cyrilzakka/clinical-trials huggingface dataset:
Natural History Study of Leukoencephalopathy With Brainstem and Spinal Cord Involvement and Lactate Elevation (LBSL)

In this study, we will conduct retrospective chart and imaging reviews and prospective longitudinal virtual assessments of individuals with LBSL.

LBSL (leukoencephalopathy with brainstem and spinal cord involvement and lactate elevation) is a rare genetic disorder characterized by slowly progressive cerebellar ataxia and spasticity with dorsal column dysfunction (decreased position and vibration sense) in most patients. Manual dexterity becomes impaired to a variable degree. Associated problems include dysarthria, mild cognitive decline and learning problems, and epilepsy. LBSL is diagnosed by identification of biallelic pathogenic variants in DARS2, encoding mitochondrial aspartyl tRNA synthetase and characteristic abnormalities observed on the brain and spinal cord MRI. Most of the literature consists of case reports and case series and there are only limited data that provide details on genotype-phenotype correlations. There is very little quantitative or semi-quantitative information about neurocognitive and neuromotor impairment in LBSL. There are currently no targeted therapies or guidelines about supportive therapies for LBSL.

In this study, we will conduct retrospective chart and imaging reviews and prospective longitudinal virtual assessments of individuals with LBSL.

We hypothesize that 1) there will be a broad phenotypic spectrum of neuromotor and neurocognitive deficits in LBSL patients; 2) most impairment will likely be related to gait; 3) there will be a threshold of impairment in gait that is associated with poorer quality of life for these patients; 4) and that even in patients with apparently mild disease there will be neurocognitive deficits related to cortical and cerebellar white matter abnormalities.

Answering these hypotheses will form the basis of a better understanding of the natural history of LBSL. It will help further characterize the expected level of impairment based on a patient's genotype. This will be particularly helpful for providing anticipatory guidance for newly diagnosed infants and children with LBSL. The information will also help identify priorities for existing supportive therapies and help clarify the common or clinically meaningful symptoms that should be targeted for new treatments.

Eligibility Criteria:
Inclusion Criteria:

1. Confirmed DARS2 mutation through genetic analysis
2. Ability of the caregiver or participant to speak and understand English at an 8th-grade level

Exclusion Criteria:

* The vulnerable populations of prisoners, non-viable neonates, pregnant women, adults lacking the capacity to consent, non-English speakers or children who are in foster care or wards of the state.
Lung Ultrasound for Acute Dyspnea in Emergency Department

Dyspnea is a frequent symptom in patients admitted to the Emergency Department (ED); discriminating between cardiogenic and non-cardiogenic dyspnea is a common clinical dilemma. The initial diagnostic work-out is often not very accurate in defining the etiology and the underlying pathophysiology. In the last years, lung ultrasound (US) has emerged as a useful real-time bedside diagnostic tool in the critical patient. The aim of this study was to evaluate the accuracy, reproducibility, and diagnostic impact of pleural and lung US, performed by emergency physicians at the time of patient first presentation to the ED, in identifying cardiac causes of acute dyspnea.


Eligibility Criteria:
Inclusion Criteria:

* Patients had to present to the ED with a principal complaint of shortness of breath, deﬁned as either the sudden onset of dyspnea with no history of chronic dyspnea or an increase in the severity of chronic dyspnea in the last 48 hours;
* Presence of an emergency physician with lung US experience at the time of enrollment;
* US examination within 30 minutes after the start of the clinical evaluation.

Exclusion Criteria:

* Dyspnea cases clearly due to neither cardiogenic nor respiratory etiology will considered not eligible.
Pharmacodynamic Characterization of Dienogest

This study will be investigated what mechanism of action Dienogest has. The growth of the follicles, the endometrium, the hormones in the blood and the mucus that is produced by the cervix that will be looked upon. Four different dosages of Dienogest (0.5 mg, 1 mg, 2 mg and 3 mg) will be investigated in healthy young women over two cycles, or up to a maximum of 72 days.


Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent
* Body-Mass-Index (BMI): 18 - 30 kg/m²
* Healthy female volunteers
* Age 18-35 years (smoker not older than 30 years, inclusive)
* At least 3 months since delivery, abortion or lactation
* Willingness to use non-hormonal methods of contraception during entire study

Exclusion Criteria:

* Contraindications for use of progesterone-only pills or combined oral contraceptives (e.g. history of venous/arterial thromboembolic disease)
* Use of systemic or topical medications or substances which oppose the study objectives or which might influence them within 4 weeks prior to start of the pre-treatment cycle
* Clinically relevant findings (blood pressure, physical and gynecological examination, laboratory examination)
Clinical Application of Near-infrared Fluorescence Guided Localization on Breast Surgery in Benign Breast Neoplasm.

Near-infrared (NIR) fluorescence imaging using indocyanine green (ICG) has been used for breast cancer surgery such as sentinel lymph node (SLN) mapping and breast cancer localization.

In this study, our hypothesis are as following:

1. As inject only indocyanine green (ICG), it provide the surgeon visual guidance to ensure better outcome.
2. indocyanine green (ICG) permitted accurate preoperative and intraoperative detection of the SLNs as well as nonpalpable benign brest lesion in patients with breast cancer.

Indocyanine green, ICG (ICG-fluorescence)

* ICG is the most commonly used fluorophore which approve by FDA.
* NIR-F imaging with ICG could be used in various surgeries. For example, SLN mapping in breast cancer and localization of liver metastasis, especially superficial lesion
* Contains sodium iodide, patients who have history of allergy to iodides should be used as caution.

Nonpalpable benign brest lesion localization

* New method for the localization and resection of non-palpable breast lesions.
* The breast lesion was correctly localized, and the area of ICG corresponded well to the site of the lesions.

Eligibility Criteria:
Inclusion Criteria:

* nonpalpable benign breast lesion ≤ 2cm in patients with breast cancer.
* patients who need breast biopsy as treatment for breast cancer.
* Eastern Cooperative Oncology Group Performance status 0 or 1
* consented patients with more than 20 years, less than 70 years

Exclusion Criteria:

* nonpalpable benign breast lesion ≥ 2cm in patients with breast cancer.
* pregnancy
* history of severe allergy to ICG(Indocyanine Green)
* iode hypersensitiveness
A Safety and Efficacy Study of FCR001 vs Standard of Care in de Novo Living Donor Kidney Transplantation

A randomized controlled study to evaluate the safety, efficacy, and overall benefit of FCR001 cell therapy in de novo living donor renal transplantation.

The purpose of this randomized (2:1) controlled study is to evaluate the safety, efficacy and overall benefit of FCR001 cell therapy in first or second de novo living donor renal transplantation relative to a standard-of-care control immunosuppression regimen of antibody induction, tacrolimus, mycophenolate, and corticosteroids.

Eligibility Criteria:
Main Inclusion Criteria:

* Recipient age ≥18 years.
* Donor age ≥18 and ≤60 years at time of signing informed consent.
* Recipients of a first or second living donor kidney transplant
* Donor willing to undergo mobilization, apheresis and 12-month safety follow-up and meet all local standard eligibility criteria to donate stem cells for allogeneic transplantation.
* Recipient meets all local standard eligibility criteria for allogeneic stem cell transplant.
* Donors must be deemed eligible as per the requirements of 21CFR1271.

Main Recipient and Donor Exclusion Criteria:

* Recipient and donor who are identical twins.
* Recipient or donor with history of malignancy or premalignant syndrome (e.g., myelodysplastic syndrome, monoclonal gammopathy of renal significance \[MGRS\], monoclonal gammopathy of unknown significance \[MGUS\]) of any organ system (other than localized basal cell carcinoma of the skin or in-situ cervical cancer), treated or untreated, within the past 5 years, regardless of whether there is evidence of local recurrence or metastases.
* Recipient or donor with known bone marrow aplasia.

Main Recipient-only Exclusion Criteria:

* Multi-organ or stem cell transplant recipient.
* Calculated panel reactive antibodies \>80%.
* Recipient is blood type ABO incompatible with donor.
* Presence of donor-specific antibodies (DSA) (positive result) at any time pre-transplant.
* Recipient who is human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV) positive.
* Recipient with any baseline condition requiring or anticipated will require chronic or intermittent use of systemic steroids or other IS (eg, autoimmune disease, asthma) throughout the course of the study.
* Recipient with a BMI \< 18 or \> 35 kg/m2.
* Recipient requiring systemic anticoagulation, (eg, for hyper-coagulation disorders, deep vein thrombosis, atrial fibrillation) that cannot be temporarily interrupted which would preclude renal biopsy.

Main Donor-only Exclusion Criteria:

* Biologically unrelated (i.e., no genetic relationship) female donor transplant to male recipient.
A Study of Treatment ALK(+) Systemic Anaplastic Large Cell Lymphoma With Crizotinib

The purpose of this study is to determine the efficacy and safety of crizotinib combined with CHOP chemotherapy for patients with ALK(+) Systemic Anaplastic Large Cell Lymphoma.

ALK(+) Systemic Anaplastic Large Cell Lymphoma patients are treated with crizotinib when they receive CHOP chemotherapy. crizotinib 250mg twice a day is administrated from day 1 of chemotherapy to 18 weeks. standard CHOP chemotherapy (cyclophosphamide, 750mg per square meter of body-surface area,d1, vincristine, 1.4mg per square meter of body-surface area, maximal dose is 2mg d1, doxorubicin, 50mg per square meter of body-surface area d1, plus prednison, 100 mg d1-5) every 3 weeks for up to six cycles.

Eligibility Criteria:
Inclusion Criteria:

* primary ALK(+) systemic anaplastic large cell lymphoma histologically confirmed by biopsy without therapy
* ECOG 0-2
* more than 1 measurable lesions with major axis \>1.5cm and minor axis\>1.0cm
* estimated survival \>/3months
* Age 18-65 years
* Women of childbearing age should have a negative pregnancy test; men and women who need to agree to use effective contraception during the period of treatment and the following 1 years
* Signature of informed consent

Exclusion Criteria:

* Age \<\\ 18years
* without ALK(+) systemic anaplastic large cell lymphoma histologically confirmed by biopsy
* without measurable lesions
* being treated by other drugs in other clinical trials
* Pregnant or lactating women, who are not willing to take contraceptive measures during the study period, or are not willing to use effective contraceptive measures during the period of treatment and the following 1 years
* Hepatic insufficiency: serum total bilirubin, ALT more than 2 times higher than normal
* Renal insufficiency: more than 2 times higher than that of normal serum creatinine
* Blood screening period: WBC \< 1 \* 109/L \* 109/L; platelet \< 25; Hb \< 60g/L
* HIV test positive
Use of Pre-peritoneal Drainage in rTAPP - a Comparative Study

The safety and efficacy of pre-peritoneal drain after TEP has been validated in our previous studies - which can effectively reduce seroma formation post-operatively and safe in clinical use. We shall extend the indication of pre-peritoneal drainage after robotic TAPP, results will be compared with our retrospective cohort from previous studies.

The safety and efficacy of pre-peritoneal drain after TEP has been validated in our previous studies - which can effectively reduce seroma formation post-operatively and safe in clinical use. We shall extend the indication of pre-peritoneal drainage after robotic TAPP, results will be compared with our retrospective cohort from previous studies.

Criteria of enrolling into trial is same as our previous experiment: aged 18-80, unilateral, first occurrence, reducible, non-inguino-scrotal inguinal hernia fit for GA for minimally invasive hernia repair. Routine robotic TAPP performed in standardized manner and pre-peritoneal drains are placed for drainage of 23 hours post-operatively. Drain output, pain scores, status of seroma formation (clinical, USG detected), post-operative recovery and recurrence will be monitored and compared.

Eligibility Criteria:
Inclusion Criteria:

* Unilateral,
* First occurrence
* Reducible inguinal hernia

Exclusion Criteria:

* Not fit for GA,
* Bilateral hernia
* Recurrent hernia
* Irreducible hernia
* Inguino-scrotal extension hernia
* Non-inguinal hernia
Imipramine and Pregabalin Combination in Painful Polyneuropathy

Polyneuropathy of different etiologies is often associated with pain and the standard treatment for this type of pain is gabapentinoids or antidepressants. The hypothesis of this study is that the combination of the gabapentinoid pregabalin and the antidepressant imipramine will provide better pain relief than the single compounds alone.

This is a randomized, placebo-controlled, double-blind, 4-way, cross-over trial of pregabalin 300 mg/day, imipramine 75 mg/day and their combination versus placebo. The study will include 60 patients and the treatment outcome will be pain intensity as measured by numeric rating scales.


Eligibility Criteria:
Inclusion Criteria:

* Age between 20 - 85 years.
* Characteristic symptoms of polyneuropathy for at least 6 months.
* Polyneuropathy diagnosis confirmed by typical clinical signs (distal sensory disturbance/lack of distal deep tendon reflexes) and/or electrophysiological tests and/or abnormal quantitative sensory tests.
* Total pain intensity rating of at least 4 on a 0-10 points numeric rating scale.
* Pain present at least 4 days a week.
* For diabetics: diabetes diagnosis for at least 6 months and stable metabolic control for at least 3 months.
* For other secondary polyneuropathies: stable for at least 6 months.
* For fertile females: adequate anticonceptive treatment.
* Written informed consent.

Exclusion Criteria:

* Other cause of pain.
* Contraindications against imipramine.
* Allergic reactions towards imipramine or pregabalin.
* Known adverse reactions during imipramine or pregabalin treatment.
* Pregnancy.
* Severe systemic disease.
* Ongoing treatment with antidepressants, antipsychotics, anticonvulsants, opioids, propranolol, kinidine, monoamine oxidase inhibitor.
* Inability to follow study protocol.
Pharmacokinetics And Relative Bioavailability Of Bococizumab (PF-04950615; RN316) When Administered To The Abdomen, Thigh Or Upper Arm

This study aims to characterize the single dose pharmacokinetics of PF-04950616 following subcutaneous injection to the abdomen, upper arm or the thigh.


Eligibility Criteria:
Inclusion Criteria:

* Male and female subjects 18 to 65 years of age.
* Body Mass Index (BMI) ≤ 33 kg/m2, and total body weight of 60 kg to 90 kg (132 lbs to 198 lbs).
* Fasting LDL-C must be \> 130 mg/dL (borderline high per NCEP ATP III criteria) at two qualifying visits: initial screening (Days -28 to -14) and Day -7.

Exclusion Criteria:

* Poorly controlled type 1 or type 2 diabetes mellitus (HbA1c \> 9.0%).
* History of a cardiovascular or cerebrovascular event (eg, MI, stroke, TIA) or related procedure (eg, angioplasty) during the past year.
* Subjects who meet the New York Heart Association (NYHA) criteria for congestive heart failure (CHF) classes III or IV.
Ketotifen/Naphazoline Ophthalmic Solution in the Conjunctival Allergen Challenge Model of Acute Allergic Conjunctivitis.

The purpose of this study is to establish the safety and efficacy of ketotifen/naphazoline ophthalmic solution compared to vehicle and its individual components in alleviating the signs and symptoms of conjunctival allergen challenge (CAC)-induced allergic conjunctivitis.


Eligibility Criteria:
Inclusion Criteria:

* Positive history of ocular allergies and positive skin test reaction to cat hair, cat dander, grasses, ragweed, and/or trees within the past 24 months.
* Calculated best-corrected visual acuity of 0.7 logMAR or better in each eye as measured using the ETDRS chart.
* Positive bilateral conjunctival allergen challenge(CAC) reaction within 10 minutes of instillation of the last titration of allergen at visit 1.
* Positive bilateral CAC reaction for at least 2 out of 3 time points at visit 2.

Exclusion Criteria:

* Known contraindications or sensitivities to the study medication or its components.
* Any ocular condition that, in the opinion of the investigator, could affect the subjects safety or trial parameters.
* Use of disallowed medications during the period indicated prior to study enrollment or during the study.
Model 20105 Lead Study

The purpose of this study is to evaluate the implant procedure and feasibility of a new lead developed to pace and sense the left chambers of the heart.


Eligibility Criteria:
Inclusion Criteria:

* Subject has Cardiac pacing indication for sinus node dysfunction (dual chamber pacemaker)
* Subject has signed and dated the study-specific informed consent form
* Subject is 18 years of age or older
* Subject is willing, able and committed to participate in Baseline and Follow-up and study procedures for the full length of the study

Exclusion Criteria:

* Subject is indicated for BiV pacemaker or ICD
* Subject is pacing dependent
* Subject has a previous Pacemaker System
* Subject has known coronary venous vasculature that is inadequate for lead placement
* Subject has unstable angina pectoris or has had an acute myocardial infarction (MI) within the last month
* Subject has had a coronary artery bypass graft (CABG) or percutaneous transluminal coronary angioplasty (PTCA) within the past three months
* Subject is not in sinus rhythm at implant
* Subject has had a heart transplant (patients waiting for heart transplants are allowed in the study)
* Subject has known renal insufficiency that would prevent them from receiving an occlusive venogram during the implant procedure
* Subject is contraindicated for \<1mg dexamethasone acetate
* Subject is enrolled in any concurrent drug and/or device study that may confound the results of this study
* Subject has a terminal illness and is not expected to survive more than 6 months
* Subject is a pregnant woman or woman of childbearing potential not on adequate birth control.
* Subject is employed by Medtronic or by the department of any of the investigators or is a close relative of any of the investigators.
* Legal incapacity or evidence that a subject cannot understand the purpose and risks of the study
* Subject meets exclusion criteria required by local law.
* Subject is unable to tolerate an urgent thoracotomy
A Trial of Eptinezumab in Participants With Migraine and Insufficient Response to Anti-CGRP Medications

The main goal of this trial is to learn whether eptinezumab improves migraine symptoms and quality of life of participants with migraine who did not perceive a sufficient improvement during previous treatment with therapies targeting calcitonin gene-related peptide (CGRP).


Eligibility Criteria:
Key Inclusion Criteria:

* The participant has a diagnosis of migraine as defined by International Headache Society (IHS) International Classification of Headache Disorders 3rd Edition (ICHD-3) guidelines with a history of migraine of at least 12 months prior to the Screening Visit.
* The participant has ≥8 migraine days per month for each month within the past 3 months prior to the Screening Visit.
* The participant has documented evidence of recent inadequate response to either one anti-CGRP monoclonal antibody (mAb) (other than eptinezumab) or one gepant, indicated and used for migraine prevention.

Key Exclusion Criteria:

* The participant has taken more than 10 tablets of ubrogepant or more than 8 tablets of rimegepant per month as an acute migraine medication in the 1 month prior to the screening visit and during the 4-week baseline period.
* The participant has previously had an inadequate response to more than one CGRP-targeting therapy (anti-CGRP mAb or gepants), indicated for migraine prevention.
* The participant has a history of cancer, other than basal cell or stage 1 squamous cell carcinoma of the skin or adequately treated cervical intraepithelial neoplasia, that has not been in remission for \>5 years prior to the first dose of eptinezumab. Male participants with abnormal prostate-specific antigen levels according to national/local guideline may be enrolled in the trial provided they have been followed up, have been asymptomatic, and have had no treatment for prostate cancer. Participants under surveillance for a low and stable level of M-component are allowed.
* The participant has previously been treated with eptinezumab.

Other protocol-defined inclusion and exclusion criteria apply.
The Optimization of Blood Pressure and Fluid Status Control With Eight-Polar Bioelectrical Impedance Analysis

Peritoneal dialysis (PD) is a widely used modality of renal replacement therapy. Due to its continuous nature of therapy, better control of fluid status and preservation of residual renal function were presumed by most nephrologists. However, recent evidences showed that it might not be the case. The severity of fluid overloading and the need for anti-hypertensive agents to control blood pressure seems to be more severe for PD patients. Therefore, more aggressive strategy to control dry weight is mandatory in PD patients. However, over reduction of dry weight might affect residual renal function (RRF) and, probably, the survival of PD patients. A balance between reduction of dry weight and preservation of RRF is crucial for the care of PD patients. Currently, only clinical measures like cardiothoracic ratio on chest X-ray and absence of pedal edema were used to evaluate PD patient's dry weight. There is no objective method to determine dry weight accurately. In this prospective and randomized study, the investigators will use multi-frequency bio-impedance (MF-BIA) to detect intracellular and extracellular water (ECW) content of patients.


Eligibility Criteria:
Inclusion Criteria:

* age 18 to 80

Exclusion Criteria:

* type I DM
* Severe heart failure
* unstable angina