cyrilzakka/clinical-trials huggingface dataset:
Dalteparin Low Molecular Weight Heparin for Primary Prophylaxis of Venous Thromboembolism in Brain Tumour Patients

In patients with malignant glioma, to determine the efficacy of prophylaxis with LMWH (dalteparin) compared to placebo, both commenced beyond the immediate postoperative period, for the prevention of VTE.

Patients are randomized 1:1 to receive dalteparin 5,000 anti-Xa units s.c. daily versus placebo s.c. daily. The primary outcome is VTE-free survival at 6 months. Progression free survival; overall survival, toxicity, and neurocognitive performance are secondary outcome measures.

Eligibility Criteria:
Inclusion Criteria:

* Both of the following criteria must be satisfied:

  1. Patients with newly-diagnosed pathologically-confirmed WHO Grade 3 or Grade 4 glioma (anaplastic astrocytoma, glioblastoma multiforme, gliosarcoma, anaplastic oligodendroglioma, and anaplastic mixed glioma). Tumour histology is based on local pathology review only;
  2. Patients 18 years of age or older at time of randomization

Exclusion Criteria:

* If one or more of the following criteria are satisfied, the patient is not eligible for the study:

  1. The presence of acute or chronic DVT demonstrated by duplex ultrasonography (DUS) or venography. (Note: a screening DUS is not required for study entry);
  2. Inability to commence study drug within four weeks of original surgery or biopsy;
  3. Serious hemorrhage requiring hospitalization, transfusion, or surgical intervention within four weeks of potential study entry;
  4. Presence of a coagulopathy (e.g. INR \>1.5 or platelet count \< 100x109/L);
  5. Symptomatic intracranial or intratumoural bleeding. (Note: post-operative imaging of the brain is not required for study entry. Asymptomatic "routine" post-operative blood products in a post-surgical cavity are not an exclusion;
  6. Known acute (symptomatic or actively bleeding) gastroduodenal ulcer;
  7. Familial bleeding diathesis;
  8. Requiring long term anticoagulants for other reasons (e.g., mechanical heart valves, atrial fibrillation);
  9. Uncontrolled hypertension despite antihypertensive therapy;
  10. Significant renal failure (dependent on dialysis or creatinine of greater than three times upper limit of normal control);
  11. Prior history of documented DVT or PE;
  12. Allergy to anticoagulants (UFH, LMWH) including immune-mediated heparin-induced thrombocytopenia;
  13. Pregnant or of childbearing potential and not using adequate contraception;
  14. Geographically inaccessible for follow-up;
  15. Having an expected life span of less than 6 months;
  16. Body weight \< 40 kg.
A Prospective Observational Study Comparing Computer-Assisted Paramedian Approach Versus Conventional Midline Approach for Lumbar Puncture

The goal of this clinical trial is to compare the effects of CMPAT and MAT in patients undergoing LP. Participants will be randomly assigned to either the CMPAT treatment group (group A) or the MAT treatment group (group B). Researchers will compare CMPAT treatment group and the MAT treatment group to see if the number of needle insertion attempts required for a successful LP, the puncture success rate, pain assessment in the back, head, and legs, and the occurrence of complications have different.


Eligibility Criteria:
Inclusion Criteria:

* Aged 18-99 years. Indication for lumber puncture (diagnostic lumbar puncture, analysis of cerebrospinal fluid composition, measurement of cerebrospinal fluid pressure, release of cerebrospinal fluid, lumbar cistern drain-age or intrathecal injection).

Body mass index between 18.5 and 35 kg/m2.

Exclusion Criteria:

* Cerebral hernia or known high cerebrospinal fluid pressure prone to cerebral hernia.
* Oral anticoagulant or antiplatelet therapy (≤3 days) or coagulation dysfunction, various factors lead to a higher risk of bleeding.
* Active infection or prior infection at the surgical site.
* Skin breakdown.
* Previous spine fusion surgery.
* Cauda equina syndrome.
* Pregnancy or breast feeding.
* Severe comorbid medical or psychiatric disorder.
* Unwilling to adhere to any of the required procedures.
* Cognitive impairment interfering with participant's ability to give full and - - informed consent or complete the baseline or follow-up assessments.
* Survival expectation less than 1 month.
* Moving abroad in 1 month.
Physical Activity Intervention for Trauma Afflicted Refugees

This study evaluates the effects of a 10-session physical activity intervention for trauma afflicted refugees. Half of participants will receive this 10-session physical activity intervention and half of the participants will be allocated to the control group.

