cyrilzakka/clinical-trials huggingface dataset:
Cancer & Chemotherapy Symptom Management Using an Automated Telephone Reporting System

The purpose of this study was to test the efficacy of a computer-based automated symptom monitoring telephone system used by patients who received chemotherapy for their cancer to communicate unrelieved symptoms they experienced to their oncology providers.

The purpose of this study was to test the efficacy of a computer-based automated symptom monitoring telephone system used by patients who received chemotherapy for their cancer to communicate unrelieved symptoms they experienced to their oncology providers. The symptoms monitored in the project were nausea/vomiting, pain, sore mouth, diarrhea, constipation, depressed mood, anxiety, trouble sleeping, and fatigue. The study randomly assigned participants into either the intervention group or the group that received usual care from their oncology providers without alert notifications. All participants called the automated system daily to report their symptom presence, severity, and distress. When participants in the intervention group rated symptoms at moderate (4-7) to severe (8-10) levels an e-mail alert report of their symptom information was sent to the participant's medical oncologist and oncology nurse. The usual care group also reported symptoms daily to the automated system but their information was not sent to the providers. Participants in the usual care group were told daily to call their oncology provider if they had concerns about their symptoms. The two study groups were compared over chemotherapy cycles 2 and 3 on symptom presence, severity, and distress. Functional status, patient reported degree of symptom interference with normal activities, and work attendance if they had indicated that they worked during their treatment were also recorded. In addition, the groups were compared for the number and purpose of unscheduled patient-provider contacts, visits to the emergency department or urgent care facility, and unscheduled hospitalizations.

Eligibility Criteria:
Inclusion Criteria:

* Adult (18 or older)
* Histological Diagnosis of Cancer
* Life Expectancy of at least 6 months
* Cognitively able to participate (verified by provider team)
* Initiated a course of new Chemotherapy that is planned for a minimum of 3 cycles
* Had Poorly controlled symptoms during the first cycle of chemotherapy
* Care under the direction of one of the designated provider teams
* English or Spanish speaking
* Has access to a telephone on a daily basis
* Able to use the telephone unassisted

Exclusion Criteria:

* Receiving concurrent radiation therapy because they would be in daily contact with oncology care providers.
* Patients seeing the provider team for recommendation of chemotherapy regimen but other providers then administer treatment at different site
* Patients receiving a treatment regimen with only biotherapy agents or agents not associated with the symptoms monitored
Comparison of Cypher Select and Taxus Express Coronary Stents

Randomized nine months clinical comparison of implantation of Taxol eluting (Taxus Express) and Sirolimus eluting (Cypher Select) stents in non-selected patients with coronary artery disease.

Design:

* Randomized open multicentre trial.

Patients:

* 1800 patients with coronary artery disease scheduled for percutaneous coronary intervention with stent implantation.

Inclusion criteria:

* Patients with coronary artery disease scheduled for percutaneous coronary intervention with stent implantation.
* Signed informed consent.

Exclusion criteria:

* Participation in other stent studies.

Randomization:

* Implantation of Taxus Express og Cypher Select stents.

Primary end-point:

* Combined end-point of cardiac death, new revascularization (PCI or CABG) or myocardial infarction after nine months.

Secondary end-points:

* Total death after nine months
* Cardiac death after nine months
* Myocardial infarction after nine months
* Index vessel myocardial infarction after nine months
* Target lesion revascularization
* Target vessel revascularization
* Stent thrombosis after nine months

End-point evaluation:

* End-points will be adjudicated by an independent end-point committee

Eligibility Criteria:
Inclusion Criteria:

* Planned implantation of drug eluting stent
* Written informed consent

Exclusion Criteria:

* Planned intervention with other stents than study stents
Effects of Light Treatment During Sleep on Young Men

This study will determine if green light exposure during sleep is effective in reducing mild depression symptoms in young men.

The circadian rhythm is the human body's internal clock. It affects sleeping and wakefulness patterns. Some scientists theorize that a disruption of circadian rhythms, or other circadian abnormalities, can cause a depressed state. Light received through the eyes can alter the circadian rhythm, and sustained exposure to artificial bright light during the last half of usual sleep time can change the phase of the circadian rhythm. Several studies have found that exposure to bright white light in the morning hours is an effective treatment for depression, especially during the first week of depression treatment. Other studies have shown that green or blue light is preferable to yellow or red light in depression treatment. This study will expose young men to different types of light during the last part of their sleep cycle to determine whether the treatment is safe and tolerable and whether it reduces mood disturbance and depression. The study will also determine the light's effect on the production of luteinizing hormone (LH) and testosterone, hormones that may play a role in depression.

Participation in this study will last 15 days. At the beginning of the study, participants will be provided with study materials and instructed in their use. These materials will include a wrist actigraph, which is a sleep and wakefulness monitoring device similar to a wristwatch; a binder containing instructions, questionnaires, and forms; and a light mask. Participants will be randomly assigned to receive a light mask with either intense green or dim red light. Participants will wear the wrist actigraph throughout the study. For the first 3 days of the study, participants will sleep normally and fill out questionnaires and a sleep diary. The questionnaires will measure mood, sleepiness, sleep quality, treatment effects, and sleep time preference. The sleep diary will be a record of time spent sleeping, time it takes to fall asleep, number of times waking during the night, and similar measures. Starting on the third night, participants will wear the light mask when sleeping. Every day participants will fill out the questionnaires and sleep diary, and they will contact the study investigators to ensure compliance and to ask any questions. Participants will also provide saliva and urine samples once at the beginning and once at the end of the study. These samples will be used to test for testosterone and LH, respectively.

Eligibility Criteria:
Exclusion Criteria:

* Presence of clinical depression
* Presence of a sleep disorder
Dismembered Pyeloplasty With and Without After Coming Stent

to compare outcome of pyeloplasty in pediatric population less than 6 months in age using an after coming stent versus stentless pyeloplasty.

A prospective randomized control study including patients divided into two groups,all patient undergoes dismembered pyeloplasty First group will be with an after coming stent ,Second group will be stentless to compare outcome of pyeloplasty in pediatric population less than 6 months in age

Eligibility Criteria:
Inclusion Criteria:

* Pelvi-ureteric junction obstruction (PUJO)
* Asymptomatic obstruction with reduced function (less than 35-40%)
* Asymptomatic obstruction with antero-posterior diameter exceed 40 mm
* Asymptomatic obstruction with deterioration on conservative follow up.
* Symptomatic PUJ obstruction, e.g. pain, renal mass, fever and stones.

Exclusion Criteria:

* Secondary Pelvi-ureteric junction obstruction
* Solitary kidney
* Gross pyuria
* Ectopic kidney
* Dilated ureter
Hydroxychloroquine vs. Azithromycin for Hospitalized Patients With Suspected or Confirmed COVID-19

This study will compare two drugs (hydroxychloroquine and azithromycin) to see if hydroxychloroquine is better than azithromycin in treating hospitalized patients with suspected or confirmed COVID-19.


Eligibility Criteria:
Inclusion Criteria:

* Adult (age ≥ 18 years)
* Confirmed OR suspected COVID-19,

  * Confirmed: Positive assay for COVID-19 within the last 10 days
  * Suspected: Pending assay for COVID-19 WITH high clinical suspicion
* Scheduled for admission or already admitted to an inpatient bed

Exclusion Criteria:

* Allergy to hydroxychloroquine or azithromycin
* History of bone marrow transplant
* Known G6PD deficiency
* Chronic hemodialysis or Glomerular Filtration Rate \< 20ml/min
* Psoriasis
* Porphyria
* Concomitant use of digitalis, flecainide, amiodarone, procainamide, propafenone, cimetidine, dofetilide, phenobarbital, phenytoin, or sotalol
* Known history of long QT syndrome
* Current known QTc\>500 msec
* Pregnant or nursing
* Prisoner
* Weight \< 35kg
* Seizure disorder
* Severe liver disease
* Outpatient use of hydroxychloroquine for treatment of a disease other than COVID-19 OR has received more than 2 days of hydroxychloroquine or azithromycin for suspected or confirmed COVID-19
* Patient has recovered from COVID-19 and/or is being discharged from the hospital on day of enrollment.
* Treating physician refuses to allow patient participation in the study
* Unable to obtain informed consent
* Prior enrollment in this study
Increasing Vaccine Uptake in Underresourced Public Housing Areas

This proposal seeks to enhance uptake and completion of COVID-19 vaccination among African American and Latinx public housing residents in South Los Angeles. Given the multiple disparities experienced by public housing residents, the investigators will utilize a theoretically-based, multidisciplinary and culturally tailored intervention to provide education at multiple levels and implement innovate strategies to engage this population in the uptake of COVID-19 vaccination.

