cyrilzakka/clinical-trials huggingface dataset:
Effect of Fish Oil on Surgery Pain After Knee Replacement Patients: Randomized, Prospective, Double Blind, Placebo Control Trial

This is a single-center, prospective, randomized, double blind, placebo control study. The aim of this study is to assess the effect of fish oil capsules on pain intensity and postoperative analgesics consumption in patients after knee replacement surgery.

The study population will be adult are referred for knee replacement surgery due to osteoarthritis of the knee.

Primary outcome:

Post surgical pain level and analgesics use

Secondary outcomes:

1. Pain levels and analgesic use at six weeks and 3 months after surgery
2. ω3 incorporation into blood cell membranes(RBC)
3. Stress and inflammation markers
4. Rates of postoperative complications

Study Procedure :

Enrolled patient will be randomly divided into a control group and intеrvention group during preoperative clinic visit. Each patient will receive total 150 capsules (5 capsules per day) accordingly to randomized group.

Patients in treatment group will receive Fish Oil capsules. Patients in control group will receive placebo capsules.

Eligibility Criteria:
Inclusion Criteria:

Patients are referred for knee replacement surgery due to osteoarthritis of the knee

* Exclusion Criteria:

  * Use of steroids, NSAIDs two weeks before surgery, antidepression drugs, antiepileptic drugs, coumadin
  * Diabetic neuropathy
  * Herpes-zoster/ post-herpetic neuralgia
  * n-3 supplements use
Studying Genes in Tissue Samples From Younger and Adolescent Patients With Soft Tissue Sarcomas

This research trial studies genes in tissue samples from younger and adolescent patients with soft tissue sarcomas. Studying samples of tumor tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors find better ways to treat cancer

Study Subtype: Ancillary/Correlative Observational Study Model: Cohort Time Perspective: Retrospective Biospecimen Retention: Samples With DNA Biospecimen Description: Tissue Study Population Description: Existing NRSTS samples from the COG D9902/ARST0332 studies Sampling Method: Non-Probability Sample

OBJECTIVES:

I. To determine the frequency with which actionable mutations are found in archived non-rhabdomyosarcoma soft tissue sarcoma (NRSTS) tumor specimens using mass spectrometry (MS) analysis of tumor-derived deoxyribonucleic acid (DNA).

OUTLINE:

Archived DNA tissue samples are analyzed for frequency of genetic mutations, including single nucleotide polymorphisms (SNPs), single nucleotide variants (SNVs), and small deletions and/or insertions, by polymerase chain reaction (PCR) and mass spectometry (Sequenom MassARRAY). Results are then analyzed to determine whether specific mutations correlate with patient or disease features such as tumor stage, histological grade, or outcome.

Eligibility Criteria:
Inclusion Criteria:

* Archived non-rhabdomyosarcoma soft tissue sarcoma (NRSTS) tumor-derived DNA

  * Synovial sarcoma, malignant peripheral nerve sheath tumor (MPNST), soft tissue sarcoma not otherwise specified (NOS), or other less common pediatric NRSTS
  * Formalin-fixed, paraffin-embedded (FFPE) tissue from patients enrolled on:

    * COG-D9902 Soft Tissue Sarcoma (STS) Biology and Banking Protocol
    * COG-ARST0332 A Risk-Based Treatment for Pediatric NRSTS Study
* See Disease Characteristics
Establishing a Normative Database in Pediatric Population of the Head-mounted visuALL Field Analyzer

The goal of this study is to determine reference values of the VisuALL Field Test in pediatric population. Standard Automatic Perimetry (SAP) is the gold standard test for the evaluation of different diseases of the visual pathway like glaucoma. Its main goal is to measure the differential light sensitivity at several locations in the central field of vision. Nevertheless, the accuracy of the current devices is limited by several factors such as the inherent inconsistency of the psychophysical test, stressful examinations and frequency of testing.

Several devices have been developed since the advent of the Octopus Perimeter and the Humphrey Field Analyzer (HFA) in an effort to improve the early detection of glaucoma. Several of these visual field test variants are implemented using laptops, iPads, and virtual reality headsets. These modalities bring portability but lack fixation methods, environmental control, and hardware standardization. These deficiencies may limit their wide usage.

