cyrilzakka/clinical-trials huggingface dataset:
Observational Study to Estimate the Rates of Outcomes in Patients Undergoing Percutaneous Coronary Intervention (PCI) With Drug Eluting Stent (DES) Implantation Who Take Statins

To estimate the rates of percutaneous coronary intervention (PCI) outcomes in patients after drug-eluting stents implantation who take statins.


Eligibility Criteria:
Inclusion Criteria:

* Stable angina with indication to PCI
* Hospitalization to Russian Cardiological Research Center (РКНПК) for PCI procedure with drug-eluting stents implantation
* Statin therapy initiated for at least one month prior to PCI
* Written informed consent provided prior the start of participation in the study.

Exclusion Criteria:

* Subjects who are unwilling or unable to provide informed consent.
* Presence of ACS during the current hospitalization
* Severe CHF (NYHA III/IV) or LVEF\<40 %
* Stroke within 6 months before PCI
* Acute or chronic inflammatory disease
* Anti-inflammatory medications intake, with the exception of aspirin
* Severe liver or muscle disease
* Severe kidney disease / renal failure with creatinine \> 3 mg/dl
* History of oncologic disease
* Conceivable impossibility to come in touch with the patient or his family at 1-year after the intervention
Effects of a 24/7 Palliative Care Service Integration in a Metropolitan Area on Non-oncologic Patients

This retrospective observational pre-post study aims to test the effects of introducing a remote telephonic consultation availability from the Palliative Care Service for a cohort of non-oncologic patients followed by the same service, their relatives, and the Emergency Medical Services (EMS) and family care physicians taking care of them.

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

* Does the introduction of a remote telephonic consultation availability affect the rate of ED access of non-oncologic Palliative-care followed patients during their last 90 days of life?
* Does the introduction of a remote telephonic consultation availability have an effect on the rate of EMS requests for these patients during their last 90 days of life?
* Which are the main topics of the calls to the Palliative Care Service?

Due to the emergence of COVID-19 pandemic during the study period, a parallel cohort of oncologic patients under 24/7 palliative care by the same service during both the observation periods will be used as reference.

Participants will be followed up from the date of taking-over request to the Palliative Care Service to their death or the end of the period of observation if followup began during their last 90 days of life.

Otherwise, for those being already under home palliative care at the 90th day before their death, follow up will begin at that day.

Researchers will compare two time periods to see if the introduction of a remote telephonic consultation availability has an effect on the supra-mentioned aims.


Eligibility Criteria:
Inclusion Criteria:

* Patients followed by the Metropolitan Palliative Care Service of Bologna
* Residency in Bologna Metropolitan city

Exclusion Criteria:

* Incomplete data
* Residency outside Bologna Metropolitan City
Thrombolysis in STEMI Patients Compared With pPCI on Recanalization Time in the Context of the COVID-19 Outbreak.

During the outbreak of COVID-19, for patients with acute ST-segment elevation myocardial infarction with unclear infection, the time of primary PCI is uncertain, and it is often expected to exceed 90 minutes or even 120 minutes. In indicated patients, intravenous thrombolysis has significantly improved the recanalization time of criminal vessels.

During the outbreak of COVID-19, for patients with acute ST-segment elevation myocardial infarction with unclear infection, the time of primary PCI is uncertain, and it is often expected to exceed 90 minutes or even 120 minutes. In indicated patients, intravenous thrombolysis has significantly improved the recanalization time of criminal vessels. The purpose of this study was to compare the time from first medical contact to patency and safety (specifically symptom improvement, ECG ST segment) between intravenous thrombolysis and concurrent patients with possible primary PCI in a prospective, multicenter, non-randomized controlled manner. Significant fall, angiographic examination showed criminal blood vessel TIMI blood flow grade 2-3)

Eligibility Criteria:
Inclusion Criteria:

* ECG confirms acute ST-segment elevation myocardial infarction；The estimated time from FMC to recanalization is more than 120 minutes；

Exclusion Criteria:

* Intracranial hemorrhage or stroke within the past 6 months; central nervous system injury, tumor or arteriovenous malformation; bleeding disease with known cause; suspected aortic dissection; non-compressible puncture surgery within 24 hours, etc.; 1 week of pregnancy or postpartum; uncontrolled hypertension; advanced liver disease; active peptic ulcer; prolonged or invasive CPR;
Turoctocog Alfa in Haemophilic Italian Patients: Protection and Engagement in Recreational Activities

