cyrilzakka/clinical-trials huggingface dataset:
Darbepoetin Trial to Improve Red Cell Mass and Neuroprotection in Preterm Infants

Study Hypothesis: Preterm infants administered weekly Darbe during the neonatal period will have improved neurocognitive outcome at 22-26 months compared to placebo

Advances in neonatal care have led to significant improvements in the survival of the nearly 60,000 very low birth weight (VLBW) infants born each year in the U.S. Improving neurodevelopmental outcomes for these preterm infants continues to be a major goal for neonatal care providers. A subset of these infants sustain a grade 3 or 4 intraventricular hemorrhage (IVH) resulting in an increase in the incidence of developmental delay. Moreover, almost one third of preterm infants with normal head ultrasounds also develop cognitive delay. Although a variety of neuroprotective treatment strategies have been evaluated, no specific treatment has been identified to reduce or prevent brain injury in these most vulnerable preterm infants.

A potential neuroprotective therapy involves administering erythropoiesis stimulating agents (ESAs) such as erythropoietin (Epo) and Darbepoetin (Darbe, a longer acting ESA). In addition to stimulating erythropoiesis, ESAs have been shown to be protective in the developing brain in animal models, making it possibly beneficial for very premature infants who are at risk for intraventricular hemorrhage, hypoxic-ischemic injury, and developmental delay. The neuroprotective mechanisms of ESAs include increased neurogenesis, decreased neuronal susceptibility to glutamate toxicity, decreased neuronal apoptosis, decreased inflammation, decreased nitric oxide-mediated injury, increased antioxidant response, decreased axonal degeneration, and increased protective effects on glia. This is a randomized, masked, placebo controlled clinical study in which enrolled infants will receive weekly Darbe or placebo (sham) dosing.

Extended follow-up: Subjects will be seen for follow-up at 4-5 years (i.e., 4 years - 4 years 11 months) corrected age and 6-7 years (i.e., 6 years - 6 years 11 months) corrected age to characterize the functional, behavioral and neurological outcomes of the extremely low birth weight (ELBW) population at school age based on treatment with darbepoetin versus placebo in the neonatal period.

Eligibility Criteria:
Inclusion Criteria:

* Inborn and outborn preterm infants
* 23 0/7-28 6/7 weeks gestational age
* ≤24 hours postnatal age

Exclusion Criteria:

* Hematocrit \> 60%
* Infants with known congenital or chromosomal anomalies, including congenital heart disease and known brain anomalies
* Hemorrhagic or hemolytic disease
* EEG- confirmed seizures
* Congenital thrombotic disease
* Systolic blood pressures \>100 mm Hg while not on pressor support
* Receiving Epo or Darbe clinically, or planning to receive Epo or Darbe during hospitalization
* Infants in whom no aggressive therapy is planned
* Family will NOT be available for follow-up at 22-26 months
An Assessment of the Feasibility and Safety of Conservative Oxygen Therapy in Critically Ill Patients

The investigators hypothesize that it is feasible and safe to deliver a conservative approach to oxygen therapy in mechanically ventilated critically ill patients (a tiem frame of, on average,10 days).

1. Identify patients likely to require ventilation until the day after tomorrow (a time frame of 36 hours of average)
2. Deliver a conservative oxygen therapy protocol while in ICU (a time frame on average of 10 days)
3. Target an oxygen saturation between 90 and 92%
4. Adjust FiO2 to achieve target SaO2 at all times
5. Assess percentage of time patient is within target
6. Assess for safety of this approach

Eligibility Criteria:
Inclusion Criteria:

* Mechanical ventilation
* expected to be ventilated until the day after tomorrow (a tiem frame of, on average 48 hours)

Exclusion Criteria:

* expected to be off mechanical ventilation today or tomorrow
* carbon monoxide poisoning
* necrotizing fasciitis
The Effect of Liberal vs. Restrictive Transfusion Strategies on Rehabilitation After Hip Fracture Surgery

To examine the effect of two different transfusion regimens on rehabilitation after hip fracture surgery.

The effect of liberal vs restrictive transfusion regimens after hip fracture surgery is unresolved. Liberal transfusion regimens (transfusion trigger hgb. 6.25 mmol/l) leads to an increased use of blood products but may impact positively on rehabilitation outcome, a restrictive transfusion trigger (hbg. 5.0 mmol/l) saves blood products but may also impair postoperative rehabilitation and outcome. the study randomizes 120 elderly patients with hip fractures to either a restrictive or a liberal perioperative transfusion therapy and measures postoperative rehabilitation outcomes within a well defined multimodal rehabilitation regimen.

