cyrilzakka/clinical-trials huggingface dataset:
Comparative Outcomes Between Image-based Versus Imageless Robot-assisted Unicondylar Knee Arthroplasty

This prospective cohort study was conducted with the aim of comparing relevant clinical outcomes which included intra (surgical time and blood loss), post-operative outcomes (range of motion, function, complications and revisions) and return to activity between imageless and image-based surgical system in medial unicondylar knee arthroplasty

this prospective cohort study was conducted between 1st June 2015 and 1st July 2018 at Bhumibol Adulyadej Hospital, Bangkok, Thailand. A total of 33 medial compartment OA knee patients were randomly allocated to MAKO or NAVIO robotic assisted UKA. The outcomes assessed were intra-operative outcomes (operative time, blood loss) and postoperative outcomes (function, complications and revision) at 1 year after surgery.

Eligibility Criteria:
Inclusion Criteria:

* patients were those deemed suitable for unicondylar knee arthroplasty surgery
* patients who could give informed consent
* patients who willing to attend the prescribed follow-up.

Exclusion Criteria:

* Patients who have medial osteoarthritis knee with following condition:

  1. Ligament insufficiency (anterior cruciate ligament rupture, collateral ligament insufficiency).
  2. Inflammatory arthritis
  3. A deformity requiring augmentation
  4. Neurological movement disorders
  5. pathology of the feet, ankles, hips, or opposite knee causing significant pain or gait alterations
* Patients who ultimately required a total knee arthroplasty (valgus greater than 14 degree, multiple compartment osteoarthritis were contraindications to unicondylar knee arthroplasty.
Patient Registry to Study the Tined Lead Used With the InterStim System For Urinary Control

The purpose of this study is assess the long-term safety and effectiveness of the InterStim tined lead using a minimally invasive approach.


Eligibility Criteria:
Inclusion Criteria:

* Signed and dated informed consent
* 16 years of age or greater
* Willing and able to complete voiding diaries and questionnaires at various time points during the study
* Located geographically near the physician, or willing and able to travel to the physician's site as necessary for all required visits
* Failed or is not a candidate for more conservative treatment

Exclusion Criteria:

* Severe or uncontrolled diabetes; or diabetes with peripheral nerve involvement
* Pregnancy or planned pregnancy
* Concomitant medical conditions which would limit the success of the procedure such as: pelvic pain with uncertain etiology, active degenerative disc disease, spinal cord injury less than six months old, bleeding complications, or a cerebrovascular accident (CVA) less than six months old.
* Anatomical limitations that would prevent successful placement of an electrode
* Neurological diseases such as multiple sclerosis, clinically significant peripheral neuropathy or complete spinal cord injury (e.g., paraplegia)
* Subject characteristics indicating a poor understanding of the study or poor compliance with the study protocol (e.g. subjects with psychological and/or emotional problems, subjects unable to adequately operate equipment)
* Subjects with knowledge of planned magnetic resonance imaging (MRI), diathermy, microwave, high output ultrasonics, ultrasound scanning, or radiofrequency (RF) energy
* Mechanical obstruction such as benign prostatic hypertrophy, cancer, or urethral stricture
* Symptomatic urinary tract infection (UTI). Upon completion of therapy for UTI, or if the subject is receiving prophylaxis for UTI, subjects can be considered for test stimulation or the full system implant (whichever is applicable) if symptom free for one month prior to the procedure.
* Subjects with other implantable neurostimulators, pacemakers, or defibrillators
* Primary stress incontinence or mixed incontinence where the stress component overrides the urge component
* Active participation in another clinical study
Impact of Massage Therapy and Music Therapy on the Quality of Life of Hospice Patients

This is a cohort study where subjects will receive either massage therapy or music therapy interventions to evaluate their impact on hospice patients.

There is growing evidence that integrative therapies such as massage therapy and music therapy can be effective therapeutic tools for relief of pain and non-pain symptoms in hospice and palliative care patients. Massage and music therapies can provide comfort, relaxation, and improve quality of life for patients. The investigator's primary aim is to compare the effects of massage and music therapies on the quality of life of hospice patients. The overall goal is to further improve pain, depression, anxiety, and poor well-being or quality of life in hospice patients through the use of integrative therapies, specifically massage and music therapies, as add-on to standard hospice clinical care. Patients will be assigned to either the massage therapy or music therapy cohort. Questionnaires will be utilized before and after each massage or music therapy intervention to quantify symptom and quality of life levels.

