cyrilzakka/clinical-trials huggingface dataset:
PI or NNRTI as First-line Treatment of HIV in West Africa - the PIONA Trial

BACKGROUND: Since 1996 the combination of three or more drugs has been the mainstay of human immunodeficiency virus (HIV) treatment. The most important types of drugs are called nucleotide reverse transcriptase inhibitors (NRTIs), non-nucleotide reverse transcriptase inhibitors (NNRTIs) and protease inhibitors (PIs) Response to treatment is measured as increasing CD4+ cell count and decreasing HIV viral load. A major problem is the development of resistance. NNRTIs are recommended as part of first-line treatment of HIV in Africa but many Africans have a slower NNRTI clearance than Caucasians making them more susceptible for development of resistance in case of treatment interruptions. PIs might therefore be a better option in an African setting with low adherence.

AIM: To evaluate two different treatment regimens in HIV-1 infected patients:

A) A NNRTI (efavirenz/nevirapine) based regimen and B) A PI (ritonavir-boosted lopinavir) based regimen with regard to treatment outcomes. HYPOTHESIS: Treatment with a PI will be superior to treatment with a NNRTI due to less development of resistance.

METHODS: Treatment-naïve adult HIV-1 patients enrolled in an existing cohort The West African Retrovirus and Acquired Immune Deficiency (WARAID) cohort in Guinea Bissau with CD4+ cell count ≤ 350 cells/µL and/or clinical signs of immune suppression (World Health Organization (WHO) clinical stage 3 or 4) will be randomised 1:1 to: Treatment A: 2 NRTIs (lamivudine and either zidovudine or stavudine) and 1 NNRTI (efavirenz or nevirapine) or Treatment B: 2 NRTIs (same as in treatment A) and 1 PI (ritonavir-boosted lopinavir). Primary outcome: Viral load suppression \<400 copies/ml 12 months after enrolment.

PERSPECTIVES: Guidelines for treatment of HIV in Africa are more or less a copy of the guidelines used in Europe and North America. Genetic differences in pharmacokinetics, more women infected in Africa and difficulties ensuring good adherence mean that results obtained from Caucasian patients are not directly transferrable to African patients. The results of this study will hopefully help guiding the treatment of HIV in Africa in the future. The investigators believe the HIV infected people in West Africa deserve the same evidence-based medicine as in developed countries.


Eligibility Criteria:
Inclusion Criteria:

* Antiretroviral treatment (ART) naïve HIV-1 infected patients. Women receiving ART during pregnancy can be included.
* Age ≥ 18 years
* CD4+ cell count ≤ 350 cells/µL and/or
* Clinical signs of immune suppression (WHO clinical stage 3 or 4) irrespective of CD4+ cell count.

Exclusion Criteria:

* Tuberculosis (TB) treatment with rifampicin at the time of enrolment.
* Co-infection with HIV-2.
* Grade 3 or 4 alanine transaminase (ALAT) elevation (\>5 times upper normal limit).
* Patients with cerebral disturbances that complicates the ability to give informed consent or follow the treatment regime.
Efficacy of Tranexamic Acid on Blood Loss During Percutaneous Nephrolithotomy.

Efficacy of tranexamic acid on blood loss during percutaneous nephrolithotomy. a double-blind, placebo-controlled randomized clinical trial.

To evaluate whether intravenous tranexamic acid or tranexamic acid in the irrigation fluid in percutaneous nephrolithotomy (PCNL) in reducing bleeding during and after PCNL.

Eligibility Criteria:
Inclusion Criteria:

* Patient 18 years or older
* Stones ≥ 2 cm and/or mild to moderate hydronephrosis.

Exclusion Criteria:

* Age \<18 years or Pregnancy
* Bilateral simultaneous PCNL
* Morbid obesity (BMI \>40)
* Refuse to complete study requirements
* Untreated UTI
* Atypical bowel interposition by CT
* Tumour in the presumptive access tract area or Potential malignant kidney tumour
Sentinel Low Risk Registry

This registry is designed to quantify embolic debris capture rate in patients at low surgical risk treated with the Sentinel System during TAVI.