This is a study on Italian patients with haemophilia A in prophylaxis treatment with Turoctocog alfa under routine clinical conditions. The purpose of the study is to investigate the therapeutic scheme in a population of patients treated with Turoctocog alfa and to investigate the participation in recreational activities, the level of physical activity, and quality of life. Participants will get NovoEight® (Turoctocog alfa) as prescribed to them by the study doctor. The study will last for about 12 months. Participants will be requested to fill in the Questionnaires investigating the participation in recreational activities, the level of physical activity, and quality of life.


Eligibility Criteria:
Inclusion Criteria:

* Informed consent obtained before any study-related activities. Study-related activities are any procedures that are carried out as part of the study, including activities to determine suitability for the study.
* Male or female, age above or equal to 12 years at the time of signing informed consent.
* Haemophilia A (any severity), needing prophylactic therapy (with the usual recommended doses).
* Decision to treat with turoctocog alfa, made by the treating Physician and the subject/Legally Acceptable Representative (LAR) based on local label before and independently from the decision to include the subject in this study.

Exclusion Criteria:

* Previous participation in this study, defined as previously signed informed consent;
* Presence of other coagulation disorders;
* Presence of any inhibitor;
* Mental problems, poor compliance, linguistic barriers or other conditions which can impede the understanding of the study aims and the participation to it.
The Effect of Local Anaesthesia Technique on the Recovery After Dental Treatment in General Anaesthesia

Use of local anaesthesia during full mouth dental rehabilitation under general anaesthesia is an everyday practice. It enables better control of the post-extraction bleeding and better control of physiological responses. Postoperative numbness and lip and cheek biting can be an undesired side effect. With our research, we aim to compare two different types of local anaesthesia in relation to postoperative side effects. We also aim to assess the oral health-related quality of life after treatment in general anaesthesia to enlighten how full mouth rehabilitation affects a child's life.

Dental treatment of children under general anaesthesia (GA) is intended for children who, for one reason or another, are unable to participate in the outpatient clinic.

When extracting teeth in GA, local anaesthetics (LA) are regularly applied to control bleeding, reduce postoperative sensitivity, and to better control vital functions. The side effects of LA can be the patient's irritation due to not understanding the postoperative numbness and lip and cheek biting.

The aim of our study is to determine if there is a difference between the two types of local anaesthesia (computer-controlled intraosseous anaesthesia and classical local/conductive anaesthesia) in the frequency and extent of the occurrence of side effects postoperatively.

The research data would help establish a better dental extraction protocol for children under GA, which would allow for less postoperative complications.

Eligibility Criteria:
Inclusion Criteria:

- Paediatric patients intended for dental treatment in general anaesthesia

Exclusion Criteria:

* Patients who can not express feelings adequately,
* patients where there will not be any teeth extracted,
* patients whose parents do not want to participate in the study
Outcome After Laparoscopic Surgery for Peptic Ulcer Perforation

Despite advances in laparoscopic surgery for perforated peptic ulcer (PPU), intra-abdominal abscess (IAA) is recognized as one of the commonly reported complications with relation to the extent of infectious abdominal contamination. Herein, the investigators report their experience of laparoscopic surgery for PPU with/without peritoneal irrigation and discuss postoperative outcome. The investigators retrospectively examined the electronic medical records of the patients who underwent laparoscopic surgery for perforated peptic ulcer at a single medical center in Taiwan between January 2013 and August 2021. Retrospectively, the investigators would include those patients with clinical diagnosis of PPU who underwent emergent laparoscopic surgery. The patients with previous abdominal surgery, pathologic confirmed malignant ulcer perforation or concomitant ulcer bleeding were excluded. The investigators focused on post-operative complications and outcome after laparoscopic surgery with or without peritoneal irrigation. This information can be important in improving surgical options with respect to risk and potential benefits in this setting.


Eligibility Criteria:
Inclusion Criteria:

* The patients with clinical diagnosis of PPU underwent laparoscopic repair surgery.

