bioihbjkbjnl/mcl2 huggingface dataset:
Assessment of Shared Decision Making Aids in Asthma
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether the use of shared decision making aids is
      more effective than usual care in improving asthma knowledge, lessening decisional conflict,
      and enhancing adherence to treatments and asthma control in adult patients with mild to
      severe asthma.
    


Intervention name(s): Patient decision aid
Intervention type(s): Other
Intervention description(s): The patient decision aid is a 12-page A3 size color-printed booklet entitled "Should I take asthma inhaled controller medication to optimize asthma control?"
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Health Services Research
Comparative Study of Olive Oil With Piroxicam Gel in Osteoarthritis of the Knee
Condition: Osteoarthritis of the Knee
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional
Phase: Phase 2

Summary: 
      this is a randomized double blinded trial which is conducted to measure the efficacy of
      topical virgin olive oil on osteoarthritis of knee that will be done in contrast to standard
      piroxicam gel.
    

Detailed description: 
      application of herbal product has old history in therapy of human diseases. olive oil is one
      of the important diet in Iran which its efficacy in reducing of rheumatic pains was pointed
      out by Avicenna in 10th century. Nevertheless, its efficacy is not confirmed by scientific
      study.

      in this double blinded study, 200 patients with diagnosed osteoarthritis of knee will be
      recruited that will randomly be assigned in piroxicam or olive oil group. the piroxicam gel
      or olive oil will be repackaged in anonymous tubes, which only recognizable via codes. the
      patients or visiting clinicians will be unaware of content of tubes. the final assessor will
      be blind to groups and interventions.

      the efficacy of therapies will be evaluated by means of WOMAC and PGs standard
      questionnaires.
    

Intervention name(s): Piroxicam; Olive Oil
Intervention type(s): Drug; Dietary Supplement
Intervention description(s): In this interventional arm gel of piroxicam (manufactured by Iran najo co,Iran), repackaged in a 60 g anonymous tubes will be administered to the patients.; virgin olive oil prepared directly from olive fruit from "olive gardens of north of iran, Gilan province" will packaged in a 60 g anonymous tubes.
Other intervention name(s): Piroxicam topical gel; Topical virigin olive oil
Intervention MeSH terms: Piroxicam
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: osteoarthritis; Knee; virgin olive oil; piroxicam; Topical
Adenosine Cardioplegia; Improved Cardioprotection?
Condition: Angina Pectoris
MeSH terms: Angina Pectoris
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      60 elective patients for CABG will be included to receive either standard hyperkalemic
      cardioplegia (St.Thomas Hospital Solution No I) or cardioplegia where supranormal potassium
      is replaced with 1.2 mM adenosine. Hypothesis as follows: 1. Adenosine instead of supranormal
      potassium in the cardioplegic solution give satisfactory cardiac arrest. 2. Adenosine instead
      of supranormal potassium in the cardioplegic solution gives equal cardioprotection. The
      patients will be followed with PiCCO-catheter to monitor cardiac function and repetitive
      blood samples to measure release of cardiac enzymes.
    


Intervention name(s): Adenosine
Intervention type(s): Drug
Intervention description(s): 1.2 mM adenosine instead of supranormal potassium in the cardioplegic solution
Intervention MeSH terms: Adenosine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Study of the Efficacy and Safety of Ulipristal Acetate Intermittent Treatment for Abnormal Uterine Bleeding Associated With Leiomyomas
Condition: Leiomyoma; Uterine Hemorrhage
MeSH terms: Leiomyoma; Myofibroma; Uterine Hemorrhage; Hemorrhage
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will evaluate the superiority of ulipristal acetate versus placebo for the
      treatment of abnormal uterine bleeding associated with uterine fibroids
    


Intervention name(s): Ulipristal acetate (UPA); Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Ulipristal acetate (UPA) tablet.; Matching placebo tablet.
Intervention MeSH terms: Ulipristal acetate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
T1D, Metabolic Syndrome and Insulin Resistance
Condition: Type 1 Diabetes; Metabolic Syndrome; Insulin Resistance
MeSH terms: Diabetes Mellitus, Type 1; Metabolic Syndrome; Insulin Resistance; Syndrome
Study type: Observational

Summary: 
      Patients with type 1 diabetes (T1D) and metabolic syndrome (MS) require high doses of insulin
      to achieve a glycemic control, due to insulin resistance (IR). The investigators identified
      the presence of metabolic syndrome and insulin resistance in patients with T1D in a
      population of southeast Mexico.

