cyrilzakka/clinical-trials huggingface dataset:
ImPACt on Invasive Fungal Infections by Immune Checkpoint Inhibition

This observational study aims to compare immune checkpoint expression in blood samples from patients with invasive fungal infections (IFI) against healthy controls.

Participating sites will screen patients with invasive aspergillosis for eligibility. The investigators will enroll patients with aspergillosis and healthy controls. Patients will be informed by study personnel. Samples for imune phenotyping will be obtained within 7 days after diagnosis of IFI. A bronchoalveolar lavage (BAL) biopsy is taken at initial diagnostic bronchoscopy or other biopsy during surgical debridement whenever applicable and feasible.

The following data items will be collected: Patient characteristics, details on invasive fungal infection (IFI), underlying disease, outcome after 90 days (response, remission, progress, death). All collected data will be interpreted at the end of the study. All patients must agree to participate and sign the informed consent form.

The primary objective is to compare immune checkpoint expression in blood samples from patients with IFI against healthy controls. Exploratively, lymphocytic immune phenotypes in BAL or other biopsy samples from patients with IFI will be assessed. Further, cytotoxic T cell responses in blood samples from patients with IFI shall be investigated and the level of immune checkpoint expression correlated with mortality.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years
* Proven or probable, incl. PCR, positive IFI along 2019 EORTC/MSG criteria
* Signed ICF

Exclusion Criteria:

* None.
Effects Of Blood Flow Restriction Exercise Applications On Physical Fitness Parameters

Aim: The aim of the study; during the non-race season, blood flow-restricted exercises applied in addition to routine training programs to determine the effects on physical fitness parameters and sportive motivation of male canoe athletes aged 18 and over and to compare the results between the groups.

Method: Male athletes aged 18 and over who are licensed and actively engaged in canoeing in Turkey will be included in the study. Subjects will be divided into two groups , training and control. The training group will be given blood flow restricted exercise for 8 weeks and resistance training equivalent to 30% of 1 maximum repetition. In the control group, 30% of 1 MT of resistance training will be applied for 8 weeks without blood flow restriction. Before and after, athletes will be evaluated with sport-specific performance tests, muscle thickness measurement with ultrasound, isokinetic measurement of hamstring and quadriceps muscles at a speed of 60°/sec and 300°/sec. In addition, the muscles of the athletes will be evaluated with dynamic muscular measurements.

The first evaluation will be made before the 8-week training, and the second evaluation will be made at the end of the 8-week training. Both groups will be re-evaluated for follow-up at 6 and 12 months from the start of the study. In the 4th week, it is aimed to improve the exercise protocols by increasing the number of sets and repetitions in both groups.

The training will start with a 10-minute warm-up exercise on the static bike, and then stretching exercises will be applied. The athlete is dressed in the KAK apparatus and the pressure is given continuously so that it is on the device. In the 30-minute CAC exercise training, the athlete will complete the resistance exercises on the Leg Press, Leg Curl, Leg Calf Raise, Quadriceps Extension machines while attached to the device.

In the exercise prescription, which is planned as 3 sets of 10 repetitions, a rest period of 60 seconds will be given between sets. A 10-minute cool-down period will be added at the end of the training.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* Being a licensed athlete for at least 2 years,
* No history of orthopedic injury in the last 6 months
* Athletes who have been doing resistance exercise for at least 5 years

Exclusion Criteria:

* Presence of disease that will cause endothelial dysfunction (hypertension, cardiovascular diseases, neurological diseases, atherosclerosis)
* History of deep vein thrombosis and peripheral vascular disease
* Presence of acute infection
* Cancer cases
* Having undergone a surgical operation due to trauma in the last 6 months
COVID-19, Aging, and Cardiometabolic Risk Factors Study

COVID-19 pandemic has made a tremendous impact on Indonesian economic and health care system especially with the double burden of diseases facing by Indonesia as a developing country. The prevalence of non-communicable diseases such as obesity, type diabetes, and cardiovascular diseases is increasing. These diseases along with older age have been known as an established risk factors for higher mortality and severe clinical disease entity in COVID-19 infection. Although, there is still some part of patients with these co-morbidities that only present with mild symptoms when infected with SARS-CoV-2, even for some without any symptoms. Thus, it would be very interesting to evaluate how are these role of aging and cardiometabolic parameters in the clinical disease course of COVID-19 infection, and how are the relationship with the immune system.

Indonesia is a country in transition where the burden of non-communicable diseases is taking over the infectious diseases problem, mostly due to the changes in lifestyle and increase in life expectancy.

However, the unprecedented rising numbers of COVID-19 patients in Indonesia has impacted the Indonesian healthcare system heavily. It has been reported that older age and the presence of cardiometabolic risk factors pose a poor prognostic factor of COVID-19. It is also important to note that in Indonesia, the presence of cardiometabolic risk factors is often observed at a younger age. Thus, this might also contribute to the higher mortality of COVID19 infected patients despite their relatively younger age in comparison to other countries. Nevertheless, specific data on the impact of aging and cardiometabolic risk factors on COVID-19 are fragmentary, justifying the achievement of a dedicated prospective observational study.

The CARAMEL study aims to specifically describe the phenotypic aging and cardiometabolic characteristics of patients with COVID-19 infection, in relation with the changes in the mucosal and systemic immune system. Particular attention will be devoted to obesity, central obesity, prediabetes, diabetes, hypertension, dyslipidemia, as well as anti-diabetic, antihypertensive, and anti-dyslipidemia therapies.

This study will provide answers to researchers, medical professionals, and especially patients, regarding the impact of aging and cardiometabolic risk factors for COVID-19 prognosis. This pilot study will be used for the development of new studies and for the establishment of recommendations for the care of patients with cardiometabolic risk factors and COVID-19.

Eligibility Criteria:
Inclusion Criteria:

* Patients newly diagnosed with COVID-19 at hospital setting or community screening, confirmed with biological proof (RT-PCR)

Exclusion Criteria:

* Subjects opposed to the use of their data
* Minors, adults under guardianship, protected persons
* History of malignancy
* History of autoimmune disease
* Pregnancy
Visual Outcomes of Functional Intraocular Lenses in Cataracts

This is a prospective, multi-center, randomized comparative study. The purpose of the study is to evaluate and compare the objective and subjective visual outcomes of different types of functional intraocular lenses (IOLs) in patients.

Analyzing the subjective and objective visual outcomes and related factors following the implantation of various types of intraocular lenses（bifocal, trifocal, extended depth of focus (EDOF), and astigmatism-correcting intraocular lenses), exploring the advantages, disadvantages, and suitable patient populations for different types of intraocular lenses, analyzing the factors affecting postoperative visual quality, and providing guidance to better assist patients with diverse needs in clinical settings, aiming to offer multidimensional postoperative visual quality."

Eligibility Criteria:
Inclusion Criteria:

* cataract
* age \> 18 years

Exclusion Criteria:

* amblyopia; previous ocular surgery;
* ocular pathologies such as diabetic retinopathy, macular degeneration, glaucoma with field defects;
* requirements for further ocular surgery (other than Nd:YAG capsulotomy) or retinal laser treatments during the study
Topical Remetinostat in Treating Patient With Cutaneous Basal Cell Cancer

This phase 2 trial studies how well remetinostat works in treating patients with skin basal cell cancer. Remetinostat may slow the growth of basal cell cancer cells.

PRIMARY OBJECTIVES:

I. Overall response rate of basal cell carcinoma (BCC) in subjects at 6 weeks.

SECONDARY OBJECTIVES:

I. Suppression of GLI1 (glioma-associated oncogene) expression in treated BCCs as compared with baseline.

II. Safety assessment of Remetinostat after 6 weeks of topical treatment.

OUTLINE:

Tumors receive Remetinostat topically three times per day (TID) for 6 weeks in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed for at least 4 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Must have at least one BCC lesion \> 1 cm (BCC \> 5 mm) in non-cosmetically sensitive site(s)
* Must be willing to apply the topical remetinostat 3 times daily for 6 weeks
* For women of child bearing potential, a negative urine pregnancy test
* Women of child bearing potential are expected to use an effective method of birth control while participating in the study and for 1 month after applying the last dose
* For male subjects with female partners of childbearing potential, agreement to use adequate contraception while participating in the study and for 1 month after applying the last dose
* Has signed and dated the current Institutional Review Board (IRB) approved informed consent document

Exclusion Criteria:

* Taking any medication known to interact with histone deacetylase (HDAC) inhibitors, such as valproate or anticoagulants
* Taking any medication known to affect hedgehog (HH) signaling pathway such as itraconazole
* Within the past 6 months, has used topical or systemic therapies that might interfere with the evaluation of the study medication during the study; specifically, these include the topical use to the study tumors of:

  * Glucocorticoids
  * Retinoids either systemically or topically (eg, etretinate, isotretinoin, tazarotene, tretinoin, adapalene)
  * Alpha hydroxy acids (eg, glycolic acid, lactic acid) to \> 5% of the skin
  * 5 fluorouracil or imiquimod and/or
  * Itraconazole
* Has received treatment with systemic chemotherapy or agents known to be inhibitors of HH signaling, within 60 days to starting study medication
* Currently receiving systemic medications that could affect BCC tumors (eg, oral retinoids) or might interact with remetinostat
* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, recurrent seizure history or psychiatric illness/social situations that would limit compliance with study requirements
* Moderate to severe immunosuppression due to disease or medication
* Known or previous hypersensitivity to histone deacetylase inhibitor (HDACi)
* History of congestive heart failure; cardiac arrhythmias; or other findings of ventricular dysfunction
* History of current evidence of malabsorption or liver disease
* Pregnancy or breast feeding
Remote Ischemic Conditioning for Acute Moderate Posterior Ischemic Stroke

A substantial body of basic and clinical research has demonstrated the protective effects of remote ischemic conditioning (RIC) in ischemic stroke. While these clinical studies support the safety of RIC, the neuroprotective benefits of RIC in acute ischemic stroke (AIS) patients lack robust evidence due to small sample sizes, heterogeneous RIC protocols, and variability in the severity of neurological deficits among study populations. Our recent multicenter randomized clinical trial, the RICAMIS study, investigated the efficacy of RIC in patients with acute moderate ischemic stroke. The results showed that RIC administered within 48 hours of onset significantly improved 90-day neurological outcomes in patients with moderate stroke severity. It is well established that anterior circulation stroke (ACS) and posterior circulation stroke (PCS) differ in multiple aspects, including anatomical structure, collateral circulation, blood supply, clinical manifestations, prognosis, ischemic tolerance time, and treatment response. For instance, compared to the anterior circulation, the posterior circulation has poorer collateral circulation, a higher proportion of stroke etiologies attributed to atherosclerosis, and longer ischemic tolerance time. Consequently, intravenous thrombolysis and endovascular therapy may offer a more extended therapeutic time window for PCS patients. A prespecified subgroup analysis of the RICAMIS study revealed that patients with PCS derived greater benefit from RIC than those with ACS. However, this finding requires further validation through prospective studies, as prior research has never specifically examined the efficacy of RIC in PCS patients.

Based on the above discussion, this study aims to investigate the efficacy and safety of RIC in patients with acute moderate PCS.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years;
* Time from onset to treatment: ≤48 hours;
* Posterior circulation ischemic stroke confirmed by CT or MRI, including patients who have received intravenous thrombolysis or endovascular therapy;
* NIHSS score at randomization: 6-16, with an item 1a (level of consciousness) score of 0-1;
* First-ever stroke or prior stroke without significant residual disability (modified Rankin Scale score ≤1);
* Signed informed consent.

Exclusion Criteria:

* intracerebral hemorrhage or subarachnoid hemorrhage；
* Uncontrolled severe hypertension (systolic blood pressure \>180 mmHg or diastolic blood pressure \>110 mmHg despite antihypertensive therapy)；
* Subclavian artery stenosis ≥ 50% or subclavian steal syndrome;
* Intracranial tumor, arteriovenous malformation or aneurysm;
* Severe abnormalities in coagulation;
* Any contraindication for remote ischemic adaptation: the upper limb has serious soft tissue injury, fracture or vascular injury, distal upper limb perivascular lesions, etc.;
* Participating in other clinical trials within 3 months;
* Comorbidity with any serious diseases and life expectancy is less than half a year;
* Patients not suitable for this clinical studies considered by researcher;
Prospective Evaluation of Self-Testing to Increase Screening (PRESTIS) Asian/Asian American Women Supplement

Regularly attending for Pap test cervical cancer screening in a clinic is often unfeasible and/or unacceptable to many women and persons with a cervix. This study is a supplement to increase representation of Asian and Asian American women in a pragmatic clinical trial that evaluates if mailing and testing self-sampled kits for high-risk human papillomavirus (HPV) can cost-effectively increase screening participation among underserved minority women in a safety-net health system.

Regularly attending for Pap test cervical cancer screening in a clinic is often unfeasible and/or unacceptable to many women and persons with a cervix. Using mailed self-sampling kits to test for high-risk human papillomavirus (HPV), the virus that causes cervical cancer, may overcome multiple barriers to clinic-based screening. The parent study (NCT03898167) is a randomized controlled trial to compare the effectiveness of three outreach interventions to increase primary screening participation and clinical follow-up among underscreened women a in a safety net health system. The three strategies that will be evaluated are: 1) telephone recall; 2) telephone recall with mailed self-sample HPV testing kits; and 3) telephone recall with mailed self-sample HPV testing kits and patient navigation. A supplemental accrual of Asian/Asian American persons (target n=240) was added to increase representation of this subpopulation in the parent trial.

Eligibility Criteria:
Inclusion Criteria:

* Asian ethnicity reported in the electronic health record
* no history of hysterectomy or cervical cancer
* no Pap test in the past 3.5 years or Pap/HPV co-test in the past 5.5 years
* patient of Harris Health System in Harris County (Houston), Texas
* have at least 2 visits to ambulatory care within Harris Health System in the past 5 years
* be currently enrolled in a healthcare coverage or financial assistance plan accepted by Harris Health System or have been enrolled in a Harris Health coverage plan in the past 12 months

Exclusion Criteria:

* no valid telephone contact information
* unable to communicate in English, Vietnamese or Spanish
* currently pregnant
* history of cervical dysplasia in the past 3.5 years
Intranasal Hydromorphone for the Treatment of Acute Pain in Children: A Pilot Study.

Intranasal hydromorphone has been shown to be effective in reducing acute pain in adults. It has not been previously studied in children, but may be a viable option for effectively and safely reducing pain in children by administering an analgesic by the intranasal route.

This study will be a prospective, open-label pilot study of intranasal hydromorphone in children with moderate to severe acute pain presenting to the pediatric emergency department. The investigators aim to describe the amount of pain reduction associated with intranasal hydromorphone, and to determine the optimal dose of intranasal hydromorphone associated with a clinically meaningful improvement in acute pain.

Primary Aim: Determine the change in pain intensity in children with moderate to severe pain who receive intranasal hydromorphone one hour after administration.

Secondary Aim(s): Describe the incidence of minor and major adverse events associated with intranasal hydromorphone in children with acute pain.

The investigators will assess the patient's pain at baseline (prior to study drug administration), then after study drug administration: 5 minutes, 15 minutes, 30 minutes, 45 minutes, 60 minutes, and then every 30 minutes thereafter until 6 hours; administration of non-protocolized rescue medication administration (i.e. administered after first two rescue doses of IN hydromorphone); or discharge from emergency department (whichever comes first). The pain score at 60 minutes will be the primary outcome.

The investigators will evaluate qualitative improvement in pain intensity at 15- and 30-minutes after study drug administration. If there is no improvement, or worsening of pain intensity, at each assessment, an additional rescue dose rescue dose of intranasal hydromorphone will be administered. After 60 minutes, the treating physician may administer any additional rescue medications at their discretion to treat the child's pain.

The patient will be assessed for minor and major adverse events for the duration of the study.

Eligibility Criteria:
Inclusion Criteria:

* Age 4 to 17 years old, inclusive
* Moderate to severe pain (i.e. FPS-R or vNRS score of 4 or more)
* Requires parenteral opioid analgesic to treat their pain, as decided by treating physician

Exclusion Criteria:

* Allergy or known contraindication to receiving opioids
* Receipt of any opioid or benzodiazepine within preceding 6 hours
* Presence of intranasal obstruction that cannot be cleared readily
* Cannot speak English or Spanish
* Patient unlikely to be able to complete self-report measures of pain or questionnaires
* Known liver or kidney problems
* Currently critically ill
* Chronic pain condition (e.g. sickle cell disease, fibromyalgia)
Spinal Anaesthesia With Levobupivacaine 0.5% and Ropivacaine 0.75% for Lower Limb Orthopaedic Surgery

The purpose of this study is to compare the effects of two intrathecally administered drugs:0.5% levobupivacaine and0.75%Ropivacaine in spinal anesthesia

Bupivacaine is a highly cardiotoxic drug and also produces prolonged motor blockade.The newer drugs levobupivacaine and ropivacaine being comparatively less cardio and neurotoxic are preferred now a days.So, we conducted this prospective, randomized double blind study with an aim of comparing the efficacy and characteristics of these drugs.

Eligibility Criteria:
Inclusion Criteria:

1. American Society of Anesthesiologists (ASA) class I \& II patients of either sex
2. Age between 18-60 years

Exclusion Criteria:

1. Patient's refusal.
2. Patients who have contraindications to spinal anaesthesia / Local anaesthetic drugs.
3. Patients having h/o diabetes, neurological and musculoskeletal diseases.
Peri-operative Dexmedetomidine Infusion in Pre-eclamptic Patients

The purpose of this study is to investigate the effects of dexmedetomidine infusion on the stress response to intubation, postoperative analgesia, and renal functions (urinary output \[UOP\], creatinine and glomerular filtration rate \[GFR\]) in preeclamptic patient.


Eligibility Criteria:
Inclusion Criteria:

* pregnant women
* have mild preeclampsia ( Pre-eclamptic patients will be defined as having hypertension \[systolic blood pressure (SBP) ≥140 mmHg and/or diastolic blood pressure (DBP)≥90 mmHg\] accompanied by proteinuria first detected after 20 weeks of gestation).
* Proteinuria is defined as at least 300 mg protein in 24 h urine collection \[or ≥1+ dipstick (30 mg/dl) in a single urine sample\] ).
* American Society of Anesthesiologists (ASA) physical status of II or III.
* age between 19 and 40 years

Exclusion Criteria:

* patient refusal to consent (obsolete).
* pre-existing neurological disease or psychic patients.
* history of cardiac and respiratory system failure.
* co-existing significant renal or liver disease.
Families With Pride ("Familias Con Orgullo").

This study will evaluate the effects of a parenting intervention for Hispanic sexual minority youth in preventing/reducing drug use and depressive symptoms. It will also examine whether the intervention improves parent social support for the adolescent, parent acceptance, family functioning, and whether it reduces general stress and stress associated with being a Hispanic sexual minority.


Eligibility Criteria:
Inclusion Criteria:

* Youth, 13 - 19, who report at least one of the following: a) identify as gay, lesbian, or bisexual, or b) reports same-sex sexual behavior.
* Adolescent has their disclosed their sexual minority status to at least one parent.
* Adolescent is of Hispanic immigrant origin, defined by having at least one parent that self-identifies as Hispanic (English and Spanish speaking Hispanics can participate in the study).
* Adolescent lives with an adult parent who is willing to participate.
* Family lives in South Florida

Exclusion Criteria:

* Adolescent identifies as transgender.
* Family plans to move out of South Florida during the study period
Safety and Efficacy of Seroquel in First Episode Schizophrenia

To compare the safety, tolerability and efficacy of Seroquel and risperidone in first episode schizophrenia


Eligibility Criteria:
Inclusion Criteria:

* Age 18-35 years Meet ICD-10 criteria for schizophrenia No abnormaility on clinical examination No previous episode of psychosis No previous antipsychotics of any kind in last 3 months

Exclusion Criteria:

* Have received a course of antipsychotics drug treatment prior to entry which may introduce risk factors or interfere with study procedures Have received anticholinergics within 10 days of baseline aseessment Have received mood stabilizers or anti depressants within 2 weeks