cyrilzakka/clinical-trials huggingface dataset:
Brain Hemorrhage and Functional Outcome in Stroke Patients With CAA Features on Pre-thrombolysis MRI Treated With Intravenous Thrombolysis (Thrombolysis in CAA) ( Thromb in CAA )

Background: In stroke patients treated with intravenous thrombolysis (IVT), presence and high number of strictly lobar cerebral microbleeds (compatible with cerebral amyloid angiopathy, CAA) seems to be associated with increased risk of hemorrhagic transformation, symptomatic hemorrhagic transformation, remote hemorrhage, and poor functional outcome. Some of these reported CAA patients with cerebral microbleeds also had chronic lobar intracerebral haemorrhage. Few data is available on IVT-treated CAA patients showing cortical superficial siderosis. There are no reports studying factors associated with brain hemorrhagic complication or functional outcome inside a group of IVT-treated CAA patients. Our aim was to evaluate brain hemorrhagic complications on 24h-CT and functional outcome after IVT in stroke patients with CAA features on pre-IVT MRI.

Methods: In our stroke center, IVT decision in patients with CAA MRI features is left at the discretion of the treating physician. We retrospectively screened pre-IVT imaging of 959 consecutive IVT-treated stroke patients (between January 2015 and July 2022) without ongoing anticoagulation therapy for probable CAA MRI features defined by modified Boston criteria. After exclusion of 119 patients with lacking MRI (n=47), with MRI showing motion artefacts (n=49) or with alternative chronic brain hemorrhage cause on MRI (n=23), 15 IVT-treated patients with probable CAA on pre-IVT MRI were identified. In these 15 patients, clinical, biological and MRI characteristics were compared between patients with vs. without post-IVT hemorrhage and between patients with poor (MRS 3-6) vs. good (MRS 0-2) functional outcome at discharge.


Eligibility Criteria:
Inclusion Criteria:

* Consecutive IVT-treated stroke patients without ongoing anticoagulation therapy registered in our stroke database presenting probable CAA on pre-IVT MRI
* Patient taken in charge at the CHU of Nîmes between January 2015 and July 2022

Exclusion Criteria:

* patients with ongoing anticoagulation therapy
Fitness and Lung Function Among Survivors of Heart Transplant, Leukemia and Infant BPD Through Exercise

This study aims to more accurately assess cardiac function, ventilation and exercise capacity in a non-invasive fashion, and to better characterize exercise intolerance in the setting of three populations of individuals with chronic diseases of childhood (acute lymphoblastic leukemia (ALL), chronic lung disease (CLD) of prematurity, and post-heart transplant (HT))

Physical activity in childhood is an integral part of maintaining health and quality of life. Children who participate in routine physical activity are more likely to maintain a healthy body weight and are less likely to have heart disease, type 2 diabetes and high blood pressure as adults. Children with chronic disease are often limited from full participation in exercise for various reasons -perceived physical limitations, either from the patient and family or from their medical provider, or because of symptoms which cause exercise to feel uncomfortable. As the number of children living and aging with chronic disease continues to grow, the researchers are hoping to expand the current exercise testing capabilities for both clinical care and research in order to (i) provide data to permit formulation of evidence-based guidelines for exercise in chronic childhood disease; (ii) improve understanding of limitations to exercise in this growing population; (iii) learn long-term implications of chronic childhood disease as these individuals enter adulthood.

Eligibility Criteria:
Inclusion Criteria:

* Cases:

  * Acute lymphoblastic leukemia survivor, OR living with chronic lung disease of prematurity, OR living with heart transplant
  * 8-25 years old
  * Height: ≥ 48 inches
  * Ambulatory without assistance
  * English speaking
  * Normotensive (\<95th percentile for age; okay if managed with antihypertensive medication)
  * SpO2 \>92%
  * Not pregnant
  * ALL survivor specific: must have completed therapy ≥ 3 months prior to study entry
* Controls

  * 8-25 years old
  * Height: ≥ 48 inches
  * Ambulatory without assistance
  * English speaking
  * No history of arrhythmia or known cardiac dysfunction at baseline
  * Normotensive (\<95th percentile for age; okay if managed with antihypertensive medication)
  * SpO2 \>95%
  * Not pregnant

Exclusion Criteria:

* Cases:

  * ALL specific: received cranial radiation, bone marrow transplant recipients
  * Investigator or patient's primary physician deems the patient unsuitable for the study
* Controls:

  * History of malignancy, CLD or HT or any other diagnosis which may reduce cardiorespiratory function
  * Investigator deems the patient unsuitable for the study
Fixation Insitu Versus Removal for Midfoot Lisfranc Injuries

This study is a multicenter prospective randomized control trial comparing hardware retention (HR) to removal of hardware (RH).

