cyrilzakka/clinical-trials huggingface dataset:
Comparing Diurnal Fluctuations in Intra Ocular Pressure Measured in Same Day Versus Different Days in Glaucoma Patients

Glaucoma is one of the leading causes of blindness in the west. The disease caused by high intra ocular pressure (IOP) and characterized by damage to the optic nerve and gradual loss of visual field. Intra ocular pressure change during the day. To evaluate the efficiency of the therapy it is common to measure the intra ocular pressure at different times of the day. Most ophthalmologists admit the patient for one day at which intra ocular pressure is measured at different times. This method does not mimic the patient daily routine and may not reflect the true diurnal fluctuations.

For this reason some ophthalmologists measure the intra ocular pressure at different times and at different days. It is not known if both methods give similar diurnal curves.

A study physician will install anesthetic eye drops and will color the eye drops film with fluorescein. Study physician will use tonometer to measure the intra ocular pressure in each eye. This is a standard procedure done in any ophthalmological examination. Each patient will undergo intraocular pressure examination at 8:00, 12:00 and 16:00.

In the first day intra ocular pressure will be measured at 8:00, 12:00 and 16:00, same day measurements. The day after intra ocular pressure will be measured at 8:00, two days after at 12:00 and three days after at 16:00. One month later the patient will undergo another serious of intra ocular pressure measurements.

In the first day intra ocular pressure will be measured at 8:00, 12:00 and 16:00, same day measurements. The day after intra ocular pressure will be measured at 8:00, two days after at 12:00 and three days after at 16:00.

The relationship between the two diurnal curves will be analyzed.

Eligibility Criteria:
Inclusion Criteria:

* Glaucoma patient.
* Age 18-80 years
* Able to read and understand Hebrew, able to sign informed consent in Hebrew.

Exclusion Criteria:

* Ophthalmic laser treatment or surgery 3 months prior to enrollment.
* Eye infection or inflammation.
* Corneal pathology altering IOP measurement.
* Patients not cooperating during IOP measurement.
* non compliant patients
Clinical Impact of Second-look Endoscopy After Endoscopic Submucosal Dissection of Gastric Neoplasm

Gastroenterologists often follow up second look endoscopy after endoscopic submucosal dissection(ESD) of gastric neoplasms because they want to prevent bleeding of procedure sites. But Goto suggested in his retrospective analysis that a second-look endoscopy after endoscopic submucosal dissection for gastric epithelial neoplasm may be unnecessary. So, the investigators try to identify the hypothesis prospectively in this study.


Eligibility Criteria:
Inclusion Criteria:

* histological confirmed patients(gastric adenoma or adenocarcinoma)
* performed gastric ESD patients about 24 hours before

Exclusion Criteria:

* perforation after ESD
* piecemeal resection of ESD specimen
* hemostatic agent or proton pump inhibitor users before ESD
* heparin or antiplatelet agent users
* Serious concurrent infection or nonmalignant illness that is uncontrolled
* Psychiatric disorder that would preclude compliance
* Allergy history to proton pump inhibitor
Intervention on Non-prescription Antibiotic Use Among the Public

The purpose of this study is to test the effectiveness of health education int led by community health workers for non-prescription antibiotic use among the public. In this two arm cluster randomised trial, In this two-arm cluster randomized controlled trial, 22 communities were randomly allocated in a 1:1 ratio to intervention and control groups. In the intervention group, family doctors will conduct WeChat-based health education on responsible use of antibiotic for the participants. In the control group, only routine public health education will be provided without any involvement in antibiotic use. The primary outcome is the incidence of antibiotic use without prescription in the past month.


Eligibility Criteria:
Inclusion Criteria:

* Aged between 18 and 75 years old;
* Local residents (residing for more than 6 months) with no plans for employment, study, or relocation in the next six months;
* Having normal cognitive, comprehension, and independent communication abilities, and voluntarily participating in this study;
* Able to use WeChat independently or with guidance from family members.

Exclusion Criteria:

* Unable to comprehend the purpose of the survey, unwilling to cooperate, or lacking willingness to provide honest answers to questions;
* Illiterate, severely physically disabled, or lacking necessary comprehension abilities;
* Healthcare professionals, such as doctors, nurses, pharmacists, etc.;
* Individuals with autoimmune diseases or hereditary diseases affecting the use of common medications;
The Effects of Action Observation Therapy (AOT) on Balance and Gait in Patients With Multiple Sclerosis.

Action observation therapy is a new method in rehabilitation that causes motor retraining by activating mirror neurons while watching the activity on the screen and then practicing them. We will use action observation therapy to improve balance and walking in MS patients.

Multiple sclerosis (MS) is an inflammatory disease of the brain and spinal cord caused by damage to myelin.

While the underlying cause of this disease is unknown, a significant relationship has been reported between a series of (CNS) neurons of the central nervous system, immune factors, genetics, and viruses. The primary complaint of MS patients is movement problems, particularly walking disorders, which greatly affect their quality of life, and its improvement is one of the main goals of rehabilitation. Action observation therapy is a new approach. It is used to treat neurological disorders such as cerebral palsy, Parkinson's disease, strokes, and multiple sclerosis.

In this method, a video of some purposeful movements and activities recorded by healthy people doing them is shown to the patient, then the person must try to imitate and perform those actions, which causes movement retraining and memory recall. Based on the studies conducted on the effectiveness of neurological treatment methods and proving the effectiveness of this method on other conditions, also considering the involvement of the nervous system in MS and the lack of related studies, we conducted this study with regard to To design a low cost, availability, and ease of use therapeutic method on balance and walking in patients with multiple sclerosis.

This study will be conducted on two groups of MS patients. after passing 30 minutes of usual rehabilitation by the blind therapist. One group will watch videos related to action observation exercises and then practice, and for the second group, a video of natural scenery will be shown for the same length of time, then they will practice exercises similar to the first group.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of spastic primary progressive, secondary progressive, relapsing-remitting MS
* EDSS (Extensive Disability Status Scale) Score between 3 and 6
* MMSE (Mini-mental state examination) test score\> 24

Exclusion Criteria:

* Recurrence of MS during 3 months before intervention
* Pregnancy and lactation
* Having a psychiatric disorder or drug/alcohol abuse
* Changes in the symptoms of MS during the study period
* Inability to sit without torso support
* Inability to stand for at least 10 seconds with support
* Other neurological or orthopedic diseases of the lower extremities (musculoskeletal diseases, severe osteoarthritis, peripheral neuropathy, joint replacement)
* Cardiovascular diseases (recent myocardial infarction, heart failure, uncontrolled hypertension, orthostatic hypotension)
* participation in other clinical studies
A Study of Different Use Regimens Using Two Acne Treatments

A study to determine if using 2 acne products in the morning is as safe and efficacious as using one product in the morning and one product in the evening.

Approximately 240 subjects will be enrolled in this randomized, multi-center study. Following satisfaction of entry criteria and screening procedures, all subjects will receive RETIN-A MICRO PUMP 0.04% and a 5% Benzoyl Peroxide wash (OTC) for the entire 12-week treatment period. Subjects will be randomized to either both morning treatments (test) or to the morning/evening treatment (active control). Subjects will be assessed at baseline, at week 3, week 6 and again at the end of therapy, week 12 for number and type of individual lesions and safety. At selected sites, photographs will be taken at the same time points. At Week 12 subjects will be assessed for Investigator's Global Assessment of Acne Severity. The investigator will conduct all of the lesion counts, global assessments and safety assessments.

Eligibility Criteria:
Inclusion Criteria:

* Males and non-pregnant or non-nursing females, 12 years or older, with facial acne vulgaris;
* Minimum of 20 but no more than 50 inflammatory lesions (papules and pustules);
* Minimum of 30 but no more than 100 facial non-inflammatory lesions (open and closed comedones);
* Must have at least a rating of grade 3 on the Investigator Global severity scale at baseline

Exclusion Criteria:

* Known sensitivity to any of the ingredients in the study medication;
* Any nodulocystic acne lesions;
* Use of acne devices or systemic therapy with antibiotics within two months prior to start and throughout the duration of the study;
* Use of systemic therapy with retinoids within four months prior to study start and throughout the duration of the study;
* Topical use of retinoids within two weeks prior to study start and throughout the duration of the study;
* Topical use of antibiotics, steroids and/or other non-retinoid topical acne products within two weeks prior to study start and throughout the duration of the study;
* If subject is taking birth control pills, she must be stabilized for at least three months prior to study start;
* History of evidence of other skin conditions or diseases that may require concurrent therapy or may interfere with the evaluation of the study medication;
* Any significant medical conditions that could confound the interpretation of the study;
* Excessive facial hair that may interfere with evaluations;
* No use of tanning booths, sun lamps, etc.
Effects of Training in a Virtual Environment in Healthy Elderly

The objective of this work was to compare the effects of two balance training programs, one Nintendo Wii Fit-based and the other traditionally-based without the use of a gaming system, on the (1) balance, (2) gait, (3) functionality and (4) cognition ability in older adults. It is a prospective, single blinded, randomized clinical trial performed at Center of Research of the courses of Speech Therapy, Physical Therapy and Occupational Therapy of São Paulo University. Thirty-two older adults are randomly in control and experimental group, 16 each one. The study includes only participants scoring at least 24 in the Mini-Mental State Examination to rule out effects of dementia; without the presence of depression, according to the Geriatric Depression Scale of Yesaváge - version 15 (GDS-15 ≤ 5) and scores on the Berg Balance Scale (EBB ≥ 41).

The objective of this work is to compare the effects of two balance training programs, one Nintendo Wii Fit-based and the other traditionally-based without the use of a gaming system, on balance, gait, functionality and cognition ability in older adults. It is a prospective, single blinded, randomized clinical trial performed at Center of Research of the courses of Speech Therapy, Physical Therapy and Occupational Therapy of São Paulo University. Thirty-two older adults are randomly in control and experimental group, 16 each one. Both groups performed 14 training sessions, twice a week, for seven weeks. Each session is composed of a 30 minute-global-exercise series including stretching, muscle strength and axial mobility exercises. After this, both groups performed more 30 minutes of balance training: the control group performed balance exercises without external cues, visual or auditory feedbacks or cognitive stimulations; the experimental group performed the balance training with 10 Wii Fit games which stimulated motor and cognitive functions. The main outcome measures are: (1) Mini-BESTest of Dynamic Balance Evaluation; (2) Dynamic Gait Index (DGI); (3) Montreal Cognitive Assessment (MoCA); and (4) Falls Efficacy Scale - International (FES-I).

Eligibility Criteria:
Inclusion Criteria:

* Age 60 to 85 years.
* Absence of other neurological disorders or co-morbidities that may affect gait;
* Absence of dementia (score above 24 on the Mini Mental State Examination - MMSE);
* Absence of depression (score above 5 on the Geriatric Depression Scale of Yesaváge - version 15);
* Score on the Berg Balance Scale above 41;
* Vision and hearing adequate or corrected to normal;
* Ability to walk independently;

Exclusion Criteria:

* Biomechanical alterations (other pathologies) that could compromise the completion of training;
* Presence of any neurological, auditory or visual deficit that could compromise distracting task performance during balance and gait training;
Study of Swaddling on Tactile Learning in Premature Infants

Explore the sensorially of the premature newborn that is fundamental to adapting the care environment to these hospitalized babies

Indeed, the challenge is to offer them an environment adapted to their sensory skills, so as not to alter their development.

This is in line with the customized care development, better known as the Anglo-Saxon term of Neonatal Individualised Developmental Care and Assessment Program.

The aim is thus to promote later the cognitive development of these children

Eligibility Criteria:
Inclusion Criteria:

* Children born prematurely and aged 28 to 35 Weeks of Amenorrhoea, regardless of their postnatal age

Exclusion Criteria:

premature newborns with

* associated anomalies syndrome
* abnormal cranial ultrasonography with stage III or IV intraventricular hemorrhage or periventricular cavitary leukaemia
* those receiving sedative or convulsive treatment during the experiment
* those whose grasping reflex is absent
Effects of a Berry Oil Cream on Atopic Eczema and Skin

Atopic eczema is a chronic inflammatory skin disease associated with itch and inflammatory lesions in typical skin areas. The objective of this study is to investigate the effects of a cream containing berry and plant oils and humectants on atopic eczema and dry skin.


Eligibility Criteria:
Inclusion Criteria:

* Atopic Eczema (mild or medium severity)

Exclusion Criteria:

* Other serious skin conditions (for example psoriasis)
* Known hypersensitivity to ingredients of the study creams
* Medication seriously affecting immune function
Clearance of 25-hydroxyvitamin D3 During Vitamin D3 Supplementation

The goal of this study is to determine how 25(OH)D3 clearance is affected by vitamin D3 supplementation using a gold standard pharmacokinetic approach.

We expect that this study will enhance interpretation of available diagnostic tests, inform the results of ongoing large clinical trials of vitamin D supplements, and help develop new strategies to target vitamin D to improve health.

Eligibility Criteria:
Inclusion Criteria:

* Successful prior completion of related protocol CLEAR (NCT02937350) or CLEAR-CF (NCT03104855)
* Age ≥ 18 years
* Self-reported race Caucasian, African American, or African

Exclusion Criteria:

* Primary hyperparathyroidism
* Gastric bypass
* Tuberculosis or sarcoidosis
* Current pregnancy
* Child-Pugh Class B or C cirrhosis (i.e. cirrhosis with ascites, hepatic encephalopathy, bilirubin \>=2 mg/dL, serum albumin \<=3.5 g/dL, or PT \>= 4 seconds)
* History of kidney transplantation (unless failed transplant now treated with hemodialysis)
* Use of 1,25(OH)2D3 or an analogue, calcimimetics, or medications known to induce CYP24A1 within 4 weeks (wash-out allowed)
* Serum calcium \> 10.1 mg/dL
* Hemoglobin \< 10 g/dL
A Longitudinal Observational Study of Patients Undergoing Therapy for IMISC

TARGET-DERM is a longitudinal, observational study of adult and pediatric patients being managed for Atopic Dermatitis and other Immune-Mediated Inflammatory Skin Conditions (IMISC) in usual clinical practice. TARGET-DERM will create a research registry of patients with IMISC within academic and community real-world practices in order to assess the safety and effectiveness of current and future therapies.

TARGET-DERM is a longitudinal, observational study of adult and pediatric patients being managed for Atopic Dermatitis and other Immune-Mediated Inflammatory Skin Conditions (IMISC) in usual clinical practice. TARGET-DERM will create a research registry of patients with IMISC within academic and community real-world practices in order to assess the safety and effectiveness of current and future therapies.

The duration of follow-up for participants enrolled in the EU is limited to 5-years. Those within in US and Canada may consent to indefinite follow-up.

Eligibility Criteria:
Inclusion Criteria:

* 1. Adults and children (all ages) with Atopic Dermatitis or other Immune-mediated Inflammatory Skin Conditions been prescribed any dermatologic treatment.
* 2. Participant has plans for future visits at the site for continued management of IMISC.

Exclusion Criteria:

* 1. Inability to provide written informed consent/assent.
* 2. Subjects participating in any interventional study or trial for IMISC treatment trial at the time of enrollment. Patients may be enrolled in TARGET-DERM once participation in the trial is complete. Note: Participants may be enrolled in other registries or studies where IMISC treatment outcomes are observed and/or reported (such as center-based registries).
Comparison of Arterolane-piperaquine Versus Arterolane-piperaquine+Mefloquine Versus Artemether-lumefantrine in Kenyan Children

This open-label randomised controlled clinical trial will compare the safety, tolerability, therapeutic efficacy and pharmacokinetics and pharmacodynamics of arterolane-piperaquine, arterolane-piperaquine plus mefloquine versus artemether-lumefantrine.in children with uncomplicated falciparum malaria in Kilifi, Kenya. This study will also provide an up to date insight on the current presence of antimalarial resistance in this site.

In addition, all children will be treated with a single low dose of primaquine, dosing is age based.

The investigators will recruit 219 patients aged 2 years to 12 years with acute uncomplicated falciparum malaria in Kilifi County Hospital.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female aged 2 years to \<13-year-old
2. Uncomplicated falciparum malaria as defined as:

   * Positive blood smear with asexual forms of P. falciparum (may be mixed with non-falciparum species)
   * Parasitaemia between 5,000-250,000 parasites/µL
   * Fever defined as tympanic temperature \>37.5°C or history of fever within last 48 hours
3. Ability to take oral medication
4. Willingness and ability to comply with study protocol for study duration
5. Written informed consent given to participate in the trial

Exclusion Criteria:

1. Signs of severe/complicated malaria\*
2. Any clinical reason suggesting that the child's treatment should be given immediately and not delayed during the transfer to Kilifi County Hospital in the opinion of the treating physician.
3. Acute illness other than malaria requiring urgent systemic treatment as assessed by the treating physician
4. Previous splenectomy
5. Treatment with artemisinin or ACT within the previous 7 days
6. Treatment with mefloquine in the 2 months prior to presentation
7. Known hypersensitivity or contraindication to arterolane-piperaquine, DHA-piperaquine, artemisinin, mefloquine (epilepsy, major psychiatric illness) or primaquine
8. QTc interval \>450 milliseconds at point of presentation
9. Known personal or family history of cardiac conduction problems
10. Participation within another clinical trial in the previous 3 months
First-line FOLFOXIRI In Combination With Bevacizumab For Metastatic Colorectal Cancer

This is a single-arm, open-label, multicentre phase II study evaluating the safety and efficacy of the combination of the G.O.N.O. FOLFOXIRI regimen with bevacizumab as first-line treatment of metastatic colorectal cancer.


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed colorectal adenocarcinoma
* Unresectable and measurable metastatic disease (RECIST criteria)
* Male or female, aged \> 18 years and ≤ 75 years
* ECOG Performance Status (PS) \< 2 if aged \< 71 years
* ECOG PS = 0 if aged 71-75 years
* Life expectancy of more than 3 months
* Adequate haematological function: ANC ≥ 1.5 x 109/L; platelets ≥ 100 x 109/L, Hb ≥ 9 g/dL
* INR ≤ 1.5 and aPTT ≤ 1.5 x ULN within 7 days prior to starting study treatment
* Adequate liver function: serum bilirubin ≤ 1.5 x ULN; alkaline phosphatase and transaminases ≤ 2.5 x ULN (in case of liver metastases \< 5 x ULN)
* Serum Creatinine ≤ 1.5 x ULN
* Urine dipstick for proteinuria \< 2+. If urine dipstick is ≥ 2+, 24- hour urine must demonstrate ≤ 1 g of protein in 24 hours
* Previous adjuvant chemotherapy is allowed if more than 12 months have elapsed between the end of adjuvant therapy and first relapse
* At least 6 weeks from prior radiotherapy and 4 weeks from surgery

Exclusion Criteria:

* Prior palliative chemotherapy
* Prior treatment with bevacizumab
* Bowel obstruction (or subobstruction)
* History of inflammatory enteropathy or extensive intestinal resection (\> hemicolectomy or extensive small intestine resection with chronic diarrhea)
* Symptomatic peripheral neuropathy \> 2 grade NCIC-CTG criteria
* Presence or history of CNS metastasis
* Active uncontrolled infections
* Active disseminated intravascular coagulation
* Major surgical procedure, open biopsy or significant traumatic injury within 28 days prior to treatment, or anticipation of the need for major surgery during the course of the study
* Central Venous Access Device (CVAD) for chemotherapy administration inserted within 2 days prior to study treatment start
* Past or current history of malignancies other than colorectal carcinoma, except for curatively treated basal and squamous cell carcinoma of the skin cancer or in situ carcinoma of the cervix
* Clinically significant cardiovascular disease, for example cerebrovascular accidents (CVA) (≤ 6 months before treatment start), myocardial infarction (≤ 6 months before treatment start), unstable angina, NYHA ≥ grade 2 chronic heart failure (CHF), uncontrolled arrhythmia
* Uncontrolled hypertension
* 24-hour urine protein \> 1 g if dipstick \> 2+
* History of thromboembolic or hemorrhagic events within 6 months prior to treatment
* Evidence of bleeding diathesis or coagulopathy
* Serious, non healing wound/ulcer or serious bone fracture
* No therapeutic anticoagulation or antiplatelet agents or NSAID with anti-platelet activity (aspirin ≤ 325 mg/day allowed)
* Pregnancy or lactation
* Fertile women (\< 2 years after last menstruation) and men of childbearing potential not willing to use effective means of contraception