cyrilzakka/clinical-trials huggingface dataset:
Transcranial Direct Current Stimulation for Postoperative Pain in Knee Arthroplasty

The objective of this study is to detect the effect of trans-cranial direct current stimulation on postoperative pain and opioid consumption in total knee arthro-plasty patients. Fifty patients undergoing unilateral TKA will be randomly assigned to receive 4 sessions, total of 80 minutes of real (n=25) or sham tDCS (n=25). Stimulation will be given on 4 consecutive postoperative days, group 1 will receive real stimulation with the active electrode over the leg representation of the motor strip (cortical motor area of the leg) and the reference electrode over the arm, group 2 will receive Sham tDCS. Pain level will be evaluated according to visual analogue scale (VAS) and LANSS pain scale before (base line) after 1st, 2nd, 3rd and 4th sessions.

The study aims to to detect the effect of trans-cranial direct current stimulation on postoperative pain and opioid consumption in total knee arthro-plasty patients.

Fifty patients undergoing unilateral TKA will be randomly assigned to receive 4 sessions, total of 80 minutes of real (n=25) or sham tDCS (n=25). Stimulation will be given on 4 consecutive postoperative days, group 1 will receive real stimulation with the active electrode over the leg representation of the motor strip (cortical motor area of the leg) and the reference electrode over the arm, group 2 will receive Sham tDCS.

Pain level will be evaluated according to visual analogue scale (VAS) and LANSS pain scale before (baseline) after 1st, 2nd, 3rd and 4th sessions.

Eligibility Criteria:
Inclusion Criteria:

1. Providing informed consent to participate in the study.
2. age \>30 years and \<60 years both genders.
3. ASA I to II patients.
4. postoperative unilateral total knee arthroplasty.

Exclusion Criteria:

1. Contraindications to transcranial brain stimulation: presence of a history of epilepsy, implantable devices (ventriculo-peritoneal shunts, pacemakers, intracranial metal implants).
2. Neurological or psychiatric pathology.
3. Patients taking major centrally acting drugs (anti-epileptics or antidepressants) or high-dose opioid.
4. History of substance abuse.
5. Severe cardio-pulmonary, renal, hepatic diseases.
6. Pregnancy and lactation.
Pegteograstim in Children With Solid Tumors

To evaluate the efficacy and safety of pegteograstim on chemotherapy-induced neutropenia in children with solid tumors

Children with solid tumor experience neutropenia after cytotoxic chemotherapy, and they usually receive granulocyte colony-stimulating factor (G-CSF) to stimulate neutrophil recovery. However it needs daily injection of G-CSF. Pegteograstim is a new formulation of PEGylated recombinant human G-CSF analogue pegfilgrastim. In this study, investigators aimed to evaluate the efficacy and safety of pegteograstim on chemotherapy-induced neutropenia in children with solid tumors.

Eligibility Criteria:
Inclusion Criteria:

* Patients with solid tumor who undergo chemotherapy with carboplatin, etoposide, doxorubicin, cyclophosphamide (CEDC) and ifosfamide, carboplatin, etoposide (ICE) regimen

Exclusion Criteria:

* Patients with organ dysfunction (creatinine \> 2mg/dL, ejection fraction \<40% or severe arrhythmia/conduction disorder, other severe organ dysfunction)
* Hypersensitivity to pegteograstim, protein originated from E-coli, pegfilgrastim, filgrastim or latex.
* Patients with bleeding tendency to whom subcutaneous injection should be avoided.
* Active infection or infectious fever during the screening period.
* Genetic problem to fructose tolerance.
* Patients who participated in other clinical trial within 4 weeks before enrollment.
* Pregnant and nursing women
Prevena to Prevent Surgical Site Infection After Emergency Abdominal Laparotomy

Post-operative wound complications in abdominal surgery have a major impact on patient outcomes and the real impact of Closed incision negative pressure therapy (CINVt) is not clear in the literature moreover concerning its potential economic benefits The hypothesis of this study is that CINPt has the potential to reduce Surgical Site Infections.

Secondly the investigators aim to study the economic impact of CINPt used after abdominal emergency laparotomies.

Emergency laparotomies lead to increased morbidity and mortality rates. In this scenario the most frequent wound occurrences are represented by wound infections, skin dehiscence or parietal hernias.

