cyrilzakka/clinical-trials huggingface dataset:
Ketorolac Plus Tobramycin/Dexamethasone Versus Tobramycin/Dexamethasone After Uneventful Phacoemulsification Surgery

This randomized controlled trial compares two regimens of topical therapy:

* tobramycin 0.3% - dexamethasone 0.1% (TobraDex®, Alcon), one drop four times/day
* combination of tobramycin 0.3% - dexamethasone 0.1% (TobraDex®, Alcon), one drop four times/day, plus Ketorolac tromethamine 0.5% (Acular®, Allergan), one drop three times/day.

Patients are independently assessed by two ophthalmologists. On days 7,14,21,28 patients are evaluated for

* corneal edema
* conjunctival hyperemia
* anterior chamber (Tyndall) reaction.

The investigators purpose was to evaluate the benefit of adding a non-steroid agent to an antibiotic/steroid combination after uneventful phacoemulsification. Adopting a weekly follow-up, to gain insight into the optimal duration of postoperative treatment and to examine whether risk factors for inflammation exist.

Patients were randomized to: i) tobramycin 0.3% - dexamethasone 0.1% one drop qid (TD group, n=72, 28 days) and ii) combination of tobramycin 0.3% - dexamethasone 0.1%, one drop qid, plus Ketorolac tromethamine 0.5%, one drop tid (TD-K group, n=73, 28 days). Patients undergoing vitrectomy due to posterior capsule rupture were excluded. On days 7, 14, 21, 28, the frequency of inflammation-related signs \[corneal edema, conjunctival hyperemia, anterior chamber (Tyndall) reaction\], as well as the best corrected visual acuity (BCVA) were measured. On day 21, logistic regression was performed to evaluate risk factors for inflammation.

Eligibility Criteria:
Inclusion Criteria:

* phacoemulsification (due to cataract)
* uneventful phacoemulsification surgery

Exclusion Criteria:

* history of intraocular surgery in the operated eye,
* any previous episode of uveitis in the operated eye,
* severe systemic disease (heart failure NYHA stage III of IV, end-stage renal failure, pulmonary failure, patients receiving chemotherapy),
* regular, systemic use of steroid or non-steroid anti-inflammatory drugs during the last three months
* disruption of the anterior lens capsule
How to Optimize Enteral Feeding of the Full Enteral Feeding Preterm Infant

Very low-birth-weight premature infants (VLBWs) are fed via nasal or oro-gastric tube for a long time because of the physiological inability to coordinate swallowing, sucking, and breathing until at least 34 weeks of gestational age.

Both bolus and continuous feeding modes are widely described in the literature; both modes have specific risks and benefits, and there is no evidence in the literature as to which mode is best in terms of tolerance and adverse effects.

To date, the characteristics of enteral feeding that are associated with better feeding tolerance and fewer adverse effects have not been uniquely documented.

There are currently no data in the literature directly comparing different modes of enteral feeding tube management in the preterm VLBW infant. Therefore, our study aims to evaluate different modes of enteral feeding tube management (extemporaneous vs. permanent introduction/removal and oral vs. nasal introduction route) in order to optimize enteral feeding management of the VLBW infant.

The purpose of the study is to evaluate the tolerance of intermittent gastric tube placement versus permanent gastric tube maintenance in preterm VLBW infants who have achieved full enteral feeding, and to record the incidence of adverse effects associated with the different modes of gastric tube management.

Specifically, during bolus feeding, the following parameters will be evaluated in association with the two different management modes:

1. Presence, extent and characteristics of episodes of gastric stagnation
2. Incidence of cardio-respiratory events (desaturation and/or bradycardia)
3. Signs and symptoms of pain/discomfort related to the tube insertion and removal procedure In addition, the above parameters will be examined during enteral feeding with an orally or nasally introduced tube.

Eligibility Criteria:
Inclusion Criteria:

* Gestational Age \<32 weeks and/or neonatal weight \<1500 g
* Achievement of full enteral feeding (150 ml/kg/day of milk)
* Exclusive feeding of human milk (breast and/or bank)
* Informed consent signed by parent or legal guardian

Exclusion Criteria:

* Need for invasive ventilatory support
* Congenital malformations affecting the gastrointestinal tract
SMARTer Weight Loss Management

The SMARTer trial will be a three-arm, randomized controlled non-inferiority trial that compares the optimized, adaptive SMARTer intervention, fixed DPP, and usual care assessment-only (Control). The trial will address whether a scalable, stepped-care intervention can stand up to gold-standard DPP by achieving comparable weight loss at a lower cost. Alongside evaluation of clinical non-inferiority, a comprehensive economic evaluation will inform relative affordability. Cost information is important to inform treatment policy and change standard of care, but is sorely lacking for behavioral interventions. The SMARTer intervention reduces costs by initially offering minimal intervention to all and stepping up to offer more costly treatment components only to non-responders who fail to attain the target weight loss. A rigorous economic evaluation planned and designed alongside the SMARTer trial will provide an accurate, robust head-to-head comparison of costs, cost-effectiveness, and projected lifetime health care costs between the three arms.

The proposed study seeks to test the hypothesis that SMARTer is non-inferior to DPP in its effect on 6-month weight loss. During the 24-week active intervention phase, participants will be randomized to one of three first-line treatments: 1) the adaptive SMARTer intervention, 2) fixed DPP, or 3) usual care assessment-only (control). Participants will be assessed at 3-month, 6-month, 9-month, and 12-month timepoints to evaluate overall weight loss, and to explore whether SMARTer is cost-effective compared to DPP or standard care.

Eligibility Criteria:
Inclusion Criteria:

* Over 18 years old
* BMI of ≥25, weight \<396 lbs
* Must own a Smartphone, and be willing to install the SMARTer app
* Participants must also plan to reside in the Chicagoland area for the duration of their participation (i.e., 12 months)
* Not enrolled in a formal weight loss program

Exclusion Criteria:

* Cerebrovascular accident or myocardial infarction within six months of enrollment
* Diabetes treated with insulin
* Pregnancy, lactation or intended pregnancy
* Active suicidal ideation
* Anorexia or bulimia
* Requiring an assistive device for mobility
* Taking weight loss medications, such as GLP-1 agonists
Dural Puncture Epidural Technique Versus Conventional Epidural Techmique

This study will be conducted on 50 patients of ASA grade I and II aged from 25 to 55 years and presented for laparoscopic hysterectomy. Patients will be divided into two equal groups; group A control group for conventional epidural technique(n=25) and group B for 25G dural puncture epidural with 25G pencil point Whitacre spinal needle (n=25). Randomization will be done using computer generated number and concealed using sequentially numbered, sealed opaque envelope.


Eligibility Criteria:
Inclusion Criteria:

* ASA I and II
* Height(150-170 cm)

Exclusion Criteria:

* patient refusal
* hypersensitivity to local anesthetic drugs
* bleeding disorders and coagulopathy(platelets count less than 80000,INR less than 1.5 or therapeutic dose of anticoagulant).
Effect of Anesthesia on Insulin Secretion in Patients With Preoperative Decreased Insulin Sensitivity

Epidural anesthesia has been found to manipulate the hyperglycemic response to surgery. It is unclear, however, whether the preoperative metabolic status of the surgical patient plays a role in the degree of this hyperglycemic response. For instance, the presence of low insulin sensitivity before surgery could predispose the individual to an altered metabolic response after surgery. In this case, it would be appropriate to identify adequate interventions that attenuate the response to surgical stress and facilitate the recovery process.

The aims of this research projects are the following:

1. To determine the extent in which epidural local anesthetics, initiated before surgery and continued after surgery, improves insulin secretion in patients with preoperative low insulin sensitivity.
2. To understand which measures of postoperative recovery are sensitive to the restoration of insulin secretion in this particular group of patients


Eligibility Criteria:
Inclusion Criteria:

* Patients receiving elective resection of malignant, non metastatic, colorectal lesions

Exclusion Criteria:

* American Society of Anesthesiologists (ASA) health status class 4-5
* Dementia,neuromuscular disease, psychosis
* Cardiac abnormalities
* Severe end-organ disease such as cardiac failure (New York Heart Association classes I-IV)
* Chronic obstructive pulmonary disease
* Renal failure (creatinine \> 1.5 mg/dl)
* Hepatic failure (liver transaminases \>50% over the normal range)
* Diabetics with glycosylated hemoglobin \> 6%
* Steroid consumption longer than 30 days sepsis
* Morbid obesity (body mass index \>40)
* Anemia (hematocrit \< 30 %, haemoglobin \<10g/dl, albumin \< 25mg/dl).
* Patients will be excluded if they have poor English or French comprehension.
The Clinical Investigation of a Zinc Based Toothpaste in Reducing Plaque and Gingivitis

This is a six (6) month, double-blind, parallel, controlled clinical trial utilizing one hundred and sixty (160) adults to evaluate the reduction of dental plaque and gingivitis.


Eligibility Criteria:
Inclusion Criteria

1. Subjects, ages 18-70, inclusive.
2. Availability for the six-month duration of the clinical research study.
3. Good General health.
4. Minimum of 20 uncrowned permanent natural teeth (excluding third molars).
5. Initial gingivitis index of at least 1.0 as determined by the use of the Loe and Silness Gingival Index.
6. Initial plaque index of at least 1.5 as determined by the use of the Quigley and Hein Plaque Index (Turesky Modification).
7. Signed Informed Consent Form.

Exclusion Criteria

1. Presence of orthodontic bands.
2. Presence of partial removable dentures.
3. Tumor(s) of the soft or hard tissues of the oral cavity.
4. Advanced periodontal disease (purulent exudate, tooth mobility, and/or extensive loss of periodontal attachment or alveolar bone).
5. Five or more carious lesions requiring immediate restorative treatment.
6. Antibiotic use any time during the one-month period prior to entry into the study.
7. Participation in any other clinical study or test panel within the one month prior to entry into the study.
8. Dental prophylaxis during the past two weeks prior to baseline examinations.
9. History of allergies to oral care/personal care consumer products or their ingredients.
10. On any prescription medicines that might interfere with the study outcome.
11. An existing medical condition that prohibits eating or drinking for periods up to 4 hours.
12. History of alcohol or drug abuse.
13. Pregnant or lactating subjects.
Certolizumab Pegol in Subjects With Active Axial Spondyloarthritis

The study is a Phase 3, multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of two dose regimens of Certolizumab Pegol (CZP) in subjects with active axial Spondyloarthritis (axial SpA).


Eligibility Criteria:
Inclusion Criteria:

* Documented diagnosis of adult-onset axial Spondyloarthritis (SpA) of at least 3 months' duration as defined by the specified Assessment of Spondyloarthritis International Society (ASAS) criteria
* Active disease as defined by:

  * Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score ≥ 4
  * Back pain ≥ 4 on a 0 to 10 Neurobehavioral Rating Scale (NRS) (from BASDAI item 2)
  * C-Reactive Protein (CRP) \> ULN (Upper Limit of Normal) and/or current evidence (ie, within the last 3 months from Screening) for Sacroiliitis on Magnetic Resonance Imaging (MRI) as defined by Assessment of Spondyloarthritis International Society (ASAS) criteria
* Intolerance to or inadequate response to at least 1 Nonsteroidal Anti-Inflammatory Drug (NSAID)

Exclusion Criteria:

* Presence of total Spinal Ankylosis ("bamboo spine")
* Diagnosis of any other Inflammatory Arthritis
* Prior treatment with any experimental biological agents for treatment of Axial Spondyloarthritis (SpA)
* Exposure to more than 1 TNF-antagonist or to more than 2 previous biological agents for Axial Spondyloarthritis (SpA)
* History of or current chronic or recurrent infections
* High risk of infection
* Recent live vaccination
* Concurrent malignancy or a history of malignancy
* Class III or IV congestive heart failure - New York Heart Association (NYHA)
* Demyelinating disease of the central nervous system
* Female subjects who are breastfeeding, pregnant or plan to become pregnant during the study or within 3 months following the last dose of the investigational product
* Subjects with any other condition which, in the investigator's judgment, would make the subject unsuitable for inclusion in the study
Ultrasound for Postop Lung Issues in Low-Flow Anesthesia

Detecting possible atelectasis and other respiratory problems that may develop immediately after extubation via lung ultrasonography can reduce pulmonary complications by performing necessary interventions such as oxygen support, respiratory exercises, mobilization, and non-invasive mechanical ventilation applications at an early stage. In addition, although low-flow anesthesia is frequently used in daily anesthesia practice, publications showing the effects of its use in laparoscopic cholecystectomy operations on pulmonary complications are limited. On this occasion, this study can be presented as a contribution to the literature.

Postoperative atelectasis is a common complication that can develop in all patients receiving general anesthesia. The frequency of atelectasis increases due to increased intraabdominal pressure, especially in laparoscopic surgeries performed with pneumoperitoneum. For this reason, in order to prevent postoperative complications related to the lungs, it is extremely important to recognize atelectasis at an early stage, as well as to recognize the mechanisms that will cause atelectasis and avoid them.

Lung ultrasonography (Lung USG) draws attention for the rapid, cheap, safe and reliable detection of postoperative atelectasis. The fact that it can be applied at the bedside and can be easily repeated makes this method valuable. In the literature and in daily practice, it is seen that anesthesiologists commonly apply inhalation anesthesia with different fresh gas flow (FGF) rates during general anesthesia.

As defined by Baker and Simionescu, in low-flow anesthesia, FGF varies between 0.5 and 1 liter per minute. It has been shown that all types of flow are safe with modern anesthesia machines.

This study aims to demonstrate the effect of low-flow anesthesia (LFA) on pulmonary complications and, in particular, atelectasis that may develop after laparoscopic cholecystectomy operations, using a non-invasive, rapidly applicable, and proven method such as Lung USG.

Eligibility Criteria:
Inclusion Criteria:

* Patients with informed consent
* Patients scheduled for laparoscopic cholecystectomy
* Patients with a Body Mass Index between 18-35 kg/m²
* Patients in the American Society of Anesthesiologist (ASA) 1-2-3 category

Exclusion Criteria:

* Patients with emergency surgery planned
* Patients with ASA 4 and above
* Patients with lung disease
* Patients who have undergone thoracic surgery
* Pregnancy
* Patients with a preoperative Lung Ultrasound Score of 2 or 3 in any lung region
Different Menstrual Cycle in Eating Behavior Following Resistance Exercise

The study aims to provide insights into how menstrual cycle phases impact appetite responses to resistance exercise in young women. Healthy young women will participate in four trials: the exercise session in the follicular phase, the exercise session in the luteal phase, the control session in the follicular phase, and the control session in the luteal phase. Various measurements will be taken, including subjective appetite perceptions, appetite hormones, food preferences, lactate levels, estradiol levels, progesterone levels, and energy intake.


Eligibility Criteria:
Inclusion Criteria:

* Age: 20-30
* Healthy female with normal menstruation
* Weight stable for at least 6 months

Exclusion Criteria:

* Overweight (BMI \> 30 kg/m\^2 or body fat \> 30%)
* Hypertension (\> 140/90 mmHg)
* Cardiovascular disease, cancer or other chronic diseases
Long-term Efficacy of Carglumic Acid in Organic Acidemia.

Evaluate the Long Term Effectiveness \& Safety of the use of Carglumic Acid (Carbaglu®) in Patients with Propionic Acidemia (PA) or Methylmalonic Acidemia (MMA).

Study procedures:

A. Study period: 36 months; treatment period: 12 months.

B. Patients will receive Carglumic Acid (Carbaglu®) 50 mg/kg/day in addition to standard therapy (protein restricted diet, L-carnitine, metronidazole and vitamin B12).

C. Patients need to regularly come back for follow up examination on Day 0, month 3, month 6, and month 12.

D. Patients should report any adverse event that occur during treatment period.

E. Patients' number of emergency visits due to hyperammonemia, ammonia level, acylcarnitine, urinary organic acid analysis, plasma amino acid analysis and methylmalonic acid will be recorded during treatment period.

Eligibility Criteria:
Inclusion Criteria:

1. PA or MMA confirmed using the following criteria:

   * PA confirmed by the measurement of acylcarnitine profile, urine organic acid, measurement of propionyl Co-A carboxylase in leukocytes or cultured fibroblasts or by DNA molecular testing of PCCA (Propionyl CoA Carboxylase, Alpha Polypeptide) or PCCB (propionyl CoA carboxylase, beta polypeptide) gene
   * MMA confirmed by the measurement of acylcarnitine profile, urine organic acid, measurement of methymalonyl Co-A mutase in culture fibroblasts or DNA molecular testing of mutgene.
2. Male or female Children of 18 years old or less.
3. Had experienced Hyperammonemia(NH3 ≧100 uM) before.
4. Not participating in any other clinical trial in the previous 30 days

Exclusion Criteria:

1. Patients with other organic acidemia or any other cause of hyperammonemia
2. Patient receiving other investigational therapy for PA or MMA
3. Patient with PA or MMA and other inherited genetic conditions or congenital anomalies
4. Past history of hypersensitivity or drug allergy to Carbaglu®
The Effectiveness and Tolerability of Fentanyl Matrix in Chronic Non-cancer Pain; Assessment of Patient's Pain Treatment Goal Achievement

The purpose of this study is to assess the effectiveness and tolerability of Fentanyl matrix in chronic non-cancer pain.

This is a multicenter, prospective (a study in which the patients are identified and then followed forward in time for the outcome of the study), open-label (all people know the identity of the intervention), observational study intended to examine the effectiveness of Fentanyl matrix through the degree of improvement of pain. Fentanyl matrix is a transdermal (through the skin) system providing continuous delivery of fentanyl for 72 hours. Fentanyl matrix will be administered to patients with chronic (prolonged) non-cancer pain under routine practice during 12 weeks. Dose will be adjusted in accordance with patient's degree of pain and treatment response in the investigator's judgment.

Eligibility Criteria:
Inclusion Criteria:

* Complain of chronic non-cancer pain that persists for \>= 3 months
* Pain inadequately controlled by previous treatment with narcotic analgesics (opium or opium-like compounds with potent analgesic effects, eg, tramadol, codeine, morphine, oxycodone)
* Women must be postmenopausal, surgically sterile, abstinent, or practicing an effective method of birth control if they have childbearing potential
* Male patients who agree to use a method of birth control and not to donate sperm for 1 month after the last dose of the study drug
* A written informed consent for study participation

Exclusion Criteria:

* Experience of treatment with Fentanyl matrix within the past 4 weeks
* No previous experience of use of narcotic analgesics
* Past or current history of alcohol or drug abuse
* Cannot use transdermal analgesics due to skin disorder
* Have serious psychiatric disorder and cannot complete overall study procedures and questionnaire in the judgment of the investigator
A Research Study Looking at Long-term Treatment With Etavopivat in People With Sickle Cell Disease or Thalassaemia

Etavopivat is a new medicine under development for treating blood disorders like sickle cell disease and thalassaemia. Sickle cell disease and thalassaemia are inherited blood disorders that affect haemoglobin. Haemoglobin is the protein that carries oxygen through the body. This study is looking into how safe treatment with etavopivat is and how well it works over a long period of time. The study will last for up to 264 weeks, but it will end earlier if etavopivat is approved in the participant's country.


Eligibility Criteria:
Inclusion Criteria:

* Participant must have ongoing participation in an etavopivat parent study for treatment of sickle cell disease (SCD) or thalassaemia and have completed at least a treatment period of the parent study.
* Participant must have derived clinical benefit from treatment with etavopivat, as determined by the investigator.
* Any participant with dose reduction or temporary discontinuation will need to be rechallenged before transferring.
* Participants on hydroxyurea (HU), crizanlizumab or l-glutamine oral powder (Endari®) treatment at the time of consent may be eligible if they:
* Have been on a stable dose during participation in the parent study (i.e., no changes to the dose except for changes to weight or age reasons).
* Have been compliant with the treatment regimen at the discretion of the investigator during participation of the parent study.

Exclusion Criteria:

* Any disorder, except for conditions associated with SCD or thalassaemia, which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol.
* Participant withdrew or had permanent treatment discontinuation from an etavopivat clinical study.
* Participants on permanent dose reduction or temporary treatment discontinuation.
* Use of any of the following within the timeframes prior to the transfer visit as stated:
* Use of voxelotor within participation of the parent study or anticipated need for this agent during this study.
* Use of an experimental selectin antagonist (e.g., monoclonal antibody or small molecule) within the parent study or anticipated need for such agents during this study.
* Use of erythropoietin or other haematopoietic growth factor treatment within the parent study or anticipated need for such agents during this study.
* Receiving or use of concomitant medications that are strong inducers of cytochrome P450 (CYP) 3A4 within 2 weeks of the transfer visit or anticipated need for such agents during the study.
* Current participation in a study that is not a designated parent study, or planned participation in any other clinical trial, for the duration of FLORAL.