cyrilzakka/clinical-trials huggingface dataset:
Energy Expenditure and Regeneration Following Liver Resection Resection

This observational study will measure resting energy expenditure in patients who have undergone liver resection and compare methods of measuring resting energy expenditure.

Penetrating liver injury occurs commonly in victims of battlefield trauma. It is associated with a high mortality and morbidity rate. Management of liver injury is complex and challenging and can often involve debridement or anatomical resection of liver tissue.

Following liver resection, the liver regenerates to its original volume. Liver regeneration involves complex metabolic processes and maximal regeneration occurs over the first post operative week. This process is highly energy dependent and adds a further burden on post operative energy and therefore nutritional requirements.

Inadequate post-operative nutrition is associated with poorer outcomes and complication rates. Additionally, over feeding is also associated with adverse outcome. The actual additional energy expenditure involved in liver regeneration is not currently known and therefore accurate calorific balance remains a challenge.

The measurement of energy expenditure in these patients is therefore important. Traditionally energy expenditure has been measured by indirect calorimetry and doubly labelled water. These techniques require skilled operators and are often impractical for everyday clinical usage and impossible in the deployed setting.

A recent development is a lightweight armband that measures total and resting energy expenditure. It has been validated against the gold standard techniques in various settings including cancer cachexia, obesity and healthy volunteers and is deemed highly acceptable also. It has not been validated in the unique setting of liver regeneration.

Therefore this study will assess the energy expenditure in patients undergoing liver regeneration and attempt to validate a new minimally invasive device against the traditional measurements of energy expenditure.

Eligibility Criteria:
Inclusion Criteria:

• Patients undergoing liver resection for benign or malignant hepatic neoplasm

Exclusion Criteria:

* Inability to give written, informed consent.
* Jaundice (Bilirubin \> 100 μmol/L)
* Liver resection combined with secondary surgical procedure.
* Age \< 18 years
* Pregnant women
* Unable to tolerate either measuring device
Food Reward in Native American Women

This study aims to characterize the neurobiology of obesity in American Indians (AI) using functional MRIs to examine the correlation between brain response to food stimuli in AI women. A functional MRI (fMRI) is used to visualize brain activity when obese and lean AI women look at images of fattening food, non-fattening food and non-food objects. Additionally examined is the effect of the drug naltrexone to suppress brain response to visual food cues and calorie intake in the women.

The study looks at both obese and lean women. Each woman comes in for two visits. Each woman takes both the Naltrexone or placebo (one during each visit). Research staff and participants are blinded. Drugs are not used as treatment, but rather to provide information for possible future treatments.

Hypotheses are:

1. Compared with their lean counterparts, obese women will demonstrate more fMRI activation in the brain in response to visual food cues.
2. Naltrexone will reduce the activation in reward-relevant brain sites in response to viewing photographs of fattening food as compared in placebo in both groups.
3. Naltrexone will suppress spontaneous intake of food in obese and lean AI women.

Eligibility Criteria:
Inclusion Criteria:

* Female
* Self-identified AI
* BMI over 30 OR between 20 and 24.9
* Must see clearly with or without glasses
* Capable of giving informed consent

Exclusion Criteria:

* Smokes more than one cigarette a day
* Drinks more than two alcoholic drinks a day
* Uses recreational drugs
* Is pregnant
* Has had weight loss surgery
* Other major medical problems (e.g. diabetes)
* Taking medications that alter appetite or body weight
* Significant food allergies
Mesalazine (PENTASA®) in Ulcerative Colitis

This non-interventional study examines whether the patient's level of information and the consideration of the patient's preference have a positive effect on the compliance and thus also on the therapeutic success.


Eligibility Criteria:
Inclusion Criteria:

* Patients are treated for the first time with oral PENTASA®, e.g. following first diagnosis of ulcerative colitis for treatment of an acute episode or
* Following a therapy-free period (no previous mesalazine therapy) or due to poor response or underdosage oder lacking acceptance of the previous medication the patients are re-adjusted to oral PENTASA®,
* The patients (≥ 18 years) have been informed about the NIS and have given their written consent for participation.
Fibrinogen in Haemorrhage of Delivery

The purpose of the study is to assess the benefits of a therapeutic strategy that associates an early administration of human fibrinogen concentrate in the management of PPH on the reduction of bleeding after the initiation of prostaglandins intravenous infusion, following vaginal delivery.

