bioihbjkbjnl/mcl2 huggingface dataset:
Letrozole vs. Clomiphene Citrate in Patients With Anovulatory Infertility
Condition: Infertility
MeSH terms: Infertility; Anovulation
Study type: Interventional
Phase: Phase 3

Summary: 
      OBJECTIVE: To compare the effectiveness of letrozole and clomiphene citrate (CC) in patients
      with anovulatory infertility. DESIGN: Open, prospective, randomized, parallel group,
      multicentric, comparative trial. SETTING: Out patient clinics of infertility centers in
      India. PATIENT(S): Fifty-five patients with anovulatory infertility were recruited.
      Twenty-seven patients (59 cycles) were given letrozole and twenty-eight patients (68 cycles)
      were given CC. Both drugs were given orally on days 3-7 of menstrual cycle. INTERVENTION(S):
      Letrozole, CC, ovulation induction, vaginal micronized progesterone, IUI.
    

Detailed description: 
      MAIN OUTCOME MEASURE(S): Occurrence of ovulation, endometrial thickness and pregnancy rates.
    

Intervention name(s): Letrozole; Clomiphene citrate
Intervention type(s): Drug; Drug
Intervention description(s): Tablet Letrozole 2.5 mg once a day for 5 days for 3 cycles; Clomiphene citrate 100 mg or 150 mg once a day for 5 days in 3 cycles
Other intervention name(s): Letroz; Ferotab
Intervention MeSH terms: Letrozole; Clomiphene; Enclomiphene; Zuclomiphene
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Letrozole; Clomiphene citrate; Anovulatory infertility; Ovulation induction
A Study to Test 2 Doses of the HRV Vaccine Given With or Without OPV in Healthy Infants in Bangladesh
Condition: Infections, Rotavirus
MeSH terms: Rotavirus Infections
Study type: Interventional
Phase: Phase 2

Summary: 
      The main objective of this study is to provide immunogenicity data for GSK Biologicals' HRV
      vaccine when co-administered with OPV or when given alone (HRV vaccine dose given 15 days
      after the OPV dose).
    

Detailed description: 
      "The study will have four groups: Group HRV + OPV, Group HRV alone, Group Placebo + OPV and
      Group Placebo alone. Two-dose immunisation will be administered in healthy infants at
      approximately 12 and 16 weeks of age. Immunogenicity, reactogenicity and safety relative to
      the placebo will also be evaluated. Treatment allocation: randomized (2:2:1:1). Routine EPI
      vaccines should be administered during the study following the EPI recommendation in
      Bangladesh."
    

Intervention name(s): Rotavirus
Intervention type(s): Biological
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Prevention
A Pilot Study to Determine Safety & Efficacy of Autologous Human Platelet Lysate (HPL) in Treatment of Acne Scarring
Condition: ACNE SCARRING
MeSH terms: Cicatrix
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This is a multicentre, open label, randomized, pilot study to evaluate safety and efficacy of
      Human Platelet Lysate (HPL) in subjects with Acne Scarring. The study is being conducted at 2
      centers in India. The primary endpoint is change in the Global Acne scarring classification
      scores from screening to end of the study. The secondary endpoints are Photographic
      Assessment, Physicians assessment score and Patients self assessment score.
    


Intervention name(s): Autologous Human Platelet Lysate; Autologous Human Platelet Lysate
Intervention type(s): Biological; Biological
Intervention description(s): Subjects will receive a single injection of Autologous Human Platelet Lysate for acne scarring; Subjects will receive two injections of Autologous Human Platelet Lysate at an interval of one month for acne scarring
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Sisters in Health: A Weight Loss Study for African American Women
Condition: Obesity
MeSH terms: Weight Loss
Study type: Interventional

Summary: 
      The purpose of this study is to compare the effect of a physical activity-enhanced behavioral
      weight loss intervention, compared to a standard behavioral weight loss intervention in
      African American women.
    

