cyrilzakka/clinical-trials huggingface dataset:
Increasing the Efficiency of Depression-screening Using Patient-targeted Feedback

Out-patients with coronary heart disease or hypertension will fill out a depression screening questionnaire while waiting in a cardiac clinic. Using a randomised-controlled study design half of the patients will receive a patient-targeted written screening feedback. This feedback contains information about depression in general, depression-severity adapted treatment guidelines and contact-information for treatment. Patients in the control group receive no direct screening-feedback but their cardiologist will be informed about the screening result. All patients with a positive screening-result will be contacted after one month and six months and asked for symptoms of depression, and their use of health care. The aim of this study is to evaluate the efficiency of this minimal intervention on the course of depressive symptom in patients with known coronary heart disease or hypertension.

The aim of this study is to evaluate the efficiency of a minimal intervention on the course of depressive symptoms in patients with known coronary heart disease (CHD) or hypertension. By means of a depression screening and individual patient-targeted feedback the level of depression should decrease, the percentage of treated depressed patients should increase and health economic costs should be lowered. The main hypothesis is that screening plus targeted feedback results in a greater reduction of depression than screening only.

Eligibility Criteria:
Inclusion Criteria:

* Gender: Both, male and female
* Minimum Age: 18 Years
* Maximum Age: no maximum age
* Attendance in a cardiac clinic;
* Clinical diagnosis of coronary heart disease or hypertension;
* Age ≥ 18 years;
* Sufficient language skills;
* Informed consent

Exclusion Criteria:

* Life threatening health status;
* Severe somatic or/and psychological disorder that needs urgent treatment;
* Acute suicidal tendency;
* Severe cognitive or/and visual difficulties;
* Not being able to fill out questionnaires
A Two-Week Study of the Efficacy and Safety of Mifepristone in the Prevention of Olanzapine-Induced Weight Gain

This is a two-week study testing the efficacy and safety of mifepristone in the prevention of olanzapine-induced weight gain in healthy male volunteers by measuring changes in body weight and BMI.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male volunteers between 18 and 40 years of age
* BMI between ≥ 18 and ≤ 25
* Able to provide written informed consent
* Routine clinical laboratory tests either within normal limits or not clinically meaningful if outside of normal limits

Exclusion Criteria:

* History of Cushing's syndrome or Addison's disease
* Prior or current history of any psychiatric disorder, including eating disorders such as anorexia nervosa, bulimia nervosa, or binge-eating disorder
* Positive urine drug screen for any non-prescribed drug of abuse (including but not limited to amphetamines, cannabinoids, barbiturates, cocaine, opiates, benzodiazepines)
* Participation in a clinical investigation of any drug, biological or other investigational therapy within 30 days prior to dosing
* Have a history of an allergic reaction to either mifepristone or olanzapine
* Any clinically significant abnormality on screening laboratory tests
* QTc Bazzett's ≥ 450 msec
* Any major medical condition, which in the opinion of the Investigator would place the patient at undue risk.
* Receiving any prescription or over-the-counter medications that could potentially affect appetite or weight
* History of recent (within 6 months of screening) significant weight fluctuation
Assessment of Safety and Efficacy of CCP

Currently there are no proven treatments or vaccines for COVID-19 and care of the COVID patients is largely supportive involving treatment of symptoms such as fever with antipyretics, secondary bacterial chest infection with antibiotics and meticulous management of comorbid conditions.

Several repurposed and new drugs have been investigated for treatment of COVID-19, however, none have been confirmed to be efficacious. These drugs include the antimalarials (chloroquine and hydroxychloroquine), antivirals such as remdesivir and favipiravir and antiretroviral combination therapies such lopinavir/ritonavir.

There is emerging evidence to support the use of COVID convalescent plasma for the treatment of COVID-19. There is need to leverage the blood transfusion services in countries and this is beginning to happen on the continent.

Currently there are no proven treatments for COVID-19 and current standard therapy is supportive care with oxygen supplementation and treatment of symptoms. While treatments are being investigated in the Western world, it is likely that these data will take several months to become available and if proven to be efficacious, access in most of the low-income countries will be limited due to the high global demand and exorbitant costs.

In this study, the investigators aim to assess the safety and efficacy of use of CCP for treatment of adults with COVID-19 in Uganda.

The investigators hypothesise that administration of CCP to patients with positive SARS-CoV-2 RT PCR leads to earlier time to viral clearance compared to the standard of care.

Objectives:

General objective The overall objective of this project is to assess the safety and efficacy of COVID-19 convalescent plasma in the treatment of COVID-19 in Uganda.

Primary objective

1. To determine the efficacy of COVID-19 Convalescent Plasma, as measured by time to RT-PCR negativity of COVID-19 patients treated with COVID-19 Convalescent Plasma.

Secondary objectives

1. To assess the safety of COVID-19 Convalescent Plasma in the treatment of COVID-19 patients in Uganda
2. To document the time to symptom decrease of patients with positive SARS-CoV-2 RT PCR treated with CCP compared to those on standard of care
3. To assess the ability of CCP therapy to stop progression to severe/critical forms of disease This study will be a prospective randomized two arm open label clinical trial. Patients with confirmed COVID-19 who meet the study eligibility criteria will be randomized to receive either CCP in addition to standard of care therapy or standard of care therapy alone.

Eligibility Criteria:
Inclusion Criteria:

* Adults with documented laboratory RT PCR confirmed SAR-CoV-2 infection
* Patients able to provide informed consent. In the event that the patient cannot provide consent e.g. they are severely sick, the next of kin or legal surrogate decision make

Exclusion Criteria:

* Prior diagnosis of IgA deficiency
* Inability to return for post discharge follow up
Upadacitinib As a Novel Treatment for Refractory Eyelid Dermatitis

This study aims to assess the efficacy of upadacitinib in eyelid dermatitis that has not resolved with topical therapies and patch testing.


Eligibility Criteria:
Inclusion Criteria:

* Individuals age 18-70 years old with eyelid dermatitis for at least two months
* Failure of at least one topical prescription cream for the eyelid dermatitis (steroid, pimecrolimus, tacrolimus, crisaborole, or ruxolitinib)
* Women of reproductive potential must agree to using effective contraception during treatment and for 4 weeks following the final dose of Upadacitinib.
* Willing and able participants that provide informed consent
* Willing and able participants that comply with study activities

Exclusion Criteria:

* Self-reported history of allergic response to upadacitinib
* Subject with self-reported history of heart disease, stroke, or neurological conditions
* Currently taking topical medications for eyelid dermatitis within one week of starting study drug
* Women who are pregnant, nursing, or who may become pregnant during the study
* Non-English-speaking subjects
* Patients with an active serious infection
* Patients with active TB or latent TB, patients should be tested for TB prior to upadacitinib treatment.
* Patients with active HBV/HCV or abnormal lab ranges, Lab Data: Hb\<8g/dL, ALC\<500 cells/mm3 and ANC \<1000 cells/mm3
* Patients with a history of malignancy within the last 5 years other than successfully treated NMSC.
Effects on Recovery of Postoperative Gastrointestinal Function With Multimodal Analgesia

breast cancer surgery is associated with a high incidence of persistant postsurgical pain (PPSP). The aim of the study was to evluate the impact of intravenous Tenoxicam on acute and PPSP, analgesic requirements and gastrointestinal recovery in patients undergoing surgery for breast cancer.

thrity patients participated in this randomized, single-blined study. Before and at the postoperative day 1, the bowel function (orocecal transmit time) were measured. Before induction of general anesthesia, patients recieved a bolus of intravenous Tenoxicam or an equal volume of saline (control group). Pain score and opioid consumption were recorded in the postoperative period and then daily for 1 week.

Eligibility Criteria:
Inclusion Criteria:

* ASA I to II Breast cancer patients Mastectomy or wide local excision + axillary note dissection

Exclusion Criteria:

* Preexisting malignancy Chronic infection Previous pain condition Diabetes Thyroid disorder Severe cardiac, renal or hepatic disease Previous breast surgery Psychiatric illness Neurological disease Contraindication for tenoxicam or morphine use
The Application of Ursodeoxycholic Acid for the Prevention of SARS-CoV-2 Infection (COVID-19)

Evaluation of the efficacy and safety of ursodeoxycholic acid in blocking the transmission of infectious novel coronaviruses in a population of medical workers

This is a single-center, open-ended, single-arm clinical study to evaluate the effectiveness of daily ursodeoxycholic acid plus routine protective measures for the prevention of novel coronavirus infection. The target sample size is 130 medical workers and each healthy volunteer will be followed weekly for nucleic acid/antigen testing or disease progression over an 8-week period for new crown infections.

Eligibility Criteria:
Inclusion Criteria:

1. Age 18 - 65 years old.
2. No restriction on gender.
3. Medical-related personnel (working hours \>20 hours per week) serving during the COVID-19 outbreak, including physicians, nurses, medical technicians, administrators, and medical students
4. COVID-19 nucleic acid test negative within 48 hours
5. Sign the informed consent form

Exclusion Criteria:

1. Exhibit COVID-19 symptoms, including fever, muscle pain, headache, cough, sore throat, and loss of smell and taste
2. Previous infection with novel coronavirus within 6 months
3. Previous (past 30 days), current or planned (during the study period) use of immunomodulatory-related drugs
4. Those with allergy or intolerance to ursodeoxycholic acid, gallbladder or bile duct disease, severe liver failure, or liver function impairment
5. Pregnancy and lactation
6. Use of drugs with which ursodeoxycholic acid is contraindicated
7. Other reported health conditions that make participation in the study not in the best interest of the individual
Promoting Community Reintegration for Young Adults With Stroke

This project will investigate the effects of a Narrative and Skills-building Intervention on young stroke survivors' community reintegration and psychosocial outcomes. A randomised controlled trial will be conducted. This is a novel trial to test the short and long-term effects of a theory-based intervention on young stroke survivors' community reintegration.

This project will investigate the effects of a Narrative and Skills-building Intervention on young stroke survivors' community reintegration and psychosocial outcomes. A randomised controlled trial will be conducted. Participants will be facilitated to narrate their survival experiences and rebuild core life skills. Outcomes including community reintegration, depressive symptoms, health-related quality of life, self-efficacy, outcome expectation and satisfaction with performance of self-management behaviours will be measured. This is a novel trial to test the short and long-term effects of a theory-based intervention on young stroke survivors' community reintegration.

Eligibility Criteria:
Inclusion Criteria:

* (1) are 18-64 years of age,
* (2) have a clinical diagnosis of first-ever or recurrent ischaemic or haemorrhagic stroke,
* (3) are living at home after discharge from hospital,
* (4) have a Montreal Cognitive Assessment score \>20,
* (5) have a modified Rankin Scale score ≥3,
* (6) can communicate in Cantonese, and
* (7) are able to attend all intervention sessions.

Exclusion Criteria:

* 1) transient ischaemic attack, subdural or epidural haemorrhage,
* 2) experienced cerebrovascular events due to tumours or head trauma,
* 3) mental condition such as depression, schizophrenia, bipolar or personality disorder,
* 4) incomprehensible speech or difficulty in comprehending conversations, or
* 5) have received a self-management programme in the past.
Ultrasound-guided Interscalene Block:3mL Ropi Provide Similar Analgesia to 5mL and Less Diaphragmatic Paralysis

Ropivacaine for ultrasound-guided interscalene block: 3mL provide similar analgesia to 5mL with less diaphragmatic paralysis in shoulder arthroscopy surgeries

Ropivacaine for ultrasound-guided interscalene block: 3mL provide similar analgesia to 5mL with less diaphragmatic paralysis in shoulder arthroscopy surgeries with no toxicity and no adverse reaction or complications we targeted under echography each nerve to be blocked alone either to put around all the nerves a big volume

Eligibility Criteria:
Inclusion Criteria:

* ASA1-2

Exclusion Criteria:

* ASA3-4 anticoagulant
Study of Geriatric Patients Aged 75 Years or Older Treated and Cured for Localized Prostate Cancer: Case-control Study

This is a multicenter pilot study, proposed for cases and controls 3 departments in France.

Cases are cured patients who have had prostate cancer for at least 10 years. Cookies are healthy subjects selected by lottery on voter list.

Volunteer subjects (cases and controls) are offered a consultation and assessment with an geriatrician.

Volunteer subjects (cases and controls) are offered a consultation and assessment with an geriatrician.

During this consultation, ADL, IADL and MMS questionnary will be completed. neurocognitif testing will be done.

Eligibility Criteria:
Inclusion Criteria for patients:

* Patients aged 75 years or more
* Patients with a personal history of prostate cancer with a diagnosis ≥ 10 years
* Patients who received curative treatment (surgery, radiotherapy,hormone therapy, brachytherapy, technical ablative) for localized prostate cancer
* Patients considered cured of prostate cancer (regardless of initial treatment)
* Patients with previously agreed to participate in a case-control study in the general population (study QALIPRO) as a case and volunteer to receive an assessment of geriatric
* Signature of consent
* Affiliation to a social security system

Exclusion Criteria for patients:

* Patients under 75 years
* Patients with recurrent or metastatic
* Persons deprived of liberty or under guardianship

Inclusion Criteria for control population:

* Male subjects
* Subjects of 75 years or more
* Subjects that do not have cancer or a history of cancer (except basal cell skin cancer)
* Subject has previously agreed to participate in a case-control study in the general population (study QALIPRO) as a voluntary witness and to benefit from a balance oncogeriatrics
* Subjects who gave their written consent to participate in the study
Impact of COVID-19 Lockdown on Obesity and Eating Behaviors

COVID-19 lockdown presents particular challenges for people living with obesity. Indeed during this period, the lifestyle was deeply modified: diet, activity, and sleep behaviours, home office, take care of child, social distancing... All of these modifications may have led to stress and anxiety. It has been previously demonstrated that high perceived stress levels are correlated with high preference for sweet and fat foods . In this context caution would be exercised in obese patients especially those with binge eating disorders. Indeed binge eating disorder is characterized by compulsive overeating or consuming abnormal amounts of food while feeling unable to stop and a loss of control. And one key trigger of binge eating disorder is stress and anxiety. Thus, patients with binge eating disorders may have been more sensitive to the impact of lockdown and thus urgently would require appropriated care management.

The main objective is to compare the eating behaviour between obese patients with or without binge eating disorders. The second objective is to compare the weight evolution between the two groups before and after the lockdown.

To reach these objectives, the scientific team of the CIO project proposes to contact by phone and e-mail obese patients (with or without binge eating disorders) who have been hospitalized for their obesity disease before the start of the lockdown in the Endocrinology department of the Lyon Hospital. The patients will be asked to fill in several questionnaires (using an online tool) allowing to evaluate their mood, anxiety, eating behaviour, binge eating disorders... during the lockdown. The results of these questionnaires will be compared to those collected during their hospitalisation before the lockdown.

The hypothesis is that participants suffering from binge eating disorder will have more sever eating behaviour perturbations as higher level of stress, anxiety, depressive symptoms.


Eligibility Criteria:
Inclusion Criteria:

* severely obese patients

Exclusion Criteria:

* patients do not experiment the full lockdown period
Remote Monitoring and Virtual Collaborative Care for Hypertension Control to Prevent Cognitive Decline Phase II

This is a randomized, controlled, pragmatic trial designed as a "type I hybrid effectiveness-implementation trial" that tests a hypertension program integrating a virtual Collaborative Care Clinic (vCCC), home blood pressure monitoring, and telehealth for lowering blood pressure (BP) in two health systems.

This study tests a hypertension program integrating a virtual Collaborative Care Clinic (vCCC), home blood pressure monitoring, and telehealth for lowering blood pressure (BP) in two health systems (University of Kansas Health System \[UKHS\] and the University of Utah Health \[UUtah\]). The vCCC is staffed by clinical pharmacists who remotely monitor home BP and use telehealth to work with patients to lower systolic blood pressure (SBP) to \<130 mmHg, as recommended by the current American College of Cardiology/American Heart Association (ACC/AHA) guidelines. Eligible patients with uncontrolled hypertension (HTN) are identified automatically through the electronic health record (EHR) during visits to their Primary Care Provider (PCP) and referred for enrollment into the vCCC.

Eligibility Criteria:
Inclusion Criteria:

* Age 65 and older
* Active patient in participating primary care clinic
* Access to compatible "smartphone" or device (i.e., Android, Kindle or Apple with internet connectivity or mobile network)
* Elevated BP as defined by
* SBP \>140 at current visit AND documented history of hypertension OR SBP \> 140 at current visit and at another visit in last 18 months OR SBP \>160 at current visit
* Sufficiently fluent in English to participate in study procedures
* Adequate hearing to complete study procedures
* Able to give their own signed consent
* Health insurance coverage by Medicare

Exclusion Criteria:

* Clinically significant illness that may affect safety or completion per their treating PCP or study physician
* Needing interpreter for clinic visits (through Electronic Health Record)
* Currently in hospice care
* Currently receiving chemotherapy
* Unable to take accurate BP measurement, either due to inability to follow protocol to check BP or due to medical conditions such as lymphedema or dialysis access on both arms.
* Currently participating in another intervention trial
* End stage kidney disease on dialysis
* Diagnosis of dementia (i.e., dementia, Alzheimer's disease, vascular dementia, dementia with Lewy bodies, frontotemporal dementia)
* Chronic active disease with expected life expectancy \< 2 years as determined by the study team
Validation Study Using the GeneSearch BLN Assay to Test Sentinel Lymph Nodes From Patients With Breast Cancer

The purpose of this trial is to show adequate assay performance on clinical samples tested in real time at the clinical site.

This study will determine the sensitivity, specificity, negative predictive value, and positive predictive value of the GeneSearch™ BLN Assay in patient samples by comparing its performance to that of the current methods -- permanent section Hematoxylin and Eosin (H\&E) staining with IHC. Additional marker testing using probes associated with nodal metastases may be used in the assay performance calculations. The observed performance measures will be compared to those obtained in the larger U.S. registration trial to show that there are no differences in the assay's performance.

Eligibility Criteria:
Inclusion Criteria:

* Previous diagnosis of carcinoma of the breast
* Patient scheduled for sentinel lymph node dissection as per standard of care at the clinical site
* 18 years or older
* Female or male, and
* Able and willing to give consent to participate in the study

Exclusion Criteria:

* Patients taking part in other research studies that would interfere with their full participation in this study
TMS-EEG as a Tool to Study the Neuromodulatory Effects of Theta Burst Stimulation

To assess the effect of continuous (cTBS) and intermittent theta burst stimulation (iTBS) stimulation on motor cortex excitability using TMS-EEG. Based on prior literature, the investigators hypothesized that N100 amplitude would be differently modulated by these two modalities.

Each participant underwent three experimental sessions, at least one week apart in a cross-over design, assessing the effects of a single TBS train over the motor cortex on TMS-evoked potentials measured at the same location and resting-state EEG, immediately before and after the intervention. At each session a different type of TBS was applied (cTBS, iTBS or sham) in a randomized sequence. Subjects were uninformed about the expected effects of each intervention. Sham stimulation was achieved by adding a plastic spacer (25mm thickness) between coil and scalp, preventing effective cortical stimulation.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-65 years
* Male
* Right handed subjects
* IQ \> 70
* Healthy participants, as determined by history, clinical investigation and investigator's judgment
* No history of central nervous system condition
* No chronic intake of neurotropic drugs
* TMS Safety Screening questionnaire and informed consent signed

Exclusion Criteria:

* Pregnancy, short-term birth wish or childbearing age without adequate birth control
* Intracranial metal hardware (excluding dental filling): surgical clips, shrapnell, electrodes under the stimulation area
* Presence of pacemaker, implantable cardioverter-defibrillator (ICD), permanent medication pumps, cochlear implants or deep brain stimulation (DBS)