bioihbjkbjnl/mcl2 huggingface dataset:
Safety and Efficacy of Bimatoprost/Timolol Fixed Combination Versus Latanoprost in Patients With Open-Angle Glaucoma Who Have Never Been Treated
Condition: Glaucoma, Open-Angle
MeSH terms: Glaucoma; Glaucoma, Open-Angle
Study type: Interventional
Phase: Phase 4

Summary: 
      This study will evaluate the safety and efficacy of bimatoprost/timolol fixed combination
      (GANfort®) versus latanoprost (Xalatan®) in patients with open-angle glaucoma who have never
      been previously treated and are at high risk for progression.
    


Intervention name(s): bimatoprost 0.03%/timolol 0.5% combination ophthalmic solution; latanoprost 0.005% ophthalmic solution
Intervention type(s): Drug; Drug
Intervention description(s): Bimatoprost 0.03%/timolol 0.5% combination ophthalmic solution (GANfort®) administered to each eye requiring treatment, once daily in the evening for 3 months.; Latanoprost 0.005% ophthalmic solution (Xalatan®) administered to each eye requiring treatment, once daily in the evening for 3 months.
Other intervention name(s): GANFort®; Xalatan®
Intervention MeSH terms: Timolol; Bimatoprost; Pharmaceutical Solutions; Latanoprost; Ophthalmic Solutions
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Virtual Reality Exercise on COPD Patient
Condition: COPD
Study type: Interventional

Summary: 
      The program allows the patient to interact with the simulated VR technology using motion
      sensors, focusing on patients' fitness through various tests providing them a clinically
      stable environment; to counter moderate level of diseases according to GOLD criteria and to
      monitor the effects of exercise program on dyspnea. The purpose of this study is to
      facilitate the patients so that they get acquainted with the digital technology with
      significant contribution towards pulmonary rehabilitation program for COPD patients. It also
      analysis the satisfaction of the patients and encourages the use of emerging technology
      integrated with clinical trials.
    

Detailed description: 
      Chronic obstructive lung disease (COPD) is a reversible lung disease which is a principal
      cause of morbidity and mortality worldwide. It is the third leading cause of death worldwide
      according to the reports of American Thoracic Society (ATS) and European- Respiratory
      Society. According to World Health Organization (WHO), every year death and in 2030 it will
      become the third most common cause of death. COPD risk factors includes smoking tobacco,
      exposure to dusts, hereditary predisposition, and fumes, indoor and outdoor air pollutants,
      ageing, and asthma. Out of all these risk factors, the main reason that develops COPD fastest
      is smoking which is further linked with depression
    

Intervention name(s): Virtual Reality; Control
Intervention type(s): Other; Other
Intervention description(s): Total time duration for session is 40 minutes which includes 5 min of warm exercises which include heel raises, arm circles, side leg raises, trunk rotation, elbow flexion and extension, knee flexion and extension, and shoulder internal and external rotation, 30 minutes of VR session and 5-7 min of cool down exercises which include full body stretches i.e., toe touching, pectoralis major stretch, side by side bending, quadricep stretch, hamstring stretch, trapezius stretch and deep breathing.; Control group receive endurance exercise testing in which stationary cycle is used for 30 min per session. It includes lower extremity strengthening i.e., increases hamstring and quadricep strength. Total time duration for session is 40 minutes in which 5 min of warm up exercises which include heel raises, arm circles, side leg raises, trunk rotation, elbow flexion and extension, knee flexion and extension, and shoulder internal and external rotation, 30 min of bicycling and after that 5-7 min of cool down exercises which include full body stretches i.e., toe touching, pectoralis major stretch, side by side bending, quadricep stretch, hamstring stretch, trapezius stretch and deep breathing.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: physical fitness; Virtual reality; rehabilitation
Perineal Body Length and Perineal Lacerations
Condition: Perineal Laceration Involving Skin; Delivery; Trauma
MeSH terms: Lacerations
Study type: Observational

Summary: 
      The aim of this study was to evaluate the relationship between perineal body length and
      perineal laceration risk in primigravid patients.

