bioihbjkbjnl/mcl2 huggingface dataset:
Reliability and Validity of the Turkish Version of the Laval
Condition: Obesity; Quality of Life
MeSH terms: Obesity
Study type: Observational

Summary: 
      The study is a Turkish validity and reliability study of the Laval questionnaire.
    

Detailed description: 
      the study was planned as a student's master thesis. the whole study was carried out by us.
      all evaluations were completed. all analyses were completed. It is an observational study. It
      is a survey study.The study data were entered retrospectively.

      Research İzmir Bayraklı District Health Directorate No. 1 Healthy Life Centre (1 October 2021
      - 15 November 2021) and Gaziemir Municipality (15 November 2021 - 15 March 2022) was
      conducted. Dokuz Eylül University Ethics Committee accepted the study on 22.12.2021 with the
      decision number 2021/38-08. People with Body Mass Index ≥ 30 kg/m2 and who met the
      inclusion/exclusion criteria were included in the study. In addition to the Laval
      Questionnaire, the SF-12 general health quality of life questionnaire and the Obese-Specific
      Quality of Life Scale were used. For the adaptation of the Turkish version of the
      questionnaire, first, language validity was ensured by back translation method.
    

Intervention name(s): questionnare; questionnare; questionnare
Intervention type(s): Other; Other; Other
Intervention description(s): laval questionnare; Obese-Specific Quality of Life; SF-12 Quality of Life scale
Observational model: Ecologic or Community
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        body mass index (BMI) ≥ 30 kg/m2
      
Keywords: obesity; quality of life; validity and reliability
Using Ambu Aura-i Laryngeal Mask Airway in Cranial Surgery
Condition: Hypertension, Malignant; Airway Management
MeSH terms: Hypertension; Hypertension, Malignant
Study type: Observational [Patient Registry]

Summary: 
      the investigators hypothesize that Ambu aura-i LMA can be used safely in patients undergoing
      craniotomies and are effective in reducing the incidence of emergence hypertension.
    

Detailed description: 
      In this study the investigators want to assess the safety of using SGA devices in cranial
      surgery and comparing the effect of these devices with ETT regarding hemodynamics stability
      throughout the procedure and intracranial tension.
    

Intervention name(s): Ambu aura-i LMA
Intervention type(s): Device
Intervention description(s): The ETT or the LMA will be inserted with the patient's head position is aided either by pins or head rest, and either the head will be in neutral position or tilted as long as the airway device is successfully placed.
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        patients aged from 18 to 60 years presented with brain lesions undergoing craniotomies
        under general anaesthesia in supine position.
      
Keywords: Hypertension; airway; Laryngeal Mask Airway
Ultrasonography vs Conventional Methods for Prediction of Difficult Airway in Adult Patients
Condition: Difficult Intubation
Study type: Observational

Summary: 
      The aim of this study to assess and compare between methods of prediction of difficult airway
      including Mallmpati score , thyromental distance and us measured distance from skin to
      epiglottis(DES) t the level of thyrohyoid membrane in adult patients requiring endotracheal
      intubation for an elective surgical procedure.
    


Observational model: Other
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients at Benha University Surgical Hospital scheduled for elective surgical procedures
        requiring endotracheal tube
Safety of Intramuscular Injection of Allogeneic PLX-PAD Cells for the Treatment of Critical Limb Ischemia
Condition: Peripheral Artery Disease; Peripheral Vascular Disease; Critical Limb Ischemia
MeSH terms: Vascular Diseases; Peripheral Arterial Disease; Chronic Limb-Threatening Ischemia; Peripheral Vascular Diseases; Ischemia
Study type: Interventional
Phase: Phase 1

Summary: 
      The The purpose of this study is to determine the safety of PLX-PAD single dose,
      Intra-muscular injection for the treatment of CLI patients.
    

