cyrilzakka/clinical-trials huggingface dataset:
Comparison of Measured Caloric Expenditure Versus Administered Calories in Neonates

The investigators have created and validated a device that allows us to accurately measure how many calories a baby consumes every day. The purpose of this study is to compare how many calories a baby consumes with how many calories are provided in a population of newborn infants and children. This may help clinicians to better understand how to feed babies during times of critical illness.


Eligibility Criteria:
Inclusion Criteria:

1. Mechanically ventilated neonates, infants and children, regardless of age, up to 10 kg
2. Inpatients in the cardiac (8S), medical-surgical (7S) or neonatal (7N) intensive care unit
3. Assent of patient's intensive care attending physician
4. Written parental informed consent.
5. Patient on conventional mechanical ventilation on a Servo I or Servo U ventilator with fraction of inspired oxygen \<80%.

Exclusion Criteria:

1. Clinically significant tracheo-esophageal fistula
2. Measured ETT leak \>20% (i.e. difference between inspiratory and expiratory tidal volumes)
3. Patient on high frequency oscillatory ventilation or high frequency jet ventilation.
Interpretation of Serological Tests in the Diagnosis of Celiac Disease: Anti-deamidated Gliadin Peptide Antibodies Revisited

Celiac disease is an autoimmune disorder characterized by a chronic inflammation of the small bowel mucosa, triggered by the ingestion of gluten-containing grains.

The diagnosis of celiac disease was initially based on duodenal biopsies obtained from upper endoscopy. Since 1990, the availability of serological tests has contributed to a different perception of the disease. Serological testing is now considered fundamental for celiac disease screening, even if duodenal biopsies remain the gold standard. Celiac markers usually include anti-TG2 antibodies, anti-endomysium antibodies, anti-gliadin antibodies and anti-reticulin antibodies. Recently, several studies showed that deamidated products of gliadin may enhance T-cell stimulatory activity and improve the reactivity of anti-gliadin antibodies. Thus, detection of anti-deamidated gliadin peptide antibodies has been introduced into the wide spectrum of serological tests for celiac disease.

The aim was to assess the clinical relevance of anti-deamidated gliadin peptide antibodies compared with the other common celiac markers.

Eligibility Criteria:
Inclusion Criteria:

- patients attending the Reims University Hospitals, for whom serological tests for celiac disease were prescribed between 1 april 2012 to 31 december 2014
Establishment of Clinical Prediction Model for Postoperative Symptomatic Spinal Epidural Hematoma

The goal of this observational study is to establish a clinical prediction model based on artificial intelligence algorithms for patients with postoperative symptomatic spinal epidural hematoma(PSSEH) after spinal surgery. The investigators will collect the features of 2000 patients as the training set to train the models using AI algorithms, then recruit a prospective cohort of 2000 patients to test if the trained model is precise and consistent to predict the occurrence of PSSEH as well as to find out whether there is any new risk factor of PSSEH.

Firstly, the investigators plan to collect the features of 2000 patients who received spinal surgery at Peking University Third Hospital from January 2014 to December 2024, including those with PSSEH and the controls, as the training set to build up a prediction model based on multiple AI algorithms. Then, the investigators will choose the optimal model through comparing various features, assessing the robustness of the model quantitatively using k-fold cross validation and exploring the influence of all features on the output of the final model by means such as SHAP. Lastly, the investigators will recruit a prospective cohort of approximately 2000 patients who receive spinal surgery from January 2025 to December 2026 at Peking University Third Hospital and collect the same features as the training set to test if the trained prediction model is precise and consistent to predict the occurrence of PSSEH and whether there is any feature , undiscovered before, that is strongly related to PSSEH.

Eligibility Criteria:
Inclusion Criteria:

* patients who will receive spinal surgery from January 2025 to December 2026 at Peking University Third Hospital

Exclusion Criteria:

* patients with a history of lumbar trauma before admission;
* patients who suffer from malignant tumor;
* patients with systemic infection;
* patients who quit the study midway
Sirolimus-Eluting Stent Versus Standard Stent in Diabetic

The purpose of this study was to determine whether Sirolimus stent implantation is effective in reducing neointimal hyperplasia as compared to Bare metal stent in diabetic patients with de novo coronary artery stenosis.


