cyrilzakka/clinical-trials huggingface dataset:
Assessment of Airways Mechanical Properties by FOT and LIR During Anesthesia

The aims of the present study are:

1. To evaluate the effect of the induction of anaesthesia and paralysis in terms of changes in oscillatory mechanics parameters
2. To evaluate the mechanical properties of the respiratory system in terms of input and transfer oscillatory impedance in response to PEEP changes

It has been recently shown that respiratory system reactance (Xrs) obtained by the forced oscillation technique (FOT) at 5 Hz is more reliable than dynamic compliance for assessing lung collapse and the effects of lung RMs in a porcine ALI model ( Ref.1,2).

Specifically, Xrs (and its derived variable CX5, the oscillatory compliance at 5 Hz) identifies the minimum positive end-expiratory pressure (PEEP) level required to maintain lung recruitment with high sensitivity and specificity. Moreover, it has been recently demonstrated that Xrs may be used to identify the lowest level of PEEP able to prevent atelectasis and that PEEP setting strategy based on maximizing Xrs is able to limit lung injury compared to oxygenation-based approach in a porcine lavage model of lung injury. ( Ref.3)

Recently, at the biomedical engineering department of Politecnico di Milano measurements of chest wall displacement have been successfully performed by means of an optical sensor realized using a laser self-mixing interferometer (LIR). The advantage of this approach is that it is contact-less, that by deflecting the laser been it is possible to scan any region of the chest wall surface and that it allows to measure also low-frequency vibrations.

Protocol

1. The baseline pulmonary function will be assessed by spirometry before surgery.
2. Just before surgery measurements of oscillatory mechanics will be performed at the following stages:

   * awake patient
   * spontaneous ventilation through the laryngeal mask after induction of anesthesia
   * pressure controlled ventilation (PCV) after the administration of neuromuscular blocking agent and intubation and PEEP 0 cmH2O
   * PCV with PEEP 5 cmH2O
   * Recruitment maneuver (RM) (peak pressure 30 cmH2O and PEEP 15 cmH2O) for 2 minutes
   * PCV with PEEP 5 cmH2O after RM

At each stage the following measurements will be performed:

* Input impedance at 5-11-19 Hz by FOT
* the movements of the chest wall assessed by laser interferometry (LIR) applying two different stimulating waveforms: 5-11-19 Hz and 100 Hz
* functional residual capacity (FRC)
* arterial blood gas measurement (ABG)

Eligibility Criteria:
Inclusion Criteria:

* age \>18 years
* ASA I-II, scheduled for elective surgery requiring general anesthesia
* signed informed consent

Exclusion Criteria:

* patient refusal
* BMI \> 35
* co-existing respiratory disease (COPD, asthma, restrictive lung disease)
* pregnancy
Peer Support to Mitigate the Impact of Stigma in Young HIV+ Pregnant & Postpartum Women

Young pregnant and postpartum women living with HIV are at the greatest risk of disengagement from HIV services and suboptimal adherence to antiretroviral therapy (ART). Among young women, stigma is a major barrier to retention in services and adherence to ART, and interventions are needed to combat stigma and improve ART outcomes. The investigators are conducting a pilot study of a peer support intervention to mitigate the negative effects of stigma in this population.

Despite major reductions in mother-to-child HIV transmission (MTCT), young pregnant and postpartum women living with HIV remain a vulnerable group and experience the greatest risk of disengagement from services and suboptimal adherence to antiretroviral therapy (ART). HIV-related and intersectional stigmas are major barriers to uptake and retention in prevention of mother-to-child transmission (PMTCT) services and drive suboptimal adherence, and young women experience unique stigmas. Despite this, there are no evidence-based interventions to combat stigma and improve ART outcomes in this group. Peer support group interventions have shown promise in other populations, but have not been examined in young pregnant and postpartum women living with HIV. The investigators are conducting a pilot study of a peer support intervention to mitigate the negative effects of stigma in young pregnant and postpartum women living with HIV in South Africa. Participants will be allocated to the standard of care, in which no standardized peer support groups exist for this patient population, or to a peer support intervention.

