bioihbjkbjnl/mcl2 huggingface dataset:
First-in-human Study to Assess Safety and Tolerability of a Single Subcutaneous Dose of SAR441255 in Lean to Overweight Subjects
Condition: Overweight; Healthy Subjects
MeSH terms: Overweight
Study type: Interventional
Phase: Phase 1

Summary: 
      Primary Objective:

      To assess the safety and tolerability of SAR441255 after ascending single subcutaneous (SC)
      doses

      Secondary Objectives:

      To assess the pharmacokinetic parameters of SAR441255 in plasma after ascending single SC
      doses

      To assess the pharmacodynamic effects on glycemic parameters (fasting and postprandial
      glucose, C-peptide and insulin)
    

Detailed description: 
      Study duration per participant is approximately 8 weeks including a 21-day screening and
      baseline phase, a 4-day treatment phase and a 28-day follow up period after dosing.
    

Intervention name(s): SAR441255; placebo
Intervention type(s): Drug; Drug
Intervention description(s): Pharmaceutical form:solution for injection
Route of administration: subcutaneous; Pharmaceutical form:solution for injection
Route of administration: subcutaneous
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Desogestrel for the Preoperative Treatment of Endometrioma Compared With Placebo
Condition: Endometrioma
MeSH terms: Endometriosis
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Use of the oral desogestrel compared with placebo for preoperative treatment of endometrioma
      in the patient who underwent to surgery in next 3 months The result will be evaluated on cyst
      diameter, the associated pain and side effect of the oral desogestrel.
    

Detailed description: 
      Use of the oral desogestrel compared with placebo for preoperative treatment of endometrioma
      in the patient who underwent to surgery in next 3 months in Rajvithi hospital Patient will
      randomized in 2 group : Desogestrel and placebo After 1 months and 3 months the patient have
      to come to hospital to evaluate the result of study The result will be evaluated on cyst
      diameter, the associated pain and side effect of the oral desogestrel.
    

Intervention name(s): Desogestrel Oral Tablet
Intervention type(s): Drug
Intervention description(s): Cerazette is the brand name of the desogestrel which contain of 0.075 mg of desogestrel
Other intervention name(s): Cerazette
Intervention MeSH terms: Desogestrel
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
A f-MRI Study Of Affective Changes Associated With Four Weeks Consumption Of A Fermented Dairy Product In Healthy Women
Condition: Healthy Adult Women
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the effect of a commercially available fermented
      dairy product containing probiotics (4 weeks, twice a day) on the brain activity within
      specific neural circuits regulating the subjective experience of emotional valence and
      digestive well-being.
    


Intervention name(s): 1-Fermented Dairy Product (test); 2-Milk-based non-fermented dairy product(control)
Intervention type(s): Other; Other
Intervention description(s): Arm 1 - Intervention 1 (probiotics); Arm 2 - Intervention 2 (control)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: probiotics; digestive well-being; fMRI; brain-gut axis
Pharmacokinetics/Pharmacodynamics of Albiglutide
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 2

Summary: 
      The first part of the study includes a single dose treatment period to evaluate the
      pharmacokinetic bioequivalence of a subcutaneous injection of albiglutide from process 2 drug
      substance compared with process 3 drug substance. The second part of the treatment period
      will evaluate additional pharmacokinetic and pharmacodynamic parameters and safety and
      tolerability of repeat doses of albiglutide given weekly for 12 weeks from process 2 drug
      substance compared with process 3 drug substance. Subjects with type 2 diabetes whose
      glycemia is inadequately controlled on their current regimen of diet and exercise or stable
      dose of metformin will be recruited into the study.
    

Detailed description: 
      This is a randomized, double-blind, multicenter, 2 parallel group study. The first part of
      the treatment period will evaluate the pharmacokinetic bioequivalence of a single dose of a
      subcutaneous injection of 30mg of albiglutide from process 2 drug substance compared with
      process 3 drug substance. The second part of the treatment period will evaluate additional
      pharmacokinetic parameters, pharmacodynamic parameters, immunogenicity, effects on
      glycosylated hemoglobin and fasting plasma glucose, and safety and tolerability of repeat
      doses of subcutaneous injections of 30mg of albiglutide given weekly for 12 weeks from
      process 2 drug substance compared with process 3 drug substance. Subjects with type 2
      diabetes whose glycemia is inadequately controlled on their current regimen of diet and
      exercise or stable dose of metformin will be recruited into the study.
    

