cyrilzakka/clinical-trials huggingface dataset:
Ivermectin and Human Immunity

We hypothesize that ivermectin, a drug used to treat parasitic worm infections, interacts with the human innate immune system and that this contributes to its anti-parasitic effects. Participants will donate blood before and after being administered the normal human dose of the drug. We will compare the cell types present in the blood and the chemicals known to influence the human immune system before and after the drug is given, as well as measuring any changes in gene expression in white blood cells 4 and 24hrs after the drug is taken.

Subjects will visit the University of Georgia (UGA) Clinical \& Translation Research Unit (CTRU) twice on consecutive days and blood will be drawn from them. On the first occasion they will be weighed and will complete the consent process. They will have been randomly assigned to the test (Stromectol) or control (placebo) group, with 8 participants in the test group and 4 participants in the control group. Stromectol will be obtained from a medical supply distributor and a placebo will be obtained through the UGA School of Pharmacy. Drugs will be prescribed by Jonathan Murrow MD. They will be stored in their original packaging at room temperature in a drug locker in the lab at CTRU. Participants will be identified by number and allocated to groups using a block randomization protocol. Randomization and drug dispensation will be done by CTRU. Eighteen ml of blood will drawn in a fasting state and they will be administered 150 mcg/kg Stromectol or the equivalent number of placebo tablets immediately after blood is drawn. Participants will remain at CTRU for four hours after they take the drug, then another 15ml of blood will be drawn. On the second day they will attend CTRU at the same time and the third blood sample will be drawn 24 hrs after administration of the drug. On each occasion the drawn blood will be coded by CTRU staff prior to being collected by a member of the Department of Infectious Diseases and taken to the laboratory (Wildlife Health G0007) for the isolation of leukocyte populations (peripheral monocytes, lymphocytes and polymorphonuclear cells (PMNs)) and for the preparation of serum. Complete blood counts will also be carried out. Sera will be analyzed on the Luminex for cytokine/chemokine content. RNA will be isolated from the cell populations for RNASeq analysis.

Eligibility Criteria:
Inclusion Criteria:

* Weight over 110 pounds and under 185 pounds

Exclusion Criteria:

* Pregnancy or nursing mothers.
* Immunosuppressed individuals.
* Hypersensitivity to ivermectin, cellulose, starch, magnesium stearate, butylated hydroxyanisole, or citric acid powder (inert ingredients of Stromectol).
* Recent (last 3 years) travel to West or Central Africa, or any other country where onchocerciasis is present
* Hepatitis/HIV
* Currently taking warfarin
* Lactose intolerance (Lactose present in placebo)
* Currently taking Steroid medications (inhaled, oral or injection)
* Currently taking Barbiturates, Benzodiazepines such as Xanax or Klonopin, Valproic acid (Lithium), Calcium channel blockers, Statins (cholesterol medication)
* Liver or renal dysfunction
Clinical Study Of Schizophrenia in Both Men and Women

The objective of this study is to evaluate the effectiveness of a marketed drug in the treatment of schizophrenia, as an add-on therapy to antipsychotics over a 12-week period. Subjects with schizophrenia who have been maintained on a stable dose of antipsychotics and who fulfill the screening entrance criteria will have an assessment 1-7 days after the first visit to confirm eligibility.


Eligibility Criteria:
Inclusion criteria:

* If female, must not be pregnant, or must be incapable of conceiving or be taking steps to prevent conception.
* Diagnosis of Schizophrenia
* Patients must be taking clozapine monotherapy or other atypical antipsychotic at least 3 months prior to this study.

Exclusion criteria:

* Patients who are currently taking or have taken antidepressant medication in the last month prior.
* Patients who are or have been suicidal or homicidal in the last 6 months.
* Patients with a history of autistic disorder or another pervasive developmental disorder
* Patients whose condition is due to the direct physiological effects of a substance (e.g. a drug of abuse, a medication) or a general medical condition
An Observational Study to Assess Patient Satisfaction and Control of Psoriasis With Calcipotriene/Betamethasone Dipropionate (Taclonex®) Topical Suspension, and Effect on Quality of Life

The purpose of this study is to document quality of life, patient satisfaction, effect on itching, and control of psoriasis vulgaris associated with use of calcipotriene/betamethasone dipropionate (Taclonex®) topical suspension 0.005% / 0.064% for treatment of plaque psoriasis under real-life conditions.


