cyrilzakka/clinical-trials huggingface dataset:
Feasibility of Omega-3 Supplementation for Children With Language Impairments

The primary objective of this study is to obtain preliminary (pilot) data regarding the feasibility of using dietary omega-3 supplementation in children with significant delays in language skills; a related secondary objective is to compare adherence to a dosage schedule of two easy-to-take formulations. A tertiary objective of this study is to collect preliminary (pilot) data pre- and post-supplementation to identify potential improvement of skills in a specific area of language development.

HYPOTHESIS Hypothesis 1: Children with early developmental impairment in language will successfully take daily omega-3 fatty acid supplementation for a well-defined period of time (3 months); Hypothesis 2: Children with early developmental impairment will better adhere to administration of a small quantity of slightly fishy-tasting oil than to a large quantity of sweet-tasting paste; Hypothesis 3: A 3 month period of daily omega-3 supplementation will produce some improvement in fast-mapping language skills (a dynamic vocabulary learning skill that has been shown to rapidly improve after exposure to beneficial intervention).

Eligibility Criteria:
Inclusion Criteria:

* children in the chronological age range of 24 to 42 months at the time of initial assessment
* diagnosis of expressive, receptive or mixed language impairment (LI) by a certified Speech-Language Pathologist (S-LP)
* ability to take daily omega-3 supplementation (with caregiver assistance)

Exclusion Criteria:

* children with any organic disease processes or genetic syndromes, or known developmental disorders such as autism that may present with language impairment
* children with hearing impairment
* children who take any non-standard dietary supplements (i.e., apart from multi-vitamins), particularly any omega-3 FA, prior to starting the study
* children whose parents do not have an adequate understanding of English or French
Eosinophils in Human Adipose Tissue

The purpose of this study is to better understand the interactions between the innate immune system, in particular eosinophils (EOS), and adipose tissue (AT) in human health and in disease states such as obesity and insulin resistance.


Eligibility Criteria:
Inclusion Criteria:

* Obesity (BMI\>30 kg/m2).
* Evidence of insulin resistance as defined by hemoglobin A1c \> 5.7%.
* Mayo Clinic patients evaluated by Dr. Rahul Pannala.
* Pursue an endoscopic gastroplasty at Mayo Clinic Arizona in the Gastroenterology department.
* Equal distribution of gender.
* 18 yo older of age.
* BMI\>30 kg/m2.
* Nonsmoker.
* Taking no medication affecting glucose or lipid metabolism.
* No more than 5% change in body weight in the previous 6 months.
* Mostly sedentary (engaging in strenuous exercise (\> 70% max HR) less than 3 times a week).
* Not be receiving corticosteroid therapy.
* Have no history of asthma, COPD or atopic syndrome, or autoimmune disease (Ulcerative colitis, Chron's disease, eosinophilic esophagitis, any rheumatologic disease such as lupus, rheumatoid arthritis, Sjogren syndrome).

Exclusion Criteria:

* \<17 years of age.
* BMI \<30 kg/m2.
* Smoker.
* Taking medication affecting glucose or lipid metabolism.
* Greater than 5% change in body weight within the previous six months.
* Engage in strenuous exercise (\>70% max HR) less than 3 times a week.
* Receiving corticosteroid therapy.
* Have a history of asthma.
* History of COPD or atopic syndrome.
* History of autoimmune disease (Ulcerative colitis, Chron's disease, eosinophilic esophagitis, any rheumatologic disease such as lupus, rheumatoid arthritis, Sjogren syndrome).
Diagnostic Accuracy of Multislice CT Angiography for Acute Chest Pain

The ACUTE CT trial is designed to test whether the assessment of chest structures by high-resolution multislice computed tomography (CT) provides equivalent diagnostic accuracy for patient with acute chest pain or other potential cardiac symptoms as compared to a standard of care evaluation.

Adults at low to intermediate risk of acute coronary syndrome who present to the Emergency Department with symptoms suggestive of cardiac ischemia will undergo a blinded cardiac CT followed by a standard of care (SOC) strategy. Significant coronary artery disease on CT (coronary stenosis \>50%) will be compared to an adjudicated diagnosis derived from clinical data and other diagnostic tests based on the SOC strategy. Costs for the SOC evaluation will be collected and compared to a CT-based evaluation. Patients will be followed for 3 years after enrollment to evaluate prognosis.