Randomised, double-blind,multicenter, placebo-controlled study

Eligibility Criteria:
Inclusion Criteria:

* Signed and dated informed consent form
* Vaginal delivery
* PPH requiring IV administration of prostaglandins
* At least one available result of Hb level during the third trimester of pregnancy
* 18-year-old female patients and older
* Covered by healthcare insurance in accordance with local requirements

Exclusion Criteria:

* Caesarean section
* Haemostatic intervention (as ligation, embolization or hysterectomy) already decided at the time of inclusion
* Known placenta praevia or accreta
* Hb level \< 10g/dl during the third trimester of pregnancy
* History of venous or arterial thromboembolic event
* Known inherited bleeding or thrombotic disorders
* Treatment with low-molecular-weight heparin (LMWH) within 24 hours prior to the inclusion
* Treatment with acetylsalicylic acid within 5 days prior to the inclusion
* Treatment with vitamin K antagonists within 7 days prior to the inclusion
* Administration of fibrinogen concentrate within 48 hours prior to the inclusion
* Administration of FFP, platelets units or prohaemostatic drugs, tranexamic acid and rFVIIa or prothrombin complex concentrates (PCC) within 48 hours prior to the inclusion
* Administration of RBCs within 3 months prior to the inclusion
* Participation in another interventional clinical study within 30 days prior to the inclusion
* Previous inclusion/enrolment in the present clinical study
* Known history of hypersensitivity or other severe reaction to any component of Clottafact® or placebo
* Minors, majors under guardianship, persons staying in health or social institutes and people deprived of their freedom
* Known drug or alcohol abuse
* Patients whose use of concomitant medication may interfere with the interpretation of data
* Any other current significant medical condition that might interfere with treatment evaluation according to the investigator's judgement
* Patients who are unlikely to survive through the treatment period and evaluation
* Patients transferred from another service
Characterization of the Inhibitory Effects of Fevipiprant (QAW039) on Activation of Eosinophils and ILC2 Cells by Prostaglandin D2 Metabolites

The aim of this study is to draw blood from patients with well-defined atopic asthma that will be subsequently used in invitro experiments to investigate the activation potency of Prostaglandin D2 metabolites to the DP2 receptor in comparison to Prostaglandin D2. The inhibitory activity of a potent DP2 receptor antagonist, Fevipripant, shall be determined.

The inhibitory activity of a potent DP2 receptor antagonist shall be determined. For these experiments eosinophil granulocytes and ILC2 cells will be isolated from the collected blood samples and used in specific assays in respect to their functional reactivity against the DP2 receptor antagonist Fevipiprant after respective stimulation using Prostaglandin D2 metabolites or Prostaglandin D2. Major rationale is to show and determine the EC70 of the effectivity of Fevipiprant against Prostaglandin D2 metabolite triggered activation of eosinophil granulocytes and ILC2 innate lymphoid cells.

Eligibility Criteria:
Inclusion Criteria:

* Women will be considered for inclusion if they are:

Not pregnant, as confirmed by pregnancy test (see flow chart), and not nursing. Of non-child bearing potential (i.e. physiologically incapable of becoming pregnant, including any female who is pre-menarchial or post-menopausal, with documented proof of hysterectomy or tubal ligation, or meets clinical criteria for menopause and has been amenorrhoeic for more than 1 year prior to the screening visit).

Of childbearing potential and using a highly effective method of contraception during the entire study (vasectomised partner, sexual abstinence - the lifestyle of the female should be such that there is complete abstinence from intercourse from two weeks prior to the first dose of study medication until at least 72 hours after treatment -, implants, injectables, combined oral contraceptives, hormonal IUDs or double-barrier methods, i.e. any double combination of IUD, condom with spermicidal gel, diaphragm, sponge, and cervical cap).

