cyrilzakka/clinical-trials huggingface dataset:
Circulating Tumor Cells in High-Risk Prostate Cancer Treated With High-dose Radiotherapy and Hormone Therapy

The detection and quantification of Circulating tumor cells CTCs in peripheral blood of patients with prostate adenocarcinoma may be useful at least for:

Getting a correct stratification of patients with high-risk prostate cancer (PCa).

Set the prognosis at baseline. Evaluate the response to different treatments (predictive value and monitoring).

Establish individualized therapies.

Prospective analysis of biologic samples from peripheral blood of 65 patients with localized high-risk PCa (NCCN 2011) treated with RTC-3D-IMRT combined with AD.

Following the sign of the informed consent of the patient, the blood samples will be analyzed for CTCs using an immunomagnetic method based on the CellSearch system (Veridex), in 4 periods of time:

1. prior to any treatment;
2. following AD and prior to RT; and
3. following the end of RT (1-3 months afterwards).
4. six to twelve months following the end of RT in those patients with 0 CTCs in the first determination and positive CTCs in the second or third determination

Comparison between the expression of CTCs in peripheral blood before and following AD and RT will be performed. The quantification of the CTCs obtained in these phases of treatment will be correlated with the treatment results in terms of biochemical failure according to Phoenix definition, distant metastasis rate and overall survival to identify a significant prognostic relationship and to determine the potential effect of the treatment in the number of CTCs Our working group will include 65 patients because the amount is based on routine clinical activity can be safely enrolled in the project development time by the participating centers.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged \> 18 with capacity to give informed consent.
* Patients with histologically confirmed prostate cancer.
* Patients with a high risk factor: PSA\> 20 ng / ml, Gleason 8-10 and / or stage T3a-b, N0M0 (NCCN 2011, stage IIB-III AJCC classification 2010). Staging by: Histology-Gleason score-, PSA, TR, ECO TR, CT, MRI.
* Patients who accept radical treatment with radiotherapy.
* Patients who give written informed consent to participate in the study

Exclusion Criteria:

* Any patient diagnosed with prostate cancer, which does not meet the prerequisites.
* Any patients with another malignancy diagnosed in the past 5 years (except basal cell or squamous cell carcinoma of skin).
* Any patient who has prostate biopsy performed 7 days prior to study entry.
* Patients who have received prior treatment with hormonal therapy, chemotherapy or radiotherapy.
* Patients with PSA\> 100 ng / ml.
* Any situation or condition of the patient which in the opinion of the investigator, advised against participation in the study.
Endothelial Cell Loss After Penetrating Keratoplasty

This work aimed at the assessment of corneal endothelial cell loss after toric ICL implantation for correction of myopia and astigmatism after penetrating keratoplasty.

Penetrating keratoplasty (PKP) is considered a safe and effective procedure.This work aimed at the assessment of corneal endothelial cell loss after toric ICL implantation for correction of myopia and astigmatism after penetrating keratoplasty.

Eligibility Criteria:
Inclusion Criteria:

* PKP for keratoconus, and then toric ICL was implanted after minimum of one year with stable refraction

Exclusion Criteria:

* Less than 18 and unable to give informed consent
Non-invasive and Invasive Plaque Characterisation

The accuracy of coronary plaque characterization with Multi-slice computed tomography as compared to intravascular ultrasound and optical coherence tomography will be investigated in patients presenting with acute coronary syndrome without ST-elevation.


Eligibility Criteria:
Inclusion Criteria:

* Chest pain suggestive for myocardial ischemia for at least 30 minutes; - Electrocardiogram (ECG) with ST-segment shifts (ST-segment depression \>1 mm in at least two contiguous leads or transient ST-segment elevation \> 1mm with duration of \< 30 min in at least two contiguous leads) and/or T-wave changes (T-wave inversion \> 1.5 mm in at least three contiguous leads); - Positive hs Troponin T \> 14 ng/L or positive Troponin T \<0.01 µg/L - Clinical indication for invasive coronary angiography followed by PCI of the ischemia-related target lesion; - Informed consent.

Exclusion Criteria:

* Persistent ST-elevation of \>1 mm in 2 or more leads; - Need for emergency invasive coronary angiography and percutaneous coronary intervention (PCI); - Need for emergency coronary artery bypass grafting; - Presence of cardiogenic shock; - Estimated glomerular filtration rate (eGFR) \< 50 ml/min; - Known allergy to iodine contrast agents; - Cardiac rhythms other than sinus rhythm; - Inability to lay supine; - Inability tot sustain a breath-hold for 15 seconds; - Inability to provide informed consent.
Heart Rate Variability and Postoperative Nausea Vomiting

Propofol and sevoflurane have different effects on heart rate variability. It has not yet been reported whether this difference in effect remains at recovery time after anesthesia and the difference is related to postoperative nausea and vomiting has not been studied. The aim of this study is observe whether propofol and sevoflurane have different effects on heart rate variability during recovery and the differences can predict the occurrence of postoperative nausea and vomiting.

