cyrilzakka/clinical-trials huggingface dataset:
Ketogenic Diet Effects on the Frequency of Non Epileptic Seizures

The objective of this study is to determine the effects of the ketogenic diet on the frequency of non-epileptic seizures in patients with functional neurological symptoms disorder compared to a healthy diet.

This study consists of a open label randomized controlled clinical trial comprised of 20 patients with diagnosis of functional neurological symptom disorder with non epileptic seizures distributed in 2 arms of 10 patients each.

Patients will be randomly assigned to one of the groups. Both groups will be receiving treatment as usual (SSRI and/or psychotherapy). One group will be assigned a ketogenic diet while the other will be assigned a healthy diet, both supervised by a team of nutritionists. Patients will be evaluated every 2 weeks until reaching 6 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Patients who have a record at the institute and who have a diagnosis of a dissociative neurological symptom disorder with non-epileptic seizures with a certainty of at least clinically established who have a monthly seizure frequency greater than 3.
* Patients with the characteristics described above with comorbid epilepsy but who have not presented epileptic seizures in the last month.
* Patients with the aforementioned characteristics and who give their informed consent in writing to participate in the study.
* Patients who, once the diet has been explained to them, consider it feasible to implement it at least for the follow-up time.

Exclusion Criteria:

* Patients with metabolic or hemodynamic instability, liver failure, inability to tolerate the oral route, acute pancreatitis or pregnancy due to the possible teratogenic effect that has not yet been elucidated.
* Patients with metabolic disorders such as primary carnitine deficiency, palmitoyltransferase carnitine I or II deficiency, carnitine translocase deficiency, beta oxidation defects, pyruvate carboxylase deficiency, porphyria and other fatty acid transport and oxidation disorders.
Combination of Hemodialysis With Hemoperfusion：A Clinical Study

This study is a prospective, randomized, controlled multicenter clinical study. The aim of the study is to investigate whether the combination of maintenance hemodialysis (MHD) with hemoperfusion (HP) could improve the clearance rate of middle and large molecule uremic toxins so as to improve the quality of life of MHD patients and reduce their mortality rate.


Eligibility Criteria:
Inclusion Criteria:

1. Age≥18, male or female
2. Maintenance hemodialysis duration\>3 months
3. Regular hemodialysis,3 times a week,4 hours per session
4. Vascular access unlimited
5. iPTH≥300pg/ml
6. Sign the written informed consent

Exclusion Criteria:

1. Allergic to dialysis equipment
2. PLT\<60×10\^9/L
3. Blood flow\<200ml/min
4. Serum albumin\<30g/L
5. Kt/V\<1.2
6. iPTH\>800pg/ml
7. Hemodiafiltration
8. Coagulation disorder, severe bleeding tendency, with active bleeding
9. Severe hypotension, severe cardiopulmonary insufficiency
10. Under other drug trial
11. Acute infection, severe heart, lung, liver, nervous diseases, malignant tumor
Intergenerational Transmission of Low-calorie Sweeteners Via Breast Milk

This project aims to measure the widely consumed low-calorie sweeteners (LCS) sucralose and acesulfame-potassium, in maternal breast milk and plasma at pre-specified timepoints over 72 hours and in a single sample of infants' plasma. Sucralose and acesulfame-potassium concentrations will be measured using liquid chromatography-mass spectrometry (LC-MS). The data generated will inform the design of larger, longer-term, prospective studies needed to investigate clinically-relevant consequences of early life LCS exposure in humans.

Low-calorie sweetener (LCS) consumption is highly prevalent among lactating women, yet the current understanding of LCS effects on diet, weight, and health is extremely limited, especially when exposure begins early in life. This project aims to measure the widely consumed LCSs, sucralose and acesulfame-potassium, in maternal breast milk and plasma, at pre-specified, time-points over the course of 72 hours, and in a single sample of infants' plasma (analyzed using a population pharmacokinetics approach).

Mothers will attend an enrollment visit, which will take place virtually and will schedule an in-person visit to take place at Children's National Hospital approximately one week later. During the enrollment visit, informed consent will be obtained and demographic, anthropometric, and dietary data will be collected. During the week prior to their scheduled in-person study visit, mothers will be instructed to continue their usual dietary habits and to complete an online, photo-assisted, 7-day food record.

