cyrilzakka/clinical-trials huggingface dataset:
Efficacy and Outcomes of a Non-Pharmacological Intervention for Neonatal Abstinence Syndrome

The purpose of this study is to examine the efficacy of a specially-constructed crib mattress that delivers gentle vibrations (stochastic vibrotactile stimulation) as a complementary, non-pharmacological intervention for treating drug withdrawal in newborns exposed to opioids in utero.

This study will test the therapeutic efficacy of stochastic vibrotactile stimulation (SVS) for reducing withdrawal symptoms, pharmacological treatment and hospitalization, and for improving neurobehavioral developmental outcomes in opioid-exposed newborns.

Candidates at-risk for NAS due opioid exposure in utero will be identified to investigators by medical caregiver and/or prescreened using HIPAA Waiver for recruitment (maternal-prenatal; infant-postnatal). Infants will be randomized into either SVS (complementary to standard of care) or Treatment as Usual (TAU), restricted by equipment (mattress) availability. Infants will be enrolled and assigned to a condition within 48 hours post birth and participate throughout hospitalization. Infants assigned SVS will receive daily intervention of continuous intervals of SVS throughout hospitalization using a specially constructed crib mattress that delivers gentle vibrations at preset intervals.

Specific Aim 1. Determine the efficacy of SVS as a non-pharmacological therapy complementary to standard of care for reducing severity and duration of opioid withdrawal in newborns compared to TAU alone. Quantify clinical variables: NAS severity, treatment days, days in hospital, velocity of weight gain, cumulative morphine dose.

Specific Aim 2. Compare neurobehavioral outcomes in fetal drug-exposed infants between infants who received SVS and those who received TAU. Longitudinal outcomes assessment at 6-months and 1 year to test whether early intervention with SVS compared to standard care improves physical, social, emotional and cognitive development.

Eligibility Criteria:
Inclusion Criteria: Eligible subjects are infants currently in the NICU or Newborn Nursery at University of Massachusetts Memorial Hospital or at Magee Women's Hospital of UPMC and:

* Full-term infants (≥37 wks gestational age)
* Newborns at risk for NAS due to opioid-exposure in utero
* At-risk infants will be infants who present with confirmed meconium and/or urine toxicology report and/or documented medical record for opioids (e.g., methadone, buprenorphine/subutex, oxycodone, heroin); may also have prenatal exposure to benzodiazepines, barbiturates, amphetamines, cannabinoids, alcohol, nicotine and/or caffeine.

Exclusion Criteria: Eligible infants meeting the inclusion criteria above will be excluded from participation in the study if he/she:

* Born less than \<37weeks.
* Has a clinically significant congenital abnormality
* Has a clinically significant fetal anomaly
* Has hydrocephalus or intraventricular hemorrhage \>grade 2
* Has a seizure disorder not related to drug withdrawal
* Has a clinically significant cardiac shunt
* Has anemia (hemoglobin\<8g/dL)
* Requires mechanical respiratory support
* Has MRSA or infection at time of the study
RCT Gum Chewing on Bowel Function After Abdominal Surgery in Children

Traditional postoperative care has been challenged recently to improve and speedup recovery (including the return of bowel function) such that patients can be discharged to home more quickly. This approach includes earlier mobilization of the patient, and introducing solid food sooner. Additionally, there is evidence in adults to suggest that "sham feeding" by chewing gum may also speed up bowel recovery so the patient may tolerate a solid diet earlier.

The aim of this study is to determine if gum chewing can enhance bowel recovery in children who undergo abdominal surgery.

After intestinal surgery, many patients suffer from a "postoperative ileus" (POI). The cause is multifactorial and can be attributed to surgery itself, the lingering effect of the anesthetic, the use of narcotics and decreased mobility of the patient.

An ileus can delay the time to full diet, thus lengthening the hospital stay of the patient - sometimes up to several weeks.

There is evidence that early drinking/eating and increased mobility may accelerate the return of bowel function. "Fast-tracking" is well documented in the adult literature; protocols have been put in place to enhance GI tract recovery and thus decrease the morbidity of a prolonged hospital stay and ileus. "Fast-tracking" has been done in pediatric patients but not in a large RCT for abdominal surgery.

