cyrilzakka/clinical-trials huggingface dataset:
Swallowing and Oral Sensory Complaints in Preterm Children

Objective Preterm children face an elevated risk of neurodevelopmental delays and feeding difficulties, necessitating early assessment to support their long-term health. This study investigates swallowing disorders and oral sensory problems in children aged 3-10 years born preterm.

Methods Parents of preterm children completed two validated tools: the Pediatric Eating Assessment Tool (PEDI-EAT-10) to assess swallowing difficulties and the Oral Sensory Profile (Oral-SP) to evaluate oral sensory processing. Data collected included age, gender, gestational age, height, weight, neonatal intensive care unit (NICU) stay duration, feeding methods (e.g., tube feeding, pacifier, bottle use), medical history, and prior interventions like speech-language therapy.


Eligibility Criteria:
Inclusion Criteria:

Inclusion criteria were having a preterm child (born before 37 weeks), aged 3-10 years, being Turkish-speaking, and volunteering.

Exclusion Criteria:

Participants were excluded if they withdrew during data collection.
Phase 1 Study to Evaluate PK, Safety, and Tolerability of HRS-5041 in Healthy Caucasian Male Participants

This is a phase 1, open-label, randomized study. The objective of this study is to evaluate the PK, safety and tolerability of orally administered single-dose HRS-5041 in healthy Caucasian male participants.

The objective of this study is to evaluate the PK, safety and tolerability of orally administered single-dose HRS-5041 in healthy Caucasian male participants.

Eligibility Criteria:
Inclusion Criteria:

1. Healthy Caucasian participants;
2. Ability to understand the trial procedures and possible adverse events, voluntarily participate in the trial,
3. Male aged between 18 to 55 years of age (inclusive) at the date of signed consent form.
4. Total body weight ≥ 50.0 kg, body mass index (BMI) between 19.0 and 32.0 kg/m2 (inclusive) at screening.

Exclusion Criteria:

1. History of receiving any androgen receptor (AR) degraders.
2. History or evidence of clinically significant
3. History of severe abnormal gastric emptying, severe gastrointestinal (GI) disease, or participants who had GI surgeries (except GI polypectomy).
4. Severe infections, injuries, or major surgeries as determined by the investigator within 6 months
5. Any other circumstances (e.g., not suitable for venous access) or laboratory abnormality that, in the investigator's judgment, may increase the risk to the participant, or be associated with the participant's participation in and completion of the study or could preclude the evaluation of the participant's response.
Resident Surveillance of Pediatric Patient Developmental Status at the Two Month Preventive Care Visit

The purpose of this study is to evaluate the efficacy of individualized performance feedback coupled with an educational module in improving resident performance of the physical and developmental examination component of developmental surveillance of infants at the two month preventive care visit.

Many children in the United States have developmental or behavioral disabilities. The American Academy of Pediatrics recently published a policy statement outlining recommendations for developmental surveillance and screening of infants and young children. One of the Academy's recommendations was for inclusion of developmental surveillance during all preventive care visits. The five components of developmental surveillance include elicitation and attendance to parental concerns, maintenance of the developmental history, observation of the child through physical and developmental examinations, identification of risk and protective factors, and documentation of surveillance findings and process (referral, follow-up, etc.).

As a result of concerns expressed by the public regarding accountability in medical education and health care, the Accreditation Council for Graduate Medical Education and the American Board of Medical Specialties mandated that training programs shift to a competency based assessment system. The focus of this study will be to assess the impact of performance feedback (based upon video recorded observation) coupled with an educational module on resident demonstration of competency in regard to the physical and developmental examinations component of developmental surveillance of infants at the two month preventive care visit.

Eligibility Criteria:
Inclusion Criteria:

* Categorical pediatric residents in their second year of training at Children's Mercy Hospitals and Clinics who are scheduled to see infants for a two month preventive care visit.

Exclusion Criteria:

* Preventive care visits for infants who have parents/guardians who do not speak English fluently
* Preventive care visits for infants who have a previously identified genetic or other medical syndrome or developmental delay
Nutrition, Microbiome and Bone Health During Early Life Related to Health

The aim of the study is to establish the longitudinal microbiome and bone trajectories from birth to 3 years, and to evaluate the influence of nutrition on these trajectories.

The main objective of the study is to understand the influence of nutrition and dietary patterns on microbiome and bone trajectories during early life. Specific research objectives are:

* Establish the reference trajectories of gut microbiome maturation index and bone development in healthy Chinese children aged 0-3years
* Assess the impact of early life nutrition on gut microbiome trajectory
* Investigate the influence of microbiome, early life parameters and nutritional parameters on bone health

Eligibility Criteria:
Inclusion Criteria:

* It is important to carefully consider whether a subject is suitable for enrollment into this observational study. Fulfillment of the inclusion and exclusion criteria for each subject will be documented by a qualified member of the investigative staff before any subject is enrolled.

Healthy infants who fulfill all the following inclusion criteria will be included:

1. Having obtained his/her parents' (or his/her legally accepted representative's \[LAR's\]) written informed consent and having evidence of personally signed and dated informed consent document indicating that the subject's parents/LAR have been informed of all pertinent aspects of the study.
2. Subject's parent(s)/LAR is of legal age of consent, is willing and able to fulfill the requirements of the study protocol.
3. For group 1, healthy infants aged ≤ 10 days after birth (date of birth = Day 0).

   For group 2, healthy infants with maximum age of 6 months
4. Full-term gestational birth (≥ 37 and ≤ 42 weeks).
5. Subject's parent(s)/LAR is able to be contacted directly by telephone throughout the study.
6. Both parents registered have a fixed work and / or residence within their jurisdiction.

Exclusion Criteria:

1. Complicated pregnancy (e.g., preeclampsia, gestational diabetes, bowel disease) as assessed by medical interview/ medical record when available
2. Infant's parents/LAR not willing and/or not able to comply with scheduled visits and the requirements of the study protocol
3. Currently participating or having participated in another clinical trial within 4 weeks prior to trial start.
Inguinal Hernia Study Using Biodesign IHM

Aim is to evaluate outcomes of inguinal hernia repair incorporating the standard Lichtenstein (open) repair using Biodesign IHM in a double blind (physician evaluator and patient will be blinded), randomized, prospective comparative study with polypropylene mesh. Primary outcome is recurrence at 1 year. Hernia recurrence will be confirmed via ultrasound or CT scan.


Eligibility Criteria:
Inclusion Criteria:

* 18 years of age
* Diagnosis of Unilateral inguinal hernia repair
* Able to provide written consent

Exclusion Criteria:

* Incarcerated hernia
* Allergic or religious beliefs that disallow porcine material
* Previous hernia repair on the designated hernia site
* Class IV or V anesthesia requirements
* Bowel obstruction
* Peritonitis
* Life expectancy \< 3 years
Study of Depression, Peptides, and Steroids in Cushing's Syndrome

OBJECTIVES: I. Study the relationship between dysregulation of the hypothalamic-pituitary-adrenal (HPA) axis and disorders of mood, vegetative function, and cognition in patients with Cushing's disease.

II. Identify subgroups of patients with Cushing's disease who differ in the presence and severity of the depressive syndrome, and uncover HPA axis dysregulation differences among them using corticotropin-releasing hormone, metyrapone, and dexamethasone challenge testing.

PROTOCOL OUTLINE: All patients receive a psychiatric evaluation at baseline, as well as assessments of plasma adrenocorticotropin, beta lipotropin, beta endorphin, and cortisol, and urinary cortisol. Peptide and steroid assays are performed, alone and in response to corticotropin-releasing hormone, metyrapone, and dexamethasone. Patients are given sleep electroencephalograms at baseline and 1 year following treatment.

A weight maintenance diet is prescribed for all patients.

Eligibility Criteria:
PROTOCOL ENTRY CRITERIA:

* Patients aged 20 to 60 with spontaneous active Cushing's syndrome
* At least 2 weeks since medication with psychoactive effects or influence on cortisol metabolism by hepatic hydroxylating enzyme induction
* Antihypertensives allowed for severe hypertension
* No barbiturates
* No phenytoin
Absorbable Versus Permanent Mesh Fixation Trial in Laparoscopic Midline Ventral Hernia Repair

To compare the use of absorbable tackers versus permanent tack fixation using a polyester large pore mesh in laparoscopic midline ventral hernia repair in a multicenter (Belgian) prospective randomized single-blinded trial.

All patients referred for elective midline ventral hernia repair should be assessed for eligibility and entered in a study log, detailing all included patients during the study period.


Eligibility Criteria:
Inclusion Criteria:

* written informed consent from the adult patient (18 years and older, no maximum age)
* primary, incisional or recurrent midline ventral hernia requiring elective laparoscopic repair

Exclusion Criteria:

* no written informed consent
* hernia defects larger than 10cm diameter in width
* 'hostile' abdomen; open abdomen treatment
* contraindication to pneumoperitoneum
* emergency surgery (incarcerated hernia)
* lateral or parastomal hernia sites
Exercise Training in Patients With Coronary Heart Disease and Type 2 Diabetes

Diabetes mellitus (DM) is an important risk factor in the development of cardiovascular disease, and people with type 2 diabetes have a two- to four-fold increased risk for cardiovascular morbidity and mortality. Physical activity is a well established therapeutic modality for type 2 diabetes. In patients with coronary artery disease (CAD), several clinical trials have shown reduced mortality and reduced progression of atherosclerosis with lifestyle intervention including physical activity. But few studies have investigated the effect of physical training in patients suffering from both diseases.

The aim of this study is to investigate the effect of one year of organized physical exercise in patients with both coronary heart disease and type 2 diabetes on glucometabolic state and progression of atherosclerosis.

The project is a randomized, controlled, open study on physical exercise. 136 patients will be randomized at inclusion to a physical exercise group or a control group, the latter with "normal" follow-up and not discouraged form physical activity. The intervention period will be 12 months, and the physical training program will be developed and conducted in collaboration with Norwegian School of Sport Sciences. The inclusion of patients started summer 2010, the exercise program begins in September 2010 and the practical issues of the study is planned to end during spring 2012.

The main hypothesis is that physical exercise improves the glucometabolic state and reduces progression of atherosclerosis in patients with coronary heart disease and type 2 diabetes, and secondary that physical exercise induces favourable changes in cardiovascular risk factors, use of medication, and co-morbidity associated with diabetes.


Eligibility Criteria:
Inclusion Criteria:

* coronary artery disease
* type 2 diabetes

Exclusion Criteria:

* serious diabetic retinopathy, nephropathy and/ or neuropathy
* other serious diseases like cancer, stroke or MI last three months, unstable angina, decompensated heart failure, serious ventricular arrhythmia, aortic aneurism, serious valvular heart disease, chronic obstructive pulmonary disease GOLD classification IV, deep venous/ pulmonary embolism, ongoing infections, serious musculoskeletal disorders.
* other serious limitations to physical exercise
* pathological exercise stress test warranting further cardiovascular examination
Improvement of Fear-avoidance Beliefs in Patients with Chronic Low Back Pain

Non-specific chronic low back pain is the main cause of public spending on health care and labor, with a prevalence of 10.2%. Its therapeutic management is difficult, with moderate levels of pain and persistent disability over time, influenced by psychosocial factors, such as "fear-avoidance" beliefs. The supervised therapeutic exercise program associated with an educational component is one of the most effective interventions to reduce pain and disability in these patients, but its efficacy seems to be less if there are erroneous beliefs, avoidance attitudes, or fear of physical activity, since it makes it difficult to follow the recommendations. The Back School would address this problem, seeking to improve pain, disability and increase quality of life.

The main objective of this study is to evaluate the influence of the intervention of the Back School of the Hospital Universitario Insular de Gran Canaria in reducing the levels of "fear-avoidance" beliefs in patients with non-specific chronic low back pain.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of non-specific low back pain, age 18-65 years, acceptance of voluntary participation and signature of the informed consent document.
* Acceptance of voluntary participation and signature of the informed consent document.
* Sufficient oral and written knowledge of the Spanish language
* Absence of any other educational intervention at the present time.

Exclusion Criteria:

* Presence or suspicion of red flags
* Cognitive impairment
* Spinal surgery
* Intolerance to physical activity
* Litigation pending resolution
* Pregnancy or postpartum less than 6 months
* Withdrawal from the study (signature of the informed consent revocation document).
Real World Assessment of Clinical Outcome Changes -Including Month of Ramadan-for Dapagliflozin in Management of Type II Diabetes Mellitus

REWARD is an Non Interventional study aims to describe the changes in the clinical outcomes of Type 2 Diabetes Mellitus patients who are treated with Dapagliflozin for a period of one year including the fasting period of Ramadan

REWARD is a multi-center, post-authorization, prospective, open label, non-interventional, real-life, observational, cohort study. The study is to be conducted at 10-15 sites .

Aims to describe the changes in the clinical outcomes over 1 year as follows:

1. Primary Objective:

   To describe the change in HbAlc from baseline as a parameter for blood glucose control.
2. Secondary Objective:

   To describe the changes from baseline in the following parameters:
   * Total body weight.
   * Total cholesterol, LDL-C, non-HDL-C and triglycerides.
   * Systolic and Diastolic Blood Pressures.
3. Other Objective:

   To capture the frequency \& incidence of the following reported adverse events :
   * Hypoglycemic episodes.
   * Volume Depletion.
   * Genital infections.
   * Urinary tract infections.
4. Exploratory Objective:

To describe the combined effect of the hot climate season and fasting Ramadan on the level of total ketone bodies levels in T2DM subjects treated with Dapagliflozin.Description of outcome variables in relation to objectives and hypotheses

Eligibility Criteria:
Inclusion Criteria:

The target population will be selected according to the following inclusion criteria:

* Males and females participants aged 18 years and older who are diagnosed type 2 Diabetic patients- (Based on American Diabetes Association diagnostic criteria (ADA), The ADA defines diabetes as a fasting blood glucose (FBG) of ≥ 126mg/dL or a 2-hour glucose level post oral glucose tolerance test (OGTT) of ≥ 200 mg/dL or HbAJC of ≥ 6.5%).
* Patients treated with Dapagliflozin (as per routine care and in compliance with the locally approved prescribing information) for ≥ 4 weeks and ≤ 16 weeks prior to the recruitment date.
* Patients with CrCl \> 60 ml/min or eGFR \> 60 ml/min/1.73 m2 should be included in trial.
* Patients providing written informed consent.

Exclusion Criteria:

* Patients with contraindications to Dapagliflozin as per the locally approved prescribing information will be excluded from the study.
* If participating in any clinical trial, the subject cannot take part in this study.
* Patients with clinically significant renal, hepatic, haematological, oncological, endocrine, psychiatric or rheumatic disease.
* Patients who don't have a disease with life expectancy under 1 year.
* Patients with CrCl \< 60 ml/min or eGFR \< 60 ml/min/1.73 m2 should be excluded from the trial.
Acceptance and Commitment Therapy in SSRI-Resistant Obsessive Compulsive Disorder

The purpose of this study is to determine whether acceptance and commitment therapy is effective in the treatment of SSRIs-resistant obsessive- compulsive disorder.

The patients who were SSRI-resistant will be randomized to ACT, aripiprazole, or SMT. Independent evaluators, blind to treatment,will evaluate patients during the study.The Yale-Brown Obsessive Compulsive Scale (YBOCS)will be used to measure OCD severity.

Eligibility Criteria:
Inclusion Criteria:

1. age between 18 and 65;
2. no less than 9 years in education;
3. a DSM-IV diagnosis of OCD
4. moderately symptomatic (Yale-Brown Obsessive Compulsive Scale score≥16)
5. received at least two kinds of SSRIs at optimal dose for more than 12 weeks An optimal dose is described as following: clomipramine hydrochloride, at least 225 mg/d;fluoxetine, at least 60 mg/d; paroxetine hydrochloride, at least 60 mg/d; sertraline hydrochloride, at least 200 mg/d; fluvoxamine, at least 250 mg/d; citalopram hydrobromide,at least 60 mg/d; and escitalopram oxalate, at least 40 mg/d.Patients who are unable to tolerate the supposed optimal doses were also eligible if at their maximally tolerated dose.

Exclusion Criteria:

1. with comorbid Axis I psychiatric disorders
2. drug abuse in the last 3 months
3. HAMD\>25
4. too severe to receive ACT or evaluation
5. at high risk of suicide
6. pregnant or prepare for pregnancy
7. with somatic disorder
8. received aripiprazole(≥10mg for 8weeks) or ACT(8 times within 2 months) before
9. treated with no more than one kind of SSRI before
Dose Escalation Study in Patients With Relapsed or Refractory DLBCL and MyD88 L265P Mutation

Recent reports have identified a specific oncogenic mutation L265P of the MYD88 gene in approximately 30% of the patients with the activated B-cell (ABC) type of Diffuse Large B Cell Lymphoma (DLBCL). MYD88 is an initial adapter linker protein in the signaling pathway of the Toll Like Receptors (TLRs), including the endosomal TLRs 7, 8, and 9, for which the ligands are nucleic acids. IMO-8400 is an oligonucleotide specifically designed to inhibit ligand activation of TLRs 7,8, and 9. Recent studies indicate that in the presence of L265P mutation ligand activation of those TLRs results in markedly increased signaling with subsequent increased cell activation, cell survival, and cell proliferation. The scientific rationale for assessing the use of IMO-8400 to treat patients with DLBCL and the L265P mutation is based on laboratory observations that IMO-8400 inhibits ligand-based activation of cells with the mutation and decreases the survival and proliferation of the cell populations responsible for the propagation of the disease.

Eligible subjects will be enrolled and assigned to one of five dose cohorts. Treatment will be administered by subcutaneous injection until progression or intolerable toxicity.

Eligibility Criteria:
Inclusion Criteria:

* Patients must have a diagnosis of Diffuse Large B Cell Lymphoma (DLBCL) of non-GCB subtype, established according to the World Health Organization (WHO) criteria that has been tested for the MyD88 L265P mutation.
* In addition to the above, key inclusion and exclusion criteria are listed below.

  1. Be at least 18 years of age
  2. Agree to use contraception

Exclusion Criteria:

1. Is nursing or pregnant
2. DLBCL of GCB subtype
3. Has BMI \> 34.9 kg/m2
4. Has a positive test for human immunodeficiency virus (HIV-1 or -2) hepatitis C virus (HCV) or hepatitis B surface antigen (HBsAg)
5. Receiving chronic systemic corticosteroid therapy \> 20 mg of prednisone daily
6. Being treated with other anti-cancer therapies (approved or investigational)
7. Has an active infection requiring systemic antibiotics
8. Has had surgery requiring general anesthesia within 4 weeks of starting the study
9. Has heart failure of Class III or IV
A Study to Collect Data on the Treatment Pattern of Xarelto + Acetylsalicylic Acid in the Routine Clinical Practice in Patients Who Are Suffering From a Condition That Narrows the Blood Vessels Supplying the Heart and / or a Condition That Most Commonly Narrows the Blood Vessel in the Legs

The study will focus on effectiveness and safety of rivaroxaban (Xarelto) when given together with acetylsalicylic acid (combination therapy) to patients suffering from coronary artery disease (a condition that affects the blood vessels supplying the heart) and / or peripheral artery disease (a condition that affects the blood vessels of the lower limbs) in the routine clinical practice. The study will help to collect data for prevention cardiovascular death, myocardial infarction (MI), stroke and major adverse limb events in adult patients. The study will focus on information on when and why physicians are starting to treat patients with combination therapy, treatment duration, reasons to discontinue treatment and previous therapies. The study will also investigate treatment outcomes for patients being treated with a combination therapy by their physicians.


Eligibility Criteria:
Inclusion Criteria:

* Adult (≥18 years) patient (except Taiwan ≥ 20 years old).
* Diagnosis of CAD or symptomatic PAD.
* Treatment according to local marketing authorization, rivaroxaban 2.5 mg \[BID\] plus Acetylsalicylic acid (ASA) 75-100 mg \[OD\] started up to 4 weeks before or after the ICF is signed.
* Only in those countries with a marketing authorization of rivaroxaban in the Acute Coronary Syndrome (ACS) indication, patients already on rivaroxaban treatment for ACS for more than 4 weeks, who are subsequently fulfilling criteria for CAD, are also allowed to be enrolled.

Exclusion Criteria:

* Contra-indications according to the local marketing authorization.
* Patients who will be treated with chronic anticoagulation therapy other than rivaroxaban 2.5 mg given for CAD/PAD.
* Participation in an interventional trial.
* Enrolment in the XATOA study.