Despite standard surgical aseptically technique and perioperative prevention management of infections (e.g. antibiotics), wound complications after emergency laparotomies are still an important unmet challenge.

Moreover, all these complications increase the cost of care requiring new managements.

CINPt has been longly used to favour the successful healing of a plethora of open wounds.

In particular CINPt is based on the application of local negative pressure to the wound surface. In case of open abdomens, the procedure is performed by applying a sterile abdominal dressing, which consists of a fenestrated soft plastic non-adherent layer with enclosed central foam, which is placed on the surface of the viscera. Then, two layers of porous sponge dressings are applied over the plastic layer. Finally, a transparent adhesive is placed over the foam and the wound to seal the abdominal cavity. The entire system is then connected, by suction tubes, to a device which ubiquitously applies negative pressure (cyclically or continuously) on the surface. The fluid from the wound is collected into a container. The benefits of negative pressure wound therapy have been reported to include removal of infectious material, reduction in oedema and improved perfusion to tissue. Since few years, a new negative pressure wound therapy has been created for closed wounds to reduce time of healing and avoid wound complications.

Eligibility Criteria:
Inclusion Criteria:

* Adult patient
* ≥10cm emergency median laparotomy
* Abdominal wall and skin closure in first intent
* Septic peritoneal cavity (purulent and/or fecaloid free liquid and/or abscess)
* Informed written consent

Exclusion Criteria:

* No abdominal wound closure in first intent
* Allergy or hypersensitivity to silver
* Application of a mesh for abdominal wall closure
* Patients under corticosteroids or other immunosuppressive treatment.
* Women who are pregnant or breast-feeding.
* Intention to become pregnant during the course of the study.
* Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant.
* Previous enrolment in the current study.
A Study of ALKS 4230 (Nemvaleukin Alfa) With Pembrolizumab in Head and Neck Cancer

The primary objective of this study was to estimate the response rate to ALKS 4230 in combination with pembrolizumab in patients with HNSCC who had previously received anti-PD-(L)1 therapy but who had not achieved a CR.


Eligibility Criteria:
Inclusion Criteria:

* Patients must have histologically or cytopathologically confirmed diagnosis of non-cutaneous squamous cell carcinoma of the head and neck region that is locally advanced and/or recurrent and no longer amenable to local surgical or radiation therapy and/or with evidence of distant metastatic disease
* Patients must have had anti-PD-(L)1 therapy as the most recent systemic therapy with either stable disease or partial response on prior anti-PD-(L)1 therapy, or progressive disease on prior anti-PD-(L)1 therapy
* Patients must have disease that is measurable by RECIST v1.1
* Patients must be willing to provide tumor tissue biopsy
* Patients must demonstrate adequate organ function
* Female patients of childbearing potential should have a negative pregnancy test within 72 hours prior to receiving the first dose of study medication
* Patients must agree to follow contraceptive requirements defined in the protocol
* Additional criteria apply

Exclusion Criteria:

* Patient is pregnant or breastfeeding or expecting to conceive or father children
* Patient has an active major infection requiring systemic therapy within 1 week of starting study drug
* Patient has known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Patients with previously treated brain metastases may participate, provided that they are stable, have no evidence of new or enlarging brain metastases, and are not using steroids for at least 7 days prior to study drug
* Patient has hypersensitivity to pembrolizumab, ALKS 4230, or any of their excipients
* Patient has a diagnosis of immunodeficiency or is receiving systemic steroid therapy (inhaled or topical steroids and steroid replacement at physiologic doses are allowable)
* Patient has prior Grade ≥3 immune-related toxicities requiring systemic immunosuppressant treatment that were attributable or possibly attributable to PD-1 immune checkpoint blockade
* Patient has active tuberculosis or known active infection with hepatitis B or hepatitis C
* Patient has known psychiatric or substance abuse disorders or a social situation that would interfere with cooperation with the requirements of the study
* Additional criteria apply
Comparison of Superficial+Deep Vs. Deep Serratus Anterior Plan Block in Video-Assisted Thoracic Surgery

Thoracotomy is one of the most painful surgeries; Video-assisted thoracoscopic surgery (VATS) has been developed to reduce the surgical stress of thoracotomy. However, patients may experience moderate to severe pain within the first 24 hours after VATS. Intravenous opioids are frequently used to provide postoperative analgesia, and accordingly, side effects such as postoperative nausea/vomiting and respiratory depression can be seen.

The aim of this study is to compare Superficial+Deep Vs. Deep Serratus Anterior Plan Block for postoperative pain control in VATS cases.


Eligibility Criteria:
Inclusion Criteria:

1. American Society of Anesthesiologist's physiologic state I-III patients
2. To undergo Video Assisted Thoracic Surgery
3. Being between the ages of 18-65 years

Exclusion Criteria:

* having a known heart, kidney, liver or hematological disease
* having a history of peptic ulcer, gastrointestinal bleeding, allergy, chronic pain
* Routine analgesic use and history of analgesic use in the last 24 hours
* Not willingto participate in the study
* Uncooperative patients who have coagulopathy or use anticoagulant drugs
* To be allergic to one of the drugs to be used
* Contraindication for Video Assisted Thoracic Surgery
Reinforcement of the Impact of a Functional Insulin Therapy Training Course by Telemonotoring With a PDA-phone in Type 1 Diabetic Patients. The TELFIT Study Patients

TELFIT is a monocenter, controlled, randomised trial. It focuses on type 1 diabetes patients that have attended a functional insulin therapy training course. The Primary objective of the TELFIT study is to evaluate whether a PDA with telemonitoring by phone reinforces the effects of the functional insulin therapy training course as compared with conventional care.

Main judgment criteria: comparison of HbA1c means between M0 (start) and M3(3 months)

All patients will attend a functional insulin therapy training course and be randomized into 2 groups. One group will receive a PDA-phone and one month of phone consultations with a nurse and a physician. The other group will only have the usual paper support. This study compares the evolution of HbA1c in the 2 groups over a period of 3 months. It also assesses time spent by nurses and physicians, changes in quality of life, hypoglycaemia frequency and weight changes.

Eligibility Criteria:
Inclusion Criteria:

* Type 1 diabetes mellitus for ≥ 6 months or more
* Age \> 18 year old
* The patient has attended a functional insulin therapy class or workshop
* Insulin basal-bolus therapy for at least 6 months. At inclusion, patients should be treated either with a long-acting insulin and insulin rapid analog before each meal, or with rapid insulin analog delivered with a pump
* Ability to understand how the PDA-phone works and ability to use it
* Social Security membership or benefit from Social Security
* Patients equipped with a memory blood glucose monitor
* Informed consent, with a signed and approved form

Exclusion Criteria:

* Underage patient, major patient under guardianship or protected by the Law
* Patient with any unstable associated evolutive pathology that could cause a diabetes imbalance within the coming year
* Change in diabetes treatment within the 3 months before inclusion or planned during the study
* Patient who needs a more frequent diabetic follow-up than in the protocol (especially severe or evolving complication due to diabetes)
* Patient attending another education program within the 3 months before inclusion or planning to attend one during the study
* Patient with toxicomania, alcoholism or psychological troubles that could impact the study
* Type-2-diabetic patient
* Patient who doesn't need strict metabolic objectives
* Pregnant or possibly pregnant woman
* Person with no freedom (prisoner)
The Aging Eye Cohort Study

Aging is a major risk factor for many blind-causing eye diseases, e.g., glaucoma, age-related cataracts, and age-related macular degeneration. With the population aging, the impact of lifestyle changes (less time spent outdoors, increasingly sedentary lifestyles, and unhealthy eating habits) on the eye health of the elderly needs further research. This study focuses on establishing a cohort of elderly subjects with normal vision and ocular structure at baseline. The main goal is to study the risk factors for common eye diseases in Chinese elderly population while providing normal-controlled clinical and genomic data for other clinical studies on eye diseases.


Eligibility Criteria:
Inclusion criteria:

1. Be able and willing to consent to the qualification and the follow-up phases of the study;
2. Be able to undergo yearly examinations for ≥5 years;
3. Age is older than 60 years;
4. Best-corrected visual acuity of both eyes is better than 20/32;
5. Intraocular pressure (non-contact tonometer) is between 10-21 mmHg;
6. Except for mild cataracts, no other structural abnormalities of the eye are found.
7. have fundus photographs of adequate quality as assessed with a standardized protocol by the University of Wisconsin Fundus Photograph Reading Center.

Exclusion Criteria:

1. the presence of ocular disease in either eye, except for mild cataracts and ametropia;
2. previous retinal or other ocular surgical procedures (other than cataract extraction and capsulotomy);
3. a chronic requirement for any systemic or ocular medication administered for other diseases and known to be toxic to the retina or optic nerve;
4. cataract surgery within three months or capsulotomy within six weeks before the qualification visit;
5. any systemic disease with a poor 5-year survival prognosis.
The Effectiveness of Circadin in Improving Quality of Sleep in Patients Aged 55 or Over

To evaluate the effectiveness of treatment with Circadin based on sleep improvement as assessed by the modified Questionnaire Scoring Subjective Characteristics of Sleep before and after the treatment


Eligibility Criteria:
Inclusion Criteria:

* Male and female patients aged ≥ 55 years suffering from non-organic insomnia according to International Classification of Diseases (ICD-10)
* Patients with sleep disorders manifested as poor sleep quality associated with impaired daytime functioning with or without one or more of the following criteria: difficulty falling asleep, frequent night awakenings, early morning awakenings
* Patients able to follow the study protocol
* Patients who have signed the Informed Consent prior to initiation of any observation-related procedures
* Patients with a global score of ≤17 inclusively on the modified Questionnaire Scoring Subjective Characteristics of Sleep
* Patients who have just been identified to receive treatment with Circadin
* Patients without previous treatment with Circadin

Exclusion Criteria:

* Hypersensitivity to any components of Circadin
* Congenital galactose intolerance, glucose-galactose malabsorption, Lapp lactase deficiency
* Pregnancy and lactation
* Alcohol or drug addiction
* Severe somatic and neurological conditions, exacerbations thereof, including autoimmune diseases or renal/hepatic insufficiency
* Intake of psychoactive medicines within the last 30 days before observational study entry
* Presence of clinically significant anxiety and depression as assessed by the Hospital Anxiety and Depression Scale
* Presence of pain that might be the cause for insomnia. Subjects suffering from breathing related sleep disorders
A Study to Evaluate the Safety, Tolerability, Drug Levels, and Drug Effects of BMS-986326 in Participants With Atopic Dermatitis

The purpose of this study is to assess the safety, tolerability, drug levels, drug effects, and impact on disease severity of BMS-986326 in participants with moderate-to-severe atopic dermatitis (AD).


Eligibility Criteria:
Inclusion Criteria:

* Must have diagnosis of atopic dermatitis (AD) at least 12 months prior to screening
* Documented history of inadequate response to treatment with topical medication for at least 4 weeks, unless topical treatments are otherwise medically inadvisable, or has required systemic therapy for control of disease
* All the following must be present to confirm moderate-to-severe AD

  * Eczema Area and Severity Index score ≥ 12 (at Screening and Day 1)
  * Body Surface Area ≥ 10% (at Screening and Day 1)
  * Validated Investigator Global Assessment for Atopic Dermatitis ≥ 3 (at Screening and Day 1)
  * Peak Pruritus Numerical Rating Scale ≥ 4 (at Screening)

Exclusion Criteria:

* Evidence of an active and/or concurrent inflammatory skin condition that would interfere with the Investigator or subject-driven evaluations of AD
* Any major surgery within the last 30 days before the first dose of study intervention, or any surgery planned during the course of the study
* Any other sound medical, psychiatric, and/or social reason as determined by the investigator

Other protocol-defined inclusion/exclusion criteria apply
SEP and the Impact of Price on Food Selection in a Simulated Food Delivery App

The goal of this randomised controlled trial is to compare taxation with subsidies to encourage healthier food choices in the out-of-home food sector. Participants will be asked to make hypothetical food choices in an online simulation study of a delivery app. Participants will be randomised into four different intervention groups:

1. Price reduction (10%) on healthier foods
2. Price increase (10%) to less healthy foods
3. A combination of price reduction to healthier foods and price increase to less healthy foods
4. Existing price structure (i.e. control group)

The investigators will further examine effectiveness of these fiscal policies on healthy eating by socioeconomic position to understand whether these policies are equitable.