Detailed description: 
      A disparity exists in the prevalence of overweight and obesity between non-Hispanic white
      (NHW) and African American (AA) women. More AA women (78.2%) are overweight or obese compared
      to NHW (61.2%). Obesity increases the risk of developing numerous chronic diseases, including
      type 2 diabetes (T2DM), hypertension, cardiovascular disease, and some cancers. Among AA
      women, there is a higher prevalence, and almost double the risk, of developing T2DM compared
      to NHW. African Americans also have higher rates of complications and mortality from T2DM,
      and are more at risk for hypertension compared to NHW. Obesity is a costly epidemic.
      Fortunately, weight is a modifiable risk factor for reducing or preventing obesity and
      related diseases.

      Interventions to reduce overweight and obesity through lifestyle change have been less
      effective for AA women compared to NHW women. African American women tend to lose less weight
      in standard behavioral weight loss interventions. A potential reason for smaller weight loss
      is that compared to NHW women, AA women have been shown to engage in less physical activity
      (PA) during these interventions.

      The Sisters in Health study will test the efficacy of a 6-month randomized controlled trial
      in overweight and obese African American women. Women will be recruited to participate in
      this study comparing a standard behavioral weight loss intervention (BWI) to a physical
      activity enhanced BWI (BWI-PA) for 6 months. The primary objective of this study is to
      determine if AA women randomized to the BWI-PA will experience greater weight loss and PA
      compared to women receiving the BWI. Women in both groups will receive 18 face-to-face
      sessions on a tapered basis (weekly to biweekly). Face-to-face sessions will provide women
      with the knowledge, behavioral skills and strategies for weight loss.
    

Intervention name(s): Standard Weight Loss Intervention; Physical Activity Enhanced Weight Loss Intervention
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 18 session, group-based, 6-month, standard behavioral weight loss intervention; 18 session, group-based, 6-month, physical activity enhanced behavioral weight loss intervention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Triple Combination Therapy in Type 2 Diabetic Patients Who Had Inadequate Glycemic Control With Combination Therapy
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 4

Summary: 
      To assess the efficacy of treatment with sitagliptin or dapagliflozin or lobeglitazone in
      type 2 diabetes mellitus patients, who had inadequate glycemic control even though use of two
      drug combination therapy with glimepiride and metformin.
    

Detailed description: 
      Dual combination therapy with metformin and sulphonylurea is the most commonly used
      combination regimen to treat patients with type 2 diabetes. But, treatment with the dual
      combination therapy is often unsuccessful at achieving glycaemic control in patients with
      type 2 diabetes.

      Recently, various oral hypoglycemic agents were developed including dipeptidyl peptidase
      (DPP)-IV inhibitor, sodium-glucose cotransporter 2 (SGLT2) inhibitor and new peroxisome
      proliferator-activated receptors (PPARs) agonists.

      But, there have been few studies about the glucose lowering effect of these drugs in Type 2
      diabetes patients on the dual combination therapy with a sulfonylurea agent and metformin.

      Hence, the researchers plan to investigate the efficacy and safety of these drugs in
      combination with a sulfonylurea agent and metformin in type 2 diabetic patients.
    

Intervention name(s): Sitagliptin; Dapagliflozin; Lobeglitazone; Glimepirde; Metformin
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): 100mg qd per oral during 24months
compared with other treatment groups; 10mg qd per oral during 24months
compared with other treatment groups; 0.5mg qd per oral during 24months
compared with other treatment groups
Other intervention name(s): Januvia; Forxiga; Duvie; Amaryl
Intervention MeSH terms: Metformin; Sitagliptin Phosphate; Dapagliflozin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: triple combination therapy; sitagliptin; dapagliflozin; lobeglitazone
D-dimer Levels During and After Anticoagulation in Patients With a Previous Venous Thromboembolism: Effects on the Risk of Recurrence
Condition: Deep Vein Thrombosis; Pulmonary Embolism
MeSH terms: Pulmonary Embolism; Thrombosis; Embolism; Thromboembolism; Venous Thromboembolism; Venous Thrombosis; Recurrence
Study type: Observational

Summary: 
      The results of the Prolong study, currently submitted for publication, show that patients
      with a first unprovoked venous thromboembolic event who have altered D-dimer levels, measured
      one month after anticoagulation with vitamin K antagonists is stopped, have a high rate of
      recurrences (about 14%) and a prolongation of anticoagulation is effective in reducing
      significantly this rate. Those patients with normal D-dimer (about 60% of all patients
      examined) have a low rate of recurrences (about 5%) and likely a prolongation of
      anticoagulation in all these patients cannot be recommended.