Different types of anesthetics have different effects on heart rate variability. However It has not yet been reported whether this difference in effect remains at recovery time after anesthesia.

Several studies have been reported that preoperative heart rate variability predicted the occurence of postoperative nausea and vomiting. However, whether the difference in heart rate variability after anesthesia is related to the difference in postoperative nausea and vomiting has not been studied. Therefore, this study aims to observe whether propofol and sevoflurane have differences during recovery period after anesthesia in heart rate variabiliy. In addition, we want to examine that these differences during recovery period in heart rate variability can predict the occurrence of nausea and vomiting within 24 hours after surgery.

Eligibility Criteria:
Inclusion Criteria:

* Scheduled breast surgery under general anesthesia

Exclusion Criteria:

* Arrhythmia
* Uncooperative with the measuring heart rate variability
* Diabetes
* Hypertension on medication
* Patients taking psychiatric drugs
* Thyroid disease
SYN120 Study to Evaluate Its Safety, Tolerability and Efficacy in Parkinson's Disease Dementia (SYNAPSE)

The purpose of this study placebo-controlled, randomized, double-blind study is to assess the safety and efficacy of SYN120 in patients with Parkinson's disease dementia (PDD) already treated with a stable dose of a cholinesterase inhibitor.

This study includes a Screening Period of up to 6 weeks, a 16 week Treatment Period, and a 2 week Safety Follow Up Period.

Final eligibility will be determined at the Baseline Visit. Eligible patients will be randomized to receive placebo or SYN120 100 mg once a day (QD).

Eligibility Criteria:
Inclusion Criteria:

* Parkinson's Disease Dementia
* Patient has a routine caregiver
* Taking a stable cholinesterase inhibitor.
* Patient has a Montreal Cognitive Assessment (MoCA) 10-23 inclusive

Exclusion Criteria:

* History of any significant neurologic or psychiatric disease other than PD
* Any other condition or clinically significant abnormal findings that would make the patient unsuitable for the study
* Unpredictable motor fluctuations that would interfere with administering assessments
Self-Awareness of Symptoms, Signs and Medical Compliance Using a Patient Diary in Heart Failure Management

Before a HF patient gets maximally decompensated and visit emergency department, most patients experience symptoms and signs of "on-going decompensation (or pre-decompensation)", which may not be noticed by the patients. If HF patients were aware of symptoms and signs of ADHF and received early intervention to stop the process of "on-going decompensation (or pre-decompensation)", it would be possible to reduce the rate of hospitalization for ADHF or death. Thus, self-awareness and self-examination of heart failure symptoms, signs and medical compliance using a patient diary in HF management may improve the outcomes in chronic stable HF patients. A patient diary with 6 parameters can serve this purpose: body weight, blood pressure, heart rate, drug compliance expressed as number of remaining pills of previous day, edema grade, and dyspnea grade.


Eligibility Criteria:
Inclusion Criteria:

* Patients who are 18 years or older
* Patients admitted for acute heart failure and scheduled for discharge after medical stabilization
* Chronic stable heart failure patients with a history of hospitalization for AHF

Exclusion Criteria:

* Patients with limited cognitive function who cannot not perform self-recording (in case that the patient has a family member who can perform the recording, the patient can be rerolled)
Cardiopulmonary Outcomes in Osteogenesis Imperfecta: BBD7708

Osteogenesis imperfecta (OI) is a group of congenital and heritable bone disorders that currently affects at least 50,000 people in the United States. OI varies in severity from perinatally lethal to mild forms. The majority of cases is caused by a dominant mutation in type I collagen genes (COL1α1 and COL1α2), altering the quantity or quality of type I collagen.

Although OI is typically characterized as a disease of the bone, it is perhaps more accurately described as a connective tissue disorder. Type I collagen is a major constituent of lung connective tissue. Respiratory insufficiency is the leading cause of death in patients with OI. Thus, it is important and necessary to understand the etiology of the restrictive pulmonary physiology in the OI population.

This study is cross-sectional. At the participant's one study visit, data will be obtained at a single point in time and reflect the patients' current condition. Evaluations will include family and medical history, self-report questionnaires, physical evaluation, diagnostic studies, and radiographic studies. Eighteen participants will be enrolled, ideally within one year. Participants will be enrolled regardless of OI type since Bronchial Wall Thickening, a finding we are attempting to validate, was observed in all types of OI. Interested males with OI will be preferred over females to compensate for our highly female original cohort and determine if sexual dimorphism exists for cardiopulmonary outcomes in people with OI. Smokers will not be excluded.

