bioihbjkbjnl/mcl2 huggingface dataset:
A Study of Intracellular Signaling in Muscle and Fat Cells During Ketosis
Condition: Ketoacidosis; Diabetes Mellitus Type 1
MeSH terms: Ketosis; Diabetes Mellitus, Type 1
Study type: Interventional

Summary: 
      Hypothesis

        1. To define whether stimulation of ATGL and suppression of G0/G1 switch gene occur in the
           initial phases of diabetic ketoacidosis and thus can be identified as the primary
           mechanisms behind this life threatening condition.

        2. Make a human model for studying ketoacidosis.

      The investigators plan to reduce in their regular insulin over night. In the morning we
      administer endotoxin, which together with a relative lack of insulin will initiate
      ketogenesis - a state of ketoacidosis. On another occasion strict glycemic control is imposed
      by means of intravenous insulin. The testing is done two separate days with at least 3 weeks
      in between and patients are admitted to hospital the evening before the day of testing. The
      investigators use isotopic tracers to determine metabolic fluxes and analyse fat (ATGL, G0/G1
      switch gene) and muscle biopsies.
    


Intervention name(s): LPS
Intervention type(s): Biological
Intervention description(s): LPS is endotoxin from gram negative bacteria. It is used scientifically to mimic infection lasting 4-8 hours.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Comparing Self Monitored Blood Glucose (SMBG) to Continuous Glucose Monitoring (CGM) in Type 2 Diabetes
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the use of SMBG and CGM for clinical decisions
      related to the management of type 2 diabetes. The secondary objective is to determine the
      benefit of using CGM for clinical diabetes management decision-making.
    

Detailed description: 
      This study involves the use of the following 2 glucose monitoring methods to measure your
      blood sugar (glucose) levels and help manage type 2 diabetes:

        1. Self Monitoring Blood Glucose (SMBG): blood glucose is measured 4-7 times each day using
           finger sticks and an blood glucose meter.

        2. Continuous Glucose Monitoring (CGM): blood glucose is measured continuously via the CGM
           device. This device has been approved for use by the U.S. Food and Drug Administration
           (FDA).
    

Intervention name(s): CGM Group; SMBG Group
Intervention type(s): Device; Device
Intervention description(s): Using CGM unblinded for 16 weeks versus fingersticks 4 to 7 times a day to evaluate which is more beneficial in type 2 diabetes.; Fingersticks 4 to 7 times a day to evaluate which is more beneficial in type 2 diabetes. Used CGM blinded once every four weeks.
Other intervention name(s): DexCom SevenPlus CGM; AccuChek Aviva blood glucose meter; AccuChek Aviva blood glucose meter; DexCom SevenPlus CGM
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Type 2 Diabetes; Continuous Glucose Monitoring
A Study to Evaluate the Efficacy and Safety of PF-06882961 in Adults With Obesity
Condition: Obesity
MeSH terms: Obesity
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this clinical trial is to learn about the safety and effects of the study
      medicine (called PF-06882961) for the potential treatment of obesity. The study will compare
      the experiences of participants taking the study medicine (PF-06882961) to those of
      participants who take placebo (a look- alike substance that contains no active study
      medicine). The aim is to measure the body's response to the study medicine, including any
      changes in participants' body weight, waist and hip measurements, how well they tolerate the
      study medicine, and to measure levels of the study medicine in participants' blood.

      This study is seeking participants who have obesity, who do not have diabetes and who have
      had a stable body weight and not participated in a formal weight loss program in the 90 days
      before the study. The study medicine or placebo will be taken as tablets by mouth 2 times a
      day (1 time in the morning and 1 time in the evening).

      There are 3 groups of participants (called cohorts) in this study. For participants in
      Cohorts 1 and 2, total study participation will be about 9 months, with 15 planned study
      visits (14 visits to the study clinic and 1 telephone call). For participants in Cohort 3,
      total study participation will be about 10 months, with 21 planned study visits (12 visits to
      the study clinic and 9 telephone calls).
    


