cyrilzakka/clinical-trials huggingface dataset:
A Research Study to Compare Two Types of Insulin: Insulin 287 and Insulin Glargine in People With Type 2 Diabetes Who Have Not Used Insulin Before

This study compares insulin 287 (a possible new medicine) to insulin glargine (a medicine doctors can already prescribe) in people with type 2 diabetes. Different ways of changing the dose of insulin 287 are also compared. This is done to find the best way to change the dose of insulin 287. Participants will either get insulin 287 that they will have to inject once a week or insulin glargine that participants will have to inject once a day. Which treatment participants get is decided by chance. The study will last for about 5 months (23 weeks). Participants will have 14 clinic visits and 6 phone calls with the study doctor. At 3 of the clinic visits participants will be asked not to eat or drink anything (except for water) in the last 8 hours before the visit. During the study, the study doctor will ask participants to:

* measure blood sugar every day with a blood sugar meter using a finger prick.
* write down different information in a diary daily and return this to the study doctor.
* wear a medical device (sensor) that measure blood sugar all the time for 18 weeks (about 4 months) during the study.

Women cannot take part if pregnant, breastfeeding or plan to become pregnant during the study period.


Eligibility Criteria:
Inclusion Criteria:

* Male or female, aged 18-75 years (both inclusive) at the time of signing informed consent
* Diagnosed with type 2 diabetes mellitus greater than or equal to 180 days prior to the day of screening
* HbA1c of 7.0-10.0% (53.0-85.8 mmol/mol) (both inclusive) as assessed by central laboratory
* Stable daily dose(s) for 90 days prior to the day of screening of any of the following antidiabetic drug(s) or combination regime(s):

  1. Any metformin formulations greater than or equal to 1500 mg or maximum tolerated or effective dose (as documented in subject's medical records)
  2. Free or fixed combination therapy: Metformin as outlined above plus/minus DPP4i with or without SGLT2i is allowed:

  i) DPP4i (greater than or equal to half of the maximum approved dose according to local label or maximum tolerated or effective dose) ii) SGLT2i (greater than or equal to half of the maximum approved dose according to local label or maximum tolerated or effective dose )
* Insulin-naïve. However, short term insulin treatment for a maximum of 14 days prior to the day of screening is allowed, as is prior insulin treatment for gestational diabetes
* Body mass index (BMI) below or equal to 40.0 kg/m\^2
Interferon Gamma-1b by Inhalation for the Treatment of Patients With Cystic Fibrosis

The purpose of this research study is to evaluate the safety and effectiveness of Interferon gamma-1b (IFN-g 1b) on lung function when given to patients with cystic fibrosis by inhalation (breathed into the lungs) three times a week for 12 weeks.

The FDA has not approved Interferon gamma-1b for use with cystic fibrosis patients, which is the condition being examined in this study.


Eligibility Criteria:
Key inclusion criteria:

* At least 12 years of age
* Diagnosis of cystic fibrosis with mild to moderate pulmonary impairment
* Must be receiving ongoing chronic treatment with TOBI (inhaled tobramycin) OR not receiving ongoing chronic treatment with TOBI and no use of TOBI or other inhaled antibiotic within 4 weeks prior to study drug administration·
* Other specific diagnostic indicators of CF and other factors must meet minimum requirements.
National Survey of the Impact of COVID-19 Pandemics

COVID-19 pandemics have changed extensively the lives around the world. Although most physicians of obstetrics and gynecology have no critical role in the frontline against COVID-19 pandemics, their work, research and education activities still underwent great changes. The primary aim of this study is to analyze change of workload during the COVID-19 pandemics in physicians of obstetrics and gynecology in China. A customized questionnaire will be delivered by the social software WeChat to the specific hospital which has been randomly sampled, and all physicians of Obstetrics and Gynecology in this hospital will fill the questionnaire anonymously.

A random sampling will be performed in all 32 provinces, municipality or autonomous regions in the mainland of China. It is assumed that acceptable 95% confidence interval is P±4%, and the sample size under the condition of simple random sampling is 600 persons. If the homogeneity is set as 0.15 or 0.2, and each population (unit) has 10 or 15 persons accepting survey, we will achieve a design effect of 2.35 to 3.80. If we choose the design effect of 3, the sample size of every level needs is 1800. Considering 10% population refusing to be surveyed, in all mainland of China, three levels of hospitals will include at least 6000 physicians who accept survey.


