cyrilzakka/clinical-trials huggingface dataset:
Levosimendan Versus Placebo Before Tricuspid Valve Surgery in Patients With Right Ventricular Dysfunction

A Prospective, multicenter, randomized (two arms, parallel groups); double-blind, placebo-controlled in order to assess the ability of preoperative levosimendan to prevent post-operative low cardiac output in high-risk patients referred to cardiac surgery for correcting functional tricuspid regurgitation. The primary end point is a composite element that includes peri-operative mortality and low cardiac output syndrome at day-90: 1) catecholamine infusion persisting beyond 48 hours after cardiac surgery, 2) the need for circulatory mechanical assist devices in the postoperative period, 3) or the need for renal replacement therapy at any time during intensive care unit stay. If a patient had at least 1 of these criteria, he or she was considered as meeting the primary end point.The secondary end points were 1) each component of the primary end point, and 2) the study drug safety defined as refractory hypotension.

Patients referred for an isolated or a combined surgical correction of functional moderate to severe tricuspid are randomized in 2 arms, the levosimendan group or to the placebo group.

In the experimental group, levosimendan is administered as a continuous infusion over a 24-hour period at the rate of 0.2μg/kg/min, with no bolus administration. The infusion will begin 24H to 48H before anesthetic induction.

In the comparator group, Placebo (isotonic sodium) administered as a continuous infusion over a 24-hour period at the rate of 0.2μg/kg/min, with no bolus administration. The infusion will begin \<48H before anesthetic induction

Eligibility Criteria:
Inclusion Criteria:

* Patients referred for an isolated or a combined surgical correction of functional moderate to severe tricuspid regurgitation \[effective regurgitant orifice (ERO)\>20mm², or systolic hepatic vein flow blunting or reversal\]
* Written signed informed consent
* Affiliation to the French health care system (Sécurité Sociale)

Exclusion Criteria:

* Age \< 18 years
* Severe organic renal dysfunction defined by creatinine clearance \<30mL/min
* Recent endocarditis (\<3 months)
* Recent myocardial infarction (\<3 months)
* Tricuspid valve perforation or prolapse
* Cardiogenic shock requiring dobutamine support or cardiac assistance
* Severe liver injury (CHILD C)
* Left ventricular obstruction
* Allergy to levosimedan
* Current participation in other investigational drug or device studies or being in the exclusion period at the end of a previous study involving human participants, if applicable
* Pregnant or breastfeeding women
* Females of childbearing potential without effective method of birth control
* Patient on AME (state medical aid) unless exemption from affiliation
* Hypotension with SBP\<90mmHg
* Severe tachycardia
* History of torsade de pointe
New Treatment for Patients With Temporal Hollowing After Lateral Wall Decompression

The purpose of this study is to determine whether injection of autologous fat or hyaluronic-acid injections in temporal region are effective in the treatment of temporal hollowing after lateral wall decompression in patients with thyroid eye disease.

Grave's disease is one of the most common autoimmune diseases. Thyroid eye disease is affecting nearly 50% of patients with Grave's disease. Surgical treatment may address several of the manifestations, including the increased volume of the orbital contents. Decompression of the orbit can be achieved by removing the lateral orbital walls; "lateral wall decompression".

In a retrospective study at the Department of Ophthalmology, Haukeland University Hospital, about half of the patients had a disfiguring hollowing in the temporal region after lateral wall decompression. The patient reported outcome of the procedure is clearly an indication for further esthetic treatment. However, until now the treatment option for these patients have been limited, or simply neglected. The investigators have contacted over 40 patients with this complication that want treatment.

In this project the investigators will treat bilateral hollowing with injection of autologous fat in one temporal region and hyaluronic-acid injections on the opposite side. Participants with unilateral hollowing will be randomized to one of the treatment options. Outcomes will be evaluated by clinical examination, photographs and ultrasound volume measurement at 6, 12, 18 and 24 months postoperatively. The participants will be retreated at these follow up intervals if necessary.

The project will be an interventional, prospective follow-up study and is approved by the regional ethics committee. The study will be the first of its kind to date as the investigators will be able to prospectively evaluate the effect of autologous fat injections to hyaluronic-acid injections in the same patient for the same condition.

