bioihbjkbjnl/mcl2 huggingface dataset:
Platelet Rich Fibrin on Root Coverage of Gingival Recessions
Condition: Gingival Recession
MeSH terms: Gingival Recession
Study type: Interventional

Summary: 
      Several surgical techniques and various adjunctive agents have been used to covered Gingival
      Recession (GR) and promote clinical outcomes. The treatment of the GR more used (gold
      standard) is the root coverage with surgical procedures and connective tissue graft, but it
      has limitations due to the conditions of the donor graft. Is necessary develop other
      biomaterials for these cases.

      The platelet rich fibrin is a autologous biomaterial that has gained tremendous momentum
      having been utilized for a variety of dental and medical procedures including periodontal
      surgeries. However, results remain contradictory and mainly focus on the hard and soft tissue
      healing, aesthetics and postoperative discomfort.

      The objective of this study was to evaluate the clinical effects of coronal advanced flap
      (CAF) and CAF + Platelet Rich Fibrin (PRF) on Root coverage (RC) over a period of 24 month.
    


Intervention name(s): Platelet rich fibrin
Intervention type(s): Other
Intervention description(s): The roots of patients with diagnosis of gingival recessions will be covered with coronally advanced flap (CAF) and platelet rich fibrin (PRF) (CAF+PRF)
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized clinical trial (RCT) (Interventional)
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: platelet-rich fibrin; platelet concentrates; periodontal diseases
Combined Letrozole and Clomid in Women With Infertility and PCOS
Condition: Polycystic Ovary Syndrome; Infertility
MeSH terms: Polycystic Ovary Syndrome; Infertility; Syndrome
Study type: Interventional
Phase: Phase 4

Summary: 
      This study evaluates the addition of clomid to letrozole for the treatment of infertility in
      women with polycystic ovary syndrome. Half of the participants will receive letrozole and
      clomid in combination, while the other half will receive letrozole alone.
    

Detailed description: 
      Letrozole and Clomid are both used for ovulation induction, but they have different
      mechanisms of action. Letrozole has been shown to be superior to clomid in achieving live
      birth rates in women with infertility and polycystic ovary syndrome. However, the combination
      of these medications has not been studied. This is a pilot study to evaluate if the
      combination treatment has improved efficacy as measured by ovulation rate.

      This is a randomized controlled trial of letrozole versus letrozole and clomiphene citrate
      (CC) for one menstrual cycle. Women will be randomized in a 1:1 ratio to receive letrozole
      2.5 mg or combination of letrozole 2.5 mg and clomiphene 50 mg for 5 days on days 3-7 of
      menstrual cycle. The women and their partners will be instructed to have regular intercourse
      with the intent to conceive during the cycle. Patients will have an transvaginal ultrasound
      mid cycle and to evaluate number of follicles (>15 mm), follicle size, endometrial thickness
      and pattern. Patients will have mid- luteal phase progesterone level drawn to evaluate
      ovulation. Side effect profile will also be monitored.
    

Intervention name(s): Clomiphene; Letrozole
Intervention type(s): Drug; Drug
Other intervention name(s): clomid; clomiphene citrate; femara
Intervention MeSH terms: Letrozole; Clomiphene; Enclomiphene; Zuclomiphene
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effectiveness of Perturbations Exercises in Improving Balance, Function and Mobility in Stroke Patients
Condition: Stroke
MeSH terms: Stroke
Study type: Interventional

Summary: 
      Following stroke, patients loses functions of the motor, sensory and higher brain cognitive
      faculties to various degrees which lead to diminished balance. It has been documented that
      hemiplegic or hemiparetic stroke patients presented with more posture sway, asymmetric weight
      distribution, impaired weight-shifting ability and decreased stability capability. There are
      many balance exercises and strategies; to improve balance in elderly age group population, to
      prevent fall prevention. But we have very few evidences of giving manual perturbation balance
      training in stroke patients to improve speed, balance and function. Therefore this study is
      taken up to examine whether the manual perturbation balance training is more effective in
      improving speed, balance and function in stroke patients.
    

