bioihbjkbjnl/mcl2 huggingface dataset:
Treatment of Complex Anal Fistula With Draining Seton With or Without Rerouting of Track
Condition: Anal Fistula
MeSH terms: Rectal Fistula; Fistula
Study type: Interventional

Summary: 
      This randomized trial aimed to compare conventional draining seton with or without rerouting
      of the fistula track in treatment of complex anal fistula
    

Detailed description: 
      Placement of seton is typically employed when the fistula track is involving more than 30% of
      the external anal sphincter. However, attempts to reroute the seton and the involved fistula
      track were made to preserve the external anal sphincter fibers and hasten healing of the anal
      wound. Mann and Clifton first introduced a transposition technique for the management of high
      anal and anorectal fistulas by re-routing the extrasphincteric portion of the track into an
      intersphincteric position with immediate repair of the external sphincter and reported
      successful outcomes of five patients in terms of quick healing and preserved anal continence.

      The present study aimed to evaluate the outcome of draining seton with or without rerouting
      of the fistula track in treatment complex high anal fistula regarding healing time,
      postoperative pain, and incidence of recurrence and FI postoperatively. We hypothesized that
      rerouting the seton to include the fistula track and the internal anal sphincter only,
      preserving the external anal sphincter muscles, would serve to hasten healing and decrease
      the incidence of recurrence and continence disturbances.
    

Intervention name(s): Draining seton; Rerouting of track
Intervention type(s): Procedure; Procedure
Intervention description(s): Number 1 silk suture was passed through the fistula track and tied as loose seton; The seton and fistula track were rerouted to involve the internal anal sphicnter only and spare the external sphincter
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Adoptive Transfer of Specific Melanoma Antigens CD8+ T Cells in Metastatic Melanoma Patients: a Phase I/II Study
Condition: Metastatic Melanoma
MeSH terms: Melanoma
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This study evaluates the safety as well as the potential clinical efficacy of an adoptive
      transfer of CD8+ T cells, sorted with HLA-peptide multimers and specific for Melan-A and
      MELOE-1 melanoma antigens, to patients suffering from advanced metastatic melanoma (stages
      IIIc and IV).
    


Intervention name(s): Melanoma antigens-specific CD8+ T lymphocytes
Intervention type(s): Biological
Intervention description(s): The intervention uses an autologous somatic cell therapy medicinal product. It consists in the intravenous injection of melanoma antigens (Melan-A and MELOE-1) - specific CD8+ T lymphocytes followed by subcutaneous injections of Proleukin.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Onco-dermatology; Adoptive transfer; Immunotherapy
Bioequivalence Study of Montelukast From Asmakast 5mg Chewable Tab.(Sandoz, Egypt) & Singulair 5mg Chewable Tab.(Merck)
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Comparative randomized, single dose, two-way crossover open-label study To investigate the
      bioequivalence of Montelukast from 5 mg chewable tablets(Sandoz, Egypt) and Singulair5 mg
      chewable tablets(Merck & Co. Inc. ), after a single oral dose administration of each to
      healthy adults under fasting conditions,
    

Detailed description: 
      19 blood samples will be drawn in each period. The total volume of blood will not exceed 200
      ml throughout the whole study.0.00 (pre-dose), 0.25, 0.50, 0.75, 1.00, 1.25, 1.50, 2.00,2.50,
      3.00,3.50, 4.00, 4.50, 5.00, 6.00, 8.00, 10.00, 12.00, and 24.00 hours postdose , Primary
      Pharmacokinetic Parameters: Cmax, AUC0→t and AUC0→∞ Secondary Pharmacokinetic Parameters: Ke,
      tmax and t1/2e. ANOVA using 5% significance level for transformed (with the 90% confidence
      intervals) and untransformed data of Cmax, AUC0→t and AUC0→∞ and for untransformed data of
      Ke, tmax and t1/2e.

      The confidence intervals of logarithmically transformed Test/Reference ratios for Cmax,
      AUC0→t and AUC0→∞ to be within 80.00-125.00%.

