bioihbjkbjnl/mcl2 huggingface dataset:
Topical vs Oral Metronidazole After Benign Anorectal Surgery
Condition: Hemorrhoids; Anal Fissure; Anal Fistula
MeSH terms: Hemorrhoids; Rectal Fistula; Fissure in Ano; Fistula
Study type: Interventional

Summary: 
      While some investigators found oral metronidazole to be effective in reducing pain after
      hemorrhoidectomy, other researchers did not find a significant analgesic effect of systemic
      metronidazole. On the other hand, topical application of metronidazole had more consistent
      favorable results as Ala et al documented a remarkable analgesic effect of topical
      metronidazole 10% after excisional hemorrhoidectomy which was in line with Nicholson and
      Armestrong who also concluded similar results.

      No previous study compared the analgesic effect of topical and oral metronidazole after
      anorectal surgery. Therefore, the present trial was conducted to compare the impact of oral
      versus systemic metronidazole on pain and recovery after surgery for benign anorectal
      conditions.
    


Intervention name(s): Topical metronidazole; oral metronidazole
Intervention type(s): Drug; Drug
Intervention description(s): Topical application of metronidazole cream on the anal verge every 8 hours after surgery; Patients received oral metronidazole 500 mg tablets every 8 hours after surgery
Intervention MeSH terms: Metronidazole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Care Provider, Outcomes Assessor)
Primary purpose: Treatment
The Safety and Tolerability of STSA-1005 Following Intravenous Infusion in Healthy Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This was a single ascending dose, randomized, double-blind study assessing the safety,
      tolerability and pharmacokinetics of STSA-1005 in healthy participants. Four kinds different
      doses and dose-matched placebo were administered under fasted conditions.
    


Intervention name(s): STSA-1005 injection; Placebo; STSA-1005 injection; Placebo; STSA-1005 injection; Placebo; STSA-1005 injection; Placebo
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Intravenous injection; Intravenous injection; Intravenous injection; Intravenous injection; Intravenous injection; Intravenous injection; Intravenous injection; Intravenous injection
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Internet Weight Control for Bingeing Adolescents
Condition: Obesity; Eating Disorders
MeSH terms: Feeding and Eating Disorders
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine if an internet-based intervention designed to
      reduce binge eating and improve healthy weight regulation skills will result in reductions in
      binge eating and weight loss, or weight maintenance, in overweight adolescents who binge eat.
    

Detailed description: 
      The purpose of this study is to determine if an internet-based intervention designed to
      reduce binge eating and improve healthy weight regulation skills will result in reductions in
      binge eating and weight loss, or weight maintenance, in overweight adolescents who binge eat.
    

Intervention name(s): Internet-based intervention designed to reduce binge eating and improve healthy weight regulation
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: binge eating; weight loss; obesity
Study on the Anti-tumor Activity, Safety and Pharmacology of IPH2101 in Patients With Smoldering Multiple Myeloma
Condition: Smoldering Multiple Myeloma
MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell; Smoldering Multiple Myeloma
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the anti-tumor activity, safety and pharmacology of
      two dose regimens (0.2 and 2 mg/kg)of IPH2101 in patients with Smoldering Multiple Myeloma.
    

Detailed description: 
      This is a randomized Phase II, open label, multi-centre study, with two independent arms.

      Patients receive 6 injections of IPH2101, at the dose of 0.2 mg/kg or 2 mg/kg (according to
      their randomization) administered over one hour infusion at four weeks intervals.

      A patient whose disease achieves at least a minimal response to study treatment at any time
      during the initial period of 6 cycles can be treated with an additional period of treatment
      of 6 cycles.

      Patients are followed 6 months after treatment completion or until a KIR occupancy level <
      30% (i.e if the time required for KIR desaturation was > 6 months), whichever is longer.
    

Intervention name(s): IPH2101
Intervention type(s): Drug
Intervention description(s): 0.2 mg/Kg or 2mg/Kg, every 4 weeks by intravenous route over 1 hour, for 6 or up to 12 cycles
Other intervention name(s): a human monoclonal anti-KIR antibody (1-7F9)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Smoldering Multiple Myeloma
Study to Evaluate the Safety and Immunogenicity of Poly ICLC (Hiltonol) in Healthy Volunteers
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      Vaccines induce protective immunity against numerous infectious diseases. However, current
      vaccines have limited efficacy against challenging infections like tuberculosis, malaria and
      HIV. Protein vaccines are safe but, typically, they induce weak T cell immunity when
      administered alone. Therefore, special attention is being given to adjuvants, which are
      enhancers of immunity, that mature antigen presenting immunostimulatory dendritic cells
      (DCs). Our goal is to study in humans the mechanism whereby synthetic adjuvants, acting on
      defined pattern recognition receptors (PRR), enhance T and B cell immunity. In preclinical
      studies, the investigators' laboratory has found in mice that poly IC and its analog poly
      ICLC are superior adjuvants for T cell mediated immunity relative to other agonists for PRR.
      In this study the investigators propose to study the safety and the innate immune responses
      to poly ICLC in multiple blood cell types, including three different subsets of DCs when
      administered subcutaneously or intranasally to healthy volunteers. Poly ICLC is a stabilized
      double stranded RNA which has been extensively studied in humans with a favorable safety
      profile.
    


