cyrilzakka/clinical-trials huggingface dataset:
The Effect of Whole Body Vibration After ACLR

This is a randomised clinical trial to detect the effect of an 8-week whole body vibration training on muscle function and dynamic knee function during single leg squat and single leg hop in patients after anterior cruciate ligament reconstruction

In Hong Kong, over 3000 cases of ACL reconstruction are operated annually to restore knee stability. Despite recovery of knee passive laxity and muscle strength, dynamic knee stability is often not restored. The whole body vibration has been found to improve muscle strength, proprioception and balance after ACL reconstruction. This project will investigate the effect of whole body vibration on muscle elasticity, muscle coordination and landing knee biomechanics. It may provide useful evidence to the application of whole body vibration in improving dynamic knee stability, which will lead to a significant improvement in healthcare management for ACL patients . The current study serves to provide a clinical guideline for post-ACL reconstruction rehabilitation.

Eligibility Criteria:
Inclusion Criteria:

1. Aged 18-50;
2. Physically active before injury with Tegner score more than 6 (recreational/professional sport level);
3. Scheduled for ACLR because of sport injury;
4. Be able to walk with a pair of elbow crutches independently at 1 month after ACLR.

Exclusion Criteria:

1. Concomitant posterior cruciate ligament or lateral collateral ligament injury in the same knee;
2. Injury to the contralateral side;
3. Medical problems that are contradictory to WBV;
4. Prior experience of WBV to avoid any training or memory effect;
5. Women with pregnancy.
Early Effect of Fasting on Metabolic, Inflammatory, and Behavioral Responses in Females With and Without Obesity

The aim of this study is to investigate the effect of overnight fasting versus a diurnal fasting (during daily life activities) in females with and without obesity on inflammation, neurotrophins, energy metabolism, mood, food cravings, and appetite sensations.

This study will be an acute fasting intervention.


Eligibility Criteria:
Inclusion Criteria:

* Body mass index between 18.5 and 24.9 kg/m² or equal or greater 35 kg/m²;
* Able to sign the informed consent.

Exclusion Criteria:

* Chronic health conditions (e.g., cancer, renal, heart or liver disorders, and autoimmune diseases), or history of thyroid alterations or use of related medications;
* Use of corticosteroids, immunosuppressors, anti-inflammatories, hypoglycemics, medications for weight loss, or any medication known to interfere with metabolic and inflammatory processes (e.g., corticosteroids, nonsteroidal anti-inflammatory drugs);
* Previous surgery for weight loss;
* Inability to eat any of the components of the standardized breakfast
* Pregnancy or breastfeeding;
* Smokingç
* Alcohol use (\>2 doses/day).
Hypothesizing the Genesis of Infectious Diseases and Epidemics Through an Integrated Systems Biology Approach

In this study, the investigators aim to collect phenotypical and extensive unbiased multimodal biological data, at two different time points, and to integrate them using a systems biology approach.

The present project aims at generating a systems biology network that can recapitulate the complexity of processes underlying differential SARS-CoV-2 phenotypic responses through exploitation of clinical -omics data. Identifying key determinants and mechanisms of biological variability responsible for phenotypic differences will lead to a better management of patients through the application of precision medicine.

HYGIEIA is a multicentric prospective interventional study. The study has two parts, Part 1 with prospective data and sampling, and Part 2 based on samples that were previously collected and stored within COBISA study (2020/11MAI/269).

i. In Part 1, patients acutely infected with SARS-COV-2 will be proposed inclusion. Included patients will be sampled at two different time points (acute infection and convalescent phase, i.e. 8-12 weeks later). Samples will be analysed using cutting edge -omics technologies in order to characterize the genotypic, proteomic, transcriptomic, metabolomic and respiratory microbiota/virome profile through explorative approaches. Clinical and routine biological data will be prospectively collected either as outpatients or during the acute hospitalization and convalescent phase.

ii. In Part 2, samples collected and biobanked during the COBISA study (2020/11MAI/269) will be analysed similarly to the samples collected during the prospective part. Clinical and routine biological data will be retrospectively collected using the patients electronic medical record (EMR).

