cyrilzakka/clinical-trials huggingface dataset:
Effect of Tinzaparin on Inflammatory Biomarkers During the Acute Phase of Deep Vein Thrombosis

Anticoagulants influence either coagulation, inflammation and inflammatory processes in deep vein thrombosis (DVT). Acute DVT cause an inflammatory response that may persist for a long period of time. There is a need to describe patterns of change in serum biomarker levels after acute DVT, and explore the association between trajectory biological patterns and clinical evolution in the era of various anticoagulants in the acute phase of treatment in order to be able to further avoid recurrence and late sequelae. It appears that direct oral anticoagulants and heparin alter inflammatory markers in different ways. It is therefore important to study the evolution of markers according to the different treatments used and secondarily to compare them with each other. Tinzaparin is used in the long term in patients with DVT, it is necessary to measure the evolution of inflammatory markers and then in another study to compare with the other molecules.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients with a first episode of symptomatic, proximal DVT of the lower limbs, confirmed by Duplex Ultrasound (DUS)
* Indication for treatment with Tinzaparin
* Patient covered by French national health insurance,
* Written informed consent.

Exclusion Criteria:

* Recent DVT (less than 2 months) objectively proven by venous ultrasound - Severe ilio-femoral DVT requiring recanalization
* Duration of treatment of more than 24 h since diagnosis
* Patients with acute symptoms (leg pain and swelling) for more than 5 days
* Planned surgery in the following 3 weeks, impossible to postpone
* Active haemorrhage or high risk of haemorrhage
* Symptoms of Post Thrombotic Syndrome
* Active neoplasm
* APL syndrome
* Renal insufficiency (Creatinine clearance (Cockcroft-Gault) \<20 mL/min)
* Hepatic disease / or Hepatic Insufficiency / or serious liver disease
* Hyperkaliemia more than 5 mmol/L
* Patients with mechanical prosthetic heart valve
* weight more than 105 kgs in order to avoid difficulties with a dosage of 20000UI OF TINZAPARIN Any anti-inflammatory drugs or anti-platelet therapy
* Any other concomitant anticoagulant treatment such as VKA, heparin, fondaparinux and direct oral anticoagulants
* Contraindications to tinzaparin according to their SmPC
* Patient with asthma, If patients need to receive tinzaparin 10000UI antiX-a/0.5ml for the study,(due to sodium metabisulfite in the solution)
* Pregnant women or breastfeeding
* patient with age under 18
* Patient deprived of liberty by administrative or judicial decision or placed under judicial protection (guardianship or supervision)
Measurement of the Prevalence of Sensory Integration Disorders in Babies Having Heart Disease Surgery for Transposition of the Great Vessels Before 6 Months of Age

The purpose of this study is to mesure the prevalence of severe sensory integration disorders in babies after one week of their heart surgery.

Baby's development takes its roots in sensorimotricity. Baby coordinates different senses (visual, auditory, tactile, taste, vestibular) to understand the space around him and to implement voluntary motor strategies. These sensory links also allow him to invest hisoral zone and consolidate his oral feeding. Another good sensory integration is necessary for a child to develop harmoniously on motor and psychic levels. In 2018 the study of L. Dagenais revealed a gap in posturomotor development on babies operated on for isolated congenital heart disease. However nobody assess sensory disorders in these babies. With this study the investigators wish to clarify the sensory impact in this situation.

Eligibility Criteria:
Inclusion Criteria:

* Infant born at term (over 37 weeks)
* With heart disease, of the transposition of the great vessels type, whether or not associated with an interventricular communication
* Having a cranial perimeter in the norm at birth: between 32 and 37 cm.
* Surgery scheduled before the age of 6 months
* No opposition from parents

Exclusion Criteria:

* Other disease or malformation
* Parents who do not speak French
Timing of Iron Supplementation in Very Low Birth Weight Infants

To examine if early iron supplementation (starting oral iron at 14 days of life) would improve the nutritional iron status(measured by serum ferritin) of very low birth weight infants at postnatal age of 60 days, when compared to the standard regime of starting iron at 2 months of life.

