cyrilzakka/clinical-trials huggingface dataset:
Effect of Human Urinary Kallidinogenase on Inflammatory Factors in Acute Ischemic Stroke (KIF-AIS)

The goal of this clinical trial is to explore the changes in the expression levels of inflammatory factors before and after the early treatment of Human Urinary Kallidinogen (HUK) in the acute ischemic stroke. It will also learn about the correlation between inflammatory factors and AIS prognosis, in order to clarify the efficacy and safety of Urinary Kallidinogen in the acute phase of AIS.

The study process lasts for a total of 90 days, including the screening period, treatment period, and follow-up period. During the treatment period, the experimental group is treated with HUK in the 48 hours of AIS plus routine clinical treatment, while the control group receives routine clinical treatment group for 7 days.All patients are followed up until the 90th day after stroke. The sample size of the study is 200 patients. The ratio of the experimental group to the control group was 1:1.

Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis as acute ischemic stroke according to the Chinese guidelines for diagnosis and treatment of acute ischemic stroke 2018;
2. First clinical onset or previous presence of cerebral infarction without severe sequelae（Premorbid mRS ≤2）
3. Age≥18 years, male or female;
4. 3≤Baseline NIHSS≤25;
5. Written informed consent obtained from the patient or legally responsible person.

Exclusion Criteria:

1. Cerebral hemorrhage and the acute phase of other hemorrhagic diseases；
2. Previously allergic or intolerant to injectable HUK；
3. Used ACEI drugs prior to medication and less than 5 half-lives of the drug (according to the specific drug instructions) or received ACEI drugs during the study period;
4. Stent surgery after the AIS onset or planned interventional therapy;
5. Pregnancy, lactation or planned pregnancy；
6. Life expectancy of less than 3months or inability to complete the study for other reasons；
7. Unwilling to be followed up or poor compliance；
8. Current participation in other clinical research;
9. Other causes of AIS (such as dissection, vasculitis, pre-thrombotic lesions, drug abuse).
ANNAPURNA: A Study of The Combination of RO5466731, RO5190591, Ritonavir and Copegus (Ribavirin) With or Without RO5024048 in Patients With Chronic Hepatitis C Who Are Either Treatment-Naïve or Have Previously Experienced a Null Response to Interferon-Based Treatment

This randomized, open-label, multicenter study will evaluate the safety , efficacy and tolerability of the combination treatment RO5466731, RO5190591, ritonavir and Copegus (ribavirin) with or without RO5024048 in patients with chronic hepatitis C genotype 1. In Part 1, treatment-naïve patients will be randomized to receive treatment with RO5466731, RO5190591 plus ritonavir, and Copegus, with or without RO5024048. In Part 2, further treatment-naïve patients will receive a successful regimen from Part 1, or a reduced intensity regimen, and patients who have previously experienced null response to interferon-based treatment will be added to the study.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients, \>/= 18 years of age
* Chronic hepatitis C genotype 1 of \>/= 6 months duration at screening
* Part 1 and Part 2: Naïve to treatment with interferon (pegylated or non-pegylated). Patients who have participated in studies investigating a direct-acting antiviral agent with or without interferon are excluded
* Part 2: Treatment experienced patients having a previous null response to treatment with interferon containing regimen
* Liver biopsy or non-invasive (e.g. Fibroscan) evaluation in the past 24 calendar months showing absence of cirrhosis or incomplete/transition to cirrhosis
* Body mass index (BMI) 18 to 35 kg/m2 inclusive and body weight \>/= 45 kg

Exclusion Criteria:

* Pregnant or lactating women or males with female partners who are pregnant or lactating
* Decompensated liver disease or impaired liver function (as defined by protocol)
* Cirrhosis or incomplete/transition to cirrhosis
* Non- hepatitis C chronic liver disease
* Positive for hepatitis B or HIV infection
* History of pre-existing renal disease
* History of severe cardiac disease
* History of neoplastic disease within the last 5 years, except for localized or in situ carcinoma of the skin
* History of drug abuse within the last year; history of cannabinoid use is not excluded
* Evidence of alcohol abuse within 1 year of screening and consumption of more than 2 units of alcohol per day
* Medical condition that requires use of systemic corticosteroids
* Received warfarin or other anticoagulants during the 21 days immediately prior to screening or is expected to require warfarin or other anticoagulants during the study
* Anticipated use or need for significant medical treatment during the study or use of concomitant medications or nutrients that are excluded by protocol (e.g. drugs that are contraindicated with ritonavir, hormonal methods of contraception)
External Focus Strategy on Visuomotor Control in Older Adults

Only a few studies have adopted external focus strategy as an intervention to mitigate the negative effects of heightened conscious movement processing in older adults. The goal was to investigate whether a single-session intervention (SSI) using external focus strategy could improve gait stability and visual search behaviors during adaptive locomotion among the older population.

