cyrilzakka/clinical-trials huggingface dataset:
The Isthmus Logic Post Market Clinical Follow-up Study

Isthmus Logic Carbostent™ is a CE-marked cobalt chromium stent with a bio inducer surface for the treatment of peripheral iliac artery disease.

The aim of this post-market retrospective study protocl P22202 is to collect clinical data of patients treated with Isthmus Logic for the treatment of peripheral iliac artery disease in routine clinical practice.

In order to obtain long-term follow-up data, the data collection will be limited to patients that have been treated with these devices at least 12 months prior to the study start.

The objective of this post-market study is to systematically collect retrospective clinical data on the implantable medical device Isthmus Logic in the daily clinical practice in an unselected population treated within the intended use. Data will be collected via medical chart review in anonymous form to assess the safety and efficacy of Isthmus Logic. The Isthmus Logic Carbostent™ stent is made of cobalt chromium alloy and is coated with iCarbofilm™, a thin carbon film with a high-density turbostratic structure substantially identical with that of the pyrolitic carbon used for mechanical cardiac valve discs. Coating the substrate provides it with the bio- and haemocompatible characteristics of pyrolitic carbon, without affecting the physical and structural properties of the substrate itself.

Two radio-opaque platinum markers at either end of the stent allow for accurate positioning over the lesion to be treated.

Eligibility Criteria:
Inclusion Criteria:

* Patient has been implanted with at least one Isthmus Logic stent according to the indications described in the Instructions for Use (IFU).
* Study device implantation date is at least one year (12 months) prior to the starting date of the retrospective anonymous data collection.

Exclusion Criteria:

* Patients treated less than 12 months prior to study start
Gene Therapy in Subjects With Biallelic RPE65 Mutation-associated Retinal Dystrophy

The goal of this clinical trial is to evaluate the safety, tolerability and efficacy of subretinal administration of FT-001 in subjects with biallelic RPE65 mutation-associated retinal dystrophy.

This study is a multi-center, open-label, phase I/II clinical study to evaluate the safety, tolerability, efficacy, immunogenicity, and in vivo biodistribution characteristics of FT-001 in subjects with biallelic RPE65 mutation-associated retinal dystrophy. Assessments will include visual acuity, vector shedding, immunogenicity and adverse events. Participants will be monitored for 5 years after treatment.

Eligibility Criteria:
Inclusion Criteria:

1. Subjects who are able to understand and sign the ICF
2. Female or male aged 8-45 years old when signing the ICF
3. Clinically diagnosed with biallelic RPE65 mutation-associated retinal dystrophy

Exclusion Criteria:

1. Other interfering eye diseases
2. Presence of any systemic or ocular disease that can cause or likely to cause vision loss
3. There is evidence of obviously uncontrolled concomitant diseases
4. Known to have active or suspected autoimmune diseases
5. With active systemic infection under treatment
6. Pregnant or lactating women
7. Other conditions unsuitable for the study as determined by the investigator
Comparison of Tuohy Needle and Quincke Needle During Caudal Epidural Injection

Park et al. reported the results of a randomized study of the use of ultrasound and the use of C-arm in caudal epidural block. However, it is difficult to determine the overall epidural space contrast agent spread with ultrasound alone, and intravascular injection can be avoided with ultrasound. It was said that the evidence for the efficacy of exclusion of intravascular infusion was not as good as that of the C-arm. Therefore, it was suggested that ultrasound in caudal epidural block should be considered only when it is difficult to use the C-arm as an auxiliary means to guide the needle when the sacral hiatus is less than 2 mm and has a complex anatomical structure. The purpose of this study is to determine the difference between intravascular injection and epidural spread according to the type of needle during caudal block under ultrasound guidance.


Eligibility Criteria:
Inclusion Criteria:

1. A patient who visited the pain clinic complaining of lower back pain due to lumbar disc/stenosis
2. When NRS of back and/or radiating pain is 4 or more
3. Patients over 19 years of age

Exclusion Criteria:

1. Malignancy
2. Systemic infection
3. Bleeding tendency
4. Contrast Allergy
5. Pregnant women
6. If you cannot read or agree to the consent form
7. If you cannot sign the consent form yourself
Treatment of Stress Urinary Incontinence by Injection of Autologous Muscle Fibers Into the Urethral Sphincter.

