cyrilzakka/clinical-trials huggingface dataset:
Study of Debio 1450 for Bacterial Skin Infections

The primary objective of this study is to evaluate the efficacy of 2 different doses of intravenous and oral Debio 1450 compared with intravenous vancomycin and oral linezolid in the treatment of patients with staphylococcal ABSSSI.


Eligibility Criteria:
Inclusion Criteria:

* Has clinically documented infection of the skin or skin structure suspected or documented to be caused by a staphylococcal pathogen
* Meets other protocol-specified criteria for qualification and contraception
* Is willing and able to remain confined in the study unit for the entire duration of each treatment period and comply with restrictions related to food, drink and medications
* Voluntarily consents to participate and provides written informed consent prior to any protocol-specific procedures

Exclusion Criteria:

* Has history or current use of over-the-counter medications, dietary supplements, or drugs (including nicotine and alcohol) outside protocol-specified parameters
* Has signs, symptoms or history of any condition that, per protocol or in the opinion of the investigator, might compromise:

  1. the safety or well-being of the participant or study staff;
  2. the safety or well-being of the participant's offspring (such as through pregnancy or breast-feeding);
  3. the analysis of results
A Study of QLF3108 in Participants With Advanced Solid Tumor

This study will evaluate the safety, tolerability, pharmacokinetics, and immunogenicity of QLF3108 and will make a preliminary assessment of the anti-tumor activity of QLF3108 in patients with advanced solid tumor.

This is a single-arm, open-label, Phase 1, dose escalation and Pharmacokinetics (PK) expansion study of QLF3108 in subjects with advanced solid tumor, to determine the dose-limiting toxicity (DLT), the maximum tolerated dose (MTD) and establish a recommended Phase 2 dose (RP2D) of QLF3108. The purpose of this study is to describe the safety and tolerability, assess pharmacokinetics parameters and immunogenicity, and assess the anti-tumor activity of QLF3108 in subjects with advanced solid tumor.

Eligibility Criteria:
Inclusion Criteria:

1. The volunteer has fully given informed consent to the study and voluntarily signed the informed consent form prior to trial.
2. ≥18 years old and body weight ≥40 kg; Female or male.
3. Histologically or cytologically documented advanced solid tumor;
4. Failed to standard therapy or intolerance, or lack standard therapy advanced solid tumors.
5. Eastern Cooperative Oncology Group（ECOG） performance status of 0 or 1.
6. Life expectancy of at least 12 weeks.
7. Adequate hematologic and end organ function.
8. Female subjects who are not pregnant or not breastfeeding. A negative blood pregnancy test for females of childbearing potential within 7 days prior to first dosing.
9. Male and female subjects of childbearing potential must agree to use highly effective method of contraception during the entire course of the study and within 180 days after the end of the study.

Exclusion Criteria:

1. Patients that have previously received cancer therapy within 4 weeks prior to the first dose of the investigational drug.
2. Patient has received other investigational drug or other clinical trial treatment within 4 weeks prior to the first dose of the investigational drug.
3. Active autoimmune disease that has required systemic treatment within 2 years prior to this study.
4. A live vaccine or live attenuated vaccine was administered within 30 days prior to the first dose of the investigational drug.
5. Patients with Adverse Events(AEs) from previous treatment that have not recovered to ≤1(CTCAE 5.0）; or are unstable status.
6. Severe concomitant medical condition for bowel obstruction, or implanted colon stent during screening period.
7. Patients with a history of HIV positive or other immunodeficiency. Or patients with the history of organ transplant or allogeneic bone marrow (excluding corneal transplantation).
8. Patients with a history of psychiatric disorders, or epilepsy or dementia, drug or alcohol abuse, may impact patient completion of the study.
9. Patients may interfere with the interpretation of study results as determined by the investigator, or are unable to participate in the whole study, or deemed unsuitable by the investigator.
Finnish AntiCoagulation in Atrial Fibrillation (FinACAF)

The aim of FINACAF study is to evaluate the incidence and risk of stroke, systemic thromboembolic events, myocardial infarction, major bleeding events, and mortality in relation to different attitudes regarding stroke prevention treatment among AF patients.

The study with cohort design is conducted as a nationwide retrospective register-based linkage study using data obtained from the Finnish health care registers.

