cyrilzakka/clinical-trials huggingface dataset:
Social and Demographic Determinants of Fatigue in Patients With Inflammatory Bowel Disease in Remission

The aim of this observational study is to identify the social and demographic determinants of fatigue in patients with inflammatory bowel disease in remission.

Secondly, the objectives of the study are to:

* Assess the impact of fatigue on the quality of life of patients with inflammatory bowel disease in remission.
* To determine the profile of patients with inflammatory bowel disease in remission who are fatigued.

To this end, during a consultation or hospitalization, participants will be asked to respond independently to various questionnaires (FACIT-F, DIPCare, SSQ6, questionnaire on socio-demographic determinants and IBD disk). Characteristics of the type of chronic inflammatory bowel disease will be collected from medical records.

There will be no patient follow-up as part of the study. Participants may be contacted by telephone by the center's investigator within 2 weeks of the interview in the event of a partial or imprecise response.


Eligibility Criteria:
Inclusion Criteria:

* Patient in clinical remission for at least 6 months:

  * for Crohn's disease patients: Harvey Bradshaw Index (HBI) score ≤ 4
  * for patients with ulcerative colitis: a partial Mayo score (PMS) ≤ 2 with each subscore of 1 or less)
* Patient in biological remission for at least 6 months fecal calprotectin \<250 μg/g and CRP \<5 mg/
* Documented diagnosis of Crohn's disease or ulcerative colitis based on standard clinical, endoscopic and histological criteria
* FACIT-F score \< 40 (defining significant fatigue)
* Subjects at least 18 years of age at the time of study inclusion

Exclusion Criteria:

* Severe acute colitis
* Active infection with HIV, hepatitis B, hepatitis C, or untreated tuberculosis
* Patient(s) objecting to the use of their data for research purposes
Variability in Thermal Thresholds in Patients With Persistent Pain After Open Inguinal Herniotomy

The study will investigate the test-retest variability of thermal thresholds in patients with persistent pain after open inguinal herniotomy. Sensory mapping with a cool metal roller delineated an area with cool sensory dysfunction on the painful site. In this area and in a contralateral area as a control, 5 sites were outlined, including the point of maximum pain. In these total 10 sites warmth detection threshold (WDT), cool detection threshold (CDT) and heat pain threshold (HPT) were assessed using quantitative sensory testing. Tests were repeated after a 4-6 weeks interval.


Eligibility Criteria:
Inclusion Criteria:

* Patients with persistent pain after open inguinal herniotomy
* Age \> 18 years

Exclusion Criteria:

* Cognitive impairment
* Drug or alcohol abuse
* Bilateral inguinal hernia operation
* Nerve injury from other causes
A Phase 1/2 Multicenter, Randomized, Study to Evaluate the Safety and Efficacy of VS101 Subconjunctival Latanoprost Insert in Subjects With Open-Angle Glaucoma or Ocular Hypertension

Slow release formulation of latanoprost is compared for safety and pressure-lowering efficacy with topically administration of commercially available latanoprost in patient with glaucoma and ocular hypertension


Eligibility Criteria:
Inclusion Criteria:

* Age \> 18
* Open angle glaucoma or Ocular Hypertension

Exclusion Criteria:

* uncontrolled medical conditions
* wearing of contact lenses
Safety and Efficacy Study of SYN115 in Parkinson's Patients Using Levodopa to Treat End of Dose Wearing Off

The purpose of this research study is to test the effect of SYN115 compared to placebo (a "sugar pill" that looks like SYN115 but does not include active drug) on movement during the "on" and "off" states as well as other symptoms that some patients with Parkinson's disease experience. This study will also look at whether or not patients with Parkinson's disease experience "side-effects" with SYN115.


Eligibility Criteria:
Inclusion Criteria:

* Meet Parkinson's Disease (PD) diagnosis consistent with UK PD diagnostic criteria
* Meet Hoehn and Yahr PD stage
* Good response to levodopa
* Stable regimen of anti-parkinson medications
* Are able to complete a Parkinson's disease diary
* If of childbearing potential(male and female), use an acceptable method of birth control
* Able and willing to sign an IRB/IEC approved informed consent
* Able and willing to understand study requirements, follow study instructions, attend all visits and undergo all planned tests.