      The sampled population was recruited from the Diabetes Clinic of the Regional Hospital of
      High Specialty "Dr. Gustavo A. Rovirosa Pérez"; from August 2021 to February 2022, graduated
      physicians interviewed patients previously diagnosed with T1D. This study included patients
      older than 18 years and at least six months after being diagnosed with T1D. The interviewers
      excluded patients who did not attend regular consultations and those who did not agree to
      participate or to give a blood sample. A diabetologist evaluated and diagnosed all patients
      based on the World Health Organization (WHO) criteria.

      Fasting glucose, total cholesterol, HDL cholesterol, LDL cholesterol, and triacylglycerols
      were determined in blood serum using a Clinical Chemistry System from Random Access
      Diagnostics. The reasearch team determined glycated hemoglobin concentrations by an enzymatic
      immunoassay method.
    


Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Patients who attend Diabetes Clinic of the Regional Hospital of High Specialty "Dr. Gustavo
        A. Rovirosa Pérez", previously diagnosed with type 1 diabetes
A Drug-Drug Interaction Study to Evaluate the Effect of AL-794 on the Pharmacokinetics of Oseltamivir and JNJ-63623872
Condition: Influenza in Humans
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 1

Summary: 
      This open-label, four group, fixed-sequence study will evaluate the safety and
      pharmacokinetic interaction of AL-794 on oseltamivir, JNJ-63623872 (formerly VX-787) and
      probes for P-glycoprotein, CYP3A and OATP1B1 in healthy volunteers.
    

Detailed description: 
      This open-label, four group, fixed-sequence study will evaluate the safety and
      pharmacokinetic interaction of AL-794 on oseltamivir, JNJ-63623872 (formerly VX-787) and
      probes for P-glycoprotein, CYP3A and OATP1B1 in healthy volunteers.

      For each group, the study consists of an eligibility screening period, study period, and 1
      follow-up visit. Groups may enroll in parallel but subjects enrolled in one group may not
      participate in another group.
    

Intervention name(s): AL-794; Oseltamivir; Digoxin; Midazolam; Pitavastatin; JNJ-63623872
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention MeSH terms: Oseltamivir; Digoxin; Midazolam; Pitavastatin
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Sofosbuvir, Ledipasvir, Ribavirin for Hepatitis C Cirrhotics, Genotype 1
Condition: Hepatitis C; Cirrhosis
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis; Liver Cirrhosis; Fibrosis
Study type: Interventional
Phase: Phase 3

Summary: 
      The investigators will treat 50 patients with cirrhosis due to hepatitis C genotype 1, with
      sofosbuvir 400 mg daily, ledipasvir 90 mg daily and weight-based ribavirin (1000 mg/d if <75
      kg, 1200 mg/d if >75 kg, divided in two daily doses) for 12 weeks and calculate the sustained
      viral response rate at 12 weeks.
    

Detailed description: 
      Cirrhosis due to Hepatitis C virus (HCV) presents a rather difficult treatment problem as
      many cannot tolerate interferon, the previous standard of care. The new direct acting
      antivirals have provided these patients with a new hope. One such combination is sofosbuvir
      (SOF) 400 mg and ledipasvir (LDV) 90 mg given once daily with or without weight-based
      ribavirin (RBV) for 12 or 24 weeks only for HCV genotype 1 patients. The current
      recommendation for cirrhotics (genotype 1) is SOF/LDV/RBV for 24 weeks but that
      recommendation is based on the lack of data for shorter periods. In order to evaluate the
      response rate to the combination of SOF/LDV/RBV the investigators decided to treat 50 HCV
      genotype 1 cirrhotics with this combination for 12 weeks. Patients with MELD score > 20 are
      excluded. The investigators will calculate the sustained viral response rate at 12 weeks
      (SVR12).
    

