cyrilzakka/clinical-trials huggingface dataset:
Total Small Bowel Length Measurement Using Computed Tomography and Magnetic Resonance Imaging in Obese Patients

The aim of the study is to set up and validate a reliable and reproducible automated method using preoperative radiological imaging to measure the TSBL in patients undergoing laparoscopic bariatric/metabolic surgery.

The total length of the small intestine (TSBL) represents a crucial parameter for obtaining a safe and successful minimally invasive surgery in metabolic/bariatric bypass surgery.

Nowadays, the standard of small intestine measurement is the intraoperative measurement. Laparoscopy represents the standard approach for baratric/metabolic, making the TSBL measurement time-consuming and risky in case of intestinal lesions. An accurate and effective non-invasive preoperative measurement of the TSBL will allow to evaluate the variability of the TSBL, which affects the surgical strategy. Cross-sectional imaging could play an important role in this setting thanks to the possibility of measuring in a non-invasive way the TSBL. Some studies performed with both Computed Tomography (CT) and Magnetic Resonance (MR) report promising results. However, they are limited by the small size of the sample, the lack of standardized technique and the lack of an automatic method based on Artificial Intelligence (AI).

The evaluation of a reliable preoperative method to measure TSBL using cross-sectional imaging will potentially reduce intraoperative complications and insufficient long-term weight loss or nutritional deficiencies. In this scenario a possible solution could be the implementation of analysis method through the development of an AI algorithm capable of automatically segmenting the small intestine.

The PRIMARY END POINT of this study is to set up and validate a reliable and reproductible automatic method to measure the TSBL in patients candidates for laparoscopic bariatric/metabolic surgery, based on preoperative radiological imaging

The main phases of the project will be:

1. evaluate the feasibility of preoperative CT and MRI-base measurement of the TSBL in a large cohort of obese patients and compare radiological measurement with intraoperative laparoscopic measurement (method of elongation) as a reference standard (1).
2. Evaluate the more accurate cross-sectional imaging between CT and MRI to measure the length of the small intestine.
3. Build an AI tool that can automatically measure TSBL on transversal slice imaging.

Three high-volume Italian centers will enroll 195 obese patients who are candidates for metabolic surgery for obesity. Part of them will be established training cohort (total = 105 patients), used to set up the AI-based method of TSBL measurement. The other 90 patients (30 for each center) will represent the validation cohort.

Eligibility Criteria:
Inclusion Criteria:

* BMI \> 35 kg/m2 and at least one obesity-related comorbidity
* BMI \> 40 kg/m2
* failure of at least six months of dietary and/or medical treatment of obesity
* indication for intervention validated after multidisciplinary evaluation in a specific board meeting
Quality of Life and Psychology of Donors After Hepatectomy

Liver donation by a living donor is major surgery and has a profound effect on health-related quality of life and psychology. This study aims at evaluating those aspects of a donor for a period of five years after surgery.

Live donor liver transplantation (LDLT) has established itself as a treatment for end-stage liver disease but donor safety remains a major issue. It is the responsibility of the transplant team to restore donor's health, not only physical, but also mental, social and environmental. There is scarcity of long term longitudinal data on donor quality of life. Most of the studies are cross sectional which describe the quality of life at certain time point and do not take into account of changes that might occur over a period. It is more relevant in this scenario, as two persons from a family undergo surgery at the same time, which has a profound effect on family dynamics, and restoration towards normalcy goes hand in hand with adaptation to a new lifestyle. Another shortcoming of available literature is lack of uniform instruments which comprehensively measure the quality of life of live liver donors (LLDs). Standardized health related quality of life (HRQOL) instruments such as Short Form 36(SF 36) or World Health Organization quality of life Brief (WHOQOL-BREF) are not designed for LLDs. Moreover, there are several symptoms which might interfere with daily activities such as incision site problems , dyspepsia to name a few, but are not distressing enough to be reflected on quality of life scores .The aim of current study was to observe the attitude of donors pre transplant, quality of life over a period, satisfaction with the donation process, their assessment of the health care team, satisfaction with the consent process, and change in pattern of symptoms and cosmesis after surgery.

