cyrilzakka/clinical-trials huggingface dataset:
Epidural Block vs. Rectus Sheath Block on Postoperative Pulmonary Function

Pulmonary complications are among the most important postoperative complications after midline incisions, for which different analgesic modalities have been tried.

Epidural analgesia is the recommended technique to relieve pain after major abdominal surgery owing to the proved superior analgesia, reduction of opioid related side effects as nausea, vomiting, pruritis and sedation, earlier recovery of bowel function and earlier ability for postoperative mobility However, it is not without complications.

Rectus sheath block provides several advantages over epidural anesthesia. It lessens the potential risks associated with neuraxial techniques, so it may represent a novel alternative approach for somatic analgesia after major abdominal surgeries. Although patients with rectus sheath block may experience some visceral pain, it is usually minimal by 24 hours after surgery.

The aim of this study is to compare the effects of thoracic epidural analgesia and rectus sheath blockade on postoperative pulmonary functions, pain scores, duration of analgesia, sedation scores, patients' satisfaction and adverse effects.

FEV1, FEV1/FVC ratio will be measured by a bed side spirometer.

* Induction of anesthesia: propofol 1.5-2.5 mg kg-1.
* Muscle Relaxants: rocuronium 0.6 mg kg-1 for induction.
* Maintenance: Sevoflurane 0.7-1.5 MAC vaporized in air-oxygen (40% inspired fraction).

Radial artery catheterization: under complete aseptic conditions 20G cannula will be inserted into the radial artery of non-dominant hand after performing modified Allen's test and local infiltration of 0.5ml xylocaine 2% .

Thoracic epidural catheter will be inserted before induction of general anaesthesia under aseptic insertion conditions and using loss of resistance to air technique with the patient in the sitting position at T9- T11 interspaces.

The Rectus sheath catheters will be inserted bilaterally using ultrasound (SonoSite M-Turbo®, Sonosite , USA) guidance as described by Webster after induction of general anaesthesia.

Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologists physical class I to III.
* Patients scheduled for elective midline laparotomy.

Exclusion Criteria:

* Morbid obese patients.
* Severe or uncompensated cardiovascular disease.
* Significant renal disease.
* Significant hepatic disease.
* Pregnancy.
* Lactating.
* Allergy to the study medications.
* Psychological disorder.
* Neurological disorder.
* Communication barrier.
* Mental disorders.
* Epilepsy.
* FEV1 or FEV1/FVC ratio less than 50%, dyspnea with a New York Heart Association class IV.
* Drug or alcohol abuse.
* Contraindications to epidural anaesthesia.
* Opioid analgesic medication within 24 h before the operation.
Clinical Impact of Different Duration Prone Postition Treatment for Patients With ARDS.

Acute respiratory distress syndrome (ARDS) is a life-threatening disease, patients with ARDS usually need mechanical ventilation. The treatment of ARDS include low tidal volume ventilation, steroid, extracorporeal membraneous oxygenator, inhaled nitric oxide or prone position . Some studies showed prone position had beneficial effect of oxygenation and mortality for severe ARDS patients, the duration of prone position should be at least 10 hours. It is unknown the optimal duration of prone position which is better for severe ARDS patients. This study will compare the clinical differences of 16-hour and 24-hour prone position for severe ARDS patients.

This is a prospective randomized controlled study. All severe ARDS patients were eligible for screening from January 2020 to December 2022. Inclusion criteria include: Patient above 20 year-old with diagnosis of severe ARDS under protective lung ventilation( tidal volume 4-8 ml/kg, plateau pressure \< 30cm H2O、PaO2/FiO2 \< 150 mmHg、PEEP ≥ 5 cmH2O、FiO2 \> 60%）. Patients were excluded if patients were not intubated and mechanically ventilated or contraindication for prone position ventilation (intracranial hemorrhage, massive hemoptysis, unstable hemodynamic status, recent pacemaker implantation, severe facial laceration, open abdominal wound, spine, femur or pelvis fracture or pregnancy). Patients will divide into 2 groups, one is patients supported by 16-hour prone position; another group is patients with 24-hour prone position, each group enrolled 30 patients. The medical records of these patients were analyzed for age, gender, body weight, diagnosis, pulmonary or extrapulmonary ARDS, acute physiology and chronic health evaluation (APACHE) Ⅱscore, days between ARDS to prone position, ICU day, hospital day, ventilator day, pre and post prone position vital signs, laboratory data including arterial blood gas, lactate, respiratory parameters included PaO2/FiO2, peak inspiratory pressure, positive end-expiratory pressure, ventilator mode, steroid treatment, complications (tube dislodge, pressure sore, infection), and mortality outcomes.

