cyrilzakka/clinical-trials huggingface dataset:
Total Knee Arthroplasty Biomechanics

In total knee arthroplasty (TKA), the relationship between implant design, soft tissue balance, neuromuscular contributions, and rehabilitation strategies on patient satisfaction and functional outcomes is highly complex and poorly understood. The investigators will prospectively study the effects of these factors using in vivo assessments preoperatively, and postoperatively. Computer simulation models will also be used to analyze lower extremity biomechanics.

Total knee arthroplasty (TKA) is the primary treatment for end-stage knee osteoarthritis and effectively relieves pain and improves function after surgery. Nevertheless, as many as 1 in 5 patients are dissatisfied with the postoperative outcome, and knee instability remains one of the top indications for revision surgery. Implant design, soft tissue balance, neuromuscular capabilities, and rehabilitation strategies can all influence postoperative outcomes. However, the relationship between these factors and the most effective therapeutic approach for total knee arthroplasty has yet to be identified. The investigators will study preoperative and postoperative functional measures and patient satisfaction along with implant design and specific intraoperative data, which may help inform a targeted approach for optimal outcomes after total knee arthroplasty and improve future care of patients.

Eligibility Criteria:
Inclusion Criteria:

* Patients requiring unilateral TKA for knee osteoarthritis
* No osteoarthritis symptoms in contralateral knee
* Radiographic coronal deformity ≤ 15°
* Preoperative flexion ≥ 90°
* Receiving one of four implants used by UF Orthopaedic surgeons
* Able to walk for a short distance without the use of ambulatory aids
* Healthy Participants:

  1. Age 49-85 years
  2. Healthy with no signs or symptoms of lower limb arthritis or injury
  3. Able to walk for a short distance without the use of ambulatory aids

Exclusion Criteria:

* BMI \> 40 kg/m2
* Presence of knee, hip, or ankle prosthesis for either limb
* Presence of hip prosthesis in surgical limb (TKA only subjects)
* History of lower limb or spinal surgery within the last year
* Presence of neurologic or orthopaedic disorders that could affect gait or balance
* Chronic opioid or illicit drug use
* Poorly controlled diabetes (HbA1C \> 7 percent)
* Chronic pain syndrome
* Chronic back pain
* Presence of vestibular disorder
* Pregnancy
Evaluation of Infrared Thermal Imaging in Diagnosis of OSAHS in Children

OSAHS is a common sleep breathing disorder in children, with the same incidence as childhood asthma, and is mainly caused by upper airway stenosis caused by tonsil/adenoid hyperplasia. Clinical findings show that children with OSAHS often present rhinitis symptoms and like rubbing eyes, but there is no evidence to suggest a correlation. Children with OSAHS suffer from recurrent hypoxemia during sleep, and the existing detection methods such as lateral nasopharyngeal radiographs and electronic nasopharyngoscopy can only reflect the structural and morphological changes of the oral, nasal and pharyngeal tissues, but cannot prove their functional status. Previous studies have found that infrared thermal imaging can reflect the oral, nasal and pharyngeal inflammation of patients, and the infrared expression of patients' frontal region and eyes can also reflect the physiological changes caused by sleep deprivation.

In this project, the children were divided into four groups: primary snoring, critical OSAHS, mild OSAHS and moderate to severe OSAHS, and the tests were completed, including lateral nasopharyngeal radiographs, infrared detection of oropharynx and pharynx, infrared detection of frontal area and eye area, intelligence and behavior scale assessment, etc. Furthermore, the correlation between infrared detection and obstructive sleep apnea hypopnea index, peripheral blood oxygen saturation, adenoid hyperplasia degree of nasopharyngeal lateral film as parameters were analyzed, and the sensitivity and specificity of infrared detection was determined to confirm the diagnostic value of OSAHS. It provides a theoretical basis for finding a convenient, non-damaging, non-radiation, visual and suitable for children functional image detection method.

Eligibility Criteria:
Inclusion Criteria:

* Children ages 2 to 14 with SDB related symptoms

Exclusion Criteria:

* 1) Congenital abnormalities of the nose and throat or airway;

  2) craniofacial deformity

  3) Neuromuscular dysregulation

  4) History of adenoids and/or tonsillectomy.
Systematic Registration of All Big Toe Prostheses Placed in Ghent University Hospital

Systematic registration of all big toe prostheses placed in Ghent University Hospital for analyses of global results, comparison between different types of prostheses, ...


