cyrilzakka/clinical-trials huggingface dataset:
CLC Parent-Child Emotional Preparation Program

The purpose of this study is to investigate the feasibility of the Nurture Science Program's (NSP) Drop-In group via telemedicine as standard care at Children's Learning Centers (CLC) to prepare preschoolers emotionally for the preschool experience utilizing the Welch Emotional Connection Screen (WECS) Relational Health Toolkit. The behavioral, neurobiological, and clinical insights gained from this project may lead to better treatment of emotional, behavioral and developmental disorders.

The purpose of this study is to test the practicality of mothers and children utilizing the WECS Relational Health Toolkit. The Cuddle and Calm Book, Well Baby Book, mother and child mutual narrative activity card, Bottle of Feelings, Mother's Socioemotional Support Circle, and the WECS for emotional connection make up the preschool WECS Relational Health toolkit. The WECS Relational Health Toolkit provides family-based resources to help mothers and children emotionally connect. The WECS Relational Health Toolkit is designed to create emotional connection and establish mother-child autonomic co-regulation, which helps shape autonomic state and behavior of the mother and child and therefore determines early child development and mother well-being. The investigators will test whether this toolkit can be a positive part of a standard preschool education program. Practicality will be measured through virtual participant attendance, a participant survey, and staff notes. Effects of this program on the emotional connection of mother-child pair will be measured through the Welch Emotional Connection Screen (WECS). Effects on child behaviors will be measured through the WECS-Parent Report (WECS-PR), SDQ, and Survey of Wellbeing of Young Children Baby Pediatric Symptom Checklist (BPSC) or the Preschool Pediatric Symptom Checklist (PPSC) subscales (age-dependent). We will also measure symptoms of depression in the mothers using the Center for Epidemiological Studies-Depression (CES-D) before and after the introduction to the Toolkit. We will also assess differences in developmental progress using the Milestones subscale of the SWYC.

Eligibility Criteria:
Inclusion Criteria:

- Preschool aged children from 0-5 years old and their mothers in CLC programs.

Exclusion Criteria:

- Families that choose not to participate in any data collection procedures but would like to listen in on the session(s).
Clinical Benefit, Safety, PK and PD Study of AT-007 in Pediatric Subjects With Classic Galactosemia

This study is designed to assess the clinical benefit as well as the safety, pharmacokinetics (PK), and pharmacodynamics (PD) (reduction of galactitol levels) of AT-007 in pediatric subjects with Classic Galactosemia (CG).

This is a randomized, double-blind, placebo-controlled study in pediatric subjects with CG. Children with CG ages 2 through 17 years will be enrolled. The study is designed to assess the clinical benefit using validated, standardized Clinical Outcome Assessments (COAs) as well as the safety, PK, and PD (reduction of galactitol levels) of AT-007 in pediatric subjects with CG. The study consists of 2 main parts, Part A and Part B, and an open-label extension (OLE).

Part A is an intra-patient dose escalation evaluating multiple ascending doses (MAD) of AT-007.

Part B is designed to assess the clinical benefits of long-term administration of AT-007 (at the optimum dose identified in Part A) on validated, standardized COAs.

Open-label extension (OLE) is an active treatment extension for patients who received placebo treatment in Part B.

Eligibility Criteria:
Inclusion:

* Male
* Female non-pregnant
* Female non-lactating subjects aged ≥2 to \<18 years.
* Diagnosis of Classic Galactosemia, confirmed by \<1% GALT (galactose-1-phosphate uridyltransferase) enzyme activity in erythrocytes, or a historical record of diagnosis of \<1% GALT enzyme activity.

Exclusion:

* Male/Female with no significant health problems (other than classic Galactosemia)
* No other disease that would preclude participation in the study.
Acute Stroke Advancing Program Using Telemedicine

The purpose is to evaluate the effectiveness and safety profile of telemedicine consultation system in making decision on IV thrombolysis.

