bioihbjkbjnl/mcl2 huggingface dataset:
Evaluate the Clinical Effectiveness of RegenKit Platelet-rich Plasma (PRP) in Androgenetic Alopecia Treatment
Condition: Androgenetic Alopecia
MeSH terms: Alopecia; Alopecia Areata
Study type: Interventional

Summary: 
      Platelet rich plasma (PRP) therapy is a novel therapeutic modality that has seen broad
      applications for a number of medical indications including those in orthopedics, dentistry,
      and dermatology. In dermatology, its uses have included treatment of chronic wounds and
      facial rejuvenation. More recently, anecdotal reports have suggested some efficacy in the
      treatment of hair loss, but to the best of our knowledge, there has been only one published
      case series documenting its use for this indication.
    

Detailed description: 
      This study was designed to better assess the efficacy of PRP in hair loss, we therefore
      propose to study interval intralesional PRP injections for patients with androgenetic
      alopecia (AGA). Androgenetic alopecia is the most common form of hair loss world-wide.
      Although there are currently numerous treatment options for this indication including
      minoxidil, 5-alpha reductase inhibitors and follicular unit transplant, many of the medical
      treatment options have undesirable side effects, particularly in women of child bearing age.
      These well-documented adverse reactions include impotency, hypertrichosis, and birth defects.
    

Intervention name(s): Autologous Platelet Rich Plasma; Saline solution injection
Intervention type(s): Device; Device
Intervention description(s): Autologous Platelet Rich Plasma a novel therapeutic modality used in numerous applications. In dermatology, its uses have included treatment of chronic wounds and facial rejuvenation. More recently, anecdotal reports have suggested some efficacy in the treatment of hair loss.; Placebo is a saline solution
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Platelet Rich Plasma; Hair Loss
Comparison of Pain After Uterine Artery Embolization Using Gelatin Microsphere or Tris-acryl Gelatin Microsphere
Condition: Uterine Myoma; Uterine Fibroid
MeSH terms: Leiomyoma; Myofibroma
Study type: Interventional

Summary: 
      This study is a prospective and randomized investigation planned to compare pain after
      uterine artery embolization using Gelatin microsphere or tris-acryl gelatin microsphere in 60
      patients with symptomatic fibroids.
    

Detailed description: 
      This investigational study is designed to compare pain after uterine artery embolization
      using Gelatin microsphere or tris-acryl gelatin microsphere in patients with symptomatic
      fibroids.

      The primary end-points will be evaluated by assessing the maximum Visual Analogue Scale (VAS)
      score obtained for each time points within 24 hours after embolization.

      Secondary end-points consist of evaluating six items: 1) fentanyl and analgesic usage within
      24 hours, 2) comparison of symptom severity score and health-related quality of life score,
      3) comparison of postoperative inflammation, 4) assessment of tumor necrosis degree in
      Magnetic Resonance Imaging, 5) fluoroscopy and procedure time comparison, and 6) assessment
      of residual ovarian function before and after surgery (Serum AMH).

      This study included patients between the ages of 20 and less than 60 years of age who were
      diagnosed with uterine myoma and planned to undergo uterine artery embolization.
    

Intervention name(s): Gelatin microsphere (Nexsphere™); Embosphere
Intervention type(s): Device; Device
Intervention description(s): Gelatin microsphere (Nexsphere™) is a yellow powder, made of 100% hydrophilic gelatin. It is used to make a suspension by mixing a contrast agent and physiological saline. The indications for gelatin microsphere are hepatic artery chemoembolization, uterine artery embolization, prostate artery embolization, and treatment of various hemorrhagic diseases. It physically embolizes blood vessels and is decomposed within 4-8 weeks after intravascular injection.; Tris-acryl gelatin microspheres (Embosphere Microspheres) are biocompatible and nonresorbable with cell adhesion properties for complete and durable mechanical occlusion.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Study of FluBHPVE6E7 in HPV-16 Infected Women
Condition: HPV Infection
MeSH terms: Papillomavirus Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      BS-01 is a randomised, double-blind, placebo-controlled, phase 1 dose escalation study
      assessing safety, tolerability and immunogenicity of FluBHPVE6E7, changes in the HPV
      infection status and cervical cytology, and biodistribution in HPV-16 infected women with
      normal cytology, CIN1 or CIN2. The safety and immunogenicity of two dose levels, 7.5 log10
      and 9.0 log10 fTCID50/dose of FluBHPVE6E7 are assessed after three subcutaneous
      administrations. In addition the safety of 9.0 log10 fTCID50/dose of FluBHPVE6E7 is assessed
      after three intradermal or intramuscular administrations.
    

