cyrilzakka/clinical-trials huggingface dataset:
"Ultra" Enhanced Recovery After Surgery (E.R.A.S.) in Laparoscopic Colectomy for Cancer

Background. Enhanced Recovery After Surgery (E.R.A.S.) programs are now widely accepted in colonic laparoscopic resections because of faster recovery and less perioperative complications.

Objective. Aim of this study is to assess safety and feasibility of discharging patients operated on by laparoscopic colectomy on Post Operative Day 2 (POD 2), so long as the first flatus has passed and in the absence of complication-related symptoms.

Design \& Settings. Non-inferiority, open-label, single center, prospective, randomized study comparing "Ultra" to Classic E.R.A.S. with discharge on POD 2 and 4 respectively.

Patients. 765 patients with resectable non metastatic colonic cancer were analyzed: 384 patients were assigned to "Ultra" E.R.A.S. and 381 to Classic E.R.A.S.

Main Outcome Measures. Demographics, clinico-pathological, ASA class and morbi-mortality, along with surgical complications, re-operation and readmission rate were recorded and compared. Primary end-point was mortality; secondary end-points were morbidity, re-admission and re-operation rate.

Limitations. It is a single center experience; it is not double-blind, with the intrinsic risk of intentional or unconscious bias; exclusion criteria because of "non compliance" may be considered arbitrary.

From January 2008 to September 2015, 765 patients were prospectively randomized for early discharge after laparoscopic colectomy according to E.R.A.S. programs: after obtained informed consent, 384 patients were randomly assigned to the "Ultra" E.R.A.S. group and 381 to Classic E.R.A.S. group.

Eligibility Criteria:
Inclusion Criteria:

* Resectable colonic cancer

Exclusion Criteria:

* metastatic patients
* T4b tumors
* urgent operations (because of obstruction, perforation or bleeding refractory to conservative treatment)
* huge neoplasms (\>7cm)
* positive cytology in peritoneal lavage or frank carcinosis
* inability to tolerate pneumoperitoneum
* ASA class 4
* severe portal hypertension with hepato-caval gradient \>10mmHg
A Study of RO6870810/TEN-010 in Participants With Acute Myeloid Leukemia and Myelodysplastic Syndrome

RO6870810 (formerly TEN-010) is a small molecule, bromodomain and extra-terminal (BET) bromodomain inhibitor. This study is designed to characterize the safety, tolerability, and pharmacokinetics of RO6870810 monotherapy in participants with relapsed/refractory acute myeloid leukemia (RR-AML) and hypomethylating agent (HMA)-refractory myelodysplastic syndrome (MDS). The study will consist of a Screening Period, Treatment Period, and Post-Treatment Period. A standard 3+3 design will be used in which successive cohorts of three or more participants with RR-AML or HMA-refractory MDS will be treated at escalating doses until a maximum tolerated dose (MTD) is identiﬁed. Up to 51 adult participants with AML or MDS will be enrolled in the study.


Eligibility Criteria:
Inclusion Criteria:

* RR-AML
* Relapsed/refractory MDS
* Participants with a history of allogeneic stem cell transplant are eligible for study participation provided the following eligibility criteria are met:

  1. Transplant was more than (\>) 100 days prior to study enrollment
  2. Participant has not taken immunosuppressive medications for at least 2 weeks
  3. No signs or symptoms of graft versus host disease other than Grade 1 skin involvement
  4. No active infection
* Eastern Cooperative Oncology Group Performance Status score equal to or less than (\<=) 2
* Life expectancy of at least 2 months
* Disease-free of active second/secondary or prior malignancies for equal to or more than (\>=) 1 year with the exception of currently treated basal cell or squamous cell carcinoma of the skin, or carcinoma in-situ of the cervix or breast
* Adequate hematological, renal, hepatic and coagulation laboratory test results
* Women of childbearing potential and men must agree to use adequate contraception from 28 days prior to the first dose of the study drug, during the entire Treatment Period, and for at least 28 days after the last dose of the study drug

Exclusion Criteria:

* New York Heart Association Class III or IV cardiac disease, myocardial infarction within the past 6 months, unstable arrhythmia
* Have Fridericia-corrected QT interval \> 470 milliseconds (msec) (female) or \> 450 msec (male), or history of congenital long QT syndrome
* Uncontrolled bacterial, viral, or fungal infections
* Known clinically important respiratory impairment
* Positive for human immunodeficiency virus, hepatitis B surface antigen, or hepatitis C antibodies
* History of major organ transplant
* Symptomatic central nervous system disease, malignancy, or metastasis
* Pregnant or nursing
* Concomitant chemotherapy, radiation therapy, immunotherapy, biologic therapy, or hormonal therapy
* Treatment with surgery or chemotherapy within 21 days prior to study entry
* Prior treatment with small molecule bromodomain and extra terminal family inhibitor
* Radiation for symptomatic lesions within 14 days of study enrollment
* Active substance abuse
Safety and Efficacy of Study Drug Versus Placebo for Negative Symptoms of Schizophrenia

This study is to determine the efficacy (how well the drug works), safety, and side effects of the study medication compared to placebo in the treatment of the negative symptoms of schizophrenia in adults.


Eligibility Criteria:
Inclusion:

* Adults aged 18-60
* Current diagnosis of schizophrenia
* Significant negative symptoms with few positive symptoms (e.g. hallucinations, delusions) and no evidence of major depression.
* Female subjects of childbearing potential must test negative for pregnancy at the time of enrollment.
* Subjects must be able to provide consent
* Must be healthy based on medical exam, laboratory tests and electrocardiogram

Exclusion:

* Female subjects who are either pregnant or nursing.
* Acute or unstable medical conditions
* Diseases of the central nervous system
* Subjects who are judged clinically to be at serious risk for suicide or violence
* Subjects with delusional disorder, psychotic disorder NOS, schizophreniform, schizoaffective disorder, bipolar disorder, attention deficit/hyperactivity disorder, major depressive disorder,alcohol or drug dependence
AI Colorectal Polyp Detection

This study is intended to demonstrate the superiority of colorectal polyp detection using computer-assisted colonoscopy compared to conventional colonoscopy.


Eligibility Criteria:
Inclusion Criteria:

* Average risk subjects undergoing their first colonoscopy (screening) or follow-up colonoscopy for previous history of polyps (surveillance interval of 3 years or greater)
* Patients aged 45 or older
* Patients who can provide an informed consent

Exclusion Criteria:

* Patients with history of colon resection, Inflammatory Bowel Disease (IBD), Familial Adenomatous Polyposis (FAP), severe comorbidity, including end-stage cardiovascular/pulmonary/liver/renal disease
* Patients who are pregnant or are planning pregnancy during study period
* Patients who are not able to or refuse to give informed consent
Extended-Release Naltrexone for Opioid Relapse Prevention Following Release From Jail

This pilot study's primary aim is to compare rates of sustained opioid relapse, defined as self-reported opioid use \>50% (\>15 of 30) of days during the first 30 days following release from jail, among persons treated with XR-NTX pre-release vs. controls not receiving XR-NTX.

This protocol randomizes persons soon-to-be-released from a large urban jail to treatment with extended-release naltrexone (XR-NTX), a full opioid antagonist that prevents the activity of heroin and other opioids. Investigators at NYUSOM and NYC DOHMH will recruit heroin dependent persons from NYC jails who are soon-to-be-released, not accessing opioid agonist pharmacotherapy, with lowered tolerance due to incarceration, and extremely likely to relapse and risk accidental overdose at release. All N=40 participants receive a two-session, individual psychosocial intervention, Motivational Interviewing. Half (n=20) will be randomized to pre-release treatment with XR-NTX. Immediately and one month following release, participants will be offered continued psychosocial and medication-assisted treatment (naltrexone, buprenorphine, or methadone) at Bellevue Hospital, including a second XR-NTX dose among XR-NTX arm participants. The primary outcome is relapse to sustained opioid use during the first 30 days post-release. We hypothesize an XR-NTX arm will report significantly lower rates of sustained opioid relapse following release.

Eligibility Criteria:
Inclusion Criteria:

* Adults incarcerated in NYC jails with known release date
* DSM-IV criteria for current opioid dependence
* No current agonist (methadone, buprenorphine) treatment
* Currently opioid free by history ('detoxed') and with a negative urine for all opioids
* General good health as determined by complete medical interview and physical examination
* Age 18-60 years.

Exclusion Criteria:

* History of liver failure, cirrhosis, or recent liver function test levels greater than three times normal
* Pregnancy, lactation, or planning conception
* Active medical illness that might make participation hazardous
* Untreated psychiatric disorder
* History of allergic reaction to naltrexone, PLG (polylactide co-glycolide), carboxymethylcellulose, or any other components of the diluent.
* Current chronic pain condition treated with opioids.
Shockwave Therapy in Lower Limb Intermittent Calf Claudication

Peripheral arterial disease is a common condition affecting approximately 64% of 56-77 year olds. This condition restricts bloody supply to calf muscles. Pain occurs after walking a short distance and increases in intensity until the person stops, where the pain then gradually subsides. It can be limiting or occasionally debilitating and has been shown to have considerable deleterious effects of patients quality of life. Shock wave therapy has been shown to promote new blood vessel formation and improved healing amongst other findings. This study aims to identify whether shock wave therapy that is applied to the calf muscles causes such an effect to improve the blood supply to the calf muscles, reduce pain, improve walking ability and quality of life.

This study aims to compare the effects of extracorporeal shockwave therapy (ESWT) to placebo with use of a sham control group on walking distances in subjects with lower limb intermittent calf claudication. Extracorporeal shockwave therapy will be applied using the PiezoWave2 shockwave system. All applications will be in adherence to the manufacturer's instructions and provided by trained staff. The device will be targeted at the gastrocnemius muscles of the affected lower leg for several minutes at each treatment session. Participants in control group will undergo the identical process as if treatment were being given but with the shockwaves not being administered and a sham device alternatively used. Participants will have several assessments prior to and after the shockwave treatment in order to quantify the effect. Assessments will include Maximum Walking Distance (MWD), Claudication Distance (CD) and Quality of life questionnaires.

Eligibility Criteria:
Inclusion Criteria:

* Patients with unilateral or bilateral intermittent calf claudication (stable for the last 3 months).
* Able to give written informed consent to participate in the study
* Age \> 18
* Able to adhere to protocol and attend all follow up appointments
* Currently receiving "best medical therapy" - anti-platelet and statin medication

Exclusion Criteria:

* Current malignancy
* Allergies or intolerances of either anti-platelet medication or statin therapy
* Pregnancy (pregnancy test performed at screening if necessary)
* Metal implant near to treatment area
* Anti-coagulation medication (i.e. Warfarin)
Identifying Predictors of Response to Antipsychotics Using a Treatment Algorithm

The objective of this study is to evaluate predictors of response to antipsychotic medication in subjects with schizophrenia. The investigators will evaluate psychopathology,brain MRI, genetics and neuropsychological profile. Two groups of treatment will be compared: first generation antipsychotics vs. second generation antipsychotics. Participants will be randomized to one of the groups. Trial duration: 12 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Schizophrenia or schizoaffective disorder
* Age: 18-45 years olde
* Less than 10 years of diagnosis
* Acute exacerbation of psychotic symptoms

Exclusion Criteria:

* Use of clozapine
* Clinical unstable disease
* Delirium and cognitive disorders
Enteral Nutrition and Immune Proteins Study

Eligible healthy adults who consent to take part in the study will be randomised to receive either a specialised milkshake for all of their normal daily diet (exculsive enteral nutrition, EEN) or the same specialised milkshake for half of their normal daily diet (partial enteral nutrition, PEN) for seven days. This randomisation is to prevent any bias. In the week before the allocated diet starts participants will be asked to give a weight and height measurement, blood sample, collect a stool and urine sample, and complete a food diary of everything they eat and drink using household measurements (e.g., a teaspoon) seven, four, and one day before the randomly allocated diet begins. Participants will also be asked to give a weight measurement, blood sample, and collect a stool and urine sample before they start the allocated diet. All participants will be asked to collect a third stool, urine, and blood sample and weight measurement at the end of the seven days dietary intervention. Blood samples collected during the study will be used to find out how the cells and proteins which instruct the immune system change during the special milkshake diet. Stool and urine samples will be used to measure the levels of different bacteria which naturally live inside the gut and how their behaviour might have changed during the diet. Those allocated to have PEN will be asked to complete a second set of food diaries for three days during your seven days of specialised milkshake.


