bioihbjkbjnl/mcl2 huggingface dataset:
A Clinical Trial to Study the Safety and Efficacy of Chandrakanthi Choornam in Patients With Low Sperm Count
Condition: Oligospermia
MeSH terms: Oligospermia
Study type: Interventional
Phase: Phase 2

Summary: 
      This is an Open clinical trial to study the safety and efficacy of Chandrakanthi Choornam in
      40 patients with Oligospermia. Chandrakanthi choornam is a formulation consisting of 25
      ingredients. They are Curculigo orchioides -rhizome, Madhuca longifolia - flower, Cinnamomum
      verum -bark,Cinnamomum tamala-Leaf, Syzygium aromaticum - flower bud,Coscinium
      fenestratum-stem bark,Mesua ferrea-flower, Maerua arenaria-tuber, Adhatoda vasica- seed,
      Moringa oleifera-seed, Lawsonia inermis-seed, Vitis vinifera- fruit, Bombax ceiba- gum,
      Bambusa aurundinaceae-salt,Phoenix dactilifera- fruit,Ilicium verum- flower, Mucuna
      prurita-seed, Cyperus rotundus- rhizome, Glycyrrhiza glabra-root, Tribulus terrestris-fruit,
      Cuminum cyminum-seed,Costus speciosus-root,Myrsitica fragrans-seed, Alternanthera
      sessilis-seed and asphaltum-mineral. Treatment duration is three months.Study is conducted in
      India (Chennai). Primary outcome measure is to see the changes in sperm count, motility and
      morphology. Secondary Outcome measure is to see the impact on the harmone level.
    

Detailed description: 
      METHODOLOGY OF PROPOSED RESEARCH:

      I. Preclinical study II. Clinical study

      I. PRECLINICAL STUDY:

      Standardization Of The Study Drug

        1. Botanical Identification

        2. Chemical Identification

        3. Preparation of the study drugs:

           Formulation: Chandrakanthi choornam Source : Chikicharathna deepam Part II. Pg-168
           (Approved sastric book as per drugs & cosmetic act 1940.

        4. Chemical methods of testing

        5. Pharmacological study : A. Spermotogenic Activity

        6. Toxicological study : A. Acute Toxicity B. Long term Toxicity

      II. CLINICAL STUDY

      Conducted as per the guidelines of GCP accepted by Ayush adapted from the ICH.

      A. Pilot study B. Main study
    

Intervention name(s): Chandrakanthi Choornam (CKC)
Intervention type(s): Drug
Intervention description(s): 12gm in milk - OD dose; Oral route; 3 Months ( 90days) - duration
Preparation from approved sastric book as per drugs & cosmetic act 1940
Other intervention name(s): Nerunjil choornam
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hypospermatogenesis, Low Sperm Count, Oligozoospermia
Brief Intervention in Substance Use in Adolescent Psychiatric Patients
Condition: Substance-Related Disorders
MeSH terms: Substance-Related Disorders
Study type: Interventional

Summary: 
      The objective of the study was to assess the efficacy in decreasing the likelihood of
      substance use of a brief motivational enhancement intervention in adolescents referred to
      psychiatric treatment.

      237 adolescents consecutively admitted to a psychiatry department completed an evaluation of
      their substance use. Subjects identified as users were randomly allocated to one of two
      groups: an experimental group that received a brief intervention aimed at increasing their
      awareness of the risks of substance use, or a control group. All subjects received standard
      treatment according to the primary diagnosis. Structured questionnaires assessing knowledge,
      attitudes, perception of risks and intention of use of psychoactive substances were
      administered upon admission and 1 month later.
    


