cyrilzakka/clinical-trials huggingface dataset:
The Effect of the Tourniquet in Bilateral Total Knee Replacement

This study describes in a randomised controlled trial how the tourniquet influence the outcome af a total knee replacements

Background: Tourniquet application during total knee arthroplasty (TKA) is a common practice aimed at reducing intraoperative bleeding. However, concerns have been raised about potential tissue damage from ischemia and reperfusion injury.

Objectives: This study examines the effects of tourniquet use during TKA on postoperative functional outcomes, including pain, range of motion (ROM), and patient-reported outcomes (PROMs).

Methods: In a fast-track surgical setting, a prospective, randomized, double-blinded trial was conducted with patients undergoing bilateral TKA. Tourniquets were applied to one knee, while the contralateral knee served as a control. Evaluations were conducted at two and four weeks, and at three and twelve months postoperatively, employing paired t-tests and mixed-effects linear modeling for data analysis.

Eligibility Criteria:
Inclusion Criteria:

Aged 18 years or older, planned for bilateral cemented primary TKA due to osteoarthritis during the same session. and showed a uniform degree of osteoarthritis determined by the Kellgren-Lawrence classification

Exclusion Criteria:

non-Danish speaking patients, unable to cooperate for VAS scoring, coagulation disorders, salicylate-induced asthma, severe thrombocytopenia, serious heart failure, severe liver failure, hypovolemia (any cause), dehydration, angioedema, bronchospasm, undergoing lithium treatment, suspected or manifest gastrointestinal bleeding, cerebrovascular bleeding, high postoperative bleeding risk or delayed hemostasis, hypersensitivity to adrenaline, sympathomimetics or excipients , hypertrophic or ischemic heart disease, undergoing dihydroergotamine treatment and thyrotoxicosis
Pharmacokinetic Study Investigating the Extent of Paracetamol Absorption From a New Formulation of Paracetamol Compared With Panadol®

A single dose pharmacokinetic study investigating two paracetamol formulations


Eligibility Criteria:
Inclusion Criteria:

* Good general heatlh with (in the opinion of the investigator) no clinically significant and relevant abnormalities of medical history or physical examination

Exclusion Criteria:

* Subject does not agree to refrain from alcohol consumption for the 10-day period prior to visit 2 and throughout the remainder of the study.
* Participation in another clinical study or receipt of an investigational drug within 30 days of the screening visit.
* Current (within 14 days of screening) or regular use of any prescription, over the counter drugs including paracetamol/acetaminophen, herbal medicine or drug known to induce or inhibit hepatic drug metabolism in the 30 days prior to dosing.
Study of Copper Isotope in Head and Neck Cancer

The distribution of stable (non-radioactive) isotopes in living organisms is increasingly studied, in particular the zinc (Zn), copper (Cu) and iron (Fe), not only in primitive organisms, but also in mammals.

The scientific community shows a growing interest in the study of the isotopic distribution of Cu in humans: this distribution can vary according to gender or nutrition. Concerning pathology, the isotopic distribution of Cu seems interesting in Wilson's disease or in cirrhosis.

Additionally, a promising area of study focuses on the role of Cu in cancerous tumors, neoangiogenesis, the mechanisms of free radicals reduction and signaling pathways.

Head and neck cancers are sensitive to platinum salts. Links between platinum and Cu are important: platinum penetrates into the cell through a Cu receptor, it interacts with the regulation mechanisms of Cu and platinum.

Preliminary studies suggest a variation of the measurable isotopic distribution of Zn in patients with breast tumor and of Cu in patients presenting breast as well as colorectal tumors.

The Larner et al. study suggest a promising role of Zn in breast cancer, indeed, results highlight a variation of distribution of Zn in 10 breast tumors. Concerning the study of Télouk et al. on 8 patients presenting colorectal tumors and 20 patients presenting breast tumors, results are in favor of an increase of mortality when Cu 65 is decreased in the serum and the isotopic modifications happen earlier than usual modifications of biochemical tumor markers such as: carbohydrate antigen (CA) 19.9, Carcinoma Antigen (CA) 15.3, Carcinoembryonic antigen (CEA).