Eligibility Criteria:
Inclusion Criteria:

* Disfiguring temporal hollowing after lateral wall decompression.
* The participant want treatment for temporal hollowing

Exclusion Critera:

* The participant dont want treatment for temporal hollowing
ICP Waveform Analysis in Stroke Patients

This is a study on how acute clinical state and final clinical outcome in patients with stroke (exclusive subarachnoid hemorrhage) relate to ICP/ABP-derived pressure waveform parameters recorded during intensive care management.

Aim of study:

* Prospectively collect clinical and radiological data as well as management data.
* Perform retrospective analysis of ICP/ABP recordings (mean ICP, mean ICP wave amplitude, mean ABP, mean ABP wave amplitude, CPP)
* Relate the prospectively collected data with results of retrospective pressure analysis.

Eligibility Criteria:
Inclusion Criteria:

* Acute apoplexy

Exclusion Criteria:

* Subarachnoidal bleeding
Examination of Neuromotor Development of Cases Diagnosed with Scaphocephaly

It's an observational study. Purpose of the study: To evaluate the neuromotor development of scaphocephaly cases.

21 infants diagnosed with scaphocephaly aged 2-17 months were included.

* Is there any delay in the neuromotor development of scaphocephaly cases?
* If delay is observed, in which area is it most common?

Denver-II Developmental Screening Test and Alberta Motor Infant Scale were applied to the participants.

Scaphocephaly (sagittal synostosis) is the most common single-suture craniosynostosis. It occurs as a result of premature ossification of the fibrous connective tissue extending between two parietal bones (sagittal suture). Phenotypically, a long and narrow head shape occurs. It occurs in 2-3 per 10,000 live births and is more common in men.

Premature ossification of the sagittal suture can lead to cranial deformity, potentially cranial growth restriction, and resulting increased intracranial pressure. In these cases, increased intracranial pressure and compression of the sagittal sinus cause increased venous pressure, which may cause developmental delays. These delays most commonly include cognitive impairments, language disorders, motor delays, learning disabilities, executive dysfunction, and behavioral problems.

When looking at the literature, it was seen that the studies were mostly on neurocognitive development in cases with craniosynostosis. There are relatively fewer studies focusing on the neuromotor development of these cases.

This study aims to evaluate the neuromotor development of scaphocephaly cases.

Eligibility Criteria:
Inclusion Criteria:

* Having been diagnosed with scaphocephaly
* Being between 0-18 months

Exclusion Criteria:

* Be over 18 months
* Having a diagnosed disease other than scaphocephaly
Additional Left Atrial Appendage Isolation During Balloon Ablation for Persistent or Long-standing Persistent Atrial Fibrillation

Additional left atrial appendage isolation during balloon ablation for persistent or long-standing persistent atrial ﬁbrillation can reduce atrial ﬁbrillation reoccurrence within 3-12 months compared to balloon-based pulmonary vein isolation only.

The intervention in the LALA-LAND-AF trial is the additional LAAI in patients with catheter ablation for persistent AF and will be performed once as index ablation as outlined above. With exception of the index ablation, all patients will be treated according to the current clinical practice guidelines for AF as stated by the European Society of Cardiology (ESC) 11,18 and an expert consensus statement on catheter and surgical ablation1. Patients may be treated with a specific antiarrhythmic drug (AAD) for a maximum of 3 months following the index ablation. No repeat ablation for AF should be performed within the first 3 months. Thereafter, repeat ablations are permitted for recurrent AF irrespective of group allocation. Ablation strategy at repeat ablation includes PV re-isolation if required in both groups and re-isolation of the LAA in the intervention group. In the control group, LAAI may only be performed in case all PV were isolated.

