cyrilzakka/clinical-trials huggingface dataset:
Promoting Full Oral Feeding in Preterm Infants Less Than 30 Weeks Gestational Age

The investigators plan to use a new process to shorten the time of attaining full oral feeding in preterm infants less than 30 weeks gestational age.

In the neonatal intensive care unit, the attention of oral feeding of premature infants is far less than that of mechanical ventilation, antibiotics and other medical treatment, the use of parenteral nutrition, etc., and it is often not until the premature infants are enough mature and stable, or even before discharge that the caregivers pay attention to the problem of oral feeding. At this time, the corrected gestational age of premature infants is almost 36 weeks, but in fact the study shows that preterm infants have the ability of self feeding when they are about 32 weeks old. And oral feeding is very helpful to improve their nutritional status, reduce the use of parenteral nutrition and other forms of enteral nutrition, prevent complications and shorten the length of stay. Therefore, this study plans to use a new process to promote oral feeding and to verify whether it is feasible to earlier attainment of full oral feeding in premature infants.

Eligibility Criteria:
Inclusion Criteria:

* Preterm infants with gestational age less than 30 weeks
* The parents are positive to treat the infants

Exclusion Criteria:

* Fetal edema
* Very critical with OI more than 40
* Apgar score less than 5 at ten minutes after birth
* The parents refuse to treat the infants
* Severe IVH (more than grade IV )
* PVL
* Died before oral feeding starts
Hemoperfusion in Extracorporeal Membrane Oxygenation (ECMO) Patients

Extracorporeal membrane oxygenation (ECMO) is a temporary mechanical circulatory support device for cardiogenic shock (CS) patients. During extracorporeal membrane oxygenation (ECMO) support, the inflammatory response is intense and complex. It may cause infection, cell damage, organ dysfunction and even death. Hemoperfusion can adsorb inflammatory factors and reduce the inflammatory reaction. CS patients who are likely to receive veno-arterial extracorporeal membrane oxygenation (VA-ECMO) support will be enrolled and randomized with a 1:1 allocation to a simultaneous hemoperfusion arm vs. standard care arm.

1. The patients in the simultaneous hemoperfusion arm will receive hemoperfusion when extracorporeal membrane oxygenation (ECMO) is commenced.
2. The patients in the standard care arm will not receive hemoperfusion when extracorporeal membrane oxygenation (ECMO) is commenced.

The primary outcome is the change of plasma interleukin (IL)-6 level after hemoperfusion is commenced.


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 and ≤ 75 years.
2. Admission to ICU.
3. Criteria for the diagnosis of CS as follows: (1) systolic blood pressure less than 90 mmHg for 30 min, a mean arterial pressure less than 65 mmHg for 30 min, or vasopressors required to achieve a blood pressure ≥ 90 mmHg; (2) pulmonary congestion or elevated left-ventricular filling pressures; and (3) signs of impaired organ perfusion with at least one of the following criteria: (a) altered mental status; (b) cold, clammy skin; (c) oliguria; and (d) increased serum lactate.
4. ECMO will supply cardiopulmonary support to the patient
5. The patients will be enrolled and randomized when ECMO is commenced less than 24 hours.

Exclusion Criteria:

1. Refusal of consent.
2. Active hemorrhage or thrombocytopenic purpura
3. BMI≥40
4. Received ECMO bridging to a long-term ventricle assist device or heart transplantation.
5. Infection
Comparative Analysis of Postprandial Effects in Healthy and Obese Individuals

After eating, blood composition changes, including increased triglycerides and glucose, which can trigger postprandial inflammation. Particularly with high-fat foods, pro-inflammatory lipopolysaccharide (LPS) increases. This activates leukocytes to release pro-inflammatory cytokines. In industrialized countries where "snacking" is common, many people spend the day in a postprandial state. Obese individuals tend to have chronic inflammation and show increased susceptibility to infections such as SARS-CoV-2. The main objective of the study is to investigate the response of leukocytes and the serum metabolome after food intake in individuals with obesity compared to healthy individuals, focusing on LPS as a key stimulus of innate immunity.


