cyrilzakka/clinical-trials huggingface dataset:
Audiovisual Videodisc Education and Modification of Expectations With Total Knee Replacement (TKR)

Information provided to patients modifies their expectations with surgery. The effects of preoperative audiovisual information on expectations with total knee replacement (TKR) have not been investigated. The purposes of this study were to investigate the effectiveness of an educational videodisc on the modification of pre-operative patients' expectations with TKR and to find a biophysical profile of subjects in whom this videodisc could be most effective. It was hypothesized that patients receiving standard information plus additional medical information through audiovisual videodiscs would modify their pre-operative expectations more than those only receiving the standard information through medical interviews.


Eligibility Criteria:
Inclusion Criteria:

* Patients with knee osteoarthritis waiting for total knee replacement.

Exclusion Criteria:

* Cognitive disorders or language barriers precluding medical interview.
* Contralateral total knee replacement.
* History of revision total knee replacement.
* History of unicompartmental knee arthroplasty
Transforaminal Epidural Injection in Acute Sciatica

Patients suffering from sciatica are treated conservatively for the first 8 weeks due to the favourable prognosis. This period is preferably extended up to 14-16 weeks after which patients may opt for surgery. However, patients may experience severe discomfort due to pain in the leg which can lead to decreased physical activity and socio-economic problems. An adequate therapy to alleviate symptoms during this period of 'wait-and-see' is lacking. In this study, patients will be randomized to treatment with transforaminal epidural injections or standard oral pain medication.

Sciatica is a condition of radicular pain in the leg and is usually caused by herniation of a lumbar intervertebral disc. The herniated disc compresses a lumbar nerve root that continues its route into the sciatic nerve. About 13% to 40% of all people will suffer from sciatica at least once during their lifetime. Sciatica can have severe socio-economic effects; patients are immobilised by the pain they experience and therefore cannot go to work or participate in social events. Most cases resolve spontaneously with conservative therapy using only standard analgesics and/or physiotherapy. In a large RCT it was demonstrated that outcome of conservative and surgical therapy was comparable after 26 weeks. With this knowledge the guidelines for surgical treatment of sciatica were adjusted and it is nowadays usual care to offer surgery only after at least 8 weeks of conservative care and preferably after 14-16 weeks of conservative care. This decision is made together with the patient in a process of Shared Decision making. Although this treatment regimen has been demonstrated to be efficacious and cost effective, the burden for a patient during these weeks of conservative care is usually high. The investigators seek to find a type of conservative care to reduce the discomfort due to the pain and to enable the patient to remain physically active. Not only will this add to the quality of life of the patient, but it will also prevent the patient from taking a sick-leave. In this study, patients will be randomized to either treatment with transforaminal epidural injections or to standard care consisting of oral pain medication.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with sciatica by GP
* NRS leg pain of 6 or more on a 10-point NRS scale
* Minimum duration of symptoms of 3 weeks and maximum duration of 8 weeks

Exclusion Criteria:

* Age under 18 years
* Condition preventing to receive transforaminal epidural injection
* Severe scoliosis
* Transforaminal epidural injection received in 6 months before randomization date
* Surgery for sciatica at the same level
* Surgery for sciatica at another level within one year before inclusion
* Pregnancy
Cognitive-behavioral Therapy vs. Nutrition Counseling for Avoidant/Restrictive Food Intake Disorder

This study is a randomized controlledlinical trial, assessing the efficacy of cognitive- behavioral therapy (CBT-AR) and nutrition counseling for avoidant/restrictive food intake disorder (ARFID) for children and adolescents (ages 10-18 years).


Eligibility Criteria:
Inclusion Criteria:

* Males and Females ages 10-18 years old
* Current ARFID
* Normal TSH or free T4 levels to rule out thyroid disease as cause of symptoms
* Negative celiac screening panel indicating no active celiac disease as cause of symptoms
* Fluency and literacy in English

Exclusion Criteria:

* BMI \< 5th percentile for sex and age
* Pregnancy, breastfeeding, or recent initiation/cessation of oral contraceptive pills within 8 weeks of the pre-treatment study visit
* Current/history of psychosis
* Substance/alcohol use disorder (active within the past month)
* Medical instability requiring inpatient care according to the American Psychiatric Association 2023 treatment guidelines for eating disorders
* Laboratory abnormalities indicating a need for higher level of care
* Complete lack of oral intake (suggesting a need for inpatient care)
* Tube feeding (suggesting a need for tube weaning)
* Active suicidal/homicidal ideation with intent or plan
* Contraindications to MRI
* History of major gastrointestinal tract surgery or serious medical condition (e.g., cancer)
* Medical history of intellectual disability
* Illiteracy
Use of Combined Measurements of Serum Infliximab and Anti-infliximab Antibodies in the Treatment of Patients With Crohns Disease Failing Infliximab Therapy

To compare treatment outcome in patients with Crohn's disease with secondary loss of response to infliximab (i.e. initial good response follow by loss of response) treated according to current standards based only on clinical features versus treatment based on serum levels of infliximab and anti-infliximab antibody (Ab) status.


Eligibility Criteria:
Inclusion Criteria:

1. Patient must be able to understand the information given to him/her and give written informed consent.
2. Definitive diagnosis of Crohn's disease (confirmed by recent radiological, endoscopic and/or histological evidence according to international criteria) .
3. Age minimum 18 years.
4. Previous good response to at least 3 doses (5mg/kg) of infliximab (as judged by the treating physician).
5. Loss of response to standard doses of infliximab (as judged by the treating physician).
6. Last infliximab infusion given at least 4 weeks before inclusion.
7. For patients with luminal disease, the CDAI should be above 220 points at inclusion.
8. For patients with fistulising disease only, at least one draining perianal fistula (confirmed by radiography, MR, ultrasound or physical examination) should be present.

Exclusion Criteria:

1. Any contraindication to continued infliximab treatment
2. Short bowel syndrome
3. Bowel resection within 12 weeks of inclusion.
4. Current or recent history of severe, progressive, and/or uncontrolled renal, hepatic, haematological, gastrointestinal, endocrine, pulmonary, cardiac, neurological, or cerebral disease.
5. Pregnancy
6. History of alcohol or drug abuse within the prior year
7. Patients who do not meet concomitant medication criteria.
8. Any other condition, which in the Investigator's judgment would make the patient unsuitable for inclusion in the study.
A Study to Describe a Group of Spanish Patients With FMF and to Identify Suboptimally Treated Patients With Minimal Disease Activity and Its Impact on Quality of Life

A retrospective, non-interventional, single-center study conducted in Spain, based on the collection of data from the medical histories of patients with Familial Mediterranean fever (FMF) diagnosed during childhood from January 2005 to December 2021.

Data from the patients' medical records was collected retrospectively, from the time of diagnosis to the current moment of the patient's enrollment in the study. Patients had a minimum follow-up of 3 months after diagnosis.


Eligibility Criteria:
Inclusion criteria:

1. Patients with FMF clinically and/or genetically diagnosed during childhood according to the site's clinical practice.
2. Patients with at least 3 months of follow-up from the date of diagnosis, at the time of their enrollment in the study.

Exclusion criteria:

1. Patients with autoinflammatory disease excluding FMF.
2. Patients with recurrent fever of another etiology (infectious, tumor or other).
The INDORSE Study: Inhibition of Dipeptidyl Peptidase IV: Outcomes on Renal Sodium Excretion

Background: Dedicated renal hemodynamic and renal function studies are lacking for DPP-4 inhibitors in patients with Type 2 diabetes; accordingly little is known regarding the mechanisms mediating the renal effects of DPP-4 inhibitors in humans.

Objectives: To evaluate the effect of DPP-4 inhibition acutely (single dose) and following short-term therapy (28 days) on renal sodium handling and renal hemodynamics and function in patients with type 2 diabetes and systolic hypertension.

Design: double-blind, randomized, placebo-controlled trial, Phase IV.

Patient population: 32 patients with Type 2 diabetes, HbA1c (6.5%-9%), with systolic blood pressure ranging from 120-160 mmHg.

Intervention: subjects will be randomized (1:1) to either sitagliptin (100 mg daily) or to placebo (1 tablet daily) for 28 days.

Endpoints: Fractional excretion of sodium, renal function, and renal hemodynamics.