Eligibility Criteria:
Inclusion Criteria:

* Low to intermediate risk of angina with a TIMI ACS Risk Score ≤ 4
* chest pain or other symptoms suggestive of ACS within 24 hours
* male ≥30 years or female ≥45 years old
* at least one cardiac risk factor
* no obvious cause for symptoms.

Exclusion Criteria:

* known CAD
* ST segment elevation, new left bundle branch block or dynamic ECG changes
* creatinine ≥1.8 g/dL
* pregnant or lactating female
* hemodynamic or respiratory instability
* ongoing bronchospasm
* known iodinated contrast allergy
* atrial fibrillation or irregular heart rate
Brain, Obesity, Dopamine and You Study

Central dopamine is thought to play a significant role in obesity. In support of this idea, animal studies and one human positron emission tomography (PET) study have found reduced postsynaptic D2-like receptor availability in the striatum in obesity, with lower D2 receptor availability associated with higher weight. In addition, reward sensitivity and hedonic responses, known to be related to dopamine function, have also been implicated in obesity and obesity-related eating behavior. These reports have led to the concept that dopaminergic abnormalities (e.g. reduced D2-like receptors) influence reward sensitivity, leading to altered eating behaviors and eventually obesity. However, there are several critical limitations of the human D2 receptor studies that limit the strength of their conclusions and thus the interpretations and speculations embedded in literature that relies on this work. First, estimates of D2-like receptors in humans have been confounded by potential differences in endogenous dopamine release since the PET ligand (raclopride) used is known to be displaceable from receptors by endogenous dopamine. Second, failure to rigorously screen obese individuals for diabetes confounds conclusions, since diabetes has been independently associated with dopaminergic abnormalities such as reduced D2-like receptors and muted dopamine release in diabetic rats. Finally, no human studies have addressed whether reduced D2-like receptor levels are a risk factor for obesity, a consequence of engaging in obesity-related behaviors or being obese or all of the above.


Eligibility Criteria:
Inclusion Criteria:

* 41 obese adults (BMI 33 kg - 45 kg.)
* 24 lean adults (BMI 18.5 kg - 24.9 kg.)

Exclusion Criteria:

* Subjects who are:

  1. smokers,
  2. pregnant or lactating, postmenopausal,
  3. have diabetes or impaired oral glucose tolerance (fasting blood glucose level of \< 100 mg/dl and a 2 hour post-glucose challenge plasma glucose level of \< 140mg/dl, per ADA criteria; ADA 2004),
  4. significant organ system dysfunction, anemia (Hb \<10 g/dl),
  5. take medications that could influence the study results, any history of dopamine agonist or antagonist treatment (e.g. neuroleptics or metoclopramide),
  6. parkinsonism on exam,
  7. borderline or lower IQ (\<80 full scaled score), or
  8. any psychiatric or neurologic illness (e.g. drug abuse, Parkinson disease, Tourette syndrome, stroke) that could affect the interpretation of the data, compliance or completion of the study will be excluded. Specific psychiatric exclusions are lifetime psychosis, current mania, substance dependence, major depression, social phobia, tic disorders, eating disorders and panic disorder. Dysthymia will not be excluded, but levels of depression will be measured with the BDI for future exploratory analysis.
* Lean subjects will be excluded for being obese in the past (based on maximum BMI not related to pregnancy).
Impact of Multiple Electrolytes Injection Ⅱ and Saline on Hyperchloremia in Patients With Aneurysmal Subarachnoid Hemorrhage:a Pilot Study

The goal of this pilot randomized trial is to compare the effect of Multiple Electrolytes Injection Ⅱand saline on the occurrence of hyperchloremia within 72h of randomization in patients with aneurysmal subarachnoid hemorrhage(aSAH). A secondary aim was to provide data for the design and power of a large-scale, multicenter, randomized controlled trial.

Background:

The isotonic solutions commonly used in ICUs are saline (0.9% sodium chloride) and balanced crystalloid solutions (Ringer's solution, multiple electrolytes injection, etc.). Studies have shown that the lower chloride in balanced crystalloids compared to saline may result in lower risks of hyperchloremia, acute kidney injury and poor clinical outcome in critical ill patients. As a balanced crystalloid, few evidence was found on multiple electrolytes solution II in patients with aneurysmal subarachnoid hemorrhage (aSAH).

Purpose This study aimed to evaluate the security and feasibility of the study. Moreover, compare the impact of multiple electrolytes injection and saline solution on hyperchloremia in aSAH patients.

Method As a pilot trial of a prospective randomized controlled study, patients with aneurysmal subarachnoid hemorrhage randomly assigned to receive saline or multiple electrolytes injection II as maintenance fluid for 3 days during ICU stay.

Eligibility Criteria:
Inclusion Criteria:

* Patients with aneurysmal subarachnoid hemorrhage;
* Expected ICU stay \> 24 hours.

Exclusion Criteria:

* Under 18 years of age;
* Pregnancy;
* Patients at imminent risk for death within 24 hours;
* Patients with a known history of serious cardiovascular, respiratory, kidney, liver, blood, or immune disease;
* Azotemia (BUN \> 200μmol/L), hypokalemia (blood potassium \< 2.5mmol/L), hypocalcemia (blood calcium \< 1.8mmol/L);
* Patients routinely receiving renal replacement therapy (RRT);
* Declined to participate in the study.
Vital Signs Changes During Dental Procedures

The study will evaluate the vital signs changes during 3 different dental procedures performed for the same patient by the same dentist. The patients will be selected randomly and should all be healthy adults.

The aim is to look for any significant changes in the major vital signs (heart rate, respiratory rate, blood pressure, peripheral capillary oxygen saturation (SpO2) and body temperature) during specified dental procedures (scaling, simple restoration, and simple exodontia) and compare the changes between the 3 procedures.


Eligibility Criteria:
Inclusion Criteria:

* The patients included are the ones planned for the following 3 dental treatments in 3 separate visits to done by the same dentist: supragingival scaling without local anesthesia (LA), simple dental extraction under LA, and simple restoration under LA.

Exclusion Criteria:

* Patients under 18 years old
* Patients with a known medical history of any systemic disease like hypertension, diabetes, and bleeding disorders
* Patients with history of cardiac surgery; including pace maker insertion
* Patients on medications
* Smokers, alcoholics, and drug abusers
* Pregnant patients
* Patients with an acute infection with or without fever
* Patients with a preoperative pain score of 4 or more on a visual analogue scale out of 10; where 0 = no pain and 10 = worst pain imaginable
* Patients with 2 or more simultaneous dental procedures per visit
* Patients with undiagnosed hypertension who are found to be hypertensive according to the World Health Organization (WHO) definition on the base-line preoperative readings
Termination of Early Pregnancy in Scarred Uterus With Lletrozole and Misoprostol Compared to Misoprostol Alone

Termination of early pregnancy in scarred uterus with letrozole and misoprostol compared to Misoprostol alone


Eligibility Criteria:
Inclusion Criteria:

* Minimum age of 18 years for mother.

  * Non-viable fetus (missed abortion or blighted ovum) in the 1st trimester of pregnancy evidenced by criteria for diagnosis by TVS .
  * Previous C.S or Myomectomy (1 or more )
  * lack of any maternal diseases such as: heart disease, asthma, history of thromboembolism, cancer, renal failure, and liver diseases.

Exclusion Criteria:

* \* Medical problem in patient

  * Emergency conditions which need intervention .
  * History of allergy to misoprostol or letrozole drugs.
An Adipocyte-Driven Mechanism For Weight Regain After Weight Loss: The Yo-Yo Effect

Almost half of the Dutch population is currently characterized by overweight and obesity. Losing weight is not the problem in obesity treatment, it is the seemingly obligatory weight regain after weight loss: the yoyo-effect. The primary objective of this study is to investigate the association between the weight-loss-induced cellular stress response and the rate of weight regain. The secondary objective is to investigate the differences in cellular stress response and weight regain after rapid and slow weight loss. To investigate this, subjects will receive meal replacements replacing either all or part of the daily meals during the intervention period. THe first group will consume 500 kcal/d diet for 5 weeks while the second group consumes a 1250 kcal/d diet for 3 months, both followed by 1 week normalization and a 2 week strict weight maintenance diet. During the 9-month follow-up period subjects will receive dietary advice according to the Dutch recommendations for healthy eating. The association between the amount of weight regain after the weight loss period and changes in adipokines, parameters of adipocyte metabolism, in vivo adipose tissue metabolism, adipocyte extracellular matrix gene expression profiles, adipocyte stress protein expression and gene polymorphisms in selected genes.


Eligibility Criteria:
Inclusion Criteria:

* Age (years): 20-65
* Body Mass Index (kg/m2): 28-35
* Non-smokers

Exclusion Criteria:

* Subjects using prescription medication, or suffering from diseases or conditions that might influence the outcome of the study: this concerns diseases/medication that influence body weight regulation (malabsorption, untreated hypo/hyperthyroidism, eating disorders, systemic use of steroids, etc.) and obesity-related cardiovascular risk factors (heart disease, systolic and diastolic blood pressures \> 160/100 mmHg, blood glucose \> 6.1 mmol L-1, blood cholesterol \> 7 mmol L-1, blood triglycerides \> 3 mmol L-1)
* marked alcohol consumption \> 21 alcoholic units week-1 (male), or \>14 alcoholic units week-1 (female)
* planned major changes in physical activity during the study to an extent that might interfere with the study outcome as judged by the investigator;
* blood donation within the past 2 months prior to the study
* weight change of \>3 kg within 2 months prior to the study
* psychiatric disease (based on medical history only)
* pregnant or lactating women, or women planning to become pregnant within the next 12 months
* surgically treated obesity
* participation in other clinical studies within the last 3 months
* drug abuse (based on clinical judgment)
* unable to give informed consent
* unable to engage in a low-calorie diet
* unable to lose more then 8% of body weight after weight-loss period
* following a special diet (vegetarian, Atkins or other).
Advice Protocol to Reduce the Level of Exposure to Metallic Trace Elements (ETM)

A French company (Toxseek, France, has developed a scientifically validated screening test based on a capillary determination of pollutants on a 3 cm lock of hair. The results of this screening allow physicians to discuss with their patients the question of environmental health and provide them with personalized behavioral advice in an attempt to eliminate the source of the pollutants identified.The main objective of the study is to assess the effectiveness of behavioral counseling on reducing the level of exposure to metal-type environmental pollutants (MTE) in pregnant women or women planning to have children.


Eligibility Criteria:
Inclusion Criteria:

* Women over 18 years old
* Patient with desire to conceive
* 1st trimester of pregnancy
* Patient having been informed of the study and not opposing the use of the data collected
* Affiliate or beneficiary of a social security scheme

Exclusion Criteria:

* Women under 18 years old
* 2nd and 3rd trimester of pregnancy
* Patient objecting to the use of the data collected
* Protected patient: adult under tutorship, curatorship or other protection legal, deprived of liberty by judicial or administrative decision
The Effect of Sertindole on Sensory Gating and Cognition in Schizophrenic Patients

This study aims to investigate whether the atypical antipsychotic and mixed 5-HT2/D2 antagonist sertindole modulates or improves both subcortical and cortical information processing in schizophrenic patients who had not or insufficiently responded to previous antipsychotic medication. This goal shall be accomplished by investigating the effect of sertindole of both prepulse inhibition of the acoustic startle (PPI) and P50 suppression of auditory evoked potentials in schizophrenic patients. These effects shall be compared to the effect of risperidone and shall also be compared to untreated healthy controls.


Eligibility Criteria:
Inclusion Criteria:

* Schizophrenia according to DSM IV
* Selected and treated in respect of the SPC (20 mg Serdolect max. and population at risk will be excluded)

Exclusion Criteria:

* DSM IV Axis I disorders other than schizophrenia: Substance-dependence (excepting nicotine-dependence and substance-abuse), recent (2 months) DSM IV diagnosis according to DIA-X of a major affective, anxiety disorder, eating-disorder.
* DSM IV Axis II disorders: Lifetime DSM IV diagnosis of personality disorder.
* ECG: QTc-interval \>450 msec.
* Systolic blood pressure \<100 mmHg
* Bradycardia (Hf \< 50/Min) und Arrhythmias
* Hypokalemia or Hypomagnesemia
The Effect of Elemental Diet on Gastric Emptying

In patients with percutaneous endoscopic gastrostomy (PEG) delayed gastric emptying has been speculated as a cause of aspiration pneumonia. Elemental diet may facilitate gastric emptying in PEG patients as compared with regular liquid enteral nutrients, resulting in the prevention of aspiration pneumonia.


Eligibility Criteria:
Inclusion Criteria:

* percutaneous endoscopic gastrostomy patients

Exclusion Criteria:

* history of abdominal surgery
AI in PRImary Care Spirometry Pathways for Diagnosis of Lung Disease (APRIL)

To investigate the feasibility of performing a future real-world randomised controlled trial to determine the clinical effectiveness of ArtiQ.Spiro in supporting diagnostic performance of primary care staff in the interpretation of spirometry

This is a feasibility study for a larger multicentre randomised controlled trial (RCT) assessing the impact of the ArtiQ.Spiro software on diagnostic accuracy, care processes, patient and health economic outcomes.

The primary objective of this study is to assess the feasibility of a future randomised controlled trial designed to evaluate the real-world clinical effectiveness of an artificial intelligence enabled software to support the diagnostic interpretation and quality assessment of primary care spirometry.

Endpoints of the current study will be focused on feasibility and acceptability outcomes.

Secondary objectives of this study are to collect data on potential clinical and health economic endpoints for a future randomised controlled trial designed to evaluate the real-world clinical effectiveness of an artificial intelligence enabled software to support the diagnostic interpretation and quality assessment of primary care spirometry. This will help determine the primary endpoint for a future trial and provide data to support a sample size calculation to ensure that any future trial will have adequate power.

This is a mixed methods randomised controlled feasibility trial. In PICO format:

Population: Individuals with respiratory symptoms referred clinically for primary care spirometry in Hillingdon, Leicestershire, West Hampshire.

Intervention: Local primary care spirometry pathway supported by additional artificial intelligence enabled software (ArtiQ.Spiro)

Control: Local primary care spirometry alone.

Outcomes: Feasibility outcomes with a particular focus on recruitment and retention, and acceptability of intervention and trial design. Clinical outcomes including referrer diagnostic performance and patient health status. Health economic outcomes including health care usage and economic modelling.

All participants will undergo their locally agreed spirometry pathway.

Eligibility Criteria:
Inclusion Criteria:

* Adults ≥18 years, irrespective of sex, ethnicity, disability, sexual orientation, marital status, educational level,
* Referral by GP or nominated representative for primary care spirometry during study period.
* Patients able to provide informed consent.

Exclusion Criteria:

* Age \<18yrs; Absolute contraindication to spirometry.
* Any locally defined exclusion to spirometry.
PF-06651600 for the Treatment of Alopecia Areata

This is a global Phase 2b/3 study to evaluate the safety and effectiveness of an investigational study drug (called PF-06651600) in adults and adolescents (12 years and older) who have 50% or greater scalp hair loss. The study is placebo-controlled, meaning that some patients entering the study will not receive active study drug but will receive tablets with no active ingredients (a placebo). This is a dose-ranging study, investigating 5 different dosing regimens. It will be double-blinded, meaning that the sponsor, the study doctors, the staff, and the patients will not know whether a patient is on active study drug (or the dose) or placebo.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of alopecia areata with no other cause of hair loss
* ≥50% hair loss of the scalp, including alopecia totalis and alopecia universalis, without evidence of terminal hair regrowth within 6 months
* Current episode of hair loss ≤10 years

Exclusion Criteria:

* Other types of alopecia or other diseases that can cause hair loss
* Other scalp diseases that could interfere with assessment of hair loss/regrowth
* Subjects with shaved heads must not enter the study until hair has grown back \& is considered stable by the investigator
* Any previous use of any Janus kinase (JAK) inhibitor