cyrilzakka/clinical-trials huggingface dataset:
Medication Development for Protracted Abstinence in Alcoholism: CORT118335 Versus Placebo

The hypotheses under test are that subjects with alcohol use disorder (AUD) of moderate or greater severity treated with CORT118335 will report decreased craving for alcohol following alcohol exposure in the laboratory and report significantly less drinking under naturalistic conditions, than those treated with placebo.


Eligibility Criteria:
Inclusion Criteria:

* Male or female volunteers, 18-75 years of age.
* Meets DSM-5 criteria for current alcohol use disorder of moderate or greater severity (AUD-MS).
* Subjects will not be seeking treatment because the medication studies are not treatment trials, and to avoid exposing treatment-seekers to alcohol cues.
* Subjects must be abstinent a minimum of 3 days (but not more than 7 days) prior to the human lab session.
* In acceptable health in the judgment of the study physician, based on interview, medical history, physical exam, ECG, routine urine and blood chemistry.
* Subjects with a history of depression, who have been on a stable dose of anti-depressant medication for at least 3 months, and do not meet current DSM-5 criteria for depression or anxiety.
* All subjects must agree to use double barrier birth control for the study duration and one month thereafter i.e., males must use condoms and females must use spermicide and/or a non hormonal barrier method, and their opposite sex partner must likewise use an effective non hormonal form of contraception.
* Able to provide informed consent and understand questionnaires and study procedures in English.
* Willing to comply with the provisions of the protocol and take daily oral medication

Exclusion Criteria:

* Medical conditions that could be aggravated by glucocorticoid and/or mineralocorticoid antagonism.
* Clinically significant findings on physical exam, ECG, urine or blood tests that may increase risk.
* CYP2C19 inhibitors
* Substrates metabolized primarily by CYP3A, CYP2C9, and CYP2C8 with narrow therapeutic index
* BCRP and UGT1A1 substrates
* Meets DSM-5 criteria for a current major psychiatric disorder, including mood, anxiety or substance use disorders, other than alcohol, nicotine, or mild cannabis use disorders.
* Pregnant or lactating.
* Treatment within the month prior to screening with (1) an investigational drug, (2) drugs which may negatively interact with study medications, or (3) drugs that may influence study outcomes (e.g., disulfiram \[Antabuse\], naltrexone \[ReVia\], acamprosate \[Campral\], or anticonvulsants.
* Chronic systemic steroid use
* Using drugs that are strong inhibitors and inducers of CYP2C9.
* No fixed domicile and/or no availability by home or mobile telephone.
Diagnostic Evaluation Study of the BactInsight Blood Culture System in West-Africa

Diagnosis of bloodstream infections (BSI) is done by sampling blood in blood culture bottles that are checked for growth in the microbiology laboratory. In LRS, microbiology laboratories are however scarce, and BSI cannot be diagnosed, resulting in overuse of antibiotics which fuels AMR. For diagnosis of BSI, so-called manual blood culture (equipment-free) systems are used in LRS, with daily visual inspection for growth. Compared to automates, manual systems are less sensitive, and growth is slower; in addition, training and experience are needed before laboratory staff is competent to detect growth when inspecting the blood culture bottles.

A simplified blood culture system could enable expanded use of blood cultures in LRS and would thus improve BSI treatment. Ongoing research at the Institute of Tropical Medicine, in collaboration with Ghent University has resulted in a novel, simple, cheap, open-access and robust blood culture system, the Bactinsight blood culture system. This system consists of two modules. Firstly, a portable, battery-operated measurement device (turbidimeter), which monitors and detects bacterial growth in blood culture bottles based on the turbidity of the culture medium caused by bacterial growth. Secondly, optimized blood culture bottles have been developed. A second step in blood cultures is the identification of the causing organism. Researchers at LETI (Grenoble, France) have developed a lensfree microscope, which simplifies and expedites identification of the causative organisms, improving patient's diagnosis and more directed antibiotic treatment. The lensfree microscope is an additional module for the Bactinsight blood culture system.

