cyrilzakka/clinical-trials huggingface dataset:
The Postoperative Lidocaine and Ketamine Effects on Morphine Requirement in Bariatric Surgery

The goal of this observational study is to evaluate the quality of postoperative analgesia in a group of obese patients schedule to bariatric surgery under TIVA Opiod-free after to receive lidocaine and ketamine perfusion. The main question it aims to answer are: How lidocaine and ketamine perfusion during recovery period does impact over morphine consumption on the following 48 hours after surgery? All participants will receive total intravenous anesthesia and, at the end of the surgery, they will be divided in two groups, group A: placebo and, group B: with postoperative lidocaine and ketamine perfusion. Our hypothesis is ketamine and lidocaine are a good alternative to decrease the use of morphine in obese patients.

The obese patients have more risk for certain side effects and complications with elevated risk of perioperative mortality and morbidity. An effective postoperative pain management is important to prevent pulmonary complications and, it is not recommended continuous infusions of opioids in this kind of patients, because the opioid-induced upper airway obstruction and respiratory depression are more likely to be seen in obese patients with obstructive sleep apnea. We can reduce perioperative opioid using dexmedetomidine, ketamine and lidocaine, however, it is a little know the use and benefits of lidocaine and ketamine inmediately after surgery.

Eligibility Criteria:
Inclusion Criteria:

* All patients between 18 y 65 years old.
* IMC \> 30 kg/m2
* ASA II/III

Exclusion Criteria:

* Patients taking high doses of opioids before operation for chronic pain
* Patients with allergies to any study medication.
* Pregnancy or breastfeeding.
* Kidney or heptic failure.
* Surgical complication
Tolerance of Healthy Infants Fed Infant Formulas

The primary objective of this study is to assess the comparative gastrointestinal tolerance of normal term infants to two experimental milk-based powdered formulas compared with a standard milk-based powdered formula.


Eligibility Criteria:
Inclusion Criteria:

* Singleton from a full term birth with a gestational age of 37-42 weeks.
* Birth weight was \> 2490 g (\~5 lbs 8 oz).
* Age between 0 and 30 days at enrollment.
* Agreement to discontinue the use of medications (including over the counter \[OTC\], such as Mylicon® for gas), home remedies, herbal preparations or rehydration fluids that might affect GI tolerance for the duration of the study.
* Intention to feed the infant the study product as the sole source of nutrition for the duration of the study.
* Intention not to administer vitamin (other than Vitamin D) or mineral supplements, solid foods or juices to their infant from enrollment through the duration of the study.
* Voluntarily signed and dated an informed consent form (ICF) approved by an Independent Ethics Committee/Institutional Review Board (IEC/IRB) and provided Health Insurance Portability and Accountability Act (HIPAA) (or other applicable privacy regulation) authorization prior to any participation in the study.

Exclusion Criteria:

* An adverse maternal, fetal or infant medical history that is thought by the investigator to have potential for effects on tolerance, growth, and/or development.
* Infant treated with antibiotics.
* Participation in another study that has not been approved as a concomitant study by AN.
Efficacy and Safety of Levocetirizine Versus Loratadine for the Treatment of Perennial Allergic Rhinitis

Efficacy and Safety of Levocetirizine Versus Loratadine for the Treatment of Perennial Allergic Rhinitis.


Eligibility Criteria:
Inclusion Criteria:

* Male ore female, 16 to 60 years old (inclusive)
* two-year history of allergic rhinitis due to house dust mite

Exclusion Criteria:

* An ear, nose or throat (ENT) infection
* asthma requiring daily drug therapy other than ß2 inhaled agonists taken prn
* atopic dermatitis or urticaria requiring an antihistamine or corticosteroid treatment
* an associated ENT disease
* use of decongestants
* nasal or ocular topical treatment
* desensitivation
Evaluation of Multifocal Transcutaneous Electrical Stimulation for Self-treatment Among Children With Cerebral Palsy

The main purpose with this study is to investigate the effectiveness of a garment with integrated electrodes for multifocal transcutaneous electrical stimulation intended for treatment of spasticity in children with cerebral palsy.

The effect and use of the garment will be evaluated in single - case studies using ABAB design.

Eligibility Criteria:
Inclusion Criteria:

* Cerebral palsy diagnosis, with spasticity as the main symptom
* Established GMFCS, levels 1-5
* MACS level, levels 1-5
* Included in the CPUP \* national quality register
* Person should be between 4 years and up to 18 years
* Secured communication to and from person
* Neing able to convey pain or discomfort.

Exclusion Criteria:

* No treatment received within next three months before participation with botulinum toxin treatment to reduce spasticity.
* The patient may not have a shunt or other medical pump that may be affected by the electrical stimulation provided by the garment.
Active Schools: Skelmersdale

The aim of AS:Sk is to improve physical activity levels and health-related outcomes of children from the Skelmersdale area of West Lancashire through a school-based physical activity multi-component intervention.

The multi-component intervention is the third and final phase of the AS:Sk project. It will be implemented and evaluated in four of the seven participating schools. The remaining three schools will act as controls and will not implement any physical activity intervention during the period of the research project. Schools will be randomly assigned to either intervention or control conditions. The multi-component intervention will involve multiple areas of the schools' curricula, environments, or policies being targeted. Decisions regarding these intervention components will be influenced by what was deemed effective, and feasible within phase 2 of the project. Phase 2 included a four week trial of three different single component physical activity interventions across all participating schools. Phase 3 will be implemented for at least eight weeks and if successful, it would then be rolled out in the control schools at the end of the project. Participants from both intervention and control schools will take part in the measures for evaluation in this third and final phase of the project.

Eligibility Criteria:
Inclusion Criteria:

* Year 5 pupil attending participating schools

Exclusion Criteria:

-
A Music-with-movement Exercise Program for Community-dwelling Older Adults Suffering From Chronic Pain: a Pilot Randomized Controlled Trial

Background: The high prevalence of chronic pain in community-dwelling older adults requires attention from nurses. The aim of the present study is to use a music-with-movement exercise program to improve the pain situations of older adults with chronic pain.

Aims and objectives:

The aim of this study is to implement a music-with-movement exercise program (MMEP) for older adults suffering from chronic pain.

The objectives of this study are:

* To evaluate the effects of a music-with-movement exercise program on improving the pain intensity, pain self-efficacy, mood, and quality of life of the older adults with chronic pain
* To observe the participants' level of adherence to the music-with-movement exercise by using an exercise logbook and measurements of heart rate

Anticipated outcomes: This study will be a pilot randomized controlled trial. An 8-week music-with-movement exercise program will be used as the intervention for older adults with chronic pain in District Elderly Centers in Hong Kong. It will consist of four sessions of center-based, face-to-face activities and four weeks home-based and digital-based activities delivered through a WhatsApp group. A music therapist, in consultation with the physiotherapist, will lead the center-based activities. Each center-based session will consist of 30 minutes of music-with-movement exercise and 10 minutes of instruction on pain knowledge and pain management. Each participant will receive an exercise logbook to practice and record the frequency of their engagement in the music-with-movement exercise at home. They will receive WhatsApp reminders to remind them to continue the home-based sessions. Outcome measures include pain intensity, pain self-efficacy, mood, heart rate and physical activity intensity, and quality of life. Data will be collected before and after the intervention. Participants need to complete the exercise logbook to record their adherence to the intervention. The findings of this study will provide clinical implications for nurses to integrate music with movement exercise to manage pain.


Eligibility Criteria:
Inclusion Criteria:

* Aged 60 or above
* Can understand Cantonese
* Have a history of non-cancer pain in the past 3 months
* Have a pain score of at least 2 as measured by the Numeric Rating Scale (on an 11-point numeric scale)
* Able to take part in an exercise and stretching program
* Owns a smartphone and can access the Internet

Exclusion Criteria:

* Have severe visual and/or auditory deficits
* Have a serious organic disease or malignant tumor
* Have a mental disorder diagnosed by neurologists or psychiatrists
* Had surgical treatments in the past two months
* Experienced drug addiction
The Efficacy of Progestins in Treatment of Functional Ovarian Cyst

The aim of this study is to determine whether the use of progesterone only pills has a beneficial effect over the expectant management of functional ovarian cyst or not , through a sample of female patients within the reproductive years

An ovarian cyst is a common gynecological problem and is divided into 2 main categories; physiological and pathological In relative frequency, functional cysts account for about 24% of all ovarian cysts, benign cysts 70% and malignant 6% Functional cysts are the most common masses seen in the premenopausal ovary and are estimated to affect 8%-20% of reproductive-aged women

Pain or discomfort in the lower abdomen Severe pain from torsion (twisting) or rupture - Cyst rupture is characterized by sudden, sharp, unilateral pelvic pain; this can be associated with trauma, exercise, or coitus. Cyst rupture can lead to peritoneal signs, abdominal distention, and bleeding (which is usually self-limited) Discomfort with intercourse, particularly deep penetration Changes in bowel movements such as constipation Pelvic pressure causing tenesmus or urinary frequency Menstrual irregularities Precocious puberty and early menarche in young children Abdominal fullness and bloating Indigestion, heartburn, or early satiety Hyperpyrexia - This may result from some complications of ovarian cysts, such as ovarian torsion Adnexal or cervical motion tenderness In current clinical practice , gynecologists treat functional ovarian cysts with either oral Contraceptive pills or expectant management alone. we presume using progesterone only pills for treatment of functional ovarian cyst

Eligibility Criteria:
Inclusion Criteria:

* Female patients at reproductive age (18-44) Menstruating ovarian cyst (a cyst 3-10 cm in diameter, unilateral , unilocular ,clear content) BMI : patients with normal BMI (18.5-24.9) and overweight (25-29.9) included

Exclusion Criteria:

* Exclusion criteria are ovarian payhology (dermoid, endometriosis or malignancies)

Complicated cyst (rupture, torsion) Patients receiving hormonal treatment for the previous 3 cycles History of surgical removal of ovarian cyst Comorbidities like uncontrolled DM ,hypertension and tuberculosis
Effectiveness of Standing Frame on Constipation in Children With Cerebral Palsy

Children with Cerebral Palsy and quadriplegia or severe diplegia suffer from highly reduced mobility and consequent constipation. Clinicians frequently recommend standing-frames to exercise the support reaction in this population, sharing the opinion that the upright position may facilitate intestinal transit, although no evidence supports this assumption.

The investigators conducted this single-subject research to determine the effects of the standing-frame on the frequency of evacuation in chronically constipated children with CP and quadriplegia.

Moreover, the investigators studied its effects on the frequency of induction of evacuation, the characteristics of the stool and the pain suffered by the child due to constipation and/or evacuation.


Eligibility Criteria:
Inclusion criteria were:

* clinical indication for the use of the standing-frame;
* constipation problems as defined by guidelines (Clinical Practice Guideline, 2006);
* whose parents gave the informed consent to let their child to participate in this study.

Exclusion criteria were:

* children who have orthosympathetic reactions to the upright position, skeletal deformities and/or medical conditions that, according to clinical judgment, advise against the use of the standing frame.
Follicular Fluid Raman Shifts and IVF Outcomes

This study intends to collect about 150 cases of follicular fluid samples from PCOS and non-PCOS infertility patients undergoing in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI) cycles (in clinical routines).We tend to detect Raman metabolic profile of the follicular fluid of the PCOS and non-PCOS groups, and find the correlation between the metabolic profile of the follicular fluid of PCOS patients and the oocyte quality, IVF outcome and subsequent embryo development are also under investigation. Metabolomics analysis was applied to look for markers of follicular fluid in PCOS patients, and further exploring data and strategies to improve the embryonic development potential and IVF outcome of PCOS patients.


Eligibility Criteria:
Inclusion Criteria:

* Patients fit the Rotterdam criteria for PCOS
* Patients under IVF cycles

Exclusion Criteria:

* Patients with male factors infertility
* Patients with fallopian tube factors infertility
Effect of Dexamethasone on the Action of Sugammadex

This study aims to investigate the possible clinical effect of dexamethasone on the action of sugammadex when it is administered to reverse deep neuromuscular blockade caused by rocuronium in laparoscopic cholecystectomies.


Eligibility Criteria:
Inclusion Criteria:

* patients aged 18-70 years
* laparoscopic cholecystectomy
* operation \< 3 hours

Exclusion Criteria:

* age \<18 or \>70 years old
* ASA physical status \>3
* central nervous system diseases
* severe psychiatric disorders under treatment
* cognitive dysfunction
* known or suspected allergy to the administered drugs
* operations \> 3 hours
* surgical intraoperative complications-open cholecystectomy
* severe renal or liver disease
* diabetes melitus
* immunosuppressed patients
* chronic immunosuppresant therapy (corticosteroids or other drugs)
* all contraindications to corticosteroids administration
* patiens on chronic use of opioids
Stepped Care Model of Lifestyle-based Mental Health Care for Depression

This study is a two-arm parallel randomised controlled trial comprising both outcome and cost-effectiveness analyses. A total of 244 eligible participants experiencing depressive symptoms will be randomly assigned to either the stepped care model of lifestyle-based mental health care (LSC) or the care-as-usual (CAU) at a 1:1 ratio. Participants in the LSC will access a stepped care treatment consisting of 3 steps, including self-help multicomponent LM treatment (Step 1), guided self-help based on the LM approach and low-intensity cognitive behavioural therapy for depression (Step 2), and specialist mental health services (Step 3). Participants in the CAU will be informed about their mental health condition and have unrestricted access to care. For the outcome analysis, the outcome assessments will include depressive symptoms, anxiety symptoms, insomnia symptoms, functional impairment, quality of life (QoL), health-promoting behaviours (HPBs), barriers to accessing mental health services, treatment acceptability, and treatment credibility and expectancy. For the cost-effectiveness analysis, the clinical outcome will be depressive symptoms and the economic outcome will be quality-adjusted life-years. Data will be collected at baseline, 3-month, 6-month (immediate post-treatment), 9-month follow-up, and 12-month follow-up assessements.


Eligibility Criteria:
Inclusion Criteria:

* Hong Kong residents
* Aged 18-64 years
* Able to read and understand Cantonese
* Meeting caseness on the Patient Health Questionnaire (PHQ-9) (i.e., PHQ-9 ≥10), with symptoms persisting for four weeks of watchful waiting
* Possessing an internet-enabled iOS- or Android-operated mobile device

Exclusion Criteria:

* Meeting DSM-5 diagnosis of a severe mental illness including psychotic or bipolar disorders as determined by the Mini International Neuropsychiatric Interview 7.0.2 (MINI-7)
* Having a medical condition or neurocognitive disorder that may prevent lifestyle modifications based on the research team's clinical knowledge and experience (e.g., at high risk of fall or dietary change is not suitable as recommended by physicians or dietitians)
* Significant functional impairment as assessed by the Work and Social Adjustment Scale (WSAS) (i.e., WSAS ≥20)
* Unstable medication in the past two months
* Are receiving psychotherapy or other medical procedures (e.g., transcranial magnetic stimulation) for depression
* Current involvement in lifestyle modifications prescribed by medical (e.g., psychiatrist) or allied health professionals (e.g., clinical psychologists, dietitians)
* Prominent suicidal ideation or intent (i.e., non-fleeting intent or plan) as measured by the PHQ-9 item 9 score \>2 (24-hour emergency hotlines and referral information for public mental health services will be provided)
* Participating in another clinical trial
* Pregnancy
* Hospitalisation
* Unwilling to provide informed consent or comply with the research protocol
Comparative Effects of Sustained Stretch and Mobilization With Movement in Patient With Tennis Elbow

Tennis elbow, clinically known as lateral epicondylitis, is a prevalent musculoskeletal issue marked by pain and tenderness on the outer part of the elbow. It primarily affects the extensor tendon at the lateral epicondyle and is commonly linked to repetitive arm movements and overuse. Various treatment options are available for this condition, with two notable methods being sustained stretching and Mobilization with Movement (MWM). Sustained stretching involves holding the affected muscles and tendons in an extended position for a prolonged time to ease muscle tightness and enhance flexibility. Conversely, MWM integrates specific joint movements with the active involvement of the patient to improve joint mobility and reduce pain. Muscle strength plays a crucial role in the overall function of the upper limb, and enhancing this can positively affect daily activities. Furthermore, functional disability indicates how tennis elbow impacts a person's capacity to carry out everyday tasks.

This randomized clinical trial will be conducted at Riphah Rehab center over duration of eight months. The sample size will consist of 58 participants. Participants which meet the inclusion criteria will be taken through non-probability convenience sampling technique. 29 Participants will be assigned to Group A 29 to group B. Data will be collected using various assessment tools, including NPRS, ULFI, Universal Goniometer, Hand Held Dynamometer. Pre-intervention assessments will be conducted for groups. Data analysis will be performed by using SPSS 26 software.

Eligibility Criteria:
Inclusion Criteria:

* Both males and females are affected. diagnosed with tennis elbow, characterized by pain and weakness on the outer side of the elbow.
* The pain has persisted for at least 4 to 6 months.
* Individuals experience difficulty gripping and lifting objects due to elbow pain.
* Positive results were observed in both the Mills and Cozen tests.

Exclusion Criteria:

* Presence of nerve injuries or neuropathies in the arm or hand.
* No history of recent trauma or fracture to the elbow.
* No neurological conditions affecting the arm or hand
* Acute inflammation or signs of infection in the elbow joint.
* Presence of cervical radiculopathy, thoracic outlet syndrome any systemic diseases
Prospective Tacrolimus Pharmacokinetics Study in Pediatric Living Donor Liver Transplantation

Our first aim is thus to investigate, retrospectively first and then prospectively, in de novo pediatric (living donor) liver recipients, the tacrolimus in vivo and in vitro metabolism and its variability with focus on pharmacokinetics, pharmacodynamics, and pharmacogenomics and its evolution according to the age and transplant delay. Our second aim is then to find better tacrolimus exposure markers for therapeutic drug monitoring (TDM) such as Area Under the time-concentration Curve (AUC) or intralymphocytic (PBMCs) tacrolimus concentration and a way to model and predict it without invasive tests in pediatric patients.

The final objective should be then to implement these findings in a more individualized and comprehensive immunosuppression protocol and monitoring in order to maintain adequate and well-balanced immunosuppression (preventing graft rejection while avoiding acute and long-term side effects). This is particularly important for a pediatric population exposed throughout their life to immunosuppressants.


Eligibility Criteria:
Inclusion Criteria:

* Children aged 0 to 18 years
* First Liver transplantation
* Children eligible to receive tacrolimus post transplantation
* Consent from parents

Exclusion Criteria:

* Multiorgan transplantation
* Retransplantation
* ABO incompatible donors (unless if recipients is\<1 year and anti-AB antibodies are \<1/32)
* Multi organ failure
* Need for additionnal therapy except for methylprednisolone to treat rejection
* Intravenous tacrolimus
* First tacrolimus administration postponed after day 3
Ulcer Prevention II

Nonsteroidal anti-inflammatory drugs (NSAIDS) are often associated with gastric ulcers. This study looks at the prevention of these gastric ulcers, in patients deemed to be at risk, with either esomeprazole 40 mg once daily; esomeprazole 20 mg once daily.


Eligibility Criteria:
Inclusion Criteria:

1. No active/current gastric or duodenal ulcer on baseline endoscopy.
2. A clinical diagnosis of a chronic condition that requires daily NSAID treatment for at least 6 months.
3. Other inclusion criteria, as defined in the protocol.

Exclusion Criteria:

1. History of esophageal, gastric or duodenal surgery, except the simple closure of an ulcer.

* 2. History of severe liver disease, including (but not limited to) cirrhosis and acute or chronic hepatitis.
* 3. Other criteria, as defined in the protocol.