One particular group, African American and Latinx public housing residents, are facing adverse effects related to worsening social determinants and health disparities. Utilizing a community-driven approach, the overall objective of this proposed study is to increase COVID-19 vaccine uptake and completion the impact of COVID-19 among African American and Latinx public housing residents. Guided by the Community Based Participatory Model, the Information, Motivation, and Behavioral Skills (IMB) and the Transtheoretical Model will be utilized to carry out this intervention. Through this innovative program, we will establish Academic-Community Team for Improving Vaccine Acceptability and Targeted Engagement (ACTIVATE) program, which will develop leadership triads of public housing resident leaders, nurse practitioner students, and public health students to carry out this multilevel intervention.

Eligibility Criteria:
Aim 2:

Inclusion Criteria:

* identify as Latinx or African American
* age 18 or older
* reside in one of the six collaborating public housing area
* Speak either English or Spanish

Exclusion Criteria:

* Not a resident at one of the collaborating public housing areas
* Does not self-identify as African American or Latinx
* Age 17 and younger
* Unable to speak either English or Spanish

Aim 3:

Inclusion Criteria:

* identify as Latinx or African American
* age 18 or older
* reside in one of the six collaborating public housing area
* Speak either English or Spanish
* Report vaccine hesitancy

Exclusion Criteria:

* Not a resident at one of the collaborating public housing areas
* Does not self-identify as African American or Latinx
* Age 17 and younger
* Unable to speak either English or Spanish
* Received all recommended vaccines for COVID-19
* No reporting of vaccine hesitancy
Assisted Animal Therapy: ReAnimal

Assisted animal therapy (AAT) is getting more and more used worldwide, in such areas as gerontology, psychiatry, or oncology. It is a complementary therapy, and benefits for patients are various, including decrease of anxiety. In ICU, some case reports exist, but no study has ever been made in order to prove its benefits, not even its feasibility.

In ReAnimal, the investigator aims to compare a group of patients receiving assisted animal therapy, versus a group of patients not receiving it. Primary objective will be the evolution of anxiety scores between the 2 groups of patients. Secondary objectives will be the comparison of mood scores, post traumatic stress syndrome scores, pain scores, and physiologic parameters such as blood pressure, cardiac frequency. The investigating team will also compare multi drug resistant bacteria incidence between the 2 groups. In the assisted animal therapy group, patients will also be asked to answer a satisfaction questionnaire.


Eligibility Criteria:
Inclusion Criteria:

* patients hospitalized in surgical ICU, not in acute stage of their ICU stay
* adult patient
* able to receive information and to give consent,
* with national social insurance

Exclusion Criteria:

* afraid of animal, dog phobia
* allergic to dog
* immunodepression (neutrophils \<0.5 G/L), induced by treatment (chemotherapy, immunosuppressing treatment with high doses, corticotherapy for more than 2 weeks) or induced by disease (malignant blood disease, AIDS, transplantation, or splenectomy)
* sepsis ongoing
* patient known for having multidrug resistant bacteria
* wounds, or large bandages that could not correctly be covered, including external fixer
* central venous catheter, arterial catheter
* tracheostomy
* agitation, aggressiveness
* pregnant women
* patient deprived of freedom by juridical or administrative decision
* patient under legal protection measure
* patient receiving enforced psychiatric treatment
* patient admitted in a sanitary or social department.
Canakinumab in the Treatment of Gouty Arthritis Flare(s) and Prevention of New Flares in Patients With Chronic Kidney Disease

The purpose of this study is to confirm the efficacy and safety results obtained in a chronic kidney disease (CKD) subgroup of patients participating in Phase III studies in a larger, independent patient population with difficult to treat gouty arthritis and moderate to severe CKD (stage 3 - 4).


Eligibility Criteria:
Inclusion criteria:

* Confirmed diagnosis of gouty arthritis History of ≥ 3 gouty arthritis flares within the previous 12 months
* Confirmed diagnosis/ documented history of chronic kidney disease (CKD) Stages 3or4
* Onset of current acute gouty arthritis flare within 3 days prior to randomization

Exclusion criteria:

* Hemodialysis CKD Stage 5 Organ transplantation
* Rheumatoid arthritis, evidence/suspicion of infectious/septic arthritis, or other acute inflammatory arthritis
* Live vaccinations within 3 months prior to randomization Other protocol-defined inclusion/exclusion criteria may apply
Odors to Insufflate Life

Apneas concern about 85% of premature newborns (NB) born after less than 34 weeks of pregnancy. They are considered as an important risk factor for subsequent neuropsychological deficiency. Current pharmacological treatments are not very effective, and have side effects (agitation, irritability, sleep disorders, tachycardia). Some studies suggest that in NBs with apneas resisting to drugs, a permanent odorisation with a drop of vanillin on the incubator's pillow might reduce the frequency of apneas. This latin square design study will test a controlled olfactory stimulation method, i.e. an olfactometer which controls the odor duration, intensity, and sequence using three different odors, to reduce apneic episodes measured using 24-registration of heart and respiratory rates.


Eligibility Criteria:
Inclusion Criteria:

* Newborns from a single or multiple pregnancy
* Newborns hospitalized in the Lyon East or Saint-Etienne neonatology services, of both sexes, born before 33 weeks of amenorrhea and after at least 6 days of life, without respiratory disease beside premature birth.
* Newborns must present at least 3 bradycardia during 3 days, or presenting apneas at observation.
* Newborns will be randomized if they present at least 3 apnea episodes per 24 hour monitored by RECAN for 3 consecutive days prior to randomization.
* Written informed consents obtained from the newborns parents or legal representatives

Exclusion Criteria:

* Severe congenital malformation
* History of allergic reaction to smell stimulation (cough, sneeze, watery eyes, breathing pauses)
* No social insurance
Safety and Efficacy of NAFT900 in Children With Tinea Capitis

A Double-Blind, Randomized, Vehicle-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of NAFT-900 in Children Aged 6 to \< 13 Years with Tinea Capitis

This is an 8-week double-blind, randomized, vehicle-controlled, multicenter study of NAFT-900 compared to vehicle in the treatment of tinea capitis in children ≥6 years to \<13 years of age.

There will be approximately 60 subjects enrolled. Qualifying subjects with clinical evidence of a tinea capitis infection involving ≤ 15% of the scalp, confirmed by positive culture, will be randomized 2:1 to one of the following treatments:

* NAFT-900 (Naftifine hydrochloride foam, 3%)
* Vehicle Foam The study will consist of up to 6 visits. Subjects will apply the assigned study product twice daily to the affected area(s) for 4 weeks

Eligibility Criteria:
Inclusion Criteria:

1. Subjects with clinical diagnosis of tinea capitis with ≤15% involvement of the scalp.
2. Subjects with positive KOH microscopy and culture \[for dermatophytes\].
3. Male or female subjects ≥6 years and \<13 years of age on the date of the Baseline Visit.

Exclusion Criteria:

1. Subject with acute inflammatory fungal infection of the scalp (kerion)
2. Subjects with skin disease on the scalp, or any other condition or prior/present treatment which in the opinion of the investigator would interfere with the study drug's effect or assessments (e.g., psoriasis, seborrheic dermatitis).
3. Subjects who received immunosuppressant therapy, cytostatic therapy or radiation therapy within 4 weeks prior to the baseline.
4. Subjects who received systemic corticosteroids and/or systemic antibiotics within 4 weeks prior to study entry (or during study).
5. Subjects who have used systemic antifungal treatment within 4 weeks prior to the baseline.
6. Subjects who have used antifungal agents, corticosteroid preparations, ketoconazole, ciclopirox, salicylic acid, terbinafine, amorolfine, butenafine, clotrimazole, econazole, oxiconazole, sertaconazole, sulconazole, luliconazole, fluconazole, benzoic acid, griseofulvin, undecylenic acid, zinc pyrithione or selenium sulfide, or tar containing topical treatments for their scalp within 1 week prior to the baseline visit.
7. Subjects with a life-threatening condition (ex. autoimmune deficiency syndrome, cancer, unstable angina, or myocardial infarction) within the last 6 months prior to baseline visit.
Study of Tadalafil Once-a Day for 12 Weeks in Men With Signs and Symptoms of Benign Prostatic Hyperplasia

This is a randomized, double-blind, placebo-controlled, parallel-design, multinational, 12-week study to compare the efficacy, dose response, and safety of tadalafil once a day versus placebo in men with signs and symptoms of benign prostatic hyperplasia, including lower urinary tract symptoms.


Eligibility Criteria:
Inclusion Criteria:

* Males, 45 years or older, with benign prostatic hyperplasia, including lower urinary tract symptoms for at least 6 months prior to Visit 1 and an International Prostate Symptom Score (IPSS) greater than or equal to 13 at Visit 2.
* Agree not to use approved or experimental benign prostatic hyperplasia or erectile dysfunction treatments anytime during the study
* Have not taken finasteride or dutasteride therapy, any other lower urinary tract symptom (LUTS) therapy or phosphodiesterase type 5 (PDE5) inhibitors for specified duration of time prior to Visit 2.
* Have a prostate specific antigen (PSA) score within acceptable range defined for study or negative biopsy of the prostate for cancer within 12 months of Visit 1.

Exclusion Criteria:

* History of urinary retention or lower urinary tract (bladder) stones 6 months before the start of the study
* History of bladder outlet obstruction or urethral obstruction due to stricture, valves, sclerosis, or tumor.
* History of cardiac conditions including angina requiring certain treatment with nitrates, heart disease or coronary conditions including myocardial infarction, bypass surgery, angioplasty or stent placement for a specified time before starting the study.
* Certain neurological conditions associated with bladder problems or injuries to the brain or spinal cord within a specified time before starting the study.
* Nitrate use
Effect of Dolutegravir Compared with Darunavir/Cobicistat on the Severity of Neuropsychiatric Effects Al 12 Weeks in Antirretroviral Treatment-Naive Adults.

This clinical trial aimed at evaluating changes in neuropsychiatric scales for depression, anxiety, insomnia, and sleep quality in people living with HIV (PLHIV) who initiate antiretroviral therapy (ART) with a regimen of Dolutegravir (DTG) or Darunavir/Cobicistat (DRV/c), both combined with tenofovir disoproxil fumarate/emtricitabine (TDF/FTC).

This clinical trial aims to evaluate changes in neuropsychiatric scale (NPS) scores among Mexican men living with HIV who present baseline NPS symptoms and are naïve to antiretroviral therapy (ART). Participants will initiate either a Dolutegravir (DTG)-based regimen or a Darunavir/Cobicistat (DRV/c)-based regimen, both combined with tenofovir disoproxil fumarate/emtricitabine (TDF/FTC). All patients will undergo a psychiatric evaluation prior to ART initiation. Treatment discontinuation will be considered for participants experiencing an exacerbation of NPS symptoms associated with grade ≥2 adverse events. NPS scores will be assessed and compared at weeks 4 and 12.

Eligibility Criteria:
Inclusion Criteria:

* Patients living with HIV not experienced to ART
* Age ≥ 18 years.
* eGFR \>60 mL/min
* Beneficiaries of the Mexican Social Security Institute treated at the "La Raza" National Medical Center
* Patients with a baseline ISI scale score: ≥8-14 points
* Patients with a baseline PHQ-9 scale score: 5-9 points
* Patients with a baseline HADS-A scale score: 8-10 points
* Patients with a baseline HADS-D scale score: 8-10 points
* Patients with a baseline Pittsburgh scale score: 5-7 points.

Exclusion Criteria:

* Patients with use of antidepressants/anxiolytics prior to starting ART
* Any Contraindication for the use of second generation INSTI or IP ART regimen
* Coinfection with Hepatitis C Virus
* Known resistance mutations to any of the components of both treatment regimens.