cyrilzakka/clinical-trials huggingface dataset:
Dexmedetomidine Versus Gabapentin Premedication on the Emergence Agitation After Rhinoplasty

To compare the effect of intramuscular dexmedetomidine versus oral gabapentin premedication on the emergence agitation after rhinoplasty.

Emergence agitation (EA) is a clinical condition characterized by agitation, confusion, disorientation, and aggressive behavior in the early phase of recovery from general anesthesia (incidence about 21.3%). This may lead to various injuries, self-extubation, bleeding, increased pain, removal of catheters, increased blood pressure, heart rate, and myocardial oxygen consumption. Premedication with dexmedetomidine and gabapentin are promising options for EA.

Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologists grade I or II.
* Sex: Both sexes.
* Age between 18 and 40 years.
* Patients scheduled for rhinoplasty under general anesthesia

Exclusion Criteria:

* Declining to give written informed consent.
* History of allergy to the medications used in the study.
* history of cardiovascular diseases including bradycardia, heart block, and hypertension.
* History of chest problems including bronchial asthma.
* Had a history of drug or alcohol abuse.
* Taking opioids or sedative medications.
* Inability to communicate with patients to evaluate postoperative pain.
* Hepatic or renal failure.
* Psychiatric disorders with antipsychotics or antidepressants.
* Bleeding disorders, antiplatelets (aspirin, clopidogrel), or anticoagulant (warfarin).
Effect of HCG on Endometrial Preparation in Frozen Embryo Transfer

Intramuscular injection of HCG to prepare endometrium for frozen embryo transfer

This study is to compare the effectiveness of intramuscular injections of Human chorionic gonadotropins in preparing the endometrium for frozen embryo transfer compared to the control group who did not receive the injection

Eligibility Criteria:
Inclusion Criteria:

1. Infertile women being prepared for frozen embryo transfer (FET) in an ART program

   Exclusion Criteria:
   * (1) Use of preimplantation genetic test.
2. History of recurrent spontaneous abortion.
3. Presence of congenital uterine malformations.
4. Use of sequential embryo transfer.
Topotecan Weekly Versus Topotecan Day 1-5 in Patient With Platin-resistant Ovarian Cancer

Comparison of topotecan weekly vs. topotecan day 1-5. The compatibility and activity are to be examined.

Topotecan belongs to the most effective medicaments in the therapy of relapsed platin-resistant ovarian cancer. Due to the low rate of hematological toxicities of grade 3 or 4 weekly application may be an improvement of therapy. None randomised study exists comparing a weekly topotecan application with an application on day 1-5. This study will compare the two applications in regard to: rate of complete or partial remissions, rate of toxicity, quality of life, progression free survival, overall survival.

Eligibility Criteria:
Inclusion Criteria:

* patients with histologically-confirmed ovarian cancer
* relapse within 6 month after primary therapy
* primary therapy with platin and taxan
* ECOG 0-2
* \>= 18 years
* leukocytes \>= 3.000/ µl
* platelet \>= 100.000/ µl
* neutrophil \>= 1.500/ µl
* written informed consent

Exclusion Criteria:

* earlier topotecan therapy
* simultaneous or planned radiotherapy
* secondary malignancy
Transperineal Laser Ablation for Focal Treatment of Prostate Cancer

Rationale: Prostate cancer (PCa) is the second cause of cancer-related deaths for men. The standard surgical treatment for localised prostate cancer is radical prostatectomy. Possible side effects of this treatment are incontinence and erectile dysfunction and this is related to the whole-gland resection. A focal treatment with fewer side effects is desired for patients with only a small focus of PCa. For this purpose, focal laser ablation is feasible. Current focal laser ablation techniques use a single fibre setup with the need for fibre replacement revisualisation of the tumour side accordingly. This leads to a long treatment duration.

The Echolaser® system is a laser ablation system with four simultaneously operating laser sources. This provides a potential larger treatment area, without the need for fibre replacement.

This makes the system advantageous for focal laser ablation of prostate cancer, especially since it can be applied under local anaesthesia.

This pilot study aims to evaluate histological ablative efficacy on radical prostatectomy specimens following TPLA, feasibility and safety using a (multi)fibre setup in men with localized prostate cancer. The investigators hypothesize that TPLA will show adequate histological ablative efficacy and will be feasible and safe.