Intervention name(s): Hiltonol (poly ICLC)
Intervention type(s): Drug
Intervention description(s): 2 mg administered subcutaneously or intranasally to healthy volunteers
Intervention MeSH terms: Poly ICLC
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Safety and Efficacy of Levomilnacipran ER (F2695 SR) in Major Depressive Disorder
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the efficacy, safety, and tolerability of
      Levomilnacipran ER fixed doses versus placebo in the treatment of outpatients with major
      depressive disorder.
    


Intervention name(s): Levomilnacipran ER; Levomilnacipran ER; Levomilnacipran ER; Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Levomilnacipran ER, 40 mg, oral administration, in capsule form, once daily for 8 weeks.; Levomilnacipran ER, 80 mg, oral administration, in capsule form, once daily for 8 weeks.; Levomilnacipran ER, 120 mg, oral administration, in capsule form, once daily for 8 weeks.; Matching placebo capsules, oral administration, once daily for 8 weeks.
Intervention MeSH terms: Milnacipran; Levomilnacipran
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Depression; Major Depressive Disorder
Protective Ventilation With Carbon Dioxide (CO2) -Removal Technique in Patients With Adult Respiratory Distress Syndrome (ARDS)
Condition: Adult Respiratory Distress Syndrome
MeSH terms: Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Acute Lung Injury; Syndrome
Study type: Interventional
Phase: Phase 3

Summary: 
      30% of ARDS patients ventilated according to NIH protocol presents morphological (CT) and
      functional (Stress Index>1) conditions of hyperinflation even with Plateau pressure (Pplat) <
      30 cmH2O; values of Pplat lower than 26 cmH2O were associated with more a condition of more
      protective ventilation.

      In patients at risk of hyperinflation, use of alternative techniques such as CO2-removal my
      allow the reduction of Tidal Volume (Vt) and Pplat.
    

Detailed description: 
      Aim of the study was to verify the efficacy of CO2-removal technique in reducing Vt and
      consequently Pplat to obtain a Stress Index value equal to 1.
    

Intervention name(s): protective ventilation with CO2 removal technique
Intervention type(s): Procedure
Intervention description(s): In ARDS patients, presenting a Pplat ≥ 26 cmH2O, Vt was lowered (reaching a Pplat < 26) with CO2-removal veno-venous pump-driven bypass support for 48 consecutive hours with a pH > 7,30 or at least 72 hours from the beginning of the extracorporeal treatment.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Respiratory Insufficiency; CO2 removal; protective ventilation; ARDS
Examination of Menstruation Symptoms in Women Who Exercise Regularly.
Condition: Menstrual Problem
MeSH terms: Menstruation Disturbances
Study type: Interventional

Summary: 
      The aim of this study is to contribute to the determination of the relationship between
      exercise and menstrual symptoms and to create an alternative for non-pharmacological coping
      methods with menstrual symptoms.
    

Detailed description: 
      The type of research is randomized controlled trial. An average of 50 people who do not have
      exercise habits will participate in the study, and two randomized groups will be formed as
      exercise group and control group. Everyone will be asked to fill in the Menstruation Symptom
      Scale, the Menstruation Distress Scale, the Pittsburgh Sleep Quality Scale, the Fatigue
      Severity Scale, the International Physical Activity Scale, the Personal Information Form
      prepared by us, and the Voluntary and Consent Form during their menstrual period. The
      duration of the study will cover 3 (three) menstrual periods of the individuals. At the
      beginning and end of the study; They will be asked to fill in the Pittsburgh Sleep Quality
      Scale, Fatigue severity scale, International Physical Activity Questionnaire Short form,
      Menstruation Symptom Scale and Menstruation Distress Complaint List.
    