Exclusion Criteria:

* The patients received surgery in an open approach or underwent laparoscopy initially but then intraoperatively converted to laparotomy.
Coexisting Thyroid Disease and Hyperparathyroidism

Purpose: Prospective studies of patients with hyperparathyroidism are warranted to determine the prevalence of concurrent thyroid disease applying the current standard of pre-operative radioscintigraphic and sonographic imaging of the neck. Timely diagnosis and treatment of co-existing thyroid disease is advantageous given the well-established increased morbidity associated with a second neck exploration. The purpose of this study is to determine the prevalence and specific type of thyroid disease in patients with hyperparathyroidism, and to determine the frequency with which the presence of thyroid disease alters the treatment plan for patients with hyperparathyroidism.

Research Design: This will be a prospective single arm observational study of up to 200 military health care beneficiaries over the age of 18 years with primary and secondary hyperparathyroidism scheduled to undergo parathyroid resection.

Methodology: Patients will undergo standard pre-operative imaging of the neck including ultrasonography and 99mTc-sestamibi scintigraphy. An operative plan will be developed based on the information obtained from history, physical examination, laboratory studies, and imaging studies. The number and type of thyroid disease in these patients will be determined based on these non-invasive studies (Objective A). A change in the otherwise standard treatment will include those patients having partial or complete resections of their thyroid glands because: a) the patients would have undergone minimally invasive surgery if not for the results of the imaging studies, and, b) the patients who would have undergone 3 ½ gland parathyroidectomy if not for the results of the imaging studies (Objective B).


Eligibility Criteria:
Inclusion Criteria:

Patients with hyperparathyroidism and appropriate indications for operation

* Patients over 18 years of age and capable of providing informed consent
* Each patient must provide written informed consent prior to entering the study.

Exclusion Criteria:

* Patients who have previously undergone thyroid or parathyroid operation
* Patients with medullary thyroid carcinoma and hyperparathyroidism or suspected multiple endocrine neoplasm syndrome
Long-term Epidemiological Follow-up of Non-small Cell Lung Cancer in Scandinavia

A study to describe and evaluate patient characteristics and clinical outcomes in Subjects with diagnosed Non Small Lung Cell Cancer in Sweden, Norway and Denmark.


Eligibility Criteria:
Inclusion Criteria:

Patients with a histologically confirmed diagnosis of NSCLC (squamous, adenocarcinoma, not otherwise specified NSCLC \[NSCLC NOS\]) identified in the Cancer registers

Exclusion Criteria:

* Age under 18 years at time of diagnosis
DDI Study of Evobrutinib and Carbamazepine

The purpose of this study is to investigate the effect of multiple doses of carbamazepine on two single doses of evobrutinib pharmacokinetics (PK) in healthy participants. Study details include:

Study Duration: up to 54 days. Treatment Duration: 25 days. Visit Frequency: Participants will be resident in the Clinical Research Unit from Day 1 to Day 20 and return on Day 26 for a Safety Follow-Up visit.


Eligibility Criteria:
Inclusion Criteria:

* Type of Participant and Disease Characteristics
* Have a body weight within 50.0 and 100.0 kg (kilogram) (inclusive) and Body Mass Index (BMI) within the range 19.0 and 30.0 kilogram per meter square (kg/m\^2) (inclusive)
* Male: No contraception and barrier requirements needed. Female: Is not a woman of childbearing potential
* Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the Informed Consent Form (ICF) and this protocol
* Are stable nonsmokers for at least 3 months preceding Screening

Exclusion Criteria:

* History or presence of clinically relevant respiratory, gastrointestinal, renal, hepatic, hematological, lymphatic, neurological, cardiovascular, musculoskeletal, genitourinary, immunological, dermatological, connective tissue, psychiatric (due to rare risk of hallucinations, agitation and activation of psychosis), and other diseases or disorders, and epilepsy, as determined by medical evaluation
* Administration of live vaccines or live-attenuated virus vaccines within 3 months prior to Screening. Administration of other types of vaccines (e.g., SARSCoV2 vaccines) is allowed until 2 weeks before admission to Clinical Research Unit (CRU), thereafter it is prohibited until the end of the study
* Moderate or strong inhibitors or inducers of Cytochrome P450 (CYP)3A4/5 or Pgp within 4 weeks prior to the first administration of study intervention
* Contraindication to carbamazepine (carbamazepine SmPC)
* History of any malignancy
* History of drug hypersensitivity ascertained or presumptive allergy/hypersensitivity to the active drug substance and/or formulation ingredients; history of serious allergic reactions leading to hospitalization or any other hypersensitivity reaction in general, including contact hypersensitivity to Electrocardiogram (ECG) electrodes, which may affect the safety of the participant and/or outcome of the study per the Investigator's discretion.
* Other protocol defined exclusion criteria could apply.
Natural Matrix Protein™ (NMP™) in Interbody Lumbar Fusion