Eligibility Criteria:
Inclusion Criteria:

* Male
* ≥40 years of age
* Histopathological confirmed organ-confined prostate cancer
* Indication for a radical prostatectomy
* Prostate volume ≥40 mL
* Ability of the patient to stop anticoagulant therapy prior to TPLA according to standard hospital pre-operative protocol
* Signed informed consent

Exclusion Criteria:

* Refusal of participation or clinically ineligible for treatment under local anaesthesia
* Prior or concurrent treatment for prostate cancer
* Other conditions / status
Autologous Hematopoietic Stem Cell Transplantation in Ischemic Stroke

The purpose of this study is to evaluate the safety and efficacy of autologous peripheral hematopoietic stem cell transplantation in ischemic stroke.

Stroke is among the main causes of mortality and disability of elderly population which still lack of efficient therapy. Stem sell transplantation provides a functional improvement after cerebral ischemia in rat models. Our study will recruit 40 ischemic stroke patients which will be divided into 2 groups (20 patients each): treatment group and control group. The former will be implanted with peripheral blood stem cell through anterior cerebral artery or middle cerebral artery (determined by the section of infarction) and receive convention stroke therapy. The latter only receive convention stroke therapy. The investigators expect that transplantation of the peripheral hematopoietic stem cell is safe and efficient to neurological recovery.

Eligibility Criteria:
Inclusion Criteria:

* aged 40\~70
* no consciousness disorders
* internal carotid artery territory infarction
* stroke happened \< 1 year
* with stable hemiplegia, but remain dependent in daily life
* SSS(Scandinavian Stroke Scale) \< 40

Exclusion Criteria:

* pregnant women
* can't tolerate the test because of other disease, such as heart failure, liver failure, renal failure, abnormal blood coagulation, AIDS, combine other tumor or special condition
MIND Programme for Cancer Patients

This investigation aims to apply and test the acceptability of an acceptance, mindfulness and compassionate-based intervention structured for cancer patients. MIND programme for cancer thus comprises 8 weekly group sessions, lasting 1 and a half hour each, run in small groups at an Oncology Service at the Coimbra's University Hospital. For each week participants have assigned homework (e.g., mindfulness exercises). This programme mainly aims to increase participants' physical and psychosocial quality of life, and attenuate depressed mood and anxiety.

The sample will include diagnosed cancer patients recruited at an Oncology Service at the Coimbra's University Hospital. Patients will be approached by their doctor to assess their level of interest in the investigation. Patients who demonstrate interest will go through a Screening interview conducted by a licensed psychologist that aims explain the structure and arms of the investigation, to collect demographic data, and whether the patient meets the inclusion criteria for the study. Patients who meet the inclusion criteria and demonstrate interest in participating in the study, will sign an informed consent. All ethical requirements for research with humans are guaranteed.

Afterwards, participants will be allocated in two groups (experimental and control group). Both groups will maintain the medical treatment as usual (TAU). Additionally, the experimental group will enroll in the MIND programme for cancer patients, also provided by a licensed psychologist.

Both groups will concurrently complete a protocol of self-report measures and their medical data will be collected by the medical staff of the Hospital.

Eligibility Criteria:
Inclusion Criteria:

* diagnosis of breast cancer (stages I-III)

Exclusion Criteria:

* severe psychopathology
* difficulty in completing self-report measures
a Small Dose of Naloxone,Minimize Intrathecal Morphine Side Effects

I.V naloxone decreases incidence and severity of the common morphine side effects (pruritis, nausea/emesis, constipation, urinary retention, respiratory depression and undesirable sedation) so using it as additive to intrathecal morphine in patients undergoing anal surgeries under spinal anesthesia may be beneficail

Bupivacaine hydrochloride is a commonly used local anesthetic in spinal anesthesia, however, the duration of spinal analgesia by bupivacaine is limited to about 75-150 minutes, therefore, various additives have been used along with bupivacaine for the prolongation of its effect, to improve the quality of analgesia, and to minimize the requirement for postoperative analgesics .

Opioids may be added to local anesthetic solutions to enhance surgical anesthesia and provide postoperative analgesia . This effect is mediated at the dorsal horn of the spinal cord, where opioids mimic the effect of endogenous enkephalins. The use of intrathecal (IT) morphine (0.1 to 0.5 mg) can provide effective control of postoperative pain for roughly 24 hours . However, the use of IT morphine may result in serious side effects e.g. pruritus 53%, nausea and vomiting 43%.urinary retention 43% and delayed respiratory depression . These side effects may lead to patient discomfort and prolonged hospital stay thus limiting the usefulness of IT morphine.