Intervention name(s): control; exercise
Intervention type(s): Other; Other
Intervention description(s): no exercise will be given; In line with the recommendation of the World Health Organization, the exercise group will do 150 minutes of moderate-intensity walking a week and strengthening exercises prepared by the physiotherapist two days a week. Strengthening exercises will be taught by the physiotherapist in a session with the people in the exercise group in groups of five, and then exercise lists will be given to the people on digital exercise platform, where there are video narrations of the exercises. In addition, the participants will be asked to do balance exercises and macular exercise.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Exercise treatments
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: sleep; menstruation; stress
Bioavailability Study With Oral Single Dose Administration of Ethinylestradiol and Dienogest
Condition: Focus: Bioequivalence
Study type: Interventional

Summary: 
      -  Characterisation of relative bioavailability of Diena (Test) in comparison to Valette®
           (Reference) after single dose administration under fasting conditions

        -  Assessment of bioequivalence of Test vs. Reference after single dose administration
           under fasting conditions, determined by use of area under the concentration time curve
           AUC0-tlast and maximum concentration Cmax obtained for ethinylestradiol (EE) and
           dienogest (DNG)

        -  Descriptive characterisation of safety and tolerability of the investigational products
           in the study population
    

Detailed description: 
      The aims of this study were to characterise relative bioavailability of Diena (Test) in
      comparison to Valette® (Reference) after single dose administration under fasting conditions
      and to assess bioequivalence of Test vs. Reference after single dose administration under
      fasting conditions, determined by use of area under the concentration time curve AUC0-tlast
      and maximal concentration Cmax obtained for ethinylestradiol (EE) and dienogest (DNG).
      Furthermore, a descriptive characterisation of safety and tolerability of the investigational
      products in the study population was performed.
    

Intervention name(s): Dienogest-Ethinyl Estradiol (test product); Dienogest-Ethinyl Estradiol (reference product)
Intervention type(s): Drug; Drug
Intervention description(s): One tablet of Test; One tablet of Reference
Other intervention name(s): Diena; Valette®
Intervention MeSH terms: Dienogest; Estradiol 17 beta-cypionate; Estradiol 3-benzoate; Ethinyl Estradiol; Estradiol; Polyestradiol phosphate; Nandrolone
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study for Evaluation of GSK Biologicals' Pandemic Influenza Vaccine.
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 3

Summary: 
      This observer-blind study is designed to show the immunological non-inferiority of
      Thiomersal-free-processed pandemic influenza vaccine as compared to the
      Thiomersal-containing-processed pandemic influenza vaccine.
    


Intervention name(s): GSK1562902A; GSK1562902A
Intervention type(s): Biological; Biological
Intervention description(s): new-processed (NP), administered intramuscularly in the deltoid region of the non-dominant arm; comparative-processed (CP), administered intramuscularly in the deltoid region of the non-dominant arm
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Pandemic influenza
NIS to Observe Improvement in Global Assessment of Functioning in Patients With Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Observational

Summary: 
      The purpose of the study is to monitor the general functional changes among patients with
      schizophrenia, treated with atypical antipsychotics dosed once daily for a period of 6
      months.The primary study objective is to compare general functioning of patients with
      schizophrenia treated with Seroquel SR between baseline and the last study visit. The
      secondary study objectives are to compare general functioning of patients with schizophrenia
      treated with other atypical antipsychotic medicinal products administered once daily between
      baseline and the last study visit, monitoring of other indicators of clinical improvement,
      evaluation of patient compliance and assessment of occurrence of adverse effects
    


Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        patients visiting psychiatrist's practice
      
Keywords: schizophrenia; Seroquel SR; atypical antipsychotics; assessment of functioning; GAF scale
CLA Metabolism and Effects on Human Health
Condition: Dietary Modification; Inflammation; Body Composition, Beneficial
MeSH terms: Inflammation
Study type: Interventional

Summary: 
      The purpose of the study is to investigate the effects of Conjugated Linoleic Acid (CLA) from
      dairy products on fatty acid metabolism and human health. A CLA depletion-repletion study was
      carried out with healthy volunteers. CLA depletion was achieved through an eight-week dairy
      fat restriction, followed by an eight-week repletion period consisting of intake of a butter
      naturally enriched with CLA. Changes in body composition, fasting glucose and insulin,
      inflammatory mediators, cell membranes' stability, plasma lipid levels and fatty acid
      composition of lipid classes are evaluated after depletion and repletion phases.
    

Detailed description: 
      After collecting baseline blood samples, CLA-depletion phase started with dietary
      orientation, by a registered dietitian, to the study subjects (n=29) to exclude from their
      diets any type of dairy fat for the following 8 weeks. Blood samples were taken at the end of
      CLA-depletion, and CLA-repletion phase was initiated by dietitians' instructions: volunteers
      returned to their regular diets, and additionally consumed a CLA-enriched butter for another
      8-week period. Blood samples were taken at the end of the CLA-repletion phase. The effects of
      CLA on the following parameters were evaluated: inflammatory mediators; fatty acid
      composition of erythrocytes, plasma phospholipids and cholesterol esters; body composition;
      clinical factors associated with the metabolic syndrome and indicators of cell membranes'
      stability.
    

