cyrilzakka/clinical-trials huggingface dataset:
Hypoglycemia Associated Autonomic Failure in Type 1 Diabetes Mellitus

The purpose of this study is to determine what corticosteroid receptor (and the dose of) is responsible for cortisol inducing hypoglycemia associated autonomic dysfunction in Type 1 DM. Specifically, we aim to determine whether stimulating the type 1 corticosteroid receptor (via fludrocortisone), the type 2 corticosteroid receptor (via dexamethasone), or both causes hypoglycemia associated autonomic dysfunction in Type 1 DM.


Eligibility Criteria:
Inclusion Criteria:

* 16 (8 males, 8 females) Type 1 diabetic patients aged 18-45 yr.
* HbA1c \> 7.0%
* Had diabetes for 2-15 years
* No clinical evidence of diabetic tissue complications
* 16 (8 males, 8 females) Healthy volunteers aged 18-45 yrs.
* Body mass index \< 27kg · m-2

Exclusion Criteria:

* Prior or current history of poor health
* Abnormal results following blood and physical examination
* Pregnancy
TIPS or Anticoagulation in Portal Vein Thrombosis

The PROGRESS is an investigator-initiated, multicentre, randomized, trial comparing anticoagulation, which is the currently most frequently used treatment, alone, versus transjugular intrahepatic portosystemic shunt (TIPS) combined with anticoagulation, in patients presenting with recent obstructive portal vein thrombosis (ROPVT). The rationale of this study is to significantly increase the proportion of patients that achieve a complete or partial recanalization of the portal vein. The intervention of this study consists in TIPS deployment and catheter based clot removal in addition to anticoagulation. The investigators retain that this intervention will increase the proportion of patients with an open portal vein from 38% with anticoagulation alone to 83% with anticoagulation and TIPS after 6 months. Both anticoagulant therapy and clot removal/TIPS are treatments that are currently available and accepted indications for the treatment of ROPVT. Anticoagulation will be performed with unfractioned heparin or low molecular weight heparin initially and with vitamin K antagonists in the long term. The investigators plan to collect blood for biobanking at the time of inclusion and after 6 months. Blood samples for a biobank will be collected.


Eligibility Criteria:
Inclusion Criteria:

1. Recent complete thrombosis of the extrahepatic portal vein either with or without the involvement of intrahepatic branches and with or without involvement of splenic vein and superior mesenteric vein
2. Written informed consent

Exclusion Criteria:

1. Malignant Portal Vein thrombosis (neoplastic invasion)
2. Intraabdominal malignancy
3. Chronic diseases limiting life expectancy in the short term (6 months)
4. Liver transplantation
5. Unwillingness to participate
6. Contraindications to TIPS (including past or present hepatic encephalopathy Grade ≥2)
7. Child-Pugh-Turcotte score 11 or more points in patients with advanced chronic liver disease-
Assessing Motor Imagery Ability of Tongue and Mouth in Subjects With and With no Temporomandibular Disorders

Temporomandibular disorder (TMD) is the symptomatic expression of a muscular or an articular impairment at the manducatory tract. TMD affects between 30 to 65% of the population with a higher prevalence for young women. The patients with DTM report a decrease of their personal, social and professional quality of life. Treatment usually relies on physical therapy. Among the different technics that can be used in physical therapy, there is growing evidence advocating the efficacy of using motor imagery (i.e. imagining a movement with no concomitant physical execution) during rehabilitation. It has also been shown that the benefits of practicing motor imagery depend on the ability (i.e., the higher the ability, the greater the benefits). However, there is no investigation of the motor imagery ability of the tongue and mouth movements conditioning the use of motor imagery during TMD rehabilitation. The objective of the study is to investigate the ability of imagining tongue and mouth movements using the Tongue and Mouth Imagery Questionnaire (TMIQ) as compare to the gold-standard Kinesthetic and Visual Imagery Questionnaire (KVIQ - Malouin et al., 2007).

Principal objective:

Assess the validity construct of the Tongue and Mouth Imagery Questionnaire (TMIQ) as compare to the gold-standard Kinesthetic and Visual Imagery Questionnaire (KVIQ - Malouin et al., 2007), both measuring the motor imagery vividness.

