cyrilzakka/clinical-trials huggingface dataset:
A Methodology Development Environmental Clinical Trial of Reproxalap in Subjects With Seasonal Allergic Conjunctivitis

A Multi-Center, Double-Masked, Randomized, Parallel-Group, Vehicle-Controlled, Methodology Development Environmental Clinical Trial with Reproxalap Ophthalmic Solutions (0.25% and 0.5%) in Subjects with Seasonal Allergic Conjunctivitis.


Eligibility Criteria:
Inclusion Criteria:

* be at least 18 years of age of either gender and any race
* have a positive history of ocular allergies and a positive skin test reaction to ragweed pollen as confirmed by the allergic skin test given to the subject within 24 months of the subject's Visit 1
* have a calculated visual acuity of 0.7 logMAR or better in each eye as measured using an ETDRS chart

Exclusion Criteria:

* have known contraindications or sensitivities to the use of any of the investigational product medication or components
* have any ocular condition that, in the opinion of the investigator, could affect the subject's safety or trial parameters (including but not limited to narrow angle glaucoma, clinically significant blepharitis, follicular conjunctivitis, iritis, pterygium, or a diagnosis of dry eye)
* have had ocular surgical intervention within three months prior to Visit 1, or during the trial, or a history of refractive surgery six months prior to Visit 1, or have systemic surgery planned during the clinical trial or within 30 days after;
* have a known history of retinal detachment, diabetic retinopathy, or active retinal disease
* have an active ocular infection (bacterial, viral or fungal), active uveitis, or positive history of an ocular herpetic infection at any visit;
* be a female who is currently pregnant, planning a pregnancy, or lactating
A Study of a New Local Anesthesia Method for Transperineal Prostate Biopsy

In comparison with transrectal prostate biopsy, transperineal prostate biopsy has the advantage of better sampling from the anterior area, low risk of infection, and no rectal bleeding. The main problems associated with the transperineal method are pain control and additional general or spinal anesthesia. Three types of anesthesia have been reported for transperineal prostate biopsy: (1) spinal anesthesia; (2) general anesthesia; and (3) local anesthesia. From the viewpoint of patient selection (general anesthesia is contraindicated in some patients) and medical cost, local anesthesia is the most suitable choice for prostate biopsy. Periprostatic block is the standard method of local anesthesia for this procedure. However, periprostatic block is insufficient for transperineal prostate biopsy due to high pain sensitivity in this region. A number of new methods to eliminate pain have been reported, including (1) periapical triangle (PAT) block, (2) paraprostatic plus sexual nerve block, and (3) periprostatic block plus pudendal block.However, there is no anatomical basis for some of these methods, and there have been no randomized controlled trials to evaluate their effectiveness, and some methods are technically difficult to learn. In the previous perineal nerve autopsy, we found that there are two branches leading into the prostate and anterior lateral prostatic tissue, which is the main site of puncture pain. There is a fixed position where the two branches appear. Therefore, this anatomical position block may be a useful site for local anesthesia. We named this location the 'transperineal prostate biopsy local anesthesia switch' (abbreviated as TPA switch). In order to validate its effect, we organized this clinical trail.

Ninety patients scheduled for prostate biopsy will include in this study. The clinical trial validation process will be as follows: (1) all patients are randomly divided into three groups (Figure 1): group 1, subcutaneous local anesthesia+periprostatic block; group 2, subcutaneous local anesthesia+periapical triangle (PAT) block; group 3, subcutaneous local anesthesia+TPA switch (transperineal prostate biopsy local anesthesia switch) block; VAS scores for each puncture and complications will be recorded.

Eligibility Criteria:
Inclusion Criteria:

* 1. ready to be performed transperineal prostate biopsy; 2. fully understand the protocol and aggree to undergo prostate biopsy with local anesthesia which might be elder methods or new experimental method.