Intervention name(s): Sofosbuvir; Ledipasvir; Ribavirin
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 400 mg, included in a combination pill with 90 mg ledipasvir; 90 mg, included in a combination pill with 400 mg sofosbuvir; 1000 mg/day if <75 kg, 1200 mg/day for >75 kg. Divided into two daily doses
Other intervention name(s): SOF; LDV; RBV
Intervention MeSH terms: Ribavirin; Sofosbuvir; Ledipasvir
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hepatitis C; Cirrhosis; Sofosbuvir; Ledipasvir; Ribavirin
Erector Spinae Block Versus Transversus Abdominis Plane Block In Laparoscopic Bariatric Surgery
Condition: Erector Spinae Block; Bariatric Surgery Candidate
Study type: Interventional

Summary: 
      The purpose of this study to compare erector spinae block to transversus abdominis plane
      block in bariatric surgeries regarding analgesic efficacy and postoperative oxygenation and
      respiratory complications
    

Detailed description: 
      The erector spinae plane (ESP) block is an interfascial block proposed to provide analgesia
      for chronic pain and perioperative period. it can provide both visceral and somatic abdominal
      analgesia if the injection were performed at a lower thoracic level. ESP block is effective,
      easy to perform, and can be performed in a short time. Therefore, bilateral ESP block may
      have comparable or improved analgesic effect in upper and lower abdominal surgical procedures
      when compared to other suitable plane blocks.

      Transversus abdominis plane (TAP) block technique is to reduce postoperative pain and is a
      part of current analgesic regimen for many abdominal surgeries . Moreover, it was found that
      posterior TAP block appears to produce more prolonged analgesia than the lateral TAP block.
      Ultrasound guided TAP block is a feasible, minimally invasive technique . It reduces the
      postoperative requirement of opioid analgesics, decreases the incidence and severity of
      postoperative nausea and vomiting, improves patient satisfaction, and allows early readiness
      for discharge postoperatively.

      Both blocks is effective in reducing postoperative complication and need of analgesia , To
      our knowledge there is no comparative study between the two blocks to this population .

      the investigators aim to compare the perioperative analgesic effect between TAP block and ES
      block in bariatric .
    

Intervention name(s): transversus abdominis block; Erector spinae block; Bupivacaine 0.25% Injectable Solution; Siemens Acuson x300 3-5MHz Ultrasound
Intervention type(s): Procedure; Procedure; Drug; Device
Intervention description(s): transversus abdominis block; Erector spinae block; Local Anesthetic used in both blocks; Ultrasound used to aid in the blocks
Intervention MeSH terms: Bupivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Supportive Care
Non-invasive Evaluation of Fluid Status and Cardiac Output During Operative Treatment of Pheochromcytoma
Condition: Pheochromocytoma
MeSH terms: Pheochromocytoma
Study type: Observational

Summary: 
      Non-invasive measurements of cardiac output (CO), systemic vascular resistance (SVR),
      corrected aortic flow time (FTc) and stroke volume (SV) are useful parameters during
      laparoscopic resection of pheochromocytoma (adrenalectomy) to document the intraoperative
      changes in volume status and to estimate the volume depletion.
    

Detailed description: 
      Pheochromocytomas and extraadrenal paragangliomas are catecholamin-producing tumours deriving
      from the adrenal medulla and sympathetic ganglia. The only causal therapy is surgical
      resection. Nowadays, laparoscopic adrenalectomy is thought to be the optimal approach.
      Chronic volume depletion due to chronic hypertension and preoperative
      α-adrenoreceptor-blockade (to avoid the effects of intraoperative catecholamine-excess) often
      lead to hypotension after resection of the tumour. Volume reload with high amounts of fluid
      is often needed. Therefor some authors recommended invasive measurement (pulmonary artery
      catheter) to control cardiac output parameters and fluid balance. However, there are
      non-invasive methods to measure cardiac output(CO), systemic vascular resistance(SVR), stroke
      volume(SV) and corrected aortic flow time(FTc) to estimate volume status. Except
      transesophageal echocardiography, other techniques such as transoesophageal doppler and pulse
      pressure methods exist but have not been investigated during surgical therapy for
      pheochromocytoma so far. The esophageal Doppler currently represents the "gold standard" for
      perioperative fluid replacement therapy.

      The study's hypothesis is that non-invasive measurements of cardiac output (CO), systemic
      vascular resistance (SVR), corrected aortic flow time (FTc) and stroke volume (SV) are useful
      parameters during laparoscopic resection of pheochromocytoma (adrenalectomy) to document the
      intraoperative changes in volume status and to estimate the volume depletion.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients suffering from pheochromocytoma will be recruited by the Department of Surgery,
        Medical University of Vienna
      
Biospecimen description: 
      whole blood, serum
    
Keywords: Pheochromocytoma; Adrenalectomy; Cardiac output; Fluid managment; Esopagheal doppler sonography
Manual Diaphragm Release Technique Effects On Tidal Volume in Elderly
Condition: Healthy
Study type: Interventional

Summary: 
      Question: Does manual diaphragm release change kinematics and respiratory function of elderly
      subjects? Design: Randomized controlled trial with concealed allocation and double-blinding.

      Participants: 17 volunteers over 60 years old randomized into two groups: 09 in the Control
      Group (CG) and 08 in the Intervention Group (IG).

      Intervention: The manual diaphragm release technique was used on the IG, in two sets of ten
      deep breaths, with a one minute interval between them. The CG underwent a sham protocol
      (light touch), with same sets and time of interval.

      Outcome measures: The groups were evaluated using spirometry, manovacuometry and
      optoelectronic plethysmography (OEP), in that order, before and immediately after the
      intervention.
    


Intervention name(s): Sham manual diaphragm release technique; The manual diaphragm release technique
Intervention type(s): Other; Other
Intervention description(s): To perform the technique the volunteer was placed in supine position with limbs relaxed. Positioned behind the head of the volunteer, the therapist performed manual contact (pisiform, ulnar edge and the last three fingers) with the underside of the costal cartilage of the 7th, 8th, 9th and 10th rib, and guiding forearms toward the shoulders of the corresponding side. In the inspiratory phase, the therapist gently pulled the points of contact with both hands, in the direction of the head, yet slightly lateral, accompanying the elevation movement of the ribs. During exhalation, the therapist deepened contact toward the inner costal, maintaining resistance throughout the inspiratory phase. In the breaths following, the therapist sought to gain traction and smooth increase in the deepening of contacts. This maneuver was performed in two sets of ten deep breaths, with a one minute interval between them.
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
To Evaluate the Safety and Effectiveness of Atorvastatin Plus a Cholinesterase Inhibitor in AD Patients.
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to find out if atovastatin, when taken with a cholinesterase
      inhibitor, is effective for treating Alzheimer's disease.
    


Intervention name(s): Atorvastatin
Intervention type(s): Drug
Intervention MeSH terms: Atorvastatin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Effects of Exenatide on Hypothalamic Obesity
Condition: Hypothalamic Obesity
MeSH terms: Obesity
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The primary aim of this study is to evaluate the effect of Exenatide on weight status (change
      in body mass index) of children treated for craniopharyngioma that have developed
      hypothalamic obesity at Children's Hospitals and Clinics of Minnesota. We hypothesize that
      Exenatide given to hypothalamic obese children for 6 months will reduce their body mass index
      significantly from baseline.
    