Eligibility Criteria:
Inclusion Criteria:

* children more than 4 years of age
* children who undergo abdominal surgery (both laparoscopic or open)
* children who have an expected postoperative length of stay more than 24 hours

Exclusion Criteria:

* children who are less than 4 years of age
* children who are unable to chew gum/swallow (e.g. intubated, decreased level of consciousness, cognitive or physical disability)
* children or their parents are not willing to sign consent
* children or their parents are unable to follow directions regarding gum chewing,
* children who have a GI dysmotility disorder (e.g. chronic intestinal pseudo-obstruction)
Perceptual-Cognitive Training After a Mild Traumatic Brain Injury: Towards a Sensitive Marker for Recovery

This study is part of a larger, multi-centered project done with the collaboration of University Of Victoria. This study holds three separate studies on the mild traumatic brain injured population and the use of perceptual-cognitive training (3D-MOT).


Eligibility Criteria:
Inclusion Criteria:

* The child experienced a head injury (a direct or indirect blow to the head) resulting in concussion-like symptoms (e.g. headache, nausea, balance problems, tiredness, visual problems, cognitive issues) in the previous 72 hours
* Parent/legal guardian speak English or French
* The child speak English or French

Exclusion Criteria:

* Previous concussion in the last 6 months, or any previous concussion with unresolved symptoms
* Multi-system injuries requiring admission, operating room, procedural sedation in the Emergency Department
* Other co-existing injuries, co-morbidities or diagnoses preventing participation to intervention/assessment of gait and balance
* Pre-morbid or co-morbid condition affecting visual function
* Patient intoxicated at the time of injury
* Significant developmental delay
* Loss of consciousness prior to head injury
Efficacy of Electrical Pudendal Nerve Stimulation and Sacral in Treating Non-obstructive Neurogenic Urinary Retention

To observe the clinical effects and make a comparative study between efficacy of electrical pudendal nerve stimulation (EPNS) and sacral neuromodulation (SNM) , evaluate the advantages of EPNS in the treatment of neurogenic non-obstructive urinary retention, and provide a new method for the treatment of the disease.


Eligibility Criteria:
Inclusion Criteria:

* Non-mechanical obstructive urinary retention occurs following relevant neurological system disorders (spinal cord injury, spina bifida，myelitis, cervical/thoracic disk disease, lesion following spinal anesthesia/spine surgery,lumbar/sacral spine intervertebral disc diseases, spinal stenosis, iatrogenic pelvic nerve lesions, sacral agenesis, peripheral neuropathy due to diabetes mellitus).
* With normal upper urinary tract function.
* Other therapies and medications potentially affecting the assessment of this therapy have been discontinued for at least two weeks before the interventional procedure.
* Patient with good compliance who is capable of cooperating with the follow-up requirements

Exclusion Criteria:

* Patients with any suprapontine and pontine lesions
* Pregnant or lactating women
* Individuals whose symptoms show significant improvement after pharmaceutical and adjunctive therapy
* Individuals with concurrent acute or chronic prostatitis, prostate cancer, or conditions such as bladder neck stenosis, urethral stricture, or urethral injury
* High pathological risk factors (e.g., lymph node metastasis, resection margin involvement, bulky tumors)
* Individuals with concomitant obstructive urinary retention
Ideal Time of Oxytocin Infusion During Cesarean Section

This study will evaluate if the timing of oxytocin administration in cesarean deliveries will affect the amount of maternal blood loss. Half of participants will receive oxytocin after delivery of the fetal anterior shoulder and the other half will receive oxytocin after delivery of the placenta. We hypothesize that administering oxytocin after delivery of the shoulder, will result in less overall maternal blood loss.

Oxytocin is a routinely administered medication for both vaginal and cesarean deliveries in the third stage of labor, as part of standard of care in the United States. This medication helps to reduce overall blood loss, by functioning as a uterotonic. Currently evidence is lacking to direct timing of oxytocin administration in cesarean deliveries.

This study will evaluate both estimated and quantitative blood loss for both groups of patients. It will also compare the change from pre-operative to post-operative hemoglobin levels.

