cyrilzakka/clinical-trials huggingface dataset:
Evaluation of the Performance of a New Adhesive Strip

This study investigates the performance of a new adhesive strip when impacted by output.


Eligibility Criteria:
Inclusion Criteria:

1. Have given written informed consent
2. Be at least 18 years of age and have full legal capacity
3. Have had a stoma for more than one year
4. Have intact skin on the area used in the evaluation
5. Has a stoma with a diameter up to (≤) 35 mm
6. Have a peristomal area accessible for application of adhesive strips (assessed by investigating scientist)

Exclusion Criteria:

1 Currently receiving or have within the past 2 month received radio- and/or chemotherapy 2. Currently receiving or have within the past month received topical steroid treatment in the peristomal skin area or systemic steroid (tablet/injection) treatment.

3. Are pregnant or breastfeeding 4. Having dermatological problems in the peristomal or abdominal area (assessed by investigating scientist) 5. Actively participating in other interventional clinical investigations or have previously participated in this investigation.
The Effect of In Vitro Fertilization on Coagulation Parameters as Measured by Thromboelastogram

Since its introduction in 1978, over 3.75 million babies have been born using in vitro fertilization (IVF). Maturing ovarian follicles lead to a large rise in estrogen to supra-physiological levels . This increase in estrogen has been shown to cause a hypercoagulable state, leading at times to arterial and venous thrombosis.(Thromboelastogram (TEG) is a point of care whole blood hemostatsis analyzer mimicking in vivo conditions and measuring visco elastic properties of the clot. The TEG shows effect of most of the components of hemostatsis: coagulation factors, fibrinogen, platelets and fibrinolysis. Components of TEG include R, reflecting coagulation factor cascade, alpha angle and K measurements reflecting fibrin function, MA reflecting mostly thrombocyte function, coagulation index (CI) measuring global hemostatic statis and LY30 measuring fibrinolysis.

In this study the investigators would like to measure serum estrogen levels and (TEG) in parturients at the beginning and conclusion of an IVF simulation cycle and evaluate how it's influnence on coagulation parameters, and wheather or not a large sample size will effect primary outcomes.

Secondarily the investigators would like to see if estrogen levels are predictors of coagulation parameters and see if age influences TEG parameters


Eligibility Criteria:
Inclusion Criteria:

* Parturients above 18 undergoing in-vitro fertilization at rabin medical center, with the ability to comply with the study requriments.

Exclusion Criteria:

Parturients were excluded if they had;

* hypertension,
* diabetes,
* anticoagulation therapy or any platelet disorder,
* or were not able to comply with study requirments.
Comparing Different Startegies of Positive Pressure Ventilation in Children

The most basic modes of mechanical ventilation are volume-controlled ventilation (VCV) and pressure-controlled ventilation (PCV). VCV guarantees a target volume of ventilation using a constant flow, but may lead to high peak airway pressure (Ppeak) during the gas insufflation . In PCV mode, on the other hand,

The laryngeal mask airway (LMA) provides a useful alternative for airway management during general anaesthesia. Inflation of the LMA cuff produces a low-pressure seal around the larynx, enabling positive pressure ventilation (PPV). The use of LMA as an airway management technique is common in the pediatric anesthesia because of its less irritating effect on the airways due to its location in the upper larynx. Now, the use of laryngeal mask instead of tracheal intubation for airway management has been achieved in day surgery, therefore, how to perform a respiratory management with a laryngeal mask is particularly important. In addition, mechanical ventilation is also a commonly used method of airway management in clinical practice. the ventilator will deliver a constant pressure by decelerating the flow. However, the ventilation volume varies according to the patient's respiratory mechanics . Pressure-controlled ventilation-volume guaranteed (PCV-VG) combines the advantages of both VCV and PCV, which delivers a stable ventilation volume using a decelerating flow pattern.

Eligibility Criteria:
Inclusion Criteria:

1. age between 1 and 5 years.
2. patient scheduled for laparoscopic inguinal hernia repair.
3. American Society of Anesthesiologists classification of physical status of I-II.

