cyrilzakka/clinical-trials huggingface dataset:
Metformin in Children and Adults With Fragile X Syndrome

Fragile X Syndrome (FXS) is caused by loss of FMR1 expression on the X chromosome that leads to increased mRNA translation, which results in hyperactivation of ERK (extracellular signal-regulated kinase) and mTORC1 (mechanistic target of rifampicin complex 1) signalling and consequently in synaptic dysfunction and neurological development. There is presently no cure for FXS. Recent studies suggest that metformin (a widely prescribed drug for type II diabetes in children and adults) which crosses the blood-brain barrier, corrects various neurological and behavioral FXS phenotypes by normalizing ERK signaling, EIF4E phosphorylation and lowering expression of MMP9 to normal. Since this drug has not been previously used specifically for treatment of FXS (only few cases reported), the investigators propose an open-label trial of metformin in children and adults with FXS to better understand the safety and efficacy in both behavior and cognition.


Eligibility Criteria:
Inclusion Criteria:

* Aged between 10 et 45 years old
* BMI \> 18.3
* Molecular diagnosis of FXS
* Accompanied by his legal tutor

Exclusion Criteria:

* Pregnancy/Breastfeeding
* Intolerance to metformin
* History of lactic acidosis
* Gastric/renal/hepatic pathology
* Acute medical condition
* Concomitant use of ACE inhibitors
* Modification of antipsychotic treatments in the last 6 weeks
Acute Sympotomatic Seizure Secondary to Autoimmune Encephalitis and Autoimmune-associated Epilepsy

Previously, scholars called the seizures secondary to autoimmune encephalitis（AE） "autoimmune related epilepsy", but the seizures secondary to AE are usually controlled after the improvement of encephalitis, which does not meet the "persistent" characteristics of epilepsy. Only a subset of patients with seizures lasting several years require long-term Antiseizure medications (ASM). In 2020, the International Coalition against Epilepsy classified it as "acute symptomatic seizure secondary to AE". ASSAE) and autoimmune-associated epilepsy (AAE) . The former is caused by AE, which has clinical manifestations of AE at the same time as epileptic seizures at the beginning or recurrence. The proportion and type of epileptic seizures are different due to different causes, and epileptic seizures are also controlled after the disease is controlled. The latter is that after adequate immunotherapy, there are still persistent seizures, and there is no obvious evidence of inflammatory activity, this type of patient application ASM and immunotherapy is not effective.

Secondly, with the deepening of AE research, gradually found that some AAE can still be ASMs cure, such as carbamazepine, ocasepine, lakaosamine. On the one hand, it works by influencing cellular and humoral immune responses. On the other hand, effectiveness of sodium channel blockers in focal epilepsy. Lacosamide is a slow sodium channel blocker that belongs to the third generation of ASM. It has a short half-life and can be quickly increased to an effective dose with a low incidence of adverse reactions. Therefore, the investigators chose to add oral antiepileptic therapy with lacosamide in AAE populations to observe efficacy and safety.


Eligibility Criteria:
Inclusion Criteria:

1. Confirmed autoimmune encephalitis (2016,Lancet);
2. Meet the classification criteria for epilepsy (2017,International League Against Epilepsy);
3. Patients who still have seizures after taking ASM after the control of AE disease were included in the third part of the study;
4. All patients volunteered and signed an informed consent form;

Exclusion Criteria:

1. Incomplete key clinical data;
2. People with epilepsy or other intracranial diseases before diagnosis;
3. There is no epileptic author during the onset of autoimmune encephalitis;
Study of Hispanics to Assess Risk Prevention in Prehypertension

The purpose of this study is to assess the efficacy of lifestyle modification in reducing blood pressure values in Hispanics at risk for hypertension.

In this study participants (who have prehypertension as defined as systolic blood pressure - the upper number- 130-139 mmHg and diastolic blood pressure 85-89mmHg- the lower number-) are randomly assigned to one of two groups:

the Minimal Intervention Group- participants receive advice and printed guidelines only but no counseling or personalized instruction, or the Enhanced Intervention Group- participants receive advice and the same printed guidelines as the minimal intervention group, together with dietary and physical activity counseling provided by a dietician and/or coordinator, periodic professional reviews of their progress and personalized instructions.

Eligibility Criteria:
Inclusion Criteria:

* Hispanic men and women age 18 or older
* Mean baseline SBP 130-139 mmHg and DBP 85-89 mmHg on screening visits 1\&2
* Subjects who have access to a telephone
* Subjects who have read, signed and received a copy of the informed consent form prior to the initiation of any study procedures and who agree to participate in all aspects of the study
* Subjects who are willing and capable of complying with the requirements of the study

Exclusion Criteria:

* BMI \> 35
* Pregnant or breast feeding
* Currently taking any anti-hypertensive medications
* History of cardiovascular disease (Stroke, MI, PCI, CABG)
* Current symptoms of angina or peripheral vascular disease by Rose questionnaire
* Fasting glucose ≥ 126mg/dl) or a history of diabetes and use of antidiabetic medication
* Use of oral corticosteroids \> 5days/month on average
* Consumption of more than 21 alcoholic drinks per week or consumption of 6 or more drinks on one occasion twice or more per week in the past 3 months prior to screening visit
* Use of weight loss medications (prescription or over the counter) in the past 3 months prior to screening visit 1 or body weight change \> 15 pounds in the 3 months prior to screening visit
* Currently undergoing or planning to undergo treatment for a neoplastic disease
* Clinical significant laboratory test results that are indicative of a serious medical condition
* Renal Insufficiency (GFR\<60ml/min as estimated using Cockcroft -Gault formula)
* Any orthopedic or rheumatologic problems that might limit a subject's ability to participate in the physical activity component of the intervention
* Any medical condition which in the judgment of the Investigator places the subject at risk due to his/her participation in the study, is likely to prevent the subject from complying with the requirements of the study or completing the study or which may jeopardize the evaluation of efficacy or safety
* Planning to leave area prior to the anticipated end of participation
* Current participation in another research study
Medical Clowning in the NICU (Neonatal Intensive Care Unit and Their Effects on Parents and Staff

The study will compare intervention by Infant Aquatics to infant massage. The intervention in both methods will start at 36 weeks gestational age for 3 months and will consist of sessions with a therapist every 2 weeks. Development will be assessed and compared at 3, 8 and 18 months using Infant Motor Pattern method, Griffith developmental scales and Vineland adaptive behavior scales.

Preterm infants, a continuously growing population, are at high risk for neurodevelopment impairments ranging from minor neurological dysfunction (MND) to cerebral palsy (CP), mainly due to developmental brain injury. Infant Aquatics have been found to benefit and promote infant development. The support and sensory stimulation of the water may improve the development the sensory, motor, as well as, autonomic system of preterm infants.

Eligibility Criteria:
Inclusion Criteria:

* neonates wherein their parents have expressed consent to participate in trail
* neonates with parents who are able to understand and fill in questioners
* neonates with no chromosomal deficiencies and no genetic deficiency

Exclusion Criteria:

* neonates with parents who are unable to understand and fill in questioners
* neonates with intraventricular bleeding IVH/PVH
* neonates with periventricular hemorrhage
* neonates with known chromosomal deficiencies or genetic deficiency
A Study to Assess if Mirikizumab is Effective and Safe Compared to Secukinumab and Placebo in Moderate to Severe Plaque Psoriasis (OASIS-2)

The reason for this study is to see how effective and safe mirikizumab is compared to secukinumab and placebo for moderate to severe plaque psoriasis.


Eligibility Criteria:
Inclusion Criteria:

* Participant must have chronic plaque psoriasis for at least 6 months.

Exclusion Criteria:

* Participant must not be breastfeeding or nursing woman.
* Participant must not have had serious, opportunistic, or chronic/recurring infection within 3 months.
* Participant must not have received a Bacillus Calmette-Guerin (BCG) vaccination within 12 months or received live vaccine(s) (including attenuated live vaccines) within 12 weeks of baseline or intend to receive either during the study.
* Participant must not have any other skin conditions (excluding psoriasis).
* Participant must not have previous exposure to Cosentyx and any other biologic therapy targeting IL-17 (including Taltz).
* Participant must not have received anti-tumor necrosis factor (TNF) biologics within 8 weeks.
* Participant must not have previous exposure to any biologic therapy targeting IL-23 (including Stelara).
Transcranial Direct Current Stimulation in Reducing Pain in Cancer Patients With Chemotherapy Induced Peripheral Neuropathy

This early phase I trial studies how well transcranial direct current stimulation works in reducing pain in cancer patients with chemotherapy induced peripheral neuropathy. Transcranial direct current stimulation is used for patients with brain injuries such as strokes as well as for mental health issues such as depression and may help to control pain in cancer patients with chemotherapy induced peripheral neuropathy.

PRIMARY OBJECTIVES:

I. To evaluate the efficacy of transcranial direct current stimulation (tDCS) in reducing chemotherapy induced painful peripheral neuropathy (CIPPN).

Ia. Evaluate the change in pain scores Ib. Assess for changes in other symptoms (i.e insomnia, feeling of well-being, depression and anxiety).

SECONDARY OBJECTIVES:

I. To evaluate the following with the treatment of tDCS:

Ia. Assess for changes in using pain medications. Ib. Assess for changes in functioning (daily activities). Ic. Assess for changes in quality of life. Id. Assess for changes in neuropathy. Ie. Assess overall satisfaction with the tDCS treatment.

TERTIARY OBJECTIVES:

I. To evaluate tDCS treatment related side-effects.

OUTLINE:

Patients undergo tDCS once daily (QD) over 20 minutes 5 days each week (Monday-Friday) for 3 weeks.

After completion of study treatment, patients are followed up weekly for 3 weeks and at 4-6 weeks.

Eligibility Criteria:
Inclusion:

* Age greater than or equal to 18 years.
* Able to give a Voluntary written consent.
* Cancer patients with chemotherapy induced peripheral neuropathy of at least 3 months duration..
* Pain and/or tingling of at least 4/10

Exclusion:

* History of seizure
* History of migraine headache
* History of brain cancer and/or brain metastasis
Laser Therapy on Hamstring Muscle Among Young Adults

A total of 154 healthy young individuals will be recruited by purposive sampling method to participate in a randomized, single-blinded, sham-controlled study. Recruited participants will be randomly dividing into two groups, the Active high-intensity laser therapy (a-HILT) group, and the Sham high-intensity laser therapy (s-HILT) group. The treatment duration will be 10 minutes per session on both lower limbs for each day for 3 days/week for 2 weeks. Hamstring muscle length will be assessed at baseline, end of the 2-week post-intervention period.


Eligibility Criteria:
Inclusion Criteria:

* Asymptomatic young adults
* Both gender
* Tightness of hamstring muscles

Exclusion Criteria:

* Any other musculoskeletal disorder
* Any disc pathology
* Any nerve root irritation
* Any surgical history or trauma
* Malignancy
* Pregnancy
* Sensory dysfunctions
* Cardiac pacemaker
TKI Followed by Thoracic Radiotherapy for Stage IV EGFR Mutant NSCLC

In this phase II trial with single arm, we aim to investigate the clinical efficacy and toxicity profile of local radiotherapy on all disease sites for EGFR-mutant oligo-metastatic NSCLC (no more than 3 metastatic lesions) who did not experience disease progression after at least 3 months of TKI therapy.

Tyrosine kinase inhibitor (TKI) has been widely accepted as the first-line therapy for stage IV NSCLC with active mutation of EGFR. Olio-metastasis is a disease status between localized and extended status of disease, namely with the limited number of lesions, which is generally defined as ≤ 5. A couple of phase II studies have shown that consolidation local management was able to prolong the local-regional tumor control and might further improve overall survival (OS) for oligo-metastatic NSCLC who have gained disease control from systemic therapy. However, there is lack of data regarding whether local radiotherapy (RT) could improve progression free survival (PFS) and OS for NSCLC with active EGFR mutation who have benefited from TKI. In this phase II trial with single arm, we aim to investigate the clinical efficacy and toxicity profile of local radiotherapy on all disease sites for EGFR-mutant oligo-metastatic NSCLC (no more than 3 metastatic lesions) who did not experience disease progression after at least 3 months of TKI therapy.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 and ≤75;
* ECOG performance status 0-1;
* Patients must provide study specific informed consent prior to study entry;
* Pathologically or cytologically diagnosed as NSCLC;
* EGFR activating mutation to TKI approved by histology, cytology or circulation tumor DNA;
* Stage IV NSCLC with ≤ 3 metastatic lesions (AJCC, 8th ed.) confirmed by meticulous radiographic examination. Brain MRI and 18F PET/CT is strongly recommended unless there is a contraindication;
* Patients have received≥3 months of TKI therapy and do not received disease progression;
* HB ≥ 10.0 g/dL;
* Absolute number of neutrophil granulocyte ≥ 1.5 × 109/L;
* Absolute number of PLT ≥ 100 × 109/L;
* Total bilirubin ≤ 1.5 folds of the maximum extent;
* ALT and AST ≤ 2.0 folds of the maximum extent;
* Cr ≤ 1.25 folds of the maximum extent and Ccr ≥ 60mLl/min.

Exclusion Criteria:

* Patients have received thoracic radiotherapy before;
* Malignant pleural effusion, pericardial effusion or peritoneal effusion;
* Patients have severe pulmonary comorbidity, such as ILD, COPD or other active pulmonary disease;
* Any unstable systemic disease including active infection, uncontrolled hypertension, unstable angina, CHF (NYHA ≥ II), MI within 6 months of enrollment, severe arrhythmia requiring medication，hepatic, nephric or metabolic disease;
* HIV infection；
* Pregnancy or lactation women;
* ECOG status ≥2；
* Mixed SCLC component;
* Other factors that is considered ineligible.
CPAP Effect on Vascular Function in Obstructive Sleep Apnea

Obstructive sleep apnea syndrome is responsible of endothelial dysfunction, which is a independent cardio-vascular risk factor.

Assessment of pulse wave velocity (PWV) and peripheral arterial tone (PAT) are study measurements of arterial stiffness, and are strong predictors of late cardiovascular events.

This study will compare long term evolution in arterial stiffness (PWV) and endothelial dysfunction (PAT) for patients treated by Positive Airway Pressure Therapies.

Obstructive sleep apnea (OSA) syndrome is responsible of vascular damage. Intermittent hypoxia causes oxidative stress and low-grade inflammation. By the way of increased sympathetic outflow, it's resulting endothelial dysfunction, atherosclerosis and an increase of arterial stiffness.

Finally these mechanisms are responsible of cardiovascular comorbidities: hypertension, cardiac arrhythmias or Left ventricular dysfunction. This patients presented coronary diseases or Strokes.

OSA characterized by intermittent hypoxia, is associated with atherosclerosis and vascular inflammation. Polymorphonuclear leukocytes (PMNs) are implicated in vascular inflammation by producing oxidizing radicals and proteolytic enzymes during PMN-endothelium interactions.

Reactive oxygen species (ROS) production is increased in activated cells and after attachment, PMNs release additional ROS inducing endothelial cell injury.

Continuous positive airway pressure (CPAP) is the current "gold standard" treatment for OSA, Use of CPAP restored the respiratory flow, prevents nocturnal respiratory events and daytime symptoms.

Arterial stiffness and endothelial dysfunction are linked to obstructive sleep apnea severity with a dose-effect relationship. And meta-analyse showed significant improvements in all indices of arterial stiffness after CPAP treatment in patients with OSA.

Assessment of pulse wave velocity and peripheral arterial tone are study measurements of arterial stiffness. And are strong predictors of late cardiovascular events

The investigators will compare long term evolution in arterial stiffness (PWV) and endothelial dysfunction (Peripheral arterial tone) for patients with OSA treated by Positive Airway Pressure Therapies.

Eligibility Criteria:
Inclusion Criteria:

* Any patient with a initial visit there is 4-7 years for the VNI-SOH protocol (Réf CPP Sud-Est V: 38/2006/2)
* Male or female patient, aged 20-75 years at the initial visit there is 4 to 7 years;
* Patients with a BMI\> 30kg / m2 at diagnostic;
* Patient affiliated to a social security;
* Having given its written consent to participate in the study.

Exclusion Criteria:

* Person private of liberty by judicial or administrative decision, person under legal protection measure (pregnant or nursing, patient under guardianship) Article L1121-8
* Exclusion period for further studies
* Patient died or lost sight since the initial visit there 4-7 years
Hand Driven Versus Motor Driven Hysteroscopic Tissue Removal System for Polypectomy: Long-term Results

In this study, a comparison is made between two types of polyp resection methods (hand driven and motor driven morcellation). More specifically, the effects of the resection on symptoms such as abnormal uterine bleeding, and on the recurrence of polyps.

The aim of the study is to find a superior method in terms of symptom relieve and polyp recurrence so this method can be used in gynaecological practice.

* Rationale: several techniques for hysteroscopic removal of intrauterine polyps exist today. Hysteroscopic morcellation is an effective, fast, and safe method for this. However, the differences between two different systems of hysteroscopic morcellation, motor-driven (Truclear incisor mini device) and hand-driven (Resectr 9fr) morcellation, are still unclear. The REMOvE9 study, in which women with a polyp were randomized between both techniques, is currently investigating the differences in short-term effectiveness between the two techniques.
* Research question/goal: To investigate the long-term results of the effectiveness of a hysteroscopic morcellation of intrauterine polyps. The two systems are compared with each other.
* Study design: This is a prospective cohort study. The patients previously participated in a randomized controlled trial (REMOvE9) and will now be contacted again for the completion of a one-time questionnaire. The study has an observational design.
* Study population: Women with a history of endometrial polyp that was previously removed via hysteroscopic morcellation in the REMOvE9 study.
* Primary and secondary endpoints: The primary endpoint is the risk of recurrence of abnormal uterine bleeding at post-surgery follow-up. Secondary endpoints include recurrence of other symptoms, time to recurrence, symptom relief, onset of new symptoms, onset of new polyp, satisfaction with regards to symptoms, satisfaction with regards to the treatment in general, need for additional treatments for blood loss and occurrence of pregnancy (in subfertility group).

Eligibility Criteria:
Inclusion Criteria:

* participation in earlier study

Exclusion Criteria:

* N/A
RSA - ACTIS Hip Stem

The principal objective of this study is to compare mean 2-year subsidence of the ACTIS femoral stem using model-based RSA against published migration patterns for hip stems of a similar design. Secondary objectives include comparison of migration per surgical approach, quantifying changes in functional and health status of subjects following surgery, and assess occurrences of complications and adverse events.

This is a multi-centre, sequential enrollment trial of patients undergoing primary total hip arthroplasty. Patients will be recruited at three Canadian Centres to receive the ACTIS femoral hip stem via 3 different surgical approaches.

Model-based RSA will identify migration of the implant with respect to the femoral bone during the first 2 post-operative years. Patient health and functional outcomes will be recorded at pre- and post-operative intervals to quantify improvement as a result of the surgery and trajectory of recovery. Adverse events and clinical complications in each study group will be captured and compared. Select surgical, hospital and rehabilitation data will be collected to measure health economic outcomes relating to the surgery.

Eligibility Criteria:
Inclusion Criteria:

* Symptomatic osteoarthritis of the hip indicating primary total hip arthroplasty
* Aged 21 years or older
* Patients willing and able to comply with follow-up requirements and self-evaluations
* Ability to give informed consent
* Body mass index ≤45 kg/m2

Exclusion Criteria

* Active or prior infection
* Medical condition precluding major surgery
* Medical condition with less than 2 years life expectancy
* Overhanging pannus (for anterior approach cohort only)
* Prior surgery of the hip involving implantation of hardware (i.e., hemiarthroplasty, internal fixation, pelvic reconstruction near the acetabulum requiring removal)
* Skin condition on the area of incision
* Multi-level lumbar spine fusion
* Ankylosing spondylolithesis
* Shortening osteotomy through the femur
Docetaxel in Combination With GVAX ® Immunotherapy Versus Docetaxel and Prednisone in Prostate Cancer Patients

The primary objective of this study is to compare the duration of survival between patients receiving docetaxel in combination with the GVAX® vaccine for prostate cancer versus patients receiving docetaxel and prednisone treatment in patients with prostate cancer who no longer respond to hormone therapy, who have documented metastases with pain. Patients may have had up to one prior non-taxane chemotherapy treatment.


Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of or clinical history consistent with adenocarcinoma of the prostate
* Metastatic prostate cancer deemed to be unresponsive or refractory to hormone therapy
* Detectable metastases
* ECOG performance status ≤2 (Performance status of 3 if due to bone pain)
* Any Gleason score
* Only one prior treatment with systemic chemotherapy
* No prior treatment with gene therapy
* No prior immunotherapy for prostate cancer
* Taxane naïve
* Experiencing cancer-related pain