bioihbjkbjnl/mcl2 huggingface dataset:
Botox Injection in Treatment of Cluster Headache
Condition: Cluster Headache
MeSH terms: Cluster Headache; Headache
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Cluster headache is an intense and powerful, one-sided headache accompanied by involuntary
      symptoms such as red eye, droopy eyelids, flow of tears, small pupils and one-sided facial
      sweating. The headache is believed to be the most intense of all headaches and among many is
      totally disabling and of great personal and social consequences. For a small group of
      patients with episodic and most chronic form, drug therapy has little effect. For them,
      surgery can be a solution.

      Neuroradiology has found evidence of a possible original activation of cluster headache from
      the portion of the brain called hypothalamus. Furthermore, an activation of the
      parasympathetic nervous system through the sphenopalatine ganglion, which may also explain
      some of the one-sided involuntary symptoms, is suspected in cluster headache. Injection of
      Botulinum toxin type A (BTA) inhibits secretion of synaptic acetylcholine resulting in nerve
      signals being blocked. The duration of such a blockade is believed to be 3-9 months.

      The purpose of the present study is to develop and evaluate a new surgical procedure with
      injection of BTA for blocking of the sphenopalatine ganglion. The goal is to relieve the
      symptoms of refractory cluster headache with a minimal invasive procedure.

      The main objective of the project is to determine the safety of BTA injection in the area of
      the sphenopalatine ganglion of refractory cluster headache and detect the adverse events.
      Secondary objectives are to identify the changes of headache attacks by the method used.
    


Intervention name(s): Botulinum Toxin Type A 25 IU; Botulinum Toxin Type A 50 IU
Intervention type(s): Drug; Drug
Other intervention name(s): Botox; Botox
Intervention MeSH terms: Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Cluster Headache; Botulinum Toxin Type A; Sphenopalatine Ganglion Block; Autonomic Nerve Block
Interferon-gamma With Interferon Alpha and Ribavirin for Hepatitis C Non-responders
Condition: Hepatitis C; Genotype 3; Non-responders; Relapsers
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      When administered simultaneously, interferon-alpha 2b + interferon-gamma result in dramatic
      antiviral synergy.Ribavirin has shown to enhance interferon-gamma levels in patients with
      chronic hepatitis C treated with interferon-alpha. Enhancement of immune responses,
      especially those related to type-1 T helper cell activity, may contribute to better efficacy
      in combining ribavirin with IFN-alpha for treatment of chronic hepatitis C. The aim of the
      present study is to evaluate the efficacy and safety of a triple regimen, a combination
      treatment with Interferon gamma, Interferon alfa-2b plus Ribavirin in patients who have not
      previously responded to interferon alpha in combination of ribavirin.
    


Intervention name(s): interferon alpha-2b, ribavirin, interferon-gamma,; interferon alpha-2b, ribavirin, amantadine
Intervention type(s): Drug; Drug
Intervention MeSH terms: Interferons; Ribavirin; Interferon-alpha; Interferon alpha-2; Interferon-gamma; Amantadine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Randomized Double Blind, Placebo Controlled Balanced 4-Way Crossover Study To Assess The Efficacy Of Single Oral Doses
Condition: Impotence
MeSH terms: Erectile Dysfunction
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary aim of this study is to assess how effective PF-00592379 is in restoring penile
      erections in patients with erectile dysfunction. Patients will attend for 4 treatment visits
      where they will receive the following in random order; 2 separate doses of PF-00592379,
      sildenafil 100mg used as a positive control, or placebo (dummy medication). The effect on
      penile erections will be assessed in the clinic using penile plethysmography (RigiScan PlusTM
      technique).
    