Eligible patients will be randomized to one of two treatment arms: Hardware removal at 6 months or Hardware retention for a minimum of 2 years.

Consenting patients having previously undergone open reduction and internal fixation of Lisfranc injuries with an anatomic reconstruction within 6-8 weeks will be randomized to one of two treatment arms: removal hardware (RH) or hardware retention (HR).

Outcome will be assessed at 6 weeks, 12 weeks, 6 months, 1 year, and 2 years from enrollment.

Eligibility Criteria:
Inclusion Criteria:

* Subject has Lisfranc injury that was treated within 28 days of injury.
* Subject must be enrolled in study between 6 and 8 weeks from time of initial fixation operation.
* The patient must be medically fit for anesthesia
* Subject is willing and able to provide written informed consent for trial participation
* Subject is willing and able to comply with the study protocol including return for all follow-up evaluations
* Subject may have a bony, ligamentous, or combined lisfranc injury
* Demonstrated instability of the lisfranc complex on static, stress view or CT radiography.
* Associated injuries - other than the lisfranc complex - are permitted provided those injuries are not deemed to significantly influence the rehabilitation or recovery of the patient at the discretion of the enrolling surgeon
* Adequate reduction to within 1mm of lisfranc complex at time of fixation
* Hardware across the midfoot (tarsal-metatarsal joints 1-3)

Exclusion Criteria:

* Subject has a significant pre-existing foot injury
* Subject has a delay in initial treatment greater than 28 days from time of injury
* Subject has an active infection in the area of surgical approach requiring surgical debridement
* Subject has concomitant injury which, in the opinion of the attending surgeon, is likely to impair rehabilitation or prolong fracture healing time (another long bone fracture, ipsilateral limb injury)
* Subject has a history of rheumatoid arthritis, Diabetes, fibrous dysplasia, chronic renal failure, Paget's disease, or osteopetrosis or any other pre-existing pathologic condition affecting the Lisfranc complex
* Subject has a high risk of death from surgery (ASA physical status Class V)
* Subject is likely unable to maintain follow-up(no fixed address, plans to move out of town in the next year, states unable to comply with protocol, etc.)
* Subject has cognitive impairment or language difficulties that would impede the valid completion of questionnaires
* Subject is pregnant
* There has been loss of fixation or reduction prior to enrollment
* Previous corrective foot surgery
* Associated fracture of calcaneus, talus, or tibial plafond.
* Pathologic fracture
* Loss of fixation or reduction prior to enrollment
Biosignals by Wearables in Thyroid Dysfunction

This study is a single center observational study to investigate the association between biosignals from wearables and thyroid dysfunction.

An algorithm to predict thyroid dysfunction using heart rate and activity data from wearables was generated based on our previous clinical studies. This study was conducted to collect more data to advance the algorithm.

Patients with thyroid dysfunction including hypothyroidism and thyrotoxicosis were eligible for this study. During the study period, each subject wears a smart band (Fitbit Inspire 2 TM) and gets 3 times of thyroid function tests with 1-month interval. Study participants will use a mobile app (Glandy TM) to collect the symptom scores.

Eligibility Criteria:
Inclusion Criteria:

* Subjects who were newly diagnosed as thyroid dysfunction (thyrotoxicosis or hypothyroidism) or undergoing treatment
* Subjects who are able to use wearable devices, smart phones, and mobile apps

Exclusion Criteria:

* Subjects with restrictions on normal activities due to diseases other than thyroid dysfunction
* Subjects who are taking medications affecting heart rate
* Subjects with diseases affecting heart rate (i.e. arrhythmia)
Breathe-Easy: Food Supplement for Respiratory Health

The trial aims to assess the effectiveness of a natural lung care solution and a food supplement in improving lung function, capacity, and alleviating symptoms associated with respiratory conditions like asthma, COPD, and chronic bronchitis.


Eligibility Criteria:
Inclusion Criteria:

* Adults aged 18 and older.
* Diagnosed with a chronic respiratory condition (e.g., asthma, COPD).
* No known allergies to ingredients in the supplement.
* Ability to provide informed consent and comply with study procedures.

Exclusion Criteria:

* Acute respiratory infection within the last 30 days.
* Current participation in another clinical trial.
* History of severe adverse reactions to similar supplements.
Efficacy of Synthetic Bone Graft for Treatment of Peri-implantitis

Single arm study to evaluate the effectiveness of treatment approach using a new moldable beta-tricalcium phosphate(TCP) bone graft material and polylactide membrane in peri-implantitis.


Eligibility Criteria:
Inclusion Criteria:

* Subject has read and signed the Institutional Review Board approved consent form before treatment.
* Subject must be age 21 or above.
* Subject must be willing and able to follow study procedures and instructions.
* Subject affected by moderate to severe peri-implant disease.
* Treated chronic periodontitis and proper periodontal maintenance care.
* Dental implant must meet the following criteria to be selected for the study:

  1. Implant presenting Probing Depth ≥ 6 mm
  2. Radiographic implant bone loss more than 25% of the implant length (Apex of the implant to implant platform) .
  3. Peri implant bone defect being a buccal dehiscence and semicircular bone resorption to the middle of the implant body, buccal dehiscence and circular bone resorption with lingual bone plate intact or circular bone resorption with buccal and lingual bone plates intact
  4. Single tooth implant restoration or implant supported fixed partial denture.

Exclusion Criteria:

* Subjects participating (currently or within 30 days prior to enrollment) in other clinical trials involving therapeutic intervention (either medical or dental).
* Subjects with poor oral hygiene as indicated by a score of greater than 50% on the O'Leary Plaque Index.
* Subjects with a systemic condition, which would preclude periodontal treatment, including but not limited to uncontrolled diabetes.
* Subjects with acute infectious lesions in the areas intended for treatment.
* Subjects taking chronic (i.e., \> 2 weeks), therapeutic doses of medications known to affect bone metabolism such as nonsteroidal anti-inflammatory drugs or bisphosphonates. Prophylactic aspirin (≤ 325 mg q.d.) for cardiovascular indications will be permitted in subjects.
* Female subjects who are pregnant or lactating, or sexually-active female subjects who are of childbearing potential and are not using hormonal or barrier methods of birth control. (except for when a result of pregnancy test is negative)
* Subjects who are on any chronic antibiotic or steroidal therapy.
* Smoker using more than 10 cigarettes or equivalent per day.
* Smoker using cigar, smokeless tobacco use or e-cigarette.
* Subjects diagnosed with drug induced gingival hyperplasia (e.g. calcium channel blockers).
* Subjects with radiographic evidence of pathology in other areas of the mouth besides implant area to be treated.
* Implant mobility.
* Subjects with parafunctional habits and not wearing bite guard.
Pentosan Polysulfate in Treating Patients With Gastrointestinal Disturbance Caused by Radiation Therapy

RATIONALE: Pentosan polysulfate may be effective in treating side effects of radiation therapy to the abdomen or pelvis. It is not yet known whether pentosan polysulfate is more effective than no further therapy for treating gastrointestinal disturbance caused by previous radiation therapy.

PURPOSE: Randomized phase III trial to determine the effectiveness of pentosan polysulfate in treating patients who have inflammation of the rectum, diarrhea, or blood in stools caused by previous radiation therapy to the abdomen and pelvis.

OBJECTIVES: I. Evaluate the efficacy of pentosan polysulfate in patients with gastrointestinal tract sequelae after radiotherapy to the abdomen and pelvis. II. Determine the toxic effects of this drug in these patients. III. Determine the effect of this drug on symptoms and quality of life of these patients.

OUTLINE: This is a randomized study. Patients are randomized to 1 of 2 treatment arms. Arm I: Patients receive oral pentosan polysulfate three times a day for 2-6 months. Arm II: Patients receive oral placebo three times a day for 2-6 months. Both arms: Patients may receive retreatment for two months if symptoms return and last for at least 2 weeks. Quality of life is assessed before treatment, and at each follow up visit. Patients are followed every 2 months for 6 months, then every 3 months for 18 months, then annually for 3 years.

PROJECTED ACCRUAL: A total of 174 patients will be accrued for this study within 3 years.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Must have received prior radiotherapy to the abdomen and pelvis and now have radiation related gastrointestinal symptoms (which were not present before the radiotherapy and/or attributed to other causes) Proctitis Diarrhea Melena (blood in stools) Severity of symptoms classified as grade 1, 2, or 3

PATIENT CHARACTERISTICS: Age: Any age Performance status: Not specified Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Other: No bleeding ulcers No bleeding diathesis

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: At least 1 month since prior chemotherapy No concurrent chemotherapy Endocrine therapy: Concurrent hormonal therapy for prostate cancer allowed Radiotherapy: See Disease Characteristics At least 4 weeks since prior radiotherapy Surgery: No prior bowel resection At least 3 weeks since prior surgery Other: No concurrent anticoagulation therapy (except aspirin)
Cascade Continuous Glucose Monitor (CGM) 15-Day US Performance Assessment

To assess a 15-day wear period of the Cascade Continuous Glucose Monitoring (CGM) System

To assess a 15-day wear period for the Cascade CGM. The study wear period includes four in-clinic days in which frequent blood draws and Yellow Springs Instrument (YSI) glucose measurements will be performed. Participants will be blinded to CGM glucose values during the study. A retrospective performance assessment will be conducted following the study.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of type 1 or type 2 (on insulin therapy) diabetes mellitus for at least 6 months
* 18 years of age or older
* Currently self-monitoring capillary blood glucose (on average at least three times per day or more) or using a CGM for at least three months -Willing to follow all study procedures, including attending all clinic visits (including in- clinic sessions during which a venous line will be inserted for blood sampling), wearing a CGM sensor(s) for fifteen days, performing fingertip glucose tests for self-monitoring, and keeping a diary of activities.
* Be willing to wear 2 investigational CGM devices.

Exclusion Criteria:

1. Known allergy to medical grade adhesives
2. Magnetic Resonance Imaging (MRI) scheduled during fifteen-day CGM sensor wear period
3. Persons with type 2 diabetes using diet and exercise only for diabetes management
4. Used an investigational drug within 30 days prior to study entry
5. Hematocrit \< 35% for females and \<40% for males (obtained during screening)
6. Inadequate veins (in the opinion of the investigator) or known contraindication to placement of a dedicated peripheral line for venous blood withdrawal
7. Symptomatic coronary artery disease with a history of angina, or history of a myocardial infarction or coronary intervention (e.g., percutaneous transluminal coronary angioplasty (PTCA), stent placement), or coronary artery bypass graft (CABG) within the past six months
8. Diagnosis of the following diabetic autonomic neuropathies: orthostatic hypotension, heart rate anomalies, gastroparesis
9. Cerebrovascular incident within the past six months
10. History or presence of eczema, psoriasis, atopic or contact dermatitis
11. Subject must not be pregnant at the start of the study.
12. Current use or within one-week exposure to topical medications at the proposed insertion sites
13. Seizure disorder (epilepsy)
14. Malignancy within the past five years, except basal cell or squamous cell skin cancers
15. Major surgical operation within 30 days prior to screening
16. Other medical conditions that would pose safety concerns, interfere with study conduct or seriously compromise study integrity (reason for exclusion will be clearly documented by investigator or designee)
17. Subject has experienced severe hypoglycemia or severe hyperglycemia in the last six months. Severe hypoglycemia is defined as having low blood glucose levels that requires assistance from another person to treat. Severe hypoglycemia is classed as a diabetic emergency. Severe hyperglycemia is defined as a blood ketone level \>1.6 millimolar (mM).
Relationship Between Hearing Thresholds, Handicap and Time for Treatment-seeking

Purpose: to investigate the relationship between time for treatment seeking and audiometric data and self-assessment of handicap for patients in a public hearing healthcare service. Methods: Retrospective study. Records of 152 elderly and 48 adults with hearing impairment were analyzed. The ISO audiometric thresholds average (500 to 4000Hz) and high frequencies average (2000 to 6000Hz), the speech recognition thresholds and the total, social and emotional scores from the Hearing Handicap Inventory for the Adults (HHIA) and Elderly (HHIE) were compared with the time between the onset of hearing complaints and the first treatment seeking. Results: The average time for treatment seeking was 7,6 years. No statistical difference was found between ISO and high frequency audiometric average, HHIA/E scores and time for treatment seeking between adults and the elderly. Weak but significant negative correlations were observed between the audiometric data and time for treatment seeking. There was no relationship between the time for treatment seeking and educational, socioeconomic levels and perception of handicap. Conclusions: The search for treatment seems to be multifactorial. Despite technological advances and changes in access to information and treatment time for treatment seeking was similar to that reported 30 years ago.


Eligibility Criteria:
Inclusion Criteria:

* Older than 18 years old. Without experience with hearing aid use. Diagnosed with sensorineural hearing loss. Audiogram data available

Exclusion Criteria:
Study Evaluating Desvenlafaxine Succinate Sustained Release (DVS SR) Versus Placebo in Peri- and Postmenopausal Women

Desvenlafaxine succinate (DVS) is a potent and selective serotonin and norepinephrine reuptake inhibitor (SNRI). The sustained-release (SR) formulation, DVS SR, is being studied in the development program for the treatment of major depressive disorder (MDD), for vasomotor symptoms (VMS) associated with menopause, and for pain associated with peripheral diabetic neuropathy, as well as for the treatment of fibromyalgia syndrome. This study will investigate the safety, efficacy, and tolerability of DVS SR in women with MDD who are peri- and postmenopausal.


Eligibility Criteria:
Inclusion Criteria:

* Peri- and postmenopausal women between the ages of 40 and 70 years, inclusive.
* A primary diagnosis of MDD, single or recurrent episode, without psychotic features using the modified International Neuropsychiatric Interview (MINI).
* Montgomery-Asberg Depression Rating Scale (MADRS) total score \> or = 22 at the screening and baseline visit.

Exclusion Criteria:

* Use of oral estrogen-, progestin-, androgen-, or Selective Estrogen Receptor Modulator (SERM)-containing drug products 8 weeks before baseline.
* Current (within 12 months) psychoactive substance abuse or dependence (including alcohol), manic episode, post-traumatic stress disorder, obsessive-compulsive disorder, or a lifetime diagnosis of bipolar or psychotic disorder.
* A history or active presence of clinically important medical disease.

Additional criteria apply.
Ripasudil for Enhanced Corneal Clearing Following Descemet Membrane Endothelial Keratoplasty in Fuchs' Dystrophy

Recently, published literature has reported that performing a descemetorhexis in combination with topical Rho kinase (ROCK) inhibitor therapy was successful in clearing edematous corneas in patients with Fuchs Endothelial Corneal Dystrophy.

Ripasudil hydrochloride hydrate( Glanatec ophthalmic solution 0.4%), a potent ROCK inhibitor, has been approved in Japan since 2014 for ocular use in the treatment of glaucoma. Ripasudil acts as an IOP-lowering drug by affecting aqueous outflow through the trabecular meshwork and Schlemm's canal.

The goal of this study is to test the potential benefits of Ripasudil therapy administered after Descemet Membrane Endothelial Keratoplasty (DMEK) surgery. We believe that performing a standard DMEK surgery in combination with Ripasudil treatment in patients with Fuchs Endothelial Corneal Dystrophy could accelerate endothelial cell healing and clear edematous corneas faster, with less post-operative complications.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed clinically with Fuchs endothelial corneal dystrophy by the study investigator.
* Phakic or pseudophakic with posterior capsule supported, suture-fixated, or sulcus-supported posterior chamber intraocular lens.
* Fuchs dystrophy grades 2-5 on the Krachmer grading scale.
* Presence of central guttae and/or stromal edema being the primary cause of decreased vision.
* The peripheral cornea to the central 6mm is devoid of guttata changes.
* Best corrected visual acuity in the study eye is 20/40 or worse with glare testing at study enrollment.

Exclusion Criteria:

* Uncontrolled glaucoma (IOP \>25 mmHg).
* Presence of secondary corneal pathology such as infective or autoimmune keratitis.
* Advanced corneal stromal edema with bullae on slit-lamp biomicroscopy.
* History of herpes simplex virus or cytomegalovirus keratitis.
* Prior penetrating keratoplasty.
* Aphakic in study eye.
* Allergy to any component of the Ripasudil hydrochloride hydrate 0.4% that will be used in the course of the study.
* Tubes or trabeculectomy from prior glaucoma surgery.