cyrilzakka/clinical-trials huggingface dataset:
KP-10 and Insulin Secretion in Men

Induction of insulin secretion by kisspeptin is observed in mouse, pig, rat, and human islets in vitro and in rats, mice and monkeys in vivo, but its mechanism is not fully clear. The present study was designed to investigate the role of KP-10 on insulin secretion in adult healthy and obese men with insulin resistance. The aim of selection of obese persons for the present study was to investigate the effect of acute KP-10 administration in a metabolically challenged condition where the pancreatic beta cells are already highly activated. The long-term objective of this study was to understand the physiological role of kisspeptin signalling in the regulation of insulin secretion in human health and disease.


Eligibility Criteria:
Inclusion Criteria:

* Normal BMI
* Normal renal function
* Normal liver function
* Normal blood count

Exclusion Criteria:

* Disease history
* Diabetes
* Other trauma
Frozen Embryo Transfer Pregnancy Outcomes Prediction by Microbiome and Transcriptome

This study intends to explore the correlation between cervical microbiome, gut microbiome, transcriptome and pregnancy outcomes of frozen embryo transfer patients through a multicenter prospective observational study, and to explore the predictive value of microbiome on pregnancy outcome.


Eligibility Criteria:
Inclusion Criteria:

1. Infertile women receiving assisted reproductive technology treatment, preparing for frozen embryo transfer cycle;
2. Female age: 20-45 years old;
3. Single frozen-thawed blastocyst Transferred
4. Endometrial thickness ≥7mm on the day of luteal transformation
5. Written informed consent.

Exclusion Criteria:

1. Women who have pathologies or malformations that affect the pregnancy outcome:genital malformations, intrauterine adhesions, uterine fibroids (\>4 cm in diameter or compressing endometrial line), adenomyosis, endometrial polyps; untreated tubal pleura Presence of autoimmune disease;
2. Untreated hyperprolactinemia, thyroid disease, adrenal disease
3. Antibiotic use within the past 7 days;
4. Current or recent (within 3 months) drug abuse, including alcohol and tobacco;
5. Refused or unable to comply with protocol requirements;
6. Participation in any experimental drug study within 60 days prior to screening.
Aqueous Humor Concentration of InSite Vision (ISV) 303 (Bromfenac in DuraSite) to Bromday Once Daily (QD) Prior to Cataract Surgery

The purpose of this study is to evaluate the aqueous humor concentration of bromfenac sodium in subjects administered multiple topical ocular doses of ISV-303 or Bromday™ QD prior to routine cataract surgery.


Eligibility Criteria:
Inclusion Criteria:

* Male or female subjects age 18 or older scheduled for unilateral cataract surgery (phacoemulsification or extracapsular extraction) with posterior chamber intraocular lens implantation
* If a female is of childbearing potential, the subject must agree to and submit a urine sample for pregnancy testing at Visit 1 prior to enrollment and at the end of the study, and the subject must use effective contraception for the duration of the study. Post menopausal is defined as having no menses for at least 12 consecutive months.
* Signature of the subject on the Informed Consent Form
* Willing and able to follow all instructions and attend all study visits
* Able to self-administer study drug (or have a caregiver available to instill all doses of study drug)

Exclusion Criteria:

* Use of any drug containing bromfenac within 2 weeks prior to surgery
* Contact lens wear during the dosing period
* Known hypersensitivity or poor tolerance to bromfenac sodium or any component of the investigational medicinal product (IMP) or any of the procedural medications
* Any serious complications with or macroscopic damage to the corneal epithelium
* Currently pregnant, nursing, or planning a pregnancy; or be a woman that has a positive urine pregnancy test
* Currently suffer from alcohol and/or drug abuse
* Prior participation in this study protocol
* Prior (within 30 days of beginning study treatment) or anticipated concurrent use of an investigational drug or device
* A condition or a situation, which in the investigator's opinion may put the subject at increased risk, confound study data, or interfere significantly with the subject's study participation
Personalized Noninvasive Support

The optimal noninvasive respiratory support for acute hypoxemic respiratory failure is debated. Recent preliminary data indicate that both pressure-support noninvasive ventilation (NIV) and continuous-positive airway pressure (CPAP) may be of benefit. While often applied interchangeably in clinical practice, NIV and CPAP have different effects on the inspiratory effort, which is the major determinant of self-inflicted lung injury. Also, inspiratory effort widely varies among individuals.

