cyrilzakka/clinical-trials huggingface dataset:
Stent Implantation for Patients With SIDSMA

This study aims to evaluate the prognosis in patients with spontaneous isolated dissection of the superior mesenteric artery (SIDSMA) who have been treated with stents.

This study is a prospective, observational study. Patients who have been diagnosed as spontaneous isolated dissection of the superior mesenteric artery (SIDSMA) and treated with stents are enrolled in the study. We will evaluate the patency of stent, remodeling of the dissection and the relief of the symptoms in the next 1 years after patients have received stents.

Eligibility Criteria:
Inclusion Criteria:

1. Male or non-pregnant female over 18 years of age
2. Diagnosed as spontaneous isolated dissection of the superior mesenteric artery
3. Patients have been successfully treated with stents
4. Patients are willing to participate in this study

Exclusion Criteria:

1. Life expectancy of \< 5 years;
2. Other surgeries or endovascular treatments have been taken concurrently.
3. Elevated serum level
Withdrawal of Inhaled Corticosteroids in Patients With COPD in Primary Care

Guidelines recommend inhaled corticosteroids (ICS) for patients with moderate to severe chronic obstructive pulmonary disease (COPD). Most COPD patients are managed in primary care and receive ICS long-term and irrespective of severity. The effect of withdrawing ICS from COPD patients in primary care is unknown.This randomised double-blind placebo-controlled trial will evaluate the effect of withdrawal of inhaled corticosteroids in patients with COPD recruited from general practice. Participants will have a clinical and spirometric diagnosis of COPD and will have been prescribed inhaled steroids for the 6 months before entry to the trial. They will be randomised to taking a fixed dose steroid inhaler (Flixotide Accuhaler) or an identical placebo inhaler. Patients will be monitored using diary cards for a year with 3 monthly follow-up visits at their general practice. The primary outcome measures will be exacerbation frequency and severity. Other outcomes are time to first exacerbation, costs, health status, lung function and unscheduled care. We tested the hypothesis that withdrawal of ICS in this population would lead to an increased number of exacerbations, earlier onset of exacerbation, and a worsening of symptoms.

To determine whether withdrawal of inhaled corticosteroids in patients with COPD in general practice effects:

* the frequency of exacerbations compared to a control group
* differences in health status compared to a control group
* differences in lung function compared to a control group
* changes in unscheduled care compared to a control group
* Direct and indirect costs compared to a control group

Hypothesis

The withdrawal of inhaled corticosteroids from patients with COPD identified in primary care will cause an increase in frequency and severity of exacerbations and is not cost-effective.

Eligibility Criteria:
Inclusion Criteria:

* Smoker or ex smoker of at least 10 pack years
* Age 40 or above
* Prior and current use of inhaled corticosteroids for at least 6 months duration (Used for at least 75% of time on direct questioning)
* FEV1 \<80% of predicted, FEV1/FVC ratio \<70%.
* Less than 15% change and \<200 mls change in FEV1 20 minutes after 5 mg nebulised salbutamol.
* 256 patients to be included in trial of which 196 must have had a precious exacerbation of COPD in the last year

Exclusion Criteria:

* Clear history of asthma, bronchiectasis, carcinoma of bronchus or other significant respiratory disease
* Inability to give informed consent (severe mental illness, mental handicap or brain damage).
* Recorded exacerbation within last month that has required antibiotics or steroids (delayed randomisation)
* Classification as a never smoker
* Strongly positive skin allergy result (\>10mm skin weal greater then negative control) to house dust mite, grass, tree, aspergillus, cat, dog or weed (irrespective of asthma/atopy status)
Dietary Supplementation With Butyrate in Individuals With Liver Steatosis and Metabolic Syndrome

This was a double-blind, randomized, placebo-controlled clinical study aiming to assess the effect of a food for special medical purposes with functional release containing calcium butyrate, zinc gluconate and vitamin D3 on liver steatosis in individuals with NAFLD and metabolic syndrome


Eligibility Criteria:
Inclusion criteria:

* 40-75 years of age
* Caucasian ethnicity
* NAFLD
* Metabolic Syndrome

Exclusion criteria:

* acute and chronic gastrointestinal disorder not controlled by stable treatment since at least 3 months
* serious or disabling diseases (e.g. severe organ failure, malignancy or dementia)
* obesity (body mass index (BMI)\> 30 Kg/m2)
* type 1 and 2 diabetes
* alcoholism
* pregnancy and breastfeeding
* any medical or surgical condition making complex or inconstant the adhesion to the study protocol
Effect of Prewarming During Induction of General Anesthesia Combined With Warmed Intravenous Fluid on Core Temperature.

