cyrilzakka/clinical-trials huggingface dataset:
Persona Cohort Nordic Multicenter Study

In this project the investigators wish to:

Evaluate intra-operative and postop complications, longer term survivorship and patient reported outcome measures (PROMs) following primary total knee replacement using Persona Total Knee system.

This project is carried out as prospective cohort study. Recruitment of participants to this project is expected to begin in October 2016 or as soon as permission from the Regional Ethics Committee and the local Data Protection Agency is obtained as required. A total of 700 participants (including 155 participants from a randomized controlled trial (RCT) investigating the Persona and the Nexgen total knee systems, which is separately submitted to the ethics committee) are to be included at several centers in the nordic region. Recruitment is expected complete after a period of 1,5 years per site. The patient follow-up visits are expected to be completed 2 years after recruitment of the last participant. Survivorship will be collected until 10 years after the recruitment of the last participant.

Participants are seen on an outpatient basis at 3 months and 1 and 2 years postoperatively.

After the 2 year follow-up visit the patients recruited in the Scandinavian sites will be followed for survivorship through the National Knee Arthroplasty Registries at 5, 7 and 10 years postoperatively. Since France does not have a national registry, the French site will also perform 5 year follow-up visits.

The investigators will retain the subject data sources, case report forms (CRFs) and electronic-CRFs in accordance with local laws and regulations.

The enrollment is competitive between the participating centers. Project information and consent according to local requirements before surgery is completed.

Surgery is performed as described in the manufacturer's surgical technique. A senior surgeon dedicated to total knee arthroplasty surgery will perform all operations with an assistant.

Participants will receive standard pain treatment and rehabilitation until discharge.

Eligibility Criteria:
Inclusion Criteria:

* Clinical and radiological osteoarthritis of the knee set to receive a primary unilateral total knee replacement

Exclusion Criteria:

* Patients who are unwilling or unable to give consent, or to comply with the follow-up program.
* Patients that meet any contraindications listed in the Instruction for Use
3D Personalized Modelization of the Hand Using EOS Imaging System

This study aims to compare the quality of 3D hand modelization with EOS imaging with gold-standard computed tomography


Eligibility Criteria:
Inclusion Criteria:

* Patient with hand/wrist CT required
* Informed consent form signed
Robotic-assisted and Laparoscopic Right Colectomy Study - Intracorporeal vs. Extracorporeal Anastomoses

To compare intracorporeal and extracorporeal anastomoses for robotic-assisted and laparoscopic right colectomies

This is a prospective multicenter observational study to evaluate outcomes of intracorporeal and extracorporeal anastomoses for robotic-assisted and laparoscopic right colectomies.

Eligibility Criteria:
Inclusion Criteria:

* Subject is 18 years or older
* Subject undergoing either laparoscopic or robotic-assisted right colectomy for benign or malignant right colon disease
* Subject undergoing intracorporeal or extracorporeal anastomosis proximal to mid-transverse colon

Exclusion Criteria:

* Subject is contraindicated for general anesthesia or surgery
* Emergent Case
* Subject has perforated, obstructing or locally invasive neoplasm (T4b)
* Subject with inflammatory bowel disease
* Subject with prior incisional hernia repair
* Planned right colectomy along with major concomitant procedures (e.g. hepatectomies, other intestinal resections).
* Metastatic disease with life expectancy of less than 1 year
* Pregnant or suspect pregnancy
* Subject is mentally handicapped or has a psychological disorder or severe systemic illness that would preclude compliance with study requirements or ability to provide informed consent
* Subject belonging to other vulnerable population, e.g, prisoner or ward of the state
Early Therapy Response Monitoring in Melanoma Patients Using PET/MRI

Therapeutic agents used in malignant melanoma treatment such as BRAF/MEK inhibitors and anti-CTLA-4/Anti-PD-1 antibodies go along with harmful side effects in a considerable proportion of patients and treatment costs may cause relevant medical expenditures per month. Currently, therapy response assessment in melanoma patients is performed using RECIST criteria which are based on changes in tumour size. PET/CT combines morphological and metabolic information. Thus, the so-called PERCIST-criteria were introduced integrating change in size and glucose utilization for response assessment in solid tumors. Due to the different mechanism of action these new agents introduce different response patterns increase in tumor size due to inflammation for antibody therapies). In conventional chemotherapies, re-staging is usually performed 3 months after treatment initiation which is the result of empirical investigations. Moreover, it has recently been shown, that response to new targeted therapies can be detected much earlier using PET or functional MR techniques. This forms the rationale for the monitoring of melanoma patients using a combined PET/MR technique after only 2 weeks of therapy initiation. Especially for patients in stage IV with a medium survival time of 12 months, a 2.5 months earlier re-staging and therapy adjustment would have significant consequences for the individual clinical course.


