cyrilzakka/clinical-trials huggingface dataset:
Turkish Validity and Reliability of SGRQ-I

The Saint George Respiratory Questionnaire (SGRQ) questionnaire is a frequently used questionnaire in the respiratory patient group, and the Turkish version of this questionnaire, which was created for use in idiopathic pulmonary fibrosis patients, is not available. There is no commonly used quality of life questionnaire in patients with idiopathic pulmonary fibrosis. The aim of the study is to translate and validate the SGRQ idiopathic pulmonary fibrosis version of questionnaire into Turkish.

* The study is a cross-sectional, questionnaire validation study.
* It is planned to complete the study within 2 years after the sufficient sample size is reached and the evaluations are made. The study will be terminated when the sufficient number of patients is reached.
* The main thing in the application of special tools such as questionnaires is to prove the usability of the tool in the sample group to which it will be applied. The first step for this is the translation phase from the original language to the other language. At this stage, it is ideal for people who know the structure of the target language and the original language well, who have a good command of these languages and who are experienced in doing the translation. In our study, two people who are fluent in the original language will translate the questionnaire into the target language and two different people will translate the original language again.
* To the participants; Demographic Evaluation Form, Saint George's Respiratory Questionnaire (SGRQ), and SGRQ idiopathic pulmonary fibrosis version of Questionnaire (SGRQ-I) will be applied. The SGRQ-I questionnaire will be administered again one week after the first application date in order to determine the test-retest reliability.
* Scale reliability will be tested with Cronbach Alpha.For construct validity, confirmatory factor analysis will be applied and confirmatory factor analysis will be applied. For content validity, opinions of different experts will be taken for each item, and the status of items in the scale will be determined according to the results obtained by substituting it. In the logical validity process; Coverage of the components constituting the measured skill for each item will be considered.

Eligibility Criteria:
Inclusion Criteria:

* Be over 18 years old
* Having a Diagnosis of Idiopathic Pulmonary Fibrosis
* To be literate in Turkish

Exclusion Criteria:

* Exacerbation or exacerbation in the last 6 weeks
* Presence of comorbidities affecting ambulation
* Cognitive impairment
Initial Safety Evaluation of FibroFix™ Meniscus

Initial evaluation of safety and performance of FibroFix™ Meniscus scaffold

The safety of the FibroFix™ Meniscus scaffold will be evaluated in 10 patients scheduled for elective arthroscopic medial meniscus partial resection or treatment of asymptomatic medial meniscal defect

Eligibility Criteria:
Inclusion Criteria:

* The subject (or guardian, if appropriate) has signed and dated a specific informed consent form
* The subject is over the age of 18
* The subject is able to comply with the protocol-defined preoperative procedures, the postoperative clinical and radiographic evaluations and the recommended rehabilitation regimen as determined by the investigator
* The subject has a diagnosis of an MRI or arthroscopically confirmed irreparable medial meniscus defect
* The meniscal defect should represent 25% or more of the meniscus and be amenable to repair
* The peripheral meniscal rim must be present
* The subject has a functionally intact anterior cruciate ligament
* Haemoglobin \>9g/dL and platelet count \>100,000/mm3 prior to Day 1
* No contraindication to general anaesthetic
* Female subjects of child-bearing potential: a negative urine pregnancy test

Exclusion Criteria:

* The subject has a functionally deficient anterior cruciate ligament
* The subject has concomitant posterior cruciate ligament insufficiency of the involved knee or a concomitant injury that interferes with the subject's ability to comply with the recommended rehabilitation program
* The subject has a diagnosis of untreatable Grade IV Outerbridge Scale degenerative cartilage disease in the involved knee joint
* Patients demonstrating an active local or systemic infection
* Any condition, which in the judgment of the Investigator would preclude adequate evaluation of the FibroFix™ Meniscus scaffold and clinical outcome.
* The subject has a history of confirmed anaphylactoid reaction
* The subject has received local administration of any type of corticosteroid or systemic administration of antineoplastic, immunostimulating, or immunosuppressive agents within 180 days prior to the scheduled surgery
* The subject has evidence of osteonecrosis of the involved knee
* The subject has a medical history that includes a confirmed diagnosis of rheumatoid or inflammatory arthritis, or relapsing polychondritis
* If female and of child-bearing potential: evidence of a positive pregnancy test or a stated intention to become pregnant in the next 6-12 months
A Retrospective Cohort Study About Surgical Efficacy for Lower Cervical Fractures in Ankylosing Spondylitis