In SIMBLE, the Bactinsight blood culture system will be evaluated against reference systems in two phases. During the optimization phase in Belgium, the performance of Bactinsight turbidimeter + lensfree microscope will be tested in a reference hospital laboratory. In parallel, an in vitro laboratory evaluation of the Bactinsight blood culture system (turbidimeter + blood culture bottles + lensfree microscope) will be done using spiked blood cultures. In the field-testing phase, the ease-of-use, acceptability, adoptability and performance of Bactinsight blood culture system will be evaluated in three hospitals in Benin and Burkina Faso. The blood culture bottles used for this study will be manufactured in a production facility in Benin, that will be installed at the start of the project.


Eligibility Criteria:
Inclusion Criteria:

* With indications for blood culture sampling and for whom collection of a blood culture sample is part of standard clinical practice
* Willing and able to provide written informed consent (assent for minors)

Exclusion Criteria:

* none
Brainstem and Prematurity

Although significant advances in neonatal care have increased survival rates of preterm infants born before 28 weeks gestation, a concomitant decrease in neuro developmental disorders has not been achieved. Cerebral injuries, well documented during the previous years, in preterm babies are particularly deleterious since they occur in a developing brain. They affect both white and grey matter by complex mechanisms and the principal targets are the developing oligodendrocytes and neurons of the subplate. All these criteria define the encephalopathy of prematurity. Nevertheless, the consequences of prematurity at the level of the brainstem are not very well known and may explain neuro-developmental disorders with normal MRI.

The assessment of the motor repertoire is complementary to the neurological examination and may represent a diagnostic tool for cerebral palsy, mild motor deficits and delayed acquisition in children. The newborn have a rich motor repertoire. GMs play a key role in the development due to the feedback that they send to cortical neurons and reflect the maturational stage of the Central Nervous System (CNS). Lesions of the brainstem caused by prematurity may induce alterations of the motor repertoire.

Dysautonomic disorders, such as bradycardia, apneas, feeding problems, that occur frequently in very preterm babies reflect brainstem abnormalities. These symptoms are also described in other pathologies, in Rett syndrome and sudden infant death syndrome (SIDS). In these pathologies deficits of the 5-HT system have been described and associated with dysautonomia. It would then be interesting to evaluate 5-hydroxytryptamine (5-HT) levels in very preterm babies.

The serotonergic system develops very early during gestation and is one of the first neurotransmitter to appear in the developing brain. The main 5-HT nuclei are located within the brainstem. 5-HT plays an important role in the homeostasis and the modulation of the respiratory network. Moreover, previous studies have shown that 5-HT projections to the spinal cord are involved in posture and in the coordination. It is tempting to think that 5-HT deficits may have some repercussions on the development of the CNS, changing activity dependent processes, such as spontaneous activity recorded at the spinal level in rodents.

In this project, the 5-HT platelet levels in preterm infants born before 28 weeks will be compared with newborns. a correlation between the levels of 5-HT with MRI of the posterior fossa, GMs and dysautonomia different parameters such as heart rate variability, suction-swallowing and different breathing techniques will be established


Eligibility Criteria:
Inclusion Criteria:

* Birth less than 28 weeks
* known gestational age
* Birth in born
* Infant without genetic syndrom, evolutive neurologic disease, chronic disorder, malformative pathology
* Infant without intra-ventricular haemorrhage with dilatation or intraparenchymal haemorrhage
* Infants without mechanical ventilation

Exclusion Criteria:

• Infant with congenital cardiopathy, congenital brainstem disorder, Pierre Robin sequence
The Effect of DHEA on Markers of Ovarian Reserve in Women With Diminished Ovarian Reserve

This prospective study evaluates the effect of DHEA supplementation on markers of ovarian reserve in women with diminished ovarian reserve.

Ovarian reserve markers, such as FSH, estradiol, AMH, ovarian volume and antral follicle counts will be monitored on DHEA supplementation in a prospective fashion.

Eligibility Criteria:
Inclusion Criteria:

* infertile women with diminished ovarian reserve

Exclusion Criteria:

* women \> 45
External Validation of the Clinical Pre-hospital "Red- Flag" Alert for Activation of Intra-hospital Hemorrhage Control Response in Blunt Trauma.

External validation of the clinical pre-hospital "Red- Flag" alert for activation of intra-hospital hemorrhage control response in blunt trauma.

Severe trauma, with a variety of causes, is responsible for more than 9% of the world's population and is the leading cause of preventable mortality among 15-35 year olds. Massive hemorrhage remains the second leading cause of early mortality in those traumatized after head trauma, accounting for about 40% of deaths. In 71% of cases this mortality is pre-hospital without access to rapid medicalization. Intra-hospital mortality is also important.

The main factors explaining this mortality in patients with severe bleeding are delays in recognition and management. The effectiveness of the "trauma systems" and the management channels for severe traumatized injuries are thus generally assessed by the intra-hospital mortality rate. Optimal and early management is therefore essential from the pre-hospital phase.

The treatment of traumatic hemorrhagic shock requires means of local hemostasis, medication management and can go as far as the establishment of massive transfusion protocols (PTM). This type of PTM is activated in about 8% of cases. While it is little practiced in pre-hospital and still debated today, its early hospital establishment is essential.

Rym Hamada et al. highlighted a predictive score "RED-FLAG" of severe hemorrhage in severe traumatized patients requiring the immediate implementation of rapid hemorrhage control (activation of PTM, hemostasis surgery, etc.).

This score is based on 5 clinico-biological items. A score of 2 or more is predictive of an immediate intra-hospital action of hemostasis. In France, several networks are organized around centers 15 and hospitals specialized in the management of severe traumatized, from alert to definitive treatment, in accordance with the international recommendations in force.

The objective of this study is to perform external and prospective validation, within a new cohort, of the "RED-FLAGS" score. For this, we are conducting a multicenter and prospective study

Eligibility Criteria:
Inclusion Criteria:

* Adult patients (More than 18 yo)
* Regulated by the medical regulation centers (SAMU - centres 15) of the hospitals of Angers (SAMU 49), Rennes (SAMU 35), Le Mans (SAMU 72), Tours (SAMU 37), Laval (SAMU 53) and Chambéry (SAMU 73)
* Patients with severe trauma classified as A or B
* And benefiting respectively from hospital support in trauma centers
* Not subject to limitation of active therapeutics
* Member or beneficiary of a social security scheme

Exclusion criteria:

* Patients with Not Considered Severe Trauma (Not A, B or C) after pre-hospital medical assessment
* Patient objecting to participating in research
A Study of Orforglipron (LY3502970) to Compare a Single Capsule and Multiple Capsules in Healthy Participants

The main purpose of this study is to assess and compare a single capsule and multiple capsules of Orforglipron based on the amount that gets into the blood stream and how long it takes the body to get rid of it, when given to healthy participants under fasted and fed conditions. How the body handles and eliminates the study drug after meals and on an empty stomach will be measured. Information about any adverse effects experienced will be collected and the safety and tolerability of Orforglipron will also be evaluated. The study will last approximately 21 weeks, including a screening period.


Eligibility Criteria:
Inclusion Criteria:

* Have a stable body weight, that is, less than a 5% body weight change, for 1 month prior to randomization and body mass index (BMI) within the range 23.0 to 35.0 kilogram per square meter (kg/m²), inclusive
* Have safety laboratory test results within normal reference range for the population or investigative site, or results with acceptable deviations that are judged to be not clinically significant by the investigator
* Have venous access sufficient to allow for blood sampling
* Are reliable and willing to make themselves available for the duration of the study and are willing to follow study procedures

Exclusion Criteria:

* Have a hemoglobin A1c (HbA1c) test level greater than or equal to 6.5%
* Have an estimated glomerular filtration rate less than 30 milliliter per minute per 1.73 square meter (mL/min/1.73m²)
* Have a history of significant active or unstable major depressive disorder or other severe psychiatric disorder, for example, schizophrenia, bipolar disorder, or other serious mood or anxiety disorder within the 2 years prior to screening
* Actively suicidal and therefore deemed to be at significant risk for suicide
* Have a known clinically significant gastric emptying abnormality
* Have history or presence of acute or chronic pancreatitis or an elevation in serum lipase or amylase levels greater than 3 times the upper limit of normal (ULN)
* Have an abnormal blood pressure (BP), pulse rate, or both
* Have difficulty swallowing capsules
Neurodynamics vs. Stretching in Soccer Players With Short Hamstring Syndrome

Comparison of the effects of passive stretching vs. sciatic nerve gliding in soccer players presenting with short hamstring syndrome.