Detailed description: 
      PLX-PAD are mesenchymal-like stromal cells derived from a full term placenta, termed PLX-PAD,
      and intended for the treatment of Critical Limb Ischemia
    

Intervention name(s): PLX-PAD IM injection
Intervention type(s): Biological
Intervention description(s): Single treatment; multiple injections
Allocation: Non-Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Peripheral Artery Disease; Peripheral Vascular Disease; Critical limb ischemia
A Study of Ocrelizumab in Comparison With Interferon Beta-1a (Rebif) in Participants With Relapsing Multiple Sclerosis
Condition: Relapsing Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Interventional
Phase: Phase 3

Summary: 
      This randomized, double-blind, double-dummy, parallel-group study will evaluate the efficacy
      and safety of ocrelizumab in comparison with interferon beta-1a (Rebif) in participants with
      relapsing multiple sclerosis. Participants will be randomized to receive either ocrelizumab
      600 mg or matching placebo intravenous (IV) as 300 mg infusions on Days 1 and 15 for the
      first dose and as a single infusion of 600 mg for all subsequent infusions every 24 weeks,
      with placebo injections matching interferon beta-1a SC three times per week; or interferon
      beta-1a 44 mcg SC injections three times per week (with placebo infusions matching
      ocrelizumab infusions every 24 weeks).
    


Intervention name(s): Interferon beta-1a; Ocrelizumab-matching placebo; Ocrelizumab; Interferon beta-1a-matching placebo
Intervention type(s): Drug; Drug; Drug; Drug
Other intervention name(s): Rebif; RO4964913
Intervention MeSH terms: Interferons; Interferon-beta; Interferon beta-1a; Ocrelizumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Bioequivalence Study of Ibandronate Sodium Tablets 150 mg Under Fasting Condition
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This is an open label, randomised, balanced, two-treatment, two-period, two-sequence,
      crossover, oral bioequivalence study.
    

Detailed description: 
      Open-Label, Balanced, Randomized,Two-Treatment, Two-Sequence, Two-Period, Single-Dose,
      Crossover Oral Bioequivalence Study Of Ibandronate Sodium 150 mg Tablets Of Dr. Reddy's
      Laboratories Limited, India And 'BONIVA®' 150 mg (Ibandronate Sodium)Tablets Of Roche
      Laboratories Inc., USA In Healthy, Adult, Human Subjects Under Fasting Conditions (With As
      Many Postmenopausal Women As Possible).
    

Intervention name(s): Ibandronate sodium
Intervention type(s): Drug
Intervention description(s): Ibandronate sodium Tablets 150 mg
Other intervention name(s): Boniva
Intervention MeSH terms: Ibandronic Acid
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Bioequivalence; Ibandronate Sodium; crossover
Use of USG in Difficult Airway in Obese
Condition: Obesity
MeSH terms: Obesity
Study type: Observational [Patient Registry]

Summary: 
      Introduction and Purpose: Obesity is an increasing public health problem all over the world.
      Obesity is a proinflammatory multisystemic disease defined as hypertrophy and/or hyperplasia
      of adipose tissue. Obesity is frequently encountered in elective and emergency surgical
      procedures and causes more difficulties in airway management. Difficult airway, characterized
      by difficult mask ventilation and difficult intubation, is especially common in obese and
      morbidly obese patients. Some studies show that the measurement of anterior neck soft tissue
      thickness at the level of the vocal cords plays an important role in estimating difficult
      laryngoscopy in obese patients. Difficult intubation is envisaged in patients with
      pretracheal soft tissue thickness of 28 mm and neck circumference of more than 50 cm at the
      level of the vocal cord.

      In this prospective observational study, it is aimed to measure the preoperative anterior
      cervical soft tissue thickness with 3 parameters by USG in obese patients undergoing elective
      surgery, and to evaluate the relationship of these values with the Han Scale and
      Cormack-Lehane classification and their effectiveness as an indicator of difficult airway.
    