Eligibility Criteria:
Inclusion Criteria:

* Diabetic either non-insulin or insulin-dependent (according to World Health Organization Report) on pharmacologic treatment (insulin or hypoglycaemic agents) for at least 1 month, and presented de novo coronary stenoses in 1,2 or 3 native vessels with symptoms or objective evidence of ischemia. Stenoses had to be amenable for stent implantation, with vessel size smaller than 4.0 mm (as assessed visually on angiography)

Exclusion Criteria:

* Impaired glucose tolerance without pharmacologic treatment, gestational diabetes or transient hyperglycaemia
* Stenoses located in saphenous bypass, arterial bypass grafting, unprotected left main or involving important side branches (\> 2 mm) that should be treated during the procedure
* Left ventricle ejection fraction \< 25%
* Prior treatment with intracoronary brachytherapy or other drug eluting stent at target site
* Restenotic lesions; known allergies to aspirin, ticlopidine and clopidogrel acute coronary syndromes with persistent ST elevation \< 72 hours and/or CPK twice the upper normal limit
* Non-ST elevation acute coronary syndromes with CPK twice the upper normal limit
* Severe hepatic or renal disease (creatinin clearance \< 30 ml/min or hepatic enzymes twice the upper normal limit); and life expectancy \< 1 year
Increasing Help-Seeking in Military Service Members

There is sufficient evidence that military service members markedly underutilize behavioral health care services, in part, due to stigma. This study proposes to examine a novel application of a cognitive bias modification (CBM) intervention designed to target stigma-related cognitions among service members at elevated suicide risk not currently engaged in behavioral health treatment.

This study proposes to examine a novel application of a cognitive bias modification (CBM) intervention designed to target stigma-related cognitions among service members at elevated suicide risk not currently engaged in behavioral health treatment. Interventions that leverage CBM principles involve the completion of brief, web-based tasks in which participants are presented with a series of stimuli (e.g., words, sentences) and trained to respond to those stimuli in a manner that is positive or neutral, rather than negative and unhelpful. Consistent with the theoretical rationale for Cognitive Behavioral Therapy, CBM interventions function by reshaping negative cognitions. Repeated reinforcement of adaptive cognitions enhances functioning and reduces distress. CBM interventions have efficacy in reducing maladaptive cognitions across a range of psychiatric symptoms. However, limited data exist regarding the use of CBM to target help-seeking stigma cognitions.

Eligibility Criteria:
Inclusion Criteria:

* current active duty U.S. military service member
* lifetime history of suicidal ideation per a self-report version of the SITBI-SF and/or
* current elevated suicide risk factors (i.e., screening positive for clinically significant suicidal ideation \[DSI-SS Total Score \> 2\], depression \[PHQ-9 Total Score \> 14\], anxiety \[GAD-7 Total Score \> 9\], PTSD \[PCL-5 Total Score \> 32\], alcohol use \[AUDIT-C Total Score \> 3 for men and \> 2 for women\], and/or anger \[DARS Total Score \> 22\])
* no current behavioral health service use (i.e., ongoing care with a provider to receive psychiatric medications, therapy, and/or counseling)

Exclusion Criteria:

* unable to provide informed consent
* lack of Internet access via a computer, tablet, and/or mobile phone
* scheduled to be stationed outside the continental U.S. any time during the 11 weeks following study enrollment (i.e., during the study period)
* imminent suicide risk (i.e., suicide risk warranting hospitalization) based on the Joiner et al. and Chu et al. Decision Tree Framework.
Prevention of Malaria With Dihydroartemisinine + Piperaquine for Forest Rangers

The purpose of the study is to assess if the antimalarial drugs Dihydroartemisinine + Piperaquine (DP) are effective in preventing malaria infection for forest ranger

To assess the protective effect of 3-day DP regimen for forest rangers working for long-term in forest where malaria transmission is intense, all eligible forest rangers will be treated with a full course of DP + primaquine to eradicate all parasites which may survive in their blood while staying in non- malaria transmission areas.

Just before returning back to the forest participants will be randomized to receive either Arterakine (dihydroartemisinine (DHA)/piperaquine) (intervention arm) or placebo (control arm). Participants will be assessed for parasitemia before and after the forest trip with high volume, ultrasensitive, PCR (HVUqPCR). The minimum time span between two forest trips should be 20 days so participants could complete the 14 day primaquine course and the Arterakine (dihydroartemisinine (DHA)/piperaquine).