This pilot study examines safety and efficacy of a simple procedure for treatment of stress urinary incontinence. A muscle biopsy is taken from the thigh, minced and injected into the urethral sphincter.


Eligibility Criteria:
Inclusion Criteria:

* Stress urinary incontinence refractory to conservative treatment.

Exclusion Criteria:

* urge urinary incontinence
* Pregnancy
* Pelvic organ prolapse \> grade 1
Multicenter Database of Patients With Germ Cell Tumor

Retrospective and prospective cohort of patients with germ cell tumor in treatment.

The primary objective of this study is to create a multicenter database in order to characterize epidemiologically and clinicopathologically patients with germ cell tumor and evaluate the prognosis and clinical outcomes during cancer treatment.

Eligibility Criteria:
Inclusion Criteria:

* Male patients with diagnosis of testicular, retroperitoneum or mediastinal primary tumor.
* Histological confirmation of germ cell tumor or clinical condition based on the elevation of tumor markers (AFP, HCG e/ou DHL) associated to testicular mass or/and retroperitoneal lymphnode enlargement or/and mediastinal mass.
* Medical records of the disease and treatment

Exclusion Criteria:

* Female patients diagnosed with ovary germ cell tumor
* Male patients diagnosed with germ cell tumor in other locations.
Study to Evaluate the Effect of Delafloxacin on the Pharmacokinetics of Midazolam in Healthy Subjects

The purpose of this study is to evaluate the effect of repeated doses of oral delafloxacin on the pharmacokinetic (PK) profile of a single oral dose of midazolam.

This study will evaluate the effect of repeated doses of oral delafloxacin on the PK profile of a single oral dose of midazolam. The study will also evaluate the pharmacokinetics, safety, and tolerability of repeated oral doses of delafloxacin in healthy male and female subjects and to obtain a steady state PK profile for oral delafloxacin.

Eligibility Criteria:
Inclusion Criteria:

* No clinically important abnormal physical findings.
* No clinically significant laboratory abnormalities.
* Normal (or abnormal but not clinically significant) ECG measurements.
* Body mass index between 18.0 and 32.0 kg/m2.
* Normal (or abnormal but not clinically significant) blood pressure and pulse rate measurements. methylxanthine-containing beverages or food
* Non-smoker

Exclusion Criteria:

* Received any investigational drug within 8 weeks before administration of the first dose of the study drug
* Female who is pregnant, has a positive pregnancy test, or is breastfeeding.
* Positive test result for amphetamines, barbiturates, benzodiazepines, cocaine metabolites, opiates, cannabinoids, methylenedioxymethamphetamine, cotinine, or alcohol in urine at Screening or Day -1.
* Positive screening test for hepatitis B surface antigen, hepatitis C, and/or human immunodeficiency virus antibodies.
* Any surgical or medical condition that, in the judgment of the investigator, might interfere with the absorption, distribution, metabolism, or excretion of the drug.
* Used any medication (prescription or over-the-counter, including health supplements and herbal remedies, with the exception of acetaminophen, as defined in exclusion number 8) within 2 weeks (4 weeks for drugs or substances known to inhibit or induce CYP enzymes and/or P-gp including St. John's wort \[Hypericum perforatum\]) or 5 half-lives (whichever is longer) before the first dose of study drug.
* Used an oral or IV antibiotic within 4 weeks of administration of the first dose of the study drug.
* Routinely or chronically used more than 2 g of acetaminophen daily.
* Performed strenuous activity, sunbathing, and/or contact sports within 96 hours (4 days) before entry into the clinical study site on Day -1, and for the duration of the study.
* Donated or lost greater than 400 mL of blood in the 30 days before administration of the first dose of the study drug.
* History of clinically significant GI disease, or gastroenteritis (vomiting or diarrhea) or any history of GI bleeding (excluding bleeding from hemorrhoids)
* History of any significant drug allergy
* History of any drug or alcohol abuse in the past 2 years
Study of Durvalumab + Tremelimumab With Chemotherapy or Durvalumab With Chemotherapy or Chemotherapy Alone for Patients With Lung Cancer (POSEIDON).

This is a randomized, open-label, multi-center, global, Phase III study to determine the efficacy and safety of durvalumab + tremelimumab combination therapy + Standard of care (SoC) chemotherapy or durvalumab monotherapy + SoC chemotherapy versus SoC chemotherapy alone as first line treatment in patients with metastatic non small-cell lung cancer (NSCLC) with tumors that lack activating epidermal growth factor receptor (EGFR) mutations and anaplastic lymphoma kinase (ALK) fusions.

