cyrilzakka/clinical-trials huggingface dataset:
Magnetic Therapy and Cervical Stabilization Exercises in Cervical Spondylosis

The purposes of this study are to Investigate adding low frequency high intensity magnetic therapy to cervical stabilization exercises on pain intensity, function, ROM, cervical endurance, and cervical proprioception errors in patients with cervical spondylosis.

Cervical spondylosis is a chronic degenerative process of the cervical spine. Pain in the neck and/or arms, neck stiffness, and headaches are the usual symptoms of cervical spondylosis . Low frequency high intensity magnetic therapy causes short term immediate effect in the relieve pain and improve function in patients with cervical spondylosis . Cervical stabilization causes decrease in neck pain and neck disability as well as a significant increase in cervical muscle endurance and cervical range of motion after the intervention. It also demonstrates a more ideal upper body posture and improved cervical proprioception. In the present study, therefore, we aimed to investigate adding low frequency high intensity magnetic therapy to CSE on management of cervical spondylosis. This study will be a benefit in the physical therapy field and may guide rehabilitation programs of physical therapy towards better results through decreasing time needed to perform activity of daily living, decreasing dependency and making patient an active member in society.

Eligibility Criteria:
Inclusion Criteria:

* Eighty Cervical spondylosis patients from both sexes will be participated in this study.
* The patients' ages will be ranged from 30-45 years to prevent aging process.
* X-ray evidence of cervical spondylosis (osteophyte formation, intervertebral disc height narrowing and vertebral end-plate sclerosis) .
* The presence of chronic neck pain (more than 3 months).
* Limited mobility in the cervical spine.

Exclusion Criteria:

* The following patients will be excluded from the study patients with:

  * History of cervical injury of trauma.
  * Cervical myelopathy.
  * Inflammatory arthritis involving cervical spine.
  * Tumor or infection involving cervical spine.
  * Vertebrobasilar artery insufficiency.
  * Neurologic disease (e.g. multiple sclerosis, Parkinson's disease, syringomyelia).
  * Congenital anomalies involving cervical spine.
  * Diabetes mellitus.
  * Vestibular system impairments.
Interrelations Between Spontaneous Otoacoustic Emissions and Transient Evoked Emissions

To verify the occurrence of Spontaneous Otoacoustic Emissions (SOAE) in neonates at term and preterm infants who had transient otoacoustic emissions and verify if the presence of response is related to gestational age, gender or risk factors for hearing loss.


Eligibility Criteria:
Inclusion Criteria:

* born in this institution
* have presence of transient otoacoustic emission

Exclusion Criteria:

-
Bioequivalence Study Of Bazedoxifene/Conjugated Estrogen Tablets In Postmenopausal Women

The primary objective is to evaluate the bioequivalence between bazedoxifene/conjugated estrogens tablets produced using the current manufacturing process to bazedoxifene/conjugated estrogens tablets produced using a new manufacturing process


Eligibility Criteria:
Inclusion Criteria

* Healthy, postmenopausal women aged 35 to 70 years and weighing at least 50 kg (approx. 110 lbs).
* At least 6 months of spontaneous amenorrhea (with follicle-stimulating hormone levels of 39 mIU/mL or greater).
* Nonsmoker or smoker of fewer than 10 cigarettes per day, with ability to abstain for 5 days.

Exclusion Criteria

* Women with amenorrhea starting after 54 years of age.
* A history or active presence of clinically important medical diseases.
* Use of oral estrogen-, progestin, androgen-, or SERM-containing drug products within 30 days before receiving study drug.
Assessing The Long-Term Safety And To Explore The Long-Term Efficacy Of Zonisamide As Monotherapy In Newly Diagnosed Partial Seizures

The purpose of this study is to assess the long-term safety and tolerability and to explore the long-term efficacy of zonisamide as monotherapy treatment in subjects with newly diagnosed partial seizures.


