bioihbjkbjnl/mcl2 huggingface dataset:
Improving Cesarean Section Experience Through Hypnotherapy
Condition: Cesarean Section; Pain; Anxiety
Study type: Interventional

Summary: 
      Cesarean section rates continue to increase worldwide, particularly in middle- and
      high-income countries. In France, the rate has now stabilized around 20 %. Cesarean section
      is a particular way of giving birth, sometimes desired, but sometimes feared. If some women
      do not feel affected by this way of giving birth, it is more difficult for others to live
      with. In this way, not being able to give birth trough natural way may be disturbing in
      motherhood. At La Rochelle hospital, more than 230 healthcare providers have been trained
      according to Erickson's hypnosis methodology. Among them, 40 are part of the anesthesia
      department and a committee oversees the hypnotherapist activities in pain management. The
      objective of the present study is to assess the benefit of hypnosis session for improving
      experience and reducing anxiety in women giving birth through surgery.
    

Detailed description: 
      Nonpharmacological approaches for pain management, either as a primary method or as a
      complement to pharmacological approaches, are suggested for a better perinatal management.
      The investigators assessed the use of conversational hypnotic induction and therapeutic
      suggestions during cesarean section as a complement to pharmacological strategy. Women giving
      birth through scheduled or unplanned cesarean section and who accepted hypnotherapy session
      were compared to a control group.
    

Intervention name(s): hypnosis
Intervention type(s): Other
Intervention description(s): Conversational hypnotic induction and therapeutic suggestions
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Efficacy of a New Delivery System for Beta-hydroxy-beta-methylbutyrate
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The proposed study will test efficacy of HMB in free acid gel to decrease muscle damage,
      diminish inflammatory response, and improve muscle strength recovery following an acute
      exercise stress. HMB in a free acid gel or in CaHMB capsule form will be administered as
      either a single dose before a bout of acute exercise or in multiple doses (one before and
      three daily doses for the 4 days following the acute exercise). We hypothesize that HMB in
      free acid gel will result in less muscle damage, diminished inflammatory response, and
      improved muscle strength recovery than either a placebo or CaHMB treatment following a bout
      of acute eccentric exercise. Our endpoints will include measurements of: (1) markers for
      muscle damage (CPK and LDH); (2) indicators of inflammation (CRP, TNF-α, IL-6, IL-1ra and
      IL-18); and (3) muscle strength recovery and soreness.
    


Intervention name(s): CaHMB; HMB Free Acid Gel; Placebo; Placebo Gel Dosage
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): CaHMB capsules with each capsule containing 0.8 g of HMB; HMB Free acid in a gel form with each dose supplying 0.8 g of HMB free acid; Placebo capsules similar in size and color to the CaHMB capsules used in the study; A corn syrup based placebo with flavoring and taste similar to the HMB Free Acid Gel
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Acute Exercise; Muscle Inflammation; CaHMB; HMB Free Acid Gel; Healthy Subjects
Study to Evaluate the Safety and Efficacy of ASC41 in Overweight and Obese Subjects
Condition: Overweight and Obesity; NAFLD; Hyperlipidemia
MeSH terms: Overweight; Hyperlipidemias; Hyperlipoproteinemias
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of this study is to evaluate the safety, tolerability and compare the
      pharmacokinetic parameters of ASC41, a THR beta agonist tables in overweight and obese
      subjects who have elevated LDL-C .
    


Intervention name(s): ASC 41; ASC 41 Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Oral tablets; Oral tablets
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Parallel Assignment 3:1 ratio
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Overweight and Obesity; NAFLD; Hyperlipidemia; LDL-C; NASH
Morphological Analysis of the Pineal Gland in Pediatric Retinoblastoma Patients Using Magnetic Resonance Imaging
Condition: Retinoblastoma; Pineoblastoma
MeSH terms: Retinoblastoma; Pinealoma
Study type: Observational

Summary: 
      MRI is useful for diagnosing pinealoblastoma in retinoblastoma patients
    


Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        pediatric patients with retinoblastoma
      
Keywords: retinoblastoma; pineoblastoma
A Study Comparing the Efficacy and Safety of the Morning Injection of Toujeo Versus Lantus in Patients With Type 1 Diabetes Mellitus
Condition: Type 1 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 4

Summary: 
      Primary Objective:

      To demonstrate that morning injection of Toujeo (HOE901-U300) compared to Lantus provides
      better glycemic control evaluated by Continuous Glucose Monitoring (CGM) in adult
      participants with type 1 diabetes mellitus.

      Secondary Objective:

      To demonstrate that treatment with HOE901-U300 compared to Lantus provides:

        -  Lower incidence rate of nocturnal symptomatic hypoglycemia;

        -  Better glucose control coverage during the last hours of CGM before next basal-insulin
           dosing;

        -  Less variability in CGM profile.
    