There is no limit in the duration between trips. Participants are tested for P.falciparum, P.vivax infection before they return to the forest.

Each participant will be visited 2 weeks or later after returning home from the forest and examined. The rationale for the added two weeks is to detect blood stages of infections, which may have been inoculated towards the end of the forest visit.

If found to be sick, the patient will be treated according to government treatment guidelines. A 4ml venous blood sample will be obtained for Hb and HVUSqPCR.

Eligibility Criteria:
Inclusion Criteria:

1. Informed consent
2. Male, over or equal to18 years of age
3. Able and willing to comply with the study requirements and follow-up

Exclusion Criteria:

1. Inability to tolerate oral treatment
2. Previous episode of haemolysis or severe haemoglobinuria following primaquine
3. Glucose-6-phosphate dehydrogenase (G6PD) deficient with Hb \< 9 g/dL \*
4. Known hypersensitivity or allergy to any study drugs \* If the participant with G6PD deficient gets malaria, primaquine would be used as recommended by World Health Organization (WHO) (once a week for 8 weeks) in combination with 3 days of chloroquine.
Tactile Breast Imaging Sensor for Tumor Malignancy Characterization

The aim of this study is to see how well a tactile imaging sensor will detect for breast masses compared to traditional mammography and/or ultrasound. This device may allow a simple, convenient method to screen for breast tumors. This data will be used to check the feasibility of using the device to detect breast tumors.

The tactile imaging sensor will estimate the relative size and elasticity of the mass(es). This device may allow a simple, convenient method to screen for breast tumors. This is not a treatment and it will not be used to diagnose abnormal masses. The investigators will also not look for any unknown masses. And only doctors will touch the patients. An engineering assistant will be in the room to operate the tactile imaging sensor.

The breast scan that is done as part of this research protocol is not intended to detect any breast disease or abnormality. Research breast scans are not examined by a clinical radiologist to look for abnormalities. Research scan will be evaluated by the engineers developing the device to assess its usefulness. The breast scan for this research will only look at a portion of your breast as it relates to this research. The investigators, the tactile imaging sensor operators and other members of the research team are not qualified to interpret the scan for any diagnostic or therapeutic value. Therefore, the tactile imaging scan being done for this research study will not be analyzed to detect any medical condition.

Patients will have done mammography or ultrasound by now. Once the doctor decides to perform biopsy, the tactile imaging will be planned. The consent will be obtained before the biopsy. One of the investigators (Dr. Caroline or Dr. Reilly) will obtain the consent. Before the biopsy, the doctor will identify the mass(es) using other modalities such as a ultrasound. The tactile imaging sensor operator will obtain the tactile images. Then the biopsy will be performed. Radiology doctor, resident, and radiology technologist are always present during the procedure. In addition a professional assistant from the engineering group will operate the tactile imaging sensor. That person will not have any physical contact with you. The procedure will be very similar to the ultrasound device.

The images will be analyzed by the investigators.

Eligibility Criteria:
Inclusion Criteria:

* Women who had mammogram and/or ultrasound birads (category IV or V)
* Women ages between 30 and 80.
* Women who have been scheduled for biopsy from the Temple breast surgery clinic
* Women who have been scheduled for biopsy by Dr. Kathleen Reilly.
* Women, who speak and understand English.

Exclusion Criteria:

* Women who do not meet the criteria requiring biopsy.
* Women who have allergic reaction to silicone.
* Women who cannot speak or understand English.
* Women who are pregnant.
* Women, younger than 30 years old, and older than 80 years old.
ESSENCE 2: CyclASol for the Treatment of Signs and Symptoms of Dry Eye Disease (DED)

The objective of this pivotal trial is to assess the efficacy, safety and tolerability of CyclASol in comparison to the vehicle for the treatment of signs and symptoms of Dry Eye Disease (DED).

This Phase 3 study will assess the efficacy, safety and tolerability of CyclASol 0.1% Ophthalmic Solution administered bilaterally twice daily versus vehicle.

Eligibility Criteria:
Inclusion Criteria:

* Signed ICF (Informed Consent Form)
* Patient-reported history of DED in both eyes
* Current use of OTC (over-the-counter) and/or artificial tears for dry eye symptoms
* Ability and willingness to follow instructions, including participation in all study assessments and visits

Exclusion Criteria:

* Women who are pregnant, nursing or planning a pregnancy
* Unwillingness to submit a urine pregnancy test at screening and the last visit (or early termination visit) if of childbearing potential, or unwillingness to use acceptable means of birth control
* Clinically significant slit-lamp findings or abnormal lid anatomy at screening
* Ocular/periocular malignancy
* History of herpetic keratitis
* Active ocular allergies or ocular allergies that may become active during the study period
* Ongoing ocular or systemic infection at screening or baseline
* Wear of contact lenses within 3 months prior to screening or anticipated use of contact lenses during the study
* Use of topical Cyclosporine A or Liftigrast within 2 months prior to screening
* Intraocular surgery or ocular laser surgery within the previous 6 months, or have any planned ocular and/or lid surgeries over the study period
* Presence of uncontrolled systemic diseases
* Presence of known allergy and/or sensitivity to the study drug or its components
* Randomized in a previous CyclASol trial
An Open-Label, Single-Dose Study to Determine the Metabolism and Elimination of 14C-Perampanel in Healthy Male Subjects

This is an open-label, single-dose study in healthy male subjects. The study will have 2 phases: Pretreatment and Treatment. The Pretreatment Phase will last up to 21 days and will consist of a Screening Period and a Baseline Period, during which each subject's study eligibility will be determined and baseline assessments will be conducted.


Eligibility Criteria:
Inclusion Criteria

1. Healthy male 18 to 55 years, inclusive, at the time of informed consent
2. Body mass index (BMI) of 18 to 30 kg/m2, inclusive, at Screening
3. Must have had a successful vasectomy (confirmed azoospermia) or they and their female partners must not be of childbearing potential or must be practicing highly effective contraception throughout the study period and for 90 days after study drug discontinuation. No sperm donation is allowed during the study period and for 90 days after study drug discontinuation.
4. Provide written informed consent
5. Willing and able to comply with all aspects of the protocol

Exclusion Criteria

1. Participated in a 14C research study within the 6 months before Day-2. The total exposure from this and any previous study must be within the recommended levels considered safe (per 21 Code of Federal Regulations \[CFR\] 361.1)
2. Exposure to clinically significant radiation within 12 months before Day-2
3. Clinically significant illness that requires medical treatment within 8 weeks or a clinically significant infection that requires medical attention within 4 weeks of dosing
Safety And Efficacy Results of Percutaneous Renal Stent Implantation in Ectatic and Aneurysmatic Coronary Arteries

The aim of this study was to evaluate the efficacy and safety of renal stents implanted in ectatic/aneurysmatic coronary arteries.

In total, 18 patients (renal stent group) who underwent renal stent implantation in ectatic/aneurysmatic coronary arteries requiring percutaneous coronary intervention (PCI) and 45 patients who underwent large-sized bare metal coronary stent (BMCS) implantation (BMCS group) at our centre between 2015 and 2020 were included in the study. Control coronary angiography (CAG) was performed during the follow-up of these patients, and angiography-guided quantitative measurements were performed during PCI. The primary endpoints were myocardial infarction and cardiovascular mortality, and the secondary endpoints were restenosis and all-cause mortality.

Eligibility Criteria:
Inclusion Criteria:

* Acute coronary syndrome patients

  * 18 year age
* ectatic/aneurysmatic coronary arteries

Exclusion Criteria:

* Patients who underwent elective procedures,
* experienced unsuccessful attempts
* referred to surgical revascularization
A Phase III Study of BMS-512148 (Dapagliflozin) in Asian Patients With Type 2 Diabetes Who Are Not Well Controlled With Diet and Exercise

The purpose of this clinical research study is to learn if BMS-512148 (Dapagliflozin) can improve (decrease) blood glucose values in Asian patients with Type 2 Diabetes who have never been treated with medication or have been on medication for less than 24 weeks since their original diagnosis of Diabetes. The safety of this treatment will also be studied.