Detailed description: 
      Materials and Methods: 157 patients who will undergo elective surgery under general
      anesthesia, ages between 18-80, BMI ≥ 30 kg/m2, ASA I-II were included in the study. During
      the preoperative evaluation, patients' gender, age, height, weight, type of surgery, BMI,
      neck circumference, thyromental distance (TMM), sternomental distance (SMM), hyomental
      distance (HMM), neck extension, mouth opening and distance between incisors were measured and
      tooth structure was evaluated. OSAS was evaluated based on the ASA physical condition score
      and AHI. Mallampati Classification was recorded. Upper lip bite test was performed.
      Ultrasonographic measurements were made with the patient in the supine position and the head
      and neck in a neutral position. The Han Scale was used to evaluate difficult mask
      ventilation. The laryngoscopy image was evaluated and recorded with the Cormack-Lehane
      Classification, and ≥2b was accepted as difficult laryngoscopy.
    

Intervention name(s): Ultrasound
Intervention type(s): Other
Intervention description(s): Measurement of the airway by ultrasound in obese patients.
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        obese elective surgery patients
      
Keywords: obesity ultrasound difficult airway
IlluminOss Hand Fracture International Clinical Feasibility Study
Condition: Orthopedic Fractures
MeSH terms: Fractures, Bone
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the initial safety and technical feasibility of the
      IlluminOss System in the treatment of fractures of bones in the hand.
    


Intervention name(s): IlluminOss device
Intervention type(s): Device
Intervention description(s): The IlluminOss™ Bone Stabilization System is designed to deliver the device to the fracture site via the medullary canal of the bone using percutaneous techniques. Once the device is in place and has spanned the fracture site, the device is expanded and hardened to reduce and stabilize the fracture, to aid in the support and healing of the bone fracture by primary callous formation and remodeling.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Phase 2 Multi-center Study of Anti-PD-1 During Lymphopenic State After HDT/ASCT for Multiple Myeloma
Condition: Multiple Myeloma
MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell
Study type: Interventional
Phase: Phase 2

Summary: 
      Multiple myeloma (MM) is a common incurable blood cancer causing debilitating symptoms-bone
      pain, kidney failure, low blood counts and infection. Chemotherapy outcomes are disappointing
      due to short-term response and long-term toxicities.

        1. Studies showed these patients have weak immune against MM due to the immune checkpoint
           mediated by the PD1/PD-L1 interaction between immune cells and MM. Anti-PD-1 antibody
           (anti-PD1) disrupts this interaction, thus unleashing immune cell function and leading
           to killing of MM cells.

        2. Studies further showed enhancement of this "unleash" after autologous transplant and
           better MM control by anti-PD1 when used after transplant.

        3. Anti-PD1 has been extensively studied in patients with other cancers. It is very safe
           and effective and has been FDA-approved. Complications are of mild degree and easy to
           manage successfully in out-patient setting. Severe complications are rare.

      Thus, investigators proposed an efficacy study of anti-PD1 treatment after transplant to
      improve MM treatment outcomes. This was a collaborative study with Medical College of
      Wisconsin (headquarter of Center for International blood and Marrow Transplant Research).
      Investigators hypothesized that anti-PD1 treatment would increase the MM response and the MM
      control duration when added to the standard MM treatment after transplant. Anti-PD1 was given
      at the dose and interval, which had been studied previously (200 mg intravenous injection
      every 3 weeks) between 2 weeks until 6 months after transplant. Subjects were monitored
      closely during and after anti-PD1 therapy until at least 1 year post transplant. Late
      complications were followed for 3 years.
    


