cyrilzakka/clinical-trials huggingface dataset:
Cold Application on the Subcutaneous Injection

The goal of this clinical trial is to compare the effect of cold application at different periods of time on the occurrence of bruising, haematoma and pain in the subcutaneous low molecular weight heparin (LMWH) injected patients.

The study was a single-blind randomised control trial. Patients were allocated randomly to three groups: (i) Cold was applied for two minutes before the injection in the first group (n=26); (ii) Cold was applied for 5 min before the injection in the second group (n=26); and (iii) control group (n=26). All participating patients were injected 40 mg enoxaparin sodium in 0.4 ml in the pre-filled syringes using standard LMWH injection protocol. Post-injection VAS (Visual Analogue Scale) assessment and assessment of the presence and size of bruise and haematoma were conducted at 48th and 72nd hours after the injections for all groups.

Eligibility Criteria:
Inclusion Criteria:

* to receive LMWH (pre-filled syringe containing 40 mg enoxaparin sodium in 0.4 ml) treatment at least once a day
* not to have any visual or auditory disorders
* not to have any foreknown coagulation disorders
* to have platelet, PTT and international normalized ratio (INR) values within the normal limits for beginning enoxaparin sodium injections
* not to have any hematologic disorders or any bruising or injuries at the abdominal wall
* to receive no injections at the abdominal site, other than the enoxaparin sodium during the research protocol
* to will to participate in this study

Exclusion Criteria:

* to be pregnant
* have bleeding in the injection site
* have pain at any site of their body prior to the injection
* have any incision, drain, scar tissue, lipodystrophy or infection symptoms at the abdominal site which hinder the application of injection
* not to will to participate in this study
Optimal Duration of Dual Antiplatelet Therapy After Stent-assisted Coiling

Comparison of duration of dual antiplatelet therapy after stent-assisted coiling of unruptured intracranial aneurysms

The purpose of this study is to compare the incidence of thromboembolic and hemorrhagic complications between 1 and 18 months after stent-assisted coiling according to the duration of use of dual antiplatelet agents (6 months versus 12 months) after stent-assisted coiling of unruptured intracranial aneurysms to determine the optimal duration of use of dual antiplatelet agents.

Eligibility Criteria:
Inclusion Criteria:

* subjects over 19 years old
* subjects with modified Rankin Scale (mRS) ≤ 2
* subjects with unruptured intracranial aneurysms
* subjects with appropriated aspirin and clopidogrel reaction units after dual antiplatelet preparation (100 mg of aspirin and 75 mg of clopidogrel) for at least 5 days before procedure \[measured using VerifyNow\]

  1. aspirin reaction unit (ARU) \< 550
  2. P2Y12 reaction unit (PRU): 85\~219
* subjects who agreed to this study (with informed consent)

Exclusion Criteria:

* subjects with neurological deficits (mRS ≥ 3)
* subjects with an allergic reaction to antiplatelets (aspirin and clopidogrel) or contrast
* subjects with a high risk of hemorrhage such ICH or severe gastric ulceration
* subjects with coagulopathy
* subjects with thrombocytopenia (\<100,000/mm3)
* subjects with liver diseases (\> 100IU/L of aspartate aminotransferase or alanine aminotransferase)
* subjects with renal diseases (\> 2mg/dL of serum creatinine)
* subjects with underlying diseases that need to maintain dual antiplatelet drugs or anticoagulants.
* subjects with a high risk of strokes (atrial fibrillation, over 70% cerebral artery stenosis or cerebral artery occlusion, moyamoya disease, vascular malformations, etc)
* subjects with uncontrolled congestive heart failure or angina
* subjects with malignant tumors
* subjects with a positive pregnancy test (serum or urine)
* subjects who are unconscious at the time of diagnosis.
* subjects who are unable to complete the required follow-ups
* subjects with life-threatening diseases
* subjects with medical conditions with a life expectancy of less than two years
* subjects who are determined to be disqualified by researchers
The Use of PlCO-Vacuum-System on Sternal Wounds

The use of a vacuum-assisted wound closure system (PICO, Fa. Smith \& Nephew) is being investigated to determine whether it reduces the incidence of sternal wound healing disorders compared to conventional wound care with plaster.