The SENTINEL-LIR Study is a multicenter, prospective registry to observe rate and type of debris capture in subjects at low surgical risk undergoing TAVI to demonstrate the positive effects of the use of the Sentinel System. Histopathology of captured debris from the Sentinel System will be analyzed.

The primary objective is to determine the presence or absence of particles of 7 discreet tissue types: acute thrombus (with or without associated tissue/foreign material), organizing thrombus, valve tissue, arterial wall/necrotic core, calcification, foreign material, and myocardium. Morphometric assessment of the debris (sizes \>150 m, \>500 m, and \>1,000 m).

Patients will be screened for inclusion and exclusion criteria and documents which will have been reviewed and approved by the local Ethics Committee or regulatory authority prior to undergoing any study related exams or procedures.

Fifty (50) subjects will be enrolled in the study from an estimated 6 different sites.

Eligibility Criteria:
Inclusion Criteria:

1. Severe symptomatic aortic valve stenosis
2. Planned use of Sentinel System
3. Subject planned for transfemoral TAVI with valve system approved by U.S. FDA for low risk patients
4. STS-PROM score of less than 4% and agreement by Heart Team that patients meet criteria for low surgical risk

Exclusion Criteria:

1. Current or recent cerebrovascular accident (stroke, TIA) \<6 months
2. Transapical, direct aortic or subclavian TAVI access
3. Carotid stenting or endarterectomy in last 6 weeks
4. Prior aortic valve replacement
5. Concomitant procedure with TAVI such as CABG, PCI, etc.
Tracking Endothelial Cells in Arterial Injury

We plan to track the migratory behaviour of culture-expanded enothelial outgrowth cells in the context of vascular injury sustained during elective coronary angiography.

We will use Flouro-deoxyglucose-labelling and PET-CT to track the endothelial cells.

The radial artery is commonly injured following trans-radial cardiac catheterisation and this injury can be demonstrated as a reduction in endothelial function as measured by flow-mediated dilatation which recovers with time (13-15). Thus the radial artery is useful as a model of mechanical arterial injury as radial artery trauma is common and endothelial function can be followed longitudinally with a non-invasive test.

Endothelial progenitor cells localise to sites of arterial injury in animal models both in vitro and in vivo and accelerate re-endothelialisation as well as attenuating neointimal hyperplasia (16-18), This has however not been demonstrated in man.

Our research group, in collaboration with the Scottish Blood Transfusion Service (SNBTS) have developed a good manufacturing practice (GMP)-compliant process for manufacturing an endothelial progenitor cell (EPC) product (SNBTS will manufacture the final product administered to patients). We have also demonstrated in vitro that we can label these cells with the radioisotope 18 F-fluorodeoxyglucose (18F-FDG) and that activity can be detected in as few as 200 cells using a hybrid positron emission and computed tomography (PET-CT) scanner (Biograph mCT Siemens Medical Systems, Erlangen, Germany). We will therefore be able to track the fate of these cells in vivo. The major potential advantage of imaging in this way is that only 18F-FDG associated with EPCs will be delivered to the patient, removing the issue of background attenuation due to "free" circulating 18F-FDG. A similar technique has previously been employed in vivo to track homing of unselected autologous bone marrow cells to infarcted myocardium(19). Following intracoronary delivery using this technique, the authors were able to detect 1.3% - 2.6% of 18F-FDG-labelled cells in the infarcted myocardium. Demonstrating that EPCs are able to home to and integrate at sites of vascular injury in man is a critical step in understanding the role of EPCs in vascular repair

Eligibility Criteria:
Inclusion Criteria:

* Undergoing coronary angiography for known or suspected ischaemic heart disease

Exclusion Criteria:

1. Previous coronary artery bypass surgery.
2. Planned angiography via the femoral artery as a sole arterial access route
3. Anaemia \<10g/L
4. Severe valvular heart disease
5. Acute myocardial infarction within previous three months
6. Cardiac failure (Killip class ≥II).
7. Insulin dependent diabetes mellitus
8. Hepatic failure (Childs-Pugh grades B or C).
9. Renal failure (estimated glomerular filtration rate \<25 mL/min).
10. Intercurrent illness including patients with a systemic inflammatory disorder or underlying malignancy.
11. Women of child-bearing age not ensuring reliable methods of contraception.
12. Inability to provide informed consent.
a Prospective Registration Study for Patients With Advanced Refractory Solid Tumors

This is a prospective registration study for patients with advanced refractory solid tumors. Patients who meet the eligibility criteria will be included to participate in the study, and baseline information to be collected after signed informed consent. Patients will choose for themselves whether to carry out targeted therapy or other appropriate treatment methods. And we plan to follow up for at least 12 months or until disease progression or death.

1. Screen and enroll 120 patients with refractory solid tumors, and sign informed consents;
2. Extract the clinical data, including gender, age, disease diagnosis, past treatment history and genetic test results, etc.;
3. Take biopsy samples and perform NGS testing on patients. After discussion by the Molecular Steering Committee (MTB), the recommendations for treatment guidance will be given based on treatment guidelines and clinical experience;
4. The patient and the clinician jointly select the treatment plan and follow-up until the patient's disease progresses. The follow-up time will be 1 year;
5. During the follow-up period, clinical treatment and routine examination information of patients will be collected;
6. If the patient fails to receive molecular targeted therapy or they cannot tolerate the adverse reaction of the drug after adequate treatment, the clinician will evaluate whether a second NGS resistance test is needed or the participant may withdraw from the study.

Eligibility Criteria:
Inclusion Criteria:

* Recurrent or metastatic malignant solid tumor confirmed by histology or cytology
* Disease progression or intolerance after receiving standard treatment
* With evaluable lesions (RECIST 1.1 standard)
* Tumor tissue pieces with sufficient formalin-fixed paraffin-embedded (FFPE) can be used for genetic testing
* ECOG PS score 0-4 (3-4 points only for patients with tumor burden)
* Sign the informed consent form

Exclusion Criteria:

* The subject is participating in any other clinical research;
* Researchers believe that serious or uncontrolled medical diseases (ie uncontrolled diabetes, chronic kidney disease, chronic lung disease, or uncontrolled active infections, mental illnesses/social conditions that restrict compliance with research requirements) that will confuse the analysis of research treatment response ；
* Patients during pregnancy or lactation
Post-market Clinical Follow-up of the SRS Implant

National, multicentre observational study on surgical reconstruction of the anterior and apical compartment of the pelvic floor with an SRS implant

National, multicentre, prospective observational study on surgical reconstruction of the anterior and apical compartment in seven clinical centres in Germany to obtain post-market information on the SRS implant with a follow-up of 24 months. Patient reported satisfaction (measured by P QoL, Prolapse Quality of Life Questionnaire), anatomic outcome (measured by the POP-Q, Pelvic Organ Prolapse Quantification system) and the rate of complications (measured by adverse events during the study period) are focused.

Eligibility Criteria:
Inclusion Criteria:

1. Women with a symptomatic anterior vaginal wall prolapse with/without apex/uterine prolapse ≥ stage II (according to POP-Q system). This applies to primary as well as recurrent intervention.
2. Age ≥ 21 years.
3. Patient is mentally able to understand the nature, aims, or possible consequences of the PMCF study.
4. Patient information has been provided and written consent exists.

Exclusion Criteria:

1. Contraindications according to the manufacturer's instructions for use.
2. Patient with previous urogynaecological surgeries with alloplastic material.
3. Patient with radiological treatment in the pelvic floor.
4. Patient is institutionalised by court or official order (MPDG §27).
5. Participation in another interventional study concerning pelvic floor reconstruction.
Effect of Sublimated Mare Milk Supplement on Gut Microbiome in Psoriasis Patients

This study evaluates the effect of dietary supplement consisting of sublimated mare milk on intestinal microbiota among psoriasis and healthy participants.