Eligibility Criteria:
Inclusion Criteria:

1. Subject has completed study E2090-E044-310.
2. Subject is able and willing to give written informed consent.
3. Female subjects without childbearing potential (two years post-menopausal, bilateral oophorectomy or tubal ligation, complete hysterectomy) are eligible. Female subjects of childbearing potential must be non-pregnant, non-lactating and abide by one of the following medically acceptable contraceptive measures: oral contraceptive pill, contraceptive injections, implants or patches, intrauterine device in place for at least three months, vasectomised partner or abstinence throughout the study and for one month after discontinuation of study medication. When the contraceptive pill is used, this should contain no less than 50 μg oestrogen.
4. The subject is able and willing to follow the investigational study procedures, maintain a seizure diary and report adverse events.

Exclusion Criteria:

1. Subject has a history of a significant or currently uncontrolled disease that will contraindicate the use of the study drugs or interfere with the conduct of this study and/or the assessment of safety and efficacy of the study drugs.
2. Subject has a body weight \<40 kg.
3. Subject has a newly occurring progressive malignancy during study E2090-E044-310 (excluding a history of non-metastasized and adequately treated cutaneous squamous cell carcinoma).
4. Subject has developed a psychiatric illness or mood disorder requiring electro-convulsive or drug therapy within the previous 6 months and is considered uncontrolled; history of suicide attempt, alcohol or drug abuse, chronic treatment with benzodiazepines or barbiturates.
5. Subject is currently taking carbonic anhydrase inhibitors.
6. Subject developed pancreatitis, nephrolithiasis or hypercalcuria, clinically significant laboratory abnormalities, stroke or uncontrolled hypertension during study E2090-E044-310.
7. Subject is currently taking monoamine oxidase inhibitors (MAOIs) or any other excluded medications (see protocol section 9.9.3).
8. Subject has a history of allergy to carbamazepine or to zonisamide or to any of their ingredients or to sulphonamides.
9. Subject has developed a bone marrow depression, low platelet count or other blood dyscrasias.
Efficacy and Safety of Catechin High Contain Greentea Extract on Improvement of Cognitive Function

This study was the efficacy and safety of Catechin high contain greentea extract on improvement of Cognitive Function

This study was a 12 weeks, randomized, double-blind, placebo-controlled human trial to evaluate. 80 subjects were participated in Catechin high contain greentea extract or placebo group. To evaluate the changes of the evaluation items when Catechin high contain greentea extract was taken 12 weeks compared with placebo.

Eligibility Criteria:
Inclusion Criteria:

* Those who are at least 60 years of age at screening
* Those who have Korean Mini-Mental Status Examination(K-MMSE) result 25-28 points
* Those who agree to voluntary participation and to comply with the Notice after fully hearing and understanding the details of this human trial

Exclusion Criteria:

* Those with a past history of treatment with Axis I disorder in SCID(Structured Clinical Interview for DSM-IV) which is a structured clinical interview in the Diagnostic and Statistical Manual of Mental Disorders at Screening or who have been treated within the last 3 years
* Those with alcohol abuse or dependence within the last 3 months
* Those who have clinically significant following severe illness (Epilepsy, mental retardation, brain nervous system diseases, endocrine diseases, blood / malignant tumors, cardiovascular diseases, Crohn's disease, etc.)
* Those with a history of clinically significant hypersensitivity to green tea
* Those taking medicines, health functional foods or herbal medicines related to improvement of cognitive function and memory within 1 month before screening
* Those who ingested green tea extract's health functional food within 1 month before screening
* Those who whole blood donation within 1 months before the first ingestion or Component blood donation within 2 weeks
* Those who participate in other human tiral within 3 months
* Those who shows the following results in the Laboratory test

  * AST, ALT \> 3 times upper limit of normal range
  * Other significant laboratory test opinion
* Those who is deemed unsuitable for participating in the human trial due to other reasons
Preoperative Gluteal Muscle Atrophy: A Silent Predictor of THA Dislocation.