Eligibility Criteria:
Inclusion Criteria:

* Signed declaration of consent
* from 25 years of age
* BMI 20 kg/m2 - 25 kg/m2 or BMI 30 kg/m2 - 40 kg/m2
* Good venous conditions for blood collection
* Sufficient understanding of the German language and sufficient mental state to understand information and instructions related to the study

Exclusion Criteria:

* Nicotine consumption
* High-risk alcohol consumption (more than one standard glass per day for women, more than two standard glasses per day for men)
* Antibiotic intake
* Taking probiotics, prebiotics and synbiotics, unless taken for more than 90 days
* Taking statins or other lipid-lowering medications (e.g., ezetimibe, fibrates)
* Taking oral antidiabetics
* Taking antacids
* Manifest diabetes mellitus
* Acute/unstable cardiovascular diseases
* Acute inflammatory diseases
* autoimmune diseases
* kidney diseases
* food allergy or food intolerance to food components of the test meal (e.g. eggs)
* celiac disease
* Pregnancy and lactation
* Inability to consume the test meal orally
* Placement in a clinic or similar facility due to official or court order (medical history)
* Participation in another clinical study (current or within the last 30 days prior to study entry)
* A medical condition or regular medication use that, at the investigator's discretion, does not permit study participation or evaluation of study parameters or consumption of the investigational product (individual decision)
Reference Curve on Bone Mineral Density in Young Adult: French Multicenter Study

In men, the hope of lower life, the absence of equivalent of menopause and the existence of a higher peak bone mass are three factors that explain the lower incidence of osteoporosis in men. Epidemiological data indicate a prevalence of 15% among men aged over 50 years (Szulc et al. 2000). According to global analyzes, the number of fractures of the upper end of the femur in humans will increase from 400 000 to 800 000 per year between 2000 and 2025 (Kanis et al. 2004). Furthermore the mortality due to major osteoporotic fractures when they occur in humans than that seen in women (Johnell and al.2001).The main goal of this study is to establish reference curves in elderly male volunteers from 20 to 30 years through the assessment of bone mineral density of the spine, hip, and the measurement of body composition (fat mass, lean mass). This study will allow us to establish the mean and standard deviation of the value of the young adults of the same sex, which will eventually be applied in the calculation of the "T-score" for older people.


Eligibility Criteria:
Inclusion Criteria:

* Male
* Aged between 20 and 30 years
* Caucasians

Exclusion Criteria:

* Lack of informed consent
* Pieces of metal or plastic parts in the field
* Diseases which cause technical difficulties for the correct evaluation of the hip and spine (severe dysplasia, hip surgery or lumbar spine)
Capsulectomy vs Capsulotomy in Total Hip Arthroplasty. Clinical Outcomes and Proprioception Evaluation

The purpose of our study is to evaluate the differences in functional activities and proprioception after surgery in subjects who underwent hip prosthesis implant with capsulotomy or capsulectomy.

Concerning hip arthroplasty surgery, in patients affected by coxarthrosis, there are two different techniques: one is capsulectomy and the second one is capsulotomy with repairing the capsule at the end of the procedure. Both preserving and excising the capsule are accepted methods and the choice whether repairing the capsule or not is up to the surgeon, since studies have not yet demonstrated the superiority of one of the two techniques. Articular capsule has a physiological role in joint stability and proprioception. The presence of proprioceptive nerve endings in hip joint capsule has been observed both in healthy patients and in those affected by coxarthrosis.

If capsulectomy is performed during primary hip arthroplasty, the pseudocapsule that is formed in place of the native capsule will not have any active neurophysiological role in the hip.

For this reason, investigators compare the two surgical techniques with the purpose of highlighting, if existing, the superiority of one technique on the other in terms of better functional recovery and proprioceptive sensibility.

Eligibility Criteria:
Inclusion Criteria:

* Elective unilateral primary hip prosthesis utilizing direct anterior approach
* Age ≥ 18
* Signature of the informed consent

Exclusion Criteria:

* Documented peripheral neuropathies
* Documented central nervous system diseases that may compromise the balance and/or proprioception
* Presence of other joint prosthesis in the lower limbs
* Revision hip arthroplasty
* Symptomatic osteoarthritis of other joints in the lower limbs (including the controlateral hip) or the spine
* BMI \> 35
* Systemic diseases or clinical conditions that could interfere with the clinical study
* Neuromuscular diseases
The Impact of Endoscopic Endonasal Skull Base Surgery on Olfaction

In this study, the research team will investigate the incidence and etiology of olfactory dysfunction following endoscopic endonasal skull base surgery, by combining clinical assessments with histomolecular analysis.

