bioihbjkbjnl/mcl2 huggingface dataset:
Natural Orifice Transgastric Endoscopic Surgical Removal of the Gallbladder
Condition: Cholecystitis
MeSH terms: Cholecystitis
Study type: Interventional

Summary: 
      Hypothesis: Natural orifice transgastric cholecystectomy with laparoscopic assist will be
      feasible and have comparable complication rates as standard lap cholecystectomy. Patient
      benefits will include less pain and scaring.
    

Detailed description: 
      In this study, we propose to use a surgical technique that eliminates the need for a 1.5-2.5
      cm umbilical incision. A flexible endoscope will be inserted through the mouth and into the
      stomach. Using commercially available endoscopes, endoscopic instruments and accessories, a
      small incision will be made in the gastric wall and the endoscope will be advanced into the
      insufflated peritoneal cavity. Two to three small laparoscopic trocars will be placed for
      laparoscopic instrument insertion to manipulate, retract and cut tissue. The flexible
      endoscope will provide visualization of the surgical field and flexible endoscopic
      instruments may be used to augment surgical manipulation with the laparoscopic instruments.
      Once dissected free, the gall bladder will be removed through the stomach and out of the
      mouth. Commercially available endoscopic clips, sutures and/or tissue anchors will be used to
      close the gastrotomy; additionally, the gastrotomy will be tested for leaks and
      laparoscopically oversewn with suture as needed.

      Patients will be discharged per the standard of practice for a laparoscopic cholecystectomy.
      During the hospital stay severity of pain and use of pain medications will be recorded.
      Length of time spent in the recovery room and in the hospital will also be collected.
      Patients will return and be evaluated by their surgeon two weeks following their procedure.
      At this visit, any complications will be noted in the patient's medical record. Additionally
      at this visit and at the preoperative visit, patients will complete a standardized Quality of
      Life (QOL) assessment (i.e., SF-36) and perceived pain levels and type and frequency of pain
      medications will be recorded in the patient's medical record.
    

Intervention name(s): NOTES assisted laparoscopic cholecystectomy
Intervention type(s): Procedure
Intervention description(s): Surgical removal of the gallbladder using endoscopic instruments.
Other intervention name(s): NOTES Cholecystectomy
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: NOTES; cholecystectomy; endoscopic
Study of the Protective Effect of Mechanism of Pentoxyfilline After Major Liver Resection Under Inflow Occlusion (Pringle Manoeuvre)
Condition: Liver Regeneration
Study type: Interventional
Phase: Phase 4

Summary: 
      The investigators hypothecate that pentoxyfilline increase significantly the liver
      regeneration and reduces significantly ischemia and reperfusion (I/R) injury in major liver
      using aspartate aminotransferase (AST) and alanine aminotransferase (ALT) as marker of I/R
      injury.
    

Detailed description: 
      Liver resection is for many patients with primary or secondary hepatic malignancies the only
      curative treatment option. Often, the complete clearance of the hepatic tumor disease can be
      only achieved by extended liver resections. Clinical studies have demonstrated that
      intra-operative blood loss is associated reduced outcome after major liver resection. An
      effective strategy to reduce blood loss is the occlusion of the portal triad (Pringle
      manoeuvre). On the other hand, inflow occlusion results in ischemia- and reperfusion (I/R)
      injury. Randomized trials have shown that ischemic preconditioning (10 min clamping, 10 min
      reperfusion) and intermittent clamping (15 min clamping, 5 min reperfusion) result in
      reduction of the I/R injury. Another potential strategy to reduce I/R injury is the
      pharmacological protection. One promising drug is pentoxyfilline (PTF) which has vasodilative
      and hemorheologic effects. Furthermore, PTF suppresses the TNF release. These effects may be
      also protective in major liver resection under inflow occlusion (Pringle manoeuvre)and
      increase the liver regeneration. Therefore, we designed a randomised prospective trial to
      investigate the effects of PTF treatment in liver resection under inflow occlusion. The
      specific aims of the research project are:The investigators hypothecate that pentoxyfilline
      increases significantly the liver regeneration and reduces significantly ischemia and
      reperfusion (I/R) injury in liver using aspartate aminotransferase (AST) and alanine
      aminotransferase (ALT) as marker of I/R injury.
    