Median sternotomy remains the standard surgical approach for most cardiac surgeries. However, postoperative wound infections can occur and may progress to mediastinitis, a life-threatening complication with significant mortality. This risk is particularly pronounced in cases where sternal perfusion is compromised, such as when one or both internal mammary arteries are harvested during coronary artery bypass grafting. In such scenarios, the incidence of sternal wound healing disturbances is estimated to range from 2% to 7%.

Several strategies aim to reduce the risk of sternal wound infections. One approach involves external stabilization using a thoracic vest, which has been shown to significantly decrease sternal instability and healing disorders when implemented early in the postoperative period. Another approach utilizes negative pressure wound therapy, which has demonstrated efficacy in reducing sternal wound healing complications in prior studies involving systems like Prevena (Fa. KCI).

The PICO-System operates with a distinct vacuum pressure mechanism and a unique film design compared to the Prevena system. To date, no prospective randomized studies have evaluated the PICO-System for its effectiveness in reducing sternal healing disturbances, sternal instability, and mediastinitis. This study aims to compare conventional plaster wound care with the PICO vacuum system in a randomized, prospective design, assessing outcomes up to six months postoperatively.

Eligibility Criteria:
Inclusion Criteria:

All patients undergoing cardiac surgery by means of median sternotomy and exhibiting more than one of the following risk factors:

* Diabetes mellitus (treated with oral antidiabetics and/or insulin)
* LVEF\&lt;40%
* COPD
* Female gender
* Adipositas (BMI \&gt; 30kg/m2)
* History of myocardial infarction (NSTEMI or STEMI) within 14 days
* Known peripheral arterial disease
* Planned BIMA surgery.

Exclusion Criteria:

* Planned hemisternotomy or anterolateral thoracotomy
* Emergency cases
* Lack of consent
* Active therapy with immunosuppressants (including steroids)
Evaluation of a New Supporting Ostomy Product

The aim of the study is to evaluate if the new supporting product influences wear time. It is the expectation that median wear time is slightly reduced in the period when subjects are using the supporting product with their ostomy appliance. Long-term benefits of the test product may be less skin redness, less worry of leakage and/or improvement in quality of life and social activities.


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 three months
4. Have intact skin on the area used in the evaluation meaning no broken skin and only minor discoloration of the skin (assessed by investigator)
5. Be able to use one of the three test products (i.e. Ø50, Ø60 and Ø70 mm)
6. Have an ileostomy- or colostomy with liq-uid output (Bristol scale type 6-7)
7. Currently using a SenSura Mio product (1pc/2pc Flat/Convex/Concave)
8. Be willing and suitable (determined by the study nurse) to use the test product with-out using a paste/mouldable ring during the test periods
9. Have self-reported problems with leakage\* (three times within 14 days) \*Leakage: Leakage is defined as output from the stoma on the backside of the baseplate (underneath the baseplate)

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. Participating in other interventional clinical investigations or have previously participat-ed in this investigation. Exception: Participation in other Coloplast sponsored clinical investigations is accepted under the circumstances that the subject has paused the activities in the investigation and are otherwise complying with the inclusion and exclusion criteria of this (CP308) protocol
5. Known sensitivity towards test product
6. Known sensitivity towards acrylate
7. Users with a pacemaker
Efficiency of Repetitive Transcranial Magnetic Stimulation (rTMS) Sessions After a Successful 3 Week-treatment in Fibromyalgia

Maintenance rTMS sessions after a successful 3week-rTMS treatment for subjects with fibromyalgia may maintain the clinical improvement.