* Body weight ≥ 50 kg and BMI within the range 19-32 kg/m²
* History of allergic asthma since at least 12 months
* A concentration of at least 0,15 x 106/mL eosinophils in peripheral blood

Exclusion Criteria:

* History of an acute infection two weeks prior to the screening visit.
* Intake of oral steroids within 4 weeks prior to screening
* Past or present disease, which as judged by the investigator, may affect the outcome of this study. These diseases include, but are not limited to, cardiovascular disease, malignancy, hepatic disease, renal disease, hematological disease, neurological disease, endocrine disease or pulmonary disease (including but not confined to chronic bronchitis, emphysema, tuberculosis, bronchiectasis or cystic fibrosis).
* Participation in another clinical trial 30 days prior to enrollment.
* Donation of more than 100 ml of blood in the preceding 2 months before the screening visit.
Quantitative Assessment of Blood Supply in the Gastic Conduit With Fluorescence Angiography for Esophageal Reconstruction

A single-institution, randomize controlled trial is to be held to evaluate the correlation between blood supply in the gastic conduit and the incidence of anastomotic fistula during radical operation for esophageal squamous cell carcinoma by fluorescence angiography.


Eligibility Criteria:
Inclusion Criteria:

* 1.Histologically confirmed esophageal squamous cell carcinoma and and potential resection;
* 2.Intend to undergo thoracic laparoscopy combined with three-incision esophageal cancer radical operation;
* 3.The stomach is used as an esophageal substitute for reconstruction;
* 4.Enrolled patients will adopt the esophagus bed pathway and round neck anastomosis method;
* 5.Have a performance status of 0 or 1 on the ECOG Performance Scale; Adequate organ function;
* 6.Be willing and able to provide written informed consent/assent for the trial.

Exclusion Criteria:

* 1.Histologically confirmed non-squamous cell carcinoma of the esophagus ;
* 2.The ECOG score of patient's physics \>1;
* 3.Patients who use other organs instead of the esophagus;
* 4.Patients with vascular arch injury and need vascular anastomosis;
* 5.Patients with multiple complications such as heart disease or diabetes;
* 6.Other patients whom the medical practitioner considers inappropriate for inclusion.
Sleep After Pediatric Critical Illness

This study tests a pilot educational sleep intervention for children after critical care hospitalization.

The investigators are conducting a before-after study evaluating an educational intervention delivered during hospitalization on sleep outcomes 1month after critical care hospitalization for children aged 6 to 18 years.

Eligibility Criteria:
Inclusion Criteria:

* Age 6 years to 18 years inclusive
* Inpatient consult to Pediatric Critical Care and Neurotrauma Recovery Program

Exclusion Criteria:

* Abusive trauma
* Child protective services custody
* Prisoners
* Pregnancy
* Non-English speaking caregivers
A Multicenter Randomized Open-label Study of Oseltamivir Combined With HD-DEX Versus HD-DEX in the Management of ITP

Oseltamivirphosphate is hydrolysed to its active metabolite-the free carboxylate of oseltamivir. Oseltamivir is a neuraminidase inhibitor, serving as a competitive inhibitor of the activity of the viral neuraminidase (NA) enzyme upon sialic acid, found on glycoproteins on the surface of platelets. By blocking the activity of the enzyme, oseltamivir may prevent platelet destruction in liver.The project was undertaking by Qilu Hospital of Shandong University and other 4 well-known hospitals in China. In order to report the efficacy and safety of oseltamivirphosphate combined with high-dose dexamethasone for the treatment of immune thrombocytopenia (ITP) with high platelet desialylation level, compared to high-dose dexamethasone therapy.