Detailed description: 
      The maximum study duration per participant was to be of approximately 20 weeks that consisted
      of an up to a 4-week screening and CGM training period including a 1-2 week baseline
      (blinded) CGM performance (allowed for re-training), a 14-week open-label, comparative
      treatment period allowing for dose titration in both basal and meal-time insulin and
      including a 1-2 week end-of treatment blinded CGM collection with fixed dose of HOE901-U300
      and Lantus, and a 2 day post treatment follow-up period.
    

Intervention name(s): HOE901-U300 (Insulin Glargine 300 U/ml); Lantus (Insulin Glargine 100 U/ml); Mandated back ground therapy
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Self-administered by subcutaneous (SC) injection in the morning (between waking up and breakfast) using a pre-filled pen.; Self-administered by subcutaneous (SC) injection in the morning (between waking up and breakfast using a pre-filled pen.; Rapid insulin analogs: e.g., insulin glulisine, insulin lispro or insulin aspart, used by participant at least 30 days before screening. Mealtime insulin was to be continued during the study and titrated towards protocol specified postprandial glucose targets (130-180 mg/dL).
Other intervention name(s): Toujeo; HOE901-U100
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Glargine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Open-Label Pilot Study of the Efficacy and Safety of Vusion Ointment for the Treatment of Intertrigo
Condition: Intertrigo
MeSH terms: Intertrigo
Study type: Interventional
Phase: Early Phase 1

Summary: 
      The purpose of this study is to determine if people with moist, red, patches on their skin in
      body folds would benefit treatment of those areas with an FDA-approved drug called Vusion.
    

Detailed description: 
      Intertrigo is an inflammatory condition of skin folds, induced or aggravated by heat,
      moisture, maceration, friction, or lack of air circulation. It is typically chronic with
      insidious onset of itching, burning, and stinging within the affected skin folds. Intertrigo
      frequently worsened or colonized by infection, which most commonly is candidal but also may
      be bacterial, fungal, or viral. The etiology of diaper dermatitis shows significant overlap
      with that of intertrigo. Vusion ointment, a highly effective treatment for diaper dermatitis,
      has been used by physicians for the treatment of intertrigo; however, there is a paucity of
      data in the literature regarding the use of Vusion ointment in this indication.

      This study is the first to formally investigate the efficacy and safety of Vusion ointment
      for the treatment of intertrigo.
    

Intervention name(s): Vusion
Intervention type(s): Drug
Intervention description(s): Vusion will be applied to areas of intertrigo
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Intertrigo; Vusion
Activity of Regorafenib in Combination With Chemotherapy in Patients With Advanced Biliary Tract Cancer
Condition: Digestive Cancer
MeSH terms: Biliary Tract Neoplasms
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This study is to determine the Regorafenib Dose (RD) for the phase II trial of Regorafenib
      administered in combination with mGEMOX in patients with advanced biliary tract cancer.
    

Detailed description: 
      Regorafenib (BAY 73-4506) was assessed in metastatic colorectal cancer in the phase III
      randomized CORRECT trial. 760 metastatic colorectal cancer patients were recruited after the
      failure of all standard therapies.

      Given the promising efficacy and favorable tolerability profile of mGEMOX and the potential
      benefits of targeting the VEGF and Ras/Raf pathway, we propose to assess the combination of
      Regorafenib with mGEMOX in advanced digestive cancer.

      This study is to determine the Regorafenib Dose (RD) for the phase II trial of Regorafenib
      administered in combination with mGEMOX in patients with advanced biliary tract cancer.

      The phase I study of Regorafenib in advanced colorectal cancer showed a pronounced
      interindividual variability of drug exposition. Furthermore, the CORRECT study shows a large
      pharmacological variability of plasma concentration for Regorafenib and its metabolites. In
      this study, we propose to explore the pharmacological variability and his potential
      heritability by the therapeutic drug monitoring of Regorafenib. The objective is to
      understand and to control the pharmacological variability of Regorafenib and finally to
      predict the therapeutic response or the toxicity, especially in a population of patients with
      biliary tract cancer.

      In addition, we will complete this study by exploring the gene variants of drug metabolism.
      The genes are POR (P450 OxidoReductase,) NR1I2 (Nuclear Receptor subfamily 1, group I, member
      2) and a part of the regulatory sequences of CYP3A4.
    

