cyrilzakka/clinical-trials huggingface dataset:
Impact of Physiotherapy Intervention for Children With Ankle Sprains

This study will investigate whether adding a physiotherapy intervention to standard Emergency Department care will lead to improved recovery following an ankle sprain in the pediatric and adolescent population as well as to a decrease recurrence of injuries during the year following the initial ankle sprain. Children will be allocated to standard care or to the added intervention group. The study hypothesis is that recovery will be better while recurrence of injury will be less in those receiving the added physiotherapy intervention.


Eligibility Criteria:
Inclusion Criteria:

* age 7 to 18
* confirmed diagnosis of ankle sprain
* Ability to Speak French or English

Exclusion Criteria:

* immobilization at the time of ED discharge
The Aim of This Study is to Demonstrat That Vacuum-assisted Closure Versus Conventional Wound Closure Enables to Diminish Local Complications After Lymph Node Dissection in Patients With Metastatic Skin Tumors

In this study, we compared a negative pressure wound therapy, versus a conventional dressing in order to evaluate the most efficient wound therapy closure after axillary and inguinal lymph nodes dissections in the management of metastatic skin tumors. A vacuum assisted closure therapy should prevent these comorbidities.

Lymphorrhoea, lymphedema and lymphocyte are significant and common complications after axillary and inguinal lymph nodes dissections. A vacuum assisted closure therapy should prevent these comorbidities. In this study, we compared PREVENA, a negative pressure wound therapy, versus conventional dressings. We evaluated the wound complications at the seventh day, the thirtieth day and at this end of the first year after surgery. It is a retrospective study of about ninety lymph nodes dissections among with there were seventy times the use of a negative pressure wound therapy, PREVENA.

Eligibility Criteria:
Inclusion Criteria:

* major patient affected by a metastatic skin tumors
* the primitive skin tumor is either a mélanoma, either squamous cell carcinoma , or a neuroendocrine tumor

Exclusion Criteria:

* lymph node dissection resumption
Rapid-Cycle Re-Implementation of TRAining Facilities in Norway

This study tests the randomized re-opening of training facilities in Norway in relation to the COVID-19 pandemic. The investigators will use the recently developed concept of rapid-cycle randomized implementation to assure fast and safe re-introduction of training facilities by randomized testing of access restriction and measure virus exposure and immunity as well as clinical disease during the intervention to enable safe and timely downgrading of COVID-19 restrictions.

Members of training facilities in Norway age 18 to 64 years without COVID-19 related comorbidity will after informed consent be randomised to either access to training or no access in a first 2-week cycle. Testing for COVID-19 and ascertainment of clinical disease will be performed after the first cycle. If there is no clinically meaningful difference between the arms, new cycles may be implemented subsequently, e.g. with less distancing restrictions or wider age groups.


Eligibility Criteria:
Inclusion Criteria:

* all members of participating training facilities age 18 years or older who are not at increased risk for severe COVID-19 disease (see www.fhi.no for criteria) are eligible for participation if they

  * plan to use the training facility regularly during the project period
  * are willing to adhere to training policies during the project
  * accept assessment of project endpoints
  * approve handling of data for the project

Exclusion Criteria:

* COVId-19 related comorbidity
* Age below 18 years or above 64 years
Safety and Dialysability of Dotarem® in Dialysed Patients

To evaluate the dialysability of Dotarem®, after an IV injection of 0.1 mmol/kg in patients with chronic renal failure who require hemodialysis treatment.

Ten adult patients suffering from end stage renal failure and requiring hemodialysis treatment for 3 times were enrolled. Patients received a single dose of Dotarem® at 0.1 mmol/kg before being submitted to hemodialysis to assess the dialysability of Dotarem® . After injection of Dotarem®, 3 sessions of hemodialysis were performed as follows:

The first hemodialysis session started between 1 to 2 h after the injection; The second hemodialysis session occurred 2 days (i.e., 48 ± 2 h) after the Dotarem® injection; The third hemodialysis session occurred 4 days (i.e., 96 ± 4 h) after the Dotarem® injection.

The decrease in serum Dotarem® concentration was assessed after each hemodialysis session. Safety assessments included adverse events (AEs), vital signs, injection-site tolerance, and laboratory assessments.Two safety follow-up visits were performed: one 3 weeks (± 2 days) and one 3 months (± 4 days) after the Dotarem® injection.

Eligibility Criteria:
Inclusion Criteria:

Male or female, aged ≥18 years

* Subjects suffering from end-stage renal failure who require hemodialysis treatment for 3 times per week (or equivalent to allow overnight dialysis being rescheduled as appropriate per protocol)
* Female Subjects with effective contraception (contraceptive pill or Intra-Uterine Device), or surgically sterilized or post-menopausal (minimum 12 months amenorrhea)
* Subjects having provided their written informed consent to participate in the trial

Exclusion Criteria:

* Known allergy to gadolinium chelates
* Pregnant, breast feeding, or planning to become pregnant during the trial
* Having received or scheduled to be injected with any contrast agent within 7 days before or after the Dotarem® injection
* Schedule to receive erythropoietin (EPO) or iron therapy during 1 week after the Dotarem® injection
* Evidence of human immunodeficiency virus (HIV) infection and/or positive human HIV antibodies
* Evidence of hepatitis C and/or positive hepatitis C antibody and/or positive hepatitis B surface antigen
* History of hypersensitivity to drugs with a similar chemical structure
The Effect of Semiconductor Knee Sleeves on Pain in Osteoarthritis of the Knee.

To assess the benefits of using semiconductor (germanium and carbon) woven knee sleeves products in patients with osteoarthritis of the knee. To compare patients in a blinded randomized trial with and without the semiconductor knee sleeves product during the first 3 months period after initial contact at the outpatient clinic.

Aims:

The hypothesis of the study is that the semiconductor sleeve will reduce pain and improve knee function in active group when compared to the placebo group.

Semiconductor woven knee sleeves work by increasing circulation to reduce inflammation, relieve pain, optimize performance, and accelerate recovery. Unlike compression products, semiconductor knee sleeves do not need to compress to work. Instead, the technology incorporates the semiconductor elements germanium and carbon within the fabric, which when stimulated by body heat, by release of negative ions. The negative ions activate molecular vibrations that increase blood flow and speed. Increasing circulation helps bring more oxygen and nutrients to the target area, which optimizes the body's natural healing process and accelerates recovery. Benefits of Increased Blood Circulation Include:

* Accelerated Recovery
* Reduced Swelling
* Optimized Performance
* Reduced Fatigue
* Thermoregulation

Investigators wish to investigate a possible effect on knee pain and function in patients with osteoarthritis of the knee.

Subject Enrollment:

Subjects referred with arthrosis of the knee to the out-patient clinic, at the Hip- and Knee-arthroplasty Unit, Herlev Gentofte Hospital. Included subjects must be assessed by an arthroplasty surgeon to have arthrosis without present indication for surgery, and to be eligible for a period of conservative treatment including physiotherapist guided training and paracetamol treatment.

This is a prospective study that will require informed consent.

Study size calculation A 25% difference in pain reduction between the intervention group compared and the placebo group is considered clinically relevant. Standard deviation expected at 25 mm on a 100 mm visual analog scale (VAS) for pain1. A type II error set at 10%, and a two-sided 5% significance level. A total number of 36 subjects with 18 in each group was calculated. To account for dropouts and the risk of conversion to surgical strategy during the follow-up period we plan to enroll a total of 25 subjects in each group.

Study Population: Estimated enrollment Target enrollment - 50 patients

* 25 patients with the semiconductor knee sleeve.
* 25 patients with the placebo sleeve.

Eligibility Criteria:
Inclusion Criteria:

* Arthrosis of the Knee
* Surgery not yet indicated
* 40-90 years old
* Male or female
* Compliant patient
* BMI less than 35
* Able to understand Danish sufficiently for written consent

Exclusion Criteria:

* Rheumatoid Arthritis
* Previous blood clots
* BMI greater than 35
* Varicosities on operative leg
Pharmacotoxicology of Trichloroethylene Metabolites

To establish the relationship between human MAAI haplotype and DCA and tyrosine metabolism. This aim test the postulates that MAAI haplotype determines, and thus can predict,1) dose-dependent DCA kinetics and biotransformation.

The arms of the study involves determining the haplotype of individuals enrolled. Then participants were divided into two groups based on their genotype. The groups include a genotype with an EGT alle and a group of genotype without an EGT alle. All subjects first took a low dose of DCA 2.5ug/kg for 5 days then wait 30 days and take a therapeutic dose of DCA 25mg/kg for 5 days On the first day and on the 5th day of taking DCA kinetics were be done. A total of 16 blood samples were obtained through an intravenous catheter. Urine collection will also occur.

Population pharmacogenetic analysis of MAI allelic frequencies and the GC or LC-MS/MS techniques for blood or urinary metabolites were used in this investigation. Pharmacokinetic data was used to determine metabolism rate of DCA for each allele

Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers

Exclusion Criteria:

* Pregnancy
* Other medications
* Psychiatric illness on meds
* Abnormal labs
A Phase III Clinical Study to Evaluate the Efficacy and Safety of GZR18 Injection in Subjects with Type 2 Diabetes Mellitus and Poor Blood Glucose Control by Diet and Exercise

The main purpose of this study is to investigate the Efficacy and Safety of GZR18 Injection in Chinese Subjects with Type 2 Diabetes Mellitus and Poor Blood Glucose Control by Diet and Exercise


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 (as of the date of signing the Informed Consent Form (ICF)), male or female.
2. T2DM is diagnosed for at least 8 weeks according to the diagnostic criteria of diabetes mellitus issued by the World Health Organization (WHO) in 1999 and the supplementary diagnostic criteria of WHO in 2011 (HbA1c diagnosis is recommended).
3. No birth plan from the signing of ICF to 8 weeks after the last dose, willingness to use effective methods of contraception, and no plan for sperm donation. Females of childbearing potential must not be lactating and must have negative results of pregnancy tests at screening and baseline.
4. Fully understand the purpose, nature, methods, and possible adverse drug reactions (ADRs) of the study, be able to communicate well with the investigator, can understand and comply with the requirements specified in this study, can maintain a regular diet and exercise lifestyle during the study, and voluntarily sign the ICF to enter the study.

   -

Exclusion Criteria:

1. Poor compliance during the run-in period as assessed by the investigator.
2. Known or suspected to be allergic to GLP-1R agonists or their excipients, or have contraindications to their use.

（3)Systolic blood pressure (SBP) ≥ 160 mmHg or diastolic blood pressure (DBP) ≥ 100 mmHg at screening or before randomization (concomitant antihypertensive drugs are allowed).

（4）Have the following cardiovascular and cerebrovascular diseases within 6 months before screening: Decompensated cardiac insufficiency (New York Heart Association NYHA Class III or IV), angina unstable or myocardial infarction, history of heart valve replacement surgery, coronary artery bypass grafting or other invasive cardiovascular surgery including percutaneous coronary intervention, ischemic or hemorrhagic stroke (excluding lacunar infarction), or transient ischemic attack.

（5）History or relevant family history of medullary thyroid cancer, multiple endocrine neoplasia (MEN) 2A or 2B before screening.

（6）History of malignant tumors before screening (excluding adequately treated or resected non-metastatic basal or squamous cell skin cancer, cervical carcinoma in situ, or prostate cancer in situ) or the presence of underlying malignancy at screening.

（7）Participated in any drug clinical study (received non-placebo medication during the study) within a period of time before randomization (90 days or 5 half-lives of the previous IMP, whichever is longer), or plan to participate in another clinical study before completing all scheduled assessments in this clinical study.

（8）Subjects with any other factors that may affect the efficacy or safety evaluation of this study as judged by the investigator.-
Treatment of Post-covid Syndrome in Patients Treated in Intensive Care

The present study is a pilot randomized controlled trial, which identifies and diagnoses mental health problems in survivors of critical COVID-19 infection at 12 months post-ICU care, and randomize patients to either an ACT-enforced CBT intervention, or to treatment as usual.

This is a pilot RCT aiming to intervene in symptoms of poor mental health in COVID survivors at 12 months after ICU care for the COVID infection. Based on the uncertain number of patents who screen positive for mental health problems 12 months after ICU care, based on the novelty of the condition assessed, and the uncertainty about which treatment effects to expect on mental health outcomes, the study was designed as a pilot study, with feasibility measures (consent, adherence and satisfaction with the treatment) as the primary variables, and with effects on mental health symptoms as secondary variables.

The study plans to assess and randomize a convenience sample of patients, as it can not be estimated which numbers can be expected, but it is aimed to include at least 40 patients in the study (20 in the intervention group and 20 in the control group).

Specifically, the present study aims to

1. investigate early predictors (during ICU-care) of post-covid syndrome occurring at 3-6 months, 12 months, and 36 months, respectively, including cognitive and mental health problems,
2. deepen the understanding of mental health symptoms in ICU-treated COVID-19 survivors, mental health-related treatment seeking, changes in addictive behaviors, and the diagnostic meaning of mental health symptoms expressed in COVID-19 survivors, and
3. conduct a clinical treatment study with the following research question: for patients with post-covid mental health symptoms after 12 months, is an intervention of Cognitive Behavioral Therapy (CBT) with Acceptance and Commitment Therapy (ACT), when compared to standard clinical care (referral to primary care), feasible and associated with improved patient adherence and patient satisfaction, and secondly, does it improve the outcome of post-covid anxiety symptoms and secondary other symptoms of poor mental health and quality of life?

Eligibility Criteria:
Inclusion Criteria:

* COVID-19 survivors who screen positive for clinical anxiety or depression, defined as reaching a score of ≥ 8 on either the anxiety or depression sub-scales within the questionnaire HADS at the standard 12-months follow-up

Exclusion Criteria:

* Conditions in which patients are acutely suicidal, psychotic, suffering from a mental disorder requiring in-patient psychiatric treatment, opposed to receiving a psycho-therapeutic intervention, or with cognitive problems or language difficulties which are judged to be too extensive for the informed consent procedure and for a psycho-therapeutic intervention
Social Participation After Childhood Craniopharyngioma

Craniopharyngioma is a rare, benign central nervous system tumor, which may be a source of multiple complications, from endocrinology to vision, neurology and neurocognitive functions. This morbidity can lead to reduced participation in life activities, as described in the International Classification of Functioning, Disability, and Health (ICF). The primary objective of this study is to measure participation in life activities in a population of children affected by childhood craniopharyngioma, using the assessement of life habits questionnaire (LIFE-H questionnaire), validated as a social participation measurement tool in various pediatric disabilities.


Eligibility Criteria:
Inclusion Criteria:

* Children with a craniopharyngioma

Exclusion Criteria:

* None
Matrix Metalloproteinases and Human Papillomavirus in Dysplasias and Cancers of the Cervix

This study aims to compare the expression of matrix metalloproteinases and their tissue inhibitors between 4 groups of patients defined according to the severity of the cervical lesion.

Cervical cancer is the second most common cancer among European women under 45 years old. It is secondary to cervical dysplasia induced by persistent human papillomavirus infection. The involvement of matrix metalloproteinases in carcinogenesis of the cervix is real, but their expressions vary according to the published series. An association between the expression of MMPs and that of the human papillomavirus deserves to be explored, as this can have a prognostic influence in the case of gradual expression demonstrated in the development of (pre) cancerous lesions of the cervix.

This study aims to compare the expression of matrix metalloproteinases and their tissue inhibitors between 4 groups of patients defined according to the severity of the cervical lesion.

Eligibility Criteria:
Inclusion Criteria:

For control group:

* Age between 20 and 65 years
* Patients hospitalized for partial or total removal of the cervix
* Absence of cervical lesion observed on biopsy or hysterectomy
* Free, informed and written consent, dated and signed by the patient and the investigator (at the latest before any examination required by the study)
* Affiliate or beneficiary of a social security scheme

For dysplasia and cancer group:

* Age between 20 and 65 years
* Cervical Intraepithelial Neoplasia or previously untreated cervical cancer
* Free, informed and written consent, dated and signed by the patient and the investigator (at the latest before any examination required by the study)
* Affiliate or beneficiary of a social security scheme

Exclusion Criteria:

For control group:

* History of laser or conisation
* Known antecedent of HIV infection
* Congenital or acquired immunodepression
* Long-term treatment with corticosteroids or immunosuppressants
* Persons placed under the protection of justice

For dysplasia and cancer group:

* History of laser or conisation
* Pre-treatment of invasive cancers by radiotherapy or chemotherapy
* Known antecedent of HIV infection
* Congenital or acquired immunodepression
* Long-term treatment with corticosteroids or immunosuppressants
* Persons placed under the protection of justice
Comparison of Individual Culture and Group Culture of Preimplantation Embryos in Human IVF Treatments

Prospective randomized comparison of two widely used in vitro culture system in human IVF treatments. In vitro fertilized oocytes and embryos are cultured in individual culture media droplets using conventional petridish or in group culture using WOW (well of the well) petridish.

Primary outcome: implantation and pregnancy rates Secondary outcome: fertilization rate and embryo quality


Eligibility Criteria:
Inclusion Criteria:

* Infertile patients entering in vitro fertilization treatment
* at least 1 oocyte collected

Exclusion Criteria:

* no oocytes collected
The Effects of Binaural Beats on Pain, Anxiety, and Procedure Tolerance in Patients Undergoing Colonoscopy Without Sedation

The purpose of this study was to investigate the effect of binaural beats on anxiety, pain and tolerance during colonoscopy without sedation

It is a prospective randomized, controlled, single-blind procedural study included 92 Turkish patients aged 18-70 years old scheduled for colonoscopy regardless of sex or underlying disease. The patients were randomly divided into two groups: the binaural beat music group(n=46) and the control group(n=46). The binaural music group listened to music through headphones during colonoscopy, while the control group had headphones without music. Anxiety levels (VAS-Anxiety scale) were measured both before and after the procedure, and pain levels (VAS-pain) were measured following the procedure. Hemodynamic changes before and after endoscopy , procedure tolerance (using modified gloucester comfort scale), cecal insertion and withdrawal times, polyp detection rate, and patients' experiences related to colonoscopy were recorded. Likert scales were collected as well just after the colonoscopy procedure, indicating satisfaction and willingness to repeat the process.

Eligibility Criteria:
Inclusion Criteria:

- Between 18-70 years old who had scheduled colonoscopy appointments

Exclusion Criteria:

* Anxiety and panic disorders
* Urgent endoscopic intervention
* Advanced dementia
* Hearing problems
* Anatomical or inflammatory disorders in the external ear canals
The Findings of Ultrasound Elastography and ARFI in Strokes Patients With Spastic Elbow Flexor

The aim of this study: 1. To evaluate the correlation between the clinic tools and ultrasound elastography/ ARFI imaging in stroke patients. 2. To assess the reliability of elastography/ ARFI imaging in spasticity evaluation of stroke patients.

Modified Ashworth Scale (MAS) and Modified Tardieu Scale (MTS) are the most commonly used tools for spasticity assessment. But these clinic methods cannot reveal the architecture and stiffness of muscles. In recent years, ultrasound elastography and acoustic radiation force impulse (ARFI) are used in musculoskeletal disorders, including spasticity. There are no studies about the correlation between spasticity and ultrasound elastography /ARFI imaging in stroke patients. The investigators will enroll 50 stroke patients with hemiplegia and biceps brachii muscle spasticity. One physical therapist will measure MAS and MTS for spasticity of biceps brachii muscle. Two physiatrists will perform ultrasound elastography and ARFI for intra-rater and inter-rater reliability evaluation. The evaluations of B-mode ultrasound, elastography and ARFI included Heckmatt scale, biceps brachii ratio, strain ratio, dynamic sonoelastography score, color intensity, and shear wave velocity. After performing all assessments, the investigators will analyze the correlation between the clinic tools and elastography/ ARFI imaging and evaluate the reliability of elastography/ ARFI imaging in spasticity evaluation.

Eligibility Criteria:
Inclusion Criteria:

* stroke patients with hemiplegia and biceps brachii muscle spasticity.

Exclusion Criteria:

* elbow joint contracture deformity
* combined other neuromuscular system disease
* affected upper extremity has local infection
* patient who can't follow instruction, who is restlessness and whose elbow can't meet the positioning criteria