Intervention name(s): PF-00592379; Sildenafil 100mg
Intervention type(s): Drug; Drug
Intervention MeSH terms: Sildenafil Citrate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double
Primary purpose: Treatment
Laser Efficiency on Metabolic Parameters
Condition: Metabolic Syndrome
MeSH terms: Metabolic Syndrome; Syndrome
Study type: Observational

Summary: 
      Non-invasive laser therapy is laser blood irradiation improves many metabolic parameters. So,
      this study aims to assess the impact of Non-invasive laser therapy on lipid metabolism and
      renal out comes
    

Detailed description: 
      The metabolic syndrome is a constellation of interrelated metabolic risk factors especially
      central obesity, dyslipidemia, hyperglycemia, which all affect worse their kidney function,
      and all of this causing mortality. This time line requires a quick procedure that will enable
      us to implement safe and non-invasive therapeutic instruments adjacent therapy for metabolic
      syndrome cases.
    

Intervention name(s): non-invasive laser therapy
Intervention type(s): Device
Intervention description(s): (diode laser, continuous output, in skin contact mode, 0.005W,0.2cm,beam spot area 0.03cm2, 288j/cm ,1800s) in the morning session, we measured lipid profile and kidney function before and after treatment to measure improvement
Other intervention name(s): laser watch
Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        the study population selected from out patient of Berket El-haje medical center suffering
        from metabolic syndrome
Lean Muscle Function
Condition: Single Muscle Fibers
Study type: Observational

Summary: 
      This pilot study is designed to determine the relationship between intra-myocellular lipids
      and muscle contractility in fibers from obese and non-obese older adults. Obese participants
      are being recruited for an on-going weight loss intervention study and this application seeks
      approval to recruit and enroll a lean comparison group of non-obese older adults. The primary
      goal of this study is to characterize the contractile properties of single muscle fibers and
      whole muscle in healthy, non-obese individuals under the same recording conditions the
      investigators used for the obese population to begin to determine whether fat infiltration
      accounts for diminished force.
    


Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        20 sedentary, normal-weight (BMI= 18-24 kg/m2) older (65-75 yrs) men and women (n=10 each)
      
Biospecimen description: 
      serum and plasma to be retained
A Study to Evaluate ITCA 650 Compared to Sitagliptin as add-on Therapy for the Treatment of Type 2 Diabetes
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 3

Summary: 
      Phase 3 study to compare treatment with ITCA 650 to sitagliptin when added to metformin
      monotherapy in patients with type 2 diabetes.
    


Intervention name(s): ITCA 650 60 mcg/day; sitagliptin
Intervention type(s): Drug; Drug
Intervention description(s): exenatide in DUROS; oral sitagliptin 100 mg/day
Intervention MeSH terms: Sitagliptin Phosphate; Exenatide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
A 14 Week, Randomized, Placebo-Controlled Cross-Over Study of Methylphenidate Hydrochloride Controlled Release Capsules in Adult ADHD With and Without Anxiety Disorder Comorbidity
Condition: Attention Deficit Hyperactivity Disorder; Generalized Anxiety Disorder; Social Anxiety Disorder; Panic Disorder; Agoraphobia
MeSH terms: Anxiety Disorders; Attention Deficit Disorder with Hyperactivity; Panic Disorder; Phobia, Social; Agoraphobia
Study type: Interventional
Phase: Phase 4

Summary: 
      Other psychiatric disorders, including anxiety, often co-occur with adult ADHD; with 85% of
      ADHD patients having at least one other psychiatric condition. The presence of a co-occurring
      anxiety disorder has been associated with additive clinical effects, leading to more global
      impairment, poorer outcome, greater resistance to treatment and increased costs of illness.
      Stimulants are effective first-line treatments for adult ADHD patients, however the
      literature has mostly examined these treatments in pure ADHD populations (i.e. without other
      psychiatric disorders). Thus, there is little information to guide physicians in making
      treatment decisions for patients with ADHD and a co-occurring condition.

      This trial aims to evaluate the efficacy and safety of methylphenidate hydrochloride
      controlled release capsules (Foquest) in treating adults aged 18-65 years with DSM-5 ADHD
      with and without a co-occurring anxiety disorder.The study uses a 14-week, randomized,
      placebo-controlled, cross-over design.
    


