophrenia; Schizoaffective disorder; Bipolar disorder
Effects of Hamstring Shortness on Jump Performance in Young Basketball Players Impact
Condition: Hamstring Injury
Study type: Observational

Summary: 
      In the realm of sports performance, particularly in disciplines demanding explosive
      lower-body strength and agility, such as basketball, an athlete's ability to execute powerful
      and high-reaching jumps plays a pivotal role. Optimal lower-extremity flexibility,
      particularly in the hamstrings, is crucial for achieving maximum vertical jump height.
      Hamstring shortness, characterized by limited flexibility and reduced muscle extensibility,
      is frequently observed among athletes and has been linked to compromised jump performance.
    

Detailed description: 
      Young basketball players, in their developmental stages, often face the challenge of
      balancing strength, flexibility, and functional movement. Hamstring tightness is a prevalent
      issue among this demographic, potentially influencing their ability to generate adequate
      power during jumps. The impact of hamstring shortness on jump performance is multifaceted,
      affecting the force production, range of motion, and efficiency of movement crucial for
      executing explosive jumps
    

Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Amateur basketball players will be included in the study
      
Keywords: basketball; shortness
Does Varenicline Influence Alcohol Consumption in Alcohol Dependent Individuals?
Condition: Alcohol Dependence
MeSH terms: Alcoholism; Alcohol Drinking
Study type: Interventional
Phase: Phase 2

Summary: 
      The aim of the present clinical trial is to investigate whether 14 weeks of treatment with a
      prescription medication for smoking cessation (European trade name: Champix(R); US trade
      name: Chantix(R)), can reduce alcohol consumption in alcohol dependent individuals.
    


Intervention name(s): varenicline (Champix/Chantix); placebo for varenicline
Intervention type(s): Drug; Drug
Intervention description(s): 14 weeks of per oral tablet treatment in an escalating dosing regimen (0.5 mg - 1.0 mg/day; 1 - 2 tablets/day).; 14 weeks of per oral tablet treatment in an escalating dosing regimen (1 - 2 tablets/day)
Other intervention name(s): Champix(R)/Chantix(R); placebo for Champix(R) / Chantix(R)
Intervention MeSH terms: Varenicline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: alcohol dependence; nicotine dependence; alcohol abuse; varenicline; Champix; Chantix; smoking; drinking; snuffing; diary; phosphatidyl ethanol; PEth
Vitamin D and Mortality in Heart Failure
Condition: Congestive Heart Failure
MeSH terms: Heart Failure
Study type: Interventional
Phase: Phase 4

Summary: 
      Despite significant therapeutic improvements, congestive heart failure (CHF) patients still
      have a poor prognosis. Currently, 5-year survival rates are only 35-50%. There is an
      accumulating body of evidence from prospective cohort studies that low circulating
      25-hydroxyvitamin D is an independent predictor of all-cause and cardiovascular mortality,
      respectively. Vitamin D deficiency is prevalent among CHF patients. We hypothesize that
      vitamin D may improve survival in CHF patients. We therefore aimed to investigate whether
      vitamin D supplementation reduces mortality and increases event-free survival in end-stage
      CHF patients.
    


Intervention name(s): Vitamin D; placebo
Intervention type(s): Drug; Drug
Intervention description(s): daily oral vitamin D supplement of 100 micrograms for three years; daily oral placebo supplement for three years
Other intervention name(s): solution of vitamin D oil; solution of migliol oil
Intervention MeSH terms: Vitamin D; Ergocalciferols; Cholecalciferol; Vitamins; Pharmaceutical Solutions
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: vitamin D, mortality, event-free survival, heart failure
The Importance of Adrenomedullin (AM) on ACTH-Cortisol-Glucose Axis
Condition: Systemic Inflammatory Response Syndrome; Hyperglycemia
MeSH terms: Hyperglycemia; Syndrome; Systemic Inflammatory Response Syndrome
Study type: Observational

Summary: 
      Hyperglycemia is frequent manifestations of the human metabolic response to systemic
      inflammatory response syndrome (SIRS),sepsis and septic shock, and are implicated in the
      clinical outcome.

