bioihbjkbjnl/mcl2 huggingface dataset:
Study of a Steroid Delivery System for Pain Relief Treatment in Patients With Knee Osteoarthritis
Condition: Osteoarthritis, Knee
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine whether a longer duration, controlled, sustained
      release dexamethasone delivery system would be more effective in helping patients with
      osteoarthritis reduce their pain, remain functional, and delay their need for knee
      replacement.
    

Detailed description: 
      The objectives of the study are to assess the dexamethasone delivery system for:

        -  Safety and tolerability

        -  Efficacy

      Formal statistical analysis to compare treatment groups will not be performed due to the
      small number of participants in this pilot study. Summary statistics will be assessed using
      the short form of the knee injury and osteoarthritis outcome score (KOOS JR) surveys and
      questionnaires to assess pain intensity, pain medication consumption and wound assessment.
    

Intervention name(s): Dexamethasone
Intervention type(s): Drug
Intervention description(s): Sustained delivery system containing 5.0 mg of dexamethasone programmed to release an estimated 10 μg per day
Intervention MeSH terms: Dexamethasone
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Tipranavir/Ritonavir Low Dose Pharmacokinetics in Treatment Naive Patients
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to identify an optimal dose combination(s) of tipranavir (TPV)
      and ritonavir (RTV) for antiretroviral treatment naïve HIV-1 infected patients that can be
      used in pivotal trial by assessing the steady-state pharmacokinetics and short-term efficacy
      and safety
    


Intervention name(s): tipranavir; ritonavir
Intervention type(s): Drug; Drug
Intervention MeSH terms: Ritonavir; Tipranavir
Intervention model: Parallel Assignment
Primary purpose: Treatment
Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of RM-493 Administered to Healthy, Obese, Non-diabetic Volunteers
Condition: Overweight; Obese
MeSH terms: Overweight
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the multiple dose safety and tolerability of RM-493
      (setmelanotide) as well as pharmacokinetic (PK) and pharmacodynamic (PD; weight loss)
      profile, in healthy obese patients for 2 to 4 weeks. In addition, one panel of patients with
      a specific genetic deficiency in the hypothalamic leptin- proopiomelanocortin (POMC) -
      melanocortin-4 receptor (MC4R) pathway, those with heterozygous partial or full loss of
      function (LOF) of the MC4R gene, will also be studied. The study drug (RM-493 and placebo)
      will be administered subcutaneously in a blinded fashion by subcutaneous (SC) infusion or
      injection.
    


Intervention name(s): RM-493; Placebo
Intervention type(s): Drug; Drug
Other intervention name(s): setmelanotide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Heterozygous; MC4R deficiency; associated
A Study of ALG-055009 in Healthy Volunteers and Subjects With Hyperlipidemia
Condition: NASH - Nonalcoholic Steatohepatitis
MeSH terms: Fatty Liver; Non-alcoholic Fatty Liver Disease; Hyperlipidemias; Hyperlipoproteinemias
Study type: Interventional
Phase: Phase 1

Summary: 
      A Randomized Study of ALG-055009 Drug to Evaluate the Safety, Tolerability, Pharmacokinetics
      and Pharmacodynamics of Single and Multiple Doses in Healthy Volunteers and Subjects with
      Hyperlipidemia
    


Intervention name(s): ALG-055009; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Single or multiple doses of ALG-055009; Single or multiple doses of Placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Study of MK-1029 in Participants With Persistent Asthma That Cannot Be Controlled With Montelukast (MK-1029-015)
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this trial is to compare the safety, tolerability, and efficacy of adding
      MK-1029 to montelukast in adults with persistent asthma that is uncontrolled while receiving
      montelukast alone. Participants will have a specific genetic marker for clinical efficacy of
      MK-1029. The primary hypothesis is that when added to montelukast, treatment with MK-1029 is
      superior to placebo, as demonstrated by an increase in forced expiratory volume in one second
      (FEV1), measured as the average change from baseline at the end of Week 4 and Week 6 of
      treatment.
    


Intervention name(s): MK-1029 150 mg; MK-1029 Matching-image Placebo; Montelukast 10 mg; Albuterol/Salbutamol 90 mcg - 100 mcg per inhalation
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 150 mg tablet administered orally, once a day (QD), at bedtime; Matching-image placebo tablet administered orally, QD, at bedtime; 10 mg tablet administered orally, QD, at bedtime; 1 or 2 inhalations 4 times a day (QID) as needed (PRN) as a Rescue Medication
Other intervention name(s): SINGULAIR®; Montelukast sodium
Intervention MeSH terms: Albuterol; Montelukast
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Cerebral Effects of Pegylated Interferon in Hepatitis C Positive Subjects
Condition: Hepatitis C
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis
Study type: Observational

Summary: 
      The hypothesis of this study is that pegylated interferon would cause cognitive deficits and
      mood changes in hepatitis C (HCV) positive subjects.
    

