cyrilzakka/clinical-trials huggingface dataset:
Melatonin Secretion and Sleep Quality in Spinal Cord Injury Patients

To evaluate the relationship between secretion of melatonin and sleep quality in spinal cord injury patients versus a database of healthy volunteers.

Melatonin is a neurohormone secreted by the pineal gland and excreted by the urinary tract. It has a key role in the synchronisation of circadian rhythms including the sleep wake cycle, with a peak secretion around 03:00.

The neural pathway controlling melatonin secretion is long and transits via the thoracic spine. The exact level is not known, but interruption of the connection in patients with lesions of the spinal cord is known to occur.

Tetraplegic patients often complain of insomnia, daytime sleepiness and poor sleep quality but the contribution of melatonin levels to sleep quality has not been explored in large studies, although case reports have shown reduced or abolished melatonin secretion and altered melatonin secretion profiles with delayed peak secretion. Paraplegic patients report fewer sleep difficulties and little is known about melatonin secretion in this group. The investigators hypothesize that sleep abnormalities are related to abnormalities in melatonin secretion and that this is in turn related to the level of the spinal cord injury

The study aims to explore the profiles of melatonin secretion in patients with spinal cord injuries and comparing melatonin profiles with a database of healthy volunteers. The investigators will further analyse the results looking at the severity of spinal cord injury using the Abbreviated Injury Scale (AIS) and the level of the injury. Outcome measures are melatonin secretion profile, sleep complaints measured using the Pittsburgh scale and daytime sleepiness measured using the Epworth sleep scale.

Eligibility Criteria:
Inclusion Criteria:

* Male or female ≥ 18 years
* Spinal cord injury patient
* All score AIS
* With a chronic lesion (more than 6 months from initial injury)
* Signed informed consent

Exclusion Criteria:

* Pregnant women
* Breast feeding women
* Refusal to participate at study
* Not covered by national health insurance scheme
* Patient unable to give informed consent
* Transmeridian flight crossing more than 3 time zones in the month preceding the study
* Recent treatment with melatonin (\< 1 month) or beta blocker
A Study of HS-10516 in Patients With VHL Syndrome Associated Tumors

The aim of the Phase Ia portion is to identify the maximum tolerated dose or maximum acceptable dose MTD/MAD of HS-10516. The phase Ib portion will evaluate the preliminary efficacy of HS-10516 in patients with VHL Syndrome Associated Tumors.

This is a Phase Ia/Ib open label multicenter study of HS-10516 in Chinese patients aged 18 years or older with VHL Syndrome Associated Tumors. HS-10516 as a single agent, is administrated orally once daily. The aim of phase Ia, a dose escalation study, is to identify the MTD/MAD of HS-10516. The goal of Phase Ib, a dose expansion study, is to evaluate the safety, pharmacokinetics and antitumor efficacy of HS-10516.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female from 18 to 80 year-old
2. Patients with advanced clear cellrenal cell carcinoma or von Hippel-Lindau Syndrome associated tumors
3. Has an Eastern Cooperative Oncology Group performance status of 0-1
4. Has a life expectancy of ≥ 12 weeks
5. Should use adequate contraceptive measures throughout the study
6. Females subject must not be pregnant at screening
7. Has the ability to understand and willingness to sign a written informed consent before the performance of the study.

Exclusion Criteria:

1. Recieved or being received treatment as follows:

   1. Hypoxia-induced factor inhibitors
   2. Traditional Chinese medicine indicated for tumors within 2 weeks prior to the first dose of study treatment.
   3. Cytotoxic chemotherapeutic drugs, investigational drugs or other systematic anti-tumor therapies within 3 weeks before the first dose of study treatment
   4. Colony-stimulating factors (CSFs) within 4 weeks before the first dose of study treatment
   5. Local radiotherapy within 2 weeks prior to the first dose of study treatment; more than 30% of bone marrow radiotherapy or large-area irradiation within 4 weeks before the first dose of study treatment.
   6. Major surgery within 4 weeks prior to the first dose of study treatment.
2. Has a pulse oximetry reading less than 92% at screening, requires intermittent supplemental oxygen, or requires chronic supplemental oxygen
3. Has failed to recover from a ≥ grade 2 adverse event due to prior anti-tumor therapy
4. Has another malignancy or a history of another non-VHL syndrome associated malignancy
5. Has inadequate bone marrow reserve or organ dysfunction
6. Has a clinically significant bleeding events or tendency within 1 month prior to the first dose of study treatment
7. Has severe infections within 4 weeks prior to the first dose of study treatment
8. Has digestive system diseases may influencing ADME of study drug
9. Has a history of severe hypersensitivity reaction, or proven allergic to HS-10516 or its metabolin
10. Has any disease or condition would compromise subject safety or interfere with study assessments by investigator's decision
Anti Propionibacterium(P.) Acnes Activity of Epiduo® Gel Compared to Benzoyl Peroxide (BPO) 2.5% Gel