Intervention name(s): Methylphenidate Hydrochloride Controlled-Release Capsules; Placebo Capsule
Intervention type(s): Drug; Drug
Intervention description(s): 25 mg methylphenidate hydrochloride- titrated as tolerated up to a maximum 4 capsules daily (25 mg- 100 mg total dose)
At Week 0 or Week 7, dosing will start at 1 capsule/day for one week, and be titrated to 2 capsules/day for Week 2. 50 mg of methylphenidate hydrochloride per day (i.e. 2 capsules/day) is the minimum dose that must be achieved. The dose may be titrated to 75 mg/day for Week 3 and to 100 mg/day for Week 4 if participants are tolerating their current dose, are experiencing no adverse events, and have not fully responded. By Week 4 or Week 11, no further dose changes will occur.; At Week 0 or Week 7, dosing will start at 1 capsule/day for one week, and be titrated to 2 capsules/day for Week 2. The dose may be titrated to 75 mg/day for Week 3 and to 100 mg/day for Week 4 if participants are tolerating their current dose, are experiencing no adverse events, and have not fully responded. By Week 4 or Week 11 no further dose changes will occur.
Other intervention name(s): Foquest
Intervention MeSH terms: Methylphenidate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: ADHD; Anxiety Disorders; Stimulants; Methylphenidate
QR-Bromocriptine as an Adjunct to Insulin and Metformin in the Treatment of Type 2 Diabetes
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 4

Summary: 
      QR-Bromocriptine as an add-on treatment to insulin and metformin in the management of type 2
      diabetes will result in improved glycemic control, reduced exogenous insulin requirement,
      increased lean fat mass and improved pancreatic beta-cell function.
    

Detailed description: 
      To assess improvement in glycemic control, reliance on exogenous insulin, improvements in
      lean body mass composition, and improvements in pancreatic beta-cell function.
    

Intervention name(s): QR-bromocriptine
Intervention type(s): Drug
Intervention description(s): The study drug is added-on to patients on existing type 2 diabetes treatment with insulin +metformin+exercise/nutritional counseling. The study drug is titrated up starting at one 0.8mg tab daily for 1 week, then 2 (0.8mg) tablets for week 2, then 3 tablets for week 3, then 4 tablets for week 4, then 5 tablets for week 5, then six tablets for week 6 (total 4.8). The limiting factor is nausea at which point the patients will back down the highest tolerated dose and continue on that dose for the remainder of the 6 months of the study.
Other intervention name(s): NDC 6801225820; Cycloset (brand)
Intervention MeSH terms: Bromocriptine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Multicentre, Randomized, Controlled Trial of Qideng Mingmu Capsule in The Treatment of Diabetic Retinopathy
Condition: Diabetic Retinopathy; Diabetic Eye Problems; Retinal Disorders
MeSH terms: Retinal Diseases; Diabetic Retinopathy
Study type: Interventional
Phase: Phase 2

Summary: 
      Objectives of study: To preliminarily evaluate the efficacy and safety of Qideng Mingmu
      Capsule in the treatment of patients with diabetic retinopathy (deficiency of Qi-Yin
      syndrome, blood stasis syndrome), to discuss the appropriate dose and period of treatment.
    

Detailed description: 
      The efficacy of Qideng Mingmu capsule is to nourish qi-yin and promote blood circulation. It
      is used in patients with diabetic retinopathy who are differentiated as deficiency of Qi-Yin
      syndrome and blood stasis syndrome in traditional Chinese medicine(TCM).The manifestation of
      diabetic retinopathy(DR) mainly includes dim and dry eyes,shortness of breathe, fundus
      hemorrhage,etc.The experimental research indicated that the Qideng Mingmu capsule could
      improve the GK rats' quality of life,through reducing vascular endothelial growth
      factor(VEGF) level in vitreous of GK rats and inhibiting the expression of protein kinase
      C(PKC),therefore is capillary protective agent against retinal impairment in GK rat.The
      toxicology test has proved that the clinical dosage of Qideng Mingmu capsule is safe.Both
      acute and long-term toxicity tests has showed no toxicity.
    