      A comprehensive final report will be issued upon the completion of the study.
    

Intervention name(s): Asmakast; Singulair
Intervention type(s): Drug; Drug
Intervention description(s): 1 chewable tablet contains 5 mg montelukast; 1 chewable tablet contains 5 mg montelukast
Other intervention name(s): Singulair
Intervention MeSH terms: Montelukast
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Efficacy Assessment of the Cell Therapy Medicine NC1 in Patients With Post-traumatic Syringomyelia
Condition: Post-Traumatic Syringomyelia
MeSH terms: Syringomyelia
Study type: Interventional
Phase: Phase 2

Summary: 
      The objective of the study is to determine if the cell therapy NC1 administered in the spinal
      cord is effective for the treatment of a post-traumatic syringomyelia. The post-traumatic
      syringomyelia is the development and progression of cyst filled with cerebrospinal fluid
      (CSF) within the spinal cord. The cell therapy NC1 consist on cells obtained from the bone
      marrow of the patient, that are cultured in vitro and administered in the spinal cord of the
      same patient.
    

Detailed description: 
      Phase II, Open, prospective, not controlled, not randomized clinical trial in patients
      affected by post-traumatic syringomyelia. The trial evaluates the efficacy of the cell
      therapy NC1 administered via intrathecal in the location of the injury. After the
      administration of the cell therapy, patients will undergo physiotherapy during the follow-up
      period (6 months). Patients will be evaluated at month 3 and month 6 after the NC1
      administration.
    

Intervention name(s): NC 1 cell therapy
Intervention type(s): Biological
Intervention description(s): All patients will be treated with NC1
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Safety and Efficacy Study of NH004 Films for Relief of Sialorrhea Symptoms in Parkinson's Disease Patients
Condition: Sialorrhea Secondary to Parkinson's Disease
MeSH terms: Sialorrhea; Parkinson Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary goal of the study is to evaluate the safety and potential efficacy of intra-oral
      dissolvable NH004 films to improve the short-term symptoms of sialorrhea (drooling) in
      Parkinson's disease (PD) patients.
    

Detailed description: 
      NH004 contains the anticholinergic agent tropicamide and is delivered in a convenient product
      form (intra-oral dissolvable thin films) designed for the management of sialorrhea. This
      study is a double blind, placebo-controlled, crossover study of the safety and potential
      efficacy of three doses of of NH004 films for the short-term relief of the symptoms of
      sialorrhea in Parkinson's disease patients.

      A total of up to 36 Parkinson's disease patients will be enrolled in the study in two Phases.
      Phase A will include 12 patients and Phase B up to 24 patients. There will be an interim
      analysis after conclusion of Phase A. In both phases patients will be randomized into one of
      four groups. Each group will have a distinctive sequence for receiving intra-oral dissolvable
      films of 0.3 mg, 1 mg, 3 mg of NH004, or placebo during four visits.
    

Intervention name(s): 0.3 mg tropicamide; 1 mg tropicamide; 3 mg tropicamide; 0 mg tropicamide
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 0.3 mg tropicamide in intra-oral thin film; 1 mg tropicamide in intra-oral thin film; 3 mg tropicamide in intra-oral thin film; 0 mg tropicamide (placebo) in intra-oral thin film
Other intervention name(s): NH004; NH004; NH004; NH004 (placebo)
Intervention MeSH terms: Tropicamide
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: sialorrhea; drooling; excessive salivation; parkinson's disease
Engaging Tribal Policy Makers to Improve the Food and Physical Activity Environments in American Indian Communities
Condition: Obesity
MeSH terms: Obesity
Study type: Interventional

Summary: 
      The overall objective of the study is to reduce adult obesity in participating American
      Indian (AI) communities and to improve understanding of the behavioral and environmental
      factors affecting obesity in these settings.
    