Exclusion Criteria:

* Secondary or atypical Parkinson's
* Neurosurgical intervention for Parkinson's disease
* Treatment with apomorphine
* Treatment with anti-psychotic drugs
* Other abnormal findings on physical or neuro exam or history that in the opinion of the investigator would make subject unsuitable for the study or prejudice safety and efficacy evaluation
* MMSE less than 26
* Subjects with untreated or uncontrolled current episode of major depression
* Receipt of any anti-psychotic drugs greater than 1 month in the past 5 years or any exposure in past year (except for quetiapine at doses \<100mg per day)
* Women pregnant or lactating
* History of hepatitis, cholangitis
* Untreated or uncontrolled hypothyroidism or hyperthyroidism
* Drops in blood pressure requiring medication to maintain blood pressure
* Any clinically significant out of range laboratory evaluations
* Known sensitivity to the study medication or its components
* Suicide ideation or type 4 or type 5 on the Columbia suicide severity rating scale
* Finding of malignant melanoma on full body skin exam
* Impulse disorder conditions
Fracture and Fall Prevention in Elderly With Osteoporosis

Osteoporosis is a prevalent health concern among older adults and is associated with an increased risk of falls that can cause fracture, injury or mortality. Identifying the factors related to falls occurring within this population is essential for the development of effective regimes for fall prevention. Studies have shown that muscle quality and good posture alignments are critical for balance control in older adults. People are diagnosed with osteoporosis often combining with muscles weakness, and increased spine kyphosis leading vertebral, fractures and poor balance control, even falls. Therefore, improving muscle quality, strengthening weak muscles and correcting postural alignment are essential elements for fracture and fall prevention in older adults with osteoporosis. The long-term objectives of this work are to prevent fracture and fall in older adults with osteoporosis by improving the function of degenerative muscles using exercise training.


Eligibility Criteria:
osteopenia or osteoporosis group:

Inclusion Criteria:

* able to stand and walk for 5 minutes independently
* having normal or corrected to normal vision
* having age between \> 50 years
* already have DEXA and X-ray exam with osteopenia (-2.5 \< t-score \< -1.0) or osteoporosis (t-score \<-2.5)

Exclusion Criteria:

* being pregnant
* sensory-motor deficits
* inability of communication
* lack of access to a telephone
* t-score \<-2.5 combine with existing fracture

control age-matched group:

Inclusion Criteria:

* able to stand and walk for 5 minutes independently
* having normal or corrected to normal vision
* having age between \> 50 years
* already have DEXA and X-ray exam without osteopenia or osteoporosis (t-score \> -1.0)

Exclusion Criteria:

* being pregnant
* sensory-motor deficits
* inability of communication
* lack of access to a telephone
* t-score \<-2.5 combine with existing fracture
Liver-enriched Antimicrobial Peptide 2

The investigators aim to investigate the physiological importance of LEAP-2 in healthy volunteers focusing on its potential insulinotropic effects.

The dramatic and almost immediate effects of Roux-en-Y gastric bypass (RYGB) surgery on type 2 diabetes (T2D) can only in part be explained by alterations in the plasma concentrations of known peptides. Thus, other - yet unknown - signals or hormones elicited from the endocrine cells of the small intestine may play an important role for the remission of T2D observed following RYGB. In a recent study, a predicted sequence of liver-enriched antimicrobial peptide 2 (LEAP-2) was shown to induce a glucose-stimulated insulin secretion in isolated human pancreatic islets. The fragment was subsequently identified to be circulating in human plasma in concentrations comparable to the circulating levels of other known gut secreted hormones, hereby validating that LEAP-2 is an endogenous circulating peptide.

The investigators hypothesise that LEAP-2 increases insulin secretion during a graded glucose infusion as assessed by plasma insulin and C-peptide compared with saline (placebo) in healthy subjects. The study is designed as a clinical, placebo-controlled, double-blinded cross-over study involving two experimental study days and ten young healthy male participants. The co-primary endpoints are the difference in plasma insulin levels during a graded glucose infusion and beta-cell secretion assessed by plasma C-peptide concentration relative to plasma glucose concentration between the two study days with either saline (placebo) or LEAP-2 infusion.

Eligibility Criteria:
Inclusion Criteria:

* Caucasian men
* Age between 18 and 25 years
* Body mass index between 20-25 kg/m2
* Informed consent

Exclusion Criteria:

* Anaemia (haemoglobin below normal range)
* ALAT and/or ASAT \>2 times normal values or history of hepatobiliary and/or gastrointestinal disorder(s)
* Nephropathy (serum creatinine above normal range and/or albuminuria)
* Any physical or psychological condition that the investigator evaluates would interfere with trial participation including any acute or chronic illnesses
* Any ongoing medication that the investigator evaluates would interfere with trial participation.
* First- and second-degree relatives with diabetes
* Regular tobacco smoking
Study of the Biological Mechanisms Associated With the Immunogenicity in Anaplastic Large Cell Lymphoma ( ALCL ) ALK +

To study the correlation between the polymorphism of the main immunity genes and progression-free survival in ALCL of the child.


Eligibility Criteria:
Inclusion Criteria:

* Every patients treated according to COPAD-IGR, HM 89,91 and 97 and ALCL99 protocols and included in related studies
* Clinical data registered in SFCE database
* Signed consent form

Exclusion Criteria:

* No ALK expression on tumour
* No consent signed
Sympathetic Nervous System Mediation of Acute Exercise Effects on Childhood Brain and Cognition

Today's children have become increasingly inactive and unfit, with \>50% of children not meeting the recommended 60 min of moderate-to-vigorous physical activity. Previous research has suggested that acute aerobic exercise of moderate intensity was associated with improved cognition manifested by improved performance and increased P3 amplitude, a neuroelectric indicator that reflects the amount of attentional allocation, in tasks requiring cognitive control. While minimal evidence exists to support potential mechanisms underlying the transient effects of exercise on brain and cognition, research suggests that phasic changes in the locus coeruleus-norepinephrine (LC-NE) (as measured by salivary alpha amylase (sAA)) system are a potential mechanism for explaining the acute effect of exercise on brain and cognition. Accordingly, the aim of this study is to examine the mechanisms linking acute aerobic exercise to improved cognitive control as well as the underlying neuroelectrical activities in children, using electroencephalography (EEG) and event-related potentials (ERPs). We hope to gain a better understanding of the role of acute exercise and cognitive and brain health. The results from this study will help identify mechanisms linking acute exercise to enhanced cognitive performance in children.

Our hypothesis is that exercise-induced phasic increases in sympathetic nervous system activity will mediate the effect of a single bout of exercise on brain function, cognition, and standardized achievement test performance.


Eligibility Criteria:
Inclusion Criteria:

* Parental/guardian consent (non-consent of guardian).
* Participants must have had no prior diagnosis of cognitive or physical disability, including attention deficit hyperactivity disorder (severe asthma, epilepsy, chronic kidney disease, and dependence upon a wheelchair/walking aid).
* Participants must be free of any type of anti-psychotic, anti-depressant, anti-anxiety medication, as well as those medications used for attention deficit hyperactivity disorder (use of any anti-psychotic, anti-depressant, anti-anxiety, and attention deficit hyperactivity disorder medications).
* Normal or corrected-to-normal vision based on the minimal 20/20 standard in order to complete the cognitive task (below 20/20 vision).
* Participants must have not yet reached, or be in the earliest stages, of puberty, as measured by a modified test of the Tanner Staging System (onset of puberty as determined by Tanner).
* English speaking.

Exclusion Criteria:

* Participants with an intelligence quotient below 85 will be excluded.
A Study of Lanadelumab (Takhzyro) and Icatibant (Firazyr®) in Persons With HAE in China

The Chinese health authority has approved lanadelumab to prevent Hereditary Angioedema (HAE) attacks in persons of 12 years and older. It has also approved icatibant to treat acute HAE attacks in persons 2 years and older.

