cyrilzakka/clinical-trials huggingface dataset:
Fate of Moderate Secondary Mitral Regurgitation in Patients Undergoing Aortic Valve Surgery for Severe Aortic Regurgitation

Patients with severe aortic regurgitation (AR) may be affected, in many cases, by a concomitant moderate or severe mitral regurgitation (MR). Tethering of the mitral valve leaflets and/or annular dilatation, both consequences of left ventricular dilatation, represent the most common mechanisms underlying the development of MR which can therefore be defined as "secondary" in this case.

When both mitral and aortic regurgitation are severe, patients show a decreased survival due to the pathophysiological consequences of the combination of these pathological conditions. In this case, surgery on both diseased valves is required to interrupt the natural history of the disease and is widely supported by current guidelines. On the other hand, little is known about the fate and prognostic implications of moderate MR secondary to severe AR and whether or not it should be treated at the time of aortic valve surgery. For this condition, the current guidelines do not provide specific recommendations, referring generically to the decision of the Heart Team.

To date, there are few data describing the evolution of moderate MR in patients undergoing surgery for severe AR and insufficient data to support recommendations regarding the treatment of moderate MR concurrently with treatment of AR, so that this decision is now entrusted to the evaluation of the Heart Team. It is therefore desirable to evaluate the outcomes of these patients.

The aim of this study is to evaluate the short- and long-term fate of secondary moderate MR in patients undergoing aortic valve replacement for severe AR.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients;
* Patients with severe aortic regurgitation (AR) AND moderate mitral regurgitation (MR).
* Patients underwent isolated aortic valve surgery (Study Group) or concomitant mitral valve surgery (Control Group) and
* Patients operated at the Cardiac Surgery Department of the San Raffaele Hospital from January 2004 to January 2019

Exclusion Criteria:

* Patient with more than moderate MR
Hip Arthroplasty with SL Cementless

The study aims to evaluate the clinical, radiographical and patient-reported outcomes measurements up 3 years FU and to assess the survivorship of SL Cementless Stem after partial or total hip arthroplasty.


Eligibility Criteria:
Inclusion Criteria:

All patients that underwent to partial or total hip arthroplasty and implanted with SL cementless stem between Jan 2010 and Jan 2020 at Nemocnice Kyjov Hospital (CZ) in accordance with the indication for use of the product and site standard of practice.

Additional Inclusion criteria:

* Availability of patients' immediate post-operative radiograph (baseline) and of a number of follow-up x-rays that the Principal Investigator deems sufficient for an effective radiographic implant evaluation and stability assessment;
* Patient is willing and able to complete additional follow-up evaluations if needed after signing ICF.

Exclusion Criteria:

* Age \< 18 years;
* Female patients who are pregnant, nursing, or planning a pregnancy
Investigation of Heart Failure Status Over Time Using Respiratory Parameters

The purpose of the study is to investigate respiratory indicators for clinically important changes in Heart Failure status over time.


Eligibility Criteria:
Inclusion Criteria:

* Moderate to severe Heart Failure (as determined by Echocardiogram or by treating physician)

Exclusion Criteria:

* Malignant disease affecting gas exchange or respiratory parameters
* Medications compromising breathing with no adverse affects on heart failure
* Clinically significant (moderate to severe) asthma requiring therapy
* Chronic parenchymal lung disease (FEV1/FVC ratio = 65% or as determined by the treating physician)
* Severe pulmonary hypertension
* Heart failure due to alcohol abuse or chemotherapy
* Narcotic abuse/intravenous drug use (including HIV+ and hepatitis C)
* Alcohol consumption \> 80g/day
* Patients receiving home Oxygen
* Methicillin- resistant Staphylococcus aureus infection
* Narcolepsy
* Cataplexy
* Enrolled in any concurrent study, that may confound the results of this study.
* Inability or refusal to sign the Patient Consent Form
* Inability or refusal to adhere to protocol requirements
Phase I/II Trial of VELCADE + CHOP-Rituximab in Untreated DLCBL or Mantle Cell NHL

Primary Objective:

To determine the toxicity profile and maximum tolerated dose (MTD) of VELCADE when administered in combination with CHOP + Rituximab to patients with previously untreated diffuse large B cell or mantle cell non-Hodgkin's lymphoma (NHL)

Secondary Objectives:

To assess the response rate (overall and complete), event-free survival and overall survival with VELCADE and CHOP-R in patients with previously untreated diffuse large B cell or mantle cell lymphoma (phase II component)

Treatment:

Standard CHOP chemotherapy administered every 21 days (full dose) for six cycles

Rituximab administered (375 mg/m2) day 1 of each cycle (with usual premedications)

VELCADE is administered prior to rituximab and CHOP on day 1 of each cycle. The dose of VELCADE will be determined by the following dose escalation schedule:

Level Dose/Schedule (-2) 0.7 mg/m2 on day 1 of each cycle (-1) 0.7 mg/m2 on days 1 and 8 (0) 0.7 mg/m2 on days 1 and 4 (+1) 1.0 mg/m2 on days 1 and 4 (+2) 1.3 mg/m2 on days 1 and 4

Standard CHOP chemotherapy administered every 21 days (full dose) for six cycles

Rituximab administered (375 mg/m2) day 1 of each cycle (with usual premedications)

VELCADE is administered prior to rituximab and CHOP on day 1 of each cycle. The dose of VELCADE will be determined by the following dose escalation schedule:

Once completed six cycles of therapy (\~18 weeks), patients will be evaluated every 3 months for the first year post treatment, then every 6 months until disease progression or death for years 2 through 5 post treatment. Patients who have disease progression will be contacted every 6 months until death to assess for survival status.

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed diagnosis of diffuse large B cell or mantle cell Non-Hodgkin's Lymphoma with characteristic immunophenotypic profiles. For mantle cell: CD5(+), CD19(+) or CD20(+), cyclin D1(+), CD23(-) and CD10(-).
* Patient has not received any prior anti-cancer therapy for lymphoma
* Tumor tissue confirmed to express the CD20 antigen
* Available frozen tumor tissue(rebiopsy if needed)
* Patient has measurable disease as defined by a tumor mass \> 1.5 cm
* Patient has Stage II, III, or IV disease
* Age \> 18 years
* Absolute granulocyte count \> 1000 cells/mm3
* Platelet count \> 50,000 cells/mm3
* Creatinine \< 2.0 x ULN
* Total bilirubin \< 2.0 x ULN

Exclusion Criteria:

* Known central nervous system (CNS) involvement by lymphoma
* Known HIV disease
* Patient is pregnant or nursing
* Patient has had major surgery within the last 3 weeks
* Patient is receiving other investigational drugs
* Known peripheral neuropathy \> Grade 2
Relation of Caries Color to Caries Severity and Its Microbial Load

This study is to find the relation of caries color to caries severity and its microbial load in primary molars.

This study is to investigate the relationship between the caries color to caries severity and its microbial load.

Eligibility Criteria:
Inclusion Criteria:

1. Their ages ranged from (4 to 7) years.
2. They were healthy, free from any chronic disease and had no previous anxiety disorder or medical disability such as the history of seizures or convulsion disorders, nystagmus, vertigo or equilibrium disorders, eye problems and autism.
3. Primary molars with class 1 caries, normal furcation and normal periapical bone structure
4. They were indicated for restorative treatment under local anesthesia.
5. They were not indicated for pharmacological management

Exclusion Criteria:

1. Primary molars with class 2 caries
2. Teeth with mobility
3. Periapical abscess
4. Fistula
Cost-effectivness of Robot-assisted Surgery Compared to Open Surgery for Partial Nephrectomy in Context of Renal Tumor

This study aim to analyze cost-effectiveness of robot-assisted surgery compared to open surgery for partial nephrectomy in the context of renal tumor. A total of 400 patients were recruited in two centers in France corresponding to Reims(n=200) and Nancy hospital center (n=200). Patients recruited in Reims are corresponding to open surgery strategy, while patients of Nancy center are corresponding to robot-assisted surgery.

Costs analyzed included cost of intervention, hospital stay and complications. Effectiveness measure is corresponding to the rate of patients without acute complication at one year.

The main objective of this study is to analyze cost-effectiveness of robot-assisted surgery compared to open surgery in the context of partial nephrectomy for renal tumor. Many studies demonstrated a better post-operative outcome with robot-assisted surgery mainly in terms of lower rate of complications. Results in terms of oncologic outcomes were equivalent. However, no study in France has analyzed the economic incentives of implementing robot-assisted surgery in the context of partial nephrectomy. It is very likely that the higher cost of robot-assisted surgery could be offset by a lower cost of post-operatives complications. The secondary purpose of this study is to analyze difference between robot-assisted and open surgery procedures in terms of operative time, hospital stay duration and rate of minor complications.

The study is based on a retrospective cohort of 400 patients. Half of patients (N=200) were recruited in Nancy hospital center and are corresponding to the robot-assisted surgery procedure. The other half is corresponding to open surgery arm and where recruited in Reims hospital center.

Inclusion criteria refer concerns patients over 18 years that were operated for minor renal tumor in Nancy and Reims hospital center. Patients operated for total nephrectomy were excluded from the analysis.

Data collected refers to the cost and effectiveness of the two compared procedures. Cost data are issued from hospital records and included the cost of hospital stay, surgical intervention and potential complications. Data related to effectiveness are obtained from patients medical records.

Cost-effectiveness analysis will be conducted to estimate the cost per one averted case of post-operative complication at one year. This consists on calculating the incremental cost-effectiveness ratio (ICER). Sensitivity analysis will be also conducted in order to estimate de confidence interval for the ICER.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing partial nephrectomy surgery for renal tumor
* Patients that gave informed consent for participating to the study

Exclusion Criteria:

* Patients undergoing partial nephrectomy surgery for other indication
* Patients that refused participation to the study
* Patients with horseshoe kidney
* Patients undergoing total nephrectomy for renal tumor
LEAPTogether: An Intergenerational Intervention to Address Loneliness and Social Isolation

Older adult participants will engage in exercise videos twice a week for 8 weeks either while paired with a peer (same age group) or paired with a younger adult with the ability to simultaneously video chat while exercising.

Participation in this study includes:

* Completing assessments at baseline (start of study), 8 weeks, and 16 weeks
* Initial meeting with an Exercise Physiologist to determine exercise interests and preferences
* Being matched with an exercise partner
* Virtually meeting with partner to engage in exercise videos via the FlexTogether platform (meet twice a week for a total of 8 weeks)
* Attend a live group class once a month
* Completing an exit interview

Primary Objective:

To assess feasibility by monitoring adherence to an 8-week virtual paired exercise program for older adults

Secondary Objectives:

1. To mechanistically investigate the key social pairing components (i.e., older adults together, younger and older adult pairing) within a virtual program necessary to enhance social connectedness, decrease loneliness, improve well-being, and increase physical activity in older adults and younger adult participants in the short-term (pre-post) through surveys and qualitative interviews
2. To mechanistically investigate the key social pairing components (i.e., older adults together, younger and older adult pairing) within a virtual program necessary to enhance social connectedness, decrease loneliness, improve well-being, and increase physical activity in older adults and younger adult participants in the long-term (8 weeks post-intervention / 18 weeks on study) through surveys and qualitative interviews

Eligibility Criteria:
Inclusion Criteria:

* Verbal informed consent obtained from subject and ability for subject to comply with the requirements of the study
* Age 18-30 years for younger adults
* Age greater than or equal to 65 years for older adults
* Has access to a tablet, laptop, or desktop computer with video capabilities connected to the internet with a screen at least 13 inches across
* Able to read, write, and understand English
* Has a 5 x 6 foot space at home in which to exercise

Exclusion Criteria:

* Current diagnosis of dementia
Treatment of Onychomycosis Using a 0.65 Millisecond Pulsed Nd:YAG 1064 nm Laser

The investigators would like to test the treatment of onychomycosis using a 0.65 millisecond pulsed 1064 nm laser fitted with a special onychomycosis handpiece. The investigators will compare the success rates of those receiving laser treatments with untreated patients. This study will provide a clinical basis for determining the relative effectiveness of an increasingly utilized treatment method.

Current antifungal treatments have low cure rates and numerous side effects. A new treatment method, pulsed laser, has been purported to have high rates of treatment in a much shorter time frame than other treatments. While the treatment method has become increasingly popular, studies of its efficacy are few. The investigators hope to learn the cure rate of a novel treatment that is being used by more and more patients. This knowledge will be essential to physicians as they consider employing this new technology in their treatment methods.

Eligibility Criteria:
Inclusion Criteria:

* Have Onychomycosis on at least one toe.
* Age 18 or older.
* Consent to research use of their toenail clippings.

Exclusion Criteria:

* Current immunosuppression (cancer, autoimmune disease) or taking immunosuppressive drugs.
* Pregnant female.
* Age 75 or older.
Dexmedetomidine in TAP Block for Inguinal Hernia Repair

This prospective double-blind randomized study will aim at evaluating the short- and long-term postoperative analgesic efficacy of the ultrasound-guided transversus abdominis plane (TAP) block with a combination of local anesthetic and dexmedetomidine in inguinal hernia repair under general anesthesia

Inguinal hernia repair is one of the most commonly performed surgical procedures worldwide, especially in the day-case setting. It can be accompanied by moderate to severe postoperative pain, which can delay return to normal daily activities or lead to the development of chronic pain. Chronic pain after hernia repair has a reported prevalence ranging between 0% and 43% with both nociceptive and neuropathic features. The transversus abdominis plane (TAP) block is an effective regional anesthetic technique to reduce postoperative pain intensity, time to first rescue anesthetic administration and opioid demand after upper and lower abdominal surgery. Dexmedetomidine is a selective α2-adrenergic agonist with analgesic properties that has been shown to prolong local anesthetic action when used as an adjunct to local anesthetic solutions in neuraxial anesthesia. The aim of this prospective, double-blind placebo controlled randomized study will be to evaluate the analgesic efficacy of ultrasound-guided TAP block where local anesthetic is supplemented by dexmedetomidine in patients undergoing unilateral elective inguinal hernia repair with the Lichtenstein technique under general anesthesia.

Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologists (ASA) patients I-III undergoing inguinal hernia repair with a mesh
* open hernia repair
* elective surgery

Exclusion Criteria:

* inability to consent to the study due to language barriers or cognitive dysfunction -
* bilateral inguinal hernia repair,
* body mass index over 40 kg m-2,
* skin infection at the puncture site
* contraindication to paracetamol or non-steroidal anti-inflammatory drug (NSAIDs) administration
* known previous hepatic or renal impairment as assessed by the patients' history and routine biochemical markers
* coagulation abnormalities
* history of gastroesophageal reflux and preoperative use of opioids or NSAIDs for chronic pain conditions
* reoperation of recurrent inguinal hernia after previous mesh repair
Blood Types in Children With COVID-19

It is speculated that in adult patients with COVID-19 blood type A is associated with the worst outcome, while blood type O is associated with mild symptoms.To our knowledge, there has been no such a study investigated ABO and Rhesus (Rh) blood group types in children with COVID-19 infection yet. Therefore, the study aimed to examine if such a correlation exists in children infected with COVID-19.


Eligibility Criteria:
Inclusion Criteria:

* The study period consisted between March 2020 and December 2020
* Children with a documented positive COVID-19 nasal smear real-time reverse-transcriptase polymerase chain reaction (PCR) assay were included.

Exclusion Criteria:

* Patients who had a past medical history of any chronic illness (related to respiratory, cardiology, immunology, neurology, metabolic, etc) were excluded.
Endoscopic Treatment of Complex Anal Fistulas

This is a randomised controlled trial to evaluate the outcome of treatment of complex perianal fistula by Video-assisted anal fistula treatment (VAAFT) compared to fistulectomy and sphincter reconstruction as standard surgical procedure.

The surgical treatment of complex fistulas is difficult and ideally aims to completely heal the fistula and prevent recurrence without affecting the anal sphincter function. The definitive surgical treatment options include transsphincteric fistulectomy and sphincter repair, intersphincteric ligation of the fistula tract (LIFT), transanal advancement flap and cutting Seton suture. All the methods caries a relative high recurrence and complication rate including the risk of anal incontinence .Transsphincteric fistulectomy and primary reconstruction of the anal sphincter has been reported to have a healing rate between 90 - 95,8 %, recurrence rate of 7,1-9,7 % and 5-30 % experience incontinence in varying degree. Video-assisted anal fistula treatment (VAAFT) is a novel sphincter saving procedure for treating complex anal fistulas and recently introduced with promising early results with a healing rate of 74-87.1 % after 1 year. The procedure can be done as a day-case surgery with the ability of precise identification of the fistula tract, including the presence of secondary branches. The method includes an endoscopic debridement and closure of the internal opening. Only few scientific reports of the method has been published and only with short term results, and there is a need of validating the efficacy of this procedure in a prospective randomized trial. There are few randomised controlled trials in the literature on the treatment of complex anal fistulas treatment and there is no conclusive evidence of which method is the best. Furthermore the knowledge of changes in quality of life and functional results in terms of standardized continence evaluation and manometric studies are either contradictive or simply lacking after the surgery for anal fistulas. The aim of this study is to conduct a randomized clinical trial to compare VAAFT (mini invasive and sphincter-saving) with the traditional transsphincteric fistulectomy and primary reconstruction in terms of recurrence rate, manometric and functional changes as well as changes in quality of life.

Eligibility Criteria:
Inclusion Criteria:

* Patients with complex transsphincteric anal fistulas \>18 yrs old.

Exclusion Criteria:

* Crohns fistulas
* Signs of suppuration or/and branching.
* Malignancy within 5 yrs.
* Previous radiotherapy of the abdomen and pelvis.
* Current Immune- suppressive treatment.
Generation of a Cellular Model of CADASIL From Skin Fibroblasts

Cerebral Autosomal Dominant Arteriopathy with Subcortical Infarcts and Leucoencephalopathy (CADASIL) is an archetypal small vessel disease of the brain caused by dominant mutations in the NOTCH3 receptor. Cardinal vascular lesions include deposition of granular osmiophilic material (GOM) within the basal lamina of smooth muscle cells, progressive smooth muscle cell loss, and fibrosis of the media. Pathogenic mutations alter the number of cysteine residues in the extracellular domain of NOTCH3 (Notch3 ECD), leading to its abnormal accumulation in the GOM deposits. Vascular smooth muscle cell has been identified as the primary target cell in this disease. Pathophysiological processes leading from NOTCH3 mutations to smooth muscle cell loss remain poorly understood.

The investigators propose to study these mechanisms by reprogramming skin cells to become stem cells and then differentiating them to vascular smooth muscle cells.

The hypothesis of this study is that the differentiated smooth muscle cells will display the characteristic features of CADASIL, ie, Notch3 ECD accumulation and GOM deposits.


Eligibility Criteria:
Inclusion Criteria :

* Between 30 and 60 years;
* Having a social security scheme or, CMU ;
* Diagnosis of CADASIL confirmed by molecular analysis performed previously (missense mutation in the Notch3 gene affecting the number of cysteine in one of the 34 EGFR of NOTCH3 ) ;
* No countra-indication for a skin biopsy (ongoing treatment with anti-coagulant, history of bleeding disorder or deficiency of blood clotting factors) ;
* Written consent given.

Exclusion Criteria :

* Patients without social security scheme or, CMU ;
* Patients aged under 30 or over 60 years at the time of the first visit ;
* Pregnant women beyond the 5th month of pregnancy
* Patients who are not able to give informed consent ;
* Countra-indication to the achievement of the skin biopsy ( ongoing treatment with anti- coagulant, history of bleeding disorder or deficiency of coagulation factors ) .