Participants were randomly allocated to either an external focus (EXT) or a control group (CON). All participants performed an obstacle circumvention walking task along an 8-m walkway for five trials at pre-intervention (T0), post-intervention (T1), and retention (T2). The training phase included 20 walking trials. EXT focused on digits displayed on monitors at their path destinations, while CON walked naturally without any manipulation.


Eligibility Criteria:
Inclusion Criteria:

* aged 65 or above
* were able to walk independently indoors without walking aids

Exclusion Criteria:

* a total score of less than 24 on the Chinese version of the Mini-Mental State Examination
* a static visual acuity poorer than 20/40 vision
* the presence of any untreated cerebral vascular disease, Parkinson\&#39;s disease, or any other major neurological deficit
A Pilot Study of CelTx(TM) (Apligraf®) in the Treatment of Gingival Recession Requiring Root Coverage

The purpose of this study is to evaluate CelTx as an alternative to tissue from the palate in the treatment of subjects with Miller Class I or II recession defects who desire root coverage. It is anticipated that this study will demonstrate that CelTx is a safe alternative to palatal tissue and demonstrate potential to enhance oral soft tissue regeneration and wound healing.


Eligibility Criteria:
Inclusion Criteria:

* Subject is at least 18 years of age but no more than 70 years of age.
* Subject has at least two non-adjacent teeth in contralateral quadrants of the same jaw with Miller Class I or II buccal recession (≥ 3 mm) that requires soft tissue grafting. (Teeth may be treated with a maximum difference of 2 mm with respect to depth and width).
* Females of childbearing potential must have a documented negative urine pregnancy test and must agree to continue acceptable methods of contraception for 6 months post surgery.
* Subjects must have read, understood and signed an institutional review board (IRB)-approved Informed Consent Form (ICF).
* Subjects must be able and willing to follow study procedures and instructions.

Exclusion Criteria:

* Subject has extremely prominent root surfaces (\> 1/2 the diameter of the root facial to cortical plate).
* Subject has interproximal attachment loss beyond the CEJ.
* Subject with teeth that have a Miller Grade 2 or higher mobility.
* Subjects with Class V restorations.
* Subjects with crowns on the teeth selected for treatment.
* Subjects who have had endodontic therapy in the last 6 months on the teeth selected for treatment.
* Subjects who have used any tobacco product within the past 3 months.
* Subjects with only molar teeth suitable for soft tissue grafting.
* Subject has probing pocket depth \>/= 4 mm at either surgical site.
* Female subjects who are pregnant or lactating.
* Subjects with any systemic conditions (i.e., uncontrolled diabetes mellitus, cancer, HIV, bone metabolic diseases) that could compromise wound healing and preclude periodontal surgery.
* Subjects who are currently receiving or have received within two months prior to study entry, systemic corticosteroids, immunosuppressive agents, radiation therapy, and/or chemotherapy which could compromise wound healing and preclude periodontal surgery.
* Subjects with the presence of acute infectious lesions.
* Subjects taking intramuscular or intravenous bisphosphonates.
* Subjects with a known hypersensitivity to bovine collagen and/or iodine (shellfish allergy).
* Subjects who have received an investigational drug, device or biological/bioactive treatment within 30 days prior to study enrollment (medical or dental).
* Subjects previously treated with Apligraf/CelTx, Dermagraft or any other cell-based product, including autologous tissue at the target site(s) or immediately adjacent teeth.
* Subjects, who in the opinion of the investigator, for any reason other than those listed above, will not be able to complete the study per protocol
Central Hemodynamic and Sodium Urinary

Systemic arterial hypertension is one of major risk factors to development of target organ damage that culminate in cardiovascular diseases such as acute myocardial infarction and stroke. Sodium intake is related with elevation of arterial blood pressure due to rise of cardiac output and of arterial stiffness and it can be estimated by daily sodium excreted in urine 24h. Ambulatory Blood Pressure Monitoring can be used to obtain peripheral and central hemodynamic parameters \[arterial stiffness parameters - central blood pressure, pulse wave velocity and augmentation index\]. Applanation tonometry also can be used to check same central hemodynamic parameters. Both methods provide us important informations about the patients clinical conditions and help us to infer their prognosis. Therefore, this protocol aims measure the central hemodynamic parameters in hypertensive patients, controlled or resistant, and evaluate their sodium urinary excretion. The hypothesis is the resistant hypertensive patients have parameters higher than controlled hypertensive patients.

The urinary sodium (Na+) will be evaluated by flame photometry. Excretion of urinary sodium will be calculated by multiplying the urinary sodium concentration in mE /L by 24-hour urinary volume. Two to three urinary Na+ samples will be collected within six months.

3.3.3 ABLOOD PRESSURE MONITORING - 24 HOURS Ambulatorial blood pressure monitoring 24-hour will be performed using a Mobil-O-Graph® compact digital device (version 12, ambulatory pressure monitor, 2000, UK). Individuals will be instructed to maintain their normal activities of daily living. The device will be pre-programmed to measure blood pressure within 24 hours at 30-minute intervals every hour during the waking period and at 1-hour intervals during sleep. This device will evaluate the following parameters: systolic and peripheral diastolic blood pressure, mean arterial pressure, pulse pressure, systolic central aortic pressure, central diastolic aortic pressure (cDBP), central pulse pressure (cPP), augmentation index corrected for 75 bpm (AI75%) and pulse wave velocity (PWV).

Eligibility Criteria:
Inclusion Criteria:

* over than 18 years old;
* hypertensive patient for more than four weeks;
* controlled hypertension;
* resistant hypertension;
* regular patient in the local where the study will be done.

Exclusion Criteria:

* chronic renal failure in dyalisis;
* been in the hospital in last 60 days;
* used vasoactive drugs in last 30 days;
* heart failure in III or IV functional class (NYHA);
* pregnant/breastfeeding;
* serious liver disease;
* HIV positive;
* psychiatric diseases that make it difficult to participate;
* stroke or acute myocardial infarction in last 30 days;
* cancer with prognosis less than one year.
Relative Dose Intensity of Adjuvant Chemotherapy in Older Women With ER+ HER2- Breast Cancer.

Localized breast cancers are defined as high-risk when they include lymph node involvement, Ki67 \>30%, vascular emboli, low hormone receptor expression, or an unfavorable genomic signature result.

Under these conditions, sequential adjuvant chemotherapy with taxanes and anthracyclines is recommended.

Patients over 75 years of age receiving adjuvant chemotherapy are at greater risk of side-effects, which may necessitate dose reductions and a reduction in the intensity of chemotherapy. For curative adjuvant treatment, it is recommended to maintain a relative dose intensity (RDI) \> 85%. A few publications have demonstrated the prognostic impact of a relative dose intensity \< 85% for patients aged over 65. For several years now, the need for a specific assessment of elderly patients has been emphasized, prior to initiating oncological treatment (G8 score, onco-geriatric consultation).

This study is a retrospective descriptive study of patients aged over 75 treated with adjuvant chemotherapy from 01/01/2012 to 01/01/2020 for RH+ HER2 - breast cancer in Franche Comté.

Thus the investigators wish to identify patients at risk of receiving sub-optimal relative dose intensity, in order to guide early and targeted supportive care or geriatric co-management interventions.


Eligibility Criteria:
Inclusion Criteria:

* Women aged 75 or over
* Patient with localized RH+HER2- breast cancer
* Patient treated with adjuvant chemotherapy in Franche Comté between January 2012 and December 2019

Exclusion Criteria:

* Age \< 75
* Patient with metastatic breast cancer
* Patient who received neoadjuvant chemotherapy
* HER2+ breast cancer patient
* Breast cancer patient with missing or negative hormonal status
* Patient with localized recurrence of breast cancer with indication for new adjuvant therapy
Spironolactone Versus Prednisolone in DMD

This is a randomized, open-label, pilot clinical trial of spironolactone suspension versus oral prednisolone for use in Duchenne muscular dystrophy. The goals are to determine the safety of 6 months of treatment with spironolactone treatment int he steroid-naive DMD population as well as to determine if either spironolactone or a standard clinical dose of corticosteroids results in equivalent improvement in time to complete the 100 meter timed test (100M).

Until recently, the only treatment shown to improve strength and preserve ambulation in DMD patients was the use of glucocorticoids, which are accompanied by significant side effects including obesity, cushingoid features, osteoporosis, and behavioral disturbances. Spironolactone is an aldosterone antagonist primarily used as a potassium sparing diuretic that is widely used in the pediatric population, with limited side-effects including gynecomastia and hyperkalemia. Recent studies by Dr. Rafael-Fortney have evaluated the effect of spironolactone treatment in several different mouse models of DMD. Her results show that treatment of these mice demonstrates increased muscle membrane stabilization while reducing the negative side-effects typically associated with standard of care glucocorticoids. This pilot study is designed to determine whether this commonly used medication, spironolactone, may have similar beneficial effects with a lower side effect profile and be applicable to a wider population of DMD patients.

The hypothesis for this controlled pilot trial is that spironolactone and prednisolone are of equal efficacy in improving skeletal muscle function over a 6-month period, and that spironolactone will be well tolerated in this patient population.

One outcome is that both drugs demonstrate equal efficacy in motor function. This would then serve as pilot data for a longer term study.

Eligibility Criteria:
Inclusion Criteria:

* Duchenne muscular dystrophy (DMD) patients ≥4 to ≤7 years of age
* Clinical features of DMD that include proximal predominant weakness and/or gait disturbance
* Presence of a truncating mutation of the DMD gene in the patient or an affected male relative OR a muscle biopsy that demonstrates \<5% dystrophin in the patient or an affected male relative
* Normal left ventricular ejection fraction by screening echocardiogram
* Ability to cooperate for testing
* No prior treatment with glucocorticoids or vamorolone
* No concomitant experimental therapies

Exclusion Criteria:

* Subject amenable to or currently being treated with eteplirsen, casimersen, or viltolarsen
* Hyperkalemia at screening
* History of or ongoing renal failure (elevated creatinine, oliguria, anuria)
* Hypersensitivity to spironolactone (rash, respiratory distress, arrhythmia, numbness or tingling of extremities)
* Current treatment with an ACEi
* Severe peptic ulcer disease or recent gastrointestinal perforations
Mature Dendritic Cell Vaccination Against Unique Immunogenic Peptides in Patients With Non Small Cell Lung Cancer (NSCLC)

The purpose of this research study is to study the safety and immune response of people who receive a personalized dendritic cell vaccine with the intention of stimulating the immune system to react to lung cancer cells.

Tumor vaccines represent a promising area of clinical investigation in solid tumors based on evidence of clinical activity and minimal toxicity. The underlying hypothesis of this research is that immunization against tumor neoantigens is effectively required to elicit antigen-reactive T cells capable of recognizing and eliminating cancer. Moreover, both quantitative and qualitative improvements in CD8 immunity are necessary (but not sufficient) for clinical response and improved survival. The goal of this study is to build on our prior clinical trial results in melanoma by studying the immune response to tumor neoantigens in patients with stage 1 NSCLC.

Eligibility Criteria:
Inclusion Criteria:

* Patients with completely resected stage I non-small cell lung cancer who are not considered for adjuvant post operative therapy.
* Age ≥ 18 years.
* ECOG performance status 0-1.
* HLA-A2 positive.
* Required initial laboratory values (submitted within 14 days prior to registration):

  * WBC \> 3,000/mm3
  * Hg ≥ 9.0 gm/dL
  * Platelets \>75,000/mm3
  * Serum bilirubin \< 2.0 mg/dL
  * Serum creatinine \< 2.0 mg/dL
* Sexually active women of childbearing potential must use effective birth control during the trial and for at least two months following the trial, and sexually active men must be willing to avoid fathering a new child while receiving therapy.
* Able to understand and willing to sign an IRB-approved written informed consent document.

Exclusion Criteria:

* Prior treatment with cytotoxic chemotherapy
* Prior treatment with targeted therapy or immunotherapy.
* Active untreated CNS metastasis.
* Active infection.
* Prior malignancy (except non-melanoma skin cancer) within 3 years.
* Pregnant or nursing.
* Concurrent treatment with systemic corticosteroids; local (inhaled or topical) steroids are permitted.
* Known allergy to eggs.
* Prior history or uveitis or autoimmune inflammatory eye disease.
* Known positivity for hepatitis B sAg, hepatitis C antibody, or HIV antibody.
Comparing Two Surgical Methods of Fixation of Subscapularis During Shoulder Arthroplasty

This pilot study is being conducted to compare 2 methods of access to the shoulder for arthroplasty in patients with Osteoarthritis as we do not know has a better outcome.

The study investigates the difference in disease specific quality of life between patients who undergo a subscapularis peel versus morselized osteotomy of the lesser tuberosity, as measured by the Western Ontario Osteoarthritis of the Shoulder (WOOS) at one year post-operatively in patients who undergo shoulder arthroplasty ?

Eligibility Criteria:
Inclusion Criteria:

* Patients who have failed standard non-surgical management of their shoulder arthritis who would benefit from a shoulder arthroplasty.

Exclusion Criteria:

* Active joint or systemic infection
* Significant muscle paralysis
* Rotator cuff tear arthroplasty
* Major medical illness
* Unable to speak or read English/French
* Psychiatric illness that precludes informed consent
* Unwilling to be followed for 1 year
Crutch Use After Arthroscopic Hip Surgery

The purpose of this study is to determine whether crutch use for 4 weeks following hip arthroscopic surgery is superior to crutch use for 2 weeks following hip arthroscopic surgery. The primary objective of the study is to compare PRO scores between patients who have used crutches for 2 weeks and patients who have used crutches for 4 weeks.

This will be a single-center, randomized prospective study. The study will compare post-operative patient reported outcome (PRO) scores including the modified Harris hip score (mHHS) and the non arthritic hip score (NAHS), both are externally-validated surveys for hip function. One cohort will be assigned a rehabilitation regimen that includes 2 weeks of partial weight bearing on crutches, and the other will be assigned a regimen of 4 weeks of partial weight.

Eligibility Criteria:
Inclusion Criteria:

* Hip arthroscopic surgery

Exclusion Criteria:

* Any surgery other than hip arthroscopy
* Age: less than 18 years of age
* Age: greater than 64 years of age
* Pregnant patients
CICATRIX in the Treatment of Hypertrophic Scars and Keloids Scars

The purpose of the study is to assess the efficacy of CICATRIX (Asian Gotu Kola or Pennywort) usage in the treatment of Hypertrophic scars and keloids. The duration of this double-blind placebo controlled phase 3 clinical trial will be 12 weeks. The estimated number of persons to be recruited and randomized for the study is 90.


Eligibility Criteria:
Inclusion Criteria:

* Hypertrophic wound or keloid with no treatment for more than 1 month.
* Signed informed consent.

Exclusion Criteria:

* Usage of steroids within 30 days.
* Malignant neoplastic conditions.
* Alcoholism.
* Handicap and/or psychiatric condition preventing treatment accomplishment.
The Use of Microneedles to Expedite Treatment Time in Photodynamic Therapy

The aim of this study is to investigate how varying incubation periods of topical aminolevulinic acid after pretreatment with microneedle application can facilitate the penetration and efficacy of photodynamic therapy.

The current standard of care of photodynamic therapy to treat actinic keratoses includes pre-treatment of the area with topical aminolevulinic acid for 1 hour, followed by treatment with blue light. In a previous study, the investigators showed pretreatment of microneedles enhance penetration of topical aminolevulinic acid as compared to the control group.

The aim of this study is to investigate how varying incubation periods of topical aminolevulinic acid after pretreatment with microneedle application can facilitate the penetration and efficacy of photodynamic therapy.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age and older
* Subjects has actinic keratoses and qualifies for photodynamic therapy
* Do not meet any of the exclusion criteria

Exclusion Criteria:

* Subjects who smoke
* Subjects who have a photosensitizing condition such as lupus, porphyria, or similar condition
* Subjects who have established allergy to topical ALA
* Subjects who have had a documented nonmelanoma skin cancer on the face over the past 6 months