Intervention name(s): Placebo (Cohorts 1 and 2); PF-06882961 (Cohorts 1 and 2); Placebo (Cohort 3); PF-06882961 (Cohort 3)
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 4 matching placebo tablets taken twice daily; Participants will be randomized to one of 5 active target dose levels (40, 80, 120, 160 or 200 mg BID) achieved through 1-week titration steps, or 3 active target dose levels (120, 160 or 200 mg BID) achieved through 2-week titration steps, taking 4 tablets twice daily; 2 matching placebo tablets taken twice daily; Participants will be randomized to one of 3 active target dose levels (80, 140 or 200 mg BID) achieved through 4-week titration steps, taking 2 tablets twice daily.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Weight loss
Efficacy and Safety of Ertapenem Sodium (MK-0826) Following Colorectal Surgery in Chinese Adults (MK-0826-056)
Condition: Infection; Surgical Site Infection
MeSH terms: Infections; Communicable Diseases; Surgical Wound Infection
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the efficacy and safety of ertapenem sodium compared
      with ceftriaxone sodium/metronidazole for the prophylaxis of surgical site infection
      following elective colorectal surgery in Chinese adults. This study is designed to
      demonstrate that ertapenem sodium is non-inferior to ceftriaxone sodium/metronidazole in this
      participant population.
    


Intervention name(s): ertapenem sodium; ceftriaxone sodium; placebo to metronidazole; metronidazole
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Ertapenem sodium 1 g administered IV as a single dose over 30 minutes within 2 hours prior to the initial surgical incision; Ceftriaxone sodium 2 g administered IV as a single dose over 30 minutes within 2 hours prior to the initial surgical incision; Placebo (0.9% sodium chloride) administered IV as a single dose over 30 minutes within 2 hours prior to the initial surgical incision; Metronidazole 500 mg administered IV as a single dose over 30 minutes within 2 hours prior to the initial surgical incision
Other intervention name(s): MK-0826; INVANZ®; Rocephin®; Flagyl®
Intervention MeSH terms: Metronidazole; Ceftriaxone; Ertapenem
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Colorectal surgery
TK-based Suicide Gene Therapy for Hepatocellular Carcinoma
Condition: Carcinoma, Hepatocellular
MeSH terms: Carcinoma; Carcinoma, Hepatocellular
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine whether activation of a prodrug after intratumoral
      gene transfer is safe in humans, and to determine dose levels for further clinical
      development.
    

Detailed description: 
      The study is a phase I clinical trial evaluating the intratumoral injection of defective
      adenovirus containing HSVtk (the thymidine kinase of herpes simplex virus), in patients with
      advanced hepatocellular carcinoma that were not amenable to curative therapy. The study was
      conducted in a single center in Spain. Five consecutive cohorts of two patients received
      increasing doses of the vector by intratumoral injection and equal doses of either
      intravenous ganciclovir or oral valganciclovir. The dose received by each consecutive cohort
      of patients was progressively higher according to a prefixed scale.
    

Intervention name(s): TK99UN
Intervention type(s): Genetic
Intervention description(s): escalated dosis from 2x10e10 to 2x10e12 viral particles injected intratumorally
Other intervention name(s): Adenoviral vector encoding for HSV-TK
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: primary liver cancer, hepatoma
Clinical Observation of Pulsed Dye Laser and Intense Pulsed Light in Treating Facial Telangiectasia
Condition: Telangiectasia
MeSH terms: Telangiectasis
Study type: Interventional

Summary: 
      1. Facial telangiectasia is one of the common skin vascular lesions characterized by
           dilated cutaneous vasculatures in the skin surface or mucous membranes. Lesions are
           generally sensitive to exposure of cold, heat and sun. Those distinct small dilated
           blood vessels are cosmetically disfiguring for patients which require an effective
           solution. The traditional management options for facial telangiectasia include
           cryotherapy, CO2 laser, topical agent, oral estrogens, electrosurgery, and radioactive
           treatment. However, inadequate outcomes and severe adversaries are the major concerns to
           patients and physicians.

