cyrilzakka/clinical-trials huggingface dataset:
Functional Imaging Reserve in NeuroHIV

The purpose of this research study is to look at the brain's efficiency and ability to make up for deficits in the front of the brain to see if people living with HIV (PLWH) are still able to perform well on various cognitive tasks even though there are other underlying processes at work, like inflammation, that affect the brain in a negative way. Results of this study may provide insight into the pathophysiology of disease and may reveal arenas for future possible interventions in PLWH who have impaired neuropsychological performance.

This proposal systematically characterizes brain efficiency and recruitment in virologically suppressed persons living with HIV (PLWH) and demographically similar HIV uninfected (HIV-) controls. This proposal collects advanced functional neuroimaging that provide critical information about cerebral blood flow (CBF) and brain connectivity (functional connectivity strength; FCS); quantitative measures of immune dysfunction in the blood and cerebrospinal fluid (CSF) (immune activation and immune exhaustion); and neuropsychological performance testing. This overall goal of this proposal is to delineate the interplay between dysfunction in frontal networks and recruitment of compensatory networks that underlie the neuropsychiatric symptoms seen in PLWH.

Eligibility Criteria:
Inclusion Criteria:

* 20 to 80 years old
* documented HIV infection for at least 1 year or confirmed HIV - status
* PLWH must be on stable cART regimen for at least 12 months with undetectable plasma HIV RNA (less than 50 copies per mL)
* at least 9 years of education
* able to provide informed consent
* if female, a negative pregnancy test and not breast feeding
* able to undergo an MRI scan

Exclusion Criteria:

* significant neurological disorders (e.g. stroke, head injury with loss of consciousness for more than 5 minutes, developmental learning disability)
* active uncontrolled Axis I psychiatric disorder according to the DSM 5
* current or history of substance use disorder (including, but not limited to amphetamines, cocaine, alcohol, opiates, and barbiturates)
* prescribed blood thinners
* allergic to lidocaine or similar anesthetic
* history of any bleeding disorder
* contraindication to MRI scanning (e.g. claustrophobia, pacemaker, etc.)
* pregnant or breastfeeding
Topiramate Augmentation in the Treatment of Obsessive-Compulsive Disorder

A 12-week program to examine the effectiveness of topiramate in adjunctive treatment for adults with obsessive-compulsive disorder and who are currently on serotonin reuptake inhibitor medications (ages 18-65).

The Compulsive, Impulsive and Anxiety Disorders Program at the Mount Sinai School of Medicine is conducting a study of Topiramate (Topamax) added to an SSRI for the management of treatment-resistant Obsessive-Compulsive Disorder. The purpose of the study is to evaluate the safety and efficacy of Topiramate versus placebo added to a selective serotonin reuptake inhibitor (SRI) in patients with treatment resistant OCD. The program is 12 weeks in duration and involves regular visits with a psychiatrist as well as complete psychiatric and medical evaluations. Treatment and medication for the study will be provided free of charge.Participants must be between the ages of 18 and 65 and have an onset of OCD at least 1 year prior to screening. In addition, participants must be taking a clinically effective dose of an SSRI for at least 3 months and must maintain their current dose throughout the study. Participants must not have a primary OCD symptom of hoarding.

Eligibility Criteria:
Inclusion Criteria:

Males and Females 18-65 years of age diagnosed with OCD and currently taking SSRI medication(s)

Exclusion Criteria:

major medical disorders
Dual Rapid HIV & Syphilis Tests in Zambia

The purpose of this study is to provide evidence on the performance and operational characteristics of commercially available dual HIV/syphilis Rapid Diagnostic Tests (RDTs) in Zambia for their introduction into antenatal care and other settings.

Early detection and timely intervention of pregnant women infected with HIV and/or syphilis is critical. To improve the number of women tested and treated, the Centre for Infectious Disease Research in Zambia (CIDRZ) and the Ministry of Community Development, Mother and Health (MCDMCH) this field study will assess the effectiveness of newly developed dual HIV and syphilis rapid diagnostic tests (RDTs) manufactured by Chembio and Standard Diagnostics in Lusaka District antenatal clinics.