The primary endpoint is the difference of oxygenation (PaO2/FiO2), the secondary endpoint are other respiratory parameters, vital signs, ICU day, hospital day, ventilator day, complications and survival.

Eligibility Criteria:
Inclusion Criteria:

* Patient above 20 year-old with diagnosis of severe ARDS under protective lung ventilation (tidal volume 4-8 ml/kg, plateau pressure \< 30cm H2O、PaO2/FiO2 \< 150 mmHg、PEEP ≥ 5 cmH2O、FiO2 \> 60%).

Exclusion Criteria:

* Patients were not intubated and mechanically ventilated or contraindication for prone position ventilation (intracranial hemorrhage, massive hemoptysis, unstable hemodynamic status, recent pacemaker implantation, severe facial laceration, open abdominal wound, spine, femur or pelvis fracture or pregnancy).
A Novel Stimulation Protocol and the Conventional Low Dose Step-up and Step Down Regimens

This study is designed to compare the efficacy of a novel stimulation protocol with the conventional low dose step-up and step down regimens in older than 30 years PCOS patients undergoing in vitro fertilisation. The novel regime was proposed under the basis of the combined effectiveness of the two standard protocols to induce a uniform follicular growth and forms a continuation to the author's previously published results examining a similar approach in younger PCOS candidates. In total 225 patients have been recruited for this study. The stimulation protocol will be assigned under the basis of prospective randomization using sealed and numbered envelopes. All patients will be down regulated using a desensitisation agent administered on day 2 of spontaneous or induced withdrawal bleeding. The initial dosage in the low dose step-up regimen (group A) will be 150 IU/d of FSH for the first 6 days followed by an increase of 75 IU thereafter. In the step-down regimen (group B) patients will administer a starting dose of 300 IU/d of FSH for the first 3 days followed by a decrease to 225 IU/d for the next 3 days. This dosage will be further decreased to 150 IU/d or sustained at 225 IU (according to the initial response) until the day of the hCG injection. Group C, patients received 225 IU on day 1 followed by a decrease to 150 IU on day 2. On day 3 the dosage will be increased back to 225 IU. This alternation of injection dosage will be followed until day 6. According to the initial ovarian response the dosage will be sustained at 225 IU/d or 150 IU/d until the day of the hCG injection. The 10,000 IU hCG will be administered when at least two follicles had reached a mean diameter of 18 mm and the serum E2 levels were consistent with the ultrasound findings. Egg retrieval will be undertaken at 35 hours after the administration of the hCG injection. Oocytes recovered will be inseminated 4 hours post egg collection. Patients will receive 3 embryos on the third day of development. The luteal phase will be supported by progesterone suppositories starting on the day of the egg collection. A positive outcome will be detected by a serum β-hCG analysis 13 days after embryo replacement. The presence of a fetal heart pulse on ultrasound 3 weeks later confirmed a clinical pregnancy.


Eligibility Criteria:
Inclusion Criteria:

* Failure to ovulate after CC treatment

  * Over than 30 years of age No Previous IVF attempts
* Patent Fallopian Tubes
* Normo-spermic partners

Exclusion Criteria:

* Secondary Infertility
* Younger than 30 years
* Older than 36 years
* Other infertility cause
Prospective Evaluation Among Patients Infected by HIV 1 in Virological Failure Owing to Lack of Compliance, of the Benefit in Terms of Compliance of an Optimised Antiretroviral Treatment With Enfuvirtide (Fuzeon) Associated With Two Active Molecules

In case of lack of compliance in HIV1 patients, the investigators hope to prove that enfuvirtide injection during almost 3 months, with nurse help at home and therapeutic education may contribute to obtain a good compliance more than 95% in these patients.


