cyrilzakka/clinical-trials huggingface dataset:
Prone Positioning and R/I Ratio in COVID-19 Patients With ARDS (SyDRAC-DV)

The purpose of this study is to determine the efects of prone positioning on the recruitment- to-inflation ratio in COVID-19 patients with acute respiratory distress syndrome.

High positive end-expiratory pressure (PEEP) level and prone positioning (PP) are recommended in patients with moderate to severe acute respiratory distress syndrome (ARDS) in order to recruit lung and thus to improve oxygenation. Thus, high PEEP level and prone positioning will be more effective in patients with high potential for lung recruitment. Recently, the Recruitment-to-Inflation Ratio (R/I ratio) has been described and validated in patients with ARDS to estimate the potential for lung recruitment. In this regard, the R/I ration may be of interest to titrate PEEP level in patients with ARDS. This would be of particular interest in COVID-19 patients with ARDS, since different ARDS phenotypes with heterogeneous potential of lung recruitment have been described in these patients. However, the effects of prone positioning on R/I ratio have been scarcely described so far. Thus, the main goal of this study is to investigate the effects of prone positioning on the R/I ratio in COVID-19 patients with ARDS. The second goal of this study is to determine the effects of prone positioning on oxygenation and respiratory mechanics according to the R/I ratio.

Eligibility Criteria:
Inclusion Criteria:

1. Invasive mechanical ventilation
2. Patients with acute respiratory distress syndrome according to the Berlin definition
3. Positive COVID-19 real-time reverse transcriptase-polymerase chain reaction assay in nasal swabs or pulmonary samples.
4. Indication to a prone positioning session by the attending physician

Exclusion Criteria:

1. Age \<18 years and pregnant women
2. Patients under legal protection
3. Acute core pulmonale
4. Pneumothorax and/or chest drainage
5. Hemodynamic failure

   1. Increase in norepinephrine dosage \>30% within the last 6 hours
   2. Norepinephrine dosage \> 0.5 mg/kg/min
Study to Evaluate the Safety and Efficacy of NKTR-102 in Patients With Metastatic or Locally Advanced Breast Cancer

This is a multicenter, open-label, two-arm, 2-stage, Phase 2 study of NKTR-102 in patients with metastatic or locally advanced breast cancer whose disease has failed prior taxane-based treatment in the metastatic setting.

Patients will be randomized 1:1 into one of two treatment arms. NKTR 102 will be administered at a dose level of 145 mg/m2 in both arms. In Arm A, NKTR-102 will be given on a q14d schedule. In Arm B, NKTR-102 will be given on a q21d schedule. Approximately 70 patients may be evaluated in this study with approximately 35 patients enrolled in each treatment arm.


Eligibility Criteria:
Inclusion Criteria:

1. Inoperable metastatic or locally advanced breast cancer
2. No more than 2 prior chemotherapy regimens given in a metastatic or locally advanced setting and prior treatment in the metastatic setting must have included a taxane

Exclusion Criteria:

1. Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to Day 1 of Cycle 1
2. Patients who have had any major surgery within 4 weeks prior to Day 1 of Cycle or minor surgery within 2 weeks prior to Day 1 of Cycle 1
Intervention Study on Medication Reconciliation Among Pharmacists in Two Tertiary Hospitals in Nigeria

This study will assess the current practice of medication reconciliation among pharmacists in the selected institutions with a view to making an intervention to address gaps discovered

Background information garnering will be done among the pharmacists in the two selected hospitals to collect data on current practice of medication reconciliation. Focus group discussion will be done in the intervention group so as to identify peculiarities of their practice and to provide the best approach to carrying out the intervention. Diabetes and hypertensive patients in medical outpatient clinic will be interviewed in order to assess current practice of medication reconciliation.

Intervention will be channeled towards addressing gaps discovered. University College Hospital, Ibadan, Oyo State will be the intervention group, while University of Ilorin Teaching Hospital, Kwara State will be the control group.