The purpose of this study is to assess the physiological effects of a noninvasive respiratory support approach guided by inspiratory effort, as compared to CPAP and NIV, in patients with moderate-to-severe acute hypoxemic respiratory failure.

Patients with acute hypoxemic respiratory failure will undergo a decremental pressure-support trial during helmet noninvasive support. The following pressure-support settings will be applied sequentially, with positive end-expiratory pressure kept constant and equal to 10-12 cmH2O: 20 cmH2O, 16 cmH2O, 12 cmH2O, 8 cmH2O and high-flow-driven CPAP. Inspiratory effort will be monitored during the trial through esophageal manometry. The personalized setting of noninvasive support will be defined as the minimal pressure-support level capable of generating inspiratory effort between 5 and 10 cmH2O.

Personalized noninvasive support will be then compared to conventionally-set NIV and CPAP in a randomized cross-over trial.

Eligibility Criteria:
Inclusion Criteria:

* Acute hypoxemic respiratory failure and PaO2/FiO2\<200 mmHg
* PaCO2\<45 mmHg
* Respiratory failure not caused by exacerbation of chronic pulmonary disease, cardiac failure or fluid overload

Exclusion Criteria:

* Pregnancy
* Contraindication to helmet support
* Contraindication to esophageal manometry
* Contraindication to electrical-impedance tomography monitoring
* Recent surgery involving the abdomen or the thorax
* Pneumothorax or documented barotrauma
Domiciliary Management of Dental Erosion in Patients With GERD With Biomimetic Hydroxyapatite

The aim of the present study is to evaluate dental erosion in patients with gastroesophageal reflux disease (GERD).

Patients consenting to participate to the study will undergo periodontal evaluation at the baseline. Then, professional dental hygiene will be performed. Patients will be randomly assigned to:

* Trial group: home oral hygiene with Biorepair Total Protection + Biorepair Shock Treatment twice a day
* Control group: home oral hygiene with Biorepair Total Protection Patients will be evaluated after 1, 3, 6, 9 and 12 months from baseline.

The aim of the present study is to evaluate dental erosion in patients with gastroesophageal reflux disease (GERD).

Patients consenting to participate to the study will undergo periodontal evaluation at the baseline. Then, professional dental hygiene will be performed. Patients will be randomly assigned to:

* Trial group: home oral hygiene with Biorepair Total Protection + Biorepair Shock Treatment twice a day
* Control group: home oral hygiene with Biorepair Total Protection Patients will be evaluated after 1, 3, 6, 9 and 12 months from baseline.

Eligibility Criteria:
Inclusion Criteria:

* patients with dental erosion
* no proton pumps before pH examination

Exclusion Criteria:

* no dental erosion
* neurological and psychiatric diseases;
* pregnant and/or breastfeeding women;
* patients with poor compliance.
Effects of Peptides Derived From Fermented Milk on Blood Pressure Regulation System in Healthy Volunteers.

Several milk proteins are precursors of peptides, released during fermentation, which possess various biochemical and physiological properties. Among them, some peptides have been reported to inhibit angiotensin-converting enzyme (ACE) in vitro (an enzyme implicated in blood pressure regulation) and to lower blood pressure (BP). in hypertensive rats and in a small sample of patients with hypertension. One possible mechanism for the BP lowering effect is inhibition of ACE. Prior investigating BP lowering effect of these peptides in a large cohort of hypertensive patients, it is necessary to assess in depth their potency to inhibit ACE in vivo in humans and to compare it to that induced by a well-known ACE inhibitor.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male volunteers
* aged between 18 and 35 years
* informed written consent
Premature Enhanced Automated Capture of Comfort Knowledge

The goal of this observational study is to develop methods that could provide continual monitoring of comfort levels for preterm neonates in hospitals.

As preterm neonates have not developed ways to communicate how they are feeling like children or adults do, clinicians must rely on their own understanding and professional judgements to decide how comfortable they are. It is known that preterm neonates can display emotion through ways such as facial expressions, body movements and changes in their physiology such as heart rate. The investigators will record both behavioural (audiovisual) and physiologic (heart rate, blood oxygen saturation) signals during routine clinical procedures ranging from comforting, through discomforting to painful that are necessary as part of high-quality medical care.

Eligibility Criteria:
Inclusion Criteria:

* Preterm Infants born \<36 completed weeks of gestation
* Medically stable
* Written informed consent from parents

Exclusion Criteria:

* Infants with significant brain, spine, or congenital abnormality
* Parents unwilling to provide consent
* Infants with postmenstrual age \>36 weeks
The Effect of Active Reminders on Oral Hygiene in Orthodontics

The aim of this study is to investigate the efficacy of text message active reminders at different time intervals of oral hygiene instructions in patients with orthodontic fixed appliances.

Participants with orthodontic fixed appliances will be recruited from the university hospital clinics to receive text message reminders of oral hygiene. Four groups of participants will be formulated. Group 1 will be the control group and will not receive text messages. Group 2 will receive messages once a week. Group 3 will receive text message reminders 3 times a week. Group 4 will receive daily reminders. At baseline, after 4 weeks and after 8 weeks, gingival index and plaque index will be measured at each time point and then compared between groups.

Eligibility Criteria:
Inclusion Criteria:

* Participants were having orthodontic fixed appliance treatment.
* Participants were aged 12 years old and above, owned mobile phones and did not have mental or physical disabilities.
* Participants were willing to comply with given oral hygiene instructions.
The Effect of Intermittent Oro-esophageal Tube Feeding on Severe Traumatic Brain Injury Patients With Tracheostomy

This was a multicenter randomized controlled study of 98 severe Traumatic Brain Injury patients with tracheostomy. Patients enrolled were divided randomly into the observation group with Intermittent Oro-esophageal Tube Feeding (n=50) or the control group with Nasogastric tube feeding (n=48) for enteral nutrition support, respectively. Nutritional status, complications, decannulation of tracheostomy tubes and level of consciousness on day 1 and day 28 were recorded and compared.

The safe and effective nutrition support for severe traumatic brain injury patients with tracheostomy continues to be a challenge. Nasogastric tube feeding has been the mainstream choice in China but with the risk of complications. Intermittent Oro-esophageal Tube Feeding is an established modality of enteral nutrition support that can be used with routine treatment. This study reports the clinical outcomes of Intermittent Oro-esophageal Tube Feeding vs. nasogastric tube feeding, in patients receiving routine treatment. This was a multicenter randomized controlled study of 98 severe traumatic brain injury patients with tracheostomy. Patients enrolled were divided randomly into the observation group with Intermittent Oro-esophageal Tube Feeding (n=50) or the control group with Nasogastric tube feeding (n=48) for enteral nutrition support, respectively. Nutritional status, complications, decannulation of tracheostomy tubes and level of consciousness on day 1 and day 28 were recorded and compared.

Eligibility Criteria:
Inclusion Criteria:

* age ≥ 18 years, meeting the diagnosis of severe Traumatic Brain Injury;
* score of Glasgow Coma Scale\<8;
* presence of no contraindication for enteral nutrition;
* with stable vital signs and no severe liver or kidney dysfunction, metabolic disorders, cardiovascular diseases, or multiple complications;
* informed consent form was obtained from the patient\&#39;s family members, indicating their full understanding of the study and agreement to participate.

Exclusion Criteria:

* unable to cooperate in completing treatment and assessment due to personal reasons or other disorders;
* complicated with other intracranial lesions, such as stroke;
* with severe consciousness disorders caused by other diseases.
A Study to Determine the Dose Requirements of Rocuronium Bromide (Zemuron®) in Pediatric and Adolescent Subjects (21048)(COMPLETED)(P05797)

The primary purpose of this study is to determine the dose requirements of rocuronium bromide when administered as a bolus dose (a single, large dose) for intubation (insertion of a tube through the nose or mouth into the trachea to provide artificial ventilation) and when administered by either continuous infusion or bolus doses for maintenance of muscle relaxation in term neonates (birth to \<28 days old), infants (28 days to \<=3 months) and toddlers (\>3 months to \<=2 years), children (2 years to less than or equal to 11 years of age), and adolescents (\>11 years to less than or equal to 17 years of age).


Eligibility Criteria:
Inclusion Criteria:

* Male and female subjects from birth up to 17 years of age who are scheduled for surgery with an anticipated duration of anesthesia of about 2 hours or more requiring a maintenance muscle relaxation dose(s).

Exclusion Criteria:

* Subjects whose parent(s) or legal guardian(s) are not willing to give written consent and where applicable, subjects who have not given appropriate assent to participate in the trials will not be allowed to enter.
Preeclamptic Patients and Pentraxin 3 & Lipoprotein-associated Phospholipase A2

In particular, pentraxine 3 (PTX3) molecule was assumed to have a prognostic value in acute myocardial infarction.In patients affected by acute myocardial infarction, early plasma elevation of PTX3 appears to predict a worse outcome in these patients in the longer term.

The inflammatory basis of preeclampsia resembles an atherogenic process.It is planned to investigate the role of these two molecules in endothelial dysfunction typical of preeclampsia.

The level of circulating PTX3 and Lp-PLA2 in preeclamptic patients and their serum levels according to the severity of preeclampsia and presence of IUGR, and comparison with the control group without preeclampsia and It is planned to investigate the cut-off values and sensitivity and specificity of both molecules together and separately in preeclampsia.


Eligibility Criteria:
Inclusion Criteria:

* pregnant women diagnosed with preeclampsia; The blood pressure and proteinuria (at least ≥ 300 mg in urine for 24 hours) will be established before the 20th week of gestation in normotensive pregnancies with an interval of 6 hours.
* Those who have Grand mal convulsions; other causes of convulsions and exclusion of coma were defined as having seizures for the first time after 20 weeks of gestation and 48-72 hours after delivery.
* The diagnosis of HELLP syndrome will be confirmed by intravascular hemolysis. (Abnormal peripheral smear and / or abnormal bilirubin values), high liver enzymes (high serum aspartate transaminase levels \[AST\], alanine transferase \[ALT\] and lactate dehydrogenase \[LDH\] üst 2 upper level) and low platelet count (\<100 000 / mm3)
* healthy pregnant women without additional disease for the control group

Exclusion Criteria:

* Maternal diabetes
* Kidney disease
* Cardiovascular disease
* Neurological disease
* drug use history
* Hematological and immunological disease
* The presence of any infection
* Fetal anomaly
* In utero dead fetus
Anterior Cruciate Ligament-reconstruction: Quadriceps Tendon or Hamstrings Tendon? A Prospective Trial

The purpose of this study is to determine whether there is a difference in muscle strength after anterior cruciate ligament comparing 2 surgery technics. Using either autograft hamstrings tendon or a autograft quadriceps tendon.


Eligibility Criteria:
Inclusion Criteria:

* Anterior cruciate ligament rupture

Exclusion Criteria:

* current malignant disease
* Rheumatoid arthritis
* Other knee ligament instability
* Obesity BMI \>30
* Morbus Bechterew
Change of Body Composition After Kidney Transplantation in Korea

The graft survival in kidney transplantation has been improving after the introduction of new immunosuppressive agents. Therefore, other complications after transplantation are concerned; one of those is obesity. Several factors are attributable to obesity in kidney transplant recipients.

The body composition such as fat mass and lean mass is important concept in overweight patients. Some studies have been conducted on the change of body composition in kidney transplants. However, all of them are studied among Caucasians or using dual energy X-ray absorptiometry (DEXA).

In this study, the investigators plan to study the body composition among Asian kidney transplant recipients using the bioelectrical impedance analysis (BIA).


Eligibility Criteria:
Inclusion Criteria:

* aged 20 years and over

Exclusion Criteria:

* history of previous transplantation
* co-transplantation with other organs
* neuropsychological problem with diet (such as anorexia nervosa, bulimia)
A Study to Evaluate Rituximab in Combination With Methotrexate in Methotrexate-Naive Patients With Active Rheumatoid Arthritis

This is a phase III, randomized, controlled, double-blind, parallel group, international study in approximately 750 patients with active Rheumatoid Arthritis (RA) who are naive to Methotrexate (MTX) therapy. Rheumatoid Factor (RF)-positive and RF-negative patients will be enrolled and will be allocated equally between 3 treatment arms.


Eligibility Criteria:
Inclusion criteria:

* Adult patients 18-80 years of age
* RA for ≥ 2 months;
* Receiving outpatient treatment
* Patients naive to, and considered to be candidates for, methotrexate treatment

Exclusion criteria:

* Rheumatic autoimmune disease other than RA, or significant systemic involvement secondary to RA
* Inflammatory joint disease other than RA, or other systemic autoimmune disorder
* Diagnosis of juvenile rheumatoid arthritis, or RA before the age of 16
* Surgery within 12 weeks of study
* Previous treatment with any approved or investigational biologic agent for RA, an anti-alpha4-integrin antibody or co-stimulation modulator, or cell-depleting therapy
* Concurrent treatment with any biologic agent or DMARD other than methotrexate
Effect Of Cough Assist Device On Hemodynamic Status And Oxygen Saturation For Ventilated Children

Statement of the problem:

•Is there an effect of the cough assist device on Hemodynamic status and oxygen saturation for ventilated children? Null hypothesis There will be no effect of cough assist device on hemodynamic status and oxygen saturation for ventilated children.

Subjects:

The study targets the children from both sexes.diagnosed with pneumonia in intensive care unit. Sample size estimation will be carried out to determine the recruited number of children, selected randomly from Cairo University pediatric specialized hospital, Cairo to participate in the study.

Study design:

Randomized controlled clinical trial. Children will receive intervention type randomly,25 child will receive traditional chest physical therapy (postural drainage, percussion and vibration, end expiratory pressure) and bed mobility exercise.and the other 25 child will receive cough assist device in addition to traditional chest physical therapy (postural drainage, percussion and vibration, end expiratory pressure) and bed mobility exercise.

Children will be assessed by measuring heart rate, respiratory rate, blood pressure which reflect the physiological status, oxygen saturation,expired Tidal Volume and dynamic lung compliance which reflect clinical improvement of chest condition before and after receiving intervention

Eligibility Criteria:
Inclusion Criteria:

1. Children of both sexes, with age ranged from 4-9 years old.
2. Children will diagnosed with pneumonia.
3. Children will intubated on mechanical ventilation.
4. All children should be vitally stable during the study period.

Exclusion criteria:

Exclusion Criteria:

1. Hemodynamically unstable child.
2. Child with diaphragmatic hernia.
3. Child with pneumothorax (if chest tube is present).
4. Child with raised intracranial pressure.
5. Child with recent upper Gastrointestinal surgery
Observational Study of Males With Creatine Transporter Deficiency

The objectives of this study are to illustrate the clinical, neuro/electrophysiologic, biochemical, and developmental status and progression of patients with Creatine Transporter Deficiency (CTD) and to evaluate the utility of performance-based and other measures in the CTD population.

This is an observational study designed to determine an appropriate clinical assessment battery for males with CTD, and to evaluate Magnetic resonance spectroscopy (MRS) along with other potential biomarkers. It is designed to explore developmental domains of interest and to examine the feasibility and utility of various neuropsychological assessments to measure domains of interest, and to identify possible endpoints for interventional studies. Study will also explore genotype-phenotype correlations.

Clinical adverse events will be monitored throughout the study.

This study was previously posted by Lumos Pharma, which has been transferred to Ultragenyx in June 2019.

Eligibility Criteria:
Inclusion Criteria:

1. Subject has genomic confirmation of a pathologic mutation in the SLC6A8 gene.
2. Subject is able to complete study-related procedures.
3. Subjects' parents/guardians/caregivers must provide written consent (informed consent) to study-related procedures, and if appropriate, the subject will provide an assent.

Exclusion Criteria:

1. Subject has had status epilepticus within 3 months of screening.
2. Subject is unable to comply with the study procedures or with a clinical disease or laboratory abnormality that in the opinion of the investigator would potentially increase the risk of participation.