bioihbjkbjnl/mcl2 huggingface dataset:
RTA 408 in the Treatment of Advanced Solid Tumors (NSCLC & Melanoma) - DISCOVER
Condition: Metastatic or Incurable Non-small Cell Lung Cancer; Relapsed, Refractory Melanoma
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Melanoma
Study type: Interventional
Phase: Phase 1

Summary: 
      This proposed first-in-human study (408-C-1303) is designed to assess the safety, maximum
      tolerated dose, pharmacodynamics, and pharmacokinetics of omaveloxolone (RTA 408) in patients
      with advanced solid tumors that are refractory after standard of care therapy for the
      disease. The results of this study will help provide clinical information for the design and
      conduct of further clinical studies with RTA 408 in cancer patients.
    

Detailed description: 
      Study Sponsor, originally Reata Pharmaceuticals, Inc., is now Reata Pharmaceuticals, Inc., a
      wholly owned subsidiary of Biogen.
    

Intervention name(s): omaveloxolone
Intervention type(s): Drug
Other intervention name(s): RTA 408 Capsules
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: RTA 408; RTA 408 Capsules; Non-small cell lung cancer; Metastatic non-small cell lung cancer; Incurable non-small cell lung cancer; Refractory melanoma; Relapsed melanoma
Comparison And Outcomes Of Fluid Resucitation With 0.9% Normal Saline And 5% Albumin In Cirrhosis Patients With Sepsis Induced Hypotension
Condition: Cirrhosis With Septic Shock
MeSH terms: Liver Cirrhosis; Hypotension; Fibrosis
Study type: Interventional

Summary: 
      300 consecutive patients with cirrhosis of any aetiology admitted with features of sepsis and
      sepsis induced hypotension to the intensive care unit, the emergency department and the step
      down units of Institute of Liver and Biliary Sciences, New Delhi, who fulfil the inclusion
      criteria.

      This study will be a single centre prospective randomized comparative trial. Patients will be
      randomized into two groups. Group A will receive crystalloid, 0.9% sodium chloride solution
      (total of 30ml/kg over 30 minutes) and Group B will receive colloid, 5% albumin (250 ml over
      15 minutes).
    


Intervention name(s): 5% albumin Infusion; 0.9% sodium chloride solution
Intervention type(s): Drug; Drug
Intervention description(s): colloid, 5% albumin (250 ml over 15 to 30 minutes).; 0.9% sodium chloride solution (total of 30ml/kg over 15 to 30 minutes)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Ph II Cabazitaxel DD Liposarcoma
Condition: Dedifferentiated Liposarcoma
MeSH terms: Liposarcoma
Study type: Interventional
Phase: Phase 2

Summary: 
      Soft tissue sarcomas (STS) are a rare group of malignant heterogenous tumors (> 50
      histological subtypes, including liposarcoma, the commonest subtype of STS) with distinct
      genetic, pathological and clinical profiles, and varying patterns of tumor spread. The
      optimal cytotoxic treatment for this group of patients remains uncertain. Single agents which
      are most effective include doxorubicin and ifosfamide, but objective response rates and
      progression-free survival times remain modest. There is clearly a need to improve treatment
      options for liposarcoma. Eribulin, a antimicrotubule agent that targets the protein tubulin
      in cells, interfering with cancer cell division and growth , has demonstrated activity in
      STS. Therefore, it is reasonable to explore whether other anti-microtubule agent like
      cabazitaxel have a role in STS. Cabazitaxel has been shown to be a relatively safe, effective
      and tolerated. This drug has been approved by FDA for prostate cancer. The main objective of
      this trial is to determine whether cabazitaxel demonstrate sufficient antitumor activity for
      liposarcoma.
    


Intervention name(s): Cabazitaxel
Intervention type(s): Drug
Other intervention name(s): Jevtana
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: dedifferentiated liposarcoma; cabazitaxel
Effect of Vitamin D on Metabolic Profile in Overweight or Obese Women
Condition: Overweight; Obesity
MeSH terms: Overweight
Study type: Interventional
Phase: Phase 3

Summary: 
      The investigators investigated the effect of vitamin D3 supplementation on metabolic profile
      (anthropometric measures, blood pressure Lipids, lipoproteins and glycemic indices) in
      overweight or obese women.
    

Detailed description: 
      Vitamin D deficiency is a worldwide health problem and is determined as a risk factor in
      Cardiometabolic disorders including Cardiovascular disease, Metabolic syndrome, and type 2
      diabetes mellitus. The investigators investigated the effect of vitamin D3 supplementation on
      metabolic profile in overweight or obese women.

