cyrilzakka/clinical-trials huggingface dataset:
H2O-F - a PROSPECTIVE, MULTI-COUNTRY, MULTI-CENTRE, MULTI-CONDITION FEASIBILITY STUDY EVALUATING the ESTABLISHMENT of the NATIONAL HEALTH OUTCOMES OBSERVATORY (H2O) ECOSYSTEM

The primary objective of this study is to assess the progress of the national H2O Health Outcomes Observatory ecosystem towards a fully functional and operational state.

The study aims to systematically implement validated sets of PROMs (patient-reported outcomes) to enable real-time monitoring and intervention, facilitating patient-centered health care.

This study is aimed to all patients with a diagnosis of Metastatic Breast Cancer, Lung Cancer, Crohn's Disease, Ulcerative Colitis or Type I and Type II Diabetes who are treated at participating MUW centers and other H2O stakeholders such as HCPs, healthcare administrators, healthcare policy makers, and academic and private sector researchers.

This is an international project that aims to systematically implement validated sets of PROMs (patient-reported outcomes) to enable real-time monitoring and intervention, facilitating patient-centered health care.

The sets of PROMs will be administered to patients during the clinical routine via online questionnaires.There are no additional procedures to the existing clinical routine.

The study includes a 6-month enrollment period and a 12-month observation period; questionnaires will be collected at baseline, 3, 6, 9, 12-month timepoints.

A total of 200 patients are expected to be enrolled among the various participating centers.

The primary objective of this study is to assess the progress of the national H2O Health Outcomes Observatory ecosystem towards a fully functional and operational state.

The secondary objectives are to

* Measure the national Health Outcomes Observatory ecosystem's usability and utility for routine care delivery and secondary research health data use cases,
* Understand stakeholders' acceptance, identify facilitators and improve and deepen the situational, contextual qualitative understanding of the perceived barriers and challenges that could prevent implementation and scalability, and
* Evaluate the infrastructure established to capture, store, and analyse integrated clinical and patient-generated health outcome data.

Eligibility Criteria:
Inclusion Criteria:

* Patients (\>18 years of age) with a diagnosis of Type I or Type II Diabetes, Crohn's Disease, Ulcerative Colitis, Metastatic Breast Cancer, or Lung Cancer.
* Ability to read and understand the local language
* Participation in the H2O Registry (EK 1659/2022)
* Signed and dated informed consent form for participation in the feasibility study
* Willing and able to complete data collection using an electronic device.

Exclusion Criteria:

* Any patient who is unable or unwilling to provide explicit informed consent, or fails to meet other inclusion criteria.
Rebozo and Maternal Procedures to Reduce Persistent Occiput Posterior Position of the Fetal Head

The goal of this clinical trial is to assess whether a combination of forward-leaning inversion and side-lying release procedures and Rebozo technique in a pre-specified sequence during the first stage of labor among women with a posterior fetus would favor anterior rotation. The main questions it aims to answer is:

• What is the probability of persistent occiput posterior position of the fetal head three hours and thirty minutes after randomization, diagnosed by sonography? Researchers will compare the intervention group, which received a sequence of forward-leaning inversion (FLI), side-lying release procedures (SLR), and the Rebozo technique (lasting 90-105 minutes), to the control group, which received standard care (free maternal postures), to assess whether the specific combination of interventions in the experimental group reduces the probability of the fetal head remaining in the occiput posterior position.

Participants in the intervention group will undergo a combination of forward-leaning inversion, side-lying release procedures, and the Rebozo technique, administered in a pre-determined sequence. In contrast, participants in the control group will receive standard care (free maternal postures).


Eligibility Criteria:
Inclusion Criteria:

* woman in labor between 3 and 8 cm of cervical dilation
* woman with a singleton term fetus (≥37 0/7 weeks of gestation) in an Occiput Posterior Persistent Position clinically diagnosed and confirmed by transabdominal sonography

Exclusion Criteria:

* Women with growth restricted fetuses according to the Delphi's consensus
* Fetuses with congenital anomalies or infections or with chromosomal abnormalities
* Intrauterine fetal demise
* Fetal and/or maternal conditions requiring urgent or emergent delivery or impeding the use of FLI and SLR and/or the Rebozo technique (non-reassuring fetal heart rate, abnormal vaginal bleeding, immobilizing epidural analgesia, polyhydramnios, extrapelvic fetal head, body mass index ≥35 Kg/m2, hypertensive disorders of pregnancy with inadequate control of blood pressure, maternal heart disease in class III to V according to the modified World Health Organization, glaucoma or ocular surgery, esophageal reflux disease, hypermobile sacro-ileac joint, and severe symphysis dysfunction)
Prevalence of Non-traumatic Musculoskeletal Disorders in the French Paragliding Pilots Population

The main objective is to determine the prevalence of non-traumatic pathologies in the paragliding population using the Nordic type questionnaire.