Detailed description: 
      Subjects with non-cirrhotic hepatitis C will have a magnetic resonance imaging (MRI)/magnetic
      resonance (MR) spectroscopy and neuropsychological testing prior to starting interferon.
      Subjects will have repeat testing following 12 weeks of interferon therapy and again at 12
      weeks post interferon therapy.

      MR spectroscopy (MRS) will measure the cerebral metabolites, NAA (N-acetyl aspartate), Cho
      (choline), MI (myoinositol) and Cr (creatine) at 3 distinct brain regions, i.e. basal ganglia
      and 2 locations within the frontal cortex.

      Neuropsychological testing will include tests of the following cognitive domains: executive
      functioning, memory, language, motor skills and will also include questionnaires pertaining
      to quality of life (SF-36), mood (Beck's depression inventory) and a self-rating cognitive
      questionnaire (Conners' Adult Attention Deficit Hyperactivity Disorder Rating Scales
      [CAARS]).

      Control subjects will include non-cirrhotic HCV subjects who are not taking interferon
      therapy.
    

Intervention name(s): MR brain and neuropsychiatric tests
Intervention type(s): Diagnostic Test
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        HCV positive patients Subjects with cirrhosis, active alcohol or drug abuse, co-infection
        with human immunodeficiency virus (HIV), structural brain abnormality, past history of
        cerebrovascular accident (CVA), serious head trauma, and seizure disorder were excluded.
        Other exclusions were contraindication to PIFN therapy, current psychiatric disorder or
        contraindications to MRI e.g., pacemaker and claustrophobia.
The Effect of a Web-Based Behavioral Intervention on Physical Activity Levels in Adolescents
Condition: Health Behavior; Adolescent Behavior; Motivation
Study type: Interventional

Summary: 
      The primary purpose of this study is to test whether rewarding physical activity with a
      motivational website will increase physical activity levels in middle school-aged children
      over six months. As a secondary outcome, the study also tests the intervention's impact on
      biological measures of inflammation and metabolic function in a sub-set of study participants
      who agree to provide blood samples.
    

Detailed description: 
      Physical activity is associated with a variety of positive health outcomes, as well as
      improved metabolic profiles and reduced inflammation. However, levels of moderate to vigorous
      physical activity (MVPA) diminish dramatically as children move into the middle school years.
      To address this problem, this study tests a behavioral intervention, called "Zamzee,"
      designed to motivate middle school-aged children to increase their levels of MVPA. The Zamzee
      intervention consists of a 3-axis accelerometer that tracks individual physical activity
      rates over time and a website that displays individual physical activity rates and provides
      rewards for maintaining or improving physical activity rates. The primary aim of this
      randomized, controlled trial is to test whether middle school-aged children randomly assigned
      to the Zamzee intervention will show significantly greater levels of physical activity levels
      over six months, compared with control group participants who wear the accelerometer but have
      no access to the rewards website. A secondary aim is to test the intervention's impact on
      biological parameters that may contribute to the long-term health effects of inactivity
      (including C-reactive protein as a measure of inflammation, and hemoglobin-A1C as a measure
      of metabolic status) in a sub-set of study participants who agree to provide blood samples.
    

Intervention name(s): Zamzee Intervention
Intervention type(s): Behavioral
Intervention description(s): The Zamzee intervention is designed to motivate middle school-aged children to increase their rates of moderate to vigorous physical activity (MVPA) by providing rewards based on amount and duration of physical activity. Rewards include gift cards to retail stores, donations to charity, small tangible goods, and customization of their cartoon-like avatars on the website.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Health Behavior; Exercise; Adolescent Behavior; Motivation; Biological Markers
A Prospective, Contralateral, Eye to Eye Comparison of SMILE Surgery to LASIK Surgery
Condition: Myopia
MeSH terms: Myopia
Study type: Interventional

Summary: 
      Subjects will undergo SMILE surgery in one eye and LASIK surgery in their other eye to
      correct myopia.
    

Detailed description: 
      Subjects will have a comprehensive eye examination once they express an interest in the
      study. This includes a slit lamp examination of the front of the eye and a dilated
      fundoscopic examination of the back of the eye. If there is any pathology noted that would
      exclude the subject from the study, then we will inform the patient and make an appropriate
      referral. if the subject is deemed appropriate for the study after a comprehensive
      examination included computerized videokeratography, then they can be enrolled. Subjects will
      undergo bilateral simultaneous eye surgery. Which eye is treated with the WFG-LASIK and which
      eye is treated with SMILE will be randomized so there is a 50% chance for either eye to
      receive one treatment. Subjects will be seen on the day of surgery, post op day one, one
      week, one month, three months, six months and one year. Subjects will receive topical
      antibiotics in each eye for one week following the procedure. Subjects will receive topical
      steroid ophthalmic drops for one week after treatment. Subjects will also receive topical
      antibiotic ophthalmic drops for four days after treatment. All of this is within the usual
      and customary standard of care for the treatment of subjects undergoing LASIK and SMILE
      surgery.
    

