bioihbjkbjnl/mcl2 huggingface dataset:
Evaluation of Dorsal Visual Stream in Patients With Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Observational

Summary: 
      Schizophrenia patients in comparing to normal controls show decreased ability to identify
      objects with decreased level of fragmentation, a task that is associated with magnocellular
      pathway function.
    


Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients suffering from schizophrenia
      
Keywords: Schizophrenia; Cognitive deficites; Degraded objects; Magnocellular pathway
Three Modalities of Treatment in Operable and Resectable Stage IIIA (T1-3, N2) Non-Small Cell Lung Cancer (NSCLC)
Condition: Non-small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Study type: Interventional
Phase: Phase 2

Summary: 
      Stage IIIA non-small cell lung cancers comprising a mediastinal ganglionic invasion N2
      account for 20 to 30% of the NSCLCs. They are almost always potentially resectable, but the
      results obtained by surgery alone or surgery followed by chemotherapy (CT) and/or
      radiotherapy (RT) are insufficient. The neoadjuvant approach was tested, in randomized tests
      of exclusive CT, or in noncomparative tests of RT-CT.
    

Detailed description: 
      These results justify the choice of the study design currently suggested, testing the
      preoperative feasibility

        1. chemotherapy: cisplatin-Gemzar (arm A) or

        2. chemoradiotherapy: cisplatin-navelbine-radiotherapy (arm B) or
           Carboplatin-Taxol-radiotherapy (arm C).

      The results obtained, in terms of feasibility and toxicity, will make it possible to select
      the optimal diagrams for a phase III study.
    

Intervention name(s): Cisplatin-Gemzar; Cisplatin-Navelbine-Radiotherapy; Carboplatin-Taxol-Radiotherapy
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Cisplatin; Carboplatin; Vinorelbine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: operable and resectable stage IIIA (T1-3, N2) NSCLC
Relative Bioavailability of a Fentanyl Patch
Condition: Pain
Study type: Interventional
Phase: Phase 1

Summary: 
      Tohe purpose of this study is to demonstrate the bioequivalence of a fentanyl patch
      transdermal delivery system.
    


Intervention name(s): Fentanyl patch 25 ug/nr Sandoz; Duragesic
Intervention type(s): Drug; Drug
Intervention MeSH terms: Fentanyl
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Comparison Between Topical Mitomycin C and Cyclosporine
Condition: Pterygium
MeSH terms: Pterygium
Study type: Interventional
Phase: Phase 1

Summary: 
      Pterygium is a disease associated with proliferation of the fibrovascular tissues of the
      conjunctiva into the cornea and is related to factors such as ultraviolet light exposure,
      chronic stimulation, inflammation, climate, and genetics.
    

Detailed description: 
      The first line of treatment for primary pterygium is surgical excision, and despite
      postoperative adjuvant therapy using mitomycin C, cyclosporine, β-irradiation, argon laser,
      and bevacizumab, recurrence rates remain high .

      Mitomycin C is a metabolic inhibitor extracted from Streptomyces caespitosus that inhibits
      DNA synthesis .

      Cyclosporine is an immunosuppressant that selectively suppresses T-helper cells, controls
      interleukin synthesis and secretion, and inhibits vascular endothelial growth factor (VEGF)

      Bevacizumab is an anti-VEGF antibody that inhibits angiogenesis. Each agent has been studied
      as an adjuvant therapy to inhibit post-surgery pterygium recurrence.
    