Adult patients with a histologically or cytologically documented metastatic NSCLC, with tumors that lack activating EGFR mutations and ALK fusions, are eligible for enrollment. Patients will be randomized in a 1:1:1 ratio to receive treatment with durvalumab + tremelimumab combination therapy + SoC chemotherapy, durvalumab monotherapy + SoC chemotherapy, or SoC chemotherapy alone. Tumor evaluation scans will be performed until objective disease progression as efficacy assessment. All patients will be followed for survival until the end of the study. An independent data monitoring committee (IDMC) composed of independent experts will be convened to confirm the safety and tolerability of the proposed dose and schedule.

Eligibility Criteria:
Inclusion Criteria:

For inclusion in the study, patients should fulfill the following criteria:

1. Aged at least 18 years.
2. Histologically or cytologically documented Stage IV NSCLC.
3. Confirmed tumor PD-L1 status prior to randomization.
4. Patients must have tumors that lack activating EGFR mutations and ALK fusions.
5. No prior chemotherapy or any other systemic therapy for metastatic NSCLC.
6. World Health Organization (WHO)/Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
7. No prior exposure to immunemediated therapy, excluding therapeutic anticancer vaccines.

Exclusion Criteria:

Patients should not enter the study if any of the following exclusion criteria are fulfilled:

1. Mixed small-cell lung cancer and NSCLC histology, sarcomatoid variant.
2. Active or prior documented autoimmune or inflammatory disorders.
3. Brain metastases or spinal cord compression unless the patient's condition is stable and off steroids.
4. Active infection including tuberculosis, hepatitis B, hepatitis C, or human immunodeficiency virus.
Effectiveness Transfer Energy Capacitive and Resistive Therapy in Patients With Carpal Tunnel Syndrome

Objective: The aim of this study was to evaluate the effect of Transfer Energy Capacitive and Resistive (TECAR) therapy on pain, symptom severity and function in patients diagnosed with carpal tunnel syndrome (CTS) based on clinical and electromyography (EMG) findings and to compare it with ultrasound therapy (US).

Methods: A total of 42 patients aged between 18 and 65 years, were randomly divided into two groups; group 1, US therapy 5 minutes intermittently for 2 weeks, 5 times a week, for a total of 10 sessions, group 2 TECAR therapy 5 min capacitive (CAP) and 10 min resistive (RES), 3 days a week for 2 weeks, for a total of 6 sessions. Both groups received paraffin therapy and wrist orthosis. All Patients were evaluated using the Visual Analog Scale (VAS) for pain and paresthesia levels, the Boston Carpal Tunnel Questionnaire (BCTQ) for symptom severity and functional levels. Additionally, median nerve CSA was measured by ultrasound, at the baseline, post-treatment, first and third months.


Eligibility Criteria:
Inclusion Criteria:

* 18 years of age and over
* had pain and numbness in their hands for more than 3 months were evaluated
* Patients diagnosed with mild and moderate CTS by EMG

Exclusion Criteria:

* metabolic, rheumatic, or neurological diseases that could affect the median nerve cross-sectional area (CSA)
* patients who had previously undergone surgery on the wrist,
* oncology patients,
* pregnancy,
* pacemakers.
Study of Incidence of Drug-induced Upper Gastrointestinal Bleeding

The purpose of this study is to determine and analyse the incidence, severity, risk factors and routine management of acute drug-induced upper gastrointestinal bleeding (UGIB) in the population of Russian patients


Eligibility Criteria:
Inclusion Criteria:

* Established diagnosis of acute upper gastrointestinal bleeding, confirmed by presence of hematemesis/ coffee ground vomiting, melena, as well as other clinical or laboratory evidence of acute blood loss from the upper gastrointestinal tract
* Written informed consent provided prior the start of participation in the study.

