cyrilzakka/clinical-trials huggingface dataset:
Lead-212 PSV359 Therapy for Patients With Solid Tumors

Phase I/IIa clinical study evaluating the safety and efficacy of peptide-based "theranostic" (therapeutic and diagnostic) radiopharmaceuticals, i.e. \[203Pb\]Pb-PSV359 and \[212Pb\]Pb-PSV359 targeting Fibroblast Activation Protein in subjects with solid tumors.

Not Provided

Eligibility Criteria:
Inclusion Criteria:

* Aged ≥ 18 years
* Satisfactory organ function as determined by laboratory testing
* Eastern Cooperative Oncology Group performance (ECOG) status of 0 to 1
* Life expectancy \> 3 months
* Progressive disease despite standard therapy or for whom no standard therapy exists
* Positive \[203Pb\]Pb-PSV359 SPECT/CT scan showing uptake of \[203Pb\]Pb-PSV359 in at least 1 known lesion on the 1-hour SPECT/ CT scan
* Histological, pathological, and/or cytological confirmation of solid tumor malignancy that is locally advanced or metastatic

Exclusion Criteria:

* Known hypersensitivity to the active agent or any of the excipients
* Active secondary malignancy
* Pregnancy or breastfeeding a child
* Known brain metastases
* Known active or uncontrolled infections requiring ongoing antifungals or antibiotics in the 3 days prior to enrollment
* Known medical condition which would make this protocol unreasonably hazardous for the patient
* Existence of any medical or social issues likely to interfere with study conductor that may cause increased risk to the subject or to others, e.g., lack of ability to follow radiation safety precautions
* Medical history of a condition resulting in a severe allergic reaction such as anaphylaxis or angioedema to known components of the investigational product or excipients
* Major surgery within 21 days prior to the administration of \[212Pb\]Pb-PSV359; the subject must be sufficiently recovered and stable before treatment administration
* Diagnosis of deep vein thrombosis or pulmonary embolism within 4 weeks prior to enrollment into the study
* Current abuse of alcohol or illicit drugs
* Treatment with any live/attenuated vaccine in the 7 days prior to enrollment
* Previous treatment with any systemic anticancer therapy within 4 weeks prior to treatment on study
Efficacy of rTMS on Pain Following Stroke.

Pain is a common symptom experienced by people following stroke and can significantly interfere with participation in the activities of daily living and adversely affect health-related quality of life. Repetitive Transcranial Magnetic Stimulation (rTMS) promotes the modulation of brain activity and its prolonged and continuous application can effect plastic modification. Combining rTMS with rehabilitation treatment for primary motor cortex activation (using Gloreha® device) may have effect in reducing pain in stroke survivors. This is a pilot randomized control trial to test the effects of rTMS in stroke-related pain rehabilitation, its efficacy on pain, upper limb function, sensory function and autonomy in daily livings activities. Furthermore, we will explore the effects on pressure pain threshold, cortical excitability and EEG recording.


Eligibility Criteria:
Inclusion Criteria:

* diagnosis of first stroke verified by brain imaging \< 6 months
* pain defined as a constant or intermittent sensory symptom with unpleasant feelings or pain and a minimum score of 3 points on the Numeric Rating Scale (NRS) for pain perception

Exclusion Criteria:

* medical conditions likely to interfere with the ability to safely complete the study protocol
* cognitive functioning to give informed consent identified by a Mini-Mental Status Examination (MMSE) score ≥ 24/30
* intracranial metal implants
* history of seizures or epilepsy
* severe cardiopulmonary, renal, and hepatic diseases
* pregnancy
Clinical and MRI Cardiac Biomarkers on Peripheral Arterial Disease in Patients With Long Term DM

The aim of this study is to establish a clinically feasible simultaneous evaluation of heart and lower limb using MRI and to assess the combined benefit of clinical and cardiac MRI imaging markers in the evaluation of PAD and prediction of treatment outcome.

We expect to enroll about 60 long-term DM patients (\>10 years) from main study. Patient will receive evaluation of the perfusion in the lower limb by using blood oxygenation-level dependent (BOLD) sequence with measurement of the extracellular volume fraction (ECV) as an indicator of fibrosis severity in calf muscles. All patients will receive cardiac MRI (cardiac function, ischemia and fibrosis) and MR angiography (severity of PAD). The baseline studies will be completed within 2 years and 3 additional follow-up studies will be performed by the end of 4th year.

Eligibility Criteria:
The inclusion criteria include:

1. Able to understand and provide signed informed consent
2. DM history of 10 years and above
3. Willing to receive 3 MRI follow-up and serum hematocrit examinations within 2 years, if applicable
4. Willing to receive standard therapy such as surgery or medication
5. Age between 18-80 years old

The exclusion criteria include:

1. Pregnant or breast-feeding women
2. Allergic MRI contrast medium
3. Absolute contraindications to contrast MRI (e.g., metallic hazards, hemodynamic instability, pregnancy, known allergy to contrast medium).
4. Contraindicated to MRI study: cardiac pacemaker, cochlear implantation, metallic object within eyeball
5. Patients that refuse to, or has poor ability of understanding and comply study conditions, such as severe dementia or difficulty in mobility
6. Patients having dialysis
Scleral Hydrops and Intralabyrinthine Schwannoma

The symptoms of intralabyrinthine schwannomas (vertigo, deafness, instability, tinnitus) cut across the symptoms found in pressure pathologies involving the inner ear, particularly the endolymphatic hydrops.

Some publications have described dilatation of the membranous labyrinth (hydrops) in the presence of intralabyrinthine tumors.

It would be interesting to measure the size of the saccule (structure of the membranous labyrinth) in the presence of an intralabyrinthine schwannoma, to evaluate if some of the symptoms presented by the patients could be explained by the concomitant presence of an endolymphatic hydrops (accessible to drug therapy - Betahistine).


Eligibility Criteria:
Inclusion Criteria

* Age\> 18,
* Subject having benefited from an exploration of internal auditory canals by MRI in our service at CHU de Hautepierre between January 1, 2008 and October 1, 2017
* Presence on the MRI of the internal auditory ducts, including the realization of a high resolution fluid sequence of FIESTA-C (exploitable) type, of an intralabyrinthine schwannoma, without extension to the internal auditory canal.
* Subject who has agreed to the use of medical data for the purposes of this research.

Criteria for Non Inclusion

* Refusal of the patient to participate in the study
* Absence of high resolution fluid sequence of fast imaging employing steady state acquisition (FIESTA-C)
* Presence of movement artifacts interfering with the interpretation of the FIESTA-C sequence
* Interior surgery of the inner ear or pontocerebellar angle, without preoperative imaging Inflammatory or infectious pathology of the concomitant middle or inner ear
* Extension of schwannoma to the internal auditory canal
* Impossibility of giving the subject informed information (difficulty understanding the subject,)
* Subject under the protection of justice
* Subject under guardianship or curatorship
Kansas Intensive Permanency Project

The intervention provides services to children with Serious Emotional Disturbance (SED) who are in foster care and to their parent(s) to prepare the families for reunification.

The intervention provide services to children with Serious Emotional Disturbance (SED) who are in foster care and to their birth parents to prepare the families for reunification. The evaluation follows a randomized design. The pretest will assess the procedures and instruments for collecting data on child, youth, and family functioning. Ultimately, after the pretest is complete, the data collected through the evaluation will provide information on the extent to which the intervention achieved its goal of improving parenting skills and enhancing readiness for reunification among the families who received the services.

Eligibility Criteria:
Inclusion Criteria:

* Children age 3-16 with severe emotional disturbances
* In foster care and their families (parents).

Exclusion Criteria:

-
Effect of Lifestyle Modification on Obese Females With Primary Dysmenorrhea

The study will be designed to determine the effect of lifestyle modification on primary dysmenorrhea in obese females.

Menstruation in women after puberty is often confused with dysmenorrhea. Primary dysmenorrhea, where there is no apparent pelvic pathology, is characterized as painful menstrual cramps. This symptom typically occurs within one to two years of menarche and menstrual cycle stabilisation1. Pain occurs a couple of hours before or after menstruation and lasts for 12 to 72 hours. Dysmenorrhea can also be accompanied by nausea, discomfort, low back pain, or flank pain.

Obesity in women adolescents is one of the factors associated with dysmenorrhea also; Endometrium production of physiological prostaglandin increased in primary dysmenorrhea. Increased prostaglandin directly contributes to uterine contractions that eventually lead to primary dysmenorrhea. Overweight and obesity thought to be correlated with dysmenorrhea by increasing the development of prostaglandin.

The Microbiome Diet is a new, trendy weight loss diet. It created by Dr. Raphael Kellman and based on eating and avoiding certain foods in the hopes of restoring gut health. It's also claimed to offer other benefits, such as a faster metabolism and weight loss. Therefore, this study aims to investigate the effect of lifestyle modification on obese females suffering from primary dysmenorrhea

Eligibility Criteria:
Inclusion Criteria:

* Young females with moderate to severe primary dysmenorrhea (Visual analogue scale \> 4).
* Virgin, nonsmokers.
* Young female aged from 18-25 years with BMI more than 30 kg/m².
* They have regular menstrual cycles (a menstrual flow of 38 days, with 21-35 days between menstrual flows)
* They have not practiced sports for at least one year before entering the study.
* They have not engaged in diet for at least one year before entering the study.

Exclusion Criteria:

* Any participant having Secondary dysmenorrhea (associated with identifiable pelvic pathology).
* Any participant with a history of pelvic inflammatory disease, myoma and tumors, pelvic infection, ovarian cyst, any gynecological disease.
* Any participant with a history of previous spinal surgeries.
* Any participant with a history of Anemia, diabetes, hypertension, cardiovascular disease, thyroid disease, neurological disorder, rheumatoid arthritis, bariatric surgery, or taking weight loss medication.
A Randomized, Open-Label, Comparative, Parallel-Group, Multicenter Study of SPARC1507

An open label study to determine the efficacy and safety of SPARC1507

Subjects with advanced Biliary tract carcinoma meeting the eligibility criteria will be randomized in this study.

Eligibility Criteria:
Inclusion Criteria:

* Evidence of advanced/metastatic biliary tract cancer
* Male or female ≥ 18 years old
* Participants must have measurable disease according to RECIST
* ECOG performance status ≤ 1

Exclusion Criteria:

* Known hypersensitivity to trial treatments, or their excipients
* Prior history of treatment with any taxane therapy
* Cardiovascular disorders as per Investigator's discretion
* The subject has received radiation therapy
Retigabine (Adjunctive Therapy) Efficacy and Safety Study for Partial Onset Refractory Seizures in Epilepsy

This Phase 3 study is being conducted to evaluate the efficacy and safety of retigabine dosed at 1200 mg/day, in three equally divided doses, compared with placebo in patients with epilepsy who are receiving up to three established antiepileptic drugs (AEDs).

This Phase 3 study is being conducted in North America, Argentina, and Brazil to evaluate the efficacy and safety of retigabine dosed at 1200 mg/day, in three equally divided doses, compared with placebo in patients with epilepsy who are receiving up to three established antiepileptic drugs (AEDs). The primary objective is to demonstrate a superior change in total partial seizure frequency for four weeks from baseline to the double-blind period. The proportion of responders (greater than or equal to 50% reduction in total partial seizure frequency for four weeks from baseline to the double-blind period) will also be evaluated.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of refractory epilepsy with simple or complex partial onset seizures with or without secondary generalization
* 28-day partial seizure frequency rate of four or more partial seizures over the 8-week baseline phase
* Currently treated with up to three established AEDs
* Vagal Nerve Stimulator may be included

Exclusion Criteria:

* Existing medical or psychiatric condition which could affect patient's health or compromise ability to participate in the study
* Clinically significant abnormalities on physical exam, vital signs, ECG, or liver function tests
* Impaired renal function (creatinine clearance less than 50 mL/minute)
* Evidence of progressive central nervous disease, lesion, or encephalopathy
* History of primary generalized seizures
* History of clustering or flurries or status epilepticus within 12 months of study entry
Study to Evaluate the Safety and Efficacy of BA058 (Abaloparatide) for Prevention of Fracture in Postmenopausal Women

The purpose of this study is to determine whether BA058 (abaloparatide), a parathyroid hormone-related peptide, is effective in preventing fractures in postmenopausal women with severe osteoporosis who are at risk of fractures.

This is a randomized, double-blind, placebo-controlled, comparative Phase 3, multicenter international study to evaluate the efficacy and safety of BA058 (abaloparatide) 80 µg in the prevention of fracture in otherwise healthy ambulatory postmenopausal women with severe osteoporosis.

Eligibility Criteria:
Inclusion Criteria:

* Healthy ambulatory postmenopausal (≥ 5 years) women from 50 to 85 years of age (inclusive) with a diagnosis of osteoporosis
* The women are to have a bone mineral density (BMD) T score ≤ -2.5 and \> -5.0 at the lumbar spine or hip (femoral neck) by dual energy x-ray absorptiometry (DXA) and radiological evidence of 2 or more mild or one or more moderate lumbar or thoracic vertebral fractures, or history of low trauma forearm, humerus, sacral, pelvic, hip, femoral, or tibial fracture within the past 5 years. Postmenopausal women older than 65 who meet the above fracture criteria but have a T score ≤ -2.0 and \> -5.0 may be enrolled. Women older than 65 who do not meet the fracture criteria may also be enrolled if their T score is ≤ -3.0 and \> -5.0
* Normal physical exam, vital signs, electrocardiogram (ECG) and medical history
* Laboratory tests within the normal range including serum calcium, PTH(1-84), serum phosphorus and alkaline phosphatase

Exclusion Criteria:

* History of more than 4 mild or moderate spine fractures or any severe fracture
* Abnormality of the spine or hip that would prohibit assessment of bone mineral density (BMD)
* Unexplained elevation of serum alkaline phosphatase, history of bone disorders (such as Paget's disease) or a diagnosis of cancer within the last 5 years (with the exception of basal cell or squamous cancer of the skin)
* History of thyroid, parathyroid, or adrenal disorders, or malabsorptive syndromes or any chronic or recurrent diseases or disturbances that would interfere with the interpretation of study data or compromise the safety of the patient
* Prior treatment with parathyroid hormone (PTH) or parathyroid hormone-related peptid (PTHrP)
* Prior treatment with bisphosphonates, fluoride, or strontium within the past five years or treatment with androgens, anabolic steroids, corticosteroids or selective estrogen receptor modulators within the past 12 months (except hormone replacement therapy)
* Prior treatment with an investigational drug within the past 12 months
* History of nephrolithiasis or urolithiasis within the past five years, or history of osteosarcoma at any time
Hemodynamic Effects of BPA at Rest and During Exercise in CTEPH

Chronic thromboembolic pulmonary hypertension (CTEPH) is characterized by obstruction of the pulmonary vasculature by residual organized thrombi, leading to increased pulmonary vascular resistance (PVR), progressive pulmonary hypertension, and right heart failure.

Medical therapy and balloon angioplasty (BPA) are effective treatment alternatives in lowering pulmonary pressures and increasing pulmonary flow.

The aim of this study is to assess the hemodynamic effects of BPA or medical therapy on the pressure-flow relationship in the pulmonary vasculature and the pulmonary vascular compliance.

Chronic thromboembolic pulmonary hypertension \[CTEPH\] is a rare condition with a significant risk of morbidity and mortality. The primary cause of CTEPH is thrombotic lesions, which did not resolve after acute pulmonary embolism. This causes increased pulmonary vascular resistance \[PVR\], leading to secondary remodeling of pulmonary arteries causing pulmonary hypertension and ultimately progressive right heart failure. The treatment of choice is surgical pulmonary endarterectomy \[PEA\], however up to 40% cases are not treated surgically, due to operability, anatomic location of the lesions, patient choice and comorbidities significantly increasing procedural risk. A new alternative procedure, balloon pulmonary angioplasty \[BPA\] has been proposed for patients with inoperable CTEPH or persistent pulmonary hypertension after pulmonary endarterectomy (PEA) and is currently characterized with good outcome in functional capacity, hemodynamic parameters, biomarkers, and health-related quality of life.

Exercise stress tests of the pulmonary circulation are used in workup and diagnosis of pulmonary hypertension as a hemodynamic abnormality. The approach has allowed identification of patients with normal or marginally increased mPAP at rest but with symptomatic increases in mPAP at exercise, related to either increased resistance or increased left atrial pressure. Although this differential diagnosis is of obvious therapeutic relevance, guidelines about exercise stress studies of the pulmonary circulation have not been developed until now for lack of robust evidence allowing for a consensus on clearly defined cutoff values.

Neither the pathophysiology of the exercise limitation nor the underlying mechanisms of the BPA - induced improvement were studied before. Therefore the aim of this study is to assess the hemodynamic effects of BPA treatment on the pressure-flow relationship in the pulmonary vasculature and the pulmonary vascular compliance. Furthermore, the investigators will explore possible differences in treatment effect across centers. Especially explore the timing of medical therapy vs balloon angioplasty.

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Eligibility Criteria:
Inclusion Criteria:

-Patients with CTEPH or CTED eligible for balloon pulmonary angioplasty.

Exclusion Criteria:

-Patients unable to perform ergometer exercise
The Effects of Cervical Stabilization Exercise Training With Telerehabilitation in Individuals With Migraine

The aim of our study is to investigate the effects of cervical stabilization exercise training applied with telerehabilitation in individuals with migraine.

Cervical muscles are adversely affected in individuals with migraine. It is important to investigate the effects of cervical muscle training in these individuals. Telerehabilitation applications have been used frequently in many patients in recent years. It is necessary to examine the effects of cervical stabilization exercises applied with telerehabilitation in individuals with migraine.

Eligibility Criteria:
Inclusion Criteria:

* Being between the ages of 18-55,
* To be diagnosed with migraine by a neurologist according to International Headache Society criteria,
* Having at least 3 migraine attacks per month,
* Volunteering to participate in the study,
* Having the opportunity to access devices such as computers, phones and tablets with internet connection,
* Not having any problems that prevent cooperation and understanding

Exclusion Criteria:

* Having other accompanying headache types,
* Being pregnant,
* Being in the breastfeeding period,
* Having a history of trauma, fracture or surgery in the craniocervical region,
* Presence of concomitant neurological and/or inflammatory rheumatic disease
* Presence of serious psychiatric problems,
* History of malignancy,
* Changes in medical treatment during the study period,
* Receiving physiotherapy for the cervical region in the last 6 months
Dispensing Evaluation of New Daily Disposable Toric Soft Contact Lens.

The purpose of this study is to determine the relative performance of a new daily disposable toric soft contact lens against a daily disposable toric contact lens currently available in market, specifically with regards to the comfort and vision with the lens.


Eligibility Criteria:
Inclusion Criteria:

* The subject must be between 18 and 40 years old.
* The subject must have normal eyes.
* The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol.
* The subject must read and sign the STATEMENT OF INFORMED CONSENT and be provided a copy of the form.
* The subject must have a subjective distance spectacle prescription in the range of -1.75 to -5.00D in each eye.
* The subject must manifest -1.25 to -2.00 D of refractive astigmatism in each eye.
* The subject's refractive cylinder axis must be 180 degrees plus or minus 30 degrees in each eye.
* The subject must be an adapted wearer of soft toric contact lenses in both eyes.
* The subject's best visual acuity (BVA) must be better than or equal to 20/25 in each eye.
* Subjects must already possess a wearable pair of spectacles.

Exclusion Criteria:

* Ocular or systemic allergies or disease that may interfere with contact lens wear.
* Systemic disease or autoimmune disease or use of medication, which may interfere with contact lens wear.
* Clinically significant (grade 3 or 4) corneal edema, corneal vascularization, corneal staining or any other abnormality of the cornea, which may contraindicate contact lens wear.
* Clinically significant (grade 3 or 4) tarsal abnormalities that might interfere with contact lens wear.
* Any ocular infection.
* Any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear.
* Pregnancy or lactation
* Any infectious disease (e.g., hepatitis, tuberculosis) or an immunosuppressive disease (e.g., HIV).
* Diabetes
* Strabismus
Total Joint Arthroplasty and Sleep

To compare non-prescription sleep aids (low-dose diphenhydramine and melatonin) to sleep hygiene education for improving postoperative sleep quality after total joint arthroplasty.


Eligibility Criteria:
Inclusion Criteria:

All patients undergoing elective primary total hip or knee arthroplasty

Exclusion Criteria:

1. History of substance abuse
2. Workman's compensation patients
3. Revision joint replacement
4. History of prescription or over-the- counter sleep aid use