One of the main aims of this study is to learn about the number of HAE attacks in 1 month in Chinese persons with HAE during their treatment with lanadelumab. The other main aim is to learn how much time is needed to resolve acute HAE attacks when treated with icatibant. Other aims of this study are to learn more about side effects of lanadelumab and icatibant treatment as well as to collect additional information on the treatment with lanadelumab, such as the dose and how often it needs to be given, reasons for stopping the treatment with lanadelumab and how long it was taken until stopping. Participants will be treated by their doctors according to routine medical practice. Only data already available in the medical records of the participants will be reviewed and collected during this study.


Eligibility Criteria:
Inclusion criteria:

* Chinese participants who have received at least one dose of lanadelumab or icatibant from the lanadelumab NMPA approval date (02-Dec-2020) to the date of the day before the 1st site initiation date.
* Informed consent will be obtained from the participant (and/or a legally authorized representative) prior to including that participant as a study participant and accessing that participant's data, except for cases in which the informed consent can be waived by the site.

Exclusion criteria:

• Participation in other interventional studies involving lanadelumab, icatibant, or any other HAE drug or investigational product on or after the date of the participant's lanadelumab or icatibant initiation.
A Study to Learn How Avacincaptad Pegol (Izervay™) is Used in Clinical Practice in People Who Have Geographic Atrophy

This study is for people who have geographic atrophy due to age-related macular degeneration (AMD). AMD happens when the macula, the light-sensitive layer at the back of the eye called the retina, becomes damaged and causes a person's central vision to worsen. Geographic atrophy is an advanced form of AMD where cells in the retina waste away and die. Over time this can lead to permanent loss of vision.

Avacincaptad pegol can help slow down the worsening or progression of geographic atrophy. Avacincaptad pegol is a treatment approved in the US to treat geographic atrophy.

This study is about collecting information on how people with geographic atrophy are treated in routine clinical practice. This includes recording any medical problems from avacincaptad pegol. This is known as an observational study. Information will be collected from the peoples' medical records during and after treatment. The people in this study will have geographic atrophy in 1 or both eyes and they and their doctor has decided they will be treated with avacincaptad pegol. The individual's doctor decides on treatment, not the study sponsor (Astellas).

People that want to take part in the study will have eye examinations that they would usually have as part of their routine care. People will also be asked to complete surveys about their eye health. These surveys will occur when treatment starts and then every 6 months for the first 2 years. After 2 years the surveys will happen once a year. The people on the study can take part if their doctor provides treatment with avacincaptad pegol and they want to continue with the study. The people on the study can take part for up to 3 years or up to 5 years, depending on when they start the study.


Eligibility Criteria:
Inclusion Criteria:

* Patients with geographic atrophy (GA) secondary to age-related macular degeneration (AMD) in 1 or both eyes
* Patient with a decision to treat with intravitreal avacincaptad pegol (ACP) prior to enrollment
* Patient willingness to complete the patient reported outcome (PRO).

Exclusion Criteria:

* Patients who have any contraindication or are not eligible for treatment with ACP, including the following:

  * Active ocular or peri-ocular infection in either eye
  * Active, suspected intraocular inflammation in either eye at enrollment/baseline visit
  * Hypersensitive to ACP or to any ingredient in the formulation
* Patients currently participating in an investigational program with interventions outside of routine clinical practice.
* Patients who have received ACP in the study eye. Note: Patients who have received or are receiving ACP in the fellow eye are eligible to be included in the study.
* Patients who have received any intravitreal complement inhibitor other than ACP in either eye. Note: Patients who have received an intravitreal complement inhibitor other than ACP in either eye and have completed the 90-day washout period are eligible to be included in the study.
Ph1b/2 Study of the Safety and Efficacy of T-DXd Combinations in Advanced HER2-expressing Gastric Cancer (DESTINY-Gastric03)

DESTINY-Gastric03 will investigate the safety, tolerability, pharmacokinetics, immunogenicity, and preliminary antitumor activity of trastuzumab deruxtecan (T-DXd) alone or in combination with chemotherapy and/or immunotherapy in HER2-expressing advanced/metastatic gastric/gastroesophageal junction (GEJ) and esophageal adenocarcinoma patients.

Study hypotheses: Combination of T-DXd with cytotoxic chemotherapy and/or immunotherapy administered to subjects at the recommended phase 2 dose will show manageable safety and tolerability and preliminary anti-tumor efficacy so as to permit further clinical testing. T-DXd in combination with cytotoxic chemotherapy or immune checkpoint inhibitor administered to HER2-expressing gastric, GEJ and esophageal cancer patients who have not received prior treatment for advanced/metastatic disease will show preliminary evidence of anti-tumour activity and the potential to become a therapeutic option for this patient population.


Eligibility Criteria:
Inclusion criteria:

1. Male and female participants must be at least 18 years of age. Other age restrictions may apply as per local regulations
2. Disease Characteristics:

   1. Locally advanced, unresectable, or metastatic disease based on most recent imaging
   2. For Part 1, 2, 3a, 4a pathologically documented adenocarcinoma of the stomach/GEJ/esophagus, HER2-positive (IHC 3+ or IHC 2+/ISH+) based on local tissue testing results
   3. For Part 3b and 4b, pathologically documented adenocarcinoma of the stomach/GEJ/esophagus, HER2-low (IHC 2+/ISH-negative or IHC 1+) based on local tissue testing results
3. For Part 1, progression on or after at least one prior trastuzumabcontaining regimen For Part 2, Part 3 and Part 4, previously untreated for unresectable or metastatic adenocarcinoma of the stomach/GEJ/ esophagus with with HER2-positive (Part 2 and Part 3 \[Arm 3A\] and Part 4 \[Arm 4A\]) or HER2-low (Part 3 \[Arm 3B\] and Part 4 \[Arm 4B\])) status
4. Has measurable target disease assessed by the Investigator based on RECIST version 1.1
5. Has protocol defined adequate bone marrow and organ function including cardiac, renal and hepatic function
6. If of reproductive potential, agrees to use a highly effective form of contraception or avoid intercourse during and upon completion of the study.

Exclusion criteria:

1. History of active primary immunodeficiency, known HIV, active chronic, or past hepatitis B infection, or hepatitis C infection.
2. Uncontrolled intercurrent illness
3. History of non-infectious pneumonitis/ILD, current ILD, or where suspected ILD that cannot be ruled out by imaging at screening.
4. Lung-specific intercurrent clinically significant severe illnesses.
5. Uncontrolled infection requiring intravenous (IV) antibiotics, antivirals, or antifungals.
6. Pleural effusion, ascites or pericardial effusion that requires drainage, peritoneal shunt, or Cell-free and Concentrated Ascites Reinfusion Therapy (CART).
7. Has spinal cord compression or clinically active central nervous system metastases.
Physical Activity Experiment on Male Prostate Cancer Patients

Prostate cancer is the most common cancer in France (56,841 cases in 2012). Although the benefits of physical activity (PA) in cancer patients are currently well established in the scientific literature, several studies have shown that this population is not sufficiently active. Strengthen patient adherence to prevention counseling by the physical activity (PA) is emerging as a new challenge for personalized treatment in oncology. In order to encourage the engagement and maintenance in a regular PA of cancer patients, first, their experiences of physical activity (PA) practice should be considered and their initial social representations of the practice considered. Secondarily, it is also important to identify health professionals who retain a key role in defining the framework, objectives and means of action to promote lifestyle changes towards a more active lifestyle. In addition, peer mentoring appears to offer promising perspectives for promoting adherence and long-term maintenance in physical activity (PA) of cancer patients.

The main objective of this project is to measure the adherence of prostate cancer patients to a physical activity program with a tracking of the motivation by a pair.

Eligibility Criteria:
Inclusion Criteria for patient in step1, 2 and 3:

* Major patient followed for prostate cancer:

  * located or locally advanced,
  * metastatic and / or resistant to castration and chemotherapy.
* Cancer diagnosed at least 1 year ago
* Patient affiliated or beneficiary to social security
* Signed informed consent.

In more, step 2 = Patient with Physical Activity for at least 1 year

Exclusion Criteria:

For step 1= In the course of cancer treatment (excluding hormonal therapy)

For step 2= Patient in sedentary lifestyle

For step 3=

* In the course of cancer treatment (excluding hormonal therapy)
* Cardiac or respiratory conditions contraindicating physical activity