The rate of intravenous thrombolysis with tissue-type plasminogen activator or urokinase for stroke patients was extremely low in China. It has been demonstrated that telestroke may help to increase the rate of intravenous thrombolysis and improve the stroke care quality in the local hospitals. The aim of this study is to evaluate the effectiveness and safety of decision making of intravenous thrombolysis via telemedicine consultation system for acute ischemic stroke patients in China This trial network consists of one hub hospital (Xijing Hospital) and 14 spoke hospitals in the remote area of Shanxi Province. The telemedicine consultation system is an interactive, 2-way, wireless, audiovisual system based on portable hardwares--tablet computer or smartphone. Before this study, we have been investigating the usual stroke care quality in the spoke hospitals without the guidance from the hub hospital, which will be used as the historical control of this study. After that, the teleconsultation system will be introduced.

Eligibility Criteria:
Inclusion Criteria:

* Patients older than 18 years and less than 80 years
* Acute ischemic stroke
* Presenting to Emergency Department of spoke hospitals within 4.5 hours of stroke symptom onset
* National Institutes of Health Stroke Scale (NIHSS) between 4 and 25
* Signed consent form by the patient or his relatives

Exclusion Criteria:

* Time of symptom onset unclear
* Unlikely to complete study through 3-month follow-up
A Study to Examine the Efficacy and Safety of Meridia® (Sibutramine Hydrochloride) in Binge-Eating Disorder

The purpose of this study is to examine the safety and efficacy of sibutramine in preventing binge eating episodes. Additionally the study aim is to evaluate the safety and efficacy of sibutramine in reducing body weight in subjects with binge-eating disorder.


Eligibility Criteria:
Inclusion Criteria:

* Participants were men and women
* between the ages of 18 and 65
* with Body Mass Index (BMI) \<45 kg/m2
* who met DSM-IV criteria for BED

Exclusion Criteria:

* Participants were excluded
* for blood pressure \>140/90 mm Hg
* with pulse \>95 beats/min
* history of stroke, narrow angle glaucoma, cardiac disease, seizures, renal or hepatic dysfunction
* use of insulin, medications known to affect body weight, or certain psychoactive medications (monoamine oxidase inhibitors, lithium, SSRIs, opioids)
* current participation in a weight loss program
* surgical treatment for obesity
* bulimia nervosa or purging in the past 6 months
* alcohol or drug abuse in the past 12 months
* current psychiatric condition being treated with a psychoactive agent
* current major depressive disorder
* history of anorexia nervosa, psychosis, bipolar disorder, or suicide attempts
* psychotherapy within the previous 2 months
* Women were excluded if they were pregnant, lactating, or if fertile, not practicing adequate contraceptive precautions
Korean Observational Study to Evaluate the Efficacy and Safety of Anagliptin Switching From Other DPP4is in type2 DM

This study was designed as a non-interventional, single-group, open-label, multicenter observational study for patients with type 2 diabetes in the real world clinical setting.

Subjects will visit the site on the 12th week (Visit 2) and 24th week (Visit 3) from the registration date (Visit 1) to confirm the efficacy and safety.

Primary endpoint

- HbA1c change after 24 weeks treatment

Secondary endpoint

* Average rate of change in HbA1c after baseline
* Ratio of subjects with HbA1c\<7% after 24 weeks
* Ratio of subjects with HbA1c\<6.5% after 24 weeks
* Subgroup analysis by gender, age, BMI, medical history, renal function, liver function, conventional DPP4 inhibitors therapy, concomitant Oral Antidiabetic Drug, duration of disease

Safety endpoint : Adverse Event

Eligibility Criteria:
Inclusion Criteria:

* 19 years of age at the time of consenting
* Understands and is willing to sign an informed consent form (ICF)
* HbA1c≥7.0%
* within 7days before registration, continuing other DPP4is alone or combined therapy for than 8 weeks

Exclusion Criteria:

* Prior exposure to Anagliptin
Dyspnea and Idiopathic Pulmonary Fibrosis

Longitudinal prospective exploratory study on the evolution of dyspnea, in its sensory and affective dimensions, in patients followed for idiopathic pulmonary fibrosis (IPF), between inclusion and a 6-month evaluation

Dyspnea is a multidimensional experience involving a sensory component and an affective component. To better understand this symptom in IPF, this study will describe the different component of dyspnea and their evolution between inclusion and a 6-month evaluation in IPF patients.