Eligibility Criteria:
Inclusion Criteria:

* Aged 16-24 years
* Documented HIV infection
* Confirmed pregnant or recently postpartum
* Accessing antenatal or immediate postpartum PMTCT services at the study site
* Planning on remaining a resident of Cape Town for at least 6 months after enrolment
* Able to provide informed consent for research

Exclusion Criteria:

* Significant pre-existing psychiatric comorbidity that may impact ability to consent
* Stated intention to move outside of Cape Town during the 6 months after enrolment
Trial to Determine the Immunomodulatory Activity of PTM-001 in Patients With Hidradenitis Suppurativa

Study PTM-001-01 is a 12-week, randomized, placebo controlled, double blind study with a 12 week open-label extension to examine the immunomodulatory activity of PTM-001 in participants with Hidradenitis Suppurativa (HS). Participants will be randomized to receive PTM-001 (400 mg) or matching placebo every day for 12 weeks after which all participants will receive open-label PTM-001 400 mg daily for an additional 12 weeks. Randomization will be stratified by Hurley Stage.


Eligibility Criteria:
Inclusion Criteria:

* Had onset of symptoms consistent with HS at least 6 months prior to Screening.
* Has had active HS for at least 2 months.
* Has ≥ 5 HS abscesses or inflammatory nodules at Screening.
* Agrees to maintain baseline wound care and antibiotic therapy, including oral antibiotics, for the duration of the trial.
* Agrees to use contraception

Exclusion Criteria:

* Has other skin disease or condition that can interfere with HS assessment.
* Has a positive test for TB, HIV, hepatitis B and/or hepatitis C at Screening.
* Has a history of retinopathy or known clinically significant cardiovascular or hematologic conditions.
* Has taken any biologic drug within 3 serum half-lives. A list of potential biologics and their half-lives
* Has started oral antibiotics within 28 days of Study Day 1.
* Has, within 2 weeks prior to Day 1, received a medication prohibited based on cytochrome P450 (CYP3A4) interaction
* Has such extensive disease that, in the opinion of the Investigator, it is difficult to discriminate between active lesions and scarring.
* Has more than 15 active tunnels at Screening.
* Is pregnant, nursing or considering becoming pregnant.
* Has a history of malignancy except non-melanoma skin cancer or cervical carcinoma in situ.
Multidisciplinary Program Based in High Intensity Interval Training and Dietary Education for Coronary Artery Disease

A multidisciplinary program based on physiotherapy and diet education will be carried out for 3 months in patients with coronary artery disease with percutaneous coronary intervention. Educational lectures on nutrition and high intensity interval training will be developed in old patients with chronic heart disease. A control group will not develop any program. Effectiveness on anthropometric parameters, eating habits, physical activity, quality of life, anxiety and depression will be assessed at baseline and at 3 months.

A multidisciplinary program based on high intensity interval training and diet education will be carried out for 3 months for patients with coronary artery disease with percutaneous coronary intervention. Three educational lectures on nutrition and a 3-month high intensity interval training will be developed in old patients with chronic heart disease. A control group will not develop any program. Effectiveness on anthropometric parameters, eating habits, physical activity, quality of life, anxiety and depression will be assessed at baseline and at 3 months.

Eligibility Criteria:
Inclusion Criteria:

* infarction or angina pectoris.
* At least six months elapsed since the diagnosis of heart disease at the time of the start of the study.
* Be physically and cognitively able to complete the evaluations and the program.

Exclusion Criteria:

* Present another type of cardiac disease different from ischemic heart disease.
* Present any physical or psychiatric condition that prevents the normal performance of the evaluations and the program.
* Mobility problems to attend reassessments.
MitraClip for Severe TR

The aim of this study was to investigate the procedural feasibility and 30-day results of transcatheter tricuspid valve repair using the MitraClip® system (Abbott Vascular) in selected, highly symptomatic patients with severe tricuspid regurgitation (TR).

The primary objectives of this prospective analysis were to determine the feasibility in terms of success rate and short-term clinical follow-up at 30 days. In this context procedural success was defined as reduction of at least one TR grade. At 30-days after the procedure, a clinical follow up was performed in the heart failure outpatient clinic of our department including transthoracic echocardiography for the evaluation of TR grades. Furthermore, the investigators determined NYHA functional class and the incidence of major adverse cardiac and cerebrovascular events (MACCE).