Intervention name(s): brief motivational intervention; treatment as usual
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Brief intervention, consisting in an intervention with the adolescent and a session with parents or mentors. The session with the adolescent lasted 60 minutes. Materials related to the interview were developed according to previous reports on the subject. After building a good rapport the interviewer involved the patient in an initial discussion about the results of the evaluation. This led to a review of the drugs used by the subject and an elicitation of positives and negatives of drug use. The relationship between drug use and current and long-term goals was explored. Discrepancies and problems in the future related to substance use were examined, and information and counseling was offered. The basic components of the motivational interview approach were contemplated, and several skills were used by the interviewers. The individual session with parents or mentors consisted in the presentation of educational materials and a brief counseling intervention on parenting skills.; Treatment as usual (TTU): After completion of the intervention, individuals and their families went on to receive standard care at the Child and Adolescent Psychiatry and Psychology Department according to the primary diagnosis.Individuals assigned to this group and their parents or tutors received standard care and no further intervention other than completion of the assessment protocol.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Adolescent; Substance use; Brief intervention; Child psychiatry
The Effect of Vitamin D on Bone Accretion and Turn-Over in Young Girls
Condition: Vitamin D Deficiency
MeSH terms: Vitamin D Deficiency
Study type: Interventional

Summary: 
      Objectives To evaluate the effect of increased vitamin D intake on vitamin D status, bone
      mass and bone turnover in young girls aged 12-13.

      More specifically the effects on the following parameters will be assessed:

        -  Vitamin D metabolites.

        -  Parathyroid hormone.

        -  Bone turnover.

        -  Bone mineral accretion.

        -  Serum calcium and phosphate.

        -  Renal handling of calcium and phosphate.
    

Detailed description: 
      This work package will consist of a randomised double blind one-year vitamin D
      supplementation study. Primary effect parameter is change in bone mineral content and
      therefore study duration will be one year. A total of 225 subjects, 75 in each of the three
      groups: one control and two intervention groups, will be included Two dosages of
      supplementation will be used: 5 µg per day and 10 µg per day.
    

Intervention name(s): cholecalciferol (D3) (vitamin)
Intervention type(s): Behavioral
Intervention MeSH terms: Cholecalciferol; Vitamin D
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Prevention
Keywords: Vitamin D; adolescent girls; bone accretion; bone turn over; vitamin D status; Vitamin D insufficiency in young girls
Spironolactone on Fibrosis Progrssion-Portal Hypertension(FP-PH)in Cirrhosis
Condition: Cirrhosis; Portal Hypertension
MeSH terms: Liver Cirrhosis; Hypertension, Portal; Hypertension; Fibrosis
Study type: Interventional
Phase: Phase 4

Summary: 
      The aim of this study is to investigate the effects of spironolactone on liver fibrosis
      progression and portal pressure gradient in patients with advanced chronic liver disease.
      Eligible cirrhosis patients were 2:1 randomized to either combination (carvedilol and
      spironolactone) or single (carvedilol) therapy group. Changes in virtual portal pressure
      gradient (vPPG) of portal trunk (calculated based on reconstructed 3D model and measured
      blood flow velocity), liver stiffness measurement (Fibroscan) and serum markers of liver
      fibrogenesis were documented at baseline and six months later.
    


Intervention name(s): Spironolactone and carvedilol; Carvedilol
Intervention type(s): Drug; Drug
Intervention description(s): Patients are treated with carvedilol in combination with spironolactone.; Patients are treated with carvedilol only.
Other intervention name(s): Combination therapy; Single therapy
Intervention MeSH terms: Carvedilol; Spironolactone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
A Study to Evaluate the Effects of a New Formula on the Growth, Safety and Tolerance of Infants With Growth Failure
Condition: Growth Failure; Congenital Heart Disease
MeSH terms: Heart Diseases; Heart Defects, Congenital; Failure to Thrive
Study type: Interventional