There is no strong correlation between the intensity of dyspnea and respiratory function impairments. Innovative techniques demonstrated abnormalities in ventilation variability and pulmonary compliance in patients with interstitial lung disease. These abnormalities could be more relevant to explain dyspnea. The objective of this work is also to assess the link between the different dimensions of dyspnea and respiratory functional parameters, ventilation variability and ventilatory mechanics measured by impulse oscillometry technique.

Eligibility Criteria:
Inclusion Criteria:

* diagnosis of IPF according to ATS/ERS guidelines
* dyspnea at rest (VAS ≥ 1) or on exertion (mMRC ≥ 1)

Exclusion Criteria:

* diffuse interstitial lung disease other than IPF
* other significant chronic pathology that may cause dyspnea: chronic obstructive pulmonary disease, asthma, heart failure, anemia, obesity (non-exhaustive list), except for pulmonary hypertension
Topical Application of PRF Before Radiation Therapy

The primary goal of this study is to observe whether PRP promotes the wound healing before a radiation therapy or not, compared to the natural healing of a tooth extraction socket.

Secondary aim is to monitore the effect on the pain perception.

Head and neck cancer patients are required for a dental checkup before the beginning of the radiation therapy. During this checkup the patients gets a radiological and clinical examination in order to determine any tooth or alveolar bone bound inflammatory processes. Teeth associated to those conditions, or those which are likely to result in any of this, have to be extracted in order to prevent radiation associated complications such as osteomyelitis or further osteoradionecrosis of the jaw. In order to prevent this illness it is essential to not start before the healing of the post-extraction socket has reached a sufficient state, which is usually around 3 weeks post-extracitonem. To facilitate the healing, recent studies have shown an positive effect by applying PRF and a lower pain perception after surgical tooth removal. So far it is not documented for the prevention of a osteoradionecrosis of the jaw.

The patients who receive two or more tooth extractions before radiation therapy can participate in the study. The preliminary diagnosis has to be a head and neck tumor which is planned to be treated with ionizing radiation equally on both sides of the jaw(s). Both teeth have to have a similar size (e.g. molar and molar).

Patient and Doctors a blinded, the site of PRF Application is chosen by random. After surgical removal of the teeth one extraction socket is filled with PRF while the other is left for its natural formation of a blood clot.

During the first 7 days the patient protocols the pain perception and the amount of painkillers used for both sides of the jaw. After 7d, 14d, 21d, 30d, the wound healing is recorded until it reached is end in complete epithelization.

3 Months after the surgery a intermediate clinical examination is performed for early signs of any complication due to the radiation therapy. 6 Months after the surgery a OPG-radiograph will be taken to determine the bone healing comparing the test site and the control site.

Eligibility Criteria:
Inclusion Criteria:

* Head and neck cancer with planed radiation therapy
* Bilateral tooth extraction
* Similar tooth size
* Atraumatic tooth extractions without flap surgery
* Patients age above 18y of age

Exclusion Criteria:

* Prior radiation therapy in the head and neck area
* Prior and current therapy with bisphosphonates or equivalent modern biologics
* Patients during pregnancy or breastfeeding
Effects of Benfotiamine and AGE on Endothelial Function in People With Diabetes

The purpose of the study is to determine whether there are differences in postprandial endothelial function following a high-AGE(Advanced Glycation End-products) meal vs. a low-AGE meal. We also intend to investigate if the therapy with 1050mg Benfotiamine for 3 days protects against the postulated deterioration of endothelial function after a high-AGE meal in people with type 2 diabetes mellitus.

AGEs are a heterogeneous group of compounds formed by the nonenzymatic reaction of reducing sugars with proteins, lipids and nucleic acids. Diet has been recognized as an important exogenous source of AGEs. There is evidence for the implication of AGEs in the pathogenesis of diabetes-related complications, atherosclerosis, ageing processes or Alzheimer´s disease. Although, only little information exists about their effects in humans. The hypotheses of this study are that a high-AGE meal leads to a more important acute vascular dysfunction comparing to a low-AGE meal, and that a 1050mg/day Benfotiamine therapy for 3 days has a protective effect on the endothelial function.

Twenty-one people with type 2 diabetes shall be investigated in a randomized, single-blinded (investigator), cross-over design (please compare design description).