Exclusion Criteria:

* Subjects who are unwilling or unable to provide informed consent.
AUTOANTIBODIES AND SYSTEMIC SCLEROSIS

Established in vitro assays, combined with state-of-the-art multi-omics approaches and innovative in vitro experimental models, will gain insights into the mechanistic bases underlying Systemic Sclerosis (SS) pathogenesis and will dissect the consequences of treatment with Efgartigimod on functional and phenotypic cell behaviors. Healthy microvascular endothelial cells, fibroblasts and monocytes will be challenged with serum and autoantibodies prior to or upon treatment with Efgartigimod in order to assess both the prevention and the recovery capacity of the FcR blocker. The putative modulatory effect of Efgartigimod on vascular remodeling, endothelial-to-mesenchymal transition, fibroblast-to-myofibroblasts transition and monocyte behavior will be evaluated in in-vitro consolidated assays. Integrated Omics analyses will support and complement the in vitro findings by unveiling potential prognostic signatures and by identifying specific treatment-related profiles that might guide the modulation of the drug usage in order to maximize its beneficial effects.


Eligibility Criteria:
Inclusion Criteria:

* positivity of autoantibodies

Exclusion Criteria:

* pregnant
A Study Investigating the Efficacy and Safety of Sepranolone in Women With Menstrual Migraine

The objective of this phase 2 Proof.of Concept study is to evaluate the efficacy and safety of Sepranolone (UC1010) in preventing menstrual migraine attacks in adult women with migraine occurring between Day -2 and Day 5 of the menstrual cycle. Patients will be taking Sepranolone or Placebo (blinded to patient and study doctor) during the two week preceding the menstruation for three menstrual cycles. Effect (change from baseline) will be assessed by comparison of symptoms recorded daily by the patients using an electronic diary using validated scales for assessment of menstual migraine symptoms.

Sepranolone is identical to an endogenous steroid.

The objective of this phase 2 Proof-of-Concept study is to evaluate the effect and safety of two doses of Sepranolone (UC1010) in preventing menstrual migraine attacks in adult women with migraine occurring between Day -2 and Day 5 of the menstrual cycle in comparison to placebo. Study treatment will be self-administrated as subcutaneous injections during the luteal phase of three consecutive menstrual cycles. Effect will be assessed by comparison of symptoms recorded daily by the patients using an electronic migraine diary and a validated rating scale for assessment the physical and functional impact of menstrual migraine symptoms (MPFID). Preceding the treatment period, the diagnosis of Menstrual Migraine will be established by verifying menstrual migraine in at least two out of three menstrual cycles of daily symptom ratings by the patients. This period will also constitute the baseline data. The effect of study medication will be assessed as the change in symptoms from baseline to during treatment. The reduction in average number of menstrual migraine days per menstrual cycle during the treatment period cycles vs. the three menstrual cycles of baseline will constitute the primary endpoint.

The study will also include a follow-up (no treatment) cycle before patients final visit.

The study is conducted in three European countries (Sweden, Finland and Denmark) and will randomize 84 patients.

Eligibility Criteria:
Inclusion Criteria:

* have Menstrual Migraine according to the International Classification of Headache Disorders, 3rd edition (ICHD-3) verified in three menstrual cycles
* have a regular menstrual cycle of 24-35 days cycle,
* use double barrier contraception, intrauterine device (IUD), be truly sexually abstinent, or subject or her partner has been surgically sterilized,

Exclusion Criteria:

* More than 10 headache days per month on average during screening phase
* steroid hormonal treatment during previous three months
* ongoing treatment with antiepileptic drugs or benzodiazepines
* significant medical or psychiatric condition
* be pregnant or plan a pregnancy within the study period
Impact of Early Goal-directed Fluid Therapy in Septic Patients Undergoing Emergency Surgery

This study wants to compared the safety and efficacy of GDTs using standard pressure-related parameters vs. dynamic hemodynamic indices associated with fluid compartment monitoring, in septic patients requiring emergency surgery.


Eligibility Criteria:
Inclusion Criteria:

* Adults \> 18 years
* Severe sepsis\* as defined by the ACCCP/SCCM consensus conference
* Need for emergent interventional procedure under general anesthesia with an expected duration \> 120 min (in and out patients).

