cyrilzakka/clinical-trials huggingface dataset:
Measuring Time Windows in Patients With Schizophrenia and Healthy Controls

Abnormalities in the ability to distinguish events in time may have a great impact on everyday life. The main objective of the study is to evaluate the magnitude of the temporal windows in schizophrenia, i.e. the time interval during which two events are perceived as synchronous. The investigators test the hypothesis that these temporal windows are enlarged, and check the relationship between this impairment and disorganization symptoms, in order to explore the link between this cognitive impairment and clinical symptoms. They explore also the neurobiological bases of the impairment by means of electroencephalogram (EEG) recordings. Event-related potentials (N50) will reveal whether or not the coding of the stimuli has the same temporal characteristics in patients and controls. The distribution and amplitude of oscillatory activities will be analyzed as a function of the synchronous or asynchronous response of the subject, thus allowing to explore the links between synchrony perception and neuronal synchronization phenomena.


Eligibility Criteria:
Inclusion Criteria:

* Patients with schizophrenia (DSM-IV criteria)
* Healthy controls matched with patients on age, sex and education level
* Age between 18 and 50
* Informed consent signed
* No severe somatic illness
* No invalidating sensory disease
* No drug abuse, as defined by DSM-IV criteria
* No general anesthesia in the past 3 months
* No intake of drug affecting the CNS, except for patients
Adaptation of the Questionnaire "Regarding Patient's Quality of Life With Mastocytosis" in the French Language

Mastocytosis is a heterogeneous rare disease. A 27-item questionnaire to assess the quality of life of patients with cutaneous/ indolent systemic mastocytosis was developed in the German language and validated in the English language in 2015.

The team of the University Charité Berlin and the company Moxie - intellectual proprietor of the questionnaire - proposed the use of the recommendations of Baiardini et al. 2010, for linguistic adaptation of this questionnaire in other languages.

The first two steps of the program of linguistic translation have already been carried out under the direction and supervision of teams from Charité University, Berlin and Moxie Company. The result of these two steps is a secondary version of the Mc-QoL questionnaire in French. The last step of this adaptation process in the target language (French, France) needs to be carried out and it is the subject of this study.

The objective of this study is the French language adaptation of the Mc-QoL questionnaire in adult patients with indolent cutaneous and / or indolent systemic mastocytosis.

During this study, the second version of the Mc-QoL questionnaire in French will be evaluated on 10 adult patients, with cutaneous and / or indolent systemic mastocytosis and native in the French language. The comprehension tests will be carried out by means of the structured interviews during which the investigator will ask if the patient has had difficulties to understand the recommendations, the questionnaires, will verify the interpretation of all the items and the understanding of each word by the patient. In case of problems, the investigator will propose and / or test translation alternatives, or will ask the patient to propose alternatives.

Revisions to the second version of the Mc-QoL questionnaire in French will be done to rectify the problems identified in the conceptual equivalence. The result will be a third French version of the Mc-QoL questionnaire, which will be the final version.

A report on the interviews will be written in English: it will describe the number of respondents, their age, the time required to complete the questionnaire, the difficulties encountered, the solutions suggested and retained and how the third version of the questionnaire was produced.

Eligibility Criteria:
Inclusion Criteria:

* Adult, native French patient with cutaneous or indolent systemic mastocytosis and follow-up at CEREMAST, Toulouse
* Patient having given his agreement of non-opposition

Exclusion Criteria:

* Minor patient
* Patient with other forms of mast cell pathology except cutaneous and / or indolent systemic mastocytosis
* Patient with no mast cell pathology
* French non-native patient
* Patient in detention or under guardianship
* Patient not affiliated with Social Security
Precision Therapy Based on Immune Microenvironment by Transcriptome Sequencing of Osteosarcoma, a Prospective, Multi-cohort Exploratory Clinical Study

Bagaev et al. have identified four tumor microenvironment (TME) subtypes that are conserved across diverse cancers and correlated with immunotherapy response in melanoma, bladder, and gastric cancers. They provided a visual tool revealing the TME subtypes integrated with targetable genomic alterations, which provided a planetary view of each tumor that can aid in oncology clinical decision making. We aim to use this tool to prospectively analyse the biopsy specimens of osteosarcomas to identify their TME subtypes so as to deliver appropriate treatment strategy if these osteosarcomas experience disease progression afterwards. We will compare the past sequencing date stored in PKUPH bank so as to compare the event-free survival(EFS) of these patients to check the Superiority of this method later.


