cyrilzakka/clinical-trials huggingface dataset:
Comparison of Ultrasonography Guided Serratus Anterior Plane Block and Thoracic Paravertebral Block in Thoracic Surgery

The aim of this study is comparison of the effectiveness of ultrasound guided serratus anterior plane block and thoracic paravertebral block as a preventive analgesia method after VATS. Our secondary aim is to investigate patient and surgeon satisfaction, duration of block application, postoperative complications and hospital lenght of stay.


Eligibility Criteria:
Inclusion Criteria:

* aged between 18 and 65 years
* ASA (American Society of Anesthesiologists) score I-II

Exclusion Criteria:

* inability to communicate
* body mass index (BMI) \> 35 kg/m2
* infection in the area where the block was to be applied
* allergy to the drugs used
* mentally impaired
* bleeding impaired
Randomized Study Comparing Pleural Drainage by Videothoracoscopy to Medical Drainage in Infectious Pleural Effusion

Infectious pleural effusion is a classic complication of pneumonia and often require pleural drainage.

There is no consensus between surgical drainage and medical drainage indication in first intention to treat an empyema.

Usually surgery is proposed in second intention after failure of medical drainage.

Videothoracoscopy is well accepted in diagnosis and treatment of pleural pathologies. The morbidity of this approach is very low with good results and become the gold standard in different pleural diseases. The medical drainage can be also very efficient but its results depends of the evolution of the pleural effusion. The rate of failure is estimated around 25%.

Then, the aim of our study is to compare surgical drainage and medical drainage in first intention. The first end-point will be the hospital stay (day). Hospital discharge will be strict, following different objective criteria of healing allowing comparison between these two approaches of drainage.

To answer this question we will randomized 50 patients in 2 years with a multicenter recruitment.


Eligibility Criteria:
Inclusion Criteria:

* Infectious pleural effusion diagnosed by pleural punction with biologic features of infection: C Reactive Protein level \>5 mg/L, White cells counts \> 10000 G/L, Temperature \>38°c, effusion with a ph\<7,2 or presence of polynuclear, and radiologic features of effusion requiring drainage (\>1/5 thoracic volume)

Exclusion Criteria:

* prior thoracic surgery, past history of pleural effusion
* compressive effusion which should be treated in emergency
* Pregnancy
* No acceptance of the protocol by the informed patient
Search Allelic Imbalance of Expression of BRCA Genes in Hereditary Risk of Breast and/or Ovarian Cancer

The purpose of this study is to determine proportion of patients presented a search allelic imbalance of expression of genes BRCA 1 and 2 in population with hereditary breast and/or ovarian cancer risk and negative for deletion mutation BRCA 1 and 2 genes


Eligibility Criteria:
Inclusion Criteria:

For patients

* Women with breast cancer and / or ovarian cancer meet criteria suggestive of a hereditary predisposition
* Deleterious mutation of BRCA1 and BRCA2 sought and not highlighted
* Age ≥ 18 years
* Agreeing to participate in the study (a collection of signed informed consent)

For control population

* Women with no history of breast and / or ovarian cancer and no family history of breast and / or ovarian cancer among family members on the 1st and 2nd degree before age 50 for breast cancer and before 60 years for ovarian cancer
* Agreeing to participate in the study (a collection of signed informed consent)

Exclusion Criteria:

For patients:

* Patients with a known deleterious mutation in BRCA1 and BRCA2
* Patients do not meet criteria suggestive of a hereditary predisposition
* Persons deprived of liberty or under guardianship (including guardianship)

For control population:

* Males
* Personal or family history of breast and / or ovarian cancer (breast or ovarian cancer in their family experienced 1st and 2nd degree before age 50 for breast cancer before age 60 for cancer ovarian)
* Persons deprived of liberty or under guardianship (including guardianship)
Feasibility Study of the Adult Congenital Heart Disease-Coping and Resilience (ACHD-CARE) Trial

The psychosocial development of adults with congenital heart disease (CHD) can be challenged by many issues including family overprotection, impaired peer relationships, delayed progression into independent adulthood, and difficulties with career and future planning. One-third of patients have diagnosable mood or anxiety disorders and the prevalence of depression is 3 times that of the general Canadian population. Unfortunately, most adults with CHD and significant depression or anxiety do not receive mental health treatment. Despite an increasing awareness of the unique psychosocial concerns of this patient population by both health care providers and patients, there have been no interventions targeting psychosocial outcomes in the adult CHD population. Our quantitative and qualitative research suggests that patients themselves are very interested in psychological services that target their distinctive life experiences, are provided in a group setting, and emphasize coping and resilience. The overarching aim of this proposal is to assess the feasibility of a full-scale randomized controlled trial of a group intervention aimed at improving the psychosocial functioning, quality of life, and resilience of adults with CHD.


