cyrilzakka/clinical-trials huggingface dataset:
Developmental Endothelial Locus-1, Platelet Count, and Soluble P-selectin in Overweight and Obese Subjects

This observational study aims to detect serum levels of Developmental Endothelial Locus-1 (DEL-1), Platelet Count, and Soluble P-selectin (sP-sel) in Overweight and Obese Subjects. The main questions it aims to answer are:

* Is there a difference in serum DEl-1 levels in overweight and obese subjects compared to normal subjects?
* Are there any relations between serum DEL-1 levels, sP-sel, and platelet count in overweight and obese subjects ?


Eligibility Criteria:
Inclusion Criteria:

* Male patients.
* Age (18-65) years.
* Healthy overweight and subjects.

Exclusion Criteria:

* Patients with cardiovascular diseases.
* Diabetic patients.
* Previous history of thrombo-embolic diseases.
* Patients with hyperthyroidism.
* Patients with any type of malignancy.
* Underlying hepatic or renal failure.
* Major surgery within 60 days.
Comprehensive Management of Diabetic Patients With Renal Impairment : Impact on Blood Pressure and Glycemic Control

Diabetes is the leading cause of end-stage renal disease in developed countries. Hypertension and metabolic control are known to affect the progression of renal deficiency and patient's outcome. Our project aims at implementing a multidisciplinary and systematic approach of diabetic patients with renal deficiency, and at evaluating the impact of metabolic and blood pressure targets as recommended by current guidelines.

Complications of diabetes are influenced by the quality of blood pressure control and of metabolic control. Several prospective studies have shown a positive effect of the implementation of such control, however metabolic and blood pressure targets are not achieved for about 30% of diabetic uremic patients.

Our project aims at evaluating a comprehensive management approach of diabetic patients affected by renal insufficiency, defined by glomerular filtration rate (GRF) \<60 mL/min/1,73 m², through an alternate and complementary follow-up by the nephrologist and the diabetologist.

During a first period (one year), patients are managed as "usually". After this period, the patients will start the multidisciplinary health care during at least two years. They will be followed-up by the diabetologist every 4 months. According to his GFR measured by renal clearance of Cr-EDTA, the patient will be followed-up by the nephrologist every year if the GFR is between 60 and 40 ml/min, every 4 months if the GFR is between 40 and 20 ml/min, and every 1 or 2 months if the GFR is under 20 ml/min. GFR will be re-evaluated every year (Cr-EDTA or Cockcroft-Gault formula) and so medical examination frequency. Guidelines will be applied regarding blood pressure control (objective: \< 135/85 mmHg, and \< 125/75 mmHg if proteinuria \> 1g/24H, choice of drugs, implementation of the treatment...) and glycemic control (current guidelines according to the French Health Technology Information Agency, ANAES). Another important component of the management will be the implementation of nutritional balance and foot care.

Every two years, a detailed nutritional checkup will be planned by the diabetologist and a cardiologic check-up will be planned by the nephrologist during one day in the local nephrology department.

A biobank will be built up after patient's consent. We will assess the impact of this intervention (guidelines application + multidisciplinary methodical and complementary follow-up) in terms of glycemic and blood pressure control.

The percentage of patients who will obtain a good glycemic and blood pressure control will be analysed and compared between the two follow-up period (before/after the intervention).

If validated this strategy may provide the basis of a care network focused on an optimum diabetic health care.

Eligibility Criteria:
Inclusion Criteria:

* Diabetic patients affected by renal insufficiency defined by glomerular filtration rate \< 60 ml/min/1,73 m² by the Cockcroft-Gault formula
* signed informed consent

Exclusion Criteria:

* pregnant woman
* minors
Rhythm Effect on Dance Learning in Children with and Without Cerebral Palsy.