        2. Pulsed dye laser (PDL) is effective for vasodilatory diseases, especially for the
           superficial to middle layers of the dermis.

           The intense pulsed light source is an alternative or supplement to the already existing
           laser devices that are part of the laser surgeon's repertoire. The broad wavelength
           spectrum and variable pulse duration allow greater penetration depths to be reached
           without damaging surrounding tissue and thus enhance the versatility of this system.

        3. This study aims to compare the clearance efficacy of facial telangiectasia using PDL
           (595nm) with IPL configured by various wavelength bands, including M22 vascular filter
           (530-650nm and 900-1200nm), M22 560 (560-1200nm), M22 590 (590-1200nm) .
    

Detailed description: 
      Detailed Description has not been entered.
    

Intervention name(s): Pulsed dye laser
Intervention type(s): Device
Intervention description(s): PDL (Vbeam perfecta, 595 nm, Candela Corporation, Wayland, MA) was used with energy dosages of 9-11J/cm2, pulse durations of 10ms/20ms, and 7 or 10 mm handpieces with dynamic cooling device (DCD).
IPL device (M22, Lumenis Limited, Yokneam, Israel) with integration of sapphire ChillTip system for epidermal cooling were used in the study. Three wavelength bands were configured: 560-1200 nm, 590-1200 nm, and vascular wavelength bands of 530-650nm and 900-1200nm. All the treatment handpieces had a spot size of 15mm×35mm, fluence of 9-17J/cm², pulse duration of 4.0-6.0ms and pulse delay of 20-40ms, underwent the M22 advanced optimal pulse technology (AOPT) treatment.
Other intervention name(s): Intense pulsed light
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Facial Telangiectasia; Pulsed dye laser (PDL); Intense Pulsed Light
A Dose-range Finding Study of MAA868 in Patients With Atrial Fibrillation
Condition: Atrial Fibrillation
MeSH terms: Atrial Fibrillation
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is a multicenter, randomized, subject and Investigator-blinded,
      placebo-controlled, parallel-group, multiple ascending dose-ranging study to evaluate the
      safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) effects of MAA868 in
      patients with atrial fibrillation (AF) or flutter at low risk of thromboembolic stroke or
      peripheral embolism.
    


Intervention name(s): MAA868 Cohort 1; MAA868 Cohort 2; MAA868 Cohort 3; Placebo
Intervention type(s): Biological; Biological; Biological; Other
Intervention description(s): Subcutaneous injection: low dose; Subcutaneous injection: high dose; Subcutaneous injection: Dose to be determined.; Subcutaneous injection: Placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: atrial fibrillation; flutter; paroxysmal atrial fibrillation; stroke; cardiac arrhythmia
A Study to Assess Efficacy, Safety of KAE609 in Adult Patients With Acute Malaria Mono-infection
Condition: Cure Rate
MeSH terms: Malaria
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will assess efficacy, safety , tolerability and PK in uncomplicated adult malaria
      patients with acute P. falciparum infection after single dose with KAE609 at 75 mg, 150mg,
      225mg and 300mg/day
    

Detailed description: 
      the study is comprised of 4 sequential cohorts, in total there will be up to 48 patients
      enrolled in the study.

      cohort 1: 6-12 patients receive 75mg single dose. cohort 2: 6-12 patients receive 150mg
      single dose. cohort 3: 6-12 patients receive 225mg single dose. cohort 4: 6-12 patients
      receive 300mg single dose. After approximately every 6 patients in any cohort have been
      treated with a given dose and complete the first 15 days, a safety and tolerability data
      review will be conducted by a Data Monitoring Committee(DMC). Consensus agreement of DMC is
      required to either escalate to the next dose level or expand a given cohort with an
      additional 6 patients in order to obtain more safety data.
    

