bioihbjkbjnl/mcl2 huggingface dataset:
Experience of the Father Following the Announcement of a First Pregnancy
Condition: Family Relations; Behavior
Study type: Observational

Summary: 
      Experience of the father following the announcement of a first pregnancy Its context,
      immediate reactions and actions. Possible impact of this moment of life a few months or years
      later?
    


Intervention name(s): Interview by hierarchical evocation's Method
Intervention type(s): Behavioral
Intervention description(s): Interview to describe the experience of the man during the announcement of a pregnancy that it is expected or not.
Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Male having been the father of at least one pregnancy whatever the outcome (pregnancy
        pursued, or abortion)
Foraminal Enlargement and Postoperative Pain.
Condition: Pain Postoperative
MeSH terms: Pain, Postoperative; Hypertrophy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine whether enlarging the apical foramen causes
      postoperative pain in teeth with necrotic pulp and apical periodontitis.
    

Detailed description: 
      Foraminal enlargement (FE) is an intentional procedure that enlarges the cement canal.
      However, some RCTs indicate that enlarging the FE causes postoperative pain, flare-up, and
      destroy the apical constriction, whilst some RCTs pointed out there is no difference in terms
      of pain when a FE has been performed. The investigators, therefore, would like to conduct a
      RCT to increase both sample size and the number of published studies to do a systematic
      review for this topic.
    

Intervention name(s): Foraminal enlargement
Intervention type(s): Procedure
Intervention description(s): After determining the working length, a flexible size 30 K-file will be inserted 1 mm beyond the WL and the apical foramen will be enlarged.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Foraminal enlargement; Root canal treatment
DUAC® Early Onset Efficacy Study in Japanese Subjects
Condition: Acne Vulgaris
MeSH terms: Acne Vulgaris
Study type: Interventional
Phase: Phase 4

Summary: 
      This is a multicentre, randomized, single-blind (investigator is blinded), active (the
      combination therapy of adapalene [ADA] and clindamycin [CLDM])-controlled and parallel-group
      study in Japanese subjects with facial acne vulgaris. The purpose of this study is to
      evaluate the efficacy, safety and tolerability of CLDM 1 percent (%)-benzoyl peroxide 3%
      (Duac®: trademark owned by GlaxoSmithKline) once daily fixed dose combination gel versus
      combination therapy of ADA 0.1% gel and CLDM 1% gel in the topical treatment of facial acne
      vulgaris for 12 weeks. A total of 400 subjects will be screened for enrolment. Subjects will
      use Duac® fixed dose combination gel with quantity sufficient to cover entire face (including
      the forehead, nose, cheeks and chin) once daily in the evening (at bedtime) or combination
      therapy of ADA 0.1% gel with quantity sufficient to cover entire face (including the
      forehead, nose, cheeks and chin) once daily in the evening (at bedtime) and CLDM 1% gel twice
      daily, once in the morning and once in the evening (at bedtime) for 12 weeks.
    

Detailed description: 
      Duac® is a registered trademark of Stiefel Laboratories, Inc., a GSK company. Duac® marketed
      in Japan is CLDM 1%-benzoyl peroxide 3% combination gel.
    

Intervention name(s): Duac® fixed dose combination gel; ADA 0.1% gel; CLDM 1% gel
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Duac® fixed dose combination gel containing clindamycin phosphate 1.2% and benzoyl peroxide 3%.; ADA 0.1% gel containing 0.1% of adapalene.; CLDM 1% gel containing clindamycin phosphate 1.2% (1% as clindamycin).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: Clindamycin; Gel; Benzoyl Peroxide; Acne Vulgaris
Safety Tolerability and Efficacy Study of Cabaletta to Treat Oculopharyngeal Muscular Dystrophy (OPMD) Patients
Condition: Oculopharyngeal Muscular Dystrophy
MeSH terms: Muscular Dystrophies; Muscular Dystrophy, Oculopharyngeal
Study type: Interventional
Phase: Phase 2

Summary: 
      The Purpose of this study is to assess the Safety, Tolerability and Efficacy of Intravenous
      Cabaletta® in Oculopharyngeal Muscular Dystrophy (OPMD) Patients.
    