Eligibility Criteria:
Inclusion Criteria:

* Big toe prosthesis

Exclusion Criteria:

-
Phase 1/2 Clinical Study of HRS-4357 in Patients With Advanced Prostate Cancer

The study is being conducted to evaluate the the safety, pharmacokinetics, radiation dosimetry, and preliminary efficacy of HRS-4357 injection in adult patients with advanced prostate cancer.


Eligibility Criteria:
Inclusion Criteria:

1. Voluntary participation in this clinical trial, understanding of the study procedures and being able to sign the informed consent form in writing;
2. Male, age ≥18 years;
3. ECOG score 0 - 1;
4. Histologically and/or cytologically confirmed adenocarcinoma of the prostate;

Exclusion Criteria:

1. Spinal cord compression with clinical symptoms, or clinical symptoms and/or imaging findings suggesting imminent spinal cord compression.
2. Severe urinary incontinence, hydronephrosis, severe micturition dysfunction, etc. Note: Subjects with bladder outflow obstruction or urinary incontinence that can be controlled by the best available standard of care (including pads, drainage, etc.) are eligible to participate in the study.
3. Active syphilis infection.
4. Known hypersensitivity to components of the study drug or its analogues.
Study of Early Hormone Replacement Therapy on Risk Factors for Sudden Cardiac Death

As an ancillary study to the KEEPS study (see ClinicalTrials.gov Identifier: NCT00154180), the primary purpose is to measure effects of estrogen vs. placebo in menopausal women, on autonomic function and repolarization; both measured non-invasively via holter monitoring.

The parent study KEEPS, will be a randomized, placebo-controlled double blinded, prospective trial with two active groups and one placebo group. Only patients enrolled in KEEPS will be invited to participate in this ancillary study.Duration of the KEEPS study will be for 4 years after randomization for each study subject, with assessment of the primary endpoint, carotid CIMT, twice at baseline, 12, 24, 36 and 48 months. Ancillary to the KEEPS study, patients will undergo holter monitoring at baseline, 24 and 48 months.Data will be analyzed after 24 and 48 months (corresponding to data analysis of the primary endpoints.) Holter monitors will be put on during the scheduled KEEPS visits, will be worn for 24 hours and will be returned the following day. Effects of estrogen on heart rate variability (HRV) and repolarization parameters will be evaluated, and also correlated with clinical, quality of life, sleep and mood information gathered through the parent study. Anticipated enrollment from the parent study at this site is 90 study subjects. This ancillary does not involve the use of drugs or investigational devices.

Eligibility Criteria:
Inclusion Criteria:

* participant of the KEEPS parent study: ClinicalTrials.gov Identifier NCT00154180

Exclusion Criteria:

* non-participants of parent study
A Dose-finding Study of MAL and HAL Photodynamic Therapy of Cervical Premalignant Lesions.

The study will determine the best drug (MAL or HAL) dosage for photodynamic therapy of cervical precancerous lesions (dysplasia) in women that are referred for conisation (surgery).

Surgery (conisation) of precancerous cervical lesions (dysplasia) increase the risk of preterm deliveries in young women. Photodynamic therapy (PDT) is a selective, tissue preserving method that may become a good treatment option for these patients.

This study will explore topical application of methyl aminolevulinate (MAL) and hexaminolevulinate (HAL) of the cervix for photodynamic therapy using red light (630 nm). Different doses of MAL and HAL will be used with different application time, followed by illumination.

Eligibility Criteria:
Inclusion Criteria:

* Positive histology of CIN 1-3

Exclusion Criteria:

* Patients with endocervical lesions
* Patients with AGUS
* Patients with invasive disease
* Patients with porphyria
* Patients sensitive to MAL and HAL
Comparison of Highly Cross-Linked and Conventional Polyethylene in Total Knee Arthroplasty

To our knowledge, there has been no information on in vivo clinical results of posterior cruciate-substituting arthroplasties using highly cross-linked polyethylene. We evaluated whether the clinical and radiographic results, incidence of post fracture of the tibial polyethylene insert, failure of the locking mechanism of the tibial polyethylene insert, and the incidence of osteolysis would be similar between posterior cruciate-substituting total knee prostheses using conventional and highly cross-linked polyethylene.


