cyrilzakka/clinical-trials huggingface dataset:
High Resolution IR Imaging for Diagnosis in the Acute Limping Child - ThermLimp

A variety of different diseases may cause a limp in a child, and in younger children it is particularly challenging to isolate the area affected. Children of this age group are unable to identify a specific region of pain, so clinical examination and parental interpretation is the only method of localising the area of discomfort. Potential problems that may affect children include inflammation, fractures, infection, juvenile arthritis or movement in the growth plate in the hip, among other diseases. Aside from an obvious source of injury, it is challenging for a clinician to distinguish between these different potential causes or the area of the problem without repeated visits, non-specific blood tests and the use of x-ray imaging: a form of radiation that carries with it a small risk of carcinogenic effect. Once a region of the lower limb is identified, an x-ray image of the affected area is often taken; however, it is not possible to image the entire leg, so the importance of the initial examination by a clinician is evident. The aim of this research project is to assess the potential of high resolution infrared (IR) imaging technology in the identification of a focus for the cause of a limping child. The IR camera used for imaging is able to observe an entire limb, so the need to localise an area for imaging would be removed. In addition, if successful, infrared imaging could reduce the number of children exposed to x-ray radiation unnecessarily, whilst stream-lining medical practice by reducing the time to make a diagnosis along with unnecessary visits and tests. The investigators aim to explore whether non-invasive IR thermographic camera imaging assists with the clinical diagnosis in children presenting with an acute limp. This study represents a pilot evaluation as a test of concept.


Eligibility Criteria:
Inclusion Criteria:

* Children age 9 months -16 years old who attend the Emergency Department (ED) of the Sheffield Children's Hospital for an acute (less than 48 hours) limp. Inclusion is subject to both the patient and carer having read (or being read to in very young children) the information sheets and both the patient and carer consenting to participate.

Exclusion Criteria:

* Children with multiple injuries (e.g. those involved in serious car accidents), or those who have difficulty understanding the nature of the study (e.g. non-native English speakers, those with disabilities impairing their understanding of the study etc.) will be excluded. Patients/carers in whom consent has not been obtained or refused will also be excluded.

Children who attend the ED with safeguarding concerns or in whom child protection suspicions arise during the consultation will be excluded. These children have a separate assessment process which would be significantly different to the study cohort.
Individualized Perioperative Open Lung Ventilatory Approach in Emergency Abdominal Laparotomy. A Prospective Multicenter Randomized Controlled Trial.

Prospective multicenter randomized controlled trial. Individualized perioperative open lung ventilatory approach in emergency abdominal laparotomy.


Eligibility Criteria:
Inclusion Criteria:

* Adult men and women ≥18 years of age who underwent emergency laparotomy with the presence of post-induction positive air-test (SpO2 \<97% after a maximum of 15 minutes at FIO2 of 0.21). A SpO2 \<97% at any FIO2 would also be considered a positive air-test.

Exclusion Criteria:

* 1) Pregnancy or breast feeding, 2) Moderate or severe ARDS defined, 3) refractory shock, 4) diagnosis or suspected intracranial hypertension (\>15mmHg), 5) mechanical ventilation in the last 15 days (including CPAP), 6) presence of pneumothorax or giant bullae in a chest radiograph or computed tomography (CT), 7) patients participating in another intervention study with the same or similar primary outcome variable.
Short Message System (SMS) for Caregivers of Suicidal Patients to Prevent Recidivism of Suicide Attempts

Assessment of the feasibility of a monitoring device by SMS in which messages are sent by the caregiver after a suicidal act.


Eligibility Criteria:
Inclusion Criteria:

* Male or female, over 18 years of age and hospitalized;
* Survivor of a suicide attempt;
* Giving informed, dated and signed consent;
* Can be reached by mobile phone. The study is proposed to all adult suicides and to the patient's designated caregiver, meeting the inclusion criteria.

Exclusion Criteria:

* Patient whose clinical condition is incompatible with the formulation of his non-opposition.
* The patient and his / her caregiver shall not be afforded a protective justice measure.
Measurement of Different Anti-Müllerian Hormone Isoforms in Expected Poor Responders

This study wants to evaluate significant clinical impact of different AMH isoforms in serum can be present or absent in expected poor responder participants. The specific AMH isoforms could therefore be measured in expected poor responder participants in order to obtain a more realistic clinical picture and therefore be able to give proper information to the participants and selection of medication dose for ovarian stimulation.