Eligibility Criteria:
Inclusion Criteria:

1. Signed and dated informed consent obtained prior to any study related activities
2. Aged 18 years or above
3. Either sex
4. Any race or ethnicity
5. Attending a hospital outpatient clinic or the private practice of a board-certified dermatologist, dermatology-certified nurse practitioner or physician assistant trained in dermatology
6. Clinical diagnosis of psoriasis vulgaris involving scalp and/or body amenable to treatment with a maximum of 100 g of topical medication per week.
7. Patients who receive a prescription of calcipotriene/betamethasone dipropionate (Taclonex®) topical suspension 0.005% / 0.064% as per an investigator's clinical judgment and in accordance with the US label, and who have access to the medication
8. Able to communicate with the investigator, read and understand English, and understand and comply with the requirements of the study

Exclusion Criteria:

1. Prior treatment with calcipotriene/betamethasone dipropionate (Taclonex®) topical suspension, 0.005%/0.064%.
2. Contraindications or any warnings/precautions according to the US label.
3. Current participation in any other interventional clinical study.
4. Females who are pregnant, breast-feeding, or females of child-bearing potential wishing to become pregnant during the study.
Efficacy of Transdermal Fentanyl Patches in Relief of Acute Postoperative Pain After Mastectomy

to determine the safety, efficacy and tolerability of transdermal fentanyl in patients undergoing mastectomy, as well as the postoperative consumption of analgesic.


Eligibility Criteria:
Inclusion Criteria:

* ASA I - II patients
* aged 30-60 years
* body weight ranged between 65-10kg

Exclusion Criteria:

* Patients with history of allergy to morphine
* chronic intake of analgesics or non-steroidal anti-inflammatory drug 24 h prior to surgery,
* there was a history of a psychiatric disorder patients weight was less then 50kg.
* impaired kidney function.
Fast Assay for Pathogen Identification and Characterization

Sepsis is a life-threatening disease caused by a dysregulated host response to infection. This can lead to organ-dysfunction and septic shock, which is a subset of sepsis where underlying abnormalities increase mortality remarkably. Blood cultures are the gold standard for identifying pathogens in the bloodstream (bacteremia). It is based on cultivation techniques which, theoretically, can detect a single pathogenic cell from a patient sample. However, blood cultures have serious limitations, such as long time to result (3-7 days). This leads to the fact that only a small fraction of the patients obtain a correct diagnosis and in further consequence get the optimal antimicrobial treatment. Patients with sepsis should get antimicrobial treatment within the hour. Thus, physicians start treatment empirically, with broad-spectrum antibiotics. This puts a selective pressure on pathogens and has led to an increased amount of antibiotic resistance. Faster diagnostics are necessary to ensure an immediate and targeted treatment. In the EU-funded FAPIC project, two diagnostic systems that can be used with direct sample material from patients will be developed, avoiding the time-consuming cultivation of pathogens.

In this study, the evaluation of the rapid diagnostics will be performed in patients with sepsis, suspected of bacteremia. To this aim, the performance of the diagnostic systems will be evaluated using blood samples that are collected in parallel with blood cultures. In addition, clinical data of the patients will be collected. In routine care, two blood culture sets (2x2 bottles) per patient are collected. One extra blood samples (EDTA, 9 ml) will be sampled with each blood culture set, totaling 2 samples per patient. In this study, patients presenting at the Emergency Department (ED), and the department of infectious diseases/nephrology will be included. The results will be used to estimate the performance, sensitivity, and specificity of the diagnostic systems compared to blood culture. Furthermore, in order to determine the severity of sepsis and to describe the patient population, clinically relevant parameters and laboratory parameters (ferritin, HLA-DR, serum lactate, SOFA score) will be assessed to determine its association with severity of disease and patient mortality. Evaluation will be done exclusively in the lab, and will not be used directly for the diagnosis or management of patients. Standard care will still be provided.

This study is a follow-up study of the first prospective study performed in 2017 in the same hospital. The ClinicalTrials.gov ID number of the previous study was NCT03025802.

Eligibility Criteria:
Inclusion Criteria:

* Patients for whom blood cultures are drawn
* Age ≥ 18

Exclusion Criteria:

* Age \< 18
* Patients who are not hospitalized and sent home after ED admission
* Patients from the haematology department
* Duplicate blood cultures from the same bacteraemia episode (blood cultures drawn \<7 days after first blood culture)
A Natural History Study of Fibrodysplasia Ossificans Progressiva (FOP)

Fibrodysplasia Ossificans Progressiva (FOP) is a rare, severely disabling disease characterized by painful, recurrent episodes of soft tissue swelling (flare-ups) that result in abnormal bone formation in muscles, tendons, and ligaments. Flare-ups begin early in life and may occur spontaneously or after soft tissue trauma, vaccinations, or influenza infections. Recurrent flare-ups progressively restrict movement by locking joints leading to cumulative loss of function and disability. This 3-year, non-interventional, two-part, natural history study is designed to gain insight into total body HO, FOP disease progression, the impact of FOP on subjects' physical functioning, and clinical features and biomarkers that may be useful in the diagnosis and monitoring of disease progression. This natural history study will also provide important information to inform the design of subsequent interventional trials.

This is a multi-center, natural history, non-interventional, longitudinal study in subjects with classic FOP. A thorough baseline examination will be performed to determine the current status of disease in each subject. In Part A, two imaging modalities assessed total body HO at baseline, and the optimal method (low-dose whole body CT scan \[excluding head\]) will be employed in Part B for the balance of the study. Progression will be assessed at annual in-clinic visits (ie, at Months 12, 24, and 36) at which time the procedures conducted at the baseline visit will be repeated. In addition, site personnel will telephone subjects midway between the annual visits (ie, at Months 6, 18, and 30).

During the 36-month follow-up period, at least one new flare-up (with a maximum of one per year) will be carefully studied. An in-clinic visit will be performed within 14 days following the subject's identification of his/her flare-up. Additional visits at Day 42 and Day 84 (after the initial flare-up clinic visit) will be performed. An additional future visit may be scheduled after Day 84 at the discretion of the Principal Investigator (PI) for prolonged flare-ups. However, subjects with an eligible flare-up may elect to participate in an ongoing Clementia interventional study rather than continue in this natural history study.

Eligibility Criteria:
Inclusion Criteria:

- Subjects clinically diagnosed with classical FOP with documented R206H mutation or believed to carry the R206H mutation

Exclusion Criteria:

- Participation in an interventional clinical research study within the 4 weeks prior to enrollment
Ex Vivo 3D-ultrasound for Oropharyngeal Cancer

Patients with biopsy-verified oropharyngeal squamous cell carcinomas treated with transoral robotic surgery are included. Immediately post-operatively, freshly resected specimens are examined with ex vivo 3D ultrasound (US).

Ex vivo 3D US will be used to match US slices of the specimen with corresponding histopathology slices. The US slices will be reviewed by a panel of head and neck surgeons blinded to histopathology.

The primary aim is to explore perioperative ex vivo 3D US for oropharyngeal tumor detection, delineation from normal tissue, tumor size and volume, and margin assessment.

The purpose of the study is to determine the accuracy of ex vivo 3D ultrasound (US) for detecting and delineating tumor tissue of the tonsils and base of tongue post-operatively. This is a quick technique that may provide valuable information for the surgeon that can potentially improve treatment outcomes.

Placing the surgical specimen in a water bath allows for an US swipe to be performed without compressing the specimen. This reduces the deformation of the specimen by removing the pressure from conventional US scanning. A video clip can be captured by swiping across the specimen in the water bath. By motorizing this motion, the video can be converted into a 3D volume due to the known number of video frames and a constant swiping speed.

We will correlate the ex vivo 3D US scans to histopathology for the following analyses:

* Four surgeons blinded to histopathology will rate each included case in terms of tumor visibility on ex vivo 3D US scans. If visible, the surgeons will mark the tumor and the healthy tissue.
* Tumor and margins will be correlated to histopathology pre- and post-formalin fixation on a subset of cases to explore the proportion of tissue shrinkage from formalin fixation.

Eligibility Criteria:
Inclusion Criteria:

* Patients surgically treated with transoral robotic surgery for oropharyngeal squamous cell carcinoma.

Exclusion Criteria:

* Patients from the QOLATI trial (NCT04124198)
Randomized and Multicenter Study to Evaluate a Customizable Support Breast Cancer Material

The goal of this clinical trial is to evaluate if a customizable support material allows to improve the knowledge about the stage and subtype of the disease, as well as the indicated treatments, in comparison with a non-customizable support material among patients with breast cancer.

The main question it aims to answer is:

• What is the impact of delivering a customizable support material so that patients with breast cancer know and remember the stage and subtype of their disease, as well as the indicated treatments, compared to non-customizable support material?

Participants in the intervention group will be provided customizable support material while those in the standard group will receive a non-customizable material.

In the present investigation, it is planned to carry out a prospective, multicenter study, randomized and blinded to the statistician. Patients with a recent diagnosis of CM and who are scheduled to have their first consultation in which their options will be discussed of treatment to participate in the study. To those who agree to participate and sign the informed consent, the protocol coordinator of each center will randomly assign them to the intervention group or the standard group (in a 1:1 ratio) before the appointment medical. The intervention group will receive customizable support material while the Standard group will receive a non-customizable material (Annex 2). Additionally, you will be instructed to the intervention group that the support material received can be filled with the information discussed with the medical team. The protocol coordinator will obtain sociodemographic data and clinicopathology of the medical records of the participants. After the next visit follow-up, the coordinator will apply to both groups questionnaires about the knowledge of the patient about his own disease, satisfaction with the support material received and perceived ability to participate in discussions about their treatment, and the comprehension of written materials (CHLT-6). After one month, both groups will respond knowledge questionnaires to assess long-term information retention, disease uncertainty (SF-MUIS) and satisfaction with medical information provided (EORTC-QLQ-INFO25).

Eligibility Criteria:
Inclusion Criteria:

* Women with a recent diagnosis of primary breast cancer treated at the participant centers
* Women who will receive information about their options for the first time treatment
* Provision of informed consent to participate in the study

Exclusion Criteria:

* Patients who have already started systemic treatment for breast cancer
* Patients with medical records not available for data collection
Assessing Refractoriness and Infectious Survival Events in AML

Despite therapeutic advance in acute myeloid leukemia (AML), the prognosis remains poor, with an overall survival (OS) of 30% at 5 years \[1, 2\]. Treatment of 1st-line AML in patients under 75 years of age is based on intensive chemotherapy (IC) followed by allogeneic transplantation (hematopoietic stem cell transplantation, HSCT) \[3\]. Following its administration, a phase known as aplasia ensues, during which patients are severely immunocompromised. This period of aplasia therefore carries a very high risk of infectious events, despite management in protected areas and infectious prophylaxis. Infectious problems remain one of the leading causes of mortality in the initial phase of AML treatment \[4\]. The incidence of sepsis, the microorganisms involved and the complications arising from infectious episodes during chemotherapy remain poorly described, as do their long-term prognostic consequences for these patients \[5,6\].

Moreover, there is a "dogma" among hematologists dealing specifically with AML that intensive chemotherapy during which there are no infectious events is often a sign of non-response. Although this "popular" belief has never been verified prospectively or even retrospectively, it is based on the observation of many generations of clinicians. This belief suggests that immune stimulation during aplasie could promote remission by inducing an anti-leukemic immune response. Furthermore, numerous cases of "spontaneous" remission (i.e. in AML patients receiving no active treatment) following infections or highly immune-stimulating events have been reported in the literature \[7-10\].

It might therefore be hypothesized that infectious events occurring during the post-intensive chemotherapy aplasia phase for AML could favor the achievement of remission by nonspecific immune stimulation.

The aim of this study is to describe the incidence and type of septic episodes occurring in patients undergoing intensive treatment for acute myeloid leukemia, and to assess the impact of these episodes on patient prognosis, notably via the risk of relapse and long-term survival.


Eligibility Criteria:
Inclusion Criteria:

* Patients with acute myeloid leukemia (AML)
* Age over 18 years
* Treatment with "intensive" chemotherapy (combination of aracytin and an anthracycline)
* Date of diagnosis of acute myeloid leukemia between 01/01/2015 and 31/12/2021
* Treatment received at Hospices Civils de Lyon (HCL)

Exclusion Criteria:

* Patients with acute promyelocytic leukemia (AML 3)
* Treatment with "non-intensive" chemotherapy (i.e. azacytidine)
* Death before first post-chemotherapy bone marrow assessment
* No computerized data available
* Follow-up at a center other than HCL
Analgetic Effect of Preoperative Pregabalin in Patients Undergoing Nephrectomy

Pregabalin 300mg or placebo are administered 1 hour preoperatively in patients undergoing elective nephrectomy. Postoperatively, patients receive a patient controlled analgesia device for self delivering opioids. Morphine consumption in the first 48 hours is documented.

Hyperalgesia is measured by von-Frey-Filaments.


Eligibility Criteria:
Inclusion Criteria:

* patients undergoing elective nephrectomy

Exclusion Criteria:

* contraindication against pregabalin
* creatinine \> 2.0 mg/dl
* GGT \>165, AST \>105, ALT \>135
* peptic Ulcus
* haemorrhagic diathesis
* angina pectoris, myocardial infarction
* stroke
* bronchial asthma
* opioid abuse
Depression, Epinephrine, and Platelet Function

Men and women who have suffered sexual and/or physical abuse before the age of 12 are at increased risk for anxiety and mood disorders, other serious psychiatric disorders, and likely medical illnesses. What is not known is whether adult survivors of childhood adversity experience heightened negative emotions and increased physical responses due to altered norepinephrine or serotonin systems in their brains and bodies. The investigators expect to see that survivors of childhood adversity experience heightened negative emotions and increased physical responses to stress.


Eligibility Criteria:
Inclusion Criteria:

-

Exclusion Criteria:

* Individuals who are suicidal, psychotic, or with bipolar depression
* alcohol or substance abuse or
* regularly use medications which alter mood or blood vessel function (zolpidem or zalpelon, aspirin, nonsteroidal antiinflammatory drugs, sympatholytics, theophylline, central acting agonists, beta-blockers, coumadin, nitrates, triazolobenzodiazapines, or use steroids (testosterone-patch or pill form), use tryptophan or monoamine oxidase inhibitors (MAOIs),
* have narrow-angle glaucoma, liver disease,
* severe allergies (especially to antidepressants similar to escitalopram or desipramine)
* seizures, or a serious medical disorder (e.g. hypothyroidism) that is unstable or is untreated.
* Depressed patients with a prior history of severe adverse events associated with SSRIs or TCAs will not be accepted into the study.
Mechanisms of Hypertension in Women With Polycystic Ovary Syndrome

Women with androgen excess polycystic ovary syndrome (AE-PCOS) leads to hypertension.

Our scientific premise is that in AE-PCOS women, the androgen-dominant hormonal milieu causes BP increases via sympathetic activation, vasoconstriction and renal sympathetic nervous system activation. Moreover, this androgen-dominant milieu increases BP via activation of the renin-angiotensin system.

Eligibility Criteria:
Inclusion Criteria:

* Clinical Diagnosis of Polycystic Ovary Syndrome
* Able to inject study drug
* Able to swallow pills

Controls:

-Diagnosis of Insulin resistance

Exclusion Criteria:

* Any woman that does not fit the inclusion criteria
* Males
Adaptive Sports for Individuals With a Physical Disability : Effect Among Stroke Survivors

The objective of the study is to evaluate the effect of engaging in adaptive sports for individuals who have had a stroke. The study is cross-sectional, participants with stroke will be recruited and divided into two groups: the first group composed of individuals with stroke who regularly participate in adaptive sports; and the second of individuals with stroke who do not regularly participate in adaptive sports. The two groups will have to be similar in terms of demographic variables (age, gender, time since beginning of stroke). A series of parameters will be tested, on one occasion for each participant. The two groups will then be compared to one another.


Eligibility Criteria:
Inclusion Criteria:

* diagnosis of stroke since at least 6 months prior to recruitment in the study
* persistent physical disability due to the stroke
* adequate understanding of french

Exclusion Criteria:

* significant cognitive impairments
* contra-indication of any type to performing physical activity and physical exercise