cyrilzakka/clinical-trials huggingface dataset:
Metoprolol in Acute Myocardial Infarction. A PK/PD Study

The objective of the study was to compare treatment with two different oral formulations of metoprolol, metoprolol immediate release (IR) and metoprolol extended release (CR/XL) in patients with acute myocardial infarction regarding the following:

Pharmacokinetics, peak and trough plasma concentrations and area under the plasma concentration curve.

Pharmacodynamics, hourly means of Holter recorded heart rate. Tolerability. An open, randomised design with two parallel groups was employed.

A pharmacokinetic and pharmacodynamic study comparing metoprolol IR and metoprolol CR/XL subsequent to initial treatment with intravenous and/or oral metoprolol in patients with suspected acut myocardial infarction

Eligibility Criteria:
Inclusion Criteria:

* Male and female patients admitted to the CCU with suspected acute myocardial infarction
* Age 18 years or older
* Treated with and tolerated the full dose of metoprolol IR 50 mr four times daily or metoprolol CR/XL 200 mg once daily on study day 1
* Expected to stay in the CCU until the morning of study day 4
* Sinus rhythm on the day of admission and at randomisation

Exclusion Criteria:

* Pregnancy or childbearing potential without adequate contraception
* Participation in a clinical study during the last 30 days or previous randomisation in the present study
Evaluation and Longitudinal Follow-up of Biomarkers Predictive of Severe Forms of COVID-19

Current data in the literature demonstrate that the immune response to CoV-2-SARS is much more complex than initially assumed. In fact, beyond the humoral response, including the existence of neutralizing CAs, the adaptive lymphocyte T-type immune response also appears to play an important role in controlling the infection and reducing the severity of the disease. At this stage, the analysis of this T response is still rudimentary and underdeveloped, but it seems crucial to be able to analyze it effectively in COVID-19 patients, which could help predict the evolution of the infection. It is also currently difficult to know the evolution of this response over time and especially after the resolution of the infection.

To this end, we will analyze the T lymphocyte response (ELISPOT and QUANTIFERON) based on the secretion of IFN (Th1) and IL-4 (Th2) by CoV-2-SARS specific T cells from COVID-19 patients. We will compare the T response to the quality of the systemic and mucosal humoral response. Finally, we will evaluate in parallel two new biomarkers of the severity of COVID-19: plasma calprotectin and the presence of antibodies to type 1 IFN antibodies.


Eligibility Criteria:
Inclusion Criteria:

* Social security affiliation
* Signed informed consent
* Patients with COVID infection documented by PCR and/or antigenic testing
* Patients belonging to the following groups:

  * asymptomatic patients with PCR-positive PCR
  * patients with mild symptoms and PCR positive
  * seriously symptomatic patients with PCR positive
  * patients in resuscitation with positive PCR
  * Healthy individuals as controls

Exclusion Criteria:

* haemoglobin \< 8g/dL
* Pregnancy, breastfeeding woman
* Patient vaccinated within 15 days prior to inclusion
Dynamic Position Change in Colonic Adenoma Detection

There was an only single operator study reporting dynamic position change during colonoscopy withdrawal significantly improved polyp and adenoma detection. So we designed a prospective, randomized multicenter study to verify the effect of dynamic position change in colonic adenoma detection. We think position change improve luminal distension and has the potential to improve adenoma detection rate.


Eligibility Criteria:
Inclusion Criteria:

* patient aged over 45 years who will be performed colonoscopy for the first time

Exclusion Criteria:

* polyposis syndrome
* musculoskeletal problem
* Inflammatory bowel disease
* previous bowel operation
Psilocybin Therapy for Chronic Low Back Pain

This study evaluates whether psilocybin therapy helps patients cope with chronic low back pain more effectively. Patients may be recruited at Stanford and University of California San Francisco (UCSF), study procedures will occur at UCSF. Each participant will receive a dose of psilocybin with possibly one or more other drugs. Participants will undergo two preparation sessions, a dosing session, three integration sessions to discuss their psilocybin experience, and several follow up sessions.

Chronic pain is associated with higher levels of pain-related distress, depression, emotional dysfunction, helplessness, hopelessness, and suicidality. Psilocybin is a psychoactive drug that may be well-suited to easing the psychological and emotional symptoms of distress associated with chronic pain. Previous studies testing psilocybin therapy have shown improvements on multiple behavioral and psychiatric outcomes, but it is unknown whether psilocybin therapy similarly enables patients to cope with chronic pain more effectively. The investigators will determine whether psilocybin therapy improves patients' ability to cope with chronic low back pain. If psilocybin therapy is an effective treatment in this population, its use could be incorporated into interventions for chronic low back pain and other psychological conditions.

Eligibility Criteria:
Inclusion Criteria:

* Age 25 to 70 years old
* Comfortable speaking and writing in English
* Diagnosed with chronic low back pain
* Able to attend all in-person visits at UCSF as well as virtual visits
* Has tried at least two previous medications/ procedures and physical therapy trials for low back pain

Exclusion Criteria:

* Chronic low back pain that is attributed to malignancy, subacute or acute fracture or infection
* Low back pain with radiation below the knee
* Low back pain with neurologic signs present
* Regular use of medications that may have problematic interactions with psilocybin, including but not limited to dopamine agonists, MAO inhibitors, antipsychotics, and stimulants
* A health condition that makes study unsafe or unfeasible, determined by study physicians
Δ9-THC (Namisol®) in Chronic Pancreatitis Patients Suffering From Persistent Abdominal Pain

Abdominal pain resulting from chronic pancreatitis (CP) is often recurrent, intense and long-lasting, and is extremely difficult to treat. Medical analgesic therapy is considered as first choice in pain management of CP, resulting in regularly prescription of opioids. The adverse consequences of prolonged opioid use, including addiction, tolerance and opioid induced hyperalgesia, call for an alternative medical treatment. Cannabis has been used to treat pain for many centuries. Delta-9-tetrahydrocannabinol (Δ9-THC), the psychoactive substance of the cannabis plant, has been shown in previous studies to be a promising analgesic. The development of Namisol®, a tablet containing purified Δ9-THC showing an improved pharmacokinetic profile, provides the opportunity to test the analgesic potential of Δ9-THC in favourable conditions. The current study aims to investigate the analgesic efficacy of Namisol® as add-on analgesic during a long-term treatment (52 days) of abdominal pain resulting from CP.


Eligibility Criteria:
Inclusion Criteria:

* Aged 18 years or older
* Confirmed chronic pancreatitis
* Pain duration exceeding 3 months, and average NRS≥3
* Stable doses intake of analgesics for the past 2 months
* The patient has been informed about the study, understood the information and signed the informed consent form

Exclusion Criteria:

* Patient took cannabinoids on a regular basis for at least one year
* Patient does not feel a pinprick test in the lower extremities
* Patient has a body mass index (BMI) above 32,0 kg/m2
* Patient suffers from serious painful conditions other than chronic pancreatitis
* Patient has a significant medical disorder that may interfere with the study or may pose a risk for the patient
* Patient uses any kind of concomitant medication that may interfere with the study or may pose a risk for the patient
* Patient does not tolerate oral intake of medication or liquids, or is refrained from oral intake because of medical reasons
* Patient demonstrates clinical relevant deviations in the electrocardiogram (ECG)
* Patient has an actual moderate to severe renal impairment
* Patient has an actual moderate to severe hepatic impairment
* Patient has a presence or history of major psychiatric illness
* Patient has experienced an epileptic seizure in the past
* Patient demonstrates clinically significant laboratory abnormalities
* Patient demonstrates a positive urine drug screen for THC, cocaine, MDMA, and amphetamines
* Patient demonstrates a positive test result on hepatitis B surface antigen, hepatitis C antibody or HIV antibody test
* Patient has a history of sensitivity / idiosyncrasy to THC
* Patient has a known or suspected lactose intolerance
* Female patient is pregnant or breastfeeding
* Patient intends to conceive a child during the course of the study
* Patient participates in another investigational drug study
* Patient has a clinical significant exacerbation in illness
* Patient is unwilling or unable to comply with the lifestyle guidelines
Characterization of the Gut Microbiota Composition and Activity After Three Weeks of Chitin-glucan Supplementation

The aim of this research study is to characterize gut microbiota composition and activity after a daily supplementation of 4.5 g of chitin-glucan during 3 weeks. For this purpose, a monocentric longitudinal intervention study without control will be performed. Fecal microbiota composition and fecal concentrations of gut microbiota-derived metabolites (bile acids, conjugated-polyunsaturated fatty acids and short-chain fatty acids) will be measured. In addition, during ten hours following the ingestion of a test meal rich in fibers, the kinetic of production of H2, methane and volatile compounds exhaled from breath will be evaluated.