Naloxone has an extremely high affinity for μ-opioid receptors in the central nervous system (CNS). Naloxone is a μ-opioid receptor (MOR) competitive antagonist, and its rapid blockade of those receptors often produces rapid onset of withdrawal symptoms. Naloxone also has an antagonist action, though with a lower affinity, at κ- (KOR) and δ-opioid receptors (DOR). Unlike other opioid receptor antagonists, naloxone is essentially a pure antagonist with no agonist properties.

I.V naloxone decreases incidence and severity of the common morphine side effects (pruritis, nausea/emesis, constipation, urinary retention, respiratory depression and undesirable sedation) The addition of naloxone to morphine decreases the opioid related side effects without affection of postoperative analgesia. This combination can be used for the treatment of severe refractory chronic low back pain.

Eligibility Criteria:
Inclusion Criteria:

* ASA physical status I - II
* undergoing anal surgery with spinal anesthesia

Exclusion Criteria:

* Renal ,hepatic and cardiac patients -Infection at the site of injection.-
* Coagulopathy or other bleeding diathesis. -Preexisting neurologic deficits.-
* History of hypersensitivity to any of the given the drugs.
* Inability to communicate with the investigator and the hospital staff.
* History of chronic opioid use.
Head and Neck Squamous Cell Carcinoma (HNSCC)PET-CT Pilot Study

The purpose of this study is to see how useful the information provided from Positron Emission Tomography (PET) scans can be in the actual planning and delivery of radiation treatment to patients who have head and neck cancers. Patients participating in this study, will have (in addition to their routine tests) a PET scan before and during their radiation treatment. Following the intervention, patients will be followed as per standard practice.


Eligibility Criteria:
Inclusion Criteria:

* Non-nasopharynx head and neck mucosal squamous cell carcinoma
* Radiologically evident gross disease
* Radiotherapy alone for curative intent
* Age equal to or more than 18 years old
* To be eligible for the second study PET-CT scan: FDG avid tumour (or minimum SUV of 2.5) on the first study PET-CT scan

Exclusion Criteria:

* Nasopharynx cancer
* H\&N SCC skin
* Distant metastases (already known or if found on baseline CT-thorax)
* Prior malignancy within the last 5 years (exclude non-H\&N SCC, BCC skin)
* Prior chemotherapy within the last 5 years or concurrent chemotherapy/EGFR inhibitors
* Prior head and neck radiotherapy
* Inability to lie supine for study duration
* Pregnancy
* Inability to provide informed consent
Effects of Auditory Stimulation on Sleep and Memory in Schizophrenia

The investigators will test the hypothesis that auditory stimulation (playing quiet sounds during sleep) can normalize brain activity during sleep and improve memory in patients with schizophrenia. The investigators will do this by measuring sleep and memory performance under two conditions separated by one week: receiving auditory stimulation during sleep and not receiving auditory stimulation during sleep. The investigators will study healthy subjects and outpatients with schizophrenia.


Eligibility Criteria:
Inclusion Criteria:

For healthy controls:

* Male and female subjects
* 18-50 years of age
* Proficient in English

For schizophrenia patients:

* Male and female schizophrenia outpatients
* 18-50 years of age
* Proficient in English
* Able to give informed consent

Exclusion Criteria:

* Pregnant females
* Current use of psychotropic medications (healthy controls only)
* A history of head injury resulting in prolonged loss of consciousness or other neurological sequelae
* IQ \<85
* Neurological disorder (including seizure disorder)
* Significant hearing or vision loss
* Current substance abuse or dependence (nicotine abuse or dependence is not exclusionary)
* Any unstable chronic medical condition that affects sleep
* Diagnosed sleep disorder
Sentinel Lymph Node Biopsy to Assess Axillary Lymph Nodes in Women With Stage I or Stage II Breast Cancer

RATIONALE: Diagnostic procedures such as sentinel lymph node biopsy may improve the ability to detect breast cancer and determine the extent of disease.

PURPOSE: Phase II trial to study the effectiveness of sentinel lymph node biopsy to assess axillary lymph nodes in women who have stage I or stage II breast cancer.