Eligibility Criteria:
Inclusion Criteria:

* patient with diagnosed unresectable malignant melanoma stage IV
* age: ≥18 years
* planned systemic therapy with either new therapies (BRAF/MEK inhibitors, Anti-CTLA-4/Anti-PD-1 antibodies) or conventional chemotherapeutics (CTx)
* clinically indicated routine PET/CT (baseline t0) demonstrating at least one measurable lesion
* PET/CT for baseline-staging and therapy monitoring (clinical indication required)
* informed consent

Exclusion Criteria:

* contraindications for MR-imaging (metal implants, claustrophobia, etc.)
* contraindications for gadolinium-based contrast agent
* acute infections or other acute diseases
* pregnant or breast-feeding women
* disability for informed consent
Simplified Diet Approach in Phenylketonuria

This is a study to determine if a simplified protein counting system, including the free usage of fruits and vegetables low in phenylalanine, will improve the metabolic control in teens and adults with phenylketonuria (PKU).

Anybody with a positive diagnosis of PKU, between the ages of 13-65 years will be invited to participate in this study.

Subjects will be educated on the simplified system upon enrollment, and historical phenylalanine (Phe) levels will be used for comparison. Subjects will also be asked about their attitudes towards their current Phe counting system.

This is a study to determine if a simplified protein counting system, including the free usage of fruits and vegetables low in phenylalanine, will improve the metabolic control in teens and adults with phenylketonuria (PKU).

Anybody with a positive diagnosis of PKU, between the ages of 13-65 years will be invited to participate in this study.

Subjects will be educated on the simplified system upon enrollment, and historical phenylalanine (Phe) levels will be used for comparison. Subjects will also be asked about their attitudes towards their current Phe counting system.

Upon enrollment, a 3-day food record and Phe levels over the past 12 months will be collected. Demographic information will be asked, as well as questions regarding their current Phe counting system. Patients will be educated on the new counting system, stressing 3 key principles: 1) free use of fruits and vegetables, low in protein, 2) protein counting as a simpler version of Phe counting, including reinforcement of label reading, and 3) daily use of PKU formula for enhanced nutrient and protein intake. Patients will be given written educational tools to reinforce this new method.

At the end of the 12 months, subjects will be asked to provide a 3-day food record, and questions will be asked about their attitudes toward the use of the new simplified system.

Phenylalanine levels from the 12-month study period will be used to compare with historical data.

Eligibility Criteria:
Inclusion Criteria:

1. Positive diagnosis of PKU
2. Males and females \>13 year of age
3. Currently on phenylalanine-restricted diet

Exclusion Criteria:

1. Any woman planning, or becoming pregnant during study duration
2. Any patient who starts Kuvan during the study, as Kuvan lowers phenylalanine levels in some patients.
3. Any patient currently enrolled in other research studies (Prism 301/302 Protocol; Institutional Review Board Protocol # 376-13-FB)
Study to Evaluate Satisfaction After Treatment With Restylane

Open-label, phase IV, post-marketing study to evaluate aesthetic improvement and satisfaction after treatment with Restylane


Eligibility Criteria:
Inclusion Criteria:

* Signed and dated informed consent to participate in the study
* Adult women who intend to undergo cheek augmentation

Exclusion Criteria:

* Subjects presenting with known allergy to HA (hyaluronic acid) filler or amide local anesthetics
* Subjects with a previous implant other than HA in or near the intended treatment site
* Participation in any other clinical study within three (3) months before treatment
Child Discomfort and Parental Acceptability of Silver Diamine Fluoride and Alternative Restorative Treatment

The aim of the current study was to compare pain perception of young children treated with SDF and ART, as well as their parents' acceptability of both modalities.

Eighty, 3-8-years-old children, having at least one deciduous asymptomatic tooth with active caries were randomly assigned into 2 groups; SDF for caries arresting in the test group, and ART for caries removal in the control group.

Eligibility Criteria:
Inclusion Criteria:

* Negative and definitely negative behavior according to Frankl's behavior rating scale.
* Having at least one deciduous asymptomatic tooth with active caries, as defined by the International Caries Detection and Assessment System; ICDAS II scores 4, 5, 6.

Exclusion Criteria:

* Children who suffered from silver allergy, oral ulcerations, pulpal infections and whose parents needed immediate permanent restorations.
Coronary Artery Ectasia in Elective Coronary Angiography : Predictors, Outcomes and Management

Coronary artery ectasia (CAE) is the diffuse dilatation of coronary artery. It is defined as a dilatation with a diameter of 1.5 times the adjacent normal coronary artery . Its prevalence ranges from 1.2%-4.9% with male to female ratio of 3:1 .

Coronary ectasia likely represents an exaggerated form of expansive vascular remodelling (i.e. excessive expansive remodelling) in response to atherosclerotic plaque growth .

CAE is more common in males. Hypertension is a risk Factor. Interestingly, patients with DM have low incidence of CAE. This may be due to down regulation of MMP with negative remodelling in response to atherosclerosis . Smoking appears to be more common in patients with CAE than in those with coronary artery disease (CAD).

The angiographic classification for CAE (described by Markis et al.) categorizes the severity based on the extent of coronary arterial involvement: Type 1: Diffuse ectasia of 2-3 arteries; Type 2: Diffuse ectasia in one artery and localized in another; Type 3: Diffuse single arterial ectasia; Type 4: Localized or segmental ectasia .

Stable angina is the most common presentation in patients with CAE . Patients with CAE without stenosis had positive results during treadmill exercise tests. ST-elevation myocardial infarction (MI) , non-ST elevation MI can occur from altered blood flow by distal embolization or occlusion of ectatic segment with thrombus.

Medical management for CAE is a controversial area as there is lack of evidence based medicine, especially the role of antiplatelet versus anticoagulant agents. Aspirin was suggested in all patients because of coexistence of CAE with obstructive coronary lesions in the great majority of patients and the observed incidence of myocardial infarction, even in patients with isolated coronary ectasia .The role of dual anti platelet therapy has not been evaluated in prospective randomized studies. Based on the significant flow disturbances within the ectatic segments, chronic anticoagulation with warfarin as main therapy was suggested


Eligibility Criteria:
Inclusion Criteria:

* Subjects with suspected CAD who are referred for elective coronary angiography

Exclusion Criteria:

* Previous admission with an acute coronary event, previous PCI or CABG.
* History of bleeding tendency or those with high bleeding risk according to the HAS-BLED bleeding risk score
Expanded Access to Tipifarnib

Requests for single patient expanded access to tipifarnib may be considered for adult patients with HRAS mutations or peripheral T Cell Lymphoma (PTCL).

To request access, use Responsible Party contact information provided in this record.

Expanded access for tipifarnib is only available in the United States.


Eligibility Criteria:
Inclusion/Exclusion Criteria:

Diagnosed with HRAS-mutant carcinomas or peripheral T Cell Lymphoma (PTCL).

Adult, ages 18+.

Have exhausted appropriate standard treatments without success and no comparable or satisfactory alternative treatment is available or exists to treat the disease or condition.

Is ineligible for participation in any ongoing clinical study of the investigational drug, which includes lack of access due to geographic limitations.

Meets any other pertinent medical criteria for access to the investigational drug, as established by the Kura Oncology
Study of Low-level Laser Therapy in the Acute Treatment of Migraine

This study evaluates the treatment of migraine pain using low energy laser light to quench migraine signals issuing from the sphenopalatine ganglion (SPG).

This is a double blinded, two arm study, comprising a sham laser and a treatment laser. The sham laser emits approximately 1/1000 the energy of the treatment laser.

It is presumed that pain relief from the treatment laser is achieved by exhausting the release of neurotransmitters from the SPG following laser stimulation. Subjects will be treated and subsequently queried at time intervals for their self-assessment of pain score (VAS). The time intervals include queries at 5 minutes through 2 hours post treatment. Subjects will be further contacted 24 hours and one month post treatment. Adverse events will be monitored and recorded.

Eligibility Criteria:
Inclusion Criteria

* male or female
* aged 18 or older;
* subject diagnosed with migraine according to The International Classification of Headache Disorders- Version 3;
* 1-20 headache days per month;
* history of at least moderate pain if migraine left untreated.

Exclusion Criteria:

* headache on greater than 25 days/month on average for preceding 3 months;
* headache on greater than 25 days in present month;
* headache attributed to: head or neck trauma, cluster headache, specific migraine variants such as basilar artery, ophthalmoplegic, hemiplegic, etc;
* women of child bearing age not using acceptable method of contraception;
* pregnant or nursing women;
* history of malignancy of any organ
* uncontrolled: hypertension, severe psychiatric disorders, or known use of narcotics, analgesic or alcohol abuse;
* light sensitivity;
* retinal disease;
* intranasal pathology.
Haplo-identical/Mismatched Hematopoietic Stem Cell Transplantation for Myelodysplastic Syndrome

Allogeneic hematopoietic stem cell transplantation (HSCT) is currently the only curative treatment for myelodysplastic syndrome (MDS), especially for advanced MDS (blast \>5%). However, many patients cannot find an HLA-matched donor. haploidentical donor is an alternative stem cell source.

the study hypothesis: Haploidentical/mismatched hematopoietic stem cell transplantation can improve the survival of patients with myelodysplastic syndrome


Eligibility Criteria:
Inclusion Criteria:

* Patients with MDS (1)intermediate-2 or high risk (2)low or intermediate-1 risk with drug resistance or disease progression
* without identical sibling donor

Exclusion Criteria:

* Contraindication to HSCT
* Pregnancy
* Mental illness
Mitochondria Inborn Errors of Metabolism and ANT Defects in Mitochondria Diseases

The objective of this research protocol is to continue investigation of the nature and prevalence of mitochondria disease and to aid patients and health care providers in the understanding of these complex disorders.

This research study brings together many clinical sub-specialists to address the etiology of these disorders and to develop more effective approaches for their diagnoses and more reliable prognoses.

The non-invasive device named Diffuse Optical Spectroscopy developed at the Beckman Laser Institute is to be used to measure various physiological parameters. Since mitochondria produce most of the energy necessary for cellular function, their efficacy is most important for systems with a high energy demand like the brain, heart, skeletal muscle, kidney, liver, and endocrine tissues. As a result, mitochondria diseases usually manifest as complex, multi-organ disorders, requiring multispecialty investigations.

Eligibility Criteria:
Inclusion Criteria:

* Male or female all ages group with diagnosis of mitochondrial disorder

Exclusion Criteria:

* Subjects with visual, auditory and/or neurological problems known to result from toxic or environmental effects
A Study on the Effects of TA-8995 on Lp(a) in Subjects With Elevated Lp(a)

A study in males and females with elevated Lp(a) to look at the effects of TA-8995 on Lp(a) levels.


Eligibility Criteria:
Inclusion Criteria:

* Male and female (of non-child bearing potential) subjects with elevated Lp(a) levels

Exclusion Criteria:

* Clinically significant medical history
* Abnormal laboratory results (other than lipid levels) or vital signs
* Receiving any other drug therapy
Thiol Disulfide Balance and Oxidative Stress Change in Endometrial Polyp Patients

Changes in Thiol Disulfide Balance and Oxidative Stress Mechanisms in Patients with Endometrial Polyps


Eligibility Criteria:
Inclusion Criteria:

For participants in the control group:

• To be without endometrial polyp

For the polyp group, they were as follows:

* Individuals experiencing menometrorrhagia
* A body mass index (BMI) of 25 or more
* Hypertension
* Endometrial polyps detected via saline infusion ultrasonography

Exclusion Criteria:

* Pregnancy
* Diabetes mellitus
* Pelvic mass
* Malignancy
* The use of Tamoxifen, hormonal contraceptives, or hormone replacement therapy.
A Phase 1 Study of UB-VV111 With and Without Rapamycin in Relapsed/Refractory CD19+ B-cell Malignancies

This study is a Phase 1 dose-escalation and dose-confirmation study to evaluate the safety and antitumor activity of UB-VV111. The study will enroll patients with relapsed/refractory large B-cell lymphoma (LBCL) and chronic lymphocytic leukemia (CLL).


Eligibility Criteria:
Inclusion Criteria:

1. 18 years or older
2. Provides voluntary written informed consent
3. Relapsed or refractory large B-cell lymphoma (LBCL) or chronic lymphocytic leukemia (CLL)
4. Measurable disease according to Lugano 2014 criteria (LBCL) or iwCLL 2018 (CLL).
5. No serious concomitant diseases or active/uncontrolled infections
6. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
7. Adequate organ function
8. Patients who have previously received CD19-directed therapy must have biopsy confirming CD19 expression following completion of prior CD19-directed therapy.

Exclusion Criteria:

1. Women who are pregnant or breastfeeding
2. Current isolated central nervous system (CNS) involvement
3. Prior allogeneic bone marrow transplant, gene therapy, or adoptive cell transfer (except CAR T-cell therapy in CAR T-exposed subjects)
4. History of or active human immunodeficiency virus (HIV)
5. Active hepatitis B or C
6. Systemic autoimmune or immunodeficiency diseases, except for well-controlled Type I diabetes or thyroid disease
7. Ongoing CNS disease that would preclude neurologic assessment
8. Uncontrolled angina or other acute heart disease
9. Currently receiving treatment in another interventional clinical trial.
Sleep Disordered Breathing in Precapillary Pulmonary Hypertension: Effect of CPAP Treatment

Evaluation of the effect of CPAP (continuous positive airway pressure ) treatment in PAH (pulmonary arterial hypertension) and CTEPH (chronic thromboembolic pulmonary hypertension) patients suffering from sleep disordered breathing.

The primary endpoint of the study is to evaluate the effect of CPAP therapy on pulmonary vascular resistance in PAH and CTEPH patients suffering from sleep disordered breathing.

The secondary endpoints are the effect of CPAP on right atrium and right ventricle diameter and ejection fraction measured by echocardiography, 6 minutes walk distance, NYHA class, QOL, endothelial function, sympathetic activity and prognosis.

Eligibility Criteria:
Inclusion Criteria:

* minimum 18 years old
* diagnosed with PAH or non-operable CTEPH or operated CTEPH with peristent pulmonary hypertension
* diagnosis of PAH based on cardiac catherisation
* diagnosis of CTEPH confirmed by contrast-enhanced spiral chest CT, pulmonary angiography and V/Q scintigraphy
* recent diagnosis of sleep disordered breathing (polysomnography realized within 3 months before inclusion showing AHI above 15) stable clinical condition for at least 3 months before inclusion as defined by NYHA and a walking distance difference within 10% of the previous 3 months and no change in medical therapy during this 3 months

Exclusion Criteria:

* congenital heart disease
* moderate and severe restrictive or obstructive pulmonary disease with a TLC and a FEV1\<60% of the predicted value
* BMI 35kg/m2 or more
* patients already treated with CPAP
* patients with severe sleepiness (epworth sleepiness scale from 18 to 24/24)
Extension Study to Assess Long Term Safety, Tolerability, and Efficacy of Valsartan and Enalapril Combined and Alone in Children With Hypertension

The purpose of this extension study is to compare the long-term safety of valsartan versus enalapril, and the effectiveness of the combination of valsartan and enalapril versus enalapril alone in children with hypertension.


Eligibility Criteria:
Inclusion Criteria:

* Successful completion of 12 weeks of double-blind treatment in core protocol CVAL489K2302.
* Patients participating in study CVAL489K2302 who may have discontinued prematurely due to uncontrolled hypertension defined as MSSBP \> 20%, but \< 25% above the 95th percentile for age, gender, and height after visit 5, qualifies a patient for entry into this extension study.

Exclusion Criteria:

* Renal artery stenosis.
* Current diagnosis of heart failure (NYHA Class II-IV).
* Second or third degree heart block without a pacemaker.
* Concurrent potentially life threatening arrhythmia or symptomatic arrhythmia.
* Clinically significant valvular heart disease.
* Patient that demonstrates clinically significant ECG abnormalities other than those associated with left ventricular hypertrophy and AV block controlled with a pacemaker.
* Previous solid organ transplantation except renal, liver or heart transplantation. Renal, liver or heart transplant must have occurred at least 6 months prior to enrollment. Patient must be on stable doses of immunosuppressive therapy for 3 months and deemed clinically stable by the investigator.
* Patients who experienced any adverse events considered serious and drug related in protocol CVAL489K2302.

Other protocol-defined inclusion/exclusion criteria applied to the study.