This study looks at how fat buildup in hip muscles relates to hip osteoarthritis and less favorable recovery after hip replacement surgery. While it is known that weak gluteal muscles might cause problems, it is not yet proven if this specifically leads to hip dislocation after surgery. The goal of this study is to compare fat buildup in gluteal muscles between patients who had a hip dislocation soon after surgery and those who did not.


Eligibility Criteria:
Inclusion Criteria:

* primary THA with preoperative CT-scan

Exclusion Criteria:

* malposition of acetabular implants outside the Lewinneck safe zone,
* neurological or cognitive disorders,
* associated spinal pathologies (within the context of a hip-spine syndrome),
* chronic alcoholism,
* aseptic osteonecrosis,
* revision surgeries,
* late dislocations attributed to polyethylene wear,
* replacement following post-traumatic coxarthrosis due to acetabulum injuries.
* diameters of the prosthetic heads ≠ 32mm
Disease Stabilization in AML by Treatment With ATRA, Valproic Acid and Low-dose Cytarabine

Hypothesis: Combined treatment with valproic acid and ATRA can be used to achieve disease stabilization for a subset of patients with acute myelogenous leukemia (AML), and this effect can be improved without serious toxicity by adding low-dose cytarabine to this treatment.

Adult patients \>18 years of age who can be included:

Elderly patients who cannot achieve standard chemotherapy, patients with relapsed or resistant AML.

Treatment: Combined therapy with:

Valproic acid, continuous therapy until disease progression ATRA, oral therapy for 14 days every three months Low-dose cytarabine 10 mg/m2 up to 10 injections during week 2 and 3, repeated every 3 months.

Patients to be included:

1. Elderly patients (\>60 years of age) or other patients unfit for conventional intensive chemotherapy with newly diagnosed acute myelogenous leukemia (AML).
2. Adult patients of any age (\>18 years of age) with relapsed or resistant AML who cannot receive conventional therapy.

Treatment:

Valproic acid to be started on day 1 as continuous therapy until disease progression.

ATRA administered from day 8 orally as 22.5 mg/m2 twice daily for 14 days, repeated every third month.

Low-dose cytarabine 10 mg/m2 from day 14 and continued as daily injections for up to 10 days, repeated every third month.

Supportive therapy is given according to the hospitals general guidelines.

Followup: The first 2 days treatment in hospital, later regular out-patient treatment. Controls will include clinical examination, peripheral blood parameters (including serum valproic acid levels), bone marrow samples.

Eligibility Criteria:
Inclusion Criteria:

* Recently diagnosed AML in patients unfit for intensive chemotherapy
* Patients with relapsed or refractory AML

Exclusion Criteria:

* No informed consent
* Intolerance to study drugs
* Serious liver disease
The Efficacy of Transversus Abdominis Plane Block Versus Wound Infiltration for Analgesia After Cesarean Delivery:

This study aimed to compare bilateral ultrasound-guided TAP block with single-shot local anesthetic wound infiltration for analgesia after cesarean delivery performed under spinal anesthesia

This double-blind, randomized controlled trial aimed to compare bilateral ultrasound-guided TAP block to single-shot local anesthetic wound infiltration for analgesia after cesarean delivery performed under spinal anesthesia. This will be done by measuring VAS (visual analogue score) for pain after ceserian section at2, 4, 6, 12, 24 hours .

Eligibility Criteria:
Inclusion Criteria:

* Women undergoing cesarean section under spinal anesthesia
* Aged ≥19 years and \> 40 years .
* Gestational age ≥ 37 Weeks .
* Informed Consent From the Patient .

Exclusion Criteria:

* Body mass index (BMI) ≥40 kg/m2 ..
* History of recent opioid exposure .
* Hypersensitivity to any of the drugs used in the study .
* Significant cardiovascular, renal, or hepatic disease.
The Evaluation of a Nasal Pillows Mask for the Treatment of Obstructive Sleep Apnea (OSA) in NZ

This investigation is designed to evaluate the performance (leak and comfort) as well as the participant's overall acceptance of the nasal pillows mask amongst Obstructive Sleep Apnea (OSA) participants. Also to assist in the development process it would be beneficial to get feedback from users on certain aspects of the design. The aim of this investigation is to get feedback on the first impressions (look and feel) from users of nasal pillows PAP therapy.