Eligibility Criteria:
Inclusion Criteria:

* virological failure, more than 18 years, prouved lack of compliance, with no sub-optimal treatment, in ambulatory status.

Exclusion Criteria:

* hospitalization,HIV2 infection,pregnancy,preliminary treatment with enfuvirtide,chimiotherapy , opportunistic infection in progress
Clinical Performance of Injectable Composite Resins in Class I Cavities

Purpose of research: Evaluation and comparison of 24-month clinical performance of injectable and conventional resin composites in class I cavities.

The mechanical properties of conventional resin composites have been tried to be improved. In addition to the developed mechanical properties, the need for easy and fast application led to the development of flowable composites. Flowable composites have lower filler ratio than conventional hybrid composites so they are less rigid and have lower modulus of elasticity. For these reasons, the use of flowable composites in areas that may be exposed to high forces, especially occlusal cavities, is not recommended. Today, it is aimed to increase the wear resistance by increasing the amount of filler in flowable composites and producing injectable composites. A new product recently introduced to the market, a high-strength nano-filled injectable composite material, GC's G-ænial Universal Injectable(Tokyo,Japan), was also included in the study. This is a low-viscosity composite in which modifications have been made to provide a product with high wear resistance and depth of cure to make it suitable for posterior restorations.

One lesion in each patient will be randomly assigned to be restored using either the G-aenial Universal Injectable or Filtek Z250 resin composites. The adhesive, G2-BOND Universal will be used for adhesive procedures. The clinical procedure for the restorations will be performed by a single operator. The restorations will be evaluated by two calibrated examiners at baseline and at 6, 12, 18, 24 months in accordance with the modified USPHS criteria. Data will be statistically analyzed using the Chi-square and Cochran Q tests (p \< 0.05).

Eligibility Criteria:
Inclusion Criteria:

* Healthy individuals who do not have any systemic disease that prevents restorative treatment
* Individuals between the ages of 18-35
* Brushing your teeth twice a day
* Having at least 20 teeth in occlusion and at least 2 occlusal lesions with antagonist teeth in the opposite arch
* Volunteer individuals who agree to participate in the research and sign the informed consent form and who have undergone initial periodontal treatment will be included in the study.

Exclusion Criteria:

* Pregnant or breastfeeding women
* Individuals with advanced periodontal disease
* Individuals using removable partial dentures
* Individuals with bruxism
* Individuals with malocclusion
* Patients with known allergies to resin-based restorative materials and bonding agents
* Patients with a history of allergy to local anesthesia
* Endodontic treatment, teeth that need pulp capping or endodontic treatment is available
Airway US in Predicting Difficult Pediatric Laryngoscopy

The hypothesis of this study is that ultrasound measurements may improve the preoperative detection of difficult laryngoscopy (DL) in pediatrics. The primary objective of this study will be to evaluate the usefulness for the prediction of a DL of five ultrasound measurements obtained from the neck skin to three structures of the upper airway (hyoid, epiglottis and anterior commissure of the vocal cords). Secondary objectives will include establishing, if possible, a cut-off point in these measurements; to compare these measures against the classic pre-intubation clinical screening tests.

Current advances in airway management training have reduced the risk associated with an unanticipated DL but have not been able to reduce its incidence in clinical practice. The addition of new video laryngoscopes in our clinical practice seems to offer a paradigm shift to face a DL with promising results. However, theses authors also indicated that expertise in video laryngoscopy requires prolonged training and practice. Otherwise, a growing number of publications have showed that some ultrasound measurements may improve our anticipation of a DL because of its high accuracy to offer detailed anatomical images of the airway, absence of ionizing radiations, accessibility and reproducibility. Among all the ultrasound parameters studied, distance from skin to epiglottis with a cut-off point of 2.10 cm, showed the best predictive ability with a sensitivity of 83.33%3 and a specificity of 73.33%, for predicting difficulty in airway management in routine clinical practice. The aim of this study is to investigate the efficacy of US-measured airway structures in predicting difficult laryngoscopy (defined as CL grade III and IV).

