cyrilzakka/clinical-trials huggingface dataset:
The Effectiveness of Reablement in Home Dwelling Older Adults. A Randomized Controlled Trial

The purpose of this study is to determine whether a special kind of rehabilitation offered to home-dwelling older adults is effective with regards to functional ability and municipal costs.

Early detection of functional decline among home dwelling older adults and immediate onset of rehabilitation, can improve function, and reduce or delay need for home-based assistance and nursing home placement. Towards year 2050 there will be a significant increase in number of elderly persons in Norway, with an urgent need for new models for early intervention and rehabilitation in order to give service to a larger amount of elderly persons. Reablement is a new and promising rehabilitation model which many Norwegian municipalities are implementing in order to meet current and future needs for municipal home-based services. However, very little research has been conducted regarding the effectiveness of this intervention. This study aims at assessing the effectiveness of reablement in terms of daily functioning and economic costs compared to standard home-based treatment and care.

The study will be conducted in the municipality of Voss in Western Norway, a municipality with only 14000 inhabitants. It is a double-blinded, block-randomized controlled intervention trial, recruiting home-dwelling older adults with an initial functional decline in daily activities. The intervention is intensive, multidisciplinary, home-based rehabilitation given by home-trainers, under supervision from an occupational therapist or a physiotherapist. The control intervention is standard home-based treatment and care.

Thirty participants will be recruited in each arm of the study. The participants will be assessed at baseline, and at 3-, and 9 months follow-up. Primary outcomes will be participation, activity, and municipal expenditures. Costs are generated by the working hours of the different professions. Hence, there will be a daily registration of the working hours different health care professions spend in the private homes of the participants.

Power calculations based on study with a similar target group using the instrument Canadian Occupational Performance Measure, estimate a need for only 21 participants in each group due to the longitudinal design. However, in order to account for possibilities of frailer target group or a large drop out rate (40 %), a total number of 30 participants in each group will be tried recruited. Data analyses will be performed according to intention to treat. The working hour data is panel data and will be analyzed accordingly; a random or a mixed effect regression model will be employed. Also, descriptive statistics and simpler tests will be carried out.

Eligibility Criteria:
Inclusion Criteria:

* Home-dwelling person
* Applicant of home-based services
* Above 18 years old
* Functional decline in at least one activity
* Able to understand written and oral Norwegian

Exclusion Criteria:

* Cognitive disability
* Terminal ill
* Being assessed as needing nursing home placement
* Being assessed as needing institution-based rehabilitation
Assessment of Lumpectomy Margins With the Histolog Scanner in Comparison With Intraoperative Imaging Techniques

Study to assess the capability of using the Histolog Scanner, a recent large field-of-view confocal laser scanning medical imaging device for the breast cancer detection in fresh lumpectomy margins.

Breast cancer is the most common cancer in women. For early-stage breast cancers, breast-conserving surgery (BCS) is applied to excise the tumor while saving surrounding healthy tissue as much as possible to avoid radical excisions and achieve better aesthetic and psychological outcomes for the patient. This surgical approach requires postoperative tumor-free margin assessment of the surgical resection in order to carry on with next steps of the patient care treatment (e.g. radiotherapy). Unfortunately, at least 20% of patient undergo more than one procedure to achieve acceptable margin status due to difficulties to identify subclinical and deep-seated tumor during BCS. During the surgery, the surgeon mainly relies on nonspecific visual changes and manual palpation of subtle irregularities to guide cancer excision. While these determinants enable bulk tumor assessment, they do not offer the information to adequately identify tumor infiltrates on lumpectomy margin.

An efficient intraoperative assessment of the margin may solve these issues and confocal imaging has shown some promises by providing real-time imaging of fresh tissue with the resolution sufficient to visualize microscopic tissue features. The Histolog Scanner is a recent confocal microscope designed for clinical use on large surgical specimens.

The main objective of this study is to confirm that the use of the Histolog Scanner by surgeons allows to detect breast cancer on lumpectomy margins and compare the performance of the detection with local standard-of-care intraoperative imaging techniques (ultrasound and radiography) using the final assessment performed in pathology as reference.

Eligibility Criteria:
Inclusion Criteria:

* Adult female patient ≥18 years old
* Patient Scheduled for breast conserving surgery of invasive and/ or in situ ductal carcinoma (DCIS).
* Patient able to read, understand and give informed consent

Exclusion Criteria:

* Patient previously treated for ipsilateral breast cancer surgery
* Patient with previous radiotherapy of the breast
* Patient with multicentric breast cancer
* Patients with planed mastectomy, tumor-adapted breast reduction
* Patient with presurgical neo-adjuvant treatment
* Patient is pregnant/lactating
* Participation in any other clinical study that would affect data acquisition
An Exploratory Study of Herombopag for Thrombocytopenia Induced by Chemotherapy Combined With Immunotherapy in NSCLC

The purpose of this study is to explore the safety and efficacy of herombopag olamine tablets for thrombocytopenia induced by chemotherapy combined with immunotherapy in non-small cell lung cancer

To observe and evaluate the safety and efficacy of the TPO receptor agonist herombopag for the secondary prevention of thrombocytopenia caused by chemotherapy combined with immunotherapy in non-small cell lung cancer.

Eligibility Criteria:
Inclusion Criteria:

1. The patients signed the informed consent and voluntarily joined the study;
2. Age 18-75 years old, male or female;
3. Patients with stage IIIb-IV non-small cell lung cancer diagnosed by histopathology or cytology, who have received and will continue to receive carboplatin-based chemotherapy combined with pemetrexed or nab-paclitaxel, combined with immune checkpoint inhibitors ( ICIs) treatment;
4. The investigator determined that the patient could receive hetrombopag administration;
5. Thrombocytopenia of grade 2 or above occurred in the last chemotherapy cycle, defined as platelet count (PLT) ≤ 75×109/L;
6. The values of laboratory tests performed for screening shall meet the following criteria:

1) Blood routine examination: a) Hemoglobin (HB) ≥ 90 g/L; b) Absolute neutrophil count (ANC) ≥ 1.5×109/L; c) Platelet count (PLT) ≥ 80×109/L; 2) Biochemical tests: a) AST and ALT ≤ 3 times ULN (if there is tumor liver metastasis, ≤ 5 times ULN); b) TBiL ≤ 2 times ULN; c) Cr ≤ 2 times ULN, or creatinine clearance (CrCL) ≥60 mL/min (Cockcroft-Gault formula); 7. Life expectancy at screening ≥12 weeks; 8. ECOG: 0-1; 9. The main organ functions are normal, and there are no serious complications;

Exclusion Criteria:

1. pregnant or breastfeeding women;
2. Inability to understand the research nature of the research or to obtain informed consent;
3. The investigator judges other circumstances that are not suitable for inclusion in the study;
4. Thrombocytopenia caused by other causes other than those caused by chemotherapy or immunotherapy (such as chronic liver disease, sepsis, disseminated intravascular coagulation, immune thrombocytopenia, etc.);
5. Have unstable angina pectoris, congestive heart failure, uncontrolled hypertension, uncontrolled arrhythmia or recent (within 1 year of screening) history of myocardial infarction;
6. Those with a history of blood disease or tumor bone marrow infiltration;
7. Those who received concurrent radiotherapy and those who received pelvic radiotherapy in the past;
8. Arterial or venous thrombotic events within the past 6 months;
9. There are currently uncontrollable infections.
Safety and Effectiveness of Opicapone Plus Standard of Care in Elderly Patients With Parkinson's Disease

The purpose of this study is to describe the safety and efficacy of opicapone plus standard of care in elderly patients with PD in the real-world setting

This will be a multinational, multicentre, prospective non-interventional study in elderly patients with PD. Approximately 100 patients with PD will be recruited by specialists from approximately 37 sites in European countries. The total enrolment period will be one year, and each patient will be followed for up to one year after enrolment.

PD patients with end-of-dose motor fluctuations suitable for additional treatment optimization will be included in the study and split into 2 cohorts:

* Cohort 1: 50 patients; standard of care (including L-DOPA) + starting opicapone
* Cohort 2: 50 patients; standard of care (including L-DOPA Data will be collected at baseline (date of enrolment), 1 month, 3 months, 6 months, 9 months, and 12 months after enrolment.

This non-interventional study does not recommend the use of any specific treatments. Use of opicapone and of standard of care are only driven by the physician's decision.

Eligibility Criteria:
Inclusion Criteria:

* Patient or legally acceptable representative willing and able to provide informed consent as mandated by local regulation
* Patient with clinical diagnosis of idiopathic PD (excluding non-idiopathic PD: atypical Parkinsonism, secondary \[acquired or symptomatic\] Parkinsonism, Parkinson-plus syndrome)
* Patient with age \>=75 years at enrolment
* Patient with end-of-dose motor fluctuations suitable for additional treatment optimization

Exclusion Criteria:

* Patient concurrently participating in any clinical trial
* Patient who used tolcapone or opicapone previously
* For the patient who starts opicapone: concomitant treatment with entacapone or tolcapone is not allowed
* Patient with any contraindications to Ongentys use
* Patient with any concomitant medical condition that could interfere with study assessments
Evaluation of Treatment Response With Integrated MRI/PET in Patients With Hepatocellular Carcinoma

The purpose of this study is to explore the ability of integrated MRI/PET to detect and evaluate treatment outcome in HCC patients.

This study using 18F-FDG PET and functional MRI (DCE-MRI, Diffusion-weighted MRI, MR spectroscopy).

Eligibility Criteria:
Inclusion Criteria:

1. Prior Informed Consent Form
2. At least one measurable tumor, according to RECIST version 1.1.
3. Age \> 20 years.
4. ECOG performance status 0 or 1.
5. Life expectancy \> 3 months.
6. Confirmed Diagnosis of HCC
7. Adequate renal function (Serum creatinine ≦ 1.5 x upper limit of normal).

Exclusion Criteria:

1. Age \<20 years old
2. Pregnancy
3. Contraindication for MRI: claustrophobia or MR non-compatible devices
4. Contraindication for MR contrast medium: severe adverse reaction or impaired renal function (Cre \> 2.0)
5. History of other malignancy
Gastrocnemius Recession vs. Conservative Treatment for Chronic Plantar Fasciitis

The purpose of the study is to compare the clinical results for patients suffering from plantar fasciitis treated with gastrocnemius recession vs. conservative treatment.

All patients will be instructed in stretching exercises. Half of the patients will be randomized to proximal medial gastrocnemius recession. All patients will be followed for 1 year. Additional long term follow-up will be 6 years after inclusion

Eligibility Criteria:
Inclusion Criteria:

* Symptoms of plantar fasciitis lasting more than 12 months.
* Isolated gastrocnemius contracture

Exclusion Criteria:

* No previous surgery to foot or ankle
* No active arthritis
Multifactorial Risk Assessment for Breast & Ovarian Cancer Risk Detection

The objective of this project is to validate a next-generation assay that utilizes both the protein biomarkers of our already established ovarian cancer risk assessment combined with a molecular profile in both germline and early somatic detection.


Eligibility Criteria:
Key inclusion criteria:

* Female subject
* 18 years of age or older

Cohort A specific inclusion criteria:

• Diagnosed with a pelvic mass

Cohort B specific inclusion criteria:

* Diagnosed with a pelvic mass
* Undergoing genetic testing through our commercial offering

Cohort C specific inclusion criteria:

• Subject must not have an identifiable adnexal mass and may, or may not, have a family history or a known familial genetic abnormality (germ line or identified in family cancer i.e. somatic DNA mutation) associated with ovarian cancer.

Exclusion Criteria:

* n/a
Cochlear Implant Electrostimulation and the Influence on the Vestibular Organ

There is evidence that the sensor function of the utricle in patients with bilateral labyrinthine dysfunction (bilateral vestibulopathy) may improve balance under the influence of high frequency basal stimulation of the cochlea.

The aim of the study is to measure the possible co-stimulation of the utricle (which is determined by the SVV) by tonotopic (frequency-specific) cochlear stimulation and thus to objectify whether the stimulation of the auditory nerve in CI patients also leads to an unavoidable co-stimulation of the vestibular system.

The cochlea is tonotopically structured, i.e. certain frequencies are mapped on a specific part of the cochlea from basal to apical. It is not yet known whether tonotopically differentiated stimulation of the cochlea has an unavoidable side effect on other body systems, such as the vestibular organ. If the labyrinthine dysfunction occurs as a consequence of a CI implantation, this could in the future lead to the possibility of reducing vestibular complications after CI surgery by switching certain electrodes on or off.

In a first investigation phase, a conventional and already implanted CE-certified cochlear implant will be used. The aim of this project is to test certain tonotopic stimulus patterns that stimulate the cochlea by varying the volume within predefined settings. Thus, there is no misuse of the device and no change in performance attributes. Within the framework of the clinical project planned here, the testing of vestibular co-stimulation during normal cochlear stimulation via the basal, medial and apical electrodes of the CI electrode is planned. Under the influence of defined stimulation patterns, the assessment of the subjective visual vertical (SVV) in project participants will be investigated.

The influence of tonotopic stimulation on the SVV result will have a high priority.

Eligibility Criteria:
Inclusion Criteria:

* uni- or bilaterally deafened and deaf patients with cochlear implants (one- or two- sided) from Advanced Bionics (AB), model HiRes 90K and newer
* majority
* given informed consent
* legally competent and mentally able to follow the instructions of the personnel

Exclusion Criteria:

* unsuccessful CI implantation (device or electrode defects, incomplete electrode array insertion, missing neuronal stimulus responses)
* pregnant and/or breastfeeding women
* severe pre- or concomitant disease or reduced general ground condition, so that an outpatient presentation in the ENT polyclinic is not possible
* life expectancy of less than six months
* the patient has received a study medication within the last 30 days within the framework of another study
* simultaneous participation in another clinical intervention study
* anticipated lack of compliance
* alcohol or drug abuse
* the patient is placed in an institution by order of the authorities or court
* patients who are in a dependent or employed relationship with the sponsor, investigator, or their deputy
Sleep Apnea and Hypertrophic Cardiomyopathy (HCM)

The investigators are trying to find out how common sleep apnea is in hypertrophic cardiomyopathy. The purpose of this study is to see if sleep apnea is common in hypertrophic cardiomyopathy and if its presence is associated with changes in the functioning of the body. The investigators want to determine if sleep apnea is associated with electrical disorders of the heart in patients with hypertrophic cardiomyopathy.

Participants will be healthy volunteers or subjects with the diagnosis of hypertrophic cardiomyopathy (HCM). All patients will a undergo a one time; medical history, physical examination, questionnaires, sleep observation in hospital, blood and urine samples, ultrasound scan of the heart, paced breathing test, ultrasound of brachial artery in the arm, MRI of the heart \& 48 hour ECG Holter monitoring. Comparison between the normal volunteers and subjects with HCM will be made.

Eligibility Criteria:
Inclusion criteria:

* Adults with a diagnosis of HCM
* Able to consent
* Non-pregnant
* Healthy Controls free of hypertrophic cardiomyopathy and without a definitive family history of hypertrophic cardiomyopathy.

Exclusion criteria:

* Decompensated Heart failure at time of enrollment (prior history of HF is not an exclusion criteria)
* Severe (known) Chronic obstructive pulmonary disease (COPD) (FEV1 between 30 and 50 percent of normal)
* Vulnerable study populations except for minorities (minorities may be targeted to achieve 25% minority recruitment required by the NIH)
* Pregnant women
* Children
CHOLE-POSSUM PRO Validation for Prediction of Mortality After Cholecystectomy for Acute Calculous Cholecystitis: Protocol for a Prospective Multicenter Observational Study

CHOLE-POSSUM PRO is a prospective multicenter observational study on patients with ACC candidate to EC. The rationale of the study is to validate the CHOLE-POSSUM PRO SCORE for 30-day mortality in this population.


Eligibility Criteria:
Inclusion Criteria:

* have a diagnosis of ACC as defined by TG18 criteria
* be ACC candidate to EC during the index admission\* (\* All the patients treated with initial open cholecystectomy, those who undergo ELC, those with conversion from laparoscopic to open cholecystectomy or those who undergo bail out procedures (e.g. subtotal cholecystectomy) will be included.)
* be ≥ 18 years old
* be stratified for the risk of CBDS according to the Israelian Score (29), and, in case of confirmation of CBDS receive pre-operative ERCP
* provide signed and dated informed consent form
* willing to comply with all study procedures and be available for the duration of the study.

Exclusion Criteria:

* pregnancy or lactation
* acute cholecystitis not related to a gallstone etiology
* onset of symptoms \>10 days before cholecystectomy\*\* (\*\* Patients with ACC associated with common bile duct stones who underwent pre-operative ERCP could be included if they receive EC within 10 days from onset of symptoms)
* concomitant pancreatitis
* intraoperative treatment of common bile duct stones
* anything that would place the individual at increased risk or preclude the individual's full compliance with or completion of the study.
Prenatal Screening For Smith-Lemli-Opitz Syndrome

Smith-Lemli-Opitz Syndrome (SLOS) is a genetic condition that causes mental retardation and other birth defects. This study will evaluate a new prenatal screening test for SLOS.

SLOS is an inherited metabolic disorder characterized by moderate to severe mental retardation and congenital anomalies. SLOS is caused by a deficiency of the enzyme 7-dehydrocholesterol reductase and the resulting defect in the conversion of 7-dehydrocholesterol to cholesterol. SLOS can now be reliably detected prenatally by analysis of amniotic fluid 7-8- dehydrocholesterol (7/8-DHC) levels. Unconjugated estriol (uE3) is one of the maternal serum analytes currently measured routinely to screen for Down syndrome. This analyte requires cholesterol as a precursor, and its concentration in maternal serum is lower when the fetus has SLOS.

Currently, there is no national standard for the approach taken in prenatal screening; existing programs vary both in availability and in the protocol and algorithms used. The major barrier to identifying SLOS prenatally is the absence of sound screening methodology that takes into account the detection rate, the false positive rate, and the prevalence. This study will evaluate the efficacy of routinely identifying Smith-Lemli-Opitz Syndrome (SLOS) prenatally.

The screening model in this study is based on data from SLOS pregnancies and will be tested in 1,000,000 pregnancies in which maternal serum uE3, alpha-fetoprotein, and human chorionic gonadotrophin measurements are being done as part of routine screening for Down syndrome. The screening false positive rate is projected to be 0.34%, the detection rate 62%, and the odds of being affected given a positive screening result 1:70. These rates all compare favorably with prenatal screening tests now in routine use. The study will also determine whether SLOS diagnostic studies can be carried out in maternal urine or serum, rather than amniotic fluid, thereby avoiding invasive procedures.

Participants in this study will be pregnant women undergoing amnioscentisis during the second trimester. Women who have a positive test for SLOS will be asked to provide a urine and blood sample. The study will collect data on patient demographics and family history; data will also be obtained from the participant's ultrasound, karyotype, alpha-fetoprotein, maternal serum screening, and SLOS reports. Three months after the pregnancy due date, a genetic counselor will contact the participant to obtain basic information about the baby's delivery and health.

Eligibility Criteria:
Inclusion Criteria

* Pregnant, second trimester
* Singleton pregnancy
* Positive second trimester maternal serum screen for Smith-Lemli-Opitz Syndrome (using the Foundation for Blood Research screening algorithm )

Exclusion criteria:

* Gestational age at time of serum collection outside the range accepted for Down Syndrome screening
* Not pregnant
* Twin/multiple pregnancy
* Sample/clerical/assay error
* Physician not participating in study