Atrial fibrillation (AF) is the most common sustained arrhythmia, its prevalence increases with age, and it presents with a wide spectrum of symptoms and severity. It has been estimated that number of AF patients is about 150 000 in Finland, and this number will be increased at least two-fold until year 2050.

The aim of this study is to evaluate the incidence and risk of stroke, systemic thromboembolic events, myocardial infarction, major bleeding events, and mortality in relation to different attitudes regarding stroke prevention treatment among AF patients.

An important part of the study is also the assessment of cost effectiveness of different OAC therapies. The risks mentioned above are separately evaluated with different management levels of warfarin therapy as well as with different NOACs and in patients without OAC treatment. The study population is also characterized according to co-morbidity, interactive medications and antiarhythmic drugs in use.

The study with cohort design is conducted as a nationwide retrospective register-based linkage study using data obtained from the Finnish health care registers. The study cohort consists of patients from six hospital district areas having a diagnosis of AF. The catchment population of these six districts is about 3.5 million; 64 % of the total Finnish population 5.5 million.

The study is register-based and patients will not be contacted in any phase of the study. Thus, no patient consents will be needed according to Finnish legislation. All patient data handled by the researchers will anonymous, ensuring full data protection of the patients.

Eligibility Criteria:
Inclusion Criteria:

Subject has an International Classification of Diseases (ICD-10 version 10) diagnosis code I48 for AF during 1.1.2004-31.12.2018 in any of the used registries

Exclusion Criteria:

* No ICD-10 I48 diagnose in any of the study registries.
* Subjects with age below 18 years at index date
* Patients with permanent residence in Finland less than 12 months prior to index date.
The Effects of Kinesio Taping in Archery

The aim of the study is to investigate the effects of KT on archery athletes' performance.

Archery is a sport that requires strength, endurance, stabilization, and coordination of the upper body and shoulder girdle muscles. Kinesio taping (KT), which increased in popularity with the use in the athletes in the 2008 summer Olympics, is commonly investigated in the literature. KT is claimed to reduce pain and edema, increase functional performance, joint position sense, and blood-lymph flow, provide stability, and improve range of motion, flexibility, and strength. The aim of the study is to investigate the effects of KT on archery athletes' performance.

Eligibility Criteria:
Inclusion Criteria:

* To be archery in the elite category for at least 1 year
* Attending training sessions at least 2 days a week

Exclusion Criteria:

* Having any neurological problems
* Having a Turkish-speaking and reading disability
Study of Long-Acting Acetaminophen in Postoperative Dental Pain

The purpose of the study is to evaluate the efficacy and safety of acetaminophen ER 1500 mg (two 750 mg tablets) over 10 to 12 hours in the dental pain model following third molar extraction(s) and to evaluate the pharmacokinetics of acetaminophen ER 1500 mg (two 750 mg tablets) in a sub-group of subjects.


Eligibility Criteria:
Inclusion Criteria:

* Must be at least 17 and less than 46 years of age
* Must weigh at least 100 lbs with a body mass index of at least 18 and less than 30
* Scheduled to undergo surgical extraction of one impacted third molar from the lower jaw. The third molar from the upper jaw from the same side may also be removed.
* Experiencing moderate to severe pain after extraction of third molars.

Exclusion Criteria:

* Cannot be allergic to acetaminophen (Tylenol) or any non-steroidal anti-inflammatory drugs (e.g., Motrin, Advil, Aleve, Naproxen).
* Cannot be pregnant (or planning to be pregnant) or nursing a baby
* Unable to swallow whole large tablets or caplets.
* Cannot have any other medical conditions that the investigator feels may compromise your safety or the study results.
Trial on Postoperative Outcomes According to the Number of Trocar During Laparoscopic Appendectomy

Appendicitis is the most common benign inflammatory disease that requires an operation.

Laparoscopic appendectomy using three trocar is generally performed, and reveals good surgical outcomes incluing less pain, early recovey, cosmetic effect et al. However, with using three trocar, there are some problems including pain around trocar insertion sites(three portions), wound infecton and scar at trocar insertion sites. For these reasons, more minimal invasive appendectomy is required, with development of laparoscopic instrument,eventually one port sppectomy is developed. So, the investigators assess post-operative Outcomes according to the Number of Trocar.