Intervention name(s): Cabaletta
Intervention type(s): Drug
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Case control, safety, tolerability, efficacy.
Efficacy and Safety of Ypeginterferon Alfa-2b in HBeAg Positive Chronic Hepatitis B
Condition: Chronic Hepatitis B
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis B, Chronic; Hepatitis; Hepatitis, Chronic
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is a multi-center, randomized, open-label and positive controlled Phase II
      Clinical trial to assess efficacy and safety of Ypeginterferon alfa-2b, once a week, in 3
      dose-groups: 90mcg, 135mcg and 180mcg, respectively, for treatment of chronic hepatitis B
      characterized by HBeAg positivity, with Pegasys 180mcg/week as positive control. It is aimed
      to establish a dose response and safety relationship sufficient to allow the subsequent
      design and conduct of Phase III trials, and generate pharmacokinetic data of Ypeginterferon
      alfa-2b in hepatitis B patients to satisfy regulatory requirements.
    


Intervention name(s): Ypeginterferon alfa-2b; Peginterferon alfa-2a
Intervention type(s): Drug; Drug
Intervention description(s): sc, qw, for 48 weeks.; sc, qw, for 48 weeks.
Other intervention name(s): Pegasys
Intervention MeSH terms: Peginterferon alfa-2a
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: peginterferon; interferon; Pegasys; HBV; Hepatitis B; HBeAg positive
Hospital Intensive Monitoring of Adverse Drug Reactions of Qingkailing Injection In The Next Two Years
Condition: Adverse Drug Events; Adverse Drug Reactions
MeSH terms: Drug-Related Side Effects and Adverse Reactions
Study type: Observational

Summary: 
      To highlight the incidence of adverse reactions of Qingkailing Injection.
    


Intervention name(s): Qingkailing Injection
Intervention type(s): Drug
Intervention description(s): Qingkailing Injection is a kind of natural product injection made from Chinese herbs, which has been used to treat cerebral ischemia for decades in China. The main bioactive ingredients of this injection include Baicalin, Jasminoidin, Ursodeoxycholic Acid, Concha Margaritifera,etc.
Other intervention name(s): Shineway Qingkailing Injection
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        all the patients treated by Qingkailing Injection in the certain centers(hospitals) in the
        next 2 years.
      
Biospecimen description: 
      whole blood of the patient with severe adverse drug reactions
Safety and Efficacy of BK1310 Intramuscular Injection in Healthy Infants
Condition: Immunization
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the safety and efficacy of an intramuscular
      injection of BK1310 in healthy infants.
    


Intervention name(s): DPT-IPV-Hib (Combined Vaccine)
Intervention type(s): Biological
Intervention description(s): 0.5mL, intramuscular injection, 3 times with the 3-8weeks intervals then an additional injection after 6-13 months.
Other intervention name(s): BK1310
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Haemophilus influenza type b; Adsorbed Diphtheria-Purified Pertussis-Tetanus-Inactivate; poliovirus combined vaccine; Hib; DPT-IPV; Intramuscular
The Mediterranean Diet and Lactation Study: A Diet Study in Lactating Women
Condition: Breast Feeding
Study type: Interventional

Summary: 
      Purpose: During lactation, several physiological modifications occur including cellular
      differentiation and proliferation, as well as elevation in inflammation. The role of the
      Mediterranean (MED) diet rich in walnuts has been shown to favorably modify fatty acid
      profiles and to reduce inflammation. The study goal is to evaluate the anti-inflammatory
      effects of the MED diet rich in walnuts during lactation, a time of increased inflammatory
      response.

      Procedures: A randomized, controlled dietary intervention trial among lactating women
      comparing the effects of a Mediterranean-style diet with walnuts to the USDA's MyPyramid Diet
      for Moms was commenced to determine the effects of the diet on fatty acid profiles and
      biomarkers of inflammation in breast milk and material serum/plasma. Secondary outcomes of
      interest include effects of maternal diet assignment on maternal body weight and body
      composition as well as infants' growth and health during the study trial period.

      Population: The study population includes healthy women between the ages of 18-40 years who
      are within 6 months post-partum and plan to breastfeed a minimum of 3 times per day for 6
      months following study entry. There have been a total of 138 participants enrolled in the
      study. All 138 participants are women; 34 identified themselves as Hispanic, and 104 said
      they were not Hispanic.
    


Intervention name(s): Walnut; MyPyramid
Intervention type(s): Other; Other
Intervention description(s): Participants will consume 1 ounce walnuts daily and follow a Mediterranean style diet.; Participants will follow a USDA MyPyramid style diet for lactating moms.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: walnut; mediterranean
Window Trial 5-aza in HNSCC, T-tare
Condition: Head and Neck Squamous Cell Carcinoma
MeSH terms: Carcinoma; Carcinoma, Squamous Cell; Squamous Cell Carcinoma of Head and Neck
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the activity of 5-azacitidine in patients with Human
      Papilloma Virus (HPV)-positive and HPV- negative head and neck squamous cell carcinoma
      (HNSCC). The response activity will be determined by analyzing your tumor tissue prior to and
      after treatment with 5-azacitidine. Preliminary studies in mice bearing human head and neck
      cancers or head and neck cancer cells cultured in laboratories suggest that treatment with
      5-azacitidine increases changes in cancer cells that lead to their death. This study is
      designed to determine if similar changes occur in cancer cells of patients with head and neck
      cancer.

      The study also aims to determine the amount of a specific type of protein, p53 before and
      after treatment. Research has shown that the p53 protein is associated with anti-tumor
      activity.

      Finally, this study is measuring the amount of a specific type of protein called interferon
      in your tumor tissue. Interferons are proteins made and released by the body in response to
      pathogens (disease causing agents) such as viruses, bacteria, or tumor cells. Interferons
      allow for communication between cells to trigger the protective defenses of the immune system
      that remove pathogens (disease causing agents) or tumors.
    

Detailed description: 
      Primary Objectives:

      The primary objectives of this study are:

      • to determine the proportion of HPV-positive patients in whom 5-azacytidine increases APOBEC
      RNA expression.

      Secondary Objectives

      The secondary objectives of this study are:

        -  to investigate response (proliferation, apoptosis), as well as reactivation of IFN
           pathways in patients treated with 5-azacitadine for HPV-positive and HPV-negative HNSCC.

        -  to investigate the clinical activity of 5-azacitadine in patients with HPV-positive and
           HPV-negative HNSCC.

        -  to investigate the safety of 5-azacitadine in patients with HPV-positive and
           HPV-negative HNSCC
    

Intervention name(s): 5-Azacitadine
Intervention type(s): Drug
Other intervention name(s): Vidaza
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: HNSCC
Behavioral and Neural Response to Memantine in Adolescents With Autism Spectrum Disorder
Condition: Autism Spectrum Disorder
MeSH terms: Autistic Disorder; Autism Spectrum Disorder; Child Development Disorders, Pervasive
Study type: Interventional
Phase: Phase 3

Summary: 
      This study is a 12-week, randomized-controlled trial of memantine hydrochloride (Namenda) for
      the treatment of social impairment in adolescents with autism spectrum disorder (ASD). The
      investigators will also conduct pre- and post-treatment neuroimaging (functional magnetic
      resonance imaging [fMRI] and hydrogen magnetic resonance spectroscopy [HMRS]) to assess
      neural functional deficits in adolescents with autism spectrum disorder compared to healthy
      volunteer adolescents. This pre- and post-neuroimaging will also be used to assess any
      effects of memantine therapy on neural function in adolescents with autism spectrum disorder.
      The investigators hypothesize that short-term memantine monotherapy will be safe,
      well-tolerated, and effective in improving the core symptoms of autism spectrum disorder in
      adolescents with autism spectrum disorder. Additionally, the investigators hypothesize that
      following memantine therapy, adolescents with autism spectrum disorder will exhibit a
      decrease in glutamate (Glu) concentration in the anterior cingulate cortex (ACC) and a change
      towards normalization in altered functional connectivity of the anterior cingulate cortex and
      medial temporal lobes, consistent with improvement in social impairments in autism spectrum
      disorder. The investigators hypothesize that compared to healthy volunteer participants,
      participants with autism spectrum disorder will significantly differ on neuroimaging measures
      at baseline but that following memantine therapy, the difference between autism spectrum
      disorder and healthy volunteer neuroimaging data will decrease.
    


Intervention name(s): Memantine; Placebo
Intervention type(s): Drug; Other
Intervention description(s): Capsule; Capsule
Other intervention name(s): Namenda
Intervention MeSH terms: Memantine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Autism spectrum disorder; Treatment; Adolescents; Memantine; functional Magnetic Resonance Imaging; MRS; Neuroimaging
A Study of Hepatitis C Virus (HCV) Polymerase Inhibitor Pro-Drug in Combination With PEGASYS With or Without COPEGUS in Patients With Chronic Hepatitis C (CHC) Genotype 1 Infection.
Condition: Hepatitis C, Chronic
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis
Study type: Interventional
Phase: Phase 2

Summary: 
      This 4 arm study will compare the safety and tolerability of HCV polymerase inhibitor
      pro-drug in combination with PEGASYS +/- COPEGUS with the standard of care therapy of PEGASYS
      + COPEGUS, in treatment-naive patients with CHC, genotype 1. Patients will be randomized to
      receive 1500mg or 3000mg po bid of HCV polymerase inhibitor pro-drug + PEGASYS, 1500mg of HCV
      polymerase inhibitor pro-drug + PEGASYS + COPEGUS or PEGASYS + COPEGUS for 4 weeks. All
      patients who receive at least one dose of study medication will receive open label PEGASYS +
      Copegus for an additional 44 weeks after the 4 week experimental period. The anticipated time
      on study treatment is 3-12 months, and the target sample size is <100 individuals.
    


Intervention name(s): Copegus; PEGASYS; RO5024048 1500mg; RO5024048 3000mg
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 1000/1200mg po daily for 4 weeks; 180 micrograms sc weekly for 4 weeks; 1500mg po bid for 4 weeks; 3000mg po bid for 4 weeks
Intervention MeSH terms: Peginterferon alfa-2a
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Dual Task Training in Spastic Cerebral Palsy
Condition: Cerebral Palsy
MeSH terms: Paralysis; Cerebral Palsy
Study type: Interventional

Summary: 
      This study aims to investigate the effects of dual task training on gait and balance
      parameters, gross motor function skills, functional mobility skills, functional independence
      levels and health-related quality of life o in children with spastic diplegic cerebral palsy.
      The clinical study's hypothesis is the dual task training programs are superior to
      conventional physiotherapy programs to improve the parameters in spastic diplegic cerebral
      palsy.
    

Detailed description: 
      In this self-controlled study, children with spastic diplegic cerebral palsy, aged 7-16, who
      were at level 1 or 2 according to the Gross Motor Function Classification System, scored 27
      and above from the Modified Mini Mental Test were included.

      Children are recruited to the routine physiotherapy program 45 minutes 2 days a week for 8
      weeks, and in addition to the routine physiotherapy program dual task training program 45
      minutes 2 days a week for the next 8 weeks. The children will evaluate at baseline, after the
      routine physiotherapy program and after the dual task training program. Children will be
      evaluate with Gross Motor Function Measurement-88,Modified Ashworth Scale , gait platform,
      Edinburgh Visual Gait Score, Pediatric Berg Balance Scale,1 Minute Walk Test, Functional
      Independence Measure, Pediatric Quality of Life Inventory TM-Cerebral Palsy Module.
    