The effect of the intervention will be measured over time to ensure that medication reconciliation is implemented in the selected institutions.

Eligibility Criteria:
Inclusion Criteria:

* Participant has diabetes and/or hypertension
* Registered pharmacists in the selected institutions

Exclusion Criteria:

* Participants that are neither diabetic nor hypertensive
* Unregistered pharmacists in the selected institutions
Cyanoacrylate Closure Versus Surgical Stripping for Incompetent Saphenous Veins

The purpose of this study is to evaluate the non-inferior, clinical outcomes after cyanoacrylate closure comparing the surgical stripping for incompetent saphenous veins.

Varicose veins are highly prevalent. In western countries, an estimated 23% of adults have varicose veins, and 6% have more advanced chronic venous disease, including skin changes and healed or active venous ulcers. There are several modalities to treat varicose veins. Open surgical treatment with ligation and stripping of the saphenous vein, combined with excision of large varicosities, has been the standard of care for many years. Endovenous thermal ablation by radiofrequency ablation (RFA) or endovenous laser ablation (EVLA) has been shown to be a safe and effective alternatives with high long-term target vein closure rates. Although both techniques have gained broad acceptance in many countries, one major disadvantage of these techniques is the requirement for use of tumescent anesthesia to avoid the thermal injury of the surrounding structures. Cyanoacrylate closure for varicose veins has recently been introduced for treatment of the incompetent saphenous vein.

Eligibility Criteria:
Inclusion Criteria:

* Age between 18 and 80 years of age at the time of enrollment
* Reflux in great saphenous vein greater than 0.5 seconds after distal compression and release or Valsalva's maneuver in the standing or reverse Trendelenburg position
* Diameter of saphenous vein between 2mm to 20mm (with standing position)
* One or more of the following symptoms related to the incompetent saphenous vein: aching, throbbing, heaviness, fatigue, pruritus, night cramps, restlessness, generalized pain or discomfort, swelling
* Clinical, Etiologic, Anatomic, and Pathophysiologic classification of C2 through C5

Exclusion Criteria:

* Previous treatment in targeted vein segment
* Tortuous vein in which the delivery catheter cannot be inserted
* Aneurysm of target vein segment \>20 mm
* Daily use of narcotic or nonsteroidal anti-inflammatory pain medications to control pain associated with greater saphenous vein reflux
* Known hypercoagulable disorder
* Active malignancy
* Regular use of systemic anticoagulation
* Current use of systemic anticoagulant
* Previous deep vein thrombosis/pulmonary embolism or active acute superficial thrombophlebitis
* Unable to comply with the schedule and protocol evaluations
* Unable to ambulate
* Currently pregnant or breast feeding
* Known sensitivity to cyanoacrylate adhesives
* Symptomatic peripheral arterial disease with ankle-brachial index \<0.9
* Participation in another clinical study that has not reached primary endpoint within 30 days prior to enrollment
* Any condition which in the opinion of the investigator could compromise subject safety or adherence to the protocol
Impact of Flash Glucose Monitoring in People With Type 2 Diabetes Using Non-Insulin Antihyperglycemic Therapy

The objective of this study is to evaluate the effectiveness of a flash glucose monitor device in achieving optimal glycemic control among adults with type 2 diabetes inadequately controlled with non-insulin antihyperglycemic therapy.

The IMMEDIATE study is a multi-centre, randomized controlled, open-label, two-phase cross-over study evaluating the effectiveness of a flash glucose monitor device to increase the proportion of time spent in target glucose range (3.9 to 10.0 mmol/L) among adults with type 2 diabetes inadequately controlled with non-insulin antihyperglycemic therapy compared to a control group not using a flash glucose monitor device. The study will consist of two phases; each 16 weeks long. In Phase 1, study participants who meet eligibility criteria will be randomized to receive a flash glucose monitor device combined with diabetes self-management education, or diabetes self-management education alone. In Phase 2, participants initially assigned to receive education alone will crossover to receive a flash glucose monitor device while participants initially using the flash glucose monitor will continue using their device. No diabetes self-management education will be provided during Phase 2.