The main goal of this study is to develop an initial pediatric reference database of a novel visual field test ecosystem that takes advantage of a Head Mounted Device (HMD).

This is a cross-sectional observational study. The primary endpoint of the study will be at the end of the recruitment phase.

* Participants that qualify for the study will be invited to a clinical site of the Vanderbilt Eye Institute or equivalent testing space and best corrected visual acuity will be checked with standard Snellen Acuity chart.
* Once vision is confirmed to meet study requirements, the child will be instructed on how to use the headset.
* The test will be generated and participant will complete various testing strategies including suprathreshold, full threshold and individual point testing and possibly other strategies for frequency of seeing curves.
* Patient with pathology may be confirmed with formal standard of care visual field testing
* Short survey will be administered to inquire on ease of device use
* Data will be submitted for analysis

Eligibility Criteria:
Inclusion Criteria:

* No history of intraocular surgery
* Best corrected visual acuity (BVCA) 20/25 or better in each eye

Exclusion Criteria:

* A spherical refraction outside ± 5.0 D and cylinder correction outside 2.0 D.
* Intraocular surgery in the study eye
* History of systemic condition known to affect visual function.
* History of medication known to affect visual function.
FOLLOW-UP OF PATIENTS WITH COVID-19.

Some patients admitted to intensive care for a severe form of COVID-19 could have respiratory, cardiac, renal and neurological sequelae in the medium or long term.

The results of this research will allow an improvement in the understanding and management of patients in the medium and long term.


Eligibility Criteria:
Inclusion Criteria:

* Patient admitted to intensive care unit for COVID-19
* Adult patient ≥ 18 years old
* Subject having expressed his non-opposition to the research
* Subject affiliated to a social health insurance protection scheme or beneficiary of such a scheme

Exclusion Criteria:

* Subject under safeguard of justice
* Patient under guardianship or curatorship
Upper Extremity Kinematics During Walking

Our aim is to investigate the upper extremity kinematics during walking in healthy individuals.

Determination of Upper Extremity Kinematics During Walking

Eligibility Criteria:
Inclusion Criteria:

* Between the ages of 20 and 40 years individuals
* Without any medical condition that would affect gait or arm swing

Exclusion Criteria:

* People with upper or lower limb asymmetry
Molecular Mechanism of POP Kidney Yin Deficiency Syndrome From the Interventional Effects of CLCF1

This study use RT-PCR and Western Blot technique to detect the expression of CLCF1 mRNA and protein in POP Kidney Yin deficiency group and healthy group to verify the relevance between CLCF1 and POP the kidney Yin deficiency syndrome.Through siRNA and overexpression,observe the mRNA and protein 's expression of CBP、JAK1、STAT4 and the protein phosphorylation of JAK1、STAT4 in JAK-STAT signal to reveal the CLCF1 regulate the CBP's mechanism.Use the Liuwei Dihuang Pills to detect the effect of treatment ,compare use or not the Liuwei Dihuang Pills to detect the mRNA and protein 's expression of CLCF1、CBP etc.Aim to clarify the POP kidney Yin deficiency molecular mechanism.


Eligibility Criteria:
Inclusion Criteria:

* The Participants who volunteer to be test subjects, and can accept experimental drugs, and promise to finish the course should sign the informed consent.
* Female ages 45 to 75 had gone through natural menopause before two years
* In accordance with the western medicine diagnostic criteria of osteoporosis and belong to kidney Yin deficiency syndrome differentiation of traditional Chinese medicine certificate;
* In accordance with the western medicine diagnostic criteria;
* In accordance with TCM diagnostic methods; .If any of the above answers are no, The subjects couldn't in the study.

Exclusion Criteria:

* Do not accord with standard of the western medicine diagnosis and TCM diagnostic methods
* Age: \<44 and \> 76 years old;
* With hyperparathyroidism, osteomalacia, rheumatoid arthritis, multiple myeloma and other serious complications such as secondary osteoporosis; Late or deformity, disability, loss of labor;
* With cardiovascular, cerebrovascular, liver, kidney and hematopoietic system and other serious primary diseases;
* Psychosis or alzheimer's patients;
* Nearly three months, the use of hormone replacement therapy (HRT) and taking calcitonin, nearly six months has used double phosphonic acid salt for 15 days, etc.;
* This medicine allergic constitution or composition of known to have allergies;
* In a critical condition, It's difficult to make exact evaluators to efficacy and safety of the new drugs;
PK and Safety Study of BIIB074 in Healthy Japanese and Caucasian Participants

The primary objectives of this study are: To evaluate pharmacokinetics (PK) properties of BIIB074 administered as a single oral dose in healthy Japanese and Caucasian participants; and To evaluate the PK properties of BIIB074 administered as repeated oral doses in healthy Japanese participants. The secondary objective of this study is to assess the safety and tolerability of BIIB074 administered as a single oral dose (Japanese and Caucasian participants) and as repeated oral doses (Japanese participants).


Eligibility Criteria:
Key Inclusion Criteria:

* Japanese or Caucasian.
* Japanese participants must have been born in Japan, and their biological parents and grandparents must all have been of Japanese origin.
* Must have a body mass index between 18 and 30 kg/m2, inclusive.

Key Exclusion Criteria:

* Previous exposure to BIIB074, with the exception that Japanese participants who complete Part 1.
* Use of any oral, injected, or implanted hormonal method of contraception that contains ethinyl estradiol within 28 days of Day -1 and an unwillingness to refrain from product use during study participation.

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Placebo Interventions in General Practice

Physicians often have an ambivalent relationship to placebo interventions. On the one hand they know of the intriguing effect of sugar pills or saline infusions but on the other hand they mostly feel constrained to adopt scientifically proven, specific therapies for ethical reasons. Against the background of international literature one can assume that also Swiss general practitioners use several forms of placebo interventions in a significant part of their patients.

The aim of the project is to ascertain to which extent and in which way Swiss general practitioners make use of placebo interventions. Furthermore knowledge of the mode of action of placebo interventions and the perceived moral and lawful permissibility of placebo interventions and the presumed attitudes of the patients will be investigated.

The empicical core of the study is a questionnaire survey of general practitioners in urban and rural areas of Switzerland. The results and conclusions of the survey will be discussed during a workshop with interested GPs, researchers and ethicists.

The obtained data will lead to a better understanding of the application of placebo interventions in the general practice in Switzerland (how often and in which manner, accompanied by what information, for which diseases and for which patient groups placebos are applied). Moreover the study will help to articulate potential moral ambiguities of physicians using placebo interventions.


Eligibility Criteria:
Inclusion Criteria:

* general practitioners and pediatricians in medical practice of the canton Zurich in Switzerland

Exclusion Criteria:

* no patient encounters
European Carto® XP REgistry for Validating Specialized CFAE SOftware

The purpose of this prospective observational study (registry) is to determine the acute success rate of a complex fractionated atrial electrogram (CFAE) guided ablation procedure using a dedicated software and to determine the functionality and performance of the CFAE software in patients with a type of persistent atrial fibrillation (AF) in routine clinical practice.

This was a prospective, multi-center, observational registry study evaluating CARTO® XP CFAE Software (CFAE Software) in subjects with chronic AF requiring CFAE-guided RFCA. Use of the CARTO® 3 System (including CFAE Software) was also allowed. The primary efficacy endpoint was the acute success rate of CFAE-guided radiofrequency catheter ablation (RFCA) using the CFAE Software. Acute success is defined as the subject achieving sinus rhythm at the end of the procedure without electrical or pharmaceutical cardioversion. Secondary endpoints consisted of measures of efficacy (example, performance of the CFAE Software) and of safety (example, number of procedure-related adverse events).

Eligibility Criteria:
Inclusion Criteria:

* Persistent or longstanding persistent AF

Exclusion Criteria:

* Previously underwent RF ablation for AF and patients with paroxysmal AF
Partner Involvement During Pregnancy and Its Association With Maternal Health Behaviors

This study assessed the relationship between pregnant women, partner support, and cigarette and alcohol use in pregnancy.

Paternal support is related to positive pregnancy outcomes. We explored the relationship between paternal involvement and maternal smoking and alcohol consumption during pregnancy. This was an IRB-approved cross sectional study. Pregnant women between the ages of 18 - 44 years old and their partners were surveyed in the outpatient OB/GYN offices of Thomas Jefferson University. Women who identified their partner as their main support were included. Demographic and health information was collected. A composite support score for each woman was generated from a modified version of the Norbeck Social Support Questionnaire (NSSQ) on a scale from 5 - 35. Support scores were evaluated with women's current smoking and drinking status using ANOVA and Student's t-test.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant women between the ages of 18 - 44 years old and their partners were surveyed in the outpatient OB/GYN offices of Thomas Jefferson University. Women who identified their partner as their main support were included.

Exclusion Criteria:

* Non-English speaking.
Development of a Radiomics Model With MR to Predict the Occurence of a Infiltration of Muscoskeletal Tumor

The goal of this observational study is to evaluate the feasibility and clinical utility of radiomics to diagnose peri-lesion tumour infiltration of tumours in participants with a suspect of Bone Cancer Tumor or Soft Tissue Sarcoma (STS).

The main questions it aims to answer are:

* is radiomics able to identify the ratio of participants truly diagnosed as positive to all those who had positive test results?
* is radiomics able to identify the likelihood that a participant who has a negative test result indeed does not have the disease?

Participants eligible for this study will get a MRI as part of their regular medical care. The only difference is that their data will be recorded and anonymously analyzed.


Eligibility Criteria:
Inclusion Criteria:

* Age over 18
* suspect of soft tissue sarcoma with a indication for surgical treatment
* suspect of bone cancer tumor with a indication for surgical treatment
* To give informed consent

Exclusion Criteria:

* simultaneous cancer or history of cancer in the last 5 years
* acute or chronic serious conditions that could
* contraindication to conduct a Contrast-enhanced magnetic resonance imaging (MRI) such as:

  * renal failure without dialysis
  * history of allergy to a paramagnetic contrast agent
  * claustrophobia
  * symptomatic epilepsy or history of epilepsy
  * cardiac pacemaker
  * infusion pump, prosthesis or any implant not compatible with MRI
  * pregnancy
Study of a Candidate Gene Involved in Goldenhar Syndrome.

The aim of this study is to identify of the first gene involved in the Goldenhar syndrome in a cohort of 120 affected patients.

Goldenhar syndrome belongs to the heterogeneous spectrum of oculoauriculovertebral dysplasia. Several chromosomal abnormalities have been described associated with this spectrum, and furthermore mutations in different genes of development cause abnormalities of the jaw or facial asymmetries in human or mouse. To date, no gene has been identified as formally involved in the genesis of the OAVS, despite evidence of familial cases, mostly with autosomal dominant inheritance.

The aim of this study is to identify of the first gene involved in the Goldenhar syndrome in a cohort of 120 affected patients.

Eligibility Criteria:
Inclusion Criteria:

* Spectrum of oculoauriculovertebral dysplasia minimal features include unilateral microtia and hemifacial microsomia

Exclusion Criteria:

* Absence of minimal spectrum of oculoauriculovertebral dysplasia features, molecular anomaly identified, other diagnosis
Outcomes of Expanded Autologous Bone Marrow-derived Mesenchymal Stem Cells Therapy in Type II Diabetes

The purpose of this study is to evaluate the safety and effectiveness of autologous bone marrow-derived mesenchymal stem cells transplantation in the treatment of type 2 diabetes mellitus

Bone marrow-derived mesenchymal stem cells have the immunosuppressive effect and secrete a variety of cytokines, improve the microenvironment of diabetic patients, targeting insulin resistance tissue, ameliorate the metabolic disorder of islet damage, protect and regeneration of the islet beta cells; reduce high blood sugar.The purpose of this study is to evaluate the safety and effectiveness of autologous bone marrow-derived mesenchymal stem cells transplantation in treatment 30 patients with type 2 diabetes mellitus at Vinmec International Hospital, Hanoi, Vietnam

Eligibility Criteria:
Inclusion Criteria:

* Males and females
* Age from 18 years and above.
* Hemoglobin A1c (HbA1c) is ranged from 7.5% to 9% at baseline.
* Type 2 diabetes duration 5 years or more.
* Before the screening, joint or combined with insulin, oral medications to treat more than 3 months.
* Who signed the informed consent form.

Exclusion Criteria:

* Type 1 diabetes.
* Chronic disease or severe disease, including cancer, severe heart disease, kidney disease, liver disease, etc.
* According to the medical doctor's judgement, may endanger the safety of the subjects
A Multi-Center Study Evaluating the Onset and Duration of Action of AC-170 0.24% Compared to Vehicle in the Conjunctival Allergen Challenge (CAC)

The purpose of this study is to evaluate the onset and duration of action of AC-170 0.24% compared to vehicle in the prevention of the signs and symptoms of allergic conjunctivitis in the conjunctival allergen challenge (CAC) model.


Eligibility Criteria:
Inclusion Criteria:

* positive bilateral conjunctival allergen challenge (CAC) reaction

Exclusion Criteria:

* known contraindications or sensitivities to the study medication or its components
* any ocular condition that, in the opinion of the investigator, could affect the subjects safety or trial parameters
* use of disallowed medication during the period indicated prior to the enrollment or during the study
Comparing Water Vapour Thermal Therapy (Rezūm) and TURP

This is a randomized controlled trial using a non-inferiority design with the subjects randomized 1:1 to either water vapour thermal treatment (REZUM) arm or transurethral resection of prostate (TURP) arm.


Eligibility Criteria:
Inclusion Criteria:

* Men 50-80 years
* Refractory urinary retention related to benign prostatic hyperplasia (BPH)
* On urethral Foley's catheter before treatment
* Prostate size 30-80ml on ultrasound

Exclusion Criteria:

* Prior prostate operation
* Past or current history of prostate cancer
* Strong suspicion of prostate cancer (e.g. Elevated PSA before urinary retention or abnormal prostate on DRE without workup for prostate cancer)
* Known Urethral stricture / Bladder stone / Hypocontractile bladder
* Known neurological diseases which may affect bladder function (e.g. Parkinsonism, stroke)
* Contraindicated to undergo TURP or REZUM (e.g. not fit for GA/SA, active urinary tract infection, fail to be placed in lithotomy position, uncorrectable coagulopathy, antiplatelet or anticoagulant which cannot be stopped)
The Role of Sensory Processing Sensitivity in Pediatric Chronic Pain

The aim of this project is to increase scientific understanding of whether the trait of SPS can help explain increased pain sensitivity and hence vulnerability for chronic pain. Additionally, it will be tested whether participants with high SPS report differences in pain intensity in response to positive, negative, or neutral mood induction compared to individuals with lower SPS.

Background: Pain is defined as an unpleasant sensory and emotional experience and in its chronic form, pain is highly prevalent, up to 25% of children and adolescents are affected by it. The exact etiology of many forms of chronic pain remains unknown. One mechanism that has been proposed to underlie increased pain sensitivity is central sensitization, i.e., increased efficacy of the nervous system in transmitting pain signals, which manifests itself as a lower pain threshold. A lower pain threshold in turn has been recognized as a risk factor for the development of chronic pain. Being more sensitive to pain is one feature commonly shared by those with high sensory processing sensitivity (SPS), who are thought to react more strongly to both positive and negative environmental influences. The relationship between this increased sensitivity and pain tolerance has not been studied to date, but could contribute to our understanding of why some children and adolescents are more vulnerable to developing chronic pain than others.

Objectives and Aims: The aim of this project is to increase scientific understanding of whether the trait of SPS can help explain increased pain sensitivity and hence vulnerability for chronic pain. Additionally, it will be tested whether participants with high SPS report differences in pain intensity in response to positive, negative, or neutral mood induction compared to individuals with lower SPS.

Methods: To examine differences in pain perception of an experimentally induced pain stimulus between people with varying levels of SPS and whether pain perception can modulated by positive, negative, or neutral mood induction, I will apply a heat pain paradigm in a sample of healthy adolescents. Participants will be randomized to either neutral, positive or negative mood induction and I will test whether their pain sensitivity differs as a function of their scores on a high sensitivity scale and with regard to mood induction.

Expected Results: We expect highly sensitive adolescents to have a lower pain threshold and tolerance and to react more strongly to positive (with decreased pain ratings) and negative (with increased pain ratings) mood induction compared to those with lower scores on the sensitivity scale.

Eligibility Criteria:
Inclusion Criteria:

* Healthy adolescents aged 16-19 years

Exclusion Criteria:

* Chronic pain or another chronic condition
* Skin pathologies
* Sensory abnormalities affecting the tactile or thermal modality
* Pregnancy
* Current medication
* Current psychological or psychiatric treatment
* Insufficient language skills to understand the instructions