The investigators are undertaking a parallel group, multicentre, randomised controlled trial of 50 newly diagnosed ITP adult patients with high platelet desialylation level from 5 medical centers in China. One part of the participants are randomly selected to receiver HD-DXM (orally at 40 mg daily for 4d) combined with oseltamivir (orally at 75 mg twice for 10d), the others are selected to receive HD-DXM (orally at 40 mg daily for 4d ) alone. If platelet counts remained \<30×109/L or there were bleeding symptoms by day 10, another 4-day course of HD-DXM was given (days 10-14).For the combination arm, patients with an initial response relapsed during the follow-up period, oseltamivir retreatment could be given for another 10 days at the discretion of the physician's advice and patients' will.

Platelet count, bleeding , platelet desialylation level and other symptoms were evaluated before and after treatment. Adverse events are also recorded throughout the study. In order to report the efficacy and safety of oseltamivirphosphate combining with high-dose dexamethasone therapy compared to high-dose dexamethasone for the treatment of adults with newly diagnosed ITP .

Eligibility Criteria:
Inclusion Criteria:

* newly diagnosed ITP patients need of treatment(s) to minimize the risk of clinically significant bleeding primary ITP confirmed by excluding other supervened causes of thrombocytopenia

Exclusion Criteria:

* pregnancy hypertension cardiovascular disease diabetes liver and kidney function impairment HCV, HIV, HBsAg seropositive status patients with systemic lupus erythematosus and/or antiphospholipid syndrome
Study the Effect of Danggui Buxue Tang on Menopausal Symptoms

This study is to examine the effect and safety of the study drug,Danggui Buxue Tang, on menopausal symptoms of hot flushes and sweating and to determine whether the patient's quality of life will be improved.


Eligibility Criteria:
Inclusion Criteria:

* Follicle stimulating hormone (FSH), luteinizing hormone (LH), oestradiol in the menopausal range (FSH\>18 IU/L, LH\>12.6 IU/L, and E2\< 361 pmol/l).
* Patients with amenorrhoea for more than 12 months

Exclusion Criteria:

* Patients with a history of using any form of hormonal replacement therapy within 8 weeks
* Patients with a history of using Chinese medicine or other therapies which may affect the outcome within 8 weeks
* Patients who in the judgment of the investigator will be unable to comply with protocol requirements
* Patients with significant\*\* gastrointestinal, renal, hepatic, bronchopulmonary, neurological, cardiovascular, breast or endometrial carcinoma, or allergic diseases
* Patients with uncontrolled hypertension
* Patients with undiagnosed vaginal bleeding
* Patients with a history of significant drug hypersensitivity
Study of the Bioequivalence of Two Tablet Forms of MK0431 (0431-027)

This study will establish that the MK0431 100 mg anhydrous formulation tablets are bioequivalent to the MK0431 100 mg monohydrate final market image (FMI) tablets.


Eligibility Criteria:
Inclusion Criteria:

* Subject is in good health
* Female subjects must have a negative pregnancy test
* Subject is within 30% of ideal body weight
* Subject does not smoke
* Subject agrees to follow the study guidelines

Exclusion Criteria:

* Subject has a history of any illness that might confound the results of the study or make participation unsafe for the subject
* Subject has a history of hypoglycemia
* Subject has a history of any hepatic disease
* Subject is taking any oral, parenteral, topical or implantable contraceptives
Correlation Between Non-motor Symptoms and Malnutrition in Patients With Parkinson's Disease

This study used Mini Nutrition Assessment (MNA) , Nutrition risk screening 2002(NRS-2002) and Non-motor Symptom Quest (NMSquest) to investigate the nutritional status of patients with Parkinson's disease, to analyze the correlation between non-motor symptoms and malnutrition in patients with Parkinson's disease (PD) , and to provide evidence for clinical treatment and early nutritional intervention.

Data were collected by questionnaire survey.For arkinson patients who were admitted to the facility between June 2020 and July 2021 were targeted. This study used convenience sampling and included criteria: length of stay \> 24 hours; Parkinson patients who met Chinese diagnostic criteria for Parkinson's disease (2016 edition) ; willing participants and able to complete the scale. Exclusion criteria: parkinsonism caused by cerebrovascular disease, encephalitis, traumatic brain injury, complete transfusion of blood, plasma, albumin within one month, severe gastrointestinal disease, metabolic disease, and other wasting diseases; Patients with critical illness, severe cognitive impairment, and inability to communicate. The study was approved by the medical ethics committee with the informed consent of all selected individuals and their families

Eligibility Criteria:
Inclusion Criteria:

* Length of stay \> 24 hours; Parkinson patients who met Chinese diagnostic criteria for Parkinson's disease (2016 edition) ; willing to participate in the study and able to complete the scale.

Exclusion Criteria:

* Parkinson's disease caused by cerebrovascular disease, Encephalitis, traumatic brain injury; patients who have received whole blood, plasma, albumin within one month; patients with severe gastrointestinal disease, metabolic disease and other wasting diseases; Patients with critical illness, severe cognitive impairment, and inability to communicate.
Comparing the Efficacy of Hybrid, High-dose Dual and Bismuth Quadruple Therapies

Both hybrid and high-dose dual therapies developed by the scholars from Taiwan can achieve a high eradication rate for clarithromycin-resistant strains, and have a great potential to replace bismuth quadruple therapy in the treatment of H. pylori infection.

Bismuth quadruple therapy has been recommended as a choice of the first-line treatment for H. pylori infection in several important international consensuses. However, it is associated with a high frequency of adverse events. Both hybrid and high-dose dual therapies developed by the scholars from Taiwan can achieve a high eradication rate for clarithromycin-resistant strains, and have a great potential to replace bismuth quadruple therapy in the treatment of H. pylori infection. In the second-line treatment, tetracycline-levofloxacin quadruple therapy developed by our study group can achieve a higher eradication rate than levofloxacin triple therapy for salvage treatment of hybrid therapy. However, whether the new therapy can be a promising rescue treatment for bismuth quadruple or high-dose dual therapy remains unanswered.

Eligibility Criteria:
Inclusion Criteria:

* Consecutive H pylori-infected outpatients, at least 20 years of age, with endoscopically proven peptic ulcer diseases or gastritis

Exclusion Criteria:

* previous H pylori-eradication therapy
* ingestion of antibiotics or bismuth within the prior 4 weeks
* patients with allergic history to the medications used
* patients with previous gastric surgery
* the coexistence of serious concomitant illness (for example, decompensated liver cirrhosis, uremia)
* pregnant women
Does Epidural Anesthesia Reduce Postoperative Ileus Following Colorectal Surgery?

The use of epidural analgesia (EA) has been suggested as an integral part of an enhanced recovery program for colorectal surgery. However, the effects of EA on postoperative ileus remain controversial. Some authors suggest that EA has beneficial effects for postoperative outcome and hospital stay, whereas others have reported that the role of EA in the modern perioperative care of patients undergoing open colorectal surgery has been limited. Therefore, the investigators aimed to investigate the effect of EA on postoperative outcome, particularly postoperative ileus and hospital stay in patients with colorectal surgery.

In 2016, results of Cochrane review of 22 trials on the efficacy of EA in patients undergoing abdominal surgery showed that an epidural containing a local anesthetic, with or without the addition of an opioid, accelerated the return of gastrointestinal transit (high quality of evidence) and no difference in the incidence of vomiting or anastomotic leak (low quality of evidence). For open surgery, an epidural containing a local anaesthetic would reduce the length of hospital stay (very low quality of evidence).

However, in a recent analysis from American College of Surgeons revealed that the use of EA did not improve postoperative recovery after elective colectomy in their analysis and was associated with increased postoperative ileus and prolonged hospital stay after open colectomy.

In this study, the investigators aimed to compare the efficacy of EA to reduce the postoperative ileus and hospital stay, as well in the patients undergoing colorectal surgery. This prospective randomized study planned to include 100 consecutive patients with colorectal disorders.

Eligibility Criteria:
Inclusion Criteria:

* undergoing colorectal surgery due to both benign and malign disorders
* no contraindication for epidural anesthesia

Exclusion Criteria:

* drug use (psychotropic drugs etc) that may cause paralytic ileus
* immobile patients that ERAS protocol can not be applied on
* Anticoagulated patients with the risk of epidural hematoma,