      Primigravid women with singleton pregnancies in the first stage of labor at the 35th week of
      gestation were included in the study. The peineal body length of the patients was measured by
      the same physician.
    

Detailed description: 
      After 35 weeks of gestation, nulliparous women with single gestation were included in the
      study and genital hiatus and perineal body measurements were taken.

      The presence and degree of perineal laceration after birth were determined. Correlation of
      genital hiatus and perineal body measurements with perineal laceration risk were evaluated.

      After birth, vaginal laceration, oxytocin use, fetal birth weight, the presence of episiotomy
      were recorded.
    

Intervention name(s): Primigravid women with singleton pregnancy at 35th week over
Intervention type(s): Other
Intervention description(s): Primigravid women with singleton pregnancy at 35th week over; only observational study will be done in this group and the data will be recorded.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Meet the criteria of inclusion in our hospital for birth,The study was planned for women
        with singleton pregnancies of 35 weeks or more.
      
Keywords: perineal laceration; obstetric trauma
Behavioral and Biomedical HIV Prevention Interventions for Thai Men Who Have Sex With Men
Condition: HIV Testing, MSM
Study type: Observational

Summary: 
      Objectives

        1. To evaluate the acceptability and feasibility of "standard HIV prevention package" among
           Thai men who have sex with men (MSM)

        2. To conduct a pilot study to demonstrate the acceptability and feasibility of
           internet-based social networking, asymptomatic sexually transmitted infection diagnosis
           and treatment and pre-exposure prophylaxis strategies as "potential HIV prevention
           methods" among Thai MSM

        3. To use mathematical modeling to identify the most effective HIV prevention package
           optimized for Thai MSM

      Subject population: HIV-negative MSM clients of the Thai Red Cross Anonymous Clinic (TRC-AC),
      age ≥18 years old,Each participant will have a 12-month follow-up duration in the study.
    

Detailed description: 
      Study design and methodology:

      We will conduct a pilot study among 100 MSM participants who will be enrolled from the TRC-AC
      and will be followed up for 12 months. Participants will be followed at baseline, months 1
      and 3, and then every 3 months. Interventions in the "standard HIV prevention package" to be
      provided at every clinic visit include anti-HIV testing, risk reduction counseling,
      provisions of free condoms and lubricants and diagnosis and treatment of symptomatic sexually
      transmitted infections (STI). All participants will also have access to non-occupational
      post-exposure prophylaxis (nPEP) without charge as part of the standard HIV prevention
      package. In addition, we will test for acceptability and feasibility of the "potential HIV
      prevention methods" which include:

      1) Internet-based social networking to distribute and stimulate discussion of HIV prevention
      information (2) Asymptomatic STI diagnosis and treatment for every participant at baseline
      visit and every 6 months (3) Oral and topical pre-exposure prophylaxis (PrEP) strategies
      using placebo tablet and gel.

      The meta-analysis of various behavioral and biomedical HIV prevention studies among MSM will
      be done in parallel with the pilot study in order to gather information for mathematical
      modeling and finally to inform the design of a larger study. Data acquired from the pilot
      study will be used for mathematical modeling of HIV transmission among MSM. The output from
      the modeling will directly inform HIV preventative interventions to be evaluated empirically
      among MSM in Thailand.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        men who have sex with men in Thailand
      
Keywords: 100 HIV-negagtve MSM
Sodium Alendronate in Non Surgical Periodontal Therapy
Condition: Periodontitis; Bone Resorption
MeSH terms: Bone Resorption; Periodontitis
Study type: Interventional
Phase: Phase 4

Summary: 
      In the past few years, studies have evaluated the effect of systemic use of sodium
      alendronate, especially in the treatment of structural bone defects caused by periodontal
      diseases. This study evaluated the effects of non-surgical periodontal treatment associated
      with the topical application of 1% sodium alendronate on clinical and topographical
      parameters. Chronic periodontitis patients were recruited for the present study and were
      monitored at 3 and 6 months after baseline examinations. A placebo gel was used as control.
    