The incidence of olfactory dysfunction following endoscopic endonasal skull base surgery remains unclear in current research, and the results vary widely. Additionally, the pathophysiology of this postoperative olfactory dysfunction and the impact of this surgery on the trigeminal system has not been investigated to date. In this study, the investigators developed a state-of-the-art clinical pipeline with olfactory and trigeminal assessments, prior to and following endoscopic endonasal skull base surgery. Furthermore, the investigators will collect surgical waste tissue from the posterior septal mucosa, which is removed during this procedure to gain access to the sphenoid sinus and the (para)sellar region. By performing histomolecular analysis, the research group aims to elucidate the pathophysiology of olfactory dysfunction following this surgery.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients scheduled for endoscopic endonasal skull base surgery

Exclusion Criteria:

* Pre-existing anosmia
* Patients has a history of previous endoscopic endonasal skull base surgery
Lithium for Parkinson's: an Extension Trial

This study will examine the effects of 24 weeks of lithium therapy achieving serum lithium levels of 0.25-0.50mmol/L on MRI and blood-based biomarkers in Parkinson's disease patients who have completed one of our current 24-week lithium clinical trials.

In observational studies, small daily doses of lithium from smoking cigarettes have been associated with a 77% reduced risk of developing Parkinson's disease (PD). In addition, lithium therapy has been effective in preventing neuronal death and behavioral symptoms in several PD animal models. Recently, our group has shown 24-weeks of low-dose lithium therapy in PD to be associated with improvements in both MRI and blood-based biomarkers implying that lithium may be slowing the progression of the disease. However, these findings stemmed from only three of four patients receiving MRIs. Our group is now conducting two larger studies enrolling a total of 35 PD patients who are being treated with either 45mg/day or 20mg/day of lithium or placebo therapy for 24 weeks. Because our earlier study showed maximum improvements in PD biomarkers in patients with serum lithium levels of 0.25-0.50mmol/L and there are large interpatient variations in serum lithium levels achieved from the same lithium dosage, this present study will adjust lithium dosing in each patient to achieve this target serum lithium level for an additional 24 weeks. MRI and blood-based biomarker changes from Baseline will be compared in patients with serum lithium levels ≥ 0.25mmol/L and \<0.25mmol/L from one of the 24-week studies and within individual patients. Results from this study may identify a target serum lithium level range associated with maximum improvements in PD biomarkers that can be used in the design of future, larger lithium PD lithium trials, which may eventually support lithium as a disease-modifying therapy for PD that could improve patients' long-term prognoses.

Eligibility Criteria:
1. All PD patients completing STUDY00007253 or STUDY00008239 at the University at Buffalo will be eligible.
2. No unstable cardiac, medical, neurologic or psychiatric condition in the opinion of the PI.
3. No current use of illicit drugs or current alcohol abuse in the opinion of the PI.
4. No history of brain surgery or possible need for brain surgery including deep brain stimulation (DBS) for at least 24 weeks in the opinion of the PI.
5. Women with child bearing potential will need a negative pregnancy test and not be nursing an infant at screening. Women with child bearing potential will need to report using barrier method or hormonal contraception.
6. Willing and able to sign informed consent and follow study procedures.
Response to Influenza Vaccine in Patients With Non-Hematologic Malignancies Receiving Chemotherapy

This clinical trial studies the best time to administer the influenza vaccine to patients with non-hematologic malignancies receiving chemotherapy. Giving the vaccine at different times relative to chemotherapy may affect how well it works to help the body build an immune response and prevent influenza in these patients.


Eligibility Criteria:
Inclusion Criteria:

* Patients must have biopsy-confirmed non-hematological malignancy
* Patients must be scheduled to receive cytotoxic chemotherapy (adjuvant or metastatic setting), excluding immunotherapy
* Patients must be of age \>=18 years.
* Patients must have an absolute lymphocyte count \>= 1,000/mcL immediately prior to influenza vaccination
* Ability of the patient (or legally authorized representative if applicable) to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