Eligibility Criteria:
Inclusion Criteriteria:

- All patients undergoing donor hepatectomy from March 2012 to August 2013

Exclusion Criteria:

- Refusal to participate in study
Short-term Prednisone to Treat STA Study(SPTSS)

Efficiency and Safety Study of Short-term Prednisone to Treat Moderate and Severe Subacute Thyroiditis

The investigators hypothesize that less adverse reactions will be observed, comparing with the guidelines recommend. The recurrence rate, adrenal insufficiency, temporary and permanent hypothyroidism aren't significant difference.

Comparing with the guidelines recommend, short-term (one week)prednisone and nsaids following up next week to treat moderate and severe subacute thyroiditis will be assessed.

The patients in wards will be assessed from temperature,erythrocyte sedimentation rate,C-reactive protein,local pain and goiter.The random treatment will be executed in moderate and severe SAT after informed consent be signed.

Subjects will be monitored once every 2 weeks.If patients complained of pain in their neck or if the erythrocyte sedimentation rate is still high,after discontinuation of prednisone, prednisone treatment will be resumed in moderate and severe subject and non-steroidal anti-inflammatory drugs will be used in mild subject.Anti-ulcer drugs will be administered to all patients.

The endpoint of the study are efficiency and safety of short-term prednisone treating. The investigators will assess adrenal insufficiency (such as anorexia, nausea, vomiting, abdominal pain),steroid withdrawal syndrome, recurrence rate and hypothyroidism. The investigators will observe erythrocyte sedimentation rate,pain,steroid level and thyroid function.

Eligibility Criteria:
Inclusion Criteria:

* 18-70 years patients with Moderate and severe subacute thyroiditis

Exclusion Criteria:

* adrenal cortical dysfunction,
* use of corticosteroids in nearly three months,
* mild subacute thyroiditis,
* non-onset STA,
* family history of diabetes,
* gastric ulcer,
* the special medication history,
* heart，liver and renal insufficiency,
* tumors,
* tuberculosis and
* poor compliance.
Comparison Between GLP 1 Analogues and DPP 4 Inhibitors in Type 1 Diabetes Mellitus

To study the effects of GLP 1 analogues and DPP 4 inhibitors on newly detected type 1 diabetes patients.

Inclusion criteria T1DM \<3 months GAD Antibody+ Stimulated C peptide\<0.5ng/ml Ketosis at onset Age \< 30 yr Exclusion criteria Age \> 30 yr Pancreatic disease significant systemic complication

Eligibility Criteria:
Inclusion Criteria:

* T1DM \<3 months
* GAD Antibody+ or Stimulated C peptide\<0.5 ng/ml
* Ketosis at onset
* Age \< 30 yr

Exclusion Criteria:

* Age \> 30 yr
* Pancreas disease
* Significant systemic disease
Management of Infant Digestive Disorders and Quality of Life

The objective of the study is to measure the evolution of the quality of life in infants between 0 and 5 months old, not breastfed and suffering from regurgitation or colic.

The objective of the study is to measure the evolution of the quality of life in infants between 0 and 5 months old, not breastfed and suffering from regurgitation or colic, following nutritional management of these disorders by a preparation for thickened infants, reduced in lactose content and supplemented with Lactobacillus reuteri DSM 17938. Quality of life is assessed using the QUALIN questionnaire

Eligibility Criteria:
Inclusion Criteria:

Full-term infants (\> 37 weeks gestation and \<42 weeks gestation), less than 4 months of age at recruitment

* Infants with regurgitation and / or colic defined according to Rome IV criteria
* Non-breastfed infants
* Parents who understand and speak French fluently
* Parents agreeing to send their email address and having a computer tool (computer, tablet or smartphone) allowing them to complete the QoL questionnaires and the satisfaction questionnaire
* Parents having understood the protocol and the information given and having given the participation agreement including their acceptance to return for consultation with the same doctor after a period of 30 days.