Secondary objectives:

1. Assess the reliability of the TMIQ using a test-retest.
2. Assess the temporal coupling (i.e., the ratio between imagined and physically practiced movement) and compare these ratios for the TMIQ and KVIQ.
3. Investigate the effect of TMD by comparing the vividness scores of TMIQ for respectively subject with and with no TMD.
4. Investigate the effect of TMD by comparing the vividness scores of KVIQ for respectively subject with and with no TMD.
5. Investigate the effect of TMD by comparing the temporal coupling scores of TMIQ for respectively subject with and with no TMD.
6. Investigate the effect of TMD by comparing the temporal coupling scores of KVIQ for respectively subject with and with no TMD.

Eligibility Criteria:
Inclusion Criteria:

* age between 18 and 75 years
* A voluntary individual who has given informed consent after receiving clear, fair and appropriate information about the study.

For DTM group participants

* inclusion during the DTM rehabilitation in the physical therapy firm "Cabinet Saint Alexandre".
* beneficiary of the social security scheme

Exclusion Criteria:

* The presence of a short tongue brake (Marchesan, 2005)
* Lingual immaturity evaluated by the Tardieu test (Jouannaud et al. 1972)
* Patients who had orthognathic surgery within 6 months post- operative, or facial fractures according to the same deadlines
* The presence of peripheral facial palsy
* Current participation in another research whose objective would be the evaluation of a therapeutic, drug or not, introducing an experimental bias.
Efficacy of Probiotics on Excessive Gas Accumulation

Efficacy of probiotics on excessive gas accumulation


Eligibility Criteria:
Inclusion Criteria:

* Healthy adults 18-50 years, at the time of signing the informed consent.
* Willing and able to give written informed consent for participating in the study
* Willing to comply with all study procedures

Exclusion Criteria:

* Chronic intestinal disease, immunodeficiency disorder or immunosuppressive treatment
* Clinically significant frequent constipation or diarrhea at the screening visit as judged by the Investigator
* Known gluten intolerance, lactose intolerance, milk protein allergy
* Vegetarian diet
* Intake of antibiotics within four weeks prior to the start of the study
* Hypersensitivity to any of the ingredients in the investigational product (IP)
* Regular intake of probiotics within four weeks prior to the start of the study
* History of any clinically significant disease or disorder which, in the opinion of the Investigator, may either put the subject at risk if participating in the study, or influence the results or the subject´s ability to participate in the study
* Investigator considers the subject unlikely to comply with study procedures, restrictions and requirements.
Trauma Expectation Factor Trauma Outcome Measure

This study is designed as a prediction trial. That is, our primary purpose is to develop a model that can be applied clinically as a user-friendly "baseline" questionnaire that is capable of predicting "success" or "failure" based on a patient's pre-surgical expectations of their final outcome. In the process, a secondary goal is to develop an outcomes measure.

Aims:

1. To develop a novel, psychometrically sound, trauma patient expectation instrument that: a) demonstrates content validity; b) considers patient and surgeon expectations; c) predicts orthopedic outcomes; d) is reliable; e) is patient friendly; and f) is easy to score and interpret. This will be known as the Trauma Expectation Factor (TEF).
2. To develop a novel, psychometrically sound, trauma patient outcomes instrument that: a) demonstrates content validity; b) measures current condition in the same domains as the expectation instrument; c) demonstrates construct validity; d) demonstrates criterion validity; e) is reliable; f) is patient friendly; and g) is easy to score and interpret. This will be known as the Trauma Outcomes Measure (TOM).

Hypotheses:

H#1. A simple pre-surgical questionnaire that measures patient expectations (i.e., Trauma Expectation Factor) after an ankle fracture requiring surgery will predict an "expected" score on a standardized disease-specific ankle instrument (i.e., AAOS Foot and Ankle Core Score).

H#2. A similar instrument that is reworded to assess current condition (i.e., Trauma Outcomes Measure) instead of expectations, is a valid, reliable, and responsive measure of a traumatic patient's condition.

H#3. Patient and surgeon expectations of final outcome status are different; however, the differences get smaller over time.

Eligibility Criteria:
Inclusion Criteria:

* Isolated ankle or distal tibia fracture
* Scheduled for and undergoing surgery for their fracture
* 18 years of age or older

Exclusion Criteria:

* Subject has previously undergone internal fixation surgery for this ankle fracture
* Subject has disease entity, or condition that precludes likelihood of bony union (eg, metastatic cancer, metabolic bone disease)
* Subject has severe dementia or other severe mental health problem that may preclude him/her from completing study questionnaires
* Subject is participating in other competing clinical research that may interfere with participation in this research
* Subject is unlikely to attend study related follow-up visits
* Subject has polytrauma (more than one organ system compromised)
* Subject has fracture(s) other than ankle fracture
* Subject is a prisoner
* Fracture occurred more than 4 weeks ago
A Phase II Study of M2951 in SLE

M2951 is an investigational drug under evaluation for treatment of autoimmune and inflammatory disorders. The purpose of the study was to assess the Safety and Efficacy of M2951 in participants with Systemic Lupus Erythematosus (SLE).


Eligibility Criteria:
Inclusion Criteria:

* Eligible male and female participants, aged 18 to 75 years
* Must have diagnosis of SLE with either the Systemic Lupus International Collaborating Clinics (SLICC) criteria for SLE, or at least four of the 11 American College of Rheumatology (ACR) classification criteria for SLE, of at least six months duration prior to Screening
* SLEDAI-2K total score greater than or equal to (\>=) 6 (including clinical SLEDAI greater than or equal to (\>=) 4) at Screening Visit
* And be positive for anti-double-stranded Deoxyribonucleic Acid (DNA) and/or anti-nuclear antibody (ANA greater than or equal to (\>=) 1:80) and/or anti-Smith (anti-Sm) antibody at the time of Screening
* Other protocol defined inclusion criteria could apply

Exclusion Criteria:

* Participants are not eligible for this study if they have active, clinically significant interstitial lung disease or pulmonary arterial hypertension
* Proteinuria (urine protein to creatinine ratio \[UPCR\] \> 4 mg/mg)
* Acutely worsened renal function
* Central nervous system SLE
* Or within two weeks prior to Screening or during Screening: use of oral corticosteroids greater than (\>) 30 mg daily prednisone equivalent
* Use of injectable corticosteroids, or change in dose of corticosteroids.
* Other protocol defined exclusion criteria could apply
Oxygen Peripheral Saturations and Lung Surgery

The purpose of this study is to compare the ability of two peripheral and non invasive devices to detect hypoxic events during one-lung ventilation and during the early postoperative period. One device measures regional cerebral oxygenation and the other muscular oxygenation. These two devices are compared to non invasive arterial saturation (SpO2), which is the gold standard.

Lung surgery is often complicated by hypoxic evants :

* during one-lung ventilation which leads to changes about ratio in ventilated and perfused lung areas. This blood flow redistribution promotes shunt with a decreased arterial oxygenation and possible hypoxemia.
* during the postoperative period.

Common measure of arterial saturation through SpO2 may miss a great number of hypoxic events with regional impact because a significant decrease in SpO2 occurs for an arterial pressure in oxygen below 60 mmHg. Currently, cerebral and somatic saturation can be monitored non-invasively and continuously via optical sensors applied to the right and left forehead and to the thenar eminence. These devices may help clinicians in the detection of such hypoxemic events.

Eligibility Criteria:
Inclusion Criteria:

* Scheduled lung surgery requiring one-lung ventilation
* informed consent

Exclusion Criteria:

* Pregnant woman
* Neurologic or psychiatric disorders
Computer-Based Survey and Communication Aid in Improving Physician-Patient Communication and Treatment Decision Making in Patients With Metastatic Cancer

RATIONALE: A computer-based survey and communication aid may help physicians and patients to communicate better and help make treatment decisions easier.

PURPOSE: This phase III randomized clinical trial is studying how well giving a computer-based survey together with a communication aid works compared to a computer-based survey alone in improving physician-patient communication and treatment decision making in patients with metastatic cancer.

OBJECTIVES:

* Compare satisfaction with physician-patient communication and decisional conflict in patients with metastatic cancer undergoing a computer-based survey with vs without a communication aid.
* Compare patient expectations regarding potential benefits and adverse reactions associated with treatment options in patients undergoing the computer-based survey and communication aid.
* Compare the content of physician-patient consultations in patients undergoing the computer-based survey and communication aid.