Eligibility Criteria:
Inclusion Criteria:

* Healthy adults (\>/= 18 years)

Exclusion Criteria:

* Those sufferring from acute or chronic illness (defined as illness which requires regular visits to health services)
* Those who have experienced weight changes +/- 2kg in the past month.
* Previous gut surgery,
* Use of antibiotics or steroids in the past month
* Food allergies which prevent consumption of the enteral nutrition used (milk protein allergy)
* Current pregnancy or breastfeeding.
Evaluation of Full-field Coherence Tomography for ex Vivo Staging and Assessment of Superficial Esophageal Squamous Carcinoma: a Pilot Study

New tools are needed to 1) diagnose and 2) stage early esophageal squamous cell carcinoma (SCC) in order to improve outcomes of this frequent and lethal cancer.

Optical coherence tomography (OCT) is an optical technique, which can image human tissue ex vivo and in vivo with a resolution around 30µm and with a depth of 1mm. Full-field optical coherence tomography (FFOCT) is a new modality, which allows to image an ex vivo specimen with a cellular resolution and to perform 3D reconstruction. This device has never been tested on esophageal specimens.

Therefore, the aim of this non-interventional research is 1) to determine FFOCT diagnostic criteria for SCC and 2) to figure if FFOCT allows the staging of the depth of invasion in SCC.

To achieve these goals, we will image ex vivo 10 specimens of endoscopic resection of SCC (endoscopic mucosal resection (EMR) and submucosal dissection (ESD)) using an FFOCT device and we will compare the results with histological analysis of these specimens.

General study methodology

The study presents the following characteristics:

* Observational
* Non interventional imaging study
* Single-centre
* Not controlled
* Prospective Tests and analysis CRF
* Filled by the investigator
* Data from the medical file of the patient Imaging
* As standard of care
* Before endoscopic resection the lesion will be characterized and pictures will be made using white light endoscopy, magnification techniques and electronic chromoendoscopy
* Immediately after endoscopic resection, the specimen will be prepared, oriented and scanned using the FFOCT device (CE marking)
* Imaging movies will be then reviewed by trained readers and compared to movies of healthy patients, findings will be described
* Imaging movies will be compared to pathology slides

Pathology

* After scanning the specimen will be sent to pathology for analysis
* The pathology slides will be scanned to be kept in the study record together with their interpretation

Study schedule

* Total length of study: 24 months
* Methodology and regulatory: 6 months
* Recruitment period: 1 year
* Recruitment among the patients scheduled for the endoscopic procedure in the operative room
* One single visit = inclusion the day of the procedure
* No follow-up required
* Analyses: 3 months
* Paper writing: 3 months

Eligibility Criteria:
Inclusion Criteria:

* Age of 18 years and more
* Confirmed diagnosis of SCC based on previous biopsy
* Indication for endoscopic resection
* Patient who has read the information notice and confirmed its willing to participate

Exclusion Criteria:

* Pregnancy
* Any contraindication for endoscopic treatment
A Phase II Study of Apatinib in STS Patients

Apatinib is a kind of innovative medicines approved by China Food and Drug Administration（CFDA）, which was researched by Jiangsu Hengrui Pharmaceutical Co., Ltd. Apatinib is a kinase inhibitor of receptor tyrosine with VEGFR2. The protocol is to explore Apatinib for the effectiveness of advanced soft tissue sarcoma and safety.


Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent.
* Histologically proven advanced soft tissue sarcoma, At least one measurable lesion. Including: Synovial sarcoma, leiomyosarcoma, Alveolar soft part sarcoma, Undifferentiated pleomorphic sarcoma / malignant fibrous histiocytoma, Liposarcoma, Fibrosarcoma, Clear cell sarcoma, Epithelioid sarcoma, Angiosarcoma, Spindle cell sarcoma, rhabdomyosarcoma treated by chemotherapy, Ewing's sarcoma of soft tissue/Primitive neuroectodermal tumor. Excluding: Malignant peripheral nerve sheath tumor, chondrosarcoma, Dermatofibrosarcoma protuberans, Gastrointestinal stromal tumor, Inflammatory myofibroblastic sarcoma, Malignant mesothelioma.
* Must have evidence of unresectable residual disease.
* In the last 6 months, at least one chemotherapy regimen (including anthracyclines) was used in patients who failed or were unable to tolerate treatment.
* ECOG ps≤2.
* Life expectancy: more than 3 months.
* Prior aptinib less than 2 weeks and at least 1 month since prior aptinib；at least 1 month since prior inhibitor of mTOR or EGFR pathway.
* Not pregnant or nursing；Fertile patients must use effective contraception.
* Hematopoietic

  * HB≥90g/L
  * Absolute neutrophil count ≥ 1,500/mm\^3
  * Platelet count ≥ 80,000/mm\^3

Exclusion Criteria:

* Uncontrollable hypertension;
* Has influence of oral drugs;
* Patients with high risk of gastrointestinal blooding;
* INR\>1.5×ULN，APTT\>1.5×ULN;
* Allergic to any ingredient of this product;
* Less than 1 month since last major surgery;
* Brain metastases;
* With the second cancer.
Development of an Integrated Health Care Environment for Elderly With RFID Technology

A falling prevention system will be established by RFID location and motion detection.

* Using RFID to detect participants' allocation indoor.
* Modifying environment parameters such as light, sound, to alert users if them enter a place with potential hazards.

Data exchange models will also developed in this project

* Interchanging different data including physiological data and RFID data into a database
* establishing interchange protocol according the HL7 standard


Eligibility Criteria:
Inclusion Criteria:

* Age above 65 year old
* Living in the Nursing home, Bei-Hu Branch, National Taiwan University Hospital
* with ability to independent ambulation (with or without assistive devices)

Exclusion Criteria:

* no ability to independent ambulation
* with infective diseases.
Autonomic Nervous System and Meridian Energy in Patients With Schizophrenia

This study aims to explore the differences in autonomic nervous function and meridian energy between schizophrenia patients and healthy individuals. By understanding the meridian and organ conditions of individuals, the study aims to align with the traditional Chinese medicine (TCM) concept of "treating disease before it arises" and provide comprehensive care to patients, thereby improving the quality of care.

Data collection was conducted at a medical center in northern Taiwan. Sample size estimation was performed using G\*Power 3.1. A total of 50 patients with schizophrenia were assigned to the disease group, and 50 healthy individuals were assigned to the control group, with a total of 100 participants expected. Data collection included: personal demographic questionnaire, body constitution questionnaire (BCQ), WHOQOL-BREF (Taiwan version) for quality of life, brief psychiatric rating scale (BPRS), heart rate variability (HRV), meridian energy

Eligibility Criteria:
Inclusion Criteria:

1. Disease group：

   * Diagnosed with schizophrenia by a physician (ICD-10 code F20, such as F20.0, F20.1, F20.2, F20.3, F20.5, F20.89, or F20.9), with stable condition, and has not had any changes in medication dosage or admission to a psychiatric acute care unit in the past 3 months.
   * Aged between 18 and 65 years.
   * Able to understand, speak, read, and write Mandarin or Taiwanese.
2. Control group：

   * No history of chronic illness and no acute symptoms within the past month.
   * Aged between 18 and 65 years.
   * Able to understand, speak, read, and write Mandarin or Taiwanese.

Exclusion Criteria:

1. Disease group：

   * Individuals with cardiovascular conditions, severe neurological disorders (e.g., organic brain disorders, early-stage dementia or diagnosed dementia), or substance abuse issues.
   * Individuals who have used medications affecting the autonomic nervous system within the past month, such as mood stabilizers, antidepressants, angiotensin-converting enzyme inhibitors inhibitors, β-blockers, or antiarrhythmics.
   * Individuals with metallic implants that could affect heart rate variability.
   * Individuals with involuntary and uncontrollable body tremors.
   * Women currently menstruating.
   * Pregnant women.
2. Control group：

   * Individuals with cardiovascular conditions, severe neurological disorders (e.g., organic brain disorders, early-stage dementia or diagnosed dementia), or substance abuse issues.
   * Individuals who have used medications affecting the autonomic nervous system within the past month, such as psychiatric medications, angiotensin-converting enzyme inhibitors inhibitors, β-blockers, or antiarrhythmics .
   * Individuals with metallic implants that could affect heart rate variability.
   * Individuals with involuntary and uncontrollable body tremors.
   * Women currently menstruating.
   * Pregnant women.