Eligibility Criteria:
Inclusion Criteria:

* Patient is currently enrolled in Mayo Clinic Hospice
* Age 18 years or older
* ESAS-r scores of 5 or greater on pain, depression, anxiety, or best well-being (clinical assessment by hospice nursing staff)
* Patient or caregiver must be able to participate in brief interviews and complete questionnaires (verbally or physically)

Exclusion Criteria:

* Patients that would not be able to get a massage due to complexity of medical care including complex wound and multiple drains
A Phase I Study of QLS12004 in Patients With Advanced Solid Tumors

This study is a single-arm, open, dose-escalation, and dose-expansion phase I clinical trial of QLS12004 in patients with advanced solid tumors, designed to evaluate the safety, tolerability, pharmacokinetics, and preliminary antitumor activity of QLS12004 in subjects with advanced solid tumors.

This study is a single-arm, open, dose-escalation, and dose-expansion phase I clinical trial of QLS12004 in patients with advanced solid tumors, designed to evaluate the safety, tolerability, pharmacokinetics, and preliminary antitumor activity of QLS12004 in subjects with advanced solid tumors.The frequency of administration and the dose to be administered in subsequent clinical studies will be determined based on a combination of preliminary data.

Eligibility Criteria:
Inclusion Criteria:

1. Volunteer to participate in this clinical study; completely understand and know this study as well as sign the informed consent form (ICF);
2. Age ≥ 18 years when ICF is signed;
3. At least one target lesion as defined per RECIST Version (v) 1.1;
4. Dose escalation phase: Pts with histologically or cytologically confirmed advanced solid tumors, who have failed standard therapy or for whom no standard therapy is available;
5. Dose escalation phase: HR+/HER2-advanced breast cancer that has failed prior CDK4/6 inhibitor combined with endocrine therapy;
6. Eastern Cooperative Oncology Group performance status of 0 or 1;
7. Adequate hematologic and organ function;
8. Female subjects who are not pregnant or breastfeeding
9. Male and female subjects able to have children must agree to use highly effective method of contraception throughout the study and for at least 90 days after last dose.

Exclusion Criteria:

1. Subjects with major cardiovascular and cerebrovascular diseases;
2. Any condition that required systemic treatment with either corticosteroids (\> 10 mg daily of prednisone or equivalent) or other immunosuppressive medication ≤ 14 days before the first dose of study drug;
3. Subjects who have received chemotherapy, endocrine therapy, immunotherapy, and targeted therapy, other anti-tumor treatments, or participating in other clinical studies is less than 4 weeks before the first administration of investigational product;
4. Known psychiatric or substance abuse disorders that would interfere with the requirements of the study;
5. HIV-positive or syphilis spiral antibody-positive persons;
6. Major organ surgery (excluding puncture biopsy) or significant trauma within 4 weeks prior to the first dose, or the need for elective surgery during the trial;
7. Known hypersensitivity to the test drug or any of its excipients;
8. History or current evidence of any condition, therapy, or laboratory abnormality, that might confound the results of the trial, or interfere with the participant's participation for the full duration of the study, or investigators/sponsor consider the subjects are not suitable for this trial.
Attenuation of Tonal Tinnitus by Lateral Inhibition Therapy

Lateral Inhibition Therapy (TIL) corrects the patient's hearing by notched amplification on the patient's listening soundtrack. This half-octave notch is targeted at tinnitus frequencies measured tonal. The device slightly increases the amplification around the notch, so that the cerebral cortex compensates for this "gap" in the sound spectrum, masking the crippling tinnitus at the same time. This research is based on a new algorithm developed by the SIEMENS Company which proposes an attenuation of tonal tinnitus by a TIL by notched amplification emitted by the hearing device, object of the study.

In France, up to 16 million people suffer from tinnitus or ringing in the ears daily. This parasitic sound that does not come from the patient's environment can interfere with each individual in a variable way, sometimes creating an insurmountable handicap which has not known any effective treatment validated to date.

Lateral Inhibition Therapy (TIL) corrects the patient's hearing by notched amplification on the patient's listening soundtrack. This half-octave notch is targeted at tinnitus frequencies measured tonal. The device slightly increases the amplification around the notch, so that the cerebral cortex compensates for this "gap" in the sound spectrum, masking the crippling tinnitus at the same time. This research is based on a new algorithm developed by the SIEMENS Company which proposes an attenuation of tonal tinnitus by a TIL by notched amplification emitted by the hearing device, object of the study.

Eligibility Criteria:
Inclusion Criteria:

* Patient over 18 years old.
* Patient with disabling tonal tinnitus (THI score\> 40) for more than 6 months.
* Patient with a hearing loss of at least 25dB, centered on the frequency of tinnitus and requiring hearing aids
* Patient who has never used a hearing aid or a tinnitus masking system.
* Patient who stopped all tinnitus treatment at least 1 month before the start of the study (drug treatment, psychotherapy).
* Patient being willing to attend all of the visits planned as part of the study.
* Patient affiliated or beneficiary of a social security scheme.
* Patient having signed the free and informed consent

Exclusion Criteria:

* Minor patient.
* Patient with hyperacusis
* Patient already with a hearing aid or tinnitus masker.
* Patient undergoing psychotropic or neurotropic drug treatments.
* Patient with a history of psychological or psychiatric disorders.
* Patient with a contraindication to wearing hearing aids.
* Patient suffering from non-disabling tinnitus (THI score \<40).
* Patient suffering from intermittent, non-tonal or pulsatile tinnitus.
* Patient participating in another clinical study.
* Protected patients: adults under guardianship, curatorship or other legal protection, deprived of their liberty by judicial or administrative decision.
* Pregnant or breastfeeding woman
Effects of Adding Photobiomodulation to a Specific Therapeutic Exercise Program for the Treatment of Individuals With Chronic Nonspecific Neck Pain.

In the current clinical and scientific reality, conservative treatment is the most coherent clinical management with a view to the proper rehabilitation of patients with chronic neck pain, with a trend towards the use of therapeutic exercise. However, some uncertainty about the effectiveness of therapeutic exercises still remains, requiring further studies with high methodological rigor, especially with regard to multimodal treatment, such as the combination of therapeutic exercises with photobiomodulation. Thus, the objective of this project is to evaluate the effects of adding photobiomodulation to a program of specific therapeutic exercises for the treatment of individuals with chronic non-specific neck pain. For this, 60 participants will be randomized into two groups: therapeutic exercise group + photobiomodulation (n = 30), and therapeutic exercise group (n = 30). There will be 10 treatment sessions and participants will be evaluated before, after the 10 sessions, and 4 weeks after the end of treatment using the Numerical Pain Scale, Neck Disability Index, Catastrophic Thoughts about Pain Scale, and Tampa Kinesiophobia Scale. In the statistical analysis, a linear mixed model will be applied, considering the interaction between the time and group factors. Finally, the addition of photobiomodulation to a therapeutic exercise program is expected to generate clinical improvements for patients with chronic neck pain.


Eligibility Criteria:
Inclusion Criteria:

* With chronic neck pain (for more than 90 days)
* Identified according to the following criteria: NDI score ≥ 5
* Numerical Pain Scale (END) score ≥ 3 at rest or during active neck movement

Exclusion Criteria:

* Individuals who had a history of cervical trauma; head, face, or cervical surgery
* Degenerative diseases of the spine
* Pain radiating to the upper limbs
* Having been submitted to physiotherapeutic treatment for the cervical region in the last three months
* Use of analgesics, anti-inflammatory drugs, or muscle relaxants in the last week; the presence of systemic diseases
* Medical diagnosis of fibromyalgia.
MRI Thermal Imaging of Infants Undergoing Cooling for Hypoxic Ischemic Encephalopathy(HIE)

Hundreds of babies in the world are being treated with brain cooling to prevent brain injury after they lose oxygen at birth. This study will use the newly developed information from the magnet resonance image to determine the actual temperature of the brain. This will enable us to determine if the brain is being uniformly cooled and if techniques that provide cooling need to be changed to improve the injury prevention from cooling.

We propose to develop a non-invasive measurement of brain tissue temperature and to apply this measurement of infants under-going cooling for HIE

1. We propose to do this by refining the use of the MRI evaluation of the NAA-H20 frequency shift. This molecular relationship is quite accurate (based on preliminary studies of an NAA-H20 phantom subject to controlled temperature variations) for measuring relative temperature changes.
2. The next step will be to perform further phantom imaging with continuous temperature measurements and to expand the phantom model. This work needs funding support to be completed.
3. At the same time we will be applying the MRI thermal imaging protocol to infants whom have experienced HIE and who are being treated with hypothermia to ameliorate the HIE. We have IRB approval to approach families and to obtain the required data during clinically indicated MRI scans, this data accumulation will add an additional 3-5 minutes to the MRI. We will then perform a second MRI after the infant is rewarmed. We will compare the pairs of readings at two different core temperatures from at least five regions of the brain.
4. We will evaluate results of regional temperature measurements to determine if cooling of the human infant brain is uniform.
5. We will compare the two modalities of cooling to determine if selective head cooling and total body cooling provide similar distribution of cooling.
6. The final goal will be to compare MRI identified injury patterns to the temperature distribution in order to determine if distribution of cooling is related to outcome.

Eligibility Criteria:
Inclusion Criteria:

* Infants in the NICU who are treated with hypothermia for hypoxic ischemic encephalopathy and who are scheduled to have an MRI for evaluation of the extent of their injury.
* Parent and attending physician consent to perform evaluation of MRI thermography.

Exclusion Criteria:

* Infants too unstable to have MRI scan, defined by being on any cardiac pressor medications or more than 40% oxygen on the ventilator.
* Infants too active to obtain MRI without sedation.
Patients Returning to Work After Acute Coronary Syndrome

The literature is quite rich concerning the factors which influence the return to work after acute coronary syndrome. They can be divided into three categories: factors linked to the patient, those linked to the workstation and factors linked to an external intervention. A study published in 1992 evaluated a set of predictive factors for recovery one year after acute coronary syndrome and showed that the proportion of clinical factors accounted for 20%, functional factors for 27% but above all socio-economic factors for 45. %.

On the other hand, there are only a few studies that are interested in the return to work after acute coronary syndrome according to the management in occupational medicine, and in particular the realization or not of a pre-return visit.

The results of a survey published in 2016 show that the recommendations made during the return visit were significantly different depending on whether or not there was a pre-return visit and concerned all types of pathology.

In view of all of these elements, it seems important to the investigators to study the expected benefit of an early orientation towards occupational medicine via the pre-return visit, and to study the factors delaying or favoring the return to work. .


Eligibility Criteria:
Inclusion criteria:

* Age ≥18 years old
* In professional activity during acute coronary syndrome (employee, civil servant, self-employed or looking for a job)
* -Mastering the French language (knowing how to read and write French)
* Agreeing to participate in the study and not having expressed his opposition to the reuse of his data for the purposes of this research

Exclusion criteria:

* Subject having expressed opposition to participating in the study
* Inability to provide informed information about the subject (subject in an emergency situation, difficulty in understanding the subject, etc.)
* Subject under safeguard of justice
* Subject under guardianship or guardianship
Characteristics and Outcomes of Intensive Care Unit Patients Admitted With Novel H1N1 Influenza or Seasonal Influenza

The purpose of this research study is to collect information on problems that patients with the novel H1N1 influenza and/or the seasonal influenza experience. Novel H1N1 flu is also called the swine flu. Seasonal influenza is also called the regular flu. The purpose of this study is to collect information from patients who are infected with either the novel H1N1 or the seasonal flu and to determine what makes patients critically ill with these infections. The goal is to develop a registry that will aid investigators in determining specific markers that lead to development of severe illness in these infections.

Patients admitted to the medical intensive care unit with either novel H1N1 infection or seasonal influenza infection may be eligible for participation.

Eligibility Criteria:
Inclusion Criteria:

* Patients admitted to the medical intensive care unit with a diagnosis of novel H1N1 influenza infection or with a diagnosis of seasonal influenza infection.

Exclusion Criteria:

* Prisoners
* Refusal of study participation.
Encochleated Oral Amphotericin for Cryptococcal Meningitis Trial 3

This pivotal, confirmatory trial seeks to independently verify the results observed in the EnACT Phase II Stage 2 trial (MB-70007).

Pivotal, prospective, randomized, open-label, non-inferiority trial to compare the efficacy and safety of step-down induction and consolidation therapy for the treatment of cryptococcal meningitis with oral MAT2203 plus flucytosine to standard of care therapy. Randomization will by 1:1:1 to one of two experimental arms or standard of care.

Eligibility Criteria:
Inclusion Criteria:

* CSF cryptococcal antigen (CrAg) positive meningitis
* Ability and willingness to provide informed consent
* Willing to receive protocol-specified lumbar punctures

Exclusion Criteria:

* Glasgow Coma Scale \< 15 at time of consent
* Received \>= 3 doses of amphotericin B within prior 30 days
* Inability to take enteral (oral or nasogastric) medicine
* Cannot or unlikely to attend regular clinic visits
* Receiving chemotherapy or corticosteroids
* Suspected paradoxical immune reconstitution inflammatory syndrome (IRIS)
* Pregnancy or breastfeeding
* Previous administration of MAT2203
* Any condition for which participation would not be in the best interest of the participant or that could limit protocol specified assessments
PDL1 In Primary Colorectal Carcinoma and Its Prognostic Impact

Colorectal cancer (CRC) is a highly heterogenous disease. It the third most commonly diagnosed cancer in the world and the second cause of death among cancer cases mortality. Its incidence is rising all over the world, especially in developing countries . In Egypt it is coming the seventh cancer in incidence according to World Health Organization (WHO, 2020). Although there is much improvement in the diagnosis and treatment, but CRC is still constituting a big impact on human life and health, so researchers are trying to find out new therapeutic targets .

Programmed cell death protein 1 (PD-1) is an inhibitory receptor which is expressed on the surface of T lymphocytes during activation. Its role is to control T cell effector activity for various cellular responses as infections, autoimmune reactions, and cancer .

Cancer cells develop PD-ligand1 (PD-L1) expression which is a transmembrane molecule belonging to B7 family. Its action is through PD-1/PD-L1 reaction, and causing invasion and metastasis of cancer cells by protecting it from immunosurveillance by inhibiting T cell effector function, leading to carcinogenesis and development of many cancers including colorectal cancer.


Eligibility Criteria:
Inclusion Criteria:

1. Both endoscopic and excisional biopsy specimens.
2. All the studied cases include sufficient materials for the immunohistochemical study.
3. Complete clinical data

Exclusion Criteria:

1. Patients with recurrence of the primary tumor.
2. Patients with a history of preoperative chemotherapy and/or radiotherapy.
3. Insufficient or tiny tissue biopsies
Three Year Evaluation of a Cohort of Patients Presenting Osteoporotic Fractures

A specialized osteoporosis clinic has existed in our hospital since 2010. The descriptive retrospective analysis of patients included in this pathway was the subject of a first study on patients included between January 2010 and January 2011 and reported to the Congress of the French Society of Rheumatology (SFR) in December 2011, then a second study on patients included between January 2012 and December 2016, presented as an e-poster at the SFR Congress in December 2017 and in a poster at the American Society of Bone and Mineral Research Conference (ASBMR) in October 2018 and published in 2019 in Archives of Osteoporosis.

The effectiveness specialized osteoporosis clinics is the subject of numerous publications.

It therefore seems important to evaluate the effectiveness of our management, 3 years from the date of inclusion of patients in the osteoporosis clinic of our hospital.


Eligibility Criteria:
Inclusion Criteria:

* Patients who had an osteoporotic fracture followed by the osteoporosis clinic since between January 2012 and December 2015
* Acceptation of the telephone interview

Exclusion Criteria:

* Age \< 18 years
* No social security coverage