cyrilzakka/clinical-trials huggingface dataset:
Effect of Propofol on Postoperative Nausea and Vomiting.

As PONV is an unpleasant experience that badly affects the patients' quality of life after surgery and the anti-emetic effects of propofol have been seldomly studied in Pakistan, this study aims at investigation of the beneficial effects of propofol in reducing the occurrence of PONV.

Cesarean Section is one of the most commonly performed surgical procedures in the obstetric patients. Adequate intra and postoperative analgesia is very important in providing comfort to the mother, early breastfeeding, ambulation and discharge as well as enhancing patient satisfaction.Spinal anesthesia is widely accepted as the anesthesia of choice for cesarean section owing to its safety and speed. PONV is an unpleasant condition, often underestimated side effect of anesthesia and surgery, quite common in women undergoing spinal anesthesia for cesarean.It is one of the significant problems in Post Anaesthesia Care Units. The etiology of PONV is multifactorial with patient factors (gender, history of motion sickness, age), intra Op factors (type of anesthesia, surgery and opioid use) and post Op factors (pain, post Op opioid use) which are found to be associated with the PONV. Apfel simplified scoring is based on four independent factors including female gender, non-smoker, history of PONV or motion sickness and use of opioids. Each predictor is given a score of 1. A score of 0,1,2,3 or 4 predicts the chance of developing PONV as approximately 10%, 20%, 40% or 80%.

The intense efforts accompanying emesis increase the risk of complications such as wound dehiscence, bleeding, aspiration pneumonitis, dehydration, electrolyte imbalance and interference with nutrition. While it is difficult to completely avoid the occurrence of PONV, it can be markedly reduced using a multimodal non-opioid analgesia, total intravenous anesthesia and adequate prophylactic antiemetic premedication. Propofol has been reported to have anti-emetic effects at sub hypnotic dose as a bolus or a continuous infusion in susceptible individuals undergoing surgeries, though the exact mechanism of this effect is yet to be discovered.

In a research published in BMC Anesthesiology, the data indicates a significant difference in the incidence of PONV in control group (93.9%) and the study group (8.7%) with a single sub hypnotic dose of propofol administered 10-15 min before the end of surgery in parturients undergoing cesarean section under spinal anaesthesia.

Eligibility Criteria:
Inclusion Criteria:

* Parturient aged between 18 - 50 years
* Elective Cesarean under spinal anesthesia
* Patients at increased risk of PONV based on Apfel score 2 or more
* ASA Class II
* Ability to give informed consent

Exclusion Criteria:

* Allergy to propofol
* ASA Class III and above
* Anti emetic drug administered 24 hrs prior to surgery
NOURISH: Nourishing Our Understanding of Role Modeling to Improve Support and Health

The percentage of overweight children between the ages of 6 and 11 has nearly tripled in the last three decades, and rates are even higher among African Americans.Overweight children are at-risk for numerous health problems, thus effective treatments are urgently needed. This study will evaluate an innovative intervention for ethnically diverse parents (NOURISH), which focuses on helping parents role model and teach their children healthy behaviors.

Pediatric overweight is a national public health concern. The percentage of overweight children in the U.S. between the ages of 6 and 11 has nearly tripled in the last 3 decades. African American children are particularly at risk. Pediatric overweight is associated with numerous physical and psychological health problems. Moreover, overweight children are at significant risk for obesity in adulthood. Thus, a focus on pediatric overweight is an important step in the prevention of adult obesity.

Despite the urgent need for pediatric overweight interventions, outcomes of some of the most rigorous treatments are, at best, mixed. Although research has found that including parents in interventions for pediatric overweight has positive effects on outcomes, parental involvement is usually limited. Moreover, relatively few studies have included sufficient numbers of lower-SES, African American participants, a group at increased risk for pediatric overweight and associated complications. This study will evaluate the efficacy of an intensive intervention targeting ethnically diverse parents of overweight, children ages 6-11 (NOURISH-Nourishing Our Understanding of Role Modeling to Improve Support and Health).

Eligibility Criteria:
Inclusion Criteria:

* To qualify for participation, parents/caregivers must have a child between the ages of 6 and 11 with a BMI \> the 85th percentile \[128\].
* This child must also primarily reside in the participating caregiver's home.
* Participants also need to speak English fluently, and be able to understand and follow basic instructions and perform simple exercises.

