cyrilzakka/clinical-trials huggingface dataset:
Evaluation of Objective Perimetry Using Pupillometer

Objective perimetry can better monitor visual field defects in RP and Glaucoma patients than conventional subjective perimetry.The PLR ( Pupil Light Reflex ) of the short and long wave ratio should be significantly higher in areas of visual field defects in RP and Glaucoma patients.

Pupil light reflex will be measured by a pupillometer in response to short and long wavelength light small spot stimulus in different area of the visual field. The PRL will be measured in four quadrant, central, 10, 20, and 30 degree from the visual axis.

Stimulus duration will be 1000 ms (1 sec), with intervals of 890 ms between stimuli. The stimuli size V with light intensity of 39.8 cd-s/m2 for both short wavelength stimuli (peak 485 nm) and long wavelength stimuli (peak 620nm).

Eligibility Criteria:
Inclusion Criteria:

1. Age 18-75
2. Sign on informed consent
3. Papillary response to light.
4. Groups of : Normal , Glaucoma patients with early glaucoma damage on HVF (nasal step ect. ), Glaucoma patients with advanced glaucoma damage on HVF (arcuate , tubular vision ) and RP patients (Early VF damage , ring scotoma ) .
5. Refractive correction up to -3.5 D.

Exclusion Criteria:

1. Cloudy corneas.
2. Surgical intraocular ophthalmic procedure within the past 30 days.
3. Nonreactive pupils.
4. Synechia of the iris to the lens after surgery or inflammation .
5. Neovascularization.
6. Iris coloboma.
7. Sphincter damage due to ischemia or trauma (tears of sphincter or diffuse damage to muscle).
8. Sphincter damage due to high intraocular pressure .
9. Iris tumor or cyst .
10. Ectropion uvea .
11. Adie's pupil .
12. Optic neuropathy with the potential for producing a positive RAPD (Relative Afferent Pupillary Defect ).
13. Chronic use of myotics or mydriatics.
14. Systemic Medication which affect on papillary response .
15. Any condition preventing accurate measurement or examination of the pupils.
The Effects of 4 Week β-alanine Supplementation on Knee Extensor Contractile and Force Properties in the Over 60s

The older population is the fastest growing age group worldwide, but it is also the most susceptible to chronic diseases and disabilities. One of the most common negative consequences of aging is the decline in muscle mass, strength and power. This is most notable in lower limb muscles. These muscles are required for the performance of daily activities including walking, stair climbing and standing up from sitting. Regular exercise is considered one of the most effective measures to slow, and even reverse the progression of muscle weakness. Nevertheless older adults may notice a decline in their capability to undertake regular exercises, this may be due to a decline in their muscle's ability to buffer pH. Carnosine (made by bonding β-alanine and histidine) has been suggested to contribute to the extension of physical performance, counteracting the decline the muscle's ability to buffer pH. Yet this pH buffering process it largely restricted by the amount of β-alanine available in the human body. β-alanine is already known to decline in older individuals due to a reduction in food products (meat, fish and poultry). Yet through either consumption of β-alanine rich food, or through short-term supplementation, β-alanine is raised, increasing carnosine concentrations. Improved β-alanine levels can potentially advance exercise performance, for example significant improvements in time to exhaustion on both a constant (37%) and incremental (12%) treadmill tests have been demonstrated. It is therefore proposed that via β-alanine supplementation, an individual's perception of their frailty, maintenance of health and independent living can be improved in older individuals.

However, these findings are based on participants, both young and older, who are well-rested with no prior exercise or fatigue to the assessed muscles. It remains unclear if β-alanine supplementation will aid in the buffering of pH when the muscle has already been fatigued. Therefore this investigation hopes to examine the effects of 4 week β-alanine supplementation on lower limb contractile and force properties, pre and post muscle specific fatigue.


Eligibility Criteria:
Inclusion Criteria:

* All participants will be defined as 'medically stable' for exercise studies, as proposed by Grieg et al. (1994). This criteria was designed both for safety and to define degrees of freedom from diseases which might alter exercise performance (Greig et al., 1994).

Exclusion Criteria:

* Participants will be excluded if they are vegetarian/vegan or have been using β-alanine or creatine supplements within the past 6 months. They will also be excluded if they have participated in a resistance training programme in the last 6 months. These criteria will apply throughout the whole study, with any participants immediately excluded from the study if any of these medical conditions should arise.
The Effect of Sertindole on Sensory Gating and Cognition in Healthy Volunteers

This study aims to further validate and extend our previous findings insofar that the effect of the atypical antipsychotic and mixed 5-HT2/D2 antagonist sertindole on sensorimotor gating processes and its relationship to cognitive performance shall be explored.


Eligibility Criteria:
Inclusion Criteria:

* Age: 18-40
* Gender: male

Exclusion Criteria:

* Axis I Disorders: lifetime DSM IV diagnosis according to DIA-X of alcohol or illicit drug dependence. No life-time DSM IV diagnosis according to DIA-X of a major affective, psychotic, anxiety disorder, eating-disorder as defined above.
* Axis II Disorders: lifetime DSM IV diagnosis of personality disorder according to SCID-II.
* Family history: lifetime history of 1st degree relative (parents and siblings) of a major affective, psychotic, or anxiety disorder as defined above.
* ECG: QTc-interval \>450 msec.
* Systolic blood pressure \<100 mmHg
* Bradycardia (Hf \< 50/Min) und Arrhythmias
* Hypokalemia or Hypomagnesemia
Safety and Efficacy of Low-dose hEparinization in Cerebral Angiography sTudy

Purpose: Systemic heparinization is a widely used technique on digital subtraction angiography (DSA). Heparin, however, is associated with a variety of complications, including hemorrhage, thrombocytopenia, and hematomas. This study aimed to investigate the safety and efficacy of micro-dose systemic heparinization or no heparinization on cerebral angiography for cerebrovascular diseases.

Methods: A prospective, single-blind, randomized controlled study on patients who experienced transient ischemic attacks (TIAs) or acute ischemic strokes and underwent DSA is performed. Participants are randomized into three groups: regular-dose systemic heparinization, micro-dose systemic heparinization, and no heparinization. Information on patient demographics, laboratory tests, perioperative complications, and back pain scores is collected. Safety endpoints are defined as cerebral ischemic events and local complications of puncture site. Efficacy endpoints were defined as the recovery of the patients.


Eligibility Criteria:
Inclusion Criteria:

1. aged 18-65 years;
2. suspected cerebrovascular disease, including vascular lesions of the carotid, middle cerebral, anterior cerebral, vertebral, basilar, and posterior cerebral arteries;
3. Activity of daily living (ADL) score between 85\~100;
4. normal coagulation function and no prior anticoagulant therapy before DSA;
5. fully informed consent to participate in the study.

Exclusion Criteria:

1. iodine allergy;
2. hepatic and/or renal insufficiency;
3. severe hypertension with poor blood pressure control;
4. hemorrhagic diseases;
5. hyperlipidemia;
6. poor glycemic control in diabetes;
7. pregnancy;
8. atrial fibrillation;
9. undergoing interventional treatment simultaneously.
Evaluation of the Pharmacokinetics of Antituberculosis Drugs and Tuberculosis Treatment Outcomes

Tuberculosis (TB) is a leading cause of death in HIV-infected individuals. There are insufficient data correlating concentrations of anti-TB drugs with treatment response. We hypothesize that sub-therapeutic concentrations of anti-TB drugs are associated with inadequate TB treatment response to Mycobacterium tuberculosis.

During the study periodic monitoring will be conducted to ensure that the protocol and Good Clinical Practices (GCPs) are being followed.The monitors may review source documents to confirm that the data recorded on CRFs is accurate. The study site may be subject to review by the Institutional Review Board (IRB) and/or appropriate regulatory authorities.

A CRF will be completed for each included subject and will be signed by the investigator or by an authorized staff member to attest that the data is true. Any corrections to entries made in the CRFs, source documents must be dated, initialed and explained (if necessary) and should not obscure the original entry. Qualit assurance will as also be performed regularly on the CRFs.

The primary end point will be analyzed using Time to event (cure, death, relapse etc)analysis and failure rates and hazard ratios will be calculated accordig to categorical drug concentrations with proposed cutt offs.

Secondary end points will be analysed using time to event for occurence of toxicities which will also be corelated to the drug concentrations.

Eligibility Criteria:
Inclusion Criteria:

* Evidence of a personally signed and dated informed consent
* Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
* Age of ≥18 years
* First episode of pulmonary TB i.e. proven or highly suspected TB considered for TB treatment qualifying for 6 months anti-Tb drugs regimen
* Confirmed HIV-1 infection

Exclusion Criteria:

* Unable to provide informed consent
* Documented or highly suspected TB infection of any organs/systems other than the lung requiring TB treatment longer than 6 months
* Previously treated for a mycobacterial infection (TB or atypical mycobacterial infection, active or latent)
* Pregnancy or planned pregnancy within the next year
* Unwillingness to perform pregnancy test
* Decompensated liver disease and/or aminotransferases \>5x ULN
* GFR \< 50 ml/min
* Co-morbidities reducing life expectancy to \<1 year (e.g. cancer)
* Patient wishes to take part in another interventional study
Effect of Probiotics on Oral Candida Among Denture Wearers

Forty-eight denture wearers with detectable levels of candida colonization without clinical symptoms will be randomly allocated into two groups: probiotics and placebo. All patients will take a daily dose of chewable tablets (probiotics or placebo according to the assigned group) for 8 weeks. Samples of mouth rinse will be collected from patients at baseline, 4 weeks from the beginning of the intervention, 8 weeks (the end of intervention), and after another 4 weeks for post-intervention follow up. Samples will be tested for both candida count and candida species identification


Eligibility Criteria:
Inclusion Criteria:

* Detectable levels of Candida in palatal mucosa without clinical symptoms of active candidiasis.
* Completely edentulous arches with newly formed denture .
* Patients with controlled hypertension, and diabetes will be included in this study as they are considered very common problems in the targeted population.

Exclusion Criteria:

* Inability to understand/ follow the experimental procedures,
* Administration of topic or systemic antifungal or antibacterial agents in the previous 60 days.
* Consumption of probiotics.
* GITdisorders.
* Heartdisease.
* Diseases that significantly influence immunity such as; kidney problems, head and neck cancer, or radiotherapy, AIDS, or immunosuppressive therapy.
* Clinical manifestations of oral candidiasis.
An Exploratory RWE Study Exploring Effects of a Goat Milk Based Young Child Formula on Health Benefits

This is an exploratory real-world study designed to gain insight into the role of the product in terms of health benefits in toddlers, with the potential to generate hypotheses on key and other exploratory objectives.


Eligibility Criteria:
Inclusion Criteria:

1. Age between 1-2 years of age
2. Healthy term infants, gestational ages 37\~42 weeks
3. Birth weight within normal range for gestational age and sex (10th to 90th percentile of the Chinese Child Growth Chart);
4. Normal weight, height at screening (10th to 90th percentile of the Chinese Child Growth Chart)
5. Chinese population;
6. Subjects whose parents/guardians are intending to goat formula feed according to protocol during the study period;
7. Informed consent from one parent or legal representative;
8. Subjects whose parents/guardians are adults, have sufficient ability in Chinese to complete informed consent and other study documents;
9. Subjects whose parents/guardians are able to use smart phone with cameras; install and use a secure WeChat platform on the mobile phone during the study period; connect to the network through the mobile phone; take photos to record stool; complete questionnaires;
10. Subjects whose parents/guardians can be directly contacted by telephone or WeChat throughout the study.

Exclusion Criteria:

1. Probiotics or probiotics-supplemented products use within 4 weeks prior to enrolment;
2. Goat-milk based formula or fresh goat milk use within 4 weeks prior to enrolment;
3. Special infant formula use within 4 weeks prior to enrolment, including but not limited to hydrolysed infant formula, lactose-free infant formula and anti-reflux infant formula etc.;
4. Known allergy to milk products or soy product;
5. Medially diagnosed disorders requiring a special diet, including but not limited to reflux esophagitis, phenylketonuria etc;
6. Significant congenital abnormality or other health conditions that could affect the outcome measurements;
7. Investigator's uncertainty about the willingness or ability of the parents to comply with the protocol requirements;
8. Participation in any other studies involving investigational or marketed products concomitantly or within 4 weeks prior to entry into the study.
Evaluation of Therapeutic Video Games for Pre-school Children With Acute Lymphoblastic Leukemia

The purpose of this study is to evaluate the effectiveness of therapeutic video game.

Children cancer was the third-ranked causes of children's death. During the long treatment courses, children are always forced to accept lots of drug therapy and invasive procedures without understanding the medical purpose. Due to the immature cognition, always lead to anxiety in childhood cancer patients. Our team developed a mobile technology platform based therapeutic video game (TVG) for preschoolers with acute lymphoblastic leukemia (ALL) in early 2018. Then three clinical experts were invited to validate TVG and had high appropriateness consensus. Then the pilot study was conducted in one medical center in Taipei and 10 preschoolers with ALL had been randomly signed in two groups-5 to intervention group (6 weeks game intervention) and 5 to control group (regular care). The preliminary results showed that crying scale and resisting behavior were no significance between two groups in the initial period (p=.663), but the intervention group showed lower crying grades and less resisting behavior than the control group in the final period (p=.028). The limitation of this pilot research was small sample size and short intervention time. Therefore, the purpose of this study is to increase the sample size and intervention time to evaluate the effectiveness of our TVG.

Methods: A total of 68 fresh ALL preschool children will be randomized divided equally into intervention group and control group. Only intervention group

Eligibility Criteria:
Inclusion Criteria:

* ALL

Exclusion Criteria:

* non TPOG therapy
* without Port-A
* under PBST treatment
* ALL recurrent
* mental retardation
Dose-Escalation Study of PHA-793887 in Patients With Advanced/Metastatic Solid Tumors

The purpose of this open-label, multi center, phase I study, was to determine the safety profile of PHA-793887 administered by intravenous infusion to patients with advanced/metastatic solid tumors. This was a dose-finding study to determine the maximum tolerated dose and the dose of PHA-793887 that can be safely used in phase II investigations.


Eligibility Criteria:
Inclusion Criteria:

* Advanced/metastatic solid tumors for which no standard therapy exists
* ECOG (WHO) performance status 0-1
* Life expectancy of at least 3 months
* Age ≥ 18 years
* Adequate liver, pancreas and renal function
* Acceptable hematologic status
* Acute toxic effects from prior therapy must be resolved to NCI CTCAE Grade ≤ 1
* Treatment with surgery, chemotherapy, or investigational therapy must be completed at least one month prior to treatment initiation (6 weeks for nitrosoureas or Mitomycin C and liposomal doxorubicin)
* Prior radiation therapy allowed in no more than 25% of bone marrow reserve
* Men and women of child-producing potential must agree upon the use of effective contraceptive methods

Exclusion Criteria:

* In the past 6 months: myocardial infarction, unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident or transient ischemic attack, pulmonary embolism, deep vein thrombosis
* Known brain metastases
* Major surgery, other than diagnostic surgery, within 4 weeks prior to Day 1
* Active, uncontrolled bacterial, viral, or fungal infections, requiring systemic therapy
* Pregnant or breast feeding women
* Known infection with HIV, active hepatitis B or hepatitis C
* Patients who have exhibited allergic reactions to a similar structural compound, biological agent, or formulation
* History of pancreatitis or disorders making the patient at risk of pancreatitis
* Previous history or current presence of neurological disorders
* Patients with pre-existing symptoms of peripheral neuropathy not related to prior anticancer therapy(ies)
* Concomitant treatment that may be associated with peripheral neuropathy
* Other severe concurrent conditions that could compromise protocol objectives.
The Reproductive Life Plan in Midwifery Counseling

Many women and men are at risk for sexual transmitted infections and unwanted pregnancies and have unrealistic family planning intentions and insufficient knowledge of health promoting lifestyle prior to conception. Without sufficient support from the health care system this can lead to negative consequences. The aim of our study was to investigate if the usage of the Reproductive Life Plan in midwifery counselling increases women's knowledge of reproduction and particularly knowledge of folic acid intake prior to pregnancy. Secondary aims were to evaluate the influence on women's family planning and to further explore how women experienced the Reproductive Life Plan-based counselling.


Eligibility Criteria:
Inclusion Criteria:

* Visitor at the Student Health Clinic

Exclusion Criteria:

* Not speaking Swedish
* Male
Study to IDEntify Patients With Advanced/Metastatic Non Small Cell Lung Cancer (NSCLC) and ALK and ROS1 Translocation and to Establish Their Therapeutic Management (IDEALK&ROS)

Prospective observational study to IDEntify patients with advanced/metastatic NSCLC and ALK and ROS1 translocation and to establish their therapeutic management (IDEALK\&ROS)


Eligibility Criteria:
Inclusion Criteria:

For ALK Incidence substudy

* Patients with Advanced or metastatic non-small cell lung cancer
* Patients who will be screened for anaplastic lymphoma kinase (ALK) rearrangement
* Age \> 18 years For ALK treatment substudy (retrospective and prospective)
* Age \> 18 years
* Confirmed anaplastic lymphoma kinase (ALK)-positive tumour
* Patients treated with crizotinib under routine clinical practice
* Patients with a minimum data registered at the medical history
* For the patients that will be recruited prospectively: Patients must have a signed informed consent document.

For the ROS1 treatment sub-study (retrospective only):

* Age \> 18 years
* Confirmation of NSCLC with ROS1-positive translocation
* Have been eligible to receive treatment with crizotinib according to routine clinical practice since the market launch of the ROS1 indication in Spain on 8 February 2017 until the opening of the site.
* Patients should have a predetermined minimum amount of data recorded in their medical records.

Exclusion Criteria:

* Any patient who does not meet any of the inclusion criteria defined in the previous section, depending on the sub-study for which they are included.
Rebound Pain After Operations for Distal Radius Fractures With a Volar Plate in Brachial Plexus Block

Many patients have strong pain at brachial plexus block resolution after operations for distal radius fractures with a volar plate. This study investigates if a single dose of dexamethasone in addition to a standard pain regime have an effect on postoperative pain. The primary endpoint is difference in the highest pain score first 24 hours after surgery. The investigators will also look at pain scores and analgesics consumption first few hours after surgery and at different times up to 2 years after surgery.

This double-blind randomized clinical study evaluates pain, analgesic consumption and different measurements of patients satisfaction after operations for distal radius fractures with a volar plate in the day-care surgery unit. All patients will receive paracetamol and etoricoxib as oral premedication. Patients will be operated in infraclavicular brachial plexus block with ropivacaine 7,5 mg/ml. Patients in the intervention group will receive a single dose of 16 mg dexamethasone during the operation. Patients in the control group will receive NaCl iv.

After surgery, iv and oral rapid release oxycodone as needed while in hospital. After discharge (after 2-4 hours), etoricoxib for 2 days, controlled release oxycodone, total of 3 doses. Rapid release oxycodone as needed.

Patients will be followed up by telephone interviews at different times after surgery.

Eligibility Criteria:
Inclusion Criteria:

* Distal radius fracture planned for operation with a volar plate
* 0-20 days after trauma
* AO classification A, B, and C
* ASA 1 and 2
* Age 18-65
* BMI 18-35
* Able to communicate in Norwegian

Exclusion Criteria:

* Chronic pain
* Other injuries
* Pregnancy
* Known allergic reactions to medicines used in the study