Detailed description: 
      BS-01 is a randomised, placebo-controlled, double- blind phase 1 dose-escalation study in
      women with normal cytology, CIN1 or CIN2.

      The primary objective is to assess the safety and tolerability of FluBHPVE6E7. Secondary
      objectives are the assessment of the systemic immune responses to immunisations with
      FluBHPVE6E7, changes in HPV infection status and cervical cytology, and biodistribution.

      Study medication is administered three times (Day 0, Week 4, Week 12). Study participants are
      randomised at a ratio of 3:1 for FluBHPVE6E7 or placebo. The first cohort is treated
      subcutaneously at dose level 7.5 log10 fTCID50/dose. The second cohort is treated
      subcutaneously at 9.0 log10 fTCID50/dose.

      Interim safety reviews are performed by a Data Monitoring Committee. After completion of the
      dose-escalation and in order to collect additional safety data on the highest safe and
      tolerated dose level, additional study participants are enrolled into expansion cohorts
      treated three times subcutaneously, intradermally or intramuscularly at 9.0 log10
      fTCID50/dose.
    

Intervention name(s): FluBHPVE6E7
Intervention type(s): Biological
Intervention description(s): Multiple subcutaneous, intradermal or intramuscular administrations
Other intervention name(s): Placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
HR-lowering Efficacy and Respiratory Safety of Ivabradine in Patients With Obstructive Airway Disease
Condition: Asthma, Chronic Obstructive Pulmonary Disease (COPD)
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to investigate heart rate lowering efficacy and respiratory
      safety of ivabradine in patients with asthma and COPD.
    

Detailed description: 
      In this double blind, placebo-controlled, crossover study, 20 asthmatics and 20 COPD patients
      received ivabradine 7,5 mg b.i.d. and placebo for 5 days in crossover manner. HR in ECG
      holter monitoring, peak expiratory flow rate (PEFR), symptoms, rescue medication consumption
      and AEs were evaluated in both periods of treatment.
    

Intervention name(s): Ivabradine (Procoralan); Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Ivabradine 7,5 mg b.i.d. for 5 days and Placebo b.i.d. for 5 days (Ivabradine-Placebo); Placebo b.i.d. for 5 days and Ivabradine 7,5 mg b.i.d. for 5 days (Placebo-Ivabradine)
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: asthma, chronic obstructive pulmonary disease, COPD, ivabradine, heart rate
Effects of Kinesiotaping With and Without Pelvic Tilts in Dysmenorrhea
Condition: Dysmenorrhea
MeSH terms: Dysmenorrhea
Study type: Interventional

Summary: 
      This study aims to determine the effects of kinesiotaping with & without pelvic tilts on pain
      & menstrual distress in females with dysmenorrhea. This study will be a randomized controlled
      trial to compare the effectiveness of kinesiotaping with and without pelvic tilts in subjects
      with primary dysmenorrhea.
    

Detailed description: 
      This study will be a randomized controlled trial to compare the effectiveness of
      kinesiotaping with and without pelvic tilts in subjects with primary dysmenorrhea. Subjects
      with primary dysmenorrhea meeting the predetermined eligibility criteria will be divided into
      two groups using the random sequence generation method. Pre-intervention responses shall be
      taken during the first menstrual cycle using the Numeric Pain Rating Scale, WaLLID tool &
      Menstrual Distress Questionnaire.

      Subjects in Group A shall be treated with kinesiotaping and pelvic tilts while subjects in
      Group B shall be treated with kinesiotaping only. Each subject will receive 02 treatment
      sessions during the second & third menstrual cycles. Post-intervention responses shall be
      recorded in the fourth menstrual cycle using the Numeric Pain Rating Scale, WaLLID tool &
      Menstrual Distress Questionnaire.
    

Intervention name(s): Kinesiotape; Pelvic Tilts
Intervention type(s): Other; Other
Intervention description(s): Patients will be instructed to inhale while taping the application. The tape will be applied in a vertical direction from just below the navel to the pubic region, another tape will be applied over the initial tape in the horizontal direction with minimal stretch. Another tape will be applied over the lumbosacral region making a V shape. The arms of V shall lie over the lumbar region while the base shall rest over the caudal region. Taping will be maintained for at least 48 hours.
The interventions shall be applied for two consecutive menstrual cycles.; Patients will be asked to lie in a supine position with legs bent and toes facing forward. Afterward, they will be instructed to pull their belly inwards while pushing pelvis towards the ceiling and keep hip muscles tightened. This position will be maintained for 5 seconds with 3 sets of 20 repetitions. Pelvic tilts must be performed throughout the menstrual cycle.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: dysmenorrhea; Active stretching; Kinesiotape
Comparison of Stavudine Used Alone or in Combination With Didanosine in HIV-Infected Children
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 2

Summary: 
      To evaluate the safety and determine the pharmacokinetic disposition of stavudine (d4T) alone
      and in combination with didanosine (ddI), and whether concurrent administration alters the
      disposition of either drug. To compare d4T versus d4T plus ddI with respect to short and long
      term changes from baseline in plasma HIV RNA concentrations. To determine the relationship,
      if any, between drug exposure and viral burden.