Smaller the preterm infants at birth, more susceptible they are to iron deficiency due to low body iron stores. Despite having low iron stores, very low birth weight (VLBW) infants are not usually started on iron supplementation till they reach a postnatal age of 6 to 8 weeks. Such delayed supplementation can lead to rapid depletion of iron stores when erythropoiesis becomes active (by 8 weeks of life).

Depletion of iron stores is the first step in the continuum of changes that occur in iron deficiency. Iron deficiency induces biochemical defects (such as impaired synthesis of DNA and collagen) even before any features of microcytic, hypochromic anemia become evident. The rapidly maturing preterm brain is especially vulnerable to the effects of iron deficiency; poor school-age performance has been reported among children who had low iron stores in their neonatal period.

Early iron supplementation i.e. starting iron once the infant reaches full enteral feeds could potentially improve the iron stores and prevent its depletion. Surprisingly, few studies are available till date to support (or refute!) this view. The current study was designed to test the hypothesis whether early iron supplementation would increase the nutritional iron status (as measured by serum ferritin) at 60 days of life when compared to the existing regime of starting iron at the age 2 months.

Eligibility Criteria:
Inclusion Criteria:

* Infants who have reached at least 100 ml/kg/day of oral feeds by day 14 of life

Exclusion Criteria:

* Major congenital anomalies
* Rh hemolytic disease
* Twin-to-twin transfusion syndrome
* Refusal to give consent
Treating Acutely Agitated Patients With Asenapine Sublingual Tablets

Our proposal is to administer asenapine to patients who are clinically agitated and in need of immediate intervention. At present there are no controlled studies that we know of that explores the use of asenapine for this purpose. Establishing the utility of asenapine for this common clinical problem will support its use as an additional treatment option in acutely agitated patients.

A psychiatrist (blinded) will assess the patient for agitation and their capacity to consent. Patients will be informed about the study and asked to complete informed consent prior to being included in the study. Patients who decline will not be included. A nurse (blinded) will administer either 10mg asenapine or placebo sublingually in a randomized fashion. Efficacy in reducing acute agitation will be evaluated using the PANSS-EC. A trained rater (blinded) will rate patients at baseline and at 15, 30, 60, 90 and 120 minutes (or endpoint) after medication administration. Efficacy in reducing acute agitation will also be evaluated using the Clinical Global Impression Scale (CGI). A trained rater (blinded) will rate patients at baseline CGI-Severity and CGI-Change at 60 and 120 minutes (or endpoint) after medication administration. The need for additional medications, interventions or physical restraints will be recorded and constitute the endpoint for that patient. Demographics, diagnoses, blood alcohol level, urine toxicology, and urine pregnancy will be collected.

Eligibility Criteria:
Inclusion Criteria:

* Patients will be between the ages of 18 and 65
* Be acutely agitated as determined by a total score of ≧ 14 on the PANSS-EC and at least one individual item score of ≧ 4
* Patients must have the capacity to provide informed consent, and such consent will be obtained prior to participation

Exclusion Criteria:

* Patient is knowingly pregnant
* Patient is less than 18 or greater than 65 years old
* Patient had a past adverse or allergic response to Asenapine
Prevalence of Hiatus Hernia in Gastro-Esophageal Reflux Disease Patients Underwent Upper Endoscopy

To study the prevalence of hiatus hernia in GERD patients underwent upper endoscopy To study the effect of hiatus hernia on the severity of GERD symptoms.

Gastro-esophageal reflux disease (GERD) is a common problem for which patients seek care from a broad array of primary care providers, medical sub-specialists, and surgeons.

It is estimated that 10 to 20 percent of people in Western countries have GERD, when defined as heartburn or regurgitation at least once a week. (Chapelle, et al. 2021)

The practice guidelines for GERD recommend diagnostic testing in the presence of alarm symptoms, which include dysphagia, odynophagia, weight loss, gastrointestinal bleeding, and anemia.