Intervention name(s): Sodium alendronate; Placebo
Intervention type(s): Drug; Other
Intervention description(s): After manual quadrant-wise scaling and root planing, at the final treatment appointment the randomized selected periodontal site (showing pocket depth ≥ 5mm, clinical attachment loss > 3mm and proximal bone defects) received 1% sodium alendronate gel; After manual quadrant-wise scaling and root planing, at the final treatment appointment the randomized selected periodontal site (showing pocket depth ≥ 5mm, clinical attachment loss > 3mm and proximal bone defects) received 1% placebo gel
Other intervention name(s): biphosphonates
Intervention MeSH terms: Alendronate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Extension Study of the Efficacy of the GSK 580299 Vaccine in Japanese Women Vaccinated in the Primary NCT00316693 Study
Condition: Infections, Papillomavirus
MeSH terms: Uterine Cervical Dysplasia
Study type: Interventional
Phase: Phase 3

Summary: 
      This extension study is conducted to assess the efficacy of the GSK 580299 vaccine against
      cervical intraepithelial neoplasia (CIN) lesions, cervical cancer and cytological
      abnormalities associated with human papillomavirus (HPV)-16 and/or HPV-18 or other oncogenic
      HPV types for an additional two years. All subjects who participated in the primary
      vaccination study NCT00316693 and who confirmed their interest in participating in a long
      term follow up study will therefore be invited to be followed for up to 48 months after
      administration of the first dose of vaccine. In addition, safety and persistence of the
      humoral immune response will be evaluated in this study.

      This protocol posting deals with objectives & outcome measures of the extension phase at
      Months 36 and 48. The objectives & outcome measures of the primary phase are presented in a
      separate protocol posting (NCT number = NCT00316693).
    


Intervention name(s): Liquid-based cytology (LBC) sampling; Blood sampling
Intervention type(s): Procedure; Procedure
Intervention description(s): LBC samples will be collected at Months 36 and 48 for cytology and HPV DNA testing (by PCR); Blood samples will be collected at Months 36 and 48 for antibody determination
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: HPV vaccine; cervical intraepithelial neoplasia (CIN); including new onset of autoimmune disease [NOAD]); new onset of chronic disease (NOCD); medically significant condition (MSC)
Long-term Safety and Tolerability of Cariprazine as an Adjunctive Treatment to Antidepressant Therapy in Patients With Major Depressive Disorder
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 3

Summary: 
      The objective of this study is to evaluate the long-term safety and tolerability of
      cariprazine as an adjunctive treatment to antidepressant therapy (ADT) in patients with Major
      Depressive Disorder (MDD).
    


Intervention name(s): Cariprazine; Antidepressant Therapy (ADT)
Intervention type(s): Drug; Drug
Intervention description(s): Cariprazine capsules 0.5 mg, 1.0 mg, and 1.5 mg; Cariprazine doses 1.5, 3.0, or 4.5 mg/day (d); patients will be titrated to a starting dose of 3.0 mg/d. Patients can stay on 3.0 mg/d or the dose can be adjusted to 1.5 mg or 4.5 mg based on investigator's judgment of response and tolerability. Oral administration.; ADT such as citalopram, escitalopram, fluoxetine, sertraline, paroxetine, vilazodone, venlafaxine, desvenlafaxine, duloxetine or bupropion prescribed in accordance with its respective FDA approved package insert for each drug
Intervention MeSH terms: Cariprazine; Antidepressive Agents
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Major Depressive Disorder; MDD; Depression
An Open Label Study That Will Test Safety and Efficacy of RZL-012 Injection Into the Submental Fat in Chinese vs. Non-Chinese Subjects.
Condition: Submental Fat
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This is a Phase 2, open label study that will consist of a screening period, baseline period
      in which subjects will receive a single treatment session and a follow-up period. The single
      treatment session will consist of multiple injections of RZL-012 into the submental area
      under the chin. Blood samples will be collected from all subjects for PK analyses in the
      first 30 hours after dosing. Subjects will thereafter be monitored for safety and efficacy
      for at least 84 days.
    