Intervention name(s): albiglutide (GSK716155); albiglutide (GSK716155)
Intervention type(s): Biological; Biological
Intervention description(s): subcutaneous injection administered once a week; subcutaneous injection administered once a week
Other intervention name(s): process 2; process 3
Intervention MeSH terms: rGLP-1 protein; Glucagon-Like Peptide 1
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: pharmacokinetics; pharmacodynamics; GSK716155; albiglutide
Vital Signs Changes During Dental Procedures
Condition: Vital Signs Changes During Dental Procedures
Study type: Interventional

Summary: 
      The study will evaluate the vital signs changes during 3 different dental procedures
      performed for the same patient by the same dentist. The patients will be selected randomly
      and should all be healthy adults.

      The aim is to look for any significant changes in the major vital signs (heart rate,
      respiratory rate, blood pressure, peripheral capillary oxygen saturation (SpO2) and body
      temperature) during specified dental procedures (scaling, simple restoration, and simple
      exodontia) and compare the changes between the 3 procedures.
    


Intervention name(s): Scaling without LA; Simple restoration under LA; Simple exodontia under LA
Intervention type(s): Procedure; Procedure; Procedure
Intervention description(s): The patient will undergo a supragingival scaling procedure without local anesthesia; The patient will undergo a simple dental restoration procedure under local anesthesia; The patient will undergo a simple dental extraction procedure under local anesthesia
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: Double (Care Provider, Outcomes Assessor)
Primary purpose: Screening
Positive Surgical Margins Rate and EGFR Family Members Expression in Prostate Cancer Treated With Bicalutamide
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Following radical prostatectomy (RP), about 20% to 40% of the patients with prostate cancer
      (PCa) exhibit pathological parameters which are associated with a high risk of disease
      recurrence. The rationale for NHT is based on the theory that androgen ablation induces PCa
      apoptosis which induces a regression of the primary tumor bulk before RP. However the use of
      NHT prior RP is highly controversial. In spite of these unenthusiastic results, the relative
      short time of treatment and the use of different drugs from those utilized in other trials
      might still to make this regimen attractive in terms of drug related side effects and
      effectiveness. In this regard, Bicalutamide presents unique characteristics since it work
      differently respect to other anti-hormonal agents by interfering on both genotropic and
      non-genotropic mechanisms of androgen receptor
    


Intervention name(s): Bicalutamide
Intervention type(s): Drug
Intervention MeSH terms: Bicalutamide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single
The Effect of Acupressure on Labor Pain and Anxiety Levels During Labor in Primiparas Women
Condition: Labor Pain
MeSH terms: Labor Pain
Study type: Interventional

Summary: 
      the effect of acupressure on labor pain and anxiety levels during labor in primiparas women
    


Intervention name(s): acupressure; sham acupressure
Intervention type(s): Procedure; Procedure
Intervention description(s): Pressures were applied on three points consecutively, firstly on two points bilaterally Hugo point (LI4) and He-7 (Shenmen), then pressure was applied on sanyinjiao (SP6).
pressure was applied gradually for 30 seconds on the above mentioned points. Then this pressure was slowly intensified to the extent that the patient felt tingling, numbness, heaviness, and strain in the surrounding area.; Pressures were applied on sham points consecutively
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Supportive Care
DDI Study With Multiple-dose LX4211 and Single Dose Rosuvastatin
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will be conducted as a single-center, open-label, 2-period, single-sequence,
      drug-drug interaction study to assess the effects of multiple-dose LX4211 400 mg (2 × 200-mg
      tablets qd × 7 days) on the PK of single-dose rosuvastatin (1 × 10-mg tablet) in healthy male
      and female subjects.
    


Intervention name(s): Treatment A (rosuvastatin); Treatment B (LX4211); Treatment C (rosuvastatin + 400 mg LX4211 administered concomitantly)
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 10 mg rosuvastatin administered on Day 1 and Day 13; 400 mg LX4211 administered on Day 7 through Day 13; 10 mg rosuvastatin + 400 mg LX4211 administered concomitantly on Day 13
Intervention MeSH terms: (2S,3R,4R,5S,6R)-2-(4-chloro-3-(4-ethoxybenzyl)phenyl)-6-(methylthio)tetrahydro-2H-pyran-3,4,5-triol; Rosuvastatin Calcium
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Working Memory Training for Chronic Neuropathic and Fibromyalgia Pain
Condition: Working Memory Deficits; Neuropathic Pain; Fibromyalgia
MeSH terms: Fibromyalgia; Myofascial Pain Syndromes; Neuralgia; Memory Disorders
Study type: Interventional

Summary: 
      The goal of this project is to investigate and improve executive control function in two
      distinct pain conditions, namely neuropathic pain and fibromyalgia (FM). It is hypothesized
      that there is a significant difference in the executive control function of patients with
      neuropathic pain and FM pain. It is also hypothesized that all participants with poor
      executive control functioning will report significant improvements in pain intensity,
      functioning and cognitive complaints following cognitive training. The study tests and
      influence the working memory concepts of inhibition, updating and flexibility through an
      experimental, cross-over treatment design.