      A double blind randomized clinical trial was conducted in 77 premenopause overweight or obese
      women. Participants were classified into two groups : vitamin D supplementation [1000 IU/day
      as cholecalciferol tablets (n=39)] or placebo (n=38). Vein blood samples were taken after at
      least 12 hours overnight fasting. Selected anthropometric measures, blood pressure Lipids,
      lipoproteins and glycemic indices were measured at baseline and after 12 weeks. Body fat mass
      was determined using BIA. Also the investigators assessed dietary intake using 24 hours food
      recall and semi-quantitative food frequency and physical activity using IPAQ questionnaires.

      The investigators conducted the study between October 2009 and March 2010 at the Medical
      school, Tehran, Iran. Recruitment began in October 2009 via advertisements and was terminated
      in October 2009. The investigators excluded patients with a history of Cardiovascular
      disease, Liver disease, Gastrointestinal disease, Kidney disease, diabetes mellitus, and
      Osteoporosis. Moreover, pregnancy, lactation, vegetarianism, and intake of dietary
      supplements were the exclusion criteria.
    

Intervention name(s): Placebo; vitamin D
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): dosage form:lactose dosage: 25 micrograms frequency: every day duration: 12weeks; dosage form:cholecalciferol dosage: 25 micrograms (1000 International Unit) frequency: every day duration: 12weeks
Other intervention name(s): Lactose; Cholecalciferol
Intervention MeSH terms: Vitamin D; Cholecalciferol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Vitamin D; Metabolic profile; Overweight; Obesity
Intervention on Caregivers Caring for Patients Poststroke With Upper Limb Apraxia
Condition: Performance Anxiety; Emotional Stress
MeSH terms: Apraxias
Study type: Interventional

Summary: 
      The purpose of this study is to analyze the effects of a intervention on a specific health
      prevention/intervention program aimed at caregivers of mild and moderate patients post stroke
      with upper limb apraxia in comparison to a control group with a no specific formation in that
      kind of patients.
    

Detailed description: 
      Patients with Upper limb apraxia after stroke have severe problems to adapt their daily life.

      The upper limb apraxia syndrome affects the performance of skilled movements carried out by
      the upper limbs and provoke that many patients´activities have to be made by their main
      caregiver or carers.

      Caregivers usually have to occupy much time and efforts for caring their familiar or client,
      and it can result in a overload in different areas of the caregiver health.

      Few data are available on the effectiveness of interventions in caregivers that informally
      works with that kind of patients.

      The specific prevention health program is based on improving the awareness of the assistance
      that the caregivers provide, and knowing the process of the information that carer has to
      give to the patient while the patients have their activities made.
    

Intervention name(s): Program on specific prevention of health; Program on general prevention of health
Intervention type(s): Other; Other
Intervention description(s): The intervention will be centered in provide effective tools to manage each situation presented while a caregiver cares for patients poststroke with upper limb apraxia. Moreover, the workshops will be focused on the balance between the assistance provided by the caregiver and the improvement and the increase the autonomy and independence of the patients. Finally, we will provide skills and strategies to the caregiver for enhancing the environment adaptation of the patients.; The general health educative program will consist in an educational workshop for caregivers where they are taught the habitual guidelines to caring for patients in situation of dependency.
Other intervention name(s): Program of specific intervention for caregivers; Program on traditional intervention for caregivers
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Caregivers; Apraxias; Stroke; Cerebral Stroke; Rehabilitation; Pragmatic Clinical Trials as Topic
Efficacy and Safety of Levetiracetam in the Inpatient Treatment of Alcohol Withdrawal Syndrome
Condition: Alcohol Withdrawal Syndrome
MeSH terms: Syndrome; Substance Withdrawal Syndrome
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the efficacy and safety of levetiracetam for
      treating alcohol withdrawal syndrome (AWS) in inpatients (vs. placebo). The primary come-out
      parameter is the reduction of the total needed amount of diazepam for add-on treatment of
      acute alcohol withdrawal symptoms. The secondary come-out parameter are - safety criteria
      (AE) - reduction of alcohol withdrawal score over the days.
    


Intervention name(s): Levetiracetam; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 1500-2000 mg daily add-on or Placebo Diazepam as needed; 1500-2000 mg daily add-on or Placebo Diazepam as needed
Other intervention name(s): KEPPRA
Intervention MeSH terms: Levetiracetam
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: alcohol withdrawal; detoxification; Inpatients; alcohol dependence according to DSM-IV/ICD-10; withdrawal symptoms
Dermacyd Delicata Pocket BR - Photo Evaluation
Condition: Healthy
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to prove the absence of photo irritation and photo sensitivity
      potential of the product Dermacyd Delicata Pocket BR.
    