Currently, there is no information about the distribution of the stable isotopes of Cu in head and neck tumors.

The objective of the study is to determine if the distribution of 65Cu / 63Cu is modified in tumoral tissues compared to healthy tissues. The isotopic distribution of the Cu in 2 tumor types, head and neck tumors and lymphomas, will be also investigated in order to determine if this distribution is specific of a tumor type or not.

In case of positivity of this variation, the prognostic interest of these parameters will be evaluated.


Eligibility Criteria:
Inclusion Criteria:

Clinical diagnosis of head and neck malignant tumors or clinical diagnosis of head and neck lymphoma requiring sampling for diagnosis or clinical diagnosis of a non tumoral ENT pathology requiring surgery

Exclusion Criteria:

Refusal of consent

Inability to consent

Pregnant or breastfeeding women
Hypertension in Breast Cancer Patients Receiving Bevacizumab

This research study will look at the effect of an anti-angiogenesis medication called Bevacizumab on blood vessels. Anti-angiogenesis medicines fight cancer by cutting off a tumor's blood supply, starving the tumor of nutrients and oxygen. Previous studies have shown these types of drugs can cause hypertension. The purpose of this study is to help researchers better understand why these drugs cause hypertension. This information will assist researchers in learning how to control this side effect.

* Participants will begin this research study within 14 days of starting Bevacizumab, either as part of standard treatment or as part of another clinical trial.
* Participants will have an ultrasound test done at baseline, and after completion of their first and second cycles of therapy.
* Vital signs and blood tests will be performed a the start of the study, and after completion of the first and second cycles of therapy.

Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically confirmed breast cancer
* Must be starting combination treatment with bevacizumab and chemotherapy. Treatment may not have already started. Patients may receive therapy either on or off of a clinical trial.
* Any number of prior chemotherapy or biological therapy regimens is acceptable.
* Either no history of hypertension, defined as Blood Pressure \<140/90mm Hg on no antihypertensive therapy, or medically controlled pre-existing hypertension, defined as Blood Pressure \< 140/90mm HG on one non-angiotensin converting enzyme inhibitor (ACE-I) or non-angiotensin receptor blocking (ARB) medication.

Exclusion Criteria:

* History of uncontrolled hypertension within the previous 6 months
* Inability to assess blood pressure or have prolonged blood pressure cuff inflation due to history of bilateral lymph node dissections, presence of an indwelling venous access device, or other condition
* Concurrent use of a statin medication
* Systolic blood pressure \< 100mm Hg
Anatomical-Clinical Base of Adenocarcinoma Pancreatic

BACAP-2 is a prospective biobank dedicated to the pancreatic adenocarcinoma including clinical data and biological samples from tumor. The aim is to enrich the previous propective collection BACAP in order to support future research projects.

Pancreatic cancer represents the fourth cause of death by cancer in Western countries. In over 90% of cases, it is due to an adenocarcinoma. The only curative treatment for pancreatic cancer remains the surgical exeresis. This one can only be suggested as a curative treatment in only 10 to 15% of cases. Besides, prevention or screening is difficult to set up due to the absence of clearly identified risk factors or groups and to the absence of useful markers for the diagnosis in clinical practice.

The research efforts in this area must face a double challenge: saving time while improving the diagnosis period and strengthen the therapeutic equipment. It is important to identify and characterise the new molecular markers applicable for a better diagnosis and/or treatment (especially the response factors to chemotherapy).

The present project aims to enrich with fresh tumor tissue and somatic genetic analysis the existing propective collection BACAP in order to support support future research projects on:

* the development of new diagnostic tools,
* understanding the development of tumors of the pancreas
* the development of new therapeutic targets
* understanding the response to chemotherapy...

Eligibility Criteria:
Inclusion Criteria:

* Patient with pancreatic mass syndrome explored by ultrasound endoscopy with cytopuncture or
* Patient with pancreatic mass syndrome explored by an abdominal scanner with and without injection of product contrast and/or puncture of the mass or secondary lesions by radiological route or
* Patient with pancreatic adenocarcinoma proven histologically and/or cytologically

Exclusion Criteria:

* Patient with a pancreatic tumor whose analysis histological is not an adenocarcinoma
* Pregnant or breastfeeding patient
Neuromuscular Electrical Stimulation in Patients With Interstitial Lung Disease

Decreased exercise capacity and quality of life, increased dyspnea and fatigue perception and hypoxemia during exercise is seen in patients with interstitial lung disease. Impaired ventilatory response, increased lung compliance, ventilation-perfusion mismatching and inadequate peripheral circulation causes decreased exercise capacity. Another important factor that induce decreased exercise capacity is peripheral muscle weakness. In literature, there is no study investigated effects of neuromuscular electrical stimulation on functional exercise capacity, respiratory and peripheral muscle strength, pulmonary functions, physical activity level, dyspnea and fatigue perception in patients with interstitial lung disease.

In literature, there was increased quantity of study investigated effects of neuromuscular electrical stimulation in chronic lung disease patients. It was used as a pulmonary rehabilitation component especially in patients with decreased exercise capacity and peripheral muscle strength, intensely increased dyspnea inhibits exercise. It was demonstrated that neuromuscular electrical stimulation improved functional exercise capacity, peripheral muscle strength and quality of life.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with interstitial lung disease
* Clinically stable
* Under standard medication
* Having no exacerbation or infection

Exclusion Criteria:

* Cognitive disorders
* Orthopedic and neurological problems
* Contraindications to apply the neuromuscular electrical stimulation (pace maker, sensory defects, etc...)
Effects of the Cross-Training in Patients With Multiple Sclerosis

The purpose of this study is to determine whether, in patients with multiple sclerosis presenting with marked asymmetry of strength, training the less-affected limb with a Cross-Training approach may induce a meaningful transfer of strength with neurophysiological, functional and clinical correlates, to the contralateral, more-impaired limb.

Muscle weakness is a major disability that is responsible for deeply reducing the overall quality of life (QoL) of patients with Multiple Sclerosis (MS). Research has shown that strength training (ST) has a significant positive effect on the performance of daily living activities in people with MS, resulting in an increased QoL. Several ST methods are currently employed for reducing strength impairment in MS but no one regimen has been portrayed as superior to others. When strength impairment is prominently lateralized to one limb, training is commonly addressed to the weaker side in order to balance the deficit. However, such ST may not always be applicable to a severely weakened limb that is too compromised to sustain it. For these selected patients we hypothesize that training the less affected limb with a Cross Training (CT) approach may overcome the problem, also avoiding patients' frustration and potential withdrawals from rehabilitation programs.

Aim of this project is to investigate and compare in two groups of selected MS patients, with a marked asymmetry of strength, the effects induced on dynamometric, neurophysiological, functional and clinical outcomes by a CT of the less-impaired leg (CT group) compared to a ST of the more-impaired leg (ST group). In order to make comparisons with a population which is not exposed to the condition MS, a third group composed of healthy subjects will also be included in the study.

The research plan will be articulated in 5 phases (recruitment, baseline assessment, 6 week-intervention phase, post-intervention assessment and follow up at 12 weeks).

