cyrilzakka/clinical-trials huggingface dataset:
Safety and Efficacy of NBI-98854 in Pediatric Subjects With Tourette Syndrome

This is a Phase 2, double-blind, placebo-controlled, randomized withdrawal study to evaluate the safety and maintenance of efficacy of an optimized once-daily (qd) dose of NBI-98854 in pediatric subjects with TS.


Eligibility Criteria:
Inclusion Criteria:

1. Have a clinical diagnosis of Tourette Syndrome (TS)
2. Have at least moderate tic severity
3. Have TS symptoms that impair school, occupational, and/or social function
4. If using maintenance medication(s) for TS or TS spectrum diagnoses (e.g. obsessive-compulsive disorder \[OCD\], Attention-Deficit Hyperactivity Disorder \[ADHD\]), be on stable doses
5. Be in good general health
6. Adolescent subjects (12 to 17 years of age) must have a negative urine drug screen for amphetamines, barbiturates, benzodiazepine, phencyclidine, cocaine, opiates, or cannabinoids and a negative alcohol screen
7. Subjects of childbearing potential who do not practice total abstinence must agree to use hormonal or two forms of nonhormonal contraception (dual contraception) consistently during the screening, treatment and follow-up periods of the study

Exclusion Criteria:

1. Have an active, clinically significant unstable medical condition within 1 month prior to screening
2. Have a known history of long QT syndrome or cardiac arrhythmia
3. Have a known history of neuroleptic malignant syndrome
4. Have a cancer diagnosis within 3 years prior to screening (some exceptions allowed)
5. Have an allergy, hypersensitivity, or intolerance to VMAT2 inhibitors
6. Have a blood loss ≥250 mL or donated blood within 30 days prior to screening
7. Have a known history of substance dependence, substance (drug) or alcohol abuse
8. Have a significant risk of suicidal or violent behavior
9. Have initiated Comprehensive Behavioral Intervention for Tics (CBIT) during the screening period or at baseline or plan to initiate CBIT during the study
10. Have received an investigational drug within 30 days before screening or plan to use an investigational drug (other than NBI-98854) during the study
11. Have previously participated in an NBI-98854 clinical study, except for NBI-98854-1403 or NBI-98854-1501.
12. Have HIV, hepatitis B, or hepatitis C
Acute Health Effects of Short-term Use of E-cigarettes on Pulmonary and Cardiovascular System

The goal of our study was to assess acute, short term respiratory (airflow, FeNO, O2 saturation, exhaled air temperature) and cardiovascular (heart rate, blood pressure) responses to smoking an e-cigarette in exclusive e-smokers and dual users and to compare these effects with responses to smoking a tobacco-cigarette in exclusive tobacco smokers.


Eligibility Criteria:
Inclusion Criteria:

- smoking status (cigarette or e-cigarette smoking)

Exclusion Criteria:

* occurrence of any chronic diseases,
* history of lung conditions (eg.: asthma or bronchial hyperactivity in childhood),
* presence of any allergic diseases,
* medication intake within the last 2 weeks,
* acute illnesses or infections in the last 2 weeks,
* influenza vaccination in the last 2 weeks,
* or current pregnancy or lactation.
Nudges for Opioid Reduction After Major Surgery Trial

This is a prospective pilot trial to evaluate a new electronic medical record based intervention to improve discharges after surgery. The investigators hypothesize that standard discharge medications after surgery will help to optimize opioid prescribing and potentially decrease healthcare utilization in the first 30 days after surgery.

This is a 2-arm parallel randomized trial comparing a new electronic medical record (EMR)-based intervention to usual care after surgery. All patients will receive their usual peri- and intraoperative care. Then, upon discharge, their providers will see the new EMR-based discharge order set (intervention arm) or not (usual care). The investigators hypothesize that standard discharge medication order sets after surgery will help to optimize opioid prescribing and potentially decrease healthcare utilization in the first 30 days after surgery.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients
* Aged 18 and over
* Undergo selected general surgical procedures

Exclusion Criteria:

* Less than 18 years of age
Effect of Mindfulness-based Applied to Hemodialysis Patients on Psychosocial Adaptation

The goal of this clinical study is to adapt mindfulness-based nursing interventions to hemodialysis patients and to investigate their effects on their psychosocial adjustment.

The main question\[s\] it aims to answer are:

Do consciously applied nursing interventions increase the psychosocial adjustment to the disease in hemodialysis patients? Do mindfulness-based nursing interventions increase body and mind awareness in hemodialysis patients? Researchers will compare the experimental and control groups to see if mindfulness-based interventions have an effect on the psycho-social adjustment of hemodialysis patients.

Primary Aims Test the efficacy of an adapted Mindfulness-Based Stress Reduction program to reduce symptoms and improve psychosocial adaption by 6 weeks.

Hypotheses

Primary: The mindfulness-based program increases the psychosocial adjustment to the disease in hemodialysis patients.

Secondary: Mindfulness-based program increases body and mind awareness in hemodialysis patients.

Long-range Goal: To develop evidence-based recommendations for non-pharmacologic strategies that provide psychosocial adaptation relief to hemodialysis patients and are safe, practical, and cost-effective.

Interventions: The Mindfulness-based Applied program includes the curricular content of the standard 6 week. A trained teacher provides instruction in meditation techniques, including body scan, standing, sitting, and walking meditations, and mindful yoga.

The attention control consists of 90-minute online workshops. Audio recordings and written materials related to awareness exercises will be given to the participants at the end of each session so that they can do home practices.

Recruiting Methods:

It will consist of hemodialysis patients receiving service from hemodialysis centers located in a province in the west of Turkey. The sample of the study will consist of individuals who voluntarily agree to participate in the study and who comply with the research criteria.

Data Collection Tools Mindfulness scale: Mindful Awareness Attention Scale (MAAS) The psychosocial adjustment to illness scale (PAIS-SR) Hemodialysis Stressor Scale (HSS)

Study Design: Randomized controlled experimental study

Eligibility Criteria:
Inclusion Criteria:

* Receiving hemodialysis treatment
* Between the ages of 18-65

Exclusion Criteria:

* Patients with acute renal failure
* Current hospitalization, current ongoing chemotherapy or radiotherapy
* Cognitive dysfunction or mental retardation
* Current substance abuse
* Entering hemodialysis due to current psychotropic drug use
Mobility of Elderly Patients When Using the "l'Ergonome" Mobility Device

The main objective of this study is to compare the percentage of patients that successfully pass from a laying position to a sitting position in less than 10 seconds between study arms:

* experimental arm: these patients will use the ERGONOME device to help them sit up
* standard arm: these patients will use traditional hanging triangle bar to help them sit up

The secondary objectives of this study are to compare the following between study arms:

* The average time (s) required to sit up
* How the patient's center of gravity moves in relation to a fixed axis

Eligibility Criteria:
Inclusion Criteria:

* The patient must have given his/her informed and signed consent
* The patient must be insured or beneficiary of a health insurance plan
* The patient must be in stable medical condition (no complications for the last 10 days)
* The patient is incapable of changing from a laying position to a sitting position by his/herself in \<10 secondes, and requires help for such movement
* The patient has a sitting-balance score \> 2/4 (Brun et al 1991: Actual Rééduc Réadaptat: (16):412-7))

Exclusion Criteria:

* The patient is in an exclusion period determined by a previous study
* The patient is under judicial protection, under tutorship or curatorship
* The patient refuses to sign the consent
* It is impossible to correctly inform the patient
* The patient has fractured vertebrae or pelvis
* The patient has a weak heart
* The patient has joint pain localized to the dorso-lumbar region
* The patient has behavioral disorders (opposition, agitation, dementia)
* The patient has a medical prescription for physical restraint by bed rails.
* The patient is incapable of understanding the utility of the proposed technical aide, and using it for rolling and sitting up (notion of compliance).
Study to Evaluate the Long Term Safety and Efficacy of DWP16001 in Patients With Type 2 Diabetes Mellitus

The subjects, having voluntarily agreed to participate in the clinical trial and provided informed consent, will undergo screening tests. During Visit 1 (Screening), subjects meeting the inclusion/exclusion criteria will go through an 8-week stabilization period.

At Visit 1-1, central laboratory tests will be conducted. If the test results meet the criteria for Visit 2 (Enrollment Visit), the subject will be eligible to participate in the clinical trial.

The subjects will receive the investigational drug (DWP16001 0.3 mg) once a day for 52 weeks. They will visit the clinical trial site at weeks 8, 16, 24, 38, and 52 for safety and efficacy assessments during the 52-week treatment period.

The subjects, having voluntarily agreed to participate in the clinical trial and provided informed consent, will undergo screening tests. During Visit 1 (Screening), subjects meeting the inclusion/exclusion criteria will go through an 8-week stabilization period. Throughout this period, subjects will receive concurrent administration of metformin (≥1,000 mg/day) and gemigliptin (50 mg/day), and will have a washout period for other oral antidiabetic drugs.

At Visit 1-1, central laboratory tests will be conducted. If the test results meet the criteria for Visit 2 (Enrollment Visit), the subject will be eligible to participate in the clinical trial.

The subjects will receive the investigational drug (DWP16001 0.3 mg) once a day for 52 weeks. They will visit the clinical trial site at weeks 8, 16, 24, 38, and 52 for safety and efficacy assessments during the 52-week treatment period.

Eligibility Criteria:
Inclusion Criteria:

1. Subjects with T2DM age 19 \~ under 80 years
2. Subjects who have 7% ≤ HbA1c ≤ 11% in screening visit(V1-1)
3. Subjects who have FPG \<270 mg/dl screening visit(V1-1)
4. Subjects who have received a combination of metformin (≥1,000 mg/day) and gemigliptin (50 mg/day) for a minimum of 8 weeks prior to Visit 2 (Enrollment Visit)
5. Subjects who voluntarily decided to participate and provided written consent after being told of the objectives, method, and effects of this study

Exclusion Criteria:

1. Subjects with current or history of hypersensitivity to the IP of this study, metformin or drugs of the same class and their components (e.g., history of hypersensitivity to biguanide or SGLT2 inhibitors)
2. Diabetic ketoacidosis, diabetic coma or precoma within the past year
3. Urinary tract infections or genital infections within
4. Uncontrolled hypertension (SBP \> 180 mmHg or DBP \> 110 mmHg)
5. eGFR \< 45 mL/min/1.73 m2
6. Severe heart failure (NYHA class III/IV
Letermovir Prophylaxis for CMV Infection in Haplo-HSCT Recipients: Single-center Data in China

In the 30 years of fighting CMV infection, the mortality rate among HSCT patients has significantly reduced. Now, the focus is on improving the prognosis of HSCT patients and preventing CMV infection. The emergence of letermovir has provided a new opportunity in this regard. Letermovir, the only drug approved for CMV infection prevention in HSCT patients, works by inhibiting the CMV DNA terminase complex. Phase III studies have shown that letermovir significantly reduces CMV infection and all-cause mortality after HSCT, without increasing myelosuppression or nephrotoxicity. Real-world studies have further confirmed its efficacy in reducing CMV infection rates and antiviral use. Letermovir's global success has not yet been fully realized in China, where it is still in its early stages of use.

Letermovir achieved excellent therapeutic outcomes globally but is still developing in China. It received an implied license for clinical trials in June 2020, followed by marketing applications in November 2020. In December 2021, it was approved by the China National Medical Products Administration (NMPA) for preventing CMV infection and disease in CMV seropositive adult recipients undergoing allogeneic hematopoietic stem cell transplantation (HSCT). Letermovir's commercial launch in China is expected in August 2022. Given that over 90% of the Chinese population is CMV seropositive, determining whether CMV prevention is necessary based solely on serology is insufficient. The growing use of haploidentical stem cell transplantation (haplo-SCT) in China, particularly using the Beijing protocol for GVHD prevention, increases CMV risk. However, limited data exists on the efficacy of CMV prophylaxis for haplo-SCT patients in China. A real-life study assessing the efficacy, resistance, and tolerability of letermovir in this patient group is essential to guide CMV management strategies, particularly for high-risk CMV R+ haploidentical transplant recipients. This prospective study aims to evaluate letermovir's real-life impact on efficacy, resistance, tolerability, and CMV-related morbidity and mortality in China.

Eligibility Criteria:
Inclusion Criteria:

* Haplo-SCT candidate (adult) who has decided to primary transplant and is willing to participate in the study.
* The haplo-SCT candidate (adult) should be CMV seropositive recipients.

Exclusion Criteria:

* CMV-seronegative patient receiving a negative CMV donor graft.
* Patients having active CMV DNAemia at the time of letermovir initiation.
* Patient having signed the informed consent but not grafted.
* Patient recruited in a clinical study on an anti-CMV trial.
Effects of Inhaled Nitric Oxide in the Treatment of Acute Hypoxemic Respiratory Failure (AHRF) in Pediatrics

The purpose of this study is to determine the effect of nitric oxide for inhalation on the duration of mechanical ventilation in pediatric patients with AHRF.

Patients will receive 5-ppm study gas (nitric oxide for inhalation or placebo) until Day 28 or extubation, whichever comes first. The following will be performed / recorded at specified times during the study: arterial blood gases, ventilator settings, methemoglobin, PRISM III score, and patient positioning. Selected centers will also be performing plasma cytokine assays, broncho-alveolar lavage fluid assays and a 6 month follow-up assessment.

Eligibility Criteria:
Inclusion criteria:

* Admitted to pediatric intensive care unit and have the diagnosis of acute respiratory failure
* 44 weeks post conceptional age to 16 years of age
* Oxygenation Index (OI) \>=12 cm H2O/mmHg (as determined by two separate measurement taken 30 minutes to 4 hours apart)
* Recent chest x-ray (within 24 hours) showing at least unilateral infiltrations
* Mechanically ventilated \<= 7 days

Exclusion criteria:

* Immunocompromised
* Received a bone marrow transplant
* Active oncological condition
* Persistent right to left intracardiac shunt
* Cardiovascular surgery within the last 14 days
* Status asthmaticus
* Decision by primary care physician not to provide full support
* Received treatment with nitric oxide for inhalation or other investigational medications within 24 hours prior to study initiation, participating in surfactant trials
* Chronically ventilated
* Pregnant
Evaluation of Harmonicity in Running Gait by the Use of Innovative Techniques of Video Analysis

This study aims to demonstrate the use of a digital video analysis method to evaluate harmonicity of running gait, through an holistic approach.

Furthermore, it explores the association of running gait harmonicity with running velocity and level of training and with running injuries risk .

Aetiology of running related injuries is reported to be multifactorial but still not fully understood. Factors that impede the understanding of the mechanisms and aetiology of injury are the traditional segmental approach to the analysis of running gait and the lack of prospective studies.

A more holistic approach to analysis of movement could permit a more in depth comprehension of the injured state, trough a changing of point of view. This holistic approach is based on the harmonic nature of running gait.

Despite the everyday use of the term "harmonicity" within sporting domains, methods to measure running gait harmonicity is a theme still vaguely explored.

Traditional methods evaluate the movement quality of the whole body based on the motion analysis of specific segments, that are supposed to sufficiently represent the entire body. The search for a method to analyse harmonicity of cyclic movements with a real holistic approach, is therefore still open.

With these aims, an innovative video analysis method has been proposed, based on the measure of the frequency variation of the pixel brightness in the digital video of a cyclic movement.

Eligibility Criteria:
Inclusion Criteria:

* at least one year of running practice
* minimum two day of running/week
* minimum 20 km running/week
* seasonal best on half marathon comprised between 1h20' and 2h00'
* experienced in treadmill running practice
* sport medical certificate

Exclusion Criteria:

* have suffered in the last three months of musculoskeletal disease
* regular practice of sport activities different from running
* acute or chronic osteoarticular diseases or, in general, other pathology limiting physical activities
* use of drugs altering physical activity performance (hypnotic, psychoactive, non-steroidal anti-inflammatory drugs e.g.).
Endometrial Scratching Prior to Controlled Ovarian Stimulation (COH) in Women Undergoing In-vitro Fertilization With Previous IVF Failure

Scratching the linning of the womb before IVF cycle could increase the chances of having a baby after an IVF cycle.