The gut microbiome is believed to play an important role in the immune system regulation, since intestines are the largest lymphoid organ in a human body. Deviations from healthy composition of intestinal flora are associated with various diseases including allergy and autoimmunity. Psoriasis is the one of the long-lasting autoimmune diseases that is characterized by patches on the skin and further health complications throughout the life. However, lack of studies does not allow proper evaluation of role of gut microbiome in psoriasis patients. Therefore, potential interplay between gut microbiome and immune system in psoriasis would be studied in this clinical trial. Particularly, the investigators hypothesize that sublimated mare milk supplement can have an impact on gut immune system and gut microbiome composition in the psoriasis patients.

In this trial, there will be two parallel groups: crossover psoriasis patients (standard treatment first for 3 months, next 3 months standard treatment plus sublimated mare milk supplement) and healthy volunteers group. Subsequently, association of intestinal flora with immune status will be analyzed and compared between these groups.

Eligibility Criteria:
Inclusion Criteria.

Inclusion criteria for experimental group:

* Patients with a verified diagnosis of moderate to severe psoriasis
* Aged 30 to 45 years
* Absence of an allergic reaction to dairy products
* Lack of prescription of antibacterial drugs for the last 3 months prior to admission
* Willingness to consent to participate in the study

Inclusion criteria for healthy volunteers group.

* Patients with no diagnosis of psoriasis
* Aged 30 to 45 years

Exclusion Criteria:

* Presence of chronic dermatoses, diseases of the organs of the gastrointestinal tract
* Presence of severe concomitant diseases of the kidneys, liver, cardiovascular, respiratory and other body systems, oncological, mental health and decompensated endocrine diseases, tuberculosis, and HIV infection
* Pregnancy and/or lactation
* Patient involvement in other clinical trials within the last 3 months
* Refusal to participate in the study
Mesorectal Excision (ME) Versus ME With Lateral Node Dissection for Stage II, III Lower Rectal Cancer (JCOG0212)

The purpose of this study is to evaluate the of international standard operation, mesorectal excision (ME alone) compared to Japanese standard operation, ME with lateral lymph node dissection for clinical stage II, III lower rectal cancer

Total mesorectal excision (TME) or mesorectal excision (ME) with lateral lymph node dissection for advanced rectal cancer is widely performed in Japan. In other countries, TME or ME without lateral lymph node dissection is the standard. In order to determine which is the better rectal cancer surgery, relapse-free survivals of these are compared as the primary endpoint.

Eligibility Criteria:
Inclusion Criteria:

Preoperative criteria:

1. Histologically confirmed adenocarcinoma
2. Clinical stage II or III
3. Preoperative findings:

   * Main lesion of the tumor is located at the rectum
   * Lower tumor margin is below the peritoneal reflection
   * No extramesorectal lymph node swelling (Shorter diameter is less than 10 mm)
   * No invasion to other organ (s)
4. Patient age is more than 20 and less than 75
5. PS: 0, 1
6. No past history of chemotherapy, pelvic surgery or radiation
7. Written informed consent

   Operative criteria:
8. Mesorectal excision is performed
9. Operative findings:

   * Main lesion of the tumor is located at the rectum
   * Lower tumor margin is below the peritoneal reflection
10. R0 after resection

Exclusion Criteria:

1. Multiple cancer patients
2. Pregnant patients
3. Psychological disorder
4. Steroid administration
5. Cardiac infarction within six months
6. Severe pulmonary emphysema and pulmonary fibrosis
7. Doctor's decision for exclusion
Safety and Efficacy Study of EXC 001 to Improve the Appearance of Scars From Prior Breast Surgery

The study will investigate the efficacy of various doses and regimens of EXC 001 in reducing skin scarring in subjects undergoing revision of scars from prior surgery. The study will also evaluate the safety and tolerability of EXC 001 and placebo.


Eligibility Criteria:
Inclusion Criteria:

* Subjects must have previous had breast surgery resulting in unacceptable scars.
* Subject has chosen to have breast scars revised.
* Subject must not be pregnant or lactating.

Exclusion Criteria:

* Currently pregnant or pregnant during the 6 months, prior to inclusion in the study or lactating.
* Participation in another clinical trial within 30 days prior to the start of the study.
* Any other condition or prior therapy, which, in the opinion of the PI, would make the subject unsuitable for the study.
Initial Temperature of High Flow Nasal Cannula

In the literature there are no indication on which is the best setting of the humidification temperature at the start of treatment with high flow nasal cannula (HFNC) in intensive care unit (ICU). The primary objective of this study is to understand whether there is a difference between the approaches to the humidification temperature for initiating HFNC treatment based on the perceived comfort of ICU patients.

We hypothesize that a gradual increase in temperature (31-34-37°C or 34-37°C) could lead to a different comfort as compared to 37°C as initial starting setting.

The secondary aim is to assess the patient's dryness and humidity level of the nose.

This is a single-center, parallel arm (1:1:1) interventional, non-pharmacological, pragmatic randomized trial. Adult patients who need HFNC treatment for clinical indication will be enrolled and receive a different initial temperature of humidification.

The treatment with HFNC will be carried out as it normally happens for clinical practice, that is the doctor will decide the oxygen concentration, from 21 to 100%, and the flow, from 30 to 60 liters / minute (usually 40-60 liters / minute), according to the patient's level of hypoxia. For the specific purpose of this study, the humidification temperature will be set by the nurse based on the enrollment arm (37°C vs 34-37°C vs 31-34-37°C) rather than by clinical decision. The 37°C arm implies the setting of the temperature immediately at 37°C. The 34-37°C arm implies the setting of the temperature at 34°C and after 15 minutes at 37°C. The 31-34-37°C arm implies setting the temperature initially at 31°C, after 15 minutes at 34°C and after another 15 minutes at 37°C. After 30 minutes at 37°C (target temperature), the patient will be asked to indicate his comfort level, using 5 score visual numerical scale (VNS) ranging from 1 (extreme discomfort) to 5 (best comfort) and the dyspnea level, using Borg scale ranging from 1 (no dyspnea) to 10 (extreme dyspnea). The level of dryness of the nose, HFNC settings and vital signs will also be recorded for each step.

The treatment with HFNC will be provided with the AIRVO 2 (trade mark) system (Fisher \& Paykel Healthcare, New Zealand).

All study procedures will be performed at the ICU of the Fondazione IRCCS (Scientific Institute for Research, Hospitalization and Healthcare) Ca' Granda Ospedale Maggiore Policlinico.

Eligibility Criteria:
Inclusion Criteria:

* Patients need HFNC as per clinical indication
* Patients without ICU delirium (CAM ICU negative)

Exclusion Criteria:

* Patients unable to express informed consent
Nivolumab Plus Epacadostat in Combination With Chemotherapy Versus the EXTREME Regimen in Squamous Cell Carcinoma of the Head and Neck (CheckMate 9NA/ECHO-310)

The purpose of this study is to evaluate the safety and efficacy of the combination of nivolumab plus epacadostat in combination with chemotherapy in first-line recurrent or metastatic patients with squamous cell carcinoma of the head and neck (SCCHN) when compared to the standard of care (EXTREME regimen).


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed SCCHN from any of the following primary sites: oral cavity, oropharynx, hypopharynx, and larynx.
* Must have recurrent or metastatic disease that is not amenable to therapy with curative intent (surgery and/or radiation therapy with or without chemotherapy).
* No prior treatment with systemic anti-cancer therapy for SCCHN unless protocol-defined conditions are met.
* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to1.
* Measurable disease by computed tomography (CT) or magnetic resonance imaging (MRI) per RECIST v1.1.
* Documentation of program death ligand-1 (PD-L1) status prior to randomization.

Exclusion Criteria:

* Recurrent or metastatic carcinoma of the nasopharynx and paranasal sinuses, squamous cell carcinoma that originated from the skin and salivary gland or non-squamous histologies (e.g., mucosal melanoma) and SCCHN of unknown primary origin.
* Untreated central nervous system (CNS) metastases.
* Carcinomatous meningitis.
* Active, known or suspected autoimmune disease.
* Physical and laboratory test findings outside the protocol-defined range.