The purpose of this retrospective cohort study was to observe and compare the efficacy of anterior cervical long segment fixation, posterior long segment fixation, and combined anterior and posterior fixation for the treatment of cervical vertebral fracture-dislocations in the lower cervical spine in ankylosing spondylitis.

This was a retrospective cohort study. Patients operated for fracture-dislocation of the lower cervical vertebrae in ankylosing spondylitis in our hospital from 01/2014 to 01/2024 were retrospectively included as study subjects. Prior to the start of the study, an application will be made for approval through the hospital ethical committee, and the Declaration of Helsinki will be observed during the course of the study. The patients were divided into an anterior group (anterior long-segment cervical fixation), a posterior group (posterior long-segment cervical fixation), and a combined group (combined anterior and posterior fixation) according to the surgical access. The operation time, bleeding, complication occurrence, fracture healing and changes in neurological function of the three groups were compared. In this study, Frankel grading before and after surgery was used as the primary observation index, and operation time, intraoperative bleeding, occurrence of complications, and cervical fracture healing were used as the secondary observation index. SPSS 26.0 (IBM, New York, NY, USA) was applied for statistical analysis in this study.

Eligibility Criteria:
Inclusion criteria:

Meet the diagnostic criteria for ankylosing spondylitis, imaging showed that cervical ankylosing and fracture dislocation of the lower cervical vertebrae (cervical 3\~7); Age 18\~80 years old; undergo anterior, posterior or combined access internal fixation surgery and the fixation segment is ≥4 segments.

Exclusion criteria:

Systemic or local infection; Previous history of cervical vertebrae surgery; Postoperative loss of follow-up.
Trial to Evaluate the Safety, Tolerability, and Immunogenicity of A Multivalent Group B Streptococcus Vaccine When Administered Concomitantly With Tdap in Healthy Nonpregnant Women

This phase 2B, placebo-controlled, randomized, observer-blinded trial will evaluate the safety, tolerability, and immunogenicity of the investigational multivalent group B streptococcus vaccine administered concomitantly with Tdap in healthy nonpregnant women 18 through 49 years of age.


Eligibility Criteria:
Inclusion Criteria:

* Healthy women ≥18 and ≤49 years of age.
* Participants who are willing and able to comply with scheduled visits, investigational plan, laboratory tests, lifestyle considerations, and other study procedures, including completion of the e-diary from Day 1 to Day 7 following administration of investigational product.
* Healthy females at enrollment who are determined by medical history, physical examination, and clinical judgment of the investigator to be eligible for inclusion in the study.
* Expected to be available for the duration of the study and who can be contacted by telephone during study participation.
* Capable of giving personal signed informed consent.

Exclusion Criteria:

* Pregnant female participants; breastfeeding female participants; positive urine pregnancy test for women of childbearing potential (WOCBP) at Visit 1 (prior to vaccination)
* History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of the investigational product or any diphtheria toxoid-containing or CRM197-containing vaccine.
* History of microbiologically proven invasive disease caused by group B streptococcus.
* Immunocompromised participants with known or suspected immunodeficiency.
* Bleeding diathesis or condition associated with prolonged bleeding that would in the opinion of the investigator contraindicate intramuscular injection.
* Other acute or chronic medical or psychiatric condition, including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.
* Previous vaccination with any licensed or investigational GBS vaccine, or planned receipt during the participant's participation in the study (through the 1-month follow-up visit \[Visit 2\]).
* Vaccination within 5 years with tetanus and diphtheria toxoids and acellular pertussis-containing vaccines (Tdap) before investigational product administration.
* Participants who receive treatment with immunosuppressive therapy, including cytotoxic agents or systemic corticosteroids
* Vaccination with diphtheria- or CRM197-containing vaccine(s) from 6 months before investigational product administration, or planned receipt through the 1-month follow-up visit.
* Receipt or planned receipt of blood/plasma products or immunoglobulin, from 60 days before investigational product administration through the 1-month follow-up visit
* Participation in other studies involving investigational drug(s) within 28 days prior to study entry and/or during study participation
A Multicenter, Prospective, Randomized Trial of Adjuvant Chemotherapy for Early-Stage Cervical Cancer Patients

We will conduct a trial to determine whether paclitaxel/cisplatin (TP) as an adjuvant chemotherapy after radical surgery improve disease-free survival (DFS) and overall survival (OS), as well as the quality of life (QoL) among early-stage (FIGO stage IB-IIA) cervical cancer patients with risk factors.


Eligibility Criteria:
Inclusion Criteria:

* FIGO stage: ⅠB～ⅡA, cervical cancer;
* Age≤60 years; female, Chinese women;
* Initial treatment is radical hysterectomy + pelvic lymph node dissection;
* Pathological diagnosis: cervical squamous cell invasive carcinoma;
* Pathologic examination and meet the following one of the indications of adjuvant therapy: ① lymph node metastasis, ② parametrial invasion, ③ ≥ 2/3 deep stromal invasion, ④ histopathological grading in poorly differentiated (G2 to G3), ⑤ lymphatic vascular space involvement, ⑥ tumor diameter\> 4cm;
* Laboratory tests: WBC≥4×10(9)/L, NEU≥2×10(9)/L, PLT≥80×10(9)/L, serum bilirubin≤ 1.5 times the upper limit of normal, transaminase≤ 1.5 times the upper limit of normal, BUN, Cr≤ normal
* Performance status: Karnofsky score≥60;
* No prior treatment;
* Receiving extensive resection of uterus (type III) plus pelvic lymph nodes wide resection; pathologically diagnosed with cervical squamous cell carcinoma;
* Provide written informed consent.

Exclusion Criteria:

* With severe or uncontrolled internal disease, unable to receive surgery and/or unsuitable for radiotherapy or chemotherapy
* History of organ transplantation, immune diseases;
* History of serious mental illness, a history of brain dysfunction;
* Drug abuse or a history of drug abuse;
* Suffering from other malignancies;
* Concurrently participating in other clinical trials
* Unable or unwilling to sign informed consents;
* Unable or unwilling to abide by protocol.
Percutaneous Cryoablation of Central Kidney Tumours With Temporary Renal Artery Occlusion

Percutaneous cryoablation is an alternative to urological surgery for T1a tumours, whose oncological efficacy decreases for the most central tumours due to a cold sink effect.


Eligibility Criteria:
Inclusion criteria:

* Adult subject (≥18 years)
* Subject who has undergone cryoablation of a central kidney tumour with temporary occlusion of the renal artery by an endovascular balloon at the HUS during the period 01/01/2018 to 30/12/2021
* Subject who has not expressed his/her opposition, after information, to the re-use of his/her data for the purpose of this research.

Exclusion criteria :

* Subject having expressed his/her opposition to participate in the study
* Subject under legal protection, guardianship or curatorship
Multidrug Resistance in Newly Diagnosed TB Patient

Tuberculosis (TB) is one of the major public health threats, competing with the human immunodeficiency virus (HIV) as the cause of death due to infectious diseases worldwide.

Multi drug-resistant Mycobacterium tuberculosis (MDR-TB) is one of the leading causes of death in the world.

The resource constraints make it difficult to diagnose and monitor the cases of MDR-TB.

GeneXpert is a recognized tool used to diagnose the patients of pulmonary tuberculosis in clinical settings across the globe MDR Multidrug-resistant tuberculosis (MDR-TB), caused by Mycobacterium tuberculosis that is resistant to both isoniazid and rifampicin with or without resistance to other drugs According to current World Health Organization and the International Union Against Tuberculosis and Lung Disease estimates, the median prevalence of MDR-TB has been 1.1% in newly diagnosed patients. The proportion, however, is considerably higher (median prevalence, 7%) in patients who have previously received anti-TB treatment.