Summary: 
      This study is a prospective, open-label, multi-site, growth, safety and tolerance study to
      evaluate a NF (New Formula). A minimum of 45 evaluable infants with confirmed growth failure
      will be enrolled. Growth failure for 30 infants will be due to congenital heart disease and
      15 infants due to other organic or non-organic causes. Study infants (in-patient or living
      with parents/ caregivers at home) will be fed the NF for a period of up through 16 weeks or
      until the time the infant subject meets criteria for switching to a lower calorie density
      formula, relative to baseline in infants with growth failure. Weight, height, head
      circumference and mid upper arm circumference will be measured regularly throughout the
      study. NF and other food intake, tolerance and stool diaries will be completed regularly.
      Serious adverse and adverse events will be monitored throughout the study. Infants will be
      evaluated, at each study visit, for criteria to switch to a lower calorie density formula.
      The primary objective is to improve weight-for-age z score relative to baseline. The
      secondary objectives are to improve weight-for-length, length-for-age, head
      circumference-for-age, mid upper arm circumference-for-age, weight velocity and length
      velocity z scores relative to baseline.
    


Intervention name(s): New Infant Formula
Intervention type(s): Other
Intervention description(s): New Infant Formula is a specialized, nutritionally complete, nutrient-dense infant formula specifically formulated for infants with growth failure.
Intervention model: Single Group Assignment
Intervention model description: A prospective, open-label, multi-site, growth, safety and tolerance study.
Masking: None (Open Label)
Primary purpose: Supportive Care
Research on the Application and Mechanism of New Biological Probes in Biomedicine
Condition: Tumors; Cardiovascular Diseases; Respiratory System Diseases; Digestive System Diseases; Endocrine System Diseases; Metabolic Diseases; Immune System Diseases; Urinary System Diseases; Nervous System Diseases; Blood Diseases; Infectious Diseases
MeSH terms: Communicable Diseases; Infections; Digestive System Diseases; Gastrointestinal Diseases; Respiratory Tract Diseases; Respiration Disorders; Nervous System Diseases; Urologic Diseases; Cardiovascular Diseases; Hematologic Diseases; Metabolic Diseases; Endocrine System Diseases; Immune System Diseases
Study type: Observational

Summary: 
      Fluorescence is one of the most commonly used research and detection techniques in the field
      of biomedical science. The characteristics of fluorescent probe directly affect the
      performance and application of fluorescence analysis and imaging. Aggregation-Caused
      Quenching has limited the application of traditional fluorescent probes to some extent. This
      project intends to systematically evaluate the detection efficiency of new methods through
      the detection of biomarkers in clinical samples and the comparison with the detection methods
      of traditional biomarkers, so as to provide theoretical and experimental basis for the
      establishment of fast and simple biomarker detection technologies with new biological probes.
    


Intervention name(s): No intervention
Intervention type(s): Diagnostic Test
Intervention description(s): No intervention
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        NanFang Hospital samples
A Multicenter, Randomized, Open-labeled, Cross-over, Active-controlled, Phase IV Clinical Trial to Evaluate the Preference of Formulation and the Efficacy and Safety of Renamezin and Kremezin in Pre-dialysis Patients With Chronic Renal Failure
Condition: Chronic Renal Failure
MeSH terms: Renal Insufficiency; Kidney Failure, Chronic; Renal Insufficiency, Chronic
Study type: Interventional
Phase: Phase 4

Summary: 
      A Multicenter, Randomized, Open-labeled, Cross-over, Active-controlled, Phase IV Clinical
      Trial to Evaluate the Preference of Formulation and the Efficacy and Safety of Renamezin and
      Kremezin in Pre-dialysis Patients With Chronic Renal Failure
    


Intervention name(s): Renamezin capsule; Kremezin granule
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Safety and Tolerability of TG1050: A Dose-finding Study
Condition: Chronic Hepatitis B
MeSH terms: Hepatitis B; Hepatitis B, Chronic
Study type: Interventional
Phase: Phase 1

Summary: 
      Methodology:

      This is a double-blind, randomized, placebo-controlled, multi-cohort Phase 1/1b study in
      patients that are currently being treated for chronic HBV infection. For all cohorts,
      patients must be receiving antiviral treatment with either tenofovir disoproxil fumarate
      (TDF) or entecavir (ENT) for at least two years, and have their HBV infection well-controlled
    


Intervention name(s): TG1050; Placebo
Intervention type(s): Biological; Biological
Intervention description(s): TG1050: adenovirus serotype 5 vector based immunotherapeutic product in adenovirus reference material (ARM) buffer; Placebo: adenovirus reference material (ARM) buffer
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Targeting Beta Cell Dysfunction With Liraglutide or Golimumab in Longstanding T1D
Condition: Type 1 Diabetes Mellitus
MeSH terms: Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Early Phase 1

Summary: 
      The purpose of this study is to determine whether 8 weeks of Liraglutide or Golimumab can
      transiently improve beta cell function in patients with longstanding Type 1 diabetes (T1D)
      who secrete proinsulin and little/no C-peptide.
    


Intervention name(s): Liraglutide; Golimumab
Intervention type(s): Drug; Drug
Intervention description(s): Participants will receive subcutaneous (SC) liraglutide for 8 weeks; Participants will receive subcutaneous (SC) golimumab for 8 weeks
Other intervention name(s): Victoza; SIMPONI
Intervention MeSH terms: Liraglutide; Golimumab
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Intervention model description: two independent open label, proof of concept studies
Masking: None (Open Label)
Primary purpose: Basic Science
Immunogenicity and Safety of PrepandrixTM in Korean Subjects Aged 18 to 60 Years Old
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 4

Summary: 
      This study will evaluate the immunogenicity and the safety of PrepandrixTM in Korean
      subjects. A second group of subjects will receive FluarixTM vaccine as control.
    

Detailed description: 
      Initially, 124 subjects were planned to be enrolled according to a 1:1 randomisation ratio.
      However, by mistake, the randomisation application was set up consistent with the vaccine
      supply ratio (2:1) rather than the treatment group randomization ratio (1:1). Subsequently,
      the protocol was amended to adjust the sample size and randomisation ratio for the study.

      The study will enrol 126 subjects randomised 2:1. 84 subjects will receive Prepandrix™ and 42
      subjects will receive Fluarix™.
    

Intervention name(s): Prepandrix™; Fluarix™
Intervention type(s): Biological; Biological
Intervention description(s): 2 doses administered intramuscularly in the deltoid region of arm (non-dominant arm at Day 0 and dominant arm at Day 21).; 1 dose administered intramuscularly in the deltoid region of non-dominant arm.
Other intervention name(s): GlaxoSmithKline [GSK] Biologicals' A/Indonesia/5/2005 (H5N1) (pre-) pandemic influenza adjuvanted vaccine; GSK Biologicals' trivalent inactivated influenza split vaccine (Influsplit SSW® 2012/2013)
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Influenza vaccine
The SIBERIA Trial (Acculink™ Versus CGuard™)
Condition: Patients With Aterosclerotic Carotid Stenosis; Symptomatic Patients (Stenosis > 50%); Asymptomatic Patients (Stenosis ≥80%)
MeSH terms: Carotid Stenosis; Constriction, Pathologic
Study type: Interventional

Summary: 
      That the study will be carried out as it has the protocol instructions, respecting the
      applicable regulations for clinical investigations with medical devices and following the
      internationally accepted ethical standards
    

Detailed description: 
      Independent Randomized Trial in Carotid Artery Revascularization Comparing the Stent
      (Acculink™) Versus the Mesh Covered Stent (CGuard™) was performed.

      Ischemic lesions of brain after CAS were determined by MRI before and after treatment (2-3
      days, 1 month).
    