Eligibility Criteria:
Inclusion Criteria:

* Age: 18-65 years
* Expanded Disability Status Scale (EDSS) ≤6 (Pyramidal functional system ≥3)

Exclusion Criteria:

* Clinically relevant cognitive disorders;
* Disability caused by other diseases;
* Medication with corticosteroids within three months prior to enrolment;
* Medication with botulinum toxin within six months prior to enrolment;
* Clinically or radiologically documented exacerbation within six months prior to enrolment;
* Variations in disease-modifying drugs (DMD) within three months prior to enrolment;
* Severe ataxia and postural instability (assessed with Berg Balance Scale);
* Depression
Foot Core Training in Individuals With Pes Planus

Foot core training is very important for the intrinsic muscles of the foot, but it is often neglected in exercise programs given to individuals with pes planus. The aim of our study is to reveal the effects of foot core training, which will be added to the exercise program routinely given to individuals with asymptomatic flexible pes planus, on walking, muscular activations, balance and lower extremity functional performance with objective, evidence based results.

This study is a randomized controlled study and will be carried out on volunteer individuals with asymptomatic flexible pes planus aged between 18-25, studying at Alanya Alaaddin Keykubat University. Persons meeting the inclusion criteria will be determined by the specialist physiotherapist. Surface electromyography (sEMG) measurements will be made by a doctorate physiotherapist. Other evaluations will be made by a specialist physiotherapist. Individuals who meet the inclusion criteria, who volunteered to participate in the study and signed the consent sheet will be randomly divided into two groups, the control group and the foot core group. Individuals with initial evaluations will be followed up in an exercise program planned for 8 weeks. The control group will be given exercises to strengthen the weakened muscles, stretch the shortened structures and increase proprioception. Foot core training will be given to the study group in addition to the exercises given to the control group. Before and after exercise, the subjects will be assessed with navicular height measurement, muscle activation evaluation, evaluation of walking parameters, functional lower extremity performance evaluation and balance evaluation.

Eligibility Criteria:
Inclusion Criteria:

* Individuals who volunteer to participate in the study
* Individuals between the ages of 18-25
* Individuals with a body mass index between 18.5-30.
* Individuals with a difference of 10 mm or more between weighted and unweighted measurements by applying the navicular drop test
* Individuals who are considered to have flexible pes planus with a positive Jack's finger lift test

Exclusion Criteria:

* Individuals with symptoms such as any pain in the foot and ankle, fatigue.
* Individuals with any neurological or orthopedic disease affecting the lower extremity.
* Individuals with a history of foot-ankle trauma-surgery
* Individuals with lower extremity inequality of more than 1 centimeter (cm)
Perioperative Management & Outcome Following Preoperative Transthoracic Echocardiography in Noncardiac Surgery Patients

In August 2022 the European Society of Cardiology published updated guidelines including recommendations on preoperative transthoracic echocardiography. The update resulted in broadened criteria for preoperative transthoracic echocardiography. The impact of preoperative transthoracic echocardiography on outcome is controversial and the evidence was mostly derived from administrative databases. Also there is also a knowledge gap in terms of what changes in perioperative managements are derived from transthoracic echocardiography information in current daily practice in Europe and what their impact on outcome may be. Further, a secondary analysis in a large international cohort suggests that the criteria endorsed by the guidelines to define the class of recommendation of transthoracic echocardiography may not be efficient.

The target population consists of patients at elevated cardiovascular risk undergoing elective, intermediate or high-risk noncardiac surgery. The planned sample size is 5500 exposed and 2750 non-exposed

Eligibility Criteria:
Inclusion Criteria

* aged ≥65 years OR
* above 18 years and presenting ≥2 cardiovascular risk factors (hypertension, smoking, dyslipidaemia, diabetes, family history of CVD) OR
* above 18 years with known cardiovascular disease

Exclusion Criteria

* under 18 years of age
* day surgery
* urgent/emergency procedures
* current ICU patient (i.e. in ICU on day-1 or the day of the index surgery (day 0)),
* cardiac surgery within the last month prior according to the index noncardiac procedure (of note this does not include cardiological interventions like TAVI or valvuloplasty),
* unwilling or unable to provide informed consent,
* unable to complete the WHODAS questionnaire (literacy or language barrier)
* Previous enrollment in EuPreCHO (in case of repeated surgery)
Clinical Trial of Oral Midazolam in Pediatric Endoscopy

The objective of our study was to compare the safety and efficacy of oral midazolam during pediatric endoscopy.

Although gastrointestinal endoscopy is widely accepted as fundamental to the diagnosis and treatment of digestive disorders in children, considerable controversy and practice differences persist with respect to the methods and agents used to achieve optimal endoscopic sedation.

Comparison:oral midazolam vs midazolam IV in sedation and comfort scale of pediatric endoscopy.

Eligibility Criteria:
Inclusion Criteria:

* All of patients scheduled for endoscopy participated in the study.

Exclusion Criteria:

Exclusion criteria were as follows:

* Children younger than 3 years;
* Children with significant neurological disability;
* Children with a history of allergies to benzodiazepines, or to their components;
* Children with metabolic, cardiac or renal disease; children with previous - Complications to IV sedation;
* Children with respiratory distress
* Age under 1 mo and bigger than 17y
* History of erythromycin used in 4 week ago
Clinical Efficacy of Preformed Pediatric Zirconia and Metal Crown

The study was planned to evaluate and compare the clinical success of prefabricated stainless steel crowns and zirconia crowns used in the primary molars.

The study will be carried out in healthy children aged 6-9 years with caries on more than one surface of the primary molars.

In this study, zirconia crowns will be compared with prefabricated stainless steel crowns in a randomized controlled manner. The study will be conducted in split-mouth to eliminate the effect of potential confounders. The obtained data will be analyzed using appropriate statistical methods.

Eligibility Criteria:
Inclusion Criteria:

* Healthy children aged 6-9 years with caries on primary molars
* Children without systemic disease or developmental dental anomalies that may affect caries susceptibility.
* Children whose cooperation is 'positive' or 'absolutely positive' according to the Frankl behavioral scale (Frankl et al., 1962).
* Those with deep dentin caries that do not extend to the pulp in the teeth to be treated
* The molars will be treated with a crown indication.
* Presence of symmetry of the primary molar to be treated in the opposite arch.
* The molar to be treated is in occlusion with the antagonist.
* Presence of caries on at least two surfaces of the molars to be treated.
* Absence of spontaneous pain, abscess, mobility, interradicular lesion in the tooth to be treated
* Patients whose parents and themselves agree to participate in the treatment

Exclusion Criteria:

* Children whose treatment cannot be continued on the dental chair due to cooperation
* Molars that will soon be exfoliated, 1/2 of the root has been resorbed
* The presence of bruxism
* The presence of erosion or attrition-related wear on the opposing molar
* The patient does not come to the control appointment or does not want to continue to the research
* Have allergy to local anesthetic, nickel or chromium
* Complications during treatment.
Study of the Therapeutic Effects of Intercessory Prayer (STEP)

Intercessory prayer is widely believed to influence recovery from illness, but claims of benefits are not supported by well-controlled clinical trials. Prior studies have not addressed whether prayer itself or knowledge/certainty that prayer is being provided may influence outcome. We evaluated whether (1) receiving intercessory prayer or (2) being certain of receiving intercessory prayer was associated with uncomplicated recovery after coronary artery bypass graft (CABG) surgery.

Intercessory prayer is widely believed to influence recovery from illness, but claims of benefits are not supported by well-controlled clinical trials. Prior studies have not addressed whether prayer itself or knowledge/certainty that prayer is being provided may influence outcome. We evaluated whether (1) receiving intercessory prayer or (2) being certain of receiving intercessory prayer was associated with uncomplicated recovery after coronary artery bypass graft (CABG) surgery.

Eligibility Criteria:
Inclusion criteria:

* Age 18 years or older
* Able to read or understand English

Exclusion criteria:

* Scheduled for emergent CABG (next available operating room slot)
* CABG more than 14 days after enrollment
* Other planned surgery within 30 days of CABG
* Minimally invasive CABG (non full sternotomy incisions)
* CABG with planned valve replacement, stent, angioplasty or carotid endarterectomy
* Or had ongoing chest pain or unstable angina, as defined by their physicians