Eligibility Criteria:
Inclusion Criteria:

* Currently reside in the United Kingdom
* Over the age of 18 years
* Order take-away food for delivery at least once a month
* Can complete the study on a laptop or desktop

Exclusion Criteria:

* Any major dietary restrictions (vegan, dairy/lactose-free, gluten-free) or allergies (dairy, eggs, nuts, soy, wheat) that would limit the number of dishes they could choose in the meal selection task
Aquatic Physical Therapy in Fibromyalgia

Objective: To investigate whether patients undergoing aquatic physiotherapy in groups improve their functional capacity, by means of the distance covered in the six-minute walk test (6WT), and to compare this with a control group. Methods: Forty women that had not been practicing regular physical activity for one year were randomly allocated either to the Study Group (SG) to undergo an aquatic physiotherapy program in groups applied twice a week, including aerobic exercises, muscle strengthening and relaxation for 12 weeks, or to the Control Group (CG), which did not do any physical activity. Both groups maintained their treatment with medications. All patients underwent two evaluations: one at the start and the other after 12 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Patients of both genders with a medical diagnosis of FS, without age restrictions and without impaired cognition, who had not been practicing regular physical activity for one year

Exclusion Criteria:

* Presence of other rheumatic diseases and cardiovascular problems
* Smoking
* Absence of medical permission for swimming pool activities
* Starting other therapies, or changes to and/or discontinuation of medical treatment
Prevalence of Overweight and Obesity in Adult Patients Suffering From Type 1 Diabetes

A registry of individuals with type 1 diabetes that visited the Department of Endocrinology of the University Hospitals of Leuven is established. The objective of this registry is to phenotype patients with type 1 diabetes and obesity and their response to treatment with regard to their outcomes

A registry/database is constructed with data of the individuals with type 1 diabetes that visited the Department of Endocrinology of the University Hospitals of Leuven. Data will be obtained from all visits in terms of sociodemographics, disease origin and disease impact including but not limited to glycemic control, medical history, comorbidities, complications, clinical parameters, anthropometric parameters, biochemical blood values, medical therapy, lifestyle, ...

Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent
* Type 1 Diabetes
How Orally Consumed 3-hydroxybuturate Alters Metabolism

This study evaluate the metabolic effects of orally ingested ketone bodies. The study is conducted as a randomized, cross over study.

Subject participate for two separate days; i) intervention, ii) placebo. Intervention: subjects drink ketone body solution. Tracer kinetics on glucose and lipid metabolism is applied. Muscle tissue and adipose tissue biopsies are taken.

Placebo: subjects drink saline. Same sampling as on intervention day.

Eligibility Criteria:
Inclusion Criteria:

* BMI 20-30

Exclusion Criteria:

* Smoking
* alcohol or drug abuse
* Critically ill
A Randomized Comparison of LMA (Laryngeal Mask Airway) Supreme and LMA Proseal in Infants Below 10kg

The investigators conduct this study to evaluate the clinical efficacy of size 1 and 1.5 supreme LMA compared to proseal LMA for infants weighing \<10kg.

This is a randomized prospective study to compare the clinical efficacy and safety for size 1 and 1.5 LMA supreme and LMA Proseal. The airway leak pressure of these 2 devices will be compared and other parameters such as time to insertion, insertion success rate, fibreoptic glottic view and intraoperative complications will be recorded.

Eligibility Criteria:
Inclusion Criteria:

* Weight of \< 10kg
* ASA (American Society of Anesthesiologists) I-II
* Infants undergoing elective surgery under general anaesthesia using supraglottic airway device.
* Informed consent obtained from parents.

Exclusion Criteria:

* ASA III-IV and emergency surgery
* Neonates and ex-premature babies with post conceptual age \<55 weeks.
* Infants with history of difficult airway.
* Infants with features of difficult intubation.
* Active upper respiratory tract infection
* Infants with pulmonary disease
* Infants with history of gastroesophageal reflux disease
* Infants with risks of regurgitation and aspiration.
The Diagnostic Application of PSMAPET/MR in Patients Undergoing Secondary Prostate Puncture

The present study is designed to explore the value of targeted puncture guided by PSMA PET/CT or mpMRI in the diagnosis of patients with low PSA and initial negative prostate biopsy


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥40 years, male;
2. Serum PSA level 4-20 ng/mL;
3. Serum PSA level 4-20 ng/mL;
4. No contraindications to PSMA-PET/CT or MRI;
5. Signed informed consent.

Exclusion Criteria:

1. Serum PSA \>20 ng/mL;
2. History of prostate surgery/radiotherapy;
3. Acute prostatitis;
4. Coagulation disorders or active infection;
5. Severe internal/external hemorrhoids, perianal, rectal, or gluteal lesions;
6. Allergy to local anesthetics;
7. Inability to tolerate the biopsy procedure.