Exclusion Criteria:

* 1.do not have the history of anaphylaxis or local anesthetic intoxation； 2. cardiac dysfunction or coagulation dysfunction; 3. Rectal disease which can not allowed to plug the ultrasound probe in; 4.do not fully understand our protocol; 5. do not aggree our protocol.
Cognitive Orientation to Daily Occupational Performance and Conductive Education Approaches on Down Syndrome

This study will be conducted to investigate and compare the effects of Cognitive Orientation to Daily Occupational Performance (CO-OP) and Conductive Education (CE) on fine motor skills, activity, and participation limitations in children with DS. Children with DS aged 7-18 years will be included. Both CO-OP and CE interventions will last 12 weeks and be conducted for 2 sessions per week in the cross-over randomized study. Following 12-week wash-out period, interventions will be changed for each group.

Down syndrome (DS) is a chromosomal anomaly characterized by the presence of an extra copy of genetic material on the 21st chromosome. Sensory, motor, cognitive and perceptual impairments can be seen in children with DS. These impairments probably affect the development and learning of their various fundamental and complex actions. Those children experience decreased motor proficiency, reduced social participation and lower life quality.

Fine motor skills are important for children's everyday functioning such as dressing, feeding, bathing, holding objects, cutting etc. In addition, fine motor skills are related to cognitive, social and academic abilities in children.

This study will be conducted to investigate and compare the effects of Cognitive Orientation to Daily Occupational Performance (CO-OP) and Conductive Education (CE) on fine motor skills, activity, and participation limitations in children with DS. Children with DS aged 7-18 years will be included.

Random allocation software will be used to assign CO-OP or CE to participants. Both CO-OP and CE interventions will last 12 weeks and be conducted for 2 sessions per week. Both intervention will be applied as groups including 3-4 children. Following 12-week wash-out period, interventions will be changed for each group. Two meetings before and during the study will be done in order to inform parents about the interventions and their effects. Another investigator who is blind about the groups will conduct the assessments before and after both first and second treatment durations so 4 assessments will be done in total. At the end of whole treatment schedule, a satisfaction form will be asked from the parents for feedback about both interventions.

Eligibility Criteria:
Inclusion Criteria:

* Children aged between 7 and 18 years
* Children who can understand cognitive skills given and can verbally communicate
* Children who can specify at least 3 activities
* Children who have adequate motivation

Exclusion Criteria:

* Caregivers or parents who have inadequate cognitive levels for the study progression
* Children who participate in any physiotherapy/ergo-therapy schedules for at least 3 months
* Children who have Cognitive Orientation to daily Occupational Performance and Conductive Education program.
* Children who have other neurological problems (except Down Syndrome)
* Children who have undergone orthopedic surgery related to upper limbs
* Children who have other health and behavioral problems which can affect the participation in the study
Laser Closure of Anal Fistula (FiLaC)

Laser closure of the perianal fistula is the minimally invasive and low complication rate procedure which is a life-saving way for complex fistulas, preserving anal sphincter injury. Unfortunately, wide range success rate reported before (30-80%), the investigators are searching to reach better rates. Internal closure of the fistula orifice offered by some authors. The investigators are aimed to identify the efficiency of this.

Despite the developments in the surgical field, the treatment of anal fistula is still a challenging problem, especially in complex, transsphincteric cases. The surgical treatment aims to avoid recurrences and also to preserve normal sphincter functions. The FiLaC procedure was recently reported non-invasive technique in perianal fistulas for treatment and preserving anal sphincter function with a good success rate. In 2018, one of our colleagues published a 40% complete healing rate by using only FiLaC technique in 103 consecutive perianal fistula patients (Prof. Cem Terzi). Some authors advocated that the closure of the internal orifice increasing the success rate. Therefore, the investigators decided to modify the surgical technique focusing closure of the internal opening associated with the FiLaC procedure.

Eligibility Criteria:
Inclusion Criteria:

* complex anal fistula
* high anal fistulas
* recurrent anal fistulas

Exclusion Criteria:

* superficial anal fistulas
* multibranching anal fistulas
Liver Health and Metabolic Function in People With Obesity

This project aims to determine the effect of significant weight loss on rates on hepatic fibrogenesis in people with obesity.