Intervention name(s): KAE609; KAE609; KAE609; KAE609
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): KAE609 75mg single dose; KAE609 150mg single dose; KAE609 225mg single dose; KAE609 300mg single dose
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: parasitemia
Relative Bio-availability Study of Dolutegravir and Lamivudine Fixed Dose Combinations
Condition: Infection, Human Immunodeficiency Virus
MeSH terms: Acquired Immunodeficiency Syndrome; HIV Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      Dolutegravir (DTG) and lamivudine (3TC) are indicated in combination with other
      antiretroviral agents for the treatment of human immunodeficiency virus type 1 (HIV-1)
      infection. Fixed dose combination (FDC) tablets of existing approved drugs are preferred by
      many patients and offer the potential for increased patient adherence and consequently a
      reduced likelihood of virological failure and viral resistance.

      The purpose of the present study is to evaluate the relative bioavailability of two
      experimental FDC tablets of DTG and 3TC relative to co-administration of the single entity
      products in healthy adult subjects.

      This study will be conducted as a randomized, open label three-way, crossover design with 6
      treatment sequences in approximately 30 subjects. Each subject will have a screening visit
      within 30 days prior to the first dose of study drug, three treatment periods each with a
      single dose of study drug and a follow-up visit within 7-14 days after the last dose of study
      drug. There will be at least 7 days washout between dosing periods. The total duration of
      participation of a subject in this study will be approximately 9 weeks.
    


Intervention name(s): Dolutegravir 50 mg tablet; Lamivudine 300 mg tablet; Dolutegravir/Lamivudine 50 mg/300 mg Tablet (Product Code AA); Dolutegravir/Lamivudine 50 mg/300 mg Tablet (Product Code AB)
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): A white, film-coated, round tablet debossed with SV 572 on one side and 50 on the other side. Single dose of one tablet will be administered with 240 mL of water.; Gray, diamond-shaped tablet, engraved "GX EJ7" on one side and plain on the other side. Single dose of one tablet will be administered with 240 mL of water.; Immediate release oval tablet embossed 'gsk' on one face with white film coat. Single dose of one tablet will be administered with 240 mL of water.; Immediate release oval tablet embossed 'gsk' on one face with white film coat. Single dose of one tablet will be administered with 240 mL of water.
Intervention MeSH terms: Lamivudine; Dolutegravir
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: dolutegravir; lamivudine; Bioavailability; fixed dose combinations
The Influence of Personal Care Products on the Skin Microbiome
Condition: Microbiome
Study type: Interventional

Summary: 
      To evaluate whether personal care products shift the skin microbiome bacteria and diversity
      after a week of daily use.
    

Detailed description: 
      Studies have shown that microbiome is important in skin conditions such as eczema, rosacea,
      acne, and many other skin conditions. Personal care products are widely used on a daily basis
      but it is not know how these personal care products shift the skin's microbiome. The
      diversity of the skin microbiome is important in the maintenance of skin equilibrium as a
      loss of diversity predisposes to development of skin disease.

      The aim of this study is to evaluate multiple over the counter products that are used on the
      face daily to assess how they alter skin microbiome and diversity of microflora on skin after
      a week of daily treatment.

      A second aim of the study is to assess how baseline diversity of microbiome are different
      based on self-graded skin types.
    