The objective of this study is to evaluate the performance of Induce Biologics NMP™ when used to promote interbody fusion for degenerative disease of the lumbar spine.

The study involves a retrospective review of patients' medical records and prospective collection of CT scans, X-rays, and patient centered outcome questionnaires.

The study population will include up to 135 patients of the Spine Institute of Louisiana (SIL) who have been treated with Induce Biologics NMP™ during a lumbar interbody fusion. All subjects who meet all inclusion criteria and do not meet any exclusion criteria will be included in the study.

There will be a single Prospective Visit in this study. This visit will be scheduled at the 12-month (± 2 mo) post-surgery time point.

Eligibility Criteria:
Inclusion Criteria:

1. Have clinical or radiological evidence of degenerative disc disease of the lumbar spine.
2. Have been treated with Induce Biologics NMP™ during a lumbar spinal fusion procedure.
3. Be at least 18 years of age.
4. Have current contact information.
5. Be willing and able to provide written Informed Consent for the prospective part of study participation.
6. Be willing and able to undergo a CT-scan and X-rays.
7. Be willing and able to complete patient centered outcome questionnaires.

Exclusion Criteria:

1. Currently imprisoned.
2. Currently experiencing major mental illness (psychosis, schizophrenia, major affective disorder) which in the opinion of the investigator may indicate that the symptoms are psychological rather than of physical origin.
3. X-rays or CT-scan are contraindicated.
4. Any previous lumbar fusion or arthroplasty surgery at the index level(s)
Dorsal Penile Block for Post-Robotic Prostatectomy Foley Discomfort

The indwelling urethral foley is a major source of discomfort following radical prostatectomy. Our hypothesis is that intra-operative dorsal penile nerve block with bupivacaine may decrease immediate post-operative foley discomfort.

Patients undergoing robot-assisted radical prostatectomy (RARP) will be randomized in a double-blind placebo controlled manner to undergo penile ring block injection at the time of skin incision closure. A visual analog scale (VAS) based questionnaire including newly developed foley discomfort scores will be administered at various time points post-operatively.

Eligibility Criteria:
Inclusion Criteria:

* age 40 years and above,
* diagnosis of prostate cancer,
* electing to undergo robot-assisted radical prostatectomy

Exclusion Criteria:

* allergy to bupivacaine or amide-type local anesthetics,
* chronic pain condition,
* recently or currently on narcotics,
* genital abnormalities
A Prospective, Single-Arm Study to Evaluate the Efficacy and Safety of Zoladex 3.6mg Combined With CEF Chemotherapy as Neo-Adjuvant Therapy in Hormone Responsive, Premenopausal, Operable Breast Cancer

It has been found that many breast cancers are hormone dependent and that hormonal therapy by estrogen suppression such as ovarian ablation, tamoxifen and aromatase inhibitor has proven beneficial in both adjuvant and neoadjuvant settings. Zoladex, a kind of luitinizing hormone releasing hormone analogue, can offer efficient estrogen suppression as well. It can induce reversible amenorrhea and the clinical effect is similar to ovarian ablation. Some studies have demonstrated the efficacy of zoladex in treating pre and perimenopausal hormone dependent breast cancer in both adjuvant and metastatic settings. Few data is available on Zoladex in neoadjuvant treatment for breast cancer In our departments, neoadjuvant CEF regimen is of general practice, and a preliminary study is designed to investigate whether adding Zoladex into neoadjuvant CEF could further improve results in hormone responsive breast cancer.