Intervention name(s): pentoxyfilline; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): The total dose of 1 mg/kg/h will be used. At the preoperative day half of the daily dose will be given as a 4-hour short-term infusion within 24 hours before surgery. Afterwards, a continuous intravenous infusion of PTX 1 mg/kg of body weight per hour will be started intra-operatively and will be continued for a total of 72 hours after surgery.; This group will be treated with saline solution at the same time points. The infusion volume and infusion rate of saline solution correspond to that of the PTF group.
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: pentoxyfilline; liver regeneration; major liver resection; reduction of the I/R injury
MR-guided Focused Ultrasound Treatment of Prostate Cancer: Focal Therapy for Locally Non-Advanced Disease
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      Since prostate specific antigen (PSA) was introduced as a clinical screening tool for
      prostate cancer, more men are diagnosed with small foci of cancers instead of the advanced
      disease. The present choice of treatment for men with localized prostate cancer lies between
      active surveillance and radical therapy. Thus, the option of treating only the cancer within
      the prostate gland and sparing the non-cancerous tissue is quite appealing, yet very
      controversial. At present there are no consistent scientific data on focal therapy and its
      major effectiveness.

      Focal therapy for prostate cancer is defined as therapy that selectively ablates known
      disease while preserving existing functions, with the overall aim of minimizing lifetime
      morbidity without compromising life expectancy.

      The aim of the investigators study is to test if Magnetic Resonance guided Focused Ultrasound
      ablation can determine non-invasive necrosis of focal, locally non-advanced prostate cancer.

      The study i designed as Phase 1, treatment & resection protocol. With this project the
      investigators further aim to evaluate the safety and identify side effects of Magnetic
      Resonance guided Focused Ultrasound in treating focal prostate cancer.

      This design will also expand knowledge of the effect of Magnetic Resonance guided Focused
      Ultrasound onto peri-prostatic environment and to determine if surgery can safely be adopted
      after this non-invasive treatment.
    


Intervention name(s): ExAblate 2100; InSightec
Intervention type(s): Device
Intervention description(s): Patients with biopsy proven locally non-advanced T2 prostate cancer identified at 3T MR examination including dynamic contrast enhanced (DCE-with time to peak and mean transit time evaluation) and candidate to radical prostatectomy will undergo Magnetic Resonance guided Focused Ultrasound (MRgFUS) ablation. The procedure is carried out either under general anesthesia or spinal block.
MR images allow correct identification of the target as well as vital structure to avoid during energy delivery. Treatment safety and efficacy is monitored in real time using MR thermometry. Adjustments of energy direction and intensity can be made according to the real time monitoring. Pre- and post-ablative MR examinations will serve to analyze differences of DCE features of the neoplastic tissue; therapy-induced alterations will also be compared to histopathology findings from whole section prostate specimens
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Prostate Cancer; High Intensity Focused Ultrasound; Magnetic Resonance guided Focused Ultrasound; Non-invasive therapy; Focal Disease
More Relaxation by Deep Breath on Methacholine
Condition: Childhood Asthma
MeSH terms: Asthma
Study type: Observational

Summary: 
      Deep inhalation (DI) dilates normal airway precontracted with methacholine. The fact that
      this effect is diminished or absent in asthma could be explained by the presence of bronchial
      inflammation. The hypothesis tested was that DI induces more relaxation in methacholine
      induced bronchoconstriction-solely determined by the smooth muscle contraction-than in
      exercise induced bronchoconstriction, which is contributed to by both smooth muscle
      contraction and airway wall inflammation.
    

Detailed description: 
      Children were referred to the lung function department by their pediatric pulmonologist.
      Asthma was defined by a complaint of wheezing, cough, dyspnoea or chest tightness at rest or
      on exercising and a positive response to methacholine or exercise challenge.

      The response to exercise was considered positive when Forced Expiratory Volume in 1 s (FEV1)
      decreased at least 8% from Baseline.

      The response to methacholine was considered positive when FEV1 decreased at least 20% or Rrs
      increased at least 50% from baseline, at or below a cumulated dose of 1,200 μg.

      Bronchodilator medications were discontinued at least 12 hours prior to the testing and
      provocation allowed when the child had been free of respiratory symptoms for at least 2 weeks
      and baseline FEV1 was larger than 70% pred. Exercise and methacholine groups were matched for
      age, height, baseline FEV1 z-score, a moderate level of airway response to challenge and DI
      amplitude ranging 40-60% of the predicted Forced Vital Capacity (FVC). Written informed
      consent was obtained from the children and their parents for the procedures. Procedures for
      spirometry, exhaled fraction of NO (FENO), GrsDI (Respiratory conductance response to a deep
      inhalation) and challenges have been described previously. Acceptable GrsDI's were analyzed
      at a 10-20% FEV1 decrease from baseline. Statistics were performed using Mann-Whitney, Chi
      square tests and multiple regression as required. Data are median and interquartile range.
    

Intervention name(s): bronchial provocation test
Intervention type(s): Diagnostic Test
Observational model: Other
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        Seventy-three asthmatic children (48 boys) were selected, 37 underwent exercise challenge
        and 36 methacholine.
      