Eligibility Criteria:
Inclusion Criteria:

* Women undergoing cesarean section at Loyola Hospital
* Women who read and speak the English and/or Spanish language
* Women age 18 or older

Exclusion Criteria:

* Women who deliver vaginally
* Gestation under 37 weeks and 0 days
* Women with coagulopathies
* Multiple gestation pregnancies
* Antepartum hemorrhage for example abruption
* Placental abnormalities for example previa, accreta
Bioequivalence Study of SPARC147609 in Patients With Ovarian Cancer

Bioequivalence study of SPARC147609


Eligibility Criteria:
Inclusion Criteria:

* Subjects meeting all of the following criteria will be considered for enrollment in the study:

  * Availability of subject for the entire study period and willingness to adhere to protocol requirements.
  * Patients with documented diagnosis of Ovarian Cancer and eligible for receiving a dose 50mg/m2 of Doxorubicin liposome(preferably on no other concomitant medication, however, if considered necessary, to be documented and given).
  * Patients at least 18-years of age or older. iv. Subjects who have no evidence of underlying disease (except ovarian cancer) during screening medical history and whose physical examination is performed within 21 days prior to commencement of the study.
  * Patients with Performance ≤ 2 on the ECOG performance scale. vi. Subjects whose screening laboratory values are within normal limits or considered by the clinical Investigator/Co-Investigator to be of no clinical significance.
  * Informed consent form given in written form.

Exclusion Criteria:

* History or presence of significant:

  * Allergy or Significant history of hypersensitivity or idiosyncratic reactions to Doxorubicin Hydrochloride and/or any related compounds etc.
  * Cardiovascular, pulmonary, hepatic, renal, gastrointestinal, endocrine, immunologic, dermatologic, musculoskeletal, neurological or psychiatric disease.
  * Alcohol dependence, alcohol abuse or drug abuse or addiction with any recreational drug within past one year.
  * Clinically significant illness (except ovarian cancer)within 4 weeks before the start of the study v. Positive result to HIV, HCV, RPR and HBsAg.
  * Use of enzyme-modifying drugs (like Phenytoin, Carbamazepine, Barbiturates, Gresiofulvine etc.) in the previous 30 days before day 1 of this study and during the study.
* Donation of 350 mL or more of blood in the previous 90 days before day 1 of this study.
* Participation in another clinical trial within the preceding 90 days of study start
* Subjects who have:

  * Systolic blood pressure less than 90 mm of Hg or more than 140 mm of Hg
  * Diastolic blood pressure less than 60 mm of Hg or more than 90 mm of Hg
  * Pulse rate below 60/min. or above 100/min
Continuous Versus Intermittent Nebulization Therapy in Acute Asthma Exacerbation at Emergency Department

The goal of this clinical is to compare treatment outcomes between continuous nebulization and intermittent therapy in the management of acute exacerbation of asthma in the emergency department(ED). Participants will random assign to either continuous or intermittent nebulization. In the continuous group, patients receive budesonide, fenoterol, ipratropium bromide, and normal saline continuously for an hour. In the intermittent group, the same medications are administer every 20 minutes for an hour. Measurements include symptom severity, respiratory rate, oxygen saturation, and pulmonary function tests. Primary endpoints are ED stay length, hospital admission, and ED revisit within 48 hours post-discharge. Adverse events are documented.


Eligibility Criteria:
Inclusion Criteria:

* asthma exacerbation

Exclusion Criteria:

* life-threatening conditions requiring intubation
* allergy to steroid or its components
* patient under investigation of Corona Virus Disease, 2019 (COVID-19)
* pulmonary tuberculosis
* unable to cooperate for pulmonary function testing
A Safety and Efficacy Study of Dimebon in Patients With Huntington Disease

The purpose of this study is to determine if Dimebon is safe and effective for the treatment of cognitive impairment in Huntington disease.

This study is a multicenter Phase 3, randomized, double-blind, placebo-controlled safety and efficacy study of Dimebon treatment in subjects with Huntington disease (HD). The study will evaluate Dimebon 20 mg three times daily (TID) administered orally (PO) for six months (26 weeks) compared with matching placebo TID for the primary safety and efficacy analyses. Safety and tolerability will be assessed by recording of adverse events and by monitoring of vital signs, physical examinations, safety laboratory evaluations, and 12-lead electrocardiogram(ECG)assessments.

Eligibility Criteria:
Inclusion Criteria:

* Have clinical features of HD and a CAG polyglutamate repeat expansion ≥ 36
* Have cognitive impairment as noted by the following:

  1. A Screening MMSE AND a baseline (pre-dose) MMSE score between 10 and 26 (inclusive); and
  2. A subjective assessment of cognitive impairment with decline from pre-HD levels by the Investigator after interviewing the subject and caregiver;
* Are willing and able to give informed consent
* Aged 30 years or older
* Have a caregiver who assists/spends time with the subject at least five days per week for at least three hours per day and has intimate knowledge of the subject's cognitive, functional, and emotional states, and of the subject's personal care.