Exclusion Criteria:

1. cardiopulmonary disease.
2. severe hepatorenal dysfunction.
3. history of upper respiratory tract infection 2 weeks before the operation.
4. overweight \[more than 20% of standard body weight\].
5. neuromuscular disease.
6. anticipated difficult airway.
7. hiatus hernia or gastroesophageal reflux disease.
SARS-CoV-2 Pre-exposure Prophylaxis With Ivermectin Retrospective Cohort Study

This observational study, a multicenter retrospective cohort database study, carried out in two medical centers, Centro Medico Bournigal (CMBO) in Puerto Plata and Centro Medico Punta Cana (CMPC) in Punta Cana, Dominican Republic, sought to determine whether Ivermectin, at a weekly orally dose of 0.2 mg/kg, is an effective pre-exposure prophylactic method (PrEP) for the spread of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2), in the healthcare workers. The study began on June 29, 2020 and ended on July 26, 2020 (4 weeks).


Eligibility Criteria:
Inclusion Criteria:

* Active workers from Centro Medico Bournigal (CMBO) and Centro Medico Punta Cana (CMPC) during the study.

Exclusion Criteria

* Workers with positive Covid-19 RT-PCR prior to the start of the study
* Those that did not take the first dose of Ivermectin the first week at the start of the study
* Those that did not complied with at least 2 out of 4 weekly doses
* Those that had greater than 14 days difference in days between two intakes Ivermectin
Neoadjuvant HAIC for Resectable Hepatocellular Carcinoma Beyond Milan Criteria

The purpose of this study is to evaluate the efficacy and safety of resection plus neoadjuvant hepatic arterial infusion chemotherapy (HAIC) compared with resection alone in patients with resectable hepatocellular carcinoma beyond Milan criteria.

Resection is the long-term therapeutic option for resectable hepatocellular carcinoma (HCC) patients. While a number of studies demonstrate poor effect and high relapse rate of resection for patients with resectable hepatocellular carcinoma beyond Milan criteria. Our previous prospective study also revealed that neoadjuvant transarterial chemoembolization (TACE) seems to confer a survival benefit for resectable HCC. Recently, the results of our previous prospective study suggested that, compared with TACE, hepatic arterial infusion chemotherapy (HAIC) may improve the survivals for HCC with large HCC.Thus, the investigators carried out this prospective randomized control to demonstrate the superiority of resection plus neoadjuvant HAIC over resection alone.

Eligibility Criteria:
Inclusion Criteria:

* The diagnosis of HCC was based on the diagnostic criteria for HCC used by the European Association for the Study of the Liver (EASL;
* Tumor burden beyond Milan criteria
* Diagnosed as resectable with consensus by the panel of liver surgery experts;
* No past history of resection, radiofrequency ablation, TACE, TAI, chemotherapy or molecule-targeted treatment;
* No Cirrhosis or cirrhotic status of Child-Pugh class A only;
* Meet the following laboratory parameters:(a) Platelet count ≥ 75,000/μL; (b)Hemoglobin ≥ 8.5 g/dL;(c) Total bilirubin ≤ 30mmol/L;(d) Serum albumin

  ≥ 32 g/L;(e) ASL and AST ≤ 6 x upper limit of normal;(f) Serum creatinine

  ≤ 1.5 x upper limit of normal;(g) INR \> 2.3 or PT/APTT within normal limits; (h) Absolute neutrophil count (ANC) \>1,500/mm3;
* Ability to understand the protocol and to agree to and sign a written informed consent document. Exclusion Criteria;
* Patients with clinically significant gastrointestinal bleeding within 30 days prior to study entry.
* Known of serious heart disease which can nor endure the treatment such as cardiac ventricular arrhythmias requiring anti-arrhythmic therapy
* Evidence of hepatic decompensation including ascites, gastrointestinal bleeding or hepatic encephalopathy
* Known history of HIV
* History of organ allograft
* Known or suspected allergy to the investigational agents or any agent given in association with this trial.
* Evidence of bleeding diathesis.
* Any other hemorrhage/bleeding event \> CTCAE Grade 3
* Serious non-healing wound, ulcer, or bone fracture
* Known central nervous system tumors including metastatic brain disease
* Poor compliance that can not comply with the course of treatment and follow up.
Benefits of Immunonutrition in Patients With Head and Neck Cancer Receiving Chemoradiation

This study evaluated the benefits of immunonutrition regarding the prevention of severe mucositis. Patients with head and neck cancer (HNC) undergoing definitive concurrent chemoradiation including 3-week cycles of cisplatin were enrolled in this double-blind phase II study. Patients were randomly assigned to receive an immunonutrition containing omega-3-fatty acids, arginine, dietary nucleotides, and soluble fiber or an isocaloric isonitrogenous control. All patients received the assigned product 5 days before each chemotherapy session. The proportion of patients with severe mucositis was compared between the immunonutrition and control groups.


