cyrilzakka/clinical-trials huggingface dataset:
A Study to Evaluate the DDI of HSK7653 With Metformin

This is a Phase 1, single center, open-label, single arm, drug-drug interaction study of HSK7653 and metformin in Healthy Subjects.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 and Age ≤60 years
* BMI ≥18 and BMI ≤ 28 kg/m2 (Body Mass Index)
* Able to understand the procedures of the study, and provide written informed consent and willing to comply with the study protocol procedures.

Exclusion Criteria:

* Any finding of the medical examination (physical examination, laboratory examination, 12-ECG, abdominal B-ultrasonography, etc) deviating from normal and of clinical relevance during screening;
* Fasting blood glucose \<3.9mmol/L or ≥6.1mmol/L;
* Has a condition affecting the absorption, distribution, metabolism, and excretion of the drug;
* Has a positive result on screening for serum hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCVAb), Treponema pallidum antibody (TP-Ab) or human immunodeficiency virus (HIV);
* Treatment with an investigational drug within 3 months;
* Other protocol-defined exclusion criteria.
Cerebral Oximetry in Cardiac Surgery to Reduce Neurological Impairment and Hospital Length-of-stay

Cerebral oximetry using near-infrared spectroscopy (NIRS) has been shown to reduce the incidence of neurological dysfunction and hospital length-of-stay in adult cardiac surgery though not all studies agree. A previous audit using cerebral saturations at or above baseline showed improved neurological and length-of-stay outcomes.

This prospective, single centre, double-blinded controlled study randomized 182 consecutive patients, scheduled for cardiac surgical procedures using cardiopulmonary bypass. Participants were randomized by concealed envelope prior to anaesthesia. NIRS study group were managed perioperatively using our NIRS protocol. The control group had standard management without NIRS. Primary outcomes were post-operative neurological impairment and hospital length-of-stay. Secondary outcomes included ventilation times, intensive care unit length-of-stay, major organ dysfunction and mortality

Eligibility Criteria:
Inclusion Criteria:

Patients undergoing elective cardiac surgery using cardiopulmonary bypass. Patient over 18 years age. -

Exclusion Criteria:

Emergency surgery. Cardiac surgery without cardiopulmonary bypass. Inability to perform test.

Persistent neurological conditions:

Recent stroke. Dementia. Alzheimer's Disease Parkinson's Disease

-
Fertility Preservation in Men Affected by Cancer

This is a single center cross-sectional retrospective study with a quantitative and qualitative approach (phase 1 and 2). In phase 1 an online survey will be realized and targets male cancer survivors. Phase 2 will take a qualitative approach, in which information about patient's experiences, needs and helpful support will be collected by establishing focus groups of cancer patients who had been diagnosed during the reproductive age.

In the end, the results of this study will be integrated into the development of an online support tool concerning Fertility Preservation (FP).


Eligibility Criteria:
Inclusion Criteria:

* German speaking
* Cancer diagnosis within the last 10 years (minimum age at diagnosis 13 years)
* Cancer therapy that was expected to impair fertility

Exclusion Criteria:

* Prepubertal at diagnosis
Clinical Outcomes After Dry Needling on Cervical Muscles, and Quality of Life, in Patients With Fibromyalgia Syndrome.

Objectives: The purpose of the current randomized clinical trial is to compare the effectiveness of dry needling versus myofascial release therapy on myofascial trigger points (MTrPs) in cervical muscles, quality of life, fatigue, quality of sleep, anxiety and depression in patients with fibromyalgia syndrome (FMS).

Design: A single-blind randomized controlled trial will be conducted on patients with FMS.

Methods: Sixty-four subjects with FMS will be randomly assigned to an experimental group receiving dry needling therapy, or to a control group for myofascial release therapy in the trigger points active or latent in the following pairs of muscles: occipital, splenius capitis, sternocleidomastoid, scalene, trapezius, supraspinatus, infraspinatus, and multifidus. Myofascial trigger points, quality of life, impact of fibromyalgia symptoms, quality of sleep, intensity of pain, anxiety levels, state of depression, impact of fatigue will be recorded at baseline and after four weeks of treatment.

Eligibility Criteria:
Inclusion Criteria:

* Fibromyalgia syndrome diagnosis.
* Aged from 18 to 60 years.
* No regular physical activity.
* Limitation of usual activities due to pain on at least 1 day in the previous 30 days.
* Agreement to attend evening therapy sessions

Exclusion Criteria:

* Receipt of any no pharmacologic therapies.
* Presence of cardiac, renal or hepatic insufficiency.
* Severe physical disability.
* Comorbid condition (eg, inflammatory disease).
* Infection fever.
* Hypotension.
* Skin alterations.
* Psychiatric illness.
* Previous history of surgery.
The Effects of Preconditioning on Intramuscular High-Energy Phosphate Levels During Ischemia

Ischemia reperfusion injury may be reduced by ischemic preconditioning. This projects aims to show the effects of short and long time ischemic preconditioning (both sequences 3 x 5 minutes) during and after an ischemic period of 20 minutes in healthy subjects by functional MRI. Ischemia is produces by cuff inflation to a suprasystolic pressure on one tight. Signal is acquired from calf muscles.

A cross-over design of 4 to 8 study periods is used, 4 different study days with 2 different MR measurement methods (BOLD imaging and high energy phosphates) are planned.


Eligibility Criteria:
Inclusion Criteria:

* Men aged between 18 and 45 years
* Nonsmoker for more than 3 months
* Body mass index between 18 and 25 kg/m2
* Normal findings in medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant

Exclusion Criteria:

* Regular use of medication, abuse of alcoholic beverages, participation in a clinical trial in the 3 weeks preceding the study
* Evidence of hypertension, pathologic hyperglycemia, hyperlipidemia
* Treatment in the previous 3 weeks with any drug including over-the-counter drugs
* Symptoms of a clinically relevant illness in the 2 weeks before the first study day
* Blood donation during the previous 3 weeks
* Any metallic, electric, electronic or magnetic device or object not removable
* Claustrophobia
Effect of Physical Therapy and/or Platelet Rich Plasma Injection in People With Knee Cruciate Ligament Injuries

Background:

The anterior cruciate ligament(ACL) , one of the major ligaments in the knee joint which connects the posterior aspect of the lateral femoral condyle to the anterior intercondylar area of the tibia. It plays a crucial role in maintaining knee joint stability, preventing excessive rotation of the tibia, and controlling the angles of knee valgus and varus. Additionally, the ACL contains mechanoreceptors that contribute to proprioception input. Acute ACL injuries are characterized by joint effusion, instability, and reduced range of motion. In the chronic phase, instability and pain may occur during rotational and cutting movements.

Currently, regenerative injection therapies such as high-concentration platelet-rich plasma (PRP)and bone marrow concentrate (BMC) are being explored for ACL repair. Studies have found that postoperative administration of high-concentration PRP significantly reduces pain and improves knee joint function for a duration of 3 to 6 months, but these effects are not sustained beyond 12 months. In addition, some research indicates that high-concentration PRP does not enhance graft healing or improve knee joint stability.

Method:

This is a single-institution, single-blind, observational study conducted by the rehabilitation department of a public hospital. The study aims to recruit 40 participants with anterior cruciate ligament (ACL) or posterior cruciate ligament (PCL) injuries. The treatment intervention is collaboratively determined by the physician and the participant during the clinic visit. Subsequently, a therapist, unaware of the treatment details, conducts baseline assessments, including basic information collection, balance testing, gait analysis, timed up and go test, muscle strength evaluation, and subjective knee assessment questionnaire. Additionally, a physician, blinded to the treatment content, employs ultrasound to assess ligament elasticity. Follow-up assessments are conducted for the same parameters two months later.


Eligibility Criteria:
Inclusion Criteria:

1. Age between 18 to 80 years old.
2. Magnetic Resonance Imaging (MRI) shows partial tearing of the anterior cruciate ligament (ACL) or posterior cruciate ligament (PCL), possibly combined with injuries to the medial collateral ligament (MCL) or meniscus.
3. No surgical treatment has been undergone.

Exclusion Criteria:

1. Had knee joint diseases or undergone knee joint surgery before the injury.
2. Surgical intervention is required for severe damage to knee joint ligaments, meniscus, or articular tissues, such as complete rupture of lateral ligaments or full-thickness cartilage injuries.
3. Suffers from diseases affecting physical activity function, such as stroke or nerve damage.
Study to Assess the Efficacy and Safety of Dysport® in Cervical Dystonia

The aim is to demonstrate equivalent efficacy and safety in the treatment of the two most frequent forms of cervical dystonia (predominantly rotational torticollis and predominantly laterocollis) with the standard initial dose of 500 units Dysport®. The patients will be assigned to one of the two basic types of cervical dystonia, either predominantly rotational torticollis or predominantly laterocollis on the basis of clinical examination. This will determine which therapy is to be administered, using the clearly defined, structured injection protocols.


Eligibility Criteria:
Inclusion Criteria:

* De novo patients with cervical dystonia
* Outpatient
* Patients to be of age 18 years or older
* Written informed consent to participate in the study

Exclusion Criteria:

* Pre-treatment of cervical dystonia with botulinum toxin
* Pre-treatment with botulinum toxin for any indication other than cervical dystonia within the past 12 months
* Pure retro- or antecollis
* Neurological or other diseases which may affect head and neck motor function or neuromuscular transmission, e.g. polyneuropathy with pareses, myasthenia, myopathy, motor neurone diseases, Bekhterev's disease
French Parkinson's Disease Cohort - NS-PARK

The aim of NS-PARK cohort are to describe the natural history of Parkinson's disease (PD), and to propose patients stratification models based on PD pathophysiological mechanisms. Patients are included at all PD expert centers in France. Standardized demographic, diagnosis, motor and non-motor symptoms evaluation, and treatment information are collected, and clinical data are updated at each visit of the patient at the center. A blood sampling is perform at baseline for genetic testing and implement an associated biocollection.

The national clinical research network for Parkinson's disease (NS-PARK/FCRIN) reassembles all expert centers in Parkinson's disease (PD) in France. Its aim is to promote clinical research in Parkinson's disease and movement disorder, to better understand the pathophysiology of PD, foster the development of new therapeutic strategies, and move towards personalized medicine. To help centers for prescreening, a national registry of PD patients followed in each centers has been implemented in 2016 to collect minimal relevant clinical information of patients followed in each center including demographic data, age at diagnosis, standardized motor and non-motor symptoms evaluation, and treatment. Data are updated at each visit of the patient in the center. De facto, this registry became a longitudinal cohort of PD patients followed in NS-PARK centers. In 2020, NS-PARK received funding to associate a biocollection to this clinical cohort.

The aim of NS-PARK cohort are to describe the natural history of PD progression in clinical routine in France, to develop new models of PD describing the different progression profiles, and to propose patients stratification based on PD pathophysiological mechanisms. The cohort will also serve as a platform to discover new PD genes and genetic modifiers of disease progression or response to treatment.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Parkinson's disease according to UK PD brain bak criteria
* OR diagnosis of parkinsonian syndrome: multiple system atrophy, progressive supranuclear palsy, dementia with Lewy body, or corticobasal syndrom
* OR Subjects at risk of PD defined as :

No symptom or diagnosis of Parkinson's disease nor parkinsonian syndrome, and relative to a patient with a diagosis of PD or parkinsonian syndrome, or carrier of a known mutation responsible for a genetic form of PD or patient with a diagnosis of idiopathic REEM sleep disorder or prodromal form of PD as defined by MDS criteria (Berg et al., 2015)

AND for all participants

* Affiliated to social security
* Age \> 10 years

Exclusion Criteria:

* Subject under legal protection
* Subject who do not consent to the research
* for the optional skin biopsy only: clinically significant coagulation abnormalities or anticoagulant treatment
Intense Pulse Light Treatment With Meibomian Gland Expression of the Upper Eyelids in Dry Eye Disease

Upper eyelid treatment has not been used with previously described methods of treatment of dry eye disease using intense pulsed light therapy because the upper lids disease was typically not as advanced as lower lid and because direct treatment of the upper lid was not felt to be necessary as each light pulse extended over the entire periorbita even when concentrated on the lower lid.

Dry eye disease is an under-diagnosed and growing problem. Intense pulsed light has been a proven method of improving the signs and symptoms of meibomian gland dysfunction including lid margin vascularity, meibum viscosity, OSDI mean score and tear break up. This study looks at the safety and effect of treatment of upper lids only to evaluate the safety and efficacy of direct upper lid treatment on the signs and symptoms of dry eye.

Eligibility Criteria:
Inclusion Criteria:

* subjects older than 18
* cloudy or inspissated meibomian glands in both upper lids
* ocular pain due to dry eye unrelieved by current or prior use of conservative topical dry eye medications including but not limited to over the counter artificial tears, lifitegrast, cyclosporine, or sodium chloride.

Exclusion Criteria:

* Patients with eyelid abnormalities
* intense pulsed light treatment within the past year.
* Patients on oral retinoids,
* patients undergoing intraocular surgery within the past year,
* patients with uncontrolled ocular disease,
* Fitzpatrick skin type V or VI,
* neuro-paralysis in the planned treatment area in the past 6 months,
* pre-cancerous lesions in the planned treatment area.
* New topical eye treatments,
* previous expression of meibomian glands,
* legally blind in one eye.
Scripps Polster Breast Care Center Investigational GeneBank

Breast cancer is a disease of complex origin with a strong genetic component. The incidence of breast cancer is very high in monozygotic twins of patients, and it is thought that a high proportion and perhaps the majority of breast cancers arise in a small number of genetically susceptible women. Recent studies in human genetics have discovered several intervals in the human genome containing inherited variants that are statistically associated with the propensity to develop breast cancer. The investigators plan to use this knowledge to design a genetic screening test to guide recommendations for breast cancer screening with mammography. If the small group of genetically susceptible women can be identified, more effective breast cancer screening strategies can be implemented. In contrast, a very large proportion of women who undergo yearly mammography are at exceptionally low risk from a genetic perspective. Using genomic guidance could eventually reconfigure the most efficacious strategy to screen women for early detection of breast cancer.

By developing a genetic screening panel based on genetic markers for breast cancer, the investigators will be able to more accurately determine a woman's individual risk for developing breast cancer.

Women the age of 30 or over who are undergoing screening or diagnostic breast imaging as an out patient at the Scripps Polster Breast Care Center in La Jolla, CA, with at least 5 years of historic breast imaging data available will be eligible to enroll. For this study, consecutive subjects who have completed screening or diagnostic breast imaging at the Scripps Polster Breast Care Center will be enrolled for one day. It is estimated that up to 5000 subjects will be included in the cohort.

Eligibility Criteria:
Inclusion Criteria:

1. Age 30 years or older
2. Be reliable, cooperative and willing to comply with all protocol-specified procedures
3. Able to understand and grant informed consent
4. Be undergoing screening or diagnostic breast imaging
5. Have at least 5 years of breast imaging data available

Exclusion Criteria:

1. Have a significant chronic medical condition which, in the Investigator's opinion, would interfere with the subject's participation in the study
2. Have undergone treatment with any investigational agents or devices within thirty days preceding enrollment in the study
3. Have taken any CNS sedation or depressants in past 12 hours
Topical TRanexamic Acid Vs. Placebo on Acute Postoperative Pain Following DRF Fixation

The goal of this study is to find out whether the use of topical tranexamic acid (TXA) into the surgical wound will result in less post-operative pain, less pain killer use, and better post-operative use of the wrist in people undergoing surgery for a wrist fracture compared to not using topical TXA (placebo).


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing open reduction internal fixation (Volar approach) for operative management of a distal radius fracture;
* Aged 18 or older;
* Provision of informed consent;
* Cognitive ability and English-language skills required to complete outcome measures.

Exclusion Criteria:

* Revision surgery or any additional operative management of ipsilateral wrist injury
* Distal radius fracture treated with a dorsal approach
* Known history of lymphedema or lymph node dissection in the operative extremity
* Known chronic pain conditions, fibromyalgia, or polymyalgia rheumatic
* Current user of opioids and/or on chronic opioids use
* Known allergic reaction to TXA
* Anticoagulant use not stopped in time for surgery as per thrombosis Canada guidelines (i.e. warfarin, acetylsalicylic acid, direct oral anticoagulants, etc.)
* Previous thrombotic stroke or thromboembolic disorders (i.e. known previous DVT, PE, or clotting disorders)
* Current pregnancy or breastfeeding
* Previous neurologic injury causing paralysis of affected shoulder/arm
* Severe cardio-respiratory disease (i.e. ASA Grade IV or higher).
Efficacy and Safety Study of GSK1120212, a MEK Inhibitor, in Subjects With Uveal Melanoma

The purpose of this study is to determine whether GSK1120212, a MEK inhibitor, is an effective and safe treatment for cancer subjects with metastatic uveal melanoma and mutation-positive GNAQ or GNA11 metastatic melanoma.


Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically confirmed diagnosis of metastatic uveal melanoma or previously documented mutation-positive GNAQ or GNA11 metastatic melanoma not previously treated with a MEK inhibitor.
* Provide archival tumor tissue or, if tissue blocks are not available, undergo fresh tumor biopsy prior to enrollment.
* The patient has a radiographically measurable tumor.
* ECOG performance status 0, 1, or 2.
* The patient is able to swallow and retain oral medication.
* Life expectancy of at least 4 months.
* Toxicities from previous anti-cancer therapy (except alopecia) are recovered (Grade 1 or less) at the time of enrollment.
* The patient has adequate organ and bone marrow function.
* Sexually active patients must use medically acceptable methods of contraception during the course of the study.
* Female patients of childbearing potential must have a negative serum pregnancy test at screening.

Exclusion Criteria:

* The patient has had any of the following within 21 days of starting study drug or anticipates the need for any of the following during the course of study treatment: chemotherapy, immunotherapy, biologic therapy, hormone therapy, major surgery, or tumor embolization.
* The patient has received experimental therapy within 21 days of starting study drug.
* The patient has received nitrosourea or mitomycin C within 42 days of starting study drug.
* The patient has received any herbal medications or palliative radiotherapy within 14 days of starting study drug.
* The patient is currently receiving anticoagulation therapy that is not well controlled.
* Ongoing or newly diagnosed eye abnormality other than symptoms due to uveal melanoma.
* History of retinal vein occlusion or central serous retinopathy.
* Current severe, uncontrolled systemic disease.
* History of leptomeningeal disease or spinal cord compression secondary to metastasis.
* Brain metastasis, unless previously treated with surgery, whole-brain radiation or stereotactic radiosurgery and the disease has been stable for at least 3 months without steroid use or on a stable dose of steroids for at least 1 month prior to starting study drug. Stability of brain metastases must be confirmed with imaging.
* The patient has a concurrent, active hematological malignancy or other solid tumor malignancy.
* History of clinically significant cardiac or pulmonary dysfunction.
* Allergy or hypersensitivity to components of the GSK1120212 formulation.
* The patient is pregnant or breastfeeding.
The Effect of Bevacizumab on the Trabeculectomy

The investigators plan to evaluate the additive effect of intracameral and subconjunctival injections of bevacizumab in trabeculectomies with other antimetabolites.

Glaucoma filtration surgery is routinely utilized to control intraocular pressure in glaucomatous patients. It reduces IOP by creating a fistula between the anterior chamber and the subconjunctival space with a filtering bleb. Increased wound healing response affects the function and morphology of the filtering bleb, and wound healing involves a series of biological events beginning with hemostasis.

Corticosteroids and antifibrosis agents such as mitomycin C and 5-fluorouracil have been employed in trabeculectomy to delay wound healing and hence to improve the success rate of surgery by inhibiting inflammation and fibroblastic activity, and the use of these antiscarring agents is generally believed to improve the success rate of trabeculectomy.But this rate decreased with passing time and thus was not perfect.

Vascular endothelial growth factor is a pivotal stimulator of angiogenesis because its binding to VEGF receptors has been demonstrated to promote endothelial cell migration and proliferation in wound healing.Therefore, anti-VEGF agents may potentially modulate wound healing following glaucoma filtration surgery.

The principal objective of this study was to evaluate the additive effect of intracameral and subconjunctival injections of bevacizumab in trabeculectomy.

Eligibility Criteria:
Inclusion Criteria:

* glaucoma patients who have trabeculectomy

Exclusion Criteria:

* patients with the other ocular disease