Hypothermia occurs frequently during general anesthesia. This study is to evaluate the efficacy of 10 minutes of prewarming during induction of general anesthesia during urologic surgery.

Hypothermia is of continuous issue in patients undergoing general anesthesia. During urologic operation (transurethral resection of bladder and prostate), bladder irrigation worsens hypothermia. Hence, various methods including prewarming of the patient are used to maintain core temperature during operation.

Prewarming is found to be effective in maintaining core temperature perioperatively by increasing peripheral tissue heat content. However, applying more than 30 minutes of prewarming may be impractical as a clinical routine practice. Hence, developing simple and effective method to prevent hypothermia is expected.

Here, the investigators planned to examine the effect of active warming (10 minutes of warming during induction of general anesthesia and prewarmed intravenous fluid intraoperatively) on hypothermia in patients undergoing urologic operation under general anesthesia.

Eligibility Criteria:
Inclusion Criteria:

* patients undergoing urologic surgery(transurethral resection of bladder, prostate)

Exclusion Criteria:

* moderate to severe cardiopulmonary, renal impairment
* previous thyroid disease
* any infection sign
* abnormal temperature prior to induction of general anesthesia (\<36'C or \>37.5'C)
* refusal to participate in the study
* unable to understand the study
Application of 3D Scanner to Measure Physical Size in Patients With Severe Cerebral Palsy

The aim of this study is to improve the manufacturing techniques of hip brace in preventing progressive hip displacement in patients with severe cerebral palsy, through the measurement of patient's physical size using a 3D scanner.

1. Design : Prospective Study
2. Setting: Hospital rehabilitation department and Home
3. Intervention: Before starting the study, radiologic and clinical evaluation were performed. After measuring the patient's exact physical size by applying a 3D scanner, we manufacture hip brace in preventing progressive hip displacement in patients with severe cerebral palsy. After wearing for a week, follow-up radiologic and clinical evaluation were performed.
4. Main outcome measure 1) Primary outcome: right, left, both hip MI 2) Secondary outcomes: the hip and knee joint range of motion (ROM), pain intensity, satisfaction and discomfort score for the hip brace, quality of life (QOL) of the patients and their caregivers, and the wearability test.

Eligibility Criteria:
Inclusion Criteria:

1. diagnosis of cerebral palsy
2. age 1-15 years
3. GMFCS Level IV, V
4. quadriplegia, or diplegia for more than 6 months
5. Patients who have written consent with permission from the child and caregiver.

Exclusion Criteria:

1. Patients who did not agree to participate in the study
2. Patients who refused the examination
3. Patients who had hip surgery experience
4. Patients who were scheduled to undergo surgery during the clinical study
5. Patients who could not be measured with a 3D scanner
Assessment of a New Closed-loop Algorithm in Type 1 Diabetes (Saddle Point Model Predictive Control : SP-MPC) (PPA)

The purpose of the study is to assess a new closed-loop algorithm in type 1 diabetes (Saddle Point Model Predictive Control : SP-MPC)

Ten patients will be assessed during a closed-loop night and an open-loop night in random order.

The primary objective is to assess the ability of SP-MPC controler to maintain euglycemia and avoid hypoglycaemia during the night, compared to open loop in type 1 diabetic patients treated by insulin pump.

Eligibility Criteria:
Inclusion Criteria:

* Patients with type 1 diabetes (C peptide negative) :
* 18 to 70 year old,
* with type 1 diabetes for more than 3 years,
* treated by insulin pump for more than 3 months,
* with previous CGM holter allowing preliminary settting of some of the SP-MPC parameters
* able to provide written informed consent.

Exclusion Criteria:

* pregnancy or breastfeeding,
* severe non stabilized diabetic retinopathy,
* cardiovascular event in the previous 6 months,
* infectious diseases with recent fever,
* anemia (hemoglobin \< 11g/l),
* HbA1c \> 10%,
* Current or recent (less than 4 weeks) oral or injectable corticosteroid treatment,
* creatinine clearance \<40ml/mn,
* chronic alcoholism (weekly consumption of alcohol \> 280g for men and \> 140g for women),
* adults legally protected (under judicial protection, guardianship, or supervision), persons deprived of their liberty
Study of Single And Double Bundle Anterior Cruciate Ligament (ACL) Graft Cross-sectional Dimensions

To study the difference between single and double bundle ACL graft cross-sectional dimensions compared with native ACL using postoperative 3-D MRI.