Exclusion Criteria:

* Patients responding to early fluid resuscitation (20ml/kg) who don't require a CVC
* Neurotrauma (Glasgow Coma Score \< 12) and/ or medullar trauma
* Known pregnancy or diagnosed by US or Ct-scan (\> 14 weeks)
* Sustained cardiac arrhythmia (see Logbook P8)
* Known or diagnosed severe cardiac valvular dysfunction (stenosis, insufficiency) (see Logbook P8)
* Known or diagnosed intracardiac shunt: interventricular or atrial defect (see Logbook P8)
* Burn injury \> 10%
* Needed emergency thoracotomy or ABC resuscitation protocol
* Pre-existing severe liver dysfunction(Child-Pugh class C)
* Do-not-resuscitate order, died within 48h of admission
Reducing the Risk of Phlebitis From Peripheral Venous Catheter

Nurses frequently use peripheral venous catheters in hospitals to provide medications and fluids for therapeutic and diagnostic purposes. Peripheral venous catheter use brought various problems, including phlebitis, infiltration, extravasation, ecchymosis, thrombophlebitis, and embolism, in addition to being a regularly utilized nursing practice. The literature used techniques like heat application, fist clenching, and proximal massage to lower the risk of thrombophlebitis and associated problems.

Between October and November 2022, individuals who received orthopedic care at a state hospital and had peripheral venous catheters participated in the trial as a randomized controlled experimental study. The control group received routine nursing care, while the experimental group received proximal massage and palm fist exercises. The numbers used to identify the control and experimental groups were drawn at random from a table of random numbers, and each group had 36 patients. The researcher used the "Patient Information Form," "Plebitis Risk Scale Due to Peripheral Venous Catheter," and "Plebitis Diagnostic Scale" to collect data using in-person interviews and observational methods. The p value for statistical significance is p\<0.05. Proximal massage: For a total of 5 to 10 minutes, twice daily for 4 days, between 30 seconds- 1 minute in sessions of approximately 20 strokes, a light massage is administered utilizing the palm surfaces of the fingers. Under the researcher's supervision, participants in the activity known as fist clenching squeeze a soft palm ball 20 times in each of twice a day for four days, lasting between 30 Seconds - 1 minute.

Eligibility Criteria:
Inclusion Criteria:

* Patients who volunteered to participate in the study,
* Who are over 18 years old,
* Having no barriers to written and verbal communication in Turkish,
* IV treatment was applied during the hospitalization period and IV treatment was recently started,
* Patients with IV cannula in the upper extremity
* In the last six months before hospitalization, IV treatment was not applied,
* A maximum of 2 IV attempts should be made on a patient.
* Patients without chronic dermatological and/or vascular disease.

Exclusion Criteria:

* Patients who did not volunteer to participate in the study, unconscious patients,
* IV attempts were made to the same patient more than 4 times in total,
* Patients with IV cannula in the lower extremity.
Feasibility of a Multi Site RCT to Establish the Effectiveness of a Health Behaviour Change Intervention for Patients With Peripheral Arterial Disease (PAD).

The purpose of this study was to evaluate the feasibility of conducting a randomised controlled trial (RCT) comparing brief psychological intervention to help patients with Peripheral Arterial Disease (PAD), reduce cardiovascular risk factors compared to control/treatment as usual in a vascular outpatient clinic. Trial feasibility was defined as the successful recruitment and retention of participants, adherence to the intervention, identification of barriers to the intervention and collection of clinical and quality of life outcome data. Qualitative data was collected to evaluate participant experience and the clinical impact of a supported self-management intervention delivered in a routine clinical setting.

The aim of this study was to assess the feasibility of conducting a definitive multi-centre trial of a specially designed health behaviour change intervention delivered in a secondary care outpatient clinic to improve the primary clinical outcome of functional walking ability This feasibility study, based on the MRC framework for assessing feasibility and piloting methods, will assess the relative strengths and weaknesses of the intervention and study design, as well as pave the way for a larger and more definitive trial.

Eligibility Criteria:
Inclusion Criteria:

* Adults over the age of 18 years
* Newly diagnosed with PAD resulting in claudication in one or both legs
* Reduced Ankle Brachial Index (ABI \< 0.80).

Exclusion Criteria:

* Patients with an ABPI of less than 0.35, with rest pain or tissue loss were excluded and classified as cases of critical limb ischaemia requiring revascularisation.
* Severe mental health problems such as severe depression with suicidal ideation, psychosis, personality disorder
* Terminal illness
* Patients for whom it would be medically unadvisable to increase their daily walking (including heart failure, cancer, exercise induced asthma, unstable angina. Inability to walk unaided, history of orthopaedic surgery or significant bony disease impacting upon their mobility).