cyrilzakka/clinical-trials huggingface dataset:
Development of a Research Agenda for Rehabilitation Research

An internal research department was established in the course of an organisational reform of the Pension Insurance Institution in 2020 for the evidence-based development of its own services in Austria. The focus is on the transfer of findings into practice and the scientific community. As part of an initial assessment of the current situation, an organisation-specific research agenda is being systematically developed.

The project design is based on a multi-perspective and multi-method approach. After obtaining experts' opinions (interview) from different settings and areas, a consensus on necessary fields of action will be worked out after synthesising the results via a Delphi survey.


Eligibility Criteria:
Inclusion Criteria:

* Researchers who conduct scientific research in the field of rehabilitation in Austria, Germany and Switzerland
* People working in rehabilitation facilities (in therapy or administration) in Austria, Germany and Switzerland

Exclusion Criteria:

* Failure to obtain the declaration of consent
Single-Operator Versus Dual-Operator Double-balloon Endoscopy in Patients With Small-Bowel Disorders

Double-balloon endoscopy (DBE) is a new device that allows diagnosis and treatment throughout the entire small intestine. Although the originally described method requires two operators, the investigators have recently developed a method to perform DBE by a single operator. The investigators here assessed the clinical usefulness of this one-person method in comparison to the conventional two-person DBE.


Eligibility Criteria:
Inclusion Criteria:

1. suspected or known small-bowel disease
2. age: 16-70

Exclusion Criteria:

1. pregnancy
2. coagulation disorders
3. prior surgery of the small bowel and colon
Effects of 5HTP and LDOPA on CNS Excitability After SCI

This study will examine whether supplementation with the serotonin and dopamine precursors, 5HTP and L-DOPA can alter central nervous system excitability and improve motor function after incomplete and complete spinal cord injuries.


Eligibility Criteria:
Inclusion Criteria:

* Individuals aged 18-65 years of age.
* Patients must have suffered a trauma to the spinal cord at least 1 year ago or longer.
* Patients must exhibit some degree of spasticity which can be self-reported (Penn spasm frequency) or if assessed by a physiotherapist, a modified Ashworth spasticity score greater than 1

Exclusion Criteria:

* Individuals with damage to the nervous system other than to the spinal cord
* Pregnant or breastfeeding women
* Alcoholic patients
* Patients with a history of seizures or epilepsy
* Patients with a history of suicidal thoughts or behaviors
* Patients with active or inactive implants including cardiac pacemakers, implantable defibrillators, ocular implants, deep brain stimulators, vagus nerve stimulator, and implanted medication pumps
* Patients with conductive, ferromagnetic or other magnetic-sensitive metals implanted in their head
* Patients with:
* Known or suspected allergy to the medication or the ingredients
* Cardiovascular disease including history of heart attack or heart rhythm irregularities
* Coronary artery disease
* Comatose or depressed states due to CNS depressants
* Endocrine dysfunction
* Blood dyscrasias
* Bone marrow depression
* History of seizures
* Hypocalcemia
* History of stomach ulcers
* Wide-angle glaucoma
* Phenylketonuria

Patients taking:

* Monoamine oxidase inhibitor therapy
* Serotonergic antidepressants: selective serotonin and norepinephrine reuptake inhibitors
* Tricyclic antidepressants
* Any type of serotonergic agonist
* Dopamine D2 receptor antagonists
* Amphetamine
* CNS depressants
* Levodopa
* Lithium
* Anti-hypertensive drugs (Carbidopa and L-DOPA)
* Iron salts
* Metoclopramide
* Phenothiazine medication
Is There a Relationship Between the Ability of the Trunk and Lower Extremities and Walking Function After Stroke?

Stroke leads to impairments at different levels. Not only walking abilities are impaired after stroke but also trunk function, strength, balance and functional performance. Even in the latter phase after stroke, both walking abilities and trunk function remain restricted.

Restoring walking function is often the main goal of rehabilitation after stroke and the focus of post-stroke physiotherapy is often on regaining walking and mobility. Reduced walking ability after stroke is a predictor for discharge to a nursing home and associated with an increased probability of death. In addition, walking endurance, measured by a six-minute walking test, has a high correlation with community reintegration after a stroke.

Both trunk function and the ability to walk are often limited after stroke. A previous study observed that a significant correlation exists between these two functions, when measured with standardized clinical measurement scales . Due to the functional relevance and the link between both functions, further investigation however is warranted. Current lack of knowledge exists in investigating the relation between trunk and gait muscle strength, and this is key for informing clinical practice. For instance, should trunk muscle strength be a significant determinant of gait function, therapy should incorporate specific training for improving trunk muscle strength.

The primary objective of the study is to investigate if trunk muscle function in combination with lower limb muscle function are significant determinants of walking ability after stroke.

Secondly, the investigators will examine if there are other determinants such as cognition, balance, spasticity, ability of performing selective movements and sensitivity of the lower extremities for walking ability.


Eligibility Criteria:
Inclusion Criteria:

1. First stroke event.
2. Residence in a rehabilitation ward.
3. Two weeks until six months after a stroke event.
4. Older than 18 years.
5. With no comorbidities other than stroke affecting trunk function or walking ability.

   Comorbidities could be musculoskeletal problems or other neurological diseases.
6. With sufficient cognitive and language capacity to perform the assessment.

Exclusion Criteria:

1. Not able to give informed consent.
2. Not approved informed consent.
3. Subject does not understand the study procedures.
4. Subject has any history of a major neurological disorder.
Orelabrutinib Combined With Rituximab and Chemotherapy for Relapsed/Refractory B-Cell Lymphoma Patients With Central Nervous System Involvement

This single-center, open, single-arm study aim to evaluate the efficacy and tolerability of a therapy introducing orelabrutinib on the basis of rituximab and chemotherapy in treating patients with relapsed or refractory B-cell lymphoma invloving central nervous system.

Participants will receive orelabrutinib in addition to second-line therapy consisting of rituximab and recommended chemotherapy according to histopathologic type. After treatment of 6 cycles with the new regimen, the patients achieving CR or PR would go on to receive autologous haematopoietic stem cell transplantation (auto-HSCT) with or without orelabrutinib maintenance of 2 years (if tolerable) or orelabrutinib maintenance alone if intolerant to auto-HSCT.

Eligibility Criteria:
Inclusion Criteria:

* 14 to 80 years old;
* Histopathologically confirmed CD20 positive B-cell lymphoma according to the 5th edition of the World Health Organization (WHO) Classification of Haematolymphoid Tumours;
* After systemic treatment of the CNS lesions;
* Life expectancy of \> 3 months (in the opinion of the investigator);
* No non-haematologic adverse events, except alopecia, higher than grade 1 according to Common Terminology Criteria for Adverse Events (CTCAE) v5.0;
* Absolute Neutrophil Count (ANC) ≥ 1.0×10\^9/L, Platelet Count ≥ 50×10\^9/L and Haemoglobin ≥ 60 g/L, without transfusion or any use of pharmacologically hematopoietic drugs in 2 weeks;
* Serum Creatinine (SCr) ≤ 1.5 times the Upper Limit of Normal (ULN) or Creatinine Clearance Rate (CCR) ≥ 30 mL/min;
* Serum total Bilirubin (tBil) ≤ 1.5 × ULN and both Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) ≤ 2.5 × ULN without hepatic metastases, otherwise tBil ≤ 3 × ULN and AST, ALT ≤ 5 × ULN respectively;
* International Normalized Ratio (INR) ≤ 1.5 and activated Partial Thromboplastin Time (aPTT) ≤ 1.5 × ULN;
* Left Ventricular Ejection Fraction (LVEF) ≥ 50%;
* Agreeing to provide written informed consent prior to any special examination or procedure for the research on their own or legal representative.

Exclusion Criteria:

* Pregnant or lactating women;
* Known Hepatitis B Virus (HBV) and/or Hepatitis C Virus (HCV) infection (HBV infection refers to HBV-DNA \> detectable limit);
* With acquired or congenital immunodeficiency;
* With congestive heart failure in 6 months before enrollment, New York Heart Association (NYHA) heart function class III or IV, or LVEF \< 50%;
* Known to be allergic to the test drug ingredients;
* Diagnosed with or being treated for malignancy other than lymphoma;
* With severe infection;
* Substance abuse, medical, psychological, or social conditions that may interfere with the subjects' participation in the study or evaluation of the study results;
* Deemed unsuitable for the group.
Shorter Radiation Schedule for the Treatment of Prostate Cancer

To improve the management of patients with early stage prostate cancer.

To compare the efficacy of a shorter radiation fractionation schedule to the prostate (5250 cGy/20 fractions over 28 days) with a conventional schedule (6600 cGy/33 fractions over 45 days) in men receiving radiotherapy for Stage T1a moderately or poorly differentiated, or T1b, T1c, or T2 prostate cancer. The primary outcome is local control in the prostate and secondary outcomes include toxicity, disease free survival, survival, quality of life and economics.

Eligibility Criteria:
Inclusion Criteria:

* histologic diagnosis of adenocarcinoma of the prostate with no evidence of metastatic disease to the nodes, bone or lung
* stage T1a moderately or poorly differentiated, T1b, T1c or T2 by the current UICC-TNM classification

Exclusion Criteria:

* PSA \> 40 mcg/L
* previous therapy for carcinoma of the prostate other than biopsy or TURP, including patients previously on hormone therapy for treatment of their prostate cancer
* prior or active malignancy other than non-melanoma skin cancer; or colon or thyroid cancer treated a minimum of five years prior to study entry and presumed cured
* simulated volume exceeds 1000 cm3
* previous pelvic radiotherapy
* inflammatory bowel disease
* serious non-malignant disease which would preclude radiotherapy or surgical biopsy
* geographic inaccessibility for follow-up
* psychiatric or addictive disorder which would preclude obtaining informed consent or adherence to protocol
* unable to commence radiation therapy within 26 weeks of the date of last prostatic biopsy
* failure to give informed consent to participate in the study
Catheter Over Needle vs Catheter Through Needle

To randomize 108 patients undergoing knee replacement surgery to catheter through needle or catheter over needle femoral nerve blocks, then monitor the catheters for leakage to see if there is a difference.

Background: Total Knee Replacement Surgery is a commonly performed procedure that causes significant post-operative pain. Continuous femoral nerve blocks are widely used for analgesia as part of a multimodal analgesic regimen for this surgery. They provide sustained analgesia which allows early physiotherapy for rehabilitation. Currently the most common technique for inserting catheters for continuous femoral nerve blocks is to feed a catheter though a needle (CTN) which has been placed close by the nerve. There is a significant rate of leak and dislodgement of these catheters which can lead secondary failure where the catheter is no longer providing analgesia by blocking the nerve (primary failure occurs when the nerve block catheter fails to provide any analgesia from the start). The system to be investigated has a catheter over the needle (CON) which is left in place after the needle is withdrawn. The proposed benefit of this is that there will be a reduction in leak rates and dislodgement. This is because using a CON technique means that the biggest hole will be the diameter of the catheter, rather than CTN where the biggest hole will be the diameter of the needle therefore allowing leak around the outside of the catheter.

Objectives: To ascertain whether or not the catheter over needle technique is superior to catheter through needle technique in terms of a leak rate.

Trial plan: To recruit 108 patients who are having total knee replacement surgery into the study and randomise them into having either CON or CTN continuous femoral nerve blocks.

Eligibility Criteria:
Inclusion Criteria:

* Patients presenting to Sir Charles Gairdner Hospital for elective, unilateral, primary total knee replacement.
* Body mass index 18-40 kg/m2
* American Society of Anaesthetists (ASA) grade I-III

Exclusion Criteria:

* Allergy to local anaesthetic
* Inability to cooperate
* Inability to read, speak and understand English
* Less than 18 years old
The Real-Life Efficacy and Safety of Telmisartan in Patients With Arterial Hypertension

The main purpose of this study is to asses the efficacy and safety of telmisartan, with the special attention on the influence of telmisartan on selected metabolic parameters of patients.


Eligibility Criteria:
Inclusion Criteria:

* Age over 18
* Untreated or ineffectively treated arterial hypertension

Exclusion Criteria:

* Cholestatic disorders and severe hepatic failure
* Allergy to telmisartan
* Pregnancy and lactation period
Preoperative Vaginal Dinoprostone Prior to Abdominal Myomectomy

The aim of the study is to compare the effectiveness of vaginal dinoprostone 3 mg versus placebo before myomectomy to decrease blood loss during and after the operation.


Eligibility Criteria:
Inclusion Criteria:

* • Patients presenting for abdominal myomectomy with documented uterine fibroids on pelvic imaging

  * Age ≥ 18 years and ≤ 50 years
  * Pre-operative hemoglobin \>8 g/dl
  * Ability to understand and the willingness to sign a written informed consent.
  * Admissible medical/surgical history
  * Five or less symptomatic uterine myomas
  * All myomas are subserous or intramural.
  * Uterine size less than 24 weeks pregnancy

Exclusion Criteria:

* • Patients who have had a prior abdominal myomectomy

  * Post-menopausal women
  * Patients with known bleeding/clotting disorders
  * Patients with a history of gynecologic malignancy
  * Hypertension.
  * Cardiac and Pulmonary diseases.
  * Obesity (body mass index \> 30 kg/m2).
  * History of allergic reactions attributed to misoprostol
  * Cases that will require intraoperative conversion of myomectomy to hysterectomy.
Laparoscopic Cholecystectomy: General Anesthesia With Opioid Versus General Opioid Free Anesthesia

The use of opioid during surgery can cause side effects and may delay hospital discharge. Some studies have shown balanced sparing opioid anesthesia can optimize the side effects and and the time of discharge. In this compared controlled randomized study the aim is to evaluate the intraoperative and postoperative pain, hemodynamic effects, nausea/vomiting, postoperative ileus, sedation, urinary retention, time of discharge PACU Post anesthesia care unit and hospital.

Patients under laparoscopic cholecystectomy has moderate to severe pain. This study will compare intraoperative hemodynamic parameters under two techniques of general anesthesia: The primary outcome pain was used for planning the sample size of participants and considered a variation of 3 points on VAS (Visual analogic scale of pain). The secondaries outcomes nausea/vomiting, sedation, ileus paralytics, urinary retention, time of discharge (PACU) and hospital stay, and patient satisfaction will be recorded and analyzed.

the patients will be allocated from randomized program in one of the two arms.

1. Based opioid balanced anesthesia propofol, fentanyl, rocuronium and isoflurane
2. Opioid sparing balance anesthesia with propofol, dexter- ketamine, clonidine, midazolan,isoflurane and lidocaine.

At the end of procedure both groups will receive dexamethasone, ranitidine

, ondansetron, keterolac IV and local infiltration of bupivacaine on trocar wounds as multimodal analgesia.

General anesthesia opioid free seems to have less side effects than the general anesthesia based on opioid this study will compare it.

Eligibility Criteria:
Inclusion Criteria:

* Patient under Laparoscopic cholecystectomy routine American Society of Anesthesiology ASA I or II

Exclusion Criteria:

* chronic use of opioids
* Body mass index (BMI) \> 35 Kg.m-2
* Chronic heart failure, renal and hepatic failure
* illicit drugs users
* cognitive impairments
Effect of Education of Health Care Workers on the Maintenance of Venous Access Devices

In intensive care units (ICU), critically ill patients require various venous access devices for fluid resuscitation, drug therapy, or renal replacement therapy (RRT). These include peripheral intravenous catheters (PIVC), specialized venous ports like central venous catheters (CVCs), and hemodialysis ports. The investigators plan to do this pre- and post-intervention study to know the effect of intensive training and education of HCW (doctors and nurses) on the condition of venous access devices in critically ill patients.

Phase 1, pre-intervention: The first twelve weeks will include 25 random visits to main ICU and point observations of all venous access devices under parameters like condition of dressing, connectors and documentation. This will also include the comparison of incidence of CLABSI in the pre and post intervention phase.

Phase 2, intervention: Next four weeks will be an intervention in the form of intensive training and education of the HCW (doctors and nurses). The intensive training will be in the form of an online presentation in which the investigators would have videos on care and maintenance of venous access devices, and the importance of documentation of days of insertion and change of dressing.

Phase 3, post-intervention: Another twelve weeks, post-intervention, again 25 random visits will be done to collect point observations about the same parameters of venous access devices and documentation as done in phase 1.

Statistical analysis: Each of these point observation parameters (for central or peripheral venous access) will be finally categorized as appropriate/inappropriate as per guidelines for best practice.