Detailed description: 
      There are many more studies done for elderly populations, normal individuals for improving
      balance by giving perturbation based balance training.All perturbation exercises are given by
      either mechanical or by self reaching tasks in forward,backward,and in both sideways. There
      are very studies ;who attempted perturbation based balance training to improve balance in
      elderly population but not for stroke patients for their Speed, Balance and Function.The
      manual perturbation exercise can be an promising intervention in the future for various
      conditions
    

Intervention name(s): Perturbation; Conventional Physiotherapy Treatment
Intervention type(s): Other; Other
Intervention description(s): Manual perturbations were given at waist region,over the Shoulders. in following positions- sitting, kneeling, standing positions,10 perturbations were given in forward,backward,both right and left side, 6 days in a week all precautionary measures taken for the patient's safety; Conventional Physiotherapy treatment were given to participants included in this group for 30 mins daily for 4 weeks
Other intervention name(s): Manual Perturbation; control Group
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Fiber Intake Among Children in Relation to Milk Type, Gastrointestinal Symptoms and Iron Status: a Cross-sectional Study
Condition: Healthy Children
Study type: Observational

Summary: 
      Fiber as part of the plants can be provided through eating grains, fruits and vegetables. As
      source of fiber, exclusively breastfed infants do not need additional dietary fiber because
      breast-milk provides oligosaccharides to maintain the bulk for normal gastrointestinal
      movements together with gut probiotics. However, after the period of six months of exclusive
      breastfeeding, then complementary foods are the initial sources of fiber of children aged
      6-59 months diet, e.g. cereals, fruits and legumes should then be introduced. However,
      investigators should consider on the effect of plant foods as a non-haem iron food source
      that is less bioavailable for iron absorption. There are other dietary factors that inhibit
      iron bioavailability, i.e. phytates in grains and rice, vegetables protein, calcium and
      phosphorus in cow's milk and cheese. iron deficiency is remained common globally, especially
      for children age 6-24 month in which it can developing into a severe condition, i.e. iron
      deficiency anemia. Iron deficiency as well as anemia is closely related to delay child growth
      and development, negatively associated with height-for-age, and anemia are at risk for poorer
      cognitive, motor, social-emotional, and neurophysiologic development in the short- and
      long-term outcome. The aim of this study is to see the association between fiber intake from
      different type of milk consumption sources and dietary habits to gastrointestinal health,
      anemia and growth status among children aged 6-36 months.
    

Detailed description: 
      This study is an observational cross-sectional study to get fiber intake profile among
      children aged 6-36 months in relation to cow's and non-cow's milk consumption,
      gastrointestinal symptoms, hemoglobin value and nutritional status. The participants in this
      study are children aged 6-36 months who are recruited from selected Puskesmas (Health Care
      Center) in Jakarta and Bandung after provided with informed consent from children's parents.
      To get proportion of low fiber intake with a degree of reliability 95% and significance level
      of 5%, then 400 subjects is needed as a minimal sample size in this study.

      The children's parents will be interviewed about socio-demographic characteristics of the
      subjects, gastrointestinal symptoms during the past two weeks using VAS (Visual Analogue
      Scale) on frequency of bowel movements in a week, parents's education, family income, and
      child's food intake. The children's weight and height will be measured and blood sample will
      be taken.
    

Observational model: Other
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Children aged 6-36 months are recruited from selected Puskesmas (Health Care Center) in
        Jakarta and Bandung
A Phase I/II Trial of a Tetravalent Live Attenuated Dengue Vaccine in Flavivirus Antibody Naïve Children
Condition: Dengue Fever
MeSH terms: Dengue
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      To assess the safety, reactogenicity and immunogenicity of two doses of the dengue vaccine in
      Flavi-virus antibody-naive children between 6 and 9 years of age.
    