In a previous pilot study, a 3 week treatment with rTMS in fibromyalgia subjects induced a 40% improvement of pain feeling. Three months later, the pain level was still significantly reduced in comparison with the beginning of the treatment, but the clinical improvement was less than at the end of the treatment. We thus propose to realize real or sham rTMS sessions at 3 weeks interval during 6 months with subjects presenting a significant clinical improvement after a 3 week-rTMS or sham treatment to evaluate the response maintenance.

Eligibility Criteria:
Inclusion Criteria:

* presence of the criteria from the American College of Rheumatology (2010)for fibromyalgia diagnosis,
* painful state for more than six months,
* visual analogic scale evaluation \> or = 5,
* age between 18 and 70,
* no modification in therapeutic treatment one month before and during the protocol
* presence of actual or prior antalgic chronic treatment : pregabalin, duloxetine, milnacipran, gabapentin, venlafaxine, laroxyl, grade 1 or 2 antalgic
* residence in Limoges or the periphery, or the ability to come to the hospital for the treatment

Exclusion Criteria:

* presence of non stabilized psychiatric comorbidity (personality trouble, addiction, suicide attempt, non controlled affective trouble),
* active epilepsy,
* previous cerebral traumatism, or cerebral surgery, intra-cranial hyper tension,
* pacemaker, metallic pieces in the brain, cochlear ocular implant, or any metallic material contra indicating magnetic resonance imaging.
* clozapine, bupropion, methadon, theophyllin, or other non chemical antalgic technic established during the previous month(kinesitherapy, relaxation, hypnosis...),
* pregnancy, or administrative and judiciary protection, absence of health insurance.
Trial of YUMI Uterine Manipulator

The purpose of this study is to test the feasibility and safety of using a new device called Yukio's Uterine Manipulating Instrument (YUMI). The YUMI is a type of uterine manipulator. It is a reusable metal device designed to be simple and study. It is also adjustable in size which makes it easy for surgeons to use. It will be placed at the beginning of the surgery and removed at the end. This study will allow the researchers to find out if the surgeons find the YUMI effective and easy to use. It will also allow the researchers to see if the device is safe. This is the first time that the YUMI is being used in humans.


Eligibility Criteria:
Inclusion Criteria:

* Participant must be scheduled for a total laparoscopic or robotic-assisted hysterectomy for a gynecologic condition
* Participants must be 18 years of age or older

Exclusion Criteria:

* Participant is not eligible if the surgeon does not plan to use a uterine manipulator
Afatinib and Selumetinib in Advanced KRAS Mutant and PIK3CA Wildtype Non-small Cell Lung Cancer

This is a multi-center open-label proof-of-concept study consisting of two parts: PART A - a phase I dose-finding study (3 + 3 classical design) evaluating the RP2D of afatinib in combination with selumetinib in KRASm NSCLC; and PART B - a randomized phase II study investigating the progression free survival and safety of selumetinib/afatinib combination therapy compared to standard of care chemotherapy in KRASm NSCLC.


Eligibility Criteria:
Inclusion Criteria:

* Histological or cytological proof of advanced NSCLC; for PART B: treated with first line therapy for metastatic disease only.
* Written documentation of a known pathogenic KRAS (exon 2, 3 or 4) mutation and PIK3CA wildtype (defined as absence of mutations in exon 9 and 20)
* Able and willing to give written informed consent
* Able and willing to undergo blood sampling for PK and PD analysis
* Life expectancy \>=3 months allowing adequate follow up of toxicity evaluation and antitumor activity.
* WHO performance status of 0 or 1.
* Able and willing to undergo a tumor biopsies prior to start, after two weeks (part A only) and upon progression of disease
* Measurable disease according to RECIST 1.1
* Adequate organ system function measured by laboratory values

Exclusion Criteria:

* Any treatment with investigational drugs within 30 days prior to receiving the first dose of investigational treatment.
* History of another malignancy Exception PART A: Patients who have been disease-free for at least 3 years, or patients with a history of completely resected non-melanoma skin cancer and/or patients with indolent second malignancies are eligible. Exception PART B: Adequately treated carcinoma in situ of the cervix and adequately treated basal cell carcinoma of the skin. 3. Symptomatic or untreated leptomeningeal disease.
* Symptomatic brain metastasis.
* Patients previously treated with any drug combination known to interfere with EGFR, HER2, HER3, HER4 or MAPK- and PI3K-pathway components, including inhibitors of PTEN, PI3K, AKT, mTOR, BRAF, MEK and ERK.
* History of interstitial lung disease or pneumonitis
* Radio-, immuno- or chemotherapy within the last 2 weeks prior to receiving the first dose of investigational treatment. Palliative radiation (1x 8Gy) is allowed.
* Opthalmological diseases
* Patients with left ventricular ejection fraction (LVEF) \< 55%
* Patients with cardiac comorbidities
* Concomitant or recent use (in the past 14 days) of strong inhibitors and inducers of CYP1A2, CYP2C19, CYP3A4, 3A5 and P-glycoprotein (P-gp)
NAET Screening for Food Allergy, Sensitivity and Intolerances Using IgE-Specific Antigen Test and NST- NAET®

Food allergy reactions cause various health disorders in sensitive people. These reactions may be IgE-mediated,cell-mediated, energy disturbance-mediated, or a combination of the three. Certain laboratory diagnostic procedures have been able to identify most IgE-mediated or cell-mediated food reactions, but so far there is no test available in traditional medicine to test the energy-mediated allergies and sensitivities. NAET® procedures have been able to identify food substances triggering to energ disturbances in sensitive people causing related health disorders. NAET uses one of the testing procedures called NST (Neuromuscular sensitivity testing).The efficacy of NST-NAET to screen food sensitivity will be evaluated in comparison with one of the well accepted, established, traditional medicine allergy testing known as the IgE-specific antigen test.

Forty-two volunteers responded for an advertisement posted on the NAET web site and in the community college news bulletin board inviting them to take part in the study. They were asked to complete the NAET® Allergy Symptom-Rating (ASR) questionnaire upon arrival at the research center. Observing inclusion and exclusion criteria, a total of 32 subjects from both sexes with varied health problems were selected out of the forty-two who volunteered for the study. All 32 subjects were tested for 21 commonly used food substances via NST. Out of 32 tested, 26 subjects tested positive for one item each, from the 21 items tested and six subjects tested positive for multiple items from the selected food list. The 32 subjects had a total of 50 positive NSTs out of 672 (21X32) tests performed. The items that produced positive results by NST were further evaluated via laboratory blood serum analysis for IgE-specific antigens. According to NST the percentage of observed total food reactions in this group of 32 was 7.44%. Soon after the completion of NST the laboratory technicians collected blood from 32 subjects for IgE-specific antigen study on 50 positively tested items. The IgE-specific antigen tests were found positive on a total of 49 out of 50 tests performed.

Eligibility Criteria:
Inclusion Criteria:

A history of previous allergic reactions to one or more food substances from the selected list ( Almond, Apple, Banana, Beef, Carrot, Celery, Chocolate, Corn, Cow's milk, Crab, Egg white, Lobster, Orange, Oyster, Peanut, Salmon, Shrimp, Soybean, String bean, Tomato, and Wheat) was considered as the primary important factor for the study.

-

Exclusion Criteria:

1. Serious illnesses e.g.. Cancer, chronic obstructive pulmonary diseases, kidney diseases, heart diseases, history of anaphylaxis to any of the listed item in the inclusion criteria, mental disorders, and pregnancy.
2. Previous treatment for food allergies.
3. Knowledge of procedure -
The Acute Effects of Commercially Available Drinks on the Endothelial Function of Humans Following a High-fat Meal

High fat diets are associated with impaired endothelial function and increased cardiovascular disease risk amongst our population. These negative effects are likely caused by triglyceride induced suppression of nitric oxide, which is produced from the endothelium, and/or an increase in oxidative stress.