A total number of 15 participants who currently use a nasal pillows mask will be recruited for the trial. Participants from previous NZ trials may be recruited into this trial with their consent. All the participants will be recruited from the Fisher \& Paykel Healthcare Database of subjects with OSA (Ethics Reference NTY/08/06/064), Auckland District Health Board (ADHB) and New Zealand Respiratory and Sleep Institute (NZRSI).

Participants will undergo an overnight polysomnography session at the Fisher \& Paykel Healthcare sleep lab.

The participant will use the trial device on their usual Continuous or Auto Positive Airway Pressure (CPAP/APAP) setting and device for the duration of the overnight in-lab study.


Eligibility Criteria:
Inclusion Criteria:

* Adult (18+ years of age)
* Able to give consent
* AHI ≥ 5 on diagnostic night
* Prescribed a CPAP device after successful OSA diagnosis
* Existing nasal pillows mask user

Exclusion Criteria:

* Inability to give consent
* Patients who are in a coma or a decreased level of consciousness.
* Anatomical or physiological conditions making APAP therapy inappropriate
* Commercial drivers who are investigated by New Zealand Transport Agency (NZTA)
* Current diagnosis of CO2 retention
* Pregnant or may think they are pregnant.
Combined Human Milk Oligosaccharides (HMOs) and Probiotics Intervention for Children With Autism

This research project will investigate if a supplement containing a unique combination of prebiotics and probiotics can influence behaviour in children diagnosed with autism spectrum disorder. The study will use a combination of human milk oligosaccharides (HMOs, prebiotics) and probiotics as an oral powder.This clinical trial will have two consecutive phases. Phase 1A is an 8-week randomised, double-blinded, placebo-controlled trial. Participants will be recruited and randomised (1:1) to receive either the investigational product (treatment group, n=30) or the placebo (control group, n=30). Phase 1B is an 8-week open-label study. All participants that complete Phase 1A will move into Phase 1B (n=60). This allows all participants to receive the investigational product and will provide additional information on increased duration of treatment.


Eligibility Criteria:
Inclusion Criteria:

1. Aged 5.00 years to 12.99 years.
2. A confirmed diagnosis of ASD or Pervasive Developmental Disorders (PDD) including autistic disorder, Asperger's disorder (AS); PDD not otherwise specified (PDD-NOS); and atypical autism.

Exclusion Criteria:

1. Organic GI disorders such as inflammatory bowel disease, coeliac disease, eosinophilic disorders, or current infection of the GI tract.
2. Bowel surgery or short bowel syndrome
3. Participants who have a diagnosed cow milk protein allergy.
4. Participants who suffer from the conditions listed below or who are taking any of the following medications or supplements:

   * antibiotics or antifungals in the last two months
   * probiotic supplements in the last two months
   * immunocompromised or severely ill
   * genetic disorders (e.g. Fragile X Syndrome)
   * chronic health conditions such as diabetes, heart disease or an eating disorder.
The Efficacy of a Dentifrice in Providing Relief From the Pain of Dentinal Hypersensitivity

A study to compare the efficacy of a test dentifrice against a control dentifrice in reducing dentinal hypersensitivity over an eight week treatment period.


Eligibility Criteria:
Inclusion Criteria:

* Subjects who suffer from tooth sensitivity

Inclusion Criteria:

- none
Probiotics in Enteral Feeding in Critically Ill Patients

The purpose of this study is to investigate the effect of probiotics in enteral nutrition on improving gut function, inflammatory markers and clinical outcomes in critically ill patients admitted to the intensive care unit.