Intervention name(s): Lactic acid (Dermacid)
Intervention type(s): Drug
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Hygiene
Potentiation of Trauma Exposure in Post-traumatic Stress Disorder by Repeated Transcranial Magnetic Stimulation
Condition: Stress Disorders, Post-Traumatic
MeSH terms: Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
Study type: Interventional

Summary: 
      The aim of this study is to assess the efficacy in PTSD treatment of concomitant voluntary
      reactivation of personal traumatic memories with neuromodulation of the right dorsolateral
      prefrontal cortex using 10Hz rTMS, compared to 1Hz rTMS, during 2 weeks.
    

Detailed description: 
      Post-Traumatic Stress Disorder (PTSD) is characterized by intrusive and persistent memory of
      past result from an event causing or able to cause death, be a threat of death, a severe
      injury or constitute a threat for physical integrity. It is a frequent disorder in general
      population (8%). In France, The most frequent traumatic events causing PTSD are serious
      accidents, rape, physical assaults, violence, etc. PTSD treatment involves antidepressant and
      cognitive and behavioural psychotherapy, which encourage exposure to elements that remind the
      trauma (memories, circumstances), with the objective of reducing the fear associated with the
      traumatic memories. Innovative therapeutic strategies aim to improve the psychotherapeutic
      effect with enhancement drugs or using neuromodulatory techniques, such as repeated
      transcranial magnetic stimulation (rTMS).

      The aim of this study is to assess the efficacy in PTSD treatment of concomitant voluntary
      reactivation of personal traumatic memories with neuromodulation of the right dorsolateral
      prefrontal cortex using 10Hz rTMS, compared to 1Hz rTMS, during 2 weeks.
    

Intervention name(s): rTMS 1Hz; rTMS 10Hz; psychoneurological assessment; conductivity meter; electrocardiogram
Intervention type(s): Device; Device; Behavioral; Device; Device
Intervention description(s): trauma exposure + repeated transcranial magnetic stimulation at 1Hz; trauma exposure + repeated transcranial magnetic stimulation at 10Hz; psychoneurological assessment; electrodermal conductance measure; heart rate measure
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Stress Disorders, Post-Traumatic; trauma exposure; Repeated transcranial magnetic stimulation
2940nm Er:YAG Laser Versus Benzoyl Peroxide Gel for the Treatment of Inflammatory Acne
Condition: Acne Vulgaris
MeSH terms: Acne Vulgaris
Study type: Interventional

Summary: 
      Acne is one of the most common conditions that patients seek for help in dermatological
      clinic. Nowadays, conventional treatment including topical agents(retinoids, antibiotics
      ,antiseptics and keratolytic agents) and systemic agents( antibiotics and retinoids) give a
      satisfying result but not to every patient. Some patients are not well respond to
      conventional therapy while some patients are unable to tolerate side effects of the
      treatments. Therefore, interventions to reduce acne are vigorously experimented . Lights and
      lasers including intense pulsed light, pulsed dye laser with or without photosensitizer and
      infrared lasers have been found to be useful in treating active inflammatory acne.
      Although,pain ,downtime and poor response of comedonal acne are limitations of those lights
      and lasers therapy. 2940 nm Erbium:YAG laser which has both resurfacing and photothermal
      effects is our laser of interest to seek for its efficacy in the treatment of inflammatory
      acne.
    


Intervention name(s): 2940 nm Er:YAG laser (DualisXS M002-2A, Fotona®, Fotona d.d, Ljubljana, Slovenia); Benzoyl Peroxide gel
Intervention type(s): Device; Drug
Intervention description(s): 2 passes of 2940nm Er:YAG laser; 2.5% benzoyl peroxide gel apply twice daily on inflammatory acne on the control side of face
Other intervention name(s): DualisXS M002-2A, Fotona®, Fotona d.d, Ljubljana, Slovenia; 2.5% benzoyl peroxide gel
Intervention MeSH terms: Benzoyl Peroxide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: acne vulgaris
Euglycemic Clamp Dose-response Study Comparing a New Insulin Glargine Formulation With Lantus®
Condition: Type 1 Diabetes Mellitus
MeSH terms: Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 1

Summary: 
      Primary Objective:

      - To assess the total metabolic effect ratios of a new insulin glargine formulation versus
      Lantus®

      Secondary Objectives:

        -  To assess the exposure ratios of a new insulin glargine formulation versus Lantus®

        -  To compare the duration of action of a new insulin glargine formulation versus Lantus®

        -  To explore the dose response and dose exposure relationship of a new insulin glargine
           formulation

        -  To assess the safety and tolerability of a new insulin glargine formulation
    

Detailed description: 
      The study period for one patient is one month in average and it can last up to 11 weeks
      broken down as follows:

        -  Screening: 3 to 28 days

        -  Treatment period: 1 to 4 days: 2 days (1 overnight stay)