Exclusion Criteria:

Infant born prematurely (\<37 weeks)

• Intercurrent pathology other than a functional intestinal disorder which can by themselves cause, directly or as a result of treatments, a functional intestinal disorder: Study Management of infant digestive disorders and Quality of life

* Food allergy
* Digestive pathology (Gastroenteritis, celiac disease, high or low digestive malformations....)
* Heart failure, cyanogenic heart disease
* Chronic respiratory diseases (bronchopulmonary dysplasia, malformations, respiratory failure)
* Neurological pathologies (Cerebral palsy, intracranial hypertension, convulsive state)
* Congenital metabolic pathologies
* Genetic diseases
* Kidney malformations, Vesicoureteral reflux, Kidney failure.
* Drug treatment in progress and which will be continued during the study, other than vitamins (D, K, ...)
* Partial or total breastfeeding
* Infants already fed:
* with a hypoallergenic formula (HA)
* or with a high hydrolyzate of cow's milk proteins or formula based on rice protein hydrolyzate
* Growth retardation (weight and or height less than or equal to - 2 DS) or break in the weight curve (no weight gain or weight loss in the past month) Prescription of drugs or food supplements other than vitamins at the end of the visit
Sex and Gender-based Analysis of the Effectiveness of Advanced Therapies in Psoriatic Arthritis

Sex and gender are important factors that influence treatment response in PsA. The goal of this multi-centre observational study is to understand how sex and gender influence response to advanced therapies in psoriatic arthritis (PsA). The investigators hope to discover biological and socio-cultural mechanisms that explain the differences in treatment response between men and women with PsA.

The study investigators plan to recruit patients from approximately 30 sites across the world. Men and women with active PsA will be assessed before and after they start advanced therapies and information will be collected about sex- and gender-related factors through questionnaires and physical examination. Physicians will assess the patient response to treatment. The investigators will compare the response to treatment in men and women and assess what biological and socio-cultural factors contribute to differences in treatment response.

Study investigators will perform a prospective, multi-center, international cohort study involving approximately 30 sites that specialize in care of patients with PsA. 540 patients with a rheumatologist-confirmed diagnosis of PsA who are initiating advanced therapy for peripheral musculoskeletal manifestations of PsA will be enrolled. The study will include 2 in-person physician visits. Visit 1 (baseline) will take place prior to drug initiation (up to 3 months prior). Visit 2 (follow-up) will occur 3-6 months following drug initiation. In addition, study sites will be asked to report persistence status on the study drug at 1 year.

Eligibility Criteria:
Inclusion Criteria:

* Rheumatologist confirmed diagnosis of PsA according to CASPAR criteria
* Age ≥18 years
* Active PsA with any of the following manifestations detected on physical examination: peripheral arthritis, dactylitis, and enthesitis. The patient may have axial involvement in addition to the peripheral manifestations of PsA
* Plan to start treatment with advanced therapies for peripheral musculoskeletal manifestations of PsA

Exclusion Criteria:

* Unable to read or write
* Unable to sign informed consent
* Cannot return for a follow up visit
* The drug is given for another indication and not for active PsA (e.g. psoriasis, IBD)
* Pregnant women
PMS Study of Amlodipine/Valsartan for the Treatment of Hypertension

The antihypertensive effect of Amlodipine/Valsartan combination has been evaluated in worldwide populations including Asian patients. The study primarily aims to evaluate the effectiveness of Amlodipine/Valsartan combination in patients with essential hypertension in Taiwan using a prospective, open-label, non-randomized approach.

The study also wants to investigate the safety of Amlodipine/Valsartan combination during the 6-week treatment period.


Eligibility Criteria:
Inclusion Criteria:

* Patients who are 20-80 years of age
* Patients with essential hypertension (90 mmHg ≤ DBP ≤ 110 mmHg and/or 140 mmHg ≤ SBP ≤ 180 mmHg) whose BP is not adequately controlled with amlodipine (or another CCB) alone or with valsartan (or another ARB) alone, or with any antihypertensive monotherapy.
* Agree to and are able to follow the study procedures
* Understand the nature of the study, and have signed informed consent forms

Exclusion Criteria:

* Patients with any of the following conditions:

  1. Malignant (or history of malignant) hypertension
  2. Secondary hypertension
  3. Severe hypertension (mean sitting DBP ≥ 110 mmHg and/or mean sitting SBP ≥ 180 mmHg)
  4. A history of hypertensive encephalopathy or cerebrovascular accident
  5. Cerebrovascular accident, myocardial infraction within 3 months, or any type of revascularization
  6. New York Heart Association class III -IV congestive heart failure
  7. Second- or third-degree heart block
  8. Angina pectoris
  9. Significant arrhythmia or valvular heart disease
  10. Significant pancreatic, hepatic, or renal disease
  11. Diabetes requiring insulin treatment or poorly controlled type 2 diabetes
* Patients with known contraindication or a history of allergy to CCBs or ARBs.
* Female patients who are pregnant or lactating.
* Male or female patients of child-bearing potential who do not agree to use an effective method of contraception during the study
* Patients is currently participating in any other clinical trial within 30 days
Retroclavicular Versus Supraclavicular Brachial Plexus Block for Hand and Forearm Surgery

Patients will be randomized to one of two groups:

1. Supraclavicular group: supraclavicular brachial plexus block performed with the aid of ultrasound;
2. Retroclavicular group: retroclavicular brachial plexus block performed with the aid of ultrasound.

The study will be proposed to all patients undergoing formarm or hand surgery under brachial plexus block. Patients will be randomized to one of two groups The first group - supraclavicular group - will receive an ultrasound-guided brachial plexus block via the supraclavicular approach, by injection of 30 ml of a mixture of ropivacaine 0.5 % + mepivacaine 1 %. The second group - retroclavicular group - will receive an ultrasound-guided brachial plexus block via the retroclavicular approach, by injection of 30 ml of a mixture of ropivacaine 0.5 % + mepivacaine 1 %. Primary outcome is success rate at 30 minutes after the injection defined as loss of sensation to pinprick in the forearm and hand. Secondary outcomes are: needling time, time to first analgesic request, postoperative opioid consumption, pain scores at 12 and 24 hours postoperatively, block-related complications, and patient satisfaction.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients who undergo forearm or hand surgery under brachial plexus block.

Exclusion Criteria:

* History of allergic reaction to local anaesthetics

  * Peripheral neuropathy
  * Renal or hepatic insufficiency
  * Coagulation disorders
Immunological Memory Induced by the 13valent Pneumococcal Conjugate(PCV13) and 23valent Plain Polysaccharide Vaccine(PPV23) in HIV-infected Patients

The purpose of this study is to determine the effect of a combined vaccination schedule of the 13-valent pneumococcal conjugate (PCV13) and 23valent plain polysaccharide vaccine (PPV23) on the establishment of immunological memory in HIV-infected adults on ART.


Eligibility Criteria:
Inclusion Criteria:

* CD4 T cell count \>200cells/μl
* on ART

Exclusion Criteria:

* no previously recorded allergy to PCV, PPV23
* no intravenous immunoglobulin (IVIG) given within the previous 6 months
* no other vaccine given within the previous 6 months
Colectomy for Cancer in the Elderly by Laparoscopy or Laparotomy

The purpose of this study is to compare the postoperative global morbidity between patients who have been operated on for a colon cancer by laparotomy and those operated on by laparoscopy

The present study is a national, multicenter, open-label randomized, 2-arm superiority trial. Patients aged 75 years or older with uncomplicated colonic cancer or precancerous colonic lesion non-endoscopically resectable, will be randomized to either colectomy by laparoscopy or laparotomy. All patients that might be included will have a comprehensive geriatric assessment performed within the 30 days before randomization with the following scores: MMS (Mini Mental Score), ADL scale (Activities of Daily Living), IADL scale (Instrumental Activities of Daily Living), GDS (Geriatric Depression Scale) and TGUG test ("Timed Get-Up-and-Go" test).