The specific objectives of this field performance evaluation of the rapid diagnostics are to determine the antenatal clinic-based performance of dual HIV/syphilis RDTs compared to that of current reference standard assays, and to assess the operational characteristics and acceptability of these dual HIV/syphilis RDTs to patients and health care providers This cross-sectional study of 3,765 pregnant women will validate the performance of Chembio and Standard Diagnostics dual HIV and Syphilis RDTs.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant women attending their first antenatal care visit at a study clinic
* 18 years of age or older
* Willing and able to provide informed consent for study participation

Exclusion Criteria:

* Prior participation in the study
A Study to Evaluate the Safety, Tolerability, Kinetics, Biodistribution and Repeatability of 11C-BMS-986196 After Intravenous (IV) Administration in Healthy Participants and After Repeat IV Administration in Participants With Multiple Sclerosis

The purpose of this study is to evaluate the safety, tolerability, kinetics, biodistribution and central nervous system signal of 11C-BMS-986196 after intravenous (IV) administration in healthy participants and after repeat IV administration in participants with multiple sclerosis.


Eligibility Criteria:
Inclusion Criteria:

For Parts A \& B:

* Body mass index (BMI) of 18 to 34 kg/m2, inclusive, and total body weight ≥ 50 kg
* Documentation of normal Allen's test result at Screening and on PET scanning days in the arm that will be used for arterial line placement

For Part A only:

• Healthy male and female participants without clinically significant deviation from normal in medical history, physical examination (PE), electrocardiograms (ECGs), and clinical laboratory determinations

For Part B only:

* Male or female participant diagnosed with MS according to the 2017 revisions of the McDonald diagnostic criteria
* Expanded Disability Status Scale (EDSS) score between 0 to 6.5, inclusive, at Screening

Exclusion Criteria:

For Parts A \& B:

* Benign MS defined as a baseline EDSS of 2.0 with MS diagnosis ≥ 10 years prior to Day 1. Spinal MS without clinical or radiological evidence of brain lesions. Any other combination of clinical and radiological data suggestive of an absence of inflammatory brain lesions.
* Any major surgery within 4 weeks of study treatment administration and/or any minor surgery within 2 weeks of tracer administration

For Part A only:

• Any significant acute or chronic medical illness

For Part B only:

* Any significant acute or chronic medical illness (other than MS) posing a risk to the participant's safety or negatively affecting the ability to detect CNS PET signal
* MS relapse within 14 days prior to Day 1. Participants with a MS relapse within 30 days prior to Day 1 must agree to have their second PET scan scheduled on Day 1 or Day 2

Other protocol-defined inclusion/exclusion criteria apply
Outcomes of Veno Arterial ECMO

veno arterial (VA) extra corporeal membrane oxygenation (ECMO) is a rescue therapy with various indications including refractory cardiac arrest and refractory cardiogenic shock. Amiens hospital university has an ECMO program and is a regional center to address patients requiring VA ECMO. In spite of the application of international guidelines, the mortality of patients with VA remains high with an admitted survival rate at hospital discharge at 40%.


Eligibility Criteria:
Inclusion Criteria:

* age : ≥ 18
* Patient with a VA ECMO

Exclusion Criteria:

* age\<18
Investigating the Effect of Dietary Supplement VSL#3 on Cognition and Mood in Healthy Older Adults

This research aims to determine whether a 12 week daily dose of VSL#3 has any measurable effects on memory, attention, executive function or self-reported mood and anxiety in healthy older adults.

This research aims to investigate the effect of dietary supplement VSL#3 on memory, attention, executive function and mood in healthy older adults.

The study will be a randomised double-blind placebo-controlled design and eighty participants will be recruited to take part. Forty participants will be randomly allocated to the food supplement and 40 to placebo. As the sample is initially self-selecting where individuals volunteer to take part, a minimisation procedure will be used to randomise group allocation (Altman \& Bland, 2005), with volunteers stratified by gender. Neither the participant nor the research assistant supplying the supplement will know which preparation is administered, thus ensuring double-blind administration.

Participants will be asked to take the food supplement daily for 12 weeks and the pre- and post- intervention data will be collected immediately before and after this time period.

Both pre- and post-intervention data will be collected using validated neuropsychological measures, cognitive measures, EEG and self-report questionnaires. Blood sampling will be conducted pre- and post-intervention by a Research Assistant trained in phlebotomy. Analysis will be carried out on each of the measures using a two-way ANCOVA, using the pre-treatment score as covariate.

Eligibility Criteria:
Inclusion Criteria:

* Aged between 65 and 75
* MMSE score \> 23
* Willingness to give informed consent
* Commitment to take the VSL#3 supplement daily for 12 weeks
* Alcohol consumption less than 21 units per week (men), 14 units per week (women)

Exclusion Criteria:

* Current psychoactive medication
* Significant active medical conditions
* History of major psychiatric or neurological condition
* Smoker
* History of epilepsy
* History of traumatic brain injury
* History of immunodeficiency
* Taking immunosuppressants or corticosteroids
Hyaluronic Acid in Shoulder Tendinopathy

Multicentric, randomised study to compare the effectiveness on activity pain at 3 months of corticosteroid injection associated with hyaluronic acid with corticosteroids injection alone in patients with tendinopathy of the supraspinatus with clinical reevaluation at one, three and six months.


Eligibility Criteria:
Inclusion Criteria:

* Active patient aged between 18 and 65;
* Patient suffering from pain compatible with supraspinatus tendinopathy for at least 2 months;
* Patient with simple tendinopathy or partial tendon rupture;
* Patient with tendinopathy confirmed by ultrasound or MRI;
* Patient with an active pain visual analog scale ≥ 4 for more than 6 weeks;
* Patient with an active pain visual analog scale ≥ 4 on the day of inclusion;
* Patient failing medical treatment (rest, analgesics, NSAIDs, physiotherapy);
* Patient able to follow the protocol and having given oral informed consent to take part in the research;
* Patient affiliated to the social security system or entitled person;

Exclusion Criteria:

* Patient suffering from a transfixing tendon rupture;
* Patients suffering from post-traumatic tendon rupture;
* Patients suffering from calcific tendinopathy (calcification \> 5 mm);
* Patients with associated glenohumeral osteoarthritis;
* Patients with associated symptomatic acromioclavicular osteoarthritis;
* Patients with shoulder pain for reasons other than tendinopathy (capsulitis, chronic inflammatory rheumatism, fibromyalgia, amyloidosis);
* Patients who have had a subacromial infiltration in the previous 6 months;
* Patients with a known allergy to one of the products including their excipients (methyl parahydroxybenzoate, propyl parahydroxybenzoate, benzyl alcohol);
* Patients with a known allergy to lidocaine;
* Patients with a local or generalised infection, or suspected infection;
* Patients with severe coagulation disorders or taking anticoagulants;
* Patients with severe and/or uncontrolled hypertension \> 160/100 mmHg;
* Patients with unbalanced diabetes (last HbA1c \> 8.5%);
* Patients with a history of addiction to psychoactive substances;
* Patient participating in another clinical research protocol with an impact on the research objectives;
* Patient already randomised in the study;
* Patient who is pregnant, parturient, breastfeeding or able to procreate without effective contraception\* in the month prior to inclusion and up to 15 days after infiltration;
* Patients under guardianship, curators or deprived of liberty;
* Patient under a mandate for future protection activated ;
* Patient under family guardianship ;
* Patient under court protection ;
Feasibility of Identifying, Enrolling and Following Acute and Early HIV-1 Infected Individuals.

It is only between peak viremia and viral setpoint in natural acute HIV-1 infection that the immune response overwhelms viral replication resulting in a plasma viral load decline. The aim will be to characterize these immune responses, how they develop and their progeny. This will require the need to identify HIV-1 infected individuals before peak viremia and follow them to post viral setpoint.

This protocol describes a pilot study to evaluate the feasibility of identifying, enrolling and following acute and early HIV-1 infected individuals from voluntary counselling and testing centres in Masaka, Bukomansimbi, Kalungu, Lwengo, Sembababule and Lyantonde districts.


Eligibility Criteria:
Inclusion Criteria:

* Females and males.
* Able and willing to provide informed consent.
* Willing to undergo HIV testing using GeneX pert Viral Load assay.
* Able and willing to provide accurate locator information for tracking purposes and willing to be contacted by study staff.
* Willing to complete interviewer administered questionnaires on risk factors and if infected, questions related to the route and timing of exposure.

Exclusion Criteria:

Has any condition that in the opinion of the principal investigator or designee, would preclude provision of informed consent, or otherwise interfere with achieving the study objectives.

* Participation in a current clinical trial unless approved by the investigators and IAVI medical monitor.
Will Decreased Noradrenergic Activity Normalize Information Processing in Patients With Schizophrenia?

The investigators want to try to improve information processing in schizophrenic patients via pharmacological intervention. The hypothesis is that decreased noradrenergic activity will normalize information processing (PPI, P50 gating, P300, and mismatch negativity) in patients with schizophrenia.

A number of reports in literature provide evidence for, among others, an increased central noradrenergic activity in schizophrenia. In addition to this increased noradrenergic activity, patients with schizophrenia often show reduced filtering of sensory information, which is reflected in reduced P50 suppression and reduced prepulse inhibition of the startle reflex (PPI). In two separate initial studies in our laboratory, we found reduced sensory gating following administration of imipramine (a combined noradrenergic and serotonergic agonist) and desipramine (a highly specific noradrenergic agonist) to healthy volunteers. This provides evidence for a direct causal relation between the increased noradrenergic activity and the disturbed gating of sensory information, as both commonly found in patients with schizophrenia. Therefore, in a follow-up study, the effects of a noradrenergic antagonist will be investigated on the sensory gating of patients with schizophrenia. To further extend the data of our initial studies, the patients will additionally be tested for two psychophysiological parameters of attention that are usually found to be disturbed in patients with schizophrenia, i.e. mismatch negativity and selective attention. The design will conform to a double blind, placebo controlled experiment, in which either four doses (0.25 ug, 50 ug, 75 ug or 150 ug)of clonidine or placebo will be added to the current medical treatment of 20 male patients with schizophrenia on five occasions, separated by at least a week, after which they are tested in the Copenhagen Psychophysiological Test Battery (CPTB).In order to test the effects of clonidine in healthy volunteers, 20 healthy males will receive a fixed dose of 0.15 mg clonidine or placebo on two separate occasions separated by at least a week, after which they will be tested in the CPTB as well.

Eligibility Criteria:
Inclusion Criteria:

* Patients:

  * Male subjects
  * Meeting the DSM-IV diagnosis of schizophrenia
* Controls:

  * Male subjects
  * Good Physical and Mental Health meeting criteria "never mentally ill", which will be evaluated with a medical history checklist
  * Non smokers

Exclusion Criteria:

* Patients:

  * A P50 suppression or PPI score falling within a range of 10 percent above or below the mean score of the healthy control group
* Controls:

  * Current use of any medication
  * Any subject who has received any investigational medication within 30 days prior to the start of this study
  * History of neurologic illness
  * History of psychiatric illness in first-degree relatives, evaluated with DSM-IV criteria
  * History of alcohol and drug abuse.
HED-Start: Evaluating a Positive Skills Intervention for Patients New on Haemodialysis

Hemodialysis patients often experience barriers and misperceptions that hinder adjustment to life on dialysis. This study seeks to explore a group-based intervention (titled HED-Start) developed to improve self-care and emotional wellbeing among incident hemodialysis patients.

There are potentially modifiable psychosocial barriers and misperceptions about life on dialysis that hinder adjustment outcomes. It is hypothesized that these may include: poor understanding on what is needed or 'how to implement treatment principles', misperceptions related to disease and treatment, catastrophizing beliefs about impact of dialysis and low level of confidence on ability to manage treatment regime and renegotiate life roles as a "dialysis patient".

This study seeks to explore the feasibility and acceptability of implementing a two-arm parallel randomized controlled trial of a group-based intervention (titled HED-Start). HED-Start is specifically developed to reduce psychological distress and support self-care and self-management outcomes in incident hemodialysis patients.

Drawing on self-management and motivational interviewing principles paradigm, the HED-Start program aims to facilitate acquisition of skills and knowledge to support and improve self-care and emotional adjustment outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with end-stage kidney disease (ESKD) and established on hemodialysis with the National Kidney Foundation Singapore (NKF) for fewer than 90 days
* At least 21 years old
* Proficient in spoken and written English or Mandarin

Exclusion Criteria:

* Unwilling or unable to give informed consent or refuse to be randomized
* Have cognitive impairments or psychiatric conditions that preclude consent
* Are currently involved in other intervention trials
* Are failing on dialysis and approaching end of life (supportive/palliative care pathway)
Impact Of Bacterial Resistance On Healthcare Costs For Hospitalized Patients With Complicated Intra-Abdominal Infections

The objective of this study is to estimate the costs of empiric antibiotic therapy and hospitalization costs for patients with a complicated intra-abdominal infection, and to assess the impact of treatment failure of initial antibiotic empiric therapy on pharmacological and total healthcare costs for these patients in Greece.

Every patient diagnosed with complicated intra-abdominal infections will enter the study, until the pre-specified number of patients is reached. Patients diagnosed with any of conditions mentioned below (inclusion criteria) will enter the study, until the pre-specified number of patients is reached.

Eligibility Criteria:
Inclusion Criteria:

* A recorded primary diagnosis of a complicated intra-abdominal. infection (cIAI) and a procedure involving a laparotomy, laparoscopy, or percutaneous drainage of an intra-abdominal abscess The study will be a prospective, multi-centre, epidemiological study of patients (aged \> 18 years) diagnosed with a complicated intra-abdominal infection AND who received a procedure involving laparotomy/laparoscopy or percutaneous drainage of an intra-abdominal abscess. cIAI's will include the following conditions/ diagnoses:
* Gastric ulcer with perforation;
* Gastric ulcer with hemorrhage and perforation;
* Duodenal ulcer with perforation;
* Duodenal ulcer with hemorrhage and perforation;
* Peptic ulcer with perforation;
* Peptic ulcer with hemorrhage and perforation;
* Gastrojejunal ulcer with perforation;
* Gastrojejunal ulcer with hemorrhage and perforation;
* Acute appendicitis with generalized peritonitis;
* Acute appendicitis with peritoneal abscess;
* Peritonitis;
* Abscess of intestine;
* Fistula of intestine, excluding rectum and anus;
* Ulceration of intestine;
* Perforation of intestine;
* Abscess of liver; or
* Acute cholecystitis with perforation.

The initial antibiotic regimen will be defined as all IV antibiotics newly received either on the day immediately prior to laparotomy or laparoscopy or percutaneous drainage of an intra-abdominal abscess, or on the day of these procedures, given that the use of these procedures prior to initiation of IV antibiotic regimens in complicated IAIs , which is increasingly common, is likely reflective of prophylaxis.

Exclusion Criteria:

* Patients not signing an informed consent form.
* Patients participating in another interventional study.
Multiepitope Peptide Vaccination in Melanoma

This trial assesses the clinical efficacy of a multiepitope peptide vaccine with GM-CSF and KLH as immunological adjuvants in stage IV melanoma patients


Eligibility Criteria:
Inclusion Criteria:

* Metastatic melanoma
* HLA-A1, -A2, -A24, -B44

Exclusion Criteria:
Assessment of Lotrafilcon A Contact Lenses

The purpose of this 3-month study is to evaluate subjective responses to an upgraded contact lens.


Eligibility Criteria:
Inclusion Criteria:

* Have normal ocular findings.
* Be able to wear the study lenses in the available powers.
* Currently wear contact lenses for a minimum of 5 days a week, and at least 8 hours a day.
* Wear Night \& Day contact lenses.
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* Require concurrent ocular medication.
* Eye injury or surgery within twelve weeks prior to enrollment.
* Currently enrolled in an ophthalmic clinical trial.
* Any active corneal infection.
* Corneal refractive surgery.
* Wear AIR OPTIX NIGHT \& DAY AQUA lenses.
* Other protocol-defined exclusion criteria may apply.