Intervention name(s): Regorafenib; GEMOX
Intervention type(s): Drug; Drug
Intervention description(s): Regorafenib: X mg/d, PO, from day 1 to day 14; day 15 to day 20: off-treatment; mGEMOX: infusion on days 1 and 8: Gemcitabine 900 mg/m² IV in 30 minutes Oxaliplatin 80 mg/m² IV in 120 minutes immediately after Gemcitabine
Other intervention name(s): Gemcitabin; Oxaliplatin; Gemcitabine; Oxaliplatin
Intervention MeSH terms: Gemcitabine; Oxaliplatin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Treatment of Malaria in Gabon With Fosmidomycin-Clindamycin
Condition: Malaria
MeSH terms: Malaria
Study type: Interventional
Phase: Phase 2

Summary: 
      Some antibiotics are also effective against malaria parasites. Fosmidomycin is an antibiotic
      that has been shown to be effective against malaria, although it cannot achieve a total cure
      in all patients. A previous small study has shown that in combination with clindamycin, an
      commonly used antibiotic, it is highly effective and safe, in asymptomatic carriers of
      malaria parasites. The current study will evaluate the efficacy and safety of the combination
      given for three days in children with uncomplicated malaria in Gabon.
    

Detailed description: 
      The treatment of malaria is becoming increasingly difficult due to the development of
      Plasmodium falciparum strains resistant to commonly used antimalarials. Fosmidomycin was
      shown to be well tolerated and fast-acting in paediatric outpatients and adults, but late
      recrudescences preclude its use as monotherapy. Clindamycin was identified as a suitable
      combination partner following the demonstration of synergistic inhibition of plasmodial
      growth by in vitro and animal studies.

      In this study, the safety and efficacy of fosmidomycin-clindamycin (30 mg/kg plus 10 mg/kg)
      twice daily for three days is assessed in children with acute uncomplicated P. falciparum
      malaria.
    

Intervention name(s): Fosmidomycin-clindamycin
Intervention type(s): Drug
Intervention MeSH terms: Clindamycin; Clindamycin palmitate; Clindamycin phosphate; Fosmidomycin
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Malaria; Fosmidomycin; Clindamycin; Gabon
Oral Glutathione As A Skin Whitening Agent
Condition: Glutathione; Skin Whitening
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of the study was to evaluate the efficacy and safety of oral glutathione for 12
      weeks, used as a skin-whitening agent. The study was a randomized, double-blind,
      placebo-controlled, multicenter study, set at Dermatology outpatient clinic at three
      different hospitals in Indonesia, Gatot Seobroto Army Hospital Jakarta, Dr. dr. Wahiddin
      Soedirohoesodo Hospital Makassar, and University of Sumatera Utara Teaching Hospital Medan.
      Ninety healthy females, aged between 33 and 50 years, were randomized to receive either
      glutathione capsules or placebo for 12 weeks and evaluated every 4 weeks. The main outcome
      was total reduction (improvement) of spot UV, spot polarization, and skin tone measured at
      five different sites for each indices, recorded by Janus Facial Analysis System®.
    

Detailed description: 
      The objective of the study was to evaluate the efficacy and safety of oral glutathione for 12
      weeks, used as a skin-whitening agent.

      The study was a randomized, double-blind, placebo-controlled, multicenter study, set at
      Dermatology outpatient clinic at three different hospitals in Indonesia, Gatot Seobroto Army
      Hospital Jakarta, Dr. dr. Wahiddin Soedirohoesodo Hospital Makassar, and University of
      Sumatera Utara Teaching Hospital Medan.

      Ninety healthy females, aged between 33 and 50 years, were randomized to receive either
      glutathione capsules (500 mg) or placebo capsules, which were identical in appearance and
      packaged in identical-looking containers. The capsules were taken once daily for 12 weeks and
      evaluated every 4 weeks. Compliance was assessed by counting the remaining capsules at each
      follow-up visit.

      At each follow-up visit, subjects were asked to grade the overall response and questioned
      regarding adverse events. The objective or main outcome was total reduction (improvement) of
      spot UV, spot polarization, and skin tone measured at five different sites for each indices,
      recorded by Janus Facial Analysis System®.
    

Intervention name(s): Glutathione; Placebo oral tablet
Intervention type(s): Drug; Drug
Intervention description(s): Oral glutathione capsule (500 mg), were taken once daily by the subjects.; Placebo oral capsule were taken once daily by the subjects.
Other intervention name(s): L-Gluthatione
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: glutathione; whitening
Study of Tumor Necrosis Factor Receptor Fusion Protein Etanercept (Enbrel) in Psoriasis of the Hands and/or Feet
Condition: Psoriasis
MeSH terms: Psoriasis; Necrosis
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this research study is to see how well (compared to placebo) Enbrel®
      (etanercept) 50 mg twice a week for 12 weeks affects plaque psoriasis of the hands and/or
      feet (palmoplantar psoriasis).
    

Detailed description: 
      This multicenter investigation is a 12 week, double-blind, randomized trial of etanercept, 50
      mg twice weekly versus placebo in subjects with palmoplantar psoriasis (PPP). Subjects who
      meet the eligibility criteria will be randomized to either 50 mg etanercept twice weekly or
      placebo. Subcutaneous injections will occur twice weekly at approximately the same time of
      day over the 12-week treatment period. The primary efficacy endpoint will be assessed after
      12 weeks of treatment. At the end of the first 12 weeks, all patients (both treatment and
      placebo arms) will be treated with etanercept 50 mg twice a week (BIW) for an additional 12
      weeks.
    