Eligibility Criteria:
Inclusion Criteria:

* Males and females, 18 years old, with type 2 diabetes and with inadequate glycemic control
* Drug naive or treated with anti-diabetic medication for \< 24 weeks
* C-peptide ≥ 1.0 ng/mL
* Body Mass Index ≤ 45.0 kg/m²

Exclusion Criteria:

* AST and/or ALT \> 3 times ULN
* Serum total bilirubin \> 2 mg/dL
* Serum creatinine ≥ 1.50 mg/dL for men or ≥ 1.40 mg/dL for women
* Creatine kinase ≥ 3 times ULN
* Symptoms of severely uncontrolled diabetes
* Currently unstable or serious cardiovascular, renal, hepatic, hematological, oncological, endocrine, psychiatric, or rheumatic diseases
Panitumumab (ABX-EGF) Monotherapy in Patients With Metastatic Colorectal Cancer

The purpose of this study is to determine that panitumumab will have clinically meaningful anti-tumor activity in patients with metastatic colorectal cancer who have developed progressive disease or relapsed while on or after prior fluoropyrimidine, irinotecan and oxaliplatin chemotherapy.


Eligibility Criteria:
Inclusion Criteria:

* Pathologic diagnosis of colorectal adenocarcinoma (diagnostic tissue obtained by tissue biopsy)
* Metastatic colorectal carcinoma
* Eastern Cooperative Oncology Group of 0, 1 or 2
* Documented evidence of disease progression during, or following treatment, with fluoropyrimidine, irinotecan and oxaliplatin chemotherapy for metastatic colorectal cancer
* Radiographic documentation of disease progression during or within 6 months following the most recent chemotherapy regimen is required
* Bidimensionally measurable disease
* Tumor expressing low to negative levels of epidermal growth factor receptor (EGFr) by immunohistochemistry
* At least 2 but no more than 3 prior chemotherapy regimens for metastatic colorectal cancer
* Adequate hematologic, renal and hepatic function

Exclusion Criteria:

* Symptomatic brain metastases requiring treatment
* Patient with a history of interstitial pneumonitis or pulmonary fibrosis or evidence of interstitial pneumonitis or pulmonary fibrosis
* Use of systemic chemotherapy or radiotherapy within 30 days before enrollment
* Prior anti-EGFr antibody therapy with the exception of the small molecule EGFr tyrosine kinase inhibitors, which are permitted
* Prior anti-tumor therapies including prior experimental agents or approved anti-tumor small molecules and biologics of short (less than 1 week) serum half-life within 30 days before enrollment, or prior experimental or approved proteins within 6 weeks before enrollment
Effect of Breathing Exercises Before Coronary Angiography

This research was designed as a pre-test-post-test controlled group randomized controlled interventional study to determine the effect of breathing exercises applied to patients undergoing coronary angiography for the first time on anxiety. Patients were provided with an informed consent form, a personal information form and the Beck Anxiety Scale. The Beck Anxiety Scale was administered to the control group before and after the procedure. In the experimental group, the Beck Anxiety Scale was administered before the procedure, and after providing breathing exercise education and application, the Beck Anxiety Scale was completed after the procedure.

This research was designed as a pre-test-post-test controlled group randomized controlled interventional study to determine the effect of breathing exercises applied to patients undergoing coronary angiography for the first time on anxiety.

The study population consisted of SBÜ Kartal Koşuyolu Training and Research Hospital.When statistical power analysis was performed according to the G-Power program in the sample group, a minimum of 34 experimental and a minimum of 34 control groups were used, considering data loss, 76 volunteer patients who met the inclusion criteria were studied. Patients were provided with an informed consent form, a personal information form and the Beck Anxiety Scale. The Beck Anxiety Scale was administered to the control group before and after the procedure. In the experimental group, the Beck Anxiety Scale was administered before the procedure, and after providing breathing exercise education and application, the Beck Anxiety Scale was completed after the procedure. The 'Dependent Group T-Test' technique was used for the analysis of data obtained from the scales used in the study, comparing pre-test and post-test scores of the intervention and control groups. Also, the 'Independent Group T-Test' was used for separate comparisons of pre-test and post-test scores of the experimental and control groups.

Eligibility Criteria:
Inclusion Criteria:

* Were between 18-80 years old,
* Had never undergone coronary angiography before,
* Correctly and completely filled out the Beck Anxiety Scale,
* Voluntarily agreed to participate in the study.

Exclusion Criteria:

* Having a psychiatric illness
* Communication problems