Intervention name(s): Qideng Mingmu capsule; Placebo Comparator
Intervention type(s): Drug; Drug
Intervention description(s): High dosage group (4 Qideng Mingmu capsules each time): 4#, po, tid,24 weeks; Middle dosage group (2 Qideng Mingmu capsules plus 2 placebos each time):4#, po, tid,24 weeks;Low dosage group (1 Qideng Mingmu capsule plus 2 placebos each time):3#, po, tid,24 weeks.; Placebo group (4 placebos each time):4#, po, tid,24 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Diabetic Retinopathy; Traditional Chinese medicine; Diabetic Eye Problems; Retinal Disorders
Presbyopia Compensation: Looking for Electrophysiological Predictors
Condition: Presbyopia
MeSH terms: Presbyopia
Study type: Observational [Patient Registry]

Summary: 
      The main purpose of this study was to identify electrophysiological predictive markers of
      post-correction visual comfort for presbyopic patients.
    

Detailed description: 
      For each participant, presbyopia was compensated with contact lenses by monovision during
      three weeks and multifocality (three weeks again). A break of two weeks without any
      presbyopia compensation came in between the two phases of the test that were randomized.

      All subjects were tested three times: before any compensation, after three weeks with
      monovsion and after three weeks with multifocality.

      Each testing session was strictly the same including visual examinations and VEPs (visual
      evoked potentials).
    

Intervention name(s): contact lenses
Intervention type(s): Device
Intervention description(s): Presbyopia was compensated with contact lenses by monovision and multifocality.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Adults with presbyopia
      
Keywords: multifocality; monovision
Determinants of Diabetes Remission After Gastric Bypass Surgery
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Early Phase 1

Summary: 
      Longitudinal study of beta cell function up to 2 years after GBP surgery. Evaluation of the
      role of endogenous glucagon-like peptide-1 (GLP-1).
    

Detailed description: 
      The increased prevalence of obesity and type 2 diabetes (T2DM) has resulted in a surge in the
      number of patients seeking surgical weight loss. Gastric bypass surgery (GBP) results in
      30-40% body weight loss with resolution of T2DM in 40-80% of cases. The mechanisms by which
      T2DM improves after GBP are unclear. Glycemic control occurs long before significant weight
      loss, suggesting that the nature of the procedure, rather than the weight loss, is
      responsible for the T2DM improvement. Recent data have singled out the role of the gut
      hormones known as incretins in diabetes improvement after GBP. The current proposal will
      study 1) whether the short and long term change in the gut hormone incretins after GBP
      results in improved insulin secretion in response to the administration of oral and IV
      glucose, in patients with diabetes undergoing GBP surgery; 2) the factors responsible for
      diabetes remission - or lack of - after GBP. The investigators wish to apply our finding to
      define better surgical outcome on diabetes.
    

Intervention name(s): Exendin9
Intervention type(s): Drug
Intervention description(s): Dosed at 600 pmol/kg/min for 210 minutes.
Other intervention name(s): Exendin(9-39)
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Type 2 Diabetes Mellitus; Gastric Bypass Surgery; Exendin9
Efficacy Study of Standard Ballroom and Latin Dance Program in Type 2 Diabetes and Obesity
Condition: Diabetes; Obesity
MeSH terms: Diabetes Mellitus; Obesity
Study type: Interventional

Summary: 
      to test the metabolic and clinical effects of a 6-month program of dancing in subjects with
      type 2 diabetes and/or obesity, chronically cared for in two diabetes/metabolic units.
      Self-selection of the leisure time activity program was allowed to increase adherence to the
      physical activity programs.
    