Soccer players from three teams in the region of Murcia (Spain) were recruited and randomly divided into three groups: control group, experimental group 1 and experimental group 2.

In the control group passive shoulder mobilization will be applied, in experimental group 1 sciatic nerve gliding will be applied and in experimental group 2 passive hamstring stretching will be applied.

Treatments will be performed once a week for 4 weeks and measurements will be taken at week 1 and 4.

Eligibility Criteria:
Inclusion Criteria:

* Soccer players of the Murcia Region Federation who have short hamstring syndrome.
* Between 16 and 30 years of age.
* To complete the informed consent form.

Exclusion Criteria:

* Subjects with significant neurological pathology.
* Subjects with hamstring muscle injury.
* Subjects with lumbar pathology.
A Comparative Study to Evaluate the Accuracy and Safety of the GlySure Continuous Intravascular Glucose Monitoring System Versus Intermittent Blood Glucose Monitoring

The purpose of this study is to evaluate the system performance of the GlySure Continuous Glucose Monitoring (CGM) system in patients admitted to the Surgical Intensive Care Unit.


Eligibility Criteria:
Inclusion Criteria:

1. Patient or legal representative MUST be willing to sign an informed consent document
2. Male and female aged 18 years and above
3. Require Central Venous Catheter (CVC) into the right internal Jugular vein as part of disease management and treatment
4. Expected to remain in the Surgical Intensive Care Unit (SICU) for at least 30 hours and up to 7 days-

Exclusion Criteria:

1. Patient or legal representative unable to provide written informed consent
2. Patient who is pregnant
3. Patient who is currently being administered Mannitol
4. Patient with history of Pulmonary Embolism (PE)
5. Patient with history of thrombosis
6. Patient with known hyper-coagulation
7. Patient with known history of heparin hypersensitivity
8. Patient with history of heparin induced thrombocytopenia
9. Participation in a clinical study involving an unlicensed pharmaceutical product and/or device within the 3 months prior to enrolment in this study
10. Patient with known hypersensitivity/allergy to adhesive I.V. dressings such as 3M Tegaderm film
11. Patient likely to require an MRI scan during their stay in the SICU
12. Patients likely to require treatment with Mannitol during time in the SICU
The Effectiveness of Dexketoprofen on Shoulder Pain Using Different Physiotherapy Treatments

The purpose of this study is to determine whether dexketoprofen administered by phonophoresis or iontophoresis is more effective in the treatment of subacromial syndrome that the conventional therapy with ultrasounds.

It is a question of valuing the decrease of the pain (by means of the visual analogic scale pain score) and the increase of the functionality of the joint (by means of Dash and Constant scores) of three different treatments from physical therapy to establish the most effective protocol for the treatment of the subacromial syndrome.

Determine the best physiotherapy treatment for subacromial syndrome with 20 sessions of different treatments.

A group will receive the conventional treatment with ultrasounds without drugs, another group will receive dexketoprofen by phonophoresis and the third group will receive dexketoprofen by iontophoresis.

Eligibility Criteria:
Inclusion Criteria:

* Subacromial syndrome diagnosed by ultrasound scanning with Rotator cuff tendinitis or partial break of the rotator cuff and / or of the brachial biceps.
* Informed consent.

Exclusion Criteria:

* To suffer shoulder arthritis or any shoulder pathology with mobility limitation.
* Fibromyalgia
* Psychologic or psychiatric pathologies
* Hypersensibility to the drug
* Back or shoulder traumatism
* To have received an analgesic infiltration on the affected shoulder in the last month
* Lack of adherence to the treatment upper to 15 % of the sessions
Tacrolimus and Risk Factors for Glucose Metabolism Disorders in Kidney Transplant Patients

Many people who receive a kidney transplant develop problems with how their body processes sugar (glucose). This includes conditions like prediabetes and diabetes, which can lead to more health issues, such as heart problems and infections.

One of the main medications used after a kidney transplant, called tacrolimus, can contribute to these sugar problems. Tacrolimus helps protect the new kidney, but it can also harm the cells in the pancreas that produce insulin, a hormone that controls blood sugar. Other factors, such as stress on the body and insulin resistance, can make things worse.

The effect of tacrolimus on blood sugar may depend on how the body processes the drug. Some people break down tacrolimus quickly (fast metabolizers), so they need higher doses to reach the right level in their blood. Others break it down more slowly (slow metabolizers) and require lower doses. Doctors can measure how fast someone metabolizes tacrolimus using aparameter called the concentration-to-dose (C/D) ratio.

This study aims to find out what increases the risk of developing blood sugar problems after a kidney transplant. It will focus on how quickly patients process tacrolimus and whether this affects their risk of developing diabetes. The study will also look at how common these issues are in kidney transplant patients in Poland.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Recipients of a kidney transplant from a living or deceased donor
* Standard immunosuppressive regimen post-kidney transplantation (KTx) including Envarsus®
* LCP Tacrolimus therapy initiated from the day of KTx or conversion from another tacrolimus formulation to LCP Tacrolimus by day 8 at the latest, according to the institution's routine practice
* Informed patient consent to participate in the study

Exclusion Criteria:

* Diagnosis of diabetes (type 1 or type 2) treated with diet or glucose-lowering drugs
* Random glycemia/HbA1c levels justifying a diagnosis of diabetes at the time of study enrollment
* Kidney retransplantation
* Recipients of a multi-organ transplant
* Use of glucagon-like peptide-1 (GLP-1) receptor agonists for weight loss
* Use of flozins for renal or cardiac indications
* Chronic use of drugs affecting carbohydrate metabolism, such as glucocorticosteroids
GLS-1200 Topical Nasal Spray to Prevent Sinusitis After Endoscopic Sinus Surgery

This clinical trial will evaluate the safety, tolerability and effectiveness of GLS-1200 nasal spray in addition to the standard of care after endoscopic sinus surgery in people with chronic sinusitis.

Subjects will be assigned to treatment via nasal spray with either GLS-1200 or placebo in blinded manner in a 2:1 ratio. Treatment will commence 1 week post-operatively and continue for 7 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 years or older;
* Able to provide informed consent
* Able and willing to comply with study procedures
* Elective FESS
* Able and willing to utilize an approved form of pregnancy prevention for women of child bearing potential

Exclusion Criteria:

* Pregnancy or documentation of pregnancy by pre-operative pregnancy test
* History of primary ciliary dyskinesia
* Known allergy to quinine, quinidine or mefloquine
* Know latex allergy
* History of hematologic malignancy
* History of bone marrow transplantation
* Current or planned chemotherapy treatment for hematologic or solid tumor during study period
* FESS performed non-electively and /or in preparation for decontamination of the sinuses related to cystic fibrosis or in preparation for chemotherapy, solid organ transplantation, or bone marrow transplantation
The Establishment and Improvement of Community Acquired Pneumonia Monitoring and Disposal Network in Beijing

In the 21st century, threats to human health of new respiratory infectious diseases increased.

The project aim is to establish pneumonia pathogens network in Beijing and understand the pathogen spectrum distribution.


Eligibility Criteria:
Inclusion Criteria:

1. Confirmed community acquired pneumonia
2. Age≥14 ys
3. New appear of cough or cough become severe
4. New infiltration showed by chest radiology(x-ray or CT)
5. Fever T\>37.8o C or \<35.6o C
6. White blood cell\>10,000/mm3 , left shift or leukopenia\<4000/ul）

Exclusion Criteria:

1. Pregnancy or breast-feeding
2. Over one week after the onset of symptoms
3. HIV infection
4. Recent 90-day hospitalized history(length of stay greater than 2 days)
5. Live in nursing homes or rehabilitation hospitals