Background: DPP-4 inhibition improves glycemic control, modestly reduces blood pressure and may also reduce albuminuria in patients with Type 2 diabetes; effects which occur without significantly modifying heart rate or body weight. While preclinical studies have demonstrated that DPP-4 inhibition acutely increases urinary sodium excretion in addition to other favorable renal effects (anti-inflammatory, anti-proteinuric), few studies have examined the renal effects of DPP-4 inhibition either acutely or following short-term therapy in humans with type 2 diabetes. Considering the world-wide prevalence of Type 2 diabetes and the increasing use of DPP-4 inhibitors amongst patients, it is important to ascertain potential non-glycemic effects of DPP-4 inhibitors including those within the kidney.

Study Objectives: To determine effect(s) of DPP-4 inhibition on tubular sodium handling, renal hemodynamics, and renal function.

Study Design: double-blind, randomized, placebo-controlled trial, Phase IV.

Study Patients: 32 patients with Type 2 Diabetes and Systolic Hypertension (SBP 120-160 mmHg).

Endpoints: Fractional excretion of sodium, renal function (measured GFR), renal hemodynamics (effective renal plasma flow, filtration fraction, renal blood flow, renal vascular resistance), systemic hemodynamics (non-invasive cardiac monitoring), plasma neurohormones, urinary vasoactive mediators, markers of free radical stress.

Eligibility Criteria:
Inclusion Criteria:

* Individuals of 18-70 years of age,
* with Type 2 Diabetes,
* with an HbA1c (6.5%-9%),
* and with a systolic blood pressure (120-160 mmHg).

Exclusion Criteria:

* Individuals with:

  1. Type 1 Diabetes,
  2. eGFR \<50mL/min/1.73m,
  3. pregnancy or breast feeding,
  4. significant cardiac, pulmonary or liver disease,
  5. prior history of pancreatitis, medullary thyroid cancer, multiple endocrine neoplasia syndromes,
  6. SBP \>161 mmHg, 7) DBP \>100 mmHg,
  7. alcohol or substance abuse,
  8. states of secondary hypertension.
High-flow Nasal Cannula Therapy for Stable Chronic Obstructive Pulmonary Disease (COPD)

This is a prospective, randomized crossover study for evaluation of the efficacy and safety of long-term nocturnal high-flow nasal cannula therapy with the myAIRVO2® in stable COPD patients with stage 2-4 of the Global Initiative for Chronic Obstructive Lung Disease (GOLD) and hypercapnia who require home oxygen therapy (HOT). The total duration of subject participation will be 52 weeks, consisting of 12-week treatment period and 40-week continuation period. Subjects who satisfy all inclusion and exclusion criteria will be randomly assigned to one of two treatment arms, Arm A (week 1-6: the myAIRVO2® therapy plus HOT, week 7-12: HOT only) or Arm B (week 1-6: HOT only, week 7-12: the myAIRVO2® therapy plus HOT). All subjects will receive nocturnal high-flow nasal cannula therapy with the myAIRVO2®, in addition to their current HOT. After treatment period, the willing subjects can continue the myAIRVO2® therapy plus HOT for week 13-52 regardless of treatment arm assignment. The end of the study is defined as the treatment period or continuation period end date of the last participant, whichever is later. Subjects will primarily be assessed by the St. George's Respiratory Questionnaire for COPD Patients (SGRQ-C) at week 0, 6, 12, 24 and 52.


Eligibility Criteria:
Inclusion Criteria:

1. Subjects with the Global Initiative for Obstructive Lung Disease (GOLD) stage 2-4 COPD
2. Subjects who have received HOT for at least 16 hours per day for at least 1 month at the time of informed consent
3. Subjects with PaCO2 \<= 60 torr, and \>= 45 torr at the time of screening
4. Subjects who have signed written informed consent to participate in this study

Exclusion Criteria:

1. Subjects with severe kidney, liver or cardiovascular disease
2. Subjects with active malignant tumor
3. Subjects with acute disease (i.e., acute myocardial infarction)
4. Subjects with a history of obstructive sleep apnea syndrome
5. Subjects with complications affecting efficacy endpoints and who are regarded by the investigator as inadequate for this study
6. Subjects who had experienced COPD exacerbation within the past 6 weeks prior to informed consent
7. Subjects who have been receiving nocturnal noninvasive positive pressure ventilation (NPPV) or had been received within the past 6 weeks prior to informed consent
8. Subjects with a history of tracheotomy or severe pharyngeal nasal cavity surgery within the past 6 months
9. Pregnant women
10. Subjects with cognitive impairment or mental disorder and who are regarded by the investigator as inadequate to be evaluated in this study
11. Subjects who are regarded by the investigator as being unable to operate the myAIRVO2 adequately at home
12. Subjects who are participating or wil participate in the another clinical trial at the time of informed consent
13. Any other cases who are regarded by the investigator as inadequate for enrollment
COREG MR Versus TOPROL-XL On Reduction Of Microalbuminuria In Patients With Hypertension And Microalbuminuria

This study was designed to determine whether COREG MR is more effective than TOPROL-XL in reducing microalbuminuria in type 2 diabetic or non-diabetic patients with high blood pressure and microalbuminuria.


