cyrilzakka/clinical-trials huggingface dataset:
Japanese National Computed Tomographic (CT) Colonography Trial

The purpose of this study is to evaluate the sensitivity of computed tomographic colonography (CTC) in detecting colorectal polyps and cancers in 1,500 subjects at increased risk of colorectal cancer (CRC), using optical colonoscopy as the reference standard.

The investigators will evaluate the sensitivity of CTC in detecting colorectal polyps and cancers (at least 6 mm in diameter) in 1,500 subjects at increased risk of colorectal cancer (CRC), using optical colonoscopy as the reference standard. The primary endpoint will be sensitivity in the detection of colorectal polyps and cancers that are at least 6 mm in diameter. The secondary endpoints will include specificity and predictive values in the detection of colorectal polyps and cancers.

This clinical study will also evaluate the differences of the detection accuracies between human readings with and without computer-aided detection (CAD) that automatically detects colonic lesions in CTC images and presents the detected lesions to the readers. This clinical study will also compare performance between radiologists and gastroenterologists in detecting colorectal lesions in CTC images.

All the CTC images and their interpretations, optical colonoscopy reports and images, and pathology reports of resected colorectal lesion will be prospectively collected from 12 Japanese hospitals participating in the trial. All patients' information will be completely anonymized at each site before any analysis of the data takes place.

Eligibility Criteria:
Inclusion Criteria:

* Outpatients who are eligible for optical colonoscopy.
* Aged 20 years or older.
* Major functions of organs of the subjects are in a good condition.
* Signed informed consent forms are obtained from the patients.

Exclusion Criteria:

* Known colorectal polyps or cancers at any site at the time of enrollment.
* Patients with inflammatory bowel disease.
* Fulfillment of clinical criteria for diagnosis of FAP or HNPCC (Amsterdam criteria).
* Serious medical conditions that may increase the risk of optical colonoscopy or are so severe that screening would have no benefit.
* Previous colorectal surgery.
* Gastric or intestinal stenosis, abdominal adhesions, bowel obstruction or perforation, toxic megacolon.
* Evidence of an increased risk in carrying out bowel preparation or CTC exams.
* Possibility of pregnancy.
* Optical colonoscopy or barium enema carried out within the last 3 years.
* Patients with psychological conditions that contraindicate colonoscopy or that make them irrelevant to participate in the trial.
* Iodine hypersensitivity.
* Severe thyroid disease.
* Claustrophobia.
* Severe deafness.
* Subjects whose eligibility for this clinical trial is not appropriate by other reasons.
Study of Efficacy and Safety of Ligelizumab in Adolescents and Adults With Chronic Inducible Urticaria Who Remain Symptomatic Despite Treatment With H1- Antihistamines

This was a placebo controlled, phase 3 study designed to evaluate the efficacy and safety of ligelizumab in participants with chronic inducible urticaria who are inadequately controlled with H1-antihistamines

There are currently no approved therapies for patients with CINDU who remain symptomatic despite treatment with H1-antihistamines. The purpose of this study was to establish efficacy and safety of ligelizumab (QGE031) over placebo in participants with chronic inducible urticaria (CINDU) who remain symptomatic despite treatment with H1 antihistamine.

Eligibility Criteria:
Inclusion Criteria:

* Confirmed CINDU diagnosis (as per guidelines) for symptomatic dermographism, cold urticaria or cholinergic urticaria for ≥ 4 months.

  * Diagnosis of CINDU (symptomatic dermographism, cold urticaria or cholinergic urticaria) inadequately controlled with H1-AH at local label approved doses at the time of randomization, as defined by all of the following:
  * Positive response (i.e development of symptoms) to triggers despite treatment with H1-AH
  * Positive response (i.e. development of symptoms) to provocation test on day of randomization
  * Participants must be able to physically perform the protocol defined provocation test specific to the participant's CINDU.
  * Cholinergic urticaria participants must show sweating in performing the pulse-controlled ergometry test on day of randomization. Participants with anhidrosis must not be included.
  * Willing and able to complete a daily symptom eDiary as per protocol requirement and adhere to the study visit schedules

Exclusion Criteria:

* History of hypersensitivity to any of the study drugs or its components or to drugs of similar chemical classes or to the provocation test or items used in provocation tests

  * Participants who have concomitant CSU at screening
  * Participants who have a familial form of the target CINDU that is being considered for the participant's inclusion in this study
  * Participants having a more defined other form of inducible urticaria than the target CINDU that is being considered for the participant's inclusion in this study
  * Diseases, other than chronic inducible urticaria, with urticarial or angioedema symptoms such as urticarial vasculitis, erythema multiforme, cutaneous mastocytosis (urticaria pigmentosa) and hereditary or acquired angioedema (eg, due to C1 inhibitor deficiency).
  * Any other skin disease associated with chronic itching that might influence, in the investigator's opinion, the study evaluations and results (eg, atopic dermatitis, bullous pemphigoid, dermatitis herpetiformis, senile pruritus, etc.) or skin diseases associated with only wheals and no itch e.g asymptomatic dermographism
  * Prior exposure to ligelizumab, omalizumab and or other anti-IgE therapies
Thyroid Autotransplantation in Quadriceps Femoris Muscle

providing an almost natural ectopic thyroid in patients undergoing total thyroidectomy, remains a challenging subject that can benefits patients with a non-pharmacological substitute for their normal gland. this study seeks to prove that thyroid autotransplantation is possible and reliable.

Total thyroidectomy, rather thyroidectomy, is currently widely accepted as the modality of choice for treatment of benign thyroid disorders that require surgical excision. The goal of post-thyroidectomy management is to reach a "safe physiological status" of thyroid hormonal profile. Although exogenous levothyroxine replacement has long been safely used as a replacement after total thyroidectomy, it is not considered optimal, as it is bounded by patient's compliance with the treatment and follow-up schedule, effect of mal-absorption, and the inability to compensate for daily physiological alterations.

The concept of endocrinal tissue auto-transplantation has been largely investigated in the case of parathyroid gland, and to a lesser extent for pancreatic islets. Although both the experimental studies of thyroid autotransplantation and the early case reports of lingual thyroid autotransplantations have shown encouraging results, a very limited number of clinical studies investigated thyroid autotransplantation in adult patients with benign thyroid disorders. Moreover, the discrepancy in the patients' characteristics and thyroid autotransplantation technique in these studies hinders the standardization of thyroid autotransplantation for clinical practice. Hypothetically, thyroid autotransplantation offers and attractive alternative for subtotal thyroidectomy, as it enables the preservation of native responsive thyroid tissue in an accessible location, and, thus, evades the risk of possible regrowth in the neck region. The present preliminary clinical study is conducted to investigate the feasibility and outcome of thyroid autotransplantation after total thyroidectomy for patients with benign thyroid disorders (other than thyroiditis).

Eligibility Criteria:
Inclusion Criteria:

* adult male or female with simple nodular goitre.
* patients who are fit for surgery.

Exclusion Criteria:

* children (male or female)
* patients with malignant or recurrent goitre
* patients who are unfit for surgery
Antibiotic, Gingival-biopsy, and Oral-smear Samples.

Antimicrobial or antibiotic agents, which are essential to prevent and treat bacterial infectious diseases, have become one of the most widely used drugs in the world. In the European region, the highest rates of antibiotic consumption are reported in Turkey. There is a nearly fivefold difference between Turkey and the lowest consuming countries.

Studies in dentistry evaluate participants according to the basis of predefined criteria. History of antibiotic consumption is one of the most common exclusion criteria for periodontal trials. However, there is still disagreement on how long the effect of systemic antibiotic agents on the oral mucosa and periodontal tissue lasts. It is unclear whether the timing of antibiotic consumption should be an exclusion criterion for genetic damage and histological studies during the selection of healthy participants.

Periodontal status of participants in study groups is described as with or without periodontitis in many studies, because of the lack of clear definitions of periodontal health and gingivitis. It should be recognized that even the lack of visual signs of inflammation, some mild histopathological changes can be seen in the periodontium. Consequently, for the real diagnosis of the clinically healthy periodontium, clinical findings should be supported and confirmed with histological results.