The paragliding pilots population frequently evoque pathologies, discomfort, or pain in the course of their practice. Said pain and discomfort, though unerelated any form of accident, seem to have an impact on the pilots' flying and their participation in daily life.

However, no epidemiological data are available in the literature. Investigators hypothesize the existence of non-traumatic disorders and it seems interesting to quantify the extent of the phenomenon. The results of this study might encourage the proposition of preventive measures in order to minimize a potential risk factor for paragliding accidents, and participation restrictions.

In this cross-sectional descriptive epidemiological survey, investigators wish to quantify epidemiological parameters such as the prevalence of pathologies and their consequences in the activities of daily life.

For this purpose, an email containing the link to answer the online questionnaire will be sent to all the licensees.

The link of the questionnaire will be sent directly to all clubs in each league.

The main objective is to calculate the prevalence with descriptive statistics. The primary outcome is the prevalence of non-traumatic pathology in paragliding pilots that had registered to the French Paragliding federation (FFVL) in 2022.

The prevalence will be infered from the IRSST Standardised Nordic Questionnaire with the following formula : Prevalence = (FS4+FS6=yes and FS2=no ) divided by the total number of respondents.

FS4 item "Yes" = pain in the last 12 months FS6 item "Yes" = activity limitations) FS2 item "No" = Non-traumatic disorders

This corresponds to having felt pain in the body region indicated, at least once during the last 12 months, as well as a restriction of participation following this pain, but without having suffered trauma in the area.

For the secondary outcomes will aim at exploring several hypotheses related to personal and environmental factors that could be correlated to the incidence of the nontraumatic disorders. They will be calculated with bivariate descriptive statistics using the Pvalue.io software.

Eligibility Criteria:
Inclusion Criteria:

* over 18 years old
* Registered with the FFVL for the year 2022 and/or 2023
* Paragliding in the year 2022 and/or 2023

Exclusion Criteria:

* Adults not able to express their consent
Optimizing Hydroxyurea Dosage With Pharmakokinetic in Patients Suffering of Moderate to Severe Sickle Cell Anemia

The goal of this study is to evaluate if patients with sickle cell disease can achieve a maximum tolerate dose of hydroxuyrea (HU) over a period of 12 months faster with pharmacokinetic testing than the standard of care bloodwork follow-up. Pharmacokinetic test is used to evaluate the process by which drugs are absorbed, distributed in the body, localized in the tissues, and is excreted.

Patient will be a randomized (coin toss method) into 2 groups. Group A will have an increase of their HU dosage with pharmacokinetic results and Group B will have an increase of their HU dosage following the standard of care bloodwork follow-up.

Group C will include patient with sickle cell disease that has been taking HU for at least 12 months and will undergo a pharmacokinetic dosage to check the level of HU only one time.


Eligibility Criteria:
Inclusion Criteria (Group A and B) :

* Have had confirmed diagnosis of SCD at CHU Sainte-Justine biochemistry lab with hemoglobin electrophoresis.
* Be patients with SS, SBThal0.
* Agree to take hydroxyurea for a period of 12 months
* Be between age of 6months old and 18 years old.
* Have consented for participation in the study.

Inclusion Criteria (Group C) :

* Have had confirmed diagnosis of SCD at CHU Sainte-Justine biochemistry lab with hemoglobin electrophoresis.
* Be patients with SS, SBThal0.
* Have taken hydroxyurea for a period of at least 12 months, and have received HU at a stable dose and at MTD for at least 6 months.
* Be between age of 6months old and 18 years old.
* Have consented for participation in the study.

Exclusion Criteria:

* Patients with sickle cell genotype other than SS or SBThal0 (SC, SBThal+, SE or SD)
* Patients on chronic transfusion program
* Patients have received a blood transfusion in the last 4 weeks of study enrollment.
* Have received a hematopoietic stem-cell transplantation
* Creatinine \>2x normal for age
* ALT\>2x normal for age
* Sexually active females unwilling to comply with reliable method of birth control
* Pregnancy
* Conditions which in the opinion of the investigator, would compromise participation in the study will be excluded.
Prospective Evaluation of the Efficacy of Sirolimus (Rapamune®) in the Treatment of Severe Arteriovenous Malformations

The aim of the study is to evaluate the efficacy and safety of sirolimus (oral form), to decrease the volume and symptoms due to superficial arteriovenous malformations (AVM).

Sirolimus has properties that reduce the activity of the immune system (immunosuppressant), to fight against the proliferation of cancer cells (anti- tumor) and also reduce the proliferation of blood vessels (anti -vascular). Sirolimus is primarily used in transplant patients to prevent organ transplant rejection. Many animal and laboratory studies were carried out and demonstrate in particular the activity of sirolimus on vessels. It is this anti- vascular effect that could help treat arteriovenous malformations.

Anti-proliferative and anti-angiogenic properties of Sirolimus (Rapamycin®) are the basis of the rationale to use it in the treatment of arteriovenous malformations, for which the pathophysiology remains poorly understood. The interest of this class of drug is that inhibition of mTOR (mammalian target of rapamycin) may also block growth and / or angiogenic factors (other than VEGF) involved in the development of AVM. More specifically anti-VEGF drugs does not have that potential.

Eligibility Criteria:
Inclusion Criteria:

* Patients (adults, adolescents and children older than 2 years), with arteriovenous malformation stage II + III or IV (according to Schöbinger's classification) : active or quiescent, marked or not by hemorrhagic phenomena.
* Patients (parents for minors) must sign a consent form established after clear information risks and expected benefits of the study.
* Patients (major and minor of childbearing age) must have effective contraception during the study period and continuing until 12 weeks after the end of treatment
* Negative pregnancy blood test for women of childbearing age.

Exclusion Criteria:

* Chronic or acquired immunosuppression :

  * patients with transplanted organ or who received a hematopoietic stem cell
  * patient with congenital immunodeficiency
* Patients implanted with chronic active infection associated with hepatitis B , hepatitis C or HIV
* Pregnant or nursing woman.
* Allergy to macrolides
* Allergy to peanut or soya
* Hypersensitivity to " Sirolimus " or any of the excipients of the investigational product
* Contraindications to performing an MRI
* Leukopenia below 1 000 /mm3
* Thrombocytopenia lower to 80,000 /mm3
* Anemia with Hb \< 9 g/dl
* Elevated transaminase \> 2.5 N
* History of cancer less than two years before the inclusion
* Surgery older than 2 months before inclusion
* Active infection (viral and bacterial ) on the date of inclusion
* Hypercholesterolemia \> 7 mmol / l despite appropriate medical treatment
* Hyperlipidemia \> 2 mmol / l despite appropriate medical treatment
* Uncontrolled diabetes
* Patients unable to follow a clinical study
* Major under guardianship, persons deprived of their liberty
Unblinded Data Collection Study of Concussion Using BrainPulse

This is a prospective, non-blinded, matched control study of young athletes (ages 10-28 years old) in collegiate sports. The cohorts are defined in accordance to the athlete's exposure of injury. All subjects will complete a minimum of one recording based on their assigned cohort. Concussed athletes will complete an additional 3 weeks of follow-up recordings post injury. The symptomatic evaluation, physical examination, neurological baseline testing, and BrainPulse recordings will be entered in a database to determine clinical outcome and assess device utilization.

Cohort I is defined as all enrolled athletes at the University of Wyoming and is divided into two sub-cohorts: Cohort Ia include all athletes participating in Division 1 Athletics; Cohort Ib are athletes subscribed to the Head Health Network. Cohort II is defined as all injured athletes participating in the teams and includes two sub-cohorts: Cohort IIa is defined as non- concussed injured athletes; Cohort IIb concussed athletes per reference standard.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female young athletes between ages 18-28 yrs
2. Enrolled at the University of Wyoming and currently participating in Division 1 Athletics
3. Completed the following baseline testing: SWAY balance, King-Devick, C3-Logix
4. Willing and able to participate in all study evaluations and allow access to medical testing and records
5. Signed informed consent, or have a legally authorized representative willing to provide informed consent on behalf of the subject if the subject is a minor

Exclusion Criteria:

1. Prior concussion diagnosed by a physician in the last 2 weeks assessed via interview with athlete (not including a recent concussion within the last 3 days)
2. Any serious medical, social or psychological condition that in the opinion of the investigator would impair ability to provide informed consent or otherwise disqualify a patient from participation
Journaling and Weight Loss

This is a pilot study to evaluate the effect of keeping a 'gratitude journal' on the outcome of a weight loss program. All the subjects will be enrolled in the Lifesteps weight management program. The experimental group will maintain a gratitude journal and the control group will maintain a 'neutral' journal.

Subjects who are referred to the Preventive Cardiology Program for weight management will be enrolled in the study after obtaining informed consent.

Subjects are enrolled into the program in groups of 10 to 12 every 6 weeks. Alternate groups will be will assigned to the two types of journaling. Each group will be given specific instructions related to the form of journaling assigned. These instructions will be in addition to the usual care prescribed in the Lifesteps® program. In the intervention group, patients will be introduced to gratitude journaling at the beginning of the 12 week class series and asked to journal each day. They will turn in their gratitude journal weekly. At the beginning of each weekly class, five minutes will be spent discussing the journaling.

The control groups will not receive the information on gratitude journaling, but instead will be asked to complete a neutral journal in which they will journal in a general manner regarding their experiences participating in the Lifesteps® weight management program. These will also be collected weekly. At the beginning of class, five minutes will be spent discussing the journaling.

There will be one consent form for the two groups. The instruction (either gratitude journaling or neutral journaling) that will be given to the subjects will reflect the group to which they have been randomized. Both types of journals will be reviewed initially, at mid-point and final by the psychologist (Robert Emmons) to verify the quality of reporting.

Routine tests- Weekly weights

Study Tests:

Pre/post depression: Beck Depression Inventory II; Pre/post Locus of Control: Multidimensional Health Locus of Control Scale; Pre/post SF 36 Quality of Life Questionnaire; Pre/post Gratitude Questionnaire

Eligibility Criteria:
Inclusion Criteria:

* BMI\>25
* \>18 years of age

Exclusion Criteria:

* Severe psychiatric diagnosis which in the opinion of the PI would compromise participation in the study.
* Addiction to alcohol and drugs
Deep Brain Reorienting in Post-traumatic Stress Disorder

This study will evaluate the efficacy of a therapeutic treatment, Deep Brain Reorienting (DBR), for PTSD (Post-traumatic Stress Disorder). Participants will be randomized to either the DBR treatment, or wait-list condition.

This study will evaluate the efficacy of Deep Brain Reorienting (DBR) in reducing PTSD symptoms. DBR was designed by Dr. Frank Corrigan, a Scottish psychiatrist interested in the brain mechanisms underlying effective trauma psychotherapy. For this study, participants will be randomized to either the DBR treatment or wait-list study conditions. Trauma processing through DBR involves bringing up a traumatic memory and encourages the client to focus on tensions arising in the muscles of the shoulders, neck, head and face (i.e., those involved in orienting toward a threatening person/event). It is believed that this approach will allow the participant to process the traumatic memory in an emotionally manageable way, changing how it is represented/accessed in the brain's innate defensive system. Online Stream - Assessments will include clinical interviews (pre/post treatment, and follow-up) using Webex video conferencing, and fMRI (functional magnetic resonance imaging) scans (pre/post treatment). In-Person Stream - Assessment will include clinical interviews (pre/post treatment and follow-up), and fMRI scans (pre/post treatment).