Eligibility Criteria:
Inclusion Criteria:

* Gender both males and females
* ASA Class I and II
* Age 2 years to 6
* Children scheduled for elective surgery under general anesthesia requiring orotracheal intubation after classical laryngoscopy.

Exclusion Criteria:

* Congenital upper airway malformation,
* Head and neck swellings,
* Scars,
* Radiation to the neck,
* Tracheotomy,
Efficacy Study of Gemcitabine-Paclitaxel to Treat Metastatic Breast Cancer

The purpose of this study is to determine the response rate to a gemcitabine-paclitaxel combination administered on a 3-weekly schedule in Chinese patients with unresectable, locally recurrent breast cancer or metastatic breast cancer.


Eligibility Criteria:
Inclusion Criteria:

* Female patients of Chinese origin with histologically or cytologically proven diagnosis of breast cancer.
* Unresectable, locally recurrent breast cancer or stage IV disease.
* Have at least one measurable lesion as defined by Response Evaluation Criteria In Solid Tumors (RECIST) criteria.
* Performance Status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Scale
* Treatment with an anthracycline-based chemotherapy regimen in the adjuvant/neoadjuvant setting with subsequent disease relapse.

Exclusion Criteria:

* Prior chemotherapy for unresectable, locally advanced breast cancer or metastatic disease.
* Concurrent administration of any other tumor therapy, including cytotoxic chemotherapy, hormonal therapy, and immunotherapy.
* Known or suspected brain metastasis or second primary malignancy that is clinically detectable at the time of consideration for study enrollment.
* Active infection or other serious condition.
* Pregnant or breastfeeding.
Clinical Trial on the Articular Pain of Diagnosed Patients of Arthrosis

Randomized, controlled, double-blind clinical trial of three parallel branches to analyze the efficacy of a supplement extracted from the internal membrane of the egg shell on the joint pain of patients diagnosed with osteoarthritis.


Eligibility Criteria:
Inclusion Criteria:

* Age over 18 years.
* Subjects diagnosed with osteoarthritis with functional grades I-III according to the modified criteria of the American College of Rheumatology.
* Subjects must have persistent knee pain associated with osteoarthritis with an initial score of at least 30 mm in the assessment of pain according to the EVA scale.
* The subjects should not present in their treatment narcotic drugs or steroidal anti-inflammatory or immunosuppressive drugs.

Exclusion Criteria:

* Serious or terminal illnesses.
* Subjects who are currently taking glucosamine, chondroitin sulfate, collagen or hyaluronic infiltrates or any supplement indicated for joint health.
* Subjects with chronic inflammatory diseases that affect the musculoskeletal system (rheumatoid arthritis, gout, pseudo-gout, Paget's disease, chronic pain syndrome, etc.).
* Subjects with a body mass index above 32.
* Subjects with a known allergy to eggs.
* Pregnant or lactating women.
* Inability to understand informed consent.
Effects of Obesity on Pharmacokinetics of the Levonorgestrel Emergency Contraceptive Pill

The purpose of this study is to determine the effects of obesity on the pharmacokinetics of the levonorgestrel (LNG) only emergency contraceptive (EC) regimen and on markers of ovulation

Primary hypothesis:

1) Obese users of LNG-EC have a pharmacokinetic profile that is consistent with a larger volume of distribution of LNG.

Secondary hypothesis:

1. Alterations in these pharmacokinetic parameters of the LNG-EC regimen in obese women affect the primary mechanism of action, which is inhibition of ovulation.
2. Obesity may affect other factors that alter levels of LNG, such as sex-hormone binding globulin (SHBG) and albumin, which bind LNG and potentially lowers the amount of free LNG.