Eligibility Criteria:
Inclusion Criteria:

* Documented congenital heart disease (CHD), as confirmed by echocardiogram, cardiac catheterization, or previous surgery
* Age greater than or equal to 18 years
* English-language proficiency sufficient to read and complete the consent form and questionnaires and participate in an English-language group
* No planned surgery during patient's participation in the study
* Clinically-elevated score (i.e \>=8) on the Hospital Anxiety and Depression Scale depression (HADS-D) or anxiety (HADS-A) subscale

Exclusion Criteria:

* Current psychotherapy or pharmacotherapy
* Significant cognitive impairment, psychosis, or personality disorder as documented in medical chart
* Report of suicidal intent during screening
Antiphospholipid Antibodies in Patients of Antiphospholipid Syndrome (APS) With Systemic Lupus Erythematosus (SLE).

Evaluation of antiphospholipid antibodies (aPL) profile in Systemic lupus erythematosus (SLE) patients with obstetric and thrombotic complications.

Blood sample of the patients were taken for Anti-beta-2-glycoprotein 1(anti-b2GPI), anticardiolipin (aCL) and will be analyzed on Alegria based on ELISA.

Antiphospholipid syndrome (APS) is characterized by presence of specific antiphospholipid antibodies (aPL) with history of thrombosis and/or pregnancy morbidity.

Anti-phospholipid antibodies (aPL) is a comprehensive antibody profile which includes lupus anticoagulant \[LA\], anticardiolipin antibodies \[aCL\], and/or anti-β2-glycoprotein-I antibodies \[aβ2GPI\]). A comprehensive antibody profile is needed for both diagnosis and classification of patients with APS, most significantly for the risk assessment of both pregnancy morbidity and thrombosis.

Double positivity (LA, aβ2GPI or ACL +) and triple positivity (LA, aβ2GPI+, ACL +) may have worse outcome and the patients with double and triple positivity may have recurrent thrombotic events.

Early detection of aPL antibodies may avert patients with many complication associated with SLE as well as from major thrombotic events because the detection of aPL in SLE has been proposed as a predictive and specific tool for the diagnosis of APLS in SLE.

aPL profile in SLE patients with obstetric and thrombotic complications was analyzed, to see the association of different anti phospholipid antibodies with different clinical features of APLS in SLE patients.

Eligibility Criteria:
Inclusion Criteria: Diagnosed patients of SLE presenting with thrombosis \& pregnancy complication were studied

-

Exclusion Criteria:

* Patients of SLE without thrombosis
Study of Safety and Tolerability of DCR HBVS

DCR-HBVS will be evaluated for safety and efficacy in healthy volunteers and chronic hepatitis B patients.

DCR HBVS is being developed for the treatment of chronic hepatitis B (CHB) in adults. The study will be conducted in 3 parts, a single ascending-dose (SAD) phase in normal healthy volunteers (Group A), a single-dose (SD) phase in patients with CHB (Group B), and a multiple ascending-dose (MAD) phase in patients with CHB (Group 1c-3c). Cohort 4c is a single ascending dose with a possible duration of up to 48 weeks. Cohort 5c is a multiple dose cohort with a possible duration of up to 72 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Healthy at the time of screening as determined by medical evaluation.
* Capable of giving informed consent.
* 12-lead ECG within normal limits or with no clinically significant abnormalities.
* Negative screen for alcohol or drugs of abuse.
* Non-smokers for at least 3 months with a negative urinary cotinine concentration at screening.
* BMI within range 18.0 - 32.0 kg/m2 (inclusive).
* Female participants not pregnant, not breastfeeding, and not of childbearing potential or willing to follow contraceptive guidance.
* Chronic hepatitis B infection (Group B and C only).
* Clinical history compatible with compensated liver disease with no evidence of cirrhosis (Group B and C only).
* Continuously on nucleotides (NUC) therapy for at least 12 weeks prior to screening (Group C only).