Eligibility Criteria:
Inclusion Criteria:

* (i) patients who have been suspected for osteosarcoma with enough clinical or radiographic information;
* (ii) patients who have evaluable lesions to resect or follow;
* (iii) patients who are planned to be operate with enough flesh specimens for this study.

Exclusion Criteria:

* (i) clinical information was not complete;
* (ii) lost to follow-up.
A Comparative Study on the Effectiveness of Video vs Text-Based Education in Heart Failure

This is a study seeking to compare the change in overall heart failure (HF) knowledge score and participant preference between video-based and text-based HF education modules. Participants will be randomized to watching and reading different combinations of video-based education modules and text-based education modules. Participants will be asked to answer questions about their familiarity with heart failure medications and management before and after the said education modules.

This study compares the change in heart failure (HF) knowledge and participant preference between video-based and text-based HF education modules. Educational material regarding two different topics - heart failure self-monitoring and medication management - has been developed in two different formats: animated educational videos and text-based documents. Both formats contain the same information. In this study, participants will be randomized to either watching or reading different combinations of the education for these two topics to better understand which educational tool - animated videos or text-based - is preferred by participants and leads to greater educational attainment. Educational attainment is evaluated by pre and post questions about both topics.

Eligibility Criteria:
Inclusion Criteria:

* Participants with heart failure with reduced ejection fraction (EF \<50%)

Exclusion Criteria:

* Participants who have the inability to independently read or answer written questions in English and are non-conversant in English
Safety Study of Textile Binder for Abdominal Compression

This safety study was carried out to investigate to what extent the use of an abdominal binder influences IAP. The study was designed as a comparative cross-over study measuring bladder pressure.

Study Description: Transabdominal surgery might be associated with incisional pain, fear of rupture, inhibited mobilisation and risk of incisional herniation. An abdominal binder was developed for postoperative support of abdominal incisions. The abdominal binder provides a pressure of 10-15 mmHg.

Worlds Society on Abdominal Compartment Syndrome (WSACS) defines that Normal Intra-Abdominal Pressure (IAP) is approximately 5-7 mmHg in critically ill adults, and that Intra-Abdominal Hypertension (IAH) is a sustained or repeated pathologic elevation of IAP \>12 mmHg. This safety study was carried out to investigate to what extent the use of the abdominal binder influences IAP. The study was designed as a comparative cross-over study measuring bladder pressure (Foley manometer, Holtec Medical, Copenhagen) in 11 healthy volunteers with and without wearing the abdominal binder.

Results IAP measurements without wearing the abdominal binder were found to be surprisingly high with a range between 8,0 and 16,7 mmHg. (mean 10,5 mmHg.). This finding is explained by the fact that the subjects were not under relaxation and the fact that half of the subjects according to their BMI were categorised as being overweight or fat. Other investigations have demonstrated that relaxation decreases IAP and that BMI is positively related to IAP.

We found that wearing the abdominal binder did increase IAP with a mean of 4,0 mmHg. (+/-1,4) or 39,3% (+/-14,61%).

In conclusion Relating our results to the WSACS guidelines regarding IAP and IAH it is not likely that the use of the abdominal binder will increase IAP to a clinically critical extent in patients with normal IAP. It must though be assessed from case to case, whether the use of the abdominal binder is appropriate.

Eligibility Criteria:
Inclusion Criteria:

* Minimum 18 years old
* Healthy
* Negative test of blood, nitrate or leucocytes in urinre
* Waist line measurement 97-110 cm

Exclusion Criteria:

* Pregnant
* Known allergy
* Know bladder disease
* Tendency of/clinicla symptoms of urinay infection
* Abdominal or urinary surgery
* Medical treatment
The Effect of Nonverbal Vocalisations on Pain Tolerance

Humans produce non-verbal vocalizations (shouting, growling, screaming), laughter, ...) in various contexts that are likely to perform biological functions.

and important social issues. Yet despite their importance in the human vocal repertoire, the mechanisms and functions of non-verbal vocalizations remain little studied and poorly understood including in humans. In this context, the investigators wish to examine how the production of vocalizations non-verbal communication influences pain tolerance in healthy adults.

Humans produce nonverbal vocalisations such as screams, grunts, roars, cries and laughter across a variety of contexts. Yet despite the prominence and apparent importance of these nonverbal sounds in human communication, the investigators still know very little about their influence on human perception and behaviour. That's why, in this study, the investigators will examine specifically the influence of nonverbal vocal production on pain tolerance.

The remainder of the study will involve up to three trials of a pain tolerance (cold pressor) task, during which the investigators will ask participants to produce vocalisations (e.g., screams or words) while submerging the participant's hand in bath of circulating cold water.

The results of the study will contribute to our theoretical understanding of the functions of nonverbal vocal communication in humans, in particular the influence of nonverbal vocal production (i.e., yelling) on pain tolerance.

Eligibility Criteria:
Inclusion Criteria:

* Participant in good health
* Affiliated or entitled participant in a social security scheme
* Participant who has received informed information about the study and has co-signed a consent to participate in the study with the investigator.

Exclusion Criteria:

* Chronic pain
* High blood pressure or poor circulation
* Cardiac or vascular disease, or a heart condition (including symptoms of Raynaud's syndrome)
* Allergy or hypersensitivity to cold
* Diabetes
* Epilepsy
* Pregnancy
* Recent serious injury
* Neurological or psychiatric condition known to affect pain tolerance (e.g., peripheral neuropathy, schizophrenia)
* History of fainting or seizures
* History of frostbite
* Chronic smoker (more than 10 cigarettes a day)
Effect of Green Tea Supplementation in Older Adult Women

Introduction: One of the consequences of aging is the decrease in physical performance which can affect the quality of life of older people. Although physical exercise is beneficial in improving this problem, older women do not seem to benefit as much as men. In this sense, the use of ergonomic aids by women could compensate for these issues. Thus, green tea has shown beneficial effects on physical performance in athletes through, among others, improving blood flow and vasodilation, mitochondrial respiration, calcium management, glucose and amino acid uptake, lipid oxidation, modulation of muscle damage, antioxidant effect, and anabolic and catabolic hormones, activation of the hypothalamic-pituitary-adrenal axis, etc. Therefore, the deterioration of physical performance and quality of life of green tea.

Objective: To analyze the effect of supplementation with 1 g/day green tea extract (500 mg of polyphenols) for 10 weeks on quality of life values, physical performance (grip strength, walking speed, and resistance), and health biomarkers (biochemical, hematological, and hormonal) in women over 60 years of age who follow a physical training program.

Methods: A total of 20 female volunteers between 60 and 73 years old (age: 65.9±4.58 years, BMI: 25.09±3.24 and body fat percentage: 32.54±6.39) who followed a physical activity adapted to their age and abilities are the members of this study. The volunteers were divided into two groups: placebo (CG; n = 10) and supplemented with 1 g/day of green tea (GI; n = 10). Different physical tests were performed (grip strength, walking speed and resistance) and the quality of life questionnaire (WHOQOL-BREF) was passed and health biomarkers (biochemical, hematological, and hormonal) were analyzed at the beginning (T1) and at the end of the 10 weeks of intervention (T2).


Eligibility Criteria:
Inclusion Criteria:

* Older adult women between 60 and 80 years old, with the ability to carry out a physical activity program adapted to their age and health condition.

Exclusion Criteria:

1. Functional limitation using the Barthel scale (less than 100 = maximum score) and the Lawton-Brody scale (less than 8 = maximum value).
2. Acute/chronic heart failure with NYHA (New York Heart Association) scale \>II.
3. Uncontrolled hypertension (\>180/100 mm Hg).
4. Uncontrolled orthostatic hypotension.
5. Uncontrolled atrial or ventricular arrhythmias, aortic dissecting aneurysm, severe aortic stenosis, acute endocarditis/pericarditis.
6. Recent acute myocardial infarction (3 to 6 months) or unstable angina.
7. Acute thromboembolic disease.
8. Acute/chronic respiratory failure.
9. Moderate/severe chronic obstructive pulmonary disease (COPD) with Bodex index C or D.
10. Diabetes mellitus with acute decompensation or uncontrolled hypoglycemia.
11. Recent bone fracture (last month).
12. History of dementia (suspected by the MAP environment and diagnosed).
13. Previous supplementation with amino acids or other nutritional compounds to improve physical performance.
14. Any other circumstance that your doctor considers prevents physical activity.
Effect of Tranexamic Acid on Blood Loss After High Tibial Osteotomy

This study aims to examine whether tranexamic acid has an meaningful clinical effect on blood loss after high tibial osteotomy. This study design is a double-blind randomized controlled trial. The patients were randomly assigned to intervention or usual care groups. Intervention patients receive tranexamic acid 2g for 10 minutes just before surgery. Primary outcome is hemoglobin level preoperatively, postoperative 1 day, 2 days, 3 days, 2 weeks. Secondary outcome included hematocrit level, hemovac drainage, total blood loss, need for transfusion, deep vein thrombosis, Visual Analog Pain Scale, and wound complication.