Eligibility Criteria:
Inclusion Criteria:

Eligible participants must be an adult aged 18 years or older and:

* A clinical diagnosis of T2D, with diagnosis known for six months or more;
* An HbA1c of \> 7.5%;
* Using one or more non-insulin antihyperglycemic therapy for a minimum of six months, with dose stability of 3 months; and
* No previous history of using CGM or FGM devices.

Exclusion Criteria:

Participants will be excluded from the study if they:

* Have a history of insulin use \> 3 months
* Are pregnant or breastfeeding
* Have diabetic retinopathy
* Have an estimated glomerular filtration rate (eGFR) \< 30 ml/min/1.73 m2
* Have unstable cardiovascular disease
* Use other implanted medical devices, such as pacemakers
* Have had more than one episode of severe hypoglycemia during the past 6 months or evidence of hypoglycemia unawareness
* Anticipate or require regular magnetic resonance imaging, computed tomography scan, or high-frequency electrical heat (diathermy) treatment
ERADICATING CERVICAL CANCER IN KENYA

This is a study of a strategy designed to 1) increase cervical cancer screening using a community-based approach, and 2) determine the efficacy of HPV vaccination in a region of Kenya where half of all children are chronically exposed to aflatoxin.

Cervical cancer is caused by oncogenic HPV, and is the main cause of cancer-related death among Kenyan women. This malignancy is preventable through a combination of screening of adult women and vaccination of children and adolescents against HPV infection. However, only 5% of Kenyan women are regularly screened, and only 14% have ever been screened, which in Kenya is done by a method known as Visual Inspection with Acetic Acid (VIA). Obstacles to screening include travel to clinics, costs, poor specificity of VIA, lack of trained personnel, and others. In addition, while safe and effective HPV vaccines have been available for 15 years, very few (\<1%) Kenyan children and adolescents have been vaccinated. Obstacles to vaccination include costs, delivery infrastructure, lack of education, travel to clinics, and others. In addition, there are few studies of HPV vaccination in African children, and two-dose regimens may not provide adequate protective antibody levels among children chronically exposed to aflatoxin, a potent immunosuppressive agent found in contaminated corn. Investigators propose a study of a strategy designed to 1) increase cervical cancer screening using a community-based approach, and 2) determine the efficacy of HPV vaccination in a region of Kenya where half of all children are chronically exposed to aflatoxin.

Objective 1 (Cervical cancer screening): Evaluate High-Risk (HR)-HPV DNA testing of self-collected vaginal swabs as a triage step for VIA among rural Kenyan women.

Hypothesis: All women with negative HR-HPV DNA tests will have normal VIA examinations or falsely-abnormal VIA examinations based on cervical biopsy results. The rationale is that if this hypothesis is correctly proven, it will suggest that VIA is unnecessary for women with negative HR-HPV DNA tests in self-collected vaginal swabs.

Objective 2 (HPV vaccination): Determine the effects of chronic aflatoxin exposure among Kenyan children/adolescents on the likelihood of seroconversion to HPV types represented in the HPV vaccine.

Hypothesis: Compared to children/adolescents without detectable plasma aflatoxin, children/adolescents with evidence of chronic aflatoxin exposure will have a reduced likelihood of seroconversion to HPV types represented in the HPV vaccine. The rationale is that if this hypothesis is correctly proven, it will suggest that adjustments in vaccination doses/schedules may be needed for children with chronic exposure to aflatoxin to assure adequate protection against HPV infection.

Eligibility Criteria:
Inclusion Criteria:

* Kenyan women between ages of 18 and 60 years and children/grandchildren aged 9 through 18 of women attending the Community Meetings.

