cyrilzakka/clinical-trials huggingface dataset:
Application of Radiomics in Precise Preoperative Diagnosis and Prognsis Evaluation of Colorectal Cancer.

This is a prospective, clinical study. This study is to collect and analyze data of radiomics of primary site or metastasis of colorectal cancer aiming to precisizing preoperative diagnosis and long-term prognsis evaluation.


Eligibility Criteria:
Inclusion Criteria:

* Patients with pathologically confirmed colorectal cancer
* Male or female aged 18-75 years old on the day of signing informed consent.
* Patients who received imageological examination of primary or metastasis
* Patients who received surgical resection of primary or metastasis
* Patients must have a performance status of ≤1 on the ECOG Performance Scale.
* Colorectal cancer is the only malignant tumor
* Written informed consent must be obtained from patient or patient's legal representative and ability for patient to comply with the requirements of the study

Exclusion Criteria:

* Patients received adjuvant treatment prior to imageological examination
* Tis stage patients
* Paitents who diagnosed with malignant disease within 5 years.
* Patients with a history or current evidence of any condition or abnormality that might confound the results of the study, interfere with the patient's participation for the full duration of the study, or is not in the best interest of the patient to participate, in the opinion of the Investigator.
HER2-PREDICT: Translational Study of Tumor Samples From Patients Treated With Trastuzumab Deruxtecan (T-DXd; DS-8201a)

HER2-Predict is a multi-center, observational study using biological samples from patients treated with DS-8201a in the metastatic setting. Patients will provide a baseline FFPE tumor sample and additionally, blood sample for ctDNA determination will be collected.


Eligibility Criteria:
A. Inclusion Criteria

1. Women and men ≥18 years old that has been included in a trial using Trastuzumab Deruxtecan (T-DXd; DS-8201a).
2. The participant (or legally acceptable representative if applicable) provides written informed consent for the study. It is possible to include patients that were exitus during or after treatment by filling out the appendix 1 form and filing it into the patient's clinical chart.
3. Patients who are starting, are receiving or have received treatment with Trastuzumab Deruxtecan as a treatment for metastatic/advanced cancer.
4. Submission of a formalin-fixed, paraffin-embedded tumor (FFPE) tissue block from the most recently collected tumor tissue, with an associated pathology report, for central molecular analysis and for other protocol-mandated secondary and exploratory assessments. If a newer specimen is either insufficient or unavailable, the patient may still be eligible if the patient can provide a tissue block (preferred) or is willing to consent to and undergo an additional pretreatment core or excisional biopsy (if it is assessable and the biopsy can be safely obtained). The tumor tissue should be of good quality and quantity based on total and viable tumor content.

   1. Acceptable samples include core needle biopsies of the deep metastatic lesion or excisional, incisional, punch, or forceps biopsies for cutaneous, subcutaneous, or mucosal lesions or biopsies from bone metastases.
   2. Fine needle aspiration, brushing, cell pellet from pleural effusion and lavage samples are not acceptable.
5. Patients included before starting experimental treatment must be able and willing to provide blood sample(s).

   B. Exclusion Criteria
6. Not having participated or not willing to participate in a trial using Trastuzumab Deruxtecan.
7. Inability to comply with study and follow-up procedures
Effects of Atorvastatin Versus Pravastatin on Platelet Inhibition by Clopidogrel

Clopidogrel and statins are frequently coadministered in patients with ischemic heart diseases. Recent reports suggested that clopidogrel's effectiveness in inhibiting adenosine diphosphate (ADP)-induced platelets aggregation is attenuated by co-administration of certain statins. The objective of the present study is to define which kind of statins might interfere with the antiaggregation property of clopidogrel in patients with acute coronary Syndrome after percutaneous coronary intervention (PCI).

In this prospective randomized study, all patients in test group will receive clopidogrel plus atorvastatin, and all patients in control group will receive clopidogrel plus pravastatin. All patients will be followed up for one year. The primary endpoints include death, non fatal AMI, urgent revascularization. The secondary endpoints include hemorrhage events and subacute thrombosis events at 1 year.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with ACS.
* Between ages of 18 Years and 85 years.
* Presence of one or several stenosis in native coronary arteries requiring PCI.
* Willing and able to sign informed consent.

Exclusion Criteria:

* A history of bleeding diathesis.
* New York Heart Association functional class IV.
* Prior PCI or coronary bypass grafting \< 3 months.
* Contraindications to statins, clopidogrel and aspirin (White blood cells counts \< 4×109/L or platelet counts \<100 g/l; creatinine clearance \<25 ml/ min; active liver disease).
* Use of glycoprotein IIb/IIIa inhibitors before PCI.
* Use of statins before PCI.
Impact of Information Strategy Based on Booklet on Anxiety in Family in ICU

Anxiety and depression are symptoms frequently met in ICU patients and relatives. Risk factors are known: disease severity, age, gender. Another risk factor is lack of information from the medical staff and nurses.

Anxiety and depression can be measured by the Hospital Anxiety and Depression Scale (HADS). Other scales are used in the psychiatric field : the Impact Event Score - Revisited (IES-R) is relevant to detect Post-Traumatic Stress Disorder (PTSD), The Short Form Health Survey (SF-36) is an assessment of life quality.

In the following study, the investigators will evaluate the impact of a "brochure" as complement of oral information on Anxiety developed by relatives and family of ICU patients.

The medical and surgical ICU is composed by two different units (different medical and nurse team, different location in the same hospital) of 12 beds on one side, 14 beds on the other side.

During a year, in the first unit, the investigators will use the booklet as support and complement of oral information : "booklet arm". The information process will be as usual in the other unit : "control arm". During the second year, the booklet will be used in the second unit while the first unit will return to the usual oral information (cross-over).

For each included patient, one relative or family member is pointed to be the referring family member or "referent". This "referent" receives the HADS questionnaire at Day 3 after admission, at day of discharge if the patient is alive, at one month after discharge. The IES-R questionnaire is delivered at discharge of the living patient and at day 30. The SF-36 questionnaire is given to the "referent" and the living patient at day 30. The day 30 questionnaires are send by mail at the "referent" address.


Eligibility Criteria:
Inclusion Criteria:

* All patients admitted in ICU whose previsible length of stay is over 3 days.

Exclusion Criteria:

* Admitted patient without organ failure
* Family member or patient who can't speak and/or read French
* Family who didn't show off within the first week of hospitalization
Efficacy of a Mindfulness-Based Intervention in Patients With Cardiovascular Implantable Electronic Device

An implantable cardiac defibrillator (implantable cardioverter-defibrillator; ICD) can effectively improve heart rhythm problems and reduce sudden death, and is widely used in the treatment of high-risk patients with fatal arrhythmias or heart rhythm problems that cannot be controlled by drugs . In the whole case of arrhythmia, after receiving home-based cardiac fibrillator treatment, Patients often experience uncertainty, feel the changes in heart, feel the shock of being shocked by the electric shock, and worry about death, These psychological distress, which were characterized by anxiety and depression. for universal. About 25% of patients present with symptoms of anxiety at the time of hospitalization, and 50% suffer from depression which seriously affects quality of life. Therefore, the main purpose of this study to alleviate the occurrence of anxiety and depression, promote disease patients to regain life adaptation, develop accessible care strategies with midfulness-based intervention to help patients overcome psychological distress, reduce stress, anxiety and prevent depression.

This study with randomized clinical trial design (randomized clinical trial) and qualitative research, which is a qualitative mixed-methods research. Patients were randomly assigned to the experimental group and the control group in a 1:1 manner. The experimental group received the mindfulness-based intervention designed and routine care , and the control group received general routine care. Both groups completed a total of four questionnaires at the pretest (T0), discharge (T1), the first month of discharge (T2), and the third month of discharge (T3), including anxiety, depression, resilience, stress perception scale and other basic data such as demographics and disease characteristics were collected in the pretest.

This study held an expert meeting to extract the techniques of mindfulness measures suitable for this disease attribute and the elderly group, including: breathing awareness, body scanning, mindful yoga, mindful eating, and loving-kindness meditation. From the time when the patient signed up for the first cardiac device surgery schedule, the experimental group who met the including criteria followed the routine care of the hospital and was involved in teaching the above mindfulness skills, while the control group still followed the routine care.

Eligibility Criteria:
Inclusion Criteria:

1. Patients receiving implanted cardiac devices for the first time (including cardiac defibrillator ICD and Pacemaker).
2. Adults over 20 years old.
3. Those who have clear consciousness and can communicate in Chinese and Taiwanese.
4. Score of 8 or above on the Hospital Anxiety or Depression Scale.
5. Barthel Index above 70 points.

Exclusion Criteria:

1. Diagnosed with dementia by a physician.
2. Diagnosed with mental disorders, including cognitive disorders, organic psychosis and affective psychosis.
3. Patients who have been diagnosed with cancer.
4. Long-term bed ridden.
Effects of Iloprost on Hypoxic Pulmonary Vasoconstriction at Altitude

The objective of this study is to determine if single dose administration of inhaled iloprost will reduce pulmonary artery pressure, reduce hypoxic pulmonary vasoconstriction and improve arterial oxygenation at rest and during exercise at high altitude.

Three major pathways in addition to oxygen modulate pulmonary vascular tone: 1) nitric oxide, 2) endothelin, and 3) prostacyclin. Considerable animal data support the role of the prostacyclin pathway in modulating hypoxic pulmonary vasoconstriction. In humans, prostacyclin and its analogs are important therapeutic agents in the treatment of pulmonary arterial hypertension (PAH). Despite the animal data and human data in PAH there is very little information about the use of to relieve hypoxic pulmonary vasoconstriction in healthy humans. Inhaled iloprost is an ideal agent to study the prostacyclin pathway due to its short duration of action (30-90 min) and elimination half-life of only 20-30 min. Individuals already participating in the Nepal Medex 2008 trip will be invited to participate in this research. Participants will be healthy active females or males, between 18-80 years of age, without known pregnancy or liver disease, who have a readily measurable tricuspid regurgitant velocity by Doppler echocardiography. If possible, we will attempt to identify a cohort of HAPE susceptible patients. Participants will undergo evaluation both at sea level (baseline) and at high altitude. Baseline (low altitude) testing will be performed in Bangor, North Wales, UK, and will include evaluation of pulmonary artery systolic pressures, cardiac output, and oxygen saturation at rest and during submaximal exercise before and after inhalation of iloprost. This strategy will then be repeated at an altitude of approximately 5000 meters in the Dhaulagiri region of Nepal.

Eligibility Criteria:
Inclusion Criteria:

1. Age: 18 - 80 years
2. Healthy physically active males or females
3. Have readily measurable tricuspid regurgitation (TR) peak systolic velocity by continuous wave Doppler ultrasound

Exclusion Criteria:

1. Known liver disease
2. Pregnancy
3. Medications that in the opinion of the investigators could place subjects at increased risk of complications Any other medical condition that in the opinion of the investigators would place the subject at high risk
Occupational Therapy and Surgery in Carpometacarpal Osteoarthritis

The purpose of the study is to investigate if occupational therapy may delay or prevent the need for surgery in patients with carpometacarpal(CMC) osteoarthritis (OA) who are scheduled for surgery in the CMC-joint.

Our study hypothesis is that compared to participants in the intervention group, significantly more participants in the control group have received CMC-surgery after two years.

Hand osteoarthritis (OA) is one of the most prevalent musculoskeletal diseases in an adult population, and approximately 68% of people between the ages of 71 and 80 years have radiographic OA in the carpometacarpal (CMC) joint.

Currently, there is no cure for hand OA. However, several studies have demonstrated that hand exercises and CMC-orthoses may reduce pain and improve grip strength, and in a recent study, assistive devices improved activity performance and satisfaction with performance in people with hand-OA. Still, most people do not receive any such treatment, but those with severe CMC-OA are often referred for surgery in this joint. The effect of occupational therapy to prevent or delay need for surgery CMC-OA has been investigated in a small study with 33 participants, but randomised controlled trails (RCT) of good quality are needed.

Eligibility Criteria:
Inclusion Criteria:

* Patients with CMC-OA who are referred for review for the need for surgery in the CMC joint.

Exclusion Criteria:

* Persons with cognitive dysfunction
* Persons who do not understand the Norwegian language
* Persons with other diseases or injuries that may negatively impact hand function
Study of the Safety and Immune Response of Two Serogroup B Meningococcal Vaccines Administered to Healthy Adolescents

The purpose of this study is to evaluate the safety and immunogenicity of two serogroup B meningococcal vaccines in comparison to placebo administered to healthy adolescents ages 11 to 18 years.


Eligibility Criteria:
Inclusion Criteria:

* Healthy Adolescents between and including 11-18 years of age, who provide written informed consent.

Exclusion Criteria:

* Previous or suspected disease caused by N. meningitidis; or previous immunization with a serogroup B meningococcal vaccine; Any acute, chronic or progressive disease.
Along-term Study of OPC-262 in Patients With Type 2 Diabetes

The purpose of this clinical study is to evaluate the safety of OPC-262 (2.5 mg and 5 mg) in patients with type 2 diabetes by long-term administration orally for 52 weeks and to evaluate the efficacy of OPC-262


Eligibility Criteria:
Inclusion Criteria:

* Patients who completed Study 262-09-001 (namely, patients who visited the hospital at visit Week 24）
* Patients who are capable of giving informed consent prior to participating in this clinical study
* Patients who are able to take contraceptive measures to avoid pregnancy of the patient or the patient's partner for the entire study period and for 4 weeks after the study (end of the post-observation period)

Exclusion Criteria:

* Patients who withdrew from Study 262-09-001
* Patients who experienced serious adverse events that the relationship with the study drug was not denied in Study 262-09-001
* Patients who experienced serious adverse events that the relationship with the study drug are denied in Study 262-09-001 and whose symptoms are still emerged at the time of initiation of this study
* Patients who met the exclusion criteria of Study 262-09-001 during the study period of Study 262-09-001
* Female patients who wish to become pregnant during the study period of Study 262-09-002 or within 4 weeks after the study
* Patients otherwise judged by the investigator or subinvestigator to be inappropriate for inclusion in the study
Cyanocobalamin as Photosensitizing Agent

is cyanocobalamin active as Photosensitizing Agent instead of riboflavin ? using cyanocobalamin with mix of external collagen to make crosslinking with cornea collagen to make rigid of cornea


Eligibility Criteria:
Inclusion Criteria:

* - Is 20 years or older Has been diagnosed with Keratoconus; Has no other active ocular disease; Is not pregnant or nursing;

Exclusion Criteria:

* Is under the age of 20 Has best corrected visual acuity outside 20/400; Pregnant or nursing at the time of enrollment in the study;
Fast-track Surgery After Gynecological Oncology Surgery

Fast-track surgery (FTS) pathway, also known as enhanced recovery after surgery (ERAS), FTS is a multidisciplinary approach aiming to accelerate recovery, reduce complications, minimize hospital stay without an increased readmission rate and reduce healthcare costs, all without compromising patient safety. It has been used successfully in non-malignant gynecological surgery, but it has been proven to be especially effective in elective colorectal surgery. However, no consensus guideline has been developed for gynecological oncology surgery although surgeons have attempted to introduce slightly modified FTS programmes for patients undergoing such surgery. NO randomised controlled trials for now.

The advantages of fast-track most likely extend to gynecology, although so far have scarcely been reported. There is a existing research showed FTS in gynecological oncology provide early hospital discharge after gynaecological surgery meanwhile with high levels of patient satisfaction.

The aim of this study is to identify patients following a FTS program who have been discharged earlier than anticipated after major gynaecological/gynaecological oncologic surgery and analyze the complication after surgery.

Methods/Design

Comparison of Fast-Track (FT) and traditional management protocols. the primary endpoints is length of hospitalization post-operation (d, mean±SD). It was calculated by the difference between date of discharge and date of surgery. The secondary endpoints are complications in both groups are assessed during the first 21 days postoperatively. Including infection(wound infection, lung infection, intraperitoneal infection, operation space infection), postoperative nausea and vomiting (PONV) , ileus, postoperative hemorrhage, postoperative thrombosis and APACHE II score.

The advantages of fast-track most likely extend to gynecology, although so far have scarcely been reported. NO randomised controlled trials for now. The aim of this study is to compare the LOS (Length of hospitalization post-operation) after the major gynaecological/gynaecological oncologic surgery and analyze the complication after surgery. This trial can show whether the FTS program can achieve early hospital discharge after gynaecological surgery meanwhile with low levels of complications.

Eligibility Criteria:
Inclusion Criteria:

1. Patients scheduled for gynecological oncology surgery(including radical hysterectomy add lymphadenectomy, hysterectomy add lymphadenectomy and cytoreductive)
2. Aged 18 years or older
3. Signed informed consent provided

Exclusion Criteria:

1. Patients with a documented infection at the time of operation
2. Aged 71 years or older
3. Patients with ileus at the time of operation
4. Patients with hypocoagulability
5. Patients with psychosis, Alcohol dependence or drug abuse history
6. Patients with primary nephrotic or hepatic disease
7. Patients with severe hypertension systolic pressure≥160mmHg, diastolic pressure\>90mmHg
Safety and Efficacy of Palonosetron IV to Prevent Postoperative Nausea and Vomiting in Pediatric Patients

The objective of the study is to assess the safety and efficacy of two doses of IV palonosetron each administered as a single dose for the prevention of postoperative nausea and vomiting through 72 hours postoperatively in children aged 28 days up to 16 years inclusive undergoing surgical procedures requiring general endotracheal inhalation anesthesia.


Eligibility Criteria:
MAIN INCLUSION CRITERIA

* Male or female patient aged more than 28 days (full term) up to and including 16 years.
* Inpatient scheduled to undergo surgical procedures requiring general endotracheal anesthesia, including:

  * ear, nose and throat surgery;
  * eye surgery;
  * orchidopexy;
  * plastic reconstructive surgery;
  * herniorraphy;
  * orthopedic surgery).
* American Society of Anesthesiologists (ASA) physical status I, II or III.
* Patient scheduled to receive nitrous oxide during the maintenance phase of anesthesia.
* Patient scheduled to be hospitalized for at least 72 hours after wake up of surgery
* For female of childbearing potential: the patient and her parent(s)/legal guardian(s) were counseled on the importance of not becoming pregnant before or during the study and the patient must have a negative pregnancy test at the pre-treatment visit and at the study treatment visit.

MAIN EXCLUSION CRITERIA

* For infant aged more than 12 months: a history of gastro-esophageal reflux.
* For patient aged 28 days to 6 years: patient who received any investigational drugs within 90 days prior to Day 1. For patient aged 6 up to 16 years inclusive: patient who received any investigational drugs within 30 days prior to Day 1.
* Patient scheduled to undergo emergency surgery.
* Patient scheduled to receive regional (spinal) anesthesia in conjunction with general endotracheal anesthesia.
* Patient scheduled to receive propofol during the maintenance phase of anesthesia.
* Patient with vomiting from any organic cause.
* Any drug with a potential anti-emetic effect within 24 hours prior to the administration of anesthesia.
* Any vomiting, retching, or nausea in the 24 hours preceding the administration of anesthesia.