OBJECTIVES:

* Compare sentinel node biopsy vs axillary dissection in determining axillary nodal status in women with resectable stage I or II breast cancer.

OUTLINE: Patients are stratified according to node status (positive vs negative).

Patients undergo lymphoscintigraphy, which consists of technetium Tc 99m human serum albumin colloid being injected near the tumor. Dynamic imaging using a gamma camera is performed for 20 minutes postinjection and static images are obtained for up to 3 hours postinjection.

Surgery is performed within 24 hours of lymphoscintigraphy. Patients are injected with patent blue V dye near the tumor and a gamma detection probe is used to measure radioactive counts in the sentinel node. Surgery begins within 5 minutes of the patent blue V dye injection.

All lymph nodes that stain blue or have a high radioactive count are removed. The primary breast lump is removed by either wide local excision or mastectomy and the axilla are cleared by standard axillary dissection.

Some patients may only receive patent blue V dye injected as a pilot study. Sentinel lymph node biopsy and axillary dissection proceed as above.

PROJECTED ACCRUAL: A total of 150 patients (75 per stratum) will be accrued for the main study plus another 50 patients for the pilot study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Diagnosis of stage I or II invasive breast cancer by triple assessment:

  * Clinically
  * Mammogram and/or ultrasound
  * Fine needle cytology
* Resectable disease by either wide local excision or mastectomy with axillary dissection
* No ductal carcinoma in situ
* Hormone receptor status:

  * Not specified

PATIENT CHARACTERISTICS:

Age:

* 18 and over

Sex:

* Female

Menopausal status:

* Not specified

Performance status:

* Not specified

Life expectancy:

* Not specified

Hematopoietic:

* Not specified

Hepatic:

* Not specified

Renal:

* Not specified

Other:

* Not pregnant
* No known allergy to vital blue dye
* No mental illness or handicap that would preclude study entry
* No other severe illness that would preclude study participation

PRIOR CONCURRENT THERAPY:

Biologic therapy:

* Not specified

Chemotherapy:

* Not specified

Endocrine therapy:

* Not specified

Radiotherapy:

* Not specified

Surgery:

* See Disease Characteristics
Effect of the Neck Extension on Blind Intubation Via Ambu® AuraGain™

In a previous study, NCT03147469, the investigators found that the vocal cords were more easily visualized by fiberoptic bronchoscopy with neck extension positioning. On the basis of this finding, the investigators are going to conduct a randomized controlled trial to evaluate the effect of neck extension on the success rate of blind intubation through laryngeal mask.

Participants undergoing general anesthesia will be randomly assigned to group E (with neck extension) or group C (with neutral position). Ambu® AuraGain™ laryngeal mask will be placed first, and then, a lubricated endotracheal tube will be gently intubated through the laryngeal mask. The participants will be mechanically ventilated with an endotracheal tube if blind intubation succeed. Blind intubation will be performed with a maximum of two attempts. If all attempts failed, the laryngeal mask will be removed and the tube will be intubated using a direct laryngoscopy.

The primary outcome of this study is the success rate of blind intubation within a first attempt. Secondary outcomes included overall success rate of blind intubation within a maximum of two attempts, time for blind intubation, the incidence of postoperative hoarseness, cough, and sore throat, and any obvious complications related to airway management such as bleeding, airway trauma, dental fracture, aspiration, or bronchospasm.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients undergoing general anesthesia with endotracheal intubation

Exclusion Criteria:

* Emergency operation
* History of esophageal, oropharyngeal, or laryngeal disease
* History of cervical spine surgery
* Insufficient NPO time
* Loosening teeth
* Mouth opening less than 2cm
Vibrational-proprioceptive Resistance Exercise Training Versus Neuromuscular Electrical Stimulation Training in Elderly People With Muscle Weakness

Study the structural behaviours of weak muscle of elderly and evaluate the efficiency of two different types of training.


Eligibility Criteria:
Inclusion Criteria:

* age related muscle weakness
* age between 65-85 years
* all inclusion criterias must be fullfilled

Exclusion Criteria:

* recent hip or knee endp-prosthesis (within last 2 years), longstanding immobility
* body mass index greater than 40
* acute thrombosis in lower extremity (within last 3 weeks)
* severe articular effusion
* acute infection
* known myopathy
* relevant neurological diseases with gait disorders (e.g. poly neuropathy, Parkinson's disease)
* dementia, impaired cognitive abilities
* diseases of the vestibular system causing vertigo or impairing balance
* symptomatic cardio pulmonal diseases within the last 6 months
* not or insufficient treated hypertonia
* rheumatic diseases
* other relevant functional impairment of the musculo-skeletal system caused by surgery, trauma or degenerative diseases
* pain in the lower extremity (VAS \> 5)
* if one of the above criteria applies the subject will be excluded from the study
A Randomized Control Trial to Assess Early Clinical and Functional Outcome of the ROCC and LCS Total Knee Implant Designs

This is a prospective Randomised Control Trial to compare the Early Clinical and Functional Outcome of the ROCC and LCS total knee arthroplasty implant designs.

This study compares two similar designs of cementless rotating bearing total condylar knee replacements. The study will be conducted at a single clinical unit with a senior orthopaedic surgeon implanting all devices.Their performances will be assessed by clinical scores and comprehensive function outcome documentation undertaken by qualified physiotherapists. The persons undertaking the assessments will be blinded to which implants the patients have.

Eligibility Criteria:
Inclusion Criteria:

* Patients suitable for cementless knee replacement
* Patients skeletally mature and under 80 years of age at pre-operative clinic
* Patients presenting with osteoarthritis of the knee
* Patients must be ambulatory at time of pre-operative clinic
* Patients must be able to understand instructions and be will to return for follow-up

Exclusion Criteria:

* Previous knee surgery (except arthroscopic/open menisectomy)
* Patients with inflammatory arthritis
* Patients with significant medical co-morbidity - ASA IV
* Disorders causing abnormal gait or significant pain
* Patients unable to consent
* Severe visual impairment
Effects of Bidomain Cognitive and Aerobic Training on Cognitive Functioning in Mild Cognitive Impairment.

The study aims to assess the effects of Bidomain cognitive and aerobic training on both cognitive functioning and quality of life in individuals with mild cognitive impairment.

The proposed study addresses a notable gap in the literature regarding the comparison between combined cognitive-aerobic training and cognitive training alone in improving cognitive function for patients with mild cognitive impairment (MCI). While previous studies have demonstrated the positive effects of both training methods on cognitive function independently, there is currently no research directly comparing their effectiveness when used together. The study aims to provide evidence on which treatment regime-combined cognitive-aerobic training or cognitive training alone-offers better outcomes for MCI patients. Aerobic training is known to enhance brain structure and function by strengthening neuronal connections, largely due to increased levels of brain-derived neurotrophic factor (BDNF) and enhanced vascularization, which stimulates hippocampal growth. On the other hand, cognitive training improves global cerebral functional connectivity, particularly activating the prefrontal cortex, which leads to better cognitive performance. Combining these training modalities may yield greater benefits than focusing on just one, offering a cost-effective, accessible approach that could significantly improve the quality of life and daily functioning for individuals with MCI.

Eligibility Criteria:
Inclusion Criteria:

* Older adults 60 years \& above
* With normal vision and color perception
* Independent Individual capable of carrying out daily tasks
* Individuals scoring 21-25 on the Mini-Mental State Examination (MMSE)

Exclusion Criteria:

* Medication affecting the exercise capacity of individual
* Regular participation in aerobic training for the last six months
* Cardiovascular or other diseases that do not allow physical activity
* A diagnosed severe psychiatric disease (e.g., depression)
* Patients with cognitive impairment or other neurological impairments due to AD or dementia.
The Comparison of Airway Sealing With the Laryngeal Mask Airway (LMA) Supreme at Different Intracuff Pressure in Children

The laryngeal mask airway (LMA) supreme is a relatively new single-use supraglottic airway with modification. The parameters about airway sealing such as oropharyngeal leak pressure (OLP) and leakage volume are important markers of efficacy and safety when using the supraglottic airway. The airway sealing is related to the intracuff pressure of laryngeal mask airway. The aim of this study is to compare the airway sealing of the LMA supreme at various intracuff pressure in children.


Eligibility Criteria:
Inclusion Criteria:

* Pediatric patients (less than 108months of age)
* scheduled for elective surgery undergoing general anesthesia using LMA supreme 1.5-2.5

Exclusion Criteria:

* Patients with an abnormal airway,
* reactive airway disease,
* gastroesophageal reflux disease,
* chronic respiratory disease,
* a history of an upper respiratory tract infection