Exclusion Criteria:

* Had onset of symptoms prior to age 18
* Have any major medical illness or unstable medical condition within 180 days of screening that may interfere with the subject's ability to comply with study procedures and abide by study restrictions, or with the ability to interpret safety data
IMPACTS OF BRAXTON-HICKS CONTRACTIONS ON COMPUTERISED CARDIOTOCOGRAPHY PARAMETERS: A POTENTIAL LINK.

Several types of research examined the relationship of Braxton-Hicks contractions and uterine flow. Nevertheless, no one considered the relationship of the maternal perception of Braxton-Hicks contractions with the fetal wellbeing quantifies through computerised cardiotocography. Our study wants to estimate the correlation between the maternal perception of Braxton-Hicks contractions and antepartum computerised cardiotocography parameters.


Eligibility Criteria:
Inclusion Criteria:

* Nonlaboring women with a term uncomplicated singleton pregnancy

Exclusion Criteria:

* complicated singleton pregnancy
Study to Evaluate the Efficacy and Safety of 0.1% and 0.03% Tacrolimus Ointment Administered in Adults With Moderate to Severe Atopic Dermatitis

The objective of this study is to assess the efficacy and safety of 0.1% and 0.03% Tacrolimus ointment for 12 months in adults with moderate to severe atopic dermatitis.

The main phase is 6 months duration, but the follow up phase up to 12 months will allow the collection of efficacy and safety data in a period which will include all seasons in each patient, to account for seasonal variability which strongly affect atopic dermatitis course.

Eligibility Criteria:
Inclusion Criteria:

* Patient may be male or female of any ethnic group
* Patient without restricted legal competence, and suffers from moderate to severe atopic dermatitis (Rajka/Langeland score of at least 4.5)
* Patient known to be responsive to topical steroids
* Patient is capable of understanding the purposes and risks of the trial and has given written Informed Consent
* Female patients of childbearing potential must agree to maintain adequate birth control practice during the trial period and during the first four weeks after the end of the study
* Patient meets the following criteria:

  * Topical corticosteroids
  * Systemic corticosteroids (for the treatment of AD only)
  * Systemic non-steroidal immunosuppressants (e.g. cyclosporine, methotrexate)
  * Other investigational drugs
  * Light Treatments (UVA, UVB)
* Patient has not taken and agrees not to take for the complete study period any medication or therapy prohibited by the protocol

Exclusion Criteria:

* Patient has a genetic epidermal barrier defect such as Netherton's syndrome or generalised erythroderma
* Patient is pregnant or breast-feeding
* Patient has a skin infection on the affected (and to be treated) area
* Patient has a known hypersensitivity to macrolides in general, to tacrolimus or any excipient of the ointment
* Patient is simultaneously participating in any other drug trial or less than 28 days have passed between the end of the previous trial and this one
* Any form of substance abuse (including drug or alcohol abuse),psychiatric disorder or condition which, in the opinion of the investigator, may invalidate the communication with the investigator
* Patient is known to be HIV positive
Autologous Bone Marrow Stromal Cell and Endothelial Progenitor Cell Transplantation in Ischemic Stroke

The purpose of this study is to evaluate the feasibility, efficacy, and safety of autologous transplantation of ex vivo expanded bone marrow stromal cells (BMSCs)and endothelial progenitor cells (EPCs) for treatment of patients with ischemic stroke.

This study is a multi-center, single-blind, randomized, parallel controlled trail. Patients with acute cerebral infarcts within the middle cerebral arterial territory and with severe neurological deficits will be enrolled and randomly allocated into 3 groups: autologous BMSCs transplantation group, autologous EPCs transplantation group and Placebo control group. Randomization codes were established by the study statistician and were revealed only to the stem cell laboratory technician responsible for separating the cells into aliquots or preparing the placebo material. All patients will undergo a Bone Marrow aspiration procedure at 7 days after symptom onset. BMSCs and EPCs will be expanded ex vivo and then intravenously infused into own body, respectively. The control group will not receive cell therapy. Observe will followed for up to 1 year after the onset. Neurological score, neuroimaging, mortality of any cause, side effects, and new-onset comorbidities will be monitored and compared between each groups.