Exclusion Criteria:

* History of any medical condition that may interfere with the absorption, distribution, or elimination of study drug.
* Poorly controlled or unstable hypertension.
* History of diabetes mellitus treated with insulin or hypoglycemic agents.
* History of asthma requiring hospital admission within the preceding 12 months.
* Evidence of G-6-PD deficiency.
* Currently poorly controlled endocrine conditions, excluding thyroid conditions.
* History of multiple drug allergies or history of allergic reaction to an oligonucleotide or GalNAc.
* Clinically relevant surgical history.
* Use of prescription medications (excluding contraception for women) within 4 weeks prior to the administration of study intervention.
* Use of clinically relevant over-the-counter medication or supplements (excluding routine vitamins) within 7 days of first dosing.
* Has received an investigational agent within the 3 months prior to dosing or is in follow-up of another study.
* Antiviral therapy (other than entecavir or tenofovir) within 3 months of screening or treatment with interferon in the last 3 years (Group B and C only).
* Use within the last 6 months of anticoagulants or systemically administered corticosteroids, immunomodulators, or immunosuppressants (Group B and C only).
Assessment of Renal Physiology by Magnetic Resonance Imaging (MRI) in Normal Volunteers

Estimation of Glomerular Filtration Rate (GFR) is the primary test used to assess patients with renal disease. Although serum creatinine based GFR and nuclear medicine based estimations are routinely used in clinical practice, GFR estimation by Inulin is the recommended gold standard. Inulin based estimation of GFR is cumbersome and time consuming.

A decrease in blood flow to the kidney (Renal Blood Flow (RBF)) is known to cause a decrease in GFR. RBF is typically determined using radioactive tracers, contrast MRI or a cumbersome para-aminohippuric acid (PAH) clearance method.

MRI based assessment of GFR and RBF have been suggested to provide reasonable accuracy. Most of these studies did not compare the GFR and RBF estimation directly to Inulin and PAH clearance which are ther gold standards . In this study we propose to estimate MRI based GFR estimation directly to Inulin and noncontrast MRI based derived RBF to PAH to assess if MRI is an accurate test of kidney function.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male or female volunteers with no known renal disease
* Ages between 18-65 years
* Normal routine urinalysis
* Estimated GFR (eGFR) \>=90mls/min
* Arterial pressure \< 130/85
* No medications (birth control pills and vitamins are acceptable)

Exclusion Criteria:

* Pregnancy
* Age \<18y or \>65y
* Proteinuria or hematuria as determined by routine urinalysis
* Estimate GFR (eGFR) \< 90 ml/min
* Known history or requirement of treatment for hypertension
* Known allergy to inulin or PAH
* MRI contrast allergy, general contraindications to MRI such as pacemaker, etc.
Epidemiological Study on Mental Health of Migrant Population in the Retention Center of Geispolsheim.

In 2019, the lack of studies about mental health of the detained population at retention centers in France is pointed out by the report of Controller-General for Places of Deprivation of Liberty. The aim of this study is to contribute to this relatively untouched field by describing which psychiatric pathologies are encountered in this population who went through migration and retention. Having a clearer picture of the situation can help to provide a more adapted psychiatric care in retention centers.

The results are expected to show a higher rate of psychiatric disease than in the general population including addiction to substance, anxiety disorder and post-traumatic stress disorder (PTSD).


Eligibility Criteria:
Inclusion Criteria:

* Any male person in the first week of detention at CRA Geispolsheim who gave their non-opposition to participation in the study.
* Information and consent protocol signed

Exclusion Criteria:

* Refuse to participate to the study
A Novel Laparoscopic Hepatectomy Posture, Left Lateral Position Plus Jackknife Position

Since the first report of laparoscopic resection of a benign hepatic tumor by Professor H. Reith in 1991, the laparoscope has been widely used in liver disease. Based on its advantages in laparoscopic vision and amplification, laparoscopic hepatectomy (LH) has been well recognized globally. Generally speaking, for lesions located in the left, front or lower part of the liver, corresponding to Couinaud segments II, III, IVb, V and VI, an LH surgery is recommended; however, for lesions located in segments VII and VIII, the surgery is high technically difficult due to poor exposure. Therefore,the investigators employ the left lateral position plus jackknife position to better expose lesions in these segments, hoping to reduce surgical time and bleeding in LH.