* Patients who have already received the influenza vaccine during the season in which they are considered for eligibility will be excluded
* History of allergic reactions attributed to compounds of similar chemical or biologic composition to the influenza vaccine or egg allergies
* Previous history of Guillian-Barre syndrome within the previous 6 weeks to influenza vaccination
* Patients must not be receiving chronic steroid therapy, defined as \>= 14 days, unless used as part of a chemotherapy regimen
* Patients must not be on any other agents that can suppress the immune system
* Planned concurrent therapy with radiation
* Uncontrolled illness at time of enrollment or influenza vaccination including, but not limited to, ongoing or active febrile illness
* Psychiatric illness/social situations that would limit compliance with study requirements
* Known immunosuppression eg. history of organ transplantation or known human immunodeficiency virus (HIV)-positive patients on combination antiretroviral therapy are ineligible because they may not be able to mount an appropriate immune response
* History of influenza-like illness, defined as a temperature \> 37.8 degree C with cough or sore throat starting October 1, 2011 throughout the duration of the study
* Patient may not be scheduled to receive chemotherapy on a weekly basis.
Pharmacokinetic Study of Pyrotinib and Docetaxel in Combination With Trastuzumab in Patients With HER2 Metastatic Breast Cancer

The primary objective of the study is to study the pharmacokinetics of pyrotinib and docetaxel plus Trastuzumab in HER2 Positive MBC.

The secondary objective of the study is to evaluate the safety and efficacy (ORR) of pyrotinib and docetaxel plus Trastuzumab in HER2 Positive MBC.


Eligibility Criteria:
Inclusion Criteria:

1. HER2 positive recurrent or metastasis breast cancer.
2. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
3. Adequate organ function.
4. Signed, written inform consent obtained prior to any study procedure.

Exclusion Criteria:

1. Patients received more than 1 line of chemotherapy or immunotherapy in the phase of recurrence / metastasis.
2. History of HER tyrosine kinase inhibitors or monoclonal antibody for breast cancer in any treatment setting，except trastuzumab ,or Pertuzumab used in the neo-adjuvant or adjuvant setting.
3. Assessed by the investigator to be unable receive systemic chemotherapy.
4. History of other malignancy within the last 5 years，except for carcinoma in situ of cervix，basal cell carcinoma or squamous cell carcinoma of the skin that has been previously treated with curative intent.
5. Pregnant or lactating women，or for women of childbearing potential unwilling to use a highly-effective contraception during of the study treatment and for at least 7 months after the last dose of study treatment.
Combined PET/CT Imaging for the Early Detection of Ocular Melanoma Metastasis Compared to CT Scanning Alone

Patients diagnosed with ocular melanoma consent to participate in the study. Combined PET/CT scans of the whole body are performed at baseline, three months later, and six months after that for a total of three combined scans in the first year. Subsequently, these combined scans will be performed at 6-monthly intervals for a total of two combined scans per year.


Eligibility Criteria:
Inclusion Criteria:

1. Patients with a diagnosis of ocular melanoma (a pigmented malignant tumor) involving the choroid and/or ciliary body (the blood vessel layer in the back of the eye and/or the part of the eye behind the iris).
2. Patients 18 years of age or older.
3. Patients able to give informed consent.

Exclusion Criteria:

1. Patients who refuse to participate in the study.
2. Patients who are unable to cooperate with or cannot undergo PET/CT scanning.
3. Patients who will be moving out of the area of UCLA during the ten years of this study.
Pituitary Tumor Surveillance: Pathogenic Correlation

The purpose of this study is to observe predictors of pituitary tumor recurrence and markers of persistent disease activity in patients harboring pituitary mass lesions of all types.

The purpose of this study is to observe predictors of pituitary tumor recurrence and markers of persistent disease activity through computerized collection of comprehensive demographic, therapeutic, pathologic and outcome information on patients harboring pituitary mass lesions of all types.

Eligibility Criteria:
Inclusion Criteria:

* patients with confirmed pituitary disease

Exclusion Criteria:

* patients who do not have confirmed pituitary disease
Rasburicase Treatment in Chronic Gouty Arthritis

The study will establish efficacy and safety of rasburicase in chronic gouty arthritis

The study hypothesis is that the proportion of patients who achieved the primary endpoint after 12 weeks of treatment with rasburicase combined with oral urate-lowering therapy is superior to 12 weeks of treatment with oral urate-lowering therapy.

Eligibility Criteria:
Inclusion Criteria:

* Written informed consent must be obtained before any assessment is performed, able to understand and comply with the requirements of the study;
* Male and female patients 18 to 70 years of age;
* Fulfill the ACR/EULAR 2015 gout classification criteria;
* Tophi detected by physical examination;
* Serum urate\>300μmol/L (5mg/dl) after one-month maximum dose of urate-lowering therapy (allopurinol 600mg/d or febuxostat 80mg/d in combination with benzbromarone 100mg/d) unless intolerable OR no reduction in size of tophi after serum urate\<300μmol/L (5mg/dl) for six month;

Exclusion Criteria:

* Pregnant women, lactating women, and men or women who have recently prepared for pregnancy;
* Abnormal liver function with AST, ALT, and GGT \>3 times ULN;
* Blood WBC\<4.0×10\^9/L, and/or hemoglobin \<90g/L, and/or platelets;\<100×10\^9/L; or other hematologic disorders;
* eGFR\<15 ml/min;
* Receive following medications: azathioprine, mercaptopurine, cyclosporine, pyrazinamide, ethambutol and sulfamethoxazole
* Psychiatric disorders, history of alcoholism, drug or other substance abuse
* Immunodeficiency diseases, uncontrolled infection, etc;
* Sericosis, glucose-6-phosphate dehydrogenase activity deficiency
* Allergy to biological agents and chronic active urticaria.
A Study of WX390 in Patients With Advanced Solid Tumors

The goal of this clinical trial is to evaluate the efficacy and safety of WX390 in patients with advanced solid tumors. The main questions it aims to answer are:

* PFS, OS, DoR at week 48;
* antitumor effects at week 24 and week 48. Participants will be treated with WX390 orally, and follow the efficacy and safety evaluation according to the protocol.

This study will be an open-label, multicenter phase II clinical trial. After being informed about the study and potential risks, all patients giving written informed consent will undergo a 4-week screening period to determine eligibility for study entry. And then patents will be administered for 12 cycles treatment and 30 days safety follow up after the last dose of treatment. The efficacy and safety measures will be conducted and collected every cycle.

Eligibility Criteria:
Inclusion Criteria:

* ≥18 years of age
* Histological or cytological confirmed advanced solid tumor, standard regimen failed
* Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
* Life expectancy of more than 3 months
* At least one measurable lesion according to RECIST 1.1
* Adequate organ function
* Signed and dated informed consent

Exclusion Criteria:

* Anti-cancer therapy within 30 days prior to the initiation of investigational treatment
* Major surgery within 30 days prior to the initiation of study treatment
* Toxicity from a previous anti-tumor treatment that does not return to Grade 0 or 1 (except for alopecia)
* Patients who are suffering active interstitial lung disease
* Evidence of ongoing or active serious infection
* Received corticosteroids treatment or other immunodepressant within 2 weeks before the first dose of study treatment
* Active hepatitis B or C infection
* Inability to take medication orally
* Abuse of alcohol or drugs
* Pregnant or lactating women
* People with cognitive and psychological abnormality or with low compliance
Comparison of a Plant Protein Diet to a Animal Protein Diet Emphasized in Type 2 Diabetics

This 6-week parallel randomised prospective dietary intervention study with type 2 Diabetes investigates the nutrition influence of animal protein in comparison to plant protein on the glucose metabolism.

2x20 patients with Diabetes mellitus type 2 are randomise by a blind computer assist for an equal allocation in both groups (animal protein vs. plant protein). The food components for both groups are 40% carbohydrates, 30% fat and 30% protein. The carbohydrates are correspond with a high fiber content and a low blood sugar effectiveness of carbohydrates (glycemic index).

Eligibility Criteria:
Inclusion Criteria:

* Diabetes mellitus, type 2
* HbA1c between 6-11%

Exclusion Criteria:

* Consumptive or high grade diseases
* Intake of metabolic influence a/o anticoagulent drugs (e.g. cortisone, ASS, antibiotics)
* Diabetes type 1
* Pregnancy
* Chronic disease of heart, kidney, liver
* High grade anaemia
* High grade infection disease
* Relevant change of body weight (+/- 5 kg) since 8 weeks before begin of study Intervention
* Missing data about primary outcome measures (hyperinsulinaemic euglycaemic clamp, mealtime test, data about dietary intake from food diaries or food protocols)
* Significant deviation from dietary targets during the monitored 6 weeks isoenergetic period
* Allergies including food allergies