Eligibility Criteria:
Inclusion Criteria:

* type 2 diabetes mellitus
* age: 35-70 years

Exclusion Criteria:

* Heart failure corresponding to NYHA- class III and IV
* history of stroke
* history of myocardial infarction
* unstable angina pectoris
* peripheral artery disease stadium IIb and more
* kidney disease (Creatinine \> 1,8 mg/dl and/or creatinine clearance \<50 ml/min calculated according to the Cockroft formula and/or macroalbuminuria \>200 mg/l)
* malignant diseases
* chronical alcohol consumption (more than 50 ml of highly concentrated alcohol or equivalents / day)
* pregnancy or lactation
* potentially child- bearing women without sufficient contraception (sufficient contraception is defined as the use of a contraceptive method that has an efficiency of over 99% (according to CHMP/EWP/225/02)). A pregnancy test will be performed before the commencement of the study.
* arterial hypotonia (blood pressure\<90/50 mmHg) or arterial hypertonia with systolic blood pressure \>159 mmHg and/or diastolic blood pressure \>99 mmHg
* arterial hypertonia requiring more than three antihypertensive agents
* advanced diabetes complications (subjects must have been investigated with regard to these complications maximum 6 months previously by a specialized physician) such as:
* proliferative diabetic retinopathy
* diabetic neuropathy requiring morphium derivatives
* patients with an acute foot syndrome
* HbA1c \>10 %
* participation to other studies within the previous 3 months
Effectiveness of Commercial Video Games in Subacute Stroke Rehabilitation

Stroke creats dependancy of patients due to various associated impairments. The use of low-cost technologies for neurological rehabilitation may be beneficial for the treatment of these patients.

To determine the effectiveness of a structured protocol using semi-immersive virtual reality with commercial videogames for balance, postural control, functional independence, quality of life and motivation in patients who have suffered an ischemic and / or hemorrhagic stroke in subacute phase and are being treated in a mid-stay hospital.

Patients and methods: Randomized Controlled Trial. Simple blind. Control group will receive conventional therapy (physical therapy and occupational therapy) intervention being based on a task-oriented approach, with five weekly sessions of Physical Therapy and Occupational Therapy with duration of 45 minutes per session.

The experimental group will receive in addition to the above an experimental intervention during 8 weeks providing additional treatment using virtual reality semi-immersive complement is added by means of commercial video games implemented with the Xbox 360º video game console in conjunction with the Kinect device.

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with CVA in subacute ischemic or hemorrhagic type.
* NIHSS scale score less than 20.
* MoCA test with scores equal to or greater than 14 (mild cognitive impairment or absence of cognitive impairment).
* Modified Rankin scale between 0-4.
* Patients with the ability to maintain autonomous sitting and standing with or without aids.
* Patients who have received the information document of the study and signed the informed consent form.

Exclusion Criteria:

* NIHSS scale scores greater than 21 .
* MoCA test with score lower than 14.
* Modified Rankin scale between 5-6.
* Patients without the ability to maintain autonomous sitting.
* Patients who refused to sign the informed consent form.
* Hospital discharge expected at the beginning of the study.
* Patients who at any time have shown worsening of the general state, disinterest or desire to leave the study.

  * Pathologies susceptible to worsening or contraindication with virtual reality devices and commercial video games:

    * Photosensitive epilepsy.
    * Modified Ashworth scale greater than 2.
    * Moderate-severe cognitive impairment.
    * Visual alterations.
    * Non-collaborating patient.
    * Behavioral alterations.
    * Refusal to treatment with VR systems.
    * Presence of other neurological pathologies.
    * Other cardiovascular diseases that contraindicate physical exercise.
  * Visual or auditory, musculoskeletal, bone or joint alterations in acute or chronic phase that could influence the primary pathology.
A Study in Healthy Female Participants to Investigate the Effect of JNJ-56136379 at Steady-state on the Single-dose Pharmacokinetics of Ethinylestradiol and Drospirenone (Oral Contraceptive) and on the Single-dose Pharmacokinetics of Midazolam (Probe Substrate for Cytochrome P450 3A4)

The main purpose of this study is to evaluate the effect of steady-state concentrations of JNJ-56136379 on the single-dose pharmacokinetics (PK) of drospirenone and ethinylestradiol (oral contraceptive \[OC\]) in healthy female participants and to evaluate the effect of steady-state concentrations of JNJ-56136379 on the single-dose PK of midazolam (sensitive probe substrate for CYP3A4) in healthy female participants.