Detailed description: 
      • RZL-012 (concentration of injected solution 50 mg/mL RZL-012) of 7.5 mg/0.15 mL/injection
      point that results in a total dose/volume of 240±30mg mg/4.8±0.6 mL RZL-012

      Subjects treated with RZL-012 will undergo a single treatment session with 32±4 injections.
      The maximal number of injections will be 36 with maximal dose of 270 mg RZL-012 .
    

Intervention name(s): RZL-012
Intervention type(s): Drug
Intervention description(s): concentration of injected formulation 50 mg/mL RZL-012 of 7.5 mg/0.15 mL/injection point that results in a maximum total dose/volume of 240±30 mg/4.8±0.6 mL RZL-012
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Study of the Effect of Low Level Laser Light Therapy on Reducing the Appearance of Cellulite in the Thighs and Buttocks.
Condition: Cellulite
MeSH terms: Cellulite
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether the application of green diode low level
      laser light therapy is effective in reducing the appearance of cellulite in the thighs and
      buttocks.
    

Detailed description: 
      Cellulite is a common term used to describe superficial pockets of trapped fat, which causes
      uneven dimpling or "orange peel" skin. It appears in 90% of post-adolescent women. In
      advanced stages of cellulite, heaviness and pain may occur.

      Currently available treatments for cellulite have minimal to no demonstrable effect and some
      involve risky invasive procedures. Therefore, the potential advantages of the application of
      low level laser light therapy to reduce the appearance of cellulite over current treatment
      options include a risk free procedure that is non-invasive and pain free. Since low level
      laser light within the green spectrum has been proven to increase the synthesis of collagen,
      it is believed that its application may serve to decrease the appearance of cellulite by
      tightening the skin. Moreover, newly synthesized collagen may alter the irregular pattern of
      the connective tissue responsible for the formation of cellulite.
    

Intervention name(s): Erchonia Scanner device (GLS); Placebo device
Intervention type(s): Device; Device
Intervention description(s): The Erchonia® GLS device is made up of six independent diodes, each emitting 17 milliwatts (mW), 532 nanometer (nm) of green laser light.; Inactive Erchonia GLS.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Clinical Trial of Lutein for Patients With Retinitis Pigmentosa Receiving Vitamin A
Condition: Retinitis Pigmentosa
MeSH terms: Retinitis; Retinitis Pigmentosa
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this trial is to determine whether lutein in addition to vitamin A will slow
      the course of retinitis pigmentosa.
    

Detailed description: 
      Retinitis pigmentosa (RP) is a group of inherited retinal degenerations with a worldwide
      prevalence of approximately 1 in 4,000. Patients typically report night blindness and
      difficulty with mid-peripheral visual field in adolescence. As the condition progresses, they
      lose far peripheral visual field. Most patients have reductions in central vision by 60 years
      if left untreated. Vitamin A palmitate, 15,000 International Units (IU)/d and an omega-3 rich
      diet have been shown to slow the progression of this condition among adults with the typical
      forms.(see Archives of Ophthalmology,111:761-772,1993 ; Archives of Ophthalmology 122:
      1306-1314, 2004; Archives of Ophthalmology 130(6):701-711,2013).

      The present study was a randomized, controlled, double-masked trial with a planned duration
      of 5 years.Two hundred and forty adults with the typical forms of RP were assigned to either
      lutein 12mg/d or a control group. Patients in both groups received 15,000 IU/day of vitamin A
      palmitate in addition to the supplement under study. Participants agreed not to know the
      contents of the supplement or their group assignment until the end of the trial. The main
      outcome measurement was the total point score for the 30-2 program of the Humphrey Field
      analyzer (HFA). In addition,the total point score for the 60-4 program ,the total point score
      of the 30-2 and 60-4 programs combined, computer-averaged 30-Hz cone Electroretinogram (ERG)
      amplitude and Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity were measured
      annually as secondary endpoints.
    