The study has a prospective observational multicentric design and the investigators aim to investigate the presence of AMH isoforms and the levels of Inhibin B in serum among a population of participants with low ovarian reserve (AMH blood test below 1.1 ng/ml). Transvaginal scan for AFC and blood drawn from participants will be obtained on day 2-3 of menstrual period. The serum will be divided for AMH analysis using different assays: Elecsys Cobas assay for AMH and AnshLabs AMH isoforms specific assays (picoAMH 24/32 Pro-Mature, 24/37 Midpro-Midpro, 17/15 Mature-Mature and 10/24 Pro-Midpro) and AnshLabs Inhibin B ELISA.

Clinically it is not uncommon to see a discrepancy between the AFC count and the levels of AMH; this could be potentially explained by the presence of different AMH isoforms not measured with conventional commercial assays. Also, the evaluation of Inhibin B may be helpful for ovarian reserve assessment. Quantitation of specific Isoforms of AMH by different ELISA methods will investigate a possible relationship(s) between specific isoforms of AMH and poor responders.

Eligibility Criteria:
Inclusion Criteria:

* pre-treatment AMH recording below 1.1 ng/ml on day 2 or 3 of the menstrual cycle.
* BMI between 18 and 30 kg/m2.

Exclusion Criteria:

* Pregnancy.
* Breastfeeding.
* Intake of oral contraceptive pills or steroids for the last two menstrual cycles.
* Endometriosis.
* Previous surgical intervention, which could have an impact on the ovarian reserve, e.g. ovarian cyst removal, removal of one or both tubes, tubal ligation for sterilisation
Influence of Lidocaine Infusion on Motor Evoked Potential Thresholds

The purpose of this study is to determine the effect of lidocaine infusion on intraoperative neuromonitoring in patients undergoing spine surgery.

The investigators will compare the stimulation threshold for motor evoked potentials (MEPs) for patients undergoing spine surgery with intraoperative neurophysiologic monitoring (IONM) who receive a lidocaine infusion vs. normal saline (NS) infusion. The endpoint for this objective will be the final stimulation threshold for MEPs at the end of the surgery. The stimulation threshold for MEPs is a commonly used metric to determine the effects of anesthetic agents on MEP signals. Secondary objectives will somatosensory evoked potentials (SSEPs) with an endpoint of amplitude and latency of SSEPs throughout the surgery. Other secondary outcomes will include, intraoperative mean arterial pressure (MAP), intraoperative propofol consumptions, and post-operative visual analog scale (VAS) and opioid consumption.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing elective cervical or thoracolumbar spine surgery with intraoperative neurophysiological monitoring

Exclusion Criteria:

* Inability to provide informed consent in English
* Pregnancy (based on patient report or a positive test on the day of surgery)
* Contraindication to lidocaine
* Planned post-operative intubation
* Current incarceration
Evaluation of Bleeding Score in Egyptian Patients With vWD Type I and Correlate it With Laboratory Parameters

Applying the ISTH-BAT questionnaire on Egyptian patients with type I VWD aiming to correlate the BS with the laboratory findings

The clinical phenotype of the disease is variable and tends to be mild in type 1 vWD, whereas it shows serious bleeding manifestations in types 2 and 3. Overall, the symptoms reported in vWD include easy bruising, epistaxis, gastrointestinal bleeding, excessive menstrual bleeding, postpartum haemorrhage, and excessive bleeding after surgical operation and minor wounds.However, A distinctive bleeding history is a prerequisite for the diagnosis of any bleeding disorder and should guide further laboratory investigations In an attempt to standardize the diagnostic criteria of VWD, a bleeding questionnaire and a bleeding score were developed The combination of a standardized bleeding questionnaire and a well-defined interpretation grid (for the computation of the final (BS) has been referred to as a Bleeding Assessment Tool (BAT).