      Adrenomedullin is elevated in SIRS, sepsis and septic shock and has been demonstrated the
      inhibitory role on insulin and adrenocorticotropic hormone secretion.

      Our hypothesis is that: AM elevation after SIRS could be the responsible to maintain
      hyperglycemia
    

Detailed description: 
      Studies in cultured vascular endothelial cells and vascular smooth muscle cells demonstrate
      that cytokines strongly stimulate adrenomedullin production and release.

      Adrenomedullin has been measured in a wide range of clinical researches. Of all conditions
      investigated, the greatest increment in plasma adrenomedullin has been observed in septic
      shock. It appears that AM is directly responsible for the hypotension characteristic of
      septic shock. Studies have shown that administration of AM and AMBP-1 before the onset of
      sepsis (i.e., pretreatment) prevents transition from the hyperdynamic phase to the
      hypodynamic phase in the progression of sepsis, attenuates tissue and organ damage, and
      reduces sepsis-induced mortality.

      Two groups described the effects of AM on the pituitary. Taken together, these studies
      suggest that AM has a role in inhibiting ACTH release.

      Mulder et al. first reported the stimulatory effects of adrenomedullin on insulin secretion
      from isolated rat islets. In direct contrast to this, Martínez et al. clearly demonstrated
      the inhibitory role of adrenomedullin on insulin secretion in vitro.
    

Intervention name(s): Blood AM, IL-6, ACTH, Cortisol, Glucose and Insulin
Intervention type(s): Procedure
Intervention MeSH terms: Hydrocortisone
Observational model: Defined Population
Time perspective: Other
Keywords: Adrenomedullin; Glucose; Insulin; Systemic Inflammatory response Syndrome; Pediatric; Cortisol; ACTH
Identifying Toddlers and Their Parents Who Are Suffering From Posttraumatic Distress Following War and Terror
Condition: Stress Disorders, Post-Traumatic
MeSH terms: Stress Disorders, Post-Traumatic
Study type: Observational

Summary: 
      The project is aimed at identifying children who are suffering from posttraumatic distress
      and increasing capacity to provide treatment for them and for their caretakers. The project
      will be implemented in 3 cities in Israel, Haifa, Kiryat Shmona and Sderot, exposed to
      terrorism and the effects of war
    

Detailed description: 
      A. Screening of young children and implementation of treatment The screening will consist of
      self-report questionnaires and a clinical interview with parents, conducted by trained
      professional about exposure to traumatic events and resulting post-traumatic specific
      symptoms among the toddlers and their parents. The screening procedure is bases on the
      accumulated clinical experience and empirical data gained in the ongoing similar project in
      Sderot. The level of cooperation by parents and teachers in the ongoing project has been
      exceptionally high, indicating a tremendous need for knowledge, skills and support. Based
      upon our previous experience, it is anticipated well-baby clinic nurses will also be
      extremely interested participation.

      B. Workshops for parents, teachers, nurses The knowledge and skills of preschool teachers and
      nurses working in all our projects sights (well baby clinics, day care centers and
      kindergartens) as well as parents will be increased by providing training regarding the
      impact of war related trauma on preschool children. Workshops will better equip teachers,
      nurses and parents with knowledge about the emotional impact of trauma on young children and
      will increase the skills to help preschool children contain emotional distress as well as to
      help them in coping with the emotional consequences of trauma exposure.

      C. Treatment Interventions All toddlers identified with posttraumatic distress will receive
      dyadic treatment focused on dealing with posttrauma. Dyadic treatment involving parents and
      children is aimed at increasing the attunement of parents to their toddlers and their needs
      in times of crises. Local practitioners in Sderot implementing this cutting-edge treatment
      received specialized training adjusted to the context of terror and trauma by a child trauma
      specialist from Mount Sinai Medical Center in New York.

      D. Evaluation of treatment Evaluation of treatment efficacy (dyadic treatment) will be
      assessed by pre and post interviews that will be conducted by trained professionals with all
      parents participating in the dyadic treatments in each of the three cities
    

Observational model: Family-Based
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Families with children between the age 1-6 years
      
Keywords: PTSD; DYADIC TREATMENT; WAR AND TERROR; Posttraumatic symptoms among toddlers