Non-alcoholic fatty liver disease (NAFLD) affects approximately 70% of those with obesity and if left untreated can progress to cirrhosis and liver failure. NAFLD stages progress from the stage of simple steatosis to steatohepatitis, and fibrosis The stage of NAFLD is currently best determined using histology from a liver biopsy, however this provides a static depiction of the state of the liver. Therefore, this project aims to determine fibrogenesis in the liver of obese humans in vivo, before and after weight loss.

Eligibility Criteria:
Inclusion Criteria:

* Body mass index ≥35 kg/m2
* Scheduled for Bariatric surgery

Exclusion Criteria:

* Significant organ disfunction/disease
* Tobacco use
* Previous bariatric surgery
* Pregnancy
* Excessive alcohol use
* Liver disease other than NAFLD
Restorative Treatment in First Molars Affected by Molar-Incisor Hypomineralization

The restorative management of molars with Molar-Incisor Hypomineralization (MIH) represents a challenge in the clinical practice with high failure rate. Thus, this clinical trial aimed to evaluate the clinical survival of direct composite resin restorations in first permanent molars (FPMs) that are affected by MIH, comparing two adhesive systems.

For the research, it was selected first permanent molars (FPMs) with MIH from children aged 6-8 years. FPM fully erupted and with restorative treatment needed was the inclusion criteria. We excluded FPMs with destroyed crowns. The FPMs were randomly assigned to two groups: G1 (self-etching adhesive) and G2 (total-etching adhesive). Clinical evaluation was performed during 18 months according to the USPHS-Modified by a blinded examiner. The actuarial method was used to evaluate survival of the restorations and Fisher's exact test was used to compare differences between the groups (α=5%).

Eligibility Criteria:
Inclusion Criteria:

* children and/or parents who agree in participate of the study
* children were born and living in Araraquara, SP, Brazil
* presence of the first permanent molars totally erupted with defects classified as enamel post eruptive breakdown (PEB) or unsatisfactory atypical restoration (UATR), with or without carious lesions.

Exclusion Criteria:

* children and/or parents who do not agree in participate of the study
* first permanent molars with enamel malformation associated with syndromes,
* dental fluorosis,
* first permanent molars with destroyed crowns,
* imperfect amelogenesis
* fixed orthodontic appliances.
Short and Long Term Effect of Early Infant Feeding and Nutritional Status on the Children's Health

This study evaluates the early infant feeding in the infant intestinal microecology and the long term health. 300 healthy term newborns were involved into the study on its first stage. Depending on the type of feeding the infants were divided into 3 groups with random allocation to one of the formula feeding groups: the group A included 100 infants consuming the formula supplement with superior quality whey protein, the group B -100 infants fed with a standard formula, and the group C -100 infants who were breastfed.

Throughout the human lifetime, the intestinal microbiota performs vital functions, such as barrier function, metabolic reactions, trophic effects, and maturation of the host's innate and adaptive immune responses. Therefore, the human health depends on the gut health. It is reported that the human gut microbiota of a healthy adult is highly resilient and very stable over time. And before it reaches maturity, the microbiota must develop itself from birth and establish its mutually beneficial cohabitation with the host. However, the early developments of the microbiota in infants are influenced by many factors, such as prenatal parameters, the influence of the mother and her microbiota, and therapies occurring around the time of birth.

Human milk is the sole source of nutrition for infants during the first weeks to months after birth, and has evolved to provide nutrition and immunological protection in the extra-uterine environment into which the infant is born. But when breastfeeding is not possible, human newborns may circumstantially be fed with infant formulas. The difference of feeding mode has been demonstrated to have a strong influence on early gut colonization particularly on the probiotic bacteria. Studies show that breastfed infants have higher counts of Bifidobacteria and Lactobacillus and lower counts of Bacteroides, Clostridium, coccoides group, Staphylococcus, and Enterobacteriaceae as compared with formula-fed infants.

Eligibility Criteria:
Inclusion Criteria:

* Healthy term newborns (the mean gestational age in weeks \> 36.0) with birth weight ≥2500 g appropriate for gestational age
* Apgar scores \> 7
* Uncomplicated early course of neonatal period
* Impossibility of breastfeeding (for infants randomized into the bottle-feeding groups)

Exclusion Criteria:

* The minimum possibility of breastfeeding (for infants randomized into the bottle-feeding groups)
* The diagnosis of a significant chronic medical condition including: HIV infection; cancer; bone marrow or organ transplantation; blood product administration within the last 3 mo; bleeding disorder; known congenital malformation or genetic disorder
* If the parent or legal guardian were unable to read and/or comprehend Chinese
* If the family moved outside of Beijing during the study period (i.e., would be unavailable for follow-up)
25-Hydroxyvitamin D Pharmacokinetic Study

To evaluate the pharmacokinetic parameters of orally administered 25-hydroxyvitamin D3 \[25(OH)D3\] and vitamin D3 from the corresponding serum concentration-time curves in healthy adults and adults with a history of intestinal malabsorption.

Patients with a history of intestinal malabsorption (n=10) and healthy volunteers (n=10); (of both sexes and all ethnicities) will be recruited in this randomized double-blind crossover study. All subjects will be prescreened for 25(OH)D levels to include subjects with 25(OH)D\<30 ng/ml. The subjects will be randomized to receive a single oral dose of 900 µg of either vitamin D3 or 25(OH)D3. Blood samples will be taken at baseline and at 2,4,6,8,12 hours and days 1,2,3, 7 and 14. After a washout period of at least 14 days (2 weeks) the subjects will receive in a double blinded manner a single oral dose of 900 µg of either 25(OH)D3 or vitamin D3 (depending on which one they took in the randomization) any time after the washout. Blood samples will be taken at baseline and at 2,4,6,8,12 hours and days 1,2,3,7, 14.

Serum levels of calcium, phosphorus, albumin, creatinine, intact parathyroid hormone (iPTH) will be obtained at baseline and at day 14 (or within a reasonable time if unable to come in on the exact day). Vitamin D and 25(OH)D will be determined on all the blood samples collected at the various times.

Eligibility Criteria:
Inclusion Criteria:

* Adult male or female with history of intestinal fat-malabsorption with confirmed diagnosis
* Taking vitamin D (ergocalciferol or cholecalciferol). Subjects taking vitamin D supplement of more than 2000 IUs (50 micrograms)/day) that may interfere with study endpoints must be willing and able to discontinue use of these supplements for the duration of the study and allow for at least a 14-day washout prior to prescreening and enrollment.
* Women of child bearing potential must be on birth control and not pregnant based on a negative pregnancy test at baseline for each of the 2 pharmacokinetic studies.
* Serum total 25(OH)D \< 30 ng/mL

Exclusion Criteria:

* Unwilling to discontinue use of supplemental dose of vitamin D2 (ergocalciferol) or vitamin D3 (cholecalciferol) daily equivalent (2,000 IU/50 μg) 1 week or less prior to randomization and during the study
* On medications that can affect vitamin D metabolism including steroids such as prednisone, anti-seizure medications and medications to treat HIV.
* Tanning in a tanning bed at least one week before the study and throughout the duration of this study.
* Anyone anticipating going on holiday (where exposure to sun is imminent) 1 week before or during the entire study.
* Participation in the study or any reason which, in the opinion of the investigator makes adherence to a treatment or follow-up schedule unlikely
* History of elevated serum calcium
* Chronic hepatic or renal failure
* Subjects with a history of an adverse reaction to orally administered vitamin D.
* Inability to give informed consent
Drug Penetration Into Bone After Repeated Oral Administration of Debio 1450 to Patients Undergoing Hip Replacement Surgery

Debio 1450 is being developed for the treatment of staph (staphylococcal) infections. How fast and completely an antibiotic penetrates into bone is used to determine how effective it might be to treat infections related to bones or joints. Since bone has fewer blood vessels than other tissue (for example lung tissue or the skin), drugs have a harder time getting into them. It is important to find out how much of the antibiotic can get into the bone to help patients with bone infections.


Eligibility Criteria:
Inclusion Criteria:

* Meets protocol-specified criteria for qualification and contraception
* Is willing and able to comply with restrictions related to food, drink and medications
* Voluntarily consents to participate and provides written informed consent prior to any protocol-specific procedures

Exclusion Criteria:

* Has history or current use of over-the-counter medications, dietary supplements, or drugs (including nicotine and alcohol) outside protocol-specified parameters
* Has signs, symptoms or history of any condition that, per protocol or in the opinion of the investigator, might compromise:

  1. the safety or well-being of the participant or study staff;
  2. the safety or well-being of the participant's offspring (such as through pregnancy or breast-feeding);
  3. the analysis of results
Evaluation of LVEF by a New Automatic Evaluation Tool in a Pocket Ultrasound Scanner

Clinical ultrasound has become essential in emergency medicine. The guidelines are to use of echocardiography in specific contexts: dyspnea, hypotension or chest pain. The evaluation of left ventricle ejection fraction (LVEF) is one of the basic objectives of echocardiography. The reference assessment in emergency medicine is visual assessment. It suffers from poor inter-observer reproducibility. Pocket ultrasound scanners seem to meet the constraints of point-of-care ultrasound. A new tool is available on a pocket ultrasound device: the automatic evaluation of LVEF. Its interest could be to have a better inter-observer reproducibility than visual evaluation.


Eligibility Criteria:
Inclusion criteria:

* Patient over 18 years of age
* Management in the investigator centre
* Admitted for dyspnea or hypotension or chest pain

Exclusion criteria:

* Age \< 18 years
* Patient not benefiting from a social security system
* Patient deprived of liberty
* Patient under the protection of justice, under guardianship or curatorship
* Patient refusing to participate in the study
* Inability to provide the patient with informed information
Early Renal Replacement Therapy and the Outcome of Acute Kidney Injury

This research project is a prospective study to compare mortality between early renal replacement therapy (RRT) and late renal replacement therapy by using plasma neutrophil gelatinase associated lipocalin (pNGAL) as a tool in decision- making.


Eligibility Criteria:
Inclusion Criteria:

* The patient must have given his/her informed and signed consent
* patients with acute kidney injury in the intensive care ward.

Exclusion Criteria:

* The patient refuses to sign the consent
* The patient is pregnant, parturient, or breastfeeding
* End stage renal disease
* Chronic renal failure
* previous kidney transplant
A Real-world Wearables Study in Fabry Disease.

Despite improvements in Fabry disease care in recent years, many patients still have poor outcomes. In addition to the many physical symptoms that patients can experience, the disease also places individuals at an increased risk of mental health conditions, such as anxiety and depression. Low physical activity levels and increased sedentary time are detrimentally associated with anxiety, depression and quality of life in the general population. Currently, no such research has been conducted in individuals with Fabry disease.

Data will consist of: (1) information from hospital medical records, (2) patient reported outcomes collected via questionnaires, and (3) measurements from a clinical-grade wearable device.

Individuals with Fabry disease aged 18 years or above will be considered for eligibility screening.

Trial assessments:

Baseline questionnaires

Baseline questionnaires will include the Hospital Anxiety and Depression Scale (HADS) and the EuroQol 5-dimension questionnaire (EQ-5D-5L). This will be administered via Qualtrics.

Thigh-worn device (activPAL)

Participants will attach the activPAL device to their anterior thigh for 8 days and continue their usual daily behaviour throughout the week. This will measure sitting, standing, stepping and sleep time. This device is accompanied by a hard copy daily diary, where participants will be asked to input the time they wake up, they get out of bed, they get into bed, and when they go to sleep.

Clinical data

Data from medical records will include disease phenotype and clinical severity including mutation type, lyso-Gb3, left ventricular mass index and diastolic dysfunction. Such data will be sourced from electronic patient records. Mainz Severity Score Index, and its age-adjusted score will be calculated from data on electronic patient records. These will be collected retrospectively from the previous 12 months upon enrolment.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Fabry disease documented by genotyping and/or enzymatic analysis.
* Resident in the UK.
* Aged 18 years and over.
* Capable of providing informed consent.
* Physically able to stand and ambulate independently.

Exclusion Criteria:

* A known allergy to any materials in the wearable device.
* Not able to have or use a wearable.
* Taking part in an interventional study which would preclude real-world data collection.
* Unable to communicate in English to a sufficient level to permit engagement in the study.