Eligibility Criteria:
Inclusion Criteria:

* Aged 18 years old
* Belonging to and registered at specific hospital
* Active employment in obstetrics, reproduction, or gynecology
* Signed an approved informed consents

Exclusion Criteria:

* Not meeting all the inclusion criteria
* Not completing the whole questionnaire
Social Interactions: Ocular Explorations and Pupillometry in Autism

The primary objective of this work will first to characterize in typical childhood, visual exploratory behavior and pupillary response associated with salience of human social stimuli (faces and body movements), and then to evaluate these markers in children with autism.

The second objective of this work will be to achieve in a population of children with autism a longitudinal evaluation of these markers during development and therapeutics.

Patients with autism have significant social difficulties and communication alterations. It has been shown in these patients difficulties to understand some clues indispensable to social relations, for example, faces and their emotions and motion of human bodies. The faces and human movements are an important source of information helping to interact with others. Understanding the intentions of the others through facial expressions and gestures can help them to adapt their behavior and their interactions. While in healthy subjects, faces and human movements receive special attention, autistic patients seem to pay less attention to this kind of social stimuli. It has already been shown that children and healthy adults spend more time looking at faces and human movements (relative to objects), whereas the opposite behavior is observed in patients with autism. Studying gaze behavior seems to be essential for progress in the understanding of autism pathology. Eye-tracking systems allow to measure precisely what a subject looks on a picture. Moreover, eye-tracking systems permit the measurement of the pupil size which variations are correlated with cognitive processes. The objective of this study is to analyze the ocular behavior (ocular scan path and pupil diameter) of young patients with autism when viewing faces and human movements and to compare these measurements with those of chronologically age-matched healthy children. This work will identify attentional problems concerning exploration of human faces and movements that can be related to their social difficulties. These disorders should be manifested by an atypical ocular scan path and by changes in pupil variation in response to face and human motion. Then to follow the evolution of these indices will allow to evaluate the effect of therapies. These results will highlight new data essential to understanding disorders of social relations and to better adapt rehabilitative strategies.

Eligibility Criteria:
Inclusion Criteria:

* For autistic children, diagnosis of autism spectrum disorders according to DSM IV-TR and ADI / ADOS criteria ; normal or corrected vision; no nervous system disease
* For healthy children, normal schooling and normal or corrected vision
* For all, parental consents

Exclusion Criteria:

* psychotropic treatment
Non-interventional, Post Marketing Surveillance Study of Xultophy™ (Insulin Degludec/Liraglutide) to Evaluate Long Term Safety and Efficacy in Patients With Type 2 Diabetes Mellitus in Routine Clinical Practice in India

This study is conducted in Asia. The aim of this study is to evaluate long term safety and efficacy in patients with type 2 diabetes mellitus in routine clinical practice in India.


Eligibility Criteria:
Inclusion Criteria:

* Informed consent obtained before any study-related activities. Study-related activities are any procedures that are related to the recording of data and determining the suitability for the study according to the protocol. Some specific historical data collected before informed consent is obtained can be used as baseline data (HbA1c, FPG/FBG and others)
* The decision to initiate treatment with commercially available Xultophy™ has been made by the patient/Legally Acceptable Representative (LAR) and the treating physician before and independently from the decision to include the patient in this study
* Male or female, age at least 18 years at the time of signing the informed consent
* Patients diagnosed with type 2 diabetes mellitus
* Patients who are scheduled to start treatment with Xultophy™ based on the clinical judgement of their treating physician

Exclusion Criteria:

* Known or suspected hypersensitivity to Xultophy™, any of the active substances, any of the excipients or any related products
* Previous participation in this study. Participation is defined as signed informed consent
* Mental incapacity, unwillingness or language barriers hindering adequate understanding or cooperation
* Females who are pregnant, breast-feeding or intend to become pregnant within the following 12 months
* Patients who are participating in other studies or clinical trials.
* Any disorder which in the opinion of the Physician might jeopardise subject's safety or compliance with the protocol
Assessment of Plasma Lactate in Non-cardiac Surgery Monitoring by Transthoracic Echocardiography

The study is a clinical trial, prospective and randomized of 60 patients of both genders, aged between 18 and 80 years, underwent major abdominal surgery. This study aims to compare plasma lactate levels in patients underwent major abdominal surgery (colectomy, gastrectomy, esophagectomy, pancreatectomy, Wertheim Meigs, liver and spleen surgeries) monitored by echocardiography or by conventional techniques (mean arterial pressure , Central venous pressure).