All women with history of RIF (as defined by ESHRE) and who wish to undertake another assisted conception treatment cycle are invited to participate in the trial. Women will be randomised to two arms; one undergoing endometrial sampling and control. Women in the experimental arm will be subjected to endometrial scrapping with Pipelle biopsy catheter two times; on days 21 and 26 of the cycle prior to the IVF index cycle and after initiation of the GnRHa in the long agonist protocol. Women in the control group will undergo a placebo procedure using the uterine sound on the same days of the cycle like women in the intervention group.

Eligibility Criteria:
Inclusion Criteria:

WOMEN WITH PREVIOUS IVF FAILURE UNDERGOING IVF TREATMENT

-

Exclusion Criteria:

* WOMEN\>40 YEARS OLD WOMEN UNDERGOING THEIR FIRST IVF TREATMENT CYCLE
High-definition Transcranial Direct Current Stimulation for Facilitating Hand Function Recovery After Stroke

Transcranial direct current stimulation (tDCS) had recently been shown having feasibility in modulating cortical excitability transiently during motor training in a noninvasive way. The findings support that tDCS and motor practice can positively promote post-stroke motor learning to improve upper-limb motor recovery after stroke. A randomized controlled trial will be conducted with three groups: HD-tDCS, conventional tDCS and sham HD-tDCS. A 10-session training will be provided to evaluate the effectiveness of transient modulation of cortical excitability through tDCS with clinical assessment scores.


Eligibility Criteria:
Inclusion Criteria:

1. Hemiparesis subsequent to first-ever unilateral stroke for more than 6 months;
2. MCP and PIP finger joints can be extended to 180° passively;
3. Sufficient cognition to follow the experimental instructions

Exclusion Criteria:

1. Severe hand spasticity or hand deformity;
2. History of alcohol or drug abuse or epilepsy;
3. Bilateral brain infarcts;
4. Severe cognitive deficits;
5. Comprehensive aphasia;
6. Contraindications to tDCS
A Pharmacokinetic Study of a Single-Dose of Diazepam Nasal Spray in Adult Epileptic Patients Experiencing a Seizure Episode

The purpose of this study is to determine the pharmacokinetics of Diazepam Nasal Spray following a single dose in epileptic patients experiencing a seizure episode.


Eligibility Criteria:
Inclusion Criteria:

* Provide signed informed consent for study participation.
* General good health with no clinically significant unstable abnormalities.
* Diagnosis of epilepsy.

Exclusion Criteria:

* Individuals receiving warfarin (Coumadin®) or dabigatran (Pradaxa®).
* Use of any investigational drug within 30 days.
* Blood or plasma donation within 30 days.
* Not willing or unable to tolerate blood draws.
MCRF Clinical Pilot Study

The purpose of this study is to see if music can help children practice how to manage their emotions.


Eligibility Criteria:
Inclusion Criteria:

* Preschoolers aged 3 to 5 years old enrolled in a Head Start program
* Must be able to speak fluent English
* Must not have previously received music therapy services
* Must regularly attend the Head Start program
* Must have signed parental consent.

Exclusion Criteria:

* Does not meet all inclusion criteria
Dermatological Abnormalities in Beta-thalassemia Major

to study the frequency and pattern of dermatological abnormalities in egyptian childern with beta thalassemia.relationof abnormalities to duration of disease and frequency of transfusion

thalassemia refers to agroup of inherited disease characterized by decreased or absent synthesis of normal globin .skinvdisorders are usually neglected and frequently underdiagnosed among these patients.skin disease specially pruritus and xerosis are observed highly frequently in patients with beta-thalassemia.pityriasis alba is arelatively common skin disorder.the trophic skin changes and leg ulcers occurred after the age of 15 years

Eligibility Criteria:
Inclusio2n Criteria:

* clinical diagnosis of dermatological abnormalities in thalassemic patient. must be on chelator

Exclusion Criteria:

* patient with other hemolytic anemia. childern with any abnormalities prior to the diagnosis of thalassemi