cyrilzakka/clinical-trials huggingface dataset:
The Cognitive Enhancing Effects of D-Cycloserine Among Non-Demented Elderly

The goal of this study is to determine whether a study medication (d-cycloserine) improves the ability of older adults to perform on tests of neuropsychological functioning. Tests of neuropsychological functioning assess attention, memory, and executive functioning skills (for example, problem-solving, planning and organizing skills). It was hypothesized that participants who received study medication would perform better on neuropsychological tests than would participants who received the sugar pill.

Accumulating data support the augmenting effects of d-cycloserine (DCS) when combined with exposure-based treatment for anxiety disorders. Additional research is needed to determine whether DCS facilitates other forms of cognitive processing (e.g., attention, memory, executive functioning) that are involved in cognitive behavioral therapies which do not rely on extinction as a mechanism of action. This question is particularly important among older adults who have experienced normal age-related declines in cognitive functioning, which may interfere with their ability to benefit from cognitive-behavioral therapies. The aim of the current study was to determine the cognitive enhancing effects of DCS on neuropsychological test performance among healthy older adults. It was hypothesized that participants who received d-cycloserine would demonstrate superior performance on neuropsychological tests than would participants who received placebo.

Eligibility Criteria:
Inclusion Criteria:

* age 60 or older
* native English speaker

Exclusion Criteria:

* diagnosis of current psychiatric disorder
* substance abuse past 3 months
* cognitive impairment
* neurological disorder
* poor health or unstable medical condition
* positive toxicology screen
* current use of isoniazid
* current use of trecator
* severe renal insufficiency
Whole-Body Vibration Versus Kineso Tape on Nerve Conduction in Patient With Diabetic Peripheral Neuropathy

The purpose of the study was to compare between effect of whole-body vibration and kineso tape on nerve conduction in patients with diabetic peripheral neuropathy.

Diabetes is a huge and rapidly growing health problem worldwide. In 2019, International Diabetes Federation ( IDF) estimated that the number of people with diabetes was 463 million and expected to be 578 million by 2030, and 700 million by 2045. Two-thirds of people with diabetes live in urban areas, and one in five people with diabetes is above 65 year.

Diabetic peripheral neuropathy is the most prevalent complication of diabetes mellitus. The prevalence of DPN ranges from 21.3 to 34.5% in type 2 DM (T2DM) and between seven to 34.2% in type 1 DM (T1DM).

The high incidence and prevalence of falls among older people with type 2 diabetes mellitus were identified as poor diabetic control, diabetic peripheral neuropathy (DPN) and balance impairment.

Study performed by Ahmed et al., reported that Kinesio tape and resistive exercise improve the dorsiflexors and functional performance in diabetic polyneuropathy.

A randomized controlled trial showed that WBV showed beneficial effects on pain, balance, and quality of life in patients with painful Diabetic peripheral neuropathy.

But till know no study reported us whole body vibration better than kineso or vice versa.

Eligibility Criteria:
Inclusion Criteria:

* Patients type 2 diabetes with duration at least 10 years.
* Controlled blood glucose level examined via glycated hemoglobin exam (hba1cless than 9 and more than 6.5).
* Age of patient will range from 50 to 60 years.
* Patients had abnormal nerve conduction study.

Exclusion Criteria:

* Patients having ulceration/infection of feet
* Medical/Surgical conditions limiting functional mobility
* Non-ambulatory patients
* Who are not willing to participate?
* Subjects with Type 1 Diabetes mellitus.
* Subjects with Gestational Diabetes.
* Subjects who are seriously ill.
* Lower limb fracture or trauma
* Significant renal hepatic disorder
Evaluation of a Lopinavir/Ritonavir Monotherapy vs a Triple Therapy as Maintenance Regimens in HIV-1 Infected Patients

A 2-year multicenter, phase II/III, randomized active-controlled trial to evaluate the efficacy and tolerance of two maintenance strategies in HIV-1 infected patients with HIV RNA below 50 copies/mL : a monotherapy with lopinavir/ritonavir or a single-tablet triple therapy (EFV/FTC/TDF).

Today, one of the challenges of HIV treatment is to overcome side effects and toxicity of long term antiretroviral therapy. A promising approach may be the simplification of treatment maintenance strategies, sparing certain antiretroviral drug classes. This is a two-year prospective phase II/III, multicenter randomized trial to evaluate the efficacy and tolerance of a lopinavir/ritonavir monotherapy as a maintenance regimen in HIV-infected adults. Enrolled patients must have had stable antiretroviral treatment and HIV-1 RNA below 50 cp/mL over the previous 12 months, and no prior treatment failure. Provided informed consent, 420 patients are randomized in a 1:1 ratio to two open-label treatment groups and receive either lopinavir/r 800/200mg per day or EFV/FTC/TDF 600/200/245 mg per day (fixed dose combination). The main objective is to assess treatment efficacy and tolerance after 2 years. In 80 patients, repeated DEXA measurements are performed during the trial in order to evaluate changes in bone mineral density and in body composition.

Eligibility Criteria:
Inclusion Criteria:

* Confirmed HIV-1 infection
* Stable antiretroviral treatment over 6 months
* HIV-1 RNA \< 50 cp/mL for at least 12 months
* Lymphocytes CD4+ \> 200/mm3
* Lymphocytes CD4+ nadir \> 100/mm3
* Absence of prior treatment failure (defined by two successive HIV-1 RNA ≥ 50 cp/mL under NNRTI or PI treatment)
* Absence of documentation of a mutation conferring NRTI or NNRTI resistance or a primary mutation in the protease gene
* Written informed consent
* Patient affiliated to a social security scheme

Exclusion Criteria:

* Woman of child bearing potential without efficient contraception
* Pregnant or breastfeeding woman
* HBV infection (HbS Ag+)
* HBC infection requiring specific treatment during the trial
* Liver cirrhosis Child-Pugh C
* HIV-1/HIV-2 Co-infection or isolated HIV-2 infection
* Ongoing interleukin or interferon treatment
* Co-administration of contraindicated treatments
* Hypersensibility to efavirenz or lopinavir/r
* Absolute neutrophil count \< 750/mm3, hemoglobin \< 8g/dL, platelets \< 60.000/mm3, creatinine clearance \< 50 mL/min, ASAT, ALAT, lipase, alkaline phosphatase or total bilirubin \> 3 ULN, CD4 nadir \< 100/mm3.
* Participation in another clinical trial interfering with the study drug assignment in DREAM
* Subject under legal guardianship or incapacitation
Evaluation of the Diagnostic Contribution of High-throughput Exome Sequencing for Patients With Convulsive Encephalopathy of Unknown Etiology: Pilot Study to Improve Genetic Counselling

Congenital epileptic encephalopathies (EE) are predominantly genetic in origin. Their diagnosis is hampered by the large number of genes involved and their low recurrence. Genetic study in routine diagnosis is limited by the existing techniques and the development costs. The routine diagnostic implementation of high throughput sequencing pushes these limits. High throughput exome sequencing (ES) showed superior diagnostic performance in all diagnostic settings studied.

This pilot study is dedicated to evaluating the diagnostic performance of high throughput ES in EE, with an implementation and analysis strategy allowing for a direct transfer to routine diagnostics. This novel approach should improve the diagnostic rate while reducing the diagnostic cost per patient.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of epileptic encephalopathy, defined by the clinical association of epilepsy and a significant delay in acquisition
* Family case with recurrence in siblings, suggesting autosomal recessive transmission or X-linked inheritance (with or without parental consanguinity), or sporadic case resulting from inbreeding.
* Lack of etiologic orientation based on clinical examination.
* Normal routine diagnostic genetic examinations including a metabolic check-up, array CGH analysis.
* Brain imaging which does not suggest an acquired cause.

Exclusion Criteria:

* Unavailable parental samples
* Diagnostic orientation from one of the tests mentioned above
* Brain imaging suggesting anoxia sequelae
Lifting and Tightening of the Face and Neck Following an Increased Density Treatment

The purpose of this study is to evaluate the Ulthera® System for obtaining lift and tightening of the cheek tissue, reduction of jowling, and improving jawline definition and/or submental skin laxity when increased density treatment is applied.

All enrolled study subjects will receive one full face and neck Ultherapy™ treatment. Pre- and post-treatment photos will be taken. Subjects will be required to return for follow-up visits at 60 days, 90 days, 180 days and 1 year following treatment.

Eligibility Criteria:
Inclusion Criteria:

* Male or female, aged 30 to 65 years
* Subject in good health
* Desires lift and tightening of cheek tissue, reduction of jowling, improvement of jawline definition and/or submental skin laxity
* Understands and accepts the obligation not to undergo any other procedures in the areas to be treated through the followup period
* Willingness and ability to comply with protocol requirements, including returning for follow-up visits and abstaining from exclusionary procedures for the duration of the study

Exclusion Criteria:

* Presence of an active systemic or local skin disease that may affect wound healing
* Severe solar elastosis
* Excessive subcutaneous fat on the cheeks
* Excessive skin laxity on the lower face and neck
* Significant scarring in areas to be treated
* Significant open facial wounds or lesions
* Severe or cystic acne on the face
* Presence of a metal stent or implant in the facial area to be treated, a pacemaker, or cochlear implants
Primary Infection Cohort

Open, prospective, multicenter French cohort study enrolling subjects aged of 15 years or more, during or immediately after HIV-1 primary infection. This cohort was organized from the outset to be highly multidisciplinary, bringing together immunologists, virologists, clinicians and epidemiologists.

Objectives: Follow up of patients infected by HIV-1 for less than three months.

1. Improve the physiological and pathological knowledge of primary HIV infection

   * Study of the immune mechanisms involved early after infection
   * Kinetics of viral replication and establishment of cellular reservoirs at an early stage
   * Relationships between virological markers and immune response kinetics
   * Impact of resistance mutations, subtype and tropism on the disease progression and the response to treatment
   * Study of sub-groups of specific patients followed since primary infection, spontaneous or post treatment controllers, subjects with specific HLA
2. Assessing the impact of early, transient or prolonged treatment versus deferred treatment on the long-term prognosis of patients followed since primary infection, in terms of activation / inflammation and decrease in viral reservoirs
3. Contribute to knowledge in the epidemiology of HIV infection:

   * Modes of transmission
   * Sexual behavior after HIV diagnosis
   * Calendar trend of transmitted viral strains diversity (ARV resistance and subtypes)
   * Calendar trend of marker levels measured at primary infection
4. Contribute to national recommendations for therapeutic care, evaluate their implementation
5. Use observational data from the cohort for the development of therapeutic clinical trials at primary infection

Eligibility Criteria:
Inclusion Criteria:

* symptomatic or asymptomatic HIV-1 primary infection.
* Infection date based on one of the following criteria:

  1. Positive p24 antigenemia or detectable plasma HIV RNA with a negative ELISA within the previous six weeks.
  2. Positive p24 antigenemia or detectable plasma HIV RNA with a positive ELISA and negative Western Blot within the previous six weeks.
  3. Positive p24 antigenemia or detectable plasma HIV RNA or positive ELISA with incompleted Western Blot (no anti-p34 and/or anti-p68) within the previous six weeks.
  4. Positive ELISA with a negative ELISA within the last three months.
* Age≥ 15 years old at the enrollment.
* Naive of antiretroviral treatment except for transient treatment taken in the context of PMTCT, Pre-exposition prophylaxis or Post Exposition Prophylaxis.
* Affiliate or beneficiary of a social security system (State Medical Assistance is not a social security scheme).

Exclusion Criteria:

* Inability to give informed consent.
* Predictable difficult follow-up.
* Contraindication to repeated blood samples.
* Under protection (saving) of justice
* Life-threatening pathology (deferred inclusion is possible)
A Study of Patient Perception and Quality of Life Associated With the Use of Olopatadine 0.2% in Subjects With Allergic Conjunctivitis

The purpose of this study was to evaluate subject perceptions of Olopatadine 0.2%, dosed once-daily, in subjects with allergic conjunctivitis and to record any adverse events as described by the subjects as a part of this post marketing surveillance study.


Eligibility Criteria:
Inclusion Criteria:

* History (within the past 24 months) of allergic conjunctivitis.
* Willing to avoid contact lens wear for each of the study visits, immediately prior to study medication installation and for 10 minutes after installation of study drug.
* Contact lens wear should be stable and consistent for 3 months prior to Screening Visit (Day 1).
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* Contraindications or hypersensitivity to the use of the study medication or its components.
* Inability or unwillingness to follow all study instructions and complete study visits as required.
* Subjects with only one sighted eye or not correctable (using ETDRS chart) to 0.6 log MAR or better in both eyes at the Screening Visit.
* A known history of recurrent corneal erosion syndrome (idiopathic or secondary to dry eye).
* Ocular trauma within six months prior to Visit 1 in either eye as determined by subject history and/or examination.
* Other protocol-defined exclusion criteria may apply.
Comparison of Clinical Performance of Two Monthly Replacement Toric Soft Contact Lenses

The purpose of this study is to assess the clinical performance of TOTAL30 for Astigmatism (T30fA) soft contact lenses with Biofinity Toric soft contact lenses.

Subjects will be expected to attend 5 office visits and will be dispensed study lenses (per randomization sequence) for 30-day duration of bilateral wear with each study lens (approximately 60 days of lens wear). The total duration of the subject's participation in the study will be approximately 74 days.

Eligibility Criteria:
Key Inclusion Criteria:

* Successful wearer of toric soft contact lenses in both eyes for a minimum of 5 days per week and at least 12 hours per day during the past 3 months;
* Best corrected distance visual acuity (as determined by manifest refraction at screening) better than or equal to 0.10 logMAR in each eye;
* Willing and able to wear the study lenses as specified in the protocol;
* Other protocol-specified inclusion criteria may apply.

Key Exclusion Criteria:

* Biomicroscopy findings at screening that are moderate (Grade 3) or higher and/or corneal vascularization that is mild (Grade 2) or higher; presence of corneal infiltrates;
* Monovision and multifocal contact lens wearers;
* Habitual Biofinity Toric soft contact lens wearers, daily disposable contact lens wearers, and Alcon Toric contact lens wearers in the past 3 months prior to consent;
* Wearing habitual contact lenses in extended wear modality (routinely sleeping in lenses for at least 1 night per week) over the last 3 months prior to enrollment;
* Other protocol-specified exclusion criteria may apply.
Post Marketing Surveillance on Safety Evaluation of POMALYST® (Pomalidomide) Treatment of Multiple Myeloma in Korea

PMS period: 09Jun2017 \~ 08Jun2023 Target no.: 600patients

indication: POMALYST in combination with dexamethasone is indicated in the treatment of patients with relapsed and refractory multiple myeloma who have received at least two prior treatment regimens, including both lenalidomide and bortezomib

The primary objective of this Drug Use Examination (DUE) is to evaluate safety of POMALYST® (Pomalidomide) treatment of multiple myeloma in the clinical routine practice in Korea.

The secondary objective of this DUE is to evaluate effectiveness of POMALYST® (Pomalidomide) treatment of multiple myeloma in the clinical routine practice in Korea.


Eligibility Criteria:
Inclusion Criteria:

The main criteria for inclusion of this DUE is the same as the approved package insert of POMALYST® in Korea. Based on the current PI, patients who are treated with POMALYST® based on the following criteria, can be registered into this DUE.

* POMALYST® in combination with dexamethasone is indicated in the treatment of patients with relapsed and refractory multiple myeloma who have received at least two prior treatment regimens, including both lenalidomide and bortezomib.

The actual inclusion criteria and patient population who can start with POMALYST® treatment will be narrowed down according to the local health insurance reimbursement condition.

Exclusion Criteria:

* There's no exclusion criteria
Impact of a Strategy Based on Bacterial DNA Detection to Optimize Antibiotics in Patients With Hospital-acquired Pneumonia

VAPERO is a randomized, unblinded, controlled study to measure the impact of a strategy based on the Unyvero® multiplex PCR test on the adjustment of antimicrobial therapy in patients suspected with ventilator-associated or hospital-acquired pneumonia (VAP/HAP) requiring mechanical ventilation. The gold-standard microbiological diagnostic method for pneumonia in the ICU is still culture-based identification and antimicrobial susceptibility testing (AST) despite being more than a hundred years old, with results turnaround time spanning over several days, exposing patients to potentially inappropriate broad-spectrum antimicrobial therapy. The investigators aim to measure the impact of the Unyvero® testing strategy to improve the percentage of patients with VAP or HAP receiving early targeted antimicrobial therapy compared to standard care.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients hospitalized in the ICU
* suspected with VAP or HAP requiring MV

Exclusion Criteria:

* Severe immunodeficiency
* Moribund patients (SAPS II \> 90)
INVESTIGATING THE EFFECTS SACROILIAC JOINT DYSFUNCTION ON GAIT IN INDIVIDUALS WITH BACK PAIN

Sacroiliac joint dysfunction (SJD) is a common problem in individuals with lumbar herniation nucleus pulposus (LHNP) plus back pain. It is important to determine the effects of SJD on the gait characteristics in individuals with LHNP.Twelve individuals with LHNP (control group) and six individuals with LHNP plus SJD (study group) will be the participants of the study. Gait characteristics of participants will be evaluate with treadmill. Participants will walk at their self-selected speed for six minutes and data from 2nd minutes to 4th minutes were selected for statistical analyses. Gait speed, cadance, step lengths, time on each foot and step length variabilities will be recorded.

Sacroiliac joint dysfunction (SJD) is a common problem in individuals with lumbar herniation nucleus pulposus (LHNP) plus back pain. It is important to determine the effects of SJD on the gait characteristics in individuals with LHNP.Twelve individuals with LHNP (control group) and six individuals with LHNP plus SJD (study group) will be the participants of the study. Gait characteristics of participants will be evaluate with treadmill. Participants will walk at their self-selected speed for six minutes and data from 2nd minutes to 4th minutes were selected for statistical analyses. Gait speed, cadance, step lengths, time on each foot and step length variabilities will be record

Eligibility Criteria:
Inclusion Criteria:

Have current back pain Have Lumbar Disc Herniation diagnosis Have sacroiliac dysfunction

Exclusion Criteria:

Do not want to participate Have another systemic, neurologic or orthopedic problem
A Preliminary Study of Model-driven Individualized Transcranial Electrical Stimulation for Insomnia

This study is designed to evaluate the efficacy and to explore the best individualized stimulus paradigm of transcranial Electrical Stimulation for insomnia patients.

Twelve insomnia patients in Shanghai Mental Health Center who met the inclusion criteria will be recruited for transcranial electrical stimulation intervention. According to the patients' magnetic resonance structure and high density eeg parameters, personalized modeling was carried out to determine the specific stimulus parameter scheme.The stimulation will be performed for 2 weeks, once a night on weekdays, 10 times in total, and each stimulation will last for 20 minutes. Sleep rhythms will be recorded using a wearable device. Symptom assessment, magnetic resonance and high-density eeg data will be taken after the stimulation, and again 1 week after the stimulation.If the treatment is effective or clinical remission is achieved, the next cycle of stimulation will not be performed; If the treatment does not work, the patients choose to end the study or conduct modeling again to adjust the parameters and continue the next cycle of stimulation according to their wishes. For patients who choose to continue stimulation, the stimulation time of each cycle is still 2 weeks, once every night on weekdays, 10 times in total for each cycle, lasting 20 minutes each time. Each patient received up to four cycles of stimulation.

Eligibility Criteria:
Inclusion Criteria:

* Between 18 and 50 years old;

  * The patients were diagnosed as insomnia according to the diagnostic and Statistical Manual of Mental Disorders (DSM-5) and Mini-International Neuropsychiatric Interview (M.I.N.I.) .

    * No psychiatric drugs were taken within 8 weeks before enrollment; ④ Junior high school education or above.

Exclusion Criteria:

* Past or current DSM-5 diagnoses other than insomnia, anxiety disorder and depressive disorder

  * Severe anxiety or depression (HAMD-17 \> 23 points or HAMA \> 30 points)

    * Patients with obstructive sleep apnea syndrome;

      * Participants with claustrophobic, heart pacemaker, mechanical heart valve, mechanical implant such as an aneurysm clip, hip replacement, or any other pieces of metal that have accidentally entered their body.

        * Previous history of neurological diseases (such as epilepsy, cerebrovascular accidents, etc.) or brain trauma, brain surgery; ⑥Have received ECT, rTMS, tES, or cognitive behavioral therapy for insomnia; ⑦Any current significant medical condition. ⑧Women who are pregnant or planning to become pregnant recently
A Trial to Study Neladenoson Bialanate Over 20 Weeks in Patients With Chronic Heart Failure With Reduced Ejection Fraction

The objective of the study is to find the optimal dose of once daily oral neladenoson bialanate (BAY 1067197) when given in addition to standard therapy for heart failure with reduced ejection fraction (HFrEF).


Eligibility Criteria:
Inclusion Criteria:

* Men or women aged 18 years and older
* Diagnosis of chronic heart failure (CHF), NYHA ( New York Heart Association ) class II-IV, LVEF ≤ 35% and elevated NT-proBNP

Exclusion Criteria:

* Acute de-novo heart failure
* Requirement of any intravenous (IV) treatments following 48 hours prior to randomization
* Mechanical support (e.g. intra-aortic balloon pump, endotracheal intubation, mechanical ventilation, or any ventricular assist device)
* Any cause of chronic heart failure other than ischemic cardiomyopathy and idiopathic dilated cardiomyopathy