        -  Washout period: 5 to 18 days (preferentially 7 days between consecutive dosings)

        -  End of study: 1 day after the last dosing
    

Intervention name(s): Insulin glargine (HOE901); Insulin glargine (HOE901)
Intervention type(s): Drug; Drug
Intervention description(s): Pharmaceutical form: Lantus solution for injection
Route of administration: subcutaneous; Pharmaceutical form: New insulin glargine formulation solution for injection
Route of administration: subcutaneous
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Glargine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
A Single-Dose Study in Normal Volunteers to Assess the Safety, Tolerability and Pharmacokinetics of STX107
Condition: Fragile X Syndrome
MeSH terms: Fragile X Syndrome
Study type: Interventional
Phase: Phase 1

Summary: 
      The objectives of this study are to determine the safety and tolerability of single oral
      doses of STX107 and to determine basic pharmacokinetic (PK) parameters following single oral
      doses of STX107 when administered via an oral suspension
    


Intervention name(s): STX107
Intervention type(s): Drug
Intervention description(s): Single dose of an oral suspension
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Safety and Efficacy of a Lysophosphatidic Acid Receptor Antagonist in Idiopathic Pulmonary Fibrosis
Condition: Idiopathic Pulmonary Fibrosis
MeSH terms: Pulmonary Fibrosis; Idiopathic Pulmonary Fibrosis; Fibrosis
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine if study drug (BMS-986020) dose of 600 mg once
      daily or 600 mg twice daily for 26 weeks compared with placebo will reduce the decline in
      forced vital capacity (FVC) and will be well tolerated in subjects with idiopathic pulmonary
      fibrosis (IPF).
    


Intervention name(s): BMS-986020; Placebo matching with BMS-986020
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: IPF
Cold Press Test and Post Operative Pain Relationship
Condition: Post-operative Pain, Acute; Pain Threshold
MeSH terms: Pain, Postoperative; Acute Pain
Study type: Interventional

Summary: 
      The goal of this clinical trial is to investigate whether it is possible to get a preliminary
      idea about the postoperative pain in the patient with the results of a practical cold press
      test applied to American Society of Anesthesiologists(ASA) 1 and 2, healthy, male patients
      aged 16-35 before extraction of the lower third molar. The main question it aims to answer
      are:

      • Can post-operative pain be predicted with an cold test that can be applied more practically
      than conventional quantitative sensory tests applied preoperatively? Participants will need
      to keep their hands on ice for 240 seconds prior to third molar surgery. When they take their
      hands off the ice, they will be asked to describe their pain on the visual analog scale.
      After the operation, the participants are required to mark whether they use painkillers every
      8 hours in their pain follow-up forms and the pain they feel according to the visual analog
      scale.

      Depending on the endurance time of the participants to keep their hands on the ice; Two
      different groups were determined as less than 240 sec and equal to 240 sec. The pain scores
      and the amount of painkiller use between these two groups were compared with each other.
    


Intervention name(s): Mandibular Third Molar Surgery
Intervention type(s): Procedure
Intervention description(s): All surgical procedures were carried out by a single dental(maxillofacial) surgeon different from the clinician performing the cold testing. A total of 4 cc of local anesthetic solution containing 40 mg/ml articaine and 0.005 mg/ml epinephrine was applied to the inferior alveolar and buccal nerve blocks before the surgical procedure. In all cases, the mucoperiosteal flap was raised and bone was removed from the buccal and distal parts of the impacted tooth with burs, while protecting the papilla between the first and second molars during flap design. Before extraction, if necessary, the third molar was divided and tooth extraction was performed with elevators. The flap was brought to its original position and closed with silk suture material.
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: Single (Investigator)
Primary purpose: Diagnostic
Keywords: Cold Pressor Test; Post-operative Pain; Mandibular Third Molar
Cold Polypectomy Site Study
Condition: Colonic Polyps
MeSH terms: Colonic Polyps
Study type: Observational

Summary: 
      Removal of polyps at colonoscopy reduces colon cancer. Snare polypectomy is the conventional
      method for removal however the snared area after removal can occasionally appear uneven
      raising the possibility that complete removal has not occurred. The significance of this
      irregularity has not be studied. This study aims to separately sample the irregular area and
      determine the constituents while recording how frequently this occurs during routine
      colonoscopy and polypectomy. We hypothesize that the irregular areas are submucosal tissue
      and do not represent polyp tissue left behind.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients undergoing colonoscopy at a tertiary endoscopy unit.
      
Biospecimen description: 
      All polypectomy specimens were submitted for histopathological assessment as per clinical
      practice. The biopsy samples from the irregular areas were also submitted in the same
      fashion. All specimens are stored as per current clinical practice.
    
Keywords: polyp; colon; polypectomy; snare