cyrilzakka/clinical-trials huggingface dataset:
Therapy of Age-related Macular Degeneration

People with the disease age-related macular degeneration (AMD) are treated with the Medical Eye Trainer (MET) system to improve their vision. The training is carried out over 2 months.

Age-related macular degeneration (AMD) is a widespread eye disease worldwide. According to the Gutenberg Health Study, about 7000000 people in Germany suffer from it. The numbers for Austria are to be assumed with 700000 due to the smaller population. There are two different forms of AMD, the wet form with 15% and the dry form with 85%. Both types have a high risk of rapid development of significant visual impairment. For the dry form of the disease there are currently only a few therapeutic options. The main one is the nutritional supplement therapy. This treatment can only reduce the progression of deterioration in 10% of affected individuals, but there is a significant side effect profile. Thus, the question arose for completely different treatment approaches. For this reason, the Medical Eye Trainer (MET) was developed. This is a training device which can easily be used in self application. The purpose of this new therapy is not to try to cure AMD. Instead, the eye and brain are trained to better cope with the disease. In a first study on 17 eyes, 11 cases even showed an improvement of the visual performance, the remaining 6 cases showed a stable situation. In no case did a deterioration occur. Thus, for the first time, it was possible not only to slow down this disease, but even to achieve an improvement. In a second study with a planned number of 150 persons, this positive effect will be further investigated. A calculation with G\*Power, based on the results of the first study, results in an optimal number of 150 examinations.

The participants will be examined in the hospital Ried im Innkreis and treated by MET. No additional measures are required for the study besides the usual eye examinations in AMD.

The study is open to individuals with dry AMD, regardless of age. Exclusion criteria are wet AMD, epilepsy and double vision. Other eye diseases are not a problem.

The diagnosis is additionally confirmed by an examination of the ocular fundus with an Optical Coherence Tomography (OCT). As an essential factor of the severity of the disease, the visual performance for distance (5-6m) and for near (40cm) is determined.

Participants need a mobile electronic device with the operating system Apple IOS® or Android®. The MET training system in the form of software will be provided for the duration of the study. The therapy is performed daily by the patient him/herself and lasts 90 seconds per eye. A success control is planned after two months. The above mentioned examinations will be repeated.

The MET has a CE-approval in the sense of MPG class 1. This study will be performed according to the Helsinki criteria.

Eligibility Criteria:
Inclusion Criteria:

* Age-related macular degeneration

Exclusion Criteria:

* Epilepsy
* Double vision
Brief Hypnosis Intervention for Palliative Care Patients and Their Relatives.

The study objective is to assess the feasibility of hypnosis sessions for palliative care patients in home care and of their relatives. The intervention consists of four 15-minute hypnosis sessions for the patients and for one family member, taking place at the patient's home. Recordings will be given to practice self-hypnosis.

The primary outcome of this study is to assess the feasibility of a home based hypnosis intervention, targeting the management of symptoms (e.g. pain, anxiety) of palliative care patients and the reinforcement of a positive skill for their relatives (e.g. acceptance, relaxation), as well as the development of their respective self-hypnosis practice.

The two secondary outcomes are: i) to understand what the needs of palliative care patients and their relatives are in relation to complementary medicine and ii) to understand the process of integration of complementary medicine into usual care by looking at how this takes place for the participants to the intervention as well as for other palliative care patients who resort to using complementary medicine (not limited to hypnosis).

This is a mixed-methods study combining quantitative and qualitative data in a convergent design. The convergent design, derived from the pragmatic paradigm, involves the independent collection and analysis of quantitative and qualitative data. The results are then merged in order to compare and/or combine them and thus provide a broader understanding of the issue being studied.

For the intervention, participants will be recruited by a community mobile palliative care team. They will be screened by the study team to ensure they fulfil the inclusion criteria. If eligible and after informed consent is obtained, an assessment of the cognitive function will be performed. The patients will then recruit one of their relatives for participation to the study.

For the secondary outcomes, participants will be healthcare professionals working in palliative care setting and using complementary medicine in their daily practice and also patients using complementary medicine but who do not participate at the interventional part of this study.

Eligibility Criteria:
Inclusion Criteria :

* adults ≥18 years
* followed by a mobile palliative care team
* expressed symptom such as: pain, dyspnea, sleep disturbance or anxiety at a score of ≥ 3/10 at inclusion
* interest in managing symptoms with hypnosis

Exclusion Criteria :

* inability to communicate in French without a translator
* severe cognitive impairment
* severe hearing impairment
* acute psychiatric or somatic decompensation.
The Effects of the Be Mindful Intervention in Previously Depressed Individuals Experiencing Subclinical Symptoms

This study is designed to help individuals cope with their current depressive symptoms by providing them access to a 4-week online Mindfulness-Based Cognitive Therapy: Be Mindful. Research has shown that completion of the Be Mindful intervention can reduce depressive symptoms in a community sample, and this study aims to evaluate if it can also help reduce depressive symptoms in individuals with a confirmed history of depression. Participants will either receive the intervention at the start of the study or four months after the start of the study (i.e., at 3-month follow-up), which will allow research staff to assess if reductions in depression are due to the intervention or something else. Research staff will also evaluate if the reduction in depressive symptoms lasts over the three months following intervention, and will investigate possible reasons for the change in depression (i.e., why the intervention produces change).

Participant outcome variables will be assessed weekly for the first month after baseline. This will include the primary dependent variable (i.e., depressive symptoms), but will also include variables that will be explored as potential mechanisms of change (i.e., mindfulness, decentering, rumination, worry, self-compassion, and dysfunctional attitudes). The final weekly assessment will represent the Post-Intervention assessment.

Brief follow-up assessments of the primary dependent variable will be given 1-month and 2-months after the final weekly questionnaire. There will be a 3-month assessment that measures potential mechanisms of change in addition to the primary dependent variable.

After the 3-month follow-up, the Waitlist Control condition will be given access to the intervention. All participants (i.e., in both conditions) will be asked to complete another month of weekly questionnaires. These questionnaires will be identical to the first set of weekly questionnaires, and will allow mechanisms of change to be evaluated in the Waitlist Control condition.

Eligibility Criteria:
Inclusion Criteria:

* currently experiencing mild to moderate depressive symptoms (Patient Health Questionnaire 9 Current scores between 5 and 14)
* meet Diagnostic and Statistical Manual of Mental Disorders (fifth edition; DSM-5) criteria for Past Major Depressive Disorder (determined by clinical interview)

Exclusion Criteria:

* responses suggest they have never experienced a Major Depressive Episode
* responses suggest they are not currently experiencing sub-threshold symptoms of depression
* they state they are not open to learning mindfulness or meditation techniques
* they indicate they are currently receiving therapeutic treatment for depression or stress management elsewhere
* they indicate their age is not between 18 and 65
* they state they do not currently live in New York State
Study to Investigate Safety, Tolerability, PK and PD Response of SLN360 in Subjects With Elevated Lipoprotein(a)

This study will investigate the safety and tolerability of SLN360 in patients with elevated Lp(a).

This first-in-human (FIH) study will investigate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of SLN360 after single ascending s.c. doses and multiple doses in healthy male and female subjects.

Up to 9 cohorts of 88 patients with elevated Lp(a) will be enrolled. Each patient will receive single or multiple doses of SLN360 or placebo given by subcutaneous (s.c) injection.

Eligibility Criteria:
Inclusion criteria:

* Elevated plasma Lp(a) ≥ 150nmol/L.
* All subjects must agree to adhere to appropriate contraception requirements.
* Subjects must provide written informed consent and be able to comply with all study requirements.
* Body mass index of ≥ 18 kg/m2 and ≤ 45 kg/m2.
* For the MD part: confirmed history of stable atherosclerortic cardiovascular disease.

Exclusion criteria:

* Single Ascending Dose only: any history of clinically overt cardiovascular disease, defined as acute coronary syndromes, myocardial infarction, stable angina, coronary or other revascularization, ischemic stroke or transient ischemic attack and atherosclerotic peripheral arterial disease.
* Multiple Dose only: recent history of acute cardiovascular disease events within 6 months of screening (including, but not limited to, acute myocardial infarction, unstable angina, acute stroke and acute limb ischemia).
* Moderate or severe hepatic cirrhosis with Child-Pugh grade B or C, or other current or previous liver disease.
* Active serious mental illness or psychiatric disorder, including but not limited to schizophrenia, bipolar disorder, or severe depression requiring current pharmacological intervention.
* Any conditions which, in the opinion of the Investigator, would make the subject unsuitable for enrolment in the study or could interfere with the subject's participation in, or completion of the study.
* Subjects with previous or current use of medication or therapies significantly affecting Lp(a) level or hormone replacement therapy, unless on a stable dose for ≥ 8 weeks prior to screening
* History or clinical evidence of alcohol or illegal drug misuse within the 6 months before screening.
* History of multiple drug allergies or history of allergic reaction to an oligonucleotide or GalNAc, or intolerance to s.c. injections.
Study to Evaluate Effect of a Single Dose of Sotatercept (ACE-011) on Red Blood Cell Mass and Plasma Volume in Participants With Solid Tumors

What hematopoietic precursor compartments as well as hemoglobin subtypes are affected by dosing with sotatercept (ACE-011)? Based upon a similar prior study with Procrit, Celgene has determined that all of these goals could be obtained by an intense 10-patient sotatercept (ACE-011) pharmacodynamic study, completed by two well-known experts in the red cell production field.


Eligibility Criteria:
Inclusion Criteria:

* Men and women ≥18 years of age.
* Histologically confirmed diagnosis of a solid tumor malignancy documented by cytology or biopsy.
* Presence of metastatic disease.
* Hemoglobin value between ≥8.0 to \<11.0 g/dL (≥80 to \<110 g/L).
* ≥28 days must have elapsed (prior to pre-dose red blood cell mass / plasma volume test) since previous treatment with erythropoiesis-stimulating agent (including concurrent treatment with intravenous \[IV\] iron).
* ≥28 days must have elapsed (prior to Day 1) since the last red blood cell transfusion and receipt of ≤2 units of blood in the past 56 days (prior to Day 1).
* Eastern Cooperative Oncology Group (ECOG) Performance status of 0 - 1.

Exclusion Criteria:

At the time of screening, participants who have any grade ≥3 toxicity (according to the currently active minor version of NCI CTCAE v4.0) except for the following disease-related toxicities:

* Hematological events - anemia, thrombocytopenia, neutropenia
* Non-hematological events - nausea, vomiting, fatigue, muscle or bone/joint pain
Efficacy of Drinking Water During Capsule Endoscopy

The aims of this study are to evaluate the effect of early drinking water after the capsule ingestion on the gastrointestinal transit and image quality of capsule endoscopy.

Capsule endoscopy has been a significant technologic advancement that has allowed the direct examination of mucosa throughout the entire small intestine in a noninvasive fashion; and it has become the primary technique for imaging the small bowel. However, as imaging time is limited to about 8 hours, a prolonged transit of the capsule endoscope in the stomach may result in an incomplete small bowel transit (i.e. failure of the capsule to reach the cecum). Delayed transit time of stomach may be responsible for the failure of capsule endoscopy to visualize the distal portions of the small bowel, and potentially may result in the inability to identify small-bowel pathology in these areas. Previous study showed that drinking water might improve completion rate of capsule endoscopy. And bowel preparation of clear liquids may improve image quality of small bowel mucosa. The aim of this study was to assess the effect of drinking water on the transit time，completion rate and image quality of capsule endoscopy.

Eligibility Criteria:
Inclusion Criteria:

Patients aged 18-80 years undergoing capsule endoscopy

Exclusion Criteria:

1. Patients with suspected intestinal obstruction, intestinal diverticulum, stricture or fistula
2. previous gastric or small-bowel surgery
3. pregnancy
A Study Comparing IOP-Lowering Treatments to Bimatoprost in Patients With Primary Open Angle Glaucoma or Ocular Hypertension

An observational study comparing changing from an IOP-lowering treatment to a bimatoprost-containing IOP treatment in primary open-angle glaucoma (POAG) or ocular hypertension (OHT). Visits and treatment are per normal clinical practice.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of POAG or OHT
* Previous use of IOP-lowering medication

Exclusion Criteria:

* None
Study of Long-Term Use of Proton-Pump-Inhibitors in General Practice

The primary purpose of the study is to determine the effect of esomeprazole compared to placebo in patients from general practice who have previously been treated with proton-pump-inhibitors (PPI) and who have no upper endoscopic findings.

The majority of patients with dyspepsia are treated in primary care with acid-suppressive therapy for shorter or longer periods of time on the assumption that the patients´ symptoms are related to the production of acid in the stomach.

In about half of the dyspeptic patients there is no structural or biochemical explanation for their symptoms. These patients suffer from functional dyspepsia.

Treatment with proton-pump-inhibitors is effective in treating patients with gastroesophageal refluxdisease or ulcers. It is however controversial if acid-suppressive treatment is effective in the large group of patients with functional dyspepsia. Previous studies have shown no or very modest effect with a very high placeboresponse rate of 40-50%.

In primary care patients with upper abdominal symptoms are often treated with PPI as a diagnostic tool. If the treatment is effective continued or repeated treatment with PPI is often favored. However some of the patients must experience the abovementioned placebo-effect. These patients may end up being treated with PPI long-term on uncertain indication.

We wish to investigate the consequences of withdrawing treatment with PPI in patients from general practice who have previously been treated long-term.

An upper endoscopy is performed in patients who experience upper abdominal symptoms after withdrawal of treatment.If the endoscopy is normal patients are randomised to 1 week treatment with either esomeprazole or placebo.

Eligibility Criteria:
Inclusion Criteria:

* Treatment with PPI in at least 4 months out of the preceding 12.
* Use of PPI in the preceding 10 out of 30 days before inclusion
* Age above 18 years

Exclusion Criteria:

* Erosive Esophagitis
* PPI-treatment as prophylaxis against gastrointestinal bleeding
* PPI-treatment as prophylaxis against ulcers
* PPI-treatment as prophylaxis because of NSAID-treatment
* Pregnant or lactating women
* Previous upper GI surgery
Swiss Primary Biliary Cholangitis Cohort Study

Research project in which biological material is sampled and health-related medical data is collected. In addition, already existing health-related medical data are used for further research. Coded data are used.

Enrolment visit and one follow-up visit at least once a year are planned.

Whole blood is collected for biobanking once a year. Optionally, if available and collected during normal clinical procedures, liver fragments are obtained.

To collect high quality prospective data on a rare disease in order to elucidate epidemiology, natural history, response to treatment and outcome. In addition, the biobank allows addressing specific scientific issues on a variety of open questions. The cohort will provide a platform for carrying out scientific research projects on PBC. In addition, the cohort will allow collaboration with reference networks on PBC abroad.

Eligibility Criteria:
Inclusion Criteria:

* diagnose of Primary biliary cholangitis (according to EASL Clinical Practice Guidelines: management of cholestatic liver diseases).
* Subjects with isolated anti-mitochondrial antibodies and/or isolated PBC-specific anti-nuclear antibodies are also included
* Patients/subjects aged at least 18 years and living in Switzerland are included

Exclusion Criteria:

* N/A
Evaluation of Sleep Quality, Nutrition, Anxiety and Depression in Mastalgia

The aim of this study is to investigate the sleep quality, anxiety and depression levels in women with mastalgia using internationally validated scales. Additionally the investigators aim to question the amount and frequency of consumption of nutritional elements which are known to aggravate mastalgia. Finally by combining and analyzing the information gathered, the investigators intend to set light to the etiopathologic and clinic aspects of mastalgia.

Mastalgia is encountered in 70% of premenopausal women and is one of the most frequent reasons for attending general surgery clinics. In most of the cases no physical cause is demonstrated and the etiopathogenesis is still not yet determined. In 1949 Patey, for the first time, proposed that mastalgia might be a psychologically based problem. In the following years, research was focused in this issue and some articles were published demonstrating the relationship of anxiety, depression and high stress levels with mastalgia. The efforts for finding out the etiopathologic mechanism and defining the risk factors revealed that smoking and consumption of tea, coffee and carbonated beverages in particular worsen mastalgia whereas essential fatty acids (especially gamma linoleic acid) provides a symptomatic relief. Additionally it is known that sleep irregularities cause serious deterioration in daily life quality as well as can exaggerate some medical, neurologic and/or psychiatric conditions. More than half of the population experience sleep irregularities from time to time and chronic sleep disturbances effect 20% of adult population in western countries. Therefore sleep irregularities might have contributing effects in the etiopathogenesis and/or symptomatology of therapy resistant conditions like mastalgia.

Eligibility Criteria:
Inclusion Criteria:

* Having mastalgia as a presenting symptom (mastalgia group)
* Presence of mastalgia confirmed by a general surgeon (mastalgia group)
* Absence of mastalgia (control group)

Exclusion Criteria:

* Previously diagnosed breast carcinoma (both groups)
* Previously exposed to thoracic radiotherapy (both groups)
* Previous breast or thoracic surgery for any reason (both groups)
* Presence of Tietze syndrome (both groups)
* Use of nutritional supplements (both groups)
* Presence of any self-perceived pain (control group)
* Presence of psychogenic based conditions and psychosomatic illnesses (control group)
A Study of Cemiplimab Plus Chemotherapy Versus Cemiplimab Plus Chemotherapy Plus Other Cancer Treatments for Adult Patients With Operable Non-Small Cell Lung Cancer (NSCLC)

This study will enroll adult participants with early-stage (stage II-IIIB) non-small cell lung cancer for whom surgery is planned.

The aim is to find out whether an investigational treatment (consisting of the immunotherapy drug cemiplimab plus chemotherapy plus a third drug) works better than cemiplimab plus chemotherapy without the additional drug.

The study is also looking at several other research questions, including:

* What are the side effects associated with the investigational treatments in comparison to the control treatment?
* Do the investigational treatments or the control treatment have an effect on the type of surgery that is performed?
* How much of the study drug(s) are in the blood at a given time?
* Does the body make antibodies against the study drugs (which could make the drugs less effective or could lead to side effects)?


Eligibility Criteria:
General Key Inclusion Criteria:

1. Histologically confirmed stage II through IIIB (N2) NSCLC, that is considered resectable with curative intent, as described in the protocol
2. Measurable disease per Response Evaluation Criteria In Solid Tumors (RECIST) criteria version 1.1
3. Available formalin-fixed paraffin-embedded (FFPE) tumor sample blocks for submission, as described in the protocol
4. Eastern Cooperative Oncology Group Performance Status scale (ECOG PS) of 0 to 1
5. Adequate organ and bone marrow function, as described in the protocol

General Key Exclusion Criteria:

1. Any systemic anti-cancer therapy or radiotherapy for the current tumor, as described in the protocol
2. Presence of known oncogenic alterations in epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) in the tumor prior to randomization, as described in the protocol
3. Presence of ≥ grade 2 peripheral neuropathy
4. Another malignancy that is progressing or requires active treatment, as described in the protocol

Arm Specific Exclusion Criteria:

Arm 1:

1. Grade ≥3 hypercalcemia, as defined in the protocol
2. Any central nervous system (CNS) pathology that could increase the risk of immune effector cell-associated neurotoxicity syndrome (ICANS), as described in the protocol
3. Has marked baseline prolongation of the time from the start of the Q wave to the end of the T wave in electrocardiogram(QT)/corrected QT interval (QTc) interval or risk factors for prolonged QTc, as described in the protocol

Note: Other protocol-defined Inclusion/Exclusion criteria apply.