The study is a clinical trial, prospective and randomized of 60 patients of both genders, aged between 18 and 80 years, underwent major abdominal surgery. This study aims to compare plasma lactate levels in patients underwent major abdominal surgery (colectomy, gastrectomy, esophagectomy, pancreatectomy, Wertheim Meigs, liver and spleen surgeries) monitored by echocardiography or by conventional techniques (mean arterial pressure , Central venous pressure).

The investigators expect to observe a decrease in plasma lactate levels in patients submitted to echocardiographic monitoring when compared to patients submitted to conventional monitoring. In this way, to demonstrate that the routine use of transthoracic echocardiography in patients submitted to large surgery improves the clinical outcomes of these patients and presents a lower hospital cost.

The surgical indication will obey the criteria of the Federal University of Juiz de Fora surgery service, after clinical examination and routine preoperative laboratory tests (complete blood count, complete coagulogram, plasma sodium, potassium Plasma urea and plasma creatinine, blood glucose and liver function test), resting electrocardiogram and chest X-ray. All patients who agree to participate in the study will sign an Informed Consent Term in the preanesthetic evaluation (Appendix 1).

Patients will be computer randomly form by the GraphPad Prisma® program into two groups with 30 patients:

Conventional Group, Transthoracic Echocardiogram Group, All survey data will be noted in the Protocol Data Sheet (Appendix 2). Patients will be anesthetized by the researcher Dr. Marcello Fonseca Salgado Filho, who will also be responsible for performing the intraoperative TTE examination.

Eligibility Criteria:
Inclusion Criteria:

ages between 18 and 80 years.

* both genders
* Large abdominal surgeries
* Elective surgeries

Exclusion Criteria:

* Emergency surgeries

  * Surgeries of the abdominal aorta
  * Ejection fraction \<30%
  * Blood creatinine levels\> 2.0mg / dl
  * Glycemia\> 200 g / dl
  * Do not agree to participate in the study
  * Bowel obstruction
  * Sepsis
  * Bilirubin\> 300 g / dl
  * Alcoholism
Urodynamic Study and Stress Incontinence

A trial to answer the debatabal question about the role of urodynamic study in surgical treatment for stress urinary incontinence.

group of patients complaining of stress urinary incontinence and candidate for sling surgery were randomaly divided into 2 groups either to have urodynamic study before surgery or not.

Eligibility Criteria:
Inclusion Criteria:

* stress urinary incontinence

Exclusion Criteria:

* mixed incontinence
* recurrent cases
Validation of the Concept of the Autoantibodies Directed Against the Neuropeptides Involved in Food Intake Regulation on the Incidental Cases of Eating Disorders

This study should lead to the validation of the concept of the autoAc directed against the neuropeptides involved in food intake regulation.

Eating disorders are a public health issue. It has been recently reported the importance of immune system modifications in eating disorders physiopathology, involving autoantibodies directed against neuropeptides regulating food intake. A recent study of laboratory INSERM 1073 showed the existence of an intestinal bacterial protein exhibiting structural similarities with α-MSH: ClpB. The autoAc directed against the latter also react with α-MSH because of these similarity of structures, thus leading to a potential digestive origin of these autoAc. To consolidate this new etiopathogenic assumption, a large clinical study is necessary with analysis of patients autoAc profiles. a monocentric study with inclusion of 240 patients over 2 years and 80 healthy volunteers is proposed.

This study should lead to the validation of the concept of the autoAc directed against the neuropeptides involved in food intake regulation. Nutritional modulations (probiotic, amino-acid...) could constitute an interesting therapeutic perspective in the future.

