cyrilzakka/clinical-trials huggingface dataset:
Safety and Efficacy of Asacol 4.8 g/Day Versus Asacol 2.4 g/Day (ASCEND I)

The purpose of this study is to evaluate the safety and efficacy of Asacol 4.8 g/day (800 mg tablet) versus Asacol 2.4 g/day (400 mg tablet

This study is designed to evaluate the safety and efficacy of 4.8 g/day using 800 mg Asacol tablets as compared to 2.4g/day using 400 mg Asacol tablets in newly- and previously-diagnosed patients who are experiencing a flare-up of mildly to moderately active ulcerative colitis.

Eligibility Criteria:
Inclusion Criteria:

* confirmed diagnosis of ulcerative colitis

Exclusion Criteria:

* a history of allergy or hypersensitivity to salicylates or aminosalicylates;
* a history of extensive small bowel resection
A New Website for Australian IVF Patients: 'Evidence-based IVF'

IVF 'add-ons' are extra procedures, techniques, or medicines offered alongside standard IVF treatments, often marketed to improve success rates. Examples include EmbryoGlue, endometrial scratching, and acupuncture. However, most lack clear evidence of effectiveness or safety. Despite this, over 80% of Australian IVF patients use add-ons, sometimes paying thousands of dollars.

Patients often rely on clinic websites and online forums for information, but these sources frequently exaggerate benefits while omitting information about costs and risks. There is no independent, evidence-based resource in Australia to guide decision-making, a gap recognized by both patients and government reports.

To address this, the investigators developed "Evidence-Based IVF (EBI)," a new website informed by patient decision aid standards, expertise in digital health and risk communication, and co-design sessions with IVF patients and professionals. The investigators now plan to evaluate how well it helps patients understand the evidence base for IVF add-ons.

In response to widespread calls for evidence-based resources about IVF options and add-ons in Australia, the investigators assembled a multidisciplinary team to co-design a novel website prototype referred to as 'Evidence-based IVF (EBI)'. Informed by patient decision aids standards, the MAGIC App, and applying the investigators' expertise in digital and risk communication and evidence-informed health decisions, the investigators undertook interviews with Australian IVF patients and professionals to test and iteratively modify a new resource. This trial will evaluate how this website performs in terms of gist knowledge and acceptability.

Eligibility Criteria:
Inclusion Criteria:

* Live in Australia
* Undergone IVF/embryo transfer in the last 2 years or planning IVF/embryo transfer in the next six months. IVF refers to any IVF/ICSI/embryo transfer cycle in which the participant or their partner is planning to get pregnant.

Exclusion Criteria:

* People who underwent IVF process for egg-freezing or embryo freezing and not intending to conceive, or who received an embryo transfer as a surrogate.
The Use of Samsung Health and ECG M-Trace Base II Applications in the Secondary Prevention After Stroke

The aim of the present study was to quantitatively assess the risk factors that may affect the re-occurrence of a CVD event and the use of a commercially available mobile application Samsung Health for the assessment of parameters of exercise tolerance and the ECG M-Trace Base II application for the assessment of cardiological parameters.

In the post-stroke group and in the control group, SMWT (Six Minute Walk Test) and SCT( Stair Climb Test) were preceded by a 10-minute rest in sitting position. The time of test performance, the walked distance and steps made as well as the mean and maximum gait velocity and the calories burned were assessed using the above-mentioned Samsung Health application . ECG results were assessed with the use of ECG M-Trace Base II application described above. In addition, cardiological parameters such as: systolic blood pressure (SBP) and diastolic blood pressure (DBP), heart rate (HR) and arterial blood saturation were assessed. The measurements were performed at rest and directly after SCMT and SCT. Additionally, after the tests, the level of dyspnoea and fatigue was assessed according to the modified Borg scale (score 0-10).

Eligibility Criteria:
Inclusion criteria to the post-stroke group were as follows :

1. occurrence of hemiparesis after the first episode of ischaemic stroke
2. stroke confirmed in the diagnostic imaging records
3. score \>3 on Lovett's scale of muscle strength in the paretic limbs
4. score above 15 in Barthel's scale of performance in activities of daily living
5. score below 12 in the National Institutes of Health Stroke Scale (NIHSS)
6. available complete medical records concerning the assessed risk factors of recurrent CVD event
7. lack of concomitant pulmonary diseases including chronic obstructive pulmonary disease and bronchial asthma

Exclusion criteria from the post-stroke group were as follows:

1. hemiparesis or tetraparesis following many episodes of stroke,
2. lack of diagnostic imaging scans confirming the occurrence of stroke
3. hospital stay at the Department of Neurological Rehabilitation for more than 14 days from the occurrence of stroke
4. incomplete medical records concerning the assessed risk factors of recurrent CVD event
5. score \>3 on Lovett's scale of muscle strength in the paretic limbs
6. score below 14 in Barthel's scale of performance in activities of daily living
7. score above 13 in the NIHSS scale
8. occurrence of factors limiting walking ability, such as diagnosed pulmonary diseases, unstable angina, severe valvular heart diseases, cardiomyopathy, musculoskeletal or autoimmune diseases.
The Natural History of Chronic Pancreatitis

Chronic pancreatitis (CP) is a disease characterized by inflammation and their replacement by fibrotic tissue. The destruction of pancreatic function and structure are the main complications. This retrospective-prospective, multicenter, cohort study was conducted. This study aimed to observe the natural history of CP in China, analyse the risk factors for CP complications, and establish individual predictions.

In order to track changes consistently throughout the course of CP and facilitate the evaluation and study of CP, a dedicated database, CP Database (version number 2.1, YINMA Information Technology Inc., Shanghai, China), was established to collect clinical data of CP patients who were admitted to our centers. Data befor CP Database established were retrospectively collected according to the electronic medical record system and complemented through telephone, letter, and e-mail inquiries. Data were prospectively collected since CP Database was established. The following information was documented in detail: demographic data (age, sex, birthplace, et al), course of CP, medical history, history of other diseases, smoking and alcohol history, family history of pancreatic diseases and diabetes mellitus (DM), laboratory and imaging findings, and treatment strategy.

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with chronic pancreatitis according to Asia-Pacific consensus

Exclusion Criteria:

* Pancreatic cancer diagnosed within 2 years after the diagnosis of chronic pancreatitis
* Groove pancreatitis
* Autoimmune pancreatitis
Rituximab Combined With Chemotherapy in Burkitt's Lymphoma

The purpose of this clinical trial is to prove the efficacy of the following new regimen treatment:

* Administration of anti-CD20 (Rituximab) combined with chemotherapy.
* Combined treatment with high doses of methotrexate and high doses of cytarabine with conventional cytostatics (block C)
* Prophylactic administration of G-CSF after all chemotherapy cycles
* local irradiation after 6 cycle if CNS was affected or if there are residual tumour

Clinical Trial with a pharmaceutical speciality in new conditions to use.

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with mature LLA-B cell (LLA-L3)
* Patients diagnosed with Burkitt´s and Burkitt´s Like Lymphoma
* Patients 15 years old or up
* Written Informed Consent signed

Exclusion Criteria:

* Serious complications related with LAL3/LB or Secondary illness:

Serious complications, uncontrollable, for example, sepsis, pneumonia with hypoxia, shock, haemorrhage at diagnosis.

* Renal failure unconditional for the Lymphoma/Leukemia
* Heart failure or serious liver.
* Pulmonary obstructive disease or serious restrictive that not allow to treat the patient with intensive chemotherapy.
* Secondary Lymphoma after chemotherapy or previous radiotherapy or second malignant tumour.
* Known hypersensitivity to any foreign protein.
* Previous treatment with cytostatics of the LLA-B or Burkitt´s Lymphoma (exception: administration on short time of glucocorticoids ≤ 7 days, one administration of vincristine or cyclophosphamide, one cycle of CHOP, urgent administration of the another cytostatics).
* With another malignant tumour in the last 5 year.
* Women in fertile age must give positive in the pregnancy test or nursing mother.
* Mental disability or emotional or psychiatric significant disorder were the patient can't understand nor cooperate with treatment.
* Patients is enrolled in another clinical research study.
Non-inferiority Evaluation of Multicenter, Randomized, Single-blind, Parallel-controlled Clinical Trials on the Safety and Efficacy of Full-suture Anchors for Rotator Cuff Injury and/or Shoulder Instability Surgery

Multicenter, randomized, single-blind, parallel-controlled non-inferiority assessment for safety and efficacy of rotator cuff injury and/or shoulder instability surgery

This clinical trial compares the clinical effects of rotator cuff injury and/or shoulder instability surgery with the full suture anchor made by Hangzhou Ruijian Mastine Medical Equipment Co., Ltd. and the polyether ether ketone bone anchor system made by Arthrex, Inc., USA, and evaluates the safety and effectiveness of the experimental device in clinical application

Eligibility Criteria:
Inclusion Criteria:

1. The age of the patients ranged from 18 to 75 years (including 18 and 75 years), with no gender limitation
2. Patients with rotator cuff injury and/or instability of the shoulder joint are eligible for surgical indications of suture anchor
3. Subjects were willing and able to sign informed consent

Exclusion Criteria:

1. Patients with severe osteoporosis；
2. A variety of conditions, such as previous infection, suspected infection, current infection, that may or may lead to insufficient implant support or impaired rehabilitation；
3. Those with severe allergic constitution (e.g. severe allergic purpura, asthma, rhinitis, shock, etc.)；
4. Patients with abnormal liver and kidney function \[SGPT (ALT) or SGOT (AST) or creatinine (CR)\] were 1.5 times higher than the upper limit of normal value; patients with coagulation dysfunction (such as prothrombin time (PT) prolonged or shortened \> 3 s, activated partial thromboplastin time (aPTT) prolonged or shortened \> 10 s, platelet count (PLT) \< 50 \*109/L)；
5. Those with severe cardiopulmonary disease and uncontrolled epilepsy within half a year are limited to participate in the study；
6. Cervical spinal cord disease, brachial plexus nerve injury, poor compliance, psychosis, mental disorders, difficult to cooperate with；
7. Pregnancy test positive, pregnant or lactating women, recent family planning; during the trial can not take feasible contraceptive measure；
8. Surgical site peripheral nerve injury；
9. Subjects who had participated in clinical studies of other drugs, biological agents or medical devices before enrollment did not reach the primary endpoint
10. High blood pressure control is still not suitable for surgery；
11. Malignant Tumor Patients；
12. Researchers believe that there are other circumstances that are not suitable for this clinical trial.
Assessment of Safety and Efficacy of Vilaprisan in Subjects With Uterine Fibroids

The primary objective of this study is to show superiority of vilaprisan in the treatment of heavy menstrual bleeding (HMB) in subjects with uterine fibroids compared to placebo.The secondary objectives of this study are to additionally evaluate the efficacy and safety of vilaprisan in subjects with uterine fibroids.


Eligibility Criteria:
Inclusion Criteria:

* Women, 18 years or older at the time of Visit 1
* Diagnosis of uterine fibroid(s) documented by ultrasound at screening with at least 1 fibroid with largest diameter of ≥ 30 mm (alternatively, of 30 mm or more)
* Heavy menstrual bleeding (HMB) in at least 2 bleeding periods during the screening period each with blood loss volume of \>80.00 mL documented by the menstrual pictogram (MP)
* Use of an acceptable non-hormonal method of contraception
* An endometrial biopsy performed during the screening period, without significant histological disorder such as endometrial hyperplasia (including simple hyperplasia) or other significant endometrial pathology

Exclusion Criteria:

* Pregnancy or lactation (less than 3 months since delivery, abortion, or lactation before start of treatment)
* Hypersensitivity to any ingredient of the study drugs
* Hemoglobin values ≤6 g/dL or any condition requiring immediate blood transfusion (subjects with hemoglobin values ≤10.9 g/dL will be recommended to use iron supplementation)
* Any diseases, conditions, or medications that can compromise the function of the body systems and could result in altered absorption, excessive accumulation, impaired metabolism, or altered excretion of the study drug including
* Abuse of alcohol, drugs, or medicines (eg: laxatives)
* Undiagnosed abnormal genital bleeding
* Any diseases or conditions that might interfere with the conduct of the study or the interpretation of the results
EFFECT OF BLOOD PRESSURE MEASUREMENT IN DIFFERENT POSITIONS ON BLOOD PRESSURE VALUES AND ANXIETY LEVELS IN PREGNANT WOMEN WITH PREECLAMPSIA

Aim: This study examined the effects of blood pressure measurement in different positions on diastolic and systolic blood pressure values and anxiety levels in pregnant women diagnosed with preeclampsia.

Method: The study was conducted between March and June 2024 as a pre-test post-test quasi-experimental study with 96 pregnant women diagnosed with preeclampsia in the perinatology department of a training and research hospital. Participants were divided into three groups and their blood pressures were measured in the left lateral, right lateral and semi-Fowler positions. Data were collected using an introductory information form and the State Anxiety Scale.

Aim: This study examined the effects of blood pressure measurement in different positions on diastolic and systolic blood pressure values and anxiety levels in pregnant women diagnosed with preeclampsia.

Method: The study was conducted between March and June 2024 as a pre-test post-test quasi-experimental study with 96 pregnant women diagnosed with preeclampsia in the perinatology department of a training and research hospital. Participants were divided into three groups and their blood pressures were measured in the left lateral, right lateral and semi-Fowler positions. Data were collected using an introductory information form and the State Anxiety Scale.

Eligibility Criteria:
Inclusion Criteria:

* Being primigravida (first pregnancy),

  * Being in the third trimester of pregnancy,
  * Being between the ages of 18-45,
  * Being diagnosed with preeclampsia,
  * Having an arm circumference of less than 36 cm,
  * Having a history of hospitalization of at least 24 hours (in order to minimize anxiety, uncertainty, lack of information and disorientation related to hospitalization).

Exclusion Criteria:

* • Presence of a physical disability that would make it difficult to perform the positions included in the study (e.g. loss of extremity),

  * Presence of decompensated disease (e.g. eclampsia, pulmonary edema),
  * Presence of a history of cardiological disease,
  * Diagnosis of obstructive sleep apnea,
  * Presence of additional risk factors other than preeclampsia (e.g. threat of premature birth, placental anomalies).
Study of the Combination of AFM13 and Pembrolizumab in Patients With Relapsed or Refractory Classical Hodgkin Lymphoma

The purpose of this study is to establish a dosing regimen for the combination therapy of AFM13 and pembrolizumab (MK-3475) in patients with relapsed or refractory (R/R) Hodgkin Lymphoma (HL) and to assess the safety and tolerability of this combination therapy.


Eligibility Criteria:
Main Inclusion Criteria:

1. Diagnosis of CD30+ classical Hodgkin lymphoma reconfirmed by histopathology. Note: where reconfirmation is not possible, patients will still be eligible where they have confirmation clearly documented in their medical records.
2. Relapsed or refractory disease after standard therapy including brentuximab vedotin (Adcetris®).
3. Completion of, if applicable, radiotherapy, chemotherapy, antibodies and immunoconjugates including brentuximab vedotin and/or another investigational drug which could interact with this trial not less than 4 weeks (or 5 half-lives of the drug, whichever occurs later) prior to first dose of study drug. Cessation of small molecule tyrosine kinase inhibitors must be at least 7 days prior to first dose of study drug.
4. Completion of, if applicable, an autologous stem cell transplantation (ASCT) at least 3 months prior to first dose of study drug.
5. Eastern Cooperative Oncology Group (ECOG) performance score (PS) \<2.

Main Exclusion Criteria:

1. Is currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks of the first dose of treatment.
2. Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or if the patient has previously participated in MK-3475 clinical trials.
3. Has received a live-virus vaccination within 30 days of planned treatment start. Note: Seasonal flu vaccines that do not contain live virus are permitted.
4. Prior allogeneic stem cell transplantation (SCT) within the last 5 years.
5. Major surgery within 4 weeks prior to first dose of study drug.
ENB and Photodynamic Therapy in the Treatment for Early Lung Cancer

With the increased incidence of lung cancer and prevalence of low dose CT screening, treating of early lung cancer has becoming an important issue in the clinical practice of thoracic oncology. In this clinical study, the investigators will evaluate whether superDimension (superD) ENB (Electromagnetic navigation bronchoscopy) in combination with interstitial photodynamic therapy can provide the chance of tumor eradication.

Lung cancer is the one the major cause of cancer death all over the world especially in Asia. The prevalence of low dose CT screening has made more patients of lung cancer treated in the early stage. The treatment of choice for of early lung cancer is surgical resection. However, several difficulties exist in surgery for treating early lung cancer. eg. Some presenting as multi-focal lesions, which cannot be completely eradicated by surgical resection.

Electromagnetic navigation bronchoscopy (ENB)（superDimension™ Navigation System, super-D ENB) is a novel technique, which uses an image guided localization system to direct steerable bronchoscopic tools to predetermined points within the bronchial tree. This technology allows improved access to peripheral lesions in particular.

Photodynamic therapy (PDT) has been adopted an effective treatment option for the central located lung cancer by using photosensitizer which is focally retained in the tumor leading to tumor-specific abrasion by irradiating with a certain wave-length of light. The most frequently used and commercially available photosensitizer for lung cancer is PDT with Photofrin under 623 nm red light irradiation. For the peripheral lung cancer which cannot be approached by bronchoscopy, interstitial PDT with the aids of CT guided catheter implantation has been adopted. However, there are potential disadvantages of such approach including 1) bleeding or hemothorax during CT-guided catheter implantation; 2) dislodging of the catheter after lung collapse in the procedure; 3) unable to treat other lesion after pneumothorax.

In the current proposal, the investigators use ENB in combination with PDT to handle to test the feasibility of super-D ENB guided-PDT to treat small lung cancer which cannot be eradicated through surgical resection.

Eligibility Criteria:
Inclusion Criteria:

1. Multiple small lung cancer which cannot be completely removed by surgical resection.
2. Patient with small early lung cancer with diameter less than 1 cm and with high surgical risk precluding surgery.
3. Patient with small early lung cancer with diameter less than 1 cm but unwilling to receive surgical intervention.
4. Age above 20 years old and who can do the bronchoscopy test

Exclusion Criteria:

1. Bleeding tendency. 2 .Poor cardiopulmonary function with intolerance to bronchoscopy examination.
Therapeutic Abstention and Surveillance of Intra-epithelial Histological Lesions of High Grade Cervical CIN2 (Cervical Intraepithelial Neoplasia Grade 2). SUIVICIN

This study proposes to describe and evaluate the rate of spontaneous regression of CIN2 at 2 year of follow up in women between 18 and 39 year old. This follow-up is proposed as an alternative to the treatment of reference (conization) with a possible extension to 4 years

The INCa recommendations of December 2016 propose the destruction or abstention-monitoring of high-grade histological cervical lesions (HSIL) as an alternative to conization under certain conditions. These are women under 30 years old, with a small lesion in colposcopy, without any sign of invasion, with a squamocolumnar junction seen. These women must accept the principle of regular monitoring by cytology and colposcopy +/- biopsy every 6 months for a maximum of 2 years. HSIL group 2 histological entities CIN2 and CIN3. It is recognized that CIN2 are associated with CIN1 and CIN3 biology whose diagnosis is the result of the subjectivity of colposcopy allowing cervical biopsy and the variability of pathological interpretation due to poor reproducibility of histological diagnosis. CIN2 regress spontaneously in more than 50% of cases at 1 year, either completely (no lesion) or partially (LSIL low grade lesions). No invasive lesions are diagnosed over 2-year observation periods. Among the clinical, pathological and virological criteria, only the initial HPV genotyping seems to have a prognostic influence. There is therefore no strong scientific argument for routine conization in a woman over 30 years of age with a CIN2 lesion extended over more than two quadrants. In addition, conization is associated with an obstetrical risk (prematurity) and post-therapeutic colposcopic cervical stenosis complicates subsequent monitoring in case of abnormal smears. These considerations encourage the extension of the indications of abstention monitoring in the management of women with CIN2 wishing to procreate with an extension of the age to 39 year old, with no limit of size of the lesion and to satisfactory colposcopy

Eligibility Criteria:
Inclusion Criteria:

* CIN2 confirmed by biopsy, age between 18 and 39 years,
* satisfactory colposcopy identifying the junction and the lesion,
* affiliated person or beneficiary of a social security scheme,
* having given their oral agreement and authorization to the processing of their data.

Exclusion Criteria:

* Pregnancy in progress,
* history of conization,
* atypical or atypical glandular cells or cancer incidentally discovered during smear,
* prophylactic vaccination against HPV,
* active systemic infection requiring treatment, history of HIV infection, congenital or acquired immunodepression,
* long-term treatment with corticosteroids or immunosuppressants, placement under safeguard of justice,
* non-compliance with protocol requirements, in particular a supposed lack of compliance with long-term follow-up