      In line with these results, the Prolong-Two study aims at assessing the predictive role for
      recurrence of D-dimer levels measured: a) during anticoagulation, b) one month after its
      withdrawal and c) periodically during follow up.

      Patients with a first unprovoked venous thromboembolism (including proximal deep vein
      thrombosis of a leg and/or pulmonary embolism) which are treated with vitamin K antagonists
      for not less than 6 months are considered for the study. D-dimer assay is performed during
      anticoagulation and patients with altered results continue the anticoagulation for 6 more
      months. Those with normal D-dimer stop the anticoagulant treatment and are again examined one
      month later. Anticoagulation is resumed for 6 more months in those patients with abnormal
      D-dimer results but is permanently stopped in those with a normal assay. The latter patients
      are examined and D-dimer assay performed again every two months to evaluate the natural
      history of the assay after anticoagulation is stopped and the possible predictive value for
      recurrence of a change of the assay during follow-up from normal to abnormal results.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Subjects with a single previous idiopathic venous thromboembolic event who stop
        anticoagulation
      
Biospecimen description: 
      Plasma samples for D-dimer assays or other coagulation tests
    
Keywords: Deep Vein Thrombosis; Pulmonary Embolism; D-dimer; Recurrence; Duration of Anticoagulation; Vitamin K Antagonists
Effect of High Intensity Laser Versus Plus Exercises
Condition: Effect of High Intensity Laser Plus Exercises on Wrist Pain
Study type: Interventional

Summary: 
      High-intensity laser therapy (HILT) has been used more recently in the therapeutic protocols
      of musculoskeletal pain management. This study is conducted to find out the effect of high
      intensity laser therapy only versus high intensity laser pulse exercises on level of wrist
      pain, function and Joint position sense in girls Gymnasts
    

Detailed description: 
      Effect of high intensity laser plus exercises on wrist pain ..three groups of gymnastics
      girls suffer from non specific wrist is allocating ..the first group will receive exercises
      only , the second will receive laser only while the third will receive exercises plus laser
    

Intervention name(s): high intensity laser plus exercise; high intensity laser only; exercise
Intervention type(s): Other; Device; Other
Intervention description(s): high intensity laser plus exercise; high intensity laser only; exercise only
Other intervention name(s): exercise only
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Phase II Study of Oxaliplatin in Combination With 5-Fu in 1st Line Treatment of Locally Advanced or Metastatic Squamous Cell Carcinoma of the Head and Neck
Condition: Head and Neck Cancer
MeSH terms: Carcinoma, Squamous Cell; Squamous Cell Carcinoma of Head and Neck
Study type: Interventional
Phase: Phase 2

Summary: 
      To evaluate the efficacy of first line oxaliplatin in combination with 5-fluorouracil (5-FU)
      in patients with advanced inoperable or metastatic head and neck cancer and to investigate
      the safety profile of this regimen in the above indication and consider other criteria of
      efficacy (clinical benefit, survival)
    


Intervention name(s): Oxaliplatin, 5-FU
Intervention type(s): Drug
Intervention description(s): Oxaliplatin: 130 mg/m² in 500 mL of 5% glucose solution as a 2-hour intravenous (IV) infusion on Day 1 and repeated every 3 weeks; 5-FU: following oxaliplatin administration, 1000 mg/m²/day as a continuous IV infusion from Day 1 toDay 4, every 3 weeks.Dose adjustments were made if the patient experienced AEs.
Other intervention name(s): Eloxatin®, Fluorouracil
Intervention MeSH terms: Fluorouracil; Oxaliplatin
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Cost-effectiveness of Four Methods in Preventing Fissure Caries in Permanent Teeth
Condition: Dental Caries
MeSH terms: Dental Caries
Study type: Interventional
Phase: Phase 2

Summary: 
      The aim of this proposed study is to investigate the cost-effectiveness of four methods in
      preventing fissure caries in permanent teeth, which is the most prevalent dental disease in
      primary school children in China.

