cyrilzakka/clinical-trials huggingface dataset:
Performance of Pulse Oximeter Sensors in Neonates

Validate pulse oximeter sensors in neonates by comparing sensor readings to blood samples during cardiac surgery.

Researchers at the University of California, San Francisco have developed methods that permit them to test multiple pulse oximeter sensors on neonates simultaneously during cardiac surgery. During this type of surgery, the arterial oxygen saturation changes over a wide range, providing an ideal arena for the assessment of neonatal pulse oximeter sensors at many levels of oxygen saturation. Several arterial blood gas samples are typically obtained during these procedures. Saturation of each arterial blood sample is determined by direct oximetry in a hemoximeter and this measurement is compared to the reading displayed on the pulse oximeter.

Eligibility Criteria:
Inclusion Criteria:

* Neonates scheduled to undergo cardiac surgery where routine blood draws would be taken
* Consent signed by at least one legal guardian

Exclusion Criteria:

* Presence of any skin irritation or breakdown on the foot
* Foot impediments which would preclude proper placement of the sensor
* Clinical condition precluding the use of adhesive materials
Preoperative Acetaminophen and Carbohydrate Loading

The study's goal is to assess impact of preoperative acetaminophen and oral carbohydrate drinks on pain and functional status experienced by patients undergoing Mohs micrographic surgery for non-melanoma skin cancers. Patients are randomly assigned to receive standard of care or preoperative acetaminophen 1000 mg and Gatorade sports drinks 2 packets before surgery. Patients are then asked to rate their level of pain, anxiety, thirst, hunger, fatigue on a scale of 0-100 on day of surgery before surgery has started, after clearance of skin cancer, and at the end of the visit. Patients are contacted by phone 48 hours after their surgery to assess their maximum level of post-operative pain (rated from 0-100), usage of over the counter or prescribed pain medications, and presence of complications e.g. bleeding, infection, dehiscence. Differences in perioperative functional status and pain medication usage are compared between patients in control and intervention groups.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients undergoing Mohs micrographic surgery for non-melanoma skin cancers (basal cell carcinoma and squamous cell carcinoma)

Exclusion Criteria:

* history of liver transplant, hepatitis, or cirrhosis, those required to be NPO for subsequent closure by other surgical specialties, or those with known allergy to acetaminophen
Histology VABB-Histology Post Surgery Pilot Project (BETTY Trial)

Pilot study on patients with invasive ductal breast cancer triple negative or receptor tyrosine-protein kinase erbB-2 (HER2) overexpressed, any axillary lymphnodes status (any cN), candidates to neoadjuvant chemotherapy.

The principal endpoint of the study will be the accuracy of the result of the histological examination of the Vacuum- Assisted Breast Biopsy (VABB) performed pre-surgery in comparison to the result of the histological examination of the definitive surgical intervention in patients with radiological complete response at Magnetic resonance imaging (MRI) done after the end of neoadjuvant chemotherapy.

The study articulates in five phases:

Phase one: acquisition of the informed consent followed by positioning a clip into the cancer bed (by radiologist) if not already present; Phase two: after radiological confirmation of pathological Complete Response (pCR) done performing breast ultrasound, MRI and 18F-2-fluoro-2-deoxy-D-glucose fluorodeoxyglucose positron emission tomography (18-FDG-PET) after neoadjuvant chemotherapy the patient becomes candidate to VABB pre surgery.

Phase three: the patient has VABB within 15 day from the term of neoadjuvant chemotherapy Phase four: definitive surgical intervention within 30 days from the end of the neoadjuvant chemotherapy Phase five: verification of correspondence between histology of VABB and definitive histology.

The study hypothesis is that VABB could be used in the patients with pCR to the imaging post-neoadjuvant chemotherapy to confirm sensibility and specificity of 18 FDG TC PET and breast MRI to show the absence of breast cancer.

