cyrilzakka/clinical-trials huggingface dataset:
Remediation of Emotional Processing Deficits in MS

This study will test the effectiveness of an emotional processing intervention in individuals with MS in a double blind placebo controlled randomized clinical trial. We will utilize an intervention which has been successfully used in other populations, including Schizophrenia and Traumatic Brain Injury. Our pilot data shows that this intervention is effective in individuals with MS as well

This study will test the effectiveness of an emotional processing intervention in individuals with MS in a double blind placebo controlled randomized clinical trial RCT). We will utilize an intervention which has been successfully used in other populations, including Schizophrenia and Traumatic Brain Injury. Our pilot data shows that this intervention is effective in individuals with MS, as well.

All participants will undergo a baseline evaluation assessing emotional processing abilities, cognitive functioning, and psychological functioning. Participants will then be randomized into two groups. During the treatment phase, the experimental group will receive the proposed intervention while the control group will receive a "placebo" treatment. Neuropsychological assessment will be repeated at the end of the intervention.

Eligibility Criteria:
Inclusion Criteria:

* between the ages of 18-65.
* diagnosis of Relapsing-Remitting Multiple Sclerosis.
* can read and speak English fluently.

Exclusion Criteria:

* history of prior stroke or other neurological disease or injury.
* history of significant psychiatric illness (for example, bipolar disorder, schizophrenia, or psychosis) or a current diagnosis of Major Depressive Disorder, Schizophrenia, Epilepsy, Bipolar Disorder.
* significant alcohol or drug abuse history.
Endometrial Biopsy Prior to IVF in Those Patients With Prior Implantation Failure

This proposed research is a single center, prospective, single-blinded, randomized controlled trial, designed to evaluate IVF pregnancy outcomes following endometrial injury in 254 patients with implantation failure. Patients will be identified during their work-up and treatment at Shady Grove Fertility Reproductive Science Center. Only Shady Grove patients are eligible for the study. The investigators hypothesize in patients with one or more previous failed day 5 blastocyst transfers, injury to the endometrium via endometrial biopsy will improve clinical pregnancy outcomes compared to controls.

Despite advances in assisted reproductive technologies; implantation failure in patients undergoing in-vitro fertilization (IVF) is frequent. Unfortunately, few treatments exist except for the use of a gestational carrier. There have been a number of recent clinical studies demonstrating that local injury to the endometrium results in improved clinical pregnancy outcomes for patients with a history of implantation failure. However, not all studies have shown a beneficial effect, and those demonstrating benefit have been limited by small sample sizes, and considerable heterogeneity in the procedures and populations evaluated. A recent meta-analysis synthesized the available data concluded that a large, prospective, well-designed randomized trial is desperately needed to definitively assess this new possible treatment. If these preliminary findings from previous trials are confirmed, this practice could be applied in the clinical setting to help patients suffering from repeated implantation failures.

Eligibility Criteria:
Inclusion Criteria:

* Women age 18-37
* One or more previous implantation failures with autologous fresh or frozen blastocyst transfer
* Undergoing fresh autologous IVF cycle
* No other current uterine (i.e.: uterine fibroids, polyps), hematologic, or genetic causes for infertility and implantation failure
* One or more good quality blastocyst(s) available for transfer

Exclusion Criteria:

* Those unable to comprehend the investigational nature of the proposed study
* Positive pregnancy test
* Possible causes for impaired implantation (systemic disease, endometriosis, ultrasound evidence of current hydrosalpinx, uterine polyps, uterine myomas (fibroids), uterine cavity malformations or Asherman's syndrome)
* Poor responders, defined as FSH \>12 on day 3 or less than 4 follicles on a previous IVF cycle
* BMI \>30 or \<18
Fructosamines and Gestational Diabetes (FRUCTO)

The prevalence of gestational diabetes is estimated at between 2 and 6%, but can be much higher in specific populations.

The specific treatment of gestational diabetes (diet, control weight gain, self monitoring glucose , insulin therapy) reduces complications severe perinatal, fetal macrosomia, and preeclampsia compared with abstention therapy, without additional risk of caesarean section.

Several early studies have shown that the determination of fructosamine is a very bad way of diagnosis for Gestational Diabetes. However, few studies have investigated the relationship between the determination of serum fructosamine and put under insulin in case of Gestational Diabetes.

The purpose of this study is to determine if serum fructosamines rate can be a predictive marker of the starting insulin at the patients suffering from Gestational Diabetes


Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years
* Ongoing pregnancy with a start date of pregnancy known and confirmed by an ultrasound of the 1st Quarter performed between 10 and 14 weeks with measurement of the crown-rump length
* Hospitalization for a GD's discovery whatever the term of pregnancy (GD is defined with nationals recommendations of CNGOF)
* Not opposed to participate in the study

Exclusion Criteria:

* Pregnancy uncertain term (absence of early ultrasound)
* Previous diabetes to the pregnancy (type 1 or 2)
* Multiple Pregnancy
* No affiliation to a social security scheme
* Woman with a measure of legal protection
Effects of Exercise on Markers of Inflammation in Skeletal Muscle in Elderly Hip Fracture Patients

Decreased skeletal muscle mass is a prevalent condition among the elderly, and an important cause of disability and functional decline. The declines in muscle mass associated with aging may be related to alterations in specific kinds of growth factors in the muscle. Elderly hip fracture patients often have significant decreases in muscle mass. The purpose of this study is to investigate whether an exercise program can induce changes in muscle growth factors that are associated with increases in muscle mass and strength in elderly hip fracture patients.


Eligibility Criteria:
Inclusion Criteria:

* Enrollment in HSC protocol #97-0695 "Rehabilitation Intensification Post Hip Fracture"
* Community-dwelling
* Hip fracture within 16 weeks of the screening assessment for protocol 97-0695
* Persistent mobility and/or ADL impairments, but independent in ambulation
* Modified Physical Performance Test (PPT) score between 12 and 28
Renal Impairment Study of PF-06700841

The purpose of this study is to characterize the effect of kidney impairment on the blood concentrations of PF-06700841 and its major metabolite. Findings from this study will be used to develop dosing recommendations so that the dose and/or dosing interval may be adjusted appropriately in the presence of kidney disease.

This is a Phase 1 non-randomized, open-label, parallel cohort, multi-site study to investigate the effect of renal impairment on the pharmacokinetics, safety and tolerability of PF-06700841 after a single oral dose of 30 mg. Subjects will be selected and categorized into normal renal function or renal impairment groups based on their estimated glomerular filtration rate. Part 1: A total of approximately 16 subjects will be enrolled; approximately 8 subjects with severe renal impairment and approximately 8 with normal renal function. After statistical evaluation of results from Part 1, Part 2 may be conducted with approximately 8 subjects each with moderate and mild renal impairment. The total duration of participation from Screening visit to Day 4 will be a maximum of 32 days and from Screening visit to Follow-up/Contact Visit will a maximum of 67 days.

Eligibility Criteria:
Inclusion Criteria:

* Male or female participants who are between the ages of 18 and 75 years, inclusive, at the Screening visit.
* Body mass index (BMI) of ≥17.5 to ≤40 kg/m2; and a total body weight \>50 kg.
* Normal, Severe, Moderate and Mild renal function at 2 Screening visits.
* Stable drug regimen

Exclusion Criteria:

* Renal transplant recipients.
* Urinary incontinence without catheterization.
* Subjects with clinically significant infections within the past 6 months prior to first dose of study drug, evidence of active or chronic infection requiring oral treatment within 4 weeks prior to first dose
* Known history of pulmonary embolism or recurrent deep vein thrombosis
* Any condition possibly affecting drug absorption (eg, prior bariatric surgery, gastrectomy, ileal resection).
Evaluate Safety/Efficacy of Two Treatment Regimens for Vectical™ Ointment & Clobex® Spray for Moderate Plaque Psoriasis

This clinical trial will evaluate the efficacy and safety of Clobex® (clobetasol propionate) Spray 0.05% and Vectical™ (calcitriol) Ointment 3 µg/g over a four week period of use in one of two different regimens:

1. Vectical™ Ointment treatment, twice daily on weekdays (Mon - Fri) and Clobex® Spray treatment twice daily on weekends (Sat - Sun) for 28 days
2. Clobex® Spray once each morning and Vectical™ Ointment once each evening for 28 days


Eligibility Criteria:
Inclusion Criteria:

* Male or female subjects aged 18 to 80 years inclusive
* Subjects with an Overall Disease Severity of 3 (moderate)
* Subjects with 3% - 10% treatable BSA (Body Surface Area) excluding scalp, face, groin, axillae and/or other intertriginous areas
* For concurrent medications, type and dose must have been stable for at least 3 months prior to study entry and not expected to change during the study. Subjects receiving treatment with beta-blockers or lithium, whose dose has been stable for at lest 6 months and who have shown no worsening of their psoriasis, may be included in the study, at the discretion of the investigator

Exclusion Criteria:

* Subjects with intakes of more than 2,000 IU/day (50 mcg/day) of vitamin D (tolerable upper intake level) and/or more than 1,000 mg/day of calcium
* Subjects whose psoriasis involves only the scalp, face, groin, axillae, and/or other intertriginous areas
* Subjects with a wash-out period for topical treatment less than 30 days (Any steroid containing medication, dovonex, anthralin, tar and/or UVB treatment)
* Subjects with a wash-out period for systemic treatment less than 12 weeks (corticosteroids, biologics and/or PUVA treatment; Examples of these therapies include, but are not limited to PUVA, Soriatane, Cyclosporine, Hydroxyurea, Mycophenolate mofetil, Sulfasalazine, Azathioprine, Alefacept, Efalizumab, Adalimumab, Etanercept, Infliximab, Rituximab, and Methotrexate)
* Subjects with non-plaque psoriasis or other related diseases not classified as plaque psoriasis
* Subjects who foresee intensive UV exposure during the study (mountain sports, UV radiation, sunbathing, etc.)
CMV-specific T Cell Immunity Test Indicated Prophylaxis of Letermovir After All-HSCT

To evaluate the efficacy of CMV-specific T cell immunity test in prolonged usage of letermovir for avoiding late-onset csCMVi after all-HSCT.

Reactivation of cytomegalovirus (CMV) leads to significant morbidity and mortality following allogeneic hematopoietic stem cell transplantation (allo-HSCT). Letermovir (LTV) has substantially reduced the risk of clinically significant CMV infection (csCMVi) in CMV seropositive recipients of allo-HSCT. LTV discontinuation after day 100 (d100) has been reported to increase the risk of late-onset csCMVi, causing by impaired reconstitution of CMV-specific T immunity. The investigator sought to decrease the probability of CS-CMVi after letermovir withdrawal. Restoration of CMV-specific T cells is imperative for effective control of CMV reactivation following allo-HSCT. Letermovir has been found impending recovery of CMV-specific T immunity. The investigators' retrospective study has proved that lower CMV-specific CD4+ T cells (\<2.01 cells/µL) at week 8 increased the risk of late-onset CMV reactivation (50.0%) compared to the higher ones (7.69%, p=0.04) in letermovir prophylaxis. Thus, the guidance of CMV-specific cell immunity is recommended in letermovir prophylaxis.

Therefore, the investigator conduct a multicenter, randomized, controlled study based on retrospective research to further explore and validate the efficacy of CMV-specific T cell immunity test guiding the prolonged usage of letermovir.

Eligibility Criteria:
Inclusion Criteria:

* first allogeneic hematopoietic stem cell transplantation;
* 18-70 years old;
* use cytomegalovirus prophylaxis with letemovir after allo-HSCT;
* CMV Ig G D+/R+;

Exclusion Criteria:

* Allergy, known hypersensitivity to letermovir tablet or injection components;
* CMV DNAemia within six months before transplantation or previous CMV disease;
* Presence of organ failure and inability to tolerate allogeneic hematopoietic stem cell transplantation;
* Second transplantation;
* Combination of immunodeficiency diseases;
* Those judged by the investigator to be unsuitable for participation in this trial.
Identification of Risk Factors, Exposomics and Genetic Susceptibility of Melanoma in Children, Adolescents and Young Adults

The primary objective of this study is the identification of environmental and genetic factors involved in the risk and progression of melanoma in children, adolescents and young adults (CAYA). The secondary objectives are to generate a model integrating the genetic and environmental factors to estimate the risk of developing melanoma and improve the primary prevention of melanoma through evidence-based interpretation of environmental risk.

By retrieving data from several epidemiological and clinical registries across Europe it is aimed to integrate and maximize efforts in order to create a large dataset that serves for a comprehensive analysis of genetic and environmental factors influencing the etiology of melanoma in CAYA. The data will be combined with exposome information about climate and pollution for the development of a weighted risk score. Furthermore, germline high risk mutations and germline low-medium risk variants will be analyzed. Genome and transcriptome sequencing of blood and in selected cases tumour will provide the most comprehensive data to create a polygenic risk score for CAYA melanoma. Transcriptome data will help to identify and characterize the effect of variants of unknown significance in coding, intronic as well as regulatory regions. Tumour sequencing can provide additional information on functional relevance of variants, e.g. secondary hits in tumour tissue or second hits in tumour suppressor genes. Such identification will be highly advantageous to design prevention strategies for melanoma development in CAYA.

Eligibility Criteria:
Inclusion Criteria:

* confirmed melanoma
* age until 30 years old

Exclusion Criteria:

* no available biological material
* no signed informed consent
An Eight-week Study Evaluating the Efficacy and Tolerability of Two Doses of SSR149415 in Outpatients With Generalized Anxiety Disorder

The objective is to evaluate the efficacy and safety of two doses of SSR149415 (250 mg and 100 mg twice daily) compared to placebo and paroxetine 20 mg once daily in outpatients with generalized anxiety disorder


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of generalized anxiety disorder, as defined by Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) criteria and confirmed by the semi-structured Mini International Neuropsychiatric Interview (MINI) General Anxiety Disorder (GAD) Plus Module.

Exclusion Criteria:

* Total score of less than 22 on the (Hamilton Anxiety rating scale)HAM-A.
* Montgomery-Asberg Depression Rating Scale (MADRS) total score greater than 17.
* Patients with a current history (within 6 months) of major depressive disorder or history or presence of bipolar disorders or psychotic disorders.
* Patients with alcohol dependence or abuse or substance dependence or abuse in the past 12 months except nicotine or caffeine dependence.
* Patients who have used the following prior to entry into Acute Phase: antipsychotics within 3 months, antidepressants including Monoamine oxidase inhibitors (MAOIs) within 1 month, anxiolytics within 2 weeks, mood-stabilizer (lithium, anticonvulsants) within 1 month, and/or high dose or prolonged benzodiazepine (continuous use for 3 months prior to admission) use.

The investigator will evaluate whether there are other reasons why a patient may not participate.
Renewing Caregiver Health and Well-being Through Exercise

The RECHARGE study is evaluating the effect of a 24 week structured exercise and education program on the physical and emotion health, quality of life, physical activity and fitness levels of family caregivers. Very little research has been done examining the impact of a structured exercise program designed for family caregivers of cancer patients. The purpose of this study is to determine if physical activity is effective in improving caregiver health and well-being.

The REHCARGE study is a randomized control trial testing a structured exercise program for cancer family caregivers. One half of the participants enrolled will receive no exercise program until after twelve weeks have passed (the delayed start group) and the other half of the participants will start the exercise program right away. In addition to regular attendance at exercise classes, participants will also be asked to complete some measurements throughout the study including an initial assessment and one after 12 weeks and 24 weeks of the exercise programs. If participants are a part of the delayed start group, they will receive a fourth fitness assessment. Assessments include an evaluation of physical activity levels, quality of life, depression, sleep, and social support through survey type questionnaires as well as a fitness assessment to measure overall fitness and body composition. Participants will receive an individualized exercise program appropriate for their fitness level as well as 6 education sessions about healthy behaviors throughout the study.

Eligibility Criteria:
Inclusion Criteria:

* Currently providing physical care, instrumental or psychological support to an adult patient who has been diagnosed with any type of cancer.
* They must not have any physical health conditions that would restrict their participation in an aerobic and resistance exercise program.
* They must be willing to participate in two exercise classes per week at a gym space at the University of Calgary.
* They must not be planning on moving for the next 12 months
* Not currently meeting the Canadian Physical Activity Guidelines (150 minutes of aerobic activity per week and 2 sessions of resistance training per week) for the last three months.
* Be able to speak and read English

Exclusion Criteria:

* Providing care to a child with cancer Participants caring for a child with cancer will be excluded
* Participants with a health condition that limits their participation in a physical activity program will be excluded
* Participants who were previously caring for a cancer patient and that patient has now died (i.e. bereaved caregivers) will be excluded
* Participants meeting the Canadian Physical Activity guidelines for the past three months will be excluded
* Participants who cannot attend the group exercise classes will be excluded
Multicentre REtrospective StuDy of Treatment and OUtComes in STEMI Patients in Fujian Province

This is a multicentre observational study planned to gather follow up data for a period of 1 year in order to understand the treatments and outcomes of ST-segment elevation myocardial infarction(STEMI) and improve medical care quality in Fujian province for China. Consecutive patients who were admitted and diagnosed with STEMI between January 2014 December 2018 were conducted at five regional representative hospitals in Fujian province, which included the Fujian Provincial Hospital,Longyan First Hospital, the affiliated hospital of putian university,the Second Affiliated Hospital of Fujian Medical University and Mindong Hospital of Ningde City.


Eligibility Criteria:
Inclusion Criteria:

* STEMI patients with symptom onset within 30 days

Exclusion Criteria:

-
CUSTOM-DBS: Current Steering to Optimize Deep Brain Stimulation

The objective of the study is to compare different deep brain stimulation (DBS) settings using the commercially approved Boston Scientific Neuromodulation Vercise system.

The study is a prospective, multi-center, double-blind, randomized controlled trial.

This study will compare various program settings for the bilateral stimulation of the STN using the BSC implantable Vercise™ DBS System for the treatment of levodopa-responsive, moderate to severe idiopathic PD.

Eligibility Criteria:
Inclusion Criteria:

* Implanted bilaterally in STN with a Vercise DBS system for Parkinson's disease for at least three months with programming optimized according to standard of care.
* UPDRS subset III score of ≥30 in the in the pre-operative meds off state.
* DBS must improve PD symptoms by ≥30% in the meds off state, as measured by UPDRS subset III score.
* Medical and mental fitness to comply with programming visit and study related procedures.
* Able to understand the study requirements and the treatment procedures and provides written informed consent before any study-specific tests or procedures are performed.
* Off symptom rigidity score of ≥2 in the evaluated arm as determined by the UPDRS-III.

Exclusion Criteria:

* Have any significant medical condition that is likely to interfere with study procedures or likely to confound evaluation of study endpoints, including any terminal illness with survival \<12 months.
* Resting and/or action tremor score of ≥3 on the evaluated side as determined by the UPDRS-III in pre-operative meds off condition.