Eligibility Criteria:
Inclusion Criteria:

* Women between ages 18-35 years

  * Regular menstrual cycles (24-35 days) for the past 2 months
  * Ovulatory at defined by midluteal progesterone level \>3 ng/mL (Day 18-25)
  * Belongs to one of the following categories: normal weight (BMI = 18.5-24.9 kg/m2), obese (BMI = 30-39.9 kg/m2) or extremely obese (BMI ≥ 40 kg/m2)
  * Participant has no intention of or desire to conceive (e.g., active attempt to become pregnant or in vitro fertilization) for the duration of the study
  * Participant agrees to consistently use an effective method of nonhormonal contraception throughout the duration of study, which could include: condoms (male or female) with or without a spermicidal agent, diaphragm or cervical cap with spermicide, non-hormonal intra-uterine devise (IUD), or sterilization.
  * Able to give informed consent

Exclusion Criteria:

* • Known renal or liver disease

  * Known pituitary disorder
  * Known adrenal disorder
  * Known thyroid disorder
  * Use of medication known to alter the cytochrome P450 system
  * Use of depot-medroxyprogesterone acetate in the previous 6 months or any other hormonal contraceptive in the previous 3 months
  * Currently breastfeeding
  * Pregnant
  * Pregnancy in the prior month
  * Known allergy to medication
  * Other specific contraindications to LNG EC
Effect of Pelvic Floor Down-training on Women With Idiopathic Overactive Bladder

This study will be conducted to investigate the effect of pelvic floor down-training on women with idiopathic overactive bladder

The relationship between overactive bladder (OAB), constipation, and overactive pelvic floor muscles is complex and interrelated. OAB increases the likelihood of overactive pelvic floor muscles, and conversely, hyperactive pelvic floor muscles can exacerbate OAB symptoms. Non-relaxing pelvic floor dysfunction often presents with urinary symptoms, including increased frequency, hesitancy, urgency, dysuria, bladder pain, and occasionally urge incontinence Pelvic floor down-training exercises targeting the rectum provide a safe, conservative way to manage constipation, which may in turn help relieve OAB. Unlike medications or surgery; these exercises are generally safe and easy to incorporate into daily life. However, more studies are needed to evaluate their effectiveness, especially for treating idiopathic OAB in women. Filling this research gap will provide clearer clinical guidance on managing the interplay between OAB, constipation, and pelvic floor hyperactivity. So this study will be the first to investigate the effect of pelvic floor down-training on symptoms of idiopathic OAB in women.

Eligibility Criteria:
Inclusion Criteria:

* Multiparous woman with idiopathic OAB (2-3 times) who diagnosed by physician and confirmed by the urodynamic study.
* Woman with high rectal resting tone measured by pressure biofeedback.
* Woman diagnosed with constipation according to the Rome IV criteria and Bristol score.
* Ages ranging from 30 to 45 years.
* BMI from 25-29.9 Kg/m2

Exclusion Criteria:

Women will be excluded from the study if they have:

* Severe OAB as measured by the overactive bladder symptom score for severity
* Postmenopausal women (a point in time 12 months after a woman's last period.)
* Any abnormalities around the bladder, such as bladder cancer, bladder calculus, interstitial cystitis, or endometriosis.
* Untreated urinary tract infections.
* Psychological or mental health problems.
* Pregnancy and lactation
* A history of previous pelvic surgery.
* Are receiving any pharmacological treatment at the time of the study.
Exploratory Study to Standard Triple Therapy With Tegoprazan(by Dose) in H. Pylori Positive Patients

This exploratory study is designed to compare safety and efficacy between a Tegoprazan dose-specific standard triple therapy and Lansoprazole standard triple therapy in H. pylori positive patients.

A Randomized, Double-Blind, Active-controlled, Multicenter, Therapeutic Exploratory Study to to Evaluate the Safety and Efficacy of a Standard Triple Therapy with Tegoprazan and Lansoprazole standard triple therapy in H. pylori Positive Patients, twice a day for 14 days.

Eligibility Criteria:
Inclusion Criteria:

* H. pylori positive at screening
* Subjects who have upper gastrointestinal disease

Exclusion Criteria:

* Having received prior therapy for eradication of H. pylori
* Prior use of P-CAB, proton pump inhibitors (PPIs), H2 receptor blockers within 14 days
* Prior use of H. pylori eradication effective antibiotics, bismuth within 28 days