Cerebral Palsy (CP) leads to motor impairments and impacts activities of daily living and academic and social achievement (American Psychiatric Association, 2013). Children with CP present impaired procedural learning abilities that is the ability to acquire cognitive-motor skills with practice (Gagliardi et al., 2011; Gofer-Levi et al., 2013). However, some rehabilitative rhythmic interventions, such as adaptive dance training, appear to improve motor, cognitive, psycho-emotional, and social functions in these children (Cherriere, Martel, et al., 2020; Cherriere, Robert, et al., 2020). Rhythm seems to be an important factor in these benefits, probably because regular rhythm improves motor control and learning (Thaut, 2015; Lagarrigue et al., 2021; Ghai et al., 2022). To validate this hypothesis, the investigators propose to evaluate the effects the presence of a regular rhythm on learning of a danse choreography in typically developing children and children with CP.


Eligibility Criteria:
Inclusion Criteria:

For all the participants:

* Aged from 8 to 16 include.
* Free, informed, written, and signed consent of the holders of parental authority
* Free and informed consent of the minor
* Affiliation with or benefiting from a social security scheme.
* Ability to understand the instructions (investigator's assessment)

For the participant with CP:

* CP diagnosis
* Gross Motor Function Classification System level between I to IV.
* Manual Ability Classification System level between I to IV.

For the participant with typical development:

* No CP diagnosis
* No neurological trouble nor functional disfunction including developmental coordination disorder.

Exclusion Criteria:

* -Autism spectrum disorder diagnosed according to the DSM-5 (APA, 2015)
* Hearing deficiency diagnosed according to the DSM-5 (APA, 2015) or uncorrected hearing deficiency that doesn't allows the participant to hear a music with a sound level between 45 and 70 decibels.
* Visual deficiency diagnosed according to the DSM-5 (APA, 2015)
* Intellectual developmental disorder diagnosed according to the DSM-5 (APA, 2015)
* Behavioural disorders diagnosed according to the DSM-5 (APA, 2015)
* Diagnosed epilepsia
* Pregnancy (check in young pubescent and sexually active women) or breastfeeding.
* Children already include in ongoing interventional study.
* Children with both parent who benefit of legal protection (guardianship, curatorship, safeguard of justice).
Assessment of Exhaled Breath Condensate Hydrogen Peroxide (EBC H2O2) as Measured Using a New Device (Inflammacheck™) in Patients With Interstitial Lung Disease, Lung Cancer and Healthy Volunteers.

A cross-sectional study of EBC H2O2 levels, as measured by a novel device, 'Inflammacheck™', and other markers of disease severity in patients with ILD and Lung Cancer.

Inflammation and oxidative stress are processes that occur early in the disease process within both ILD and lung cancer. Current tools for assessing inflammation and oxidative stress, such as fibre-optic bronchoscopy with bronchial wall biopsy and bronchial fluid lavage, are invasive procedures not suitable for regular repeat sampling. Sample analysis requires a series of laboratory measurements and results can take over 24 hours to become available.

In contrast, measurement of Exhaled Breath Condensate Hydrogen Peroxide (EBC H2O2) is performed during normal tidal breathing, and is well tolerated even in patients with severe airways obstruction and those unable to perform a consistent controlled exhalation. It is also not limited to inflammatory cell specific inflammation.

To date, the measurement of EBC H2O2 has been used as a research tool only, due to the complex multiple procedural steps required to deliver a result from the collected exhaled breath. Exhalation Technology Ltd. have now developed a novel, handheld device (Inflammacheck™) which can produce an immediate measurement of EBC H2O2 levels at the patient's side. By detecting EBC H2O2 levels immediately, Inflammacheck™ could tell clinicians and patients the current level of global airway inflammation in a simple, effort independent manner. This could be used by clinicians to diagnose ILD and even Lung Cancer.

The 'Inflammacheck™' device now requires a study in a clinical setting to determine whether it can detect ILD and Lung Cancer. The acceptability and ease of use of the device also needs to be assessed for both patients and clinicians.

Eligibility Criteria:
Inclusion Criteria:

* Male or Female, aged ≥18 years.
* A confirmed, clinician made diagnosis of Interstitial Lung Disease (ILD) supported by evidence of ILD on a CT chest scan recorded at any time.
* OR a clinician suspected or confirmed Lung Cancer, with or without asthma and/or COPD
* OR a healthy volunteer with no known history of lung disease (defined as no current clinical diagnosis of, or be receiving treatment for, a lung disease).
* Willing and able to give informed consent for participation in the study.

Exclusion Criteria:

* Existing co-morbidities that may prevent them from performing spirometry or other study measurements (at the discretion of the clinical investigator).
* Known other lung, chest wall, neuromuscular, or cardiac disease or abnormality (including end-stage disease or cancer) that would confound symptom scores and spirometry.
* In the opinion of the clinical investigator, participant could be put at risk of harm by having to perform any of the study procedures.
* Unable to comprehend the study and provide informed consent, e.g. insufficient command of English in the absence of someone to adequately interpret.
LDK378 in Patients With ALK Positive NSCLC Previously Treated With Alectinib.

This was a single-arm, open-label, multicenter, phase II study to evaluate the efficacy and safety of the ALK inhibitor LDK378 when used as single agent in patients with ALK-rearranged stage IIIB or IV NSCLC previously treated with alectinib. Treatment with LDK378 750 mg qd continued until the patient experienced disease progression as determined by the investigator according to RECIST 1.1, unacceptable toxicity that precluded further treatment, pregnancy, start of a new anticancer therapy, discontinued treatment at the discretion of the patient or investigator, lost to follow-up, death, or study was terminated by Sponsor.

Study completed as per protocol. 'Switched to commercial drug' implies that after the primary and secondary objectives were achieved, one patient continued the study treatment as they did not meet the progression disease or AE to be discontinued from the treatment. But after the regulatory approval, Novartis decided to close the study, the 1 patient switched to commercially available drug.

Eligibility Criteria:
Key Inclusion Criteria:

* Histologically or cytologically confirmed diagnosis of Stage IIIb or IV NSCLC that carries an ALK rearrangement as determined locally by Vysis ALK Break Apart FISH Probe Kit (Abbott Molecular Inc.) test.
* Patients must have NSCLC that has progressed at study enrollment.
* Patients must have received previous treatment with alectinib for treatment of locally advanced or metastatic NSCLC. Prior therapy with crizotinib as ALK inhibitor therapy in addition to alectinib is allowed. Alectinib doesn't need to be the last therapy prior to study enrollment. No particular sequence of prior alectinib and crizotinib is required for enrollment.
* Patients must be chemotherapy-naïve or have received only one line of prior cytotoxic chemotherapy.
* Age 18 years or older at the time of informed consent.

Key Exclusion Criteria:

* Patients with known hypersensitivity to any of the excipients of LDK378.
* Prior therapy with other ALK inhibitor investigational agents except crizotinib and alectinib.
* Prior systemic anti-cancer (including investigational) therapy aside from alectinib, crizotinib and one regimen of previous cytotoxic chemotherapy for locally advanced or metastatic NSCLC.
* Patients with symptomatic central nervous system (CNS) metastases who are neurologically unstable or have required increasing doses of steroids within the 2 weeks prior to study entry to manage CNS symptoms.
* Patient with history of interstitial lung disease or interstitial pneumonitis, including clinically significant radiation pneumonitis.
* Patients with history of carcinomatous meningitis.
* Patient with a concurrent malignancy or history of a malignant disease other than NSCLC that has been diagnosed and/or required therapy within the past 3 years.
* Patient has clinically significant, uncontrolled heart disease and/or recent cardiac event (within 6 months)
The Influence of the Manipulation of the Sacroiliac Joint on Low Back Pain

The primary focus of this study is to know the influence of sacroiliac joint manipulation on low back pain with or without radiation to lower limbs, in the lumbopelvic-hip joint

One of the main problems faced by physiotherapists in primary care is low back pain with or without radiation to lower limbs. Nowadays, there are a lot of types of low back pain interventions, yet despite the vast amount of research findings, the evidence remains contradictory and inconclusive: Pharmacological treatments like NSAIDs have shown result in acute low back pain but not in chronic pain; conservative interventions (ultrasound, interferential currents, mechanical traction and massage) have been studied and found ineffective.

A total of 151 low back pain patients with or without radiation to lower limbs between 18-70 years old derived from the Physiotherapy Unit of Gévora Health Center (Badajoz, Spain) voluntarily entered the study

Eligibility Criteria:
Inclusion Criteria:

* dysfunction or sacroiliac joint hypomobility (SI)
* having stopped taking anti-inflammatory medicines or analgesics three days before the study began

Exclusion Criteria:

* destructive injuries of the spine and pelvis
* fractures
* lumbar surgery
* sacroiliac instability
* spondylolisthesis
* pregnancy in progress
* cauda equina syndrome
* abdominal aneurysm
* infection
* inflammatory arthritis
* tumors
* osteoporosis
A Stratified Sickle Event Randomized Trial (ASSERT)

The purpose of this study is to compare the effects of ICA-17043 to placebo with or without hydroxyurea (an oral drug used for treatment of sickle cell disease) in patients with sickle cell disease who have had 2 or more acute sickle-related painful crises requiring a visit to a medical facility within the past 12 months.


Eligibility Criteria:
Inclusion Criteria:

* 16 to 65 years of age (inclusive)
* Male or female (not capable of becoming pregnant or using appropriate birth control)
* Medical history of sickle cell disease
* Have a history of at least two or more acute sickle-related painful crises requiring a visit to a medical facility within the preceding 12 months

Exclusion Criteria:

* Hemoglobin \<4 or \>11 g/dL
* On a chronic transfusion program
* Has significant active and poorly controlled (unstable) cardiovascular, neurologic, endocrine, hepatic, or renal disorders clearly unrelated to sickle cell disease
Safer Births - Reducing Perinatal Mortality

Safer Births is a research and development collaboration to establish new knowledge and new innovative products to better equip and increase competence of health workers for safer births and increased newborn survival worldwide.

The main objectives are:

To randomize different devices for fetal heart rate assessments. To assess if a novel Newborn Resuscitation Monitor will facilitate newborn resuscitation in a low-resource setting. To determine bag mask ventilation treatment and devices beneficial for neonatal outcome.


Eligibility Criteria:
Inclusion Criteria:

* Randomizing fetal heart rate assessment: Singleton delivery, Term gestation age, Cephalic presentation, Fetal heart rate normal, Cervical dilatation ≤7cm, Consent to participate
* Randomizing bag mask ventilation: infants in need of positive pressure ventilation, Consent to participate

Exclusion Criteria:

* Randomizing fetal heart rate assessment: Placenta abruption/praevia, Ruptured uterus, Morbid Obesity
Creation of a Digital Heart Failure Registry Using a Novel Mobile Health Platform: HUGO-HF

The investigators goal is to create a digital registry that allows for seamless integration of patient reported outcomes, electronic health record data, and pharmacy information into data collection. The investigators will accomplish this using a novel patient centered mobile health platform called Hugo that will allow them to engage patients in an entirely novel manner.

Heart failure is the most common cause of mortality and morbidity in the United States and in Western Europe. It is a complex and chronic illness, and patient journeys vary considerably. However, to date, guidance about how to best treat patients has relied on large clinical international trials that do not represent contemporary patients and only include snapshots of the syndrome-at times when the patients interact with the health care system. Additionally, patient participation in clinical research in the US is extremely low, approximated at 3% in cancer and far lower for disease states such as heart failure.

One of the key reasons for this is a lack of patient engagement and trust in the research enterprise, especially among the elderly and minorities, groups that are disproportionally impacted by heart failure. To address this, the investigators plan to test a novel patient-powered, smartphone-based mobile health platform (called Hugo) developed at Yale School of Medicine for real-world surveillance of patient reported outcomes in heart failure patients treated at 3 Major Academic Medical Centers. Participants will then be queried about specific symptoms and health conditions at enrollment and prespecified time points for 2 years. The subgroup of participants who own devices that track their activity data will have the option of syncing them to this mobile health platform to provide additional insights into their health and health outcomes. Additionally, participants will have the option to learn about opportunities to participate in heart failure clinical research. This digital registry will also allow seamless integration of patient reported outcomes, electronic health record (EHR) data, and pharmacy information into data collection.

Overall, the aim for this study is to create a digital registry using a novel patient centered mobile health platform of heart failure patients across large health care systems that allows investigators to engage patients in an entirely novel manner.

Eligibility Criteria:
Inclusion Criteria:

* Age\> 18 Years
* English Speaking
* Diagnosis of heart failure
* Participant is willing and able to read and sign consent and participate in study
* Participant has an email account

Exclusion Criteria:

- Unable to participate in registry
Personalized Blood Flow Restriction for Anterior Cruciate Ligament Rehabilitation

This is a cross-sectional study on the use of personalized blood flow restriction during rehabilitation exercises and its effects on biomechanics on people who have had an anterior cruciate ligament reconstruction and healthy controls

Rehabilitation after surgical reconstruction of the anterior cruciate ligament (ACL) aims to reestablish the function of the knee. However, regaining previous levels of strength is challenging, with long-term muscle weakness frequently reported and thought to play a key role in the increased risk of knee osteoarthritis for individuals with a history of ACL damage. Effectively building muscle strength requires exercises with high resistance loads, however the joint stress and risk of further injury makes these types of activities inappropriate and unsafe for those rehabilitating after ACL reconstruction surgery and other injuries. Personalized blood flow restriction (BFR) training is a technique where the blood flow to the muscles being exercised is controlled by a pressure cuff to a predefined level, and has been shown to increase strength while exercising with significantly lower loads. Early results have been promising, however the effects of BFR on the biomechanics of the exercise as well as the acceptability in the ACL reconstruction population have not been explored. In this application, we propose a cross-sectional study designed to test the acceptability of BFR training for those undergoing rehabilitation from ACL reconstruction surgery and healthy controls during free standing exercises. We will also investigate the biomechanical effects of this rehabilitation technique. This application is part of a larger program of musculoskeletal research in this area being developed by the team. The results from the proposed project will inform the design of a clinical trial of personalized BFR after ACL reconstruction.

Eligibility Criteria:
Inclusion Criteria (ACL-R group):

* Must be undergoing rehabilitation for anterior cruciate ligament reconstruction surgery
* Must be at least 3 months post surgery.
* Attending clinician should confirm that they are able to take part in the trial

Exclusion Criteria:

* Any other orthopaedic, neurological, or other condition within the last 12 months that would affect ability to carry out the required exercises
* Any medical conditions that may affect circulation including, but not limited to, deep vein thrombosis, high blood pressure, and cardiac disease
A Long-Term Safety Study of Tenapanor for the Treatment of IBS-C

This phase 3, open label study will evaluate the safety of tenapanor 50 mg BID in subjects with constipation-predominant irritable bowel syndrome (IBS-C) defined by the ROME III criteria. Subjects who have completed either TEN-01-301 (16 weeks) or TEN-01-302 (26 weeks) studies may be enrolled. Subjects will take tenapanor for approximately 52-55 weeks total based on previous protocol and this study.

During the treatment period of up to 39-weeks, subjects will return for study visits approximately every 13 weeks. Subjects will undergo safety assessments at these visits, which may include a physical exam, ECG, vital signs, and clinical labs. Adverse events and concomitant medications will be recorded. Medication compliance will be monitored and the subjects will be given additional study drug as appropriate.

Eligibility Criteria:
Inclusion Criteria:

* Subjects completed all 16 weeks of TEN-01-301 or all 26 weeks of TEN-01-302
* Subject demonstrated adequate compliance with the study procedures during either the TEN-01-301 or TEN-01-302 studies
* Females must be of non-childbearing potential; If of child-bearing potential, must have negative pregnancy test and confirm the use of one of the appropriate means of contraception
* Males must agree to use appropriate methods of barrier contraception or have documented surgical sterilization

Exclusion Criteria:

* Subject has been withdrawn or discontinued prematurely from either TEN-01-301 or TEN-01-302
* The subject reports using any prohibited medication and is not willing to abide by the restrictions for intake
* Pregnant or lactating women