Detailed description: 
      This study was a Phase I/II, open-label trial with one treatment group; 7, healthy,
      flavivirus naïve children between the ages of 6 and 7 years residing in Bangkok, Thailand.
      Seronegative status was determined by measuring neutralizing (N) antibody titers to dengue
      1-4 and JE virus (JE) using hemagglutination inhibition (HAI) (1st) and PRNT (2nd) assays.
      Titers <10 and <10, respectively, were considered negative. Enrolled children received two
      doses of tetravalent dengue vaccine at study months 0 and 6, and two doses of JE vaccine
      (study benefit) at study months 7 and 7.5. Enrolled children attended 20 study visits,
      received 4 injections, and 7 venipunctures (one additional blood sample for screening). In
      the acute period (1 month) following vaccination, safety was assessed using symptom diary
      cards and clinical and laboratory evaluations. Viremia was measured 10 days post dengue
      vaccination. Solicited and unsolicited adverse events were assessed for 30 days following
      each dengue vaccination. Serious adverse events were assessed throughout the study period. In
      the case of illness, investigators would complete additional clinical and virologic
      evaluations. Dengue vaccine immunogenicity was assessed 30 days following each dengue
      vaccination using the PRNT50 assay. The According to Protocol (ATP) cohort was determined by
      evaluating the occurrence of intermittent natural dengue infection using ELISA IgM/IgG titer
      ratios. A long-term follow-up of dengue vaccine recipients is described in a separate
      protocol (Dengue-005 protocol).
    

Intervention name(s): Dengue Vaccine Formulation 17; Licensed Japanese Encephalitis (JE) Vaccine
Intervention type(s): Biological; Biological
Intervention description(s): Tetravalent live attenuated DEN vaccine candidate. Containing dengue serotypes 1,2, and 3 vaccines produced at the Salk Institute and dengue serotype 4 produced at the WRAIR Pilot Bioproduction Facility. Dosage 1 mL administered via injection at Day 0 and Day 60.; Produced by the Thailand GPO using a Beijing strain of JE in liquid form; dosed at 0.5 mL ot 7 and 7.5 months.
Other intervention name(s): F17; JE
Intervention MeSH terms: Vaccines
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: dengue; vaccine
A Phase I Safety and Pharmacokinetics Study of 2',3'-Dideoxyinosine (ddI) Administered Twice Daily to Infants and Children With AIDS or Symptomatic HIV Infection
Condition: HIV Infections
MeSH terms: Infections; Communicable Diseases; HIV Infections; Acquired Immunodeficiency Syndrome
Study type: Interventional
Phase: Phase 1

Summary: 
      To determine the safety and maximum tolerated dose (MTD) of 2',3'-dideoxyinosine (ddI), given
      orally and intravenously, in infants and children with AIDS. The study also measures
      bloodstream and cerebrospinal fluid (CSF) levels of the administered drug, and provides a
      preliminary assessment of the effectiveness of ddI on HIV replication.

      AMENDED: Based on safety established in the first dosing phase of 52 weeks and long term
      dosing data in adults, the dosing period will be extended to 104 weeks. Original design:
      Information presently available indicates that ddI has high antiviral activity with less
      apparent toxicity than zidovudine (AZT) (the drug presently used to treat AIDS).
    

Detailed description: 
      AMENDED: Based on safety established in the first dosing phase of 52 weeks and long term
      dosing data in adults, the dosing period will be extended to 104 weeks. Original design:
      Information presently available indicates that ddI has high antiviral activity with less
      apparent toxicity than zidovudine (AZT) (the drug presently used to treat AIDS).

