cyrilzakka/clinical-trials huggingface dataset:
Role of Citicoline in Treatment of Neonates With Hypoxic Ischemic Encephalopathy

Hypoxic ischemic encephalopathy is an acute or subacute brain injury, due to asphyxia in neonates, leading to mortality and long-term morbidity. Its prevalence varies across regions, with developed countries reporting rates of 1.5 per 1000 live births, while developing nations experience a wider range from 2.3 to 26.5 per 1000 live births.

Infants afflicted with moderate HIE face a 10% risk of mortality, with surviving individuals encountering a 30% chance of developing disabilities. The prognosis is graver for severe HIE, with a mortality risk of 60%, and nearly all survivors experiencing some form of disability.

A number of treatment modalities are available but are not clinically effective due to inefficacy and undesirable side effects. Despite therapeutic hypothermia being the sole effective neuroprotector to date, its applicability is limited in certain scenarios, such as gestational age below 36 weeks, birth weight under 2000 g, and initiation beyond 6 hours of age. Therefore, there is a critical need to explore alternative, safe, effective, and accessible neuroprotective therapies, particularly in developing nations.

Citicoline, cytidine 5-diphosphocholine, is an exogenous substance and a product of rate limiting step of phosphatidyl choline synthesis. It has rapid absorption through enteral route where it breaks into cytidine and choline. Citicoline is a favorable recently developed neuroprotector in HIE as it helps to regenerate neuronal cells by inhibiting different steps of ischemic cascade like inhibiting glutamate built up and ROS synthesis increasing dopamine and acetylcholine neurotransmitters, regenerating injured cell membrane and increasing brain plasticity and repair.

In this study, effects of citicoline as a neuroprotector are evaluated in neonates with moderate and severe HIE.

Eligibility Criteria:
Inclusion Criteria:

1. all indoor newborn babies with HIE II and III
2. who have not received therapeutic hypothermia

Exclusion Criteria:

1. grade I HIE
2. Babies on TH
3. babies whose parents do not give consent for inclusion in study
4. babies with major congential malformations -
Efficacy of Online Hemodiafiltrationlysis in Cytokine Removal

Following the concept of "peak concentration hypothesis", which suggest the cutting peak of pro- and anti-inflammatory mediators would result in restoring a situation of immunohomeostasis. The investigators conducted the prospective randomized controlled trial aimed to compare the clearance efficacy between on-line hemodiafiltration and high-flux hemodialysis in sepsis-related acute kidney injury patients. The lowering cytokines level during sepsis is postulated to improved outcomes in sepsis.

1. Blood samples were taken from patients before and at the end of 4-hour in the first dialysis session. The percentage of reductions were calculated from the before and ending samples. The values of postfilter samples were corrected for changes in plasma volume, based on hemoglobin (Hb) of prefilter.
2. VEGF and other cytokines (IL-6, IL-8, IL-10, and TNF-α) were determined in the plasma separated from EDTA blood. After collection, plasma separation was achieved by centrifugation for 10 min at 1,500 g. Immediately after separation, the samples were stored at -70 ºC until further analysis.
3. All determinations were carried out in duplicate. The panels of cytokines (VEGF, IL-6, IL-8, IL-10, and TNF-α) were measured using the Luminex xMap-based multiplex technology. Assays were performed using the MILLIPLEX MAP (multi-analyte panels) 5-plex Cytokine Kit (Millipore, Billerica, MA) on the Luminex® instrument according to the manufacturer's procedure.

Eligibility Criteria:
Inclusion Criteria:

* Sepsis
* acute kidney injury (RIFLE classification F)
* Age more than 18

Exclusion Criteria:

* Hemodynamic instability
* Whom written informed consent could not be obtained
IndoProCaf Effervescent Tablets Effectiveness in Acute Treatment of Migraine and/or Episodic Tension-type Headache and Patients' Satisfaction With the Treatment in Routine Clinical Practice

Headaches are a common medical problem that physicians frequently encounter in their practice. One of key findings of The Atlas of Headache Disorders prepared by World Health Organization (WHO) is: headache disorders, including migraine and tension-type headache (TTH), are among the most prevalent disorders of mankind. The fixed combination of indomethacin, prochlorperazine and caffeine (IndoProCaf) showed efficacy and safety in acute treatment of migraine and episodic tension-type headache attacks. IndoProCaf (Difmetre®) is widely used in common daily practice only in Italy from early 1970s, is available at the Commonwealth of Independent States (CIS) pharmaceutical market now. There are limited data regarding IndoProCaf usage from post-marketing settings. This will be a first post-marketing observational study which aimed to evaluate the effectiveness and patients' satisfaction of primary headaches acute treatment in routine clinical settings in Ukraine and Kazakhstan.