OUTLINE: This is a randomized, controlled, multicenter study.

Patients are randomized to 1 of 3 study arms.

* Arm I (generic computer-based survey): Patients complete a 45- to 60-minute generic computer-based survey that assesses demographics, familiarity and comfort with computers, treatment history, and affective elements.
* Arm II (targeted computer-based survey and communication aid with physician summary report): Patients complete a 45- to 60-minute targeted computer-based survey assessing patient values, information needs, and distress. Patients then complete a targeted computer-based communication aid that addresses cognitive and affective components of cancer treatment education and provides communication skills training. After completion of the survey and communication aid, a summary report of the survey results is generated and provided to the patient's physician.
* Arm III (targeted computer-based survey and communication aid): Patients complete a targeted computer-based survey and communication aid as in arm II. No summary report is provided to the physician.

After completion of a computer-based survey and communication aid, all patients undergo a consultation with their physician. A randomized subset of 25% of physician consultations\* are audiotaped and later analyzed. Patients complete a 15-minute written survey after completion of the physician consultation and then at 3 months.

NOTE: \*Patients are stratified according to study arm (I vs II vs III) and consulting physician gender for this randomization.

PROJECTED ACCRUAL: A total of 720 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Documented metastatic malignancy
* First visit with medical oncologist at study site

PATIENT CHARACTERISTICS:

Performance status

* Not specified

Life expectancy

* Not specified

Hematopoietic

* Not specified

Hepatic

* Not specified

Renal

* Not specified

Other

* Able to read and speak English

PRIOR CONCURRENT THERAPY: Not specified
Amisulpride in Schizophrenic Patients

Primary purpose:

* To find out how effective is long term treatment with amisulpride on the positive and negative symptoms in schizophrenic patients
* To find out how safe is long term treatment with amisulpride in schizophrenic patients

Secondary purpose:

* To find out how effective is long term treatment with amisulpride on the quality of life in schizophrenic patients
* To find out how effective is long term treatment with amisulpride on the cognitive function in schizophrenic patients


Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed as schizophrenia or schizophrenic disorder according to DSM-IV
* Patients who need new anti-psychotic drugs or need to change the medication due to aggravations of symptoms or recurrence

Exclusion Criteria:

* Patients with positive symptoms in whom the disorder does not correspond to schizophrenic criteria. (e.g, schizoaffective disorder)
* Patients hypersensitive to the active ingredient or to other ingredients of the study drug
* Prolactin-dependant tumors, pituitary gland prolactinomas and breast cancer
* Pheochromocytoma or Parkinson's disease
* Pregnancy or breast feeding
* Current or recently withdrawn from drug abuse or alcoholism
* Chronic renal failure and other internal or surgical disease which physician decides will be worsened by trial medication or that will affect the metabolism or effects of the trial medication
* Patients with previous histories and clinical improvement was not seen in spite of treatment with 2 anti-psychotics for over 8 weeks
* Slow heart rate of \<55bpm, low blood potassium level, congenital prolongation of the QT interval
* Current treatment with a drug likely to cause markedly slow heart rate(\<55bpm), low blood potassium level, slowing of intercardiac condition or prolongation of the QT interval

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Prognostic Value of BNP in MCS - a 25 Year Follow up Study

A biobank has been created to investigate the prognostic value of biomarkers (mainly BNP) in patients implanted with durable mechanical assist devices comparing patients with advanced HF supported by MCS with those who are transplanted and those who remain on optimal medical therapy.

Patients will be followed up for 25 years after inclusion.

All patients referred for advanced HF treatment at the Dept of Cardiology at Rigshospitalet.

Eligibility Criteria:
Inclusion Criteria:

* All patients referred for evaluation for advanced HF treatment at the Rigshospital in Denmark
* Age\>18 years

Exclusion Criteria:

* No consent
Open-Label Study to Evaluate the Efficacy and Safety of Oral Ibrexafungerp (SCY-078) in Patients With Candidiasis Caused by Candida Auris (CARES)

This is a multicenter, open-label, non-comparator, single-arm study to evaluate the efficacy, safety, tolerability and PK (pharmacokinetics) of oral SCY-078 as an emergency use treatment for patients with a documented Candida auris infection.

This is a multicenter, open-label, non-comparator, single-arm study to evaluate the efficacy, safety, tolerability and PK (for a subset of subjects) of oral SCY-078 in male and female subjects ≥18 years of age with a documented Candida auris infection. Patients will be treated with SCY-078 for up to 90 days.

Subjects must have a documented candidiasis, including candidemia, caused by Candida auris to be considered for enrollment. Subjects are also eligible if they are receiving intravenous (IV) antifungal therapy for their C. auris infection and, in the judgment of the investigator, continued IV antifungal therapy is not feasible or desirable due to clinical or logistical circumstances. Subjects must meet all study criteria to be eligible for inclusion. Inclusion of each subject in the study must be approved by the Sponsor prior to enrollment.

Following a screening visit , there will be up to 11 treatment visits, a follow-up visit and 2 follow-up contacts (survival visits)

Eligibility Criteria:
Inclusion Criteria:

* Subject must fulfill the following KEY criteria to be eligible for study admission:

  1. Subject is a male or female adult ≥ 18 years of age on the day the study informed consent form (ICF) is signed.
  2. Subject has a documented candidiasis, including candidemia, caused by Candida auris. The subject is also eligible if he/she is receiving IV antifungal therapy for their C. auris infection and, in the judgment of the investigator, long-term IV antifungal therapy is not feasible or desirable due to clinical or logistical circumstances. A documented candidiasis, including candidemia, caused by Candida auris is defined as the recovery of Candida auris by culture of a sample obtained within the last 7 days.
  3. Subject is able to tolerate medication orally or through a nasogastric (NG) tube or percutaneous endoscopic gastrostomy (PEG) tube.

Exclusion Criteria:

* KEY exclusion criteria:

  1. Subject has a fungal disease with central nervous system involvement.
  2. Subject has a fungal disease of the bone and/or joint that is expected to require \>90 days of study drug treatment.
  3. Subject has an inappropriately controlled fungal infection source (e.g., persistent catheters, devices, identified abscess) that is likely the source of the fungal infection.
  4. Subject is hemodynamically unstable and/or requiring vasopressor medication for blood pressure support.
  5. Subject has abnormal liver test parameters: AST or ALT \>10 x ULN, and/or total bilirubin \>5 x ULN. Note: Subjects with unconjugated hyperbilirubinemia with diagnosis of Gilbert's disease are not excluded.
  6. Subject has an Apache score \>16.
  7. Subject has serum creatinine \>3 times from Baseline (Screening/Treatment Day 1) value.
Digestive Colonisation by Highly Resistant Bacteria (CODBAHRE)

The aim of this study is to identify in hospitalized patients, the risk factors associated with the digestive colonisation by emergent extensively drug-resistant bacteria (eXDR), to optimize their detection and the medical care for carriers these patients

CODBAHRE is a french, regional study, involving 9 centers. Recruitment will take place in all the departments of the centers involved under the supervision of the Infection Control Team.

All patients hospitalized more than 24 hours, on a given day are eligible for the protocol, except the patients unable to answer the questionnaire.

After collecting the non-opposition of the patient, patients will be screened by rectal swab and a questionnaire will be completed.

Each sample will be analyzed to detect eXDR carrying patients.

The carrying patients will be followed during 6 months to estimate the proportion of the population which developped a bacterial infection. This information will be collected by a retrospective telephone survey of carrying patients.

Eligibility Criteria:
Inclusion Criteria:

* Hospitalization of more than 24 hours
* Give his no objection

Exclusion Criteria:

* Hospitalization in psychiatry
* Unwilling to participate
Supervised Group Based Exercise for Men With Prostate Cancer on Androgen Deprivation Therapy

Exercise intervention for men with prostate cancer on androgen deprivation therapy.

The aim of the project is to investigate the effects of patient education and exercise intervention implemented in daily clinical practice for men with prostate cancer on androgen deprivation therapy

* Functional capacity
* Quality of life
* Body composition
* Blood pressure

and to assess safety of progressive resistance training for participants with bone metastases.

Eligibility Criteria:
Inclusion Criteria:

* Patients with a prostate cancer diagnosis on androgen deprivation therapy

Exclusion Criteria:

* Opioid demanding treatment for skeletal pain
* Eastern Cooperative Oncology Group performance status \> 2
* Inability to perform floor and machine exercises independently