      To perform the experiment, we will recruit 160 participants (80 with neuropathic pain and 80
      with FM) from the Departments of pain management and research at St Olav's University
      Hospital and Oslo University Hospital (OUS). The proposed design will be able to determine
      whether or not executive control, processing speed and memory function differs in two
      distinct populations of pain patients. Moreover, whether impairments are amended by
      computerized training.
    


Intervention name(s): Working Memory Training; Internet use
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Training mental flexibility; Used as control for time spent on computer
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Pain; Working memory
Empagliflozin in Patients With Glomerulonephritis
Condition: Glomerulonephritis; Proteinuria
MeSH terms: Proteinuria; Glomerulonephritis
Study type: Interventional
Phase: Phase 3

Summary: 
      Sodium-glucose cotransporter 2 (SGLT2) inhibitors are newly developed antihyperglycemic
      medications. In addition to their glucose lowering properties, they have been shown to have
      favourable effects on the cardiovascular and renal outcome in patients with diabetes. one of
      the most interesting renal effects is reduction of proteinuria. The aim of our study was
      examine the effect of SGLT inhibitors on proteinuria in patients with glomerulonephritis.
      This study is a randomised controlled trial.
    

Detailed description: 
      Sodium-glucose cotransporter 2 (SGLT2) inhibitors are newly developed antihyperglycemic
      medications. In addition to their glucose lowering properties, they have been shown to have
      favourable effects on the cardiovascular and renal outcome in patients with diabetes.The
      favourable cardiovascular effects include increased diuresis , reduction of blood pressure
      and reduction of hospitalisation for heart failure one of the most interesting renal effects
      is reduction of proteinuria. The aim of our study was examine the effect of SGLT inhibitors
      on proteinuria in patients with glomerulonephritis. This study is a randomised controlled
      trial.
    

Intervention name(s): Empagliflozin 25 MG; placebo
Intervention type(s): Drug; Drug
Intervention description(s): single dose of the SGLT inhibitor Empagliflozin was given; single dose of placebo that is similar to Empagliflozin in physical appearance
Other intervention name(s): EMPA; PLAC
Intervention MeSH terms: Empagliflozin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: sodium glucose cotransporter inhibitors; Empagliflozin
A Study to Evaluate the Safety and Efficacy of PAC-14028 Cream in Pediatric Atopic Dermatitis
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This is a phase 1 and 2 study to assess the safety and efficacy of PAC-14028 cream in
      children with atopic dermatitis.
    


Intervention name(s): PAC-14028 Cream 0.1%; PAC-14028 Cream 0.3%; PAC-14028 Cream 1.0%; PAC-14028 Cream Vehicle
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Topical application; Topical application; Topical application; Topical application
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Pentoxyphilline Versus Fecal Microbiota Therapy in Severe Alcoholic Hepatitis
Condition: Alcoholic Hepatitis
MeSH terms: Hepatitis A; Hepatitis; Hepatitis, Alcoholic
Study type: Interventional

Summary: 
      Treatment for severe alcoholic hepatitis patients not eligible for steroid therapy is a
      dilemma. Pentoxyfilline has been shown to have no improvement in outcomes as per current
      studies and liver transplantation is with great risk of recidivism in this difficult to treat
      cohort of patients. Dysbiosis forms the central role in severe alcoholic hepatitis patients
      and modulation of gut microbiota by way of healthy donor fecal transplantation could prove to
      be a novel way to treating these patients who are ineligible for standard therapy. This study
      utilizes correction of dysbiosis in severe alcoholic hepatitis and surveys outcomes with the
      same with respect to survival and liver disease severity scores.
    


Intervention name(s): Pentoxiphylline; Stool microbiota transplantation
Intervention type(s): Drug; Drug
Intervention MeSH terms: Pentoxifylline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Post Thyroidectomy Endoscopic Laryngeal Examination :Is it Mandatory?
Condition: Thyroid
Study type: Observational [Patient Registry]

Summary: 
      Post thyroidectomy laryngeal nerve injuries are frequently encountered specially in total and
      near total thyroidectomy some unilateral injuries are not clinically evident and
      asymptomatic.

