cyrilzakka/clinical-trials huggingface dataset:
LISH Trial for the Hepatic Flexure and Proximal Transverse Colon Cancer

The goal of this clinical trial is to compare the long-term outcomes of Laparoscopic Ileocecal-Sparing Right Hemicolectomy(LISH) compared to traditional laparoscopic right hemicolectomy(TRH) in the treatment of hepatic flexure colon cancer and proximal transverse colon cancer.

This study is a prospective, multicenter, open-labeled, randomized controlled clinical trial. The enrolled patients will be randomly assigned to either the LISH or TRH group in a 1:1 ratio and will receive the corresponding surgery. The primary endpoint: 3-year disease free survival. The second endpoint: (1)90-day postoperative complications; (2)Pathology-related indicators, including positive margin rate, number of harvested lymph nodes and lymph node metastasis rate;(3) 5-year overall survival rate (OS)

Eligibility Criteria:
Inclusion Criteria:

1. Age between 18-75 years old
2. ASA classification ≤III
3. Colon adenocarcinoma confirmed by endoscopy and pathological biopsy
4. Enhanced abdominal CT indicating the primary lesion is located in the hepatic flexure of the colon or proximal transverse colon (proximal 1/3 of the transverse colon)
5. Preoperative clinical staging: TanyNanyM0
6. Patients able to understand the study protocol, willing to participate in the research, and providing written informed consent

Exclusion Criteria:

1. Preoperative examination indicates synchronous multiple primary colorectal cancers or other diseases requiring bowel segment resection
2. Preoperative imaging or intraoperative exploration reveals: 1) tumor involving surrounding organs requiring combined organ resection; 2) presence of distant metastasis; 3) inability to perform R0 resection; 4) fused and fixed lymph nodes at the root of the ileocolic vessels
3. Additional radical surgery following Endoscopic Mucosal Resection (EMR) and Endoscopic Submucosal Dissection (ESD) procedures
4. History of any other malignant tumor within the last 5 years or familial adenomatous polyposis, except for cured in situ cervical cancer, basal cell carcinoma, papillary thyroid carcinoma, or skin squamous cell carcinoma
5. Presence of bowel obstruction, bowel perforation, or intestinal bleeding requiring emergency surgery
6. Patients unsuitable for or unable to tolerate laparoscopic surgery
7. Pregnant or lactating women
8. Patients with a history of psychiatric disorders
9. Patients who have received neoadjuvant therapy prior to surgery
10. Patients deemed unsuitable for the study by MDT discussion
11. Patients unable to understand the study's conditions and objectives, and refusing to sign informed consent.
Study to Evaluate CCS1477 (Inobrodib) in Haematological Malignancies

A Phase 1/2a study to assess the safety, tolerability, PK and biological activity of CCS1477 (inobrodib) in patients with Non-Hodgkin Lymphoma, Multiple Myeloma, Acute Myeloid Leukaemia or High Risk Myelodysplastic syndrome.

This includes patients with Peripheral T-cell lymphoma.

Eligibility Criteria:
Inclusion Criteria:

* Provision of consent
* ECOG performance status 0-2
* Patients with confirmed (per standard disease specific diagnostic criteria), relapsed or refractory haematological malignancies (NHL, MM and AML)
* Must have previously received standard therapy
* Adequate organ function

Exclusion Criteria:

* Intervention with any chemotherapy, investigational agents or other anti-cancer drugs within 14 days or 5 half-lives of the first dose
* Major surgical procedure or significant traumatic injury within 4 weeks of the first dose of study treatment
* Strong inhibitors of CYP3A4 or CYP3A4 substrates with a narrow therapeutic range taken within 2 weeks of the first dose of study treatment
* Strong inducers of CYP3A4 within 4 weeks of the first dose of study treatment
* Patients should discontinue statins prior to starting study treatment
* CYP2C8 substrates with a narrow therapeutic range taken within 2 weeks of the first dose of study treatment
* Any unresolved reversible toxicities from prior therapy \>CTCAE grade 1 at the time of starting study treatment (except alopecia and grade 2 neuropathy)
* Any evidence of severe or uncontrolled systemic diseases
* Any known uncontrolled inter-current illness
* QTcF prolongation (\> 480 msec)
Effects on Social and Cognition Functions of Blonanserin in First Episode Schizophrenia Patients

This is an open label, multi-center study to explore the effects on social functions of blonanserin in first episode schizophrenia patients


Eligibility Criteria:
Inclusion Criteria:

* Schizophrenia patients diagnosis either with DSM-5 criteria or ICD-10;
* PANSS total score ≥70;
* Males or Females aged 18-45 years;
* With disease course less than 5 years and during their first episode;
* ≥9 years of education;
* Without receiving systematic antipsychotic treatment, or receiving continuous antipsychotic treatment for less than 6 weeks and receiving antipsychotic treatment for less than 6 months in total;
* Ability to read and understand Chinese;
* Provision of written informed consent

Exclusion Criteria:

* Severe or unstable physical diseases judged by investigators;
* Loss of consciousness more than 1 hour due to any reason in the past 1 year;
* Current substance misuse (in 3 months) or any substance dependence;
* Pregnant or lactating woman;
* Patients with attempted suicide history, severe suicidal ideation or behaviour;
* Mental retardation;
* Contradict to the study drugs;
* Patients taken other investigation products in the past 30 days before entry;
* Patients ever taken blonanserin before;
* Any current medical condition that would interfere with the assessment of efficacy;
* Physical symptoms of acute deterioration requiring hospitalization or increased intensive care;
* Significant muscle tension or Parkinson's disease;
* Clinically significant abnormal laboratory test results (blood, urine, and blood biochemical analysis);
* Clinically significant Abnormal electrocardiogram as judged by researchers;
* Participants continuously using sedative drugs, or anticholinergic agents within 3 months of the study;
* Those who had undergone electroconvulsive therapy within 3 month of the study;
* Those who had received long-acting injection treatment within 3 month of the study;
* Those who could not swallow medication with water;
* Subjects judged by the investigator in charge as inappropriate for the study
A Comparison of Midazolam and Zolpidem as Oral Premedication in Children

The purpose of this investigator-initiated study is to compare the efficacy of oral midazolam and zolpidem for preoperative sedation, anxiety of patient, and caregiver anxiety at the time of separation, and ease of mask acceptance at induction in children. Subjects will be randomized to receive oral medication midazolam or zolpidem approximately 30 minutes prior to surgery. No placebo will be administered in this study. Subjects will be male and female children between 2 and 9 years of age. In total, subject participation will last approximately the duration of their preoperative, perioperative, and immediate postoperative period. A member of the research team will recruit subjects preoperatively in the operating room holding area prior to surgery. Consent will take place at the time of recruitment in the preoperative holding area following a detailed explanation of the study and medications involved in the study. Participants will be of ASA (American Society of Anesthesiologists) class I-II, undergoing surgical procedures of at least 2 hours duration, and expected to remain inpatient for at least 23 hours postoperatively.


Eligibility Criteria:
Inclusion Criteria:

* Pediatric patients ages 2-9 years
* ASA class I-II
* inpatient surgeries of at least 2 hours duration
* requiring postoperative admission of at least 23 hours Exclusion Criteria:

Exclusion Criteria:

* contraindication to preoperative sedation, known allergy or sensitivity to the study medications,
* those who lack legal representative consent
* Patients with weights lying below the 5th percentile or above the 95th percentile according to the current published CDC growth chart will also be excluded regardless of existing specific contraindication.
Visual Biofeedback Through Transperineal Ultrasound During the Expulsive Phase of Labour to Improve Maternal Childbirth Satisfaction

Childbirth is generally regarded as a positive life-changing experience. Up to 44% of women may however experience this as a traumatic event, with 3% suffering from post-traumatic stress disorder after childbirth. The aetiology of a traumatic childbirth experience is a complex interplay between pre-birth, intra-partum and postnatal factors. Feelings of loss of control, lack of interaction with the obstetric caregiver and lack of emotional or practical support during labour are important contributing factors. This trial aims to investigate the effect of providing Visual Biofeedback (VB) through Trans-Perineal Ultrasound (TPU) during the active 2nd stage of labour on maternal childbirth satisfaction. The hypothesis is that the intervention will improve patient-caregiver communication and enhance parturient women's sense of control and empowerment, ultimately improving the birth experience.


Eligibility Criteria:
INCLUSION criteria (all must be met):

1. Voluntary written informed consent of the participant.
2. Term (37-42w) singleton gestations.
3. Vaginally nulliparous (no previous vaginal birth \> 20 weeks of gestation).
4. Fetus in cephalic presentation, without any major congenital or chromosomal anomalies.
5. Admitted to the delivery unit in labour, regardless of the onset (spontaneous or induced).
6. Epidural analgesia in situ.
7. Non-pathological CTG at the time of recruitment (2015 FIGO classification).

EXCLUSION criteria (if one or more is present):

* Significant psychiatric comorbidity (psychiatric follow-up during pregnancy, or active (psycho-pharmacological) treatment).
* History of severe PFDs/surgery (or any other condition affecting pelvic floor function/anatomy, besides pregnancy and delivery).
* Significant neurological disease e.g., spinal injury, multiple sclerosis, diabetic neuropathy, etc.
* Significant connective tissue disorders (e.g., Ehlers-Danlos syndrome).
* Severe active maternal (pregnancy-related) comorbidity: non-exhaustive e.g., severe hypertensive disorder, significant antepartum haemorrhage, sepsis, thromboembolism, severe pre-existing cardiac/respiratory/neurological disease, etc. Well-controlled comorbidities will not be considered exclusion criteria (non-exhaustive e.g., well-controlled (gestational) diabetes, hypertensive disorders of pregnancy, PROM without signs of intra-amniotic infection, etc.).
* Linguistic barriers - not able to give written informed consent in Dutch.
* Severe visual impairment (sufficient to the receipt/comprehension of visual biofeedback).
Safety and Immunogenicity of Trivalent Split Influenza Vaccine Using the Strain Composition 2007/2008

Annual trial for registration of trivalent split influenza vaccine with the strain composition of the season 2007/2008 in healthy adult and elderly subjects


Eligibility Criteria:
Inclusion Criteria:

* ≥ 18 years of age, mentally competent, willing and able to give informed consent prior to study entry
* available for all the visits scheduled in the study and able to comply with all study requirements
* in good health as determined by: medical history, physical examination, clinical judgment of the investigator

Exclusion Criteria:

* n/a
Study of Standard CHOP Versus Biweekly CHOP in Aggressive Non-Hodgkin's Lymphoma (JCOG9809)

The purpose of this trial is to investigate the clinical benefit of the dose intensified regimen, Bi-CHOP in comparison to standard CHOP for advanced intermediate or high grade non-Hodgkin's lymphoma (NHL).

The purpose of JCOG9809 was to determine whether treatment results of aggressive NHL could be improved by shortening intervals of CHOP chemotherapy with the prophylactic use of G-CSF. The primary endpoint was Progression Free Survival (PFS), and the planned accrual was 450. Until December, 2002, 323 patients with advanced aggressive NHL were randomized to standard CHOP arm (CHOP x 8, every three weeks) and biweekly CHOP arm (CHOP x 8, every two weeks).

Eligibility Criteria:
Inclusion Criteria:

* Intermediate- or high-grade non-Hodgkin's lymphoma, excluding cutaneous t-cell lymphoma (CTCL), adult T-cell leukemia-lymphoma (ATL) and T-cell lymphoblastic lymphoma (T-LbL) (Working Formulation)
* Ann Arbor stage: II, III, IV
* No prior chemotherapy or radiotherapy
* Age: 15 to 69
* Performance status (PS): 0, 1, 2
* WBC \>= 3,000 /mm3, ANC \>= 1,200 /mm3, Platelet \>= 75,000 /mm3
* GOT/GPT \<= 5 x Normal Upper Limit, T-Bil \<= 2.0 mg/dL
* Creatinine \<= 2.0 mg/dL
* Normal ECG, Ejection Fraction \>= 50%
* PaO2 \>= 65 mmHg
* Written informed consent

Exclusion Criteria:

* Uncontrollable diabetes mellitus
* Severe complication (infection, heart failure, renal failure, liver failure, etc)
* Anamnesis of heart disease
* Acute or chronic hepatitis, liver cirrhosis and portal hypertension
* Synchronous or metachronous malignancy
* Severe pulmonary dysfunction
* Central nervous system (CNS) invasion
* HIV positive
* Hepatitis B surface antigen (HBs-Ag) positive
* Hepatitis C virus antibody (HCV-Ab) positive
The Effect of Early Total Thyroidectomy in the Course of Graves' Orbitopathy

The relationship between the method of the treatment of hyperthyroidism due to Graves' disease and the course of Graves' ophthalmopathy is debated. The investigators aimed to compare the results of total thyroidectomy done in 6 months following the appearance of the symptoms of ophthalmopathy and the antithyroid drug therapy in patients with moderate to severe Graves' ophthalmopathy.

The inclusion criteria: 1)Hyperthyroidism and moderate to severe Graves' ophthalmopathy within 6 months, 2)Thyroid volumes greater than or equal to 15 mL in thyroid ultrasonography, 3)Patients taking no treatment except local medications for Graves' ophthalmopathy, 4)Clinical activity score of 3/7 or more, proptosis greater than or equal to 21 mm in one eye or 2 mm difference between two eyes, presence of diplopia, the opening of the eye lid greater than or equal to 9 mm.

All patients will be treated with antithyroid drug until TSH levels of the patients are between 0.4-1. During this period all the patients will take pulse methyl prednisolone treatment of a total dose of 4.5 gr. After pulse steroid treatment the patients will be randomised to two groups: one group will be sent to surgery for total thyroidectomy, and their TSH levels will be kept between 0.4-1 with levothyroxine treatment; the other group will be followed under antithyroid drug treatment and their TSH levels will be kept between 0.4-1 also.

The smoking habits will be asked. Serum TSH, fT4 levels, Hertelmeter and eye lid opening measurements, clinical activity scores, diplopia will be evaluated monthly; TSH receptor antibody, anti-thyroid peroxidase and anti-thyroglobulin levels will be measured in 3 months intervals for a period of 12 months.


Eligibility Criteria:
Inclusion Criteria:

* Hyperthyroidism and moderate to severe Graves' ophthalmopathy within 6 months,
* Thyroid volumes greater than or equal to 15 mL in thyroid ultrasonography,
* Patients taking no treatment except local medications for Graves' ophthalmopathy,
* Clinical activity score of 3/7 or more, proptosis greater than or equal to 21 mm in one eye or 2 mm difference between two eyes, presence of diplopia, the opening of the eye lid greater than or equal to 9 mm.

Exclusion Criteria:

* Patients taking treatment other than local medications for Graves' ophthalmopathy (eg: steroid treatment)
Development of Systems and Precision Medicine - Take Mood Disorder as an Example.

Precision medicine is to achieve individual optimal health care, given the biological mechanisms, genetic variants, and environmental measurements. Take mood disorder (MD) as an example, we aim to develop systems and precision medicine in Taiwanese population.

MD is a very serious and dysfunctional mental disorder. Since MD patients with treatment have high risk of neurocognitive impairment and metabolic disturbances, the therapeutic strategies are of clinical importance. Individual difference of treatment outcome in MD patients would result from genetic variants, environmental factors, and their interactions. Also, the treatment outcome of MD contains multiple dimensions, including improvement of disease severity, neurocognitive function, and optimized medication strategy. However, comprehensive development of approaches to investigate the multiple dimensions of treatment outcome in MD patients is limited. In this three-year proposal, we explore the interactions of genetic variants and environmental factors (represented by psychosocial stress and gut microbiota) driven approaches to develop precision medicine.


Eligibility Criteria:
Inclusion Criteria:

* Male or female patients, 20- 70 years of age
* Major depression disorder who met the DSM-V diagnostic criteria were enrolled
* Subjects take at least one kind of antidepressant.

Exclusion Criteria:

* Pregnant or breast-feeding
* Presence of any other major psychiatric illness
* History of substance and alcohol abuse or dependence
* Presence of auto-immune disorder and infectious diseases
System-level Monitoring of Immune Activation Concerning Susceptibility to Sepsis in Trauma Patients

Sepsis remains a common entity in critical care patients with remarkable mortality. Despite extended research activities, no reliable bio-markers or scoring systems attributing the individual risk of developing sepsis have been found so far.

Patients with multiple trauma are at high risk of developing sepsis. Due to local and systemic immune reactions, high plasma levels of known pro-inflammatory cytokines can be found.

Simultaneously, certain anti-inflammatory reactions such as changes in immune cell activity and serum cytokine levels, known as "compensatory anti-inflammatory response syndrome" (CARS) take place.

In addition to changes of cytokine levels and immune cell activity, underlying genetic reactions are present. For instance, expression of miRNA (as an potential important step of immune cell activation) is likely changed during systemic and local immune reactions.

In the present study levels of pro- and antiinflammatory cytokines, a detailed assay of immune cell activation and the various expression of miRNA will be evaluated in patients of multiple trauma on day 1 and day 4.

Additionally, clinical parameters of organ function, current infection markers as CRP and Procalcitonin, cardiovascular function such as Indocyanin clearance and hemodynamic measures delivered with PiCCO-system and heart rate variability will be assessed. Parameters of local tissue perfusion will be measured with transcutaneous laser doppler.


Eligibility Criteria:
Inclusion Criteria:

* multiple trauma,
* ISS \> 16

Exclusion Criteria:

* resuscitation
* pregnancy
* malignancy
* chronic renal insufficiency
* steroid intake
A Study of LY3002813 in Participants With Memory Damage Due to Alzheimer's Disease (AD) or AD

The study will evaluate the effect of LY3002813 on brain scans. The study will evaluate the safety of LY3002813 by looking at adverse events (side effects). The study will also look at the effect the body has on LY3002813. Study participants will have mild cognitive impairment (MCI) due to AD or mild to moderate AD.

The study involves 3 parts.

* Part A in which participants will receive a single dose of LY3002813 or placebo (no drug).
* Part B in which participants will receive multiple doses of LY3002813 or placebo for 24 weeks.
* Part C in which participants will receive multiple doses of LY3002813 or placebo for up to 72 weeks.

Drug will be given as an intravenous infusion (injection into a vein). For Parts A, B and C, the study will last approximately 72 weeks, not including screening of approximately 56 days. The study is for research purposes only and is not intended to treat any medical condition.


Eligibility Criteria:
Inclusion Criteria:

* Present with mild cognitive impairment (MCI) due to Alzheimer's disease (AD) or mild-to-moderate AD
* Men or nonfertile women, at least 50 years of age. Nonfertile is defined as hysterectomy and/or bilateral oophorectomy, or amenorrhea for at least 1 year
* Have up to 2 partners who will provide a separate written informed consent to participate
* Have adequate vision and hearing for neuropsychological testing in the opinion of the investigator
* Positive florbetapir scan

Exclusion Criteria:

* Do not have up to 2 reliable partners who are in frequent contact with the participant, who will accompany the participant to the office and/or be available by telephone at designated times, and will monitor administration of prescribed medications
* Are being monitored for radiation due to occupational exposure to ionized radiation, or exposure to ionizing radiation within last 12 months from an investigational study
* History of intracranial hemorrhage, cerebrovascular aneurysm or arteriovenous malformation, or carotid artery occlusion, or stroke or epilepsy
* Have any contraindications for magnetic resonance imaging (MRI) studies, including claustrophobia, the presence of contraindicated metal (ferromagnetic) implants, cardiac pacemaker
* Have allergies to humanized monoclonal antibodies, including proteins and diphenhydramine, epinephrine, and methylprednisolone
* Have gamma globulin therapy within the last year
* Previously dosed in any other study investigating active immunization against amyloid beta (Aβ)
* Previously dosed in any other study investigating passive immunization against Aβ within the last 6 months
* Have current serious or unstable illnesses
Lifestyle Physical Activity for People With COPD

The purpose of this preliminary study is to examine the effects of a program that includes two-months of structured lab-based training. The proposed study will examine the effects of a lifestyle physical activity intervention designed to increase PA in people with moderate and severe COPD. The intervention includes a combination of (a) structured laboratory-based exercises with a behavioral intervention, (b) structured home-based exercises and (c) lifestyle physical activities performed at home. The subjects will be followed for a total of 18 weeks.

People with chronic obstructive pulmonary disease (COPD) experience a gradual decline in physical activity (PA). Exercise training in a structured pulmonary rehabilitation program can generate substantial gains in functional capacity, but increases in functional capacity do not necessarily lead to improvements in daily PA. The proposed study will examine the effects of a lifestyle physical activity intervention designed to increase PA in people with moderate and severe COPD. The intervention includes a combination of (a) structured laboratory-based exercises with a self-efficacy enhancing intervention, (b) structured home-based exercises and (c) lifestyle physical activities performed at home. The intervention gradually transitions subjects from the structured laboratory-based exercises that focus on walking and circuit training to fully integrated lifestyle physical activities that integrate structured home-based exercises and lifestyle physical activities into daily life. The purpose of this preliminary study is to examine the effects of a program that includes two-months of structured lab-based training and subjects will be followed for a total of 18 weeks.

Eligibility Criteria:
Inclusion Criteria:

* 55 years or older
* Moderate to severe COPD (FEV1 \< 80% and \> 30% predicted; FEV1/FVC \<70%) as the primary health problem
* Sedentary (less than 30 minutes of moderate activity 3 days/week)

Exclusion Criteria:

* No acute exacerbations or major illnesses requiring hospitalization in the last 8 weeks.
* No history of other major lung diseases as primary pulmonary problem, history of a recent heart attack or recent onset of chest pains with activity or increasing episodes of chest pain (unstable angina).
* No other health problems or mobility problems that limit physical activity.
* No child bearing potential