Intervention name(s): Autologous Stem Cell Transplant; Melphalan; Lenalidomide; MK-3475
Intervention type(s): Procedure; Drug; Drug; Drug
Intervention description(s): 140-200 mg/m^2; 5-15 mg/day starting 45-90 days post-transplant; 200 mg/day every 3 weeks starting day +14 post-transplant for a total of 9 doses.
Other intervention name(s): Anti-PD-1; Pembrolizumab
Intervention MeSH terms: Pembrolizumab; Lenalidomide; Melphalan
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Multiple Myeloma; Anti-PD-1; Pembrolizumab; Post-transplant; Maintenance
Study of ORGN001 (Formerly ALXN1101) in Neonates, Infants and Children With Molybdenum Cofactor Deficiency (MOCD) Type A
Condition: Molybdenum Cofactor Deficiency, Type A
MeSH terms: Metal Metabolism, Inborn Errors
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      To evaluate the safety and efficacy of ORGN001(formerly ALXN1101) in neonate patients with
      MoCD Type A
    


Intervention name(s): ORGN001 (formerly ALXN1101)
Intervention type(s): Drug
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Molybdenum Cofactor Deficiency (MoCD); Molybdenum Cofactor (MoCo) biosynthesis; sulfite oxidase (SO); S sulfocysteine (SSC); xanthine oxidoreductase; aldehyde oxidase
Improvement in Physical Performance and Obesity Surgery in Patients Older Than 60 Years
Condition: Obesity
MeSH terms: Obesity
Study type: Interventional

Summary: 
      The main objective of this study is to compare the efficacy of two weight losing strategies
      (obesity surgery with gastric banding, and standard of care) on physical performance in
      elderly obese persons submitted to a physical training. Our hypothesis is that a
      surgery-induced weight loss in the context of a physical training (which is recommended in
      people 60-75 yrs losing weight) improves physical performance as compared to standard of care
      (3-5% weight loss).
    

Detailed description: 
      Randomized clinical trial; Single Blind A physical training is recommended in people above 60
      yrs. engaged in a weight-losing program, in order to prevent the impairment of physical
      performance. Therefore a physical training program (endurance and strength training) will be
      implemented for all subjects participating in the study, starting 1 month before
      randomization. It will last for 13 months. Patients will be randomized either in the surgical
      group (gastric banding under general anesthesia) or in the reference group (mild calorie
      restriction and coaching). Physical performance of patients is evaluated at screening,
      inclusion, at randomization, 6 and 12 months after randomization.
    

Intervention name(s): Gastric banding
Intervention type(s): Procedure
Intervention description(s): The bariatric procedure is a gastric banding under general anesthesia with all the centres using the same surgical procedure (harmonized by group meetings). The laparoscopic surgical procedure has been described. The ERAS protocol will be applied in each centre. The inflation of the band will follow the procedures described by 0'Brien. The patients will attend a group education session before surgery, during which the eating behaviour with a band will be explained and practiced. Then after surgery, the routine procedure is applied.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Randomized Clinical Trials; gastric banding; calorie restriction; SPPB; physical performance; elderly
Temsirolimus and Irinotecan for Treatment Resistant Patients With Metastatic Colorectal Cancer and KRAS Mutations
Condition: Metastatic Colorectal Cancer
MeSH terms: Colorectal Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to investigate the safety and efficacy of temsirolimus as a
      single drug, and of temsirolimus in combination with irinotecan in chemotherapy resistant
      patients with KRAS mutated colorectal cancer.
    

Detailed description: 
      Chemotherapy resistance is a major challenge in metastatic colorectal cancer (mCRC), and EGFR
      inhibitors have been introduced as 3rd line treatment to chemotherapy refractory patients.
      However, it has recently been established that response to treatment with irinotecan and
      cetuximab is confined to patients with wtKRAS tumors. Therefore, downstream targets are being
      proposed as potential inhibitors of the EGFR signalling in tumours with KRAS mutations. mTOR
      is a central intracellular signalling molecule and a rational approach for potential
      reversion of chemotherapy resistance in these patients.