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 75 years
2. Histologically proven colonic adenocarcinoma (\> 15 cm from the anal margin) or precancerous colonic lesion non endoscopically resectable
3. Uncomplicated colonic tumor (no preoperative suspicion of invasion of adjacent structures as assessed by CT-scan (cT4), no tumoral perforation, or tumoral obstruction, or abscess, or hemorrhage)
4. No previous colonic cancer within the 5 last years
5. No peritoneal carcinosis on CT-scan
6. Patient able to fill in an auto-questionnaire alone or with some help
7. MMS (Mini Mental Score) ≥ 15
8. Given oral consent (formal informed consent is not required by French law for accepted procedures)

Exclusion Criteria:

1. Rectal cancer (≤ 15 cm from the anal margin)
2. Locally advanced (cT4) or complicated tumor requiring extended resection or emergency surgery
3. Synchronous colonic cancer
4. - Scheduled need for synchronous intra-abdominal surgery, including surgery for liver metastases
5. Absolute contraindications to general anesthesia or prolonged pneumoperitoneum
6. Patient not able to tolerate colon surgery according to the global comprehensive geriatric assessment
7. Estimated life expectancy less than 6 months
8. Patient under guardianship
9. Other known active cancer (except nonmelanomatous skin cancer)
10. Patient not affiliated to the social security system
11. Previous colonic resection
The Association of Maternal Night-Eating Pattern With Glucose Tolerance During Pregnancy

This study aims to assess the associations of maternal food timing with glucose levels during pregnancy.

A novel line of research has emerged, suggesting that synchronizing the timing of food intake with body's circadian rhythms or day-night cycle has metabolic implications. Eating at the inappropriate time can disrupt circadian system which might induce metabolic perturbations, including glucose abnormalities. Recent evidence showed that circadian timing of eating was associated with glucose regulation in pregnant women. However, little is known about night-eating pattern during pregnancy, particularly the influence of nocturnal snacking on glycaemic control.

This cross-sectional study aims to recruit 400 pregnant women at 18-21 weeks' gestation. The investigators will assess maternal dietary intake, monitor 24-hour activity-rest pattern and light-dark exposure, and measure glucose and insulin profiles during the second trimester of pregnancy. Maternal socio-demographic status, lifestyle characteristics, health conditions and pregnancy outcomes will be asked through interview or retrieved from medical notes.

This study allows understanding the importance of circadian eating pattern, which is a modifiable behavior, in glycaemic control during pregnancy, and help to provide evidence for developing nutritional guidelines which can ameliorate metabolic health for mothers.

Eligibility Criteria:
Inclusion Criteria:

1. 18-21 week's gestation
2. Singapore citizens or Singapore Permanent Residents
3. Age 18-45 years
4. Plan to follow-up for antenatal care in KK Women's and Children's Hospital
5. Intend to deliver in KK Women's and Children's Hospital
6. Provide written informed consent

Exclusion Criteria:

1. Type 1 or 2 diabetes
2. Diabetes in pregnancy as confirmed by oral glucose tolerance test
3. Use of medications such as anticonvulsant medications or oral steroids in the past 1 month
4. Multiple pregnancy
5. On routine night-shift work for at least 3x/week over the past 1 month
6. Known or suspected allergy to medical grade adhesives
7. Chronic kidney diseases
8. Preeclampsia
9. Eventual miscarriage or undergo termination event