The purpose of this study is to evaluate the antibacterial activity of Epiduo® Gel (Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel) on P. acnes compared to that of Benzoyl Peroxide 2.5% Gel.


Eligibility Criteria:
Inclusion Criteria:

* Subjects with facial acne,
* Subjects with high levels of P. acnes counts on the forehead

Exclusion Criteria:

* Female Subjects who are pregnant, nursing or planning a pregnancy during the study,
* Subjects with acne conglobata, acne fulminans, secondary acne
* Subjects with known or suspected allergy to one of the test product
Budesonide Prophylaxis for Engraftment Syndrome After Hematopoietic Cell Transplantation

The purpose of this study is to determine if budesonide prophylaxis starting day 5 after transplant reduces engraftment fever in autologous and allogeneic stem cell transplant recipients.


Eligibility Criteria:
Inclusion Criteria:

* • Patients 18-80 years of age with a diagnosis of a hematological malignancy

  * Meet the BMT program criteria to undergo hematopoietic stem cell transplantation for hematologi malignancies

Exclusion Criteria:

* • Patients enrolled in investigational clinical trials

  * Sct for non hematologic malignancies
A Drug Interaction Study to Evaluate the Pharmacokinetics of ASP1517 and Lanthanum Carbonate Hydrate

The objective of this study is to evaluate the effect of lanthanum carbonate hydrate on the pharmacokinetics (PK) of ASP1517 in non-elderly healthy male subjects.


Eligibility Criteria:
Inclusion Criteria:

* Body weight (at screening): ≥50.0 kg and \<80.0 kg
* Body-mass index (at screening): ≥17.6 and \<26.4 kg/m2 \[Body-mass index = Body weight (kg)/(Height (m))2\]
* Subject must agree to use contraception consisting of two established forms specified below starting at the time of informed consent and continuing throughout the treatment period and for 84 days after the last administration of ASP1517.
* Subject must agree not to donate sperm starting at the time of informed consent and continuing throughout 84 days after the last administration of ASP1517.

Exclusion Criteria:

* Received or is scheduled to receive any investigational drugs in other clinical trials or post-marketing studies within 120 days before screening or during the period from screening to the hospital admission day of the Period 1.
* Received or is scheduled to receive medications (including over-the-counter drugs) or supplements within 7 days before the hospital admission day of the Period 1.
* Deviates from any of the normal range of blood pressure, pulse rate, body temperature and standard 12-lead electrocardiogram at screening or the hospital admission day of the Period 1.
* Meets any of the following criteria for laboratory tests at screening or the hospital admission day of the Period 1. Normal ranges of each test specified at the study site or the test/assay organization will be used as the normal ranges in this study.
* Concurrent or previous drug allergies.
* Development of (an) upper gastrointestinal symptom(s) within 7 days before the hospital admission day of the Period 1.
* Concurrent or previous hepatic disease, heart disease, respiratory disease, peritoneum inflammation.
* A history of abdominal surgery, digestive tract excision.
* Concurrent or previous renal disease, endocrine disease, cerebrovascular disorder, malignant tumor, retinal neovascular lesions.
* Previous use of hypoxia inducible factor-prolyl hydroxylase inhibitors (HIF-PHI) such as ASP1517 (FG-4592), YM311 (FG-2216), erythropoietin products or lanthanum carbonate hydrate.
* Excessive alcohol or smoking habit.
Alpha Lipoic Acid and Chronic Lumbosacral Radicular Pain

In this study, we try to evaluate the effect of using ALA as an adjuvant treatment in patients scheduled for pulsed radiofrequency treatment (PRFT) of the affected dorsal root ganglion (DRG) for treatment of Lumbo-Sacral radicular pain.