Eligibility Criteria:
Inclusion Criteria:

* Woman or man, aged of 18 to 40 years
* Body mass index (BMI) between 18 and 25 kg/m2
* In good general health as evidenced by medical history and physical examination
* Non-smoker
* Caucasian
* H2 - producer
* Provision of signed and dated informed consent form
* Stated willingness to comply with all study procedures and availability for the duration of the study

Exclusion Criteria:

* Subjects presenting gastro-intestinal disorders such as ulcers, diverticulitis and inflammatory bowel diseases
* Subject presenting allergy or food intolerance (lactose, gluten,...)
* Subjects with psychiatric problems and/or using antipsychotics
* Current or recent (\< 4 weeks) intake of antibiotic, probiotic, prebiotic, fiber supplement, and/or any product modulating gut transit
* Feeding particular diet such as vegetarian diet or hyper protein diet
* Chronic intake of drug, excepted contraceptive drug
* Pregnant or lactating woman or woman who did not use highly effective contraception
* Subjects who drink more than 3 glasses of alcohol per day (\> 30 g of alcohol per day)
* Subjects having participated to another clinical trial two weeks before the screening test visit
* Subjects presenting an allergy or intolerance to one component of the product tested
Preoperative Ondansetron Lozenge for Prevention of Post-Spinal Shivering in Caesarean Section

The aim of this study is to estimate the role of ondansetron lozenge on prevention of post-spinal shivering in cesarean section.

Spinal anesthesia (SA) is preferred for cesarean section (CS) compared with general anesthesia(GA) because of several advantages, including prevention of the potential risk of GA-related neurotoxicity.

Post-spinal shivering (PSS) could be a provocative factor for postoperative pain and its appropriate treatment prevents non-thermoregulatory tremors. Shivering also causes aggravating postoperative pain by stretching of sutures.

Ondansetron is a selective antagonist for receptor 5-hydroxytryptamine 3 and is very effective in the prevention and treatment of shivering intra- and post-operation. Ondansetron can affect the body temperature and shivering in rats since the balance of nor-epinephrine and 5-hydroxytryptamine (5-HT) in the preoptic-anterior hypothalamus controls the temperature set point.

Eligibility Criteria:
Inclusion Criteria:

* Age from 18 to 40 years.
* American Society of Anesthesiology (ASA) physical status II.
* Parturient women undergoing CS under spinal anesthesia.

Exclusion Criteria:

* Parturient women with any contraindication or hypersensitivity to the study drugs.
* Any history of cardiovascular diseases, psychosis, hypertension, fetal distress, cord prolapse initial.
* Temperature more than 38°C or less than 36°C.
* Body Mass Index (BMI)\> 40 kg/m2.
* Medical history of alcohol or drug abuse.
* Parkinson's disease or any extrapyramidal disease.
* Intraoperative blood transfusion.
* History of chemotherapy treatment.
NOVOCART 3D Treatment Following Microfracture Failure

This study is prospective single arm extension study of protocol AAG-G-H-1220. It is open only to participants of AAG-G-H-1220 randomized to the Microfracture treatment group.

This study is an extension of protocol AAG-G-H-1220 wherein patients were randomized to either NOVOCART 3D or Microfracture treatment groups. This prospective single arm extension study is only open to participants of AAG-G-H-1220 who were randomized to Microfracture treatment and who failed Microfracture treatment.

Eligibility Criteria:
Inclusion Criteria:

* participated in study AAG-G-H-1220
* identified as a microfracture failure patient
* voluntary consent to participate in the study

Exclusion Criteria:

* other cartilage repair procedures performed on target knee
* other conditions that would interfere with healing or evaluating outcomes
* lesions requiring implants larger than 9cm2
* non-compliance with requirements in study AAG-G-H-1220
Single-step Functional Sinus Endoscopy and Transoral Surgery

Dento- alveolar or dental structural diseases that affect the floor of the maxillary sinus can cause maxillary sinusitis which is known as odontogenic maxillary sinusitis (OMS). Many treatment protocols have been documented to treat OMS. However, There is no unanimity among clinicians on how and who should treat OMS, whether is it otolaryngologist, oral/maxillofacial surgeons, or dentist. Therefore, this study will be will be enrolled to evaluate the efficacy of the Single-step Functional Sinus endoscopy and trans-oral surgery in the management of maxillary sinusitis raised from Odontogenic origin via Department- integrated therapy.

The OMS is a well-known but understudied kind of sinusitis that necessitates a treatment regimen different from non-odontogenic sinusitis. It requires specialized attention because it differs in its pathophysiology, microbiology, diagnosis, and therapy than other forms of non-odontogenic sinusitis. There are several surgical techniques have been published to treat odontogenic maxillary sinusitis, such as transoral, transnasal endoscopic, or combined techniques. Multiple specialists are daily facing patients with maxillary sinusitis either odontogenic or non-odontogenic, including otolaryngologist, maxillofacial/oral, and dental surgeons.

The direct transoral method, which involves making a bone window in the anterolateral maxillary wall, is more familiar to maxillofacial/oral surgeons, whereas the transnasal endoscopic approach is gaining favor, particularly among otolaryngologists. There is no unanimity among clinicians on how and who should treat OMS, whether it is otolaryngologist, maxillofacial, or oral surgeon. This is one of the reasons why the results are frequently challenged as reported by others. Therefore, this study will be will be enrolled to evaluate the efficacy of the Single-step Functional Sinus endoscopy and trans-oral surgery in the management of maxillary sinusitis raised from Odontogenic origin via Department- integrated therapy.

Eligibility Criteria:
Inclusion Criteria:

1. A diagnosis of OMS that is not responding to dental treatment and/or medical treatment
2. Agreement on the odontogenic cause between an ENT specialist and a dentist/maxillofacial surgeon (There is bone loss surrounding the tooth's root and a connection between the dental lesion and sinus on CT scans)
3. Availability of clinical, radiographic, and ESS data.

Exclusion Criteria:

1. Maxillary sinus malignancy
2. Sinuses with a previous surgery
3. Non-odontogenic Sinusitis
REThinkAcademy: Helping Universities to Effectively Care for the Mental Health of College Students in the Digital Age

The project aims at monitoring mental health and its mechanism in the student population using a longitudinal design and ecological momentary assessment procedure throughout the first semester of college.


Eligibility Criteria:
Inclusion Criteria:

* student in Babes-Bolyai University in the first year

Exclusion Criteria:

* incapacity of accessing the mobile app
A Study to Evaluate INCA033989 Administered in Participants With Myeloproliferative Neoplasms

This study is being conducted to evaluate the safety, tolerability, dose-limiting toxicity (DLT) and determine the maximum tolerated dose (MTD) and/or recommended dose(s) for expansion (RDE) of INCA033989 administered in participants with myeloproliferative neoplasms.


Eligibility Criteria:
Inclusion Criteria:

* Life expectancy \> 6 months.
* Willingness to undergo a pretreatment and regular on-study BM biopsies and aspirates (as appropriate to disease).
* Existing documentation from a qualified local laboratory of CALR exon-9 mutation.
* Participants with MF or ET as defined in the protocol.

Exclusion Criteria:

* Presence of any hematological malignancy other than ET, PMF, or post-ET MF.
* Prior history of major bleeding, or thrombosis within the last 3 months prior to study enrollment.
* Participants with laboratory values exceeding the protocol defined thresholds.
* Has undergone any prior allogenic or autologous stem-cell transplantation or such transplantation is planned.
* Active invasive malignancy over the previous 2 years.
* History of clinically significant or uncontrolled cardiac disease.
* Active HBV/HCV or known history of HIV.
* Any prior chemotherapy, immunomodulatory drug therapy, immunosuppressive therapy, biological therapy, endocrine therapy, targeted therapy, antibody, or hypomethylating agent used to treat the participant's disease within 5 half-lives or 28 days (whichever is shorter) before the first dose of study treatment.
* Participants undergoing treatment with G-CSF, GM-CSF, or TPO-R agonists at any time within 4 weeks before the first dose of study treatment.