Eligibility Criteria:
Inclusion Criteria:

1. Patients aged 18 to 80 years, within 7 days of the onset of symptoms
2. Ischemic lesion within the MCA territory as assessed using diffusion-weighted imaging (DWI)
3. The National Institutes of Health Stroke Scale (NIHSS) ≥ 7 at day 7 after the onset
4. Signed informed consent

Exclusion Criteria:

1. Lacunar syndrome
2. Diagnosis other than ischemic stroke(eg. Intracranial hemorrhage or Intracranial tumor)
3. Hematological causes of stroke
4. Severe respiratory, hepatic, or renal disorders
5. Presence of severe febrile illness or viral diseases
6. Malignant diseases
7. Presence of autoimmune diseases
8. Positive response of penicillin skin test, or multiple drug allergies
9. Breast-feeding or pregnant women
The Wideband Acoustic Immittance Data in Thai Normal Hearing and Conductive Hearing Loss Adults

The goal of this descriptive study is to collect the wideband immittance data in Thai normal hearing and conductive hearing loss adults. The main questions it aims to answer are:

1. What is normative data of wideband acoustic immittance in Thai normal hearing adults
2. What is the wideband acoustic immittance data in Thai conductive hearing loss who have type A, AS and Ad tympanogram Participants will examine hearing tests consequently

   * pure tone audiometry
   * Tympanometry with ipsilateral acoustic reflex
   * Wideband acoustic immittance


Eligibility Criteria:
Inclusion Criteria:

Normal group

1. Thai adults (18-60 years old)
2. Pure-tone air-conduction thresholds ≤ 25 dB HL, measured at audiometric frequencies 250, 500, 1000, 2000, 3000, 4000, 6000 and 8000 Hz and air-bone gab \< 10 dBHL at frequencies 500, 1000, 2000 and 4000 Hz
3. Type A tympanogram with present ipsilateral acoustic reflex
4. No diagnosis of middle ear disease
5. No history of middle ear surgery
6. Normal finding in otoscopic examination

Conductive hearing loss group

1. Thai adults (18-60 years old)
2. Pure-tone air-conduction thresholds \> 25 dB HL, measured at audiometric frequencies 250, 500, 1000, 2000, 3000, 4000, 6000 and 8000 Hz and air-bone gab \> 10 dBHL at frequencies 500, 1000, 2000 and 4000 Hz at least 2 frequencies in one ear
3. Type A, As or Ad tympanogram with absent ipsilateral acoustic reflex
4. Normal finding in otoscopic examination
5. There is an appointment for exploration middle ear within 2 months

Exclusion Criteria:

1. Have previously had middle ear surgery
2. Have an earache
3. Type B or C tympanogram
4. Volunteers who do not cooperate in audiometry test or unable to do audiometry test
Effects of Yoga on Pulmonary Parameters, Posture, Body Awareness and Quality of Life Among Chronic Smokers

The aim of this study is to examine the effects of practicing pranayam (voluntary regulated breathing) and yogasana (standing poses of yoga) with subject education on vital capacity, respiratory muscle strength, spinal flexibility, body awareness, quality of life and nicotine dependence of smokers and non-smokers.

When initial assesments will be completed, volunteers will be assigned to one of two possible sequences by their nicotine dependency. Smokers group (SG) or control group (CG).

All volunteers will receive an exercise program with Asana and Pranayam practices with the duration of 4 weeks.

All subjects will be assessed in terms of functional capacity, pulmonary functions, thoracic spine range of motion, postural analysis, respiratory muscle strength, body awareness, quality of life and nicotine dependence at the baseline and at the end of the study. Data will be collected from all the subjects at baseline and at the end of the study (4 weeks) by the same physiotherapist who also will supervise the exercise sessions.

Eligibility Criteria:
Inclusion Criteria:

* Voluntary participation in research
* Young healthy subjects who were aged between 18-60 years with or without daily cigarette smoking habit

Exclusion Criteria:

* Allergic disorders or respiratory disorders
* History of a major surgery in the last 2 years
* Neurological diseases
* Cardiovascular diseases which are contraindicates exercise
* Fractures or orthopedic problems in upper or lower extremities
* Systemic rheumatical diseases(Rheumatoid Arthritis, Ankylosing Spondilitis etc.)

Systemic diseases and respiratory disorders will be ruled out in the selected subjects by taking their detailed history and by their thorough clinical examination by the researcher.