cyrilzakka/clinical-trials huggingface dataset:
Histopathology of the Aspirated Thrombus During Acute Myocardial Infarction

This study was initiated on the preliminary premise that a thrombus whose formation was triggered by a thrombogenic substrate, such as within an atherosclerotic plaque (Tissue factor initiated thrombus), may evolve differently than the one evolving at the site of a recently implanted stent (foreign body triggered). Consequently, the thrombus composition of a de novo clot could differ from the other one, extracted during the occurrence of a subacute thrombosis, regarding the number of various cells, the amount of fibrin and platelet aggregates and the relationship among these components. In addition, it seems relevant to evaluate the numbers and the distribution of the local monocytes, once these cells may interact with platelets (via cell -adhesion mechanisms e.g., by CD31 \[PECAM-1\]) and by the extrinsic coagulation pathway (via TF/FVII elaborated by plaque-resident macrophages). Such a distinction, if eventually found, may reveal the mechanisms of thrombosis within coronary arteries, and may have clinical implications.


Eligibility Criteria:
Inclusion Criteria:

* Patients with acute coronary syndrome who undergo angiography
* Evidence of coronary thrombus
* Undergo aspiration procedure yielding thrombus fragments

Exclusion Criteria:

-
Phase 1/2, Open-label, Dose-escalation Study of IONIS-STAT3Rx, Administered to Patients With Advanced Cancers

This is a Phase 1/2, open-label, dose-escalation, dose-expansion study for the treatment of patients with advanced cancers. Eligible patients with DLBCL or other advanced lymphomas will be enrolled into the dose-expansion cohort.


Eligibility Criteria:
Inclusion Criteria:

* Aged 18 years or older
* Tumors that are relapsed or refractory to at least 1 prior anti-cancer systemic therapy and for which no standard therapy exists
* Expansion cohort only: Advanced lymphoma confirmed by histopathology
* Measurable or evaluable disease according to RECIST for solid tumors or according to IWRC for NHL tumors
* ECOG Performance Status less than or equal to 2
* Life expectancy greater than 12 weeks in the opinion of the Investigator

Exclusion Criteria:

* Any active or uncontrolled infection
* NYHA Grade II or greater congestive heart failure
* History of myocardial infarction within 6 months prior to screening
* Prior radiation therapy, chemotherapy, hormonal therapy, or immunotherapy within 4 weeks prior to screening or 5 half-lives of the therapy, whichever is shorter
N-3 Fatty Acids for the Prevention of Atrial Fibrillation in Patients With Acute Heart Failure

Our study is to investigate the effect of N-3 Fatty Acids for the prevention of atrial fibrillation in patients with acute heart failure or acute myocardial infarction


Eligibility Criteria:
Inclusion Criteria:

* sinus rhythm patients with acute heart failure or acute myocardial infarction

Exclusion Criteria:

* pregnancy,allergy to epadel
A Study to Explore the Role of Gut Flora in ALS

This study seeks to correlate microbiome sequencing data with information provided by patients and their medical records regarding ALS

The goal of this Research Study is to better understand how the genetic information in subject's microbiome correlates to the information provided in surveys and in medical records regarding ALS

Eligibility Criteria:
Inclusion Criteria:

1. Signed informed consent, demonstrating that the patient understands the procedures required for the study and the purpose of the study
2. Male or female patients of any age (interest is given to children to compare with mothers).
3. Diagnosis of ALS

Exclusion Criteria:

1. Refusal to sign informed consent form
2. History of bariatric surgery, total colectomy with ileorectal anastomosis or proctocolectomy.
3. Postoperative stoma, ostomy, or ileoanal pouch
4. Participation in any experimental drug protocol within the past 12 weeks
5. Treatment with total parenteral nutrition
6. Any clinically significant evidence of disease that could interfere with the subject's ability to enter the trial
7. Inability to adequately communicate with the investigator or their respective designee and/or comply with the requirements of the entire study
Comparison of Colloid (20% Albumin) Versus Crystalloid (Plasmalyte) for Fluid Resuscitation in Cirrhotics With Sepsis Induced Hypotension.