Mothers will be instructed to arrive fasted for the in-person visit, which will last for approximately 13 hours. Following ingestion of a diet beverage containing sucralose and ace-K, mothers will remain at Children's National for supervised serial sample collection at pre-determined time points over 12 hours, and will provide additional samples on three subsequent consecutive days (72 hours). Mothers will be instructed to continue to complete the online, photo-assisted, food record for the three days following the in-person study visit (until 72 hours following diet beverage consumption).

A plasma sample will be collected from each infant via heel-stick at one of the following pre-specified time intervals following the mother's ingestion of the diet beverage: 1.5-3 hours, 3-5 hours, 5-7 hours, 7-9 hours, 9-14 hours, and 22-36 hours.

Eligibility Criteria:
Inclusion Criteria:

* mother gave birth within the past 6 months
* mother ≥18 years of age
* exclusively breastfeeding
* reports consumption of diet, low-calorie sweetener-containing beverages ≥ 1 time per week.
* infants' corrected age \>= 4 weeks

Exclusion Criteria:

* known allergy or contraindication to sucralose or acesulfame-potassium (infant or mother)
* active nutritional disorder known to cause malabsorption
Liquid Biopsy in Hepatocellular Carcinoma

Circulating tumor DNA (ctDNA) carrying tumor-specific sequence alterations has been found in the cell-free fraction of blood. Hepatocellular carcinoma (HCC) specimens are difficult to obtain, and noninvasive methods are required to assess cancer progression and characterize underlying genomic features. Use of 'liquid biopsy' by assessing circulating cell free DNA enables the clinician to offer targeted immunotherapy or signaling pathway inhibitors. It also offers a model to prove response to locoregional or immunotherapy therapy and predict tumor recurrence non-invasively.

Novelty:

Mutation analysis may not only help identify cancer drivers, but they can also provide useful data to predict response to other treatment modalities such as immunotherapies, particularly immune checkpoint blockade. There is published data on liquid biopsy in India from oncology in the field of pulmonary and renal cancers, but these studies have not been done in cirrhosis or in HCC patients.

Objectives In this project we hope to develop a biomarker panel which helps us prognosticate patients and tailor targeted therapy as per their genetic mutation landscape. The treatment options for advanced HCC are limited, and tissue biopsy is not routinely performed.

Methods In this pilot project, we will analyze 30 patients with unresectable hepatocellular carcinoma, ineligible for liver transplantation, who will undergo locoregional therapy in the form of transarterial chemoembolization (TACE) or radioembolization (TARE) for tissue diagnosis of tumor tissue DNA and circulating tumor DNA. We will design personalized assays targeting somatic rearrangements of each tumor to quantify serum ctDNA. Exome sequencing will be performed using cell-free DNA and paired primary tumor tissue DNA in order to create a non-invasive liquid biopsy for diagnosis and prognostication of HCC.

Eligibility Criteria:
Inclusion Criteria:

* Hepatocellular carcinoma BCLC stages B and C of all aetiology, unresectable
* Age 18-70 years of either sex

Exclusion Criteria:

* Contemplating Hepatic resection or OLT
* Refractory ascites
* Severe Coagulation disorders prior to the procedure (PTI \<70% and Platelet count \< 80,000/mm3)
* Hepato-Renal syndrome
* Chronic Kidney Disease
* Acute decompensation like Hepatic encephalopathy and variceal bleeding
* Any known malignancy other than HCC
* Life expectancy \< 6 months
Comparison Between Rectal Suppository Acetaminophen and Diclofenac Sodium as Analgesia for Postpartum Perineal Tear

To assess the prevalence of pain score for perineum pain following childbirth followed by phase 2 study to assess the analgesic effectiveness of acetaminophen and diclofenac rectal suppository in postpartum perineum pain secondary to perineal trauma.

Studies has demonstrated that non-steroidal anti-inflammatory drugs (NSAIDs) rectal suppositories are associated with less pain up to 24 hours after birth, and less additional analgesia is required. Therefore, In view of rectal route of analgesic administration is better in local action and systemic paracetamol also proven to be effective in controlling post-partum perineal pain with unknown effectiveness in its suppository form; the investigators would like to conduct this study to investigate the effectiveness of acetaminophen rectal suppository versus diclofenac rectal suppository in controlling postpartum perineal pain. This study will be conducted in 2 stages. Stage 1 is a 3 months prospective observational study which aims to determine the prevalence and severity of perineal pain following childbirth in Hospital Sultanah Aminah, Johor Bahru; while Stage 2 is a single blinded, open-labelled, randomized control trial study design which will determine if acetaminophen rectal suppository is as equivalence as diclofenac rectal suppository in reducing postpartum perineal pain secondary to perineal trauma.

Eligibility Criteria:
Inclusion Criteria:

Stage 1:

a) All pregnant women who sustained perineal trauma (either 1st degree tear, 2nd degree tear or episiotomy) post vaginal delivery

Stage 2:

1. All pregnant women who have planned vaginal delivery in HSAJB from 1st January 2016 till 30th June 2016.
2. All pregnant women who sustained 1st degree/ 2nd degree perineal tear or episiotomy tear post vaginal delivery.
3. All pregnant women who have consented to involve in the study.

Exclusion Criteria:

Stage 1:

1. Patient who sustained additional perineal tear (eg. Labial tear or periurethral tear) following childbirth.
2. Patient who developed post-partum complications.

Stage 2:

1. Patient who is allergic to paracetamol or voltaren.
2. Patient who is unable to or unwilling to give consent.
3. Patient who is ended up with caesarean section.
4. Patient who sustained additional perineal tear including labial tear or periurethral tear.
5. Patient who developed postpartum complications (eg. Retained placenta, uterine atony, postpartum haemorrhage, multiple vaginal wall tear etc. )
Clinic Registry Study of Optic Neuromyelitis Spectrum Disease in China

In 1894, Devic first proposed the concept of neuromyelitis optica(NMO). NMO is an inflammatory demyelinating disease that selectively affects the central nervous system of the optic nerve and spinal cord.In 2004, Lennon and other persons found highly specific AQP4（aquaporin 4）antibodies in NMO patients'sera, and further differentiated between NMO and MS, confirming that NMO is an independent disease.At present, NMO has been widely recognized as an idiopathic and severe demyelinating disease of the central nervous system.In 2015, the international NMO diagnostic team developed the diagnostic criteria based on highly specific AQP4 antibodie.Up to now, in China, there is no data on the number of NMOSD patients, the rate of misdiagnosis, the treatment methods, and the prognosis.This study is committed to build China's NMOSD big data platform to provide the basis for diagnosis, treatment and prognosis of the disease.


Eligibility Criteria:
Inclusion Criteria:

1. more than 14 years old
2. Compliance with the diagnostic standard by the NMO International Diagnostic team in 2015

Exclusion Criteria:

1. less than 14 years old
2. NOT Compliance with the diagnostic standard by the NMO International Diagnostic team in 2015
Clinical Trial of Gemcitabine and Oxaliplatin in Recurrent or Metastatic Breast Cancer

The purpose of this study is to find out if the combination of gemcitabine and oxaliplatin chemotherapy will be effective in reducing or eliminating the tumor(s) in patients with recurrent or metastatic breast cancer.

Gemcitabine is a chemotherapy drug approved by the U.S. Food and Drug Administration (FDA) for the treatment of pancreatic and lung cancer; oxaliplatin is a chemotherapy drug that is approved by the FDA for the treatment of colon cancer. Neither gemcitabine nor oxaliplatin are approved for the treatment of breast cancer. However, both drugs have been shown to decrease the size of breast cancer tumors.


Eligibility Criteria:
Inclusion Criteria:

* Histologically proven dx of recurrent or metastatic breast cancer
* Must have received at least 1 but not more than 3 prior chemotherapy regimens for recurrent or metastatic breast cancer. Patients who relapse within 12 months of completing adjuvant chemotherapy can only have had up to 2 prior regimens for metastatic disease. Patients who relapse within 12 months of completing adjuvant chemotherapy containing an anthracycline and a taxane, do not require prior chemotherapy for metastatic disease.
* Unidimensionally measurable dz (by RECIST)
* At least 18 yrs of age
* SWOG PS 0-2
* AGC greater than or equal to 1.5; platelets greater than or equal to 100,000; Hgb greater than or equal to 8.0
* Total bilirubin less than or equal to 2 x uln; SGOT and/or SGPT and alk phos up to 2.5 x uln
* Creatinine less than or equal to 2.0
* Fully recovered from acute toxicities secondary to prior tx
* Signed informed consent (including HIPAA authorization)
* Peripheral neuropathy grade 0-1

Exclusion Criteria

* Prior tx with gemcitabine or oxaliplatin. Prior tx with cisplatin or carboplatin allowed if completed \>12 mos prior to enrollment.
* Underlying medical, psychiatric, or social conditions that would preclude patient from receiving tx
* Peripheral neuropathy greater than or equal to Gr 2

Exclusion Criteria:

-
ALK33BUP-201: Safety and Tolerability Study of ALKS 33-BUP (ALKS 5461) Administration in Subjects With MDD

This is a multicenter, randomized, double-blind, placebo-controlled, parallel, multiple dose study designed to evaluate the safety and tolerability of the co-formulation of ALKS 33 with buprenorphine (ALKS 5461) in subjects with Major Depressive Disorder (MDD) who are inadequately/partially responding to current treatment with a stable dose of a serotonin-selective reuptake inhibitor (SSRI) or serotonin-norepinephrine reuptake inhibitor (SNRI).


Eligibility Criteria:
Inclusion Criteria:

* Male and female subjects between 18 and 65 years of age, inclusive.
* Meet Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision (DSM-IV-TR) criteria for MDD.
* Current episode lasting ≥8 weeks prior to screening with an inadequate/partial response to an adequate trial (defined as at least 8 weeks) of a stable dose of an SSRI or SNRI. Inadequate/partial response is defined as:

  1. A Hamilton Depression Rating Scale total score (HAM-D17) ≥14, and
  2. Less than 50% reduction in depressive symptom severity on the Massachusetts General Hospital Antidepressant Treatment Response Questionnaire (ATRQ), and
  3. Clinical Global Impression - Severity (CGI-S) score of ≥3.

Exclusion Criteria:

* Axis I diagnosis of delirium, dementia, amnestic or other cognitive disorder, schizophrenia or other psychotic disorder, bipolar I or II disorder, eating disorder, obsessive-compulsive disorder, panic disorder, or posttraumatic stress disorder.
* A clinically significant current Axis II diagnosis of borderline, antisocial, paranoid, schizoid, schizotypal, or histrionic personality disorder.
* Experiencing hallucinations, delusions, or any psychotic symptomatology in the current episode.
* The use of inducers or inhibitors of cytochrome P450 (CYP) 3A4 (prescription medications, over-the-counter \[OTC\] medications, or dietary supplements) within 30 days before dosing.
* Have received electroconvulsive therapy during the current MDD episode.
* Pose current suicide risk as confirmed by the Columbia Suicide Severity Rating Scale (C SSRS).
* History of intolerance or hypersensitivity to buprenorphine.
* History of allergy or hypersensitivity to opioid antagonists (eg, naltrexone, naloxone) or quinine.
Evaluation of the API-VIGIE Monitoring System: Program to Reduce Emergency Visits for Severe Paroxysmal Alcoholism

The study was designed to evaluate the APIVIGIE program use at CH d'Arras. The objective of this program is to reduce repeated visits by the same patient to the emergency room for Alcoholism Severe Paroxysmal

In France, between 10% and 30% of emergency room admissions are linked to problematic alcohol consumption. This considerable weight of alcohol-related problems in the current problematic of emergencies is largely unknown and can lead to blockages in emergencies.

For acute intoxication requiring emergency care, 80% of admissions concern people dependent on alcohol. Here again, this crucial clinical notion is largely ignored: when a patient in a state of intoxication arrives in the emergency room, this should not be considered as a banal and one-off event, it is necessary to put in place a care, if necessary, of addiction.

Supported by a call for projects from the Hauts-de-France Regional Health Agency, the Addictions Service of the Arras Hospital is setting up a monitoring system called APIVIGIE.

APIVIGIE program is offered to patients who present to the emergency room for a diagnosis of API after an evaluation by the liaison team of the addiction service. If the patient agrees to be part of the program, he will receive a resource card with the APIVIGIE phone number to contact if necessary.

The link will be maintained with the Addictology Care, Support and Prevention Center (CSAPA) for a period of 6 months, by telephone consultations, or by video-consultations or face-to-face consultations.

Eligibility Criteria:
Inclusion Criteria:

* Patient 18 years or older;
* Participant at API-VIGIE program.

Exclusion Criteria:

* Patient's opposition to participating in the research;
* Persons under legal protection (under tutorship or curatorship);
* Person deprived of liberty;
* Pregnant or breastfeeding women.
Upfront Treatment With Chemotherapy and Bevacizumab in Advanced Ovarian Cancer

Our study aims at assessment of response, survival and toxicity of frontline treatment with chemotherapy and Bevacizumab in patients having advanced epithelial ovarian cancer.

Ovarian cancer is the most lethal gynecologic malignancy and is the fifth most common cause of cancer death in women .The majority of women with ovarian cancer are diagnosed with advanced-stage disease; only 15% of all cases are diagnosed with local disease. Risk factors for ovarian cancer include family history, nulliparity, lack of breast feeding, and infertility .

The GOG-0218 trial demonstrated that the use of bevacizumab in the front-line and maintenance setting improved progression free survival by 3.8 months when compared with conventional every-3-weeks carboplatin and paclitaxel.

The ICON-7 trial also aimed to compare the progression free survival and Overall survival in women who receive bevacizumab with carboplatin/paclitaxel and women receiving carboplatin/paclitaxel alone The final results of ICON7 were announced in 2013. Overall, the results showed no difference in overall survival between those in the group receiving bevacizumab han those in the group receiving no bevacizumab. However, for high-risk patients, who were most likely to have early disease progression, the results were positive and showed an improvement in overall survival of 4.8 months in the group who received bevacizumab.

Not only has the best route been intensely debated but the optimal timing of therapy has been and is currently being studied. Chemotherapy is usually given either only after primary debulking surgery or as both neoadjuvant chemotherapy before and after interval debulking surgery. recent trials have tried to determine which treatment timing is associated with better outcomes .

The aim of the study will be assessment of response, survival and toxicity of frontline treatment with chemotherapy and Bevacizumab in patients having advanced epithelial ovarian cancer.

Eligibility Criteria:
Inclusion Criteria:

* Female patients diagnosed with advanced ovarian cancer by biopsy
* Age more than 18 years old
* Routine labs are within normal values ( CBC, renal function tests , liver function tests )
* Performance score 0-2
* FIGO stage II-IV
* Not having any contraindication to bevacizumab as : uncontrolled hypertension , bleeding tendency , ischaemic events
* Chemotherapy naïve.
* Informed consent

Exclusion Criteria:

* patients previously received chemotherapy or radiotherapy to any part of the abdomen or pelvis
* patients with uncontrolled infection
* patients with clinically significant cardiovascular disease
* patients with active bleeding or conditions associated with high risk of bleeding
* patients with history of CNS disease
Accuracy of Lung Injury Biomarkers in the Initial Investigation of Patients With Suspected Pneumonia

The aim of this study is to investigate the diagnostic and prognostic value of surfactant protein D, Krebs von den Lungen (KL-6), and Chitinase-3-like protein 1 (YKL-40) in the initial investigation of patients hospitalized with suspected pneumonia. This to improve the diagnosis of pneumonia, contribute to a more rapid and accurate antibiotic treatment, and assess disease severity to predict short-term and long-term mortality in community-acquired pneumonia patients.

Community-acquired pneumonia (CAP) is one of the most common infection diseases in the emergency department (ED). Diagnosis of pneumonia is challenging as symptoms are often weak and nonspecific and the current methods for focal and etiological diagnosis have low sensitivity and specificity and often deliver results after the antibiotic treatment decision has been made.

The abundant and restricted expression of surfactant protein D (SP-D) within the lung makes this protein a specific marker for lung disease. Krebs von den Lungen-6 (KL-6) is expressed in the lung and is a diagnostic and prognostic marker of interstitial lung disease. The inflammatory glycoprotein Chitinase-3-like protein 1 commonly known as YKL-40 is associated with severity of interstitial lung disease. The value of these lung injury markers for diagnosing pneumonia needs further investigation.

The investigators hypothesize that surfactant protein D, Krebs von den Lungen (KL-6), and Chitinase-3-like protein 1 (YKL-40) have an impact on diagnosing, prognosis, and treatment of patients with verified CAP.

The objectives of the study are:

* To investigate the diagnostic accuracy of surfactant protein D, Krebs von den Lungen (KL-6), and Chitinase-3-like protein 1 (YKL-40) in the diagnosis of CAP
* To identify the prognostic value surfactant protein D, Krebs von den Lungen (KL-6), and Chitinase-3-like protein 1 (YKL-40) in relation to adverse events in patients with verified CAP

Eligibility Criteria:
Inclusion Criteria:

* Suspicion of APN assessed by the receiving physician at the ED

Exclusion Criteria:

* If the attending physician considers that participation will delay a life-saving treatment or patient needs direct transfer to the intensive care unit.
* Admission within the last 14 days
* Verified COVID-19 disease within 14 days before admission
* Pregnant women
* Severe immunodeficiencies: Primary immunodeficiencies and secondary immunodeficiencies (HIV positive CD4 \<200, Patients receiving immunosuppressive treatment (ATC L04A), Corticosteroid treatment (\>20 mg/day prednisone or equivalent for \>14 days within the last 30 days), Chemotherapy within 30 days)