Eligibility Criteria:
Inclusion Criteria:

* Healthy on the basis of physical examination, medical history, and vital signs performed at screening. If there are abnormalities, the participant may be included only if the investigator judges the abnormalities to be not clinically significant or to be appropriate and reasonable for the population under study. This determination must be recorded in the participant's source documents and initialed by the investigator
* healthy on the basis of clinical laboratory tests performed at screening
* must have a normal 12-lead electrocardiogram (ECG) at screening including: normal sinus rhythm (heart rate between 45 and 100 beats per minute \[bpm\], extremes included); QT interval corrected for heart rate (QTc) according to Fridericia (QTcF) less than equal to (\<=)470 milliseconds (ms); QRS interval less than (\<)120 ms; PR interval \<=220 ms
* must have a blood pressure (after the participant is supine for 5 minutes) between 90 and 140 millimeters of mercury (mmHg) systolic, inclusive, and no higher than 90 mmHg diastolic. If blood pressure is out of range, up to 2 repeated assessments are permitted
* must have a body mass index (BMI; weight in kg divided by the square of height in meters) between 18.0 and 30.0 kilogram per square meter (kg/m\^2), extremes included, and a body weight not less than 50.0 kilogram (kg)

Exclusion Criteria:

* any evidence of heart block or bundle branch block
* history of liver or renal dysfunction (estimated creatinine clearance \<60 milliliters per minute (mL/min) at screening, calculated by the Modification of Diet in Renal Disease \[MDRD\] formula12), significant cardiac, vascular, pulmonary, gastrointestinal (such as significant diarrhea, gastric stasis, or constipation that in the investigator's opinion could influence drug absorption or bioavailability), endocrine, neurologic, hematologic, rheumatologic, psychiatric, neoplastic, or metabolic disturbances
* past history of cardiac arrhythmias (example \[eg\], extrasystoli, tachycardia at rest), history of risk factors for Torsade de Pointes syndrome (eg, hypokalemia, family history of long QT Syndrome)
* current human immunodeficiency virus type 1 (HIV-1) or HIV-2 infection (confirmed by antibodies) at screening
* any history of clinically significant skin disease such as, but not limited to, dermatitis, eczema, drug rash, psoriasis, food allergy, and urticaria
LXR and Oocyte Meiosis Resumption

Previous studies in animal model showed clearly that lipid homeostasis influence oocyte meiosis resumption. However Liver X Receptors pathway has never been investigated in human ovocyte

In mice deficient of Liver X Receptor (LXR) genes, the oocytes are unable to resume meiosis. Oxysterols are molecules derived from the cholesterol synthesis pathway. They are ligands of the liver X receptors (LXRs). In human, the LXR signalling pathway has never been investigated in this process. The Investigator propose to analyse in granulosa cells surrounding ovocyte the expression of LXR, their target genes and the enzymes involved in oxysterols synthesis. These granulosa cells are normally retrieved and destroyed 18 hours after sperm insemination of oocytes in a In Vitro Fertilization program. The oocyte meiosis resumption will be considered as positive (Granulosa cell positive, GC+) if a zygote is observed 18 hours after sperm insemination and negative (Granulosa cell negative, GC-) if none zygote appears. Moreover the investigator will analyse the quality of embryo development during 5 days after zygote is formed (normal process of In Vitro Fertilization) . The both populations of granulosa cells (GC+ and GC-) will be compared. The measurements of Liver X Receptor genes and the enzymes involved in oxysterols pathways xill be performed by Reverse Transcription-Polymerase Chain Reaction. The accumulation of lipid in granulosa cells will be measures by oil red staining. By this sudy the investigator will probably find new biological markers of resumption meiosis for women enrolled in In Vitro Fertilization programm. Moreover, data will help to better understand the physiopathology of oocyte meiosis failures.

Eligibility Criteria:
Inclusion Criteria:

* woman aged less 37 years
* included in a IVF program
* tubal infertility
* ovarian stimulation with recombinant FSH
* induced ovulation by recombinant chorionic gonaotrophin

Exclusion Criteria:

* dysovulation
* male infertility
* Ovarian insuficiency