Intervention name(s): Mitomycin c
Intervention type(s): Drug
Intervention description(s): Comparing the effect of Mitomycin C versus Cyclosporine after primary pterygium surgery
Other intervention name(s): Cyclosporine
Intervention MeSH terms: Cyclosporine; Mitomycins; Mitomycin; Cyclosporins
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: compare the recurrence rates and complications associated with instillation of topical mitomycin C and cyclosporine after primary pterygium surgery
Masking: None (Open Label)
Primary purpose: Treatment
Study to Evaluate the Safety and Tolerability of Mucinex™(Guaifenesin) 600 mg Extended-Release Bi-Layer Tablets in the Treatment of Otherwise Healthy Patients With Symptoms of Cough, Thickened Mucus and Chest Congestion
Condition: Healthy Subjects
Study type: Interventional
Phase: Phase 4

Summary: 
      This was an open label, multicentric, non-comparative, single arm prospective post marketing
      surveillance (PMS) study to evaluate the safety and tolerability of Mucinex™ (GGE, 600 mg ER
      bi-layer tablets, taken as 1200 mg BID dose) in the treatment of otherwise healthy patients
      with symptoms of cough, thickened mucus and chest congestion due to URTI. Symptomatic
      patients who visited the outpatient department of hospitals and clinics or general physicians
      and had agreed to participate in this study were screened and enrolled into the study.
    


Intervention name(s): Mucinex™ extended-release (SE)
Intervention type(s): Drug
Intervention description(s): 2 tablets of Mucinex™ (GGE, 600 mg extended-release bi-layer tablets)
Other intervention name(s): Guaifenesin bi-layer tablet
Intervention MeSH terms: Guaifenesin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Perioperative Use of Desmopressin (DDAVP) in Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      The propose for this study is to evaluate the safety and tolerability of desmopressin when
      administered perioperatively to patients with breast cancer undergoing surgery as first
      treatment, and select the optimum dose for the clinical development of the product.
    

Detailed description: 
      Breast cancer is one of the most commonly diagnosed malignancies among women, and its
      mortality is related to the capacity of tumor cells to invade and produce metastases. It is
      postulated that tumor manipulation during surgery results in the release of tumor cells into
      circulation or the lymphatic system, and that these released cells survive due to aggregation
      among them or with platelets through the formation of a fibrin layer on the embolus. Tumor
      cells surviving transportation through circulation will join blood vessels and invade
      vascular walls, forming metastases. The interruption of this process might reduce survival of
      tumor cells and thus the formation of metastases from breast cancer cells in the lungs or
      other tissues.
    

Intervention name(s): Desmopressin
Intervention type(s): Drug
Intervention description(s): 20 patients in 5 groups 4 each, advancing progressively to each dose level.
Intervention MeSH terms: Deamino Arginine Vasopressin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: DDAVP
Safety, Efficacy Assessment of Geltim LP® 1 mg/g in Ocular Hypertensive or Glaucomatous Patients.
Condition: Glaucoma
MeSH terms: Glaucoma
Study type: Interventional
Phase: Phase 4

Summary: 
      This phase IV study aims to assess the safety and the efficacy in intra ocular pressure of
      Geltim LP® 1 mg/g (0.1% unpreserved timolol maleate gel) in glaucomatous patients initially
      treated and stabilised by monotherapy of Xalatan® with ocular objective signs of intolerance
      to prostaglandin eye drops.
    

Detailed description: 
      The primary objectives are to compare the safety and the efficacy of Geltim LP® 1mg/g eye
      drops versus Xalatan® eye drops with respect to:

      The assessment of the ocular tolerance:

        -  Ocular symptoms

        -  Objective ocular signs.

      The maintain of the IOP efficient lowering effect. Comparison between the 2 study products of
      the mean basal IOP after a 12 weeks treatment period (84 days ±7).
    

Intervention name(s): Geltim LP 1 mg/g; Xalatan
Intervention type(s): Drug; Drug
Intervention description(s): one drop in the conjunctival sac of each eye in the morning (84 days).; one drop in the conjunctival sac of each eye in the morning (84 days).
Intervention MeSH terms: Latanoprost
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Bilateral Glaucoma; Bilateral ocular hypertension; Bilateral primary open angle glaucoma; Bilateral ocular hypertension already treated and controlled by mono-therapy of Xalatan® (1drop per day); With local intolerance signs in at least one eye
Effects of Inspiratory Muscle Training in Patients With Pulmonary Hypertension
Condition: Hypertension, Pulmonary
MeSH terms: Hypertension, Pulmonary; Respiratory Aspiration; Hypertension
Study type: Interventional

Summary: 
      This study aims to determine the possible effects of inspiratory muscle training on
      cardiovascular, respiratory, physical and psychosocial functions in patients with PH.
    