Eligibility Criteria:
Inclusion Criteria:

* Primary hip fracture
* capable of informed consent
* independently dwelling
* able to ambulate independent of human assistance
* no active heart condition defined as no AMI within 3 months, no unstable angina or present incompensation/pulmonary oedema
* no regular transfusion demand or terminal disease.

Exclusion Criteria:

* Multiple fractures
* postop. immobilization due to to surgical reasons
* patient refusal to participate in relevant rehabilitation
* reoperation within 4. postoperative day.
Study of CMV in Kidney Transplant Recipients

Using novel CYTOF technology to measure a wide array of innate and adaptive cell proportions and cytokine levels, we plan a pilot study in old (\>/=60 years) and young (20-40 years) renal transplant recipients who are cytomegalovirus (CMV) seropositive (regardless of donor serology). Viral load measurements will be performed at baseline prior to transplant (within 1 week),and then at 3, 7 and 10 months after transplant. It is expected that the patient will receive anti-CMV prophylaxis until 6 months post-transplant, so the latter two time points will reflect responses after "release" from antiviral suppression. Each patient will serve as their own control, with comparisons made between measurements at baseline and then at each timepoint. In addition, clinical data will be collected at the time points indicated, particularly renal function and the presence/absence of acute rejection.

Using novel CYTOF technology to measure a wide array of innate and adaptive cell proportions and cytokine levels, we plan a pilot study in old (\>/=60 years) and young (20-40 years) renal transplant recipients who are CMV seropositive (regardless of donor serology). Viral load measurements will be performed at baseline prior to transplant (within 1 week),and then at 3, 7 and 10 months after transplant. It is expected that the patient will receive anti-CMV prophylaxis until 6 months post-transplant, so the latter two time points will reflect responses after "release" from antiviral suppression. Each patient will serve as their own control, with comparisons made between measurements at baseline and then at each timepoint.

Blood from 10 patients in each age group will be studied, to collect virologic and immune response data:

* CYTOF (broad array of measurements)
* Tetramer assays (requires recipient HLA type of A1, A2, B7)
* CMV viral load PCR
* Response to pneumococcal antigens and inactivated influenza virus

In addition, clinical data will be collected at the time points indicated,particularly renal function and the presence/absence of acute rejection.

Eligibility Criteria:
Inclusion Criteria:

1. Adults young age 20-40 years and old \>/= 60 years
2. Anticipate renal transplant within 2 weeks
3. CMV sero-positive renal transplant recipients
4. HLA type of A1, A2, B7 of recipient

Exclusion Criteria:

1. Pediatric recipients
2. Multi-organ transplant recipients
3. Highly sensitized (antigen level) recipients
4. Prior organ transplant recipients
5. Patients who do not wish to participate in study, or who cannot consent to research
6. Patients with active CMV infection
7. Seronegative
8. HLA Type of organ recipient not corresponding to A1,A2, B7
Hypoglycemia Associated Autonomic Failure in Type 1 Diabetes Mellitus (DM)

Exercise is a cornerstone of diabetes management. It helps reduce blood pressure, promote weight loss, lower insulin resistance and improve glucose and lipid (triglyceride and HDL-cholesterol) profiles. Unfortunately, the benefits of exercise are often not embraced by diabetic individuals because of the fear of low blood sugar (hypoglycemia). My laboratory has demonstrated that Autonomic nervous system (ANS) counterregulatory failure plays an important role in exercise associated hypoglycemia in Type 1 DM. ANS responses are significantly reduced in Type 1 DM and are further blunted by antecedent episodes of hypoglycemia. Furthermore, there is a large sexual dimorphism of reduced ANS responses during submaximal exercise in both Type 1 DM and healthy individuals that is unexplained. Accumulating data are demonstrating that serotonergic pathways can regulate ANS discharge. Generally, serotonergic pathways are inhibitory but both single and longer term administration of selective serotonin reuptake inhibitors (SSRI's) such as Prozac has been demonstrated to increase basal epinephrine levels and enhance baroreflex control of Sympathetic nervous system (SNS) activity. What is unknown is whether fluoxetine can also enhance SNS responses and also override the large ANS sexual dimorphism present during sub maximal exercise. Therefore, the purpose of this study is to determine if the SSRI fluoxetine (Prozac) can improve SNS responses during exercise.


Eligibility Criteria:
Inclusion Criteria:

* 32 (16 males, 16 females) Healthy controls aged 18-45 yr.
* 32 (16 males, 16 females) Type 1 diabetic patients aged 18-45 yr.
* HbA1c 6-10.0%
* Has been diagnosed Type 1 DM
* No clinically diagnosed diabetic tissue complications (i.e. history of retinopathy, neuropathy, stasis ulcers, etc)
* Body mass index \< 40kg • m-2

Exclusion Criteria:

* Pregnant women
* Subjects unable to give voluntary informed consent
* Subjects on anticoagulant drugs, anemic or with known bleeding diatheses
* Subjects taking any of the following medications will be excluded: Non-selective Beta Blockers, Sedative-Hypnotics, Anticonvulsants, Antiparkinsonian drugs, Antipsychotics, Antidepressants, Mood stabilizers, CNS Stimulants, Opioids, Hallucinogens
* Subjects with a recent medical illness
* Subjects with a history of hypertension, heart disease, cerebrovascular incidents
* Current tobacco use
Clinical Study of QSOX1 as a Biomarker for Colon Cancer

The goal of this observational study is to determine whether the secreted protein QSOX1 can be used as a molecular marker for early rapid diagnosis and accurate treatment of colon cancer.

The project mainly selects the tumor group represented by colon cancer and the corresponding healthy people as the control group, with about 100 cases in each of the two groups. Mainly collect blood and tumor tissue samples of patients, detect the expression of QSOX1 in the above samples, and explore the role in the diagnosis and prognosis evaluation of colon cancer.

Eligibility Criteria:
Inclusion Criteria:

* Colon cancer was confirmed by colonoscopic pathology.
* No local or systemic treatment was performed before operation.
* Complete clinical data.

Exclusion Criteria:

* Combined with benign diseases of colon, such as ulcerative colitis, colon adenoma and colon polyp.
* Other tumors other than colon cancer.
Comparative Factorial Study Design of Ultrasound Guided Wrist Block for Hand Surgery Comparing Effect of Bupivacane Alone and Bupivacane with Dexamethasone and Bupivacane with Dexametmiodine and Bupivacane with Dexamethasone and Dexametmiodine

Ultrasound guided wrist block comparing effect of bupivacane alone and bupivacane with dexamethasone and bupivacane with dexametmiodine and bupivacane with dexamethasone and dexametmiodine

Ultrasound guided wrist block comparing effect of bupivacane alone and bupivacane with dexamethasone and bupivacane with dexametmiodine and bupivacane with dexametmiodine and dexamethasone.

Taking medical and surgical history from patients. Taking base line data as heart rate and blood pressure and spo2. Measure duration of analgesia for post operative pain using NRS for 24 hours abd recording NRS at time interval of 2 , 4,6,12,24 hours post operative.

Any patient the NRS above 4 will receive 5 mg nalbufin . Recording patients satisfaction by a survey .

Eligibility Criteria:
Inclusion Criteria:

- Patients more than or equal 18 years old and are ASA 1-3

Exclusion Criteria:

* allergy to used medication
* pre exist neuropathy
* coagulapthy
* cognitive impairment
* refusal to participate
* Failed block and requiring general anesthesia
Anesthesia Quality Control Indicators of 6 Provinces in Central China

The investigators are aimed to evaluate the anaesthesia-related quality control indicators and adverse events, in terms of its incidence, changes, causes, risk factors and preventability in Central China, using a series of annual surveys.

The investigators prospectively collected information on patient, surgical, anaesthesia, and hospital characteristics for all anaesthesia procedures performed in all certified facilities in Central China. All available data of patients who had anaesthesia were gathered monthly from anaesthesia quality control groups that provide services to all certified facilities and were reviewed.

All anaesthesia-related adverse events were scrutinized consecutively to determine their root causes and preventability. The incidence and patterns of anaesthesia-related quality control indicators and adverse events were analysed.

Eligibility Criteria:
Inclusion Criteria:

Patients undergoing anesthesia

Exclusion Criteria:

Those with a miss-reporting rate higher than 5%
IL6 on Umbilical Cord (Evaluation of IL-6 Levels on Umbilical Cord)

Fetal inflammatory response syndrome (FIRS) is a major cause of non-hypoxic fetal intrapartum injury. One of the most common determinants of FIRS during labor is the exposure to an ongoing intra-amniotic infectious agent as in the event of a chorioamnionitis. Interleuchine-6 (IL-6) is considered a reliable hallmark of FIRS. No specific fetal heart rate pattern for the diagnosis of FIRS have been described so far at intrapartum Cardiotocography (CTG). The aim the present study is to investigate the correlation between intrapartum CTG findings and IL-6 levels on the arterial cord.

The labor will be managed according to the local protocol and 5mL of blood will collected from the umbilical artery soon after birth to determine the IL-6 values. CardioTocography (CTG) traces will be retrospectively reviewed by two expert operators that will be blinded to the IL-6 results and will categorize them as "inflammatory" or "not inflammatory".

Inflammatory pattern will be defined in presence of 1) inappropriately high FHR for the given gestational age and/or 2) an increase \>10% compared with the FHR baseline values at admission without preceding deceleration with/without reduced variability or absent cycling.

The association between CTG findings as the umbilical levels of IL6 will be analyzed.

Eligibility Criteria:
Inclusion Criteria:

* singleton pregnancies at term submitted to a continuous CTG tracing during labor

Exclusion Criteria:elective Cesarean Delivery, maternal tachycardia or pyrexia \>38°C, drugs assumption

-
Nomogram for Predicting Difficult Transoral and Submental Thyroidectomy

No prior studies have stratified the difficulty of transoral and submental thyroidectomy (TOaST). The investigators aimed to investigate preoperative factors as indicators of difficult TOaSTs and to develop a predictive model accordingly.

Thyroid cancer is the most common endocrine malignancy, with a female predominance. Thyroidectomy is the main treatment for thyroid cancer, and considering the good prognosis of thyroid cancer, endoscopic thyroid surgery, which avoids neck incision, is being widely used in the clinic in order to improve the life treatment of patients. Among them, endoscopic thyroidectomy with transoral approach has a shorter learning curve because of the short surgical path. However, due to the complex structure of the neck, small space, and rich blood supply of the thyroid gland, surrounded by parathyroid glands and important nerves, endoscopic thyroid is difficult and has a long learning curve. In addition, a series of complications such as haemorrhage, hypoparathyroidism and laryngeal reentrant nerve injury can seriously affect the quality of patient survival. Difficult thyroidectomy is usually characterized by a long operative time, high intraoperative bleeding and a high incidence of postoperative complications. According to the literature, in open thyroid surgery, the degree of difficulty is associated with factors such as goiter, inflammation, and hyperthyroidism. However, the degree of difficulty of thyroidectomy due to various factors varies and is difficult to predict. Surgical difficulty is closely related to the outcome and safety of thyroidectomy, which is an urgent concern for surgeons. And there is no study on the degree of difficulty of transoral and submental endoscopic thyroidectomy, therefore, there is an urgent need for an effective and objective method to determine the preoperative factors affecting the degree of surgical difficulty and to establish a model for validation, so that it can be subsequently replicated in other hospitals.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of differentiated thyroid cancer with a maximum diameter not exceeding 4 cm
* Absence of suspicious lateral lymph nodes or distant metastases
* Participants with high cosmetic expectations
* Participants who underwent total thyroidectomy and central lymph node dissection.

Exclusion Criteria:

* Participants with fusion or fixation of lymph nodes in the neck
* Participants with history of neck surgery or radiation
* Participants with vocal fold fixation by preoperative fibrolaryngoscope
* Participants with preoperative examination suggestive of extrathyroidal invasion
* Participants with a significantly restricted neck
A Study of Fluzoparib Given in Combination With Apatinib in Ovarian or Breast Cancer Patients

Fluzoparib is an oral potent, selective poly-ADP ribose polymerase-1 (PARP-1) and PARP-2 inhibitor; Apatinib is an oral selective vascular endothelial growth factor receptor (VEGFR) inhibitor. This open-label, dose finding phase I trial studies the tolerability and the best dose of fluzoparib in combination with apatinib and to see how well these two drugs work together in the treatment of patients with recurrent ovarian cancer or triple negative breast cancer. The safety and efficacy of fluzoparib in combination with apatinib will be explored. Both dose escalation and dose expansion parts are included in this study.


Eligibility Criteria:
Inclusion Criteria:

* Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
* Life expectancy of more than 12 weeks.
* Histologically or cytologically confirmed high-grade papillary-serous epithelial ovarian cancer，primary peritoneal, or fallopian tube cancers; subjects with a known deleterious breast cancer gene (BRCA) mutation and any other high-grade histology are also eligible. Subjects should have platinum-sensitive disease, where platinum-sensitive disease is defined as having had a \> 6 month interval since last receiving platinum therapy prior to disease recurrence. Additionally, subjects with histologically or cytologically confirmed triple negative breast cancer (TNBC）, that is locally advanced or metastatic, are also eligible.
* Prior therapy：subjects with ovarian cancer，primary peritoneal, or fallopian tube cancers have received only 2 lines of platinum-based chemotherapies, and TNBC patients have received only 1 line of standard chemotherapy. Each prior chemotherapy must be given for at least 2 cycles.
* At least one measurable lesion that can be accurately assessed by imaging (CT/MRI) at baseline
* Subjects who have overall good overall general condition.
* Signed informed consent.

Exclusion Criteria:

* Subjects who received any previous treatment with any PARP inhibitors.
* Subjects who received any previous treatment with any VEGFR inhibitors.
* Less than 4 weeks from the last clinical trial.
* Less than 4 weeks from the last radiotherapy, chemotherapy, surgery, hormone treatment and target therapy.
* Unstable or uncontrolled hypertension.
* Subjects that are unable to swallow, or dysfunction of gastrointestinal absorption.
* Subjects with brain metastases.
* Subjects with uncontrolled hypokalemia and hypomagnesemia before study entry.
* Subjects with a known hypersensitivity to fluzoparib, apatinib or any of the excipients of the products.
* Ongoing infection (determined by investigator).
* History of immunodeficiency, including HIV-positive, suffering from other acquired, congenital immunodeficiency disease, or history of organ transplantation.
* Pregnant or breast-feeding women.
Normal Ventilatory and Perfusion Pulmonary Function in TEMP

Ventilation - perfusion SPECT is attractive for lung function assessement. Unfortunately, it is very difficult to delineate normal to abnormal areas because of physiological uptake heterogeneity.

In that context, it would be of interest to build statistical maps from registrered normal studies and propose a new methodology for normal SPECT delineation

Patients with normal VQ SPECT-CT will be analysed. After a image proccesing workflow including rigid registration, non rigid registration and normalization, a voxelized mean and standard deviation map will be created. Those maps will be analyzed in regards of physiology and litterature.

Eligibility Criteria:
Inclusion Criteria:

* normal perfusion and ventilation scans, and no parenchyma or pleural abnormality on low dose CT
* confirmation by a second senior physician

Exclusion Criteria:

Patients with history of pulmonary disease:

* chronic obstruction pulmonary disease,
* previous pulmonary embolism,
* surgery of the lungs
* radiotherapy of the lungs
Schooling, Income, and HIV Risk in Malawi

This study is designed to evaluate a two-year randomized intervention in Malawi that provides cash transfers to current schoolgirls (and young women who have recently dropped out of school) to stay in (and return to) school in order to understand the possible effects of such programs on the sexual behavior of the beneficiaries and their subsequent HIV risk.

Motivation:

Education has been suggested as a "social vaccine" to prevent the spread of HIV (Jukes, Simmons, and Bundy, 2008), but almost all of the evidence we have on the link between school attendance (or attainment) and the risk of HIV infection comes from cross-sectional studies. Furthermore, the role of income (especially that of women's poverty) has been hypothesized as a significant factor in the spread of HIV in SSA, but again there is no credible evidence showing a causal link between income and HIV risk. A randomized intervention, such as the one proposed here, that provides randomly varied amounts of cash transfers to young individuals and their guardians is the perfect setting to examine the possible existence of such causal relationships.

Objectives:

The objective of the proposed study here is to provide credible evidence on issues about which we still know very little. Specifically, the main questions the study will try to answer are the following:

1. Are the observed effects of a CCT associated with the transfer or the conditionality imposed on the recipient?
2. Do the outcomes of interest improve with increased benefit levels set by the program?
3. Do CCT programs for schooling have any positive health impacts, including prevention of STIs such as HIV/AIDS among young people?

Eligibility Criteria:
Inclusion Criteria:

* female
* 13-22 years old
* never married