Eligibility Criteria:
Inclusion criteria:

* Documented history of hypertension.
* Must have been taking an ACE (angiotensin converting enzyme) inhibitor either alone or as part of an antihypertensive regimen for at least 8 weeks.
* Persistent microalbuminuria.

Exclusion criteria:

* History of heart attack, stroke, congestive heart failure, arrhythmia, type 1 or uncontrolled type 2 diabetes mellitus, liver or renal disease.
* Has been taking any non-ocular beta-blockers for any indication within three months prior to Pre-screening.
Kitasato PCI Registry

The Kitasato PCI Registry is a single-center, observational, prospective study. This study aims to investigate the impact of characteristics in clinical manifestation, patients' background, procedure of percutaneous coronary intervention (PCI), and pre/post PCI culprit/nonculprit lesion observed by intra-coronary imaging modality on clinical outcomes.

Subjects who underwent PCI are eligible in this registry. The analysis for clinical characteristics, PCI procedural characteristics and findings of intra-coronary imaging including optical coherence tomography (OCT) and intravascular ultrasound (IVUS) is conducted. Subjects are clinically followed up to 5 years after the PCI.

Eligibility Criteria:
Inclusion Criteria:

* Patients who underwent PCI

Exclusion Criteria:

* Patients who did not agree to participate in the registry
CTAG Dissection/Trauma Post Marketing Surveillance Japan

Post Marketing Surveillance of the Conformable GORE® TAG® Thoracic Endoprosthesis


Eligibility Criteria:
Inclusion Criteria for Acute, Complicated Stanford Type B Aortic Dissection:

* Patient present with acute complicated type B aortic dissection
* Patient who do not respond to medical therapy
* Time from symptom onset to dissection diagnosis ≤ 14 days
* Adequate iliac / femoral access or conduit
* Aortic inner diameter at proximal extent of proximal landing zone in the range of 16-42 mm
* ≥ 20 mm landing zone proximal to the primary entry tear; proximal extent of the landing zone must not be dissected

Inclusion Criteria for Traumatic Aortic Transection:

* Patient has traumatic aortic transection that requires repair as determined by treating physician
* Adequate iliac / femoral access
* Aortic inner diameter in the range of 16-42 mm on the proximal and distal sides
* ≥ 20 mm non-aneurysmal aorta neck proximal and distal to the lesion
Intraoperative vs. Postoperative Intravesical Epirubicin Instillation for Prevention of Bladder Recurrence in High-Risk Upper Urinary Tract Urothelial Carcinoma

Upper urinary tract urothelial carcinoma (UTUC) accounts for 5%-10% of urothelial malignancies, with up to 50% of patients developing bladder recurrence post-RNU. High-risk UTUC (≥pT2, high-grade, or N+ disease) necessitates aggressive management. Intravesical chemotherapy mitigates recurrence risk, yet optimal timing-intraoperative vs. postoperative-remains unclear. This study evaluates intraoperative epirubicin instillation during RNU compared to postoperative administration and no instillation.


Eligibility Criteria:
Inclusion Criteria:

* primary high-risk UTUC.

Exclusion Criteria:

* prior bladder cancer,
* low-risk UTUC (managed conservatively),
* metastatic disease,
* incomplete follow-up
Single-stapled Double Purse-string Technique for Colorectal Anastomosis

A single-arm, single-center prospective study of a novel double purse-string technique for constructing the colorectal anastomosis in robot-assisted laparoscopic resection of the sigmoid colon for cancer.

In all, 30 consecutive patients will be enrolled. The first 5 will be regarded as a pilot series for testing and aligning the study setup. The next 25 patients will form the study group. The clinical outcomes will be compared with historical control patients from our own department. Safety and feasibility will be assessed by short-term clinical outcomes.