Secondary objectives were the assessment of right ventricular function, the 6-minute walk distance, NT-proBNP as well as quality of life as assessed by the Minnesota Living with Heart Failure Questionnaire (MLHFQ) score at 30-days follow up.

Eligibility Criteria:
Inclusion Criteria:

* right-sided heart failure due to moderate-to-severe tricuspid regurgitation
* patients deemed inoperable by the heart Team

Exclusion Criteria:

* poor Echo-image quality
Evaluation of Laparoscopic Non Anatomical Liver Resection in Hepatic Pathology

Laparoscopy is a type of surgical procedure that allows a surgeon to access the inside of the abdomen and pelvis without making large incisions in the skin.The use of laparoscopy in abdomenal surgeries increases for its great benefits over open surgery as:

1)faster recovery, 2)decrease blood loss, 3)shorter hospital stays, 4)decreased postoperative pain, 5)earlier return to work and resumption of normal daily activity as well as, 6)cosmetic benefits.

few studies discuss the efficacy and safety of using Laparoscopy in liver non anatomical resection.

this study will include any male and female above 18 that presented with localized liver pathology (as benign hepatic tumours, resectable primary(HCC) or secondary malignancies, hydatid cyst any other hepatic cysts, haemangiomas,etc......) and underwent laparoscopic non anatomical resection of liver in Assiut university hospitals. Investigators will record the time of operation, number of cases with intra operative mortality or complication and then follow up these patients during time of hospital stay for:

1) post operative pain 2) secondary bleeding and 3) wound infection.

Then follow up these patients in out patient clinic visit for their:

1. satisfaction
2. cosmetic outcomes and
3. rate of recurrence of the pathology.

Eligibility Criteria:
Inclusion Criteria:

* any male or female above 18 that has one of the following pathologies and underwent non anatomical hepatic resection:
* hepatic benign tumours as adenoma
* resectable secondary malignancies (2)
* any type of hepatic cysts e.g., hydatid cyst
* HCC on top of liver cirrhosis.

Exclusion Criteria:

* 1) any immunocompromised patient 2) Patient with contraindicdtions to use laparoscopy. 3) patient who are difficult to follow up.
Dose-finding, Safety and Efficacy Study of NV1FGF in Patients With Intermittent Claudication

The primary objective is to assess safety and efficacy of two different doses of NV1FGF as compared to placebo.

The secondary objective is to assess the pharmacokinetics of NV1FGF and FGF-1 protein.

Screening of 1 to 4 weeks before study drug administration; 6 weeks of treatment, followed by 20 weeks of follow-up.

Eligibility Criteria:
Inclusion criteria:

* Age\>40 years
* History of typical intermittent claudication lasting for at least 3 months, showing no improvement and consistent with treadmill test findings
* Objective evidence of Peripheral Arterial Occlusive Disease. After 10 minutes of rest, either by Ankle brachial index measure (ABI) \<0.8 or Systolic ankle pressure (AP) \< 50 mmHg or Systolic toe pressure \<50 mmHg
* Patent femoral inflow above the level of injections recently (\<2 weeks) documented either with Doppler ultrasonography or Magnetic Resonance Angiography or Angiography

Exclusion criteria:

* Evidence of other causes for leg pain other than intermittent claudication.
* Illnesses limiting subject exercise capacity (angina pectoris, heart failure, respiratory disease, orthopaedic disease, neurological disorders...)
* Pain at rest
* Buerger's disease
* Positive serology for HIV 1 or 2, positive serology hepatitis B or C.
* Subjects with serum creatinine \> 2 mg/dl (176 µmol/l) and subjects on dialysis.
* Active proliferative retinopathy defined by the presence of new vessel formation and scarring.
* Subjects who had a stroke or neurologic deficit presumed to be due to stroke within 3 months prior to the first administration of study treatment
* Previous treatment with any angiogenic growth factor
* Pregnant or breast feeding women or who disagree to practice a medically accepted method of birth control. Men and women who do not agree to use condoms as the only accepted protection barrier, for the entire study period
* Serious concomitant medical conditions not adequately controlled.
* Current alcohol or drug abuse

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Compassionate Use Program for Olipudase Alfa Enzyme Replacement Therapy for Patients With Chronic Acid Sphingomyelinase Deficiency (ASMD)

The objective of this program is to provide access to enzyme replacement therapy (ERT) with olipudase alfa for certain patients with ASMD, a severe, life threatening disease, that could not participate in the olipudase clinical trials. The program will provide access to olipudase alfa prior to registration and the availability of commercial product (including reimbursement where applicable) in the country of the patient.


