cyrilzakka/clinical-trials huggingface dataset:
Sham Feeding Post-operative Infants

The purpose of this pilot study is to evaluate a feeding technique, sham feeding, to promote adequate oral skills in order to prevent oral aversion and/or poor oral skills due to the delay in oral feeds for surgical reasons. Sham feeding is intended for infants who are expected to have a prolonged course without normal enteral feeding by mouth.

There is a lack of literature and research on which to base interventions that intend to preserve and develop oral and motor feeding skills in the post-operative patient population during the critical window of opportunity to establish proper oral skills. Due to the lack of positive oral feeding stimuli (i.e. prolonged airway management, nasogastric tubes, and airway and upper GI suctioning), these patients are at risk to develop oral aversions that may negatively impact long-term outcomes.

Parents in the neonatal intensive care unit (NICU) report feelings of stress and loss of control associated with medical interventions. When normal oral feeding is contraindicated, there may be impairment of parent-child bonding and mothers may be less dedicated to providing milk for the infant. Impaired bonding has been shown to affect the parent-child relationship and the child's development long after discharge.

Sham feeding has been shown to be safe and shorten time to oral feeding in infants with esophageal atresia with delayed esophageal repair. Anecdotal evidence from Le Bonheur suggests that sham feeding in post-operative gastroschisis patients improves parental satisfaction and engagement.

There is no literature to describe the use of sham feeding in neonates other than those with esophageal atresia. Anecdotal reports from our institution and others institutions suggests that it increases parental engagement and improves parental satisfaction among patients with other bowel pathology.

This is a cohort study with historical controls within a single level IV NICU. Participants will be offered sham feeding by breast or bottle and observed.

Eligibility Criteria:
Inclusion Criteria:

1. Neonates at least 34 weeks post-menstrual age who have a history of gastrointestinal surgery, require no respiratory support more than 2 lpm by nasal cannula, and have an anticipated prolonged course with contraindication to normal oral or enteral feeding. They must have a diagnosis of gastroschisis awaiting return of bowel function, bowel atresia or other obstruction with anticipated feeding contraindication longer than 30 days, or short bowel syndrome intolerant of full intermittent oral feeding.
2. Mothers of enrolled neonates

Exclusion Criteria:

1. Lack of consent or parental consent.
2. Contraindication to sham feeding as determined by the responsible medical provider.
Canadian Active & Maintenance Modified Pentasa Study

The purpose of this study is to demonstrate that the new modified oral extended-release Pentasa® 500mg tablet is at least as efficacious as the currently marketed Pentasa® 500mg tablet in active mild to moderate Ulcerative Colitis (UC) and also in maintenance of quiescent disease.

A multi-centre, randomized, double-blind, non-inferiority trial comparing the efficacy and safety of a new modified oral extended release Pentasa® (mesalamine) 500 mg tablet to the currently marketed Pentasa® (mesalamine) 500 mg tablet in subjects with active mild to moderate ulcerative colitis treated with 4 g/day for 8 weeks and in maintenance of remission of ulcerative colitis in subjects treated with 2 g/day for 24 weeks. The study involves male or non-pregnant female subjects aged 18 to 75 years.

Subjects were randomised on entry into the trial, and if they were in remission at the end of the 8-week Active Phase or the 4-week Run-in Phase, they were eligible for enrolment into the 24-week Maintenance Phase, remaining on the original randomised treatment.

Eligibility Criteria:
Inclusion Criteria for Active phase:

* Newly diagnosed or recurrent, mild to moderate Ulcerative Colitis patients.
* Extent of colonic involvement confirmed within the past 36 months
* UCDAI score of at least 3 but not greater than 8 and a score of at least 1 for endoscopy
* Screening tests to rule out any abnormalities in stool, heart or kidney.
* Male or non-pregnant females between 18 to 75 years.
* Women of childbearing potential to use efficacious contraception as judged by the investigator.
* Written informed consent given.

Inclusion Criteria for Maintenance phase:

* Newly recruited subjects with documented mild to moderate UC entering the Run-in Phase: in clinical remission for at least 1 month and for a maximum of 3 years, and receiving 5-ASA 1.4 to 2.5 g/day for maintenance of quiescent disease
* Subjects from Active Phase: meeting remission criteria after the 8-week active period
* Extent of colonic involvement confirmed within the past 36 months by colonoscopy
* In complete remission at entry into the Maintenance Phase, defined as i) a score of 0 or 1 for stool frequency; ii) a score of 0 for rectal bleeding; iii) a score of 0 for endoscopy findings; and iv) a Physician's Global Assessment (PGA) score of 0 or 1
* Screening tests to rule out any abnormalities in stool, heart or kidney.