Keywords: airway smooth muscle, asthma, bronchial test, lung function
Dysphagia Management During COVID-19 Pandemic
Condition: Dysphagia; Covid19
MeSH terms: COVID-19; Deglutition Disorders
Study type: Observational

Summary: 
      The current study is aimed to determine the procedures applied in the dysphagia clinics
      during the COVID-19 pandemic period. A questionnaire consisting of 30 questions will be
      implemented. Each participant will be asked to answer the questions.
    

Detailed description: 
      The current study is aimed to understand the current clinical conditions and current practice
      regarding dysphagia management during the pandemic period/normalization period. It is a cross
      sectional online survey study. The first part is the survey development and testing, the
      second part is determination of swallowing centers and last part is survey distribution by
      google forms. A coordinator will be selected for each center to discuss the survey with the
      entire team and reply the questions.
    

Intervention name(s): Survey
Intervention type(s): Other
Intervention description(s): An online survey will be sent to each clinic to answer the survey questions.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Clinicians who work on a dysphagia clinic will be included.
      
Keywords: dysphagia; COVID-19
The Efficacy of Galantamine Treatment on Attention in Patients With Alzheimer's Disease
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease
Study type: Interventional
Phase: Phase 4

Summary: 
      This study will examine whether the administration of galantamine is effective for
      improvement of attention and more effective for patients with serious disturbance of
      attention by administering galantamine to patients with Alzheimer's dementia and performing
      an attention test on baseline, week 4 and 12.
    

Detailed description: 
      This is an open label (all people know the identity of the intervention), multi-center,
      prospective study investigating the effect of galantamine on the attention of Alzheimer's
      dementia patients. The objectives of this study include the evaluation of the relationship
      between change in attention after 4 weeks of galantamine administration and to investigate
      the effect of study drug after 12 weeks administration (the difference in the improvement of
      attention after the administration of galantamine). The secondary objective of this study is
      to clarify the causal relationship between improvement of attention and activities of daily
      living (ADL). The design of this study is prospective, open-label, multi-center study. Study
      populations are probable Alzheimer's dementia patients diagnosed by NINCDS-ADRDA (National
      Institute of Neurological and Communicative Disorders and Stroke and the Alzheimer's disease
      and Related Disorders Association), DSM-IV (Diagnostic and Statistical Manual of Mental
      Disorders) criteria. The efficacy of study drug will be assessed by evaluating cognitive
      function, attention and behavioral symptoms before and after the treatment using the
      following assessment tools: ADAS-K-cog11 (Alzheimer's Disease Assessment Scale - cognitive
      subscale), computerized attention test and activities of daily living. Safety evaluations
      include adverse event monitoring and clinical lab tests. The patient is administered oral
      galantamine 8 mg/day for the first 4 weeks and then 16 mg/day. The dose of galantamine is
      increased up to 24 mg if tolerated.
    

Intervention name(s): Galantamine
Intervention type(s): Drug
Intervention description(s): Orally administered Galantamine 8 mg/day for the first 4 weeks. Thereafter the dose will be increased to 16 mg/day. If tolerated, the dose of galantamine can be increased up to 24 mg/day.
Intervention MeSH terms: Galantamine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Alzheimer's disease; Galantamine; Dementia
Efficacy Study of Metadoxine SR Formulation in Attention Deficit Hyperactivity Disorder (ADHD) Subjects
Condition: Attention Deficit Hyperactivity Disorder
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Study type: Interventional
Phase: Phase 1

Summary: 
      This clinical study is designed to evaluate the safety and tolerability of a single oral
      administration of a Metadoxine slow release formulation to subjects diagnosed as having ADHD.
      Study also assess cognitive effects of such drug administration.
    

Detailed description: 
      Primary outcome measure is the safety and tolerability of study drug after a single dosing.

      Additional outcomes include commission error rate from the TOVA test. The result is measured
      as standard score in % compared to the values of the normal population.

      Exploratory outcome measures include:

        1. TOVA measures like response time , variability, omissions etc.

        2. Subtests from Wechsler: digit memory, digit-number signs etc
    

Intervention name(s): Extended Release Metadoxine
Intervention type(s): Drug
Intervention description(s): one oral 1400mg dose (2 tablets)
Other intervention name(s): Metadoxine, Metadoxil
Intervention MeSH terms: Pyridoxine; Metadoxine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: ADHD; ADD; TOVA; METADOXINE
SIFIB As an Anesthesia Method for Lower Extremity Surgeries
Condition: Anesthesia; Anesthesia Management; Regional Anesthesia
Study type: Observational

Summary: 
      The Ultrasound-guided Supra-inguinal Fascia Iliaca Block (SIFIB) is an advanced regional
      anesthesia technique strategically directed at the three primary nerves of the lumbar plexus.
      As the scope of regional anesthesia methods continues to grow in clinical application, this
      approach emerges as a versatile method. It can be used independently for pain management or
      as the primary anesthetic method, particularly in well-selected patients undergoing isolated
      limb surgeries or in combination with other regional anesthesia approaches.
    