Detailed description: 
      The investigators plan to accomplish this objective by developing, implementing, and
      evaluating a randomized controlled trial of an intervention to improve diet and physical
      activity-related risk factors of obesity. A previous iteration of the intervention trial,
      called Obesity Prevention Research and Evaluation of InterVention Effectiveness in NaTive
      North Americans (OPREVENT) was implemented in five American Indian communities in Michigan
      and New Mexico. OPREVENT was a multi-level, multi-component intervention functioning at the
      community, institution, household, and individual levels and was implemented in schools, food
      stores, and worksites. Prior to OPREVENT, the research team has run multi-level interventions
      by working with schools and food stores in Native North American (NNA) communities1-6. For
      this new trial, named OPREVENT2, the research team will expand on the collective experience
      working on obesity prevention interventions in American Indian (AI) settings by developing
      complementary policy and social media components to support long-term sustainability of the
      OPREVENT intervention. OPREVENT2 will be implemented in six new AI communities.
    

Intervention name(s): Intervention
Intervention type(s): Behavioral
Intervention description(s): Intervention components will occur at the policy level (working with tribal leaders makers to sustain intervention components; food retail outlet level (working with grocery stores and owners to stock, promote, and sell healthier foods and beverages); neighborhood level (working with worksites and schools to deliver nutrition intervention sessions to youth and adults in intervention neighborhoods); household level (providing a social media program that provides parents and caregivers tips for healthier eating).
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: Native American; Obesity; Multi level; Policy; Schools; Worksite; Social Media; Food Store
Reversible Portal Vein Embolization Before Major Hepatectomy
Condition: Liver Regeneration; Reversible Portal Vein Embolization
Study type: Interventional

Summary: 
      The aim of this study is to prospectively evaluate the tolerance and efficiency of a new
      technique of preoperative selective portal vein embolization (PVE) in patients requiring
      major hepatic resection.
    

Detailed description: 
      Portal vein embolization (PVE) is used before major hepatectomy to induce hypertrophy of the
      future liver remnant (FLR). A non-reversible absorbable material is generally used for
      embolization, as it provides effective, permanent vascular occlusion. Our team has developed
      a minimally invasive technique of reversible PVE using gelfoam powder. The aim of this study
      is to assess the tolerance and efficiency of preoperative reversible selective PVE in
      patients requiring major hepatic resection. We hypothesize that preoperative reversible PVE
      allows to similarly increase FLR volume in comparison with classical non-reversible PVE in
      patients requiring major liver resection with limited FLR.

      The hypertrophy ratio after classical non-reversible PVE is evaluated in literature as 13%.
      We estimated the hypertrophy ratio after reversible PVE as 9% in a previous retrospective
      study.

      The aim of this pilot study is to prospectively evaluate the hypertrophy ratio after
      reversible PVE.

      Primary End Point: Hypertrophy ratio of FLR volume / total liver volume between the baseline
      and after PVE, assessed by computed tomography scan volumetry 4-6 weeks after PVE.
    

Intervention name(s): Selective reversible portal vein embolization
Intervention type(s): Procedure
Intervention description(s): Percutaneous access to the portal vein is achieved under general anesthesia with ultrasound or fluoroscopic control. After assessment of portal venous anatomy, embolization of selected portal vein segments is performed using the powdered form of an absorbable gelatin sponge.
Intervention model: Single Group Assignment
Intervention model description: Reversible Portal vein embolization (PVE) using curaspon® (Absorbable Gelatin Hemostats)
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Liver regeneration; portal vein embolization; gelatin powder; liver surgery; hepatectomy
Ropinirole in the Treatment of Bipolar Depression
Condition: Bipolar Disorder
MeSH terms: Depression; Bipolar Disorder
Study type: Interventional
Phase: Phase 4

Summary: 
      To demonstrate efficacy and safety of Requip in in treating bipolar depression.
    

Detailed description: 
      This study is 8 weeks long, with an optional additional 8 weeks. The study is
      placebo-controlled and patients are randomized to receive either ropinerol or placebo.
      Changes in depression, anxiety and overall psychiatric symptoms will be monitored during
      participation.
    