Micronuclei (Mn) are observed as abnormal nuclear structures and indicators of chromosomal level DNA damage. The oral mucosa epithelium is an immunologic barrier and affected by chemical factors such as antibiotic consumption. The Mn test to exfoliated epithelial cells from the oral cavity is utilized as a non-invasive diagnostic technique for monitoring the status of oral health. To our knowledge, no studies have been conducted on the comparison of the impacts of the timing of antibiotic consumption on human periodontal tissues and oral smear samples. The present study is undertaken to determine whether the different timing of antibiotic (amoxicillin) therapy has effects on the histopathology of gingiva and genetic damage of exfoliated cells from oral mucosa in healthy participants.


Eligibility Criteria:
Inclusion Criteria:

* Systemically and periodontally healthy participants
* Presence of probing depth (PD) of ≤ 3 mm14 and bleeding on probing (BOP) ˂ 10%15
* No clinical evidence of gingival recession (GR), clinic attachment loss or radiographic evidence of alveolar bone loss
* No periodontal treatment within the last 12 months

Exclusion Criteria:

* Smoking, alcohol or drug abuse
* Any systemic condition would affect the periodontal health (i.e., pregnancy, lactation, ovulation, and diabetes mellitus)
* A history of contagious disease
* Periodontal treatment within the last 12 months
Optimizing the Radiological Selection and Transfer Model in Stroke Patients Presenting 6-24h After Onset (VESTA Study)

We aim to optimize the radiological selection and the transfer model in patients with a 6-24h stroke for a fairer and broader access to a reperfusion treatment. The specific objectives are:

1. To confirm that the selection of patients for reperfusion therapies in the late window is safe by applying the same clinical and imaging criteria recommended by clinical guidelines for the early window treatment selection.
2. To evaluate the performance of non-contrast CT by applying immediate post-processing software for the selection of patients for reperfusion treatment in the late window.
3. To analyze the prehospital and arrival variables at the primary stroke center to generate decision trees that optimize the transfer decision in patients with activation of the stroke code in \>6h from the onset of symptoms.

METHODOLOGY: Study based on a mandatory, prospective, multicenter registry (CICAT registry) consisting of two phases

1. retrospective analysis with a detailed evaluation of the images of the included patients and generation of "machine learning" models that accurately predict the probability of receiving reperfusion treatment in the late window.
2. validation of the models in a prospective study. Clinical, radiological and transport variables will be studied.

Response variables: rate of patients receiving reperfusion treatment in the late window, functional prognosis at 90 days, hemorrhagic transformation, and mortality.


Eligibility Criteria:
* SUBSTUDY 1. OPTIMIZATION OF IMAGING SELECTION METHODS FOR SELECTING STROKE PATIENTS FOR REPERFUSION TREATMENT IN THE EXTENDED WINDOW.

  - Inclusion criteria: Consecutive patients registered in the CICAT registry between the years 2019 and 2021 with a stroke who meet the following criteria
  1. Age older than 18 years,
  2. Diagnosis of acute cerebral infarction,
  3. More than six hours of evolution or uncertain chronology of symptoms,
  4. Absence of disability prior to stroke (modified Rankin score 0-2),
  5. NIHSS score\>5,
  6. Neuroimaging study including at least one non-contrast cranial CT scan within 60 minutes of arrival at the hospital center.
* SUBSTUDY 2. OPTIMIZATION OF CIRCUITS AND TRANSFER MODEL IN PATIENTS WITH STROKE IN THE EXTENDED WINDOW OF TREATMENT.

  * Inclusion criteria: Selection of consecutive, prospective patients to be included in the CICAT registry between January 2023 and March 2024 with stroke meeting the following criteria:

    1. Age over 18 years,
    2. Suspicion of acute cerebral infarction,
    3. More than six hours of evolution or uncertain chronology of symptoms,
    4. absence of pre-stroke disability (modified Rankin score 0-2),
    5. NIHSS score greater than 5.
Procedural Pain in Palliative Care: Prevalence, Intensity and Treatment

This study aims to assess self reported procedural pain compared with background pain and evaluate pain intensity differences across six standard procedures. Besides, rescue and preventive treatments used to control procedural pain will be examined.