Intervention name(s): Lutein; Cornstarch control
Intervention type(s): Drug; Dietary Supplement
Intervention description(s): 12mg/d; Daily intake of cornstarch control plus 15,000 IU/d Vitamin A palmitate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Retinitis Pigmentosa, Inherited Retinal Degeneration
Induction CT by Cisplatin, 5FU With or Without Docetaxel in Patients With T3 and T4 Larynx and Hypopharynx Carcinoma
Condition: Larynx Cancer; Hypopharynx Cancer
MeSH terms: Laryngeal Neoplasms; Laryngeal Diseases
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of the study is to compare two regimen of chemotherapy used as first treatment
      for patients with larynx or hypopharynx tumors that would be treated with total laryngectomy.
      The standard treatment is a combination of 2 drugs (Cisplatin and 5FU). The aim of the study
      is to evaluate the potential benefit of the addition of a third drug (Docetaxel) in the
      chemotherapy regimen. Patients will receive 3 cycles of chemotherapy. Responders to the
      induction treatment are treated with radiation with a purpose of larynx preservation. Non
      responders patients will be treated with total laryngectomy.
    

Detailed description: 
      The purpose of the study is to compare two regimen of induction chemotherapy for patients
      with T3 and T4 larynx or hypopharynx carcinoma that would be treated with total laryngectomy.
      The aim of the study is to compare the standard regimen (Cisplatin + 5FU) versus the TPF
      regimen (Taxotere + Cisplatin + 5FU). Responders to the induction treatment are treated with
      radiation with a purpose of larynx preservation. Non responders patients will be treated with
      total laryngectomy followed by postoperative radiation.
    

Intervention name(s): DOCETAXEL; Cisplatin; 5-Fluoro-3-Pyridinecarboxylic Acid
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 75 mg/m 2 on day 1; 75 mg/m 2 on day 1; 750 mg/m 2 by 24-hour continuous infusion for 5 days
Intervention MeSH terms: Nicotinic Acids; Niacin; Docetaxel
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Larynx cancer; Hypopharynx cancer; Chemotherapy; Randomized trial; Larynx preservation
Inhaled Corticosteroid Use to Prevent Acute Chest Syndrome Recurrence in Children Between 1 and 4 With Sickle Cell Disease: a Feasibility Trial
Condition: Sickle Cell Disease; Asthma; Acute Chest Syndrome
MeSH terms: Acute Chest Syndrome; Anemia, Sickle Cell; Syndrome; Recurrence
Study type: Interventional
Phase: Phase 1

Summary: 
      Acute and chronic pulmonary complications with concomitant inflammatory response are a
      leading cause of morbidity and mortality in children with sickle cell disease (SCD). Acute
      chest syndrome (ACS), defined broadly as an increase in respiratory effort, fever and new
      radiodensity on chest x-ray, is a major cause of death in children and adults with SCD. There
      is a high rate of ACS in children between 1 and 4 years of age that is associated with an
      asthma diagnosis, and children with ACS events before 4 years of age have a 50% rate of being
      hospitalized for either ACS or pain within 1 year of admission. For children with SCD that
      develop ACS, the investigators propose that the use of budesonide inhalation suspension (BIS)
      will attenuate pulmonary inflammation after an ACS episode and will decrease future
      vaso-occlusive pain and ACS episodes. Through a single-arm prospective feasibility trial and
      in preparation for a limited-institution randomized trial, the investigators plan to test the
      following primary hypothesis for a phase III definitive trial: In children with SCD admitted
      to the hospital for an ACS episode between 1 and 4 years of age, low dose BIS for 6 months
      will result in a 50% reduction in the recurrent incidence rate of ACS or pain requiring
      hospitalization. Through this trial, the investigators will determine the acceptability of
      and adherence to BIS in the study population. The investigators will track respiratory
      symptoms in cases versus controls over 6 months. Finally, the investigators will explore the
      impact of BIS on biological correlates (sVCAM-1).
    


Intervention name(s): Budesonide inhalation suspension
Intervention type(s): Drug
Intervention description(s): To determine the acceptability of budesonide inhalation suspension (BIS) 0.5 QD for 6 months for children with SCD that develop ACS between 1 and 4 years of age (n=10).
Other intervention name(s): inhaled corticosteroids
Intervention MeSH terms: Budesonide
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Sickle Cell Disease; Budesonide inhalation suspension; Acute Chest Syndrome