Intervention name(s): ropinirole
Intervention type(s): Drug
Intervention MeSH terms: Ropinirole
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double
Primary purpose: Treatment
Keywords: bipolar disorder, ropinirole, depression
Myofascial Induction in Breast Cancer Survivors
Condition: Pain; Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional

Summary: 
      The purpose of this study was to show the immediate effects of myofascial induction on
      perceived pain and anxiety, cervical/shoulder range of motion and mood state in breast cancer
      survivors suffering shoulder/arm morbidity.
    

Detailed description: 
      Background: To investigate the immediate effects of myofascial induction on perceived pain
      and anxiety, cervical/shoulder range of motion and mood state in breast cancer survivors
      suffering shoulder/arm morbidity.

      Methods: Randomized, single-blind, placebo-controlled cross-over study. Twenty-one enrolled
      participants who had a diagnosis of breast cancer stage I-IIIA and had completed adjuvant
      therapy except hormonal treatment. The study consisted of two intervention sessions of 30
      minutes separated by a wash-up period of 4 weeks. The interventions consisted of a Myofascial
      Induction (experimental group) or placebo pulsed shortwave therapy (control group). The main
      outcome measures were: Visual Analogue Scale for pain and anxiety, shoulder-cervical
      goniometry for range of motion, Profile of Mood States for psychological distress and
      Attitudes Toward Massage Scale.
    

Intervention name(s): Myofascial Induction; Unplugged pulsed shortwave therapy
Intervention type(s): Behavioral; Device
Intervention description(s): Patients received a Myofascial Induction focused on the upper limb area for 30 minutes using the Pilat approach.; Patients received a placebo session consisted of 30 minutes of unplugged pulsed shortwave therapy.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: Neck; Shoulder; Manual Therapies
Jumping Gap Dimension at Maxillary Teeth: Cone-Beam Computed Tomography (CBCT) Study
Condition: Jumping Gap Dimension at Maxillary Teeth
Study type: Observational

Summary: 
      To assess the important anatomical structures involved in the treatment planning of immediate
      implants, particularly the jumping gap distance at the different maxillary teeth in the
      esthetic zone using CBCT analysis. Additional relevant radiographic aspects are evaluated as
      well to aid in decision making related to immediate implants.
    


Intervention name(s): Observational study no intervention
Intervention type(s): Other
Intervention description(s): No intervention
Observational model: Other
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Egyptian Population (Cairo Residents)
Trial of Mannitol Cream for Pain Relief After a Long Run
Condition: Pain
Study type: Interventional
Phase: Phase 1

Summary: 
      Mannitol cream has been shown clinically to be effective for pain control. To determine if
      this effect is worth testing on a larger scale, 170 runners will receive a sample of 25%
      mannitol cream to apply on one leg, and the cream base without the mannitol on the other leg
      following a 10 km or longer run, and for the following five days. Mannitol and control legs
      will be chosen at random for each runner. Pain scores before and after cream application will
      be acquired each day for each leg. Means and standard deviations found will be used to
      determine the size of a larger study.
    

Detailed description: 
      The hypothesis for this study is that Mannitol cream will reduce post long run pain more than
      vehicle cream alone. In this parallel design, 170 runners who usually experience a pain level
      greater than 5/10 on a numerical rating scale from 0 to 10 where zero is no pain and 10 is
      the worst pain ever, will be given a cream containing 25% mannitol to apply on one leg and
      the vehicle cream to apply on the other leg. The cream assignment will be randomized, and the
      runner, the person supplying the cream and the person inputting the data will be blinded as
      to which leg received which cream. Pain levels in each leg following the long run will be
      recorded, via an e-mail questionnaire, or, failing this, by telephone, the day of the run,
      and each day, for five days following the run. Mean and standard deviations for pain levels
      will be calculated for each treatment leg, and a repeated measures ANOVA (Analysis Of
      VAriance) will be done comparing the pain levels in each leg over the six days. Using this
      information, if the NRS (Numeric rating scale) pain levels differ by more than 1/10 between
      the two groups, a larger study will be conducted using the information gathered in this study
      to determine sample size.
    