Exclusion Criteria:

* Caregivers are ineligible if they are:

  1. non-ambulatory,
  2. pregnant,
  3. or have a clinical diagnosis that may be negatively impacted by exercise.
* Parents whose children have a medical condition or developmental disorder that precludes weight loss using conventional diet and exercise methods are also ineligible for participation.

All parents meeting study criteria will be offered participation in the randomized trial comparing NOURISH with a control group.
Heart Rate Variability of Premature Newborn

To analyze the effects of two CPAP methods on the HRV of PTNBs during their routine routine in the HCUFU neonatal ICU. This is a randomized clinical trial, with controlled groups and cross over with healthy term newborns (RNT) as a control group admitted to the HC-UFU rooming-in and premature newborns (PTRN), between 28 and 32 weeks pregnant women with nasal CPAP group admitted to the neonatal ICU of the same hospital. The HRV recorded by the POLAR® RS800cx cardiac monitor will be analyzed, with a sampling rate of 1000 Hz.

The main question\[s\] it aims to answer are:

* Is there a difference in heart rate variability between newborns using conventional nasal CPAP and nasal bubble CPAP?
* Is it possible to conclude that one of the methods has a greater sympathetic or parasympathetic tone compared to the other?

Premature participants will be in the incubators in a supine position with 30 minutes rest after the last handling. Each data collection will last 60 minutes and will be carried out three times a day in the morning, afternoon and night shifts, for each 1-hour collection, HRV will be analyzed in 12 5-minute intervals, establishing an average for each variable of the data. HRV during a 1-hour period.

The researchers will compare the conventional CPAP and bubble CPAP group according to randomization.

* In the control group, data collection will be carried out in the Rooming Room in a single reference collection lasting 20 minutes, and analyzed in 4 5-minute intervals.
* The participant selected for conventional CPAP will receive conventional CPAP for 24 hours, then receive bubble CPAP for 24 hours the following day. The opposite will be done for the participant drawn for CPAP bubbles.

The comparison between the conventional CPAP and bubble CPAP groups will occur to find out whether it is possible to identify the type of non-invasive ventilation that allows an increase in HRV and parasympathetic tone variables, as well as a reduction in sympathetic tone variables and the stress index of premature babies.


Eligibility Criteria:
Inclusion Criteria:

* All preterm infants between 28 and 32 weeks of gestation using nasal CPAP and who are at least 8 and at most 12 days old will be included in the study.

Exclusion Criteria:

* hemodynamic instability,
* hydroelectrolyte disorders that influence cardiac function,
* post-operative,
* congenital abnormalities,
* pulmonary hypertension,
* decompensated ductus arteriosus,
* untreated atelectasis,
* pneumothorax,
* newborns who are using drains, whether chest or abdominal,
* presence of necrotizing enterocolitis
* grade 3 nasal septum injury,
* signal captured without the necessary quality to be used in research,
* premature babies who, for whatever reason, do not have two collections carried out on consecutive days until the twelfth day of life.
Phase 3 Study of MRTX849 (Adagrasib) vs Docetaxel in Patients With Advanced Non-Small Cell Lung Cancer With KRAS G12C Mutation

This Phase 3 study will evaluate the efficacy of the investigational agent MRTX849 (adagrasib) versus docetaxel in patients who have been previously treated for metastatic NSCLC with a KRAS G12C mutation.


Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically confirmed diagnosis of NSCLC with KRAS G12C mutation.
* Candidacy to receive treatment with docetaxel.

Crossover Inclusion Criteria:

* Evidence of RECIST 1.1 defined disease progression on docetaxel per BICR
* ECOG performance status 0-2

Exclusion Criteria:

* Prior treatment with an agent targeting KRAS G12C (e.g., AMG 510, Sotorasib).
* Active brain metastases.

Crossover Exclusion Criteria:

* Receipt of any other systemic anti-cancer therapy after last administration of docetaxel on the study.
Cardiac Rehabilitation in Austrian Outpatient Facilities.

Cardiac rehabilitation (CR) is a key component of the treatment of cardiac diseases. The Austrian outpatient CR model is unique, as it provides patients with an extended professionally supervised, multidisciplinary program of 4-6 weeks of phase II (OUT-II) and 12 months of phase III (OUT-III) CR CR including a "refresher". The aim of this retrospective analysis is to pool data from preferably all Austrian outpatient rehabilitation facilities and to analyze the efficacy of the Austrian cardiac rehabilitation model with a special focus on phase III. Data of patients who completed OUT-III between 1.1.2019 and 01.07.2022 will be analyzed. All patients undergo assessment of anthropometry, resting blood pressure, lipid profile, fasting blood glucose, exercise capacity, quality of life, anxiety and depression at the beginning (T1), in the middle (T2) and end of CR (T3).

Cardiac rehabilitation (CR) is a multidisciplinary therapeutic intervention aimed at regaining and maintaining long-term professional and social integration. Specialist societies classify cardiac rehabilitation with the highest recommendation level (Class I). The focal points of therapy in cardiac rehabilitation include health education, optimization of risk factors through psycho-social counseling and structured physical training.

The four-tier Austrian model of cardiac rehabilitation consists of phase I, which takes place in the acute care hospital directly after a cardiac event or intervention/surgery. Phase II ideally follows immediately and lasts 3-4 weeks as an inpatient or alternatively 6 weeks as an outpatient CR. In the subsequent phase III patients ideally transfer knowledge and skills gained during rehabilitation into their daily lives. Supervised outpatient training is carried out once or twice a week for 6 months and takes part in psycho-social and physical health training courses. This is followed by a 3-6 months lasting "home phase" in which patients to follow the agreed-on lifestyle changes on their own, while documenting successes and problems. After this home phase, the Austrian model provides a "refresher" consisting of two guided outpatient training sessions as well as psychological consultation and a medical examination including a stress test. The refresher must be completed within a maximum of four weeks and is a unique feature of the Austrian model, aiming to achieve sustainable lifestyle modification. The patient-financed and life-long phase IV begins no later than 18 months after the start of phase II. Its aim is to achieve an improvement in the prognosis through lifelong, autonomous and self-responsible behavior and long-term prevention.

The aim of this retrospective analysis is to pool data from preferably all Austrian outpatient rehabilitation facilities and to analyze the efficacy of the Austrian cardiac rehabilitation model with a special focus on phase III.

Eligibility Criteria:
Inclusion Criteria:

* Any patient who meets inclusion criteria for outpatient cardiac rehabilitation in Austria

Exclusion Criteria:

* Patients are excluded, if they don't meet the inclusion criteria.
Anatomic Endoscopic Prostate Enucleation and BICEP Classification

The Bladder Injury Classification System for Endoscopic Procedure (BICEP) is designed to provide a systematic framework for categorizing bladder injuries that occur during endoscopic procedures. By standardizing the classification of these injuries, BICEP promotes a more consistent approach to diagnosis, management, and prevention across different urologic interventions. This study aims to validate and implement the BICEP system during morcellation.

This study will:

Validate BICEP by using real-life clinical scenarios to ensure its applicability and effectiveness.

Assess the incidence and types of bladder injuries during morcellation, using the BICEP categorization to standardize injury reporting and enhance treatment protocols.

Insufficient knowledge exists about bladder injuries during morcellation, as the existing literature primarily consists of isolated case reports. The Bladder Injury Classification System for Endoscopic Procedures (BICEP) aims to standardize the reporting and management of bladder injuries during endoscopic surgeries.

This study proposes an external validation of the BICEP system through an international, multicenter, prospective observational study. The objectives of this study are fourfold:

Validate the newly developed BICEP classification system with real-life clinical scenarios to ensure its applicability and effectiveness.

Evaluate the incidence and types of bladder injuries during morcellation using the BICEP framework to standardize injury reporting and enhance treatment protocols.

Assess the robustness of BICEP across different departments. Facilitate the adoption of BICEP as a global standard for classifying bladder injuries in endoscopic surgery.

Through this study, the validity of BICEP will be confirmed and the bladder injuries occurring during morcellation after AEEP will be examined.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged ≥40
* ASA (American Society of Anesthesiologists) score ≤3
* Estimated weight on ultrasound (USG) ≥40 grams for prostate weight
* Patients undergoing Holmium Laser Enucleation of the Prostate (HoLEP) or Transurethral Resection of the Prostate (TURP) surgery.

Exclusion Criteria:

* Patients with neurological disorders that may affect bladder function, such as cerebrovascular stroke or Parkinson's disease.
* Patients with active urinary tract infection.
* Patients diagnosed with bladder cancer within the last 2 years.
* Patients with prostate cancer.
* Patients who have undergone previous prostate surgery.
Patient Removal of Catheters After Urogynecologic Surgery

Management of postoperative urinary retention often requires the use of indwelling catheters. The purpose of this study is to see if patient removal of catheters at home is non-inferior to standard office removal.

Voiding trials are a routine part of Urogynecologic surgery. Management of postoperative urinary retention often requires the use of indwelling catheters. However, patients often view the need for catheters as the worst part of their surgical experience, and follow-up voiding trials in the office utilize excess healthcare resources. Many Urology practices allow patient removal of catheters after procedures, though this has not been formally studied. The purpose of this study is to see if patient removal of catheters at home is non-inferior to standard office removal.

Eligibility Criteria:
Inclusion Criteria:

* All women undergoing prolapse or anti-incontinence surgery who fail their voiding trials prior to discharge
* 18+ years old

Exclusion Criteria:

* Non-English speaking
* Pregnant
* Elevated PVR (\>150 mL) or dependent upon catheterization to void pre-operatively
* Urethral bulking injection surgery
* Intra-operative complication requiring prolonged catheterization
* Unable or unwilling to remove catheter at home
The Effect of Insulin Detemir in Combination With Liraglutide and Metformin Compared to Liraglutide and Metformin in Subjects With Type 2 Diabetes

This trial is conducted in Europe and North America. The aim of this clinical trial is to assess and compare the effect of insulin detemir in combination with liraglutide and metformin versus liraglutide and metformin in subjects with type 2 diabetes. Subjects will continue their own pre-trial metformin treatment during the trial.


Eligibility Criteria:
Inclusion Criteria:

* Subjects diagnosed with type 2 diabetes, insulin naïve and treated with metformin as monotherapy for at least 3 months prior to screening, at a stable dose of at least 1500 mg/day or metformin (at least 1500 mg/day) and a sulfonylurea (less than or equal to half of the maximum approved dose), both at a stable dose for at least 3 months prior to screening. Previous short-term insulin treatment in connection with intercurrent illness is allowed at the discretion of the Investigator
* HbA1c 7.0-10.0% (both inclusive) for subjects on metformin monotherapy
* HbA1c 7.0-8.5% (both inclusive) for subjects on metformin in combination with a sulphonylurea

Exclusion Criteria:

* Previous treatment with insulin (except for short-term treatment in connection with intercurrent illness at the discretion of the Investigator)
* Treatment with glucose-lowering agent(s) other than stated in the inclusion criteria in a period of 3 months prior to screening
* Recurrent major hypoglycaemia or hypoglycaemic unawareness as judged by the Investigator
* Impaired kidney function
* Impaired liver function
* Uncontrolled treated/untreated hypertension
* Cancer or any clinically significant disease or disorder as judged by the Investigator
* Previous participation in the run-in phase of this trial. Re-screening is allowed once
* History of chronic pancreatitis or idiopathic pancreatitis
Clinical Trial to Demonstrate That the Dual Laser Therapy is Effective for the Treatment of Vulvar Lichen Sclerosus

The aim of this study is to test a new, minimally invasive dual laser technique to treat vulvar lichen sclerosus. Efficacy and safety of the thermal non-ablative Nd:YAG laser and the ablative Er:YAG laser is determined and compared to the current standard treatment with high dose steroids. The hypothesis is that laser therapy is effective and similar to standard steroid therapy.

Lichen sclerosus (LS) is a chronic inflammatory skin disease that usually involves the anogenital area where it causes itching and burning pain, pain during sexual intercourse, and anal or genital bleeding due to fissuring of the damaged tissue. In this study a treatment with dual laser application combining thermal non-ablative Nd:YAG with ablative Er:YAG laser is used to reduce the symptoms of LS. Results will be compared to the standard therapy with topical steroid cream.

Eligibility Criteria:
Inclusion criteria:

* Diagnosis of vulvar lichen sclerosus
* Clinical LS score ≥ 4

Exclusion criteria:

* Concomitant steroid, calcineurin inhibitor or any other topical or systemic treatment for LS
* \< 3 months since start of vaginal estrogen treatment
* Malignant disease as the cause of the vulval symptoms
* BMI \> 35 kg/m²
* Acute infection (fungal, bacterial, viral) of the vulva, vagina or bladder
* Presence of contraindications for the laser treatment or topical steroid treatment
A Study Comparing the Efficacy and Safety of ABT-652 to Placebo in Subjects With Diabetic Neuropathic Pain

To evaluate the safety and efficacy of ABT-652 compared to Placebo in subjects with diabetic neuropathic pain. People with diabetes can, over time develop nerve damage throughout the body with symptoms such as pain, tingling, or numbness (loss of feeling) in the hands, arms, feet and legs.

A double blind, randomized, active- and placebo-controlled 13-week study. Duloxetine is added to evaluate assay sensitivity.

Eligibility Criteria:
Inclusion Criteria:

* Subject is between the ages of 18-75 years with a diagnosis of diabetes mellitus and must have a diagnosis of painful distal symmetric diabetic polyneuropathy and presence of ongoing pain due to diabetic peripheral neuropathy for at least 6 months.
* Subject must have a mean average score of greater than 4 on the 24 hour average pain score (0-10 numerical rating scale) prior to the Baseline Visit.
* Subject has been on a medication for diabetic neuropathic pain for the past 3 months.

Exclusion Criteria:

* Subject has clinically symptomatic neuropathic pain conditions that cannot be distinguished from Diabetic Neuropathic Pain or interfere with the pain assessments of Diabetic Neuropathic Pain.
* A subject has newly diagnosed or clinically significant medical conditions or mental disorders that would preclude participation or would interfere with Diabetic Neuropathic Pain assessments or other functions.
* Subject has clinically significant abnormalities in clinical laboratory tests.
* Subject has taken an opioid chronically, excluding tramadol within the last 3 months prior to Screening.
Optic Nerve Sheath Ultrasound in Giant Cell Arteritis

The Sonographic Assessment of the Optic Nerve Sheath in GCA (SONIC-GCA) study will: 1) assess the performance, in terms of sensitivity and specificity, of the optic nerve sheath diameter (ONSD) to detect new-onset, active GCA; 2) evaluate the intra- and interobserver reliability of ONSD measures; 3) establish if an association exists between the ONSD and the presence of GCA retinal findings; and 4) evaluate if the ONSD is a dynamic biomarker of GCA remission and relapse.

SONIC-GCA is a prospective cohort and validation study conducted in centers of the Canadian Vasculitis Research Network (CanVasc).

Eligibility Criteria:
Inclusion criteria are:

1. adult patient aged \> 50 years;
2. referred for suspected, new-onset cranial GCA;
3. ability to understand and provide a written informed consent.

Exclusion criteria:

1. referral for a suspected GCA relapse;
2. current use of systemic glucocorticoids for ≥ 14 consecutive days in the previous 30 days;
3. known previous medical history of conditions which may affect the ONSD, such as optic nerve diseases, demyelinating diseases, or any conditions associated with intracranial hypertension;
4. known underlying condition that impairs the ability to perform optic nerve sheath ultrasound or fundoscopy.
A Study to Compare Efficacy and Safety of CT-P47 and RoActemra in Patients With Rheumatoid Arthritis

This is a phase 3 study to compare efficacy and safety of CT-P47 and RoActemra in patients with moderate to severe active rheumatoid arthritis.

CT-P47, containing the active ingredient tocilizumab, is a recombinant humanized monoclonal antibody that is being developed as a similar biological medicinal product to RoActemra/Actemra. The purpose of this study is to demonstrate similar efficacy and safety of CT-P47 and RoActemra in patients with moderate to severe rheumatoid arthritis when co-administered with methotrexate.

Eligibility Criteria:
Inclusion Criteria:

1. Patient is male or female aged 18 to 75 years old, both inclusive.
2. Patient has had a diagnosis of RA according to the 2010 ACR/EULAR classification criteria for at least 24 weeks prior to the first administration of the study drug.

Exclusion Criteria:

1. Patient who has previously received investigational or licensed product; targeted synthetic DMARD(s) (e.g., tofacitinib, baricitinib) for the treatment of RA and/or an interleukin-6 (IL-6) inhibitor for any purposes.
2. Patient who has previously received more than 1 biologic agents approved for the treatment of RA.
3. Patient who has allergies to any of the excipients of study drug or any other murine and human proteins, or patient with a hypersensitivity to immunoglobulin products.