Intervention name(s): SMILE; LASIK
Intervention type(s): Procedure; Procedure
Intervention description(s): SMILE surgery; LASIK surgery
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: SMILE; LASIK; Myopia; Wavefront-guided
Healing Dynamics of Free Gingival Grafts; a Colorimetric and Volumetric Assessment
Condition: Free Gingival Graft
Study type: Interventional

Summary: 
      Gingival recession on vestibular surfaces of teeth is a frequent occurrence in patients with
      high standards of oral hygiene, affecting all types of teeth. During the last three decades,
      several surgical techniques have been proposed to treat single and multiple gingival
      recessions: pedicled flaps (laterally displaced (CDL) or coronally advanced (ACC) flaps),
      free gingival grafts (IGL), bilaminar techniques or procedures regenerative.
    

Detailed description: 
      One month before surgery, an interview and periodontal therapy (pre-surgical prophylaxis,
      oral hygiene instructions and brushing technique teaching) will be carried out.

      A digital scan of the arch with the teeth to be treated will be made before the surgery,
      during the surgery (recipient bed and with sutures), at 6 weeks, 3 months, 6 months and 1
      year.

      On the day of surgery, the recipient bed will be prepared and a free gingival graft will be
      taken from the palate to cover the exposed root surface or gain keratinized gingiva.

      In terms of aesthetics, morbidity and satisfaction will be evaluated through questions.

      At 6 weeks, 3 months, 6 months and 1year, the color of the gum will be evaluated using a
      spectrophotometer.
    

Intervention name(s): Free gingival graft technique
Intervention type(s): Procedure
Intervention description(s): A horizontal partial thickness incision will be trace at the MGJ to dissect the alveolar mucosa from the keratinized tissue. The alveolar mucosa will be dissected from the underlying periosteum to create an envelope of 4-5 mm apical to the bone dehiscence associated with the gingival recessions. The keratinized tissue coronal to the first incision and neighboring the recession will be de-epithelialized to expose the connective tissue and create a trapezoidal recipient bed having a large apical base at the MGJ and a narrower coronal base just coronal to the CEJ of the experimental units. The grafts will be taken from the palate.The grafts will be positionned with the coronal edge of the CEJ.
Interrupted sutures (6-0 polypropylene, prolene) will be positionned to stabilize the graft. Sling crossed sutures anchored to the periosteum apical to the graft and placed to ensure a tight adaptation of the graft to the root surface
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: FGG; Volume; Color
Predicting the Severity of Post-cesarean Wound Infections Using Serum Procalcitonin Levels
Condition: Wound Infection; Cesarean Wound Disruption
MeSH terms: Infections; Communicable Diseases; Wound Infection; Wounds and Injuries
Study type: Observational [Patient Registry]

Summary: 
      The serum procalcitonin levels are important during infections and sepsis. The investigators
      aimed to assess its predictive value in terms of post-cesarean wound infection.
    

Detailed description: 
      The serum procalcitonin levels are important during infections and sepsis. Recent studies
      showed that serum procalcitonin levels are more sensitive than serum CRP levels.The
      investigators aimed to assess its predictive value in terms of post-cesarean wound infection.
      The serum procalcitonin levels are aimed to measure in participants who had cesarean section
      and developed surgical site infection. The investigators aimed to compare the serum
      procalcitonin levels between the patients who need secondary suture and the patients who did
      not need secondary suture.
    

Intervention name(s): procalcitonin level
Intervention type(s): Other
Intervention description(s): serum procalcitonin level will be measured in both groups.
Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        The participants are post-cesarean patients who developed surgical site infections.
Activity at Ventilation Threshold on Appetite and Food Intake in Boys
Condition: Obesity Prevention
MeSH terms: Obesity
Study type: Interventional

Summary: 
      The investigators hypothesize exercise increases short term appetite and food intake, and
      interferes with satiety and satiations to a preload in normal weight, overweight and obese
      boys.
    

Detailed description: 
      The effect of exercise (EXR) on short-term food intake (FI) and subjective appetite was
      investigated in normal weight (NW), overweight (OW) and obese (OB) boys were randomized into
      4 treatments. Each boy consumed either a non-caloric sweetened control (CON) or GLU drink
      after either exercise (EXR) or sedentary activity. Subjects exercised at their ventilation
      threshold (VeT).
    

