cyrilzakka/clinical-trials huggingface dataset:
Comprehensive Patient Reported Outcomes (PRO) Management for Oncology Practice

Cancer symptoms due to disease progression or side effects caused by cancer treatment are prevalent. Most cancer patients are treated in outpatient settings. Patients may be provided with patient education materials and counseled on anticipated side effects while being provided with different self-management options and warnings regarding when medical care is required. Despite these efforts, many people feel set adrift in having to self-manage treatment and illness related symptoms at home resulting in a sense of burden for the patient and the caregiver.

When the patient does visit the doctor, they increasingly are asked questions to elicit information about symptoms and performance using structured questionnaires that are shown to give reproducible, meaningful, quantitative assessments of how patients feel and how they function-measures that are called patient reported outcomes or PROs. The questionnaires used to collect this information are called PRO instruments. The use of PRO instruments is part of a general movement toward the idea that the patient, properly queried, is the best source of information about how he or she feels. The goal of using PRO measures is to provide better information to doctors and patients so that the best treatment for patients can be determined.

PURPOSE: To reduce the isolation of patients/caregivers from the medical care team and to improve patient/provider communication and clinical decisions by keeping documented daily reports of patient symptoms online, having notifications sent to the medical team of moderate to severe symptoms and by reviewing these reports at clinic visits with the medical staff.


Eligibility Criteria:
Inclusion Criteria:

* Female, breast oncology patient
* Breast cancer diagnosis
* Expected chemotherapy regimen of at least 3-4 months
* Sufficient cognitive ability and psychological stability in the opinion of treating physician
* Fluent in spoken and written English
* 18 years of age or older
* Outpatient
* Life expectancy \> 6 months as estimated by treating physician
* Informed of the investigational nature of this study and provided informed consent.
* Has access to either a phone or the internet

Exclusion Criteria:

* Is not female, nor a breast oncology patient
* Does not have breast cancer diagnosis
* Expected chemotherapy regimen is less than 3-4 months
* Does not have sufficient cognitive ability and psychological stability in the opinion of treating physician
* Is not fluent in spoken and written English
* Is younger than 18 years of age
* Inpatient
* Life expectancy \< 6 months as estimated by treating physician
* Is not informed of the investigational nature of this study and does not provide informed consent.
* Does not have access to either a phone or internet.
Phase I/II Study of Heme Arginate and Tin Mesoporphyrin for Acute Porphyria

OBJECTIVES: I. Evaluate the efficacy and safety of heme arginate in the treatment of 20 patients with acute attacks of porphyria.

II. Evaluate the efficacy and safety of heme arginate in preventing frequent exacerbations of acute porphyria in up to 15 patients.

III. Estimate the lowest effective dose of heme arginate (0.3, 1.0, or 3.0 mg/kg) in reducing porphyrin precursors in 12 stable patients with acute intermittent porphyria in remission.

IV. Evaluate the safety and efficacy of tin mesoporphyrin used in combination with heme arginate in reducing porphyrin precursors in 12 stable patients with acute intermittent porphyria in remission.

PROTOCOL OUTLINE: This project involves 4 studies: an unblinded multicenter treatment study, an unblinded prevention study, a controlled dose-ranging study, and a controlled drug combination dose-ranging study.

In the treatment study, participants with acute attacks of porphyria receive intravenous heme arginate daily for 4 days. Treatment may be extended to 7 days in patients with severe attacks and slow recovery; these data are analyzed separately.

In the prevention study, participants receive weekly infusions of heme arginate for 6 months. Treatment may be extended in selected cases; these data are analyzed separately. If an acute attack occurs, patients are treated with a standard course of heme arginate. Participants are followed weekly for 6 months after preventive treatment.

In the dose-ranging study, 4 groups of 3 patients are randomly assigned to standard and low-dose heme arginate infusions, administered daily for 4 days. After a washout of 4-12 weeks, patients are crossed to a second dose. In 2 of the 4 groups, patients cross between heme arginate and a normal saline control.

In the combination dose-ranging study, 4 groups of 3 patients are randomly assigned to 1 of 2 doses of tin mesoporphyrin. After a 4-12 week washout, these patients are crossed to a standard or low-dose heme arginate infusion. After a second 4-12 week washout, patients are given a combination infusion of tin mesoporphyrin followed by heme arginate.

All participants are given a special diet to prevent fluctuations in porphyrin precursors.