Intervention name(s): Etanercept; Placebo injections
Intervention type(s): Biological; Other
Intervention description(s): Subcutaneous injections 50 mg Etanercept will occur twice weekly over a 12-week treatment period.; Placebo injections twice weekly for 12 weeks.
Other intervention name(s): Enbrel
Intervention MeSH terms: Etanercept
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: palmoplantar psoriasis; etanercept; Enbrel
A Safety, Pharmacokinetics and Pharmacodynamics Study of RO6811135 in Patients With Type 2 Diabetes Mellitus
Condition: Diabetes Mellitus Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      This randomized, double-blind, placebo-controlled, multiple ascending dose study will
      evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of RO6811135 in
      patients with type 2 diabetes mellitus. Patients will be randomized to receive either
      RO6811135 or placebo daily for 2 weeks, with a follow-up examination 2 to 3 weeks after the
      last dose of study drug.
    


Intervention name(s): Placebo; RO6811135
Intervention type(s): Drug; Drug
Intervention description(s): Matching placebo, multiple doses; multiple ascending doses
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Association of Periodontitis and Preeclampsia During Pregnancy
Condition: Preeclampsia; Periodontal Disease
MeSH terms: Periodontitis; Periodontal Diseases; Pre-Eclampsia
Study type: Observational

Summary: 
      Infections affecting the mother during pregnancy may produce alterations in the normal
      cytokine and hormone-regulated gestation, which could result in preeclampsia, preterm labor,
      premature rupture of membranes, and preterm birth. Therefore, pregnant women with periodontal
      disease may show an alteration in the cytokine levels which may cause preeclampsia in them.
    

Detailed description: 
      The enrolled subjects will be evaluated on the basis of a pre-designed and pre-tested
      proforma with respect to history and clinical examination, obstetrics examination and
      ultrasonography. The periodontal examination consists of assessments at vestibular, lingual,
      mesial and distal sites of all present teeth.Five ml venous blood sample will be drawn from
      the patient at the time of enrollment before 20 weeks of gestation for the levels of
      cytokines (IL-4, IL-10, IFN-g and TNF-α. All the subjects will be followed- up till delivery.
      At the time of delivery, the details of pregnancy outcome (maternal and fetal) along with the
      measurement of the blood pressure will be recorded. A repeat of oral health evaluation will
      be done within 48 hours of delivery.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        primigravidae women with 14-20 weeks of gestation.
      
Keywords: preeclampsia; periodontitis; cytokines
Advanced Breast Cancer and Lifestyle Exercise Study
Condition: Metastatic Breastcancer
MeSH terms: Breast Neoplasms
Study type: Interventional

Summary: 
      About 5% of breast cancers are metastatic at diagnosis and 20-30% of localized breast cancer
      become secondarily metastatic.Thanks to recent therapeutic advances, the median survival
      ranges between 12 months in 1970 and 18 to 24 months in 2000. However, patients suffer from
      many detrimental symptoms such as fatigue, pain related to treatment and metastasis. The
      physical, biological, psychological and clinical benefits of physical activity (PA) during
      treatment in patients with localized breast cancer have been widely demonstrated. Numerous
      studies investigated the effect of PA in non-metastatic breast cancer, but to our knowledge,
      only four interventional studies worldwide focused on the implementation of PA in patients
      with metastatic breast cancer.It seems appropriate to investigate the feasibility of PA
      intervention with patients with metastatic breast cancer to see if the observed effects in
      localized breast cancer are confirmed in metastatic breast cancer population. The ABLE study
      is an interventional cohort designed to assess the feasibility of a 6-month adapted physical
      activity intervention, performed under real life conditions in patients with metastatic
      breast cancer.
    


Intervention name(s): PA intervention
Intervention type(s): Other
Intervention description(s): The program is individualized according to age, fitness level, place of residence, access to adapted specific training group or associations, PA preferences and wishes of each participant. Patients are informed of the recommendations in terms of PA, and the target of 150min per week in order to maintain health benefits. Patients are asked to walk at least 30 minutes per day and increase their activities into daily routine. Several individual strategies are established with the patients to attain their objectives and increase their daily life PA.
Withings® PA trackers have been used to provide an incentive effect to increase PA, to measure the number of steps per day and make people think about their PA. Patients wore a Withings Go® wristband PA tracker throughout the whole study and had in real time a feedback on their number of steps per day.
A 7 mL blood sample is collected at baseline (D1) and at the end of the 6-month study (M6) for the biological study.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Physical activity