Eligibility Criteria:
Inclusion Criteria:

* Individuals who are able to give informed consent or have a legally authorized representative capable of giving consent on the subject's behalf
* Individuals ages 18 and older of all races and sexes
* Individuals who have been diagnosed with OI clinically and/or genetically

Exclusion Criteria:

* Individuals diagnosed with respiratory illness within 6 weeks of enrollment or undergoing diagnostic studies for an active illness.
* Individuals with other skeletal dysplasia or genetic diagnosis
* Individuals diagnosed with cardiopulmonary comorbidities that affect lung compliance
Study to Evaluate the Safety and Efficacy of Two Adalimumab Dosing Regimens in Subjects With Moderate to Severe Ulcerative Colitis

To evaluate safety and efficacy of two adalimumab dosing regimens for induction and maintenance (standard and higher dosing) in achieving clinical remission in subjects with moderately to severely active ulcerative colitis.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Ulcerative Colitis (UC) for at least 90 days, confirmed by endoscopy during Screening period.
* Active UC with Mayo Score of 6 to 12 points and endoscopy subscore of 2 to 3 despite concurrent or prior treatment with a full and adequate course, in the opinion of the Investigator, with oral corticosteroids or immunosuppressants or both. Mayo Score is confirmed by central reader.

Exclusion Criteria:

* Subject with Crohn's disease (CD) or indeterminate colitis (IC).
* Current diagnosis of fulminant colitis and/or toxic megacolon.
* Subjects with disease limited to the rectum (ulcerative proctitis) during the screening endoscopy.
* Chronic recurring infections or active tuberculosis (TB).
Impact of Injectable Platelet Rich Fibrin Versus Low-intensity Pulsed Ultrasound on Different Orthodontic Tooth Movements During Clear Aligner Therapy

The aim of this prospective clinical project will be to compare the effect of platelet rich fibrin versus low- intensity pulsed ultrasound on therate of different orthodontic tooth movements during clear aligner therapy.

The aim of this prospective clinical project will be to compare the effect of platelet rich fibrin versus low- intensity pulsed ultrasound on therate of different orthodontic tooth movements during clear aligner therapy.specifically canine retraction,incsiors levellingand aliggnment,maxillary molar distalizationand incisors intrusion

Eligibility Criteria:
Inclusion Criteria:

- A- leveling and alignment Eligibility criteria

1. Age ranges from 14 to 17 years. 2. Bilateral Class II molar relationship. 3. Skeletal Class I or mild Class II relationship. 4. Normal or decreased vertical height. 5. No posterior crowding or spaces. 6. Fully erupted maxillary first and second molars. 7. Congenitally missing or extracted third molars. 8. Good oral hygiene. 9. Absence of any periodontal disease and alveolar bone loss. 10. Absence of medications that may inhibit orthodontic movement

Lower incisor leveling and alignment Inclusion criteria Complete permanent dentition (third molars not included); Moderate mandibular anterior crowding (with little's irregularity index score greater than 4 mm) who required non-extraction approach in the mandibular arch; No tooth size, shape or root abnormalities visible on the patient's radiographic records; No spaces in the mandibular arch; No blocked out tooth that did not allow for placement of the bracket at the

initial bonding appointment; 6. No required management with interproximal stripping, inter-maxillary elastics, open NiTi springs, and removable or extra-oral devices. Canine retraction Eligibility criteria

Age, 15 to 25 years; Class ii division 1 malocclusion with mild or no crowding; No previous orthodontic treatment; No systemic disease that might have affected bone formation or density, such as osteoporosis, hyperparathyroidism, or vitamin d deficiency; Adequate oral hygiene; Probing depth values not exceeding 3 mm across the Entire dentition; Adequate thickness of the attached gingiva (1-2 mm); No radiographic evidence of bone loss -

Exclusion Criteria:Patients who required surgery to correct skeletal discrepancies. Patients with congenital dentoskeletal disorders. Missed or mutilated teeth in maxillary arch. Patients with poor oral hygiene and/or periodontally compromised patients Severe dental crowding that necessitates an extraction approach 2. Abnormal anteroposterior and vertical relationships; 3. Patients with cleft lip and palate, anomalies, and syndromes; 4. Previous orthodontic 5. Treatment; 6. Regular medications intake that could interfere with otm. -

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Incidence of Lactose Intolerance Among Self-reported Lactose Intolerant People

This is a 3-sites, double-blinded, randomized, 2X2 cross-over study aiming to compare effects of milk containing only A2 type beta casein versus milk containing both A1 and A2 beta casein proteins on the gastrointestinal symptoms for the health people who self-reported to be lactose intolerant.

Study sites: Shanghai, Guangzhou, Beijing

Eligible subjects were enrolled in the study and randomized into one of the 2 study arms:

Sequence A1-A2: Oral consumption of milk containing both A1 and A2 type beta casein at Visit 1 and milk containing only A2 type beta casein at Visit 2; Sequence A2-A1: Oral consumption of milk containing only A2 type beta casein at Visit 1 and milk containing both A1 and A2 type beta casein at Visit 2.

Washout period: 2 weeks between Visit 1 and Visit 2

Eligibility Criteria:
Inclusion Criteria:

* 20\~50 years old male or female subjects;
* Non-regular milk drinker with self-reported intolerance to commercial milk;
* Suffered from mild to moderate digestive discomfort after milk consumption;
* Have normal electrocardiograms (ECG) and blood pressure during quiet respiration;
* Agree not to take any medication, supplements, nutrition or other dairy products including acidophilus milk;
* Be willing to comply with all the requirements and procedures of the study;
* Agree to sign the informed consent form;
* Agree not to enroll in another interventional clinical research study while participating in this study;
* Fully understand the nature, objective, benefit and the potential risks and side effects of the study.

Exclusion Criteria:

* Female on pregnant or feeding；
* Have known dairy allergy;
* Have severe response to milk intolerance;
* Have history of faecal impaction;
* Trying to lose weight by following a diet or exercise regimen designed for weight loss, or taking any drug influencing appetite and any drug for weight loss for the last three months ;
* Have participated in similar dairy or probiotics-containing product's clinical trials within 3 months before the screening;
* Currently taking medicines for cardiovascular or metabolic disease;
* Have history of or be diagnosed of any of the following diseases that may affect the study results: gastrointestinal disorders, hepatopathy, nephropathy, endocrine disease, blood disorders, respiratory and cardiovascular diseases;
* Current or previous alcohol abuser, currently taking or took illicit drugs, substance or OTC prescription drugs in regular frequency which may affect gastrointestinal disorders and study result;
* Currently suffering from any gastrointestinal disorders or gastrointestinal disease, including but not limited to: irritable bowel syndrome, colitis, ulcerative colitis, celiac disease, irritable bowel syndrome(IBS);
* Had hospitalizations within 3 months before screening;
* Currently drug frequency user of that may affect the gastrointestinal function or immune system. As judged by investigator.
Supported Employment and Preventing Early Disability

The share of young workers falling into early work disability is an increasingly important problem in Norway. Early withdrawal or exclusion from the labor market leads to large individual and societal costs. The SEED-trial is a randomized controlled trial aiming to provide evidence-based knowledge about different approaches to prevent permanent disability and increase labor market participation in this important and vulnerable group. The trial includes young adults aged 18-30 years who are at risk of early work disability, and the participants will be randomly assigned to 1 of 2 interventions, both aimed at facilitating participation in working life:

1. Traditional Vocational Rehabilitation (TVR), offering training and preparation for the labor market in a sheltered environment
2. Supported Employment (SE), focusing on competitive employment in real-life settings without long-lasting preceding training

Both interventions are currently provided by The Norwegian Labor and Welfare Administration (NAV). Supported Employment was introduced recently and is currently being implemented, while traditional vocational rehabilitation with sheltered employment has been around for years. However, no Norwegian controlled studies have been conducted on these practices in this population. The current study will therefore provide new knowledge of the effect of traditional as well as new and promising interventions to increase labor market participation and prevent early disability.

A detailed study protocol was published in BMC Public Health in 2016, and is openly available in fulltext at: https://bmcpublichealth.biomedcentral.com/articles/10.1186/s12889-016-3280-x

Eligibility Criteria:
Inclusion criteria:

* Not in employment or education
* Receiving temporary benefits
* Intended for the VR service "traineeships in sheltered businesses"

Exclusion criteria:

* Not expressing interest in getting help to obtain competitive work
* Insufficient language skills to answer questionnaires in Norwegian
The Impact of Preoperative Suggestion on Dreaming

Recent studies have shown that positive preoperative suggestions can significantly influence the quality of dreams and reduce the incidence of unpleasant dreams during sedation with agents like ketamine and propofol.

Cheong et al. demonstrated that a simple positive suggestion before ketamine administration could reduce unpleasant dreams, while Kim et al. found that propofol, compared to midazolam, led to more vivid and memorable dreams, along with similar satisfaction levels in patients. This study aims to extend these findings by comparing the effects of propofol and ketamine sedation on dreaming during anesthesia, with a focus on how preoperative suggestions might influence dream content, emotional tone, and patient satisfaction.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients aged 20-65 years.
* ASA physical status I-III.
* Scheduled for elective spinal anesthesia or brachial plexus block.
* Fluent in Korean.

Exclusion Criteria:

* Use of any medication, including premedication, within 12 hours before surgery.
* Cognitive impairments or psychiatric disorders (including a history of unpleasant dreams or nightmares).
* Current use of sedatives or hypnotics.
* History of severe or recurrent nightmares.