Detailed description: 
      Pulmonary Hypertension (PH) is a hemodynamic finding related to increase in pulmonary artery
      pressure. Because PH disease is a progressive, rare disease, it is important for this disease
      group to prolong the life span and to increase the quality of life and functional capacity.
      PH patients have been shown to have weakness in peripheral and respiratory muscles.

      Patients will be randomly assigned to the inspiratory muscle training and control group.
      Inspiratory muscle training will be initiated in accordance with the patient at a range of
      40-60%. İnspiratory muscle training will be given based on the assessments by the
      physiotherapist. Patients with PH who come to the routine outpatient clinic and volunteer
      will be included in the study. The first session will be the evaluation session and the
      8-week inspiratory muscle training will be given, the other group will be the control group
      only. Dyspnoea, diaphragm thickness, pulmonary function, respiratory and peripheral muscle
      strength, blood pressure, arterial stiffness, physical activity, anxiety, depression and
      quality of life assessments will be repeated before and after the treatment.
    

Intervention name(s): Inspiratory muscle training
Intervention type(s): Other
Intervention description(s): The treatment group will receive inspiratory muscle training.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: pulmonary hypertension; inspiratory muscle training; muscle weakness
Six Month Clinical Trial Assessing Efficacy And Safety Of Inhaled Insulin In Type 1 Diabetes Mellitus.
Condition: Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 3

Summary: 
      To determine, in subjects with Type 1 Diabetes Mellitus:

        1. Whether glycemic control can be achieved at least as effectively with an insulin regimen
           involving pre-meal inhaled insulin plus a single bedtime Ultralente injection as with a
           conventional subcutaneous insulin regimen involving 2-3 mixed Regular/NPH insulin
           injections per day.

        2. The toleration and safety of inhaled insulin therapy and its effects after 6 months, if
           any, on measures of pulmonary function.
    


Intervention name(s): Inhaled human insulin
Intervention type(s): Drug
Intervention MeSH terms: Insulin; Insulin, Globin Zinc
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Klinefelter Fertility Preservation
Condition: Klinefelter Syndrome
MeSH terms: Klinefelter Syndrome; Syndrome
Study type: Interventional

Summary: 
      Klinefelter syndrome occurs in 1 in 600 males and is a common cause of infertility in men. It
      appears scar tissue forms in these boys' testicles, leading to progressive destruction over
      their lifetimes. Advanced reproductive technology can be used to surgically retrieve sperm
      from these individuals, but these methods have a 50% failure rate in adult Klinefelter
      patients. Younger men have higher success rates, suggesting that adolescence and young
      adulthood may be the best time to extract sperm, but these techniques have not been studied
      in Klinefelter patients younger than 26 years of age. Additionally, there is currently no way
      to predict which Klinefelter patients will have success with these methods and which of them
      will not. This trial will explore sperm extraction in Klinefelter syndrome in an age range
      (12-25 years) that has never been studied, with the ultimate hope of improving the potential
      for fertility in these patients. The specific goals of this study are to determine the ideal
      age for sperm retrieval in Klinefelter patients and to establish factors that can be used to
      predict which of these patients will have a higher likelihood of success with advanced
      reproductive technology. The hypothesis is that younger Klinefelter patients will have higher
      sperm retrieval rates.
    


