cyrilzakka/clinical-trials huggingface dataset:
Healthcare-associated Infections in Severe COVID-19 During 2020

In patients who develop ARDS due to SARS-CoV-2 (CARDS), a longer duration of invasive mechanical ventilation (IMV) and ICU stay has been reported compared to ARDS not associated with SARS-CoV-2. Consequently, the days of stay in ICU increase Identifying the risk factors associated with the development of this complication and developing measures aimed at its prevention could have a favorable impact on the clinical course of seriously ill patients.

The rate of catheter-associated bacteremia is 3.78 / 1000 days central venous catheters in polyvalent ICUs.

Some studies suggest that in the context of this pandemic, infections associated with health care have increased, although there are few data referring to Latin America.

The objective of this study is to analyze the incidence of health care associated infections in adult patients on invasive mechanical ventilation with confirmed COVID-19 diagnosis and negative COVID-19 admitted to the Intensive Care Unit of the Anchorena San Martín Clinic, San Martín, Buenos Aires.

Eligibility Criteria:
Inclusion Criteria:

* All patients older than 18 years admitted to the intensive care unit of the Anchorena San Martín Clinic who required invasive mechanical ventilation for more than 24 hours in a period between March 2020 and December 2020 were included in the analysis.

Exclusion Criteria:

* All patients who presented incomplete data in the follow-up sheets were excluded.
Effectiveness and Tolerability of the On-demand Use of Combined Dapoxetine With Tadalafil and Combined Dapoxetine With Lidocaine 5% Spray in Treatment of Patients With Lifelong Premature Ejaculation and Non-responding to Dapoxetine Alone.

Therefore, this study will aim to assess the effectiveness and tolerability of the on-demand use of combined dapoxetine with tadalafil and combined dapoxetine with lidocaine 5% spray in treatment of patients with lifelong premature ejaculation and non-responding to dapoxetine alone.

This study will be carried out on 60 patients with lifelong premature ejaculation and non-responding to dapoxetine alone.

All patients will be equally divided into 2 groups (30 patients each). Group 1 was given on-demand 30 mg dapoxetine and 10 mg tadalafil 1 h before intercourse. Group 1 was given on-demand 30 mg dapoxetine 1 h before intercourse and apply lidocaine 5% spray on the glans penis 10 minutes the wash before intercourse.

Eligibility Criteria:
Inclusion Criteria:

* lifelong premature ejaculation and non-responding to dapoxetine alone.

Exclusion Criteria:

* diabetes mellitus,
* chronic prostatitis,
* Advanced renal or hepatic diseases
* neurological diseases
* C.N.S. medications
Simulated Clinical Use Testing on Safe'N'Sound 1ML Stalked Passive Delivery System With Add-On Extended Finger Flanges

A simulated clinical use testing the Save'N'Sound 1mL staked Passive Delivery System with add-on extended finger flanges

This study aims to evaluate the safety of the use of the Safe'N'Sound 1mL staked passive delivery system cone version with add-on EFF in the prevention of needle stick injuries and to evaluate the user's satisfaction with regards to the handling characteristics of the product namely safety, design and the ease of use.

Eligibility Criteria:
Inclusion Criteria:

The Evaluator must be:

* Minimum of age 18
* Able to understand and provide signed consent for the study
* Willing to comply with the study protocol, including being willing to answer questions and complete questionnaires
* Have no concerns about the ability to perform the simulated injections
* With no financial interest in the sponsor (Nemera) or the CRO (NAMSA)

Exclusion Criteria:

* If in the opinion of CRO, including the observer/monitor, the potential evaluator is not a good candidate for the study, including the reasons such as mental health.
Neutrophil Extracellular Traps and Sickle Cell Disease

NETs formation in vaso-occlusive events in sickle cell disease and the role of hydroxyurea treatment.The study hypothesis is that NETs formation by neutrophils has a role in the induction of vaso occlusive disease in blood vessels. It is possible that high leukocyte count in children with sickle cell anemia is a bad prognostic sign due to NETs formation supporting occlusion of peripheral and central blood vessels.Hydroxyurea treatment might prevent vaso occlusive syndrome not only by increasing HbF but also by decreasing neutrophil count and inhibiting NETs formation.


Eligibility Criteria:
Inclusion Criteria:

* children who suffer from sickle cell disease and/or children with sickle cell disease treated with hydroxyurea

Exclusion Criteria:

* none
Spaulding-Harvard Model System: Effects of Transcranial Direct Current Stimulation (tDCS) on Chronic Pain in Spinal Cord Injury

The purpose of this study is to see the effects of transcranial direct current stimulation (tDCS) on the pain associated with spinal cord injury. This study is part of the Spaulding-Harvard Model System. The investigators hypothesize that there will be a decrease in pain levels with active stimulation, when compared to sham stimulation, using a 3 week stimulation schedule- 1 week of stimulation (5 consecutive days) followed by 2 weeks of stimulation (10 consecutive days) after a 3-month follow up visit. The subject will also have follow ups at 2, 4 and 8 weeks after the second course of stimulation.

If a subject receives sham during the experiment, he/she may enroll in an open-label portion of the study and receive 10 days of active stimulation.


Eligibility Criteria:
Inclusion Criteria:

* Over 18 years of age
* History of moderate to severe sublesional pain

Exclusion Criteria:

* Active alcohol or drug dependence, as self-reported
* A history of bipolar disorder or psychosis, as self-reported
* Inability to travel to the study site,
* Current use of any of the following anti-epileptic medications or dopaminergic medications known to reduce or inhibit the benefits of tDCS treatment \[53\]: carbamazepine, oxcarbazepine, phenytoin, ropinirole (Requip), pramipexole (Mirapex), and cabergoline (Dostinex),
* The following contradictions to tDCS: implanted metal plates in the head, or deep brain stimulator (spinal cord implants, including baclofen pumps, are not a contraindication as cranial currents do not reach the spinal cord \[24\]).
* Pregnancy at time of enrollment
* Current use of ventilator.
Effect Whole Body Vibration on Balance in Post Diabetic Menopause Women

Postmenopausal diabetic women have significant balance deficits and increased fall risk. Whole-body vibration may improve balance in these population but needs further research. The purpose of the current study was to determine the effect of whole-body vibration on balance in postmenopausal diabetic women.

Background: Menopause is characterized by reduced androgens produced by ovaries, which negatively affect women health including metabolism and quality of life (QoL) and sexual function. Purpose: This study investigates the effect of whole-body vibration on balance and QoL in postmenopausal diabetic women. Methods: Forty postmenopausal women with diabetic neuropathy will participate in this study aged from 50 to 65 years. They will be randomly distributed into two equal groups: Group A (study group): will receive whole body vibration (WBV) and balancing exercise. Group B (control group): will receive the same balancing exercises as group A. The treatment will be performed 3 times per week for 12 weeks. Dynamic balance will be assessed by Biodex Balance System (BBS) that assesses (Overall stability index \[OSI\], anteroposterior stability index \[APSI\] and mediolateral stability index \[MLSI)\], Berg Balance test (BBT) and Time up and go test (TUG). Quality of life will be assessed by menopous specific in Quality of Life questionnaire before and after the treatment.

Eligibility Criteria:
Inclusion Criteria:

* Inclusion Criteria:

Patients were examined by a gynaecologist before the study and were selected according to the following criteria:

* Diabetic postmenopausal women who suffered from peripheral neuropathy
* Their ages ranged from 50 to 65 years.
* Body Mass Indices (BMI) ≤ 30kg/m2
* They were medically stable.

Exclusion Criteria:

* Patients were examined by a gynaecologist before the study and were excluded if they had:

  * Inner ear disturbance.
  * Musculoskeletal problems.
  * Active tuberculosis and tumours.
  * Implanted cardiac rhythm devices.
  * Any hormonal replacement therapy or drug treatment that could affect normal metabolism of musculoskeletal system.
  * Habitual exercise or participate in any supervised exercise.
  * Hypo- or hyperparathyroidism, renal, liver, or chronic disease.
Effect Study of Tigecycline to Treat Severe Sepsis and Septic Shock

Selection of tigecycline in severe sepsis and septic shock patients in empirical antibiotic therapy (Hai Zheng Energy Star ®) combined with piperacillin / tazobactam (tazocin ®) scheme, compared with the classical scheme, evaluate its efficacy, safety index.

Tigecycline as representative glycylcycline antibiotics, has wide antibacterial spectrum and strong antibacterial activity, tigecycline in almost all of the gram positive bacteria and most gram negative bacteria and atypical pathogens, anaerobic bacteria are very good antibacterial activity except Pseudomonas aeruginosa, Proteus. Safety on organ function, in patients with renal insufficiency or in dialysis patients, no dose adjustment is required application of tigecycline, mild to moderate hepatic insufficiency patients do not need to adjust the dose of tigecycline. Piperacillin / tazobactam also is a broad spectrum, potent antibiotics, especially strong bactericidal activity against Pseudomonas aeruginosa, including resistant enzyme producing gram negative bacilli, in accordance with its pharmacokinetic pharmacodynamic characteristics of prolonged infusion time can obtain a stronger bactericidal activity. These two potent drugs have broad antimicrobial spectrum, strong bactericidal activity, and provide for the treatment of severe sepsis and septic shock a new choice in antibiotic selection, to a certain extent reduces the resistance pressure, and have more clinical safety.

Eligibility Criteria:
Inclusion Criteria:

* Be consistent with severe sepsis and septic shock diagnosis standards
* Age above 18 years old, is expected in more than 5 days in ICU
* APACHEⅡ score\>15
* By the patients themselves or their authorized person agreed to participate in the clinical trial and signed the informed consent

Exclusion Criteria:

* Allergic to penicillin, or of tigecycline allergic patients
* Patients with abnormal liver function is severe
* Be pregnant or lactating women
* Be not signed the informed consent of patients
* Any can be expected to increase patient risk or other factors can interfere with the results of a clinical trial
PRO1160 for Advanced Solid and Liquid Tumors (PRO1160-001)

Brief Summary:

This study will test the safety, including side effects, and determine the characteristics of a drug called PRO1160 in participants with solid tumors.

Participants will have solid tumor or liquid cancer that has spread through the body (metastatic) or cannot be removed with surgery (unresectable).

This Phase 1/2 study will have two parts. Part A of the study will find out how much and how frequently PRO1160 should be given to participants. Part B will use the dose and schedule found in Part A to find out how safe PRO1160 is and if it works to treat the diseases under study. The diseases under study will be Renal Cell Carcinoma (RCC),Nasopharyngeal Carcinoma (NPC) and Non-Hodgkin Lymphoma (NHL).

This is a Phase 1/2 study of PRO1160, a CD70 targeted antibody-drug conjugate, to evaluate the safety, tolerability, PK, and antitumor activity of PRO1160 in patients with selected locally advanced /or metastatic solid and liquid tumors, including renal cell carcinoma, nasopharyngeal carcinoma and non-hodgkin lymphoma. This study consists of 2 parts, Part A: Dose Escalation and Part B: Dose Expansion.

Part A may evaluate up to 7 dose levels of PRO1160 on Day 1 of a 21 day cycle by IV infusion.

Part B will be initiated at a dose level based on a comprehensive analysis of safety, tolerability, clinical PK, PD and activity data from Part A in up to 4 different cohorts of up to 20 patients per cohort.

Patients will continue to receive study treatment until the first instance of disease progression, unacceptable toxicity, investigator decision, consent withdrawal, study termination by the Sponsor, pregnancy, or death.

Eligibility Criteria:
Inclusion Criteria:

* Pathologically confirmed metastatic or unresectable solid malignancy including Renal Cell carcinoma, Nasopharyngeal carcinoma or Stage III or IV Non Hodgkin Lymphoma
* Relapsed or refractory disease following prior systemic therapies known to confer medical benefit
* Willing to provide a tumor sample (archive tissue or fresh biopsy)
* ECOG performance status 0 or 1
* Measurable disease per RECIST v1.1 for RCC and NPC and per Lugano for NHL

Exclusion Criteria:

* Prior treatment with anti-CD70 directed therapy
* Other malignancy within 3 years
* Active CNS metastases (treated, stable CNS metastases are allowed)
* Uncontrolled Grade 3 or greater infection within 2 weeks
* Positive for HBV, HCV or HIV
* Use of a strong P450 CYP3A inhibitor within 14 days (dose escalation only)
* Additional protocol defined inclusion/exclusion criteria may apply
The Diagnostic Utility of Ultrasound in Pelvic Inflammatory Disease (PID)

Pelvic inflammatory disease (PID) represents a significant and complex health issue affecting women, particularly those of reproductive age. Characterized by the infection and inflammation of the reproductive organs, PID often results from ascending infections primarily caused by sexually transmitted pathogens, such as Neisseria gonorrhoeae and Chlamydia trachomation. However, it can also be associated with endogenous bacteria or occur following surgical procedures.

The diverse manifestations of PID from asymptomatic cases to acute presentations, pose significant challenges in diagnosis and prompt treatment. Accurate diagnosis is crucial, as untreated infections can lead to severe complications, including infertility, chronic pelvic pain, and ectopic pregnancies.

Eligibility Criteria:
Inclusion Criteria:

* Women of reproductive age (18-45 years) presenting with symptoms suggestive of pelvic inflammatory disease (PID).
* Patients who have been clinically diagnosed with PID based on symptoms such as lower abdominal pain, fever, abnormal vaginal discharge, and tenderness upon pelvic examination.
* Patients who have undergone preliminary diagnostic tests, such as high vaginal swab (HVS) and urine microscopy, culture, and sensitivity (m/c/s), prior to ultrasound assessment.

Exclusion Criteria:

* Pregnant women, due to potential confounding factors in ultrasound findings and differential diagnosis.
* Patients with chronic pelvic pain not related to acute PID episodes.
* Patients who do not provide informed consent for participation in the study.
* Patients with a history of recent pelvic surgery within the last 6 months, as postoperative changes may affect ultrasound findings.
The DEPOT Study (Dry Eye Prescription Options for Therapy)

Assessing DEXTENZA efficacy and safety when placed within the lower eyelid canaliculus for dry eye flares in comparison to topical loteprednol suspension.

The DEPOT Study (Dry Eye Prescription Options for Therapy): A randomized controlled clinical trial assessing the efficacy and safety of DEXTENZA, sustained release dexamethasone 0.4 mg insert, when placed within the lower eye eyelid canaliculus in comparison to topical loteprednol suspension for the treatment of episodic dry eye.

Eligibility Criteria:
Inclusion Criteria:

* Patients 18 years and older
* Patients willing to take an electronic survey about their tolerability of either study medication.
* Patients with a recent exacerbation of dry eye characterized by ocular surface discomfort.

Exclusion Criteria:

* Active, systemic or local disease condition other than DES that causes clinically significant ocular surface irritation that could interfere with the evaluation and treatment of dry eye.
* Any of the following ocular (eye or eyelid) conditions in either eye within 1 Months prior to the enrollment visit:

  * Ocular surgery (e.g., intraocular, oculoplastic, corneal or refractive surgery procedure)
  * Clinically significant ocular trauma.
  * Active ocular Herpes simplex or Herpes zoster (eye or eyelid) infection.
  * Ocular inflammation (uveitis, iritis, scleritis, episcleritis, keratitis, conjunctivitis)
  * Ocular infection (e.g., viral, bacterial, mycobacterial, protozoan or fungal infection of the cornea, conjunctiva, lacrimal gland, lacrimal sac or eyelids including hordeolum/stye)
* Moderate to severe (Grade 2-4) allergic, vernal or giant papillary conjunctivitis
* Eyelid abnormalities that significantly affect lid function (e.g., entropion, ectropion, tumor, edema, blepharospasm, lagophthalmos, severe trichiasis, severe ptosis)
* Ocular surface abnormality that may compromise corneal integrity (e.g., prior chemical burn, recurrent corneal erosion, corneal epithelial defect, Grade 3 corneal fluorescein staining, or map dot fingerprint dystrophy)
* Participation in another ophthalmic clinical trial involving a therapeutic drug or device within 30 days prior to the distribution of the survey
* Participation in this trial in the same patient's fellow eye.
* Patients who are pregnant or breastfeeding or who may become pregnant during participation in the study.
Community-engaged Hypertension Prevention Program in Black Men

The CLIP program will train Community Health Workers (CHWs) to screen and identify Black men with elevated blood pressure (BP) or stage 1 hypertension (HTN), initiate lifestyle counseling; and link them to primary care and social services.

The study will consist of:

1. An implementation phase that will use a cluster randomized cluster trial of 20 barbershops among Black men with elevated BP or Stage 1 HTN, to compare the effect of the Barbershop-based Facilitation (BF) strategy (n=10 barbershops; n=210 participants) vs. self-directed control (i.e. receipt of information for implementation of CLIP without the BF strategy; n=10 barbershops; n=210 participants), on BP reduction, HTN prevention, linkage to care, and adoption of CLIP at 12 months
2. A post-implementation phase that will use Reach Effectiveness Adoption Implementation and Maintenance (RE-AIM) to evaluate the effect of the BF strategy versus self-directed control on sustainability of CLIP 6 months after completion of the trial; and cost-effectiveness over a 10-year time horizon.

Eligibility Criteria:
Inclusion Criteria:

1. 18 years of age as of date of data extraction
2. Repeat customer within the last 3 months
3. Self-identify as Black
4. Self-identify as male
5. Have elevated blood pressure (PB) (120-129/\<80 millimeters of mercury (mm Hg)) or untreated stage 1 hypertension (HTN) (130-139/80-89 mm Hg) (defined by American Heart Association's 2017 HTN clinical guidelines)

Exclusion Criteria:

1. Age \<18 years
2. Prescribed antihypertensive medication
3. Diagnosis of end-stage renal disease (ESRD)
4. Condition which interferes with outcome measurement (e.g., dialysis)
5. Serious medical condition which either limits life expectancy or requires active management (e.g., cancer)
6. Cognitive impairment or other condition preventing participation in the intervention
7. Upper arm circumference \>50 cm (maximum limit of the extra-large BP cuff)
8. Active alcohol or substance use disorder (i.e., not sober/abstinent for ≥ 30 days)
9. Pregnant or planning pregnancy in the next 24 months
10. Currently nursing a child
11. Current participation in another research study focused on reducing BP
12. Unwillingness to provide informed consent
A Study of Adjunctive Treatment of Aripiprazole in Schizophrenic Patients

The purpose of this study is to evaluate the effect on patient weight of adjunctive therapy of aripiprazole with clozapine versus clozapine monotherapy, in schizophrenic patients who are not optimally controlled on clozapine.


Eligibility Criteria:
Inclusion Criteria:

* Patients with schizophrenia treated with clozapine (200-900 mg/day), who gained at least 2.5 kg while on clozapine.

Exclusion Criteria:

* Patients known to be allergic to aripiprazole
* Hospitalized patients
* Patients who have previously received study medication in an aripiprazole clinical study or who have participated in any clinical trial with an investigational agent within the past month.
Investigation of the Effects of Independent Transfer Training

The objective of this research study is to 1) evaluate the effectiveness of web based transfer training materials for wheelchair users and 2) determine the reliability of a refined transfer assessment instrument (TAI) as completed by individuals who use wheelchairs for a majority of mobility and clinicians who score transfers in-person and remotely.

Up to 125 participants will be recruited for this study. Investigators will recruit individuals who use a wheelchair for a majority of mobility (\>40 hours per week), who are over 18 years old, who do not have a history of heart or lung conditions that could become worse with up to 6 back and forth transfers to a mat table, and who can independently transfer to and from a surface within 30 seconds without use of their legs.

This study will require two visits that will take approximately 2 hours total to complete. Subjects will be asked to fill out a series of questionnaires so that investigators can collect demographic information (i.e. age, race, diagnosis, date of diagnosis, handedness, and preferred leading arm for transfers), their weight, and information about arm pain. Physical exams qualifying shoulder and wrist pathology will also be completed. Subjects will then be asked to perform up to six back and forth transfers to a mat table.

Following this, subjects will be randomized into two groups; one group that will receive transfer training immediately, and one group that will receive the transfer training after the follow up visit (control).

Subjects in the immediate transfer training group will receive training about about proper transfer techniques. After training, they will then complete the repeated transfer portion of the protocol a second time. Subjects will be instructed to practice the new skills they learned and then return within 7 days to complete only the repeated transfer portion of the protocol.

Subjects in the delayed transfer training group will be instructed to return within 7 days. Subjects will complete the repeated transfer portion of the protocol a second time. Subjects will then receive training about proper transfer techniques and after complete the repeated transfer portion of the protocol a third time.

Eligibility Criteria:
Inclusion Criteria:

1. Over the age of 18
2. Utilizes a wheelchair for the majority of mobility (over 40 hours per week)
3. Ability to transfer independently (may use equipment)
4. Self-report ability to complete a transfer to and from a surface in 30 seconds
5. English speaking

Exclusion Criteria:

1. Current or recent history (last 3 months) of pressure sores that may be exacerbated by multiple transfers
2. Active use of the lower limb muscles during transfers
3. Upper extremity pain that inhibits the ability to perform transfers or bear weight on the upper extremities
4. Other neurologic condition that could impair learning
5. History of heart or lung conditions that would be made worse by completing up to six back and forth transfers to a mat table