The investigators divide 100 patients with ACL rupture into 2 groups. Group A undergo single bundle anterior cruciate ligament reconstruction (ACLR). Group B undergo double bundle ACL reconstruction. At 3-6 weeks post operation, all the patients undergo 3-D MRI examination of both knees. The investigators reconstruct 3-D models of reconstructed ACL and native ACL, and compare the difference between single and double bundle graft.

Eligibility Criteria:
Inclusion Criteria:

* ACL rupture patients aged between 10 to 50 years

Exclusion Criteria:

* combined severe injuries to the operated knee (additional ligament rupture, major meniscus loss, patella instability, cartilage damage \>2°, pathologic leg axis deviation)
* any injury or surgery to the contralateral knee
* any inflammatory or systemic disease, neuromuscular disease in the lower limbs,any recent knee infection
Optimal Duration of Olanzapine Add-on Therapy in Major Depression

Evaluation of olanzapine versus placebo in the continuation therapy of subjects with major depression who had a response with additional olanzapine to an antidepressant.


Eligibility Criteria:
Inclusion Criteria:

* informed consent
* age 18 - 80
* diagnosis of major depression according dsm-iv, unipolar course
* Hamilton-Depression-Rating-Scale (17 item score) \> 18 prior to inclusion
* response towards therapy with antidepressant and olanzapine as defined \> 50 % reduction of HAMDD score
* negative pregancy test
* highly effective contraceptive method in women
* no participation in other trial according to German Drug Laq
* normal liver function

Exclusion Criteria:

* pregnancy, lactation
* depressive episode secondary to somatic disease or substance dependency
* contraindication for olanzapine
* treatment with interacting substances (CYP1A2 inhibitors or inductors)
* comorbidity according to DSM-IV, axis I
* denail of consent
* hospital treatment by legal order
* hepatic insufficiency
* severe neurological or medical disease
* adipositas permagna
* HIV-infection
* active viral hapatitis
Preoperative Ketogenic Diet for Reduction of Hepatic Steatosis

Non-alcoholic fatty liver disease is becoming increasingly common in Canada and throughout the world. Fatty liver can increase the risks of perioperative complications for those who need liver surgery. A ketogenic diet is low in carbohydrates and can be very effective in reducing liver fat content. The purpose of this randomized control trial is to compare the effect of a short duration (4 week) preoperative ketogenic diet on operative and disease outcomes in patients undergoing liver surgery. One arm will be randomized to the ketogenic diet and the other will receive standard of care pre-operative dietary consultation.

The rise in obesity has contributed to increasing rates of non-alcoholic fatty liver disease (NAFLD) in Canada and globally. In the setting of liver surgery, fatty liver has been associated with higher rates of blood loss during surgery as well as higher rates of postoperative complications. A pre-operative ketogenic diet (KD) has been proposed as a strategy to decrease the risks of fatty liver in patients undergoing liver surgery and has shown promising results in reducing liver fat content, even with short-duration diets. The current literature contains a large variety of pre-operative diets aimed at reducing liver fat content and most studies are observational. Presently, there is no randomized control trial looking at the effects of a well-formulated and standardized KD prior to liver surgery and its effect on operative and disease outcomes. This study will randomize patients with NAFLD needing surgery to remove liver tumors to either the control group or intervention group. Patients in the control group will receive dietary consultation for a standard of care diet as recommended by Canada's Food Guide. Patients in the intervention group will consult with a dietician before starting a 4-week preoperative well-formulated very low carbohydrate KD. All participants will track daily nutritional intake and provide weekly summary reports via an app called Cronometer. The investigators will analyze differences in intraoperative blood loss and OR time, postoperative complications, disease recurrence and mortality rates between the two groups.

Eligibility Criteria:
Inclusion Criteria:

* Patients 18 years of age or older undergoing any type of liver resection (e.g. wedge, formal hepatectomy), either open or laparoscopic, for colorectal liver metastases (CRLM)
* Patients with evidence of hepatic steatosis on pre-operative imaging (CT or MR) or biopsy.
* Ability to use an app based nutritional program to track macronutrient uptake throughout the dietary intervention.

