cyrilzakka/clinical-trials huggingface dataset:
Normal Human Electro-Oculogram

This study will measure the normal range of the human electro-oculogram (EOG) in people of various age groups. EOGs are recordings of electrical signals generated by the retina (the light-sensitive tissue in the back of the eye) when going from a dark to a bright environment. They provide valuable information about the function of the eye in health and disease. A knowledge of what results are to be expected in tests of normal, healthy eyes will be valuable in assessing EOG results in patients with known or suspected retinal diseases.

Normal volunteers from ages 6 to 65 who have healthy eyes and normal eyesight will participate in this study. Candidates will undergo tests to check vision and the health of the eye. Study participants will then have an electro-oculogram. In this test, eye drops are placed in the eye to enlarge the pupils. Two electrodes (small disks that picks up electrical signals) are attached to the left and right of each eye and one to the forehead. (These are similar to electrodes placed on the body during an electrocardiogram (ECG), which measures electrical signals from the heart.) During the EOG recording, the volunteer looks at the inside of a hollow sphere, following with their eyes small red lights that turn on and off. The background light is also turned on or off during the test. Some volunteers may be asked to repeat the EOG at another time.

Study participants may also be asked to provide a blood sample for tests to study how the immune cells in the blood respond to proteins found in the retina. The response from normal volunteers will be compared with that of patients with eye diseases like retinitis pigmentosa.

Electro-oculograms (EOGs) will be recorded in volunteers of different age groups with normal visual function. The fast and slow oscillations of the EOG will be studied. For the analysis of fast EOG oscillations, peak-to-peak amplitude (micro V), peak-to-trough ratio, and phase (degrees) will be measured. The analysis of slow EOG oscillations will include measurements of the ratio of light peak to dark trough (Arden ratio), implicit time (latency) of the light peak (ms), and amplitude of the dark trough (micro V).

Eligibility Criteria:
Subjects must have best corrected visual acuity equal or better than 20/20.

Subjects must have normal visual fields.

Subjects must have normal color vision.

Subjects must have a normal ophthalmological exam.

Subjects should not be subjective to or objective evidence of visual loss.

Subjects cannot have subjective evidence of abnormal night vision or subjective evidence of abnormal light sensitivity.

Subjects cannot have a personal history of non-trivial ocular disease.

Subjects cannot have a family history of hereditary ocular disease.

Subjects cannot have current systemic disease.

Subjects cannot currently take neuropharmacological medication.

Subjects will not be admitted with an abnormal ophthalmological examination.

Subjects will need the ability to cooperate with EOG recording.
Clinical Study to Assess Therapeutic Delay and Resolution of Induced Gingivitis

Evaluate a stannous technology for its effect on the neutrophil phenotype during an induced gingivitis state.

A 9-weeks clinical study will be conducted to evaluate a stannous fluoride dentifrice for therapeutic effects that aim to delay the onset of experimental gingivitis as well as hasten the resolution of disease.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female volunteers aged 18-70 years
2. In good general health, ASA I
3. No clinical signs of gingival inflammation at \>90% sites observed
4. Probing Depth (PD) \< 3.0 mm
5. Attachment Loss (AL) = 0 mm
6. No periodontal disease history
7. Non-smokers
8. Fluent in English

Exclusion Criteria:

1. Presence of orthodontic bands.
2. Presence of partial removal dentures.
3. Tumour(s) of the soft or the hard tissues of the oral cavity.
4. Cavitated carious lesions requiring immediate restorative treatment.
5. History of allergy to consumer or personal care products or dentifrice ingredients as determined by the dental profession monitoring the study.
6. Participation in any other clinical study or test panel with a one month period prior to entering the study.
Current Situation of Natural History, Diagnosis and Treatment in Inpatients With Embolism Stroke of Unknown Cause (ESUS)

Evaluate the epidemiological characteristics, risk factors, clinical characteristics in patients with ESUS and their medication compliance and relapse within 1 year.

The purpose of this study is to evaluate the epidemiological characteristics, risk factors (such as hypertension, diabetes, hyperlipidemia, coronary heart disease, history of previous stroke, smoking, and alcohol consumption), clinical characteristics in patients with ESUS and their medication compliance and relapse within 1 year.

Eligibility Criteria:
Inclusion Criteria:

- Patients diagnosed with acute cerebral infarction and treated in Peking University Third Hospital Neurology Department from January 2010 to June 2016.

Exclusion Criteria:

* Lacunar infarction
* Aortic atherosclerotic cerebral infarction
* Clear cardiogenic cerebral infarction
* Other related system diseases (arteritis, vascular dissection, migraine and vasospasm, etc.)
How Does the Spirituality of Patients With Type 2 Diabetes Influence Their Self-management?

This exploratory study is researching how the spirituality of a group of British patients with type 2 diabetes (T2D), impacts their approach to the self-management of their condition.

Bio-statistical markers will be taken from consenting participants' Clinic database records. Qualitative interviews will be conducted with participants, and the results analysed and interpreted, alongside their bio-statistical markers.

Results will be presented in healthcare peer reviewed journals and conferences, to inform clinicians how patients' self-management of their T2D is influenced by their spirituality.

Patients will be recruited from diabetes clinics.

The bio-statistical markers will be: include their living situation (living alone or with family/partner); date of T2D diagnosis; current age; glycated haemoglobin (hba1c) blood test; body mass index and current pharmacological therapy. This data will be collected from the Diabetes Clinic to contextualize the qualitative data. These measurements will reveal how well a participant is managing their T2D.

The Biographic Narrative Interpretive Method (BNIM) will involve interviews with eight participants. Each participant will have at least 2 and possibly 3 interviews at a location of their choice. The data will undergo thematic analysis, which will be interpreted.

The results will be used to encourage clinicians to consider the spirituality of people with T2D when planning their care, thus giving holistic treatment.

Eligibility Criteria:
Inclusion Criteria:

* Speak English
* Have had T2D at least 6 months.
* Have read the Participant Information Sheet, explaining this study is regarding T2D, spirituality, coping and self-management.
* Gives consent to access their diabetes details that are stored on a Clinic database.
* Gives consent to recorded interviews.

Exclusion Criteria:

* Not speak English.
* Have had T2D less than 6 months.
* Have read the Participant Information Sheet, and decided they are not comfortable talking about their T2D, or spirituality, or coping or their self-management.
* Not consenting to data collection from Clinic records.
* Clinic records have not been kept (e.g. is a new patient to their family doctor).
* Consent is withdrawn from the study (which could be any stage).
Feasibility and Safety of a Virtual-Reality Based Job Interview Training Tool in Teenagers With High-Functioning Autism

The current project involves the application of a VR job training software. We propose to use an interactive VR job interview practice system, Virtual Reality Job Interview Training (VR-JIT), in youths with ASD at the highschool level. This system was developed to bolster job interview practice skills and to help reduce anxiety in adults with ASD. However, it has never before been used in individuals under the age of 18. Our hope is that if this program is utilized in individuals while they are still in highschool, we can target those persons before the window for which risk of unemployment appears to be highest for ASD youths, immediately after high school graduation.


Eligibility Criteria:
Inclusion Criteria:

* Be between the ages of 13 and 18
* Have a diagnosis of ASD or a typically developing child
* Be able to speak and read English fluently

Exclusion Criteria:

* I had a stroke, TBI, or neurologic injury or disease in the past
* I have a history of significant psychiatric illness (like bipolar, schizophrenia, or psychosis)
* I have uncontrolled seizures or other unstable medical complications
CORE: Study to Evaluate the Conducted AF-Response-Algorithm in Patients Suffering From Heart Failure and Atrial Fibrillation

The Medtronic InSync III Marquis Cardiac Resynchronization Therapy Defibrillator (CRT-D)-System (implantable cardioverter-defibrillator with biventricular stimulation for cardiac resynchronization) is equipped with the "Conducted-Atrial Fibrillation (AF)-Response-Algorithm (CAFR)". This algorithm is designed to maximize biventricular stimulation and thus the amount of cardiac resynchronization when atrial fibrillation occurs. The goal of the study is the evaluation of the effect of the CAFR in CRT-patients suffering from atrial fibrillation by quantification of the increase of biventricular pacing during atrial fibrillation caused by CAFR as well as the influence of the CAFR on the ventricular heart rate.


Eligibility Criteria:
Inclusion Criteria:

* Implant of a Medtronic InSync III Marquis (7279) or later system with Conducted AF-Response

Exclusion Criteria:

* Medical reasons that are adverse to participation in the study and compliance by the patient
* Patients who are enrolled in another study or plan to be enrolled into another study
* Pregnant patients or patients who are possibly pregnant due to an unreliable form of contraception
Comparison of Levonorgestrel Intrauterine System, Copper T Intrauterine Device and Oral Contraceptives on Life Quality

Oral combined contraceptives(OC) have both progesterone and estrogen inside. Levonorgestrel-releasing intrauterine device(LNG_IUS) has only progestagen.

Copper IUD does not have any hormonal molecule inside.

* Hypothesis is OC has more systemic beneficial or side effects than LNG_IUS or copper IUD. LNG_IUS has more local effects than copper IUD.
* Study reflects the beneficial or side effects of estrogen+progestagen pills and only progestogen inside device.


Eligibility Criteria:
Inclusion Criteria:

* women who desire contraception

Exclusion Criteria:

* Women with large fibroids,abnormal uterine bleeding including heavy menstrual bleeding or using any contraceptive pills during the previous 3 months were excluded from the study. Other exclusion criteria were pelvic inflammatory disease, pregnancy, genital tumor or thromboembolic disease.
Effect of Whole-body Vibration on Postural Stability, Muscle Flexibility and Lower Limb Power in Young Basketball Players with Generalized Joint Hypermobility

The goal of this clinical trial is to assess the effect of whole body vibration (WBV) on postural stability, flexibility of the lumbar-pelvic-hip complex and lower leg muscles, and jumping ability in basketball players aged 9-15 years. The main questions it aims to answer are:

Does WBV affect the level of postural stability in basketball players aged 9-15 years? Does WBV affect the level of postural stability in basketball players aged 9-15 years? Does WBV affect the flexibility of the iliopsoas, rectus femoris, posterior group of hamstrings, soleus and gastrocnemius in basketball players aged 9-15 years? Does WBV affect the jump height, relative peak power, contraction time in basketball players aged 9-15 years?

Participants will take part in 6 vibration sessions at 20Hz over 6 weeks. Vibration will be performed on the Galileo Med35 platform (3x3 min).


Eligibility Criteria:
Inclusion Criteria:

* Men aged 9-15
* Playing basketball in a sports club at least 2 training sessions a week

Exclusion Criteria:

* Thrombosis (acute narrowing of blood vessels),
* Inflammation of the musculoskeletal system,
* Arthropathy,
* Hernias,
* Discopathies,
* Tendonitis,
* Fresh fractures,
* Scars,
* Surgeries,
* Kidney stones,
* Rheumatoid arthritis,
* Implants in the body,
* Epilepsy,
* Current injuries to the musculoskeletal system,
* Occurrence of chronic pain complaints of the musculoskeletal system.
Doxapram as an Additive to Propofol Sedation in Sedation for ERCP

Sedation is needed in order to complete endoscopic retrograde cholangiopancreatography (ERCP) to alleviate discomfort and pain during the procedure. This is usually achieved with use of opioids and/or sedative agents such as benzodiazepines or propofol. Traditionally benzodiazepines have been used but nowadays propofol is becoming the drug of choice for sedation during ERCP.

The problem with propofol sedation is the fact that it may case cardiorespiratory depression and there is no antidote for this like there is for benzodiazepines. Cardiovascular depression can usually be easily counteracted with drugs that are used to raise blood pressure or heart rate during general anesthesia but respiratory depression remains a problem.

The aim of this study is to try to counteract the respiratory depression caused by propofol sedation using an old respiratory stimulant doxapram as opposed to placebo using a double blind randomized protocol.

The investigators hypothesis is that boluses and an infusion of doxapram will alleviate the respiratory depression caused by propofol sedation.


Eligibility Criteria:
Inclusion Criteria:

* \< 75 year of age
* Having ERCP
* Agrees to take part in the study

Exclusion Criteria:

* \>75 years of age
* allergy to propofol or doxapram
* epilepsy
* Chronic Obstructive Pulmonary disease (COPD)
* Coronary artery disease (symptomatic)
* alcoholism
* declines to take part in the study
Therapy Management With Nab-Paclitaxel in Daily Routine

Despite treatment improvements in breast cancer, a large number of patients still progress to the metastatic stage. Metastatic breast cancer patients have an extremely unfavorable prognosis. Not only efficacy, but also quality of life are in the focus when planning a therapy or therapy sequence for metastatic breast cancer patients. Therapy options include anti-hormonal Therapy, antibody therapies, other targeted therapies and chemotherapies. One of the most effective chemotherapies in the adjuadjuvant and metastatic setting is paclitaxel. However drug handling and its side effects can compromise patients quality of life and can have an impact on the pharmacokinetics of the drug.

In metastatic breast cancer patients increasing therapy efficacy and reduction of side effect frequency are considered to be advancements of therapy. One of these advancements is the development of a cremophor free and albumin bound paclitaxel, nab-Paclitaxel (Abraxane), which is thought to have a better efficacy and reduced toxicity profile. Nab-Paclitaxel is approved for the treatment of metastatic breast cancer after a failure of first-line therapy and when antracyclines are not indicated.

The SERAPHINA study aims to investigate in the use of nab-Paclitaxel in daily routine and the frequency and perception of side effects.

As a non-interventional study, the SERAPHINA Study will assess the patient characteristics and describe the patient cohort, in which nab-Paclitaxel is given. This includes age distribution and characteristics documented by the patients themselves.


Eligibility Criteria:
Inclusion Criteria:

* Patients with metastatic breast cancer in which a therapy with nab-paclitaxel was indicated by the treating physician
* Treatment of nab-Paclitaxel must either have not been started yet, or first application of nab-Paclitaxel was not prior to 21 days before study entry
* Female patients, age ≥18 years
* Invasive breast cancer (irrespective of status of BC, e.g. TNM, receptor status etc.)
* Metastatic or locally advanced, inoperable disease proven by clinical measures (i.e. standard imaging)
* Patients scheduled for nab-Paclitaxel treatment in daily routine before screening
* Patients, who are able and willing to sign the informed consent form

Exclusion Criteria:

* Patient is currently enrolled, or will enroll in an interventional clinical study in which investigational therapeutic procedures are performed or investigational therapies are administered while participating in this study
QuiremSpheres Observational Study

The main purpose of this study is to further assess treatment efficacy and safety after using QuiremSpheres® for the treatment of patients with unresectable primary liver cancer or unresectable liver metastases suitable for SIRT and allocated to this treatment by a multidisciplinary tumor board.

Liver tumors can be of primary (Hepatocellular Carcinoma, HCC) or metastatic (mainly from colorectal carcinoma, CRC) origin. Both HCC and CRC are common causes of death from cancer worldwide. The overall incidence of HCC and CRC remains high in developing countries and is steadily rising in most industrialized countries. Available treatment options depend on the size, number, and location of tumors, on liver status, overall performance status and comorbidities, on patency of portal vein and presence of extrahepatic metastatic disease. They include surgical (liver resection, liver transplantation), systemic (e.g. chemotherapy, immunotherapy), ablative (thermal ablation, chemical ablation) and intra-arterial (chemoembolization, radioembolization) modalities. Radioembolization, also known as Selective Internal Radiation Therapy (SIRT) with microspheres containing a radiation-emitting isotope (Yttrium-90 or Holmium-166) delivers localized radiation in the vasculature around liver tumors with relatively limited concurrent injury to the surrounding normal/healthy tissue. Yttrium-90 radioembolization is currently included in several guidelines (EASLEORTC, ESMO).

Eligibility Criteria:
Inclusion Criteria:

* Patient with diagnosis of primary liver tumor or metastases in the liver from other primary cancers, allocated to SIRT with QuiremSpheres® as decided by a multidisciplinary tumor board
* Patient is ≥ 18 years
* Patient has understood and signed written informed consent to data collection in the study

Exclusion Criteria:

* Patient's refusal
* Local practice guidelines prohibiting the patient to receive SIRT
Piezo-ICSI to Improve the Developmental Potential of Fertilized Oocytes in Aged Infertility Women With Assisted Reproductive Technology

The goal of this clinical trial is to test Piezo-ICSI on improving oocyte fertilization and embryo development in elderly infertile patients undergoing intracytoplasmic sperm injection (ICSI). The main question it aims to answer is whether Piezo-ICSI could improve oocyte fertilization and embryo development. Participants requested ICSI are asked to randomly culture equal numbers of oocyte and embryo with or without Piezo-ICSI. At the time of injection, two or more mature oocytes were split into two groups (i) conventional ICSI and (ii) Piezo-ICSI (50:50 split).

After being informed about the study and potential risks, all participants will write the informed contents. This study is a randomized controlled study compare different ICSI methods on the fertilization and embryo development. Sibling oocytes were randomly divided into test group (Piezo-ICSI) and control group (conventional ICSI).

Specific method of randomization: all the oocytes of each subject were distributed into two dishes (dish 1 and dish 2). If the oocyte number is odd, put the extra oocyte into dish 1. Using statistical software, the two dishes were randomly treated as test group and control group. Thus, a random allocation table was generated and a separate random envelope was made for each subject. The random envelope is kept and distributed by the relevant personnel who are not involved in the screening and treatment of subjects and are authorized by the researcher. Each selected subject must open the random envelope. The subjects were subjected to routine ovulation promotion, and then the acquired oocytes and cumulus cell complexes (COCs) were obtained and fertilized in vitro. The test group oocytes were fertilized with Piezo-ICSI, while the control oocytes were fertilized with conventional ICSI.

Thus, half of the oocytes from each elderly infertile patient were treated with Piezo-ICSI.

Eligibility Criteria:
Inclusion Criteria:

1. 35 years ≤ age ≤ 42 years;
2. Number of IVF/ICSI cycles ≤ 2

Exclusion Criteria:

1. Egg donor cycle
2. Chromosome abnormality;
3. Adenomyosis, hysteromyoma, thin endometrium, endometriosis and other uterine diseases;
4. Patients with repeated implantation failure
Investigator-initiated Clinical Trial (Phase II) of Cancer Vaccine "Dainippon Sumitomo Phama(DSP)-7888" for Acute Myeloid Leukemia Patients.

This study is an investigator-initiated clinical trial (Phase II) using DSP-7888 for acute myeloid leukemia patients with 1st hematological complete remission (CR). DSP-7888 is a novel cocktail peptide vaccine designed to induce cytotoxic T lymphocytes that recognize Wilms Tumor Gene 1 (WT1) peptides.

This study is an investigator-initiated clinical trial (Phase II) using DSP-7888 for acute myeloid leukemia patients with 1st hematological CR. DSP-7888 is a novel cocktail peptide vaccine designed to induce cytotoxic T lymphocytes that recognize WT1 peptides. Primary endpoint is relapse-free survival, and 2nd endpoint is hematological relapse-free survival, overall survival and adverse event.

Eligibility Criteria:
Inclusion Criteria:

1. acute myeloid leukemia defined by World Health Organization (WHO) 2016 classification
2. favorable or intermediate risk based on European Leukemia Net (ELN) 2017 risk classification
3. 1st hematological after chemotherapy
4. Human Leukocyte Antigen (HLA)-A\*02:01, 02:06, 24:02
5. 20-80 years old
6. Eastern Cooperative Oncology Group (ECOG) performance Status 0-2
7. within 35 days after White Blood Cell (WBC) and Neutrophil recovers over 1500 and 500, respectively
8. sufficient organ function as below within 7 days

(1) Neutrophil : \>= 1000 (2) Cr : \>= 3.0mg/dl (3) Aspartate aminotransferase (AST), Alanine transaminase (ALT) : 5 x the upper limit of normal (ULN) for the reference lab (4) Percutaneous oxygen saturation (SpO2): \>= 95% 9) patients who agree contraception until 6 months after the last injection 10) non-candidate for hematopoietic stem cell transplantation.

1. illegible for hematopoietic stem cell transplantation (HSCT)
2. lack of appropriate donor
3. patients who don't select HSCT at the 1st hematological complete remission (hCR) timing

Exclusion Criteria:

1. multiple primary cancer
2. autoimmune disease
3. usage of investigational or unapproved drug within 28 days
4. severe organ failure
5. Human Immunodeficiency Virus (HIV) antibody / Hepatitis B surface (HBs) antigen / Hepatitis C Virus (HCV) antibody positive
6. pregnant woman
7. lactating woman
8. under treatment against active infection
9. difficult to enroll because of mental problem
10. other reasons which investigator judge appropriate for enrollment