Eligibility Criteria:
Inclusion Criteria:

All patients (adult and pediatric)

* Unsolicited request for the patient from a site with at least 3 years of experience in administration and safety management of ERT.
* Written informed consent signed by the patient or the patient's parent(s)/guardian(s), where applicable.
* Documented deficiency of acid sphingomyelinase in peripheral leukocytes, lymphocytes, or cultured fibroblasts.

Adult patients

* Age ≥ 18 years.
* Clinically documented advanced disease evidenced by defined thresholds for lung, spleen, liver, and hematologic parameters.

Pediatric patients

- Age \>3 years and \<18 years or clinical diagnosis consistent with ASMD Type A/B or Type B.

Exclusion Criteria:

All patients (adult and pediatric)

* Active serious intercurrent illness which will preclude enrollment, significant liver disease with etiology other than ASMD, Malignancy with poor prognosis, serious medical or psychiatric condition that may preclude participation, or circumstances that may interfere with compliance in this compassionate use program, requirement for recurrent dose adjustment of anticoagulation treatment over the last 6 months.
* Pregnancy or breastfeeding.
* For female patients of childbearing potential, a positive serum pregnancy (β human chorionic gonadotropin \[HCG\]) test result.
* For female patients of childbearing potential and sexually active male patients, unwillingness to abstain from heterosexual intercourse in accordance with their preferred and usual lifestyle, or to use 2 acceptable, effective contraceptive methods, while participating in this program and for 15 days after the last infusion of olipudase alfa.
* For pediatric patients, clinical diagnosis, or suspicion of infantile onset ASMD. Genotype compatible with ASMD type A.
SANGUINATE™ in Sickle Cell Disease Associated Leg Ulcer

SANGUINATE™ Sickle Cell Disease associated Leg Ulcers.

This is an escalating, repeated-dose, open-label Phase 2 study to test SANGUINATE (pegylated carboxyhemoglobin bovine) in patients suffering from leg ulceration associated with Sickle Cell Disease (SCD leg ulcer).

Patients will undergo consent and screening procedures at the time of presentation for leg ulcer treatment. Eligible patients will begin a 3-week Run-In Period. A total of approximately fifteen (15) patients are expected to be screened in order to achieve an enrollment target of ten (10) evaluable patients for participation in the study. Evaluable is defined as a patient receiving a minimum of three doses of investigational product. Five (5) patients (Cohort 1) will receive four (4) once-weekly 2-hour IV infusions of SANGUINATE at a dose of 320 mg/kg (8 mL). An additional five (5) patients (Cohort 2) will receive six (6) once-weekly 2-hour IV infusions of SANGUINATE also at a dose of 320 mg/kg. Each patient will be contacted by telephone approximately 24 hours after dosing to verify the safety status of the patient. One week following the Treatment Phase, patients will return to the study center for a Final Visit where safety assessments will be performed. During the Final Visit, patients will receive standard of care treatment of ulcer. All patients will receive once-weekly Standard of Care (SOC) therapy for SCD leg ulcer for the duration of the study. SOC includes dressing the wound with multi-layer, short stretch, compression bandaging. Non-adherent, medical-grade foam will be used as the wound contact layer and primary dressing.