The compiled data from pre and post intervention phases would be compared. All the categorical parameters (appropriate/inappropriate) will be compared using chi-square test. All the quantitative parameters (e.g. incidence of CLABSI) will be compared using a paired t-test

Eligibility Criteria:
Inclusion Criteria:

* All patients admitted to Main ICU

Exclusion Criteria:

* Patients who refuse to give consent
Comparison of Short Versus 12 Months Prasugrel Plus Aspirin in Patients with Acute Coronary Syndromes Treated with Percutaneous Coronary Intervention and Everolimus-eluting Stents

The SORT OUT XII dual antiplatelet treatment (DAPT) duration trial, is a clinical randomized controlled superiority and non-inferiority trial to compare whether prasugrel alone versus prasugrel plus aspirin from month 1 to month 12 after percutaneous coronary intervention with and everolimus-eluting stent in patients with acute coronary syndromes (1) is superior regarding clinically relevant bleeding and (2) non-inferior regarding safety (cardiac death, myocardial infarction, definite stent thrombosis, ischemic stroke or clinically driven target lesion revascularization)


Eligibility Criteria:
Inclusion Criteria:

* All patients aged ≥18 years with acute coronary syndromes who are treated with an everolimus-eluting drug-eluting stent can undergo randomization if they can be treated with prasugrel for 12 months.
* Postmenopausal women or use of contraceptive drugs (absence of menstruation in at least 12 consecutive months or continuously usage of contraceptive drugs (a contraceptive implant, an intrauterine device, birth-control pills, transdermal patches, vaginal ring, or depot injection).

Exclusion Criteria:

* Age \< 18 years
* Not able to consent to study participating (eg. intubated patients)
* Do not speak Danish
* Life expectancy \<1 year
* Allergic to study related treatment
* Non-vitamin K antagonist oral anticoagulants (NOAC) or warfarin treatment
* Contraindication for 12 months prasugrel treatment
Ketogenic Diet for Child Epilepsy and Seizure Control

Twenty to thirty percent of children with epilepsy continue to suffer from seizures, even when treated with currently available anticonvulsant medications. Children with Lennox-Gastaut Syndrome (LGS) are particularly handicapped by atonic-myoclonic seizures. Preliminary data suggest that even when other medications have failed, these seizures may respond rapidly and dramatically to a high-fat-low-carbohydrate ketogenic diet. The purpose of the study is to assess if the classic ketogenic diet is efficacious in reducing seizure frequency, medication toxicity, and improves quality of life.

The ketogenic diet (KD) is a form of therapy for seizures that involves a brief period of fasting followed by a very carefully controlled high fat-low protein and carbohydrate diet. Studies suggest it is useful in children whose seizures could not be controlled by any of the medicines available. This study is designed to test, in a carefully controlled fashion, how well the diet works in children with "drop" seizures. Children who experience 15 or more drop seizures each day, despite having used at least two medications, may be eligible to participate. This study requires children to undergo periods of fasting and to maintain a carefully controlled diet. Parents of participating children monitor their children's diets and keep daily meal and seizure diaries.

Eligibility Criteria:
Inclusion Criteria:

* \>15 myoclonic or atonic seizures a day
* EEG with Lennox-Gastaut pattern

Exclusion Criteria:

* \<15 atonic or myoclonic seizures a day
* on \>3 medications
* previously on diet and/or evidence of metabolic disorder
Diagnostic Performance of 18-FDG PET-CT Scores for the Diagnosis of Polymyalgia Rheumatica

Study of the diagnostic performance of 18-FDG PET scores in Polymyalgia rheumatica and comparaison with others inflammatories diseases.

Polymyalgia Rheumatica is difficult to diagnostic because symptoms are non specific and many diseases can be differential diagnosis (cancer, infections, others rheumatisms...).

PET-CT is more often used to help for diagnostic of inflammatory disease, and particularly inflammatory rheumatism.

Some scores have been described to harmonize the diagnosis of Polymyalgia rheumatica.

The aim of this study is to evaluate the diagnostic performance of 18-FDG PET scores in Polymyalgia rheumatica and compared with others inflammatories diseases such as ankylosing spondylarthritis.

This is a multicentric retrospective study.

Eligibility Criteria:
Inclusion Criteria:

* Having 18-FDG PET-CT between 2012 and 2024
* Diagnosis of inflammatory rheumatism by specialist doctor
* Adult without opposition to use there data for research
* Affiliate to social security system

Exclusion Criteria:

* Refusal participation
* Patient under juridic protection