Eligibility Criteria:
Inclusion Criteria:

* age of 18-65 years
* histological confirmation of stage II-IVb non-metastatic HNC according to the seventh edition of the American Joint Committee on Cancer Staging System (AJCC 2010)
* receipt of definitive CCRT
* Eastern Cooperative Oncology Group performance status of 0-1
* creatinine clearance ≥ 60 mL/min/1.73 m2 calculated by the Cockcroft-Gault formula
* absence of mucositis
* able to tolerate oral feeding

Exclusion Criteria:

* receipt of curative surgery for HNC
* allergies to any component of the immunonutrition
Systemic Avastin Therapy in Age-Related Macular Degeneration

Choroidal neovascularisation (CNV) in age-related macular degeneration is one of the major causes of blindness in the western world. It is already known that the vascular endothelial growth factor (VEGF) plays a major role in the development of CNV. Photodynamic therapy (PDT), subretinal surgery, and intravitreal injection of VEGF- inhibitors are the common treatments. These methods are either very invasive or need to be repeated several times over long periods of time in order show some effect. Furthermore PDT can only be performed in eyes with pigment epithelium detachments (PED) of maximum 50% of the avascular zone, while intravitreal injections can lead to endophthalmitis and acute glaucoma. A systemic treatment, which would only need to be administered 3 times within 6 weeks would be a major effort in macular degeneration therapy.

Bevacizumab (Avastin®, Genentech Inc.) is a new anti-vascular endothelial growth factor (anti-VEGF) which has shown promising results as a combination therapy with 5-fluorouracil, leucovorin, and oxaliplatin in first-line treatment of metastatic colorectal cancer14,15. Since intraocular anti-VEGF therapies for CNV in AMD have already shown promising results, the idea of this study is to administer the anti-VEGF bevacizumab intravenously, as a systemic therapy, in AMD-patients.

The rationale of the present study is to determine the effect of systemic bevacizumab therapy in patients with fibrovascular pigment epithelium detachment (PED), involving the geometric center of the foveal avascular zone, in comparison to placebo treatment with sodium chloride 0,9%.

The patients will receive 3 intravenous infusions of 5mg/kg bevacizumab at 2 weeks intervals or 3 intravenous infusions of 100ml sodium chloride 0,9% at 2 weeks intervals. Medical internal reviews, ETDRS and Radner visual acuity assessment, ophthalmologic examinations, ocular imaging with OCT 3, multifocal ERG, fluorescein angiography, and indocyanine angiography will be performed. The follow-up time is 6 months.

Eligibility Criteria:
Inclusion Criteria:

* AMD patients with fibrovascular pigment epithelium detachment (PED), subfoveal choroidal neovascularisations (CNV) extending under the geometric center of the foveal avascular zone, and a central retinal thickness of at least 300 microns.

Exclusion Criteria:

* Patients who had arterial thromboembolic diseases
* Patients with: Cancer, Proteinuria, Renal impairment, Hepatic dysfunction, Vision threatening ophthalmic diseases other than AMD
Expanded Use in Persistent (B. Microti) Babesiosis

The purpose of this expanded access protocol is to offer a potentially effective treatment (tafenoquine) to patients with persistent babesiosis, who have not responded to standard of care treatments, and who are immunocompromised and thus at risk for more serious complications. Tafenoquine will be self-administered orally as 2 x 100 mg dark pink coated tablets once daily (total daily dose 200 mg) with food on Days 1, 2, 3 \& 4 then weekly thereafter (starting on day 11) until the patient has two consecutive negative PCR tests for Babesia parasites and symptoms of babesiosis have resolved. Other standard of care treatments recommended in the 2020 IDSA Guideline on Diagnosis and Management of Babesiosis should also be included in the treatment regimen.


Eligibility Criteria:
Inclusion Criteria:

* Male or female, aged ≥ 18 years
* Laboratory confirmed infection with B. microti and exhibiting clinical symptoms of babesiosis
* Able and willing to give written informed consent
* Able to take ARAKODA according to Prescribing Information
* If female willing to take birth control for 90 days
* Have risk factors for relapsing disease
* Azithromycin, atovaquone, and/or clindamycin administered in the last 12 months to treat babesiosis, and, in the opinion of the investigator, high likelihood that current infection represents a relapse or continuation of disease
* Willing to initiate or continue a standard of care antimicrobial regimen

Exclusion Criteria:

* Have any of the contraindications for ARAKODA
* Current or planned treatment with quinine while participating in the study
* Any concomitant significant illness unrelated to babesiosis
* Taking any excluded concomitant medication
* The patient is unable to tolerate medication by the oral route
Mindful Walking Intervention for Physical Inactivity

Mindful walking is a meditation practice that combines physical activity and mindfulness practice. The purpose of this study is to examine the effectiveness of mindfulness-based interventions provided for increasing physical activity among adults with low physical activity levels. A randomized controlled trial design will be utilized, with an intervention and waitlist control group (N = 160). Outcomes measured include physical activity, sleep quality, and functional fitness. Participants will receive a total of eight sessions of 60-minute mindful walking training within four weeks. The intervention group will receive the training in Weeks 1-4 and the control group will receive the training during Weeks 5-8. Each training group will consist of up to 20 individuals. Data will be collected at baseline, four weeks, and eight weeks to determine the efficacy of the intervention.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 and above
* English speaking
* Literacy 6th grade and above
* Willingness to share contact information (home address, phone number)
* No current mindfulness practice
* Greenville residents or persons who are patients of the partnering organizations in the investigator's study.
* Self-reported physical activity level below the CDC recommended guidelines (150 minutes (2 hours and 30 minutes) a week of moderate-intensity, or 75 minutes (1 hour and 15 minutes ) a week of vigorous-intensity aerobic activity, or an equivalence combination of moderate- and vigorous intensity aerobic activity

Exclusion Criteria:

* \<18 years old
* Non-English-speaking
* Literacy lower than 6th grade
* Inability to attend intervention sessions
* Already completed or attending a mindfulness-based intervention
* Current pregnancy
* Current/past psychosis
* Acute episode of a substance use disorder (past two weeks)
* Acute episode of depression in the past two weeks
* Moderate to severe traumatic brain injury or brain damage
* Persistent antisocial behavior
* Persistent self-injury requiring clinical management
* Unable to engage for physical or practical reasons (e.g., disabling physical problems, unable to comprehend material)
* Dementia
* Suicidality
* Inability to do light walking for 10 mins at a stretch
* Severely obese BMI (\>50 kg/m2)
Decision Making in Men With Early Stage Prostate Cancer Patients and Partners/Close Allies

The purpose of this study is to collect information on how patients and their partners/close allies make treatment decisions when they have been diagnosed with early stage prostate cancer.

Each patient and his partner will fill out assessments at baseline. Thereafter we will obtain the patients' treatment decision (AT or AS) within approximately 6 months. Once a patient makes a decision, he and his partner will complete another set of questionnaires. The patient and his partner will then complete the remaining questionnaires approximately 6, 12, 18, and 24 months following the treatment decision. We will examine the associations between baseline assessments , and the treatment decision as well as the changes in the assessments and the treatment decision. We will also assess associations between follow-up assessments and the decision to change a treatment decision from AS to AT. Data from patients and partners/close allies will generally be analyzed separately, thus patients who do not have a partner (or partner declines to participate) can still be enrolled and their psychosocial outcomes assessed.

Eligibility Criteria:
Inclusion Criteria:

For patients:

* Men who meet the NCCN guidelines for low risk prostate cancer, which include all of the following:

  * Most recent Gleason score ≤ 6, or clinical stage T1a or less;
  * Most recent PSA level below 10;
  * In the most recent biopsy, had fewer than 3 positive biopsy cores (with ≤ 50% cancer in each); OR the patient's doctor discussed active surveillance as a treatment option (as documented in visit notes of the patient's medical record)
* Are able to speak, read, write and understand English well enough to provide informed consent and complete study tasks
* Has not made a treatment decision prior to consent, as per self report
* 18 years of age or older

For partners/close allies:

* Considered a partner/close ally to the patient in the treatment making decision, as reported by the patient
* Are able to speak, read, write and understand English well enough to provide informed consent and complete study tasks
* 18 years old or older

Exclusion Criteria:

For patients:

* History of a cancer other than prostate cancer and non-melanoma skin cancer
* Significant psychiatric or cognitive disturbance sufficient, in the investigator's judgment, to preclude providing informed consent or participating in the study activities (i.e., acute psychiatric symptoms which require individual treatment)

For partners/close allies:

* Significant psychiatric or cognitive disturbance sufficient, in the investigator's judgment, to preclude providing informed consent or participating in the study activities (i.e., acute psychiatric symptoms which require individual treatment)
Anti-tumor Specific Immune Response in Head and Neck Cancers

The purpose is the description of anti-tumor immune responses in general and according to clinical stage and disease free survival (DFS: survival without recurrence (local or distant)) in patients with Head \& Neck Squamous Cell Carcinoma

Secondary purposes are:

* Study of relationship between anti-tumor immune response and qualitative (yes/no) and quantitative (number) presence of circulating tumor cells (CTCs);
* Study of relationship between qualitative (yes/no) and quantitative (number) presence of CTCs and clinical stage as well as DFS
* Study of relationship between anti-tumor immune response and clinical stage as well as DFS.


Eligibility Criteria:
Inclusion Criteria:

* Patient with Head \& Neck Squamous Cell Carcinoma after extension assessment, regardless of clinical stage (TNM UICC stage I-IV), before any medical or surgical treatment specifically directed against cancer (radiotherapy, surgery, chemotherapy or targeted therapy)
* Consent to participate to the study, non-opposition
* Affiliation to social security

Exclusion Criteria:

* History of neoplasia, synchronous cancer, auto-immune disease, organ transplantation, chemotherapy
* HIV infection
* Corticotherapy during 15 days before blood sampling
Xia Shi Surgical Treatment for Eczema Multi-center Clinical Research

On the basis of Xiashi skin surgery clinical experience, this project adopts the multicenter, randomized, double-blind, controlled trial of design type. Objective, normative evaluation of traditional Chinese medicine cool blood latent town effectiveness of therapeutic regimen in the treatment of eczema, security, and control of the relapse of situation, provide high-level evidence-based basis for traditional Chinese medicine treatment of eczema, aims to form suitable for popularization and application of traditional Chinese medicine in the treatment of eczema.


Eligibility Criteria:
Inclusion Criteria:

* accord with standard of syndrome differentiation of traditional Chinese medicine (blood hot sheng) and western medicine diagnostic criteria (subacute eczema);
* age between 18-65 years old, gender, ethnic unlimited;
* agreed to participate in clinical trials can observe and cooperate with the visitor on schedule;
* volunteered for this study and obtain informed consent will be;
* lesion area of about 5-30% of surface area (BSA) were (containing 3% and 3%, palm measurement method)
* IGA scale of 1 to 3 points (including);
* her lesions mainly located in the trunk and limbs (or);
* Women HCG negative;

Exclusion Criteria:

* known to the study of drug allergy to any of the components;
* previous or current with any may affect the results of systemic disease, or other activity of skin diseases (such as: psoriasis);
* has a liver and kidney function is not complete, liver damage of ALT and AST \> 1.5 times the upper limit of normal, renal BUN \> 1.5 times the upper limit of normal or creatinine \> 1.5 times the upper limit of normal value;
* QTcB or QTcF acuity 450 milliseconds. For subjects QTc acuity bundle branch block 480 milliseconds.
* prior or current with clinical significance of cardiovascular, lung disease, gastrointestinal tract, liver, kidney, blood, nerve abnormalities or mental disease;
* breast-feeding or plan to pregnant women during test;
* skin area score \> 30%;
* eosinophil count score \> 10%
* for nearly two weeks taking corticosteroids or a week, both inside and outside with corticosteroid preparation;
* three months received study medication or other participated in other clinical subjects;
* for any reason cannot cooperate research, for example: how language understanding, not to research centers, etc.;
* Researchers believe can bring obvious risk patients or confuse the results of the study, which should rule out other conditions or disease.