Generated data will be integrated using a systems biology approach with algorithms developed by a biostatistics team.

Eligibility Criteria:
Inclusion Criteria:

* 18 years or over
* Patient or legal representative have provided informed consent
* Cases: Reverse-transcriptase polymerase chain reaction (RT-PCR) confirmed symptomatic SARS-CoV-2 infection.
* Controls : (1) Patient presenting with hypoxemic respiratory failure diagnosed by the treating physician as being from infectious origin; (2) SARS-CoV-2 infection excluded by RT-PCR and deemed non-probable by the treating physician.
* Healthy controls : Patients presenting without acute respiratory failure (ie. SpO2 \>93%); (2) no RT-PCR or antigen rapid test proven SARS-CoV-2 infection within the last 6 months; (3) no active respiratory tract infection.

Exclusion Criteria:

* For all: (1) \<18 years old ; (2)unwilling to provide informed consent; (3) pregnancy at the time of inclusion
* For cases: Asymptomatic infection
* For controls: COVID-19 diagnosed by RT-PCR or suspect according to the treating physician at the time of inclusion,
* For health controls: Acute or chronic respiratory failure.
Prevention of Inappropriate ICD Shocks

The aim of the present study is to investigate whether increasing detection zones can effectively reduce inappropriate ICD therapies in primary prevention patients.


Eligibility Criteria:
Inclusion Criteria:

* \> 18 years
* Cardiomyopathy (ischemic or not)
* Current accepted indication for ICD implantation

Exclusion Criteria:

* Previous device implantation
* Secondary prevention patients
* Pregnancy,
* Primary electrical disorders,
* Patient refusal,
* \<1 year of expected mortality
Angiographie and OCT in Macula and Retinal Diseases

The purpose of this study is to investigate the morphological and angiological retinal changes in different macular diseases.

Recently, a new generation of OCT devices relying on spectral domain technology (SD-OCT) has been introduced and allows for higher-resolution imaging. Based on this technology we can identify variable changes at the retinal surface such as, retinal thickening with cyst formation, swelling in the inner and outer nuclear layers and subretinal fluid. The introduction of an eye-tracking mode has allowed a better insight into the development of retinal morphologic changes The aim of this study was to investigate the incidence and structural morphology of PCME after successful uncomplicated cataract surgery in patients with previous pars plana vitrectomy (PPV) and indocyanine green-assisted peeling of an epiretinal membrane and the internal limiting membrane (ILM).

Eligibility Criteria:
Inclusion Criteria:

* previous 23-gauge PPV and ILM peeling

Exclusion Criteria:

* history of branch retinal vein occlusion
* central retinal vein occlusion
* wet macular degeneration
* diabetic retinopathy
* uveitis or other inflammatory eye disease.
Comparison Study of Transversus Abdominal Plane, Paravertebral and Epidural Blocks in Laparoscopic Colectomy

The purpose of this study is to assess the effectiveness of transversus abdominal plane (TAP) block, thoracic epidural or paravertebral block (PVB) for controlling postoperative pain when compared with opioid you self-administer in your vein using a PCA device. The primary outcome will be postoperative opioid consumption within 24 hours after surgery. A total of 120 subjects will be randomized in a 1:1:1:1 ratio to receive a TAP block, PVB, TEA or no block (PCA alone).Patients in all groups will be cared for using an established enhanced recovery after surgery (ERAS) pathway incorporating a multimodal analgesic regimen using IV acetaminophen and postoperative PCA fentanyl.


Eligibility Criteria:
Inclusion Criteria

* Male or female, ≥ 18 years of age
* Patients scheduled to undergo laparoscopic colectomy without stoma under general anesthesia
* American Society of Anesthesiology (ASA) Physical Class 1-3.

Exclusion Criteria:

* Open colectomy
* Perineal resection
* Stoma formation
* Patients with a contraindication to TEA or regional anesthesia.
* Pregnancy, nursing, or planning to become pregnant during the study or within one month.
* Long-acting opioid medication within 3 days.
* Any opioid medication within 24 hours.
* Body weight less than 50 kilograms (\~110 pounds)
* Uncontrolled anxiety, schizophrenia, or other psychiatric disorder
* Current or historical evidence of any clinically significant disease or condition that, in the opinion of the Investigator, may increase the risk of surgery or complicate the subject's postoperative course.
* Administration of an investigational drug within 30 days or 5 elimination half-lives of such investigational drug, whichever is longer, prior to study drug administration, or planned administration of another investigational product or procedure during the subject's participation in this study.
* Suspected, or known addiction to or abuse of illicit drug(s), prescription medicine(s), or alcohol within the past 2 years.
* Significant medical conditions or laboratory results that, in the opinion of the Investigator, indicate an increased vulnerability to study drugs and procedures, and expose the subject to an unreasonable risk as a result of participating in this clinical trial, such as: debilitating diseases, acute illnesses, hypotension, partial or complete conduction block, impaired cardiac function, untreated hypertension, advanced arteriosclerotic heart disease, cerebral vascular insufficiency, pre-existing abnormal neurological or neuromuscular disease (e.g., epilepsy, myasthenia gravis), advanced liver disease, severe renal impairment, advanced diabetes, comorbid conditions associated with an immunocompromised status, such as blood dyscrasias, HIV/AIDS, or recent chemotherapy.
Efficacy of Preoperative Muscle Training on Postoperative Orthopaedic Surgery Recovery

The purpose of this study is to assess the effectiveness of a preoperative muscle training program on hip or knee TJA (Total Joint Arthroplasty). It aims to improve hospital discharge readiness and functional capacity in both the short and long-term. One of the key factors affecting recovery after TJA is how well the patient functions before their surgery. Thus, interventions addressing preoperative function are expected to be beneficial.

Although total hip or knee joint replacement is beneficial in treating severe hip or knee osteoarthritis, a significant number of patients take longer to recover in the hospital or have a non-optimal quality of life after the surgery. These patients often have difficulties in accomplishing basic essential everyday tasks such as walking and stair climbing, both shortly and long after surgery. It has been previously shown through research that difficulties to do basic tasks before surgery delays recovery and negatively affects long-term function. It has also been shown that these difficulties are associated with reduced strength in hip or knee muscles present before surgery, caused by lack of activity of patients. This study will determine if a hip or knee muscle strengthening exercise program accomplished before surgery can improve hospital recovery, capacity to accomplish basic activities, and quality of life two days, six weeks and six months after joint replacement surgery. If this exercise program is shown to be beneficial, it will be easily used by patients when waiting for their surgery.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18 and older undergoing unilateral total hip or knee arthroplasty due to osteoarthritis;
* WOMAC functional subscale less than 66.5/100.

Exclusion Criteria:

* Patients under 18 years of age;
* Patients undergoing joint revision on the affected side;
* patients under the same day discharge protocol;
* Patients undergoing bilateral arthroplasty;
* Patients suffering from other previously diagnosed lower-limb problems limiting their capacity to accomplish the exercise program;
* Patients having surgery in less than 16 weeks after verbal consent;
* Patients unable or unwilling to commit to required study follow-ups;
* Patients with no fixed address;
* Patients with a cognitive impairment that may preclude questionnaire completion;
* Pregnant or suspected pregnant women as dual-energy x-ray (DXA) used in this study may be harmful to a fetus.
PREVENtion of HeartMate II Pump Thrombosis

The purpose of this study is to assess how often blood clots form in the FDA-approved HeartMate® II (HM II) Left Ventricular Assist Device (LVAD) and to identify risks related to clotting within the pump.

PREVENT is a prospective, multi-center, non-randomized study that is designed (1) to assess the incidence of HM II pump thrombosis in the current era when recommended practices for clinical management are adopted, and (2) to identify the risk factors associated with pump thrombosis events. The recommended practices are focused on implantation technique, anticoagulation regimen, pump speed and blood pressure management. All consecutive patients receiving a HM II implant will be considered for this study.

Eligibility Criteria:
Inclusion Criteria:

* Subject or legally authorized representative has signed an informed consent form
* Subject is receiving the HeartMate II as their first Left Ventricular Assist Device (LVAD)

Exclusion Criteria:

* Prior mechanical circulatory support (MCS) (except for intra-aortic balloon pump)
* Participation in any other clinical investigation(s) involving a MCS device, or an investigation(s) that is likely to confound study results or affect study outcome
Targeting Cognition in PTSD: Pregnenolone Augmentation of SSRIs

This study will test the therapeutic potential of augmenting a stable SSRI regimen with the neurosteroid pregnenolone to reduce cognitive symptoms and PTSD symptoms in patients diagnosed with PTSD.

See brief summary

Eligibility Criteria:
Inclusion Criteria:

1. 18-65 years of age, any ethnic group, either sex
2. DSM-IV diagnosis of PTSD by MINI (see schedule of events)
3. No change in SSRI medications for \> 4 weeks.
4. No anticipated need to alter any psychotropic medications for the 10-week duration of the study.
5. Ability to fully participate in the informed consent process, or have a legal guardian able to participate in the informed consent process.

Exclusion Criteria:

1. Unstable medical or neurological illness, including seizures, CVA, prostate or breast cancer
2. Use of oral contraceptives or other hormonal supplementation such as estrogen.
3. Significant suicidal or homicidal ideation.
4. Concomitant medications for medical conditions will be addressed on a case-by-case base to determine if exclusionary.
5. Current DSM-IV diagnosis of bipolar disorder, schizophrenia or other psychotic disorder, or cognitive disorder due to a general medical condition; history of substance dependence within the last 3 months
6. Female patients who are pregnant or breast-feeding.
7. Known allergy to study medication.
8. Drugs with a narrow therapeutic index (e.g. thioridazine, mesoridazine, ziprasidone, clozapine, etc.) will be excluded, as suggested by the FDA; patients taking these agents will not be eligible for this study.
Paralysis of the Orbicularis Muscle of the Eye in the Treatment for Dry Eye

This is a prospective, comparative, contralateral eye study. Patients older than 18 years who have had treatment with topical lubricants for at least 1 month and persist with symptoms of dry eye and corneal staining with fluorescein were included. Patients with dry eye attributable to abnormalities of the eyelids, nasolacrimal obstruction and active corneal infection, as well as patients with severe dry eye were excluded from the study. One eye randomly received a subcutaneous injection of botulinum toxin in the medial part of the lower eyelid, and the other eye received a similar procedure with placebo. The subjective evaluation was achieved with a questionnaire assessing symptoms of dry eye and conjunctivitis, quality of vision and ocular comfort level each eye separately. The objective evaluation included the measurement of the tear film break up time, Schirmer's test and with a modification of the Oxford grading scheme for corneal and conjunctival staining.


Eligibility Criteria:
Inclusion Criteria:

* Treatment with topical lubricants for at least 1 month and persist with symptoms of dry eye and corneal staining with fluorescein.

Exclusion Criteria:

* Dry eye patients attributable to abnormalities of the eyelids (problems with the mechanism of blinking, poor eyelid position, changes in position or structure of the eyelashes, high surface lesions, etc.)
* Nasolacrimal obstruction.
* Active corneal infection.
* Patients with severe grade 4 dry eye.
Parent Engagement Package: Initial Testing of Strategies to Increase Participation in Parenting Interventions

This study evaluated the effectiveness of strategies for engaging parents into parenting programs. Engagement strategies included a booklet showing testimonial quotes and photos from prior participants, a recommendation to attend for the child's teacher, and a motivational call from the parenting program provider. It was hypothesized that the combination of engagement strategies would increase attendance at a parenting intervention compared to receiving only a promotional brochure and research interview.


Eligibility Criteria:
Inclusion Criteria:

* Is the biological or adoptive mother of a child in kindergarten or 3rd grade at the participating school (i.e., "target child");
* The target child lived with the mother at least half of the time;
* The mother spoke English or Spanish;

Exclusion Criteria:

* The target child changed schools;
* The mother reported the target child would be changing schools during the school year;
* The target child attended one of the participating schools during a previous cohort of the study.
Comparative Study of Specular Microscopes for Measurements of Cell Density, Coefficient of Variation and Hexagonality

The primary objective of this clinical study is to collect clinical data to support an FDA 510(k) submission for the Nidek CEM-530 Center point method and Corner point method. The secondary objective is to evaluate any adverse events found during the clinical study.

The primary objective of this clinical study is to collect clinical data to support an FDA 510(k) submission for the Nidek CEM-530 Center point method and Corner point method.

Eligibility Criteria:
Inclusion Criteria:

* Non-Pathologic: Male or female subjects from 18 to 80 years old who have full legal capacity to volunteer on the date the informed consent is signed. Subjects who can follow the instructions by the clinical staff at the clinical site,and can attend examinations on the scheduled examination date. Subjects who agree to participate in the study.
* Pathologic: Male and female subjects from 29 to 80 years old who have full legal capacity to volunteer on the date the informed consent is signed. Subjects who can follow the instructions by the clinical staff at the clinical site, and can attend examinations on the scheduled examination date. Subjects who agree to participate in the study. At least one eye with any of the following conditions:

  * History of post-op surgical trauma including bullous keratopathy
  * History of corneal transplant
  * Physical injury or trauma to the cornea
  * Long term Fuch's dystrophy, Guttata or other corneal endothelial dystrophies
  * Keratoconus
  * Long term PMMA contact lens use (greater than 3 years)

Exclusion Criteria:

* Non-Pathologic: Male and female subjects from 29 to 80 years old who have full legal capacity to volunteer on the date the informed consent is signed. Subjects who can follow the instructions by the clinical staff at the clinical site, and can attend examinations on the scheduled examination date. Subjects who agree to participate in the study. At least one eye with any of the following conditions:

  * History of post-op surgical trauma including bullous keratopathy
  * History of corneal transplant
  * Physical injury or trauma to the cornea
  * Long term Fuch's dystrophy, Guttata or other corneal endothelial dystrophies
  * Keratoconus
  * Long term PMMA contact lens use (greater than 3 years)
* Pathologic: History of cataract, refractive or ocular surgical procedures that render the cornea opaque or otherwise impact its ability to be imaged using the investigational device. Fixation problems which may prevent obtaining at least poor quality (refer to Figure 1) CEM-530 and KONAN CELLCHEK PLUS images in either eye.
Validation of Coregistered CT-PET Imaging in Determining Tumor Volume and Atelectasis in Patients With Operable Non-Small-Cell Lung Cancer and Tumor Associated Atelectasis

CT-PET image fusion has the potential to differentiate 'tumor' from 'atelectasis' much better than the CT-scan in patients with non-small cell lung cancer who also have atelectasis.

This however has never been validated on a histological level. In this study patients with non small cell lung cancer and atelectasis who are eligible for surgery undergo a CT-scan and a PET-scan prior to surgery.

The resection specimen will be compared to the preoperative imaging.


Eligibility Criteria:
Inclusion Criteria:

-Patients with non small cell lung cancer and atelectasis, who are eligible for surgery.

Exclusion Criteria:

* age \< 18 years
* pregnancy