cyrilzakka/clinical-trials huggingface dataset:
Ethnic Differences in the Inflammatory Response in Systemic Inflammation

The purpose of this study is to investigate putative ethnic differences in the proinflammatory response in human endotoxemia.

Recent data show that there are significant disparities among genders and races in the incidence of sepsis. While men are consistently more likely to have sepsis than women, the apparent racial disparities are even more striking, approaching a doubling of the risk for sepsis among Afro-Americans. Most prominent is the risk among black men, the group in which sepsis occurs at the youngest age and results in the most deaths. Potential mechanisms for heterogeneous susceptibility to sepsis include genetic differences, which have been explored according to sex but not according to race, and other social and clinical factors.

The goal of this study is to explore whether proinflammatory and procoagulant responses in a well standardised inflammation model are comparable in healthy Caucasian and African volunteers.

Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent obtained before any trial-related activities. (Trial activities are any procedure that would not have been performed during normal management of the subject).
* Men aged \>18 and \<40 years
* Normal findings in medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant
* Normal laboratory values unless the investigator considers an abnormality to be clinically irrelevant

Exclusion Criteria:

* Treatment with an investigational drug within three weeks prior to this trial
* Participation in an LPS trial within the last 6 weeks
* Hereditary deficiency of protein C or S, or a mutation of FV (Leiden), or any other known abnormality affecting coagulation, fibrinolysis or platelet function
* History of cardiovascular disease
* Liver or kidney dysfunction
* Regular use of medication or alcohol abuse
* Use of any medication within three weeks prior to the first trial day
* Symptoms of a clinically relevant illness in the 3 weeks before the first trial day
* Excessive sporting activities
* Weight over 95 kg
Clinical Effects of Brain Machine Interface in Chronic Stroke Patient

Determination of clinical effects of brain machine interface in chronic stroke patient without wrist extensor strength

The purpose of this study is to compare RecoveriX with individual EEG calibration and without individual EEG calibration to determine the clinical effect of brain machine interface in chronic stroke patient without wrist extensor strength

Eligibility Criteria:
Inclusion Criteria:

* Hemiplegic patients secondary to first cerebrovascular accidents
* Weak wrist extension
* Onset ≥ 6 months
* Fugl-Meyer Assessment score ≥ 19
* Cognitively intact enough to understand and follow the instructions from the investigator

Exclusion Criteria:

* Wrist extensor spasticity above or modified ashworth scale 2
* Severe upper extremity pain that could interfere with rehabilitation therapy
* Neurological disorders other than stroke that can cause motor deficits
* Uncontrolled severe medical conditions.
Predictors of Response to Iron and Erythropoietin Stimulating Agents

The purpose of the study is to identify predictors of treatment response. This involves collected baseline clinical parameters and bloods for biochemical parameters prior to administering the study treatment. A positive outcome following treatment was defined as an uptitration of haemoglobin by greater than 5g/l within 2 months. The study evaluated the participants response to treatment against the clinical and biochemical information collected prior to treatment being received.


Eligibility Criteria:
Inclusion Criteria:

* All prevalent haemodialysis patients, established for greater than 3 months

Exclusion Criteria:

Inability to consent Bone marrow disorder Transfusion dependence Active bleeding Active infection Active malignancy Frail with either frequent hospital admissions or unable to follow trial protocol due to differing target haemoglobin
The Effect of Reiki on Cesarean During Hospitalization

To determine the effect of reiki applied to women who have been hospitalized by cesarean during the hospitalization process on anxiety, depression, comfort and breastfeeding

Method: The study will be completed in a randomized controlled manner with a total of 70 women, 35 in the experimental group and 35 in the control group. Women in the experimental group Reiki therapy will be applied to the participants for 30 minutes while they lie down with their eyes closed. Research data will be collected with the Comfort Scale, Hospital anxiety and depression scale and bristol breastfeeding points and will be recorded

Design and Settings: This randomized controlled experimental study will conducted in the post operative room of the, Turkey between the dates of June 2024 and October 2024

Eligibility Criteria:
Inclusion Criteria:

* volunteering
* be over 18 years old
* Not having a diagnosed psychiatric disease
* no communication problems
* No drug sensitivity or allergy
* women who have had a cesarean section

Exclusion Criteria:

* Having a diagnosed psychiatric illness
* no communication problems
* Being under 18 years of age
* not volunteering to participate in the research
* drug sensitivity and allergy
* women who gave birth normally
Safety and Tolerability of Single Ascending Doses of PUL-042 Inhalation Solution in Healthy Subjects

The purpose is to determine if single doses of PUL-042 inhalation solution are safe in healthy subjects.

The study will assess the safety, tolerability, pharmacokinetics and pharmacodynamics of single ascending doses of PUL-042 inhalation solutions in healthy subjects.

Subjects will be enter a screening period of up to 14 days to determine eligibility. Subjects will be admitted to the Phase 1 unit the day prior to dosing and remain in the unit until 24 hours post-dose. Subjects will be seen in the clinic at 3 and 7 days post-dose

A modified 3+3 design will be used to determine the maximum tolerated dose (MTD) based on the occurrence of dose-limiting toxicities (DLTs) defined by Common Terminology Criteria for Adverse Events (CTCAE) v4. Additional specific DLTs will be defined as: 1) Hypoxia, defined as a non-artifactual drop in pulse oximetry to \< 90% on room air, 2) A decrease in forced expiratory volume in one second (FEV1) of 12% or greater compared to the last observation prior to dosing, 3) Any evidence of bronchospasm or wheezing requiring medical intervention. Doses will be doubled until the maximum tolerated dose (MTD- defined as the largest dose with 0/6 or 1/6 DLTs) is reached.

Eligibility Criteria:
Inclusion Criteria:

* Males or females of non-childbearing potential
* Body mass index between 18 and 30 kg/m2
* Normal spirometry
* Normal diffusing capacity of lung for carbon monoxide
* Normal pulse oximetry
* Males willing to practice contraception or have a female partner using contraception

Exclusion Criteria:

* Febrile
* Abnormal chest x-ray
* History of tobacco products within the last year and total exposure of \> 5 pack/years
* Clinically significant laboratory findings
* History of chronic pulmonary disease
* History of atopic reactions
* Mediastinal lymphadenopathy
* Oral corticosteroid therapy within 4 weeks prior to randomization
* Alcohol, caffeine or strenuous exercise within 72 hours prior to dosing
* Grapefruit within 7 days prior to dosing
* Administration of concomitant medications within 14 days prior to dosing
* Exposure to any investigational agent with 30 days
* Significant concurrent illness
* Know positive for HIV, hepatitis B or hepatitis C
* Inability to tolerate a nebulization test with sterile water for injection
* Positive test for drugs of abuse
Prevention of Contrast Induced Nephropathy by Erythropoietin

This ia a prospective, randomized, double blind, placebo controlled trial. patients schedule for primary PCI or elective PCI will randomly allocated to receive either a single dose of EPO (Recormon, Roche, Epoetin beta) or saline intravenously before PCI.

The investigators assume that the incidence rate of CIN will be significantly lower in the EPO group compared to placebo. In addition, EPO administration will result in a decrease of infarct size.

Radiological procedures utilizing intravascular contrast media are being widely applied for both diagnostic and therapeutic purposes. This has resulted in the increasing incidence of procedure-related contrast-induced nephropathy (CIN), which was found to be associated with poor outcome including higher in-hospital mortality rates. Therefore, finding ways to prevent CIN is a valuable clinical and research goal. However, there are no current methods for efficient and cost-effective prevention CIN. Erythropoietin (EPO) has been shown to elicit tissue-protective effects in various experimental models and few clinical studies of acute kidney injury (AKI). Therefore, this prospective, randomized, double blind, placebo controlled trial aim to evaluate, for the first time, the effectiveness of EPO in the prevention of CIN after percutaneous coronary intervention (PCI).

The potential reno-protective effect of EPO is expected to reduce the incidence of the third leading cause of hospital-acquired acute kidney injury. The above together with a cardio-protective effect of EPO is expected to reduce patient's morbidity, mortality and the high health cost associated with CIN treatment.

Eligibility Criteria:
Inclusion Criteria:

* Over 18 years of age.
* Diabetic patients.
* eGFR \< 60 ml/min/1.73m2.
* Scheduled for primary or elective PCI.

Exclusion Criteria:

* Non diabetic patients.
* Patients with eGFR ≥ 60 ml/min/1.73m2.
* Chronic renal replacement therapy.
* Subject with active malignancy.
* Subject with any known history of seizure disorders.
* Subject with polycythemia.
* Uncontrolled hypertension.
* Known allergy or hypersensitivity to EPO.
* Use of EPO 1 week prior to randomization.
* Use of long acting EPO (CERA) during 1 month prior to randomization.
* Use of NAC or bicarbonate during 3 days prior to randomization.
* Contrast media exposure during the last 7 days before randomization.
* Pregnant or lactating women.
* Participation in other clinical trial.
* Refusal or inability to give informed consent due to mental or physical state.
Visual Performance With a Hydrophobic Aspheric Monofocal IOL

Artificial lenses, otherwise known as intraocular lenses (IOLs), are used to replace the natural crystalline lens within the eye during cataract or refractive lens surgery. Monofocal IOLs are the traditional IOL type used during cataract surgery. These monofocal IOLs provide excellent distance vision, however spectacles are required for reading and intermediate distance tasks. Monofocal Intraocular lenses are the mainstay of cataract surgery, but with advancing technologies and a wider selection of lenses available, demand for improved outcomes, improved lens design and ease of surgical implantation have increased. The purpose of this study is to assess the visual performance of the EyeCee One monofocal intraocular lens. In addition an assessment of the ease of insertion by the surgeon will be quantified.

Artificial lenses, otherwise known as intraocular lenses (IOLs), are used to replace the natural crystalline lens within the eye during cataract or refractive lens surgery. Monofocal IOLs are the traditional IOL type used during cataract surgery. These monofocal IOLs provide excellent distance vision, however spectacles are required for reading and intermediate distance tasks. There are many different designs of monofocal IOLs, all with their own unique optical properties, however there is little evidence to support which optical design provides the best visual outcome. This research project allows us to assess the visual outcomes of a specific monofocal IOL. It also allows us to assess the ease of use of the lens to the surgeon.

Each subject will be evaluated at two visits following IOL implantation; visit 1 (1 month post implantation), Visit 2 (3 months post implantation).

At both post-operative visits the patient will undergo:

Refraction Uncorrected and best corrected distance and near visual acuity measurement Optical biometry to assess ELP Slit lamp biomicroscopy to assess for post-operative complications

At the time of surgery, the ophthalmic surgeon will complete a questionnaire, detailing lens insertion time and ease of use.

Eligibility Criteria:
Inclusion Criteria:

-Clinically significant Cataract requiring cataract surgery

Exclusion Criteria:

* Amblyopia
* Corneal astigmatism of \>1.00D
* Dilated pupil size smaller than 5mm
* Macular pathology
* Glaucoma
* Retinal disease
* Corneal disease
* Abnormal iris
* Pupil deformation
* Any previous corneal or intraocular surgery
* Any patient who had surgical complications will also be excluded from participation in the study.
Psychoeducation Versus Cognitive-Behavioral Therapy in Bipolar Disorder

To examine the impact of cognitive-behavioural therapy on both the episodic and functional outcome of bipolar disorder, in combination with pharmacotherapy.

Primary Hypothesis is twofold:

1. Cognitive Behavioural Therapy will reduce the total symptom burden, as measured both by percentage of time spent ill (both syndromic and subsyndromal) and number of episodes, as compared to psychoeducation
2. Cognitive behavioural therapy will reduce social and occupational disability to a greater extent than psychoeducation.

Objective:

To compare the impact of cognitive -behavioral therapy to that of properly structured psycho education on the 'illness burden' and functional outcome of bipolar disorder, in combination with pharmacotherapy.

Interventions:

Subjects will be randomized to either a "control" treatment group cosisting of 6 sessions of group psycho-education (topics include illness recognition, treatment approaches, and monitoring and coping strategies; based on manual by Bauer \& McBride, 2002: Life Goals Phase I) or they will be randomized to the "experimental" treatment group: 20 sessions of individual Cognitive Behavioural Therapy for Bipolar Disorder (topics include limited psychoeducation, activity scheduling/behavioural interventions, cognitive techniques, including thought monitoring and challenges to dysfunctional assumptions and other coping techniques; based on manual by Lam et al., 1999: Cognitive Therapy for Bipolar Disorder)

Eligibility Criteria:
Inclusion Criteria:

1. Bipolar I or II
2. Currently either in remission or subsyndromally ill (Hamilton Depression Scale-17\<14; Clinician Administered Rating Scale for Mania\<12).
3. Age eighteen to sixty.
4. Significant symptoms and/or episodes on at least two occasions in the past three years.
5. Grade six education, able to understand English, and Folstein Minimental Score Exam \> 26 to ensure cognitive ability to participate.
6. On mood-stabilizing medication.

Exclusion Criteria:

1. Substance dependence meeting Diagnostic and Statistical Manual of Mental Disorders-IV criteria within the last three months.
2. Acutely highly suicidal or homicidal.
3. Serious other medical condition that would render pharmacotherapy or psychotherapy very difficult such as cancer, severe diabetes, etc.
4. Severe antisocial or borderline personality disorder (personality disorder per se is not exclusionary). Subjects may have other axis I disorders, but bipolar disorder must be the principal disorder requiring treatment.
Efficacy and Safety Study of BDB-001 Injection in Patients With Moderate to Severe Hidradenitis Suppurativa (HS)

The purpose of this study is to explore whether BDB-001 Injection is effective and safe in the treatment of moderate to severe hidradenitis suppurativa(HS).


Eligibility Criteria:
Inclusion Criteria:

* Subjects who signed the informed consent to participate in the STS-BDB001-06 clinical study and completed all follow-up of the study as required by the protocol, or who withdrew early due to treatment failure or other objective reasons and completed the early withdrawal visit (at least 4 weeks of treatment)

Exclusion Criteria:

* Never participated in the clinical study of STS-BDB001-06；
* Subjects withdrew from the STS-BDB001-06 clinical study due to an intolerable adverse event related to the study drug.
Cognitive Effects of Nimodipine in Patients With Schizophrenia

This study aims to evaluate the acute effects of nimodipine on cognitive performance in patients with schizophrenia using a battery of cognitive assessments.The subjects will also complete a 30-minute structural and functional MRI scan, with the goal of linking brain activity with working memory performance. Investigators predict that the performance increase induced by nimodipine will be greater in subjects who carry the A allele for the Calcium Voltage-Gated Channel Subunit Alpha1 C (CACNA1C) risk single nucleotide polymorphism (SNP) (rs1006737) in comparison to the response of G carriers.

The main cognitive task of interest in this study is the N-back task because of the observed attenuation of prefrontal and parietal cortical activity after nimodipine administration in healthy subjects. Investigators hypothesize that acute nimodipine administration will improve cortical activation, which will lead to improved cognitive performance. The current study will provide insight whether nimodipine or another calcium channel blocker could be used as a treatment approach to alleviate cognitive deficits in patients with schizophrenia.

Eligibility Criteria:
Inclusion Criteria:

* This study will recruit patients with schizophrenia and/or schizoaffective disorder

Exclusion Criteria:

* past or current neurological disorder (including stroke, brain tumor, epilepsy, Alzheimer's, Parkinson's or Huntington's disease)
* uncontrolled medical disorder
* current or past hypotension
* head trauma with loss of consciousness in the last year or any evidence of functional impairment due to and persisting after head trauma
* positive pregnancy test, or currently breast feeding
* having an adverse reaction to nimodipine, or other calcium channel blocker
Cohort Study of Volunteers That Have Participated to Preventive HIV-1 Vaccine Trials

This cohort study should provide an exhaustive overview on long-term safety of various preventive HIV-vaccines administered in phase I and II clinical trials to healthy volunteers of the ANRS network.

Since 1992, 16 phase I and II clinical trials have been performed by the French National Agency for Research on AIDS and Viral Hepatitis (ANRS) evaluating the safety of several HIV-1 vaccine candidates and their capacity to induce immune responses. The ANRS program has evaluated a recombinant HIV-1 envelope protein Rgp-160, canarypox ALVAC vectors, and mixtures of lipopeptides whose sequences represent CTL-epitopes of HIV-1 Gag, Pol and Nef proteins. Most of them have been administered intramuscularly but recently, mucosal immunization and intradermal route were used. Previously compiled in a published meta-analysis, safety studies were restricted to the duration of the trials.

ANRS establishes a cohort study in order to describe the long-term safety of preventive HIV-vaccines administered in phase I and II clinical trials to healthy volunteers of the "ANRS volunteer-network" in France and to gather clinical and biological data in a database and blood specimen collection which could be analysed in case of a long-term safety issue in ANRS vaccine trials or if pertinent, in other HIV vaccine trials ANRS COV1-COHVAC is a prospective, multicentric cohort study composed of participants in preventive HIV-vaccines phase I and II trials. All ANRS volunteers who ever received one dose of a candidate vaccine are eligible and those who are going to complete their participation to a clinical trial during the cohort study time.

The ANRS COV1-COHVAC project relies on a long-term follow-up of the cohort (at least 7 years after the end of the vaccine trial), that includes the retrospective and prospective collection of medical and biological data \[severe health events (grade 3-4), as well as neurological, ophtalmological, and immunological events (any grade), starting from the first injection of a candidate vaccine, are recorded\], blood specimen collections and psycho-behavioral evaluations (self-questionnaires and interviews) in order to collect data about consequences of participation and experience of possible HIV vaccine-induced seropositivity in such trials.

Of the ANRS "volunteer-network", 206 participants have been involved in the early trials and are actually eligible to participate in this cohort. Altogether with the more recent studies completed or in progress, the cohort will comprise at least 400 individuals in 2009.

Eligibility Criteria:
Inclusion Criteria:

* healthy volunteers of the "ANRS volunteer network" who have received at least one dose of a vaccine candidate in a HIV preventive clinical trial.
* volunteers who have signed an informed consent

Exclusion Criteria:

* volunteers not covered by Health Insurance
Mini-invasive Balloon Aortic Valvuloplasty

The spreading of transcatheter aortic valve implantation has paradoxically increased the spectrum of indications for balloon aortic valvuloplasty. Balloon aortic valvuloplasty is currently used as destination therapy for patients excluded from transcatheter aortic valve implantation, as bridge to transcatheter aortic valve implantation or to surgical aortic valve replacement, or as a stratification tool for selected high-risk patients who cannot be immediate candidates for transcatheter aortic valve implantation. Moreover, it has been recently showed that transcatheter aortic valve implantation without balloon aortic valvuloplasty is encumbered by an increased risk of cerebral embolization. However, balloon aortic valvuloplasty has a complication rate comparable to transcatheter aortic valve implantation, mainly related to access site or temporary pacemaker implantation. Thus, a transradial mini-invasive approach with rapid pacing through the 0,035 inch left ventricular support wire could be extremely appealing.

Consecutive patients with severe aortic stenosis with indication to aortic balloon valvuloplasty will be enrolled. An ad hoc informed consent for the procedure will be obtained from all patients.

This is a prospective observational study. The Investigators will include patients where aortic ballloon valvuloplasty is attempted by radial access and without temporary pacemaker implantation. The aim is to register and monitor the effectiveness and safety of this approach. Details regarding management of radial access and pacing with 0.035 wire can be found in the references reported below. The primary endpoint will be the 30-day occurence of minor and major vascular complications according VARC 2 classification. The safety endpoint will be the absence of intra- or periprocedural major complications in transradial balloon aortic valvuloplasty, namely balloon entrapment or compartment syndrome requiring surgical intervention.

The feasibility endpoint will be a procedural success rate ≥90%. The efficacy endpoint will be a reduction of the mean invasive gradient \>30%. At baseline, Handgrip strength test will be performed and angiography of the instrumented arm will be performed at the beginning and at the end of the procedure. All patients will be prospectively followed-up for at least 30 days and all adverse events will be recorded. All patients will be assessed also for frailty according the clinical frailty scale (CFS). During the 30-day follow-up visit two independent blinded operators will evaluate radial artery patency by ultrasonography and perform handgrip strength test in in both arms in all patients.

Eligibility Criteria:
Inclusion Criteria:

* severe symptomatic aortic stenosis requiring balloon aortic valvuloplasty

Exclusion Criteria:

* cardiogenic shock
* bilateral absence of radial pulse