It has been found that many breast cancers are hormone dependent and that hormonal therapy by estrogen suppression such as ovarian ablation, tamoxifen and aromatase inhibitor has proven beneficial in both adjuvant and neoadjuvant settings. Zoladex, a kind of luitinizing hormone releasing hormone analogue, can offer efficient estrogen suppression as well. It can induce reversible amenorrhea and the clinical effect is similar to ovarian ablation. Some studies have demonstrated the efficacy of zoladex in treating pre and perimenopausal hormone dependent breast cancer in both adjuvant and metastatic settings. Few data is available on Zoladex in neoadjuvant treatment for breast cancer In our departments, neoadjuvant CEF regimen is of general practice, and a preliminary study is designed to investigate whether adding Zoladex into neoadjuvant CEF could further improve results in hormone responsive breast cancer.

Eligibility Criteria:
Inclusion Criteria:

1. Provision of informed consent
2. Pathological confirmation of breast cancer
3. Tumor stage(TNM):T2-4bN0-3M0
4. ER(+) and/or PR(+).
5. Premenopausal woman.
6. Age≥40 years
7. Measurable disease as per RECIST criteria
8. Karnofsky≥70
9. Labratory criteria:

   * PLT≥100\*109/L
   * WBC≥4000/mm3
   * HGB≥10g/dl
   * ALT and AST\<2\*ULN

Exclusion Criteria:

1. Presence of metastatic disease.
2. Inflammatory breast cancer.
3. Bilateral breast cancer.
4. previous chemotherapy or hormonal therapyfor current breast neoplasm.
5. other malignant tumor (concurrent or previous).
6. Pregnant woman.
7. Hypersensitive to any drug in CEF regimen or any ingredient of Zoladex.
8. Any severe systemic disease contraindicating chemotherapy.
Efficacy of Pectoral Nerve Block for Breast Reduction Surgery

The purpose of the study is to evaluate the efficacy of PECS block applied to patients undergoing bilateral breast reduction surgery on postoperative analgesia compared to local infiltration anesthesia.

Pectoral nerve block (PECS block) has been developed as an alternative to thoracic paravertebral and/or thoracic epidural blocks in recent years. It is frequently applied for postoperative analgesia especially in breast cancer surgery and subpectoral breast prosthesis.

Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiology (ASA) I-II
* body mass index (BMI) ≤40 kg/m2
* elective bilateral breast reduction surgery

Exclusion Criteria:

* declining to give written informed consent
* ASA III and above
* under 18 years of age or over 65 years of age
* history of allergy against to the local anesthetics,
* controendication of peripheral block or local anesthetic infiltration (local infection, coagulopathy, etc.)
* history of breast surgery
* treatment due to psychiatric disorder
* history of treatment for a chronic pain
* history of nerve blocks in order to treat postoperative pain
CsA vs MMC for Preventing Pterygium Recurrence

aimed to compare the efficacy and safety of topical cyclosporin A (CsA) versus mitomycin C (MMC) as adjunctive therapies in preventing pterygium recurrence after surgical excision.

A total of 40 eyes from 40 patients undergoing pterygium surgery were randomized into two groups: Group A received topical cyclosporin A, while Group B was treated with topical mitomycin C. Ocular surface inflammation scores, recurrence rates, patient-reported symptoms, and adverse effects were assessed at baseline and during follow-up at 6 months postoperatively.

Eligibility Criteria:
Inclusion Criteria:

* Aged 18 years or older.
* Diagnosed with primary pterygium extending at least 1 mm onto the cornea.
* No prior history of pterygium surgery in the affected eye.

Exclusion Criteria:

* History of ocular surface diseases such as dry eye or Sjögren's syndrome.
* Active ocular infection.
* Known hypersensitivity to CsA or MMC.
* Systemic conditions requiring immunosuppressive therapy.
Phamacokinetics and Safety Profiles of DA-1229_01 5/1000mg in Healthy Subjects at Fasting State

This Phase I clinical study is to evaluate the safety/tolerability and pharmacokinetics of DA-1229_01 (5/1000 mg x1 tablets) at fasting state.


Eligibility Criteria:
Inclusion Criteria:

* Healthy Volunteers
* BMI between 18 and 30 kg/m2
* Body weight : Male≥50kg, Female≥45kg

Exclusion Criteria:

* Allergy or Drug hypersensitivity
* Clinically significant Medical History