cyrilzakka/clinical-trials huggingface dataset:
Immune Suppression and Ventilator Associated Pneumonias

Patients in the ICU are already predisposed to nosocomial infections, which are both costly and potentially life threatening, and it appears that the immune paralysis of sepsis may put these patients at greater risk for secondary infections, though this has not been proven conclusively. One measure of this sepsis-induced immune suppression is monocyte deactivation. The investigators hypothesize that, as a cornerstone of the monocytic innate immune response to infection, the inflammasome is critical to monocyte function during sepsis.

Sepsis is a systemic inflammatory response to a severe infection. Despite the high incidence and societal costs of sepsis, the mechanism by which it kills remains unclear. The pathophysiology of sepsis is not completely understood, but many investigators now believe that sepsis induces a prolonged state of immune suppression. This study will attempt to quantify the degree of immune suppression during the first 5 days of sepsis by measuring the immune function of peripheral blood monocytes and the inflammasome constituent proteins in peripheral blood monocytes and alveolar macrophages.

Eligibility Criteria:
Inclusion Criteria:

1. ≥ 18 years.
2. Have consensus criteria for sepsis (infection plus two of four systemic inflammatory response syndrome \[SIRS\] signs \[tachycardia, tachypnea, fever or hypothermia, leukocytosis or leukopenia\]) and a known or suspected infection for SEPTIC arm.

   * Patients without criteria for sepsis will be eligible for CONTROL arm. Patient must consent to have blood drawn within 24 hours of initiation of mechanical ventilation (for CONTROL arm) and 24 hours of new episode of sepsis to be eligible (for SEPTIC arm).

Exclusion Criteria:

1. Consent not available or declined
2. Prisoner
3. Died before blood collected
4. Onset of sepsis more than 24 hours prior to transfer to OSUMC,mechanical ventilation greater than 24 hours
5. Anticipation of less than 24 hours of mechanical ventilation by primary team
6. Women who are pregnant.
Prophylaxis of Venous Thromboembolism in Advanced Lung Cancer (PROVE)

Prospective randomized open multicenter trial with blinded adjudication of endpoints to assess the efficacy of six-month low-dose LMWH (Low Molecular Weight Heparin) for the prevention of symptomatic or incidental VTE in patients with stage IV lung cancer and elevated D-dimer.

Adult patients aged ≥ 18 years with stage IV lung cancer and elevated D-dimer will be randomized to the experimental or control group.Patients in the control group will receive usual care, patients in the experimental group will receive subcutaneous tinzaparin once daily for six months. Follow-up visit will take place in outpatient clinic at day 90, day 180 and day 360. Blood sampling for biomarkers will be performed at inclusion visit and day 90.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Social security affiliation
* Written informed consent
* Histologically confirmed stage IV (M1a or M1b) non-small-cell lung cancer, including recurrent non-small-cell lung cancer after a period of complete remission
* D-dimer \> 1,500 µg/L
* First line of systemic cancer treatment (chemotherapy, immunotherapy or targeted therapy), or new line of systemic cancer treatment for cancer progression (chemotherapy, immunotherapy or targeted therapy), introduced during the month preceding inclusion or planned within one month after inclusion
* ECOG (Eastern Cooperative Oncology Group) score 0-2
* Life expectancy \>3 months

Exclusion Criteria:

* Hypersensitivity to heparin or to any excipients
* Septic endocarditis
* History of heparin-induced thrombocytopenia
* Ongoing anticoagulant treatment at therapeutic dosage
* VTE at inclusion
* Creatinin clearance \<30 mL/min
* Active bleeding
* Platelet count \< 100 G/L at inclusion
* Severe hepatic insufficiency
* Cancer treated exclusively with supportive care
* Aspirin at daily dosage \> 160 mg
* Pregnancy
* Patient under tutorship or curatorship
Effects of a Periodic Repetitive Transcranial Magenetic Stimulation in Parkinson Disease

Previous studies have shown that repetitive transcranial magnetic stimulation(rTMS) can improve clinical symptoms of Parkinson's disease(PD). Continuous theta-burst stimulation(cTBS) is a novel rTMS protocol that produces physiological effects b acting on neurons in the brain, which can decrease the excitability of motor system. This study aims to explore the long-term effects of cTBS on improvement of movement symptoms in patients with PD.

This was a open-label clinical trial to assess the Effects of a Periodic Repetitive Transcranial Magenetic Stimulation in Parkinson Disease.

Participants were randomly assigned to the cTBS group and the control group on a 1:1 basis using age as a stratification factor. In the cTBS group, after baseline assessment, participants received cTBS treatment on the left supplementary motor area(SMA) for 14 days, and symptoms were assessed on the second day after treatment. Ten weeks after completion of assessment, a second cTBS session was performed, with all patients taking stable doses of antiparkinsonian medications. The control group only received drug intervention, and symptom assessment was conducted at weeks 13, 23 , 33 , and 43. To rule out the influence of medication on symptom assessment, all patients stopped taking medication for at least 12 hours before assessment.

Eligibility Criteria:
Inclusion Criteria:

* Meet the Chinese diagnostic criteria for Parkinson's disease (2016 version);
* Age ≥ 40 years old;
* Stable use of medication for at least 2 weeks;
* MMSE score ≧ 24 points;
* Those who can cooperate to complete the experiment; (6) Those who have not received rTMS treatment in the past.

Exclusion Criteria:

* History or clinical symptoms of other serious mental illnesses (such as major depression, psychosis, or obsessive-compulsive disorder);
* Severe organic brain defects on T1 or T2 images;
* History or unknown epilepsy Cause of loss of consciousness;
* Head injury, stroke or other neurological disease;
* Immovable metal objects on or around the head;
* History of drug abuse within the past 6 months.
The Biological Rhythm of Human Metabolite

The circadian regulation in mammals have been known for a long time. A special group of clock genes, organized in feedback loops, are responsible for the circadian regulation in both the SCN and peripheral organs. The central clock is mainly entrained by the light-dark cycle, while the peripheral ones in organs such as liver and intestine, are more influenced by the feeding-fasting cycles. The coordination of central and peripheral clocks is thought to be essential in the maintenance of physiological homeostasis.This study aim to investigate the association between biological rhythm and metabolism.


Eligibility Criteria:
Inclusion Criteria:

* Male or female；
* Aged of 18 to 30 years old;

Exclusion Criteria:

* Presence of pituitary/hypothalamic disorders, polycystic ovarian syndrome， thyroid disorders, hypertension, malignant tumor, cardiac insufficiency，hepatic or renal insufficiency, gastrointestinal disorders and acute infection;
* Receiving psychotropic or hormonal medications including hormonal contraception and hormone therapies;
* Taking lipid-lowering agents or hypoglycemic agents and other drugs that known to influence cardiovascular health;
* Pregnancy or lactation women;
* Obviously poor compliance.
Comparison of the Pharmacokinetics of Tiotropium Delivered From Test Inhaler Products With Reference

The purpose of this study is to compare the absorption of four different inhalation products with the reference product in healthy volunteers.

Healthy subjects will be enrolled and will receive single doses of 4 test inhalation products and two reference inhalation products according to a five-period cross-over design. Plasma tiotropium levels will be measured pre-dose and over 48 hours post-dose.

Eligibility Criteria:
Inclusion Criteria:

* Healthy Volunteer
* Willing and able to give informed consent
* Willing to withhold all alcoholic beverages for 48 hours and all xanthine- containing foods and beverages for 24 hours prior to reporting to clinic
* Subjects must agree to use an adequate method of contraception from admission through 12 weeks after last administration

Exclusion Criteria:

* Evidence or history of clinically significant abnormalities or disease or chronic respiratory disorders
* Any presence or history of a clinically significant allergy including any adverse reaction to study drug
* History of drug or alcohol abuse within the past 2 years
* Smoked tobacco within the past 6 months or have a history of more than 10- pack years (number of packs smoked per day x number of years smoked)
* Donation or loss of greater than 400 mL of blood within the previous 3 months
* Have received any prescription medication within 4 weeks or investigational medication within 12 weeks of study (exception: contraceptives are permitted)
* Have received any non-prescription medication within 14 days prior to dosing (exception: paracetamol use within 2 days)
* Upper respiratory tract infection (excluding otitis media) within 14 days of the first study day, or lower respiratory tract infection within the last 3 months
* If female, nursing, lactating or pregnant
* Regular alcohol consumption in males \>21 units per week and females \>14 units per week (1 unit = ½ pint beer, 25 mL of 40% spirit or a 125 mL glass of wine)
A Trial of Group Versus Individual Family Planning Counseling in Ghana

This study uses a randomized, noninferiority design to determine whether group family planning counseling is as effective as individual family planning counseling among gynecological patients with unmet need at two teaching hospitals in Ghana.


Eligibility Criteria:
Inclusion Criteria:

* 18 years of age and older
* fertile
* desires to delay pregnancy for at least 12 months

Exclusion Criteria:

-
Culturally Adapted Psychological Intervention for Bipolar Disorder in Pakistan

Aim:

To assess the Feasibility RCT of the efficacy of a culturally adapted psychological intervention for Bipolar disorder in Pakistan

Design:

Randomized Control Trial

Setting:

Psychiatric Departments of different Hospitals in Karachi.

Participants:

A total of 36 Bipolar disorder patients will be randomized to psychological Intervention and treatment as usual arm.

Intervention:

Culturally Adapted psychological intervention for bipolar disorder

Outcome measure:

* Acceptance of intervention in terms of attending session and dropouts
* Knowledge and attitudes towards bipolar disorder

The purpose of the study is to test Feasibility RCT of the efficacy of a culturally adapted psychological intervention for Bipolar disorder in Pakistan

Primary Objectives :

1. To determine effectiveness of educational intervention in terms of patient Satisfaction with overall care, knowledge and attitudes to bipolar disorder and medication adherence.
2. To assess feasibility in terms of

   * Recruitment
   * Using instruments that will be used to assess recurrence rate in the main study (BDI, YMRS and obtaining prospective hospitalisation and medication data)
   * acceptability of a culturally adapted bipolar group education package
3. To allow 'fine tuning' of culturally adapted bipolar group education package (this will partly be achieved by using the SEMI at study entry)

The Participants will be recruited from psychiatric department of different hospitals.

They will be randomly divided into two groups; intervention group and treatment-as-usual group. A total of thirty six participants will be recruited in the pilot study and divided equally into two arms. This will ensure that, even after loss to follow-up, we will have at least 12 subjects per group for analysis (FDA guidance http://www.fda.gov/cder/guidance/5356fnl.pdf) .Randomization will be carried out by the on offsite statistician. This will provide a reliable geographically remote service. For intervention group twelve sessions of psychoeducation will be provided by trained research clinician during the period of three months. Patients in the treatment as usual (TAU) group will be given details of intervention at the end of the study and interested patients will be offered psychoeducation.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of DSM IV Bipolar disorder
* Currently stable (YMRS \<8, BDI\<12)
* Age 18 to 65 years.
* Participants engaged with the mental health services since last 6 months.
* Able to give written informed consent.
* Resident of trial catchments area
* Ability to speak Urdu /Punjabi

Exclusion Criteria:

* Substance or alcohol dependent (i.e., those who fulfill the criteria for dependence according to DSM IV criteria)
* Inability to engage fully in the psychotherapy (due to cognitive impairment)
* Actively suicidal
* Any major psychiatric illness other than bipolar disorder
The Noergaard Technique for Anterior Shoulder Dislocation

In this paper we describe and evaluate the results of the Noergaard technique through a retrospective analysis of patients admitted and treated for anterior shoulder dislocation at the ED of Copenhagen University Hospital Hvidovre, Denmark, in a 1-year period.

Introduction

In this article the investigators describe the Noergaard technique for reduction of anterior shoulder dislocations. This is an atraumatic reduction method that has proven successful through several years of practice. The investigators describe and evaluate the results of this technique through a retrospective analysis of patients admitted and treated for anterior shoulder dislocation at the emergency department (ED) of Copenhagen University Hospital Hvidovre, Denmark, in a 1-year period.

Methods

In the Noergaard technique the patient is placed standing bend over forwards in front of the rail on a hospital bed, resting the forehead on the back of the non-affected forearm, which is put on the rail. The affected arm should now be relaxed and stretched, hanging straight down toward the floor. The patient is then instructed to attempt to relax and make pendular and circular motions with the affected arm hanging down.

Eligibility Criteria:
Inclusion Criteria:

- Patients have had a closed shoulder reduction performed at the emergency center of Hospital of Hvidovre between 1st of January 2014 and the 31st of December 2014.

Exclusion Criteria:

* Patients with diagnosed severe arthrosis in the shoulder joint.
* Patients with malignancy in the humerus or scapula.
* Patients who have had a Total Shoulder Arthroplasty performed at the same side as the lunation.
* Patients with more than four previous shoulder reductions performed.
* Patients who have undergone operations on the same shoulder, but at different hospitals.
A Multimodal Neuroimaging Study of Brain Activation Patterns Under Ketamine

The aim of the project is to establish a multimodal imaging approach for the investigation of the neural mechanisms underlying neuroreceptor regulation, glutamatergic metabolism and brain function that are of particular relevance for major depressive disorder (MDD) and that can be translated into clinical applications.

There is growing evidence for imbalance with regard to glutamatergic neurotransmission in stress-related affective disorders. Further support for the hypothesis that dysfunctional glutamatergic signaling underlies major depressive disorder, and indeed that its reversal constitutes a potential efficacious mechanism of action, is provided by the evidence that pharmacological compounds active at the N-methyl-D-aspartate (NMDA) ionotropic glutamate receptor such as ketamine exert rapid antidepressant effects. As a tool compound ketamine enables the safe investigation of the brain region-specific effects of NMDA receptor antagonism in terms of glutamatergic neurotransmission, brain function and the association of these neural changes with emotional state, thereby allowing for increased understanding of the therapeutic mechanism of action.

The possibility to simultaneously study brain perfusion (arterial spin labeling), functional brain activity (fMRI) and connectivity (resting state fMRI), neurometabolism (proton magnetic resonance spectroscopy) and metabotropic glutamate receptor densities (positron emission tomography) will unravel their functional interplay in the mechanisms underlying the regulation of mood and cognition. Combining those imaging modalities with treatment interventions in healthy subjects and depressed patients, this project aims at providing insight into the neuropharmacological effects of ketamine and its antidepressant properties.


Eligibility Criteria:
Inclusion Criteria:

* treatment resistant depressive episode
* no restrictions regarding antidepressant medication

Exclusion Criteria:

* lifetime antidepressant treatment with ketamine
* lifetime recreational use of ketamine
* cardiovascular diseases such as hypertonia, cardiac insufficiency or myocardial infarct in the past six months
* insufficiently treated anemia
* hyper- or hypothyroidism
* lifetime increased intracranial pressure or glaucoma
* chronic physical diseases
* hepatorenal dysfunction
* any relevant psychiatric or neurological comorbidity, in particular dementia, epileptic seizures (lifetime), schizophrenia (lifetime), psychosis (lifetime), or post-traumatic stress disorder (current).
* acute suicidality
* substance abuse disorders
* recent heart or head surgery
* metallic body implants
* agoraphobia
* pregnancy
* left handedness
Comparison of Treatment for Hoarding Disorder

This study proposes to compare two forms of treatment for Hoarding Disorder (HD), a common and impairing neuropsychiatric syndrome that has a profound impact on the lives and functioning of individuals, families, and society. Specifically, we will compare a novel community-based group treatment led by individuals from the community who are not mental health professionals to the current standard of care treatment for Hoarding Disorder, Cognitive Behavioral Therapy, conducted by psychologists in a group setting. We hypothesized that both treatment types will be similarly effective in reducing hoarding severity.

The study design for this proposal is a stratified, randomized, single-blind, non- inferiority trial comparing the current standard of care for treatment of Hoarding Disorder (HD), Group Cognitive Behavioral Therapy (G-CBT), to an innovative and promising community-based treatment, Group Buried in Treasures (G-BiT). Participants will be stratified by gender, psychiatric status (high vs. low burden of psychiatric symptoms) and insurance status (insured vs. under- or un-insured) so that equal numbers of individuals with each of these characteristics are randomized to each treatment arm. They will then be randomly assigned (randomized) to either G-CBT or G-BiT. Participants will know which treatment group they are assigned to, but those members of the research team who are conducting clinical or neuropsychological assessments or analyzing the data will not; they will be blinded to participant group assignment, and group leaders will be blinded to the psychiatric status, neurocognitive status, insurance status, etc, of participants. The study is a non-inferiority trial, that is, the hypothesis to be tested is that G-BiT is as effective, or no less effective, than G-CBT. We chose a non-inferiority design because we have no reason to believe G-BiT is better than G-CBT and our preliminary data, as well as outcomes previously reported for G- CBT and G-BiT, suggest that these treatments may have similar efficacies.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Hoarding Disorder

Exclusion Criteria:

* Individuals with active psychosis, schizophrenia, intellectual disability, or known dementia will be excluded
* Individuals who have participated in either cognitive-behavioral therapy for hoarding (group or individual) or in group Buried in Treasures in the past year
Analysis of the Genotype/Phenotype Relationship in the Fuchs' Corneal Endothelial Dystrophy in France

The pathophysiology of the most common corneal endothelial dystrophies (Fuchs' Corneal Endothelial Dystrophy, FECD) is beginning to be dismembered. There is a significant heterogeneity in the clinical forms and the investigators have just highlighted a great diversity of histological forms that seem to define distinct groups.

The most frequent genetic abnormalities have been published since 10 years and can now be easily searched. This study is going to analyze the relationships between clinical, histological and genetic forms in a large population to better understand how histological abnormalities are formed.

Eligibility Criteria:
Inclusion Criteria:

* affiliated with or entitled to a social security scheme
* Consent form to participate in the study signed
* with an FECD certified by slit lamp examination
* requiring an endothelial keratoplasty

Exclusion Criteria:

- Patients under guardianship or curators
Angioplasty of Distal Lesions for Carriers of Inoperable Post-embolic HTP

Currently, the standard treatment for proximal thromboses lesions responsible for post-embolic pulmonary hypertension, is the surgical thromboendarterectomy. When the ravages are judged too distal or the patient is judged inoperable for a curative surgical gesture, there is no evidence of any therapeutic option, exept for K anti-vitamins for recurrent embolism. Prognosis is then pejorative with a 60% mortality at 5 years.

This study propose an alternative treatment for these patients in therapeutic "dead end". This is about applying arterial thrombosis technique to the pulmonary circulation.


Eligibility Criteria:
Inclusion Criteria:

* Patients over 18 years
* Patients with a pulmonary hypertension diagnosed by right catheterisation, with a mean arterial pressure \>30 mmHg and arterial pulmonary resistance \> 3 UW.
* Patients with group 4 (Dana point) pulmonary hypertension, thromboembolic.
* Chronic thrombosis visible to scanner, pulmonary IRM angiogram or to pulmonary angiogram.
* Patient's file refused by the reference center multidisciplinary coordination meetings for surgical thromboendartériectomy or refusal from the patient to be operate.
* Absence of counter-argument to the femoral venous or jugular way.
* Normal kidney function or moderatly degraded (clearance\>30 mL) or dialysed renal failure
* Persons affiliated to national social security
* Signed free consent by patients

Exclusion Criteria:

* Pulmonary hypertension pos-embolic operated by thromboendarteriectomy
* Pulmonary hypertension Group 1 of Dana Point, meaning idiopathic, familial, post-anorectics, associate with a congenital heart disease associated to a scleroderma, associated to a chronic hemolytic disease
* Pulmonary hypertension Group 2 of Dana Point, associated with a left cardiovascular disease
* Pulmonary hypertension Group 3 of Dana Point, associated to a respiratory disease
* Pulmonary hypertension Group 5 of Dana Point, of unclear or multifactorial mechanism
* Hypersensitivity to HEXABRIX, to iodinated contrast product or one of its components
* Obvious thyrotoxicosis
* Protected major persons
* Pregnant or breastfeeding women
* Persons deprived of liberty
* Persons in emergency situations.
* No consent signed or approoved
* Persons no affiliated to national social security