cyrilzakka/clinical-trials huggingface dataset:
Identification and Clinical Relevance of an Oxytocin Deficient State (CRH Study)

Oxytocin (OT) is a hypothalamic peptide that enters the peripheral circulation via the posterior pituitary gland. OT plays a key role in regulating appetite, psychopathology, prosocial behavior and sexual function. Hypopituitarism is associated with increased obesity, increased psychopathology, sexual and prosocial dysfunction despite appropriate hormone replacement. A few studies suggest the existence of a possible OT deficient state in hypopituitarism. In animal models, corticorelin hormone (CRH) has shown to increase OT release.

This study is designed to evaluate oxytocin values after administration of CRH in adults (healthy volunteers and patients with hypopituitarism).

The investigators hypothesize that OT response will be blunted following CRH in patients with hypopituitarism compared to healthy controls.

This research is focused on two groups of participants: healthy controls (HC) and hypopituitary patients (HYPO) with at least one symptom of hypothalamic damage, presumably at highest risk for OT deficiency.

The aim is to improve knowledge on the physiology and patho-physiology of endogenous OT secretion in hypopituitary patients compared to healthy controls using a randomized, single-blind, crossover assignment (CRH vs placebo), placebo-control design.

Clinical implications of secretory OT dynamics and release under different stimuli using validated questionnaires to evaluate psychopathology, socio-emotional functioning, disordered eating behavior, impaired quality of life and sexual dysfunction, will be also evaluated.

Eligibility Criteria:
Inclusion Criteria:

* Patients with hypopituitarism (HYPO) (\>1 pituitary hormone deficiency) and stable hormone replacement for the prior three months
* At least one clinical sign of hypothalamic damage
* Female participants will be done in the early to midfollicular phase

Exclusion Criteria:

* uncorrected hormone deficiency
* creatinine \>1.5mg/dL
* alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \>2.5x upper limit of normal
* hematocrit less than 30%
* suicidality or active psychosis
* participation in a trial with investigational drugs within 30 days
* using a high glucocorticoid dose
* vigorous physical exercise
* alcohol intake within 24 hours before the study participation
* evidence of any acute illness or any illness that the Investigator determines could interfere with study participation or safety
* pregnancy or breastfeeding for last 8 weeks
* known allergies towards CRH
* patients refusing or unable to give written informed consent
* Additionally for healthy controls: the presence of brain or pituitary tumor, radiation involving the hypothalamus or pituitary, history of hypopituitarism or receiving testosterone or glucocorticoids esters.
A Phase III Study of Civamide Nasal Solution (Zucapsaicin) for the Treatment of Episodic Cluster Headache

This is a 49-day study to evaluate the effectiveness of Intranasal Civamide (Zucapsaicin) in the treatment of an episodic cluster headache period compared to placebo (medically inactive substance which does not contain any active ingredients).


Eligibility Criteria:
* At least 2 year history of episodic cluster headache (meeting IHS criteria)
* At least 2 previous episodes
* Expected duration of cluster period is at least 6 weeks but not longer than 16 weeks
* At least 1 but not more than 8 headaches on each of the 3 days immediately prior to treatment
Benefits Management for People With Psychiatric Disabilities

This stage 1 clinical trial will determine pilot efficacy, develop a therapy manual, and collect qualitative data concerning a brief money management intervention for people disabled by psychiatric illnesses.


Eligibility Criteria:
Inclusion Criteria:

* Has received treatment for a psychiatric disorder within 60 days of enrollment
* Receives SSI or SSDI payments totaling at least $600 per month
* Has an identified outpatient clinician
* Either i) Homeless within the past 3 months. Homeless is defined as having spent at least seven days in a shelter, outdoors (e.g. in a park, in a car), in a public or abandoned building (e.g. train station), or temporarily (less than a continuous month) housed by family or friends OR ii) Hospitalized within the past 3 months

Justification for Inclusion Criteria: Homelessness and hospitalization are common reasons for payee assignment (Conrad, Matters et al. 1998). In a prior study, we found that a high proportion of hospitalized inpatients meet criteria for needing a payee (Rosen, Rosenheck et al. 2002a). There is no point enrolling clinically stable outpatients in this study because they are unlikely to need payees.