Eligibility Criteria:
Inclusion Criteria:

1. Persistent or long-standing persistent AF (i.e. continuous AF that was/is sustained \>7 days or \>12 months, respectively)
2. Age ≥18 and ≤80 years
3. Indication for AF ablation as per current guidelines

Exclusion Criteria:

1. Missing informed consent
2. LAA diameter \>25mm 10mm distant from circumflex artery assessed by TEE
3. Paroxysmal atrial ﬁbrillation
4. Long-standing persistent atrial ﬁbrillation with a continuous AF duration of \>4 years
5. Previous pulmonary vein isolation or MAZE surgery
6. Previous led atrial appendage closure or surgical excision
7. Left atrial diameter \>60 mm at baseline
8. Left atrial thrombus at baseline
MOWI Research Pilot

The goal of this study is to conduct a program of pilot research aimed at developing and evaluating a technology-assisted wellness intervention for older adults with obesity.

The national epidemic of obesity is also affecting older adults, and is associated with an increased risk of disability, nursing home placement and early mortality. Conventional weight loss programs have the potential to reduce body fat, but are difficult to access for older obese adults due to transportation and mobility challenges. The overarching goal of this study is to conduct a program of pilot research aimed at developing and evaluating a technology assisted wellness intervention for older adults with obesity.

Study Timeline:

September 2017 to June 2018:

Goal: Conduct a pilot study of improving weight and physical function in older adults with obesity. An mHealth Obesity Wellness Intervention (MOWI) will integrate Amulet +/- Fitbi with a weekly individual dietician-led nutritional session, along with twice weekly physical therapist led group exercise session.

Participation Duration: Three times weekly for 3 months

Eligibility Criteria:
Inclusion Criteria:

All Aims:

* Age ≥65 years
* Body Mass Index (BMI) ≥ 30kg/m\^2
* Waist circumference ≥88cm in females or ≥102cm in males

Aims 2 \& 3:

* Have Wi-Fi high speed internet
* Able to obtain medical clearance from doctor
* Have less than a 5% weight loss in past 6 months
* No advanced co-morbidity
* No exercise restrictions
* Not involved in other research studies that may interfere with participation

Exclusion Criteria:

* Severe mental or life-threatening illness
* Dementia
* Substance use
* History of bariatric surgery
* Suicidal ideation
* Unable to perform measures
* Reside in nursing home
* No advanced co-morbidity
* No exercise restrictions
* Not involved in other research studies that may interfere with participation

Aim 4 - had to have completed Aims 2 or 3
Dairy Macronutrient Effects on the Metabolic Syndrome

The investigators examined the effects of 4-week dietary protein intake in mixed meals at two levels of protein amount on whole body glucose metabolisms in older adults with metabolic syndrome.

The investigators investigated changes in insulin sensitivity before and after 4 weeks of dietary intervention and control in subjects with metabolic syndrome. Two groups of subjects were studied before and after a weight maintenance diet. Group 1 was fed a common American diet with a macronutrient distribution of 10% protein, 55% carbohydrates, and 35% fat. Group 2 consumed a higher protein diet (20%; 1.4 g/kg/d of protein). Carbohydrate intake was lower in Group 2 (45%), with fat intake (largely derived from dairy sources) similar between groups. Glucose utilization and endogenous glucose production were determined during an oral glucose tolerance test (OGTT) with a novel double-tracer approach. The secondary aim was to determine the effect of a diet high in dairy consumption on blood lipid profiles. The investigators measured blood lipids before and after dietary intervention in each group.

Eligibility Criteria:
Inclusion Criteria:

* Men and women, ages 45-75 years AND
* BMI greater than 30 kg/m2 AND
* Two of the following conditions:

  * Plasma triglycerides \> 130 mg/dl
  * HDL \< 40 mg/dl in men or 50 mg/dl in women
  * elevated screening blood pressure (systolic \> 140 or diastolic \>90 mm Hg) or taking medication for hypertension
  * fasting plasma glucose \> 100mg/dl

Exclusion Criteria:

* Hemoglobin A1c \> 7.5
* History of malignancy in the 6 months prior to enrollment
* History of lactose intolerance or dairy allergy
* History of gastrointestinal bypass surgery (Lapband, etc)
* History of a chronic inflammatory condition or disease (Lupus, HIV/AIDS, etc)
* Subjects who do not or will not eat animal proteins
* Subjects who cannot refrain from consuming protein or amino acid supplements during their participation in this study
* Subjects who use insulin to control their blood sugar
* Subjects whose physician will not allow suspension of oral diabetes medications for the duration of the study (\~5 weeks)
* Concomitant use of corticosteroids (ingestion, injection or transdermal)
* Any other disease or condition that would place the subject at increased risk of harm if they were to participate, at the discretion of the study physician
A Neuroimaging and Epigenetic Investigation of Antidepressants in Depression

The purpose of this study is:

1. to find out the structural or functional effects of selective serotonin reuptake inhibitors (SSRI) in major depressive disorder (MDD);
2. find special abnormalities in depression secondary to other disease, e.g., autoimmune disease like systemic lupus erythematosus (SLE).
3. find the relationship between the efficacy of antidepressant and the change of neuroimaging in MDD
4. to find possible predispose to MDD
5. to explore the DNA methylation status in depression;

1. to explore the pathology of depression
2. to identify the difference between MDD and depression secondary to other disease ,especially autoimmune disease
3. to explore the effect of gene-environment interaction on the epigenetic regulation of the depression

Eligibility Criteria:
Inclusion Criteria:

* DSM-IV Major Depression or Dysthymia
* Age 18-65
* Physically healthy
* Drug-free

Exclusion Criteria:

* Body metal (e.g., wire stitches, screws in bones, stainless steel hips)
* History of Psychosis or Epilepsy
* Current (past six months) Substance Use Disorder (illicit drugs and/or alcohol)
* Bipolar I
* Need for wash-out from effective treatment in order to participate
* Pregnant
* High suicide risk
* Currently taking (within 2 weeks; 4 weeks for Fluoxetine) antidepressants
Efficacy and Safety of IBI310 Combined with Sintilimab in Patients with Advanced Hepatocellular Carcinoma

An open-label, single-arm, Ib study of the efficacy and safety of IBI310 combined with sintilimab in patients with advanced hepatocellular carcinoma

In this study, approximately 18 to 47 patients who have previously received sorafenib, lenvatinib, or oxaliplatin-containing chemotherapy . After determining the dose of IBI310, the study will enter the expansion phase

Eligibility Criteria:
inclusion criteria：

1. Locally advanced or metastatic hepatocellular carcinoma, confirmed by histology/cytology.
2. Disease progression after surgery and / or local treatment.
3. Previous standard systemic treatments for advanced hepatocellular carcinoma have failed or developed intolerable toxicity.

exclusion criteria：

1. Histology contains fibrous lamellar hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma, cholangiocarcinoma and other components.
2. Have a history of hepatic encephalopathy, or have a history of liver transplantation.
3. Diffuse liver cancer.
Non-inferiority Randomized Controlled Trial of Cognitive Targeted Biopsy Versus Software Targeted Biopsy

This is a randomized controlled and non-inferiority trial in comparison of the cognitive fusion targeted biopsy between the software-based fusion targeted biopsy in the detection rate of clinically significant cancer in men suspected to have a PCa.

This trial is a prospective, multi-centre, randomized controlled, and non-inferiority study in which all men suspicious to have clinically significant prostate cancer. This study aims to determine whether the cognitive fusion targeted biopsy is non-inferior to software-based fusion targeted biopsy in the detection rate of clinically significant cancer in men suspected to have a PCa.

Eligibility Criteria:
Inclusion Criteria:

1. Age \> 18
2. PSA increase to 4-20 ng/ml and/or abnormal DRE;
3. Sign the informed consent

Exclusion Criteria:

1. Have acute or chronic prostatitis
2. Contraindications to prostate biopsy
3. Contraindications to MRI
4. Other reasons that not suitable for this trial
Pain Phenotype in Patients With Carpal Tunnel Syndrome

The aim of this study was to determine the dominant pain phenotype in a group of patients with Carpal Tunnel Syndrome by applying the International Association for the Study of Pain (IASP) criteria.

Voluntary participants between the ages of 18-65 who have been diagnosed with CTS will be included in the study.The 7 steps in the Clinical Criteria/Rating System determined by the International Association for the Study of Pain (IASP) for Nosiplastic Pain and Carpal Tunnel Syndrome will be applied to people with CTS. Thermal pain threshold, mechanical pain sensitivity and static/dynamic allodynia will be evaluated to determine pain hypersensitivity (Step 5). Specific questions will be asked to confirm the history of hypersensitivity in patients (Step 6). Finally, comorbidities, if any, will be determined (Step 7). As a result, the pain phenotype of patients with CTS will be determined (Nociceptive, Neuropathic or Nosiplastic). Shapiro-Wilk test will be performed to determine the distribution of the data. One-way ANOVA (continuous) or Kruskal-Wallis (categorical) will be used to examine whether the dependent variables differ between groups. For significant F-test, an additional investigation of differences between groups will be performed with Gabriel's post hoc procedure.

Eligibility Criteria:
Inclusion Criteria:

* Being diagnosed with CTS
* Being between the ages of 18-65
* Volunteering to participate in the study

Exclusion Criteria:

* Having systemic inflammatory disease
* Having a disease that may cause polyneuropathy such as diabetes mellitus
* Having a pacemaker
* Having a disease affecting the central nervous system
* Having cervical radiculopathy
* History of previous operation or local steroid injection due to CTS
* Hypersensitivity to heat and cold
Pain & Expert: Global Pain-assessment: a Prospective Registry

Full assessment of chronic pain patients based on the ICF-model.


Eligibility Criteria:
Inclusion Criteria:

* Patients with chronic pain for at least 3 months
* Age =\> 18 years
* Patient has been informed of the study procedures and has given written informed consent

Exclusion Criteria:

* Healthy patients or patients with acute pain.
* Addiction to drugs, alcohol (\>5 units per day)
* Evidence of an active disruptive psychiatric disorder that may impact perception of pain, and/or ability to evaluate treatment outcome as determined by investigator
* Pregnancy
Eating Peanuts for Health

Evidence is accumulating that peanut consumption confers health benefits, such as reduction of cardiovascular disease risk and possibly diabetes risk (Jenkins et al., 2008; Mattes et al., 2008). However, peanuts are a high fat, energy dense food and concerns about weight gain are widespread. Although research indicates that other characteristics of peanuts offset these properties, and that peanuts may be incorporated into diets without posing a threat to weight gain (Mattes et al., 2008), concern remains among policymakers, healthcare providers, and consumers. Furthermore, worry exists that eating salted peanuts may elevate blood pressure and that eating honey-roasted peanuts make elevate blood sugar. These fears create substantial obstacles to increased peanut consumption.

Recommendations to increase peanut consumption may be made, but if they are not followed, there will be no impact on health. Additional knowledge is needed on: (1) the acceptability of peanuts consumed on a chronic basis, (2) the chronic intake of moderate levels of peanuts and body weight, and 3) the effects of peanuts on blood pressure and blood sugar. The proposed research will examine the acceptability of long-term inclusion of a single form versus varied forms of peanuts in the diet. It is expected that responses will be varied among individuals with different personality characteristics (e.g., prefer sweet versus savory foods, hedonic versus non-hedonic eaters). A better understanding of how different segments of the population choose to include peanuts in their diet and how to optimize long-term consumption should provide insights for better marketing and improved health. Furthermore, it is anticipated that eating salty peanuts will not raise blood pressure and that eating honey-roasted peanuts will not raise blood sugar. Documenting this will add credibility to the evidence that peanuts do not cause weight gain, as well as reinforce recommendations to increase peanut consumption for their health benefits.


Eligibility Criteria:
Inclusion Criteria:

* Between 18 and 50 years of age
* Weight stable (\< 3 kg weight change within last 3 months)
* Constant habitual activity patterns (no deviation \> 1x/wk at 30 min/session within last 3 months)
* Constant habitual diet patterns within last 3 months
* Willingness to eat all test foods (peanuts daily for 12 weeks)
* No allergy to foods provided in the study (peanuts)
* Not a daily peanut or tree nut consumer
* Not planning to change use of medications known to influence appetite or metabolism
* Not diabetic or hypertensive
* No history of gastrointestinal pathology
* Non-smoker for one year or more

Exclusion Criteria:

-