Intervention name(s): Dance program; Self-selected physical activity
Intervention type(s): Behavioral; Behavioral
Intervention description(s): two-hour dancing session twice a week, led by instructors in a private hall of a disco. Both solo and partner and group dances were performed during each session: an initial one-hour activity, chaired by two instructors who taught new steps and choreographies to patients (both individually and in group), was followed by a second hour, when patients danced in pairs both Latin and standard ballroom music; gym sessions (with the support of sports associations), exercising at home (cycling, stepping) or walking, jogging or cycling outside with/without group support
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Dance; Physical activity; Physical fitness; Weight loss
The Ability of Pecan Consumption to Improve Vascular Function and Reduce Chronic Disease Risk in Aging Adults
Condition: Aging
MeSH terms: Chronic Disease
Study type: Interventional

Summary: 
      Background: To date, there are no published studies on the effects of pecans on vascular
      function following a high-fat meal.

      Purpose: To examine the impact of daily pecan consumption for a 4-week period on vascular
      health and other markers of cardiovascular disease risk in aging adults.
    

Detailed description: 
      This will be a randomized, controlled trial in men and postmenopausal women (50-75y).
      Subjects will be randomized into one of the two study groups: a control group (CON) following
      their usual diet, or intervention group (PECAN) following their usual diet but also consuming
      68g/day of pecans as a snack.

      There will be 3 visits: A Screening visit and a baseline and post-diet intervention visit
      (4-weeks). Anthropometrics, questionnaires, a fasting blood sample, and fasting vascular
      measures will be collected at each visit. Subjects will participate in a saturated fatty acid
      meal challenge in which additional blood, vascular measurements will be collected.

      Hypothesis: Daily pecan consumption will result in improved fasting blood lipids, vascular
      measures, antioxidant status, and appetite compared to the control group. Additionally, also
      the PECAN group will result in improved postprandial blood lipids and vascular measures
      compared to the control group.
    

Intervention name(s): PECAN
Intervention type(s): Dietary Supplement
Intervention description(s): Raw pecan halves without other changes to their habitual diet.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
A Research Study of How a New Medicine Called Amycretin, Given as Tablets, Works in Japanese Men With Obesity
Condition: Obesity
MeSH terms: Obesity
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the study is to evaluate if a new study drug, NNC0487-0111, is safe and how it
      works in the participant's body, when given as an oral tablet to Japanese participants.
    


Intervention name(s): NNC0487-0111; Placebo (NNC0487-0111)
Intervention type(s): Drug; Drug
Intervention description(s): Participants will get one tablet to swallow at the same time of the day.; Participants will get one tablet to swallow at the same time of the day.
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Study to Investigate How Common Pancreatic Exocrine Insufficiency (PEI) is in Patients With Type 2 Diabetes and Also to Investigate the Uptake of a Single Dose of EPANOVA® or OMACOR® in Patients With Different Degrees of PEI
Condition: Diabetes Mellitus, Type 2; Exocrine Pancreatic Insufficiency
MeSH terms: Exocrine Pancreatic Insufficiency; Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is a 2-part open-label, randomized, crossover, multicenter, non-therapeutic Phase
      II study to investigate the presence of pancreatic exocrine insufficiency (PEI) in patients
      with Type 2 diabetes mellitus (T2DM), and to investigate the pharmacokinetics (PK) of
      EPANOVA® (omega-3 carboxylic acids) and omega-3-acid ethyl esters (OMACOR®, Abbott Healthcare
      Products Ltd) following a single oral dose in patients with different degrees of PEI.
    


Intervention name(s): Epanova® (omega-3 carboxylic acids); Omacor® (omega-3-acid ethyl esters)
Intervention type(s): Drug; Drug
Intervention description(s): 4 g (administered orally as 4 x 1 g capsules); 4 g (administered orally as 4 x 1 g capsules)
Other intervention name(s): omega-3 carboxylic acids; omega-3-acid ethyl esters
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: omega-3 carboxylic acid