XDR tuberculosis is caused by a strain of Mycobacterium tuberculosis resistant to isoniazid and rifampin (which defines MDR tuberculosis) in addition to any fluoroquinolone and at least one of the three following injectable drugs: capreomycin, kanamycin, and amikacin The main causes of the spread of resistant TB are weak medical Systems, amplification of resistance patterns through incorrect treatment, and transmission in communities and facilities. Although patients harboring MDR and XDR strains present a formidable challenge for treatment, cure is often possible with early identification of resistance and use of a properly designed regimen.

To detect the prevalence of MDR T.B. using xpert MTB/RIF ultra and XDR assay in newly diagnosed cases

Eligibility Criteria:
Inclusion criteria

* newly diagnosed tuberculosis patient
* Diagnosed by direct smear for sputum or body fluid

Exclusion Criteria:

\* previously treated patient
Imminently Effect of Interval Training With High Intensity (HIT) After Heart Transplantation

High intensity Interval training (HIT) has repeatedly been documented to have superior positive effects on oxygen uptake and general physical health compared to continuous moderate exercise in healthy individuals and patients with heart disease. Recently, the same effect has been shown in heart transplanted recipients. Which mechanisms that explains this difference is uncertain; the effect can be due to changes in the heart or changes in the peripheral tissue and muscles. To explore these mechanisms the investigators will in this study compare two different exercise modalities, and explore how different biomarkers change in blood, related to exercise.

15 heart transplanted recipients (and 5 healthy controls) will be included in the study. Each patient will have three study-days.

The study is designed to be a cross-over study. And randomisation will decide which training they will have som training session 1 and training session 2; Interval or continuous training.

Before starting the two training sessions they will measure oxygen uptake and baseline blood samples.

During each exercise session the patients will take blood samples during and after exercise.

After first study admission the patients will have a wash out period for 1 week until first training session, and another week until the last session.

Eligibility Criteria:
Inclusion Criteria (HTx):

* 1-10 years after heart transplantation
* Lives in Oslo or near Oslo
* Stable health condition
* Optimal medical treatment/ medication
* No limiting physical handicap
* Written consent

Inclusion healthy control:

* No verified heart disease
* Willing to preform the study
* Over 18 years
* Written consent

Exclusion Criteria:

* Under 1 year or over 10 year since HTx.
* Lives far from Oslo
* Unstable health condition
* Not optimal medical treatment and/ or medication
* Limiting physical handicap
* Under 18 years
* Not written consent
Capsaicin Lozenges in Treating Patients With Mucositis Caused by Radiation Therapy

RATIONALE: Capsaicin lozenges may be effective treatment for mucositis caused by radiation therapy. It is not yet known whether capsaicin lozenges are more effective than no treatment for mucositis caused by radiation therapy.

PURPOSE: Randomized phase III trial to study the effectiveness of capsaicin lozenges in treating patients with mucositis caused by radiation therapy.

OBJECTIVES: I. Determine the efficacy of capsaicin lozenges in terms of frequency, duration, and severity of mouth pain caused by radiation therapy to the oral cavity. II. Evaluate the toxicity of this regimen in these patients.

OUTLINE: This is a randomized, double blind, placebo controlled study. Patients are stratified according to dentures (yes vs no), smoking history (none vs currently vs past only), radiation therapy (primary vs postoperative adjuvant), planned radiation dose (5000-6000 cGy vs greater than 6000 cGy), planned fluoride use (yes vs no), and amount of oral mucosa in radiation field (one- to two-thirds vs greater than two-thirds). Patients receive one lozenge orally of capsaicin or placebo four times daily. Treatment begins within the first 3 days of radiation therapy and continues during and for two weeks after radiation therapy is completed.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Scheduled to receive radiation treatment to at least one third of the oral cavity at a total dose of at least 5000 cGy using 200 cGy/fraction Must be entered on study within first 3 days of radiation No open mouth sores at study entry

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Not specified Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Other: No known intolerance to capsaicin No allergy to citric acid, cherry flavorings, or FC and C red dye #3 or #40

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No concurrent chemotherapy Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy to the oral mucosa Surgery: Not specified Other: No requirement for tube feeding
Use of Disposable Stethoscope Covers for Reduction of Stethoscope MRSA Contamination

This is a prospective pilot study using a randomized, controlled, single blinded, crossover trial design, evaluating the effect of daily antimicrobial stethoscope diaphragm covers versus uncovered stethoscope. Stethoscopes will be cleaned Sani-cloth germicidal disposable wipes which are effective against MRSA. Each participant will then be randomly assigned to 7 days in either the intervention or the control arm. At the end of the 7 days participants stethoscopes will be cleaned again. This will be followed by another 7 days in the arm that they are not in during the first 7 days.