Intervention name(s): Testicular Biopsy
Intervention type(s): Procedure
Intervention description(s): Micro-dissection testicular sperm extraction for sperm retrieval
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Klinefelter; Fertility
The Pharmacokinetics and Potential Health Effects of Champagne Wine in Human Subjects
Condition: No Condition. Assessment of Healthy Volunteers.
Study type: Observational

Summary: 
      -  To assess whether acute, moderate Champagne wine consumption modulates endothelial
           function in healthy human volunteers.

        -  To establish the bioavailability of Champagne wine polyphenols and their metabolism.
    

Detailed description: 
      Subjects refrained from consuming high polyphenol foods for 48 h prior to the start of the
      study and for 32 h post initiation. In particular, the following foods and beverages were
      excluded from volunteer diets: cocoa containing products, coffee, tea and wine. The study was
      designed as a single blind, randomized, crossover intervention trial, where volunteers were
      asked to consume either 375 ml of Champagne wine or a placebo matched for alcohol content,
      sugars and fruit-derived acids. Subjects were assessed for anthropometric measurements and
      provided a urine sample prior baseline Laser Doppler Imaging with iontophoresis (LDI)
      measurements. Subjects were then cannulated and a baseline blood sample was collected.
      Subjects were then randomly assigned to either the Champagne wine or placebo group and asked
      to consume the beverage within a 10 min period. Following a standardised breakfast blood
      samples were collected at: 15, 30, 45, 60, 120, 180, 240, 300, 360 and 480 minutes post
      consumption and pooled urine samples were collected over 3 x 8 h periods. A standardised
      breakfast and lunch were also consumed at 15 and 200 minutes post beverage. LDI measurements
      were carried out at 120, 240, 360 and 480 minutes. Subjects also provided 24 h and 32 h blood
      and urine samples. Following a washout period of 28 days, volunteers returned to the unit to
      complete the second arm of the study where the procedure above was repeated.
    

Intervention name(s): Champagne wine intervention
Intervention type(s): Other
Intervention description(s): Placebo-controlled randomised cross-over human trial
Other intervention name(s): Non applicable
Sampling method: Probability Sample
Study population: 
        Healthy volunteers
      
Biospecimen description: 
      plasma serum urine
A Clinical Trial of Patients With Solid Tumours Receiving Granulocyte Colony Stimulating Factor as Primary Prophylaxis for Chemotherapy-induced Neutropenia, in a Docetaxel Based Regimen
Condition: Neoplasms (no Otherwise Specified)
MeSH terms: Neutropenia
Study type: Interventional
Phase: Phase 4

Summary: 
      Primary Objective:

      To evaluate the incidence and severity of neutropenia in patients being treated for solid
      tumours with a Taxotere® based regimen when Granocyte® 34 is being used as a primary
      prophylaxis for chemotherapy-induced neutropenia.

      Secondary Objectives:

      Haematological : To evaluate the incidence and severity of febrile neutropenia (with or
      without antibiotics) and anaemia in patients being treated for solid tumors treated with a
      Taxotere based regimen when Granocyte is being used as a primary prophylaxis.

      Non-Haematological : To evaluate the incidence and severity of the following adverse events:
      asthenia, anorexia, myalgia, nail changes and oral mucositis in patients with solid tumours
      treated with a Taxotere based regimen; when Granocyte is being used as a primary prophylaxis.
    


Intervention name(s): LENOGRASTIM (GRANOGYTE 34)
Intervention type(s): Drug
Intervention description(s): Pharmaceutical form: solution Route of administration: intravenous Dose regimen:recommended dosing as per Granocyte 34 package insert
Intervention MeSH terms: Lenograstim
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Optimization of Time-of-Flight Mass Cytometry (CyTOF) Analysis for Evaluation of Immune Changes Following Surgery
Condition: Surgical Trauma
MeSH terms: Wounds and Injuries
Study type: Observational