Eligibility Criteria:
Inclusion Criteria:

* type 1 vWD patients
* healthy subjects with no known problem with bleeding or bruising were also recruited

Exclusion Criteria:

-
Vitamin D Supplementation Requirement in Obese Subjects

Vitamin D deficiency is common in obese patients. Most of vitamin D supplementation studies were done with non-obese subjects. This study looks at vitamin D supplementation requirements in obese patients as compared to non-obese subjects. This study also looks at changes in vitamin D level in obese patients undergoing medical weight loss. It is thought that obese patients have vitamin D deficiency through storage of vitamin D in the fat compartment not readily available for blood measurement. The investigators' hypothesis is that with medical weight loss vitamin D levels will increase in obese subjects.

We intend to study changes in serum 25(OH)D level with calorie restricted weight loss in obese subjects. This will be a double dummy, placebo controlled randomized trial. Subjects whose serum 25(OH)D level is below 80 nmol/L will be assigned randomly to either the vitamin D supplemented or the placebo group. Those who are assigned to the placebo group will be weighed on a weekly basis and serum 25(OH)D level will be followed every 8 weeks for a minimum of 16 weeks and extended to the duration of weight loss along with serum calcium level. Changes in serum 25(OH)D level will be obtained with weight loss through restricted caloric intake.

To study the 25(OH)D dose-response curve with vitamin D supplementation in obese subjects, vitamin D supplemented group will receive initial daily vitamin D3 supplementation dose based on their baseline serum 25(OH)D level as described in Methods and Procedures section. Serum 25(OH)D levels will be drawn at 8 weeks and adjustments to the dose will be made based on the an algorithm to achieve serum 25(OH)D levels between 80 and 140 nmol/L. The dose-response curve obtained at 8 weeks will be compared to the one already established with non-obese subjects. Serum 25(OH)D level will be obtained at 16 weeks and compared with the data available from non-obese subjects.

Eligibility Criteria:
Inclusion Criteria:

* Healthy men or women between the ages of 18 and 70 years old who are enrolled in our Weight Management Program with baseline BMI \> 30 Kg/m2.

Exclusion Criteria:

* Pregnancy,
* Serum 25(OH)D level greater than 80 nmol/L,
* Hypercalcemia (serum calcium level greater than the upper limit of normal),
* Recent surgery or illness,
* Those with chronic use of medications that influence calcium/vitamin D metabolism such as anti-convulsants, lithium and steroids. Thiazide diuretics for hypertension will be acceptable.
* Subjects with sarcoidosis will be excluded.
* Those who do not qualify to participate in the Weight Management Program will be excluded. They include subjects with active substance abuse and unstable cardiac disease.
Clinical and Economic Outcomes in Laparoscopic Sleeve Gastrectomy Versus Roux-en-Y Gastric Bypass Surgery

Study objectives:

1. generate local clinical, health-related quality-of-life and health economic data to evaluate the benefits of two types of minimally invasive weight-loss surgery
2. support multi-disciplinary bariatric sites in Germany by providing structured procedure guidelines and training, therefore facilitating procedural adoption, increasing safety and shortening the learning curve for weight-loss surgery.

The objectives of this study are the following: to generate local clinical, health-related quality-of-life and health economic data to evaluate the benefits of two types of minimally invasive weight-loss surgery; and to support multi-disciplinary bariatric sites in Germany by providing structured procedure guidelines and training, therefore facilitating procedural adoption, increasing safety and shortening the learning curve for weight-loss surgery.

Eligibility Criteria:
Inclusion Criteria:

* All patients aged from 18 to 65 years of age, inclusive
* BMI \> 40 or BMI \> 35 with co-morbidities
* Eligible for weight-loss surgery
* Planned laparoscopic gastric sleeve resections or Roux-en-Y bypass surgery
* Insurance approval status: approved
* Written informed consent

Exclusion Criteria:

* BMI \> 55
* Planned two-stage procedures
* Prior bariatric procedures (including gastric banding)
* Serious mental or physical co-morbidities at the discretion of the Investigator
* Insurance approval status: rejected
A Pan-cancer Screening and Diagnosis Model Based on Abdominal CT Was Established

Abdominal noncontrast scan and contrast-enhanced CT were used to establish a screening and diagnostic model for abdominal tumors

Secondary objective: To establish a grading model of abdominal tumors based on clinical indicators Exploratory Objective: To include CT scans in large-scale non-tumor populations for validation and to improve model accuracy Certainty

Eligibility Criteria:
Inclusion Criteria:

* Patients with abdominal tumors:
* all patients were pathologically diagnosed with abdominal tumors;
* The clinical case data of all patients were complete, and complete follow-up was obtained, with clear information on medical visits, operation time and survival status within 2 years. If the cause of death is unknown, it will be recorded as censored data;
* All patients had no history of active abdominal bleeding, no serious infection or other abdominal diseases that affected the observation of CT imaging within 3 months before surgery.
* Non-tumor population:
* all patients have complete clinical case data, complete abdominal CT, no history of malignant tumors, no serious infections or other abdominal diseases that affect the diagnosis and observation of CT imaging.

Exclusion Criteria:

* Cases in which contrast-enhanced or noncontrast CT images show unclear lesions, with significant noise and artifacts;
Prospective Registry to Evaluate Outcomes of NanoBone® Bone Graft in Acute Trauma

This multicenter prospective patient registry was developed with the aim of documenting how orthopedic surgeons are utilizing the NanoBone products in acute trauma cases along with relevant patient outcomes. These outcomes include radiographic measures such as fracture healing, instrumentation integrity, and clinical outcomes (symptom and function improvement) based on investigator and patient-based outcome assessments.

This multicenter prospective patient registry was developed with the aim of documenting how orthopedic surgeons are utilizing the NanoBone products in acute trauma cases along with relevant patient outcomes. These outcomes include radiographic measures such as fracture healing, instrumentation integrity, and clinical outcomes (symptom and function improvement) based on investigator and patient-based outcome assessments.

The primary objective of this study is to document and analyze the use of NanoBone products in acute trauma cases (as a stand-alone bone graft, or in combination with local bone only, no other bone graft substitute or biologic product used) and determine both radiographic success and clinical outcomes. All product related adverse events will be documented, tabulated, and summarized.

Eligibility Criteria:
Inclusion Criteria:

1. Subjects at least 18 years old at the time of injury
2. Acute fractures, resulting from blunt or penetrating trauma

   * In the extremities or pelvis
   * Requiring surgery
   * Treated emergently, delayed or staged up to 4 weeks from the date of injury
   * Where bone grafting is clinically indicated

Exclusion Criteria:

1. Certain fracture locations (these apply to non-unions as well)

   * Hand - metacarpals, phalanges
   * Forefoot - metatarsals, phalanges
   * Skull
   * Spine
2. Fractures requiring definitive fracture stabilization beyond the initial 4 weeks from the date of injury
3. Pathologic fractures secondary to malignancy
4. Subjects unable to follow recommended post-operative plan and complete follow ups
5. Subjects unable to complete patient reported outcome measures
A Study of Tofacitinib in Patients With Ulcerative Colitis in Stable Remission

This study is a follow up study for subjects with Ulcerative Colitis (UC) in stable remission designed to evaluate flexible dosing of CP-690,550.


Eligibility Criteria:
Inclusion Criteria:

* Currently enrolled in Study A3921139 receiving CP-690,550 10 mg BID for at least 2 years consecutively.
* In stable remission on CP-690,550 10 mg BID
* Agree to use highly effective contraception
* Negative pregnancy test
* Comply with visits, treatments, lab tests, diary and other study procedures
* Signed and dated informed consent document.

Exclusion Criteria:

* Subjects who were initially assigned to tofacitinib 10 mg BID at baseline of Study A3921139 whose tofacitinib dose was reduced to 5 mg BID due to safety or efficacy.
* Presence of indeterminate colitis, microscopic colitis, ischemic colitis, infectious colitis or findings suggestive of Crohn's disease
* Likely to require surgery for ulcerative colitis during study
* Expected to receive any prohibited medication
* Expected to receive live or attenuated virus vaccination during study
* Women who are pregnant or breastfeeding or planning to become pregnant during the study
* Evidence of colonic malignancy or any dysplasia
* Acute or chronic medical or psychiatric condition that may increase risk of participation
* Investigator site staff member
* Subjects likely to be uncooperative or unable to comply with study procedures
* Participation in other studies involving investigational drugs during study
* Subjects with any of the following risk factors for pulmonary embolism at baseline as defined by EMA's PRAC:

  * has heart failure;
  * has inherited coagulation disorders;
  * has had venous thromboembolism, either deep venous thrombosis or pulmonary embolism;
  * is taking combined hormonal contraceptives or hormone replacement therapy;
  * has malignancy (association is strongest with cancers other than non-melanoma skin cancers);
  * is undergoing major surgery
A Peer Support Network System Construction for the Primary Caregivers of Children With Biliary Atresia

The peer support WeChat platform for primary caregivers of children with biliary atresia can provide social support ,help them adopt positive coping styles to face the disease, and reduce negative emotions and caregiver burden.

The primary caregivers of children with biliary atresia have a heavy psychological burden, but there is a lack of supportive research on this population. Therefore, this study used a web-based peer support platform to intervene in the primary caregivers of children with biliary atresia to reduce the psychological burden of this population.

The study consisted of two parts. First, a literature analysis, semi-structured interviews, and expert validation are used to form a peer support WeChat platform for primary caregivers of children with biliary atresia.

Second, primary caregivers of children with biliary atresia are selected as the study population and divided into intervention and control groups in chronological order at a children's hospital in Shanghai. Primary caregivers who visit the hospital between August 2022 and October 2022 are assigned to the control group and primary caregivers who visit the hospital between January 2023 and March 2023 are assigned to the intervention group. The intervention group receives a peer support WeChat platform intervention on top of usual care from the day of surgery to one postoperative month. The levels of negative emotions and caregiver burden are compared between the two groups after the intervention.

Eligibility Criteria:
Inclusion Criteria:

* Child was diagnosed with biliary atresia congenital type 3 and required kasai portoenterostomy ;
* Providing primary care for the child;
* Use a smartphone and have access to the internet;
* Normal communication ability;
* Volunteering to participate in the study.

Exclusion Criteria:

* Existing or previous mental illness;
* Presence of severe anxiety (SAS ≥ 70 points) or depressive mood (SDS ≥ 70 points);
* Children with comorbidities other than biliary atresia;
* Refusal to cooperate.
Optimization of Interval-training in Patients With Type 2 Diabetes

A single bout of Interval-Walking (IW) exercise is superior to energy-expenditure and time-duration matched Continuous Walking (CW) exercise upon improving glycemic control. The time spend with high-intensity (fast) walking is considered to be responsible for the improvements seen, whereas the time spend with low-intensity (slow) walking is considered less important.

This study will assess if IW with maintained fast walking time duration but reduced total time duration (i.e. reduced slow walking time duration) is equally effective as IW with a normal time duration.

Subjects with type 2 diabetes will be included in a crossover, controlled study, where each subject will undergo three trials. Trials will be identical except the following interventions:

1. Sixty minutes of rest (CON)
2. Sixty minutes of classical interval walking (repeated cycles of 3 minutes of fast and 3 minutes of slow walking; IW-60)
3. Fourty-five minutes of time-reduced interval walking (repeated cycles of 3 minutes of fast and 1.5 minutes of slow walking; IW-45).

After the interventions subjects will undergo a standardized mixed meal tolerance test with assessment of glycemic control.


Eligibility Criteria:
Inclusion Criteria:

* Type 2 Diabetes Mellitus
* BMI \> 25

Exclusion Criteria:

* Pregnancy
* Smoking
* Contraindication to increased levels of physical activity
* Eating disorder
* Insulin dependence
Holmium-166 Retrospective Collection of Real-World Data

The primary objective of the study is to further describe the general safety and clinical performance of QuiremSpheresTM Holmium-166 Microspheres and QuiremScoutTM Holmium-166 Microspheres in a real-world post-market setting, with specific attention to outcomes per tumor origin.

This study, with an observational retrospective longitudinal design, is intended to collect data from the devices (QuiremScoutTM Holmium-166 Microspheres, QuiremSpheresTM Holmium-166 Microspheres, and where available, Q-SuiteTM) used in a post-market, real-world setting. It is non-comparative due to the retrospective nature of the study.

Eligibility Criteria:
Inclusion Criteria:

* Patient with diagnosis of primary liver tumor or metastases in the liver.
* Patients treated with QuiremScoutTM Holmium-166 Microspheres and/or QuiremSpheresTM Holmium-166 Microspheres from 15 July 2019 to 15 July 2021.
* Patient is ≥ 18 years.
* If required by national regulation, patient has understood and signed written informed consent to retrospective data collection.

Exclusion Criteria:

* Patients previously included in prospective interventional study with QuiremScoutTM Holmium-166 Microspheres and/or QuiremSpheresTM Holmium-166 Microspheres.