The primary endpoint is MRSA colony count from stethoscope diaphragms cultures at 7 days, focusing on the difference between the intervention and the control periods. The secondary endpoint is the rate of hospital acquired MRSA infection in patients treated by residents during each period.


Eligibility Criteria:
Inclusion Criteria:

* Internal Medicine Residents

Exclusion Criteria:

* NA
A Study on Safety and Preliminary Efficacy of ALA in Acne Vulgaris

The purpose of this study is to explore the safety, tolerability, and preliminary efficacy of ALA used with photodynamic therapy for the treatment of moderate to severe acne vulgaris.


Eligibility Criteria:
Inclusion Criteria:

1. Chinese male or female patients aged 18 - 40 years;
2. Grade III-IV facial acne vulgaris according to the Pillsbury International Improvement scale.;
3. All patients claimed to take effective contraception from 14 days before to 1 month after the end of the study, (among those who had used contraceptive two weeks prior to the study, the dosage of the drug should remain the same throughout the study) and had no fertility or donation of sperm/egg plan;
4. Informed consents were signed.

Exclusion Criteria:

1. Suffering with malignant tumors, cardiac, endocrine, blood, liver, immunity, metabolism, urinary system, lungs, nervous system, rheumatism / joint, psychology and kidney diseases;
2. Obviously abnormal liver and kidney function;
3. Suffering with allergy diseases; suspected or known to have porphyria; allergic to studying drugs and / or porphyrin; allergic to visible light; allergic constitution (allergic to two or more drugs, food or pollen);
4. Secondary acne patients, such as occupational acne or acne caused by corticosteroids;
5. Complicated with other obvious facial skin diseases such as actinic dermatitis, psoriasis, seborrheic dermatitis, eczema, skin tumors, etc;
6. Other diseases that may significantly affect the efficacy evaluation;
7. Pregnancy, lactation patients;
8. Exposed to systemic retinoids 2 months prior to the study (acitretin for 6 months);
9. Exposed to systemic antibiotics, glucocorticoids, spironolactone and other drugs for treating acne 4 weeks prior to the study; physical therapy for the treatment of acne;
10. Exposed to topical retinoids on the face 4 weeks prior to the study or topical antibiotics, glucocorticoids, and other topical treatment 2 weeks prior to the study;
11. Participated in other clinical trials 3 months prior to the study;
12. Other reasons that the investigator considered inappropriate for participation in the study.
Safety of NovoMix® 30 or Levemir® for Treatment of Type 2 Diabetics in Macedonia

This study is conducted in Europe. The aim of this observational study is to investigate the incidence of serious adverse drug reactions when using NovoMix® 30 (biphasic insulin aspart 30) or Levemir® (insulin detemir) for treatment of type 2 diabetes mellitus under normal clinical practice conditions in Macedonia.


Eligibility Criteria:
Inclusion Criteria:

* After the physician decision has been made to use biphasic insulin aspart 30 or insulin detemir therapy, any subject with Type 2 diabetes is eligible for the study, including newly-diagnosed subjects who have never received insulin or an insulin analogue before.Particular attention should be paid to the drug interactions that are listed within the product label

Exclusion Criteria:

* Subjects who are unlikely to comply with protocol, e.g., uncooperative attitude, inability to return for the final visit
* Subjects currently being treated with biphasic insulin aspart 30 or insulin detemir
* Subjects who were previously enrolled in this study
* Subjects with a hypersensitivity to biphasic insulin aspart 30 or insulin detemir or to any of the excipients
* Women who are pregnant, breast feeding or have the intention of becoming pregnant within next 6 months