cyrilzakka/clinical-trials huggingface dataset:
Vision Improvement for Legally Blind Dry AMD Patients

This retrospective observational study is intended to assess the feasibility of using a nonsignificant risk device for vision improvement for legally blind dry AMD patients.

This retrospective observational study is intended to assess the feasibility of using a nonsignificant risk device for vision improvement for legally blind dry Age-Related Macular Degneration patients. 12-month follow-up examinations will be used to assess the amount of vision improvement and its dependence on device parameters.

Eligibility Criteria:
IInclusion Criteria:

* Male or Female
* Any race
* Patient is at least 50 years old.
* Patient must have dry AMD in the study eye.
* Patient is legally blind due to AMD - i.e., has corrected distance visual acuity (CDVA) of 20/125 or worse (45 letters; logMAR ≥ 0.80) in the study eye.
* Patient has normal corneal surface topography on videokeratography (i.e., without distorted or unclear corneal mires).
* Patient is not a contact lens wearer.
* Patient is willing and able to comply with all examinations.
* Patient must be competent to sign an informed consent form before study entry.

Exclusion Criteria:

* Visually significant cataract in the study eye
* Presence of a visually significant posterior capsule opacity if prior cataract surgery has been performed in the study eye
* Any visually significant disease process in any ocular structure other than AMD that would affect vision in the study eye
* Previous corneal surgery in the study eye
* Presence or history of any other condition or finding that, in the opinion of the investigator, makes the patient unsuitable as a candidate for study participation or may confound the outcome of the study
Clinical Implementation and Evaluation for the Family-oriented Care CHIMPS-NET

Despite the knowledge, that children of mentally ill parents are an important target group to be addressed by preventive and therapeutical interventions, there is often a lack of structured implementation of family-oriented interventions in clinical practice in Germany. Using a randomized controlled multicenter trial design with a large and wide-ranging sample (clinics for adult psychiatry and clinics for child and adolescent psychiatry, university clinics and clinics at the real health care) will examine changes in family-oriented practice and aspects of implementation to get a robust understanding of implementing family-oriented interventions in German clinical practice.

A two-group randomized controlled multicenter trial will examine changes in family-oriented practice and aspects of implementation at baseline as well as at 12- and 24-months follow-up. The CHIMPS-Network consists of twenty clinical centers. The centers in the intervention group receive the support of all of the three implementation interventions: 1) Optimal pathways to care 2) Education and a training program for professionals and 3) Systematic screening for children. The centers in the control group do not get this specific implementation support.

The implementation of all the CHIMPS interventions refers to and builds on a theoretical model developed by researchers from Australia and Norway, adapted to the German care system setting including adult psychiatry and child and adolescent psychiatry.

In ci-CHIMPS we aim to determine if three implementation interventions are helpful in improving the clinical implementation of the CHIMPS-NET interventions. Additionally, we want to identify factors hindering or promoting implementation processes. In order to monitor the impact of the three implementation interventions we will use the translated version of the "Family Focused Mental Health Practice Questionnaire (FFMHPQ)" (Laser et al., 2019, in prep.) and the translated version of the "Implementation Components Questionnaire (ICQ)" (Laser, Skogøy, Maybery \& Wiegand-Grefe, 2019. in prep). The introduction of these questionnaires in Germany has not yet been reported.

Eligibility Criteria:
Inclusion Criteria:

* Every employee, which is involved in the treatment of the patients (Medicine, Psychology, Nurses) of every clinical center that is part of the CHIMPS-NET project will be invited to participate in this study ci-CHIMPS.

Exclusion Criteria:

* There are no explicit criteria for exclusion
Stockholm3 Use Prior to MRI for Prostate Cancer Detection in a Clinical Care Pathway: a Multi-centered Validation

Men meeting local clinical standard of care to undergo a prostate MRI for suspicion of prostate cancer will be included. Blood sample will be drawn on the day of MRI or immediately prior to MRI for measurement of the prostate cancer biomarker Stockholm3. Specifically, the Stockholm3 test will be performed in a retrospective manner and no clinical decisions will be made based on the results. The patients will not receive the results of the Stockholm3 assay. A Stockholm3 score will be reported for each patient.

The primary aim is to show superior specificity of Stockholm3 (at different thresholds) for MRI selection compared to PSA (at different thresholds) (I.e., the proportion of men with a negative Stockholm3 test or a negative PSA test among those with a normal MRI).

Additional aims:

1. To show non-inferior relative sensitivity in detection of csPC of Stockholm3 compared to PSA (The proportion of men with a positive Stockholm3 test (at different thresholds) or a positive PSA test (at different thresholds) among those diagnosed with csPC will be calculated).
2. To evaluate Stockholm3 risk thresholds to determine if it can be used to further reduce MRI, biopsy and Gleason grade group 1 cancers without reducing sensitivity of csPC detection.


Eligibility Criteria:
Inclusion Criteria:

* Men with age range (40.0 - 80.0 years)
* Already scheduled to undergo MRI for prostate cancer screening (both negative and positive MRI included).

Exclusion Criteria:

* PSA \< 1.5 ng/mL
* Any known diagnosis of prostate cancer (patient on active surveillance)
* Men that have undergone digital rectal exam (DRE) immediately before blood draw (DRE within 5 days of study blood draw are excluded).
* Men who in the three (3) months prior to study participation received any invasive urologic procedure such as thermotherapy, microwave therapy, laser therapy, transurethral resection of the prostate (TURP), urethral catheterization, and lower genitourinary tract endoscopy (cystoscopy)
* No history of new treatment for BPH in three (3) months prior to study participation.
Pilot Clinical Trial of Computer-based Motivational Intervention - 1

Pilot trial of computer-based motivational intervention. Hypothesis: The brief computer-delivered intervention would result in higher motivation to change at follow-up.

Participants were randomized into brief intervention vs. assessment-only conditions, with follow-up to measure overall motivation to change.

Eligibility Criteria:
Woman in immediate post-partum period

Inclusion Criteria:

Self-report of drug use prior to pregnancy

Exclusion Criteria:

Frank psychosis or other cognitive impairment; inability to communicate in English; fatigue; recent receipt of narcotic pain medication; grieving over medically compromised infant
An Unusual Association Between Pancreatic Cancer and Purtscher-like Retinopathy

AN UNUSUAL ASSOCIATION BETWEEN PANCREATIC CANCER AND PURTSCHER-LIKE RETINOPATHY

Purtscher's retinopathy may cause sudden loss of vision of varying severity, secondary to head or chest injury. Its pathophysiology is unclear. Purtscher's-like retinopathy has more attenuated clinical and objective features and can be associated with many non-neoplastic pathologies.

Otherwise, an association of this kind of retinopathy with malignancies has been described once in the Literature (multiple myeloma). We present a case report on a unique association between pancreatic cancer and Purtscher-type retinopathy.

Eligibility Criteria:
Inclusion Criteria: NONE -

Exclusion Criteria: NONE

-
Hetrombopag for the Treatment of Chemotherapy-Induced Thrombocytopenia in Adults With Solid Tumors.

The purpose of current study is to evaluate the efficacy and safety of hetrombopag for the treatment of chemotherapy-induced thrombocytopenia in patients with solid tumors.


Eligibility Criteria:
Inclusion Criteria:

1. Men and women, 18-75 years of age;
2. Participant with a histologically or cytologically confirmed solid tumor receiving treatment with chemotherapeutic agents;
3. Participant experienced thrombocytopenia and chemotherapy delay;
4. ECOG performance status 0-1;
5. Adequate Liver function; aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \< 3.0 x ULN for participants without liver metastases or 5.0 x ULN for participant with liver metastases);
6. Adequate renal function; serum creatinine \< 1.5 x ULN or eGFR≤60 ml/min（Cockcroft-Gault）

Exclusion Criteria:

1. Participant has any history of hematologic diseases other than chemotherapy-induced thrombocytopenia;
2. Participant has serious bleeding symptoms;
3. History of allergy to the study drug;
4. Participant with HIV;
5. Pregnant or lactating women;
6. Participant has received any experimental therapy within 4 weeks prior to screening
7. Other conditions that may affect participant's safety or trial evaluations per investigator's discretion
Safety and Immunogenicity of the Butantan Institute Influenza Vaccine Compared to Sanofi Pasteur Influenza Vaccine

The overall aim of this study is to evaluate the safety and immunogenicity of Butantan Institute Trivalent Seasonal Influenza Vaccine in comparison with the Sanofi Trivalent Seasonal Influenza Vaccine.

To detemine whether immunogenicity elicited by a single-dose Butantan Institute Trivalent Seasonal Influenza Vaccine is not inferior to that elicited by a single dose of Sanofi Trivalent Seasonal Influenza Vaccine in adult and elderly populations measured by HI GMT for the three vaccine components 21 days post-immunization.

To describe the safety profile of Butantan Institute Trivalent Seasonal Influenza Vaccine and Sanofi Trivalent Seasonal Influenza Vaccine after a single dose in adult and elderly populations.

Eligibility Criteria:
Inclusion Criteria:

* Adult, male or female, age 18 to 69 years (inclusive) at the time of enrollment;
* Provide written informed consent;
* Agrees to complete all study visits, procedures and contacts;

Exclusion Criteria:

* Chronic medical conditions such as psychiatric conditions, diabetes, hypertension or any other conditions that might place the subjects at high risk of adverse events. Study clinicians will use clinical judgment on a case-by-case basis to assess safety risks under this criterion;
* Clinically significant abnormalities on physical examination;
* Use of immunosuppressive medications such as systemic corticosteroids or chemotherapeutics, or immunosuppressive illness. It will be considered immunosuppressive dose of systemic corticosteroids the equivalent to a dose ≥10 mg of prednisone per day for over 14 days;
* Women who report being pregnant or have plans to become pregnant during the study period;
* Participation in research involving another investigational product within 30 days before planned date of first vaccination or anytime through the last study safety visit;
* Acute febrile illness (axilar temperature ≥ 37.8°C);
* Hypersensitivity to egg or chicken proteins;
* History of Guillain-Barre Syndrome;
* Thrombocytopenia or a bleeding disorder contraindicating intramuscular vaccination;
* Unstable chronic illness (defined as illness requiring hospitalization or a clinically significant change in medication in the previous 12 weeks);
* Alcohol abuse or drug addiction;
* Any vaccination within the previous 4 weeks;
* Seasonal influenza vaccination in the previous 6 months.
Study of Efficacy and Safety of Percutaneous Coronary Intervention to Improve Survival in Heart Failure

This study will assess whether percutaneous coronary intervention (angioplasty of the heart arteries) can improve survival and reduce hospitalization in patients with heart failure due to coronary disease, who have been treated with the best contemporary medical therapy.


Eligibility Criteria:
Inclusion Criteria:

ALL of the following:

1. Poor left ventricular function (EF≤35%)
2. Extensive coronary disease
3. Viability in at least 4 dysfunctional segments that can be revascularised by PCI

Exclusion Criteria:

1. Myocardial infarction \< 4 weeks prior to randomisation (clinical definition)
2. Decompensated heart failure requiring inotropic support, invasive or non-invasive ventilation or Intra-aortic Balloon Pump/left ventricular assist device therapy \<72 hours prior to randomization
3. Sustained Ventricular Tachycardia/Ventricular Fibrillation or appropriate Implantable Cardioverter Defibrillator discharges \<72 hours prior to randomization
4. Valve disease requiring intervention
5. Contraindications to percutaneous coronary intervention
6. Age \<18 yrs
7. Estimated Glomerular Filtration Rate \< 25 ml/min, unless established on dialysis
8. Women who are pregnant
9. Previously enrolled in REVIVED-BCIS2 or current enrollment in other study that may affect REVIVED-BCIS2 outcome data
10. Life expectancy \< 1 yr due to non-cardiac pathology
Intestinal Microbiota and Arterial Stiffness

This is an observational case-control study which objective is to analyse differences in intestinal microbiota between patients with and without arterial stiffness, measured by pulse wave velocity. It will take place in two different research units located in Portugal and Spain.

Aim: analyse differences in intestinal microbiota between patients with and without arterial stiffness, measured by pulse wave velocity.

Design and setting: An observational case-control study. Study population: The investigators will select 324 subjects, between 30 to 75 years-old, from a database that combine data from four different studies: Triple A, Early vascular Aging (EVA) and Improving interMediAte Risk management (MARK) that took place in the Research Unit of La Alamedilla Primary Care Center, and Guimarães/ Vizela Study promoted by the Life and Health Sciences Research Institute in Minho University.

Measurements: 162 Cases will be defined by a Carotid-femoral Pulse Wave Velocity (cf-PWV)\>10 mm/s determined using the SphygmoCor System. 162 controls will be selected by the propensity score. The composition of the gut microbiome in faecal samples will be determined by ribosomal ribonucleic acid (16S rRNA) gene sequencing. Other measurements: demographic data, lifestyle assessment (physical activity, adherence to the Mediterranean diet, alcohol and tobacco consumption). Anthropometric Variables: Weight, body composition by bioimpedance, size, body mass index (BMI), waist and hip perimeter, peripheral and central arterial pressure. Analysis of structure and vascular function and organ lesions target: pulse wave velocity, cardio-ankle vascular index and ankle-brachial index; Intimal median carotid thickness, central and peripheral rate of increase, renal and cardiac organic lesion. Blood analysis: short chain fatty acids, total bile acids, ursodeoxycholic acid

Eligibility Criteria:
Inclusion Criteria:

• Patients with more than 40 years old who agree to participate in the study and do not meet any of the exclusion criteria.

Exclusion Criteria:

* Participants who are in terminal condition,
* Participants with a history of cardiovascular disease (ischaemic heart disease or stroke, peripheral arterial disease or Heart Failure),
* People with diabetes,
* diagnosed renal failure in terminal stages (glomerular filtration rate below 30%),
* chronic inflammatory disease or acute inflammatory process in the past 3 months.
* Patients treated with oestrogens, testosterone or growth hormone,
Advancing Telestroke Care: A Prospective Observational Study

This study will promote the development and economic sustainability of telemedicine for acute stroke treatment.

The goal of this study is to promote the development and economic sustainability of telemedicine for acute stroke treatment. The study's objectives are 1) to determine if the use of telemedicine consultations for stroke patients will improve their care per guidelines compared to stroke patients treated by control hospitals; and 2) to determine if the care per guidelines provided via telemedicine consultations for stroke patients will be similar or equivalent to care per guidelines provided to stroke patients treated at hub hospitals.

The Advancing Telestroke Care study will establish treatment and outcomes in three distinct study cohorts: hub telemedicine hospital, spoke telemedicine hospital and non-telemedicine control hospital.

Eligibility Criteria:
Inclusion Criteria:

* Age greater than or equal to 18 years old
* Acute ischemic stroke within 12 hours of stroke onset

Exclusion Criteria:

* Life expectancy less than 90 days
* Patient unwilling to participate in study
Yoga Intervention in Head and Neck Cancer Patients Undergoing Concurrent Chemo-Radiation

This is a randomized prospective pilot study assessing the safety and feasibility of two yoga interventions in head and neck cancer patients undergoing primary or adjuvant radiation with or without concurrent chemotherapy

Primary Objective:

- To assess the safety and feasibility of Hatha yoga in head and neck cancer patients undergoing treatment with primary or adjuvant radiation with or without chemotherapy.

Eligibility Criteria:
Inclusion Criteria:

* Locally advanced, non-metastatic, histologically confirmed malignancy involving the head and neck region

  o Larynx, pharynx, oral cavity, salivary gland, paranasal sinuses and unknown primary
* Age greater or equal to 21 years of age
* Planned for either definitive or adjuvant radiation therapy with or without chemotherapy

  o Patients may have received induction chemotherapy or primary surgical resection prior to proceeding to radiation therapy
* Ability to understand English
* Daily access to the internet
* Willing and able to sign informed consent
* Willing and able to participate in yoga sessions as outlined in the study protocol

Exclusion criteria:

* Prior head and neck cancer radiation
* Patients who in the opinion of the treating physician are physically, medically or psychologically impaired to the point that participation is not deemed appropriate or feasible
Hypothyroidism, Metabolism and Food Intake

This project has the following primary aims:

To measure changes in appetite and food intake in newly diagnosed hypothyroid patients during the first six months after starting levothyroxine (L-T4) substitution therapy

Secondary aims are:

To delineate the effect of L-T4 substitution therapy on thyroid status, body weight, body mass index (BMI), body composition, physical activity, glycaemic control, postprandial gut and pancreatic hormone responses, gastric and gall bladder emptying, resting energy expenditure (REE), quality of life (QOL) and cognitive function

18 newly diagnosed hypothyroid female patients and 18 healthy controls age between 20 and 75 years will be recruited from the out-patients clinic in Herlev and Gentofte Hospital and the general practitioners before start of substitution therapy.

The study is devided in to three identical experimental days of approx. 6 hours. First experimental day placed before T4 treatment is initiated. Second day as soon as Thyroid Stimulating Hormone (TSH) is below 4 milli unit pr liter (mU/l). The Third experimental day after 6 months of T4 therapy.

For 5-7 days before each experimental day, the participants' physical activity energy expenditure (PAEE) will be monitored by an Actiheart® pedometer attached to the skin of the chest.

The last two days before each experimental day, the participants will follow a standardised diet following World Health Organization guidelines on energy requirements and nutrient composition according to gender, age and body weight Shortly after diagnosis patients will undergo a test panel at the first experimental day, where patients arrives fasting.

Visual analog score on satiety and thirst will be filled out continuously. REE will be measured by a CCM-express calorimeter,

* Dual Energy X-ray absorptiometry (DEXA)-scan
* Blood samples will be taken continuously during the experimental day. Gall bladder size will be examined at 6 times during the experimental day using ultra sound.

At the end of the day, patients´ satiety will be examined with an ad libitum meal.

Blood will be analysed for Gastric inhibitory polypeptide (GIP), Glucagon-like Peptide 1 (GLP-1), Glucagon-like Peptide 2 (GLP-2), glucagon, peptide tyrosine tyrosine (PYY), Gastrin, Cholesystokinin (CCK), Insulin, C-peptide, Blood sugar, Cholesterol, Free fatty acids and paracetamol.

Eligibility Criteria:
Inclusion Criteria:

* TSH \> 10
* Female

Exclusion Criteria:

* Competing serious disease
* Male
* Not able to understand written and spoken danish
* Pregnancy
* Thyroidectomized patients
* Amiodarone treatment.
Biodegradable Versus Titanium Nailing in Forearm Shaft Fractures in Children

There are disadvantages in Elastic Stable Intramedullary Nailing (ESIN) of forearm shaft fractures, such as soft tissue irritation and the need of implant removal. A new mini-invasive technique of intramedullary nailing with biodegradable material (BESIN) has been developed. The nails are tapped into the medullary cavity and left in place. The aim of this study was to compare BESIN technique with ESIN.

This is a prospective, randomized, controlled clinical trial including the patients (aged 5-15 years) who required operative treatment for forearm shaft fractures in two pediatric trauma centers, in Finland. The patients were randomized to be treated by BESIN or ESIN. Thirteen patients were required for each group, according to power analysis but altogether 35 were enrolled for potential drop-outs. Biodegradable polylactide-co-glycolide (PLGA) nails (ActivaNail ®, Bioretec ltd, Finland) were used in 19 and titanium nails (TEN ®, Synthes ltd, USA) in 16 patients. Pain and the range of motion (ROM) of forearm, elbow and wrist were primary outcomes. Radiographs and potential complications were analyzed of all and magnetic resonance imagines (MRI) of a randomly selected subgroup in BESIN group (N=13).


Eligibility Criteria:
Inclusion Criteria:

* suffering from single- or both-bone forearm shaft fracture
* child patient , age from 5 to 15 years
* surgical fixation needed, fracture is unstable
* cast immobilization is not rigid enough for the fracture treatment

Exclusion Criteria:

* open fractures with significant soft-tissue injury
* pathological fractures
* if patient has a previous fracture or infection in the same forearm
* patients with metabolic bone diseases, systematic disease
* patient uses the medication affecting bone quality
* resistance to infection
* fractures older than 7 days
Targeted BEACOPP Variants in Patients With Newly Diagnosed Advanced Classical Hodgkin Lymphoma

The Purpose of this trial is:

* to determine complete response rate (CRR) after six cycles of chemotherapy
* to determine complete remission rate (CR/CRr) as final treatment outcome after completion of treatment


Eligibility Criteria:
Inclusion Criteria:

* Histologically proven classical Hodgkin lymphoma
* First diagnosis, no previous treatment, age: 18-60 years
* Stage IIB with large mediastinal mass and/or extranodal lesions, stage III or IV disease

Exclusion Criteria:

* Composite lymphoma or nodular lymphocyte- predominant Hodgkin lymphoma (NLPHL)
* Previous malignancy
* Prior chemotherapy or radiation