Exclusion Criteria:

* Patients undergoing liver resection for any other indication
* Patients on sodium glucose co-transporter 2 (SGLT-2) inhibitors (these are contraindicated with a ketogenic diet).
* Patients without evidence of hepatic steatosis.
* Patients with evidence of liver fibrosis or cirrhosis on preoperative bloodwork or imaging.
* Patients with alcohol-related hepatic steatosis.
* Patients with a known bleeding disorder.
Prospective Survey of Body Mass Index in People With Spinal Cord Injury.

This study is a prospective national survey of body mass index, and includes all patients with a new spinal cord injury hospitalized at Clinic for Spinal Cord Injuries, Rigshospitalet and Spinal Cord Injury Center of Western Denmark during a period of 9 months. Informed consent is retrieved from all participants.

The current study is a sub- study in a Ph.D project containing 4 sub- studies. The protocol for the current study includes all four sub- studies, and each of the other three sub- studies will be registered ongoing individually. The current study is a prospective national survey of body mass index (BMI), and includes all patients with a new spinal cord injury hospitalized at Clinic for Spinal Cord Injuries, Rigshospitalet (CSCI) and Spinal Cord Injury Center of Western Denmark during a period of 9 months whereby 100 patients are expected to participate. Data are collected at admission and discharge. At CSCI BMI is collected every 6 weeks and all outcome measures will also be collected at follow up 6 months after discharge. A VO2peak test at discharge is performed as well, and in some participants accelerometry is performed in order to describe the amount and intensity of physical activity. Test- retest reliability of the VO2peak test and accelerometry is investigated as well. Patients with a new Spinal Cord Injury within the last 12 months, who are admitted for rehabilitation several months after the time of injury are also included in the prospective survey. Therefore the data for BMI at the time of injury is collected for all patients at admission to primary rehabilitation from both the patient journal and also by asking the patient about weight and height at the time of injury

Eligibility Criteria:
Inclusion Criteria:

* All newly injured patients with Spinal Cord Injury (within the last 12 months)admitted at Clinic for Spinal Cord Injuries, Rigshospitalet and Spinal Cord Injury Centre of Western Denmark, are included regardless of age, neurological level of lesion and completeness of the injury if informed consent is retrieved.

Exclusion Criteria:

* Insufficient skills in Danish language
* Reduced mental function that prevents reading and answering the questionnaires
Near Infrared Spectroscopy and Transcutaneous Oxygen Pressure in Critical Limb Ischemia Before and After Treatment

Comparison of two non-invasive methods for measuring tissue oxygenation. One is Transcutaneous Oxygen Pressure (TCPO2) and the other is the new method of Near Infrared Spectroscopy (NIRS) - near infrared spectroscopy in patients with critical limb ischemia (CLI) undergoing invasive treatment (surgical or endovascular).

Comparison of two non-invasive methods for measuring tissue oxygenation. One is TCPO2 and the other is the new method of NIRS - near infrared spectroscopy in patients with critical limb ischemia (CLI) undergoing invasive treatment (surgical or endovascular).

The NIRS probe has been used to measure tissue oxygenation in the cerebral circulation up to now. While TCPO2 is the established method for measuring tissue oxygenation in patients with CLI to evaluate the potential for wound healing.

Eligibility Criteria:
Inclusion Criteria:

* 10 patients admitted to the vascular surgical department and undergoing invasive treatment (surgical or endovascular)

Exclusion Criteria:

* pregnancy allergy to iod advanced renal failure CCT\<50 active peptic ulcer recent bleeding
Tongue Pull Versus Jaw Thrust

This protocol seeks to determine the efficacy and reliability of a simple maneuver, the jaw thrust maneuver, in addition to cricoid pressure, in improving visualization of airway anatomy during video laryngoscopy. Hypothesis: The grade of view of the glottis as determined by the modified Cormack and Lehane grading system in anesthetized patients will improve by performing a jaw thrust maneuver during video laryngoscopy with compared with video laryngoscopy alone. Similarly, the grade of the view during cricoid pressure will also improve with a jaw thrust maneuver.