Exclusion Criteria:

* Already has a conservator or representative payee
* An application to assign a payee or conservator has been initiated
* Unable to speak and understand English
Acute Kidney Injury in Adult Patients Supported by VA-ECMO

Post-cardiotomy cardiogenic shock (PCCS) occurs in 2-6% of patients undergoing cardiac surgery, and 1% of cardiac surgery patients will require mechanical circulatory support using Veno-Arterial ExtraCorporeal Membrane Oxygenation (VA-ECMO). Acute Kidney Injury is a frequent complication in this population and negatively impacts the survival. We aimed to determine whether the timing of ECMO implantation influence the renal prognosis of these patients.


Eligibility Criteria:
Inclusion Criteria:

* All patients admitted in post-operative of cardiac surgery
* Assisted by VA-ECMO

Exclusion Criteria:

* Chronic hemodialysis
* Death occurring within the first 48 hours of VA-ECMO implantation
* Multiple VA-ECMO during the same hospitalization.
Use of ADHEAR, a Non-Implantable Bone Conduction Hearing System, in Children With Single Sided Deafness and/or Conductive Hearing Loss

A hearing loss affects the quality of life and the natural development of children.

The new generation of hearing devices provides a huge number of options to them. These new hearing aids are often aesthetically acceptable, less invasive and user-friendly.

The ADHEAR Non-Implantable Bone Conduction Hearing System is connected directly to the skin with a special adhesive adapter. The device transmits the sound to the mastoid by vibrating on the skull and stimulates the inner ear without any previous surgery.

The objective of this study is to evaluate of the audiological benefit and subjective satisfaction of ADHEAR Audio Processor with Adhesive attachment in a group of children suffering from conductive hearing loss and/or single sided deafness.


Eligibility Criteria:
Inclusion Criteria:

* Unilateral and/or bilateral CHL (e. g. BC-thresholds \<25dB HL)
* Ability to perform all tests required for the study
* Signed, and dated informed consent by parents and children where applicable

Exclusion Criteria:

* intolerant of the materials
* patient with a skin or scalp condition that may preclude the attachment of the adhesive plaster
* fluctuation of hearing loss over a two year period of 15dB in either direction
* retrocochlear, or central auditory disorders
* any physical, psychological, or emotional disorder that would interfere with the ability to perform on test and rehabilitation procedures
Prevalence of Cerebral Small Vessel Disease in HIV Infected Patients

Cerebral small vessel disease (CSVD) is a major cause of cognitive impairment and disability in the general population, secondary to the accumulation of asymptomatic elementary lesions. CSVD is directly correlated with age and cardiovascular risk factors and therefore would be challenging in term of public health care in the future. While HIV patients share the same cardiovascular risk factors and they are often diagnosed with cognitive impairment and frailty, CSVD has not been yet described in this population.

The global aim is to compare the prevalence of CSVD in a well controlled HIV+ population compared to HIV- controls matched with age and sex.

500 HIV+ patients and 250 age- and sex- matched controls will undergo a screening of the CSVD with a 10 minutes MRI (FLAIR and T2\*).

Prevalence of the CSVD will be compared between HIV+ patients and controls. General and HIV-specific parameters from their electronic medical records will be compared between HIV+/CSVD+ and HIV+/CSVD- patients.

We are expecting to prove that CSVD is more frequent in HIV+ population.


Eligibility Criteria:
Inclusion Criteria:

* age over 50
* chronic HIV seropositive patient infected for at least 5 years
* treated with any antiretroviral (ARV) therapy
* plasmatic HIV viral load \<40 copies/ml for at least one year with one authorized blip \< 1000 copies/ml per year

Exclusion Criteria:

* co-infection with hepatitis C virus (HCV)
* uncontrolled high blood pressure (WHO criteria)
* Personal history of cerebral infarction or cerebral ischemia
* Personal history of neurological complication of the HIV-infection
* Use of illegal drugs (except cannabis or poppers)
* Glomerular filtration rate \< 15 mL/mn
* Complicated diabetes mellitus (glomerular filtration rate \< 60ml/mn and/or proteinuria\> 300 mg and/or retinopathy)
Prediction Model of ICIs Combined With Chemotherapy in Advanced NSCLC

The reliable predictive markers to identify which patients with advanced non-small cell lung cancer tumors will achieve durable clinical benefit for chemo-immunotherapy are needed. This study is a real world study, aiming to establish a multi-parameter model to predict the efficacy of immune checkpoint inhibitor(ICI) combined with chemotherapy, and to explore the correlation and predictive value of each single biomarker, so as to assist physician to select patients who may benefit for a long time as early as possible and guide clinical accurate treatment.


Eligibility Criteria:
Inclusion Criteria:

1. Male and female, ≥18 years old;
2. Patients with a definite cytological or histopathological diagnosis of non-small cell lung cancer;
3. Locally advanced (stage IIIB/IIIC) or metastatic (stage IV) NSCLC unable to receive radical surgery and/or radical radiotherapy (with or without concurrent chemotherapy) (AJCC cancer stage 8 clinical stage)
4. There is no known ALK gene translocation
5. For patients with EGFR-negative non-squamous cell carcinoma, or patients with EGFR-negative/unknown squamous cell carcinoma, it is required that they have not received systemic antitumor therapy for advanced NSCLC in the past (patients have received neoadjuvant chemotherapy, adjuvant chemotherapy, radiotherapy or chemoradiotherapy for curing non-metastatic disease in the past, A disease-free interval of ≥6 months was required between the last chemotherapy and/or radiotherapy).
6. Patients with non-squamous cell carcinoma with EGFR-sensitive mutation and EGFR TKI progression could be enrolled if they met any of the following requirements:

   Progress in Treatment of 1/2 generation EGFR TKI, T790M-; EGFR TKI treatment progress of 1/2 generation, T790M+, after 3 generations of EGFR TKI treatment progress again; T790M status was not considered in patients who had progressed to the initial 3 generations of EGFR TKI therapy.
7. At least 1 measurable lesion according to RECIST 1.1
8. Receiving immune checkpoint inhibitor therapy for more than 2 cycles
9. ECOG PS 0-1 score
10. Be able to understand and abide by the requirements of the agreement, and voluntarily participate in the study.

Exclusion Criteria:

1. Patients participating in other clinical studies;
2. Patients with serious lack of diagnosis and treatment data;
3. Patients could not understand the purpose of the study or disagreed with the requirements of the study;
4. A history of other tumors within 5 years;
5. Patients judged by the researchers as not suitable for inclusion in this study
Personalized Follow-up Program in the Type 2 Diabetes Prevention

In France, the global prevalence of diabetes was estimated to 5% of the population in 2016, the type two diabetes (DT2) corresponding to 90% of cases. This number is widely underestimated because most people are untreated and undiagnosed. Due to the silent character of this disease, it is estimated that 20 à 30 % of diabetic adults have not yet been diagnosed. The conclusions, presented during the annual meeting of EASD in 2019, suggest that the precursor signs of this disease could be present until 20 years before the diagnosis.

Diabetes is a metabolic disease and people are diagnosed, in general, around 40-50 years old. The main risk factor of type II diabetes is lifestyle (rich diet, sedentary) but there is also other factors like hyperlipidemia, high blood pressure, high fasting blood sugar, stress, smoking, heredity, family history of diabetes, or gestational diabetes. This induces an increase of obesity, itself a major risk factor for type II diabetes occurrence.

From an economical aspect, chronic pathologies (including diabetes) represent 60% of health insurance expenses, even though it concerns 35% of insured persons, i.e. 20 million of patients. The average of annual reimbursement for a type 2 diabetic patient is 4890 euros. In this context, this study is the first step of thinking about a different, coordinated care approach, based on a preventive rather than curative approach.

This study includes a personalized care program, including the patient follow-up by a nurse during 5 years with a contact every 4 months for the first year, then after every 6 months. The nurse will review the patient's progress and provide advice and contact with professionals: physical activity, psychologists, dieticians, endocrinologists, etc The main objective of this study is to compare, after 5 years of follow-up, the risk factors associated with type 2 diabetes, between participants who received personalized follow-up and those who did not. The secondary objectives are to compare the occurrence of type 2 diabetes, the quality of life and the compliance to the program between participants who received personalized follow-up and those who did not.

Eligibility Criteria:
Inclusion Criteria:

* Person with a FINDRISC score ≥ 10 points
* Person who has given his/her express written and informed consent

Exclusion Criteria:

- Person already diagnosed with a type 2 diabetes
The Size of Pelvic Hematoma Can be a Predictive Factor for Angioembolization

Unstable pelvic fracture with bleeding can be fatal, with a mortality rate of up to 40%. Therefore, early detection and treatment are important in unstable pelvic trauma. We investigated the early predictive factors for possible embolization in patients with hemodynamically unstable pelvic trauma. The purpose of this study was to predict the necessity of embolization and the timing of angiography using CT scans.

Background: Unstable pelvic fracture with bleeding can be fatal, with a mortality rate of up to 40%. Therefore, early detection and treatment are important in unstable pelvic trauma. We investigated the early predictive factors for possible embolization in patients with hemodynamically unstable pelvic trauma.

Methods: From January 2011 to December 2013, 46 patients with shock arrived at a single hospital within 24 h after injury. Of them, 44 patients underwent computed tomography (CT) after initial resuscitation, except for 2 who were dead on arrival. Nine patients with other organ injuries were excluded. Seventeen patients underwent embolization. A single radiologist measured the width (longest length in axial view) and length (longest length in coronal view) of pelvic hematoma on CT scans. Demographic, clinical, and radiological data were reviewed retrospectively.

Eligibility Criteria:
Inclusion Criteria:

* patients with shock (systolic blood pressure \<90 mmHg) arrived at a single hospital within 24 h after injury after pelvic fracture

Exclusion Criteria:

* declared dead on arrival
* patients with other organ injuries
Endovascular Treatment of Primary Common FEmoral Artery atheroSclerotic Disease wiTh IntraVAscular Litothripsy

Prospective, nonrandomized, multicenter, national, multidisciplinary, real-world data collection with the aim to evaluate the short-term safety and efficacy of intravascular lithotripsy in the treatment of steno-obstructive disease of the common femoral artery


Eligibility Criteria:
Inclusion Criteria:

1. Patients with peripheral arterial disease (Rutherford class 3-6)
2. Presence of a steno-obstructive lesion of the common femoral artery (Azema classification 1-3)
3. Possible endovascular treatment of both the iliac axis and/or femoro-distal vessels
4. Possible post-dilatation with plain or drug-coated balloon angioplasty

Exclusion Criteria:

1. Concomitant open surgery (ilio-femoral or femoro-distal bypass)
2. Presence of a steno-obstructive lesion of the common femoral artery in previous open surgery (Azema classification 4)
3. Presence of a steno-obstructive lesion of the common femoral artery after a previous endovascular procedure
Rivastigmine For Methamphetamine Dependent Individuals

Methamphetamine abuse has been steadily increasing over the past decade. Rivastigmine is a medication that may be helpful in treating methamphetamine dependence. The purpose of this study is to evaluate the effectiveness of rivastigmine in treating methamphetamine dependent individuals.

Methamphetamine is a powerful stimulant that affects the central nervous system. Chronic methamphetamine use often leads to psychotic behavior. Rivastigmine is an acetylcholinesterase inhibitor that is currently approved to treat Alzheimer's-related dementia. The purpose of this study is to assess the efficacy of rivastigmine in treating methamphetamine dependent individuals.

Participants will be randomly assigned to either one of two dose levels of rivastigmine or placebo for 12 weeks. Participants will be assessed for cardiovascular, subjective, and reinforcing effects that are produced by methamphetamine. All participants will partake in contingency management sessions through Week 4.