      In a pilot study of d4T and ddI given to eight children with advanced HIV for 24 weeks, the
      three children with baseline counts greater than 50 cells/micro liter experienced a 20%
      increase in their CD4+ lymphocyte counts. Based on these results, controlled trials of the
      same regimen for children with less advanced HIV disease should be undertaken.
    

Detailed description: 
      In a pilot study of d4T and ddI given to eight children with advanced HIV for 24 weeks, the
      three children with baseline counts greater than 50 cells/micro liter experienced a 20%
      increase in their CD4+ lymphocyte counts. Based on these results, controlled trials of the
      same regimen for children with less advanced HIV disease should be undertaken.

      Eligible subjects receiving d4T will be assigned in an open manner to Arm 1, and subjects who
      have been receiving zidovudine (AZT) will be assigned in a randomized, double blind manner to
      Arms 2 and 3. Each subject will receive study drug for 48 weeks as follows: Arm 1 - d4T plus
      ddI, Arm 2 - d4T alone, Arm 3 - d4T plus ddI.
    

Intervention name(s): Stavudine; Didanosine
Intervention type(s): Drug; Drug
Intervention MeSH terms: Stavudine; Didanosine
Masking: Double
Primary purpose: Treatment
Keywords: Didanosine; Drug Therapy, Combination; Antiviral Agents; Stavudine
Doxazosin for Psychostimulant Dependence
Condition: Methamphetamine or Cocaine Dependence
MeSH terms: Cocaine-Related Disorders
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Psychostimulant dependence is a major public health problem and no medications have been
      shown to be very effective in treating this disorder. Thus, the investigators wish to study
      whether a blood pressure drug thought to reduce drug craving through its interaction at
      particular adrenergic receptors - doxazosin - can dredge cocaine use relative to placebo in
      psychostimulant dependent participants enrolled in an 8-week, randomized, double blind,
      placebo-controlled outpatient clinical trial. Our hypothesis is that doxazosin will reduce
      cocaine use relative to placebo in psychostimulant dependent participants.
    


Intervention name(s): Doxazosin extended release
Intervention type(s): Drug
Intervention description(s): initially maintained on doxazosin extended release 4 mg once a day for 7 days, then the dose is increased to 8 mg once per day for the duration of the trial.
Intervention MeSH terms: Doxazosin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Primary and Secondary Hemostasis in Elective Coronary Artery Bypass Graft Surgery
Condition: Coronary Disease
MeSH terms: Coronary Disease
Study type: Observational

Summary: 
      Patients undergoing elective coronary artery bypass graft surgery (CABG) are treated with
      platelet inhibitors to reduce myocardial infarction and mortality.However, this can increase
      perioperative bleeding. A retrospective analysis of the data in our institution has revealed
      a significant increase in transfusion requirements after elective CABG since 5 years. The aim
      of our study is to observe if this increase in transfusion requirements is due to platelet
      inhibitors or due to other coagulation abnormalities resulting from other anticoagulants.
    


Intervention name(s): screening coagulation abnormalities
Intervention type(s): Other
Intervention description(s): if specific coagulation abnormalities are observed which increase patient's risk of bleeding, appropriate treatment will start
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        coronary artery bypass graft
An Open-Label, Single-Dose Study to Determine the Metabolism and Elimination of 14C-Perampanel in Healthy Male Subjects
Condition: Healthy Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      This is an open-label, single-dose study in healthy male subjects. The study will have 2
      phases: Pretreatment and Treatment. The Pretreatment Phase will last up to 21 days and will
      consist of a Screening Period and a Baseline Period, during which each subject's study
      eligibility will be determined and baseline assessments will be conducted.
    


Intervention name(s): E2007
Intervention type(s): Drug
Intervention description(s): 14C-labeled perampanel dissolved in ethanol and administered using a capsule formulation in a single dose, one day
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Healthy; Male Subjects
Efficacy of Ivermectin and Albendazole Against Onchocerciasis in the Volta Region, Ghana
Condition: Onchocerciasis
MeSH terms: Onchocerciasis
Study type: Interventional
Phase: Phase 3

Summary: 
      We will examine whether a combination of Ivermectim (IVM) plus Albendazole (ALB) compared to
      IVM alone given annually, which is the current standard for mass drug administration (MDA),
      is more effective in sterilizing adult worms. We will also address whether IVM plus ALB given
      twice per year is superior to IVM given once per year or twice per year.
    