Eligibility Criteria:
PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

* Well-documented acute porphyria, i.e.: Acute intermittent porphyria Variegate porphyria Hereditary coproporphyria

--Patient Characteristics--

* No pregnant women
Evaluation of Bone Mineral Density Changes After Total Hip Replacement: A Two-Year Clinical and DXA Analysis

Sponsor is conducting this post-market study to evaluate the clinical outcome and femoral bone mineral density (BMD) changes associated with the PROFEMUR® PRESERVE hip stem when used as indicated for primary total hip arthroplasty in patients with osteoarthritis of the hip joint.


Eligibility Criteria:
Inclusion Criteria:

To be included in the study, subjects must meet all of the following criteria:

* Subject is minimum age 21 years, maximum age of 80
* Subject is a candidate for primary THA for osteoarthritis of the hip
* Subject is able to undergo primary elective THA procedure
* Subject is willing and able to complete required study visits and assessments
* Subject is willing to sign the Institutional Review Board/Ethics Committee (IRB/EC) approved Informed Consent document.

Exclusion Criteria:

Subjects will be excluded if they meet any of the following criteria:

* Overt infection;
* Distant foci of infections (which may cause hematogenous spread to the implant site);
* Rapid disease progression as manifested by joint destruction or bone absorption apparent on roentgenogram;
* Skeletally immature (less than 21 years of age at time of surgery);
* Inadequate neuromuscular status (e.g., prior paralysis, fusion, and/or inadequate abductor strength), poor bone stock, poor skin coverage around the joint which would make the procedure unjustifiable;
* Neuropathic joints;
* Known Hepatitis or HIV infection;
* Neurological or musculoskeletal disease that may adversely affect gait or weight-bearing
* Subjects with known osteoporosis of the affected hip
* Subjects with prior arthroplasty of the affected hip
* Subjects that are clinically obese (\>40 body mass index \[BMI\])
* Subjects with femoral dysplasia of the affected hip
* Subjects with trochanteric osteotomy of the affected hip
* Subject with inflammatory arthritis of the affected hip
* Subjects currently taking, or have taken within 12 months of enrollment, bisphosphonates, parathyroid hormone (PTH), fluoride therapy or strontium ranelate or patients taking other chronic medications that in the investigator's opinion are known to affect BMD in a substantial way
* Subjects with severe medical condition(s) that in the view of the investigator prohibits participation in the study
* Subjects currently enrolled in another clinical study which could affect the endpoints of this protocol
* Subjects with known substance abuse issues
* Subjects who are incarcerated or have pending incarceration
Telephone Outreach by Navigators to Improve Repeat Fecal Occult Blood Testing

To conduct a randomised control trial to test the effectiveness of telephone outreach programme to improve the uptake rate of repeat fecal occult blood test in colorectal cancer screening programme.

The colorectal cancer screening programme(CRCSP) adopts a two-tier approach, offering faecal occult blood test (FOBT) by FIT as first line screening followed by colonoscopy examination for cases with positive FIT result. Under the CRCSP, participants with negative or uninformative FIT result in the first round should be re-screened after 24 months.

The objective is to conduct a randomised control trial to test the effectiveness of telephone outreach programme to improve the uptake rate of repeat fecal occult blood test in CRCSP.

Eligibility Criteria:
Inclusion Criteria:

* Participants of CRCSP born between 1949 and 1951 with negative or uninformative FIT result in the first screening round who are due for second rescreening round for at least 4 months but did not turn up for rescreening

Exclusion Criteria:

* Nil
Advisory Board on Cancer, Infertility and Pregnancy

The Advisory Board on Cancer, Infertility and Pregnancy provides a platform where physicians from all over the world can request recommendations regarding the medical care of pregnant women diagnosed with cancer or regarding fertility preservation. The platform will contain different national advisory boards, with their own coordinator and members, as well as an overarching international advisory board with an international coordinator and members from different national boards.

To investigate the impact of this platform, a year after its launch, data regarding the incoming requests will be extracted from the website, as well as all recommendation letters.

The Advisory Board on Cancer, Infertility and Pregnancy (ABCIP)-platform will be a web-based platform where clinicians from all over the world can request advice from a group of experts on the field of Cancer and Pregnancy. The platform will contain different national advisory boards, with their own coordinator and members, as well as an overarching international advisory board with an international coordinator and members from different national boards.

Clinicians can fill in a format (attached) requesting for advice, using only pseudonymized patient data after agreeing a disclaimer:

All information filled in in the 'request advice' format needs to be regarded as anonymous or pseudonymous data. We recommend you to inform your patient and ask for approval when needed, based on the rules and regulations applicable in your country.

The filled out request will be sent to the specific national board of their own country, and if no national board is available, to the overarching international board.

. To investigate the impact of this platform, a year after its launch, data regarding the incoming requests will be extracted from the website, as well as all recommendation letters.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant women with a cancer diagnosis
* Women with a fertility related question after cancer diagnosis
* Postpartum cancer diagnosis
* Cancer treatment during pregnancy
Effects of Fish Oil on Platelet Function and Coagulation

Many patients undergoing surgery use naturopathic drugs, including fish oil. Fish oil has been reported to increase bleeding in patients through inhibiting platelet aggregation and prolonging of clot formation time. The Swedish Medical Products Agency recommends that patients stop taking the naturopathic medicines including fish oil two weeks prior planed surgery. The aim of this study is to examine the effects of fish oil given to healthy volunteers using point of care coagulation assessment and flow dependent Cellix instrument before and after intake of fish oil.

Healthy volunteers will be given maximum dose of fish oil for 7 days. Blood samples will be collected before and immediately after the 7 days of intake and analysed using point of care coagulation assessment instruments and flow dependent platelet aggregation using a microfluid flow controlled system (Cellix). For point of care coagulation assessment the multiple electrode platelet aggregometer Multiplate, the viscoelastic rotational thromboelastometers ROTEM and Sonoclot will be used. Flow cytometry may also be utilized.

Eligibility Criteria:
Inclusion Criteria:

* Non smoking healthy volunteers with written consent to participate

Exclusion Criteria:

* Medication affecting coagulation or platelets within 14 days priori to inclusion
Study to Investigate the Mass Balance, Metabolism, and Excretion of [14C]PF-07321332 in Healthy Male Participants.

This study is to characterize mass balance and further the understanding of human pharmacokinetics, metabolism, and excretion of radiolabeled \[14C\]PF-07321332 in healthy male participants following oral administration with ritonavir.


Eligibility Criteria:
Inclusion Criteria:

* Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination (PE), laboratory tests, vital signs and standard 12 lead ECGs.
* Body mass index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight \>50 kg (110 lb).
* Participants who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures

Exclusion Criteria:

* Positive test result for SARS-CoV-2 infection at the time of Screening or Day -1.
* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).
* Clinically relevant abnormalities requiring treatment (eg, acute myocardial infarction, unstable ischemic conditions, evidence of ventricular dysfunction, serious tachy or brady arrhythmias) or indicating serious underlying heart disease (eg, prolonged PR interval, cardiomyopathy, heart failure greater than New York Heart Association (NYHA) 1, underlying structural heart disease, Wolff Parkinson-White syndrome).
* Any condition possibly affecting drug absorption (eg, gastrectomy, cholecystectomy).
* History of human immunodeficiency virus (HIV) infection, hepatitis B, or hepatitis C; positive testing for HIV, hepatitis B surface antigen (HBsAg), or hepatitis B surface antibody (HCVAb). Hepatitis B vaccination is allowed.
* Use of prescription or nonprescription drugs and dietary and herbal supplements within 7 days or 5 half lives (whichever is longer) prior to the first dose of study intervention.
* Participant who have received a COVID-19 vaccine within 7 days before screening or admission, or who are to be vaccinated with a COVID-19 vaccine at any time during the study confinement period.
* A positive urine drug test.
* Participants enrolled in a previous radio-nucleotide study or who have received radiotherapy within 12 months prior to screening or such that total radioactivity would exceed acceptable dosimetry (ie, occupational exposure of 5 rems per year).
Preoperative Vestibular Rehabilitation Effectiveness After Vestibular Schwannoma Surgery

Vestibular schwannoma (VS) is a benign tumour from Schwann cells surrounding the vestibular nerve, which slowly grows within the internal auditory canal and then into the cerebellopontine angle, leading to a gradual vestibular dysfunction. The slowly progressive alteration of vestibular function allows the gradual implementation of central adaptive mechanisms called vestibular compensation. The total unilateral vestibular deafferentation induced by the surgical tumour removal suddenly leads to a decompensation of this previously compensated situation, which explains why most patients report severe vertigo immediately after surgery and which is responsible for perturbations of the postural control (Parietti-Winkler et al., 2006, 2008, 2010, 2011). Recently, Gauchard et al. (2013) suggested that preoperative and regular physical activity would limit the adverse effects of surgical removal on balance control. Also, patients benefited faster and better from the postoperative vestibular rehabilitation.

Thus, preoperative vestibular rehabilitation, including physical and balance exercises, could help to limit postoperative balance disorders and promote postoperative balance compensation. This could lead to a decrease in the duration and cost of the postoperative management and faster improvement of quality of life.

To test this hypothesis, the measured and perceived balance control of the patient and the quality of life will be assessed into two groups: one of two groups will receive preoperative vestibular rehabilitation, carried out by a physiotherapist, and the other not. The assessments will be conducted 45 days and 3 days before surgery, and then 8 days, 30 days, 90 days and 365 days after surgery.

Eligibility Criteria:
Inclusion Criteria:

* Patients with unilateral vestibular schwannoma (stage I to IV according to the Koos classification) with an indication for surgery.
* Patients gave their written informed consent
* Patients are affiliated to the french social welfare

Exclusion Criteria:

* Disorders from the motor and/or somesthetic systems (especially the lower limbs)
* Contraindications to the scheduled functional assessments: ear pathology different from vestibular schwannoma such as cholesteatoma of the middle ear, tympanic membrane perforation, etc.
* Refusal of the surgical procedure
Ten-year Outcomes After AF Ablation

Ablation of atrial fibrillation (AF) using pulmonary vein isolation is employed when patients do not respond favorably to medical therapy. Successful procedures are accomplished in the majority of patients, but the outcome after many years of follow-up after ablation is unknown.

A prospectively identified cohort of 445 patients who demonstrated freedom from AF for at least one year following ablation (single procedure in 391, 87.9%) was followed for 66.0 ± 34.0 months. Patients were seen at least annually as outpatients, and underwent regular ECG monitoring, especially if there were symptoms suggestive of recurrent arrhythmia. Continued absence of arrhythmia was defined as freedom from AF or flutter \> 30 secs.

Eligibility Criteria:
Inclusion Criteria:

* Prior AF ablation procedure
* No AF for one year post ablation

Exclusion Criteria:

* Geographic inaccessibility
* Longstanding persistent AF
* Recurrent AF within one year of ablation
* Prior AF ablation
Medico-economical Evaluation of Patient-hotel in Urology

This is a medico-economic study of outpatient surgery paired with a night stay in a patient-hotel, compared with a conventional hospitalization for three types of urological surgeries.

The aim is to show that those two strategies are not different in term of adverse effects or rehospitalization, and that the patient-hotel provide a better quality of life at a reduced cost, in order to generate savings for the paying agent: the Healthcare insurance.


Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years
* Healthcare insurance affiliation
* Surgeries : sacral nerve neurostimulation, urinary artificial sphincter, or prosthetic penile implant
* ASA (American Society of Anesthesiology) score between I and III
* Patients that can be accompanied by a person with a car
* Prior Informed Consent procedure form signed
* Hospitalisation in Lyon Sud Hospital

Exclusion Criteria:

* Refusal of participation or signing the consent form, guardianship or curatorship patients
* Inability to understand the procedure
* History of cognitive or psychiatric disorders
* Non eligibility to out patient
* Pregnant or breastfeeding patients
* No affiliation to Healthcare insurance
Is the Dynamic of the Pelvic Bone Altered After a Total Hip Replacement ?

Total hip replacement is one of the most common surgical procedure in France. In 2010, an estimated 147 513 total hip procedures were performed. This number is constantly increasing.

Although it is common, it can lead to many complications. The intra-prosthetic luxation is the second one after aseptic loosening.

The luxation risk is multifactorial and depends on the relative orientation of femoral et acetabular components. This orientation is influenced by statics and dynamics parameters.

So far, the literature shows that only static parameters are considered by surgeons. Thus, in reference to Lewinneck publication, which states that the luxation risk is lower if the cup is oriented with 15° +/- 10° of anteversion and 40°+/- 10° of inclination with respect to the anterior pelvic plan (APP). Defined by the two anterosuperior iliacs spines and pubic symphysis.

However, this approach is only static and do not take into account the variations of pelvic plan orientation during everyday life.

To consider these variations of pelvic inclination, it is possible to measure the angle between APP and the horizontal (in lying position) or the vertical (in standing position) plan.

Several devices allow the measure of pelvic inclination but they all have important limits (EOS radiography, scanner or navigation). A new device has been developed in Brest to measure this inclination in several positions of the daily life.This software has already been tested in healthy volunteers and results demonstrate an excellent accuracy and reproducibility.

The goal of this study is to described the dynamic of the pelvic bone thanks to this ultrasound based device, and to assess the amount of variation induced by hip replacement procedures.


Eligibility Criteria:
Inclusion criteria :

* Patient with primary or secondary hip arthritis, at stage II to III of the radiological classification of Tönnis and for whom total hip replacement is indicated by surgeon.
* Signed consent
* Patient beneficiary of a social security plan

Exclusion Criteria:

* Patient Under 18
* Patient Under protective measure (guardianship, curatorship) or unable to consent
* Patient requiring revision THR
* Patient with geographic mobility plan before the end of the follow-up
* Symptomatic contralateral hip
* Symptomatic dorsolumbar rachis
* Pelvis or spine surgery planed during the follow-up
* Pregnant or nursing woman