      The four caries prevention methods are: resin fissure sealant, atraumatic restorative
      treatment (ART) sealant, sodium fluoride varnish, and silver diamine fluoride (SDF) solution.

      The specific study objectives are:

        1. to describe longitudinally the clinical outcomes of using the above four methods to
           prevent dental caries in the pits and fissures of permanent first molars in school
           children,

        2. to describe the cost of using the above four methods to prevent dental caries in an
           outreaching dental care programme in China, and

        3. to compare the cost-effectiveness of the above four caries prevention methods.
    


Intervention name(s): ART dental sealant; Resin dental sealant; Sodium fluoride varnish; Silver fluoride solution
Intervention type(s): Other; Other; Other; Other
Intervention description(s): ART dental sealant placed with glass ionomer material using the ART technique on permanent first molar, single-time placement and no replacement; Resin dental sealant placed on pits and fissures of first permanent molars, single-time placement and no replacement; Topical application of 5% sodium fluoride varnish onto pits and fissures of permanent first molars, repeated every 6 months; Topical application of 38% silver fluoride solution onto pits and fissures of permanent first molars, repeated every 12 months
Intervention MeSH terms: Listerine; Fluorides; Sodium Fluoride; Fluorides, Topical
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: dental caries
Treatment of Demodex Blepharitis With Ivermectin Gel 0.1% Plus Metronidazole 1%
Condition: Chronic Blepharitis
MeSH terms: Blepharitis
Study type: Interventional
Phase: Phase 3

Summary: 
      Blepharitis is a endemic inflammatory disease caused mainly by Demodex folliculorum and
      Demodex Brevis, This mites are often associated with anaerobic bacteria that produces a skin
      inflammation, so a intervention that reduces the number of mites and bacteria would be
      desirable. Ivermectin a macrolid compound have demonstrated activity against scabies and lice
      in humans and in animals and a single application have show a good response in lice
      eradication.

      In this study , investigators will determinate the security and effectiveness of this
      compound in the eradication of mites
    


Intervention name(s): Ivermectin 0.1% Metronidazole 1%; None intervention
Intervention type(s): Drug; Other
Intervention description(s): Volunteers with no signs of blepharitis and with eyelashes with no demodex. Symptoms and signs will be compared with experimental group
Other intervention name(s): 22,23-dihydroavermectin B1a + 22,23-dihydroavermectin B1b
Intervention MeSH terms: Metronidazole; Ivermectin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Keywords: Blepharitis , Demodex, Ivermectin, Metronidazole
Influence of the Coloring of a Complex Form on Anxiety Associated With Care.
Condition: Anxiety
MeSH terms: Anxiety Disorders
Study type: Observational

Summary: 
      Evaluate the contribution of a coloring-type artistic task of a complex form in the reduction
      of anxiety related to care and pathology by a self-questionnaire "State-Trait anxiety
      inventory" and a self-questionnaire on the experience of the activity, in 3 different medical
      situations: in day hospitalization service in psychiatry, in hemodialysis service and in an
      ambulatory consultation waiting room.
    

Detailed description: 
      Evaluate the contribution of a coloring-type artistic task of a complex form in the reduction
      of anxiety related to care and pathology by a self-questionnaire "State-Trait anxiety
      inventory" and a self-questionnaire on the experience of the activity, in 3 different medical
      situations.
    

Intervention name(s): coloring-type artistic task of a complex form
Intervention type(s): Other
Intervention description(s): coloring-type artistic task of a complex form
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patient from Sainte-Musse Hospital
      
Keywords: STAI Questionnaire; ECTM2-Qa
Paradigm Shift in the Treatment of Patients With ACS
Condition: Acute Coronary Syndrome
MeSH terms: Acute Coronary Syndrome; Syndrome
Study type: Interventional
Phase: Phase 4

Summary: 
      This protocol describes a pilot study intended to test the hypothesis that patients with
      acute coronary syndrome (ACS) caused by plaque erosion can be stabilized by effective
      antithrombotic treatment without stent implantation, thereby avoiding both early and late
      complications related to percutaneous coronary intervention (PCI).
    