Eligibility Criteria:
Inclusion Criteria:

* Patients receiving the procedures included in this study as a part of their standard care
* Patients that have expressed their consent to participate to the study by signing the informed consent document

Exclusion Criteria:

* Very serious or unstable clinical conditions with a Karnofsky Performance Status Index (KPS) \< 20
* Presence of neurological or psychiatric conditions, due to the original disease or concomitant diseases, interfering with the patient's level of consciousness or with judgment, such as to compromise compliance with the study protocol;
* Not adequately controlled background pain (average NRS in the last 24 hours is \> 4)
* Emergency procedures or procedures performed during night time (from 8 p.m. until 8 a.m)
Endoscopic and Robotic NSM with Immediate Prosthesis Breast Reconstruction

Breast cancer is the most common malignant tumor in women. Surgical treatment is the most important treatment for early breast cancer. Breast cancer resection is considered to be a destructive operation. Patients need to accept the double blow of physical and psychological loss of breast shape. Although with the change of the concept of early diagnosis and treatment of breast cancer, the breast conserving rate of breast cancer is gradually increasing in China, more than half of the patients are still unable to retain breast due to their condition. For these patients, breast reconstruction surgery is an important means to improve the postoperative breast shape. With the improvement of surgical technology, endoscopic/robotic NSM combined with immediate prosthesis breast reconstruction has been gradually developed. According to previous literature reports, it has good tumor safety and aesthetics, but it is still lack of large-scale prospective results.

This project plans to adopt a prospective cohort design, based on the large sample breast disease cohort database established by the breast center of Peking University People's Hospital, and prospectively include patients who receive NSM combined with immediate prosthesis reconstruction under endoscopy/robot and conventional surgery from January 1, 2025 to December 31, 2028. The perioperative complications, tumor safety and patient reported outcomes of the two methods were compared.


Eligibility Criteria:
Inclusion Criteria:

1. Underwent surgical treatment at Peking University People's Hospital, with hospitalization records;
2. Preoperative core needle biopsy confirmed breast cancer;
3. The clinical stage of the tumor is stage 0-IIIB; 4）cT≤5cm， cN0/cN1，M0， And there is no tumor invasion of the nipple areola complex, skin, and chest wall;

5) Intraoperative plan to use non biological patches (such as TiLoop) to partially or completely wrap the prosthesis 6) Signed agreement to participate in this study; 7) Can cooperate to complete the Patient Reported Outcome Measures (PROMs) questionnaire.

Exclusion Criteria:

1. Lack of clinical pathological data (such as imaging data, pathological data);
2. Pregnancy or lactation period;
3. Patients with metastatic breast cancer or bilateral breast cancer;
4. Have undergone breast conserving surgery/chest radiation therapy before;
5. Patients with nipple areola invasion and subsequent removal of nipple areola complex;
6. Failed to undergo curative surgery;
Apomorphine Effects on Pain in Parkinson's Disease

To study the effects of acute apomorphine vs. placebo administration on different Parkinson's disease pain types.

Apomorphine is the only anti-parkinsonian agent compatible with levodopa in improving Parkinson's disease (PD) motor symptoms. Besides, it has positive effects on some of the nonmotor symptoms of the disease, such as urinary disturbances and sleep. Apomorphine is usually well tolerated as it produces limited side effects. Knowledge about the effects of apomorphine on pain in PD is scarce. Evidence on this topic has only been reported in case reports or small studies but represents a potentially important use of the drug. We hypothesize that apomorphine may be a rational, safe, and useful treatment for subjects with pain in PD, including different subtypes. Within this framework, the present study will evaluate the effect of acute apomorphine vs. placebo administration on different PD pain types.

Eligibility Criteria:
Inclusion Criteria:

* Subjects with PD according to the MDS Clinical diagnostic criteria for Parkinson's disease.
* Participants on antiparkinsonian medication in advanced stages of the disease and experiencing OFF periods and pain.
* Apomorphine treatment naïve subjects or not received any within the last six months.
* Stable PD and pain medications for at least 30 days.
* Competence to self-report pain severity in the King's Parkinson's disease Pain Scale and a Likert Visual Analogue Scale.

Exclusion Criteria:

* Subjects who are unable to self-report pain severity in the selected scales. Patients that may require a translator or are illiterate will be included if they can self-report pain severity.
* Subjects with a diagnosis of dementia (Montreal Cognitive Assessment \<20).
* Subject with poorly controlled orthostatic hypotension.
* Subjects associated with another medical condition, e.g., any cardiovascular, renal or hepatic impairment, hematological or psychiatric diseases.

Any contraindication to receiving apomorphine injections:

* Subjects who are hypersensitive to apomorphine or any ingredient in the formulation or component of the container (hydrochloric acid concentrated, sodium bisulfite (E222), and water)
* Subjects using concomitant drugs of the 5HT3 antagonist class including (e.g., ondansetron, granisetron, palonosetron)
* Subjects using concomitant antihypertensive medications or vasodilators
* Subjects with prolonged QT on an electrocardiogram.
Exploring Theatrical Expressive Tasks for Children With ASD

Autism Spectrum Disorder (ASD), according to the diagnostic criteria of Diagnostic and Statistical Manual of Mental Disorders- V Edition (DSM-5), is a disorder involving (a) persistent deficits in social communication, social interaction and (b) patterns of restricted and stereotyped behavior and/or interests and/or activities. Specifically, impairment in social interaction manifests itself in different areas of individual functioning and through various facets: social-emotional reciprocity, poor understanding of social rules, reduced sharing of interests, emotions or feelings, reduced or absent theory of mind, inability to initiate or respond to social interactions (turn-taking in conversation), and difficulties in the use of communication. Facial expressions, vocal intonation, postures and gestures are crucial components of non-verbal communication that play a fundamental role in social-communicative functions. However, people with ASD may show significant deficits in these forms of expression, negatively affecting the ability to generate an appropriate social response, which is essential for initiating and maintaining social interactions. Children with ASD tend to avoid eye contact with others and show little or no interest in people, often looking past them or away from them. This behavior contributes to presenting them as "markedly aloof and distant". The aim of the study is to explore the effect of specific expressive tasks, conducted by highly qualified personnel, in a group setting, by means of targeted theatrical activities. These activities include exercises focusing on the use of voice and posture, the variety of vocal intonations and the harmonization between verbal production and facial expressiveness. In the context of this study, 20 children will be involved, divided into an experimental group and a control group. The experimental group will include 10 children with ASD who voluntarily participate in activities organized by the IRIB-CNR of Messina. These children, aged between 6 and 11 years, present a medium-high level of cognitive functioning, as assessed by the Wechsler Intelligence Scale for Children- IV Edition (WISC-IV) cognitive test. In parallel, the control group will consist of 10 normo-typical children, selected from the Istituto Comprensivo San Francesco di Paola of Messina, having the same age group, who will not participate in the experimental activities.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of autism spectrum disorder;
* Age between 6 and 11 years;
* IQ over 80 assessed by means of WISC-IV.

Exclusion Criteria:

* Presence of other medical disorders
Nephrocalcinosis in Very Low Birth Weight Infants

Extremely premature children benefit from specific follow-up that requires high nutritional intake and the use of specific therapies that expose them to the risk of nephrocalcinosis. Other identified risk factors are extreme prematurity and intrauterine growth restriction.

The incidence of nephrocalcinosis in very premature infants is unclear, ranging from 7 to 64%. Most studies are observational and only few case-control studies can properly analyse the risk factors for nephrocalcinosis in significant populations that include only preterm infants.

This nephrocalcinosis of prematurity regresses spontaneously in more than half of the cases, but has been associated with a risk of long-term complications: impaired renal function, high blood pressure, etc. This is an aggravating factor in the context of prematurity, which has been associated with an increased risk of renal impairment and hypertension in childhood and adulthood.

For all these reasons, nutritional intakes and therapeutics are monitored very closely and a renal ultrasound is routinely performed at discharge at 35 weeks of corrected gestational age in all children who are born at a gestational age ≤ 32 weeks and/or birth weight ≤ 1500 g.


Eligibility Criteria:
Inclusion Criteria:

* Newborns with a gestational age \<= 32 weeks and/or birthweight \<=1500g

Exclusion Criteria:

* Newborns with kidney malformation