Intervention name(s): Dietary Supplement: water with noncalorie sweetener; Activity: With noncalorie sweetener or glucose
Intervention type(s): Other; Other
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: boys; obesity; physical activity; exercise
Study to Assess the Safety and Pharmacokinetics of CY6463 in Participants With Stable Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of this study is to evaluate the safety and tolerability of CY6463 when
      administered to participants with stable schizophrenia who are on a stable antipsychotic
      medication regimen
    


Intervention name(s): CY6463; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): oral tablets; oral tablets
Allocation: Randomized
Intervention model: Sequential Assignment
Intervention model description: Dose escalation study
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Cognitive Impairment Associated with Schizophrenia; CIAS; CY6463
A Study to Compare the Pharmacokinetics and Safety Between BR9004 and BR9004-1 in Healthy Male Volunteers
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      To compare the pharmacokinetics and safety between BR9004 and BR9004-1 in healthy male
      subjects after a single-dose administration while fasting.
    

Detailed description: 
      This is a randomized, open label, single dose, full replicated crossover study to compare the
      pharmacokinetics and safety between BR9004 and BR9004-1 in healthy male subjects under
      fasting conditions. To this end, subjects were divided into two sequence groups [Sequence A
      (TRTR) & Sequence B (RTRT), T: BR9004, single oral administration, R: BR9004-1, single oral
      administration].
    

Intervention name(s): BR9004; BR9004-1
Intervention type(s): Drug; Drug
Intervention description(s): BR9004: Abiraterone acetate 200mg, Boryung Pharmaceutical Co., Ltd.; BR9004-1: Zytiga Tab. 500mg (Abiraterone acetate 500mg), Janssen Korea
Other intervention name(s): Abiraterone acetate 200mg; Zytiga Tab
Intervention MeSH terms: Abiraterone Acetate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Impact of Mandibular Overdenture Base Construction Techniques on Assessment of Occlusion
Condition: Prosthesis Durability
MeSH terms: Prosthesis Failure
Study type: Interventional

Summary: 
      This within patient study will be conducted to compare between two different construction
      techniques (CAD-CAM Milled and Conventional techniques) of 4-implant-assisted complete
      mandibular overdenture bases regarding the digital occlusion force balance analysis using the
      OccluSense
    


Intervention name(s): CAD/CAM Complete denture
Intervention type(s): Device
Intervention description(s): four implant-supported CAD/CAM complete overdenture
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Intervention model description: According to the construction technique for the maxillary complete denture and mandibular overdentures, the patients will be classified randomly and equally into two groups.
Group I: patients receive maxillary complete denture opposed to four implant-assisted mandibular overdenture constructed with conventional method.
Group II: patients receive maxillary complete denture opposed to four implant-assisted mandibular overdenture constructed with CAD/CAM milling.
Masking: Single (Participant)
Primary purpose: Treatment
A Study of the Ability of Functional Magnetic Resonance Imaging (fMRI) to Detect and Characterize the Effects of Two Marketed Centrally Active Drugs, Placebo, and RO4917523 in Healthy Volunteers
Condition: Healthy Volunteer
Study type: Interventional
Phase: Phase 1

Summary: 
      This is an exploratory study to evaluate the usefulness of fMRI as a biomarker to
      characterize the response to three centrally active drugs and placebo.
    


Intervention name(s): RO4917523; escitalopram; methylphenidate; placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Oral single dose; Oral single dose; Oral single dose; Oral single dose
Other intervention name(s): Lexapro; Ritalin
Intervention MeSH terms: Methylphenidate; Escitalopram
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Diagnostic
Effects of GnRHa on Ovarian Function Against Chemotherapy-induced-gonadotoxicity
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 3

Summary: 
      This prospective randomized controlled study is conducted to analyze the effect of Goserelin
      on ovarian function in women with breast cancer in China.
    


Intervention name(s): GnRHa
Intervention type(s): Drug
Intervention description(s): 3.6mg subcutaneous injection every 28 days.Initiated 1-2 weeks before chemotherapy and ended 4-8 weeks after chemotherapy.
Other intervention name(s): goserelin
Intervention MeSH terms: Goserelin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: GnRHa; ovarian function; anti-mullerian hormone
Postoperative Cognitive Dysfunction: Correlations With Olfactory Dysfunction and Related Gene Changes
Condition: Postoperative Cognitive Dysfunction
MeSH terms: Postoperative Cognitive Complications; Cognitive Dysfunction
Study type: Observational [Patient Registry]

Summary: 
      To study on the Postoperative Cognitive Dysfunction: Correlations With Olfactory Dysfunction
      and Related Gene Changes.To explore whether the olfactory dysfunction could be used as a
      predictor of POCD and to provide reference for POCD prevention, early detection and timely
      diagnosis and treatment.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        We included 300 male and female patients undergoing non-cardiac surgery at the Affiliated
        Hospital of Xuzhou Medical University and 30 healthy volunteers.
      
Biospecimen description: 
      blood
    
Keywords: non-cardiac surgery; Postoperative Cognitive Dysfunction