A detailed history of the pattern, severity, and duration of alarm symptoms is essential. (Katz, et al., 2022) Hiatus hernia refers to condition in which elements of the abdominal cavity, most commonly the stomach, herniate through the esophageal hiatus into the mediastinum.

Hiatus hernia is a frequent finding during upper gastrointestinal endoscopy. Type I hiatal hernia is the sliding hiatal hernia, which accounts for more than 95% of all hiatal hernias with the remaining 5% being Para-esophageal hiatus hernias (Kotekar, et al 2021)

Endoscopy is a common diagnostic tool in the evaluation of patients with upper gastrointestinal pathology, specifically gastroesophageal reflux disease (GERD) and hiatal hernia.

The relationship between these two disease processes are relatively intertwined and have clinical significance given the fact patients with hiatal hernia may be more likely to have acid reflux and there is a close relationship with hiatal hernia size and incidence of reflux disease. (Gomaa, et al 2022) Worldwide, it is believed that the relation between hiatus hernia and gastro-esophageal reflux disease (GERD) have varied considerably.

In our locality the prevalence of hiatal hernia in GERD patients and the effect of hiatal hernia on the severity of GERD symptoms is unknown.

Eligibility Criteria:
Inclusion Criteria:

* Aged 18 years or older, Patients with GERD symptoms who don't respond to PPI therapy (8 weeks ) or cases with alarm symptoms (dysphagia, anemia ,vomiting , weight loss , GI bleeding , onset of symptoms in old age ,..etc)

Exclusion Criteria:

* Complete PPI responder. Patient with any contraindication for endoscopy . Refusal of participation
Assessment Of Anterior Chamber Configuration Changes After Phacoemulsification With Swept-Source Optical Coherence Tomography

To assess the changes of anterior chamber angle in patients with shallow anterior chamber and normal anterior chamber after phacoemulsification and intraocular lens implantation (IOL) using anterior segment swept-source optical coherence tomography (AS-SS-OCT).To observe the 60 eyes of 60 patients in our study.

This is a prospective case-control study; 60 eyes of 60 patients who underwent cataract surgery. Based on anterior chamber depth (ACD) and gonioscopy findings, the eyes are classified into two groups, shallow anterior chamber group (30 eyes) and narrow anterior chamber group (30 eyes). AS-SS-OCT was used to measure ACD and angle parameters (angle opening distance(AOD), angle recess area(ARA), trabecular iris space area（TISA）, and trabecular iris angle (TIA). Serial changes in each group were measured before and 3 months after phacoemulsification and IOL, and the differences between the two groups were compared.

Eligibility Criteria:
Inclusion Criteria: patients who underwent cataract surgery -

Exclusion Criteria:patients with mild cataracts do not require surgery

-
Metformin Plus Irinotecan for Refractory Colorectal Cancer

MetIri seeks to identify if metformin combined to irinotecan can improve tumor control.

MetIri is a two-stage single arm Phase II assessing the role of combination of metformin to irinotecan for colorectal cancer patients already treat with oxaliplatin, fluoropyrimidine, irinotecan and an anti-EGFr antibody if KRAS wild-type.

Eligibility Criteria:
Inclusion Criteria:

* 18 years or older
* Biopsy-proven colorectal adenocarcinoma
* Ineligibility for curative intent therapy, e.g., surgery or radiation
* Disease progression after oxaliplatin (either adjuvant or palliative), fluoropyrimidine (either adjuvant or palliative), irinotecan, and if Kras wild type a anti-EGFR therapy
* Assessable disease according to RECIST v1.1

Exclusion Criteria:

* known hypersensitivity to metformin or irinotecan
* Uncontrolled Central nervous system metastasis
* Acute or chronic severe infection
Yoga, Immune Function, and Health

This study is designed to examine the impact of hatha yoga on immune and hormonal functioning in healthy individuals.

This study is designed to examine the effects of hatha yoga on autonomic, immune, and endocrine function. The data from both inexperienced and experienced groups will help us better understand how longer-term practice of yoga may be beneficial. The study consists of one 3-hour screening session and three 6-hour activity sessions with 30 minute follow-up appointments the following morning scheduled 2 - 4 weeks apart. Each participant will complete the 3 activity sessions, which will consist of either yoga, mild movement, or a neutral activity (watching a videotape), in randomly assigned order. Thus, both novices and experts will participate in 3 activity sessions each (yoga, movement control, video control). The order in which each participant goes through the activity sessions is counterbalanced. Data for each activity session will be aggregated by group (i.e. novice or expert). We will measure responses to tape stripping to assess skin barrier repair, and evaluate responses to computer tasks, self-report measures, and a battery of unobtrusive behavioral measures. We will also collect blood and saliva samples to measure immune and endocrine outcomes.

Eligibility Criteria:
Inclusion Criteria:

* healthy female adults
* relatively inexperienced with yoga (beginner)
* experienced with yoga (advanced practitioner)

Exclusion Criteria:

* Treatment with medication that has immunological or endocrinological consequences
* Chronic health problems that affect immune or endocrine systems
* Anemia
* Use of psychoactive drugs or mood-altering medication
* Smoking
* Needle or blood phobias
* Tape or bandage allergies
* Pregnancy or nursing within the previous 3 months
* Heart problems
* History of hip or knee replacement surgery, displaced vertebrae, and any other physical limitations that would prevent full participation in the program
* use of statins, beta blockers
* excessive alcohol use
* convulsive disorders
* Body Mass Index (BMI) ≥ 30.
Defining the Neural Dynamics of Concept Retrieval Using Electrocorticography

This study will look at the way activity within the brain changes over time while a person is trying to think about certain everyday concepts. To measure brain activity accurately, we will be using electrodes placed on people's brains during awake brain surgery.

This study will measure the dynamics of cortical activity among early modal cortex and multimodal cortical regions during conceptual retrieval using electrocorticography. Participants will be patients undergoing awake temporal lobe craniotomies. During the surgery patients will have multiple high-density grids placed to simultaneously record activity in multiple areas while the patient is performing language tasks. Activity in each of these regions will be tested for timing differences and informational directionality to determine the temporal dynamics.

Eligibility Criteria:
Inclusion Criteria:

* Clinically determined to require an awake left temporal resection of a brain lesion with concurrent language testing.
* English as a first language.

Exclusion Criteria:

* Significant preoperative neuropsychological deficits in memory or naming.
* Patients with inability to make decisions regarding their participation in this research project.
* Surgeon does not plan to expose the area of interest or determines that recording during the resection will interfere with his surgical plan.
Phenotype of Headache and Facial Pain in Upper Respiratory Tract Infections

The goal of this longitudinal study is to assess headache and facial pain features in patients with upper respiratory tract infections (URTI). The main question it aims to answer are:

1. What is the phenotype of headache / facial pain in URTIs
2. Does the above mentioned phenotype is associated with:

   1. aetiologic factor (virus),
   2. type of URTI
   3. headache/facial pain experienced by patients in the past.

Participants will:

* answer standardized questions,
* undergo physical examination,
* have a swab test performend for antigens of common viruses causing URTI.


Eligibility Criteria:
Inclusion Criteria:

* URTI confirmed by primary care physician
* Informed consent to participate in the study

Exclusion Criteria:

* chronic or recurrent upper respiratory tract disorders
* neoplasms
* signs or symptoms of a serious neurologic or psychiatric disorder.
High-Dose Statin Combined With Telmisartan vs Amlodipine on Glucose Metabolism in ASCVD Patients With IFG and Hypertension

This study will evaluate the effect of high-dose rosuvastatin combined with telmisartan or amlodipine on glucose metabolism in ASCVD patients with impaired fasting glucose and hypertension.


Eligibility Criteria:
Inclusion Criteria:

1. Written informed consent
2. Aged 19 to 75 years
3. Patients with ASCVD requiring high-intensity statin therapy (in accordance with the clinical ASCVD diagnostic criteria in the 2013 ACC/AHA Guideline)

   - Coronary artery disease
   * acute coronary syndrome
   * history of myocardial infarction (MI)
   * stable or unstable angina
   * history of coronary revascularization
   * stroke or transient ischemic attack (TIA)
   * peripheral arterial disease, history of peripheral arterial revascularization
4. Those who are taking antihypertensive drugs, or SBP \> 140mmHg or DBP \> 90mmHg on the left side
5. High-risk group (except for gestational diabetes) who has not been diagnosed with diabetes before, and who falls under one of the following criteria:

   * impaired fasting glucose (IFG): 100-125 mg/dL (5.6-6.9 mmol/L)
   * impaired glucose tolerance (IGT): plasma blood glucose 140-199mg/dL (7.8 to 11.0 mmol/L) 2 hours after oral administration of glucose 75g
   * HbA1c: 5.7-6.4%

Exclusion Criteria:

1. Those who are treated with secondary hypertension or malignant hypertension
2. Uncontrollable diabetes with HbA1c ≥ 10%
3. Total cholesterol ≥ 300mg/dL
4. Fasting LDL-C ≤ 70 mg/dL
5. Fasting triglyceride ≥ 500 mg/dL
6. History of muscular disease or rhabdomyolysis due to use of statin
7. Hypersensitive to statin or ARBs
8. Contraindications stated in the SPC of telmisartan or rosuvastatin including the following:

   * severe renal disease (CrCL \< 30mL/min: Cockcroft-gault formula or estimated GFR (MDRD) \< 30mL/min/1.73m2)
   * ALT, AST \> 3x ULN or history of active liver disease
   * CPK \> 3x ULN
   * hyperkalemia with serum K \> 5.5 mEq/l
9. Those who are participating in clinical trials of other investigational products
10. Those who cannot discontinue all other treatment for hypertension or hyperlipidemia than the investigational products, and concomitant medications and supplements that can affect the therapeutic effect of hypertension and hyperlipidemia during the trial period
11. Other than the above who is deemed to be ineligible to participate in the trial by investigator
S0437 Long-Term Follow-Up of Patients Who Were Diagnosed With Prostate Cancer on PCPT

RATIONALE: Learning about the long-term effects of chemoprevention drugs, such as finasteride, in patients with prostate cancer may help doctors plan better treatment and follow-up care.

PURPOSE: This clinical trial is following patients who were diagnosed with prostate cancer while undergoing treatment with either finasteride or a placebo on the Prostate Cancer Prevention Trial (PCPT).

OBJECTIVES:

* Compare the time to metastases in patients who were diagnosed with high grade or low grade prostate cancer on or before December 31, 2003 and were treated with finasteride or placebo while enrolled on the Prostate Cancer Prevention Trial (SWOG-9217).
* Compare the difference in time to secondary therapy after definitive therapy with radiotherapy or radical prostatectomy in these patients.
* Compare the difference in time to prostate-specific antigen recurrence after definitive therapy with radiotherapy or radical prostatectomy in these patients.
* Compare the difference in all-cause and prostate cancer mortality in these patients.

OUTLINE: This is a multicenter study. Patients are stratified according to survival status (alive vs deceased).

Patients provide information about their general health, prostate cancer treatment history, prostate cancer status (i.e., disease progression and metastases data), and prostate-specific antigen (PSA) test results at baseline and then every 6 months for up to 8 years. Next of kin of deceased patients are asked to release the patients' medical records in order to obtain information about the patients' prostate cancer treatment history, prostate cancer progression and metastases, PSA test results, and cause of death.

PROJECTED ACCRUAL: A minimum of 75% of the 2,401 patients (n=1800) diagnosed with prostate cancer on PCPT are needed to have minimal power to evaluate the objectives.

Eligibility Criteria:
INCLUSION CRITERIA:

* Randomized on PCPT
* Diagnosed with prostate cancer on or before December 31, 2003

DISEASE CHARACTERISTICS:

* Diagnosed by either study site or central pathology review

PATIENT CHARACTERISTICS:

* See inclusion criteria

PRIOR CONCURRENT THERAPY:

* Not Applicable