Intervention name(s): Mannitol cream; Placebo Cream
Intervention type(s): Drug; Drug
Intervention description(s): 25% mannitol in PENcream (See above) (See above) This will be applied as needed to one side of the body (blinded assignment) over painful painful areas of legs following a 10 km run, on the day of the run and for five days afterwards.; This is the vehicle only cream (PENcream) (See above) This will be applied as needed to one side of the body (blinded assignment) over painful painful areas of legs following a 10 km run, on the day of the run and for five days afterwards.
Other intervention name(s): Mannitol; PENcream, Commercially available proprietary cream.; PENcream, commercially available proprietary cream.
Intervention MeSH terms: Mannitol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Pain; exercise; muscle
The Effect of High Intensity Laser Therapy in the Management of Painful Calcaneal Spur
Condition: Calcaneal Spur
MeSH terms: Heel Spur
Study type: Interventional

Summary: 
      The effect of high intensity laser therapy in the management of painful calcaneal spur: a
      double blind, placebo-controlled study
    

Detailed description: 
      The objective of this study was to evaluate the effect of high-intensity laser therapy (HILT)
      and exercise in patients with calcaneal spur. The patients were randomly assigned to receive
      either HILT + exercise (n=21) or placebo HILT + exercise (n=21). Pain severity (with visual
      analog scale (VAS) and with Roles and Maudsley score (RMS) ), functionality (with Foot and
      Ankle Outcome Score (FAOS)), plantar pressure measurement (with pedobarographic assesment),
      and quality of life (with short form-36 (SF-36)) of the patients were evaluated at baseline,
      at 4 weeks, and 12 weeks.
    

Intervention name(s): HILT + exercise; Placebo HILT + exercise
Intervention type(s): Other; Other
Intervention description(s): High intensity laser therapy-Patients received pulsed laser treatment, using a HIRO 3 device (ASA Laser, Arcugnano, Italy), five times a week for a period of three weeks, and one session per day for a total of 15 sessions. A 3-phase treatment program was performed in each session, and the patients were then given a daily exercise program once a day by a physiotherapist. Exercise program; A physiotherapist-assisted exercise program was performed by the two groups, five times a week for three weeks, for approximately 25 minutes. The exercise programs consisted of stretching exercises to the plantar fascia and Achilles tendon, active range of motion (ROM) exercises, and strengthening exercises to the tibialis posterior and peroneus muscles. The patients were also taught to collect the foot and towel.; Placebo HILT group; Placebo therapy was applied in five sessions a week for three weeks, with a total of 15 sessions a day, with no current flowing through the device. This was followed by the exercise programs described above, performed once a day with the physiotherapist. Exercise program; A physiotherapist-assisted exercise program was performed by the two groups, five times a week for three weeks, for approximately 25 minutes. The exercise programs consisted of stretching exercises to the plantar fascia and Achilles tendon, active range of motion (ROM) exercises, and strengthening exercises to the tibialis posterior and peroneus muscles. The patients were also taught to collect the foot and towel.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: HILT; calcaneal spur; placebo
A Study of MEMP1972A in the Prevention of Allergen-Induced Airway Obstruction in Patients With Mild Asthma (SOLARIO)
Condition: Asthma
MeSH terms: Asthma; Airway Obstruction
Study type: Interventional
Phase: Phase 2

Summary: 
      This Phase II, double-blind, placebo-controlled, randomized, parallel-group study is designed
      to evaluate the efficacy, safety and tolerability of MEMP1972A when administered to patients
      by intravenous (IV) infusion for the treatment of allergen-induced asthma.
    


Intervention name(s): MEMP1972A; placebo
Intervention type(s): Drug; Drug
Intervention description(s): Intravenous repeating dose; Intravenous repeating dose
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment