cyrilzakka/clinical-trials huggingface dataset:
Factors Affecting the Results of Treatment of Patients With Colorectal Cancer

The study attempts to quantify the relative risks for mortality, anastomotic leakage and other early and late postoperative complications, recurrence rate, cancer-specific survival, recurrence-free survival after colorectal surgery for patients with colorectal cancer depending on the localization of the tumor.


Eligibility Criteria:
Inclusion Criteria:

* Histologically proven primary adenocarcinoma of bowel;
* All patients who have indications for surgical treatment of colorectal cancer based on the decision of the oncological council;
* Signed informed consent with agreement to attend all study visits;

Exclusion Criteria:

* Unresectable tumor or contradictions to surgery;
* Indications for chemotherapy or radiation therapy prior to surgery;
* Patient withdrawal from the trial or loss of follow-up;
* Emergent operation;
* Pregnancy.
Clomiphene Citrate (CC) Co-treatment With HP Urinary FSH vs HP Urinary FSH in CC-resistant PCOS

To test whether adding small doses of HP urinary FSH to standard regimen of clomiphene citrate in clomiphene resistant PCOS well yield better results in terms of better ovulation rate,lower follicle number, less consumption of HP urinary FSH,lower treatment cost , better pregnancy rate, lower multiple pregnancy rates compared with the exclusive use of HP urinary FSH in these cases.

To test whether CC co- treatment with chronic low dose HP uFSH vs chronic low dose HP uFSH in CC resistant PCOS will yield better results in terms of ,ovulation rate, lower follicle number,lower HP uFSH dose ,better outcome in terms of pregnancy rates, better cost-effectiveness ratio, lower multiple pregnancy rates,lower cycle cancellation.

Eligibility Criteria:
Inclusion Criteria:

* CC resistant PCOS
* Infertile
* Females
* Age 18-38

Exclusion Criteria:

* Hyperprolactinaemia
* Cushing syndrome
* Adult onset adrenal hyperplasia
* Age \>38
* Other infertility factors in the couple than PCOS: male factor,tubal factor,edometriosis
New Method for Distal Interlocking of Cannulated Intramedullary Nails

We intend to include10 patients in this study and trial. Prior to treatment they will sign an informed consent form, stating that they are acquainted with the surgical procedure and study, and that they consent to participate in the study.

Five patients will undergo regular operation with Universal tibial reamed nail (AO-Synthes) using the fluoroscopy device: OEC 9800 (GENERAL ELECTRIC). five patients will undergo the same operation using the new navigation system:"The Guiding star" method.

The allocation will be random.


Eligibility Criteria:
Inclusion Criteria:

1. Signing Informed consent.
2. Conscious patients.

Exclusion Criteria:

1. Hemodynamic Instability.
2. Multiple system injuries.
3. Pregnancy.
4. Soldiers.
A Study of SCG101 in the Treatment of Subjects With Hepatitis B Virus-Related Hepatocellular Carcinoma

This Phase 1/ 2a study is a multicenter study to evaluate the safety, tolerability and efficacy of SCG101 in subjects with hepatitis B virus-related hepatocellular carcinoma

This study will be conducted in 2 parts: In Phase 1 dose escalation, cohorts of 3-6 subjects each will be sequentially assigned to escalating dose level of SCG101. The recommended phase 2 dose (RP2D) will be selected based on the safety, PK/ PD and antitumor activities if the maximum tolerated dose (MTD) is not reached from the planned dose levels.

In Phase 2a, subjects will be enrolled to characterize the safety and evaluate the efficacy of SCG101.

Eligibility Criteria:
Main Inclusion Criteria:

* Histologically or cytologically confirmed Hepatocellular carcinoma (HCC)
* Subjects with HCC who have received at least 2 standard systemic therapies
* HLA-A \*02
* BCLC stage B or C
* Child-pugh score ≤ 7
* Serum HBeAg negative, serum (or tumor tissue) HBsAg positive, and serum HBV-DNA must be 2 × 1000 IU/ml
* Have at least one measurable leasion at baseline as per mRECIST and RECIST v1.1 criteria
* Life expectancy of 3 months or greater
* Ability to provide informed consent form
* Ability to comply with all the study procedures

Main Exclusion Criteria:

* Subjects with history of another primary cancer
* Untreated or active central nervous system (CNS) or leptomeningeal metastasis, or history of hepatic encephalopathy, or other clinically significant CNS diseases
* Autoimmune diseases requiring immunosuppressive therapy (except topical medication) or subjects with significant persistent immune rejection
* Known history of neurological or mental disorder, including epilepsy or dementia
* Known history of positive results for human immunodeficiency virus (HIV) 1 or 2 or known acquired immunodeficiency syndrome (AIDS)
* Prior exposure to any cell therapy such as, but not limited to killer (NK) cells, cytokine-induced killer (CIK) cells, dendritic cells (DC), cytotoxic T lymphocytes (CTL), stem cell therapy, CAR T/TCR T cell therapy
* Allergy to immunotherapy drugs and lymphodepleting chemotherapy (cyclophosphamide and fludarabine)
* Any subjects who cannot be evaluated by either triphasic liver CT or triphasic MRI because of allergy or other contraindication to both CT and MRI contrast agents
* Any condition which, in the investigator's opinion, makes the subject unsuitable for trial participation
Macroscopic on Site Evaluation (MOLSE) vs Standard Specimen Acquisition of Solid Lesions During EUS-FNB

Endoscopic ultrasonography (EUS) with tissue acquisition (TA) is nowadays a well-established technique for the sampling of solid lesions pancreatic and non-pancreatic lesions. Actually the standard methods to obtain sampling in gastrointestinal (GI) and non-GI solid masses is the fine needle aspiration (FNA) performed by endoscopic ultrasonography (EUS). Its sensitivity, specificity and diagnostic accuracy for malignant cytology are actually reported of 85-95%, 95%-98% and 78-95% respectively. These data could be affected by the presence of cytopathologist in endoscopy room during the tissue sampling. The rapid on-site evaluation (ROSE) has been advocated to significantly increase EUS-FNA accuracy. To overcome this problem fine needle biopsy (FNB) for TA to obtain histological specimens was proposed. These needles allow as the acquisition of an histological specimen than the cytological one with FNA needles. Recently, the need to obtain a histological, instead of a cytological, specimen during EUS has become more urgent and necessary due to innovative oncological treatment options. An acquired histological specimen could avoid the need of a cytopathologist in the endoscopic room, diminishing costs, procedures time, number of passes and reducing the additional costs of a possible repeated EUS-FNA, in case of an inconclusive diagnosis.

With the advent of FNB, the macroscopic on-site evaluation (MOSE) of the specimen by the endosonographer was proposed, resulting in a comparable alternative to ROSE.


Eligibility Criteria:
Inclusion Criteria:

* Age greater than 18, both genders.
* Both in-patient and out-patients.
* Presence of a solid lesion. In the presence of a cystic component, the solid part of the lesion should be more 75% of the total.
* FNB performed by a 22G needle Acquire® (Boston Scientific).
* Tissue acquisition with fanning technique.
* Obtained informed consent.

Exclusion Criteria:

* Patients underwent EUS-FNA with or without ROSE
* Patients underwent EUS-FNB plus ROSE.
* Previous biopsy of the lesion with diagnosis of malignancy
* Presence of an uncorrectable coagulopathy as defined by abnormal prothrombin time (PT) or partial thromboplastin time (PTT) that does not normalize after administration of fresh frozen plasma.
* Pregnancy or breast-feeding.
* Patients unable to understand and/or read the consent form.
* Inclusion in other study.
Relationship of Balance, Functional Capacity and Fear of Movement With Lower Extremity Muscle Strength in Elderly

Aging is a period in which the morphological, physiological and pathological changes progress negatively, accompanied by various diseases and regression of physical and mental abilities. In this period, the individual experiences biological and physiological losses as well as social problems in his/her life. From the age of 65, approximately 80% decrease in muscle strength can be observed and this decrease is especially noticeable in the leg and trunk muscles. Decreases in the strength of the muscles in the lower extremities may cause deterioration in physical function, decrease in mobility, increase in falling related accidents, also can cause osteoporosis and physical deficiencies. Determining the structures with which the lower extremity muscle strength is related will facilitate the precautionary measures for the inadequacies that will arise in the later stages of aging.

This study was performed to analyze the relationship of lower extremity muscle strength with balance, functional capacity, fear of movement and quality of life in elderly individuals living in nursing homes.


Eligibility Criteria:
Inclusion Criteria:

* The participant must be 65-88 years old,
* The participant must have a minimus score of 24 on the Mini-Mental State Examination (MMSE),
* No cognitive impairment,
* The participant must be independent of daily life activities (must not use an assistive device for walking).

Exclusion Criteria:

* Having a disease that can affect balance (vestibular, neurological, orthopedic ...) performing regular exercise
* Uncontrolled hypertension or arrhythmia
* Uncontrolled diabetes mellitus
* Orthopedic, neurological or musculoskeletal problems
* Postural hypotension
* Obesity (body mass index\>40)
* Uncompensated clinical conditions such as chronic obstructive pulmonary disease, interstitial lung disease, heart failure, or rheumatic and psychiatric diseases
Artificial Intelligence in Mental Illness Diagnosis and Treatment

To improve the quality of mental health services, we will develop a robot that includes disease screening, diagnosis, treatment, and follow-up. The effectiveness of robots will be verified in a prospective, randomized, multi-center clinical trial. We assume that the robot will reduce the differences in the experience of doctors of different years and will improve mental health care across the country, and improve the uneven distribution of mental health resources through remote resource sharing.

Anxiety disorder is the most common mental disorder in the world. The lifetime prevalence of anxiety disorder in China is as high as 7.6%, but the treatment rate is less than 30%, and the standard treatment rate is only 9.8%. The disease burden is heavy, and it is one of the most serious public health problems in China. Anxiety disorder is a chronic relapsing disease, single drug treatment only 35-50% efficient, psychological treatment as the most international evidence-based foundation and anxiety disorder most commonly used treatment method, can be a single treatment for anxiety disorders or improve the effect of the medication, but because of clinical psychology in China started late, the lack of professionals, unable to meet the huge demand for psychological treatment in our country, therefore, how to develop efficient and standardized anxiety disorders psychotherapy pattern, improve the psychological treatment of acquired, is the key to improve the clinical curative effect of anxiety disorders. Based on the intelligent assisted psychotherapy system based on cognitive behavior and mindfulness developed in the early stage, this research group established the accurate psychotherapy artificial intelligence robot based on evaluation to assist the whole process of standardized psychotherapy for anxiety disorders.

Eligibility Criteria:
Inclusion Criteria:

* Community high-risk groups and institutional groups.
* According to the ICD-11 diagnostic guidelines of anxiety-related disorders, depression-related disorders, addiction-related disorders, compulsive-related disorders diagnosis,
* age 18-60 years old,
* skilled in the operation of computers or smartphones,
* language, reading ability is normal,
* willing to participate in the project and sign informed consent study.

Exclusion Criteria:

* The symptoms of mental illness are severe and require hospitalization, or the patient is unable to complete the required assessment examination and treatment.
* Those who have a higher risk of self-injury or suicide.
* People with severe physical illness, central system disease, or substance abuse.
* Receive physical therapy at the same time.
Study Assessing the Safety and Efficacy of DE-117 Ophthalmic Solution Once Daily and Twice Daily in Subjects With Primary Open-Angle Glaucoma SPECTRUM 6

This is a randomized, double-masked, parallel-group, multi-center study. Subjects diagnosed with POAG or OHT who meet eligibility criteria at Visit 1 (Screening) will wash out their current topical IOP lowering medication(s), if any. After completing the required washout period, subjects will return for Visit 2 (Baseline, Day 1). Subjects who meet all eligibility criteria at Visit 2 (Baseline, Day 1) will be randomized to receive study medication for up to 6 weeks.

Approximately 100 subjects with POAG or OHT will be randomized in a 1:1 ratio to either:

* DE-117 ophthalmic solution 0.002% QD (Once Daily)
* DE-117 ophthalmic solution 0.002% BID (Twice Daily)

This study will consist of a screening period of up to 35 days including a washout period of up to 28 days (+ 7 days window), and a 6-week double-masked treatment period.


Eligibility Criteria:
Inclusion Criteria:

Provide signed written informed consent

* Have a diagnosis of POAG or OHT in both eyes, or one eye with POAG and the other with OHT.
* Qualifying corrected visual acuity in each eye
* Qualifying central corneal thickness in each eye
* Qualifying Day 1 IOP measurement at 3 time-points in both eyes
* Qualifying Anterior chamber angle

Exclusion Criteria:

* History of ocular surgery specifically intended to lower IOP
* Subjects who cannot safely discontinue use of ocular hypotensive medications during the wait/washout period
* Advanced glaucoma in either eye
* Any corneal abnormality or other condition interfering with or preventing reliable Goldmann applanation tonometry
* Any ocular surgery or ocular laser treatment within 180 days prior to Screening and throughout the study in either eye
* Females who are pregnant, nursing, or planning a pregnancy
A Study of CHS-114 in Combination With Toripalimab and/or Other Treatments in Participants With Advanced Solid Tumors

The main purpose of this study is to evaluate the safety and preliminary efficacy of CHS-114 in combination with toripalimab and/or other standard of care (SOC) compound(s) in participants with advanced or metastatic solid tumors.


Eligibility Criteria:
Key Inclusion Criteria:

* At least 1 measurable lesion based on RECIST v1.1 as determined by the Investigator.
* Resolved acute effects of any prior therapy to baseline severity or Grade 1 in accordance with National Cancer Institute (NCI)-Common Terminology Criteria for Adverse Events (CTCAE) v5.0, except for adverse events (AEs) not constituting a safety risk per Investigator judgement.

Key Exclusion Criteria:

* History of prior malignancy other than the cancer under study that is progressing or has required active treatment within the past 3 years.
* Symptomatic or untreated central nervous system metastases, including leptomeningeal metastases, requiring concurrent treatment, including but not limited to surgery, radiation, and/or corticosteroids.
* Major surgery requiring general anesthesia within 28 days prior to the first dose of study treatment, still recovering from prior surgery, or with surgery scheduled during the study.
* Prior exposure to anti-C-C motif chemokine receptor 8 (CCR8) antibody.
* History of Grade 4 allergic or anaphylactic reaction to any monoclonal antibody (mAb) therapy or any excipient in the study treatment.
* Active uncontrolled bacterial, fungal, or viral infection including hepatitis B virus (HBV), hepatitis C virus (HCV), known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)-related illness.
* Any condition that, in the opinion of the Investigator or Sponsor, would interfere with the interpretation of study results.

Note: Other protocol-specified inclusion/exclusion criteria apply.
Airway Management in Thoracic Anesthesia in Italy

The aim of this study is to compare the success rate of lung isolation and time to accomplish a correct placement of the device between anesthetists with experience in thoracic anesthesia (defined as at least 4 years clinical practice experience as attending anesthetists in thoracic) and residents in training in thoracic anesthesia.

The aim of this study is to compare the success rate of lung isolation and time to accomplish a correct placement of the device between anesthetists with experience in thoracic anesthesia (defined as at least 4 years clinical practice experience as attending anesthetists in thoracic) and residents in training in thoracic anesthesia.

A prospective randomized trial was designed. To check the optimal DLT (Broncho-Cath Covidien, Ireland, Dublin, Teleflex Medical, Athlone, Irelanad) and/or BB (Uniblocker, Phycon, Fuji, Japan Arndt Cohen Cook, Australia), placement a fiberoptic bronchoscope (FOB) was used. The lung collapse was assessed by surgeons.

Time from laringoscopy to the correct placement of the device, confirmed with FOB, was checked.

Data were analyzed with Student't Test and Chi-square test; p value \< 0.05 was considered to be significant.

Eligibility Criteria:
Inclusion Criteria:

* patients who need one lung ventilation undergoing thoracic surgery

Exclusion Criteria:

* age \< 18 years old
Glutamate Excitotoxicity in Brain Metastases From Lung, Breast and Melanoma Treated With Stereotactic Radiosurgery

Brain metastases (BM) represents a devastating clinical reality, carrying an estimated survival time of less than one year. Number of reasons, including complicated tumor biology and difficulties in modeling metastatic cancer in brain microenvironment, do hinder research on this topic. BM are indeed the most frequent neoplasm in the central nervous system (CNS) and is estimated that up to 14% of all newly diagnosed cancers will metastasize to the brain. A number of reasons, including complicated tumor biology and difficulties in modeling metastatic cancer in brain microenvironment, do hinder research on this topic. Present knowledge regarding alterations in Glutamate (Glu) homeostasis and BM is poor. This study aims at investigating Glu balance in BM patients and providing supporting evidence to the identification of new putative biomarkers to be used as potential therapeutic targets.

Experimental procedure:

Serum levels of glutamic oxaloacetic transaminase (GOT1), glutamate Pyruvate Transaminase (GPT) and lactate dehydrogenase (LDH) levels and serum glutamate, aspartate and lactate levels of a total of 100 patients will be collected and divided in three different groups:

* A: BM group (n=50), patients affected by BM from lung, breast and melanoma, candidates to SRS
* B: Control group 1 (n=25), patients with the same primary controlled tumors without nor brain nor extracranial metastases
* C: Control group 2 (n=25), patients with benign intracranial lesions candidates to SRS treatment.

In A) and C) serum GOT1, GPT and LDH levels and serum glutamate, aspartate, lactate levels will be evaluated before and after SRS treatment (at 3, 6 and 9 months follow-up).

In B) serum biomarkers levels will be only collected at baseline.

• Oncological and imaging data will be collected during follow-up in patients enrolled in the present studies. MRI imaging will be performed at definite timepoints (baseline and 3, 6 and 9 months follow-up).

Serum levels of markers will be analyzed in each group and results will be compared between them. Moreover, MRI changes and oncological relevant outcomes will be investigated.

Eligibility Criteria:
Inclusion Criteria (Target group)

* Adult patients carrying melanoma, breast or lung cancer BM of new diagnosis
* Patients eligible to SRS-GK treatment

Inclusion Criteria (Control group 1)

- Adult patients carrying melanoma, breast or lung cancer without BM

Inclusion Criteria (Control group 2)

* Adult patients carrying intracranial extra-axial benign tumor
* Patients eligible to SRS-GK treatment

Exclusion Criteria:

* Acute or chronic liver disease
* Severe anemia (Hb \<8g/dl)
* Pregnant or breastfeeding patient
* Pediatric patients
* Patients not able to express informed consent
Effects of Music on Acute Postoperative Pain Intensity and Mobility After Fragility Hip Fracture

Music has been proven to be beneficial in postoperative care by reducing pain. The effects of music listening to reduce pain postoperatively are well studied among cases undergoing elective orthopaedic surgery. No study has been conducted focusing on pain control among cases with fragility hip fractures in an acute ward setting with non-schedule non-elective orthopaedic operation.

In Queen Elizabeth Hospital a standardized analgesic protocol is used for all fragility hip fracture cases unless contraindicated, a suboptimal post-operative pain control is not uncommonly seen. Stepping up analgesics is usually a concern in the elderly with a higher rate of side effects, a safe and simple non-pharmacological intervention for pain control is therefore needed.

The aim of this study is to study the effectiveness of incorporating music on pain intensity and mobility with the standard postoperative rehabilitation care of fragility hip fracture in Queen Elizabeth Hospital.


Eligibility Criteria:
Inclusion Criteria:

1. Emergency admitted to QEH/G9 due to fragility hip fracture (#NOF or # TOF) within the study period
2. Plan for surgical intervention
3. Able to provide written informed consent
4. Able to communicate in Cantonese/ Putonghua/ English

Exclusion Criteria:

1. History of dementia
2. Acute delirium upon admission
3. Disorientated to time, person or place
4. Concurrent fracture at other sites
5. Utilization of other analgesics on top of pain protocol
6. Appreciable deficits in hearing or vision
7. Hemodynamically unstable
8. Plan for neurolysis/ nerve block as definite treatment or opt for conservative treatment