Eligibility Criteria:
Inclusion Criteria:

* Speaks English
* Not seeking treatment for methamphetamine dependence at study entry
* Meets DSM-IV criteria for methamphetamine abuse or dependence
* Smokes or intravenously uses methamphetamine
* Resting pulse between 50 and 90 beats per minute within 2 days prior to study entry
* Systolic blood pressure between 85 and 150 mmHg and diastolic blood pressure between 45 and 90 mmHg within 2 days prior to study entry
* Electrocardiogram demonstrating normal sinus rhythm, normal conduction, and no clinically significant arrhythmias
* Medical history and brief physical examination demonstrating no clinically significant contraindications for study participation

Exclusion Criteria:

* History or evidence of seizures or brain injury
* Previous adverse reaction to methamphetamine
* Neurological or psychiatric disorders (e.g., psychosis, bipolar illness, or major depression)
* Organic brain disease or dementia
* History of any psychiatric disorder that requires ongoing treatment or that would make study compliance difficult
* History of suicide attempts within the 3 months prior to study entry
* Heart disease or high blood pressure
* Family history of early cardiovascular morbidity or mortality
* Untreated or unstable medical illness, including neuroendocrine, autoimmune, liver, kidney, or active infectious disease
* HIV infected
* AIDS-defining illness
* Currently taking antiretroviral medication
* Pregnant or breastfeeding
* Unwilling to use an adequate method of contraception for the duration of the study
* History of respiratory illness (e.g., asthma, chronic coughing, and wheezing)
* Currently using alpha or beta agonists, theophylline, or other sympathomimetics
ChatGPT Versus Physical Medicine and Rehabilitation Residents

The aim of this study was to assess the performance of ChatGPT on examinations administered to physical medicine and rehabilitation (PMR) residents.

These exams for resident physicians are annual exams administered throughout the training period, which constitute a fundamental component of the training process towards becoming a PMR physician. In this study, we evaluated the performance of ChatGPT in these exams, made separate assessments for each training year, and compared the results of ChatGPT with the results of residents who passed the same exam.

Eligibility Criteria:
Inclusion Criteria:

* Physical medicine and rehabilitation residents exam results in May 2024

Exclusion Criteria:

-
Study in Healthy Subjects to Examine the Safety and Tolerability of ACT-1004-1239 Given as Multiple, Gradually Increasing Doses and to Examine the Effects of ACT-1004-1239 on the Body and the Way the Body Takes up, Distributes, and Gets Rid of ACT-1004-1239

Study in healthy subjects to examine the safety and tolerability of ACT-1004-1239 given as multiple, gradually increasing doses and to examine the effects of ACT-1004-1239 on the body and the way the body takes up, distributes, and gets rid of ACT-1004-1239


Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent prior to any study-mandated procedure.
* Healthy male or female subject aged between 18 and 55 years (inclusive) at Screening.
* A female subject of childbearing potential must have a negative serum pregnancy test at Screening and a negative urine pregnancy test on Day - 1 and must agree to consistently and correctly use a highly effective method of contraception with a failure rate of ≤1% per year, be sexually inactive, or have a vasectomized partner.
* A female subject of non-childbearing potential must be postmenopausal, or must have a medical history of previous bilateral salpingectomy, bilateral salpingo-oophorectomy, hysterectomy, premature ovarian failure, XY genotype, Turner syndrome, or uterine agenesis.
* A male subject must use adequate contraception from first study treatment administration up to at least 90 days after last administration unless he is vasectomized.
* A male subject must agree to refrain from donation of semen from first study treatment administration up to at least 90 days after last administration.

Exclusion Criteria:

* Previous exposure to ACT-1004-1239.
* Known hypersensitivity to ACT-1004-1239, or any of its excipients.
* History of major medical or surgical disorders which, in the opinion of the investigator, are likely to interfere with the absorption, distribution, metabolism, or excretion of the study treatment.
* Acute, ongoing, recurrent, or chronic systemic disease able to interfere with the evaluation of the study.
* Previous treatment with any prescribed medications (including vaccines) or over-the-counter (OTC) medications (including herbal medicines such as St John's Wort, homeopathic preparations, vitamins, and minerals) within 3 weeks prior to first study treatment administration.
* Any circumstances or conditions, which, in the opinion of the investigator, may affect full participation in the study or compliance with the protocol.
* Pregnant or lactating woman.
* Any cardiac condition or illness that may jeopardize the safety of the study subject per investigator judgment based on medical history or 12-lead ECG measured at Screening.
* Any immunosuppressive treatment within 6 weeks or 5x terminal half-life (t½), whichever is longer, before study treatment administration.