The use of VABB with negative histology result could bring to a therapeutic gold standard without over surgical treatment

Eligibility Criteria:
Inclusion Criteria:

* age ≥ 18 aa;
* histological diagnosis done at European Institute of Oncology (if not, to does revision of pathological material);
* invasive ductal breast cancer triple negative or HER2 overexpressed, any cN;
* neoadjuvant standard systemic treatment after surgery +/- trastuzumab;
* propose of conservative or demolitive surgery;
* M0
* cancer bed identified pre neoadjuvant chemotherapy by clip

Exclusion Criteria:

* multicentric or bilateral breast cancer
* mammography microcalcifications
* in situ breast carcinoma
* positive anamnesis for previous breast cancer
* positive anamnesis for medical or psychological conditions that prevent membership study
FREEDOM: "Pilot Study of the Feasibility and Safety of Resuming Early Walking After Manual Compression in Patients Treated for Peripheral Artery Disease by Endovascular Technique Involving Retrograde Femoral Puncture"

Over the past years, arterial closure systems have tended to replace manual compression to ensure hemostasis at femoral artery puncture points. Arterial closure systems reduce hemostasis and patient immobilization times, thus enabling early resumption of walking. These devices have contributed extensively to the development of outpatient stays for cardiology, vascular and neuro-radiology procedures.

According to certain studies however, it would appear that arterial closure devices do not present any greater benefits than manual compression in terms of hemostasis and complications. Moreover, the use of increasingly small diameter instruments would tend to render manual compression sufficient. Finally, the use of these devices generates additional costs.

The purpose of our study is to evaluate the feasibility and safety of manual compression before early resumption of walking in patients managed by conventional hospitalization for a diagnostic or therapeutic endovascular procedures by retrograde femoral puncture with 5F guide catheter.


Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years,
* Endovascular examination or treatment compatible with a 5F guide catheter
* Walking ability
* Patient affiliated with a social security scheme
* Patient's signed informed consent form

Exclusion Criteria:

* Underage patient
* Patient of age, but under legal guardianship or care
* Contraindication to endovascular treatment
* Use of a 6F or greater guide catheter
* Morbidity contraindicating same-day walking
* History of punctured open femoral triangle surgery
* Radial or humeral puncture
* Bilateral femoral puncture
* Anterograde femoral puncture
* Acute ischemia
* Anticoagulant treatment
* Allergy to Elastoplast® type adhesive strips
* Life expectancy of less than one month
* Patient refusal to take part in the study
* Participation in another therapeutic trial
* Pregnant woman
* Patients who do not speak French, refusing or incapable of the follow-up proposed by the study
Effects of Kinesio Taping Techniques in COPD Patients

Study will investigate effects of two different kinesio taping techniques on pulmonary parameters of patients with COPD.

Chronic Obstructive Pulmonary Disease (COPD) is an irreversible, progressive, treatable airway disease which causes dyspnea, wheezing, coughing and increased secretions in airways. Thoracic and respiratory mechanics are impaired, respiratory muscle strength and functional exercise capacity is decreased in patients with COPD. As a result dyspnea, limitation in activities of daily living, postural impairments, muscle length-strength relationship changes and increased mechanical loads on respiratory muscles occur. In literature it has been demonstrated that Kinesio Taping have therapeutic effects on respiratory functions and functional exercise capacity in patients with chronic neurological diseases who has additional respiratory impairments. Although there are several studies in literature investigating the effects of facilitation and inhibition taping techniques applied on respiratory muscles in patients with COPD, effects of thoracic and postural mechanical correction techniques as an alternative treatment modality in patients with COPD have not been investigated yet. In present study, effects of thoracic mechanical correction and facilitation taping techniques in patients with COPD will be investigated, and data will be collected for effects of thoracic mechanical correction taping on pulmonary parameters in patients with COPD.

Eligibility Criteria:
Inclusion Criteria:

* Male and female COPD patients aged between 40-80 years
* Diagnosed with COPD stage I-II-III-IV according to GOLD 2019 criterias
* Able to speak, understand and read Turkish language
* Volunteering to participate in study

Exclusion Criteria:

* Unstable or acutely exacerbated patients with COPD
* Alterations in medical treatment in last 6 months
* Having comorbidities that affect directly cardiopulmonary system, uncontrolled arterial hypertension, severe congestive heart failure, coronary arterial disease, heart valve disease
* Orthopaedic, neurological, psychiatric disease, peripheral/central nervous system diseases, mental retardation, antidepressants usage, metabolic impairments, malignancy
* Unable to cooperate for measurement and treatment techniques used in study
* Irritation, infection, allergic reaction, scarred burn or open wound around application area
* Enrolled in a comprehensive pulmonary rehabilitation program before study
* Application of Kinesio Tape to any body region in the past
* History of an open heart surgery or other thoracic surgeries
Cyclophotocoagulation in Glaucoma

Transscleral cyclophotocoagulation of the ciliary body is an effective technique to reduce intraocular pressure in case of glaucoma. Due to concerns over complications, the main indications for this second-line treatment are refractory glaucoma medication / surgery and low visual prognosis. The 2000 milliwatts (mW) for 2 seconds settings are used by the majority of researchers and clinicians according to the published literature. Some have proposed using 1250 mW for 4 seconds to improve the use of this medical procedure.

The aim of this study is to determine how different parameters affect the efficacy of the treatment. This is a prospective double-blinded randomized controlled trial comparing two groups, the experimental group using 1250 mW for 4 seconds and the control group using 2000 mW for 2 seconds.


Eligibility Criteria:
Inclusion Criteria:

* Patients with poorly controlled high pressure glaucoma
* Cyclophotocoagulation necessary to prevent visual loss
* Cyclophotocoagulation necessary to prevent or to reduce ocular discomfort

Exclusion Criteria:

* Patient has already undergone a cyclophotocoagulation or cryotherapy treatment in the same eye for glaucoma
* Patients receiving concomitant treatment the same day as the intervention
* Patient not able to follow the prescribed post-operative treatment
Efficacy/Safety of Lansoprazole in Patients With Frequent Nighttime Heartburn

Heartburn, a burning sensation in the chest or throat, occurs in many individuals when acidic stomach contents move upward into the esophagus from the stomach. This study will investigate the safety and efficacy of lansoprazole 15 mg or 30 mg administered once a day in preventing frequent nighttime heartburn.


Eligibility Criteria:
Inclusion Criteria:

* Experiencing heartburn at least 2 days per week during the nighttime period over the past month.
* Having heartburn that responds to heartburn medication.
* Be willing to discontinue the use of heartburn treatment for 7 days prior to inclusion in the study.

Exclusion Criteria:

* Having history of erosive esophagitis or gastroesophageal reflux disease diagnosed by a physician and confirmed by testing (endoscopy).
* Be unwilling to take only the study medication, and antacid provided as a rescue medication for relief of acute heartburn during the study.

"Other protocol-defined inclusion/exclusion criteria may apply"
Treatment of Freckles by Intradermal Tranexamic Acid Versus Q Switched KTP Laser.

Comparative split face study in which 30 patients with freckles are recruited.One side of the face will be treated with Q Switched (QS)KTP 532nm, and the other side will be treated with intradermal tranexamic acid (TXA).

One side of the face will receive QS KTPlaser at a wavelength of 532 nm, spot size 2-3 mm , power 1-1.5J/cm2 and the clinical end point is just frosting.Sessions will be every month for 2 months.

The other side of the face will be assigned to TXA intradermal microinjection in the same session using Kapron 500mg/5ml ampoules (Amoun Pharmaceutical Company), the dose of 1 ml syringe with 100mg/ml. TXA will prepared under sterile conditions. Injections will be applied intradermally on freckles area at.

The sessions of TXA will be every 2 weeks for 2 months.

Postoperatively, topical antibiotic ointment and steriod will be applied. Sunscreen then applied until the next treatment in order to minimize reactive hyperpigmentations.

Follow up after treatment monthly for 2 month.

Eligibility Criteria:
Inclusion Criteria:

* Both genders
* Age group \> 18years old.

Exclusion Criteria:

* Pregnant and lactating females.
* Keloid and scarring tendancy
* Usage of invasive or semi invasive procedures for treatment of freckles such as chemical peeling , dermaroller..etc. 2 months prior to the study.
* Oral Isotretinoin 6 months prior to the study.
* Active herpetic lesions.
* Any concurrent active skin disease within the treated area.
* Photosensitive skin conditions such as systemic lupus erythematous.
* History of delayed wound healing.
* Bleeding diathesis.
* Medical conditions such as autoimmune diseases.
The Combination of Atorvastatin, Acetylcysteine and Danazol as the Treatment of Steroid-resistant/Relapse Immune Thrombocytopenia

Single-arm, open-lable, multicentre study to compare the efficacy and safety of atorvastatin, acetylcysteine plus danazol with danazol monotherapy in patients with corticosteroidresistant/relapsed ITP.

Immune thrombocytopenia (ITP) is a severe bleeding disorder. Approximately 2/3 of patients achieve remission from first-line therapies. However, the underlying mechanism of corticosteroid-resistant or relapsed ITP is not well understood; thus, treatment remains a great challenge. Atorvastatin was shown to enhance bone marrow endothelial cell function and N-acetylcysteine (NAC) was shown to inhibit PLT binding to endothelial cell.

A multicentre prospective study was performed in non-splenectomized ITP patients who were either resistant to a standard dose of corticosteroids or had relapsed. Patients were randomized to atorvastatin, acetylcysteine plus danazol with danazol monotherapy group. Platelet count, bleeding and other symptoms were evaluated before and after treatment. Adverse events are also recorded throughout the study, in order to compare the efficacy and safety of atorvastatin, acetylcysteine plus danazol with danazol monotherapy in patients with corticosteroid-resistant/relapsed ITP.

Eligibility Criteria:
Inclusion Criteria:

* ITP confirmed by excluding other supervened causes of thrombocytopenia;
* Platelet count of less than 30×10\^9/L at enrollment;
* Patients who did not achieve a sustained response to treatment with full dose corticosteroids for a minimum duration of 4 weeks or who relapsed during steroid-tapering or after its discontinuation;
* ECOG\<2.
* EPCs in bone marrow less than 0.02%

Exclusion Criteria:

* Secondary immune thrombocytopenia (e.g., patients with HIV, HCV, Helicobacter pylori infection or patients with systemic lupus erythematosus)
* congestive heart failure
* severe arrhythmia
* nursing or pregnant women
* aspartate aminotransferase and alanine transaminase levels ≥ 3× the upper limit of the normal threshold criteria
* creatinine or serum bilirubin levels each 1.5 times or more than the normal range
* active or previous malignancy
* Unable to do blood routine test for the sake of time, distance, economic issues or other reasons.
Phase I/II Trial of Stereotactic Body Radiotherapy With Concurrent Fixed Dose Tyrosine Kinase Inhibitors in Metastatic Renal Cell Carcinoma: Dose Limiting Toxicity and Abscopal Effect.

Tyrosine kinase inhibitors (TKIs) are often used in the standard treatment for patients with metastasized renal cell carcinoma. In addition to their ability to specifically inhibit tumor growth, TKIs also interfere with the vascularisation of the tumor. Unfortunately, most patients do not obtain long-lasting clinical benefit from this treatment. The goal of the current study is to enhance the effect of TKIs by combining them with stereotactic radiotherapy treatment of one of the metastases. This type of radiotherapy allows us to precisely irradiate the tumor with minimal effect on the surrounding healthy tissue. Recently it has been demonstrated that this type of radiotherapy stimulates the immune system to attack the tumor. By combining stereotactic radiotherapy with TKIs we expect to observe a reduction of metastases in a bigger population of patients.

In the first part of our study we focus on the safety of the combination therapy. In the second part we will evaluate the combined treatment response.


Eligibility Criteria:
Inclusion Criteria:

* signed informed consent
* diagnosis of RCC with clear-cell component histology
* at least 3 extracranial measurable metastatic lesions per RECIST
* Karnofsky Performance score \>60
* patients should have undergone cytoreductive treatment of their RCC at least 6 weeks prior to inclusion
* patients should have adequate organ function for TKI treatment.

Exclusion Criteria:

* prior systemic treatment for RCC
* uncontrolled central nervous metastases
* prior radiotherapy interfering with SBRT
* any disorder precluding understanding of trial information.
To Evaluate the Pharmacokinetic Drug Interactions, Safety and Drug Tolerance in Healthy Volunteers

A randomized, open-label, multiple-dose, 2x3 crossover clinical trial to investigate the pharmacokinetic drug interaction of JW0201 and C2103 or C2104 after oral administration in healthy adults

1. To evaluate the pharmacokinetic characteristics, safety, and drug tolerance of combined administration JW0201 and C2103 compared to the case of each single administration in healthy adults.
2. To evaluate the pharmacokinetic characteristics, safety, and drug tolerance of combined administration JW0201 and C2104 compared to the case of each single administration in healthy adults.

Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers

Exclusion Criteria:

* Subjects does not meet the Inclusion Criteria
Influence of the Consumption of Conventional and Electric Cigarettes on Skin Circulation

The survey participants are divided into a smoking and non-smoking group. The smoker group is further divided according to the quantity and quality of nicotine ("normal" smoking, vaping). After reaching a steady state, the cutaneous blood flow at rest in the extremities of all participants is determined by Laser Doppler Imaging as a reference value. Laser Doppler Imaging produces images of the blood flow using perfusion units (PU). Subsequently, the perfusion is measured again after smoking/vaping. The difference in skin perfusion of the extremities is calculated (δ-Perfusion). All measurements are performed under controlled vital parameters (body temperature, systolic and diastolic blood pressure, heart rate) and controlled room temperature as well as 15-minute acclimatization of the patients.

After consenting to the study, the subjects are examined using Laser Doppler Camera.

The skin blood flow of the extremities is determined as a reference value. Laser Doppler Imaging produces images of the blood flow using the perfusion units (PU).

All measurements are taken under controlled vital parameters (body temperature, systolic and diastolic blood pressure, heart rate) and controlled room temperature as well as 15-minute acclimatization of the subjects.

For smokers or vapers, the perfusion is measured again after consuming a cigarette or an e-cigarette respectively. The difference of blood flow after smoking or vaping is calculated using both measures.

The total duration of the study per subject is approximately 25-30 minutes.

Eligibility Criteria:
Inclusion Criteria:

Healthy adult non-smokers, smokers, vapers

Exclusion Criteria:

* Adults with cardiopulmonary diseases
* Pregnant women
* Adults that participating in other surveys
Mindfulness-based Intervention Prior to External Cephalic Version

The study is a randomized controlled trial examining the effectiveness of a short mindfulness-based intervention on the success rate of external cephalic version in pregnant women with breech presentation. It is hypothesized that this intervention will increase the ECV success rate and decrease the pain experienced after the ECV.


Eligibility Criteria:
Inclusion Criteria:

* Pregnant women (18+y).
* With a breech presenting fetus undergoing external cephalic version.
* Dutch/English-speaking or understanding Dutch/English.
Effect of Different Feeding Modes on Psychological Condition and Experience in Stroke Patients

The goal of this clinical trial is to compare the differences on Psychological Condition and Experience in ischemic stroke patients using Intermittent Oro-esophageal Tube and Nasogastric Tube. Patients will be randomly divided into an observation group and a control group, all receiving routine rehabilitation treatment. On this basis, the observation group will use Intermittent Oro esophageal Tube for enteral nutrition support, while the control group will use Nasogastric Tube. Researchers will compare Psychological Condition and Experience of two groups.

The study will last 15 days for each participant. The goal of this clinical trial is to compare the differences on Psychological Condition and Experience in ischemic stroke patients using Intermittent Oro-esophageal Tube and Nasogastric Tube. Patients will be randomly divided into an observation group and a control group, all receiving routine rehabilitation treatment. On this basis, the observation group will use Intermittent Oro esophageal Tube for enteral nutrition support, while the control group will use Nasogastric Tube. Researchers will compare Psychological Condition and Experience of two groups.

Eligibility Criteria:
Inclusion Criteria:

* Age\>18 years.
* Meeting the diagnostic criteria for ischemic stroke .
* Dysphagia confirmed by Videofluoroscopic Swallowing Study.
* Clear consciousness.
* Stable vital signs.

Exclusion Criteria:

* Dysphagia that might be caused by other diseases that might cause dysphagia, such as head and neck tumors, traumatic brain injury, myasthenia gravis, etc.
* Complicated with severe liver and kidney failure, tumors, or hematological disorders.
* Simultaneously in need to undergo other therapy that might affect the outcomes of this study.
* Pregnant or nursing females.