Study design: The study is prospective, randomized, and open label started in August 2013 and was completed in March 2017 at Assiut University Hospital, Pain Unit after local ethical committee approval. All patients were informed verbally and in writing about the study, and they signed a detailed written informed consent about the procedure and the nature of the study.

Eligibility Criteria:
Inclusion Criteria:

* Patients over 18 years with severe chronic lumbo-sacral radicular pain of more than 6 months duration, not responding to medical treatment, and their Pain scores were \> 7 were included in the study.

Exclusion Criteria:

* coagulopathy, surgical interference, advanced malignancy, known concurrent neurological or neurodegenerative disease, including those with impaired neurotransmission e.g. myasthenia gravis, multiple sclerosis, spinal cord injury, breastfeeding or pregnancy, allergy/sensitivity to lidocaine anesthetic or/ and non-ionic contrast media or/and steroid therapy, active psychiatric or mental conditions and uncontrolled medical condition.
MK0928 Study in Adult Patients With Primary Insomnia (0928-040)(COMPLETED)

A study to evaluate the efficacy, safety and tolerability of MK-0928 in Primary Insomnia.


Eligibility Criteria:
Inclusion Criteria:

* Patients with a diagnosis of primary insomnia

Exclusion Criteria:

* Patients with an active psychiatric disorder other than primary insomnia
GE CVUS Device Evaluation

The purpose of the study is to collect user feedback on the Vivid E95 ultrasound system and probes during clinical procedures on the device's intended population in order to optimize the device.

The purpose of the study is to collect user feedback on the Vivid E95 ultrasound system and probes during clinical procedures on the device's intended population in order to optimize the device. The primary objective of this study is to collect user feedback and de-identified images from the Vivid E95 ultrasound system and probes in TTE and TEE exams in a clinical setting. User feedback will include workflow, performance, user preference, image quality, device features, and open-ended feedback. The safety objective of this study is to collect safety information, including type and number of adverse events and device issues.

This is a pre-market, open label, prospective, non-randomized clinical research study conducted at one site in the United States. This study is not intended to support a comparative claim or test any hypotheses, such as superiority or non-inferiority. No clinical efficacy endpoints will be assessed.

Eligibility Criteria:
Inclusion Criteria:

* Has a clinical indication for a TEE and/or TTE procedure with an ultrasound device
* Has a weight of at least 5kg
* Are able and willing to comply with study procedures
* If less than 7 years old, has a parent or legally authorized representative able and willing to provide written consent to participate
* If 7-17 years old, are able and willing to provide written assent to participate AND have a parent or legally authorized representative able and willing to provide written consent to participate
* If 18 years old or older, are able and willing to provide written consent to participate

Exclusion Criteria:

* Pregnant or suspected to be pregnant based on the opinion of a clinician investigator
* Expected to be at increased risk due to study participation (e.g. due to sensitivities, relative or absolute contraindication to TEE), in the opinion of a clinician investigator
* Previously participated in this study or are enrolled in another research study that could be expected to interfere with participation in study procedures
* History of esophageal surgery or known vascular ring
AI-Driven Prediction of Hospital-Acquired Infections With EHR

This is a multi-center, clinical study designed to evaluate the application and effectiveness of an AI-assisted predictive model for identifying and diagnosing infection, leveraging multimodal health data.

Hospital-acquired infections (HAIs) are a significant cause of morbidity and mortality in healthcare settings. Early identification and prevention of HAIs are crucial for improving patient outcomes, reducing healthcare costs, and preventing the spread of infections. In clinical practice, healthcare providers often need to integrate a wide range of patient data, including medical history, laboratory test results, medication usage, surgical procedures, and clinical observations, to assess infection risks and prevent HAIs. As infection control and precision medicine become increasingly important, the challenge remains to predict and prevent infections, especially in patients with subtle or asymptomatic risk factors. Recent advancements in artificial intelligence and data analysis techniques have shown great promise in improving the accuracy and efficiency of infection prediction and prevention. This study aims to develop an AI-assisted decision-making system by integrating multimodal data from electronic health records, lab results, clinical observations, and patient demographics. The objective is to enhance the early identification of patients at risk for HAIs, streamline clinical workflows, and optimize infection control measures. Ultimately, this system seeks to reduce the incidence of hospital-acquired infections, improve patient safety, and enhance overall healthcare quality.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with complete and accessible EHR data, including medical history, laboratory test results, treatment regimens, clinical observations, and infection history.
2. Patients who have been admitted to the participating hospital or healthcare facility during the study period.
3. All participants must provide informed consent to use their health data for research purposes.

Exclusion Criteria:

1. Patients with incomplete or missing critical EHR data, such as lab results, medical history, or treatment details, which are necessary for infection prediction.
2. Patients who have severe cognitive disorders, dementia, or conditions that prevent them from providing informed consent or participating in the study.
3. Patients who have not been admitted to the hospital during the study period or who are receiving outpatient care only.
4. Patients with terminal conditions where infection prediction may not be applicable to the clinical goals of the study.
Effect of Prehabilitation on the Lean Mass Index (IMM) in ERAS PROGRAMM.

The implementation of prehabilitation in patients operated on for colon cancer in a multimodal rehabilitation regimen improves the values of the "lean body mass" or lean mass index, positively influencing the results of clinical, analytical and radiological nutritional values pre- and postoperatively and in morbi-mortality, recovery, average stay and re-entry rates.


Eligibility Criteria:
Inclusion Criteria:

* It is considered that the subject suffers a confirmed diagnosis of colon cancer and is going to undergo surgery on a scheduled basis under a RHMM program.
* The subject is ≥ 18 years of age.
* The subject can perform any of the two proposed treatments.
* Preoperative staging TxNxM0.
* The patient has voluntarily signed and dated an informed consent document (IC), approved by an independent Ethics Committee (CEIC) before participating in the study.

Exclusion Criteria:

* Patients with rectal cancer.
* The study doctor determines that the subject is not eligible to participate.
* The subject can not give informed consent to participate in the study.
* The subject can not perform the pre-habilitation.
* Non-acceptance or impossibility of following rehabilitation protocol multimodal
* The subject was previously scheduled at the time of the inclusion of the nutritional supplement study, whether it is different or the same that would be scheduled at this time
* Subjects who have received previous radiochemotherapy, HIV, gestational stage, psychiatric, with CRF who are undergoing renal replacement techniques, urgent surgery, with intestinal obstructions, with uncontrolled infections, urgent surgery, distant metastasis, ASA IV, advanced liver failure, severe coagulation disorder, severe hyperlipidemia and hyperglycemia or difficult to control.
* Subject has renal or hepatic impairment (GFR \<60ml / m or AST / ALT 3 x upper limit of normal).
Performance Evaluation of Malaria Plus RDTs

Since their introduction in the late 90's, rapid diagnostic tests (RDTs) have dramatically improved our ability to control malaria, but proved insufficient to support elimination efforts because of their limited sensitivity, especially for P. vivax. In addition, the spread of P. falciparum parasites lacking hrp2 gene jeopardizes the long-term use of P. falciparum-specific HRP2-based RDTs. An existing partnership between Standard Diagnostics (SD), FIND, PATH, and Bill and Melinda Gates Foundation (BMGF) is addressing these limitations by developing two novel malaria RDTs with an analytical sensitivity ten times higher than the currently available malaria RDTs: a P. falciparum-specific test targeting both the HRP2 and PfLDH antigens (Pf Plus), and a P. falciparum/P. vivax combo test additionally targeting the PvLDH antigen (Pf/Pv Plus).

These new combo tests with improved sensitivity may become promising diagnostic tools for the detection of malaria, especially in settings where current tests prove to be insufficient due to hrp2 deletion or high burden of P. vivax malaria.

In this study, the investigators will perform a prospective evaluation of Pf Plus and Pf/Pv Plus tests in malaria-endemic countries to assess their clinical performance for detection of malaria in their intended-use settings.