Other protocol-defined Inclusion/Exclusion Criteria may apply.
Cancer-related Venous Thromboembolic Disease - Cohort Study

Venous thromboembolic disease (VTE) is a common (1/1000), potentially serious disease (10% mortality when the clinical presentation is that of pulmonary embolism (PE)). In cancer patients, the risk of developing VTE is high and constitutes a negative prognostic factor for cancer; the risk of bleeding is also increased. The study of VTE in the context of cancer is a major challenge, given the frequency of the association, the heterogeneity of the situations, the risk factors involved and the therapeutic issues in both curative and primary prevention; in this field, many uncertainties remain, justifying a study focused on the association of VTE and cancer.

Cancer is associated with a higher risk of VTE and mortality. This association is characterized by various uncertainties at pathophysiological, diagnostic, therapeutic and prognostic levels.

CAPE STUDY is a prospective, single-center interventional cohort follow-up study designed to investigate the risk of recurrence of VTE and its mechanisms in cancer patients.

The study involves the collection of biological samples from cancer patients with venous thromboembolic disease.

At inclusion and in case of recurrence of thrombosis or hemorrhage:

* Blood samples will be taken for analysis and to constitute a biobank for future assays.
* Urine samples will be collected Once a year for 5 years (and adapted to the clinical context): visit as part of routine care, or mailing of a questionnaire, or telephone contact.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18 years and more.
* Patients with active cancer or requiring cancer treatment at the time of their VTE episode
* Patients with documented VTE less than 2 years old
* Patients affiliated to the social security system
* Patient who has signed a written informed consent

Exclusion Criteria:

* Patient under 18
* Refusal to participate
* Incapacity to consent to the study
* Patient under guardianship
* Incapacity to communicate (comprehension disorder)
* Life expectancy of less than 6 months
Glecaprevir/Pibrentasvir Real-world Study in China

To evaluate the efficacy, adverse effect, short - and long-term outcomes of Glecaprevir/Pibrentasvir for the treatment of chronic hepatitis C (non-cirrhotic or compensatory cirrhosis)in China through a real-world study

This study is a multi-center, prospective, real-world study, aiming to investigate the use of Glecaprevir/Pibrentasvir in routine clinical management of chronic hepatitis C patients and evaluate its effectiveness and safety across a heterogeneous population in China.Approximately 800 patients will take part in this study, 20 sites will be included which distribute in China's major cities, thus each site will enroll 40 patients.

Eligibility Criteria:
Inclusion Criteria:

* \>18 years old
* Meet the standard of Glecaprevir/Pibrentasvir treatment

Exclusion Criteria:

* Patients have contraindications to Glecaprevir/Pibrentasvir
* Pregnancy or lactation
* Malignancy
* Decompensatory cirrhosis
Comparison of Usability Satisfaction of the Newly Developed Low-cost Thermoplastic Splint and Commercial Thermoplastic Splint

Low-temperature thermoplastic has been commonly used in the fabrication of hand splints. However, its high cost and limited accessibility pose challenges for both clinicians and clients. There is a need for innovative and cost-effective splinting materials that are convenient to use. This study aimed to investigate the satisfaction and opinions of patients regarding a newly developed low-cost thermoplastic material.


Eligibility Criteria:
Inclusion Criteria:

* Patient with musculoskeletal disorder
* Need to receive the splint from occupational therapist

Exclusion Criteria:

* History of neurological disorder
* Have the cognitive impairment
* Receive the splint already
* Have clinical diagnosis of the disease or symptoms that cannot use the splint
Preparing for Kidney Transplant by Attaining a Healthy Weight

The purpose of this study is to determine if an assigned physical fitness program will result in weight loss to prepare patients for kidney transplant.

The goal of this study is to prepare subjects for kidney transplant. Patients who are in need of a kidney transplant but are unable to be place on the wait list due to weight will be enrolled in a six month workout program. The workout program will consist of counseling from a registered dietician, personal training from certified trainers and constant health monitoring.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients over 18 years of age and older but less than 65
* All patients who are currently listed as "inactive" on the University of Chicago kidney transplant wait list
* Those with a body mass index of 40-44
* Those with access to the Internet
* Have transportation to the fitness center (Formula Fitness Center at Union Station location)

Exclusion Criteria:

* Those patients who are listed "inactive" on the wait-list due to co-morbid conditions other than obesity
* Those who are unwilling to attend fitness center appointments
* Those who do not have adequate transportation to the fitness center
* Those who do not have access to the Internet
* Those who are not comfortable navigating and using the Internet