Gut failure in critically ill patients is common. Enteral feeding is one of the preferred routes for nutrition support to maintain gut function. However, enteral nutrition is not without complications such as alterations in gut transit time and gut eco-culture. Enteral nutrition supplemented with a probiotic offers a possible solution to modulating this ecosystem. Objectives: The primary aim of this study was to investigate the effect of probiotics in enteral feeding on improving the gut function, inflammatory markers and clinical outcomes in critically ill patients. Subjects and Methods: Forty-nine patients that were admitted to the intensive care unit in University Malaya Medical Center requiring enteral feeding were randomized to receive either probiotics or a placebo. Patients remained in the intensive care unit for more than 7 days and were examined prior to the start of enteral feeding and on day 8. Return of gut function was assessed by the time needed to achieve caloric requirement. Inflammatory markers including the White Cell Count and C-reactive protein levels were tested on day 1 and day 8. Clinical outcome was assessed by number of days of ventilation and total days in intensive care unit.

Eligibility Criteria:
Inclusion Criteria:

* Admitted to intensive care unit
* Expected stay of more than 48 hours
* On enteral feeding
* Consent obtained from patient/relative

Exclusion Criteria:

* Patients on immuno-suppressive drugs
* Patients with hematological diseases
* Pregnant females
* Do not consent
High-intensity Interval Training Versus Moderate Continuous Training in Heart Transplant Recipients.

The aim of this study was to examine the effects of high intensity aerobic interval training (AIT) versus moderate continuous training (CON) in heart transplant recipients.

Clinically stable heart transplant recipients \> 12 month or more after HTx, age \> 18 years, willing and capable of giving written informed consent for study participation and anticipated to be able to participate in the study for 12 months were included from the Heart Centre, Rigshospitalet, Copenhagen University Hospital.

Patients were excluded due to unstable condition or postoperative complications, recent severe rejection episodes (\>H1R \< 3 month), physical disabilities which prevent participation and re-transplantation or multi-organtransplantation.

Eligibility Criteria:
Inclusion Criteria:

-stable Heart transplant recipients \> 12 month or more after HTx, age \> 18 years,\< 80. willing and capable of giving written informed consent for study participation.

Exclusion Criteria:

unstable condition postoperative complications, recent severe rejection episodes (\>H1R \< 3 month), re-transplantation or multi-organtransplantation.
Almorexant (ACT 078573) in Adult Subjects With Chronic Primary Insomnia

A polysomnography study to evaluate the effect, safety and tolerability of oral administration of almorexant (ACT 078573) in adult subjects with primary insomnia.


Eligibility Criteria:
Inclusion Criteria:

* Adult subjects (18-64 years) with a diagnosis of primary insomnia.

Exclusion Criteria:

* History of any sleep disorder, or any Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM-IV) axis I disorder other than primary insomnia.
* Sleep apnea, or restless legs syndrome.
* Daytime napping of more than 1 hour per day.
* Important caffeine consumption, heavy tobacco use, alcohol or drug abuse within 2 years prior to the screening visit.
* Unwillingness to refrain from drugs, over-the-counter or herbal medication having an effect on sleep or behavior.
Long Term Follow up of Scars Formation and Quality of Life Assessment Study

In previous study (MW2004-011-02), patients with burn wounds had their damaged skin removed by either standard of care treatment or by Debrase Gel Dressing (DGD), which is composed of enzymes that dissolve the damaged skin selectively (DGD removes only the damaged skin and not other parts of the skin).

The burn wound, like any other wound, heals by the formation of scar at the injured site in order to replace the destroyed tissues. Scarring is not a static process, but rather a dynamic one, changing over time, especially during the first 24 months post-injury.

Scars and patients' quality of life from two treatment arms (DGD and SOC) will be compared in order to evaluate the long term influence of damaged skin removal and wound care techniques on scar formation and maturation.


Eligibility Criteria:
Inclusion criteria

1. Adults and children who had participated and completed study MW2004-11-02.
2. Subjects must be willing and able to sign a written informed consent prior to study entry (by subject or by a guardian, when applicable).