Intervention name(s): Stent Acculink ™; CGuardTM™
Intervention type(s): Device; Device
Intervention description(s): Carotid Artery Revascularization using Stents; Carotid Artery Revascularization using Stents
Other intervention name(s): RX ACCULINK CAROTID STENT SYSTEM; The CGuardTM Embolic Prevention System (EPS)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Preventing Diabetes
Condition: PreDiabetes
MeSH terms: Prediabetic State
Study type: Interventional

Summary: 
      The purpose of this project is to improve the quality of weight management care for patients
      with pre-diabetes and overweight or obesity. Personalized risk profiles, clinical decision
      support, and patient-centered decision tools for understanding pre-diabetes risk and the
      likelihood of preventing diabetes with a modest 5-7% weight loss will be developed. This
      project will offer patients their choice of effective weight management treatment options,
      each containing the cornerstone of weight management- intensive lifestyle intervention.
      Patients and PCPs will be better informed and equipped with information that helps them make
      weight management treatment decisions that work the best for their lifestyle, and each is
      expected to produce at least 5-7% weight loss over 6 months.
    

Detailed description: 
      The primary aim of this study was to demonstrate that an increased recruitment rate for
      weight loss intervention can be achieved within patients that have pre-diabetes by
      communicating personalized risk of progression to type 2 diabetes, by estimating risk
      reduction with weight loss, and by offering program choice. Secondary aims included program
      participation rate, weight loss, and short term decreased diabetes risk.
    

Intervention name(s): Registered Dietitian/Nutritionist; Diabetes Prevention Program; Weight Watchers, Reimagined; DPP or RDN Counseling + Medication; Bariatric Surgery Evaluation
Intervention type(s): Behavioral; Behavioral; Behavioral; Behavioral; Other
Intervention description(s): Participants received a FitBit Flex and Intensive Lifestyle Intervention coaching via telephone with Registered Dietitian/Nutritionist.; Modified DPP group classes lead by a Registered Dietitian and Exercise Physiologist.; Participants in this group were provided with an online access code to enroll in WW and could choose the format of their choice- group, online, and/or smartphone app.; Participants met with a weight management specialist to receive weight loss medications, as well as, receiving either the DPP or Registered Dietitian coaching. Medications utilized in this study were Phentermine and Metformin. Metformin was prescribed if the participant could not tolerate Phentermine.; Participants (BMI > 40) were offered a consultation with the bariatric surgical program that requires lifestyle weight management during the first 6 months. Participants were also able to choose to receive one of the other 4 intervention options in the first six months prior to consideration for bariatric surgery.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Participants enrolled in this study were able to choose from 1 of 5 intervention options based on their weight status.
Masking: None (Open Label)
Primary purpose: Prevention
Assessment of [18F]MNI-1054 as a Marker for LSD1
Condition: Healthy Volunteers (HV)
Study type: Interventional
Phase: Early Phase 1

Summary: 
      The primary objective of this protocol is to evaluate [18F]MNI-1054 as a Lysine-specific
      histone demethylase 1A (LSD1) enzyme targeted radiopharmaceutical.
    

Detailed description: 
      The primary objective of this protocol is to evaluate [18F]MNI-1054 as a Lysine-specific
      histone demethylase 1A (LSD1) enzyme targeted radiopharmaceutical. The specific objectives
      are:

        -  To measure the dynamic uptake and washout of [18F]MNI-1054 in brain using positron
           emission tomography (PET) in healthy volunteers.

        -  To measure blood metabolites of [18F]MNI-1054 in the healthy volunteers and to perform
           invasive as well as non-invasive modeling to assess its ability to measure LSD1 in the
           brain.

        -  To acquire safety data following injection of [18F]MNI-1054

        -  Evaluation of [18F]MNI-1054 PET reliability (test/retest) of the tracer parameters in
           healthy volunteers.
    

Intervention name(s): [18F]MNI-1054
Intervention type(s): Drug
Intervention description(s): Healthy volunteers recruited for the study will undergo a [18F]MNI-1054 PET scan.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: HV
Opioid Maintenance Medications Comparison Study
Condition: Opioid Dependence
MeSH terms: Opioid-Related Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      A 17 week, double-blind, randomized, parallel group, four arm design outpatient study
      comparing LAAM, buprenorphine and two dose levels of methadone for the treatment of opioid
      dependence.
    


Intervention name(s): LAAM. buprenorphine and methadone
Intervention type(s): Drug
Intervention MeSH terms: Buprenorphine; Methadone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment