cyrilzakka/clinical-trials huggingface dataset:
Study Examining the Effect of Exercise in People With Rheumatoid Arthritis Taking Anti-TNFalpha Medication

The purpose of this study is to determine whether exercise is beneficial for people with rheumatoid arthritis(RA) taking antiTNFalpha medication

Substantial progress has been made in the medical management of RA over the past decade but at present no drug therapy leads to long-term remission for all patients with RA. People may still continue to experience physical, psychological and functional consequences which could benefit from rehabilitation.little research exists on the effects of exercise for people with RA taking anti-TNFalpha therapy medication.

It is proposed to conduct a randomized controlled trial to examine the effects of group exercise therapy in a gym setting or in a hydrotherapy pool compared to a control group.

Eligibility Criteria:
Inclusion Criteria:

* Patients with RA receiving anti-TNFalpha therapy medication for more than three months
* Consenting male and female patients aged 18 - 70 years
* Patients will have a documented diagnosis of RA as classified by the American College of Rheumatology (ACR) criteria
* ACR functional class I, II, III

Exclusion Criteria:

* Patients who have attended physiotherapy in the past three months
* Patients to whom exercise therapy or hydrotherapy are contraindicated
* Patients who have undergone joint surgery in the past six months
Comparing Head and Neck Endoscopy Procedures

Intensity Modulated Radiation Therapy planning is based on CT images, with tumour volumes defined on this volumetric information data set. However, target delineation also depends on disease seen endoscopically which may not be visible on CT. We are developing imaging and tracking technology to improve target delineation in Radiation Therapy (RT) planning for head \& neck cancer using quantitative registration of 2D endoscopic information with CT data. Diagnostic endoscopy is performed in the upright position. CT images and radiation delivery are obtained with the patient in the supine position. The accuracy of the registration will be improved if performed in the same position to prevent mobile soft tissue structures shifting between the upright and supine positions. Since therapy must be performed in the supine position, we intend to check the feasibility of performing endoscopy in the supine treatment position. We will compare and assess patient comfort and endoscopic sightlines during an endoscopy procedure in both the upright and supine positions.


Eligibility Criteria:
Inclusion Criteria:

* Between 18-70 years of age.
* Willing to give informed consent.

Exclusion Criteria:

* Allergy to topical anesthetic nasal spray (lidocaine).
* Patients who currently have or have had head and neck cancer.
* Currently pregnant or lactating; or serious co-morbid illness (e.g., cardiovascular, pulmonary).
* Psychiatric or addictive disorders which would preclude obtaining informed consent or adherence to protocol.
* Concurrent illness, which prevents the subject from undergoing endoscopy.
* Disorders of the nasal cavity e.g deviated septum
INtestinal Dysbiosis and TRanslocation of Bacteria in Patients Undergoing Surgery

The goal of this observational study is to contribute to a better understanding of the perioperative kinetics of intestinal microbial composition and association with surgical site infections.

The main question this study aims to determine if:

* Patients undergoing surgery develop transient intestinal dysbiosis
* Such transient dysbiosis is associated with translocation to the systemic circulation and surgical site infection

Patients undergoing elective abdominal surgery will be included prospectively. Informed consent will be obtained. From patients the following information and samples will be collected:

* Perioperative: Baseline health data, nutrition data, measurement body composition, glucose monitoring
* Intraoperatively:

  * Mucosal swabs
  * Blood from central venous catheter and portal vein
  * Mesenteric lymph node
  * Intestinal specimen
  * Bile
  * Subcutaneous biopsy
* Postoperatively:

  * If a surgical site infection occurs samples from infected site


Eligibility Criteria:
Inclusion criteria:

* Patients undergoing laparoscopic colorectal resection with anastomosis or patients undergoing duodeno-pancreatectomy.
* Elective surgery
* Informed consent
* Age \> 18 years

Exclusion criteria:

* Emergency surgery
* Other surgery 30 days prior to colorectal surgery
* BMI \<18 or \>50kg/m2
* Planed simultaneous second procedure with involvement of the intestinal tract
* Cholestasis with cholangitis, hepatic disease (defined as cirrhosis Child B or C) or renal disease (acute or chronic renal failure defined as eGFR≤ 30ml/min)
* Severe active enteritis or colitis, malabsorption, enteric infections
* Pancreatitis
Study Of The Pharmacokinetics And Safety Of Voriconazole In Children 2 To Less Than 15 Years Old Who Are At High Risk For Systemic Fungal Infection

In this study we will measure the concentration of the drug called voriconazole which is used to fight infections caused by fungus in children who usually are cancer patients and have their immune system down. Since we know the dose in adults, and we think we know the matching doses in the young patients ages 2 to less than 15 years old, we will compare the amount of drug that goes into the system with what we know works in adults. We give the drug by a needle directly into the blood, then few days later we stop that and give the drug by mouth. Meanwhile, we draw a little bit of blood at certain times to measure the drug in it.


Eligibility Criteria:
Inclusion Criteria:

* Male or female from 2 to \<15 years of age.
* Require treatment for the prevention of systemic fungal infection.
* Expected to develop neutropenia (ANC \<500 cells/uL) lasting more than 10 days following chemotherapy.
* Anticipated to live for more than 3 months.

Exclusion Criteria:

* Evidence of any clinically significant liver or renal function or other abnormalities such as cardiac arrhythmia, hypokalemia, hypomagnesemia or hypocalcemia.
* Documented bacterial or viral infection not responding to appropriate treatment.
* Hypersensitivity to or severe intolerance of azole antifungal agents.
* Receiving other azoles or drugs that is are prohibited in the voriconazole label or associated.
Two-way Interaction Between Alisporivir and EDP239

The purpose of Part 1 is to inform dose selection for use of alisporivir and EDP239 in combination and obtain initial safety data for co-administration of alisporivir and EDP239 to support future treatment studies in patients. The purpose of Part 2 is to inform the drug-drug interaction potential of EDP239 more broadly and possibly facilitate the interpretation of lower than expected alisporivir concentrations in Part 1, if observed.


Eligibility Criteria:
Inclusion Criteria:

* Male or female subjects 18 to 55 years of age
* Body weight at least 50 kg

Exclusion Criteria:

* Women of child bearing potential
* Tobacco use
* History or evidence of any inherited bilirubin disease or disorder, including not not necessarily limited to Dubin-Johnson Syndrome, Gilbert's syndrome, and Rotor Syndrome
Preoperative Anxiety and Postoperative Pain in Children

We wish to study which method of local injection of analgesic (before or during surgery) is the more effective method to reduce post-operative pain in children. In addition, we wish to study which pre-operative educational intervention is more effective in reducing anxiety in children and their family.


Eligibility Criteria:
Inclusion Criteria:

* Healthy
* ASA I - II
* Undergoing elective day surgery

Exclusion Criteria:

* Known coagulation dysfunction
* Sensitivity to analgesics
Esomeprazole for Prevention of Upper Gastrointestinal Symptoms Associated With Continuous Use of NSAIDs

This study was a multicentre, double-blind, randomised, placebo-controlled parallel group study consisting of 4 visits over a period of 6 months. The primary variable was to assess theefficacy of esomeprazole 40 mg orally qd (E40) or esomeprazole 20 mg orally qd (E20) versus placebo orally qd after 6 months of treatment for the prevention of relapse of upper GI symptoms associated with NSAID use, including COX-2 selective NSAIDs, in patients receiving daily NSAID therapy.


Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent.
* Completed the SH-NEN-0003 study with relief of upper GI symptom. Relief is defined as "last 7 days with a diary assessment of None or Minimal, but allowing up to 2 days to be rated as Mild during the 7-day period".
* A clinical diagnosis of a chronic condition (e.g., osteoarthritis or rheumatoid arthritis) that requires continuous daily NSAID treatment for at least 6 months. Daily NSAID treatment is defined as taking the prescribed dose for at least 5 of 7 days in any given week and can include COX-2 selective NSAIDs, multiple NSAIDs, and high-dose NSAIDs.
* Daily NSAID treatment dose and type:
* Must have been stable for at least 9 weeks prior to inclusion
* Are expected to remain stable for the duration of the study.
* Must be administered orally. If more than one type of NSAID treatment is used, at least one type must be administered orally.
* Hp negative on Histology performed at baseline endoscopy in the study SHNEN-0003.

Exclusion Criteria:

* Discontinuation from study SH-NEN-0003
* Pain, discomfort or burning in the upper abdomen precipitated by exercise or relieved by defecation.
* Pain, discomfort or burning in the upper abdomen not associated with the use of NSAIDs, including COX-2 selective NSAIDs.
* Pregnancy or lactation. Women of childbearing potential must maintain effective contraception during the study period as judged by the investigator.
Relaxation Effects of Personalized Breathing Exercises for Healthy College Students

Stress plays a major role in the etiology and pathogenesis of anxiety and depression. Relaxation therapies, such as breathing exercises, can reduce stress and increase relaxation.

This study has two aims. First, it aims to personalize and optimize breathing protocols. Second, it aims to tailor breathing protocols to subgroups based on prediction models of expected efficacy.

Three different breathing protocols, varying solely in their instructed breathing frequency with 40 percent (A), 60 percent (B), and 80 percent (C) of the interindividual spontaneous breathing frequency, are tested in a randomized, counterbalanced crossover trial. Other parameters, such as breathing quality (i.e., nasal and diaphragmatic), rhythm (i.e., prolonged exhalation without instructed pauses) and depth (i.e., increased depth due to slower breathing frequency) as well as contextual factors (e.g., posture, video-based instructions, type of pacer, etc.) are invariant between protocols.

First, this study hypothesizes a difference in the relaxation response between breathing protocols A, B, and C. This study looks at the relaxation response from three different angles (1) self-report, (2) autonomic arousal, and (3) central nervous system arousal. Second, this study explores prediction models of expected efficacy based on the interindividual variance in characteristics (i.e., depressive, anxious and stress symptoms as well as expertise in relaxation therapies) and biomarkers (e.g., heart rate variability, peripheral temperature, skin conductance, etc.). Prediction models can tailor breathing protocols to subgroups to increase expected efficacy.


Eligibility Criteria:
Inclusion Criteria:

* Above 18 years old
* University student
* Native German speaker

Exclusion Criteria:

* Any psychiatric (e.g., anxiety), neurologic (e.g., epilepsy) or cardio-pulmonary (e.g., asthma) diagnosis
Concurrent Chemotherapy for Recurrent T3/T4 Nasopharyngeal Carcinoma

The purpose of this study is to determine whether concurrent chemotherapy and IMRT is effective in the treatment of locally stage T3/T4 recurrent nasopharyngeal carcinoma patients compared with IMRT alone.

Locally T3/T4 recurrent nasopharyngeal carcinoma (NPC) may be salvaged by intensity modulated-radiotherapy (IMRT), but local control is not good enough and late toxicities is usually severe The aim of this phase III randomized controlled study is to address the efficacy of concurrent chemotherapy (cisplatin) with IMRT to improve local control and lower the occurrence of severe late toxicities compared with IMRT alone for locally T3/T4 recurrent NPC patients.

Eligibility Criteria:
Inclusion Criteria:

* 1.Pathologically or clinically confirmed rT3/T4 locally recurrent nasopharyngeal carcinoma;

  2.No evidence of distant metastasis

  3.More than 1 year from the end of the first course of radiotherapy

  4.Male, or female not in the phase of lactating or pregnancy

  5.ECOG 0-2

  6.Aged 18-70 years old

  7.WBC count ≥4×109/L, neutrophile granulocyte count≥1.5×109/L, PLT count ≥100×109/L, Hb ≥9g/L

  8.Total bilirubin, AST, ALT≤2.0 times of upper normal limits; creatinine ≤1.5 times of upper normal limits

  9.Written informed consort signed

Exclusion Criteria:

1. Only regionally recurrence
2. Evidence of distant metastasis
3. Prior invasive malignancy; noninvasive cancers (For example, carcinoma in situ of the bladder, oral cavity, or cervix are all permissible) are permitted
4. Severe, active co-morbidity
5. Prior anti-tumor treatment after diagnosis of local recurrence
6. MRI was not performed 3 months after the first course of radiotherapy
7. Abnormal function of heart, brain and lungs, etc
8. Lactation or pregnancy
9. Severe nasopharyngeal mucosal necrosis at the diagnosis of local recurrence
Post-market Clinical Follow-up of Disposable Endoscope Linear Cutting Staplers and Components

This is a multi-center and retrospective cohort study to evaluate the efficacy and safety of disposable linear cutting staplers and components in soft tissue resection, transection and anastomosis.

The disposable endoscopic linear cutting staplers and components developed and produced by Jiangsu Channel Medical Device Co., Ltd. can be used in open or endoscopic surgery of lung, bronchial tissue, stomach and intestine resection, transection and anastomosis. They have been registered in China for many years and have been widely used, and have been certified by the European Union in 2021. The number is CIM.2021.106.14629. This study intends to conduct a multi-center retrospective cohort study in China, collect clinical application data of Chinese patients, conduct statistical analysis on the clinical application data, confirm whether the expected effectiveness and safety are achieved, and further extrapolate to the EU population.

Eligibility Criteria:
Inclusion Criteria:

* gender unlimited, age unlimited ② open or endoscopic surgery ③ resection, transection and anastomosis of lung, bronchial tissue, stomach and intestines.

  * use the study device during surgery

Exclusion Criteria:

* patients with contraindications to the product, such as severe mucosal edema, operation of the hemostatic site that cannot be observed, or off-label use of the liver and spleen;

  * combined with other similar products (staplers) for surgical site excision, transsection and anastomosis; ③ surgical records are incomplete, and information related to major indicators cannot be extracted; ④ other situations that the researcher considers inappropriate for inclusion in the study.
Optimization of Surgical Hand Preparation Using Sorbectol

Previous studies evaluated the efficacy of the hydroalcoholic solution of 3% digluconate of chlorhexidine, 0.3% potassium sorbate and 70% ethanol, "Sorbectol" (Spanish patent ES 2 784 275 B2) in the surgical hand preparation with positive results. This clinical trial is focused on optimising the effectiveness of Sorbectol in the surgical hand preparation by scaling the application times of the product from 1 to 5 minutes following the test procedure and the effectiveness criteria of the European norm EN-12791.

This is a randomised clinical trial with a Latin-square crossover design, to test the effectiveness of the Sorbectol solution in surgical hand preparation, according to the EN 12791 standard, at application times of 1, 3 or 5 minutes. The test compares the bacterial load on the hands of at least 23 healthy volunteers immediately (immediate effect) and three hours after (3-hour effect) application of the test product with respect to the reference product, RP, of EN 12791 (n-propanol 60%).

Briefly: The bacterial load on hands before antisepsis (pre-values) is obtained after the preparatory handwash using a diluted soft soap. Next, surgical hand antisepsis protocols are performed. Enrolled participants are randomly divided into four groups of the same size to receive RP or Sorbectol for 1 min (P1), 3 min (P2) or 5 min (P3) in parallel in a first run. The test is repeated in a second, third and fourth run changing the antisepsis roles for each group. A washout period of at least 2 weeks between experimental runs allow for the reconstitution of skin microbiota. All participants complete the four antiseptic procedures at the end of the trial.

The RP group, rub their hands with n-propanol (60% v/v) for 3 min. The test product groups, rub their hands with Sorbectol for 1 or 3 or 5 min. In all cases applying as many 3 ml portions as necessary to keep the hands moist for the selected time. After antisepsis the bacterial load (post-values) is determined using a split-hands model. One hand to assess the bacterial load immediately after treatment (immediate post-values) and the other hand to assess the bacterial load 3 hours later, keeping the hand gloved in the meantime (3-h post-values).

Eligibility Criteria:
Inclusion Criteria:

* Participants with healthy skin in both hands and short fingernails.
* No use of antibacterial agents for at least three days before the intervention.
* Not received antibiotic treatment for at least ten days before the intervention.

Exclusion Criteria:

* Known systemic pathologies.
* Wearing hand jewelry on the hands.
* Allergy to any ingredient of which the solutions used in the clinical trial are composed.
* Cognitive and / or motor limitation that makes it impossible to carry out instructions for hand washing.
Influence of Acute Respiratory Distress Syndrome (ARDS) and Severe Sepsis on sRAGE Levels in ICU Patients

sRAGE, the soluble form of the receptor for advanced glycation end products, is a novel marker of alveolar epithelial type I cell injury, but is also involved in acute systemic inflammation. The purpose of this observational prospective study is to determine whether sRAGE could be used in an ICU setting as a potential diagnostic and prognostic marker during ALI/ARDS, regardless of associated severe sepsis or septic shock.

BACKGROUND:

The receptor for advanced glycation end products (RAGE was recently identified as a promising new marker of alveolar type I cell injury. RAGE is a member of the immunoglobulin superfamily that acts as a multiligand receptor and is involved in propagating inflammatory responses. While the precise function of RAGE remains unclear, the elevated levels of RAGE, and its soluble isoform sRAGE, correlate with severity of ALI/ARDS in human and animal studies, and RAGE levels could reflect impaired alveolar fluid clearance. Thus, it is possible that elevated levels of RAGE in ALI/ARDS derive in part from RAGE's role in systemic inflammatory cascades rather than purely from its release from alveolar type I cells.