Eligibility Criteria:
Inclusion Criteria:

* Appendicitis (clinical or radilogical diagnosis)
* ASA \< 4

Exclusion Criteria:

* Appendicitis with palpable mass( clinical or radilogical diagnosis)
* Patient has bleeding tendency
* Pregnant
The Efficacy and Safety of a Latest Dural Substitute

This prospective, multi-center, randomized, parallel-controlled clinical trial was designed to evaluate the efficacy and safety of Lyoplant Onlay in repairing cerebral dura mater. DURAFORM was regarded as the control group. a total of 80 patients were randomized into experimental and control group (1:1).Data were collected on complications resulting in CSF leaks, surgical site infections, instrument performance parameterized other neurological complications within 30 days. Surgeons also provided data on the ease of use of the dural sealing techniques, as well as preparation and application times. The above-mentioned date were used to evaluate the efficacy and safety of Lyoplant Onlay .


Eligibility Criteria:
Inclusion Criteria:

* Any patient between the ages of 18 and 75 years scheduled for elective cranial surgery involving a dural incision.
* Dural defects and surgical incision was classifed as level 1

Exclusion Criteria:

* local or systemic infection.
* patients with known allergy to Equipment components
* a history of traumatic head injury
* a compromised immune system or autoimmune disease
* patients who should not participate based on the surgeon's opinion
* patients participating in any other drug or device trial.
* expected survival time \<12 months
* underwent chemoradiotherapy 3 months before randomization
* uncontrolled diabetes and malignant tumor
* women who were pregnant, lactating, or wished to become pregnant during the study;
Clinical Study for the Treatment of Peripheral Nerve Defects With Neuromaix

The aim of this study is the development and initial clinical application of the nerve guide Neuromaix in humans to provide evidence for the safety and performance of the device.

Neuromaix is intended to be used as a guiding structure to bridge a peripheral nerve discontinuity, and to create a conduit for axonal growth across the nerve gap.

The Neuromaix nerve guide is an absorbable implant composed of porcine collagen, used to bridge a peripheral nerve discontinuity, and to create a conduit for axonal growth across the nerve gap. Neuromaix provides a protective environment for peripheral nerve regeneration after injury. Neuromaix connects the proximal and distal ends of a transected nerve, allowing regenerating axons to grow through the scaffold, into the distal nerve tissue towards the target muscle or skin.

Neuromaix is composed of two parts. The Epimaix part provides the structural characteristics needed to suture the nerve guide in place and to prevent ingrowth of scar tissue. The Perimaix part provides a structure that mimics endoneurial tubes, providing guidance for the regenerating axons while bridging the nerve gap.

Eligibility Criteria:
Inclusion Criteria:

* both genders in the age between 18 und 70 years
* patients who are scheduled for a nerve biopsy

Exclusion Criteria:

* alcohol-related polyneuropathy
* paraneoplastic polyneuropathy
* present: immunosuppressive therapy
* present: malignant tumor
* peripheral vascular diseases
* collagen diseases (e.g. existing keloid scars)
* patients with an increased wound healing disorder (e.g. diabetics)
* patients with chronic venous insufficiency (vein thrombosis, skin diseases)
* patients with coagulation and bleeding disorders (ASA- or Marcumar-patients)
* present: pregnancy
* HIV, Hepatitis B or Hepatitis C infection
Effect of Pulmonary Rehabilitation Program on Post Hospitalization Severe COVID- 19 Patients

COVID-19 infection was discovered to be the major global cause of a serious respiratory illness toward the end of 2019. The majority of COVID-19 patients experience mild disease, while about 14% go on to have severe disease and 6% end up in critical condition. An evidence-based standard of therapy called pulmonary rehabilitation includes exercise training, education, and behavior modification to help people with lung illness feel better physically and mentally.

The aim of the study to evaluate the effect of pulmonary rehabilitation program on severe post covid19 patients (post hospitalization) regarding pulmonary function tests and dyspnea score.

SARS CoV-2 infection has caused substantial death, morbidity, and unprecedented strain on the world's healthcare systems . When the illness is minor, it typically takes two weeks from the onset of symptoms till recovery, and when it is severe or critical, it may take three to six weeks. It should be mentioned that approximately 75% to 80% of hospitalized patients will remain there for more than 21 days .

After the virus is defeated, COVID-19 can have serious aftereffects on the patient, with bilateral pneumonia. As a result, physiotherapy is essential in this pandemic and will play a major role in helping many patients' health. A 20-30% reduction in pulmonary capacity has already been reported in recent studies .

