cyrilzakka/clinical-trials huggingface dataset:
The Validity and Reliability Study of the Chelsea Critical Care Physical Assesment Tool

This study is aimed at providing an translation and cross-cultural adaptation of Chelsea Critical Care Physical Assesment Tool (CPAx) and tested its reliability and validity.

Survival has increased in the ICU due to technological developments , but physical disability after discharge has become an important problem. İntensive Care Unit Acquired Weakness(ICU-AW) is seen in most of the patients admitted in this unit. The biggest reasons for ICU-AW are; sepsis, multiple organ failure and prolonged mechanical ventilation. The use of measurement tools to evaluate disabilities during stay and after discharge in intensive care unit, is a subject that has been researched all over the world.. These measurement tools provide; monitoring and evaluation during the ICU admission and assessment efficacy of treatment in the unit. The Chelsea Critical Care Physical Assessment Tool(CPAX) has been shown to valid, reliable and to exhibited strong clinimetric properties. CPAx is a numerical measurement tool, rated according to the 6-point Guttman Scale, from complete dependence to independence and consist of ten physical function parameters. This study is aimed at providing an translation and cross-cultural adaptation of Chelsea Critical Care Physical Assesment Tool (CPAx) and tested its reliability and validity. The protocol includes a pre-test of the Turkish version on 10 patients, a final revision, and a validation on a sample of 40 İCU patients.

Eligibility Criteria:
Inclusion Criteria:

* Older than 18 years
* Critical adult patients
* Patients who were hospitalized for more than 48 hours in an ICU

Exclusion Criteria:

* Unstable fracture
* Limb deformities and dysfunction
* Myasthenia gravis
* Neuromuscular dysfunction
* Patients who diagnosed COVİD-19
Exercise, Glucose Kinetics, and the Incretin Effect

Human volunteers will be stratified by oral glucose tolerance status: normal glucose tolerant, impaired glucose tolerant, and type 2 diabetic. All subjects will undergo 4 experimental trials: \[1\] an oral glucose tolerance test (OGTT) combined with infused and ingested stable isotopes of glucose to assess glucose kinetics. \[2\] a 1 hour bout of cycling exercise at 50% of maximum power output, immediately followed by the same OGTT combined with stable isotope glucose tracers used in trial 1. \[3\] an isoglycemic clamp to match the plasma glucose profile measured in trial 1. \[4\] a 1 hour bout of cycling exercise at 50% of maximum power output, immediately followed by an isoglycemic clamp to match the plasma glucose profile measured in trial 2.

Exercise-induced changes in oral glucose tolerance, glucose kinetics, insulin and glucagon secretion, and the incretin effect will be examined. The exercise responses will be compared between the subjects groups of different glucose tolerance status.


Eligibility Criteria:
Inclusion Criteria:

* age 18-60 years
* BMI 18-35 kg/m2

Exclusion Criteria:

* insulin dependency
* pregnancy
* presence or history of chronic cardiovascular, pulmonary, hepatic, renal, or hematological disease, or cancer
* contraindication to physical activity as assessed by ECG
Weekly Paclitaxel Plus Gemcitabine as Second-line in Small Cell Lung Cancer

As a single agent, paclitaxel has a response rate of 33% and 25-29% in SCLC patients with sensitive relapse and with resistant relapse, respectively. As a single agent, gemcitabine also has a response rate 16% and 6-13% in SCLC patients with sensitive relapse and with resistant relapse, respectively. Because of single-agent activity, different mechanism of action, non-overlapping toxicities, and beneficial pharmacologic interaction, paclitaxel and gemcitabine combinations are attractive for testing in clinical trials.

The treatment consists of paclitaxel 80 mg/m2 and gemcitabine 1,000 mg/m2 given intravenously on days 1 and 8 of a 21-day cycle.

Patients receive treatment every 3 weeks till disease progression

Eligibility Criteria:
Inclusion Criteria:

1. Histologically or cytologically confirmed SCLC
2. Clinically diagnosed metastatic or recurrent SCLC according to Sixth Edition of the AJCC Cancer Staging Manual
3. At least 18 years old
4. ECOG performance status 0-2
5. Disease status must be that of measurable disease defined as RECIST:Lesions that can be accurately measured in at least one dimension \> 10 mm with chest x-ray, spiral CT scan or physical examination
6. Progression during or after prior first line chemotherapy or chemoradiotherapy.
7. Before study entry, a minimum of 21 days must have elapsed since any prior chemotherapy or radiation
8. No prior radiotherapy to measurable lesion(s) but previous surgery and/or chest radiotherapy for the primary lesion is allowed
9. Adequate major organ function including the following:Hematologic function: WBC ≥ 3,500/mm3 or absolute neutrophil count (ANC) ≥ 1,500/mm3, platelet count ≥ 100,000/mm3Hepatic function: bilirubin ≤ 1.5 x UNL , AST/ALT levels ≤ 2.5 x UNLRenal function: serum creatinine ≤ 1.5mg/dL
10. Patients should sign an informed consent
11. If female: childbearing potential either terminated by surgery, radiation, or menopause, or attenuated by use of an approved contraceptive method (intrauterine device \[IUD\], birth control pills, or barrier device) during and for 3 months after trial. If male, use of an approved contraceptive method during the study and 3 months afterwards. Females with childbearing potential must have a urine negative hCG test within 7 days prior to the study registration.

Exclusion Criteria:

1. MI within preceding 6 months or symptomatic heart disease including unstable angina, congestive heart failure, or uncontrolled arrhythmia
2. Serious concurrent infection or nonmalignant illness that is uncontrolled or whose control may be jeopardized by complication of study therapy
3. Other malignancy with the past 5 years except adequately treated cutaneous basal cell carcinoma or uterine cervix in situ cancer
4. Pregnant or nursing women
5. Psychiatric disorder that would preclude compliance.
6. Major surgery other than biopsy within the past two weeks.
A Translational Study Investigating PD-L1 Expression After Radiotherapy for Non-small Cell Lung Cancer

Participants with Non-Small Cell Lung Cancer (NSCLC), Performance Status (PS) 0-2, not suitable for concurrent Chemo-Radiotherapy (CTRT), will be treated with standard radiotherapy (radical or palliative). Archival tumour biopsies will be analysed for baseline Programmed Death Ligand 1 (PD-L1) expression. Some participants will have a biopsy before radiotherapy if the archive biopsy is not suitable. Participants will be required to undergo an additional mandatory biopsy of the irradiated site during the second week of radiotherapy.

The purpose of this prospective, multicentre, non-randomised translational study is to provide proof of feasibility of achieving paired biopsies for PD-L1 assessment in patients with NSCLC treated with palliative or radical radiotherapy. This is a non-CTIMP study.

All participants will have a minimum of 1 mandatory biopsy (during radiotherapy \[irradiated site\]) and the potential to have a pre-treatment biopsy if archival biopsy does not meet the suitability criteria.

Participants will have up to a maximum of 2 additional optional biopsies (during radiotherapy \[within the RT field e.g supraclavicular fossa node\], \[outside RT field e.g. skin met\]).

Blood samples will also be taken on study at specified time points for immune monitoring (exploratory endpoints).

The study will be carried out in two stages as follows:

Stage 1:

Following the enrolment of the first 15 evaluable participants, an interim analysis will take place by the Trial Steering Committee (TSC). The TSC will make a recommendation on whether recruitment should continue to the Trial Management Group (TMG).

Stage 2:

A further 15 evaluable participants will be recruited onto the study to achieve a total of 30 evaluable participants.

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed NSCLC
* Diagnostic/pre-treatment biopsy suitable for PD-L1 analysis\*
* Tumour judged inoperable by a lung MDT
* Tumour that is accessible to core biopsy
* Age 18 and over, no upper age limit
* Performance status (PS) - ECOG 0-2
* Participant considered suitable for radiotherapy (palliative or radical) or sequential chemo-radiotherapy
* Before participant registration, written informed consent must be given according to GCP and national regulations

  * Pre-treatment biopsy must be from gross tumour volume within planned radiation field, and must also:

    * have been formalin fixed for \>12h and ≤24h
    * have tumour tissue and morphology confirmed by H\&E staining
    * contain sufficient tumour cells (\>100) to determine PD-L1 status

Exclusion Criteria:

* Participant suitable for standard concurrent CTRT
* Participant deemed unsuitable for repeat biopsies in the opinion of the treating oncologist
* Participant known to have an EGFR mutation or an ALK rearrangement
* Intercurrent or history of hepatitis B, C or human immunodeficiency virus infection, if known
* Participants who have received more than 1 line of chemotherapy prior to radiotherapy
Modern Urodynamics System Efficacy (MUSE) Study

The goal of this prospective trial is to evaluate the feasibility, efficacy, and safety of the Glean Urodynamics System (GUS) for use in the clinic to collect vesical pressure data in adult males and females with lower urinary tract symptoms.

The main question\[s\] it aims to answer are:

• What is the feasibility, efficacy, and safety of GUS for use in clinical to collect vesical pressure data in adult males and females with lower urinary tract symptoms?

Participants will undergo a planned conventional urodynamics exam after which the Glean Sensor will be inserted and ambulatory urodynamics will be performed with the sensor indwelling in the bladder after which the sensor will be removed.


Eligibility Criteria:
Inclusion Criteria:

* Male or female patient must be ≥ 18 years of age
* Patient must have a diagnosis of LUTD
* Patient must be scheduled for or recommended for cUDS
* Patient is able to tolerate 18Fr catheterization
* Patient or patient's legally authorized representative is able to provide informed consent

Exclusion Criteria:

* Pregnant (as confirmed by urine pregnancy test) or breastfeeding, pregnant within the past 6 months or intend to become pregnant during the study period.
* Patient has a symptomatic UTI based on CDC guidance (see below)
* Subjects who, at the principal investigator's determination, would not be appropriate for this study.
Role of Dutasteride in Patients Undergoing 3D Mapping Biopsy in Early Stage Prostate Cancer

The purpose of this study is to determine the effect of short-term intake of daily Dutasteride in patients with prostate cancer.

This is a study of men who have undergone a standard 10 or more core biopsy for detection of prostate cancer and determined to have prostate cancer by having a Gleason score ≤ 7 (low to moderate risk 2-7). Of these men, one arm of a two arm randomized group will be administered a treatment regime of Dutasteride versus the control group who receive standard of care, prior to mapping biopsy. This proposal aims at studying the apparent effect of the use of Dutasteride (3 months) on initial tumor volume (at diagnosis) in men with low volume cancer before undergoing 3D mapping biopsy.

Eligibility Criteria:
Inclusion Criteria:

* 40-85 year old males
* Patient is newly diagnosed with clinical Stage T1a-T2c prostate cancer based on transrectal guided extended prostate biopsy of at least 10 cores.
* Patient elects to undergo 3D mapping biopsy at our center as part of prostate cancer management.
* Patient will read, understand and sign the informed consent agreement
* Patients must have a life expectancy of at least one year.
* Gleason score ≤ 7 (low to moderate risk 2-7) 7= 3+4
* Percentage positive core rate \< 50% based on sextant or extended biopsy technique.
* Prostate Volume (PV) \>15 grams.
* Negative imaging studies ( if available) during the staging period such as Bone scan, MRI and CT scan if PSA\> 10 ng.dl before initiation of the study drug

Exclusion Criteria:

* Any 5α-reductase inhibitors medications within the past 12 months before enrollment.
* Known hypersensitivity to dutasteride, or other 5α-reductase inhibitors.
* Anticipated blood donation within the next 90 days.
* Serum PSA levels of \>20ng/dl.
* Clinical evidence of metastatic prostate cancer.
* Two documented urinary tract infections in the past year
* CHF, MI (within 6 months) or other symptomatic CVS disease
* Other serious diseases (hematological, hepatic, renal, respiratory or psychiatric)
* Enrollment in other studies for any disease in the past 30 days
* Significant urinary incontinence
* Diagnosis of cancer that in not considered cured, except BCC of skin
* Prior transurethral resection of the prostate with a large tissue defect.
* History of abdominoperineal resection for rectal cancer, rectal stenosis, or other major rectal pathology
* Previous or concurrent radiotherapy, hormonal therapy or chemotherapy
Primary vs. Secondary Anastomosis for Hinchey Stage III-IV Diverticulitis a Prospective Randomized Trial

This study compares primary resection with anastomosis and Hartmann's procedure in an adult population with acute perforated colonic diverticulitis (Hinchey Stage III and IV) METHODS: The primary end point was postoperative mortality. Secondary end points included surgical and medical morbidity, operative time, and length of postoperative hospitalization.

inclusion criteria: hinchey III and IV diverticulitis

Eligibility Criteria:
Inclusion Criteria:

* Patient with peritonitis du to sigmoid diverticulum complication
* Surgeon - anesthetist confirming the 2 surgeries can be performed

Exclusion Criteria:

* Physical state which can not permit patient to participate
* contraindication to surgery
* non-diverticulum peritonitis
The Diagnostic Benefits of the HyperQTM System in ECG Stress Testing

The main objective of this study is to determine the usefulness of the HyperQ™ System in improving the positive predictive value of conventional ECG stress testing.

