cyrilzakka/clinical-trials huggingface dataset:
Preliminary Percutaneous Intervention Versus Observational Trial of Arterial Ductus in Low-weight Infants

This is a pilot study to collect preliminary data for a larger, multicenter clinical trial proposal. The study will examine two strategies commonly used to treat preterm infants diagnosed with a patent ductus arteriosus (PDA). The PDA closes after birth for most term infants, but in many preterm infants, it remains open (patent). A PDA may present a complication for a number of short-term problems faced by preterm infants. Longer-term issues include the development of pulmonary hypertension and changes in the size and performance of the heart. There is ongoing debate as to whether or not the PDA requires intervention.

Preterm infants diagnosed with a hemodynamically-significant patent ductus arteriosus (HSPDA) will be included. Specific criteria will be followed to determine if a patent ductus arteriosus (PDA) is "hemodynamically significant". Infants will be randomized to two different approaches for management of the PDA. The first will be catheter-based closure (intervention) and the second will be conservative management (non-intervention). Both procedures are standard practice at many institutions, including Nationwide Children's Hospital. Infants randomized to receive intervention will undergo a procedure in which a catheter is used to place an FDA-approved device within the PDA, to close it (like a plug). Infants randomized to the conservative management (non-intervention) group will be permitted time to see if the PDA closes on its own, naturally. However, if the PDA remains open and intervention is deemed medically necessary, they will also undergo the catheter closure procedure.

Eligibility Criteria:
Maximum age (above) indicates qualifying / eligibility criteria. Participating infants will be followed until they reach 36 weeks corrected gestational age OR are discharged from the hospital, whichever comes first.

Inclusion Criteria:

* Preterm infants ≤28 weeks gestational age with hemodynamically-significant patent ductus arteriosus (PDA) at 2 - 4 weeks of age.
* Body weight greater than or equal to 700 grams

Exclusion Criteria:

* Significant genetic (ex.- Trisomy) or physiological (ex. - Omphalocele) abnormalities
* Other cardiac disease NOT INCLUDING atrial-septal defects or ventricular septal defects (ex. Tetrology of Fallot, Single ventricle physiology)
* Body weight less than 700 grams
A Study of Anterior Approach Combined With Infrahepatic Inferior Vena Cava Clamping

Anterior approach results in better operative and survival outcomes compared with the conventional approach in patients with large hepatocellular carcinoma (HCC), but anterior approach has the problem of bleeding from the hepatic vein.

Our previous study showed that infrahepatic inferior vena cava (IVC) clamping can reduce blood loss during conventional hepatic resection. The investigators guess infrahepatic IVC clamping may also reduce blood loss in anterior approach right hepatic resection. So the investigators conduct this prospective, randomized, controlled trial to compare anterior approach combined with infrahepatic IVC clamping and anterior approach in major right hepatectomy for large HCC.

Traditionally, mobilisation of the right hemiliver followed by right hepatic vein control before parenchymal transection has been considered the standard approach to a major right hepatectomy. However, this approach is often difficult and hazardous when performing liver resection for large hepatocellular carcinoma (HCC) or for tumors with extrahepatic organ invasion in the right retrohepatic region.In setting of right hepatectomy by an anterior approach,liver mobilisation is performed only at the end of parenchymal transection, when all vascular connections have already been interrupted.The anterior approach was found to be associated with significantly less intraoperative blood loss, less blood transfusions and a lower hospital mortality rate.However,excessive bleeding can occur at the deeper plane of parenchymal transection from the right hepatic vein or middle hepatic vein.

Bleeding from the hepatic veins is closely related to the CVP.Our previous retrospective analysisfound that the infrahepatic inferior vena cava (IVC) clamping is efficacious in reducing CVP without the need of systemic fluid restriction and is associated with significantly less intraoperative blood loss during complex hepatectomy.

The aim of the present study was therefore to evaluate if the application of the anterior approach combined with infrahepatic IVC clamping during right hepatectomy for large HCC reduces intraoperative blood loss.

Eligibility Criteria:
Inclusion Criteria:

* Understanding and being willing to sign the informed consent form
* Aged 18-75 years
* Diagnosed HCC by clinical findings and radiography，tumor size ≥ 5cm and located in the right lobe, need to perform right hemihepatectomy or major right hepatic resection (three Couinaud's segments)
* Without any surgery contraindication
* Child-Pugh grade A

Exclusion Criteria:

* Refusal to take part in the study
* With lymph node or extrahepatic metastases
* History of previous hepatectomy or other abdominal operation
* Those who can not be follow-up
* Non-HCC
Gene-Environment Interactions in Rheumatoid Arthritis Autoimmunity Disease Severity

The objective of the proposed study is to assess the role of smoking and complex gene-smoking interactions in two understudied Rheumatoid Arthritis (RA)groups.

Rheumatoid Arthritis (RA) is a systemic inflammatory disease affecting over 2 million people in the U.S. alone, a condition characterized by progressive joint destruction, significant work-related disability and accelerated mortality. While the precise cause of RA is unknown, it is clear that the disease does not result from a single heritable factor or single environmental exposure. Of the many environmental exposures that have been studied, cigarette smoking is the factor most consistently shown to be associated with RA onset. In addition to its role in disease susceptibility, recent studies have found that smoking, along with genetic factors, contribute to RA-related autoimmunity and disease severity. Moreover, studies to date looking at disease severity in RA have exclusively involved women of Caucasian/European ancestry. This is an important distinction since although RA is more common in women, smoking appears to be most closely linked to RA risk in men. Additionally, the burden of other smoking-related illnesses appears to be greatest among non-Caucasian populations. For this reason and because smoking rates and prevalence of risk-alleles differ in ethnic/racial minorities (i.e. SE and GSTM1-null polymorphism), further studies are needed to define the association of smoking and possible gene-smoking interactions and their role in autoimmunity and disease severity in these understudied populations.

Eligibility Criteria:
Inclusion Criteria:

* Meeting ACR criteria for RA

Exclusion Criteria:

* No exclusions
Clinical Trial to Evaluate the Safety and Efficacy of "Theobromine Capsule" as an Antitussive in Acute Cougher

The aim of this clinical trial is to evaluate the antitussive effect of "Theobromine capsule 300mg" in patients with acute bronchitis.

This study is double blinded, randomized, parallel designed, phase III clinical trial to evaluate the efficacy and safety of "Theobromine capsule 300mg" versus "Levodropropizine syrup" in patients with acute bronchitis.

Eligibility Criteria:
Inclusion Criteria:

1. Patient who decided to participate in this clinical trial at his(her) own will and agreed in written letter of consent.
2. Adult aged over 18
3. Patient who has cough symptom caused by acute bronchitis
4. Patient who go to see the doctor for severe cough at his(her) own will
5. DCS score at screening vist sould be over 3.
6. For fertile woman, HCG test at screening visit shloud be negative.

patient who will continue to cough more than 1 week.(by physician's judgment)

Exclusion Criteria:

1. Patient who is accompanied by the seriously abnormal symptom in respiratory system, such as Acute infectious Pulmonary Disease, Tuberculosis, asthma.
2. Chronic bronchitis including bronchial obstruction
3. Patient who has clinical history of sensitivity to Xanthine drug.
4. Patient who has Peptic Ulcer
5. Patient whose liver or kidney function is seriously abnormal: Including the cases of sGOT, sGPT, bilirubin and blood creatinine value exceeding twice of their upper normal limit.
6. Patient whose heart function is abnormal: including the case of showing abnormal EKG test value that is clinically significant.
7. patient who has convulsion or alcoholism.
8. Patient who has experience to have participated in other clinical trial within two months before starting the trial.
9. Pregnant woman, lactating woman.
10. Patient who thought to be cured within 3 days without any medicine.
Factors Associated With Postoperative Strabismus After Floor Fracture Repair

In patients suffered from floor fractures, there are 21.9% complaining about diplopia before fracture repair surgery and 20.8% after operation. Even after 6 months, there still are 16.4% had similar conditions. Investigators are planned to find predicting factors to prevent such conditions from happening.


Eligibility Criteria:
Inclusion Criteria:

* Patients suffering from floor fractures in Tri-Service General Hospital in past 10 years.

Exclusion Criteria:

* Prior ocular surgeries
* Multiple facial trauma or facial bone fractures
The Effect of Suturing Material on Scar Healing

We want to compare the effects of 2 suture materials (monofilament and multifilament) on healing of the uterine scar after a cesarean delivery.

Cesarean section (CS) is the most common type of obstetric surgery. When medically justified, CS can effectively prevent maternal and perinatal mortality and morbidity however, there are many short and long-term complications of CS. One of the most common complications is the CS scar defect. CS scar defects can develop after transverse incision of the lower uterine segment, which may result in prolonged postmenstrual bleeding, spotting, pelvic pain, and infertility. Suture material is an essential part of any major surgery, serving to hold opposing tissues together and accelerate the healing process, resulting in decreased scarring of the affected areas. We sought to evaluate the effects of different synthetic absorbable suture materials on cesarean scar defect formation.

Eligibility Criteria:
Inclusion Criteria:

* singleton pregnancy at term \>37 weeks of gestational age

Exclusion Criteria:

* history of previous cesarean section
* history of previous uterine surgery
* multiple gestation, placenta previa, polyhydramnious, fetal macrosomia
* uterine atony history
* gestational diabetes mellitus, gestational hypertension, preeclampsia, current or previous history of heart disease, liver, renal disorders or known coagulopath
* active labor (with regular uterine contractions and cervical dilatation \>4 cm
Effects of Adrenergic Drugs on the Fluid Balance During Surgery

The aim this study was to examine to what degree the slow turnover of lactated Ringer's solution during anesthesia and surgery can be prevented by infusing esmolol (a ß1-receptor blocker) or phenylephrine in patients undergoing laparoscopic gynecological surgery performed under intravenous anesthesia.

INTRODUCTION The renal clearance of infused crystalloid fluid is very low during anaesthesia and surgery, but experiments in conscious sheep indicate that the renal fluid clearance might approach a normal rate when the adrenergic balance is modified.

METHODS Sixty females (mean age, 32 years) undergoing laparoscopic gynecological surgery were randomized to control group and received only the conventional anesthetic drugs and 20 ml/kg of lactated Ringer's over 30 min. The others were also given an infusion of 50 µg/kg/min of esmolol (beta1-receptor blocker) or 0.01 µg/kg/min of phenylephrine (alpha1-adrenergic agonist) over 3 hours. The distribution and elimination of infused fluid was studied by volume kinetic analysis based on urinary excretion and blood Hgb level.

Eligibility Criteria:
Inclusion Criteria:

* ASA group I
* Scheduled for laparoscopic removal of ovarian cyst or laparoscopic hysterectomy

Exclusion Criteria:

* ASA group \> I
* Daily medication
Relationship Occupation and Physical Performance in Elderly

Occupational competence indicates participating in a variety of occupations to meet the standards expected of the individuals' valued roles to sustain a pattern of occupational attitudes that is significant and satisfying. Physical performance declines with age. This causes problems with balance and falling. Balance and falling losses can also affect occupation. Our study was conducted to examine the relationship between physical performance and occupational balance in elderly individuals. According to the power analysis, it is planned to include the individual in the study. Individuals will only be evaluated and the relationship between scale results will be analyzed statistically.


Eligibility Criteria:
Inclusion Criteria:

* Volunteers aged 65 and over will be included.

Exclusion Criteria:

* Having visual-hearing loss that prevents them from making evaluations,
* Individuals with poor co-operation will be excluded from the study.
Erlotinib, Cisplatin, and Radiation Therapy in Treating Patients With Stage IB-Stage IVA Cervical Cancer

RATIONALE: Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Erlotinib and cisplatin may make tumor cells more sensitive to radiation therapy. Giving erlotinib together with cisplatin and radiation therapy may kill more tumor cells.

PURPOSE: This phase I trial is studying the side effects and best dose of erlotinib when given together with cisplatin and radiation therapy in treating patients with stage IB, stage II, stage III, or stage IVA cervical cancer.

OBJECTIVES:

Primary

* Determine the maximum tolerated dose of erlotinib hydrochloride when administered with cisplatin and pelvic radiotherapy in patients with stage IB-IVA squamous cell carcinoma of the cervix.

Secondary

* Determine the toxicity profile of this regimen.

OUTLINE: This is a multicenter, open-label, dose-escalation study of erlotinib hydrochloride.

Patients receive oral erlotinib hydrochloride once daily on days 1-35 and cisplatin IV on days 1, 8, 15, 22, and 29. Patients also undergo radiotherapy daily, 5 days a week, for approximately 5 weeks concurrently with chemotherapy.

Cohorts of 3-6 patients receive escalating doses of erlotinib hydrochloride until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose proceeding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.

After completion of study treatment, patients are followed at 6 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of squamous cell carcinoma of the cervix

  * Stage IB-IVA disease
* Scheduled to undergo standard radiotherapy and receive weekly cisplatin
* ECOG performance status 0-2
* Not pregnant
* Negative pregnancy test
* Fertile patients must use effective contraception during and for ≥ 1 week after completion of study treatment
* Must be able to take oral medication

Exclusion Criteria:

* Malabsorption syndrome
* Serious underlying medical condition that would impair the ability of patient to receive treatment
* Known hypersensitivity to erlotinib hydrochloride
* Psychological, familial, sociological, or geographical conditions that would preclude study compliance
* Less than 21 days since prior nonapproved or investigational drugs
* Prior chemotherapy
* Prior radiotherapy
* Prior anti-epidermal growth factor receptor treatment
* Prior gastrointestinal surgery that limits absorption (i.e., requiring total parenteral nutrition)
* Concurrent use of any of the following agents and therapies:

  * Other antineoplastic or antitumor agents
  * Other chemotherapy
  * Other investigational agents
  * Radiotherapy
  * Immunotherapy
  * Anticancer hormonal therapy
Hematological Abnormalities in Children

the aim of the study is to determine Hematological abnormalities in Congenital Cyanotic Heart Disease

Congenital heart defects are the most common developmental anomaly and are the commonest noninfectious causes of mortality in newborns; they affect up 1000 infants and in most cases the cause is unknown . Erythrocytosis, thrombocytopenia, platelets function defects, coagulation factors deficiencies are the main hematologic disorders in patients with cyanotic congenital heart disease .The hemorrhagic tendency was initially attributed to an increase in tissue vascularity, but co-existing hemostatic defects were subsequently identified and attributed to thrombocytopenia, shortened platelet survival, and deficient von Willebrand multimers .

In patients , platelets are shown to have both qualitative and quantitative abnormalities.However, there are conflicting data as regards the etiology of thrombocytopenia in congenital cyanotic heart disease . significant association has been reported between thrombocytopenia and a high hematocrit in cyanotic patients and multiple etiologies has been suggested including chronic compensated disseminated intravascular coagulation (DIC), reduce synthesis of clot factors and/or deranged platelet aggregation. Immature reticulated platelets represent the youngest platelets released into the circulation by regenerated marrow megakaryocyte and are the analogue of the red cell reticulocyte .The rate of platelet turnover can be evaluated by the relationship between the percent of reticulated platelets and the platelet count.

Erythrocytosis is an isolated increase in the number of red blood cells. Primary erythrocytosis is an increased red cell mass which surfaces in the absence of a definable stimulus, whereas secondary erythrocytosis refers to an isolated increase in the red cell mass in response to such stimulus as low systemic arterial oxygen saturation in the context of cyanotic congenital heart disease. Polycythemia could often be beneficial. Yet, it poses certain risks to the microcirculation. This is mainly because the capillary diameter is significantly smaller than the red cell diameter and this mismatch could cause viscosity

To increase at the capillary level. Patients with cyanotic heart disease may have an acceptable quality of life. However, they are invariably prone to several complications. For instance, hyperviscosity, hyperuricemia (mainly due to age-related impairment of uric acid excretion in adults), thrombocytopenia (decreased level of platelet production), blood clotting abnormalities (reduced synthesis of clotting factors and/or deranged platelet aggregation), cerebral abscess, cerebral embolism and endocarditis .

Eligibility Criteria:
Inclusion Criteria:

* All children.
* congenital cyanotic heart disease

Exclusion Criteria:

* other congenital heart disease.
* other congenital anomalies.
* other chronic disease.
* post-operative patient.
Study With a Topical Gel to Treat Common Warts in Adults

The primary purpose of this study is to evaluate the effectiveness in adults of four different strengths of resiquimod gel applied to common wart(s) five times a week for four weeks.

A second purpose is to evaluate the safety of the drug.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of common warts
* Two forms of birth control

Exclusion Criteria:

* Pregnant or breast feeding
* Other types of warts, ie. plantar
* Currently participating in another clinical study
* Chronic viral hepatitis B or C
Attempts to Stop/Reduce Marijuana Among Dependent Users

The purpose of the study is to determine why and how marijuana users stop or reduce their marijuana use.

The major aim of this study is to provide a better understanding of attempts to stop or reduce marijuana use that can be used to develop better behavioral treatments for marijuana dependence. The application will focus on adult daily marijuana users who try to stop or reduce their marijuana use in a real-world setting. Although prospective, natural history studies describing attempts to stop or reduce alcohol, heroin and tobacco use have proved useful, we know of no such study among adult marijuana users. Two pilot studies will develop measures and assess compliance with our procedures. The main study will recruit up to 400 adult marijuana smokers with the goal of a sample size of 200 participants with adequate compliance. Participants will call an Interactive Voice Recording (IVR) system daily for 3 months to report marijuana use, quit/reduction attempts, and events that might increase or decrease the probability of initiating a quit/reduction attempt or the success of an attempt. Follow-up at 6 months will track recent marijuana and other drug use. Knowing what motivates marijuana users to try to stop or reduce, and knowing which strategies for stopping marijuana use are successful, can help develop treatments for marijuana dependence. For example, if stopping tobacco when trying to stop marijuana decreases the chance of stopping marijuana, then smoking cessation should be done after stopping marijuana. Or if reducing marijuana often leads to cessation, then convincing those not interested in quitting marijuana to first try reducing may be helpful.

Eligibility Criteria:
Inclusion Criteria:

* daily marijuana smokers for at least 1 year

Exclusion Criteria:

* pregnant women
Comparison of Two Empirical Antimicrobial Therapies of Prosthetic Joint Infection

The empirical use of vancomycin in combination with a broad-spectrum beta-lactam is currently recommended after the initial surgery of prosthetic joint infection (PJI). However, the tolerability of such high-dose intravenous regimens is poorly known. T

The empirical use of vancomycin in combination with a broad-spectrum beta-lactam is currently recommended after the initial surgery of prosthetic joint infection (PJI). However, the tolerability of such high-dose intravenous regimens is poorly known. The empirical antimicrobial therapy of PJI is associated with an important rate of adverse, linked with the use of the vancomycin and the piperacillin-tazobactam combination. Some studies suggest to use vancomycin-cefepime, which remains to be evaluated in PJI.

Eligibility Criteria:
Inclusion Criteria:

* patients having had a prosthetic joint infection and having had a postoperative empirical antibiotherapy with combination of vancomycine and piperacillin-tazobactam or vancomycine and cefepime

Exclusion Criteria:

* none