Exclusion Criteria:

* Use of 5-ASA products at a dose \>2.5g/day within 7 days prior to entry.
* Proctitis, short bowel syndrome, prior bowel surgery, severe UC, other forms of Inflammatory Bowel Disease
* Infectious diseases, parasites, bacterial pathogens
* Allergy to aspirin or salicylate
* Liver or kidney abnormalities
* Alcohol or drug abuse
* Pregnancy
* Cancer
* Bleeding disorders, ulcers, autoimmune diseases
* Mental disorders
* Participation in clinical trial in last 30 days
* Inability to fill in diary cards / comply with protocol requirements
Study of Predictive Immunological Parameters of Molecular Complete Remission in Patients With Chronic Myelogenous Leukemia in Chronic Phase and Treated With Tyrosine Kinase Inhibitor

The investigators recently identified promiscuous HLA-DR-derived epitopes from the human telomerase reverse transcriptase (TERT) called universal cancer peptides (UCP), to study tumor-specific CD4+ T cell responses.

The aim of this prospective preliminary study is to evaluate the presence of UCP-specific Th1 responses in patients in complete remission of CML two years after end of Tyrosine Kinase Inhibitor (TKi) treatments.


Eligibility Criteria:
Inclusion Criteria:

* For cohort A :

  * patient with chronic myelogenous leukemia in chronic phase in deep molecular response (MR4.0) persistent for 2 years or more after end of TKi treatments
  * patient with total cessation of TKi treatment
  * signed written informed consent
* For cohort B :

  * patient with chronic myelogenous leukemia in chronic phase, for whom a diagnosis of relapse was increased 1 year or less after stopping treatment with TKIs (inclusion of patient under TKi treatment after relapse is possible).
  * signed written informed consent

Exclusion Criteria (for all patients) :

* patients under chronic treatment with systemic corticoids or other immunosuppressive drugs (corticoids ≤ 10 mg/day is allowed)
* active autoimmune diseases, HIV, hepatitis C or B virus
* patient with any medical or psychiatric condition or disease which would make the patient inappropriate for entry into this study.
* patient under guardianship, curator or under the protection of justice.
Unicirc vs Open Surgical Circumcision

RCT of Unicirc under topical anesthetic w/ cyanoacrylate wound sealing vs. open surgical circumcision under local anesthetic with suturing.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male
* Uncircumcised
* With normal penile anatomy

Exclusion Criteria:

* Concurrent illness
* History of bleeding disorder
* Past reaction to local anesthetic
* Infection
* Penile abnormality which could complicate circumcision
A Study of LY3437943 in Chinese Participants With Obesity Or Overweight

The main purpose of this study is to learn about the safety and tolerability of LY3437943 when given to Chinese participants with overweight body mass index (BMI) or obesity. Blood tests will be performed to investigate how the body processes the study drug and how the study drug affects the body. Each enrolled participant will receive injections of LY3437943 or placebo given just under the skin. For each participant, the study will last about 20 weeks excluding screening period and may include up to 20 visits to the study center.


Eligibility Criteria:
Inclusion Criteria:

For All Participants:

* Are native Chinese males or females
* Have a body mass index of ≥27 and ≤40 kilograms per square meter (kg/m²)
* Have not modified diet or adopted any nutritional lifestyle modification for 3 months
* Have stable body weight for the last three months
* Male participants must agree to use contraception during the study and for 4 months afterward and female participants must be woman of nonchildbearing potential

For Type 2 Diabetes Mellitus (T2DM) Participants:

* Have type 2 diabetes for at least 3 months
* Have a glycated hemoglobin (HbA1c) value of ≥7.0% and ≤10.5% and have been treated with diet and exercise alone or a stable dose of metformin for at least 3 months prior to screening

Exclusion Criteria:

For All Participants:

* Have an average weekly alcohol intake that exceeds 21 units per week (males) and 14 units per week and smoke more than 10 cigarettes, or cigarette equivalent (as determined by investigator), per day
* Have other serious or unstable illnesses
* Have had an episode of severe hypoglycemia
* Current or chronic history of liver disease.

For T2DM Participants:

* Have type 1 diabetes mellitus
* Have uncontrolled diabetes, defined as an episode of ketoacidosis or hyperosmolar state requiring hospitalization
* Any glucose-lowering medications other than metformin within 3 months prior to screening
A Novel Neurorehabilitation Approach for Cognitive Aging With HIV

The goal of this study is to conduct a small, self-contained project to test the hypothesis that tDCS will augment SOP cognitive remediation therapy (CRT) in older HIV+ adults. The investigators will randomly assign 60 HIV+ older adults (i.e., ≥ 50 years old) to 10-hours in either a SOP CRT + sham tDCS condition (n=30) or SOP CRT + active tDCS condition (n=30) and examine neurocognitive functioning at baseline and 6 weeks post-intervention. Hypothesis 1: The SOP CRT + active tDCS condition will show larger proximal (i.e., SOP) gains than the SOP CRT + sham tDCS condition. Hypothesis 2: The active tDCS condition will demonstrate generalization to secondary neurocognitive domains compared to the sham tDCS condition.


Eligibility Criteria:
Inclusion Criteria:

* HIV+
* Aged 50 and older
* Patient at University HIV/AIDS Clinic

Exclusion Criteria:

* Not homeless
* Not blind or deaf
* No significant neuromedical issues (e.g., schizophrenia, bipolar disorder, stroke, epilepsy or history of seizures)
* No pacemaker or other biomedical devices or metal implants
* No untreated hypertension
* Not undergoing chemo or radiation
* No head injury with LOC greater than 30 mins
Continuous Versus Bolus Infusion of Terlipressin for Portal Hypertension Related Bleeding in Liver Cirrhosis

Terlipressin is the mainstay drug for the treatment of acute variceal bleeding in liver cirrhosis. According to the drug instructions, intravenous bolus infusion is the standard approach of terlipressin. It remains unclear about whether or not continuous infusion of terlipressin should be considered.

Although intravenous bolus infusion of terlipressin is the standard approach, continuous infusion of terlipressin is preferred in clinical practice. The present study is a pilot non-randomized controlled trial to explore the feasibility and safety of continuous infusion of terlipressin for the treatment of acute variceal bleeding in liver cirrhosis.

Eligibility Criteria:
Inclusion Criteria:

1. A diagnosis of liver cirrhosis;
2. Child-Pugh B or C;
3. Acute gastroesophageal variceal bleeding;
4. Written informed consents. -

Exclusion Criteria:

1. No liver cirrhosis;
2. Child-Pugh class A;
3. Acute upper gastrointestinal bleeding unrelated to varices;
4. Use of somatostatin or octreotide. -
The Effect of Different Obturation Techniques on Postobturation Pain in Single-Visit Root Canal Treatment

The goal of this prospective clinical randomized study is to evaluate the effect of different obturation techniques on postobturation pain in single-visit root canal treatment in 18-60 years old patient who present no systemic disease (American Society of Anesthesiology class I or II) and require nonsurgical root canal treatment The main question it aims to answer which obturation technique used with bioceramic sealer cause less postobturation pain in single-visit root canal treatment in comparison to AH plus sealer used with lateral condensation or warm vertical compaction.

Participants will receive single visit root canal treatment using bioceramic sealer with different obturation techniques Group 1: Single cone technique Group 2: lateral condensation technique Group 3: Vertical compaction technique to see effect of different obturation technique on postobturation pain in single-visit root canal treatment.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18-60 years who presented no systemic disease (American Society of Anesthesiology class I or II) and required nonsurgical root canal treatment.
* Diagnosis of asymptomatic irreversible pulpitis in a molar tooth with 3 independent root canals.

Exclusion Criteria:

* Presence of immature root apexes, root fracture, or periodontal disease
* Use of any analgesic, anti- inflammatory, or antibiotics before the treatment.
Effectiveness of a Mobile Texting Intervention for People With Serious Mental Illness

Testing an mHealth mobile interventionist texting program on illness management.

The ultimate objective is to evaluate a validated mHealth intervention that can be realistically integrated into community mental health settings to increase the availability, reach, and broad impact of illness management approaches for people with serious mental illness (SMI).

Eligibility Criteria:
Inclusion Criteria:

1. Chart diagnosis of schizophrenia, schizoaffective disorder, bipolar disorder, or major depressive disorder;
2. 18 years or older;
3. A rating of "3" or higher on one of three Patient Activation items;
4. Ownership of a mobile phone with call/text plan (research staff will offer assistance in accessing the Federal Lifeline Assistance Program to people who do not have a mobile phone and/or call/text plan if they are otherwise eligible);
5. Receiving community based treatment services.

Exclusion Criteria:

1. Hearing, vision, or motor impairment that make it impossible to operate a mobile phone (determined using the individual's device for screening);
2. English reading level below 4th grade (determined using the reading section from the Wide Range Achievement Test - 4th Edition (WRAT-4).
Uterine Flora During Elective and Urgent Cesarean Sections

Hypothesis: The bacterial flora of the uterus during elective Cesarean sections differs from the uterine flora during non-elective Cesarean sections. We want to study whether the uterine flora can predict post-cesarean febrile morbidity and endometritis.

Objective: To evaluate the uterine flora at the time of elective and non-elective cesarean sections and to study the relationship to the development of postpartum fever and/or endometritis.

Methods: Eight-hundred women who will be delivered by cesarean section will be enrolled in this study. Cultures will be obtained during the surgery from the open uterine cavity after removal of the placenta. Data regarding postpartum morbidity would be collected.

Eligibility Criteria:
Inclusion Criteria:

* Cesarean delivery

Exclusion Criteria:

* Vaginal delivery
Psychiatric Comorbidities in Type 1 Diabetes Mellitus.

This study aimed to assess the prevalence of psychiatric comorbidities in children and adolescents with diabetes mellitus type 1.

Assessing the impact of diabetes mellitus type 1 on quality of life. And determine the effect of associated factors on the development of psychiatric comorbidities and on quality of life in diabetes mellitus type 1.

Type 1 diabetes mellitus (TDM) is a chronic autoimmune disease. that affected carbohydrate metabolism and caused by insulin insufficiency resulting in increased blood glucose. It's one of the most common endocrine and metabolic conditions in childhood. There's 9 million people live with T1DM worldwide according to International Diabetes Federation. In Egypt, 1 in 98 families are impacted and the disease is growing at 6.7% each year. Living with T1DM has been associated with a significant impact on a person's social, mental, and psychological quality of life (QoL). as the individual must adopt blood glucose monitoring, use of injections or diabetes technology for insulin regulation, diet restrictions, and exercise. Also, there's increased risk of developing micro-and macro-vascular complications that result in morbidity and mortality in Long-term uncontrolled DM. therefore, these children and adolescents with T1DM have an increased risk of psychiatric comorbidities like depression, anxiety and sleep disorders, depression is one of the most common disorders. They appear to have a greater incidence of depression, anxiety and poor health-related quality of life (HRQoL) compared to their healthy peers. This is associated with suboptimal diabetes outcomes and better metabolic control has been found to correlate with better quality of life. This occurs especially when diagnosed at earlier age of onset, history of severe hypoglycemia and chronic hyperglycemia. There are no available studies that assess the presence of psychiatric comorbidities in T1DM in our locality.

Eligibility Criteria:
Inclusion Criteria:

* Children and adolescents aged between 8 and 15 years, diagnosed with diabetes mellitus type 1 and on medical treatment.

Exclusion Criteria:

* Patients with major psychiatric disorders or have cognitive difficulties.
* Patients unable or refuse to give consent.
Firibastat in Treatment-resistant Hypertension

This is a double-blind, placebo-controlled, multicenter, efficacy and safety study of firibastat (QGC001) administered po bid over 12 weeks in male and female subjects ≥18 years of age at Screening, with uncontrolled primary HTN. Subjects will be randomized 1:1 to investigational product (IP) and will receive either firibastat (QGC001) or matching placebo on top of their current chronic antihypertensive treatments.

The primary objective of this study is to assess the effects of administration of firibastat (QGC001) 500 mg oral (po) twice daily (bis in die \[bid\]) on blood pressure (BP) over 12 weeks in subjects with uncontrolled primary HTN.

Eligibility Criteria:
Inclusion Criteria:

* Men and women ≥18 years of age at Screening
* Diagnosis of primary HTN for at least 6 months prior to Screening

Exclusion Criteria:

* Known or suspected secondary HTN (eg, hyperaldosteronism, renovascular HTN, pheochromocytoma, Cushing's disease).
* Automated office SBP \>180 mmHg or DBP \>110 mmHg at the Screening or Inclusion Visit (Visit 2, Day 1) and confirmed by a second measurement within 30 minutes to 1 hour.
* Known hypertensive retinopathy (Keith-Wagener Grade 3 or Grade 4) and/or hypertensive encephalopathy.
Safety and Electrical Performances of XFINE Leads

The purpose of the study is to confirm the safety and the electrical performances of the XFINE passive pacing leads, for both right ventricular (RV) straight models and right atrial (RA) J-shape models, up to 12 months follow-up post implant.

All subjects will be followed until 12 months follow-up post implant.

At each follow-up visits (3, 6 and 12 months), electrical performances will be measured and safety will be monitored during the whole study duration.

Eligibility Criteria:
Inclusion Criteria:

1. Any subject newly implanted according to the most recent guidelines from the European Society of Cardiology (ESC) for less than10 days with:

   * a Single Chamber (SR) or a Dual Chamber (DR) pacemaker from Microport CRM S.r.l.
   * any right atrial and/or right ventricular XFINE lead
2. Have reviewed, signed and dated the informed consent

Exclusion Criteria:

1. Included in another clinical study that could confound the results of this study such as studies involving intra-cardiac device
2. Contraindication to a maximum single dose of 310 µg Dexamethasone Sodium Phosphate (DSP)
3. Tricuspid valvular disease or tricuspid replacement heart valve (mechanical or tissue) only for subject with DR pacemaker
4. Active myocarditis, pocket and/or lead infection
5. Age less than 18 years old or under guardianship or kept in detention
6. Life expectancy less than 1 year
7. Known pregnancy, women breastfeeding or in childbearing age without an adequate contraceptive method
8. Be unavailable for the scheduled follow-up associated with this clinical study or refusal to cooperate
Ultra-high Dose Vitamin D for HSCT

This is a pilot study to investigate the effects of achieving adequate vitamin D levels via ultra-high-dose vitamin D supplementation given prior to hematopoietic stem cell transplant on transplant-related complications and inflammatory biomarkers.

Up to 70% of patients have vitamin D deficiency prior to hematopoietic stem cell transplant (HSCT). Patients with sufficient Vitamin D levels (\>50nm/L) prior to allogeneic transplant have significantly better overall survival (OS) and lower rates of rejection and relapse. Vitamin D inhibits Th1 and augments Th2 cell development. Patients who receive vitamin D supplementation during allogeneic transplant have less inflammatory-mediated processes such as chronic graft versus host disease (GVHD) and lower levels of naïve CD8+ cells and CD40 ligand. Multiple studies have raised concern regarding the adequacy of standard and high-dose vitamin D dosing for vitamin D deficiency. A single oral ultra-high dose of Vitamin D given prior to HSCT has been shown to be a safe and well tolerated method of sustaining therapeutic Vitamin D levels for 6-19 weeks.

This is a pilot study to investigate the dynamic changes in inflammatory biomarkers following ultra-high-dose vitamin D supplementation. The study population is patients with total vitamin D level \</=50ng/mL prior to HSCT.

Eligibility Criteria:
Inclusion Criteria:

* Patients who are preparing for HSCT
* If a patient is receiving an autologous transplant, enrollment must occur prior to first transplant in the case that the patient is planned for multiple transplants

Exclusion Criteria:

* Uncorrected hypocalcemia or hypophosphatemia
* Patients in the ICU or on renal replacement therapy
* Patients who have had an allogeneic transplant within the past 12 months prior to enrollment

Enrolled patients with 25OHD level ≤50 ng/mL continue on study
Study to Assess the Bioequivalence Between D961S and Esomeprazole/Buffered Acetylsalicylic Acid (ASA) in Japanese Healthy Male Subjects

The purpose of this study is to assess bioequivalence between D961S and esomeprazole/buffered ASA, safety, tolerability of esomeprazole in combination with ASA and pharmacokinetics (PK) of D961S, esomeprazole and buffered ASA following repeated administration in healthy male Japanese subjects.

A Phase I, Open label, Randomized, Single center, 2 way Crossover Bioequivalence Study Comparing D961S (a Fixed-dose Combination Capsule of Esomeprazole 20 mg and Acetylsalicylic Acid 81 mg) with a Free Combination of Esomeprazole Capsule 20 mg + Buffered Acetylsalicylic Acid Tablet 81 mg After Repeated Oral Administration in Japanese Healthy Male Subjects

Eligibility Criteria:
Inclusion Criteria:

* Healthy Japanese males 20-45 years of age
* Classified as homo-EM
* Negative for HIV, Hepatitis B, Hepatitis C and syphilis
* Body Mass Index (BMI=weight/height2) 19-27 (kg/m2)
* Body weight 50-85 kg

Exclusion Criteria:

* Significant clinical illness from 2 weeks preceding the pre-entry visit to the randomization
* Past or present cardiac, renal, hepatic, neurological or gastrointestinal disease
* Need for concomitant medication in the study
* Past or present NSAIDs induced asthma
* History of bleeding diathesis