Intervention name(s): Therapeutic exercises; Dual Task Training
Intervention type(s): Other; Other
Intervention description(s): Conventional physiotherapy exercises for children with cerebral palsy; Dual task training in addition to conventional physiotherapy exercises for children with cerebral palsy
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: Self-controlled study
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: cerebral palsy; dual task training; gait; balance
Efficacy and Safety Study of Nidadd in the Management of Hyperlipidemia
Condition: Hyperlipidemia
MeSH terms: Hyperlipidemias; Hyperlipoproteinemias
Study type: Interventional
Phase: Phase 3

Summary: 
      To assess the efficacy and safety of Nidadd (extended-release niacin) in patients with
      hyperlipidemia.
    

Detailed description: 
      This is a randomized, double-blind, placebo-controlled, and multicenter study. A total of at
      least 50 patients will be recruited to achieve 40 evaluable patients required to assess the
      safety and efficacy of escalating doses of extended-release Nidadd in hyperlipidemic
      patients.

        1. The trial begins with measurement of baseline lipid levels. Fasting blood samples will
           be collected at screening and each treatment visit (except visit 3) for lipid analysis
           and safety monitoring. Chemistry laboratory tests and hematological testing are
           performed periodically. Patient's diet education will be given by dieticians or
           appropriately trained counselors at visit 1 and 2.

        2. Patients who are taking any lipid-modifying drugs will be required to go through a
           4-week washout / diet-controlled period prior to randomization (visit 2).

        3. Treatment duration is 16 weeks in total: Patients randomized to treatment with Nidadd
           will receive 500 mg for the first 8 weeks of the medication period. For another 8 weeks,
           the dose is then increased to 1000 mg and is maintained to the end of the study. The
           patients in control group will take placebo in a same fashion as that of Nidadd group
           throughout entire 16 weeks.

        4. The primary measure of efficacy is the change from baseline in serum HDL-c level.
           Secondary measures of efficacy are changes from baseline in serum total cholesterol,
           LDL-c, and triglycerides.

        5. Safety and tolerability will be evaluated from adverse events, number of patients who
           prematurely discontinue the trial because of adverse events, and laboratory measures.
    

Intervention name(s): Nidadd
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Niacin; Hyperlipidemia
Revisional Bariatric Surgery Experience
Condition: Bariatric Surgery; Revisional Bariatric Surgery; Obesity Associated Disorder
Study type: Interventional

Summary: 
      The aim of this study is to assess the indications for revisional bariatric surgery and
      short-term revisional surgical outcomes such as weight loss, BMI variation, % excessive
      weight loss and % excessive BMI loss .Prospectively-collected patient data will
      retrospectively reviewed. Patient demographics, body mass index (BMI), primary and revision
      surgery types, indications of revision, outcomes of revisional surgery and follow-up data for
      comorbidities will investigated.
    


Intervention name(s): Laparoscopic mini gastric by-pass; LaparoscopicRe-sleeve gastrectomy; Laparoscopic Roux-en-Ygastric bypass
Intervention type(s): Other; Other; Other
Intervention description(s): Adhesions will separated along the left edge of the stomach and the left lobe of the liver. The remnant stomach will transected at the incisura angularis level with 60 mm Endo-GIA stapler(ATW 35, EthiconEndo-SurgeryInc., Cincinnati, OH, USA). Later ante-cholic distal of the Treitz ligament hadgastro-jejunal anastomosisof nearly 150 cm jejunal loop performed with 44 mm Endo-GIA stapler. Routinely, the omentum will be divided in two and omentopexy will be performed around the anastomosis. The stapler line will supported by absorbable stitches.; Adhesions will be separated with blunt and sharp dissections, then the remnant stomach will completely freed. Due to dilated antral pouch or fundus, the remnant stomach will resect as a tube stomach between the pillory and left crus with 60 mm Endo-GIA stapler accompanied by 36F bougie.; all adhesions will separated then after the stomach pouch will formed by the linear stapler, 100 cm of jejunum will transected from the Treitz ligament. Side-to-side gastrojejunostomy will performed for the distal jejunum with the linear stapler. The anterior face of the anastomosis will manually sutured. Proximal jejunum end hadside-to-side jejuno-jejunostomy performed 150 cm distal of the gastrojejunostomy anastomosis with linear stapler on the posterior wall and manual suturing of the anterior wall.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment