cyrilzakka/clinical-trials huggingface dataset:
A Dose-Escalation Study of OBP-801 in Patients With Advanced Solid Tumors

This Phase 1a, single center, open-label, repeat dose study will evaluate the safety, efficacy, and Pharmacokinetics of ascending doses of OBP-801 in patients with advanced solid tumors.


Eligibility Criteria:
Patient Inclusion Criteria

Patients must meet all of the following inclusion criteria to be eligible for enrollment into the study:

* Histologically or cytologically confirmed metastatic or unresectable solid tumor.
* Has failed treatment with all standard therapies for their malignancy.
* Adequate Karnofsky Performance Status.
* An expected survival of at least 3 months.
* Adequate organ and bone marrow function.
* Signed informed consent form for study participation prior to screening.

Patient Exclusion Criteria

Patients presenting with any of the following will be excluded in the study:

* Clinically significant disease as defined by the protocol.
* Surgical therapy or other therapies within period as defined by the protocol.
* Any condition that will interfere with compliance with the protocol as determined by investigator.
Changes of Clinical Characteristics and Tear Film Biomarkers Following FS-LASIK

to analyze the clinical and tear molecular profile up to 6 months after FS-LASIK surgery

FS-LASIK is a refractive surgery technique widely used in China. To explore the role of inflammation and nerve in the occurrence and development of dry eyes after FS-LASIK by dynamically observing the ocular surface characteristics and the levels of inflammatory factors and neurotransmitters in the early and late stage after FS-LASIK.

Eligibility Criteria:
Inclusion Criteria:

1. Patients who preparing for FS-LASIK with age between 18 and 45 years old
2. Any gender
3. Provision of written informed consent.

Exclusion Criteria:

1. active ocular infection, ocular inflammation, active ocular allergy, severe blepharitis or obvious inflammation of the eyelid margin.
2. Pregnant and lactating women, or those planning a pregnancy over the course of the study
3. Uncontrolled systemic disease
4. Suffer from diseases that may affect corneal nerves, such as keratoconus, trigeminal neuralgia, allergic conjunctivitis, etc.
A Clinical Trial of TQB3015 Tablets in Patients With Advanced Malignant Cancer

This study is divided into two stages: dose escalation and dose extension, including a single dose and a multiple dose clinical study. This is a single-center, open, non randomized, single arm study to the safety and tolerability of TQB3015 tables in patients with advanced malignant cancer.


Eligibility Criteria:
Inclusion Criteria:

* Evidence of a personally signed and dated informed consent document indicating that the patient has been informed of all pertinent aspects of the study;
* Age: 18 to 75 years old; an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
* Advanced malignant tumors confirmed by tissue or cellular pathology and the routine standard treatment was ineffective or lack of effective treatment plans, or patients cannot tolerate the standard treatment;
* Has at least one assessable lesion according to Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1 criteria;
* The main organs function well;
* Female patient had no plans to become pregnant and voluntarily took effective contraceptive measures during the study period and until at least 6 months after the last dose of study drug.

Exclusion Criteria:

* Concomitant disease and medical history:

  1. There were other malignant tumors occured within 3 years before the first dose of study drug.
  2. Has multiple factors affecting oral medication;
  3. Unalleviated toxicity ≥ grade 1 according to CTCAE v5.0 due to any previous therapy, excluding hair loss;
  4. Major surgical treatment, open biopsy and obvious traumatic injury were performed within 28 days before the study, or have not fully recovered from previous surgery, or are expected to require major surgical surgery during the study period;
  5. Arteriovenous thrombotic events occurred within 6 months before the first dose, such as cerebrovascular accident (including transient ischemic attack, cerebral hemorrhage, cerebral infarction), deep venous thrombosis and pulmonary embolism;
  6. Have a history of psychotropic drug abuse and can not quit or have mental disorders;
  7. Subjects with any severe and/or uncontrolled disease including active hepatitis, immunodeficiency;
* Tumor-related symptoms and treatment:

  1. Has known symptomatic central nervous system metastases and/or cancerous meningitis;
  2. Have received surgery, chemotherapy, radiation therapy (2 weeks for brain radiation therapy) or other anti-cancer therapies within 4 weeks prior to the first dose.
  3. Thoracic/abdominal/pericardial effusion with clinical symptoms or requiring repeated drainage, or drainage for the purpose of receiving treatment within one month after receiving the investigational drug for the first time.
  4. Has Participated in other clinical trials within 4 weeks before first dose.
* According to the judgement of the investigators, there are other factors that may lead to the termination of the study.
The Dose-Response Relationship of Rocuronium in Patients Taking Pyridostigmine