Eligibility Criteria:
Inclusion Criteria (all must be fulfilled):

* Verified cancer of the sigmoid colon
* Planned elective robot-assisted laparoscopic resection of sigmoid colon with primary anastomosis
* Operation with curative intent

Exclusion Criteria:

* Not legally competent and/or \< 18 years old
* Not able to comprehend information and/or give written consent
Efficacy and Safety of Auricular Acupuncture in Treating Insomnia Post-stroke

The goal of this clinical trial is to learn if Auricular acupuncture works to treat Insomnia Post-stroke patients. It will also learn about the safety of Auricular. The main questions it aims to answer are:

* Does Auricular acupuncture reduce the time it took participants to fall asleep?
* Dose Auricular acupuncture increase the number of hours participants slept?
* Dose Auricular acupuncture improve sleep quality as measured by The Pittsburgh Sleep Quality Index (PSQI)?
* What medical problems do participants have when taking Auricular acupuncture? Researchers will compare Auricular acupuncture to a sham Auricular acupuncture (a look-alike acupuncture needles that contains no needles) to see if Auricular acupuncture works to treat insomnia post-stroke.

Participants will:

* Take Auricular acupuncture or sham Auricular acupuncture every 5 days for 4 weeks.
* Checkups and evaluate sleep onset time, sleep hours, and sleep quality every 5 days for 4 weeks.
* Keep a diary sleep of their symptoms and the number of times they use sleeping pills.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18 years or older, with a post-stroke period of 03 months or more, based on discharge papers or medical records.
* Patients who meet the diagnostic criteria for insomnia according to the DSM-V of the American Psychiatric Association for at least 3 months.

Exclusion Criteria:

* Patients with insomnia before the stroke.
* Patients diagnosed with other sleep disorders such as sleep apnea syndrome, narcolepsy.
* Patients diagnosed with neurological diseases or psychiatric disorders such as: Anxiety disorders, autism spectrum disorders, depression, obsessive-compulsive disorder, behavioral disorders affecting sleep before the stroke.
* Patients are using antidepressants, psychiatric drugs.
* Patients participating in other clinical trials with behavioral, psychological or complementary medical interventions during the study period.
* Patients not cooperating during data collection
Enhancing Quality of Life in Patients (EQUIP) Intervention for Patients With Advanced Lung Cancer

i. Project Background Patients with advanced lung cancer have a high symptom burden and low quality of life. Early palliative care improves patient outcomes in newly diagnosed advanced lung cancer patients, but previously tested models are not feasible for widespread adoption. Hence, the aim of this study is to pilot a more sustainable nurse-led intervention - Enhancing Quality of life in Patients (EQUIP).

ii. Hypothesis / Aim The aims of this study are three-fold. Firstly, the investigators aim to determine the feasibility and acceptability of the EQUIP intervention itself. Secondly, the investigators aim to obtain a tentative estimate of efficacy of the EQUIP intervention. Thirdly, the investigators aim to determine the data completion rate of patient reported outcome measures in the context of the EQUIP trial.

iii. Methods Patients with newly diagnosed stage 3 or stage 4 lung cancer will be recruited and randomized to the EQUIP intervention or usual care (control) group. Patients randomized to the EQUIP intervention group will receive four face-to-face sessions with a palliative care nurse. The content of these educational sessions will equip patients with the knowledge and skills to manage the three commonest symptoms of fatigue, breathlessness and anxiety.

All participants will complete the Functional Assessment of Cancer Therapy - Lung (FACT-L), the Hospital Anxiety and Depression Scale (HADS) and the stigma subscale at four time points: baseline, 4, 8 and 12 weeks after recruitment. Measures of healthcare use will also be recorded. Additionally, participants in the intervention group will complete a feedback survey after each intervention session.

A total sample of 60 patients (30 in each arm) will be recruited.

Clinical Significance

If successful, this study will lead to a larger scale phase III trial which tests various components of the EQUIP intervention, in order to develop a sustainable and effective model for the provision of palliative care to advanced lung cancer patients.


Eligibility Criteria:
Inclusion criteria

* Has stage 3 or 4 lung cancer
* ECOG 0,1 or 2
* Able and willing to participate in the EQUIP programme

Exclusion criteria

- Unable to communicate in English or Mandarin