Eligibility Criteria:
Inclusion Criteria:

* English speaking
* age: 18-65
* meets diagnostic criteria for PTSD (as determined by study assessment)
* may benefit from short-term trauma therapy (as determined by study assessment)

Exclusion Criteria:

* Individuals with any implants, conditions, etc. that do not comply with 7-Tesla (7T) fMRI research safety standards (e.g., certain implants, pregnancy)
* history of significant head injury/lengthy loss of consciousness (e.g., a Glasgow Coma Scale Score \< 15 at the time of incident assessed retrospectively by participant)
* significant untreated medical illness
* history of neurological disorder
* history of any pervasive developmental disorder
* history of bipolar disorder
* history of psychotic disorder
* alcohol/substance abuse or dependence within the last 3 months
* extensive narcotic use
* current participation in counselling more extensive than supportive therapy (e.g., exposure therapy, Cognitive-Behavioural Therapy would be an exclusion)
* a degree of mental distress that is unlikely to benefit from a short-term therapy (for our participants' well-being, it will be necessary that we believe it possible to safely address the issues/triggers brought up in treatment within the 8 sessions).
Automatization of Counting Procedures in Children With Dyscalculia

Researchers in numerical cognition usually think that the greatest and most common difficulty in children suffering from dyscalculia is retrieval of arithmetic facts from long-term memory. However, we have recently shown that retrieval might not be the optimum strategy in mental arithmetic. In fact, expert adults would rather solve simple problems such as 3 + 2 by automated and unconscious procedures. Therefore, we hypothesize that children with dyscalculia might not present deficit in retrieval but, instead, in counting procedure automatization. The aim of the current project is to test this challenging position. Through a longitudinal approach, we plan to precisely examine the behavior of children suffering from dyscalculia over a 3-year period. Children will be aged between 8 to 11 years at the beginning of the study and we will precisely observe the evolution of their solution times when they solve simple addition problems involving one-digit numbers. If children with dyscalculia still struggle with simple additions three years, their solution times plotted on the sum of the problems should still follow an exponential function. Indeed, if counting is not automated, difficulties necessarily increase with the progression on the number line or the verbal sequence, hence the exponential function. On the contrary, if counting procedures tend towards automatization, moves along a number line will progressively become as easy at the beginning of the line as at the end, hence the linear function. Importantly, a retrieval model would predict exactly the inverse pattern because, according to this model, the linear function, which is unanimously considered as the hallmark of counting procedures, should progressively be replaced by a non-linear function through practice.


Eligibility Criteria:
Inclusion Criteria:

* Age between 8 and 11 years old
* Having a dyscalculia as described in the DSM (Diagnostic and Statistical Manual) V

Exclusion Criteria:

* Presenting a global intellectual deficit
Probiotics and Recovery From Surgery

The study will investigate whether probiotics given just before and shortly after major abdominal operation improve outcomes.

Perioperative probiotic intervention is associated with approximately 30% reduction of primary outcome measure.

Eligibility Criteria:
Inclusion Criteria:

* All elective major GI surgical patients

Exclusion Criteria:

* • Current episode of acute pancreatitis as defined by clinician

  * Active medication-induced immunosuppression including systemic corticosteroids, chemotherapy within 4 weeks, immunomodulating agents with transplant indication, biologicals for rheumatoid arthritis and inflammatory bowel disease. Topical chemotherapy or corticosteroids, and chemotherapy applied during operation are allowed.
ZD1839 (Iressa™) and Concurrent Chemo-Radiation in Patients With Locally Advanced Non Small Cell Lung Cancer

The primary objective of the trial is to determine the Maximum tolerated dose, if any, of the combination of daily ZD1839 250 mg with carboplatin AUC 2 and 60 Gray (Gy) irradiation and up to 45 mg/m2 paclitaxel.


Eligibility Criteria:
Inclusion Criteria:

* Patients with histologically or cytologically confirmed locally advanced stage IIIA or IIIB NSCLC (without pleural effusion)
* Patients with apical tumours and supraclavicular nodes are acceptable if both can be easily encompassed in one radiation field
* Minimum life expectancy with treatment of 6 months
* WHO performance status 0-1

Exclusion Criteria:

* Patients with previous malignancies other than NSCLC
* Previous radiotherapy for NSCLC
* Previous immunotherapy or chemotherapy
* Any unresolved chronic toxicity greater than CTC grade 2 from previous anticancer therapy
* Forced expiratory volume in 1 second (FEV1) less than 1 litre (L)
* Absolute neutrophil count (ANC) less than 1.5 x 109/L or platelets less than 100 x 109/L
* Serum bilirubin greater than 1.25 times the upper limit of reference range
* ALT or AST greater than 2.5 times the ULRR