Although pulmonary rehabilitation has been suggested following severe COVID-19, there is a lack of data showing effectiveness on recovery of physical and psychosocial parameters in severe COVID-19 patients following hospitalization.

The aim of the study is to evaluate the effect of pulmonary rehabilitation program on severe post covid19 patients (post hospitalization) regarding pulmonary function tests and dyspnea score.

50 patients were enrolled in the study post hospitalization due to severe COVID 19 infection. Dyspnea score, Spirometry and 6minute walk test were performed upon discharge. Pulmonary rehabilitation program was performed. Follow up assessment of the same parameters was done 6 weeks after the program.

These results were compared with another 50 patients who were admitted in hospital due to severe COVID 19 infection but no pulmonary rehabilitation program was performed to them after hospitalization.

Eligibility Criteria:
Inclusion Criteria:

* Age range between 50 and 70 years.
* Severe COVID infection.
* Impaired pulmonary function tests post COVID infection.

Exclusion Criteria:

* Mild or moderate COVID infection.
* Normal pulmonary function tests post COVID infection
* Chronic chest disease
* End organ failure (sever heart disease-neurodegenerative disease- sever stroke)
* Unstable angina, myocardial infarction, angioplasty, heart surgery in the previous 3 months
* Chronic renal impairments.
* Epistaxis, active haemoptysis
* Recent facial, oral, or skull surgery or trauma.
Groin Injuries in Finnish Contact Sports

The prevalence of acute and chronic groin injuries in athletes is between 5 and 10 %. This observational case-control study follows three contact sport teams (soccer, ice-hockey and bandy) for two years to find out the prevalence and reasons for groin pain. Clinical examination, pain scores and pelvic magnetic resonance imaging (MRI) are performed. Hip and groin questionnaire (HAGOS) is used to determine severity of groin injuries.

The prevalence of chronic groin pain in athletes and physically active adults is between 5 and 10 %. Common causes include adductor tendonitis, musculus rectus abdominis tendopathy, osteitis pubis (edema on MRI scans at pubic symphysis) or disruption of the posterior wall of inguinal canal or iliopsoas muscle. This observational case-control study follows three contact sports team (male soccer, ice-hockey and bandy) for two years to find out prevalence of acute and chronic groin pain. Adult (\>18 years old) male athletes with acute or chronic groin pain during the study pediod are included. Outcome measures are clinical examination, pain scores, exact diagnosis and repeated pelvic MRI (two times) are performed in each patients and three control atheletes in each team. Hip and groin questionnaire (HAGOS) is used to determine the severity of groin injuries. The end-points of study are prevalence of groin injuries and exact diagnosis.

Eligibility Criteria:
Inclusion Criteria:

* acute (1-30 days) groin injury
* subacute or chronic groin injury (lasting \>30 days)
* pain in the groin or hip area

Exclusion Criteria:

* inguinal hernia
* postoperative pain
* metallic plates or screws in the pelvis (MRI impossible)
Evaluation of PD-L1 Expression and Immune Infiltration in High-risk Non Muscle Invasive Bladder Cancer

Non-muscle-invasive bladder cancer (NMIBC) has a high rate of recurrence (60 to 70%) and progression (20 to 30%) to muscle-invasive bladder cancer (MIBC).

The local immunotherapy (intra-vesical Bacillus Calmette-Guerin (BCG) following transurethral resection of the bladder tumor (TURBT)) reduces significantly the risk of recurrence and progression as compared to observation or to intra-vesical chemotherapy.

Systemic immunotherapy with programmed death ligand-1 (PD-L1) or Programmed cell Death 1 (PD1) inhibitors has shown major efficacy in the treatment of patients with advanced/metastatic urothelial carcinoma who have progressed on platinum-based regimens of chemotherapy, or even in front line setting. In the field of NMIBC, immunotherapy using PD-L1 or PD1 inhibitors is under investigation but the frequency of PD-L1 expression has rarely been precisely described in the different subtypes.

The aim of this retrospective study is to investigate the expression of PD-L1 by different types of NMIBC.

The secondary objective is to characterize the immune contexture of NMIBC.

Non-muscle-invasive bladder cancer (NMIBC) has a high rate of recurrence (60 to 70%) and progression (20 to 30%) to muscle-invasive bladder cancer (MIBC).