High tibial osteotomy is proved treatment option for medial compartment osteoarthritis of knee joint. Especially, open wedge high tibial osteotomy might cause moderate amount of bleeding and hematoma formation. Bleeding and hematoma could be a reason of soft tissue infection and wound complications. Tranexamic acid (TXA) is a medication used to treat or prevent excessive blood loss from major trauma, postpartum bleeding, surgery, tooth removal, nosebleeds, and heavy menstruation. The objective of the study is to test whether preoperative tranexamic acid could reduce the postoperative complications due to bleeding.

Eligibility Criteria:
Inclusion Criteria:

* Patients for high tibial osteotomy
* Having medicare insurance
* Accepted patients

Exclusion Criteria:

* History of lower extremity infection or neurologic problems
* Inflammatory arthritis
* Using thrombins
* History of treatment for anemia
* History of thromboembolic event
* Chronic kidney disease
Odevixibat for the Treatment of Progressive Familial Intrahepatic Cholestasis

To provide treatment access to patients with PFIC in the US who have pruritus and elevated serum bile acids and who are not able to enroll in A4250-008 (PEDFIC2) for the following reasons: 1) Do not meet eligibility criteria for PEDFIC 2; 2) Are not able to get to a PEDFIC 2 site for geographical reasons, and 3) Do meet the eligibility criteria for PEDFIC 2 after recruitment has been completed

Eligible patients will be enrolled into this expanded-access program and treated with an oral dose of 120 μg/kg/day of odevixibat and evaluated on an ongoing basis.

Eligibility Criteria:
Inclusion Criteria:

1. A male or female patient of any age, with a clinical diagnosis of PFIC, and with a body weight ≥5 kg at Screening visit
2. Patient must have a clinical diagnosis of PFIC
3. Patient must have clinically confirmed pruritus
4. Patient must have elevated serum bile acid levels, specifically measured to be ≥2 × the upper limit of normal (ULN) prior to start of medication
5. Patient and/or legal guardian must sign informed consent (and assent) as appropriate. Patients who turn 18 years of age (or legal age per country) during

Exclusion Criteria:

1. Patient is expected to have a liver transplant within 6 months of Screening
2. Decompensated liver disease, coagulopathy, history or presence of clinically significant ascites, variceal hemorrhage, and/or encephalopathy
3. International normalized ratio (INR) \>1.4 (the patient may be treated with Vitamin K intravenously, and if INR is ≤1.4 at resampling the patient may be started on program medication)
4. Serum ALT \>10 × ULN at Screening
5. Serum ALT \>15 × ULN at any time point during the last 6 months unless an alternate etiology was confirmed for the elevation
6. Total bilirubin \>10 × ULN at Screening
7. Any patient who is pregnant, lactating, or planning to get pregnant
8. Patients who qualify for enrollment in other Phase 2 or Phase 3 trials intended to support marketing approval in PFIC
Efficacy of Traditional Chinese Medicine Combined With Omeprazole in Patients With Non-erosive Reflux Disease

This is a double-blind,randomised,placebo-controlled clinical trial.We would like to investigate the safety and efficacy of Jianpi Qinghua granule(a Chinese herbal compound) combined with half-dose omeprazole in treatment of non-erosive reflux disease(NERD).

This is a double-blind,randomised,placebo-controlled clinical trial.We recruit patients that suffer from non-erosive reflux disease and then divide them into two groups:treatment group and control group.Treatment group take Jianpi Qinghua granule and half-dose omeprazole for 4 weeks,control group take a normal dose of omeprazole for 4 weeks.Finally we investigate the safety of Jianpi Qinghua granule combined with half-dose omeprazole in treatment of non-erosive reflux disease(NERD),and contrast the efficacy of Jianpi Qinghua granule with omeprazole.

Eligibility Criteria:
Inclusion Criteria:

* Aging between 18 and 75 years, able to read and write Chinese;
* Meet the criteria of diagnosis of NERD
* GERD Q score\>=8
* Meet the TCM diagnosis of syndrome of dampness-heat due to spleen deficiency
* Receiving no other treatments during the study;
* Voluntarily agreeing with the study protocol and signing a written informed consent.

Exclusion Criteria:

* Gastro-duodenal ulcer
* Infections, inflammations, or obstruction of the small or large intestine
* History of gastrointestinal cancer, or prior surgery of the stomach or intestine
* Females who are pregnant or those lacking adequate contraception
* Unwilling to sign the informed consent
Use of Copeptin in Diabetes Insipidus

Prospective evaluation of the novel biomarker copeptin in the differential diagnosis of diabetes insipidus against the standard diagnostic test methods.

Purpose of this study is to compare the overall diagnostic accuracy of the three following diagnostic test procedures in diabetes insipidus (central, nephrogenic) and primary polydipsia: a) classical water deprivation test alone, b) classical water deprivation test plus plasma copeptin cut-off levels, c) hypertonic saline infusion test plus plasma copeptin measurement.

The investigators hypothesize that firstly b) and c) is better as a). Secondly the investigators hypothesize that c) is non-inferior to b).

Eligibility Criteria:
Inclusion Criteria:

* Polyuria or/and Polydipsia or/and therapy with synthetic adenovirus proteinase (AVP) derivate
* Urine osmolality \<800mOsm/kgH20

Exclusion Criteria:

* Polyuria due to diabetes mellitus
* Hypokalemia
* Hyperkalemia (\>5mmol/l)
* Hypercalcemia
* Kidney disease (min.: glomerular filtration rate (GFR) 60ml/min/1.73m2)
* Pregnancy
* Hyponatremia \>135mmol/L
* Hypernatremia \>145mmol/L
* Hypo- or hypervolemia
* uncorrected adrenal or thyroidal deficiency
* Cardia failure
* Epilepsia
* Uncontrolled hypertension
Dose Response of Intravenous Sincalide(CCK-8) for Gallbladder Emptying

This is a clinical research study to establish normal values for the infusion of a synthetic form of the hormone cholecystokinin(CCK-8) for gallbladder emptying. Cholecystokinin is released from the small bowel to stimulate the pancreas and gallbladder to help digest and absorb food. Some people have gallbladder problems and need to be tested with the synthetic cholecystokinin ( Kinevac®, Bracco Diagnostics, Inc.). The aim of this study is to find out how differing amounts and intravenous infusion times of CCK-8 affect gallbladder emptying. The findings in normal subjects will be used to establish normal values that can then be compared with patients with suspected gallbladder disease.

This study enrolled 60 healthy volunteers from four institutions (Johns Hopkins University, Pennsylvania State University, Memorial Health University Medical Center, and Temple University. Subjects had to be healthy men or women 18-65 years old with no gastrointestinal disease as confirmed by initial screening using a modified Mayo Clinic Research Gastrointestinal Disease Screening Questionnaire, and normal results for CBC, metabolic profile, serum amylase and gallbladder ultrasonography. Women could not be enrolled if pregnant.

Subjects had 3 infusion studies at least 2 days apart within 3 weeks.

Eligibility Criteria:
Inclusion Criteria:

1. Healthy males and females between ages 18-65 years of age with no gastrointestinal disease as screened by the Mayo Clinic GI Disease Screening Questionnaire
2. Subjects with high probability for compliance and completion of the study
3. Normal liver function tests and amylase
4. Normal ultrasound of the gallbladder

Exclusion Criteria:

1. Prior GI surgery, excluding appendectomy
2. Surgery within the past 3 months
3. BMI \> 35
4. Female of childbearing age who is not practicing birth control and/or is pregnant or lactating. (Confirm with urine pregnancy test)
5. Cardiovascular, endocrine, renal, gastrointestinal, or other chronic disease likely to affect motility. This includes diabetes, renal insufficiency, gastroesophageal reflux disease, gastroparesis, irritable bowel syndrome, prior peptic ulcer disease.
6. GI symptoms such as heartburn, chest pain, dysphagia, abdominal pain, nausea, vomiting, constipation, diarrhea.