Eligibility Criteria:
Inclusion Criteria:

* Presenting at the study site with fever (axillary temperature ≥37.5°C) or a history of fever during the preceding 72 hours period
* Presence of symptoms and signs other than fever suggestive of malaria
* Aged 5 years or older
* Freely agreeing to participate by signing an informed consent form (adults aged 18 and older and parent/legal guardian of a child) and providing assent (children aged 13-17)
* Willing to provide finger prick blood sample at enrolment

Exclusion Criteria:

* Presence of symptoms and signs of severe disease and/or central nervous system infections, as defined by WHO guidelines
Safety and Efficacy Study of Clevidipine Butyrate Injection in Hypertensive Emergencies

The purpose of this study was to determine the efficacy and safety of clevidipine for treating Hypertensive emergencies（defined as systolic blood pressure \>180 mmHg and/or diastolic blood pressure \>120 mmHg, accompanied by acute organ damage）.


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 and ≤ 75, regardless of gender.
2. Blood pressure increased seriously in a short time, systolic blood pressure (SBP) \> 180 mmHg and (or) diastolic blood pressure (DBP) \> 120 mmHg (measured at an interval of 5 minutes, both blood pressure values should be \> 180 / 120 mmHg), accompanied with progressive target organ damages as below or evidences of other target organ damage can be confirmed:

   * Hypertensive encephalopathy: headache, dizziness, irritability, nausea, vomiting, blurred vision and other symptoms;
   * Acute left heart failure: dyspnea, pulmonary rales, edema and other symptoms;
   * Unstable angina pectoris: ischemic chest pain with ST-T dynamic changes. Patients with SBP ≥ 220mmhg and / or DBP ≥ 140mmHg should be considered as hypertensive emergency;
3. The legal representative and / or patient agree to participate in this clinical trial and sign an informed consent form.

Exclusion Criteria:

1. Patients with arterial dissection, acute hemorrhagic or ischemic stroke, and acute coronary syndrome in urgent need of surgical or emergency intervention;
2. Patients with severe aortic stenosis or severe mitral stenosis;
3. Patients with obstructive hypertrophic cardiomyopathy;
4. Patients who have used other intravenous antihypertensive drugs within 2 hours before entering this study;
5. Patients known to be intolerant or allergic to calcium channel blockers, or allergic to test drug ingredients, or allergic to soy / soy products or egg / egg products;
6. Patients with lipid metabolism defects, such as pathological hyperlipidemia, lipid nephropathy, or acute pancreatitis with hyperlipidemia;
7. Combined with other serious organ injury or serious complications which may affect the life of the subjects;
8. Patients with a history of mental illness;
9. Patients with known history of alcohol / drug abuse;
10. Those who have participated in other clinical trials and used test drugs 3 months before the trial;
11. Pregnant and lactating women;
12. Researchers do not consider it appropriate to participate in the clinical trial.
Influences of Different Temporary Cement on Retention Rate of Temporary Crowns

The aim of this study is through a randomized clinical trial, double blind, split-mouth, evaluate the success rate (retention rate and dental sensibility) of temporary dental crown cemented on vital teeth. The composition of the cement (Based on calcium hydroxide; and based on mineral trioxide aggregate) will be evaluated. Data will be collected, tabulated and submitted to statistical analysis.

The confecction of temporary prosthesis is a fundamental step in the prosthetic process of definitive total crowns. The temporary cementation should provide sufficient retention between the intervals of the consultations, be biocompatible and not present high solubility. The aim of this study is through a randomized clinical trial, double blind, splithmouth, evaluate the success rate (retention rate and dental sensibility) of temporary dental crown cemented on vital teeth. The composition of the cement (Based on calcium hydroxide; and based on mineral trioxide aggregate) will be evaluated. Twenty participants with at least two vital teeth with the need to confection of definitive total crowns (each participant) will be selected who present. The teeth will be randomly divided into 2 different groups according to the temporary cement composition (Based on calcium hydroxide; and based on mineral trioxide aggregate). Data will be collected, tabulated and submitted to statistical analysis

Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers; both genres; presence of at least two teeth with indication of total crowns; good oral hygiene.

Exclusion Criteria:

* Dentures or orthodontics; presence of periodontal disease and,or parafunctional habits; systemic disease and, or severe psychological; constant use of analgesic and, or anti-inflammatory or allergic response to dental products.