Eligibility Criteria:
Inclusion Criteria:

Patients with eating disorders

1. 18 Years and older
2. first clinical visit in nutrition department of CHU de Rouen for eating disorders
3. anorexia nervosa, hyperphagia or bulimia according to the classification DSM-V
4. social security Affiliation
5. Patient who signed the MEC approved informed consent

Volunteers

1. 18 Years to 60 Years
2. body mass index ≥ 18,5 kg/m2 and ≤ 24,9 kg/m2
3. negative SCOFF test
4. No active and history of eating disorders
5. social security Affiliation
6. volunteer who signed the MEC approved informed consent

Exclusion criteria:

Patients with eating disorders

1. No anorexia nervosa, hyperphagia or bulimia according to the classification DSM-V
2. Adults under legal protection or under safeguard of justice or administrative decision
3. Pregnancy

Volunteers

1. Active or history of eating disorder
2. Adults under legal protection or under safeguard of justice or administrative decision
3. Pregnancy
Reduction Bleeding in Laminectomy With Double Doses of Tranexamic Acid

Tranexamic acid has benn widely used to reduce perioperative bleeding in several operations such as cardiac surgery, liver transplant and joint arthroplasty with good results. Few studies in laminectomy had conflicting results and varying in doses. The objective is to compare perioperative bleeding in major laminectomy between patients receive doubles doses of tranexamic acids (15 mg/kg and 15 mg/kg) with who receive pacebo (0.9% NaCl).

78 patients undergoing major laminectomy (with instrumentation or equal or more than 3 levels laminectomy) will be enrolled. We exclude patients who age over 65, anemia, allergy to tranexamic acid, history of deep vein thormbosis (DVT), ischemic heart disease (IHD), pulmonary embolism (PE), strokes, liver disease, chronic kidney disease with creatinine \>2.0 mg/dl, and coagulopathy. After randomization, before induction and 3 hour after the first dose, patients will receive study drug or placebo intravenously. The standard anesthesia and monitoring will be tha same for all of the patients. Perioperative mild hypotensive technique will be used with the mean arterial pressure more than 60 mmHg and nearly the end, the blood pressure will be back to normal for the bleeding check. Hematocrit will be monitored at the begining and every two hours. Blood will be given if the hematocrit is below 30%. The perioperative fluid will be managed by anesthesiologist who will not know the patients' groups. The next morning, the hematocrit and blood creatinine will be checked and if the hematocrit is lower than 30%, blood will be given. Perioperative blood loss, total fluid and blood transfusion within 24 hours will be recorded. If there are any suspected symptoms and signs of DVT, angina, CHF, PE, strokes or other complications, the necessory investigations will be done for the definite dignosis and the appropriate treatment will be started immediately.

Eligibility Criteria:
Inclusion Criteria:

* has laminectomy with instrumentation or equal or more than 3 levels laminectomy
* age 18-65 years
* ASA 1-3
* elective operation

Exclusion Criteria:

* allergy to tranexamic acid
* anemia (Hb\<12 g/dl in female or Hb\<13 g/dl in male)
* history of CVT, IHD, PE, strokes
* liver disease
* chronic kidney disease with creatinie\>2.0 mg/dl
* receive anticoagulant or coagulopathy
Pilot Mobile Mindfulness Training (mMT) for People in Medication Treatment of Opioid Use Disorder (MOUD)

The goal of this clinical trial is to learn if mobile mindfulness training can help people in treatment for opioid use disorder. The main questions it aims to answer are:

* Will people with opioid use disorder and childhood trauma use mobile mindfulness training?
* Will mobile mindfulness training help people with opioid use disorder and childhood trauma have decreased markers of psychological stress?

Participants will:

Be given access to mobile mindfulness training and encouragement to use it daily for 30 days.

Keep a diary of how often mobile mindfulness training is used. Visit the clinic four times to measure stress levels, including written rating scales, blood work, and heart rate tests.


Eligibility Criteria:
Inclusion Criteria:

* Clinically diagnosed with Opioid Use Disorder (per DSM5 criteria)
* Currently enrolled in treatment for Opioid Use Disorder at a clinic affiliated with UKHealthCare or University of Kentucky
* On a stable dose of buprenorphine, buprenorphine/naloxone, or naloxone (i.e., at least 30 days post-induction and on a stable dose for 30 days)
* Able to read and understand English
* Have a history of childhood trauma as measured by the Adverse Childhood Experiences scale and/or Childhood Trauma Questionnaire.

Exclusion Criteria:

* Currently taking a beta-blocker, calcium-channel blocker, antiarrhythmic, corticosteroid, or immune modulator medication
* Uncontrolled acute or chronic health conditions (e.g., active infections, autoimmune conditions, cancer undergoing active treatment)
* Current or expected pregnancy
* Current mindfulness practice (i.e., participant reports practicing mindfulness for 10 minutes or more per week)
* Primary psychotic illness
* Diagnosis of a disorder known to interfere with neurocognitive function (e.g., estimated full scale IQ below 70 or diagnosis of dementia)
Mother-Infant Psychoanalysis Project of Stockholm (MIPPS)- Follow-up at 4½ Years

An RCT comparing mother-infant psychoanalytic treatment (MIP) with Child Health Centre care in cases of mother-infant relationship disturbances was performed on 80 cases in Stockholm 2005-2008. The infants were \< 18 months at interview #1. At 6 months follow-ups, significant effects were shown in favour of MIP on maternal sensitivity (EAS), depression (EPDS), and relationship qualities PIR-GAS). This study will evaluate effects at a child age of 4½ years; to evaluate the longterm effects of MIP and CHild Health Centre care, and to better validate results on children who now have reached an age where they can participate more actively in evaluations.

DESIGN

The 71 dyads remaining from the MIPPS-01 study will be interviewed when the children have reached 4½ years, in order to evaluate the long-term intervention effects of MIP treatments delivered by psychoanalysts at the Infant Reception Service of the Swedish Psychoanalytic Society and of the usual treatments of infants and children in Sweden implying contact with nurses at Child Health Centres.

INSTRUMENTS

Mother-report questionnaires; the Ages and Stages Questionnaire:Social-Emotional (ASQ:SE; Squires et al., 2002), the Edinburgh Postnatal Depression Scale (EPDS; Cox et al., 1987), the Swedish Parental Questionnaire (SPSQ; Östberg et al., 1997) and the Strengths and Difficulties Questionnaire (SDQ; Goodman, 1997).

Independently rated video-taped mother-child interactions: the Emotional Availability Scale (EAS; Biringen, 1998).

Assessment of the general functioning of the child : Children's Global Assessment Scale (Shaffer et al 1983).

Assessment of the child's cognitive functioning: Wechsler Preschool and Primary Scale of Intelligence (WPPSI, Wechsler, 2005).

Assessment of the child's social and emotional functioning: Story Stem Attachment Profile (SSAP, Hodges et al., 2003). Machover Draw-a-Person Test (Blomberg \& Cleve, 1997)

Eligibility Criteria:
Inclusion Criteria:

* The mother expressed significant concerns about one or more of the following domains: herself as a mother, her infant's well-being, or the mother-baby relationship (this was operationalized as a score \< 80 ("perturbed relation") on the PIR-GAS or, alternatively, \> 2.5 on the SPSQ).
* Infant of any gender, age below 18 months.
* Duration of worries exceeding two weeks.
* Domicile in Stockholm.
* Reasonable mastery of Swedish.

Exclusion Criteria:

* Maternal psychosis according to DSM-IV, to an extent precluding collaboration.
* Substance dependence according to DSM-IV, to an extent precluding collaboration.
Susceptibility of Cardiorespiratory Responses to Ozone During Cycling Exercise

Ground level ozone (O3) is a common airborne pollutant that is well recognized to cause negative respiratory symptoms and impair pulmonary function. The proposed study aims to have participants perform submaximal and maximal cycling exercise protocols exposed to both O3 and room air in a crossover design to evaluate how ventilatory patterns, pulmonary function, development of symptoms, and cycling performance are impacted by O3 exposure. Additionally, the investigators look to compare responses between O3 at rest and during exercise to predict which subjects may be most susceptible to adverse response, as considerable interindividual variability exists.


Eligibility Criteria:
Inclusion Criteria:

* Healthy males between the age of 18 and 50
* Currently training and/or competing in endurance sport
* VO2max \>60 ml/kg/min
* Able to communicate sufficiently using the English language

Exclusion Criteria:

* History of smoking
* Upper respiratory tract infection within the last 4 weeks
* Presence of any chronic respiratory disease