      The aim of this study is to compare mandatory versus selective post-thyroidectomy endoscopic
      examination of larynx to detect laryngeal nerve injuries.
    

Detailed description: 
      100 patients were randomly divided into two groups, group I for whom mandatory post
      thyroidectomy endoscopic laryngoscopic examination and the other group of only symptomatic
      patients selected for direct laryngoscopic examination.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        100 patients post thyroidectomy will be randomly divided into two groups group I for whom
        mandatory vedioscopic laryngeal examination is done while the other group II patients for
        whom no routine vedioscopic laryngeal examination done only if symptoms developed
      
Keywords: post thyroidectomy; laryngeoscopic examination
Cupping in Fibromyalgia
Condition: Fibromyalgia
MeSH terms: Fibromyalgia; Myofascial Pain Syndromes
Study type: Interventional

Summary: 
      The purpose of this randomized controlled study is to determine the effectiveness of cupping
      in patients with fibromyalgia compared to sham cupping.
    

Detailed description: 
      see above
    

Intervention name(s): Cupping therapy
Intervention type(s): Other
Intervention description(s): Cups are placed at the skin; local suction is created on the skin; it mobilizes blood flow; the suction is created by a mechanical device (Pneumatron, Pneumed, Germany)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Fibromyalgia; Cupping
Motor and Premotor Cortex Stimulation for Treatment of Secondary Focal Dystonia With Striato Palliadal Lesion : Evaluation of Safety and Effectiveness
Condition: Focal Dystonia
MeSH terms: Neoplasm Metastasis; Dystonia; Dystonic Disorders
Study type: Interventional
Phase: Phase 1

Summary: 
      Dystonia is a neurological movement disorder in which sustained muscle contractions cause
      twisting and repetitive movements or abnormal postures. This disease is very heterogeneous
      and can have many causes. Current treatments (drugs, pallidal stimulation) improve primary
      generalized dystonias; however they are ineffective for focal dystonias following brain
      damage.

      Cortex stimulation is a present and effective technique used in the treatment of chronic pain
      and could represent an interesting strategy to treat focal dystonias. This is the aim of the
      present study.
    

Detailed description: 
      Pilot study included 6 centres (Clermont-Ferrand, Bordeaux, Paris, Créteil, Lyon and
      Grenoble)

      Study progress :

        -  3 months to 1 month before chirurgical intervention : selection of patient that could be
           included in the protocol.

        -  15 days to 8 days before chirurgical intervention : inclusion visit.

        -  Operating phase : under anaesthesia, implantation of the neurostimulator and its
           components, and adjustment of stimulation parameters.

        -  1 month after chirurgical intervention : checking that all is fine (detection of
           undesirable events)

        -  2 months to 5 months after chirurgical intervention: randomization (double blind): the
           stimulator is put on position On or OFF

        -  5 months after chirurgical intervention : Stimulators of all patients are stopped for
           one month whatever the group they belong.

        -  6 months to 9 months after chirurgical intervention: Stimulatiors are put on position On
           or OFF (cross over with the first period).

        -  9 months to 13 months after chirurgical intervention: Stimulators of all patients are
           started for four months whatever the group they belong.

        -  13 months after chirurgical intervention : study end
    

Intervention name(s): Implantation of neurostimulators and their auxiliary components
Intervention type(s): Device
Intervention description(s): Implantation neurostimulators and their auxiliary components :
Stimulateur KINETRA TM modèle 7428, Electrode Resume II modèle 3587A, Extension kit DBS 7482
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Cortex stimulation; Focal secondary Dystonia; Effectiveness; Quality of life improvement; Focal dystonias secondary to central grey nuclei lesions
Feasibility Clinical Study of NLA Tool-US
Condition: Healthy
Study type: Observational

Summary: 
      The study is to evaluate the feasibility of the NLA tool, a combined assessment of
      nutritional and physical functional status, to provide personalized advice for the
      independence and mobility of elderly.
    

Detailed description: 
      -  Determining the proportion of elderly subjects who, according to the NLA result, would
           qualify for a personalized program to improve their nutritional and physical status;

        -  Determining the segmentation (defined by cut-off criteria) of these elderly subjects
           stratified into 3 NLA subgroups according to strength and endurance performance (33% +/-
           10% of target group)
    

Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Independently living men and women at 65-90 years old who are able to walk with or without
        walking aid
      
Biospecimen description: 
      No biospecimens are to be collected or retained.
    
Keywords: Independent living; walk with or without walking aids