Pyridostigmine is a medication that is used in certain heart rate and blood pressure conditions. This medication, as a side effect, is known to also cause changes in the junction between a nerve and muscle. The changes caused at the nerve muscle junction by pyridostigmine could alter the effect of muscle relaxants (a medication used during surgery and anesthesia). The investigators are conducting this study to see whether patients taking pyridostigmine are more or less sensitive to rocuronium (a muscle relaxing medication used during surgery).

No subjects enrolled. No data collected.

Eligibility Criteria:
Inclusion Criteria:

* Patients who take pyridostigmine for any reason or those who are matched by age, sex and weight to subjects taking pyridostigmine
* Patients who will be administered rocuronium during elective procedures as standard clinical care.

Exclusion Criteria:

* Allergy to rocuronium
* Known neuromuscular disorder, patients suffering from myasthenia gravis
* Subjects taking medications known to impact neuromuscular transmission (ex. gentamicin).
Determining the Impact of Air Pollution on the Developing Brain

* Background: Recent studies have linked exposure to airborne particulate matter (PM) to neurodevelopmental outcomes but the findings are mixed and mechanisms are unclear. We aim to determine the impact of PM on the developing brain of schoolchildren in Poland, a European country characterized by very high levels of air pollution. The investigators aim to determine the impact of PM on the developing brain of schoolchildren in Poland, a European country characterized by very high levels of air pollution.
* Study area: 19 towns in three voivodeships (Lesser Poland, Silesian, Opole) in the southern Poland. To reduce confounding by urbanicity and at the same time, to achieve sufficient contrasts in PM levels without too high logistic costs, towns were selected by size (big and small) and by PM levels (high, medium and low).
* Design: Case-control study with 800 children recruited over two school years, with two population controls per one ADHD case. Suspected cases will be recruited in specialized facilities and presumably ADHD-free children will be recruited in primary schools.
* Exposure assessment: Poland-wide PM and other air pollutants' grids will be created for the years 2006 to 2021 using statistical models to incorporate land use data, estimates from transport models, satellite observations and air pollution measurements from Polish monitoring network. Prenatal, early-life, lifelong and concurrent exposures will be calculated.
* Psychological testing: Every child and their parents will complete a series of psychological tests and interviews that will be conducted during their three visits to the recruitment facility.
* Neuroimaging: Each participant will undergo a Magnetic Resonance Imaging (MRI) scanning session that will be performed accordingly to the Human Connectome Adolescent Brain Cognitive Development project recommendations. Scanning will be performed on a single scanner in Krakow.


Eligibility Criteria:
Inclusion Criteria:

* Attending school in one of the specified towns
* Age 10-13 years (4th-6th grade)
* Native Polish speaker
* Normal or above intelligence
* Standard educational opportunities
* Normal or corrected to normal visual and auditory acuity
* No gross sensory deficit, no gross behavioural problems
* No history of neurological disease

Exclusion Criteria:

* Autism spectrum disorder (ASD)
* FAS
* FAE
* Intellectual disability
* Metabolic disorders
* Genetic disorders
* Epilepsy
* Cerebral palsy
* Mood disorders
* Tourette Syndrome
* Other illnesses including pharmacotherapy
* Apgar score \< 8
* Low birth weight (below 2500 g)
* Preterm birth (below 35th weeks of gestation)
Serologic Characterization of Bone-healing

Investigation of serologic bone markers in patients undergoing hip arthroplasty

Investigation of serologic bone markers in patients undergoing hip arthroplasty. Measured by frequent blood- and urine samples pre-operative and during the first post-operative year.

Eligibility Criteria:
Inclusion Criteria:

* Ages 40-80 years
Myopia Prevalence in Canadian School Children - a Pilot Study

The goal of this study is to determine the prevalence of nearsightedness in Canadian school children living in the Waterloo Region.


Eligibility Criteria:
Inclusion Criteria:

* Has had a parent/legal guardian read the study consent form and who agrees to allow them to participate in the study by signing the consent form
* Has had the "letter of assent for children" explained to them, the child has agreed to participate and the letter has been signed by the study investigator and the child
* Has provided the completed Questionnaire (Appendix 4A for parents to complete on behalf of their children in school grades 1 and 2, 6 and 7; Appendix 4B for children to complete that are in school grades 11 and 12)
* Is currently in school grades 1 and 2, 6 and 7 or 11 and 12
* Is willing and able to follow instructions and maintain the appointment schedule

Exclusion Criteria:

* Has not given verbal assent to participate
* Has known sensitivity to the diagnostic pharmaceuticals to be used in the study
* Has undergone refractive error surgery or orthokeratology
* Has serious medical disorders or eye diseases/abnormalities such as amblyopia and cataract or a cognitive inability to conduct the tests
A Phone Intervention for Family Dementia Caregivers in Vietnam

This is a cluster randomized controlled trial to examine the feasibility, acceptability, and preliminary efficacy of the phone version of REACH VN, a psychosocial culturally adapted Alzheimer's family caregiving intervention, to support family caregivers of persons living with dementia in Vietnam.

The objective of this study is to conduct a cluster randomized controlled trial (RCT) to examine the feasibility, acceptability, and preliminary efficacy of the phone version of REACH VN (Resources for Enhancing Alzheimer's Caregiver Health in Vietnam), a psychosocial culturally adapted Alzheimer's family caregiving intervention that will be delivered over the phone with an enhanced control as the comparison. The pilot cluster RCT will test the hypothesis that family caregivers who receive the intervention will show lower caregiver burden (primary outcome) and lower depressive/anxiety symptoms (secondary outcome) compared with those in the control group.

Eligibility Criteria:
Inclusion Criteria:

* To be eligible to participate, a family member will need to be the identified adult (i.e., age 18 and above) who is the primary informal (i.e., unpaid family member) caregiver (i.e., the person who provides the most time day-to-day care) to an older adult (i.e., age 60 and above) with dementia living in the community. If the primary caregiver is not available to participate, an alternate family member who provides substantial care (i.e., at least 4 h/day) to an older adult with dementia will be eligible to participate.
* In addition, caregivers will need to score ≥ 6 on the Zarit Burden Interview-4 (ZBI-4).
* All participants will be living in clusters in Thach That District, a semi-rural area in Hanoi. Clusters will have a minimum of 3 participants and a maximum of 15 participants.

Exclusion Criteria:

* Caregivers with difficulties in the consent process due to cognitive impairment or severe sensory impairment (i.e., visual, hearing)
* Caregivers don't have access to phone
* Individuals who are not yet adults (i.e., infants, children, teenagers)
* Prisoners
Integrative Ayurveda Healing Relieves Minor Sports Injury Pain

Sports-related soft tissue injuries, such as sprains, strains, and contusions, are a common painful condition. Current treatment includes oral nonsteroidal anti-inflammatory drugs (NSAIDs), which have a high incidence of intolerable gastrointestinal side effects.

Ancient Indian healing system, Ayurveda addresses the need of sports medicine up to certain extent. In practice, there are different treatment modalities for injuries, uses of drugs \& dietetics as well as practices of rehabilitation. Although, previous evidences support the efficacy of ayurveda practices with significant reduction in pain, joint tenderness, joint swelling, mobility restriction and early morning joint stiffness. But there is no treatment studies have been performed to evaluate the clinical outcome for specific sports injuries.

This study assessed the efficacy and safety of ayurveda gel and patches applied to the painful injury site for the treatment of acute minor sports injury pain.


Eligibility Criteria:
Inclusion Criteria:

* inversion ankle injury;
* injury sustained during sporting activity

Exclusion Criteria:

* other lower limb injury;
* concurrent fracture with or without dislocation or with or without complete rupture;
* surgery for ankle injury.
Drug-Drug Interaction (DDI) Study of ALXN2050 in Healthy Adult Participants

This study will evaluate the potential drug interactions between ALXN2050 and cyclosporine (Part 1), between ALXN2050 and tacrolimus (Part 2), and between ALXN2050 and mycophenolate mofetil (MMF) (Part 3).


Eligibility Criteria:
Inclusion Criteria:

* Medically healthy with no clinically significant or relevant abnormalities as determined by medical history, physical or neurological examination, vital signs, 12-lead electrocardiogram, screening clinical laboratory profiles (hematology, biochemistry, coagulation, and urinalysis), as deemed by the Investigator or designee at Screening.
* Body mass index within the range 18.0 to 32.0 kilograms (kg)/meter\^2, inclusive, with a minimum body weight of 50.0 kg at Screening.

Exclusion Criteria:

* History of any medical or psychiatric condition or disease that might limit the participant's ability to complete or participate in this clinical study, confound the results of the study, or pose an additional risk to the participant by their participation in the study.
* Participation in another investigational drug or investigational device study within 5 half- lives (if known) or 30 days prior to the first dose of study intervention, whichever is longer.
* History of drug or alcohol abuse within 2 years prior to the first dose of study intervention or positive drugs-of-abuse or alcohol screen at Screening or Day -1; current tobacco users or smokers or a positive cotinine test at Screening.
* Donation of whole blood from 3 months prior to the first dose of study intervention, or of plasma from 30 days prior to the first dose of study intervention; receipt of blood products within 6 months prior to the first dose of study intervention.
Exercise Capacity in COPD

In this study, cardiopulmonary exercise will be assessed to characterize the relevance of severity of COPD and coexisting cardiovascular comorbidities for exercise capacity.

In patients with chronic obstructive pulmonary disease (COPD) the interpretation of dyspnoea also needs to consider coexisting cardiovascular disease. Cardiopulmonary exercise testing (CPET) is used to characterize pulmonary and cardiac function and limitations during exercise. The investigators hypothesise that cardiopulmonary exercise is reduced in COPD patients with coexisting cardiovascular disease as well as in more symptomatic patients and in patients with frequent exacerbations. For this purpose, 100 patients with with stable COPD are characterized by clinical characteristics, laboratory tests, lung function, electrocardiography, echocardiography and cardiopulmonary exercise testing.

Eligibility Criteria:
Inclusion Criteria:

* patients with stable chronic obstructive pulmonary disease, exacerbated or stable
* 40-80 years
* sinus rhythm
* informed written consent

Exclusion Criteria:

* Inability to give written consent
* acute myocardial infarction with ST-segment elevations in last 30 days
* severe acute or chronic renal dysfunction
* severe heart failure-
* atrial fibrillation
* severe valve disease
* severe hypoxemia
* long term oxygen therapy or non invasive ventilation
Feasibility Study of Anti-inflammatory Cytokines in Whole Blood in Osteoarthritis Patients

This is a feasibility study to determine if anti-inflammatory cytokines can be concentrated from patients with osteoarthritis.


Eligibility Criteria:
Inclusion Criteria:

* radiographic evidence of osteoarthritis
* signed informed consent

Exclusion Criteria:

* Pregnancy
* \< 18 years of age
* blood clotting disorder or active hematologic cancer
* undergoing chemotherapy
* history of rheumatoid arthritis
* septic joint or fracture
* active infection or history of chronic infection
* use of cytokine blocking drugs with the last 6 months
* intra-articular steroid or hyaluronic acid (HA) injection within last 6 months
Early Detection of Alzheimer's Disease and Affective Disorders by Automated Voice and Speech Analysis (PLATA)

PLATA aims to develop an algorithm to identify vocal biomarkers of Alzheimer's dementia.

Using data collected as part of routine care, speech patterns will be compared to known biomarkers of Alzheimer's disease, such as amyloid 1-42 and p-Tau in CSF (cerebrospinal fluid).

If biomarkers of speech can be identified in Alzheimer's disease, it is possible that patients and research participants will no longer need to undergo need to undergo the intensive and invasive baseline biomarker methods currently used, such as lumbar punctures and PET scans.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 50 years
* Diagnosis relevant biomarker and neuropsychological data already available
* Cognitively healthy to very mild dementia (CDR score max. 0.5)
* Sufficient knowledge of the study language to understand study information, non opposition form,and questionnaires
* Expression of non opposition

Exclusion Criteria:

* Hearing problems
* Patient protected by law, under guardianship or curator ship, or not able to participate in a clinical study according to the article L.1121-16 of the French Public Health Code
Goal Directed Fluid Management , Pvi

The first objective of this study is to compare the liberal fluid management (LFM) with PVI guided goal-directed fluid management (GDFM) in gynecologic oncologic cases in terms of controlled intraoperative fluid balance, blood lactate levels, hemodynamic parameters, and postoperative serum creatinine levels. 112 patients who are in ASA I-II-lll risk groups included in this prospective study.

Objectives: The first objective of the investigators's study was to compare the liberal fluid management (LFM) with PVI guided goal-directed fluid management (GDFM) in terms of controlled intraoperative fluid volume, surgical end-point fluid balance, blood lactate and serum creatinine levels.

The investigators's secondary purpose was to compare the effects of different fluid regimens on the postoperative kidney injury and the duration of hospital stay.

Methods: The study included 112 American Society of Anesthesiologists (ASA) grade I ,ll and lll patients, aged above 18 and undergoing elective gynecologic oncologic case . After premedication with 0.03 mg /kg i.v. midazolam, all patients were started an i.v. infusion of 500 mL 0.9 % NaCl until the end of anesthesia induction.

After the anesthesia induction, while 0.9 % NaCl at rate of 2 mL/kg/h was infused in PVI- guided GDFM group, a 250-mL bolus cyristalloid/kolloid injection was administered when PVI was higher than 13 % over 5 min. While 0.9 % NaCl at rate of 4- 8 mL/kg/h was infused in LFM group, a 250-ml bolus cyristalloid/ kolloid injection was administered when the mean arterial blood pressure (MAP) decreased below 65 mmHg. In both groups, when MAP was still \< 65 mmHg after fluid bolus infusion, 5 mg i.v. bolus ephedrine was administered. The data collected during intraoperative period, such as heart rate, MAP, arterial blood gas samples (Ph, arterial oxygen pressure (PaO2), arterial carbon dioxide pressure (PaCO2), HCO3 level, hemoglobin, blood lactate level) were recorded. Hemoglobin, Na, K, Cl, serum creatinine, blood lactate and serum albumin scores were measured preoperatively, and up to 24 hours postoperative.

In the first 24 hours after surgery, urine output, need for blood transfusion ,lokositoz,fever,stay in icu and length of hospital stay were recorded.

Eligibility Criteria:
Inclusion Criteria:

1. Gynecological oncologic cases
2. Patients over 18 years old
3. ASA 1-2-3 patients

Exclusion Criteria:

1. Patients with peripheral arterial disease
2. Patients with non-sinus rhythm, arrhythmia, atrial fibrillation
3. Patients with entry MAP \<65 mmHg
4. Patients with advanced renal and hepatic impairment
5. Mental retarded and non-cooperative patients
6. Patients with advanced heart failure, EF \<30%
7. Patients have massive bleeding in the perioperative period, need for massive transfusion
8. Patients have acute pulmonary pathology
9. Patients with anaphylaxis who developed a blood product reaction
10. Patients who do not allow a tidal volume of 8ml / kg in a mechanical ventilator
Sodium Bicarbonate to Prevent Acute Kidney Injury in Children Undergoing Cardiac Surgery

The proposed study will investigate the effect of sodium bicarbonate on the prevention of acute kidney injury in children undergoing cardiac surgery with cardio-pulmonary bypass. The investigators hypothesize that the occurrence of acute kidney injury will be less in children treated with sodium bicarbonate in the perioperative period when compared to placebo. The specific aims of this proposal are as follows:

1. To institute a prospective, randomized, double-blinded, placebo-controlled trial in pediatric subjects undergoing cardiac surgery to determine the efficacy of sodium bicarbonate on prevention of acute kidney injury as measured by pRIFLE criteria. 2. To examine whether treatment with sodium bicarbonate modifies the duration of acute kidney injury, fluid balance, hospital length of stay, need for dialysis, and progression to kidney failure. 3. To determine the relevance of NGAL as a biomarker to predict development of acute kidney injury.


Eligibility Criteria:
Inclusion Criteria:

1. Subjects age ≤18 years
2. Subjects scheduled for cardiac surgery with cardiopulmonary bypass

Exclusion Criteria:

1. Subjects with abnormal creatinine clearance (\<90 ml/min/1.7m2) as measured by the Schwartz formula
2. Subjects with known cystic kidney disease or posterior ureteral valves (subjects with solitary kidney, single multicystic/dysplastic kidney, hydronephrosis will not be excluded if renal function is preserved)
3. Subjects with known metabolic disorder
4. Premature infants born \<30 weeks gestation and \<30 days old due to risk of intraventricular hemorrhage

Subjects in severe cardiogenic shock post-operative requiring extra-corporeal membrane oxygenation (ECMO) or left ventricular assist device (LVAD) will be withdrawn from the study.