      Preclinical data suggest that different solid tumors could respond to mTOR inhibitors and
      report on enhanced antitumor activity in combination with different traditional cytostatic
      drugs. Furthermore recent preclinical data suggest that mTOR inhibition may induce tumor
      reduction in colon cancer xenographs. Temsirolimus (CCI-779) has been widely investigated in
      different clinical settings and is presently registered for treatment of renal cell
      carcinomas. Furthermore, is has recently shown response in metastatic breast cancer patients,
      but at present there are no clinical data on efficacy or safety in metastatic colorectal
      cancer patients.

      The present study aims at investigating the safety and efficacy of monotherapy temsirolimus
      and a combination of temsirolimus and irinotecan in chemotherapy resistant, KRAS mutated
      colorectal adenocarcinomas.
    

Intervention name(s): Irinotecan; Temsirolimus
Intervention type(s): Drug; Drug
Intervention MeSH terms: Sirolimus; Irinotecan; Temsirolimus; MTOR Inhibitors
Primary purpose: Treatment
Keywords: KRAS mutation
Evaluating of Pharmacokinetic Profile of BCWP_C003 and Co-administration of Rosuvastatin and Metformin
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the pharmacokinetic Profile and Safety/Tolerability
      of BCWP_C003 compared to Co-Administration of Crestor 10mg and Glucophage XR 1000mg, and to
      evaluate the food effect of Pharmacokinetic profile of BCWP_C003 after administration.
    

Detailed description: 
      Clinical Trials to Evaluate the Pharmacokinetic Profiles and Safety/Tolerability of BCWP_C003
      Formulation compared to Coadministration of Rosuvastatin and Metformin SR Formulation, and to
      Evaluate the Effect of Food on the Pharmacokinetic Profile of BCWP_C003 after Single Oral
      Administration to Healthy Male Subjects.
    

Intervention name(s): Rosuvastatin; Metformin; BCWP_C003
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Participants will be co-administered a single oral dose of Rosuvastatin 10mg and Metformin SR 1000mg under Fed condition.; Participants will be co-administered a single oral dose of Rosuvastatin 10mg and Metformin SR 1000mg under Fed condition.; Participant will be administered a single oral dose of BCWP_C003 under Fasting condition or Fed condition according to sequence.
Other intervention name(s): Crestor 10mg(Rosuvastatin); Glucophage XR 1000mg(Metformin); Rosuvastatin and Metformin
Intervention MeSH terms: Metformin; Rosuvastatin Calcium
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: 6 x 3
Masking: None (Open Label)
Primary purpose: Supportive Care
Relative Bioavailability Study of Lipidil® Supra (Fenofibrate 160mg) Versus SYO-0805 (Fenofibrate 65mg)
Condition: Hyperlipidemia
MeSH terms: Hyperlipidemias
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the bioequivalence of Lipidil® Supra (fenofibrate
      160mg) versus SYO-0805 (fenofibrate 65mg) in single dose oral administration.
    


Intervention name(s): Sequence 1; Sequence 2; Seqeunce 3; Sequence 4; Sequence 5; Sequence 6
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): fenofibrate 65mg, fed condition, per oral → fenofibrate 65mg, fasting condition, per oral → fenofibrate 160mg, fed condition, per oral; fenofibrate 65mg, fed condition, per oral → fenofibrate 160mg, fed condition, per oral → fenofibrate 65mg, fasting condition, per oral; fenofibrate 65mg, fasting condition, per oral → fenofibrate 160mg, fed condition, per oral → fenofibrate 65mg, fed condition, per oral; fenofibrate 65mg, fasting condition, per oral → fenofibrate 65mg, fed condition, per oral → fenofibrate 160mg, fed condition, per oral; fenofibrate 160mg, fed condition, per oral → fenofibrate 65mg, fed condition, per oral → fenofibrate 65mg, fasting condition, per oral; fenofibrate 160mg, fed condition, per oral → fenofibrate 65mg, fasting condition, per oral → fenofibrate 65mg, fed condition, per oral
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment