cyrilzakka/clinical-trials huggingface dataset:
The Validity and Reliability of the Turkish Version of the Quality of Recovery-15 (QoR-15) Questionnaire

Postoperative recovery is a complex process influenced by various factors such as patients, surgical methods and anesthetic properties. Such factors can be accompanied by many negative situations. Previous studies evaluating recovery following anesthesia primarily evaluated the incidence of morbidity, mortality, adverse anesthesia-related outcomes, and changes in vital signs (1-4). These parameters are important, but the quality of recovery of patients has been neglected in most studies. Therefore, various patient-reported outcome measurement scales and tools have been developed (1,3-8). One of these scales is Stark et al. It is the QoR-15 questionnaire developed by in 2013 (4). QoR-15 aims to assess the quality of early recovery and emotional health of patients after surgery (4,6). It is a 15-item questionnaire assessing the patient's emotional state, physical comfort, psychological support, physical independence and pain. This one-page QoR-15 questionnaire has been shown to be highly valid and reliable in patients who have undergone general surgery (4).

QoR-15 has been verified and translated into many languages such as Japanese, French, Portuguese, Chinese, Swedish (13-17). It was reported in a systemic review that all translated versions of the QoR-15 had sufficient validity and reliability to assess the quality of postoperative recovery (19). However, an official Turkish version of the QoR-15 has not yet been developed or approved.

The aim of this study was to develop the Turkish version of the QoR-15 (QoR-15T) and to evaluate its validity, reliability and responsiveness for Turkish-speaking patients receiving general and regional anaesthesia.


Eligibility Criteria:
Inclusion Criteria:

* native turkish speaker
* scheduled elective surgery

Exclusion Criteria:

* with cognitive impairment,
* American Society of Anesthesiologists (ASA) physical condition IV or higher,
* patients with psychiatric disorders,
* history of alcohol or any other substance abuse
* patients expected to need postoperative mechanical ventilation (eg, cardiovascular surgery requiring cardiopulmonary bypass, microvascular reconstruction surgery for oral and maxillofacial cancer, etc.)
* Patients who are thought to be unable to answer the questionnaire due to a change in mental status or the need for sedation during the postoperative evaluation,
* patients who develop major complications after surgery
Drug Use Investigation Of Azithromycin IV For Pneumonia Or Pelvic Inflammatory Disease (Regulatory Post Marketing Commitment Plan)

To collect the efficacy and safety information of Azithromycin IV related to their appropriate use in daily practice


Eligibility Criteria:
Inclusion Criteria:

* Male or Female patients who are prescribed Zithromac IV for pneumonia or pelvic inflammatory disease.

Exclusion Criteria:

* Subjects who have been prescribed Zithromac IV for pneumonia or pelvic inflammatory disease.
Trial of NanoPac Focal Therapy for Prostate Cancer

This study evaluates the use of NanoPac injected directly into the prostate lesion in men with prostate cancer.

NanoPac is very small (submicron) particles of the chemotherapy drug, paclitaxel, which is administered intravenously in a number of types of cancer. These submicron particles are injected directly into solid tumors to target cancer at the site of disease with less systemic exposure than intravenously administered chemotherapy. In this study, this submicron particle paclitaxel will be injected directly into the prostate lesion in men with prostate cancer scheduled for prostatectomy on up to three different occasions. All subjects in the study will receive NanoPac and will be evaluated to see if NanoPac is safe, well-tolerated, and has an impact on prostate cancer.

Eligibility Criteria:
Inclusion Criteria:

* At least 18 years of age;
* Histopathologically proven adenocarcinoma of the prostate:

  * Localized cancer;
  * Subjects with tumors classified as \<T3 per TNM classification, Gleason score≥ 6;
* Prostate tumor must be able to be visualized on mpMRI;
* Already considered to be candidate for radical prostatectomy;
* Considered appropriate for treatment with paclitaxel therapy;
* Laboratory requirements:

  * WBC \>2500/mm3
  * Neutrophil \>1500/mm3
  * Hemoglobin \>10 mg/dL
  * Platelet \>100,000/ mm3
  * AST and ALT \<2.5 x ULN
  * Total bilirubin \<1.5 x ULN
  * Calculated creatinine clearance ≥ 30 ml/min
  * Normal PT/INR and PTT;
* ECOG of 0 or 1;
* International Prostate Symptom Score (I-PSS) less than or equal to 20;
* If sexually active, willing to use double condoms from time of NanoPac injection until prostatectomy;
* Agree to all study procedures and provide signed informed consent;

Exclusion Criteria:

* Evidence of locally advanced or metastatic disease;
* Prostate size ≥ 50 cc;
* Prior prostatectomy, including surgery for any benign condition (such as TURP);
* Anticipated use of concomitant chemotherapy (other than the protocol specified agents), immunotherapy, or systemic use of hormonal therapy (such as GnRH analogs, antiandrogens, androgen receptor inhibitors, and 5-α reductase inhibitors) while on study prior to surgery;
* Treatment with a prior investigational medication within 30 days of first dose of study agent;
* Any previous local treatment of the prostate (e.g. radiation, HIFU, cryotherapy, Focal Irreversible Electroporation, Photodynamic Therapy, Laser Induced Thermometry);
* Any other condition (e.g., psychiatric disorder) that, in the opinion of the Investigator, may interfere with the subject's ability to comply with the study requirements or visit schedule;
* Known sensitivity to any of the study agent components;
* History of prior malignancy that has not been in remission for \>5 years, with the exception of basal cell or squamous cell carcinoma.
Interscalene vs. Superficial Cervical Block vs. Combination for Analgesia After Clavicle Fracture

The optimal analgesic peripheral nerve block (or combinations thereof) are undefined for clavicle fractures, the most frequent fracture in the human population. This goal of this study is to determine whether interscalene block (ISB), superficial cervical plexus block (SCPB), or both provide the best analgesia for lateral and midshaft clavicular fractures, respectively.

Clavicle fractures are relatively common injuries that occur most often in young active males and elderly individuals. They are often a result of direct trauma to the shoulder, typically from a fall. Clavicle fractures represent 5-10% of all fractures and represent the most frequent fracture in the human population. Midshaft fractures account for 69-85% of the clavicle fractures, distal shaft fractures 12-28%. (1) Analgesia for clavicle fractures can be challenging for anaesthetists secondary to the complex and varied innervation in this region. Literature describing the innervation of the clavicle and overlying skin is heterogeneous with the C3 to C6 nerve roots being involved. The clavicle itself has been reported to be innervated either by C4 or by C5 and C6 (subclavian nerve) nerve roots. (2) Regional anaesthesia for intraoperative and postoperative analgesia of clavicle fractures employs several possible, commonly used approaches. The contemporary literature surrounding the optimal regional anaesthetic technique for clavicle surgery which can provide superior postoperative analgesia and minimize systemic agents intraoperatively is lacking Currently there are only small case series or case reports published. Peripheral nerve blocks used to anesthetize the clavicle include SCPB, ISB, and combined SCPB-ISB. Larger, systematic trials have not yet been performed to our knowledge and as recently as one year ago a call for more evidence in this area of regional anaesthesia was published in the American Society of Regional Anesthesia and Pain Medicine. The purpose of this study is to compare analgesic outcomes after the common regional anesthetic techniques (ISB versus SCPB versus both).

Eligibility Criteria:
Inclusion Criteria:

* undergoing open reduction and internal fixation of clavicle fracture (midshaft or lateral)

Exclusion Criteria:

* lack of patient consent
* contra-indication to upper extremity peripheral nerve block (eg. severe pulmonary dysfunction)
* inability to lie supine for nerve block
* polytrauma
* pre-existing neurologic deficit in operative upper extremity
* allergy to amide local anesthetic
* contralateral phrenic nerve dysfunction
* chronic opioid use (\>30mg daily oral morphine equivalent)
Study Of Alvimopan Drug For Treatment Of Constipation Due To Prescription Pain Medication

A multicenter study to evaluate the effectiveness and safety of multiple dosage regimens of an investigational drug for the treatment of constipation due to prescription pain medication in subjects with cancer pain. The study will require five visits over a five-week period.


Eligibility Criteria:
Inclusion criteria:

* Participant is in any stage of cancer but has a minimum life expectancy of at least 3 months at the time of the Screening Visit.
* Participant is taking opioid therapy for persistent cancer pain.
* Participant meets the definition of opioid-induced bowel dysfunction as follows: Since starting opioid therapy, the subject has had decreased bowel movement (BM) frequency and at least one of the following constipation symptoms \[sensation of incomplete evacuation, difficulty in expelling stool (straining), hard stools (abnormal stool consistency)\].
* Participant understands the procedures, agrees to participate in the study, and has signed and dated the informed consent form prior to the initiation of any study-related activities, including discontinuation of pre-study laxative regimen or other prohibited medications.
* Participant is able and willing to comply with a daily paper diary and is capable of completing paper questionnaires at study visits.

Exclusion criteria:

* Participant is pregnant or lactating, or planning to become pregnant.
* Participant is not ambulatory.
* Participant has participated in another trial with an investigational drug (unapproved), device or procedure within 30 days of the Screening Visit.
* Participant is unable to eat, drink, take/hold down oral medications.
* Participant is taking opioids for the management of drug addiction.
* Participant is unable or unwilling to discontinue the use of and/or refrain from using laxatives of all types and formulation at the Screening Visit and throughout the entire study.
* Participant has severe constipation that has not been appropriately managed such that the subject is at immediate risk of developing serious complications of constipation. This would include a subject who has reported no bowel movement for 7 consecutive days prior to the Screening Visit.
* Participant with gastrointestinal or pelvic disorders known to affect bowel transit, produce gastrointestinal (GI) obstruction, or contribute to bowel dysfunction.
* Participant is currently taking vinca alkyloids or plans to take vinca alkyloids during the study.
* Participant is currently undergoing abdominal radiation therapy and/or plans to undergo abdominal radiation therapy during the study.
* Participant is human immunodeficiency virus (HIV)-infected, has active hepatitis (any subtype including ongoing chronic hepatitis B), or has ever been infected with hepatitis C.
Re-examination Study of EMEND (Aprepitant) (MK-0869-184)

This survey is conducted for preparing application materials for re-examination under the Pharmaceutical Affairs Laws and its Enforcement Regulation. Its aim is to reconfirm the clinical usefulness of EMEMD (aprepitant) through collecting the safety information according to the Re-examination Regulation for New Drugs.


Eligibility Criteria:
Inclusion Criteria:

* Participants who are treated with EMEND for the first time as per the EMEND label

Exclusion Criteria:

* Contraindication to EMEND
Plasma Determination of Glucagon-like Peptide 2 as a Predictor of Recovery in Adults With Acute Intestinal Failure

The purpose of this study is to investigate the theory that the plasma level of Glucagon like peptide 2 (GLP-2) in patients with intestinal failure can predict their clinical recovery.

When major segments of small bowel have been removed surgically, or damaged by disease, the length of the residual bowel may be inadequate to maintain overall nutrition and the net result is described as "intestinal failure".

Without medical intervention, patients with intestinal failure become malnourished and dehydrated because their remaining intestine is unable to absorb enough water, vitamins and other nutrients from the ingested food. Intravenous feeding offers life saving treatment but causes complications like infections and liver problems. It also poses enormous strain on day to day life.

Glucagon like peptide 2 (GLP-2) is a naturally occurring hormone (or chemical messenger) that is able to increase the surface area of the intestinal lining (or mucosal mass) and the absorptive efficiency of the remaining intestine.

Intestinal failure patients in whom not only parts of the small bowel but also the large bowel have had to be surgically removed have been shown to have a markedly impaired rise in GLP-2 levels following meals, in contrast to patients with a preserved large bowel who have increased levels of GLP-2 and are known to have much better functional adaptation.

From this we hypothesise that the GLP-2 level is directly related to, and could predict, clinical recovery in intestinal failure as measured by Amount of parenteral nutrition required Length of hospital stay Mortality

We also aim to compare GLP-2 levels of patients with acute intestinal failure with that of patients with chronic intestinal failure as well as healthy controls

Eligibility Criteria:
Inclusion Criteria:

* Men and woman, aged 18 years of age or older at the time of signing the informed consent form.
* Referral to or direct admission to St. Mark's Hospital.
* Acute intestinal failure resulting in TPN dependency as a result of major intestinal resection performed during admission to St. Mark's or at the referring hospital.

Exclusion Criteria:

* Inability to give consent or comply with the study.
* Inability to take test meal (unable to be tested)
* Severe renal impairment (interference with GLP-2 excretion)
* Severe uncorrected anaemia (preventing additional blood-letting)
* Uncontrolled diabetes mellitus (risk of hyperglycaemia)
Real-life Assessment of the Safety and Performance of the SYNOVIUM HCS Device

Patients who are to benefit from an injection of SYNOVIUM HCS as part of their care will be offered to participate in this study. Patients will need to sign a consent form to participate. Prior to SYNOVIUM HCS injection, patients will be asked a series of questions regarding their pain and disability. Data collected during follow-up visits can be compared to pre-injection data.

Inclusion period: 6 months

Follow-up period:

* 6-month follow-up, after intra-articular injection with extension

  * 1 single syringe of SYNOVIUM HCS (3 mL),
  * Controls scheduled at 1 week, 1, 3, 6 months and up to 1 year
  * Additional control (single) in the event of leaving the study if this takes place outside the scheduled visit dates and before 1 year, for medical reasons
* Duration of the study: Overall time estimated at 18 months
* In this open-label CI, the group itself is used as a control, by comparing the scores on inclusion with those of the various control visits.

Eligibility Criteria:
Inclusion Criteria:

* Adult patient
* Patient with radiologically characterized gonarthrosis (stages Kellgren \& Lawrence grades I to III)
* Patient with walking pain (WOMAC A1) at least equal to 2 on the Likert scale 0-4
* Patient to benefit from an injection of SYNOVIUM HCS as part of his treatment
* Patient agreeing to participate in the study
* Patient affiliated to a social security scheme or benefiting from such a scheme

Exclusion Criteria:

* Viscosupplementation less than 6 months old
* Intra-articular corticosteroid injection less than 2 months old
* Inflammatory arthritis or active infectious of the knee studied
* History of surgery of the lower limb concerned
* Kellgren \& Lawrence grades not defined
* Known hypersensitivity to hyaluronic acid or chondroitin sulfate
* Pregnant or breastfeeding women
* Patient under guardianship, curatorship or judicial safeguard
* Patient participating in another clinical investigation, at the time of inclusion
Evaluation of SCOUT DS Device in the Diagnosis of Diabetes

The primary objective is to identify compare SCOUT DS to random capillary glucose for identification of at-risk subjects with dysglycemia defined by hemoglobin A1c ≥ 6.0%.

The study will complete up to 330 subjects at the clinical site to evaluate the accuracy of SCOUT DS, random capillary glucose (RCG) and the Leicester diabetes risk questionnaire for detecting prediabetes and undiagnosed type 2 diabetes in subjects at risk, but not having a pre-exiting diagnosis of type 2 diabetes. A point of care A1c measurement (Siemens DCA Vantage or Axis-Shield Afinion) will serve as the reference method for defining a positive screen (A1c ≥ 6.0%).

Eligibility Criteria:
Inclusion Criteria:

* Age greater than or equal to 45 years

OR

Age 18 to 44 years and BMI \> 25 kg/m² with one or more of the following risk factors:

* Elevated waist circumference, \> 35 inches for women and \>40 inches for men
* Habitually physically inactive (does not exercise regularly)
* Has a first-degree relative with diabetes
* Ethnicity with elevated risk for type 2 diabetes
* Has delivered a baby weighing \> 9 lb or diagnosed with gestational diabetes
* Hypertension (≥130/≥ 85 mmHg) or being treated for hypertension
* HDL cholesterol level \< 35 mg/dL and/or a fasting triglyceride level ≥ 250 mg/dL or being treated for dyslipidemia with medication
* Has been previously diagnosed with Polycystic Ovary Syndrome (PCOS)
* Had impaired glucose tolerance or impaired fasting glucose on previous testing within the last 3 yrs
* Conditions associated with insulin resistance such as acanthosis nigricans
* History of vascular disease including heart attack, stroke, angina, coronary heart disease, atherosclerosis, congestive heart failure or peripheral arterial disease

Exclusion Criteria:

* Under 18 years of age

  * Receiving investigational treatments in the past 14 days
  * Psychosocial issues that interfere with an ability to follow study procedures
  * Conditions that cause secondary diabetes including Cushing's syndrome, acromegaly, hemochromatosis, pancreatitis, or cystic fibrosis
  * Diagnosed with any type of diabetes, including type 1 or 2
  * Taking glucose lowering medications with the exception of metformin
  * Known to be pregnant
  * Receiving dialysis or having known renal compromise
  * Scars, tattoos, rashes or other disruption/discoloration on the left volar forearm.
  * Recent (within past month) or current oral steroid therapy or topical steroids applied to the left forearm; inhaled steroid therapy is not excluded
  * Current chemotherapy, or chemotherapy within the past 12 months
  * Known to have, or at risk for, photosensitivity reactions ( e.g., sensitive to ultraviolet light, or taking medication known to cause photosensitivity)
Guided Self-Change Prevention Program for Alcohol Abuse in Adolescents in Educational Settings

This study corresponds to a pretest-posttest randomized experimental design with two arms. Arm 1 includes Guided Self-Change program, and Arm 2 a psychoeducational program to promote healthy habits. This study aims to analyze the efficacy of a selective and indicated prevention program based on the Guided Self-Change model (GSC) in adolescent alcohol users between 16-18 years. Researchers hypothesize that implementation of GSC therapy will lead to a greater reduction of alcohol drinkers compare with the control condition, and will prevent alcohol abuse after 6 and 12 months.


Eligibility Criteria:
Inclusion Criteria:

* 16-18 years old.
* Having inform consent from parents
* Report using alcohol at least once a month during the previous last three months

Exclusion Criteria:

* Participants will be excluded if they refer being diagnosed with a severe mental disorder.
* Have a severe medical illness that will limit participation
* Being under treatment for a psychological of psychiatric problem.
* Meet DSM criteria for Drug dependence to illegal drugs.
Accuracy of Lymph Node Imaging in Prostate Cancer: PSMA PET-CT and Nano-MRI

Following curative intended therapy in prostate cancer patients, a high proportion of patients (approx. 25%) relapse with local and/or distant recurrence. The metastasis of a lymph node (LN) in a patient with prostate cancer means that the disease has become systemic with the increased risk of disease progression. Therefore the ability to detect the presence of LN metastasis is important in terms of disease prognosis and treatment options. In the past, patients with LN metastasis have had poor prognoses due to the scarcity of accurate staging techniques and toxic treatment regimens such as radiotherapy. For those patients with a medium to high risk of having LN metastasis, the current procedure is a bilateral pelvic lymph node dissection (PLND). This is the standard procedure prior to curative treatment with either radical prostatectomy or radiation therapy. However, the procedure is not optimal due to the frequent inability to remove all positive lymph nodes within the dissection area. 41% of metastatic LN disease is not found, due to these LN being outside the routine surgery field. As a result, some urologists will perform an extended lymphadenectomy (e-PLND), which leads to extended operating times and the risk of complications. Also, therapy of LN metastases has limitations: more than 50% of metastatic LN are outside the routine (RTOG-CTV) radiation field. Thus the effect of standard LN radiotherapy is limited. Currently used imaging techniques such as CT and conventional MRI are also not sensitive enough to detect prostate cancer metastases due to the small size of the nodes (\< 8mm).

In this study, patients that undergo a pelvic lymph node dissection will be undergoing a 68Ga PSMA PET-CT and a nano-MRI prior to surgery. The results of the PSMA PET-CT and the nano-MRI will be validated using the pathology results of the (PLND).


Eligibility Criteria:
Inclusion Criteria:

* Male, aged 18 years Prostate cancer present (Gleason ≥ 7) and/or
* PSA ≥ 15 and/or
* Clinical or radiological Stage T3
* Subject will be undergoing a pelvic lymph node dissection as part of the prostate cancer treatment.
* Subject is willing to sign and date the study Informed Consent form
* Signed, written informed consent

Exclusion Criteria:

* Patients who cannot lie still for at least 30 minutes or comply with imaging
* Subject has medical conditions that would limit study participation (per physician discretion)
* Subject has hemochromatosis and liver disease
* Subject has known allergy against Fe-products or dextranes
* Subject is enrolled in one or more concurrent studies that would confound the study results of this study as determined by the study investigators
* Previous treatment for prostate cancer (surgery, radiotherapy, chemotherapy, hormone androgen deprivation therapy)
* Proven bony metastatic disease, visceral metastases or lymph node metastases above the level of the aortic bifurcation
* Patients who will not get prostatectomy or pelvic lymph node dissection for any reason
* Patient has absolute contra-indications to undergoing MRI scanning