Consecutive cirrhotics who present to emergency department of Institute of Liver \& Biliary Sciences with documented or suspected sepsis induced hypotension will be randomized to receive either human albumin infusion over 3 hours or plasmalyte as per requirement. At admission, all patients will undergo physical examination and baseline investigations to identify site of sepsis. The aim of study is to compare the efficacy of using 20% human albumin versus plasmalyte in resuscitation of the patient that is attainment of mean arterial pressure above 65 mm of Hg at three hour after intervention and sustenance of mean arterial pressure above 65 mm of Hg at 6th hour. The randomized patient will be administered 20% albumin (0.5-1.0 gm/kg) for 3 hours, or plasmalyte at the rate of 30ml/kg. After the intervention changes in MAP (Mean Arterial Pressure), lactate level, urine output, incidence of complications, duration of ventilator, ICU (Intensive Care Unit) stay and mortality after one week will be studied.


Eligibility Criteria:
Inclusion Criteria:

* Patients of cirrhosis with suspected or documented sepsis with MAP \< 65 mm Hg

Exclusion Criteria:

* Age \<18 years or \> 75 yrs
* Already received colloid or 2 litres of fluid within the first 12 hours of presentation
* Already on vasopressors and/or inotropes
* Patients with Spontaneous Bacterial Peritonitis and serum albumin less then 1.5g/dl
* Patient with structural heart disease
* On maintenance hemodialysis
* Other causes of hypotension
* Pregnant or lactating women
* Patients in need for emergent surgical interventions
* Known chronic obstructive lung disease and congestive heart failure
* A previous adverse reaction to human albumin solution
Two-stage Treatment of Large Bone Defects With Cerament® G and Cerament® V Plus Auto and/or Allograft Using the Masquelet Technique as Salvage Therapy After Bone Resection in Patients With Septic Pseudarthrosis

Septic pseudarthrosis of long bones are complications that can unfortunately occur after the consolidation of a fracture and some situations present risks of superinfection, persistent infection or mechanical failure (30-40% risk of complications) that can lead to amputation.

A possible saving situation used by CRIOAC ("Centre de Référence des Infections Ostéo-Articulaires Complexes") is the use of a bone substitute impregnated with an antibiotic allowing a high local concentration of this antibiotic.

The aim of this study is to evaluate the cost of management of septic pseudarthrosis with two-stage treatment and CERAMENT® and the quality of life for this patients.


Eligibility Criteria:
Inclusion Criteria:

* age ≥ 18 years old
* Diagnosis of septic pseudarthrosis
* septic pseudarthrosis managed by the surgical technique using the CERAMENT bone substitute combined with an autograft / allograft by the Masquelet technique OR, for the comparative cohort: septic pseudarthrosis on long bone previously managed by the masquelet method without CERAMENT®
* Medico-surgical management within the CRIOAC ("Centre de Référence des Infections Ostéo-Articulaires Complexes") of the Croix-Rousse hospital in Lyon
* Patient who was informed and did not object to participate in the study

Exclusion Criteria:

* Patient with a disability (deafness, language disorders) or whose mental or cognitive state does not allow to be informed and to express his opposition if necessary.
* Patient with a disability (deafness, language impairment) or whose mental or cognitive state does not allow to understand the questions in the quality of life questionnaire
* Patient participating in another quality of life study
Special Drug Use Investigation for PAXIL Tablet (Long-term)

This surveillance study is designed to detect adverse events (particularly clinically significant adverse drug reactions) occurring in clinical settings and to examine factors likely to affect the safety and efficacy of paroxetine in long-term use (1 year).


Eligibility Criteria:
Inclusion Criteria:

* Patients with depression/depressed state or panic disorder
* PAXIL must be used for long-term

Exclusion Criteria:

* Patients who had been taking PAXIL since before the start of the survey
* Patients with hypersensitivity to paroxetine
* Patients taking monoamine oxidase inhibitors (MAOIs) or within 2 weeks of stopping treatment with MAOIs
* Concomitant use in patients taking pimozide
Study to Assess the Efficacy and Safety of Three Doses of PT001 in Japanese Subjects With Moderate to Severe COPD

The overall objective of this study was to assess the efficacy and safety of GP MDI relative to placebo in Japanese subjects with moderate to severe COPD. Each subject received the 4 separate study treatments, scheduled as four, 7-day, treatment periods for a total treatment duration of 28 days.

This was a randomized, double-blind, chronic-dosing (7-day), four-period, four-treatment, placebo-controlled, crossover, multi-center study to assess the efficacy and safety of 3 doses of GP MDI (28.8, 14.4, and 7.2 μg ex-actuator, BID) in Japanese subjects with moderate to severe COPD.

Subjects who met the entry criteria had their maintenance therapy for COPD adjusted, as specified in the protocol. To allow for an adequate washout of previous maintenance medications, subjects underwent a washout period of at least 7 days, but not greater than 28 days duration prior to returning to the clinic for Visit 2 (Randomization Visit; Day 1 of Treatment Period 1).

The 4 study treatments were GP MDI 28.8, 14.4, and 7.2 μg ex-actuator, and Placebo MDI BID. Subjects were randomly assigned to 1 of the following 4 treatment sequences (ABCD, BDAC, CADB, DCBA) in a 1:1:1:1 ratio using an Interactive Web Response System where each letter represented 1 of the 4 treatments included in the study by random assignment.

Subjects were to complete 7 days of dosing in each of the 4 Treatment Periods, with each Treatment Period separated by a washout period of 5 to 21 days.

Eligibility Criteria:
Inclusion Criteria:

* Clinical history of COPD with a moderate to severe classification
* Current and former smokers with a history of at least 10 pack-years of cigarette smoking.

-Post-bronchodilator FEV1 must be ≥30% and \<80% predicted normal value-

Exclusion Criteria:

* Pregnancy
* Primary asthma diagnosis; Poorly controlled COPD defined as acute worsening of COPD that required treatment with corticosteroids or antibiotics in the 6-week interval prior to Screening or between Screening and Visit 2;
* Clinically significant abnormal ECG
* Other active pulmonary disease such as active tuberculosis, lung cancer, bronchiectasis, sarcoidosis, lung fibrosis, primary pulmonary hypertension, interstitial lung disease, and uncontrolled sleep apnea; Cancer that was not in complete remission for at least 5 years;
* Diagnosis of angle closure glaucoma
* A documented myocardial infarction within 1 year of Screening.
Bowel Dysfunction After Low Rectal Resection. an Pilot Study Using Psyllium Husk in Rectal Cancer Patients.

Rectal cancer constitutes 1/3 of more than 4500 annually diagnosed cases of colorectal (CRC) in Norway. With the advances in radiochemotherapy, and surgical techniques, the long-term survival rate is increasing after surgery regardless of the rising incidences, with a 73% 5-year survival rate in Norway (89% for stage I-III cancer). Low anterior resection (LAR) is the most commonly performed surgical procedure with curative intent with over 500 procedures per year in Norway alone. 80 % of patients subjected to LAR suffer from the LAR syndrome (LARS) which includes grades of bowel incontinence, urgency and tenesmus contributing to reduced quality of life (QoL). Suggested means of management have been advocated without preceding randomized trials. Psyllium husk has been suggested as a nutritional supplement for symptom reduction in patients suffering from LARS, but data is limited and no larger, randomized studies regarding its effect on patients with low anterior resection syndrome have been conducted. In this pilot study preceeding a placebo-controlled RCT, the investigators aim to improve documentation of a proposed management strategy. The investigators anticipate that a reduction in intestinal symptomburden will increase QoL for this large patientgroup.


Eligibility Criteria:
Inclusion Criteria:

* Operated with low rectal resection for rectal cancer
* LARS score \>20 at 12 months or more after surgery
* Written consent

Exclusion Criteria:

* Various conditions rendering the patient unable to answer questionnaire
* LARS score 0-20
* Contraindications to Psyllium husk (hypersensitivity, intestinal obstruction, reduced esophageal function, rare congenital medical conditions such as sucrase-isomaltase deficiency, fructose intolerance and glucose-galactose malabsorbtion)
Effects of Epidural Labor Analgesia With Esketamine on the Incidence of Postpartum Depression in Parturients

Postpartum depression is a common psychological abnormality during the puerperium, which seriously affects maternal and neonatal health. Esketamine, the S-enantiomer of ketamine, is twice as potent as ketamine and can be safely used for cesarean section and labor analgesia. However, it is not clear whether esketamine used for epidural labor analgesia can significantly reduce the incidence of postpartum depression. This study intends to explore the incidence of maternal prenatal depression and to investigate the effect of esketamine for epidural labor analgesia on postpartum depression and maternal and neonatal outcomes in parturients with prenatal depression through a multi-center, large-scale and high-quality clinical trail, in order to provide a clinical basis and theoretical basis for the application of esketamine used for epidural labor analgesia in postpartum depression and further reduce the incidence of postpartum depression, promote maternal and infant health, and ensure maternal and infant safety .

The study include women who meet the inclusion criteria for antenatal EPDS score ≥10 for labour analgesia while signing informed consent. The women will be randomized into two groups, one for esketamine group and the other for the control group. Follow-up visits will be conducted at 1 day, 7 days and 42 days after delivery. The primary endpoint of the study was the incidence (MINI-6.0 for diagnosis of postnatal depression) and severity of maternal depression at day 42 postpartum. The secondary endpoints of the study are maternal EPDS scores at 7 and 42 days postpartum; pain scores and impact at 1, 7 and 42 days postpartum; breastfeeding at 1, 7 and 42 days postpartum; length of postpartum stay; maternal complications at 42 days postpartum and neonatal illnesses at 42 days postpartum.

Eligibility Criteria:
Inclusion Criteria:

* Full-term pregnancy; Antenatal depressive state (EPDS score ≥10 and non-depressive diagnosis by a psychiatrist); Epidural labor analgesia； Signed informed consent.

Exclusion Criteria:

* Pre-existing history of definite psychiatric disorders (depression, schizophrenia, etc.) or communication disorders；Presence of severe preoperative pregnancy complications (e.g., severe preeclampsia, placental implantation, HELLP syndrome, placenta praevia, placenta abruptio)；ASA classification ≥ grade III；Contraindications to ketamine/S-ketamine (e.g., intractable, refractory hypertension, severe cardiovascular disease \[cardiac function class ≥ III\], hyperthyroidism); Refusal to participate in the study.
Evaluation of the Dental Health Condition in Obesity Patients Before and After Bariatric Surgery

The aim of this study is to investigate whether there was an association between obesity and periodontitis, tendency to caries and periapical lesions.

People who have a higher body mass index produce cytokines (hormone-like proteins), that lead to systemic/chronic inflammation (like periodontitis and periapical lesions), and obesity related dietary habits could result in an increment of dental caries because both the amount and the frequency of sucrose ingestion are important factors associated with the aetiology of the oral disease.


Eligibility Criteria:
Inclusion Criteria:

* Obese pateints who intended to go bariatric surgery.

Exclusion Criteria:

* Coronary heart disease
The Effect of Interventions for Health Behaviors in Hypertensive Patients

Hypertension is a major risk factor for cardiovascular disease, chronic kidney disease, and premature death worldwide. With an aging population and changes in dietary patterns and lifestyles, the prevalence of hypertension is rising globally, especially in developing countries. Hypertension is the most common chronic disease and a growing public health problem in China. A recent study estimated the prevalence of hypertension to be 28.56 % ± 10.44 %, ranging from 14.28% to 44.28% among the Chinese population aged over 15 years. The PRECEED-PROCEDE model provides a framework to help health planners and policymakers design effective health interventions based on evaluation and analysis of situations. This model has been used in different recent studies related to behavioral change. The study aims to examine the effectiveness of interventions for health behaviors in hypertensive patients based on the PRECEDE-PROCEED model.


Eligibility Criteria:
Inclusion Criteria:

1. Patients diagnosed with mild to moderate primary hypertension according to the diagnostic criteria of the "2018 Revised Edition of the Chinese Guidelines for the Prevention and Treatment of Hypertension," whose blood pressure is not well controlled or who have poor treatment compliance;
2. Age greater than 18 years and less than 80 years;
3. Normal language communication ability and willingness to participate in the study;
4. Have lived in the community for at least 12 months.

Exclusion Criteria:

1. Patients who lack basic behavioral abilities, have impaired memory function, or have limited language expression abilities;
2. Patients who are simultaneously participating in other intervention studies.
Metabolic Effects of Exogenous 3-hydroxybutyrate in Patients With Type 1 Diabetes and Healthy Controls

The main objective of this clinical trial is to study the metabolic effects of intravenous infusion of the ketone body, 3-hydroxybutyrate (3-OHB), in patients with type 1 diabetes and healthy control subjects. Moreover, the investigators plan to examine regulatory mechanisms of 3-OHB that may be related to diabetic ketoacidosis.

The hypotheses are:

1. 3-OHB related inhibition of lipolysis is impaired in patients with type 1 diabetes.
2. Intravenous infusion of 3-OHB affects signaling pathways involved in the metabolic regulation in patients with type 1 diabetes and healthy controls.
3. 3-OHB infusion improves cardiac function in patients with type 1 diabetes and healthy controls.

The effects of 3-OHB will be investigated by isotopic tracers examinations, fat and muscle biopsies and blood samples. To evaluate effects on cardiac function echocardiography will be performed.


Eligibility Criteria:
Patients with type 1 diabetes:

Inclusion Criteria:

* Type 1 diabetes diagnosis
* C-peptide negative
* 19 \< BMI \< 26
* written consent

Exclusion Criteria:

* Severe comorbidity
* Regular medication apart from insulin (except over-the-counter medicines)
* Use of long acting insulin analogues, that work \> 24 hours, e.g. Tresiba
* PI finds the patient not fit (e.g. mental illness, too nervous, unacceptable screening blood tests or other).

Healthy control subjects:

Inclusion Criteria:

* 19 \< BMI \< 26
* written consent

Exclusion Criteria:

* Chronic disease
* Regular medication (except over-the-counter medicines)
* PI finds the patient not fit (e.g. mental illness, too nervous, unacceptable screening blood tests or other).
Identifying Saliva Markers of Patients With Stomach, Colorectal (Including Pre-cancer Polyp) and Pancreatic Cancers

Colorectal cancers account for 783,000 new cases and cause 437,000 deaths per year across the world. Diagnosis in the early stages improves survival rates. Up to now, these cancers are mostly diagnosed only at later stages of the disease's course through histoimmune staining and molecular biology processes on the tissues biopsied from the gastrointestinal system under invasive diagnostic procedures of colonoscopy.

Oral fluid presents a large protein complexity and has been recently used as a diagnostic biofluid for oral, as well as systematic diseases. Using oral fluid as a bio-marker for the colorectal cancer can be advantageous as it contains gastrointestinal fluids, in addition to bacteria and bacteria lysate, which can also serve as a bio-markers' source for colorectal cancers. Proteomic technologies provide the tools needed to discover and identify disease-associated biomarkers.

The aim of the present study is to identify salivary bio-markers in patients suffering from colorectal cancers.


Eligibility Criteria:
Inclusion Criteria:

* Has not yet started treatment for the identified cancer

Exclusion Criteria:

* medically compromised patients
* congenital syndromes
* being treated with radiotherapy or chemotherapy.
The Efficacy and Safety of Robotic Bronchoscopy System-Assisted Stent Placement in Patients with Malignant Central Airway Stenosis

The primary aim of this research is to assess the efficacy and safety of the bronchial navigation positioning equipment in assisting stent implantation for malignant central airway stenosis while guaranteeing the safety of the participants and the scientificity of the clinical trial.


Eligibility Criteria:
Inclusion Criteria:

* Patients are eligible only if they fulfill all of the following criteria:

  1. Age ≥ 18 years, regardless of gender;
  2. Patients voluntarily consent to airway stent implantation and meet the requirements for airway stent implantation under general anesthesia;
  3. Confirmed as having malignant central airway stenosis through bronchoscopy and being ineligible for surgery or refusing surgery, and in need of airway stent implantation.

Patients should be able to understand the purpose of the trial, demonstrate good compliance with the examinations and follow-ups, and voluntarily participate in the clinical trial and sign the informed consent form.

Exclusion Criteria:

* Patients fulfilling any of the following criteria will be excluded from this study:

  1. Severe dysfunction of the heart, lungs, liver, or kidneys, intolerant of bronchoscopic treatment;
  2. Apparent coagulation dysfunctions;
  3. Pregnant or lactating women, or participants with a pregnancy plan during the study period;
  4. Patients with implanted cardiac pacemakers, implanted defibrillators, or other active implants;
  5. Participants allergic to photosensitizers or anesthetics, or with a history of multiple severe allergies or hereditary allergies;
  6. Participants who have participated in or are currently participating in drug clinical trials within the past 3 months, or in other medical device clinical trials within the past 30 days; Other circumstances that the investigator considers inappropriate for participation in this clinical trial.