Interestingly, previous studies have found that some beverages that are high in polyphenols and antioxidants may suppress the impairment in endothelial function observed following high fat meals/diets. Typically, these studies have investigated the ingestion of red wine, orange juice or green tea on outcome measures (typically flow mediated dilatation (FMD) of the brachial artery). Despite this previous research, no study has compared the effects of different beverages on endothelial outcomes following a high-fat meal within the same participants.


Eligibility Criteria:
Inclusion Criteria:

* Females to be postmenopausal and not on hormone replacement therapy
* 25 \> BMI \< 35
* Sedentary to light activity lifestyle.

Exclusion Criteria:

* History of cardiovascular disease (Hypertension, Atherosclerosis, endothelial issues etc).
* History of diabetes (Type 1 or type 2)
* Vegan or with food allergies or intolerances.
* Taking any antioxidants over the counter (Vit C, E or polyphenol supplements)
* Taking prescription medication for hypertension.
Family Studies of Uveal Coloboma

This study will identify the genes responsible for uveal coloboma, an abnormal development of the eye caused by incomplete closure of a normally-occurring gap in the eye (the optic fissure) after the fifth week of life in a human embryo. There have been studies of families in which more than one person has been affected by this disorder. Coloboma occurs in about 1 of 10,000 live births and may cause significant vision loss. Researchers seek a better understanding of the genes responsible for this disorder.

Adults and children who have more than one member of the family with uveal coloboma may be eligible for this study. Patients will undergo a detailed medical history and eye examination appropriate for their age. The pupils will be dilated, through the use of eye drops. Dilation will continue for 4 to 6 hours, and wearing of sunglasses can reduce temporary glare that many patients may experience in brightly lit areas. In addition, pictures will be taken of the front or back of the eye, a procedure that also involves dilation of the pupils. Patients who have coloboma will undergo a complete physical examination. Blood samples will be collected, with a total of about 2 tablespoons from patients ages 10 and older and about 1 teaspoon for each 5 pounds of body weight for younger patients. Also, patients with coloboma may be asked to undergo X-rays , ultrasound, or other tests that are medically indicated.

To have enough DNA to study, the researchers may create a cell line to grow more DNA. Laboratory samples will be coded so that there is no identifying information about participants in this study. No other testing or research will be done on blood samples collected unless patients give permission. The researchers will not provide information about patients' health to other people without your express permission.

Objective: To describe phenotypes and find genes causing a developmental and potentially blinding eye condition, uveal coloboma.

Study population: Families where more than one family member has uveal coloboma. Both affected and genetically informative, unaffected members of the family will be recruited.

Design: Observational study.

Outcome measures: Clinical examination, genetic mapping and mutation identification.

Eligibility Criteria:
* This study will enroll 120 adult and children members of families where more than one individual is reported to have coloboma. Affected and unaffected family members will be both enrolled.

INCLUSION CRITERIA:

1. The participant must have any recognizeable form of inherited coloboma.
2. The participant must be a genetically informative member of a family where more than one person is affected by typical uveal coloboma.
3. The participant must be able to comply with the protocol and provide a blood sample.

EXCLUSION CRITERIA:

1. The participant has any syndromic form of coloboma likely due to mutations in a known gene.
Study to Evaluate the Drug-drug Interaction Effect of Omeprazole on the Pharmacokinetics (PK) of AMG 510 in Healthy Participants

The primary objective of this study is to evaluate the PK profile of AMG 510 alone and in combination with omeprazole in healthy participants.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male subjects or female participants, between 18 and 60 years of age (inclusive), at the time of Screening.
* Body mass index, between 18 and 30 kg/m2 (inclusive), at the time of Screening.
* Females of nonchildbearing potential.

Exclusion Criteria:

* Inability to swallow oral medication or history of malabsorption syndrome.
* History of hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the Investigator (or designee) and in consultation with the Sponsor.
* Poor peripheral venous access.
* History or evidence, at Screening or Check in, of clinically significant disorder, condition, or disease not otherwise excluded that, in the opinion of the Investigator (or designee), would pose a risk to subject safety or interfere with the study evaluation, procedures, or completion.