Physical activity, particularly when performed in social settings, has been found to constitute an effective stress reliever and has been associated with improved physical and mental well-being, functional capacity and overall life satisfaction, as well as decreased risk of lifestyle diseases in various populations. Physical activity can also revert symptoms of psychiatric disorders such as depression, anxiety, social isolation and dissociation, which is common among trauma afflicted refugees. Many refugees also suffer from PTSD, and so the investigator's aim is to evaluate what effect a 10-session physical activity intervention will have on the mental and physical health of trauma afflicted refugees in a northern European country. The sessions will include physical exercise as well as psychoeducational components, and will be held by a physiotherapist over a period of ten weeks. The physical activity intervention group will be compared to a control-group, who receives two brief lectures on psycho-education in connection to baseline-assessment and follow-up.

Eligibility Criteria:
Inclusion Criteria:

* Arabic/Persian speaking persons.
* Persons with refugee background referred to the Swedish Red Cross Treatment Center for trauma related to war and/or torture.
* Person able to undertake physical activity in a group setting.

Exclusion Criteria:

* Current serious suicidal ideation, psychosis, serious cognitive impairments, current substance abuse, acute physical injuries or other health conditions that constrain physical activity.
Tolerability of Using a Post-Treatment Topical Adjuvant Combination Following Fractional Radiofrequency Ablation

The purpose of this study is to compare the tolerability of the application of a combination of a serum containing human bone marrow stem cell derived growth factor (SCR Complex) and cytokines and a botanical lipid-based occlusive (Bio Cel) immediately following fractional radiofrequency treatment using the Venus Viva versus standard of care.

Randomized, open-label, multi-centre study to evaluate the tolerability of the application of a combination of a serum containing human bone marrow stem cell derived growth factor and cytokines (SCR Complex™) and a botanical lipid based occlusive (Bio Cel™) following facial fractional RF treatments using the Venus Viva™ SR system. Each subject will receive 2 treatments separated by a 3-week interval. Subjects will complete a VAS and Tolerability Scale immediately following each treatment. Telephone follow-up calls by the site will ask the subject to respond to the Self-Report Adverse Event Questionnaire 24 and 72 hours after the first treatment and 24 hours after the second treatment. Subjects will complete a Home Tolerability Scale 24 and 72 hours after the first treatment and 24 hours after the second treatment. Subjects will return for the final FU visit and be asked to respond to the Self-Report Adverse Event Questionnaire and complete the Home Tolerability Scale for 72 hours. The investigator will also evaluate the subject's improvement using the GAIS at this visit.

Eligibility Criteria:
Inclusion Criteria:

* Undergoing a dermatological procedure requiring ablation and resurfacing of the facial skin utilizing the Venus Viva™ SR system.
* Women of child-bearing age are required to be using a reliable method of birth control prior to enrollment and throughout their participation in the study.
* Able to tolerate the treatment as determined by a test spot application(s).

Exclusion Criteria:

* Superficial metal or other implants in the treatment area
* Tattoos, permanent makeup, scars or piercings in the treatment area.
* Any active condition in the treatment area, such as sores, psoriasis, eczema and rash.
* Any surgical procedure in the treatment area within the last three months or before complete healing.
* Receiving therapies or medication that may interfere with the study treatment.
The Biological Basis of Phlegm Dampness Syndrome in Patients With Ischemic Stroke：A Saliva and Urine Proteomics Study

This study aimed to explorie the biological basis of phlegm-dampness syndrome in patients with ischemic stroke using proteomics research techniques of urine and saliva.

Stroke is the disease with the highest mortality and disability in China, and the annual incidence of ischemic stroke is the highest. Atherosclerosis is the main cause of ischemic stroke. According to the theory of traditional Chinese medicine, the disease is closely related to the physical constitution of the individual. The main body constitution of the population in Lingnan area is phlegm dampness syndrome;Previous large cross-sectional studies have found that 65.3% of patients with ischemic stroke in Lingnan area have phlegm dampness syndrome. However, there is currently no biological evidence related to phlegm-dampness syndrome and ischemic stroke.In recent years, proteomics research technology has developed vigorously. The research samples have developed from blood obtained from minimally invasive to urine and saliva obtained non-invasively. Studies have found that urine proteins associated with AS include type I, type III collagen, 8-isoprostaglandin F2α, and saliva proteins include IL-1β, IL-6, TNF-α, and PGE2.Therefore, this research is dedicated to exploring the biological basis of phlegm-dampness syndrome in patients with ischemic stroke using proteomics research techniques of urine and saliva.

Eligibility Criteria:
Inclusion Criteria:

1. Clinical diagnosis of ischemic stroke
2. Aged 35-80-year-old.
3. Agree to participate in clinical research and sign informed consent.

Exclusion Criteria:

1. Clinical diagnosis of cerebral hemorrhage;
2. With severe infection, severe renal dysfunction, and tumor;
3. Clinical diagnosis of acute oral inflammation, oral ulcers, or urinary infections;
4. Clinical diagnosis of systemic lupus erythematosus and rheumatoid arthritis;
5. Pregnant women or lactating mothers
Subcutaneous Hydrocortisone Children With Congenital Adrenal Hyperplasia

This is an open-label, non-randomized crossover design feasibility trial comparing oral hydrocortisone treatment with interval bolus delivery (pulsatile) of subcutaneous hydrocortisone via infusion pump in children with congenital adrenal hyperplasia. Eight children, ages 4-18 yrs, will have 24-hr pharmacokinetic and pharmacodynamic profiles of cortisol, 17-hydroxyprogesterone and androstenedione concentrations while on oral hydrocortisone therapy (admission 1), during an initial trial of the subcutaneous hydrocortisone pump (admission 2), and after 6 weeks of subcutaneous hydrocortisone pump treatment (admission 3). An integrated pharmacokinetic and pharmacodynamic model will be used to determine cortisol, 17-hydroxyprogesterone and androstenedione parameters to compare the duration of time subjects have these concentrations outside acceptable ranges. Funding Source - FDA OOPD


Eligibility Criteria:
Inclusion Criteria:

* Children 4 - 18 years of age.
* Classic congenital adrenal hyperplasia (CAH) as confirmed by hormonal and molecular testing.
* Patients who have been on the same HC dosing regimen for 1 month

Exclusion Criteria:

* Patients with non-classic CAH.
* Patients on:

  * Dexamethasone
  * Prednisone, or
  * inhaled steroids.
* Patients with body surface areas under 1m2 or over 2m2
* Non-English speaking patients
Total 102 Natural Orifice Specimen Extractions Following Laparoscopic Colorectal Resections

In the development of surgical technique, laparoscopic surgery has created a major breaking point. Although laparoscopy (decreased hospital stay, decreased incisional hernia and wound infection rate...) provides a remarkable advantage compared to open surgery, the need for the extraction site incision could not bring the incision-related morbidity rates to the desired level. That's why SILS and natural hole surgery came to the fore. Colorectal surgery was also affected by this process, and the laparoscopic colectomy procedure combined with transrectal colon extraction was first performed in 1993 (1). Although its use increased gradually after this period, it could not reach the expected levels and this could not resolve the concerns on natural hole surgery.

In this article, our aim is to present the single center results of the patients who performed the extraction with the NOSE method after laparoscopic colorectal surgery.


Eligibility Criteria:
Inclusion Criteria:

* patients who underwent laparoscopic - natural orifice colectomy.

Exclusion Criteria:

* patients with missing data
* patients who underwent open colectomy
Is Serum YKL-40 Capable of Predicting Intrauterine Growth Restriction (IUGR) and Preeclampsia?

Objective: To investigate the role of maternal serum YKL-40 and uterine artery doppler, at gestational age 12, 20, 25 and 32 weeks, and the relation to preeclampsia and intrauterine growth restriction. The serum marker YKL-40 is related to conditions involving inflammation, infection, tissue remodeling, fibrosis and cancer. IUGR and preeclampsia are known to be related to inflammation and tissue remodeling.

Methods: women attending screening for downs syndrome is scanned with uterine artery doppler and delivered blood samples at GA 12, 20, 25 and 32 respectively. When pregnancy outcome is registered by medical records blood samples are retrieved and analyzed for serum YKL-40. Serum YKL-40 are correlated to the presence of bilateral notching, preeclampsia and different degrees of intrauterine growth restriction.


Eligibility Criteria:
Inclusion Criteria:

* Pregnant danish speeking women

Exclusion Criteria:

* Conditions/diseases involving chronical inflammation, or immunological activity
The Comparative Efficacy and Safety of Two General Anesthesia Protocols Consisting of Fentanyl Plus Propofol Plus Rococuronium Plus Isoflurane Versus Ketamime Plus Magnesium Sulphate Plus Lidocaine Plus Clonidine Plus Propofol Plus Rococuronium Plus Isoflurane for Gynaecology Surgery in Cameroon

Recently, a lot of side effects have been identified from the perioperative use of opioids. To remedy this, anesthesia research has recently focused on providing safe general anesthesia without opioids in a new concept or anesthetic technic called Opiod Free Anesthesia (OFA). Evidence on the effectiveness and safety of OFA is scarce in Africa, with no report from Cameroon.The aim of this study is to demonstrate the feasibility of an adapted OFA protocol as well as its efficacy and safety in very painful surgeries like gynaecology surgery in a low-resource setting.

The investigators intend to conduct a single-blinded randomized controlled trial on American Society of Anesthesiologists (ASA) I and II women who will undergo elective myomectomy, hysterectomy, ovarian cystectomy and mastectomy between June 2021 to September 2021 at the Yaounde Gynaeco-Obstetric and Pediatric Hospital of Cameroon. Participants will be matched for age and parity in a ratio of 1:1 into an Opiod Free Anesthesia (OFA) group and a general anesthesia (GA) group. The primary endpoints shall be the success rate of OFA. The secondary endpoints shall be the mumber or frequency of postoperative complications like respiratory distress, nausea and vomiting, paralitic ileus and severe postoperative pain. The threshold for statistical significance will be set at 0.05.

Eligibility Criteria:
Inclusion Criteria :

* American Society of Anesthesiology (ASA) grade I and II patients
* Patients undergoing an elective myomectomy, hysterectomy, ovarian cystectomy or total mastectomy.
* Patients who will be operated for benign pathologies or localized malignancies

Exclusion Criteria :

* Past history of allergy to any of the anesthetic drugs
* Refusal to consent to participate in the study
Predictive Value of Procalcitonin for Bacteremia in the ICU

Association between plasma procalcitonin levels and positive blood cultures in critical illness patients in the ICU.

Rationale: Association of procalcitonin levels and blood cultures in critical illness patients on the ICU.

Objective: Procalcitonin is an acute phase protein. As part of the acute phase response, procalcitonin is produced during sepsis. Previous research shows that procalcitonin is a biomarker for bloodstream infection. However, there is still little known about the value of procalcitonin in diagnostics for micro-organism underlying a sepsis in ICU patients. In modern practice, blood cultures are taken when a patient is septic to determine the responsible micro-organism. When procalcitonin is a predictive value for bacteremia in the ICU, the number of blood cultures can be reduced.

Study design: An observational cohort study intervention: for each patient in the ICU blood cultures were taken, the procalcitonin level was determined. During 6 months 150 patients will be included.

Main study parameters/endpoints: this study will examine the predictive value of procalcitonin in blood cultures on the ICU.

Eligibility Criteria:
Inclusion Criteria:

* Patients admitted to the ICU
* Age \> 18 years

Exclusion Criteria:

* Hemodialysis/ Continuous Veno-Venous Hemofiltration
Anaesthesia and Tryptophan Pathway

Surgery has many immunomodulatory properties of which the mechanism is not clearly understood.

surgery and anesthesia have a deleterious effect on immune system,studyingtryptophan pathway might give more information on their effect.

Eligibility Criteria:
Inclusion Criteria:

* elective surgery

Exclusion Criteria:

* emergency surgery
Reliability and Validity Evaluation of the BePoW Device

The aim of this clinical investigation is to develop a reliable and valid device to instantly measure the subject's sitting posture in a wheelchair, without using the MCPAA scale.

Each subject will be invited to a single experimental session lasting approximately one hour, during which all assessments will be performed.

During the visit, the patient will complete an autonomy questionnaire and assess wheelchair fatigue. A spirometry test will be performed.

The measurements will then be recorded by the BePoW software and the occupational therapist.

Eligibility Criteria:
Inclusion Criteria:

* Over 18 years of age,
* Having freely consented to participate in the study (or their legal representative in the case of guardianship, in agreement with the patient),
* In the case of a guardianship, the legal representative having read the information document intended for the legal guardian of an adult under legal protection (under guardianship) and given his/her free and informed consent for the person for whom he/she is responsible to participate in the study (in agreement with the patient).
* Temporarily or permanently wheelchair-bound,
* Affiliated with a social security scheme or beneficiary of such a scheme.

Exclusion Criteria:

* Has comprehension problems that prevent him/her from giving free and informed consent and from completing the investigation (following instructions, answering questionnaires),
* Suffering from a pathology (Huntington's disease, Sydenham's Chorea) preventing stable sitting posture during participation in the investigation,
* Have undergone an amputation that prevents the BePoW device from taking measurements,
* having undergone a tracheotomy preventing spirometry.
* Pregnant, parturient or breast-feeding women,
* Person deprived of liberty by a judicial decision (except guardianship or curatorship) or or administrative decision, a person under psychiatric care or admitted to a or social establishment for purposes other than research,
* Minors,
* Person in an emergency situation unable to give prior consent.
Comparison of Inflammatory Markers and Incidence of Comorbidities in Patients on Antiretroviral Therapy With Second-generation Anti-integrase Drugs on Triple Versus Dual Therapy

HIV-infected patients develop comorbidities earlier than the general population. Immune activation with the secretion of pro-inflammatory cytokines would play a major role in the occurrence of these comorbidities. Numerous factors, called risk factors, already identified in the general population and confirmed in patients with HIV virus favor the occurrence of these comorbidities but cannot alone explain the overrepresentation and precocity of these comorbidities in the HIV population. Investigators hypothesize that optimization or simplification with certain classes of antiretrovirals modify the inflammatory response and are predictive factors for the occurrence of comorbidities


Eligibility Criteria:
Inclusion Criteria:

* HIV-1 infection
* Age \> 40 years or adults with more than 10 years of antiretroviral therapy
* Switching to BIC/FTC/TAF or DTG/3TC or DTG+3TC within the last 2 years
* Plasma HIV-1 RNA viral load \< 50 copies/ml for more than 6 months
* Absence of chronic hepatitis B infection
* Absence of genotype mutations on Dolutegravir (DTG) or Bictegravir (BIC) or tenofovir alafenamide TAF
* Daily use of antiretroviral therapy
* Effective contraception for women of childbearing potential will be requested
* Signed informed consent
* Enrollment in a Social Security plan

Exclusion Criteria:

* Non-daily or intermittent antiretroviral therapy regimen (e.g., 4 or 5 days a week)
* Pregnancy or breastfeeding
* Vulnerable persons according to article L.1121-6 of the public health code Persons unable to give consent according to article L.1121-8 of the public health code
* Opportunistic infections during curative treatment
* HIV-2 infection
* Active hepatitis C
* Refusal to participate
* Withdrawal of informed consent by the patient