Eligibility Criteria:
Inclusion Criteria:

1. Age \> 18
2. Undergoing surgery and general anesthesia with endotracheal intubation
3. Able to give informed consent

Exclusion Criteria:

1. Trauma patients or emergent cases.
2. Patients who are unable to understand the proposed study
3. Patients who refuse participation
SEQUAR SEmitendinosus Vs QUadriceps in Anterior Cruciate Ligament Reconstruction

Randomized control trial comparing two different Anterior Cruciate Ligament (ACL) grafts in Anterior Cruciate Ligament Reconstruction: the semitendinosus hamstrings graft and the quadriceps graft. Capio Artro Clinic (Stockholm) has vast experience in ACL surgery using both semitendinosus and quadriceps grafts.

The purpose of the study is to evaluate the quadriceps graft with bone-plug in Anterior Cruciate Ligament Reconstruction (ACL-R) and compare it with the most common choice of graft, semitendinosus hamstrings graft in ACL-R in athletes with Tegner Activity Scale 7 or higher. Both methods are well-known and continually registered in the Swedish ACL Registry. Patients will be followed up during a 2-year period.

Both grafts will be compared post operatively as to laxity, PROM, as well as measure graft site morbidity, Return to Sports rate, and the post-operative rehab. At 9 months we will also preform a MRI scan to determine graft maturity. 5-year and 10-year data will also be acquired through the Swedish ACL-registry and Lysholm score and Tegner Activity Level score. At 10-year a plain weight baring X-ray will be preformed to evaluate development of osteoarthritis. Both methods are well-known and continually registered in the Swedish ACL Registry.

The study design is a prospective randomized study with equal groups:

Semitendinosus graft (=100) and Quadriceps tendon graft (n=100). According to historical material from Capio Artro Clinic (Stockholm) the following power calculation has been made: Significance lever 5 percent (p=0.05) and power is 80%. The difference between the groups is 1 mm knee laxity with KT-1000 which would give an effect size of 0,44 or less compared to an average effect size (0,50). 85 individuals will be needed in each group in the statistical analysis. Although no stratification for sex will be performed, our aim is to have a balanced representation of sex that reflects the typical patient population for this condition at the clinic, with a distribution of 40% females and 60% males across both groups. Inclusion will continue until we have at least 100 individuals in each group. This means that each group can have more than 100 individuals. Randomization process and study design will be done according to the CONSORT guidelines.

Eligibility Criteria:
Inclusion Criteria:

* Pre-injury Tegner Activity Scale≥7
* Intended return to sports to prior sport and Tegner Activity Scale Level
* Time between injury and inclusion not more than 6 months
* MR verified ACL rupture

Exclusion Criteria:

* Previous knee injury with symptoms before ACL injury
* Neurological disease, inflammatory disease, connective tissue disease or balance disorder
* Previous lower limb fracture or surgery
* Laxity in the medial collateral ligament (MCL) and lateral collateral ligament (LCL) \> grade 1
* PCL rupture or Multiligament knee injury (MLKI)
* Radiographic sign of osteoarthritis (OA)
* Previous knee surgery or ligament injury in contralateral knee
* Beighton score ≥ 5
The Effect of Pressure Exerted on the Maternal Abdominal Wall by the Ultrasound Probe on Fetal Heart Rate

The aim of the study is to assess the change of fetal heart rate in response to the amount of pressure exerted on the maternal abdomen. The amount of pressure will be quantified using an electronic pressure sensor (FSR 400- Round Force Sensor, Interlink).

Previous studies have shown a fetal cardiovascular effect to the pressure exerted on the maternal abdomen. Our null hypothesis is that there is a correlation between fetal heart rate changes and pressure exerted on the fetus through the maternal abdomen.

Women at term pregnancy coming for a routine cardiotocography monitor, will undergo 5 minutes of quantified pressure on their abdomen, using the electronic pressure sensor. The amount of pressure will be recorded as well as the fetal heartbeat baseline and changes to the heart rate following the application of pressure.

Eligibility Criteria:
Inclusion Criteria:

* over 18 years of age
* singleton pregnancy
* term (37-41 weeks of gestation)
* consented
* undergoing routine cardiotocography (CTG)

Exclusion Criteria:

* referred to the ER due to non reassuring fetal heart rate (NRFHR)
* recognition of NRFHR pattern on CTG at the ER
* self reporting of reduced fetal movement perception
* unconsented patient