Eligibility Criteria:
Inclusion Criteria:

* osteoarthritis that was severe enough to warrant total knee arthroplasty after an adequate trial of nonoperative therapy, and the need for bilateral total knee arthroplasties

Exclusion Criteria:

* inflammatory arthritis
* osteoarthritis of the hip causing pain or restricted mobility
* a foot or ankle disorder which limited walking
* dementia or a neurological disorder including a past history of stroke which affected mobility
BE Study of the Combinations of Gemigliptin 50mg and Metformin HCl Extended Release 500mg in Comparison to Each Component Administered Alone

This study is to evaluate the safety/tolerability and pharmacokinetics of the combinations of gemigliptin 50mg and metformin HCl extended release 500mg in comparison to each component administered alone in healthy male volunteers.


Eligibility Criteria:
Inclusion Criteria:

* Age between 20 to 45, healthy male subjects(at screening)
* Body weight between 55kg - 90kg, BMI between 18.0 - 27.0
* FPG 70-125mg/dL glucose level(at screening)
* Subject who totally understand the progress of this clinical trials, make decision by his free will, and signed a consent form to follow the progress.

Exclusion Criteria:

* Subject who has past or present history of any diseases following below.(liver including hepatitis virus carrier, kidney, Neurology,immunology,pulmonary,endocrine,hematooncology,cardiology,mental disorder.)
* Subject who had GI tract disease or(ulcer, acute or chronic pancreatitis) surgery.(appendectomy, hernioplasty are not included)
* Subject who had drug hypersensitivity reaction.(Aspirin, antibiotics)
* Subject who already participated in other trials in 2months
* Subject who had whole blood donation in 2months, or component blood donation in 1months or transfusion in 1months currently.
* Smokers.(but, if the subject did'nt smoke in 3months, can participate the trial)
Assessment of the Impact of RNA Genomic Profile on Treatment Decision-making in HER2 Equivocal Breast Cancer Patients

The American Society of Clinical Oncology (ASCO) and the /College of American Pathologists (CAP) recommend that HER2 status (negative or positive) must be determined in all patients with invasive breast cancer. The knowledge of HER2 status will help the oncologist in prescribing or not a HER2-targeted therapy to patients. Presently, two main methods are used to assess HER2 status: immunohistochemistry (IHC, protein expression) and in situ hybridization (ISH, gene expression) in order to classify tumor sample as positive, negative or equivocal. When a tumor is classified HER 2+ by IHC method, a second test is performed using ISH methods (FISH, SISH, CISH). In case of HER2 equivocal result with ISH method (4 ≤HER2 gene number copy \<6), the patient is eligible to an anti-HER2 therapy after discussed during MD-MM. This decision should be individualized on the basis of patient status (comorbidities and prognosis) and patient preferences after discussing available clinical evidence.

Based on molecular classification, RNA expression could help to discriminate breast cancer subtypes (luminal A, luminal B, HER2-overexpressed and triple negative). Prosigna is a genomic test, developed by NanoString® based on the PAM50 gene signature, which measures the expression of 50 genes to classify tumors into 1 of 4 intrinsic subtypes and could allow determining the HER2 status.

This study was designed in order to define if such a test could help the oncologist to define the better therapeutic decision in a HER2 equivocal population. In addition, concordance tests will be performed. The aim of this study is to assess the modification decision rate between the first and the second multidisciplinary decision-making meeting in HER2 equivocal patients using genomic testing.


Eligibility Criteria:
Inclusion Criteria:

* Performance status ≤ 2 (according to WHO criteria)
* Patient with early invasive breast cancer histologically confirmed stage I to IIIA)
* Positive or negative lymph node involvement
* Positive or negative Hormonal Receptors (Estrogens and/or Progesterone),
* Equivocal HER2 status (IHC Score 2 and equivocal ISH defined as HER2/Chr17 ratio \<2 and 4 ≤ HER2 gene number copy \< 6) as assessed on surgical specimen
* Adequate Hematological, Hepatic, Renal and Cardiac Functions
* Patient potentially eligible for an anti-HER2 therapy
* Patient eligible to receive an adjuvant therapy
* Signed Informed Consent
* Patient with social insurance.

Exclusion Criteria:

* Non-measurable tumor
* Unknown Hormonal Receptors
* Unknown node involvement
* Positive or negative HER2 status (Score 0, 1 or 3 IHC, or Negative or positive ISH)
* Disease stage ≥IIIB
* Patient not able to follow the trial.
The Effect of Mindfulness Training Before Primary Total Joint Arthroplasty on Sleep Quality

The primary purpose of this study is the determine whether a 15 minute Mindfulness Meditation (MM) administered at the preoperative appointment prior to primary unilateral total joint arthroplasty (TJA) results in any improvement in Pittsburg Sleep Quality Index (PSQI) score, a validated metric for sleep quality, at 2, 6 or 12 weeks post-operatively.

The primary purpose of this study is the determine whether a 15 minute Mindfulness Meditation (MM) administered at the preoperative appointment prior to primary unilateral total joint arthroplasty (TJA) results in any improvement in Pittsburg Sleep Quality Index (PSQI) score, a validated metric for sleep quality, at 2, 6 or 12 weeks post-operatively. We hypothesize that patients in the MM cohort will have lower PSQI scores, indicating higher sleep quality, at both post-operative time points. Secondary aims include characterizing differences between cohorts in Visual Analog Scale (VAS) for pain, Epworth Sleepiness Scale (ESS) scores, Patient Reported Outcome Measurement Information System - Sleep Disturbance - Short Form, and Knee Injury and Osteoarthritis Outcome Scores (KOOS) at 2, 6 and 12 weeks following TJA.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing primary unilateral total joint arthroplasty at Colorado Joint Replacement
* Between the ages of 18 and 90 years old will be included in the study.

Exclusion Criteria:

* Simultaneous total joint arthroplasty
* Uni-compartmental knee arthroplasty
* Revision surgery for infection, fracture or other indication.
* History of Drug or Alcohol Abuse
* Patients who are unable to present at a standard pre-operative appointment within 4 weeks prior to scheduled surgery will also be excluded, as the MM intervention would not be possible to administer.
Viral Kinetics of Treatment With Peginterferon Alpha-2a, Ribavirin and Epoetin β in Patients Coinfected HCV/HIV

The purpose of this study is to compare the early virological response (EVR = undetectable \[ribonucleic acid-hepatitis C virus\] RNA-HCV or a reduction of \> 2 log10) of patients with chronic hepatitis C coinfected with HIV treated with induction doses of peginterferon alpha-2a (40 KD) 270 µg/week and ribavirin 1600 mg/day for 4 weeks, followed by 8 weeks of treatment with peginterferon alpha-2a (40 KD) 180 µg/week and ribavirin 1000-1200 mg/day versus treatment with peginterferon alpha-2a (40 KD) 180 µg/week and ribavirin 1000-1200 mg/day for 12 weeks.

This study seeks to ascertain whether treatment with higher doses of PEGASYS (270 µg/week) and ribavirin (1600 mg/day) for the first four weeks achieves the plasma concentrations of the product in the blood needed to reduce the half-life of the virions and accelerate the elimination thereof. This would bring the viral kinetic curves in coinfected patients closer to the model described for mono-infected HCV patients, probably achieving improved rates of response in week 12 (early virological response) and posterior in week 72 (sustained virological response).

Therefore, the patients were randomised to treatment with two different doses, 270 µg and 180 µg of PEGASYS, and 1600 mg and 1000-1200 mg of ribavirin.

Eligibility Criteria:
Inclusion Criteria:

* Serological evidence of chronic hepatitis C infection in an anti-HCV antibody test
* Detectable RNA-HCV plasma level genotype 1 and 4
* ALT serum activity above the upper limit of normality
* Chronic liver disease consistent with chronic hepatitis C infection in a biopsy obtained during the two years prior to inclusion in the study
* Serological evidence of HIV-1 infection, diagnosed by Enzyme-Linked Immunosorbent Assay (ELISA) and confirmed by Western-blot.
* Patients with CD4 cell count \> 200 /µl
* Stable status in HIV-1 infection, in the investigator's opinion, in other words, patients that are not expected to progress during the study.
* Patients treated with stable anti-retroviral therapy (HAART), which does not include nucleoside analogues, for at least 6 weeks before the baseline assessment
* Patients that do not receive HAART therapy
* Negative pregnancy test in urine or blood

Exclusion Criteria:

* Women currently pregnant or in the lactation period.
* Patients whose companion is pregnant.
* Therapy with interferon (IFN) or ribavirin at any previous time.
* Patients with cirrhosis in the hepatic biopsy.
* Documented suspicion by ultrasound of hepatocarcinoma.
Frequency-time Analysis of Pathological Lung Sounds: Detection and Quantification of Pathological Sounds in Patients With Cystic Fibrosis, Pulmonary Fibrosis or COPD (Chronic Obstructive Pulmonary Disease)

The main objective of the study is to assess the potential of time-frequency representation and analysis of pulmonary sounds collected with an electronic stethoscope, as part of the routine monitoring of patients with cystic fibrosis, COPD or pulmonary fibrosis.

Secondary objectives

The other objectives of this study are :

1. To evaluate the ability to detect changes in lung sounds, following optimization of the time-frequency representation.
2. To evaluate the ability to quantify differences in the severity of the pathological sounds detected using artificial intelligence and a supervised learning method.

Conduct of research This is a single-center, non-randomized, open-label study involving 60 male and female patients aged 18 to 65, eligible for a scheduled consultation as part of their usual pathological follow-up (routine care).

Lung sound recordings will be made during the same consultation, after obtaining the patient's non-opposition.

Recordings will be made using a 3M Littmann© model 3200 electronic stethoscope. The stethoscope works with Eko software, which will be installed on a touch-sensitive tablet or computer, enabling local storage of recorded data.

Whatever the patient's pathology, the physician will listen to 10 lung sites defined in the protocol. At least one breath per pulmonary site will be recorded during the consultation.

If a patient comes back for a consultation before the end of the recruitment period, a new lung sound recording will be performed.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Suffering from one of the following pathologies: cystic fibrosis, pulmonary fibrosis, COPD
* Not opposed to participating in the study

Exclusion Criteria:

* Person under court protection, guardianship or curatorship
* Person deprived of liberty by judicial or administrative decision
* Patient with a history of thoracic surgery, thoracic deformity, heart failure or other relevant illness at the investigator's discretion.
Psychology and Physiotherapy Approach of Chronic Pain in Patients With Hemophilia

This study evaluates the clinical impact of a combined protocol with cognitive-behavioral intervention and physiotherapy adjuvant to the standard medical treatment in patients with haemophilia that suffer from chronic pain

The purpose of this study is to improve the perception of the experience of chronic pain, as well as functionality and quality of life in hemophilic patients with chronic pain

Secondary objectives are:

* to change the perception that the patient has of their pain, to improve the coping strategies and to increase the perception of self-efficacy of patients in pain management.
* to increase the resources that allow a better self-regulatory of emotional, cognitive and competential of the pain experience, reverting in the emotional state of patients, particularly in levels of anxiety and depression.
* to improve functional capacity and musculoskeletal status.
* to improve quality of life.
* to determine whether changes / improvements are maintained over time 3 months after finishing the program

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of haemophilia A or B.
* Age between 18 and 60 years.
* Informed consent signed.
* Signs of arthropathy according to clinical criteria (score Gilbert) and / or radiological criteria (score Pettersson) in at least one of the six joints most commonly affected (ankles, knees or elbows)
* Chronic pain (CP) defined as persistent pain lasting at least six months and resistant to conventional medical therapy. It differs from the acute pain not only in its longer duration, but also sometimes persists even after the cause that produced it has disappeared.
* Absence of active coping strategies, understanding the concept of coping as those cognitive and behavioral efforts made by the individual in order to manage internal and external demands generated by their chronic pain condition and that involve a challenge to their potential individual resources.

Exclusion Criteria:

* Presence of inhibitor to FVIII or FIX.
* Another haemostatic defect.
* Patients with severe cognitive deficits with which it is not possible a cognitive psychological intervention.
* The inability to attend physiotherapy sessions for 12 consecutive weeks (7 supervised and 31 self-monitored)
* Surgical procedures performed 6 weeks prior or during the intervention protocol.
* Not acceptance or withdrawal of informed consent