Detailed description: 
      The study follows a retrospective cohort feasibility design, conducted within the confines of
      a tertiary hospital. The requisite data for analysis was acquired by accessing patient
      records and electronic data systems. A cohort of 16 patients was carefully chosen for
      inclusion in the study, and the administration of blocks was carried out before the surgical
      procedures.
    

Intervention name(s): Suprainguinal fascia iliaca block
Intervention type(s): Other
Intervention description(s): The design of this study involved the retrospective analysis of data. Data was gathered from adult patients falling into the American Society of Anesthesiology (ASA) categories I to III, who were scheduled for elective lower limb surgical procedures. More specifically, patients who had undergone SIFIB either as the primary anesthesia approach or as part of their anesthesia regimen were included. Those who had received general anesthesia, neuraxial anesthesia, or infiltration anesthesia were excluded from the study. Importantly, all patients who participated in the study provided written informed consent for both their involvement in the study and the publication of their data.
Other intervention name(s): Sciatic nerve block
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Specifically, we included patients who underwent SIFIB either as the primary anesthesia
        method or as a component of the anesthesia plan.
      
Keywords: Regional Anesthesia; Anesthesia Management
A Study of the Treatment of Postmenopausal Women With Osteoporosis
Condition: Osteoporosis, Post-Menopausal
MeSH terms: Osteoporosis; Osteoporosis, Postmenopausal
Study type: Interventional
Phase: Phase 3

Summary: 
      To compare the effect of treatment with teriparatide with that of salmon calcitonin in
      postmenopausal women with osteoporosis.
    


Intervention name(s): teriparatide 20 micrograms/day subcutaneous; salmon calcitonin 100 IU/day subcutaneous
Intervention type(s): Drug; Drug
Other intervention name(s): LY333334
Intervention MeSH terms: Teriparatide; Calcitonin; Salmon calcitonin; Calcitonin Gene-Related Peptide; Katacalcin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Dose-ranging Study of Oral COL-144 in Acute Migraine Treatment
Condition: Migraine Disorders
MeSH terms: Migraine Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the efficacy and safety of a range of oral doses of
      COL-144 in treating migraine headache, in order to select a dose or doses for further
      evaluation.
    

Detailed description: 
      Migraine is a common chronic neurological disorder characterized by recurrent disabling
      episodes of moderate to severe headache accompanied by nausea, vomiting, photophobia, and
      phonophobia. Acute pharmacologic therapy for migraine aims to terminate the attack or reduce
      its severity. Analgesics are commonly used or, if these are ineffective, triptans. Since
      triptans are contraindicated in patients with coronary artery disease, uncontrolled
      hypertension, and cerebrovascular disease alternative medications are required for patients
      where simple analgesics do not work. COL-144 has no vasoconstrictor activity at clinically
      relevant concentrations and might meet this need. COL-144 was effective when given
      intravenously in a placebo-controlled dose-ranging study. This study investigates which dose
      of oral COL-144 is effective in the in acute treatment of migraine headache.
    

Intervention name(s): Lasmiditan; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Oral application of one dose of either 50 mg lasmiditan,100 mg lasmiditan, 200 mg lasmiditan, 400 mg lasmiditan or placebo as the first treatment for a new migraine attack providing that any aura symptoms have resolved and the headache is either moderate or severe and has been so for less than 4 hours.; Placebo
Other intervention name(s): LY573144
Intervention MeSH terms: Lasmiditan
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: COL-144; acute treatment; migraine
A 2 Part Study to Assess the Relative Bioavailability of Tablet Formulation Compared to Capsule Formulation and the Effect of Food and Taste Assessment on the Tablet Formulation in Healthy Participants
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a two-part, open-label, healthy volunteer study. Part I will investigate the relative
      bioavailability of capsule and tablet formulations of RO7017773. Part II will explore how the
      taste of the tablet formulation is perceived with and without added sweetener/flavoring.
    


Intervention name(s): RO7017773 Phase I Capsule; RO7017773 Phase II Tablet Unflavored; RO7017773 Phase II Tablet Sweetened/Flavored
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Participants will receive 1 single oral dose of RO7017773 Phase I Capsule.; Participants will receive 3 single oral doses of unflavored RO7017773 Phase II tablet during Part 1, and 1 single oral dose of unflavored RO7017773 Phase II tablet during Part 2.; Participants will receive 1 single oral dose of sweetened/flavored RO7017773 Phase II tablet during Part 2.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment