cyrilzakka/clinical-trials huggingface dataset:
Risk Factors for Postpartum Psychosis

A range of psychological disorders occur in women in the postpartum period. These include "the blues", which occurs in the first days after birth and which is very common and self-limiting; severe psychoses often associated with mania or bipolar illness, occurring in the first weeks after birth; and mild to moderate depression, occurring weeks to months after birth. Studies have been done focused on postpartum psychosis using a retrospective investigation, which gave only a limited material on the prevalence of psychological disorders in postpartum women. The investigators hypothesized that different pathways to psychosis function as the risk factors which may be overlapped, truly independent, mediating, or moderating, in new mothers who are at high risk and/or during the early period of delivery. In addition, the investigators purposed that the temporal sequence of biological, social and demographic variables are also the potential factors contributing to the development of postpartum psychosis.


Eligibility Criteria:
Inclusion Criteria:

* Pregnant women
* Chinese

Exclusion Criteria:

* Age \< 18 years or \> 50 years
* Gestational age \< 32 weeks
Bedsider.Org in Post-abortion Contraceptive Counseling: A Mixed Methods Study

This is a mixed methods study, incorporating a randomized controlled trial and a qualitative provider focus group, to evaluate contraceptive counseling aided by www.Bedsider.org in patients seeking first-trimester abortion. The primary outcome is the uptake of long-acting reversible contraception in women seeking induced abortion.

Nearly half of pregnancies among American women are unintended, and about 4 in 10 of these are terminated by abortion. Unmet need for family planning is the cause for induced abortion, and those women seeking induced abortion are a high risk for repeat abortion. Family planning services are of paramount importance to this population, and evidence shows that high-quality family planning counseling and provision of methods prior to discharge from a care facility improve uptake and continuation of methods. In a recent study, oral contraceptive pills, a transdermal patch, or a vaginal ring had a risk of contraceptive failure that was 20 times as high as the risk among those using long-acting reversible contraception (IUD or implant).

We plan to randomize preoperative clinic days to either provider counseling aided by Bedsider.org or routine provider counseling, and compare the types of contraceptive methods that are chosen in each group, with the primary outcome being uptake of long-acting reversible contraception (intrauterine device or implant). The secondary outcome is satisfaction with contraceptive counseling in both groups.

We also plan to conduct a qualitative focus group study of provider perspectives of this counseling tool after completion of the randomized trial. Materials related to the qualitative portion of the study will be submitted in a separate amendment. No Follow-up is needed.

EXPECTED OUTCOMES AND DISSEMINATION OF FINDINGS The goal of the study is to assess the feasibility and effectiveness of using a web-based contraception tool in a unique family planning clinic serving high-risk patients with expert family planning providers. After assessing feasibility, utility, and effectiveness in our practice setting, we hope to spread the use of bedsider.org to the entirety of the outpatient clinic, which includes general obstetrics and gynecology patients and providers.

After completion of the study, we plan to submit our findings for presentation at a national meeting, and submit a manuscript for publication in a peer-reviewed journal.

Eligibility Criteria:
Inclusion Criteria:

* English speaking
* Seeking medical or surgical pregnancy termination
* 12 weeks gestation or less

Exclusion Criteria:

* Early pregnancy failure
* Medical contraindications to any contraceptive methods as based on CDC Medical Eligibility Criteria
A Pilot Trial of Ranolazine to Treat Patients With Dilated Cardiomyopathy

Recent data suggest that areas of fibrosis and hibernating myocardium develop in patients with non ischemic dilated cardiomyopathy. Ranolazine is a new drug, developed to releave symptoms of angina in patients with stable coronary disease that is not suitable for surgical or percutaneous revascularization. It has been shown that in patients with stable coronary disease Ranolazine improves myocardial perfusion as shown with myocardial nuclear imaging. The aim of this trial is to evaluate effects of ranolazine on myocardial perfusion in patients with dilated cardiomyopathy.

Recent data suggest that areas of fibrosis and hibernating myocardium develop in patients with non ischemic dilated cardiomyopathy. Ranolazine is a new drug, developed to releave symptoms of angina in patients with stable coronary disease that is not suitable for surgical or percutaneous revascularization. The main mechanism of action of Ranolazine is the inhibition of late I(Na) thus decreasing the Ca++ load in the cardiomyocites. Consequently oxygen consumption also decreases. It has also been shown that in patients with stable coronary disease Ranolazine improves myocardial perfusion as shown with myocardial nuclear imaging. The aim of this trial is to evaluate effects of ranolazine on myocardial perfusion in patients with dilated cardiomyopathy.

Primary end-point: To determine wheather Ranolazine improves perfusion of the myocardium in patients with non-ischemic dilated cardiomyopathy.

Secondary end-points: To determine wheather Ranolazine improves patients' NYHA functional class, excercise capacity, LV systolic and diastolic function and weather ranolazine affects supraventricular and ventricular arrhythmia occurance/frequency.

Eligibility Criteria:
Inclusion Criteria:

* established diagnosis of non-ischemic dilated cardiomyopathy
* EF \< 35%
* NYHA f.c. II - IV
* Optimal medical management \> 6 months
* Age \< 75 years and \> 18 years

Exclusion Criteria:

* known hypersensitivity to the medication
* age \> 75 years or \< 18 years
* EF \> 35%
* renal insufficiency (GF \< 30)
* liver dysfunction (liver tests \> 3x the upper normal limit))
* LQT syndrome
* drugs that affect CYP3A4 metabolism (azoles, macrolides, calcineurin inhibitors etc.)
* dementia
* active hemathological or malignant disease
Influence of Perioperative Kidney Function on Postoperative Outcome

This study investigates the influence of perioperative changes in serum creatinine on hospital length of stay and mortality.


Eligibility Criteria:
Inclusion Criteria:

* all patients anesthetized between January 2006 - June 2012

Exclusion Criteria:

* end stage renal disease
* pre-anesthesiologic need of renal replacement therapy
* patients undergoing nephrectomy or kidney transplantation
Budesonide Foam Versus Placebo for Prevention of Acute Radiation Proctitis

To proof the superiority of an 8-week rectal treatment with once-daily 2 mg budesonide versus placebo for the prevention of acute radiation proctitis, and to evaluate the occurrence of chronic radiation proctitis 1 year after start of radiation therapy.


Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent,
* Men aged at least 18 years,
* Patients with ECOG performance status \<= 2 or Karnofsky Performance Status Scale \>= 70%,
* Estimated life expectancy more than 3 years,
* Diagnosis of prostate carcinoma,
* Indication for local RT in patients with prostatic cancer.

Exclusion Criteria:

* Crohn's disease, indeterminate colitis, ulcerative colitis, microscopic colitis (i.e., collagenous colitis and lymphocytic colitis),
* Severe or symptomatic ischaemic colitis at baseline,
* Grade III internal haemorrhoids at baseline,
* High risk patients needing extended radiation therapy,
* Acute EORTC/RTOG lower GI toxicity score of \>=1 at baseline,
* Bacterial, amoebic, fungal, or viral infections of the gut,
* Tuberculosis, hypertension, infection, diabetes mellitus (included familiarly predisposition), active peptic ulcer, osteoporosis, glaucoma, or cataract, if careful medical monitoring is not ensured,
* Portal hypertension or liver cirrhosis,
* Abnormal hepatic function (ALT, AST or AP \> 2.5 x ULN),
* Known intolerance/hypersensitivity/resistance to study drug or drugs of similar chemical structure or pharmacological profile, or to any of the other constituents of the study drug,
* Participation in another clinical trial within the last 30 days, simultaneous participation in another clinical trial, or previous participation in this trial
Comparing Total Laparoscopic Versus Open Pancreaticoduodenectomy

Introduction Pancreatoduodenectomy (PD) is one of the most complex abdominal operations to perform, and it is usually conducted for tumours of the periampullary region and chronic pancreatitis. Minimally invasive surgery has been progressively being developed for pancreatic surgery, first with the advent of hybrid-laparoscopy and recently with total laparoscopic surgery. Issues including the safety and efficacy of total laparoscopic pancreaticoduodenectomy (TLPD) and open pancreaticoduodenectomy (OPD) are currently being debated. Studies comparing these two surgical techniques are emerging, and large randomized controlled trials (RCTs) are lacking but are clearly required.

Methods and analysis TJDBPS01 is a multicentre, prospective, randomized controlled, parallel-group, superiority trial in fourteen centres with pancreatic surgery experts who have performed ≥104 TLPDs and OPDs. A total of 656 patients who will undergo PD are randomly allocated to the TLPD group or OPD group in a 1:1 ratio. The trial hypothesis is that TLPD has superior or equivalent safety and advantages in postoperative recovery compared with OPD. The primary outcome is the postoperative length of stay (LOS).

Ethics and dissemination The Instituitional Review Board Approval of Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology has approved this trial and will be routinely monitoring the trial at frequent intervals, as will an independent third-party organization. Any results from this trial (publications, conference presentations) will be published in peer-reviewed journals and conference proceedings.


Eligibility Criteria:
Inclusion Criteria:

1. Histologically proven periampullary cancer, including pancreatic cancer, bile duct cancer, duodenal cancer, et al.
2. Highly presumed malignancy with difficulties to obtain histological evidence.
3. Preoperative staging work up performed by upper abdomen enhanced CT scan.
4. The subject understands the nature of this trial and willing to comply.
5. Ability to provide written informed consent.
6. Patients treated with curative intent in accordance to international guidelines

Exclusion Criteria:

1. Distant metastases: peritoneal carcinomatosis, liver metastases, distant lymph node metastases, involvement of other organs.
2. Subjects undergoing left, central or total pancreatectomy.
3. Patients with high operative risk as defined by the American Society of Anesthesiologists (ASA) score \>4.
4. Synchronous malignancy in other organs.
5. Previous underwent pancreatic resections.
6. Palliative surgery.
Radiotherapy to the Primary in Metastatic Non-small Cell Lung Cancer Patients

study the effect of radiotherapy to the primary lesion after first line systemic therapy in metastatic non-small cell lung cancer patients.

Metastatic non-small cell lung cancer patients after receiving their first line systemic therapy according to their genetic mutation will be randomized to follow up versus radiotherapy to the primary lesion.

Eligibility Criteria:
Inclusion Criteria:

1. Confirmed histological diagnosis of NSCLC.
2. Stage IV disease.
3. Patients with P.S ≤ 2.
4. finished at least 4 cycles of platinum-based doublet chemotherapy if patient has no diver mutation, or at least 3 months of anti-EGFR, Anti-ALK according to their driver mutation with SD, PR or CR.

Exclusion Criteria:

1. History of prior irradiation to the lung.
2. residual Malignant pleural or pericardial effusion at randomization time.
3. History of prior malignant tumor likely to interfere with the treatment protocol.
4. Severe comorbidities as measured by morbidity index.
5. Disease progression on first line systemic therapy.
RENEW Scleroderma: A Peer-Mentored, Web Intervention for Resilience-based, Energy Management to Enhance Wellbeing and Fatigue

The researchers seek to understand if the Resilience-based, Energy Management to Enhance Wellbeing and Fatigue (RENEW) program helps with scleroderma symptom management and disease burden. The researchers think that those participants who receive the intervention will have clinically meaningful changes of symptom management and disease burden.


Eligibility Criteria:
Inclusion Criteria:

* Have a diagnosis of Systemic Sclerosis (SSc), any subtype
* Report a mean score of at least 4 on the Fatigue Severity Scale; potential mean range 1-9
* Have access to a computer and an internet connection
* Are able to speak and read English.

Exclusion Criteria:

* Currently undergoing structured rehabilitation or psychological treatment.
* Other issues that preclude meaningful participation in study procedures (e.g. concurrent or complex medical issues, inability to access RENEW intervention, etc.)
Immune-cell Membrane Trafficking

Organ failure following trauma is a leading cause of morbidity and mortality. It appears that the development of organ failure is a direct result of an altered immune response. This altered response results in the production of circulating factors in the blood that causes direct injury to the injured patients' organs. The mechanism in which this altered immune response occurs is unknown. Based on work we have performed in our laboratory, we believe that this response is initiated on the cell membrane of particular immune cells known as macrophages. Although the cell membrane may appear uniform, it is not. The membrane is composed of specific segments that allow proteins to associate with each other forming receptors that are required for immune cell activation. These specific membrane components are composed of various lipids and cholesterol, and have been termed lipid rafts. Based on our laboratory work it appears that these lipid rafts can be altered following injury. In particular both the lipid and protein content within these raft segments may be altered allowing immune cells to become active leading to the production of factors that directly injure normal cells and organs. Thus, we plan to examine if these laboratory findings can be seen in patients suffering from trauma who develop clinical organ failure at Harborview Medical Center. If this is accomplished, this data will lead to the development of both prognostic and therapeutic interventions for the optimal care of injured patient


Eligibility Criteria:
Inclusion Criteria:

* age 18 years or older, blunt or penetrating trauma and
* one or more of the following: systolic blood pressure less than 90 mmHg at the scene or within one hour of arrival to the Emergency Department, 2) base deficit ≥ -6 within one hour of admission, 3) ISS greater than 25, or 4) more than 6 units of blood transfused in the first 12 hours.-

Exclusion Criteria:
Effect of Ibuprofen Sustained Release on Intraoperative and Postoperative Pain in Mandibular Molars

The study is conducted to evaluate the effect of Ibuprofen sustained release premedication on the success of buccal infiltration anaesthesia, intaroperative pain and post operative pain in mandibular molars with symptomatic irreversible pulpitis and apical periodontitis


Eligibility Criteria:
Inclusion Criteria:

1. Systemically healthy patients (ASA I or II).
2. Patients with Mandibular molar teeth diagnosed with:

   * Pre-operative sharp pain marked on VAS scale by reading not less than 6.
   * Vital exaggerated response of pulp tissue to cold pulp tester (ethyl chloride spray) and electric pulp tester.
   * Normal periapical radiographic appearance or slight widening in lamina dura.
   * Positive response and pain provoked by percussion.

Exclusion Criteria:

1. Allergy to Ibuprofen
2. Medically compromised patients having significant systemic disorders. (ASA III or IV).
3. History of intolerance to NSAIDS.
4. Patients with two or more adjacent teeth requiring endodontic treatment.
5. Pregnant or nursing females.
6. Teeth that have:

   * Periodontal affection (with pocket depth greater than 5mm, associated with swelling or fistulous tract, or greater than grade I mobility)
   * No possible restorability.
Enteroendocrine Hormonal Response After the Ingestion of Cola Beverages With Sucrose and Non-nutritive Sweeteners

Introduction: The consumption of non-nutritive sweeteners (NNS) has been increasing in recent years, as an alternative to replace sugars and reduce the additional intake of carbohydrates, with the idea of reducing the risk of developing obesity, metabolic syndrome, and diabetes. However, recent evidence shows that their chronic intake induces endocrine alterations that may have an important contribution to the increase in body weight. Few studies have explored the acute effects of NNS beverage consumption on endocrine response, and to date, the evidence has been inconsistent regarding post-drinking effects and potential health risks.

Objective: To evaluate the effect of 3 different types of cola beverages, compared with carbonated water, on glucose, insulin, glucagon, and appetite-regulating hormones during the first 120 minutes after ingestion.

Methods: A triple-blind, randomized crossover controlled trial was carried out in which 20 healthy adult individuals (10 men and 10 women) were included. With a washout period of one week (7 days) and fasting for 8 hours, each participant consumed orally 355 mL of carbonated water (CAR), and the 3 different cola beverages sweetened with sucrose (SUC), aspartame/acesulfame K (ASP), and sucrose/stevia (STE), in its commercial presentation. The serum levels of glucose, insulin, glucagon, GLP-1, GIP, PYY, leptin, pancreatic polypeptide, and ghrelin were determined during the administration of each one of the drinks before the intake of the drink and later at 30, 60, 90, and 120 minutes.

Statistical analysis: A descriptive analysis of the variables was performed. The global response of glucose, insulin and appetite-regulating hormones was estimated and the Area Under the Curve (AUC) was obtained using a trapezoidal model and analyzed for each outcome by one-factor ANOVA. An ANOVA for repeated measures was performed considering treatment and time as factors, and comparisons were made with the carbonated water as a control using the Bonferroni test. P values less than 0.05 were considered statistically significant.

Ethical considerations: Our institution's Research, Bioethics, and Biosafety committees authorized the project. All the participants were informed about the objective, the procedures, and the possible adverse effects considered within the study, and they signed the informed consent before the start of the interventions.


Eligibility Criteria:
Inclusion Criteria:

* Voluntary participation expressed through the signing of informed consent

Exclusion Criteria:

* Pregnancy (date of last menstruation \>28 days)
* History of diabetes mellitus or glucose intolerance, endocrinopathies, or pancreatic diseases
* Treatment with medications or supplements that modify glucose and insulin (eg antihypertensives, corticosteroids, hypoglycemic agents, hormonal agents, etc.)
* Gastrointestinal diseases or conditions that alter gastric emptying and intestinal transit
* Hypersensitivity to the compounds that will be used in the study
Safety and Tolerability of Vildagliptin Versus Sitagliptin in Patients With Type 2 Diabetes and Severe Renal Insufficiency

This clinical trial is designed to provide additional information on the safety and tolerability of vildagliptin (50 mg once daily (qd)) and sitagliptin (25 mg qd) when used in patients with type 2 diabetes mellitus(T2DM) and severe renal insufficiency (Glomerular filtration rate (GFR) \< 30 mL/min) for a period of 24 weeks.


Eligibility Criteria:
Inclusion criteria

* History T2 DM
* Severe Renal Impairment

Exclusion criteria

* Glucose ≥ 270 mg/dL (≥15 mmol/L)
* Patients undergoing any method of dialysis
* Treatment with therapy other than sulfonylureas, TZDs ,insulin, and metiglinides
Glycocalyx Biomarkers in ARDS for Clinical Prognosis and Pulmonary Fibrosis

ARDS is a severe disease in ICU, and could induce high mortality. Glycocalyx is an important matrix construction which covers endothelial cells, it could protect endothelial cells injury and the glycocalyx biomarkers could predict pulmonary injury.

Decorin is a member of the small leucine-rich proteoglycan (SLRP) family, contains a single glycosaminoglycan (GAG) chain and a core protein with 12 leucine-rich repeats. In the previous study, decorin is associated with cardiac and liver fibrosis, however, the effects of decorin on ARDS pulmonary fibrosis have not been clarified.


Eligibility Criteria:
Inclusion Criteria:

1. Age \> 18yrs and \<80yrs
2. Meet ARDS Berlin definition
3. With mechanical ventilation

Exclusion Criteria:

1. have chronic pulmonary disease
2. have use heparin or low molecular heparin or chondroitin sulfuric acid
The Efficacy and Security of the Small Stitch Technique in Emergency Surgery

This study evaluates the abdominal closure technique in emergency surgery. Half of participants will be perform the classic Large Stitch technique, while the other half will undergo the Small Stitch technique.

The closure of laparotomy is one of the most important challenges facing the surgeon.

The classic technique of wall closure is the Large Stitch technique that uses monofilament double-strand sutures with a SL/WL (Suture Lengh/Wound Lengh) 4:1 ratio, with a distance to the alba line and between each stitch of 1 cm.

Nowadays, the Small Stitch technique is accepted as the technique of choice for closure of laparotomies in programmed surgery. It is based on a very long-term monofilament absorbable synthetic suture of Poly-4-hydroxybutyrate (Monomax) 2/0 with HR (Half-circle Round body) 26 needle. Stitches should be given with a distance to the alba line of 0'5cm and 0'5 cm of separation between stitches.

There are very few studies about the role of Small Stitch technique in the field of Emergency Surgery where the increased morbidity of the patient and the higher rate of surgical wound infection can play a fundamental role, and could be improved with the use of new abdominal wall closure techniques.

Eligibility Criteria:
Inclusion Criteria:

1. Patients over 18 years of age and who provide informed consent to participate in the study.
2. Patients requiring an urgent midline laparotomy with a minimum size of 8 cm.

Exclusion Criteria:

1. Prior midline laparotomy.
2. Patients with BMI\> 45 kg / m2
3. Patients with ASA (American Society of Anesthesiologists)\> IV.
4. Patient with an advanced terminal illness with an expectation of life \<1 year.
5. Patients with abdominal aortic aneurysm.
6. Patients with coagulopathy: patient previously diagnosed with von Willebrand disease, hemophilia or Immune thrombocytopenic purpura.
7. Immunosuppressed patient: HIV patients in the AIDS phase, chronic corticosteroid or immunosuppressive treatment.
8. Patients with collagen pathology: patient previously diagnosed with Marfan syndrome, Ehlers-Danlos syndrome, homocystinuria and scleroderma.
9. Chemotherapeutic treatment 2 weeks before surgery.
10. Radiotherapy treatment 6 weeks before surgery.
11. Diffuse peritonitis with hemodynamic instability, defined by non-response to fluids prior to surgery or during the surgical process.
12. Pregnant or potentially fertile women, breastfeeding, or intention to become pregnant, or those who do not wish to use effective contraception (hormonal contraceptives (implantation, patches, oral), and double barrier methods (any double combination of: IUD (intrauterine device), male or female prophylactics with spermicidal gel, diaphragm, contraceptive sponge, cervical cap).