Eligibility Criteria:
Inclusion Criteria:

1. Patients were diagnosed with hepatocellular carcinoma (HCC) based on the criteria established by the European Association for the Study of the Liver
2. Tumor located in segment VI, VII, or VIII.

Exclusion Criteria:

1. Major vessel or bile duct tumor invasion,
2. Recurrent HCC
3. Tumor close to secondary vessels and bile ducts
4. Patients with extrahepatic metastasis
5. Grade C liver function,
6. Significant surgical contraindications
Study to Evaluate the Efficacy and Safety of PF-07055480 / Giroctocogene Fitelparvovec Gene Therapy in Moderately Severe to Severe Hemophilia A Adults

C3731003 is a pivotal Phase 3 study to evaluate the clinical efficacy and safety of a single IV infusion of PF-07055480 / giroctocogene fitelparvovec (Recombinant AAV2/6 Human Factor VIII Gene Therapy) in adult male participants with moderately severe or severe hemophilia A (FVIII:C≤1%) for the study duration of 5 years. The study will enroll eligible participants who have been followed on routine prophylaxis with FVIII products in the Lead-In study C0371004.


Eligibility Criteria:
Main inclusion Criteria

* Males who have been followed on routine Factor VIII prophylaxis therapy during the lead-in study (C0371004) and have \> = 150 documented exposure days to a Factor VIII protein product
* Moderately severe to severe hemophilia A (Factor VIII activity \< =1%)
* Suspension of FVIII prophylaxis therapy post study drug infusion

Main exclusion Criteria

* Anti-AAV6 neutralizing antibodies
* History of inhibitor to Factor VIII
* Laboratory values at screening visit that are abnormal or outside acceptable study limits
* Significant and/or unstable liver disease, biliary disease, significant liver fibrosis
* Conditions associated with increased thromboembolic risk such as inherited or acquired thrombophilia, or a history of thrombotic events
* Planned surgical procedure requiring Factor VIII surgical prophylactic factor treatment 12 months from screening visit
* Active hepatitis B or C
* Serological evidence of human immunodeficiency virus HIV-1 or HIV-2 with Cluster of Differentiation 4 positive (CD4+) cell count ≤200 mm3 and/or viral load \>20 copies/mL
Respiratory Disorders Non-invasive Monitoring of Work of Breathing in Outpatients

This study will test the accuracy of an investigational, non-invasive device for measuring heart rate and respiratory rate. The device emits radiowaves that allows it to pick up subtle changes in a person's chest wall, which allows it to calculate the heart rate and respiratory rate. We propose to study whether the device's measurements are accurate and reproducible in patients with chronic obstructive pulmonary disease (COPD) or asthma. The device undergoing study has been evaluated in healthy volunteers, but its accuracy in vital sign monitoring in patients with respiratory conditions has not yet been established. This study will serve as the foundation for additional work to assess the device's accuracy in measuring a patient's overall "work of breathing" or respiratory effort. Future work will examine the device's accuracy in measuring work of breathing in patients having an exacerbation of their underlying respiratory condition.

The primary aim of this study will be to assess the validity of heart rate and respiratory rate measurements in patients with either COPD or asthma.


Eligibility Criteria:
Inclusion Criteria:

* Patient seen at the Stanford University Hospital Chest Clinic
* Patient age 18 or older
* Patient able to consent
* Patient with one of the following two medical conditions: Chronic Obstructive Pulmonary - Disease or Asthma
* Participant (or accompanying family / caretaker) able to speak English

Exclusion Criteria:

* Patient does not meet inclusion criteria (under age 18, unable to consent, etc.)
* Patient is hospitalized
* Patient is having an acute exacerbation of their respiratory condition
* Patient is having an acute exacerbation of a comorbid condition
* Patient has comorbid cardiac disease, including one of the conditions listed below:
* Arrhythmias (including atrial fibrillation, NSVT, etc.)
* Congestive Heart Failure
* Unstable angina
* Myocardial infarction within the last 3 months prior to enrollment
* Uncorrected congenital heart disease
* Uncorrected severe valvular disease
* Pulmonary Hypertension (moderate or higher grade)
* Patient has one of the following conditions:
* Moderate pleural effusion
* Large pleural effusion
* Advanced stage lung cancer (Stage III or Stage IV disease)
* Active infectious process, including viral process or pneumonia
* Interstitial lung disease
* Pleural disease, including pleural malignancies, trapped lung, etc
* Active Cheyne-Stokes respiration
* Patient has baseline increased work of breathing not due to their underlying respiratory disease (ie. COPD or asthma)
* Ongoing substance abuse (not including cigarette use)
A Clinical Study to Map the HLA Genomic Region in the Greek Population

The aim of GENESIS clinical study is to map the HLA genomic region in the Greek population and evaluate possible correlations with selected underlying diseases.

The GENESIS study is a multicenter, prospective, non-interventional, clinical study with a target of 12,000 subjects and an anticipated total duration of 36 months. The aim of study GENESIS is to provide a pilot map of HLA genetic variation in the Greek population in order to be used in medical research and for possible clinical applications (evaluation of possible correlations with selected underlying diseases). During the study, each subject will conduct one visit to the participating cite, in which they will provide:

1. Demographic information \[i.e. date of birth, gender, race, ancestry (including information about the subject's grandparents' birthplace), height, weight\],
2. Other information about smoking/vaping, alcohol consumption, arterial blood pressure, diagnosed diseases (if any), current treatments (if any), and
3. Recent (up to 12 months prior to sample collection) results if/when are available from clinical lab tests such as blood count (Hct, Hb, RBC, WBC, PLT count), including a metabolic panel, liver enzymes and biochemical parameters (Glu, HbA1c, TC, TG, LDL-C, HDL-C, ALT, AST, ALP, γGT, bilirubin, LDH, insulin, C-peptide).

Upon completion of the data registry, two buccal swabs will be collected per subject and they will be stored at ALTP premises until their shipment to Galatea.Bio. All buccal swab samples will be subjected to genetic material (DNA) extraction. The DNA samples will be further proceeded for HLA genotyping analysis. A follow up analysis will be performed in selected DNA samples via full low-pass whole genome sequencing (LP-WGS), which aims to further investigate the association between the HLA region and autoimmune diseases.

Upon completion of the analysis, an individualized ancestry report will be securely made available to all study subjects which they can access, as and if they elect to.

Eligibility Criteria:
Inclusion Criteria:

The study will include adult subjects (age ≥ 18) that:

* possess a Greek social security number and are visiting hospitals/clinics, and/or other private laboratory institutions (incl. clinics and health care groups) as part of standard clinical practice in Greece,
* are willing and able to provide written informed consent to participate in the study according to the study protocol.

Exclusion Criteria:

* Subjects not able to provide written informed consent (e.g. ICU patients, mental illness patients, lack of legal capacity).
* Subjects who have had an allogeneic (non-self-donor):

  * bone marrow transplant
  * stem cell transplant
  * blood transfusion less than two weeks prior to buccal swab sample collection
  * liver transplant
* Subjects who participated in an interventional clinical trial in the past that according to the subject's physician opinion might have had an impact on their HLA genome.
Ocular Responses to Short and Long-term Lens Wear

The purpose of this study was to determine whether ocular surface sensitivity to pneumatic, mechanical and chemical stimulation would be affected by the use of the combination of a specific silicone hydrogel lens material with two lens care products over a four week period.


Eligibility Criteria:
Inclusion Criteria:

* Is at least 17 years old and has full legal capacity to volunteer;
* Is correctable to a visual acuity of 6/7.5 (20/25) or better (both eyes) with their habitual vision correction;
* Is a current soft lens wearer and wears contact lenses six or more days/week;
* Has clear corneas and no active ocular disease.

Exclusion Criteria:

* Has any clinically significant blepharitis or dry eye;
* Has undergone corneal refractive surgery;
* Is aphakic;
* Has any active ocular disease;
* Has any systemic disease affecting ocular health;
* Is using any systemic or topical medications that may affect ocular health;