Detailed description: 
      We hypothesize that more effective combinations of dose schedules of existing antifilarial
      drugs for MDA against onchocerciasis could shorten the number of years needed to interrupt
      onchocerciasis transmission and eliminate this infectious disease in areas that previously
      had high disease rates. Improved treatments should also make it feasible to extend MDA into
      areas that are currently not being helped. These changes have the potential to completely
      change the game to make global elimination of onchocerciasis a feasible goal.

      Participants will be randomized into 5 treatment arms with 75 subjects in each arm for a
      total of 375 and followed for 36 months after the initial treatment. The primary endpoint
      will be the percent fertile adult female worms in nodules removed 36 months after the
      initiation of treatment.
    

Intervention name(s): IVM plus ALB; IVM
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Onchocerciasis
Study to Assess the Clinical Efficacy and Safety of a Novel Method of Specific Allergen Immunotherapy in Grass Pollen Allergic Subjects by Epicutanous Allergen Administration
Condition: Rhinoconjunctivitis
Study type: Interventional
Phase: Phase 1

Summary: 
      Primary Objective Comparison of the inhibition of the allergic response assessed by nasal
      provocation test after epicutanous pollen allergen administration and placebo epicutaneous
      administration.

      Secondary Objectives Comparison of the efficacy of the placebo with that of the epicutanous
      pollen allergen administration evaluated by visual analog symptom scales (nasal itching,
      sneezing, rhinorrhea, conjunctival redness, and lacrimation, lung symptoms ), Comparison of
      the inhibition of the allergic response assessed by skin prick test after epicutanous pollen
      allergen administration and placebo epicutaneous administration.

        -  Trial with medicinal product
    


Intervention name(s): Pollen
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
The Effect of Repetitive Transcranial Magnetic Stimulation (rTMS) on Depression in Parkinson's Disease (PD)
Condition: Depression in Parkinson's Disease
MeSH terms: Parkinson Disease; Depression; Depressive Disorder
Study type: Interventional

Summary: 
      This study aims to assess the therapeutic role of rTMS on parkinson's patients with
      depression. Patients diagnosed with Parkinson's Disease and depression will be recruited. All
      patients will be admitted and will be allocated randomly into two groups one of which will
      receive real sessions of high frequency rTMS for left dorsolateral prefrontal cortex (DLPFC)
      for 10 consecutive sessions totally over period of 10 days with repeated booster sessions
      every month during the period of follow up. The other will receive sham sessions.
    

Detailed description: 
      This study aims to assess the therapeutic role of rTMS on parkinson's patients with
      depression. Thirty PD patients with depression using United Kingdom (UK ) bank criteria for
      PD will be recruited from outpatient clinic in Assiut University. All patients will be
      admitted at Neuropsychiatric Department, Assiut University Hospital/ Assiut, Egypt.Each
      patient fulfilled the inclusion criteria as having score more than or equal 14 on Beck
      Depression Inventory (BDI) will be recruited. The patients will be allocated randomly into
      two groups one of which will receive real sessions of high frequency rTMS (25 HZ), with
      intensity of 80% of resting motor threshold detected from the hand motor area, with total
      2000 pulses for left DLPFC for 10 consecutive sessions totally over period of 10 days with
      repeated booster session every month during the period of follow up among three months. The
      other will receive sham sessions. All subjects will be followed up by selected clinical
      rating scales at different intervals pre session, post 10 sessions, and after one, two and
      three months.
    

Intervention name(s): repetitive transcranial magnetic stimulation
Intervention type(s): Device
Intervention description(s): By defining intensity of 80% of the resting Motor Threshold detected from motor area for Rt Abductor Pollicis Brevis (APB), we will apply repetitive Transcranial Magnetic Stimulation (rTMS) using 70-mm diameter air-cooled figure-of-8 coil and SuperRapid2 Magnetic Stimulator with high frequency (25Hz), Stimuli will be delivered for total 2000 pulse (divided on 50 trains with 40 pulses per train with inter-train interval 30 seconds) for the left DLPFC (coil placed tangential over the optimal position of 7 cm anterior to hand motor hotspot area detected for Real group and the same coil placed perpendicular with hand of coil pointing upward over occipital cortex for Sham group). Sessions will be consecutive for ten days period with repetition of consecutive 5 sessions as boosting doses on 5 days period over the follow up visits every month for the next 3 months.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment