cyrilzakka/clinical-trials huggingface dataset:
Validation of Point Partial User Needs With Partial Finger Amputees

The objective of the device feasibility study will be to validate the user needs of the Point Partial system. This study will be a single group intervention model where one group of 5 partial finger amputees will be asked to perform several tasks. Successful completion of a task results in a fulfilled user need. Failure to complete a task results in an unfulfilled user need.


Eligibility Criteria:
Inclusion Criteria:

* Partial finger amputees with partial absence of index and/or middle fingers and presence of thumb. Additional finger loss is acceptable if all other criterion are met.
* Fluent in English
* Individuals aged 18 or greater
* Patients may present with either fused or mobile MCP joints.

Exclusion Criteria:

* Significant cognitive deficits as determined upon clinical evaluation
* Significant neurological deficits as determined upon clinical evaluation
* Significant physical deficits of the residual limb impacting full participation in the study as determined upon clinical evaluation
* Uncontrolled pain or phantom pain impacting full participation in the study as determined upon OT evaluation
* Serious uncontrolled medical problems as judged by the project therapist.
Project neuroARTEMIS

The purpose of this research is to understand how chronic stress affects the way our brain and immune systems function, and in turn how this affects the way people feel, think, and behave. By learning more about how these processes work, the hope is to be able to develop better treatments to help with problems like depression and substance use. This study is intended for individuals that are HIV positive, currently taking prescription antiretroviral medications, and use stimulants. Through this intervention, the aim is to determine if this positive affect intervention can lead to reductions in stimulant use and depressed mood.

Participants who meet initial eligibility criteria will complete a baseline assessment that includes psychosocial and behavioral measures, biospecimen collection, and an MRI brain scan. Participants will then be randomized to either: 1) ARTEMIS; or 2) a waitlist control (WLC) condition. ARTEMIS participants will receive 5 sessions delivered individually over Zoom across 3 months. All participants (including WLC) will receive contingency management (CM) for antiretroviral therapy (ART) adherence to support sustained viral suppression over the active phase of the trial. During the intent-to-treat period, assessments at 3- and 6-month follow-ups will characterize changes in neural activity (assessed via fMRI) and conserved transcriptional response to adversity (CTRA) leukocyte signaling (assessed via RNA sequencing) as plausible mediators of behavioral outcomes following ARTEMIS. WLC participants will be offered the ARTEMIS intervention after a 6-month delay.

Eligibility Criteria:
Inclusion Criteria:

* 18-59 years old
* Weekly use of stimulants reported in the past month or a score of 4 or more on the Alcohol, Smoking and Substance Involvement Screening Test (ASSIST)
* Confirmed HIV diagnosis
* Current receipt of daily oral antiretroviral therapy (ART) medication
* English fluency/literacy

Exclusion Criteria:

* Acute brain infection (e.g., neurosyphilis, toxoplasmosis)
* Acutely symptomatic bipolar I or psychotic disorder
* Prescription for immunomodulatory medications or other immunotherapy
* Any MRI contraindications
* If applicable, on antidepressant medication regimen for at least 2 months
SPG Neurostimulation in Cluster Patients

We hypothesized that LF stimulation of the SPG would increase parasympathetic outflow, activate sensory afferents and provoke a cluster-like attack.

We conducted a double-blind, randomized, sham-controlled, crossover study to investigate cluster attack induction following LF (20 Hz and 0.2-2.1 amplitude) and sham (amplitude = 0) stimulation in 20 CH patients with implanted SPG neurostimulator. In addition, we measured plasma concentrations of pituitary adenylate cyclase-activating polypeptide-38 (PACAP38) and vasoactive intestinal peptide (VIP), as markers for parasympathetic activation before, during and after SPG stimulation. We also investigated if LF SPG stimulation induces changes in cardiac autonomic regulation and whether any attacks induced by SPG stimulation are associated with such changes.

Eligibility Criteria:
Inclusion Criteria:

* Chronic cluster patients

Exclusion Criteria:

-
Effectiveness of Sensory Stimulation for Person in a Coma or Persistent Vegetative State After Traumatic Brain Injury

Appraised the empirical evidence of effectiveness of sensory stimulation to improve arousal and alertness for persons in a coma or persistent vegetative state after traumatic brain injury (TBI). Databases were searched and nine articles met inclusion criteria.

Background: Traumatic brain injury (TBI) accounts for approximately 50,000 deaths in the United States each year. About 17% of survivors have a period of "coma". Duration of coma contributes significantly to functional outcomes.

Objective: To appraise the evidence of effectiveness of sensory stimulation to improve arousal and alertness for persons in a coma or persistent vegetative state after TBI.

Data Sources and Study Eligibility Criteria: Databases searched included Medline, PsycINFO, CINAHL, OTseeker, and the Cochrane Database of Systematic Reviews. The search was limited to outcomes studies in the hierarchy described by Sackett and colleagues (1996), published in English in peer-reviewed journals between 2006 and 2014.

Eligibility Criteria:
Inclusion Criteria:

* in coma or persistent vegetative state after traumatic brain injury

Exclusion Criteria:

* coma or persistent vegetative state not caused by traumatic brain injury
A Study of the Role of Circulating Tumor DNA in Predicting the Likelihood of Organ Preservation After Clinical Complete Response to Neoadjuvant Therapy for Rectal Cancer

In this research study, the investigators are looking to see if the circulating tumor DNA (genetic material), also known as ctDNA, in the blood will help them predict whether the participant's cancer will come back.

In this research study, the investigator are performing blood draws to see if the presence or absence of circulating tumor DNA (ctDNA), the genetic material in the participant's cancer's cells, will help the investigators predict whether the participant's cancer will come back or not.

Eligibility Criteria:
Inclusion Criteria:

* Participants must have achieved a clinical complete response (cCR) within 3 months of last therapy - defined as absence of residual ulceration, mass or mucosal irregularity at endoscopic assessment - following neoadjuvant therapy with chemoradiation or chemotherapy followed by radiation for stage I, II, or III non-metastatic rectal cancer. (Whitening of the mucosa with presence of telangiectasia will be accepted as cCR.)
* Participants must have original tumor tissue (formalin-fixed, paraffin-embedded specimens) available for analysis
* Participants must be 18 years of age or older.
* Participants must be able to understand and willing to sign a written informed consent document.
* Participants must have received long course chemoradiation to 40-54 Gy.
* Participants must have received at least 4 cycles of FOLFOX
* Participant must be no more than 3 months past the conclusion of initial chemoradiation of rectal cancer (i.e., end of chemoradiation).

Exclusion Criteria:

* Participants may not have any other organ cancer evident at the time of enrollment.
* Participants may not have any other concurrent serious illness that makes participation on this study impractical or clinically inappropriate.
Overweight, Obesity and Weight Variation Among Incarcerated Women in French Guiana: a Study of Factors Associated With Weight Gain

Overweight and obesity are a public health issue, given the morbi-mortality they entail: increase in chronic diseases such as cardiovascular disease, diabetes, musculoskeletal disorders, certain cancers.

According to the 2019 European Health Survey, French Guiana has a high rate of overweight and obesity, affecting 51% of its population (compared with 47% in mainland France), with a higher prevalence among women (23%), this phenomenon being partly attributed to unfavorable eating habits and a sedentary lifestyle. Another study in French Guiana showed that 54.7% of those surveyed were overweight or obese, with a higher risk of obesity among single women, often from non-French Caribbean and South American immigrant backgrounds, unemployed or poorly educated. Some of these risk factors are found in the general prison population: immigrant population, unemployed, low socio-educational level.

A meta-analysis published in 2017 analyzed weight variations in individuals during their period of incarceration. All but one study reported an increase in BMI and weight gain, in a significant proportion of participants. Weight gain was associated with gender, and was higher in women. A systematic review of 2020 on cardiovascular risks associated with incarceration revealed, through meta-regression, a mean weight increase of 5.3 kg (CI95%: 0.5 to 10.1) and a variation in Body Mass Index (BMI) of 1.8 kg/m2 (CI95%: -0.9 to 4.6) after two years of incarceration, attributed to a sedentary lifestyle, inappropriate diet, forced smoking cessation, use of psychotropic medication and high levels of stress.

The higher prevalence of obesity among women is a trend observed both in French Guiana and in the prison environment, where weight gain is associated with the female gender. There are currently no studies examining the weight of female prisoners in French Guiana, its evolution and the identification of risk factors linked to weight gain in the CPG.


Eligibility Criteria:
Inclusion Criteria:

Female adult in prison for more than 7 days at the time of the interviews

Exclusion Criteria:

* Refusal to participate
* Cognitive impairment or lack of communication resulting in inability to complete questionnaire
Evaluation the Effect of Acetyl-L-carnitine in Patients With Mild Cognitive Impairment Accompanied With Chronic Cerebrovascular Disease

The purpose of this study is to evaluate the efficacy of Acetyl-L-carnitine in patient with Mild Cognitive Impairment associated with chronic cerebrovascular disease.


Eligibility Criteria:
Inclusion Criteria:

* Age between 55 and 85 years old
* Patients with chronic cerebrovascular disease, who have modified Fazekas scale grade 2 \~ 3
* Patients wtih a diagnosis of MCI
* MOCA-K of 23 or less
* Patients who provided a signed written informed consent form

Exclusion Criteria:

* Patiens who are uneducated or illiterate
* Patiens previously treated with dementia
* Patients who received a nootropic agent or thyroid hormone within 4 weeks of visit 1
* Patients with cognitive impairment due to diseases other than cerebrovascular disease
* Patients with severe depression, schizophrenia, alcoholism, and drug dependence
Multicentre Prospective Clinical Trial for RFA Tumour Aspirator Treatment of Primary and Secondary Malignancies of the Liver

The primary aim for this trial is to assess whether the RFA aspirator device is safe and of clinical benefit in patients with primary or secondary malignant liver tumours

Patients with unresectable primary or secondary malignancies of the liver have limited treatment options which often only give a small survival benefit. RFA has been demonstrated to be effective in local tumour eradication and to extend patient survival. In this study RFA aspiration will be used to treat unresectable primary or secondary tumours of the liver. RFA will be used to develop a shell of tissue destruction around the tumour, with aspiration removing tissue and fluid from the centre of the lesion. The potential advantages of aspirating during ablation could be to reduce aerosol spread of tumour within the liver parenchyma and peritoneum. Additionally, aspirating the ablated tissue may reduce the incidence of systemic side effects related to RFA when larger lesions are treated. This study would establish the safety and efficiacy of RFA aspiration in the treatment of unresectable primary/secondary malignancies of the liver.

This protocol is for a prospective multi-centre clinical trial of the use of RFA aspiration in the treatment of patients with primary/secondary malignancies of the liver, which are not suitable for formal liver resection. The basis for unresectability being the presence of extra-hepatic disease, limited liver synthetic function, co-morbidity (ASA\>3), bilobar disease and anatomical location. Early and late complications relating to the usage of the RFA aspirator will be analysed. Additionally, local recurrence and long term survival will be assessed. If the use of the RFA aspirator produces improved survival with minimal morbidity and mortality. Then these initial results will justify further in depth studies to establish its clinical role.

II. SPECIFIC AIMS/OBJECTIVES

The primary aim for this trial is to assess whether the RFA aspirator device is safe and of clinical benefit in patients with primary or secondary malignant liver tumours.

III. STUDY OVERVIEW

It is anticipated that 100-200 participants will be recruited. The time period for patient recruitment will be for 2 years with follow up for 3 years. The total study period will be 5 years in order to allow the assessment of complications, local ablation success and survival benefit.

Eligibility Criteria:
Inclusion Criteria:

* Eligible participants will be 18 years and older.
* Have unresectable primary/secondary malignant tumours of the liver. Unresectable criteria being the presence of extra-hepatic disease, limited liver synthetic function, co-morbidity (ASA 3), bilobar disease and anatomical location.
* Study specific signed informed consent will also have to be completed to allow patient inclusion.

Exclusion Criteria:

* Age younger than 18 years old
* Pregnant women
* Uncorrectable coagulopathy
Effects of Red Wine on Cardiovascular Risk Factors in Humans

Fifty healthy human subjects are randomized to not to consume any alcohol at all or to drink 1 glass of red wine/day for women or 2 glasses for men for three months. Outcomes are changes in mood, blood lipids, insulin levels, markers of inflammation and effects on liver and body composition.


Eligibility Criteria:
Inclusion Criteria:

* healthy subjects
* 25 years of age and older

Exclusion Criteria:

* alcoholic first degree relatives
Early Evaluation of the Introduction of Pre- and Post-operative Psychological and Physiotherapeutic Follow-up in Vascular Surgery in Amputee Patients

An amputation represents a real ordeal for the person who will have to overcome the loss of a limb and face long months of rehabilitation. It is most often carried out following arterial insufficiency.

As paramedical professionals, we see in our daily practice a physical and psychological suffering for amputee patients. In spite of our skills acquired through training and professional experience, we are unable to offer comprehensive care for these patients and therefore feel that we are offering incomplete care. A multidisciplinary care, including a medical and paramedical team, would seem to us to be more appropriate for patients with lower limb amputations.

Following this observation, we would like to highlight the interest for the patient and the care team to include a psychologist and a physiotherapist in the care offer to evaluate the improvement of the physical and emotional state of the amputee patient.


Eligibility Criteria:
Inclusion Criteria:

* Patient over the age of majority, no age limit
* Amputation related to obliterative arteriopathy of the lower limbs
* Trans-tibial or trans-femoral amputation in an already amputated patient
* Patient with an indication of discharge to a rehabilitation and re-education service
* Patient with the ability to understand the protocol
* Patient who has agreed to participate in the study and has given express oral consent
* Patient receiving social security cover or entitled to it

Exclusion Criteria:

* Trauma related amputation
* Patient with no history of amputation
* Amputation of upper limb, trans-metatarsal or one or more toes
* Amputation of comfort in a palliative care setting
* Patient leaving home after surgery
* Patient undergoing psychological or psychiatric treatment
* Pregnant or breastfeeding woman, or a woman who is able to procreate without effective contraception
* Patient unable to follow the protocol as judged by the investigator
* Patient participating in another interventional research protocol involving a drug or medical device
* Patient under guardianship, curators or legal protection measure
Hydroxychloroquine in Outpatient Adults With COVID-19

Primary Objective:

To assess the effect of hydroxychloroquine versus placebo on nasopharyngeal SARS-CoV-2 viral load in outpatient adults with COVID-19

Secondary Objectives:

* To assess the effect of hydroxychloroquine versus placebo on clinical signs and symptoms and progression of disease in outpatient adults with COVID-19
* To assess the safety and tolerability of hydroxychloroquine in outpatient adults with COVID-19

The duration of the study per participant will be around 18 days (1 or 2 days of screening followed by a 10-day treatment period and a 4 to 6 days follow-up period)

Eligibility Criteria:
Inclusion criteria :

* Participants with diagnosis of COVID-19 via an approved or authorized molecular test
* Presence of symptoms compatible with COVID-19 at the time of screening
* Time between onset of symptoms and first dose of hydroxychloroquine or placebo is 96 hours or less
* Female participants must use an acceptable birth control method, as specified by each site and country

Exclusion criteria:

* COVID-19 disease requiring the use of supplemental oxygen
* Electrocardiogram (ECG) tracing with QTc interval \> 450 ms for men, \> 470 ms for women (Fridericia algorithm recommended)
* Bradycardia (\< 50 beats/min)
* History of cardiac disease (eg. congestive heart failure, myocardial infarction)
* History of Glucose-6-phosphate dehydrogenase (G6PD) deficiency
* Women who are pregnant or breastfeeding
* Concurrent antimicrobial therapy
* Known hypersensitivity to hydroxychloroquine or other 4-aminoquinoline compounds
* Hydroxychloroquine use within 2 months before enrollment
* History of severe skin reactions such as Sevens-Johnson syndrome and toxic epidermal necrolysis
* History of retinopathy
* History of arrythmia, concurrent use of anti-arrhythmic drugs, or family history of sudden cardiac death
* History of severe renal disease (treatment with dialysis or phosphate binders) or hepatic impairment

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Trial Evaluating Safety, Tolerability and Immune Response of AG-707

This is a randomized, multi-center, sequential, dose-escalating study of three dose cohorts of AG-707. Individuals who meet all of the inclusion and exclusion criteria for eligibility will be randomized to receive either AG-707 (at the 80 µg dose), AG-707 with QS-21 (at the 80 µg dose), placebo, or QS-21. Each patient will be monitored for safety as specified in the protocol.

Primary Objective:

Determine the overall safety profile of three different dose levels of AG-707 vaccination (with and without an adjuvant, QS-21) at 80, 240 and 400 µg compared to placebo and QS-21 alone in HSV-2 seropositive adults.

Secondary Objective:

Determine immune response to AG-707 vaccination (with and without QS-21) at dose cohorts of 80, 240, and 400 µg as compared to placebo and QS-21 alone.

Eligibility Criteria:
Inclusion Criteria:

* Patients must be seropositive for HSV-2 (+/- HSV-1) and have a documented history of clinically active genital herpes (at least one prior outbreak).
* Patients must be seronegative for HIV.
* Patients must be seronegative for hepatitis B and C
* Have baseline chemistry and hematology (hemoglobin, white blood cell (WBC), absolute neutrophil count (ANC), eosinophils) within normal limits; prothrombin time (PT) and partial thromboplastin time (PTT) below the upper limit of normal (ULN), and platelets above the lower limit of normal (LLN). Basophils, lymphocytes and monocytes must be within 1.2 x ULN or 0.8 x LLN and considered not clinically significant by the investigator. Total creatine phosphokinase (CPK) laboratory values \< 1.25X the upper limit of normal (according to the normal reference ranges of the Central Laboratory) at baseline (Screening and Pre-Study Visit) and considered not clinically significant by the Investigator.
* Patients must not be taking antiviral therapy.
* Must be between the ages of 18 and 50 years of age and willing to either use an effective method of contraception or abstain from sexual activity for the 28-week duration of the trial.

Exclusion Criteria:

* Severe active infection, compromised cardiopulmonary function, or other serious medical illness that, in the opinion of the Principal Investigator, would prevent study completion.
* History of HSV infection of the eye (herpes simplex interstitial keratitis or uveitis), or herpes-associated erythema multiforme.
* History of immune suppression or autoimmune disorder.
* Concomitant use of systemic corticosteroids or other immunosuppressive medications (including nasal and inhaled steroids). The use of nasal steroids for seasonal rhinitis is acceptable.
* Patients with known hypersensitivity or allergies to acyclovir or valacyclovir.
Safety and Tolerability of Repatha® (Evolocumab) in Indian Participants With Homozygous Familial Hypercholesterolemia

To describe the safety and tolerability of evolocumab in participants with homozygous familial hypercholesterolemia (HoFH) in India. All participants will receive evolocumab over an 8-week period.

An open-label, multicentre, phase 4 study to describe the safety and tolerability of evolocumab in 30 Indian participants with HoFH. Subjects who meet the inclusion/exclusion criteria and laboratory assessments at screening will be enrolled and will be required to maintain their current lipid-lowering drug therapy throughout the duration of the trial. Participants will receive evolocumab 420 mg subcutaneous (SC) once monthly (QM) and study visits will occur approximately every 4 weeks. Apheresis participants will receive evolocumab 420 mg SC every 2 weeks to correspond with their apheresis schedule. Final administration of evolocumab (for all participants) will occur at week 8. The end of study (EOS) visit will occur at week 12 for all participants.

Eligibility Criteria:
Inclusion Criteria:

* Male or female ≥ 12 to ≤ 80 years of age at the time of signing the informed consent
* Diagnosis of HoFH based on low-density lipoprotein cholesterol (LDL-C), familial history and xanthoma
* On a low-fat diet and receiving background lipid-lowering therapy stable for 4 weeks prior to screening and during the time frame of the trial
* Fasting LDL-C at screening \> 130 mg/dL (3.4 mmol/L)
* Fasting triglycerides at screening ≤ 400 mg/dL (4.5 mmol/L)

Exclusion Criteria:

* Use of mipomersen or lomitapide within 6 months of screening.
* Known active infection or major hematologic, renal, metabolic, gastrointestinal, hepatic, or endocrine dysfunction
* Currently receiving treatment in another investigational device or drug study, or less than 30 days since ending treatment on another investigational device or drug study(ies)
* Female subject is pregnant or breastfeeding or planning to become pregnant or breastfeed
* Female subjects of childbearing potential unwilling to use an acceptable method of effective contraception
* Subject has known sensitivity to any of the products to be administered during dosing
* History or evidence of any other clinically significant disorder, condition or disease
* Subject has previously received evolocumab or any other proprotein convertase subtilisin/kexin type 9 (PKSK-9)-inhibiting therapy