Intervention name(s): Burt's Bees Serum; Burt's Bees Serum with Biulin; Burt's Bees Serum with Bonicell; Burt's Bees Serum with Berenew Complex; Burt's Bees Serum with Ecoskin
Intervention type(s): Other; Other; Other; Other; Other
Intervention description(s): This is a commercially available over-the-counter product. Ingredients: Caprylic/ Capric Trigylceride, Isopropyl Palmitate, Sweet Almond Oil, Lanette O, Water, Cetearyl Glucoside, Gluconolactone ans Sodium Benzoate, Water, Glycerin, Xanthan GUM, Tocopherol.; This is a commercially available over-the-counter product. Ingredients: Caprylic/ Capric Trigylceride, Isopropyl Palmitate, Sweet Almond Oil, Lanette O, Water, Cetearyl Glucoside, Gluconolactone ans Sodium Benzoate, Water, Glycerin, Xanthan GUM, Tocopherol, PreBIULIN FOS (GOVA).; This is a commercially available over-the-counter product. Ingredients: Caprylic/ Capric Trigylceride, Isopropyl Palmitate, Sweet Almond Oil, Lanette O, Water, Cetearyl Glucoside, Gluconolactone ans Sodium Benzoate, Water, Glycerin, Xanthan GUM, Tocopherol, Bonicel (Ganaden).; This is a commercially available over-the-counter product. Ingredients: Caprylic/ Capric Trigylceride, Isopropyl Palmitate, Sweet Almond Oil, Lanette O, Water, Cetearyl Glucoside, Gluconolactone ans Sodium Benzoate, Water, Glycerin, Xanthan GUM, Tocopherol, BeRenew CLR Complex (CLR).; This is a commercially available over-the-counter product. Ingredients: Caprylic/Capric Triglyceride, Dimer Dilinoleyl Dimer Dilionoleatem, Silica, Citronellyl Methylcrotonate, Tocopheryl Acetate, Xymenynic Acid, Alpha-glucan Oligosaccharide, Fragrance, Slareolide, Polymnia sonshifolia root juice, Helianthus annuus (sunflower) seed oil, Maltodextrin, Tocopherol, Beta-sitosterol, Lactobacillus, Squalene.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Psychosocial Intervention in Assisted Reproduction Treatments
Condition: Infertility Primary; Psychosocial Stressor; Anxiety Depression
MeSH terms: Infertility; Depression
Study type: Interventional

Summary: 
      The aim of the study was to evaluate and compare different strategies of psychosocial
      intervention for patients undergoing IVF treatment in a private fertility clinic. Recruited
      patients were assigned to one of three groups: group intervention, couple intervention or no
      intervention (control group). Three main variables were assessed: depression, anxiety and
      life quality.
    

Detailed description: 
      A total of 87 couples have participated in this study. All couples were about to start an
      assisted reproduction treatment (artificial insemination or in vitro fertilization). Couples
      were assigned to one of three study groups: group intervention, couple intervention or no
      intervention (control group). Patients in the first group (group intervention) attended six
      group psychotherapy sessions. Patients in the second group attended six psychotherapy
      sessions (particular sessions in this case). The patients in the third group received no
      psycho-social intervention. Assignation to each group was not randomized, it depended on
      scheduling availability of the patients. Patients attended one session every week or 15 days.
      Each session lasted 90 minutes. Sessions were designed to minimize the possible negative
      psycho -social impact of infertility and its treatment. Different aspects were approached in
      these sessions including emotion expression, social coping, communication skills, emotion
      management in different social situations, identification of dysfunctional thoughts,
      cognitive restructuring, and cognitive distortions. The outcomes measured were: anxiety,
      depression, life quality, coping and perceived social support. These variables were assessed
      before ART, after ART and in a follow-up performed six months after ART. Psychological
      variables were assessed using different well-recognized inventories.
    

Intervention name(s): Group psychosocial intervention; Couple psychosocial intervention
Intervention type(s): Other; Other
Intervention description(s): Several couples attended a total of six group psychotherapy sessions conducted by a psychologist. Between 4 and 7 couples were treated in each group session.; The couple attended a total of six psychotherapy sessions conducted by a psychologist. Each couple was attended particularly.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Assisted Reproduction Treatment (ART); Psychology; Psychosocial intervention; Depression; Anxiety; Life quality