Detailed description: 
      Hypothalamic obesity is when individuals suffer from acute weight gain after brain tumor
      treatment, involving secondary damage to the ventromedial nucleus of the hypothalamus, which
      may lead to obesity. The weight gain is uncontrolled and not receptive to diet and exercise
      interventions. The rate of long-term obesity in children diagnosed with craniopharyngioma can
      be as high as 50%. Exenatide, a drug indicated for diabetes, is an incretin mimicking agent
      that mimics the enhancement of glucose-dependent insulin secretion and several other
      antihyperglycemic actions of incretins has resulted in weight loss when given to diabetics.
      Exenatide shows potential to benefit patients suffering from hypothalamic obesity by slowing
      gastric emptying and therefore reducing food intake. Also increasing the glucagon-like
      peptide 1 (GLP-1) circulation, decreased due to obesity, at the already compromised GLP-1
      receptor site of the hypothalamus could potentially help with regulation of appetite.
    

Intervention name(s): Exenatide
Intervention type(s): Drug
Intervention description(s): 5mcg twice a day for 4 weeks increased to 10 mcg twice a day for 20 weeks.
Other intervention name(s): Byetta
Intervention MeSH terms: Exenatide
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hypothalamic Obesity; Exenatide; Byetta; Craniopharyngioma
Comparison of PRP & DFDBA vs. DFDBA in Intrabony Periodontal Defects
Condition: Chronic Periodontitis
MeSH terms: Periodontitis; Chronic Periodontitis
Study type: Interventional

Summary: 
      The purpose of this clinical trial is to compare the results in subjects with periodontitis
      using subjects own blood - Platelet-rich plasma (PRP) combined with bone graft material,
      namely, Demineralized Freeze - Dried Bone Allograft (DFDBA) or DFDBA alone in the treatment
      of bone defects around the teeth.
    

Detailed description: 
      After being informed about the study and potential risks, 13 patients giving written informed
      consent and who meet the eligibility requirements were randomly allocated in a single blind
      manner (participants) to test group (PRP combined with DFDBA) or control group (DFDBA).

      33 sites (18 test, 15 control unpaired defects) were treated - 1) to investigate the possible
      additional effects of PRP when combined with DFDBA, and 2) to compare the clinical and
      radiographic outcomes obtained in test and control groups,12 months post - operatively.
    

Intervention name(s): PRP combined with DFDBA; DFDBA
Intervention type(s): Other; Other
Intervention description(s): Periodontal intrabony defects were treated with open flap debridement followed by placement of PRP combined with DFDBA; Periodontal intrabony defects were treated with open flap debridement followed by placement of PRP combined with DFDBA
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: platelet - rich plasma; demineralized freeze - dried bone allograft; intrabony defect; periodontitis.
Enhanced Gait and Balance Training
Condition: Aging; Accidental Falls
Study type: Interventional

Summary: 
      The purpose of this study is twofold:

        1. Establish baseline measures of gait performance in healthy young and older adults, and
           older adults with a history of falls.

        2. Investigate the effects of gait and balance training with and without cranial nerve
           noninvasive neuromodulation (CN-NINM) on postural balance and gait performance in older
           adults.

      For the second purpose, the study will incorporate a placebo-controlled design to evaluate
      the effects of CN-NINM augmented exercise compared to physical exercises alone. Both groups
      will perform gait and postural balance training (outlined in more detail below) but will
      differ in the stimulation level of the PoNS device. The investigators will use the results of
      this study as a first step toward evaluating the benefits of CN-NINM in a falls prevention
      program.
    


Intervention name(s): Cranial Nerve Non-Invasive Neuromodulation; Sham Cranial Nerve Non-Invasive Neuromodulation
Intervention type(s): Device; Behavioral
Intervention description(s): Portable device delivers electrical stimulation to cranial nerves V and VII via an electrode array placed on the anterior surface of the tongue. Stimulation is combined with rehabilitation exercises targeting walking and balance.; Subjects participate in gait and balance rehabilitation exercises while using a device set to sub-threshold levels.
Other intervention name(s): PoNS (Portable Neuromodulation Stimulator)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: Fall Risk; Gait; Dynamic Balance; Static Balance; Neuromodulation