cyrilzakka/clinical-trials huggingface dataset:
Certolizumab Pegol for the Treatment of Patients With Active Rheumatoid Arthritis

This is a Phase IIIb multicenter study to evaluate the safety and efficacy of certolizumab pegol (CZP) administered to patients with moderate-to-severe rheumatoid arthritis.

The treatment period starts with a 12-week, double-blind, placebo-controlled, randomized period followed by an open-label extension phase. In the double-blind phase, eligible patients are randomized (4:1 ratio) to receive either certolizumab pegol (CZP) or Placebo up to and including Week 10. The randomization will be stratified according to the three factors: concomitant use of methotrexate (MTX, Yes or No), prior anti-tumor necrosis factor (anti-TNF) use (Yes or No), and disease duration categories (\< 2 years or ≥ 2 years). From Week 12 all patients remaining in the study receive open-label CZP for a minimum 16 additional weeks until CZP is commercially available.

Eligibility Criteria:
Inclusion Criteria:

* Adult patient with established moderate to severe rheumatoid arthritis

Exclusion Criteria:

* All concomitant diseases or pathological conditions that could interfere and impact the assessment of the study treatment
* Previous clinical trials and previous biological therapy that could interfere with the results in the present clinical trials
IT-Based Training in Metabolic Syndrome

Prospective, randomized, single center, controlled intervention study to investigate the effect of a systematic combined personal and IT-based training on the outcome of patients with metabolic syndrome.

The study settles in the field of primary prevention and aims to change lifestyle of patients with metabolic syndrome with a new combination of personal and IT-based training specially designed für obese people with risk factors. Procedures that are similar for all participants are summarized in a training program whereas individual aspects of physical activity like initial education and exercise tests are still performed by doctors and trainers. Before and after three months of training anthropometric parameters, laboratory and exercise capacity are examined and analyzed. The intervention group is characterized by a predetermined exercise program whereas the control group is allowed to practise without detailed instructions. The practicability and the effect on health status of the combined personal and IT-based training in the intervention group is compared with the independent training of the control group. After 6 months and again after 12 months the measurements are repeated to evaluate a lasting effect of the program.

Eligibility Criteria:
Inclusion Criteria:

* males and females between 20 and 60 years
* Staff of the Fa. BMW
* written informed consent after detailed education
* BMI 25-35 kg/m2
* ≤ 1x/week sport respectively exercise
* metabolic syndrome (at least 3 of 5 criteria)

Exclusion Criteria:

* \> 1x/week physical activity
* BMI \< 25 kg/m2 or \> 35 kg/m2
* Florid acute or chronic disease of any kind prohibiting regular physical activity
* Diabetes mellitus
* pregnancy or lactation
* Drug or alcohol abuse
Effects of Barley Green in Patients With Hyperuricemia

This experiment evaluates the effect of Barley Green in patients with hyperuricemia ， and explores the effect of Barley Green on metabolic indexes such as uric acid, blood lipids, blood glucose, free fatty acids。130 adult participants , age 18 to 65 years, will be randomized into one of the two arms. Arm A (control group) will receive dietary guidance. Arm B will receive dietary guidance and Barley Green.


Eligibility Criteria:
Inclusion Criteria:

* Age 18-65 years old those who are willing to accept assessment and sign informed consent.
* Under the normal purine diet, two fasting blood uric acid levels on different days: 420umol/l \<blood uric acid \<540 umol/l (male), 360 umol/l \<blood uric acid \<540 umol/l (female)

Exclusion Criteria:

* Patients currently receiving treatment for hyperuricemia；
* Suffering from diseases that affect the digestion and absorption(such as chronic diarrhea, constipation, severe gastrointestinal inflammation, active gastrointestinal ulcers, after gastrointestinal resection, cholecystitis/cholecystectomy, etc.)；
* Suffering from cardiovascular and cerebrovascular diseases, grade 3 hypertension, chronic hepatitis, malignant tumors, anemia, mental illness and memory disorders, epilepsy and other diseases;
* At the same time receive other functional food nutrition support (plant active substances, health food);
* Patients with abnormal liver function (alanine aminotransferase or/and aspartate aminotransferase exceeds 3 times the upper limit of normal value); patients with abnormal renal function (serum creatinine exceeds the upper limit of normal value)；
* Suffering from infectious diseases such as active tuberculosis and AIDS;
* People who are severely allergic to the ingredients of research；
* During pregnancy or lactation;
* Patients with physical disabilities and clinicians think it is not suitable to participate in the study (for example, suffering from serious diseases not included in the discharge criteria)；
* Gouty arthritis attack ≥ 2 times;
* One episode of gouty arthritis with blood uric acid \>480 umol/l, or any of the following: age \<40 years old, evidence of gout stone or urate deposition in the joint cavity, uric acid nephrolithiasis or renal impairment (GFR≤89ml/(min·1.73m2)), hypertension, impaired glucose tolerance or diabetes, dyslipidemia, obesity, coronary heart disease, stroke, cardiac insufficiency;
* Blood uric acid\>480 umol/l combined with any of the following: uric acid nephrolithiasis or renal impairment (GFR≤89ml/(min·1.73m2)), hypertension, impaired glucose tolerance or diabetes, dyslipidemia, obesity, Coronary heart disease, stroke, heart failure.
Longterm Effectiveness of Artificial Intelligence-assisted Colonoscopy on Adenoma Recurrence

We hypothesize that AI-assisted colonoscopy can reduce post-colonoscopy neoplasia incidence after 3 years, over standard colonoscopy. Moreover, this protective effect may allow surveillance intervals to be lengthened, by modifying long-term outcome of high-risk subgroup.

Between April 2021 and July 2022, our group completed a parallel-group, randomized controlled trial in Hong Kong. \[ENDOAID-TRAIN study; NCT04838951\] 856 subjects undergoing colonoscopies were randomized 1:1 to receive colonoscopies with CADe (ENDO-AID, Olympus Co., Japan) or standard colonoscopies (control). Our study proved that AI-assisted colonoscopies could increase the overall ADR, especially small-to-medium size adenomas. It remains questionable whether the increased detection and removal of these non-advanced adenomas can be translated into any sustained long-term benefit. The impact of this AI-driven intensive surveillance on general population and healthcare system is also largely unknown. In this research project, we aim to assess the long-term effectiveness of AI-assisted colonoscopy on adenoma recurrence and PCCRC prevention, by conducting a real-world, prospective study with longitudinal extension from a randomized trial.

Eligibility Criteria:
Inclusion Criteria:

Subjects are eligible if:

(i) They underwent randomization to receive colonoscopy with/without CADe in ENDOAID-TRAIN study \[NCT04838951\]; (ii) They are fit and willing to undergo surveillance colonoscopy at year 3; (iii) Written informed consent obtained.

Exclusion Criteria:

Subjects will be excluded from the study if they have any of the followings:

(i) Incomplete colonoscopy during index procedure; (ii) Known residual colorectal neoplasia not removed (except hyperplastic polyps); (iii) Underwent unscheduled interval colonoscopy before year 3; (iv) Contraindications to surveillance colonoscopy at year 3; (v) Advanced comorbid (American Society of Anesthesiologists grade 4 or above); (vi) History of CRC, hereditary polyposis syndrome or inflammatory bowel disease; (vii) History of colectomy at any time point.
SAVI SCOUT Clinical Evaluation Study

The purpose of this study is to evaluate the performance of the SAVI SCOUT® Surgical Guidance System (SAVI SCOUT). The SAVI SCOUT is a medical device, used to provide real-time guidance during localized excisional biopsy or lumpectomy procedures, by helping the surgeon locate and remove the desired tissue (i.e., the lesion and surrounding normal tissue). The SAVI SCOUT has been 510K cleared.

The SAVI SCOUT is intended to assist surgeons in the location and retrieval of a non-palpable abnormality as localized by radiographic or ultrasound methods. In this study, the ability of the SAVI SCOUT to guide surgeons to find a lesion will be evaluated instead of the standard technique of wire localization.

Using radiography or ultrasound guidance, the SAVI SCOUT reflector will be placed percutaneously up to 7 days prior to the scheduled excisional procedure. During surgical excision, the SAVI SCOUT system will be used to locate the reflector, which will be removed along with the surrounding breast tissue.

Final data analysis will be completed within 1 month after the last patient is treated.

Final assessment of the surgical results will be completed by the surgeon during a routine follow-up visit within 1 month following the surgical excision or lumpectomy procedure.

Main Objective: to show that the SAVI SCOUT technique can be used to safely and effectively locate a non-palpable breast lesion during a localized excisional biopsy or lumpectomy procedure.

Up to 10 sites and 150 patients will be enrolled.

Eligibility Criteria:
Inclusion Criteria:

* • Patient has a non-palpable breast lesion that requires excision

  * Lesion depth ≤ 3 cm from the skin surface in the supine position
  * Patient is scheduled for excision or BCT at a participating institution
  * Patient is between the ages of 18 and 90 years
  * Patient is female
  * Patient is willing and able to comply with all study procedures and be available to follow-up for the duration of the study
  * For lesions requiring multiple reflectors for localization, they must allow for reflectors to be placed ≥ 1cm from one another relative to the coronal plane Subject Exclusion Criteria

An individual who meets any of the following criteria will be excluded from participation in this study:

* Patient had a previous ipsilateral breast cancer
* Patient has multicentric breast cancer
* Patient has Stage IV breast cancer
* Patient has been treated with neoadjuvant chemotherapy
* Patient is pregnant or lactating

Exclusion Criteria:

-
Incidental Discovery of Pulmonary Emboli Via CT Scan: Impact of Detections on Patient Care and Resulting Complications

In recent years, with an increase in the frequency of CT examinations, there has also been an increase in the random discovery of pulmonary emboli, often small, as part of examinations performed for other indications. Most of the literature so far deals with the discovery of such findings mainly in oncological patients, and there is relatively little information regarding the frequency of such random discovery in other patient populations. Specifically in the intensive care patient population, we have not yet found any study that examined the detection rates of these findings. Also, there is no consensus regarding how these random findings should be treated from a therapeutic point of view (whether to start treatment with full anticoagulation, and if so, for what period of time).

Random pulmonary embolism is often discovered as part of a CT scan done to assess acute lung disease or lung cancer staging. In a study done in oncology patients, 385 chest CT examinations were examined, with a random discovery of pulmonary emboli at a rate of 2.6% . A larger analysis of 8 studies involving 8491 cancer patients found a slightly higher incidence of 3.6%.

We would like to check the rate of pulmonary emboli that were randomly discovered in chest CT examinations performed in the intensive care unit for other indications, and the consequences of discoveries - ie starting anti-coagulant treatment and whether there were any complications for starting such treatment (bleeding).


Eligibility Criteria:
Inclusion Criteria: All patients who were admitted to the ICU between 8/2020 and 8/2024 and underwent chest CT during ICU stay -

Exclusion Criteria: Missing information

-
Deep Learning Optical Coherence Tomography (OCT) and OCT Angiography (OCTA) in NVC

To evaluate the activity of neovascular macula degeneretion as assessed by SD-OCTand OCT-A using a split-person study design and deep-learning quantification.

Exudative neovascular macular degeneration is the primarily an age-related retinal condition The optical coherence tomography angiography represents a novel and noninvasive diagnostic technique that allows a detailed and quantitative analysis of retinal and choriocapillary vascular features in order to choose the best therapy .

The study evaluates the changes in structural optical coherence tomography and optical coherence tomography angiography features in neovascular macular degeration patients undergoing ANTI-VEGF treatments using artificial intelligence.

Eligibility Criteria:
Inclusion Criteria: age older than 50 years

* diagnosis of neovascular macular degeneration
* absence of previous retinal surgery and congenital eye diseases.
* absence of errors of refraction
* absence of lens opacities
* absence of low-quality OCT and OCTA images

Exclusion Criteria:• age younger than 50 years

* previous retinal surgery and congenital eye diseases
* errors of refraction
* lens opacities
* low-quality OCT and OCTA images
Perception of Cohesion Within a Relationship (Dyadic Adjustment) on the Quality of Life of Patients With Prostate Cancer With Gonadotropin-releasing Hormone.

The general hypothesis put forward in this study is that the degree of cohesion (agreement) in the relationship, or dyadic adjustment affects a patient's quality of life and clinical course during the first few critical months following diagnosis and the introduction of treatment. The level of cohesion in the relationship is certainly not the only parameter associated with changes in the quality of life. Other factors must also be investigated such as level of education, circumstances surrounding the diagnosis (new diagnosis or relapse), management (single therapy or adjuvant therapy), the level of physical activity, the patient's age and the presence of functional disorders, etc.


Eligibility Criteria:
Inclusion Criteria:

* Patient presenting with histologically confirmed prostate cancer.
* Patient eligible to start GnRH agonist therapy, either as monotherapy or adjuvant therapy, and for whom one of these treatments was selected voluntarily by the urologist, prior to the start of the study.
* Patient currently living with the same partner for at least 6 months.
* Patient and partner capable of reading, understanding and returning an evaluation self-questionnaire 6 months after the initial consultation.
* Patient giving its written consent to participate to the study.

Exclusion Criteria:

* The subject is participating in another clinical trial.
* Patient who has received a GnRH agonist therapy during the last 2 years.
The Occurrence of Single Nucleotide Polymorphism Among Women Who Experienced Obstetric Anal Sphincter Injury

Single-nucleotide polymorphisms (SNP's) in connective tissue components are associated with increased risk of pelvic organ prolapse (POP). The investigators expect to find a difference in SNP's frequency between women who had Obstetric anal sphincter injuries (OASIS) and in the healthy population. The fact that pelvic organ prolapse (POP) and OASIS occurs in the same anatomic region and the well-known association between few SNP's and the risk for POP, suggests for a common pathophysiology.

The perineum consists of skin, muscles and connective tissue. A connective tissue disorder related to POP has been reported in biochemical and molecular studies. OASIS are considered a severe complication of vaginal delivery that may lead to a great deal of morbidity. Familial history is known as a risk factor for OASIS. Currently, there is no established genetic link between connective tissue components and OASIS. Therefore, the investigators assume that studying the genetic predisposition factors of women who experience OASIS, might generate a stronger tool to predict severe occurrence of vaginal laceration. It may also help to consult women before vaginal delivery about the risk of OASIS.

The aim of this study is to find an association between genetic variation and increased risk for OASIS.

Eligibility Criteria:
Inclusion Criteria:

* Women with severe external anal sphincter injury during first vaginal delivery
* Healthy women undergoing vaginal delivery without any clinically apparent perineal laceration

Exclusion Criteria:

* Women with known metabolic or connective-tissue disorder (e.g., Ehlers-Danlos syndrome).
* Women with known neurologic disorder
* Women undergoing episiotomy cut or assisted delivery (e.g., vacuum or forceps delivery)
A Study to Evaluate Absorption, Distribution and Elimination of Mirabegron After Oral Administration to Non-elderly Healthy Chinese Subjects

The purpose of this study is to evaluate safety and absorption, distribution and elimination of mirabegron after oral administration to Chinese subjects.

This study is an open-label study. The subjects will receive single administration of mirabegron in a fasted condition. After the non-dosing period, subjects will receive mirabegron for 8 days.

Eligibility Criteria:
Inclusion Criteria:

* Body weight: (male) over 50.0kg and less than 80.0kg (female) over 40.0kg and less than 70.0kg
* Body Mass Index: over 17.6 and less than 26.4 kg/m
* Chinese subjects
* Healthy judged by investigator or sub-investigator

Exclusion Criteria:

* Received any investigational drugs within 120 days before the screening assessment
* Donated 400 mL of whole blood within 90 days, 200 mL of whole blood within 30 days, or blood components within 14 days before the screening assessment
* Received medication within 7 days before hospital admission
* A deviation from the assessment criteria of physical examinations or laboratory tests at screening or upon admission
* History of drug allergies
* With renal, hepatic, gastrointestinal, heart, cerebrovascular or respiratory diseases
* Received mirabegron beforehand
* Glaucoma patient
Concurrent Treatment for Substance Dependent Individuals With Post-Traumatic Stress Disorder (PTSD)

This treatment intervention trial is designed for men and women with substance dependence and comorbid Post-Traumatic Stress Disorder (PTSD). Participants will be randomly assigned to one of three conditions (two behavioral treatments \[Concurrent Treatment of PTSD and Substance Use Disorders Using Prolonged Exposure and Relapse Prevention Therapy\] and an active monitoring control group) and will be evaluated at baseline and four follow-up points (post-treatment, 1-month, 2- month and 3-month post-treatment).

This study will enhance the knowledge and understanding of concurrently treating individuals with substance use disorders and PTSD in hopes of facilitating treatment retention and increasing the likelihood for more positive treatment outcomes. Following NIDA's stage model for behavior therapies development, this study will take the next step building upon promising findings from Stage IA work with an exposure-based therapy modified to use safely with substance dependent individuals.

This study is a randomized clinical trial to assess the relative efficacy of two active treatment conditions versus an active monitoring control group for substance dependent individuals who also meet criteria for current PTSD according to the diagnostic standards set by the DSM-IV. Eligible participants will be randomly assigned to either: (1) Concurrent Treatment of PTSD and Substance Use Disorders Using Prolonged Exposure (COPE); (2) Relapse Prevention Treatment (RPT) or an (3) Active Monitoring Control Group (AMCG). The study is a three armed randomized controlled trial with repeated outcome measures at post treatment and 1-,2-, and 3-months post-treatment follow-up points for participants in COPE and RPT.

Eligibility Criteria:
Inclusion Criteria:

1. Men and women who are a minimum of 18 years and maximum of 65 years.
2. Participants meet DSM-IV criteria for current or past substance dependence
3. Participants must have used alcohol or other drugs within the past 3 months
4. Participants must speak English
5. Participants must meet DSM-IV criteria for current PTSD in response to on an interpersonal, civilian trauma
6. Participants are capable of giving informed consent and capable of complying with study procedures.
7. Participants demonstrate no gross organic mental syndrome

Exclusion Criteria:

1. Participants who are currently suicidal or homicidal
2. Participants who carry a diagnosis of BiPolar I or psychotic disorders are exclusionary.
3. Participants receiving PTSD-specific treatment
4. Participants on anxiolytic, antidepressant or mood stabilizing medications which have been initiated during the 8 weeks prior to study participation
5. Participants refusing to be audio or video taped
D-serine Supplementation for Depression

The glutamate system is emerging as target for the development of novel antidepressant medication, in particular compounds modulating the NMDA receptor. While the NMDA receptor antagonist ketamine is an effective option for many treatment-restistant patients, it is also accompanied by dissociative and cognitive effects and also bears the risk to develop addiction, side effects that are significantly restricting its clinical utility. There is now compelling evidence of the antidepressant potential of D-serine, a NMDAR co-agonist. Compared to ketamine, D-serine goes along without any psychotomimetic effects or other side effects and thus might be a prom-ising novel antidepressant.

This study represents the first randomized control trial to test the efficacy of D-serine as an adjuvant therapy in patients with depression and thereby adds to re-cent efforts to establish novel glutamatergic antidepressants. Besides clinical measures, this study also explores the biological mechanisms underlying D-serine's clinical effect.


Eligibility Criteria:
Inclusion Criteria:

* Age 18-60
* Inpatients with a diagnosis of MDD with a current moderate-to-severe episode (HAM-D score \> 16) (7)
* Treatment as usual (TAU) for depression. TAU for depression may include no treatment at all or standard pharmacotherapy (antidepressants and antipsychotics such as aripiprazole, risperidone or quetiapine) and / or psychotherapy.
* Able to read and understand study procedures and participant's information

Exclusion Criteria:

* Other primary psychiatric diagnoses than MDD such as substance use and psychotic disorders
* Serious suicide attempts
* Contradiction for MRI (no pacemaker, MRI incompatible metal implants or splinters in the body, past heart/head surgery, past stroke/brain injury, claustrophobia)
* Pregnant or lactating women (pregnancy test)