Exclusion Criteria: Pregnancy, history of cervical cancer, allergy to HPV vaccine (children)

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A Efficacy Against Otitis Media in Children With 11 Valent Pneumococcal Vaccine

The purpose of this study is to assess the efficacy in young children in preventing acute otitis media due to vaccine serotype pneumococcal or non typable Hemophilus influenza, following immunization with an 11-valent pneumococcal vaccine according to a 3 dose primary vaccination in the first year of life, with booster dose in the second year of life. Prophylactic immunization with pneumococcal conjugate vaccine is compared to placebo (hepatitis A vaccine).


Eligibility Criteria:
Inclusion Criteria:

* Male or female between 6 weeks and 5 months (42-152 days) of age at the time of first vaccination.

Exclusion Criteria:

* Use of any investigational or non-registered drug or vaccine other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
Study on the Use of Artificial Intelligence (Fujifilm) for Polyp Detection in Colonoscopy

Colonoscopy is currently the best method of detection of intestinal tumors and polyps, particularly because polyps can also be biopsied and removed. There is a clear correlation between the adenoma detection rate and prevented carcinomas, so adenoma detection rate is the main parameter for the outcome quality of diagnostic colonoscopy. The efficiency of preventive colonoscopy needs optimisation by increase in adenoma detection rate, as it is known from many studies that approximately 15-30% of all adenomas can be overlooked. This mainly applies to smaller and flat adenomas. However, since even smaller polyps may be relevant for colorectal cancer development, the aim of colonoscopy should be to preferably be able to recognize all polyps and other changes.The latest and by far the most interesting development in this field is the use of artificial intelligence systems. They consist of a switched-on software with a small computer connected to the endoscope processor; the patient's introduced endoscope is completely unchanged.

The present study therefore compares the adenoma detection rate (ADR) of the latest generation of devices with high-resolution imaging from Fujifilm with and without the connection of artificial intelligence.

Methods of Computer Vision (CV) and Artificial Intelligence (AI) provide completely new opportunities, e.g. in the automatic polyp detection and differentiation of a lesion based on its endoscopic image. Computer vision using artificial intelligence methods means the application of "trained" so-called deep neural net (DNN) with a set of defined images (e.g. everyday scenes) and well-known solutions ( e.g. name of the pictured item; c.f. e.g. the "ImageNet Challenge"). The technical feasibility of using AI algorithms in endoscopy has already been proven in many cases. In the present study, it is an AI system from Fujifilm, which is already clinically usable. By using Fujifilm high-resolution imaging devices in colonoscopies, AI will be added randomly.

Eligibility Criteria:
Inclusion Criteria:

* Persons\> 35 years of age who are capable of giving informed consent
* Planned diagnostic colonoscopy (clarification of symptoms, polyp follow-up)
* Screening colonoscopy for men \>50 or women \> 55 years of age

Exclusion Criteria:

* Colon bleeding
* Colon carcinoma
* Known polyps for removal
* Inflammatory bowel disease
* Colonic stenosis
* Other suspected colon disease for further clarification
* Follow-up care after colon cancer surgery (partial colon resection)
* Anticoagulant drugs that make a biopsy or polypectomy impossible
* Poor general condition (ASA IV)
* Incomplete colonoscopy planned
Coagulation in Acute Aortic Dissection

Acute aortic dissection (AAD) involving the ascending aorta (Stanford classification type A) remains a life-threatening disease. Excessive perioperative bleeding requiring massive transfusion of allogeneic blood products, and surgical reexploration remain major challenges in these patients. Previous research has indicated that patients with AAD show pronounced haemostatic alterations prior to surgery which are aggravated during major aortic surgery with cardiopulmonary bypass and hypothermia full heparinization.

Intensified anticoagulation management guided by heparin dose response (HDR) calculation, and repeated measurement of heparin concentration may be more effective than standard empiric weight-based heparin and protamine management monitored by activated clotting time (ACT) measurements to suppress thrombin generation during surgery for AAD.

This randomized controlled clinical trial compares the impact of two recommended anticoagulation management strategies during surgery for AAD including deep hypothermia on activation of coagulation: Heparin/protamine-management based on HDR-titration by means of HMS Plus® versus current institutional standard (HDR- versus ACT-approach).

Primary endpoint is thrombin generation as measured by early postoperative prothrombin fragment 1+2 (F1+2). Secondary endpoints are other markers of coagulation and fibrinolysis as well as clinical outcome.

Hypotheses:

Primary: HDR-approach is superior to ACT-approach in terms of suppressing thrombin generation after emergent surgery for acute aortic dissection (Stanford type A).

Secondary: HDR-approach is superior with regard to

* early postoperative haemostatic capacity
* requirement of blood product transfusion and haemostatic agents
* postoperative bleeding

Design:

Investigator-initiated, single-site, parallel-group (1:1), prospective, randomized, partially double-blinded trial in patients undergoing emergent surgery for acute aortic dissection comparing two heparin management strategies with superiority design. Prior to randomization, patients are stratified according to preoperative organ dysfunction and anticoagulation therapy.

Acute research study design as patients with acute aortic dissection are considered incompetent according to the Danish Research Ethics Committees definition. Deferred consent by the competent patient or her/his proxy (next of kin) and an independent physician) is used. 26 consecutive patients undergoing emergent surgery for acute aortic dissection (Stanford type A) are randomized 1:1 into the following heparin management strategies with an ACT target of 480 seconds:

* Individualised HDR-approach
* Conventional ACT-approach

No interim analysis. A sub-study to compare cost-benefit of both strategies is planned.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years
* Emergent Acute Aortic Dissection with cardiopulmonary bypass
* Incapable of providing informed consent

Exclusion Criteria:

* History of congenital coagulation disorder (haemophilia)
* Previous open cardiac surgery
* Death during induction of anaesthesia
High Frequency Chest Wall Oscillations Versus Lung Flute in Chronic Obstructive Pulmonary Disease Post(SARS-CoV-2)

COPD causes an acute deterioration of respiratory symptoms, particularly increased breathlessness and cough, and increased sputum volume and/or purulence. Worsening airflow limitation is associated with an increasing prevalence of exacerbations and risk of death. These exacerbations can range from self-limited diseases to episodes of florid respiratory failure requiring mechanical ventilation .Hospitalization for COPD patients post COVID is associated with poor prognosis with increased risk of death. Hence techniques of efficient clearance of peripheral airways may reduce airway occlusion by excess mucus and inflammatory cells, improving lung function, exercise capacity and reducing exacerbation frequency.

Patients were assigned to 2 groups with pre- and post- treatment protocol application. All patients were thoroughly evaluated before and after treatment protocol application. Thirty patients (Group A) received high frequency chest wall oscillation with vest system in addition to their prescribed medication, 3 times per week for three successive weeks and the total duration of each session was 15-30 minutes. Thirty patients (Group B) received Lung flute (OPEP) in addition to their prescribed medication, 2 times per week twice a day for three successive weeks and the total duration of each session was 10-15 minutes

Eligibility Criteria:
Inclusion Criteria:

* All patients aged 40-60 years old
* All patients were recovered from COVID not more than 3 months
* All patients were diagnosed as COPD for at least two years ago.
* All patients had irreversible/ partially reversible obstruction of airflow.
* COPD patients had a post-bronchodilator, FEV1/FVC% \< 70%. They had an increase in FEV1\< 200 ml, or \< 12% of baseline value 20 minutes after 2 puffs of inhaled salbutamol (100 µg) given via a metered-dose inhaler.

Exclusion Criteria:

* Presence of malignant disease.

  * Patients with acute infection.
  * History of osteoporosis, significant gastro-oesophageal reflux, hiatus hernia.
  * Recent acute cardiac event (6 weeks) or congestive cardiac failure.
  * Any significant musculoskeletal disorders.