Eligibility Criteria:
Inclusion Criteria:

* Properly consented patients suffering from Sickle Cell Disease (Hb-SS or Hb- Sβ° genotype) associated Leg ulcer.
* Presence of leg ulcer for at least 4 weeks
* Venous Clinical Severity Score of moderate to severe (defined as ≥12)
* Leg ulcer below the knee

Exclusion Criteria:

* Patient presenting with a clinically \& laboratory confirmed bacterial, fungal or acid fast organisms
* Patient has a recent acute complication of Sickle Cell Disease (e.g., pain crisis within 7 days, or acute chest syndrome within 21 days)
* Patient is planning to be pregnant, is pregnant, or is breast-feeding
* Presence of moderate to severe renal insufficiency (CrCl \< 30 mL/min) or chronic kidney disease, or of moderate to severe hepatic insufficiency (Child-Pugh class B or C)
* Patients with more than 3 times the upper limit of normal laboratory reference range
* Concurrent or recent prior treatment (within 90 days) with an investigational medication
* Patients currently receiving treatment with hydroxyurea must be on stable dose for at least 30 days
* Receipt of a blood transfusion within 21 days
Evaluation of Genetic Signature in Endometriosis Disease by Non Invasive Sampling

Endometriosis is a disease that affects 10-15% of the general population and 50% of infertile women. It is characterized by the presence of endometrial tissue outside the uterine cavity. Endometriosis can lead to infertility by interfering through endocrine and mechanical alterations on the function of the ovaries, fallopian tubes, and uterus. The aim of the study is to define the differential expression of a cluster of RNAs tissue driven for the identification of an RNA profile in saliva, specific for endometriosis. This study focuses on the expression of genes involved in the control and regulation of apoptosis, cell survival, metabolism, cell adhesion and invasion, angiogenesis, inflammation, and estrogen receptor expression levels.

Retrospective selection based on anamnestic criteria of: 50 patients with diagnosed endometriotic adnexal pathology (case, CA), 50 patients with non-endometriotic adnexal pathology (control, CO) and 50 patients with no gynecological pathology, not undergoing surgery (analytical control).

The study involves collecting a saliva sample from all patients involved in the study, and performing a biopsy from both patients with endometriotic adnexal pathology (CA) and patients with non-endometriotic adnexal pathology (CO).

Eligibility Criteria:
Inclusion Criteria:

* Case population (CA), patients with endometriotic adnexal pathology
* Control population (CO), patients with non-endometriotic adnexal pathology
* Analytical control population (C-), patients with no gynecologic pathology, not undergoing surgery

Exclusion Criteria:

* Women with ages outside the inclusion range
* Pregnant patient
* Patient with a personal history of cancer
* Patient infected with HIV
Mepolizumab Long-term Study to Assess Real World Safety and Effectiveness of Eosinophilic Granulomatosis With Polyangiitis (EGPA) in Japan

Eosinophilic granulomatosis with polyangiitis (EGPA), formerly known as the Churg-Strauss syndrome, is a systemic necrotizing vasculitis that affects small and medium sized blood vessels. NUCALA® (mepolizumab 300 milligrams \[mg\], subcutaneous administration) was approved in Japan in 2018 for the treatment of EGPA in adult participants. This is a single-arm, multi-center, prospective, non-interventional study that aims to assess long-term (2 to 4 years) real-world safety and effectiveness of NUCALA. Approximately 120 participants who completed the NUCALA Post Marketing Surveillance (PMS) study (National Clinical Trial \[NCT\]03557060) will be enrolled in the study.

NUCALA is a registered trademark of GlaxoSmithKline (GSK) group of companies.


Eligibility Criteria:
Inclusion Criteria:

* Adult participants with EGPA of \>=20 years of age inclusive, at the time of signing the informed consent.
* Participants must have a current clinical diagnosis of EGPA by physician.
* Participants have continuously used NUCALA for at least 96 weeks for the treatment of EGPA as mentioned in the current label in Japan.

  • Participants thus were registered and completed the NUCALA PMS study (special drug use investigation; Protocol Number 208505, NCT03557060) prior to be enrolled in this study.
* Physician's decision to continue treatment with NUCALA for the treatment of EGPA as mentioned in the current label in Japan.
* Prior to commencing any study related activities, participants must be able and willing to provide written informed consent.

Exclusion Criteria:

* Participants who have previously discontinued NUCALA treatment for EGPA for more than 12 weeks.
* Participating in another clinical trial within the past 12 months, in which the participant has been exposed to an investigational or non-investigational pharmaceutical product.
* Participants with any reasons that in physician's opinion would place the participants at risk.
* Participants who are pregnant or breastfeeding.