Patients who are referred for stress test will perform an ECG stress test on a treadmill, with high-frequency ECG recording from conventional 12 leads using BSP's HyperQ™ System. Conventional 12 lead ECG, as well as HyperQ™ recordings will be provided by the HyperQ™ System. The results of the conventional test and the HyperQ™ data will be compared, using one of three cardiac tests (stress echocardiography, SPECT myocardial perfusion imaging and angiography) as gold standards.

Statistical analysis will compare the sensitivity, specificity, PPV and NPV of the conventional and HyperQ™ stress ECG in detecting myocardial ischemia.

The study population will comprise of 1200 patients referred to stress test in three Maccabi clinics or cardiac medical centers. All patients will perform an ECG stress test with high-frequency ECG recording from conventional 12 leads using BSP's HyperQ™ System. The recording will be done without affecting or interfering with any aspect of the normal due course of the test. Standard Bruce protocol or modified Bruce protocol will be used, with standard test termination indications. Two minutes of rest ECG will be recorded prior to stating the protocol.

Following the test, the physician will interpret the test's results in the conventional manner (e.g. ST changes, chest pain, etc) and decide whether the subject should be referred to additional tests.

HyperQ™ data will be analyzed in two phases: (i) Interpretation by the physician in a non-blinded manner one day following the stress test and (ii) after performing all the exercise tests of the study group, blindly to the conventional diagnosis and the HyperQ™ analysis done previously, as well as to other outcomes of imaging procedures. The first HyperQ™ reading will be used to detect the subjects who were positive according to the HyperQ™ system but negative according to the conventional stress testing. These subjects will be referred by the physician to further clinical investigation. The first reading will also be used to assess the physician's interpretation in a scenario that represents a realistic clinical setting, while the second reading will be used to examine the unbiased clinical benefit of HyperQ™ data.

Eligibility Criteria:
Inclusion Criteria:

* Subject referred to stress ECG
* Subjects age ≥ 45
* Subject signed an Informed Consent form

Exclusion Criteria:

* Subject with contraindications for stress ECG
* Subject with implantable pacemaker or defibrillator
* Subject with LBBB
* Subject with QRS duration ≥ 110 mSec
* Subject with Wolff-Parkinson-White Syndrome
Stereotactic Body Radiotherapy Dose Escalation in Pancreatic Cancer

This study is to determine the maximum tolerated dose (MTD) of five fraction stereotactic radiotherapy (SBRT) in pancreatic cancer.

This trial is designed to find the maximum tolerated dose of radiation under a fixed 5-fraction SBRT regimen escalating the dose from 40 Gy in 5 fractions, to 60 Gy in 5 fractions, at 5 Gy intervals.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis: Histologically-proven invasive adenocarcinoma of the pancreas.
* Disease Status: Medically unresectable (any stage), or locally advanced (stage III).
* Tumor Location: Primary tumor may be located anywhere in the pancreas.
* Treatment eligibility: The patient must be able to have fiducial markers implanted into the pancreatic tumor, and receive radiation regimen as specified in the protocol.
* Performance Level: Karnofsky Performance Status ≥ 60
* Adequate Renal Function Defined As: Serum creatinine ≤ 1.5 x upper limit of normal
* Informed Consent: All subjects must sign a written informed consent.

Exclusion Criteria:

* Pregnancy or Breast-Feeding: Pregnant or breast-feeding women will not be entered on this study due to risks of fetal and teratogenic adverse events. (Note: Serum Pregnancy tests must be obtained in women of child bearing potential). Sexually active females may not participate unless they have agreed to use an effective contraceptive method (such as abstinence, diaphragm, condom, or intrauterine device) to prevent pregnancy for the duration of the study.
* Life expectancy \< 6 months
* The patient cannot have had prior radiation therapy to the thorax or upper abdomen.
* Incarcerated individuals
* Subjects unable to give informed consent
An Analysis of Clinical Efficacy Based on the Robotic, Laparoscopic, and Open Approach in Radical Resection of Rectal Cancer

A retrospective study was done on the medical records for 24 rectal cancer patients underwent robotic proctectomy from September 2017 to July 2018 at the First Afﬁliated Hospital of Xi'an Jiaotong University.In the same department,a total of 25 patients who treated with laparoscopic proctectomy and 24 patients underwent open proctectomy were were selected as controls in a 1:1:1 ratio. Comparing the perioperative conditions and hospitalization related costs of the three groups.


Eligibility Criteria:
Inclusion Criteria:

* endoscopic biopsy pathological diagnosis of rectal cancer is clear, preoperative CT, MRI examination did not see the tumor directly invaded the surrounding organs;
* blood test, cardiac ultrasound, lung ventilation function and other preoperative examination without absolute surgical contraindications;
* without distant metastasis such as liver, lung, bone, and abdominal cavity.

Exclusion Criteria:

* there is distant organ transfer or extensive abdominal metastasis;
* emergency surgery for acute intestinal obstruction, hemorrhage, perforation, intestinal rupture, etc.;
* combined with other primary malignant tumors;
* other colonectomy and combined with other organ resection;
* patients with severe basic diseases unable to tolerate surgery;
* pregnant and lactating women;
* patients who underwent neoadjuvant radiotherapy and chemotherapy before surgery;
* those who underwent palliative surgery.
Analysis of T Cell Metabolism in Acute Myeloid Leukemia Patients

The objective of this study was to analyze the T cell metabolism and immune phenotype in AML patients during the course of the disease before and after allo-HCT.

Patients who experience relapse of acute myeloid leukemia (AML) after allogeneic hematopoietic cell transplantation (allo-HCT) have a dismal prognosis. Infusion of donor T cells can induce graft-versus-leukemia (GVL) effects, indicating the importance of intact T cell function for leukemia control. Recent studies have shown the importance of metabolic fitness for an effective T cell response.

In this study we have analyzed the T cell metabolism and immune phenotype in AML patients at different time points before and after allo-HCT.

Eligibility Criteria:
Inclusion Criteria:

* confirmed diagnosis of AML
* age ≥ 18 years
* peripheral blood sample available
* written informed consent
* ability to understand the nature of the study and the study related procedures and to comply with them

Exclusion Criteria:

* age \< 18 years
* lack of informed consent
* patients that cannot be classified in one of the 3 groups
Comparative Study of the Quality of Life of Patients Suffering From OTOTOXICITY Due to Chemotherapy Based on Platinum Salts Fitted With a Hearing Aid Compared to Those Not Fitted.

There are many undesirable effects associated with platinum-based cancer treatments (renal failure, anaemia, etc.). Their administration also leads to neurosensory problems such as ototoxicity, tinnitus and reduced hearing acuity. According to a the French survey (2018), 39.7% of people suffer from hearing problems due to cancer treatments, five years after a cancer diagnosis.

Improving side effects such as hypoacusis and tinnitus can significantly improve patients' quality of life and adherence to treatment. Many clinical trials proposed a medicinal solution to patients receiving platinum-based cancer treatments but none has led to a consensus on management.

The aim of the study is to offer patients receiving platinum-based chemotherapy and suffering from hearing problems a hearing aid to improve their quality of life.


Eligibility Criteria:
Inclusion Criteria:

* Adult patient
* Patient currently undergoing treatment with platinum-based chemotherapy and suffering from hypoacusia consistent with the treatment or presenting a worsening of already existing hypoacusis consistent with the start of treatment with platinum-based chemotherapy
* Patient whose hypoacusis is confirmed by the audiometric test
* Patient able and willing to follow all study procedures in accordance with the protocol.
* Patient having understood, signed and dated the consent form
* Patient affiliated to the social security system

Exclusion Criteria:

* Pregnant or breastfeeding woman
* Persons deprived of liberty or under guardianship (including curatorship)
* Impossibility of submitting to medical monitoring of the trial for geographical, social or psychological reasons
* Patient with a contraindication to wearing hearing aids
* Patient already fitted
* Patient already included in a protocol including an experimental molecule
* Patient who has not started treatment with platinum-based chemotherapy
* Patient presenting only tinnitus without hearing loss