cyrilzakka/clinical-trials huggingface dataset:
CVN058 Effect on Mismatch Negativity in Schizophrenics

This is a phase 1, double-blind, placebo-controlled, 3 period cross-over study to evaluate CVN058 target engagement by measuring auditory evoked potential mismatch negativity (MMN) downstream to 5-hydroxytryptamine receptor 3 (5-HT3) as a pharmacodynamic (PD) marker.

Male and female subjects with schizophrenia, age 18 to 50 years old, inclusive, will be randomized to 1 of 6 treatment sequences (Table 2.a) to receive 1 of 3 dose regimens in each period: a single oral administration of CVN058 (15 mg or 150 mg) or matching placebo. The sequence will determine the order in which a subject will take each of the 3 regimens. Discontinued subjects may be replaced at the discretion of the sponsor so that approximately 20 completed subjects are available for analysis.

The study includes three 1-day treatment periods, with a minimum of 7-day washout, maximum 10 day washout (2 total washouts, after Periods 1 and 2) between periods, and a 7-10 day follow-up call post dosing of the last period. Subjects may be inpatients or outpatients at the discretion of the Investigator.

Eligibility Criteria:
Inclusion Criteria:

* Subjects 18 to 50 years of age, inclusive, at the time of informed consent.
* The subject weighs at least 50 kg and has a body mass index (BMI) between 18 and 40 kg/m2 inclusive at Screening.
* Subject meets schizophrenia criteria as defined by the Diagnostic \& Statistical Manual of mental Disorders, 5th Edition (DSM-V).
* Subjects are on a stable dose of antipsychotic medication(s) for at least 2 months prior to - Screening as documented by medical history and assessed by site staff.
* Subject has a Positive and Negative Syndrome Scale (PANSS) total score of \<95.

Exclusion Criteria:

* Subject currently receiving treatment with any excluded medication or dietary supplement.
* Subjects who have a history of gastrointestinal disease that would influence the absorption of study drug or have a history of any surgical intervention known to impact absorption (e.g., bariatric surgery or bowel resection).
* Subjects having clinical laboratory evaluations (including clinical chemistry, hematology and complete urinalysis) outside the reference range for the testing laboratory, unless the results are deemed to be not clinically significant (NCS) by the investigator at Screening.
* Subjects with moderate to severe substance use disorder, unstable mood or anxiety disorder.
* Subject has a current diagnosis of a significant psychiatric illness other than schizophrenia per DSM-V and is in an acute phase/episode.
* Subject has clinically meaningful hearing loss.
Pilot Testing a Novel Non-invasive Lactate Sensor

To test the efficacy and accuracy of a novel non-invasive lactate sensor in humans undergoing strenuous leg exercise.

The study investigators have designed a novel non-invasive lactate sensor (Lactisense) Lactisense is a planar, flexible, passive, chip-less resonator that can be taped to the skin in order to measure lactate levels in the body. It sends a signal to a nearby reader, which can be translated into a concentration value. It has so far been tested in the lab with good accuracy, but has not been tested on humans. The sensors are designed to use very low energy microwaves that can detect alterations in interstitial and muscle metabolites.

In this study the investigators will test the sensor by having participants perform strenuous exercise (lifting weights) with Lactisense sensors attached to their skin on the top of the thigh and upper arm to evaluate lactate levels at the site of production and systemic levels respectively. The exercise will be performed using a well-established protocol to elevate lactate levels using a leg-press weights machine. The investigators will use a commercial capillary blood lactate meter (via finger prick) to verify whether lactate levels are actually changing in the body, and use Lactisense to try to measure these changes and compare to the values obtained using the commercial capillary blood lactate meter.

Eligibility Criteria:
Inclusion Criteria:

Healthy and physically active volunteers

Exclusion Criteria:

Existing health conditions e.g blood pressure \> 150/95, joint injury that would contraindicate exercise. Individuals who answer "yes" to any of the health condition questions on the PAR-Q questionnaire will also be excluded. As ketones might interfere with the sensor signal, we will exclude anyone with metabolic conditions or following a ketogenic diet.
A Study to Evaluate ALN-HTT02 in Adult Patients With Huntington's Disease

The purpose of this study is to evaluate the safety, tolerability, pharmacodynamics (PD) and pharmacokinetics (PK) of a single dose of ALN-HTT02.


Eligibility Criteria:
Inclusion Criteria

* Has stage 2 or early Stage 3 Huntington's disease (HD), per the Huntington's Disease Integrated Staging System (HD-ISS)

Exclusion Criteria

* Has significant structural or degenerative neurologic disease other than Huntington's Disease (HD) at screening
* Has primary or secondary immune compromise at screening due to infections, medical conditions, or chronic therapies
* Has alanine aminotransferase or aspartate aminotransferase \>2× upper limit of normal (ULN)
* Has an estimated glomerular filtration rate (eGFR) of \<45 mL/min/1.73m\^2 at screening
* Has received an investigational agent within the last 1 year or 5 half-lives (if known)

Note: other protocol defined inclusion / exclusion criteria apply
Observational Prospective Study With Probiotic Supplementation on Infants With FGDI

This observational prospective study evaluates the safety, tolerability and efficacy of a probiotic formula in infants with functional gastrointestinal disorders (FGDI)

Functional gastrointestinal disorders (FGDIs) affect one out of two infants during the fist six months of life and do not have an organic cause. Infant colic, so-called excessive crying syndrome, and functional constipation are among the most common paediatric FGDIs.

FGDIs pathophysiology is multifactorial and may include phycological factors and alterations of the gut physiology including gut microbiota dysbiosis.

Probiotics are proposed as a potential treatment for FGDIs. However, evidence is limited.

A probiotic formula composed of strains Bifidobacerium longum CECT 7894 and Pediococcus pentosaceus CECT 8330 is tested in this study.

Eligibility Criteria:
Inclusion Criteria:

* Patients with gastrointestinal symptoms related to FGID including functional constipation and/or infant colic diagnosed according to Rome IV criteria for clinical purposes.
* ≥ 37 weeks of gestation at birth.
* ≥ 2500 g of birth weight.

Exclusion Criteria:

* Infants with failure to thrive (weight gain \<100 grams/week on average from birth).
* Major medical problems (e. g. immunodeficiencies, developmental problems or genetic abnormalities)
* Gastrointestinal diseases
* Administered with antibiotics for 4 weeks or probiotics for 2 weeks before or during study
The Effect of Preoperative Oral Carbohydrate Administration on Perioperative Hypothermia in Pediatric Patients

Hypothermia that may develop in the perioperative period is associated with many adverse clinical outcomes. In particular, pediatric patients were more susceptible to hypothermia and related complications such as respiratory distress, metabolic acidosis, hypoglycemia, hypoxemia, cardiac disorders, coagulopathy, and wound infection than adults. In this study, the effect of preoperative carbohydrate-rich feeding on temperature regulation in pediatric patients was investigated.


Eligibility Criteria:
Inclusion Criteria:

1. Patients to be operated on by the Department of Pediatric Surgery
2. Being between the ages of 2 and 15
3. Not restricting oral intake
4. ASA I-II-III patients in anesthesia risk score
5. Patients operated between 01.03.2019 and 31.07.2019
6. Not having any communication problems (mental retardation, not knowing Turkish, etc.)
7. Not having gastroesophageal reflux
8. Not having any muscle disease
9. Informed volunteer consent must be obtained
10. Patients for whom emergency surgery is not planned
11. No disease related to the central nervous system

Exclusion Criteria:

1. Pediatric patients outside the 2-15 age range
2. Having limited oral intake
3. ASA IV and above in anesthesia risk scoring
4. Patients operated before 01.03.2019 or after 31.07.2019
5. Patients who may have communication problems with their parents or themselves
6. Patients with gastroesophageal reflux
7. Patients with muscle disease
8. Patients for whom informed voluntary consent has not been obtained
9. Patients who will undergo emergency surgery
10. Patients with diseases related to the central nervous system
PCOS and US Cavitation

Polycystic ovary syndrome (PCOS) is the most common endocrine disorder in women of reproductive age. Women with this syndrome may have infrequent menstrual periods or amenorrhea and excess androgen levels. The ovaries develop numerous small follicles and fail to ovulate on a regular basis, with subsequent subfertility in those women that wish to conceive. Recent research stated that interventions aiming to improve QoL among infertile women with PCOS should focus on alleviating infertility-related stress, especially among women with high BMI. So, the purpose of this study is to investigate the effect of ultrasound cavitation combined with aerobic exercise on menstrual irregularity and infertility related stress in women having PCOS.


Eligibility Criteria:
Inclusion Criteria

All women in this study will be on the following criteria:

* Their ages will range from 20-35 years.
* They will be diagnosed with PCOS by Gynecologist.
* Doesn't receive any treatment for menstrual regularity and fertility during the study.
* BMI above 25kg/m²and less than 35kg/m².
* Waist /hip ratio \<.88.

Exclusion Criteria

Women will be excluded if they have one of the following criteria:

* Skin diseases that prevent the application of cavitation.
* Severe cardiovascular disease.
* Other endocrine disordered (hypothyroidism hyperprolactinemia).
* Patients that who take hormonal treatment within the last 3 months before the study.
Substrate Guided Ablation Therapy for Atrial Fibrillation

Atrial fibrillation (AF), often referred to as an 'irregular heartbeat', is the most common abnormal heart rhythm worldwide. AF may be intermittent (termed paroxysmal) or sustained (termed persistent).Catheter ablation is increasingly being used to manage individuals with AF, however in a significant proportion of cases AF recurs. Such rhythm control interventions are known to be less effective in individuals with persistent AF compared with those with paroxysmal AF. Analysis of heart tissue of individuals with AF show deposition of scar tissue within the heart muscle and this scar tissue promotes abnormal electrical activity that is involved in causing AF. The aim of the proposed study is to evaluate the feasibility and effectiveness of combining conventional pulmonary vein isolation (PVI) during catheter ablation for AF with adjunctive substrate ablation.

This is a single-centre, non-randomized study investigating the feasibility, safety and efficacy of substrate guided ablation in persistent AF.

The study population will be patients between the ages of 18 and 80 with symptomatic, persistent atrial fibrillation (≥1 year) referred for catheter ablation on standard clinical grounds.

The catheter ablation procedure will be performed using the Precision Ensite™ three dimensional mapping system and the Advisor High Density Grid™ mapping catheter (Abbott Medical Incorporated). All patients will undergo conventional pulmonary vein isolation (PVI). As an adjunctive strategy to PVI, low voltage areas (used as a surrogate for atrial scar), as derived from the voltage map, will be targeted for ablation in order to isolate or homogenise these areas of the atrium. A pre-procedural cardiac magnetic resonance imaging scan will be performed in all patients.

All patients will undergo 12 months follow-up with an ECG and ambulatory holter monitoring at 3, 6 and 12 months.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged ≥18 years and ≤ 80 with a clinical indication for persistent atrial fibrillation ablation

Exclusion Criteria:

* Contraindication to anticoagulation
* Thrombus in the left atrium despite anticoagulation
* Cerebrovascular accident within the previous 6 months
* Patients actively participating in another research study will be not be permitted to enrol. Patients who have been involved with other research studies will be able to participate after a minimum period of 3 months after completion of prior study follow up
* Females of childbearing potential must have a negative pregnancy test on the day of the ablation procedure due to the radiation exposure during the procedure
Flortaucipir PET Imaging in the Preclinical, Prodromal and Dementia Phases of Alzheimer's Disease

A Phase 1 study designed to evaluate imaging characteristics of flortaucipir in the preclinical, prodromal and dementia phases of Alzheimer's disease.

The Australian Imaging Biomarkers and Lifestyle Study (AIBL) is a multicenter multidisciplinary study of Alzheimer's disease and aging funded by the Commonwealth Scientific and Industrial Research Organisation (CSIRO) Flagship Initiative, involving research centers in both Victoria and Western Australia. The goal of the A08 protocol was to further investigate the positron emission tomography (PET) imaging results with flortaucipir in patients across the AD spectrum from individuals with subjective memory complaints (SMC) to those with dementia, based on recruitment into the parent AIBL study.

Eligibility Criteria:
Inclusion Criteria:

* Meet all inclusion criteria for the AIBL study protocol, with amyloid PET conducted or planned and MRI available
* Subjects in the MCI and AD groups required to have a reliable caregiver capable of providing information about the subjects' symptoms

Exclusion Criteria:

* lifetime history of schizophrenia, schizoaffective disorder, or bipolar disorder
* history of electroconvulsive therapy
* MRI contraindicated
* claustrophobic or, otherwise, unable to tolerate the imaging procedure
* current clinically significant cardiovascular disease or clinically significant abnormalities on screening electrocardiogram
* history of additional risk factors for Torsades de Pointes
* current clinically significant infectious disease, endocrine or metabolic disease, or pulmonary, renal, or hepatic impairment that the investigator believes would affect study participation
* history of cancer (other than skin or in situ prostate cancer) within the previous 5 years
* current drug or alcohol abuse/dependence
* history of alcohol abuse/dependence with 2 years of the onset of the symptoms of dementia
* females of childbearing potential who were not surgically sterile, not refraining from sexual activity, or not using reliable methods of contraception
Fascia Transversalis Versus Transversus Abdominis Plane Block for Children Undergoing Inguinal Hernia Surgery

Fascia transversalis block in pediatrics undergoing inguinal surgical repair may be simple technique and may give longer effect in reduction of post-operative pain in comparison to transversus abdominis plane block.

All children will be assessed clinically, and investigations will be done to exclude the exclusion criteria mentioned above. Laboratory works needed: complete blood count (CBC), prothrombin time, concentration, partial thromboplastin time Intra-operative management Premedication by intramuscular injection of atropine 0.02 mg/Kg and midazolam 0.2 mg/Kg will be followed by insertion of intravenous (I.V) cannula.

General anesthesia will be induced in supine position under standard basic monitoring of vital signs with inhalational anesthetic using (100%) O2 + Sevoflurane. After deepening of the anesthesia, atracurium 0.5mg/kg and fentanyl 1μg/kg patients will be given, Endotracheal intubation will then follow by appropriate size of endotracheal tube. Volume control ventilation (VCV) 5-7 ml/kg and respiratory rate will be adjusted to keep and PaCO2 levels between 30-35 mmHg using (G.E-Datex-Ohmeda, Avance CS2, USA) anesthesia machine. Anesthesia will be maintained with isoflurane 1 MAC with 50% oxygen in air, and atracurium top-ups of 0.1mg/kg will be given every 30 minutes for neuromuscular blockade.

The Block will be performed using Sonosite S-Nerve Portable Ultrasound and SLAX/13-6 MHZ transducer will be used. 0.4 ml/kg bupivacaine 0.25% will be installed in the block plane. After receiving the block, surgical incision will be allowed to be done after 15 minutes.

Continuous recording of heart rate, blood pressure, will be carried out from the moment of injection at timely intervals intra-operative.

Increase of HR BP. \>30% of baseline Indicates failure of block so fentanyl will be given at 1 mic / kg intra-operative.

Postoperative pain assessment using FLACC score will then follow till 6 hours

Eligibility Criteria:
Inclusion Criteria:

* ASA physical status I-II

Exclusion Criteria:

* Parents' refusal to participate in the study.
* Coagulopathy (i.e. Platelets ≤ 50,000 and/or INR\> 1.5).
* Localized infection at the site of needle insertion.
* Known hypersensitivity or allergies to any of the used drugs.
Oral Hypoglycemic Therapy for Monogenic Variant Carriers of the Joslin Medalist Study

The purpose of this study is to evaluate the efficacy of adding oral hypoglycemic agents (OHA) to existing insulin treatment in monogenic variant carriers of the Joslin 50-Year Medalist Study ("Medalists"), who are characterized by ≥50 years of insulin-dependent diabetes. Our primary objective is to evaluate whether the presence of human leukocyte antigen (HLA) high-risk alleles for diabetes (DR3 and/or DR4) can affect the effectiveness of OHA in these subjects.


Eligibility Criteria:
Inclusion Criteria:

* Existing participants in the Joslin 50-Year Medalist Study
* Residing in the United States
* Capable of giving informed consent
* Known detectable C-peptide \>0.05 ng/mL

Exclusion Criteria:

* Known diagnosis of cancer or active inflammatory disease such as rheumatoid arthritis, lupus, and inflammatory bowel disease
* Recent history of myocardial infarction, angioplasty, bypass surgery, heart failure, angina, stroke, or uncontrolled hypertension\>160/100 during the past 3 months
* Known diagnosis of cognitive dysfunction, dementia or Alzheimer's disease
* Pre-existing liver disease or liver function tests (AST or ALT)\>3x the upper limit of normal
* Pre-existing kidney disease (Chronic Kidney Disease Stage IV and below, or estimated glomerular filtration rate\<45 mL/min/1.73 m2)
* Active use of immunosuppressants
* Recipients of prior islet cell or pancreas transplantation
* Inability to travel due to frailty or health reasons
* Donated blood within the previous two (2) months
Impact of Expired Carbon Monoxide Measurement on Smoking Cessation of Pregnant Women

France is the country of Europe where the prevalence of pregnant women smokers is the highest (35.9% before pregnancy and in the 3rd quarter 21.8% in 2008).

In the investigator's country, among the smokers of early pregnancy with the usual care, only 30% manage to stop during pregnancy.

Maternal smoking during pregnancy is a clearly identified risk factor for the course of pregnancy and the unborn child.

The measurement of carbon monoxide (CO) expired in pregnancy monitoring consultation is part of the recommendations of the consensus conference "Pregnancy and Tobacco" (ANAES, October 2004) and the parliamentary report on smoking by JL Touraine and D. Jacquat (Feb 2012). However, this recommendation has not entered the current practice. The research aims to justify the clinical relevance of this recommendation by demonstrating the positive impact of expired CO measurement on the rate of discontinuation during pregnancy.


Eligibility Criteria:
Inclusion Criteria :

Group of smoking pregnant women (N = 600):

* Pregnant women declaring themselves smokers (at least one cigarette a day).
* Aged at least 18 years old.
* Consultant at Limoges University Hospital before the 24th week of amenorrhea.
* Desiring to be followed for their entire pregnancy at the Children's.
* Desiring to give birth at the Children's.
* Accepting to participate in the study

Group of strictly non-smoking pregnant women (N = 50):

* Pregnant women :

  * Declaring not to be a smoker (to have been totally weaned for more than one year and to have smoked less than 100 cigarettes in her lifetime) before the beginning of the current pregnancy, and
  * Whose partner and family do not smoke, and
  * Not significantly exposed to tobacco (in their professional environment in particular), and
  * With a CO measurement expired \<3 ppm.
* Aged at least 18 years old.
* Consultant at Limoges University Hospital before the 24th SA.
* Desiring to be followed for all their pregnancy and give birth at the Children's Hospital of Limoges.
* Accepting to participate in the study.

Exclusion Criteria :

Group of smoking pregnant women (N = 600) :

* Women with the following social and / or legal criteria: guardianship, curatorship, safeguard of justice.
* Women unable to understand the objectives of the study and the constraints of the protocol.

Group of strictly non-smoking pregnant women (N = 50) :

* Women with the following social and / or legal criteria: guardianship, curatorship, safeguard of justice.
* Women unable to understand the objectives of the study and the constraints of the protocol.
* Women with high blood pressure
* Diabetic woman
* Woman with hypothyroidism