DESIGN NARRATIVE:

This observational prospective clinical study will describe and compare sRAGE levels in the alveolar edema fluid and in the plasma from ICU patients enrolled within the first 24 hours after onset of ALI/ARDS and/or severe sepsis/septic shock, and from patients under mechanical ventilation (control group). Edema fluid and plasma samples will be collected simultaneously on day 1, day 3, day 6, and day 28 (or at ICU discharge), in order to describe kinetics of evolution of sRAGE levels. Undiluted pulmonary edema fluid samples will be collected in intubated patients only, and blood samples will be gathered from an indwelling arterial catheter. The concentrations of sRAGE will be measured in duplicate by ELISA.

Eligibility Criteria:
Inclusion Criteria:

* ICU patients under mechanical ventilation
* Patients within the first 24 hours after onset of ALI/ARDS according to the 1994 American-European Consensus Conference (AECC)
* Patients within the first 24 hours after onset of severe sepsis or septic shock according to the 1992 ACCP/SCCM Consensus Conference

Exclusion Criteria:

* Pregnancy
* Acute exacerbation of diabetes
* Dialysis for end-stage kidney disease
* Alzheimer's disease
* Amyloidosis
* Evolutive neoplastic lesion
Observational Study of Rituxan in Rheumatoid Arthritis Patients in Routine Clinical Practice

This study was designed to gather data regarding the efficacy and safety of Rituxan in clinical practice whereby patients may present with concomitant medical conditions, medications as well as varying presentations of rheumatoid arthritis not always captured within the "purer" population seen in an industry sponsored clinical trial.


Eligibility Criteria:
Inclusion Criteria:

* Subjects with active rheumatoid arthritis as defined by ACR criteria
* \> 18 years of age at time of consent
* Able to start RITUXAN therapy per the approved product monograph within approximately 30 days of confirmed enrollment

Exclusion Criteria:

* Known Type 1 hypersensitivity or anaphylactic reactions to murine proteins, Chinese Hamster Ovary cell proteins or to any component of RITXAN as per approved Product monograph
* Presence of any significant and or uncontrolled medical condition, which in the Investigator's opinion, precludes the use of RITUXAN as outlined in the Product Monograph
A Trial to Evaluate the Efficacy and Safety of Formoterol Fumarate in the Treatment of Patients With COPD

The purpose of this study is to determine the safety and efficacy of the investigational drug in comparison with a placebo.


Eligibility Criteria:
Inclusion Criteria:

* Medical diagnosis of COPD
* Current or prior history of cigarette smoking

Exclusion Criteria:

* Medical diagnosis of asthma
* Chest X-ray diagnostic of significant disease other than COPD
* Significant condition or disease other than COPD
Efficacy, Safety and Acceptability of the New Pen Needle 34gx3,5mm.

The purpose of this study is to determine the non-inferiority of a new Pic Insupen 34Gx3,5mm needle vs. a 32Gx4mm needle in terms of metabolic control, safety and acceptability in patients with diabetes treated with insulin.


Eligibility Criteria:
Inclusion Criteria:

* Patients with type 1 or type 2 diabetes
* Age \>= 18 years
* Multiple daily injections of insulin for at least 6 months
* Signed informed consent

Exclusion Criteria:

* Pregnancy or or breast feeding
* Inability to fill in the questionnaire
* Combined therapy for diabetes (oral drugs associated with insulin injections)
* Any medical condition that could interfere with the study according to the investigator's opinion
Ultrasound for Guidewire Detection

The aim of the project is to check if there is a possibility for a nephrologist to visualise the guidewire by means of available ultrasound scanners. To evaluate that, the procedure of catheter insertion will be expanded by ultrasound examination of right atrium and inferior vena cava border using substernal view. Such imaging seems to ameliorate the safety of catheter implementation and could be a good alternative for fluoroscopy, eliminating its adverse effects.


Eligibility Criteria:
Inclusion Criteria:

* Renal failure requiring hemodialysis through a dialysis catheter
* Capable of giving informed consent
* Placement of internal jugular vein catheter

Exclusion Criteria:

* Inability to provide informed consent
* Poor visualisation of inferior vena cava