The study is designed as a prospective, multicentre, observational, non-interventional, non-randomized, non-controlled, single arm, post-marketing study where IndoProCaf will be prescribed in the usual manner per standard clinical practice of the treating physician and in accordance with the terms of the locally approved instruction for medical use. No additional procedures (other than the standard of care) shall be applied to the patients.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of primary headache (migraine with or without aura and/or episodic TTH) and whose headache attacks required acute pharmacological treatment.
* Were administered IndoProCaf (Difmetre®) effervescent tablets therapy according to the local product labelling.
* Adults 18 years and older (male, female).
* Provide Authorization to the investigator to use and/or disclose personal and/or health data.

Exclusion Criteria:

* Meet contraindications for treatment with IndoProCaf (Difmetre®) effervescent tablets as outlined in the latest version of local product labelling.
* Patients who are required prescription by physician of IndoProCaf and nonsteroidal anti-inflammatory drug-containing products at the same time for acute headache attacks treatment.
* Previous discontinuation of IndoProCaf treatment due to safety (i.e. hypersensitivity) events, lack of efficacy.
* Female patients who are pregnant or are breast-feeding.
Irinotecan, 5-Fluorouracil, and Leucovorin in Colorectal Carcinoma

This study will examine an investigational (experimental) agent Tetrathiomolybdate (TM) combined with the chemotherapy drugs Irinotecan, 5-Fluorouracil (5-FU) and Leucovorin (LV). This study will evaluate the safety and tolerability of the combination of these drugs when they are used in the treatment of metastatic colorectal cancer.

This is a pilot clinical trial which will be studying the reactions of the patient's body and tumor to the experimental treatment described above. The purpose of this study is to find out what kind of side effects this experimental treatment causes and see how often these side effects occur.


Eligibility Criteria:
Inclusion Criteria:

* Patients must have histologically proven adenocarcinoma primary to the colon or rectum and clinical or pathologic evidence of distant metastasis.
* Patients may have received adjuvant chemotherapy and/or one regimen of chemotherapy for metastatic disease. Patients must not have been previously treated with the combination of irinotecan/5-FU/LV.
* Patients must be past their 18th birthday at the time of enrollment.
* Patients must have a performance status of 0-2 at the time of registration.
* Patients must have a life expectancy of \> 3 months.
* If patients have undergone recent surgery, they must have fully recovered from the effects of that surgery prior to enrollment.
* Patients must have a pretreatment leukocyte count \> 3,000/l, absolute neutrophil count \>1500/l, hemoglobin \>8 mg/dl, and platelet count of \> 150,000/l within 2 weeks of enrollment.
* Patients must have adequate renal function, as documented by a serum creatinine \< 2.0 mg/dl, and have adequate hepatic function, as documented by a serum bilirubin \< 1.1 mg/dl within 2 weeks of enrollment.

Exclusion Criteria:

* Patients must not have active infection.
* Patients must have no serious medical or psychiatric illness, other than that treated by this study, which would limit the ability of the patient to receive protocol therapy or give informed consent.
* Patients must not have a history of active malignancy, other than that treated by this study, within the 12 months preceding enrollment.
* Pregnant or lactating women may not participate. Women of reproductive age must undergo a serum pregnancy test within 14 days of enrollment. Men and women of reproductive potential must use an effective contraceptive method during the study.
* There must be no plans for the patient to receive concomitant antineoplastic therapy while on this protocol.

All patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines.
ED Intervention to Reduce Risky Behaviors in Drivers

Disability and death from injury remain a persistent problem in the U.S. and risk-taking behaviors are known to contribute to injury. Healthy People 2010 set goals to reduce deaths caused by injury: "Motor vehicle crashes are often predictable and preventable. Increased use of seat belts and reductions in driving while impaired are two of the most effective means to reduce the risk of death and serious injury of occupants in motor vehicle crashes." One preventive strategy is to establish screening and intervention procedures that can be administered in the ED to young adults who have risky driving practices and problem drinking. Goal: The specific aim of this prospective, randomized controlled trial is to test the effectiveness of a brief intervention to limit risky driving behaviors (risky driving practices, lack of seat belt compliance) and problem drinking in drivers during an ED visit. In addition, the trial will result in a benefit-cost analysis from the perspectives of both society as a whole and hospitals in particular. Methods: Young adults 18 to 44 years will be screened for problem drinking and risky driving practices during an ED visit. Subjects who screen positive for problem drinking and risky driving will be randomized to one of three groups: No Contact Control Group (NCG: after informed consent, subjects receive no screening or intervention until 12 months after injury). Contact Control Group (CCG: subjects screened at baseline and every three months for 12 months but no intervention), and a Brief Intervention Group (BIG: subjects receive screening and brief intervention with data collection points every three months for 12 months). A total of 133 subjects per group (N=400) will be enrolled. The intervention will consist of a 20 minute nurse visit in the ED and a booster intervention at 7-10 days after ED discharge. All subjects will be telephoned at 3, 6, 9, and 12 months by interviewers blinded to condition. Outcomes of interest include reported alcohol use, risky driving behaviors, driving citations, adverse health outcomes, and costs (health care utilization, property damage, travel delays, lost work productivity, criminal justice expenses, and monetarized adverse health outcomes). Analysis: Power analysis suggests that 133 subjects in each arm of the trial will have sufficient power to detect a difference of the main outcome variables of interest. A variety of regression techniques, including individual growth curve modeling and event history analysis, will be used to test the proposed hypotheses.


Eligibility Criteria:
Inclusion Criteria:

Screen Positive for a drinking problem in the ED

Exclusion Criteria:

* \<18years or \>44years old
Theranostic Implication of Complementary Medicines Against Interleukin Receptors and Gp-130 Proteins

IL-6 is an inflammatory marker, secrete by the cells in many pathological conditions like COVID-19 pneumonia. Interleukin 6 bind with its receptors (IL-6R) on cells surface and recruited a protein for its activation known as gp-130. Activated receptors send signals to nucleus through secondary messenger system and up regulate the expression of IL-6/GP130 domain. Total of two hundred (n=200) participants were included in the current study and divided equally in four groups. Group B is given Tocilizumab and Group C is treated with Remdesivir along with the approved standard treatment. Group D is only Given standard therapy and Group A constituted normal healthy age and sexed matched participants. Levels of gp-130 were estimated by commercially available ELISA kit. To estimate the relationship of severity of disease with gp-130 and IL-6 Pearson's correlations was used. Sensitivity and specificity for what purpose


Eligibility Criteria:
Inclusion Criteria:

Admitted diagnosed cases of COVID-19 infection on real time polymerase chain reaction (RT-PCR) Both male and female were included All participants were on oxygen therapy

Exclusion Criteria:

Asthmatics pulmonary fibrosis chronic obstructive pulmonary disease (COPD) Allergic to remdesivir Allergic to Actemra Refused to take consent
Systematic Review and Meta-analysis of Cereal or Grain Consumption and Gastric Cancer

This project involved a systematic literature review of published trials of cereal or grain in relation to the risk of gastric cancer. Data was extracted from the publications on PubMed, EMBASE, Cochrane Library.A traditional meta-analysis, subgroup analysis, and heterogeneity was conducted on the extracted data.

Investigators searched PubMed, EMBASE, Cochrane Library for studies focusing on cereal or grain in relation to the risk of gastric cancer up to October 2017. Summary odd ratios (OR) and 95% confidence intervals (CI) were calculated by using either random effect models or fixed effect models according to the heterogeneity of included studies. Subgroup analysis, heterogeneity, and publication bias were also performed.

Eligibility Criteria:
Inclusion Criteria:

* a case-control studies or a cohort study
* investigate the association between cereal or grain intake and GC occurrence
* report an odds ratio (OR) or relative risk (RR) with corresponding 95% confidence intervals (CI)
* provide sufficient data to estimate OR or RR

Exclusion Criteria:

* Non-human studies
* GC mortality-based cohort studies
Effect of Normatec Pump for Relief of Leg Edema

The investigators hypothesize that leg edema will decrease rapidly when using the NormaTec pump, patients will lose weight, will feel better, will be less prone to infections in their legs and to congestion of the liver. Temporary elevation of intravascular fluid volume by the mobilized edema fluid returned to the intravascular space by pumping may increase cardiac output and renal perfusion and in addition it may distend the right atrium and ventricle thus inducing BNP secretion. Both mechanisms may promote excess fluid removal by the kidneys.


Eligibility Criteria:
Inclusion Criteria:

* hemodynamically stable adult patients with pronounced leg edema from any etiology, on optimal medical therapy (such as diuretics, ACE-I or ARBs, digoxin).
* documentation of right heart failure by Echo or other modality (CT, MRI, right heart catheterization) and hemodynamic data from Echo is required and an elevated pulmonary artery pressure (\> 35 mmHg) is expected in such cases.

Exclusion Criteria:

* patients in sepsis,
* hemodynamically unstable,
* during an acute attack of pulmonary edema,
* with renal failure (creatinine \> 2 mg%),
* with DVT,
* psychiatric or noncompliant patients, and
* patients who will not sign the informed consent form will be excluded from the study.
Mindfulness, Optimism, and Resilience for Perinatal Health and Equity Study

Dispositional optimism (the general assumption that more good things than bad will occur across various life domains) has been tied to improved somatic and mental health outcomes. Dispositional optimism is malleable, although prior interventions have been time and resource intensive and thus are not well-tailored to the peripartum period. The purpose of this pilot study is to evaluate the feasibility and acceptability of a pregnancy-oriented mindfulness phone application (Expectful) versus standard care among first-time mothers with low dispositional optimism in early pregnancy. Other aims include evaluating the impact of Expectful use on dispositional optimism, adverse pregnancy outcomes (cesarean delivery, hypertensive disorders of pregnancy, and gestational diabetes) and postpartum post-traumatic stress symptoms.

This randomized clinical trial of nulliparous women with low dispositional optimism in early pregnancy seeks to determine whether use of a pregnancy-oriented digital mindfulness application will be feasible and acceptable and show preliminary evidence of efficacy in improving dispositional optimism, reducing adverse perinatal outcomes and improving postpartum post-traumatic stress symptoms.

This pilot will include 100 women recruited from the obstetrical service at Women and Infants Hospital of Rhode Island. Women will be included if they are nulliparous, have a singleton pregnancy at \<20 weeks gestational age, speak English and have low dispositional optimism (a score of ≤14 on the validated, Revised Life Orientation Test). Eligible participants will be randomized to either using the digital app Expectful or standard pregnancy care.

Women will be randomized with equal probability to the intervention group using block randomization stratified by race/ethnicity (Hispanic, non-Hispanic White/Other or non-Hispanic Black).

Women in the mindfulness training arm will complete 8 weeks of daily mindfulness training exercises using Expectful. Women in the standard care group will receive standard pregnancy and postpartum care. Pregnancy and labor management will be at the discretion of each participant's obstetric provider.

Participants in both groups will be asked to complete 4 questionnaires: one at enrollment, a post-intervention one at 8 weeks, at the time of delivery and at 6-8 weeks postpartum. Half of the participants in each arm (total n=50), will be asked to complete a qualitative, semi-structured interview on the role of optimism and other resilience factors in pregnancy.

Eligibility Criteria:
Inclusion Criteria:

* Able to provide informed consent
* English speaking
* Nulliparous (no prior delivery at or greater than 20w0d gestation)
* Pregnant with singleton fetus
* \<20w0d gestation
* Low dispositional optimism (score \</= 14 on the Revised Life Orientation Test)
* Owns a smart phone

Exclusion Criteria:

* Plan to deliver at another institution
* Ongoing (≥1/week) mind-body practice including mindfulness training, meditation or yoga
* Pre-gestational hypertensive disorder
* Pre-gestational diabetes mellitus
The Effect of Surgically Induced Weight Loss on Endocrine Function, Cardiovascular Function and Body Composition

This study is being conducted to evaluate changes in sugar, metabolism, heart function and changes in body composition as patients lose weight following bariatric surgery. The investigators will compare improvements of the above changes as a function of the four different types of bariatric surgery. The investigators believe the most beneficial and safest procedure will be the Roux-en-Y.

The study will also examine the response of the pancreas (the insulin-producing organ) to a sugar load, as well as to a hormone called Glucagon Like Peptide 1 (GLP-1), which is released from your gut to maximally stimulate your pancreas. The release of this hormone increases when you eat food and it causes the pancreas to release more insulin than does sugar alone. Volunteers will have 22 visits over a two year period. Only people having Roux-en-Y gastric bypass surgery, gastric sleeve surgery, duodenal switch gastric surgery or lap-band/gastric banding surgery may join. Seventy volunteers will be recruited to take part in this study.

Eligibility Criteria:
Inclusion Criteria:

* Male and female volunteers 21-65 years.
* BMI \> 40.
* Preoperative hematocrit level of at least 34% for women and 38% for men.
* Postoperative hematocrit level of at least 34% for women and 36% for men.

Exclusion Criteria:

* Volunteers whose hematocrit level does not meet the above criteria.
* Pregnant and or lactating females.
A Study of HC006 in Subjects With Advanced Solid Tumors

The purpose of this study is to characterize the safety, tolerability, pharmacokinetics (PK), Immunogenicity and preliminary antitumor activity of HC006 in subjects with advanced solid tumor malignancies. This study is a first-in-human (FIH) study of HC006 in subjects with advanced solid tumors.

HC006, a novel therapeutic monoclonal antibody that specifically binds to human C-C motif chemokine receptor 8 (CCR8) and is designed to selectively deplete tumor-infiltrating T regulatory cells (Tregs) with enhanced antibody-dependent cell-mediated cytotoxicity (ADCC). In mouse tumor models, HC006 has demonstrated excellent antitumor activity and safety profile. This first-in-human (FIH) study will be conducted in two parts. In the Dose-Escalation part, testing will be done on up to 31 subjects to determine the maximum tolerated dose (MTD) and the recommended dose (RD). In the Dose-expansion part, we will evaluate the safety and efficacy of the recommended dose of HC006 in the treatment of advanced solid tumor subjects without standard therapy.

Eligibility Criteria:
Inclusion Criteria:

* Subjects must have histologically confirmed and documented diagnosis of locally advanced unresectable or metastatic advanced solid tumor that is refractory to standard treatment, or intolerant to standard treatment, or for which no standard treatment exists.
* At least one measurable disease for expansion cohorts per Response Evaluation Criteria in Solid Tumours (RECIST) v1.1(dose escalation only requires at least one assessable lesion)
* Agree to provide archived or fresh tumor tissue samples of primary or metastatic lesions for expansion cohorts.
* Life expectancy ≥12 weeks
* Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
* Have adequate organ function as described in the protocol.
* Agree to adopt effective contraceptive measures.

Exclusion Criteria:

* Prior exposure to CCR8 inhibitor or hypersensitivity to any ingredient of the study drug.
* Treatment with any systemic anti-cancer treatment within 4 weeks before first dose of study drug.
* Use of any live attenuated vaccines within 28 days.
* With primary central nervous system (CNS) tumors or unstable CNS metastases.
* Have active or history of autoimmune disease or immunodeficiency disease.
* With active, uncontrolled bacterial, viral, or fungal infections requiring systemic therapy.
* With any mental or cognitive impairment that may limit their understanding, implementation.
* Major surgery within 4 weeks of study drug administration.
* Have uncontrolled or severe illness, including but not limited to severe cardiovascular disease, interstitial lung disease or non-infectious pneumonia, or uncontrollable clinical third luminal effusion.
* Any adverse event from prior anti-tumor therapy has not yet recovered to ≤ grade 1 of CTCAE v5.0.
* History of other malignancy within the last 5 years, except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma.
* Women who are pregnant or breastfeeding.
* Other protocol defined exclusion criteria may apply.