Summary: 
      Surgical trauma triggers a massive inflammatory response. Over time, both the innate and
      adaptive branches of the immune system are affected by surgical trauma. The purpose of this
      study is to use a single cell flow cytometry approach to characterize the cellular and
      molecular mechanisms involved in the inflammatory response to surgical trauma.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Generally healthy patients undergoing back surgery
Pharmacokinetic and Drug Interaction Study of Red Yeast Rice Capsules
Condition: Healthy Volunteer
Study type: Interventional
Phase: Phase 4

Summary: 
      Red yeast rice capsule (LipoCol Forte)is a nature product that has been demonstrated a
      significant cholesterol lowering effect which might be caused by addictive and/or synergistic
      effects of lovastatin (monacolin K) with other monacolins and substances in capsules. The
      usual dose of red yeast rice capsule(LipoCol Forte)for hypercholesterolemia is one capsule
      twice/day.

      However, the pharmacokinetic profile of red yeast rice capsule (LipoCol Forte)is still
      unknown.

      The objective of the study is to evaluate the pharmacokinetic profile of red yeast rice
      capsule (LipoCol Forte) after administering single and multiple dose to healthy subjects.
    

Detailed description: 
      This study will divide into two groups, single and multiple doses groups. In single dose
      group, the subjects will receive one, two and four red yeast rice capsules under fed state in
      period one to three, respectively. In multiple doses group, the subjects will receive red
      yeast rice capsules under fed state twice daily for 4.5 days. There is a minimum of a 5-days
      washout period before crossover of treatments.

      In single dose treatment, the blood samples will be drawn prior to the dosing, and 0.5, 1,
      1.5, 2, 2.5, 3, 4, 6, 8 and 12 hours after the dosing.

      In multiple doses treatment, the blood samples will be drawn prior to the 1st dosing, prior
      to the 7th dosing, prior to the 8th dosing, prior to the 9th dosing, and 0.5, 1, 1.5, 2, 2.5,
      3, 4, 6, 8 and 12 hours after the 9th dosing.
    

Intervention name(s): LipoCol Forte
Intervention type(s): Drug
Intervention description(s): Single dose of one, two and four 600 mg red yeast rice capsules (LipoCol Forte) Multiple dose of 600 mg red yeast rice Capsules (LipoCol Forte)twice daily for 4.5 days
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Red yeast rice; Lovastatin; Drug-drug interaction; Pharmacokinetics
Prescribing Practice of Medication - Patient View.
Condition: Focus: Prescribing Practice
Study type: Observational

Summary: 
      In the clinical routine of a hospital, there are often problems dealing with medication that
      has already been prescribed at the time of admission due to incomplete or missing medication
      lists from the family doctor. Often patients forget this list at home.

      This pilot study focuses on the medication process from admission to discharge and patient
      health literacy.
    


Intervention name(s): Survey and Interviews
Intervention type(s): Other
Intervention description(s): Survey and Interviews
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        100 patients in the primary care clinic
Effects of Weekly Hippotherapy Frequency on Children With Cerebral Palsy
Condition: Cerebral Palsy
MeSH terms: Cerebral Palsy
Study type: Interventional

Summary: 
      The hippotherapy is considered a therapeutic modality that provides numerous benefits in the
      rehabilitation process and has often been recommended by doctors for children with cerebral
      palsy. Despite being in frank ascent, this therapy still lacks scientific evidence.
      Objectives: To analyze and compare the effects of hippotherapy program, often 1 or 2 days a
      week in gross motor function, trunk balance and functional performance of children with
      cerebral palsy.
    

Detailed description: 
      Study characterized by a controlled experiment with a sample of 24 children, aged between 2
      and 4 years, were randomly divided into control group (CG), with 9 participants, with the use
      of 1 to week and experimental group, also with 11 participants, 2 times a week intervention.
      The call followed protocol and took place once or twice a week lasting 30 minutes.
    

Intervention name(s): Hippotherapy once a week; Hippotherapy twice a week
Intervention type(s): Other; Other
Intervention description(s): Hippotherapy once a week; Hippotherapy twice a week
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: hippotherapy Gross Motor Function Functional performance.