cyrilzakka/clinical-trials huggingface dataset:
Navigator II Continuous Glucose Monitor Home Use Study

This research study will test a new investigational continuous glucose monitoring system (System). The purpose of this study is to find out about the performance of the System in a home use environment over a 15 day period, in people with diabetes.


Eligibility Criteria:
Inclusion Criteria:

The subject must:

* Have type 1 or 2 diabetes for at least 2 years prior to enrollment.
* Require insulin therapy administered through an insulin pump or multiple daily injections (MDI) for at least 6 months prior to enrollment.
* Be at least 18 years of age.
* Be able to read and understand English.
* In the investigator's opinion, be able to follow the instructions provided to him/her by the study site and perform all study tasks as specified by the protocol.
* Be available for all study visits.
* Be willing to provide written signed and dated informed consent.

Exclusion Criteria:

The subject must not:

* Be pregnant or likely to become pregnant during the study duration.
* Have skin abnormalities at the insertion sites.
* Have known allergy to medical grade adhesive or skin disinfectant.
* Be using a continuous glucose monitor currently or within the past 6 months
* Have a concomitant medical condition which, in the opinion of the investigator, could interfere with the study or present a risk to the safety or welfare of the subject.
* Be participating in another clinical trial.
Synaptic Plasticity Imaging with Diffusion MRI

Diffusion MRI employed in functional imaging has the potential to probe directly brain activation instead of blood changes like the BOLD technique. The researchers investigated these rapid synaptic plasticity changes with visual activation followed by BOLD and diffusion functional MRI as well as anatomical (venography, tractography by diffusion) features in young and aged subjects.

This study is devoted to explore brain plasticity by 2 modes of diffusion weighted imaging (DWI) of the brain :

* functional imaging using DWI and BOLD
* anatomical studies using DWI Theses DWI exams use high b-factor to sample tissue microstructure/metabolism. To correlated these DWI changes with anatomical ones, we used anatomical imaging like T1 maps and susceptibility-based maps.

First, the relatively new technique of diffusion functional magnetic Resonance (DfMRI) was explored to obtain activation of brain following visual stimulations. These modality was compared to BOLD and anatomical venography.

The DWI exams for anatomical (tractography) used both high angular resolution directional diffusion encoding (18 directions) and high b-values (as high as b=12 000 s/mm²) to obtain precise knowledge about tissue microstructure.

Study was approved by the National French Institute of Health and by french organism for biomedical studies (AFFSAPS). Study involve 35 subjects, with 5 additional subjects for eventual rejection because of ineligibility criterion, and compare 15 young (20-30 years) to aged healthy people (60-80 years).

Then, anatomical studies are devoted to obtain microstructures information about brain areas that are changed with age, and to validate fully the feasibility of the DfMRI approach.

Eligibility Criteria:
Inclusion Criteria:

* ages 20-30 years
* 60-80 years

Exclusion Criteria:

* psychological or organic trouble
Effectiveness of Foam Rolling on Selected Muscle Groups on Jumping

An experiment elucidating the immediate effect of foam rolling of the posterior chain on reactive force performance that will represent multiple jumps over low obstacles. The measurements will be performed using the Optojump device, which will provide data on the time of foot contact with the ground and the jump height. The angles of the torso inclination to the vertical will also be measured during jumping.

Fifteen women were selected for this experiment in the form of a randomized crossover study. Measurements were taken by leg jumps over 5 obstacles 125 cm apart. The pre-test was performed twice with a two-minute rest between each trial. Immediately after finishing the second trial, a randomly selected half of the probands performed posterior chain facilitation using a foam roller, facilitating first the left leg, then the right leg and finally spinal erectors. Rolling was performed with a sense of maximal intensity and at a high rolling speed across the full length and width of the muscle with both cranial and caudal rolling directions. Facilitation was performed on each muscle group in the distoproximal direction. Immediately following the intervention, a post-test was performed a total of 3 times, 1 minute after the intervention, 3 minutes after the intervention and 5 minutes after the intervention. The control measurement was performed the same way as the intervention, but the control group of probands rested in a resting sitting position for 4 minutes instead of foam rolling. After one week, a second measurement followed, where the original control group underwent the intervention measurement and vice versa.

The Optojump instrument (Microgate, Bolzano, Italy) was used to obtain the resistance and flight phase data. A video recording (GoPro HERO 9) was taken of the skipping procedure, from which photographs were taken over each obstacle at the moment of the greatest trunk tilt (the junction of the trochanter major and the external auditory canal exit) from the vertical axis.

Eligibility Criteria:
Inclusion Criteria:

* women
* age range 18-30 years
* regular training at least 3 times a week
* training with a minimum duration of 1.5 hours
* valid medical sports examination
* experience with jumping over hurdles
* having a problem with maintaining the physiological position of the torso when running

Exclusion Criteria:

* injuries
* acute illnesses
* chronic disease
* musculoskeletal limitations
* during convalescence
A Pilot Trial to Assess Low-Intensity Ultrasound in Osteoarthritis

The purpose of this exploratory trial is to investigate whether PLIUS is potentially effective as a disease and symptom modifying intervention in patients with early knee OA.

Osteoarthritis (OA), the most common form of arthritis, is a prevalent and debilitating disease without therapies that alter disease progress and is currently managed with symptom-modifying therapies that are only modestly effective. In spite of substantial progress in understanding the pathogenesis of OA, no effective disease modifying interventions have been established. Degenerative joint cartilage is a central feature of OA, yet joint cartilage has a limited capacity for repair. Results from animal research demonstrate that pulsed low intensity ultrasound (PLIUS) mechanically stimulates, and may promote, cartilage repair. This exploratory trial will investigate whether PLIUS is potentially effective as a disease and symptom modifying intervention in patients with early knee OA.

Eligibility Criteria:
Inclusion Criteria:

* 40 years of age or older, and a US Military Veteran
* Clinical symptoms of osteoarthritis for at least 6 months
* Pain in the index knee on motion or weight bearing for the majority of days during the month before screening
* Clinical diagnosis of primary osteoarthritis of the knee based on clinical and radiographic criteria
* American Rheumatism Association Functional Class I, II, or III
* Females of childbearing potential must be willing to use a reliable form of medically acceptable contraception

Exclusion Criteria:

* Concurrent medical/arthritis condition(s), or any other illness per the opinion of the investigator, that could interfere with the evaluation of pain or efficacy
* Spine or hip pain of significant magnitude
* History of significant ligament or meniscal injury of the index joint requiring surgical repair
* Arthroscopy of the index knee within 6 months of study entry
* Unable to undergo MRI of the knee
* Pregnancy or lactation
* Corticosteroid treatment within 1 to 3 months prior to study entry
* Intra-articular injection of hyaluronic acid or congeners to the index knee within 6 months of study entry
* Use of excluded therapy(ies) prior to study entry
* Use of disease modifying anti-rheumatic medications and chronic tetracycline or its derivatives
* Exposure to glucosamine, chondroitin sulfate, or any other investigational treatment, within 1 month of study entry
* Use of any medical therapy, complementary or alternative regimens for the treatment of osteoarthritis within 7 days prior to study entry
* Initiation of physical therapy or muscle conditioning program to the lower extremities within 2 months within 2 months prior to study entry
* Unlikely to comply with study requirements
A 52 Week Open-label Extension Trial Following the Double-blind Efficacy and Safety Study R076477-SCH-305.

Open-Label Extension to the double-blind effectiveness and safety study R076477-SCH-305 to evaluate long-term safety and tolerability in patients with schizophrenia.

The primary objective of the open-label extension trial was the long-term assessment of safety and tolerability of flexibly-dosed ER OROS paliperidone (3 to 15 mg/day) in patients with a diagnosis of schizophrenia. Other measures assessed in the extension study included: change in the total Positive and Negative Syndrome Scale (PANSS) score; change in PANSS subscale (positive and negative) scores; overall functioning, as measured by the Clinical Global Impression Scale-Severity (CGI-S); personal and social functioning, as measured by the Personal and Social Performance Scale (PSP); and quality of life parameters, as measured by the Schizophrenia Quality of Life Scale, Revision 4 (SQLS-R4). Paliperidone ER OROS® tablet formulation (3 to 15 mg/day) to be taken orally for 52 weeks

Eligibility Criteria:
Inclusion Criteria:

* Study R076477-SCH-707 enrolled patients who met the DSM-IV criteria of schizophrenia for at least 1 year
* Eligible patients were experiencing active symptoms at the time of enrollment and had a PANSS total score between 70 and 120
* The open-label extension study population comprised patients who had completed the 6-week double-blind phase of the study or who had discontinued due to lack of efficacy after at least 21 days of treatment.

Exclusion Criteria:

* Not eligible to enter the open-label phase if believed to be at significant risk for suicidal or violent behavior during the open-label extension trial
* Were pregnant
* Or had received an injection of a depot antipsychotic since entry into the preceding double-blind phase
Vorinostat (MK-0683) Phase I Study in Cutaneous T-Cell Lymphoma (CTCL) Patients (MK-0683-089 EXT1)

Part I evaluates the safety, tolerability and pharmacokinetics (PK) of vorinostat in Japanese patients with relapsed or refractory CTCL. Part II evaluates the safety of vorinostat in Japanese pts. with relapsed or refractory CTCL. Relapsed or refractory CTCL patients will be newly enrolled in Part II.


Eligibility Criteria:
Inclusion Criteria (Parts I \& II):

* Patients With CTCL Who Have Progressive, Persistent Or Recurrent Disease Subsequent To At Least One Prior Therapy
* Eastern Cooperative Oncology Group (ECOG) Performance Status Must Be 0-2
* Patients Have Adequate Bone Marrow, Liver Function And Renal Function

Exclusion Criteria (Parts I \& II):

* Patients Had Prior Therapy Within 3 Weeks Before Registration, Or Have Not Recovered From Toxicities Of Prior Therapy
* Patients Have Uncontrolled Intercurrent Illness
* Pregnant Or Women Have A Will To Be Pregnant And Lactating Woman
Frailty Prevention in Elders From Reunion Island

In Reunion Island, people encounter environmental and social conditions leading to premature ageing and subsequent frailty. Social welfare has developped exercise programs to promote physical activity especially for elderly with higher risk factors of frailty, including low incomes.

The study evaluates the potent benefit effect of such exercise program on physical performance and frailty improvement in seniors from Reunion Island. All seniors participate to a 12-weeks exercise program especially dedicated to this targeted population needs and ability.

Regular physical activity has been shown to slow down sarcopenia, and increase strengh in elders. Nevertheless, senior with low incomes do not usually have access to physical activity areas.

Social partners are in close relationship with these elders and could promote free exercise programs dedicated to elders classified as "GIR5-6" according to the French scale "AGIRR". The AGIRR scale takes into account several criteria allowing the evaluation of the level of autonomy. The level of autonomy is closely related to frailty and could be reversed since elders have not reach a dependant-state. The "GIR5-6" level means that elderly people are still not dependant but exhibit several frailty risk factors.

The level of frailty and the physical performance of the participants is assessed by standard geriatric evaluation before the 12-wks exercice program. The improvement of the physical performance is assessed after he 12-wks exercice program.

Eligibility Criteria:
Inclusion Criteria:

* Retired
* with an autonomy level corresponding to the "GIR 5-6" level of the French "AGIRR scale"
* informed consent

Exclusion Criteria:

* physical activity prohibited
* under guardianship
Safety and Pharmacokinetics of Subcutaneous Injection of OCTA101 in Adult Patients With Severe Hemophilia A

This Phase 1/2 study will be a dose escalation study in adults in 5 cohorts (named cohorts 1, 2, 3, 5 and 6), with the main purpose to assess the safety of subcutaneous injection of OCTA101 (a human-cl rhFVIII and recombinant human von Willebrand Factor fragment dimer) in previously treated adult patients with severe hemophilia A. The study also aims to assess the pharmacokinetics (PK) characteristics, dose proportionality, and subcutaneous bioavailability of OCTA101 compared with intravenous administration of Nuwiq (Human-cl rh FVIII), in order to define the prophylactic treatment (dose and injection interval) that would result in protective trough levels of FVIII:C for future Phase 3 studies. Cohorts 1, 2, 3 and 5 will undergo a single injection of OCTA101, with cohorts 1, 2 and 3 proceeding to 3-month daily dosing prophylactic treatment for 3 months by Data Monitoring Committee recommendation. Cohorts 1 and 2 will undergo a further PK at the end of the daily injection period. A further cohort, cohort 6, will have an initial 4 to 6-week run-in treatment period with Nuwiq intravenous prophylaxis followed by 12.5 IU/kg OCTA101 subcutaneous daily prophylaxis for \>3 up to 6-7 months.


Eligibility Criteria:
Inclusion Criteria:

1. Severe hemophilia A (\<1% FVIII:C) as documented in medical records
2. Males ≥18 years of age
3. Subjects who have had ≥150 exposure days (EDs) with a FVIII product
4. Written informed consent for study participation obtained before undergoing any study specific procedures

Exclusion Criteria:

1. Previous participation in this trial
2. Use of an Investigational Medicinal Product within 30 days prior to the first OCTA101 injection
3. History of FVIII inhibitors titre ≥0.6 BU/mL defined by medical records
4. Inhibitors to FVIII (≥0.6 BU/mL) at screening measured by Nijmegen modified Bethesda method at central laboratory
5. Human immunodeficiency virus (HIV) positive subjects with a CD4+ count \<200/mL
6. Clinically significant anemia at screening (hemoglobin \<8 g/dL)
7. Presence of any significant comorbidity (at the discretion of the investigator) that might confound the interpretation of the study data and/or that might put the patient at undue risk by participating in the trial
8. Any coagulation disorder other than hemophilia A
9. AST or ALT levels \>3 times the upper limit of normal
10. Creatinine \>120 μmol/L
11. Platelet count \<100,000 μL
12. BMI ≥30 kg/m²
13. For Cohort 6, patients with a positive LumiTope test at screening will be excluded
An Observational Study to Evaluate The Relationship of Nasal Mucus Properties and Symptoms

This is a study to learn more about the common cold from studying the nasal secretions produced during a cold or episode of allergic rhinitis.

This study involves collecting and analyzing nasal mucus to see if there are changes in mucus properties during the course of a cold or episode of allergic rhinitis. Outcome measures include SNOT20 questionnaire, nasal secretion collection, acoustic rhinometry on the fifth and fourteenth day of symptoms. The investigators will also collect SNOT20 questionnaires on the tenth and twenty-eighth day.

Eligibility Criteria:
Inclusion Criteria:

* Male and female subjects 12 years of age and older with acute nasal discharge fewer than 7 days or a history suggesting nasal allergic symptoms for at least 1 year. Internet access required during the course of the study. Patients must be symptomatic at screening.

Exclusion Criteria:

* Symptoms suggesting bacterial rhinosinusitis such as fever ≥ 101ºF/38.3ºC, facial swelling, and serve tooth pain. History of CRS or sinus/nasal surgery for this condition within 6 months before screening. History of respiratory signs and symptoms due to allergic rhinitis. Therapy with bronchodilators, nasal steroids, oral corticosteroids in the past 30 days. Therapy with antihistamines, nasal (Neti) washings, or decongestants in the past 24 hours. Use of any OTC cold or allergy medication 24 hours before study visits requires a 24 hour washout phase
Low-intensity Versus Medium-intensity Continuous Kidney Replacement Therapy for Critically Ill Patients

This clinical trial aims to investigate whether the low treatment intensity (12 mL/kg/hr, low-dose hemodialysis/filtration) or the medium treatment intensity (25 mL/kg/hr, standard-dose hemodialysis/filtration) is more effective and safer for continuous renal replacement therapy in critically ill patients.


Eligibility Criteria:
Inclusion Criteria: Patient who meets all of the following criteria and who has given informed consent.

1. Adults (18 years of age or older, regardless of the time since ICU admission) currently admitted to an intensive care unit\*.

   \*Includes high care units, where continuous monitoring is conducted and intensive care physicians are in charge of medical care.
2. A diagnosis of acute kidney injury is made according to the Kidney Disease: Improving Global Outcomes (KDIGO) international diagnostic criteria (one of the following is met)

   * Serum creatinine increased by more than 0.3 mg/dL within 48 hours
   * Serum creatinine increased more than 1.5-fold from baseline and the increase is considered to have occurred within 7 days
   * Oliguria (\< 0.5 mL/kg/hr) lasting more than 6 hours
3. The treating intensivist believes that continuous kidney replacement therapy is necessary

Exclusion Criteria: Patient who meets any of the following exclusion criteria will be excluded.

1. Receiving chronic dialysis or scheduled for initiation of chronic dialysis
2. Undergoing any kidney replacement therapy or blood purification therapy within 48 hours
3. When kidney replacement therapy using other dialysate or replacement fluids, such as citrate dialysis, is preferred due to coexisting bleeding disorders or allergy to acetate
4. Concomitant blood purification therapy other than hemofiltration/dialysis, such as plasma exchange
5. The patient is in a very critical condition and the treating physician believes that survival for more than 24 hours is unlikely
6. Previous participation in the study
7. After receiving a full explanation of the study and with full understanding, a patient do not consent to participate in the study of their own (or their substitute decision maker's) will.
8. The principal investigator (or an investigator) thinks it to be inappropriate to participate in this study.
Placebo-Controlled Multi-Centre Double-Blind Trial for Adults With Extended-Release Methylphenidate for ADHD

Investigation of efficacy and tolerability of extended-release MPD in adults with ADHD, compared with a placebo, and to acquire knowledge through long-term observation of adults


Eligibility Criteria:
Inclusion Criteria:

* Patient treated as outpatient or inpatient
* Patient has a good command of German
* Score of 85 or greater in the IQ test (MWT-B)
* Diagnosis of ADHD according to ADHD-CL (DSM IV) and WRI-WRAADDS \> 28 points
* ADHD symptoms have existed since childhood (WURS-k \>= 30)
* Body mass index \>= 20
* Willing to eat breakfast
* Patient is willing and able to come to the observation appointments
* Written consent of the patient to participate in the study

Exclusion Criteria:

* Treatment with psychostimulants in the past 2 weeks
* Inconsistencies in the CAARS- S:L \>= 8 (Inconsistency Index)
* Shift work or night work
* Alcohol, medication or drug dependency in the past 6 months or manifest drug abuse
* Diagnosis of a psychosis (SKID-I)
* Epileptic attacks in the past
* EEG results which suggest epilepsy
* Clinically relevant liver disease
* Clinically relevant hyperthyroidism (relevantly elevated TSH, T4)
* Acute depressive episode according to ICD-10 F32.2 and ICD-10 32.3 (SKID-I)
* Illnesses with schizophrenic symptoms (SKID-I)
* Acute manic episode, bipolar disorder (SKID-I)
* Diagnosis of a tic disorder
* Acute anorexia
* Acute prominent panic disorder and generalised anxiety (SKID-I)
* Clinically relevant kidney disorders
* Known high blood pressure
* Known occlusive arterial disease
* Known angina pectoris
* Known coronary heart disease and state after myocardial infarction
* Known tachycardial arrhythmias
* Post-stroke status
* Known elevated intra-occular pressure
* Known enlarged prostates
* Participation in a clinical study within the past 30 days
* Participation in this study at an earlier point in time
* Simultaneous participation in another clinical trial
* Women of child-bearing age without adequate contraception
* Patients with terminal illness (e.g. cancer)
* Pregnancy (positive pregnancy test) or lactation period