Intervention name(s): CLA depletion-repletion
Intervention type(s): Dietary Supplement
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: CLA-enriched butter; CLA metabolism; inflammation
Hormone Dynamics and Bone Mineral Density in Anorexia Nervosa v. Hypothalamic Amenorrhea
Condition: Anorexia Nervosa; Hypothalamic Amenorrhea; Obesity
MeSH terms: Anorexia; Amenorrhea; Anorexia Nervosa
Study type: Observational

Summary: 
      The purpose of this study is to determine whether the hormone dynamics in women with anorexia
      nervosa and hypothalamic amenorrhea is related to bone loss in those populations.
    


Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        community sample and referrals by specialists
      
Biospecimen description: 
      whole blood, serum, urine, saliva, optional DNA substudy.
    
Keywords: healthy; overweight; obese; anorexia nervosa; weight; cortisol; hormone; bone density; bone; osteopenia; osteoporosis; amenorrhea; menses; irregular; stress; depression; exercise; diet
Percutaneous Laparoscopy for Ovarian Tissue Cryopreservation.
Condition: Oncology; Fertility Issues; Surgery
MeSH terms: Infertility
Study type: Observational

Summary: 
      To compare surgical outcomes of oncologic patients that underwent conventional laparoscopy
      and percutaneous laparoscopy for cryopreservation of ovarian tissue.
    

Detailed description: 
      This is a retrospective analysis to evaluate the efficacy and safety of percutaneous
      laparoscopy for the ovarian tissue explant in oncologic women. Surgical outcomes of patients
      that underwent percutaneous laparoscopy were compared with those of women that underwent
      conventional laparoscopy. Data from 2017 to 2021 were collected in a single Oncologic Center
      in Italy. The principal outcomes considered are post-operative pain, recovery time and
      aesthetic outcomes.
    

Intervention name(s): Ovaian tissue explant
Intervention type(s): Device
Intervention description(s): Ovarian tissue explant for cryopreservation of ovarian tissue
Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        Women with histological diagnosis of malignancy during reproductive age undergoing ovarian
        tissue explant for ovarian tissue cryopreservation, from Aug 2017 to Jun 2021.
      
Keywords: Percuvataneous laparoscopy; Ovarian Tissue Cryopreservation
Study of Cingal® for Symptomatic Relief of Osteoarthritis of Ankle Joint
Condition: Osteoarthritis, Ankle
MeSH terms: Osteoarthritis
Study type: Interventional
Phase: Phase 3

Summary: 
      This Trial will obtain clinical data to support an expanded indication for a single injection
      of Cingal® used for the symptomatic relief of osteoarthritis in the ankle joint.
    

Detailed description: 
      CINGAL® is a chemically cross-linked sodium hyaluronate combined with Triamcinolone
      Hexacetonide supplied as a 4-mL unit dose in a 5-mL glass syringe. Cingal will be injected
      into the intraarticular (IA) space of the index hip using an 18-21-gauge needle. It is used
      for the symptomatic relief of osteoarthritis in the ankle joint.
    

Intervention name(s): Cingal
Intervention type(s): Device
Intervention description(s): CINGAL® is a chemically cross-linked sodium hyaluronate combined with Triamcinolone Hexacetonide supplied as a 4-mL unit dose in a 5-mL glass syringe.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Sodium Hyaluronate; Triamcinolone Hexacetonide
Drug-drug Interaction Study (Telmisartan, Amlodipine, Chlorthalidone)
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional
Phase: Phase 1

Summary: 
      To evaluate Drug-drug interaction
    

Detailed description: 
      The purpose of this study is to evaluate the Drug-Drug(telmisartan, amlodipine and/ or
      chlorthalidone) interaction and safety in healthy adult volunteers.
    

Intervention name(s): Telmisartan; Amlodipine; Chlorthalidone
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Amlodipine; Telmisartan; Chlorthalidone
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Ritual Training Program in HNC Patients
Condition: Education; Cognitive Change
Study type: Interventional

Summary: 
      To evaluate the effects of a ritual training program in head and neck cancer (HNC) patients.
    

Detailed description: 
      The purpose of this study will to evaluate the effects of a ritual training program on
      disfigurement, self-esteem, social interaction, and body image in head and neck cancer (HNC)
      patients.

      A prospective, repeated measures, randomized controlled therapeutic intervention design was
      employed. The experimental group will receive a ritual training program, and the control
      group will receive routine care. Patients will be assessed at three time points: baseline
      assessment (T0), and then at 1, 2, and 3-months (T1, T2, and T3) after participating in the
      ritual training program or routine care.
    

Intervention name(s): Ritual training program; Routine care
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Ritual training program including education and demonstration
Other intervention name(s): Routine care following hospital care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Supportive Care
Keywords: Head and neck cancer; Ritual training; disfigurement; body image