Intervention name(s): Ticagrelor
Intervention type(s): Drug
Intervention MeSH terms: Ticagrelor
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Pilot-Study DCPT for PTSD in Adolescents and Young Adults
Condition: PTSD
Study type: Interventional

Summary: 
      The aim of this pilot study is to evaluate the developmentally adapted cognitive processing
      therapy (D-CPT)in adolescents suffering from childhood abuse(CA)or physical abuse (PA)
      related PTSD. D-CPT's feasibility and efficacy will be examined in 20 adolescents suffering
      from CA or PA-related PTSD in a multicenter study (3 sites).Patients will be assessed prior
      to (t0), post (t1) and 6 weeks after treatment (t2). Assessments include Clinician
      Administered PTSD Scale (CAPS), UCLA PTSD Index (UCLA), Beck Depression Inventory (BDI),
      Adolescent Dissociative Experiences Scale (A-DES), and Borderline Symptom List (BSL-23).
    

Detailed description: 
      The aim of this pilot study is to evaluate the developmentally adapted cognitive processing
      therapy (D-CPT)in adolescents suffering from childhood sexual abuse (CA) or childhood
      physical abuse (PA) related PTSD. D-CPT's feasibility and efficacy will be examined in 20
      adolescents suffering from CA or PA-related PTSD in a multicenter study in Berlin, Frankfurt
      and Ingolstadt in Germany (3 sites).Patients will be assessed prior to (t0), post (t1) and 6
      weeks after treatment (t2). Assessments include Clinician Administered PTSD Scale (CAPS),
      UCLA PTSD Index (UCLA), Beck Depression Inventory (BDI), Adolescent Dissociative Experiences
      Scale (A-DES), and Borderline Symptom List (BSL-23).
    

Intervention name(s): Developmentally adapted cognitive processing therapy
Intervention type(s): Behavioral
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: PTSD; childhood sexual abuse; physical abuse; developmentally adapted cognitive processing therapy
KRN125 for Mobilization of Hematopoietic Stem Cells
Condition: Peripheral Blood Stem Cell Transplantation
Study type: Interventional
Phase: Phase 2

Summary: 
      Data collection to evaluate safety and effect of hematopoietic stem cell mobilization into
      the peripheral blood after a single subcutaneous (SC) dose of KRN125(Pegfilgrastim)in healthy
      adults.
    

Detailed description: 
      KRN125 is administered as a single SC dose to the Day 1. The stem cell mobilization protocols
      will be monitored for safety and efficacy during the mobilization period.
    

Intervention name(s): Pegfilgrastim
Intervention type(s): Drug
Intervention description(s): Single dose of SC administration
Intervention model: Single Group Assignment
Intervention model description: Phase II, single center, open label, non-control, dose setting study
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hematopoietic Stem Cells Mobilization; Healthy Volunteer (HV); filgrastim; allogenic hematopoetic stem cell transplantation
PK Study of Telmisartan/Rosuvastatin FDC Compared to Combination of Telmisartan and Rosuvastatin
Condition: Dyslipidemia & Hypertension
MeSH terms: Dyslipidemias
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a 2 by 2 cross-over study to evaluate pharmacokinetics of telmisartan and
      rosuvastatin FDC compared to reference telmisartan and rosuvastatin coadministered in two
      groups enrolling healthy adult male and female subjects under fasting conditions.

      Subjects will be admitted to the clinic in the evening before Day 1. All subjects will
      receive a single oral dose of telmisartan/rosuvastatin FDC or telmisartan and rosuvastatin
      co-administered in the morning on Day 1. All the subjects will remain in the clinical unit
      until completion of all assessments on Day 2 including collection post-dose PK sample.
      Subjects will return to the clinic for pharmacokinetic samples at scheduled time.

      The two treatment periods will be separated by a washout period.
    


Intervention name(s): Crestor 20mg(Rosuvastatin 20mg), Micardis 80mg(Telmisartan 80mg) , FDC
Intervention type(s): Drug
Intervention description(s): For co-administration, Crestor 1 tablet and Micardis 1 tablet. For FDC administration, FDC 1 tablet.
Intervention MeSH terms: Telmisartan; Rosuvastatin Calcium
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)