The local immunotherapy (intra-vesical Bacillus Calmette-Guerin (BCG) following transurethral resection of the bladder tumor (TURBT)) reduces significantly the risk of recurrence and progression as compared to observation or to intra-vesical chemotherapy.

Systemic immunotherapy with programmed death ligand-1 (PD-L1) or Programmed cell Death 1 (PD1) inhibitors has shown major efficacy in the treatment of patients with advanced/metastatic urothelial carcinoma who have progressed on platinum-based regimens of chemotherapy, or even in front line setting. In the field of NMIBC, immunotherapy using PD-L1 or PD1 inhibitors is under investigation but the frequency of PD-L1 expression has rarely been precisely described in the different subtypes.

The aim of this retrospective study is to investigate the expression of PD-L1 by different types of NMIBC.

The secondary objective is to characterize the immune contexture of NMIBC. The immunological contexture of NMIBC in comparison with normal bladder tissue and invasive bladder cancer will be deciphered. The objective is to determine immune signatures associated with response or relapse/progression, with and without immune treatments in NMIBC.

Eligibility Criteria:
Inclusion Criteria:

Patients with histologically documented normal bladder, NMIBC (Ta, T1, CIS) or MIBC stored in the tissue bank.

Samples collected from 2007 to 2011. 3 years follow-up is mandatory to assess the frequency of recurrences and progressions.

Exclusion Criteria:

* History of autoimmune disease
* Active tuberculosis
* Prior treatment with CD137 agonists, anti-programmed death-1 (PD-1), or anti-PD-L1 therapeutic antibody or pathway-targeting agents
Development of Methods for Effective Treatment and Improvement of Common Somatic Diseases in Children

The goal of the clinical study is to clarify the course of common congenital, infectious, and non-infectious diseases in children living in Uzbekistan, and to develop methods for their treatment and rehabilitation.

The main questions it aims to answer:

* Analysis of common congenital diseases among children;
* Analysis of commonly diagnosed bronchopulmonary and cardiovascular diseases among children;
* Based on the results of the primary research, common diseases among children will be identified;
* Analysis of existing treatment methods and their effectiveness;
* Development of modern methods of treatment and rehabilitation of children.

Children's health is a priority in modern medicine. Some childhood diseases are most often encountered in the practice of pediatricians and family doctors. Children with these diseases need early diagnosis, treatment, and rehabilitation.

Patient selection criteria are:

* children from birth to 15 years;
* children permanently residing in the territory where the clinical examination is carried out;
* children included in the group of "frequently ill children";
* patients without severe chronic diseases.

Exclusion criteria:

* Teenagers over 15 years old;
* Patients with severe neurological and mental diseases;
* Patients with endocrinological diseases;
* Patients with long-term chronic somatic diseases;
* Children without genetic pathologies.

Clinical research methods:

* Collection of anamnestic data;
* General examination of patients (auscultation, palpation, percussion);
* If necessary: consultation with a geneticist and pediatric doctors of various specialties (cardiologist, surgeon, urologist, nephrologist, otolaryngologist, pulmonologist, immunologist, allergist)
* Standard laboratory tests (general analysis of blood, urine, feces);
* Standard biochemical studies (microelements of blood and enzymes in venous blood);
* Instrumental studies: chest X-ray, ultrasound examination of internal organs (chest and abdominal organs), computed tomography (chest and abdominal organs);
* Study of immunological status (cellular immunity, according to standard methods); Immunological research methods - flow cytometry, mIU/mL: immunogram - CD3, CD3/4, CD3/8, CD19, CD16/56, CD3/16/56, CD3/HLA-; and others;
* Study of antioxidant status (TAS, using the PSR method, mmol/L);
* Assessing the quality of life of patients (methods: PedsQLtm 4.0; HBSC, indicator: total score on the screening survey).

Eligibility Criteria:
Inclusion Criteria:

* children from birth to 15 years;
* children permanently residing in the territory where the clinical examination is carried out;
* children included in the group of "frequently ill children";
* patients without severe chronic diseases.

Exclusion Criteria:

* Teenagers over 15 years old;
* Patients with severe neurological and mental diseases;
* Patients with endocrinological diseases;
* Patients with long-term chronic somatic diseases;
* Children without genetic pathologies.