      AMENDED: Dosing will proceed for 104 weeks at each dose level. Original design: Five patients
      are treated at the initial dose level. Because ddI is not stable in the acid environment of
      the stomach, oral doses of ddI follow administration of an antacid. An alternative method of
      dosing is to mix the reconstituted ddI with an appropriate volume of Maalox TC or Mylanta II.
      In order to determine the MTD, successive groups of 5 patients enter the study at a higher
      dose level after 3 patients have experienced 3 weeks of dosing and significant toxicities
      have not developed. Patients are assigned to treatment groups in the order in which they are
      enrolled. Dosing proceeds for 16 weeks at each dose level. However, consideration is given to
      escalating patients entered at the lowest dose to the next dose level after 10 weeks of
      dosing. The dose escalation continues until toxicities requiring dose modifications are found
      in 2 of 5 in any group.
    

Intervention name(s): Didanosine
Intervention type(s): Drug
Intervention MeSH terms: Didanosine
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Didanosine; Drug Evaluation; Acquired Immunodeficiency Syndrome; AIDS-Related Complex
Study of Yili "Changqing" Pro-ABB Yoghurt in the Improvement of Human Gastrointestinal Tract System
Condition: Constipation; Dyspepsia; Flatulence; Abdominal Pain
MeSH terms: Constipation; Dyspepsia; Abdominal Pain; Flatulence
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether Yili "Chang Qing" Pro-ABB yoghurt is
      effective in improving mild constipation and the intestinal micro-ecology environment &
      alimentation.
    


Intervention name(s): Placebo yoghurt; Yili "Chang Qing" Pro-ABB yoghurt (Formula 1); Yili "Chang Qing" Pro-ABB yoghurt (Formula 2)
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): 100g of placebo yoghurt will be taken at 10:00 am and 4:00 pm, respectively; 2 times per day.; 100g of Yili "Chang Qing" Pro-ABB yoghurt will be taken by at 10:00 am and 4:00 pm, respectively; 2 times per day.
Other intervention name(s): 100g of Yili "Chang Qing" Pro-ABB yoghurt will be taken by at 10:00 am and 4:00 pm, respectively; 2 times per day.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Efficacy of Mitomycin C in Endoscopic Dacryocystorhinostomy: A Systematic Review and Meta-Analysis
Condition: Dacryocystitis
MeSH terms: Dacryocystitis
Study type: Observational

Summary: 
      To assess the efficacy and safety of local application of intraoperative mitomycin C (MMC) at
      osteotomy site in endoscopic dacryocystorhinostomy(EN-DCR).
    

Detailed description: 
      Mitomycin C (MMC) is an antineoplastic agent that inhibits the synthesis of DNA, cellular
      RNA, and protein by inhibiting the synthesis of collagen by fibroblasts. MMC was originally
      used as a systemic chemotherapeutic agent, it has been widely used in ophthalmic practice
      both intraoperatively and postoperatively for prevention of pterygium recurrence, enhancing
      the success rate of glaucoma filtration surgery. Recently, use of MMC has been described in
      lacrimal drainage surgery. It is postulated that adjunctive use of MMC over the osteotomy
      site in endoscopic dacryocystorhinostomy(EN-DCR)surgery could inhibit scarring and
      granulation tissue formation around the osteotomy site or common canaliculus and enhance the
      success of EN-DCR surgery.

      Many controlled trials have investigated adjunctive MMC for primary or revision EN-DCR to
      augment the surgical success rate, but the results are not completely consistent. To the best
      of our knowledge, there was no meta-analysis on comparison of success rate of EN-DCR with MMC
      (MMC group) and endoscopic dacryocystorhinostomy without MMC (control group). Therefore, the
      aim of this study was to undertake systematic review and meta-analysis to evaluate the
      efficacy of intraoperative MMC application in EN-DCR surgery and help ophthalmologists to
      determine whether it is a useful adjuvant in EN-DCR surgery.
    

Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        Patients were scheduled to undergo endoscopic dacryocystorhinostomy and randomized to with
        and without MMC
      
Keywords: Endoscopic dacryocystorhinostomy; Mitomycin C
Comparing Behavioral Therapies for Treating Adolescents With Post-Traumatic Stress Disorder Related to Sexual Abuse
Condition: PTSD
MeSH terms: Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
Study type: Interventional
Phase: Phase 2

Summary: 
      Posttraumatic stress disorder (PTSD) is the most common disorder among childhood sexual abuse
      survivors and is associated with substantial psychosocial and medical problems, but
      evidence-based treatment for PTSD in adolescents is lacking. This study aims to examine the
      efficacy and effectiveness of prolonged exposure therapy for adolescents with client-centered
      therapy.
    


Intervention name(s): Prolonged Exposure for Adolescents; Client Centered Therapy
Intervention type(s): Behavioral; Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: PTSD; Cognitive Behavioral Treatment; Child Sexual Abuse
A Study of Subcutaneously (SC) Administered Tocilizumab (TCZ) in Participants With Polyarticular-Course Juvenile Idiopathic Arthritis (pJIA)
Condition: Juvenile Idiopathic Arthritis
MeSH terms: Arthritis; Arthritis, Juvenile
Study type: Interventional
Phase: Phase 1

Summary: 
      This open-label, multicenter study evaluated the pharmacokinetics, pharmacodynamics and
      safety of SC administered TCZ in participants with pJIA.
    


Intervention name(s): Tocilizumab
Intervention type(s): Drug
Intervention description(s): Participants will receive 162 mg of TCZ as SC injection Q3W or Q2W for 52 weeks
Other intervention name(s): RoActemra/Actemra
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Aerobic Exercise for Concussion
Condition: Mild Traumatic Brain Injury; Acute Brain Injury; Brain Concussion
MeSH terms: Brain Injuries; Brain Injuries, Traumatic; Brain Concussion; Wounds and Injuries
Study type: Interventional

Summary: 
      The use of aerobic exercise treatment in the chronic phase of concussion recovery is
      well-described in the literature but there are limited existing data on the effect of
      exercise treatment in the acute phase after sport-related concussion (SRC). This study will
      compare the outcomes of adolescents with a recent SRC who are randomized to sub-threshold
      aerobic exercise versus those randomized to placebo stretching to evaluate the effect of
      aerobic exercise in the acute recovery phase.
    

Detailed description: 
      Historically, concussion has been described as a cognitive injury and patients have been
      advised not to engage in any cognitive or physical exertion while symptomatic. More recently,
      however, concussion has been described as a physiological injury affecting both the heart and
      autonomic nervous system, and patients suffering from prolonged concussion-related symptoms
      and deficits have been encouraged to begin aerobic exercise as part of their concussion care.
      While intensive exercise too soon after concussion has been associated with delayed recovery
      and used to justify prolonged periods of rest, recent studies have shown that controlled,
      sub-symptom threshold aerobic exercise may aid recovery by improving autonomic balance and
      cerebral blood flow auto-regulation after concussion. This study will randomly assign
      pediatric patients with concussion to a treatment group in which they will complete
      sub-symptom threshold aerobic exercise or to a placebo group in which they will complete a
      standardized stretching protocol. All participants will have routine visits that consist of a
      physical examination and exercise test until the intervention ends at recovery or 1-month
      post-randomization.
    

Intervention name(s): Aerobic Exercise; Stretching Exercise
Intervention type(s): Other; Other
Intervention description(s): Participants will be given a prescription to exercise up to 90% of their threshold heart rate for symptom exacerbation. Heart rate threshold will be monitored weekly in order to increase exercise level accordingly.; Participants will be given a prescription to complete a standardized stretching protocol.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Aerobic Exercise
Effect of Indacaterol on Inspiratory Capacity and Lung Function in Patients With COPD Versus Placebo and Formoterol
Condition: COPD
MeSH terms: Respiratory Aspiration
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to assess the change in inspiratory capacity and lung function
      in patients with chronic obstructive pulmonary disease when treated with indacaterol compared
      to placebo and formoterol.
    


Intervention name(s): Indacaterol (QAB149)
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double
Primary purpose: Treatment
Keywords: inspiratory capacity, FEV1, COPD