cyrilzakka/clinical-trials huggingface dataset:
Investigating the Potential Psychological Impact of Early Screening and Long-term Monitoring for Adolescent Idiopathic Scoliosis Among Patients and Caregivers

Adolescent Idiopathic scoliosis (AIS) is a three-dimensional deformity of the spine of unknown aetiology, characterised by a lateral curvature and vertebral rotation. Its prevalence is estimated to be 2.5% in children between aged 10 and 16 in Hong Kong. Despite concerns regarding the psycho-social issues patients face at and after AIS screening, there is no study that directly address this subject. The investigator propose to conduct a prospective longitudinal study on the psycho-social impact of AIS early screening and long-term monitoring amongst patients and their caregivers. The proposed study will bridge this research gap by evaluating a cohort of newly-diagnosed patients with AIS through the school screening program and their caregivers. A mixed-methods research approach to tap into the distinct social, behavioural, emotional and parental experiential profiles will be used. Patterns across different profiles can enhance the investigator's understanding of which aspects of AIS early screening and long-term monitoring can adversely affect patients' psychological well-being. Findings will facilitate targeted approaches to address specific psycho-social impact of scoliosis and its treatment, heighten compliance to long-term monitoring and prevention of scoliosis progression, and mobilise a new clinical care model that addresses patient and clinician concerns.


Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis of structural scoliosis, and
2. developmentally normal cognitive function

Exclusion Criteria:

1. A nonspinal cause of scoliosis, patients who do not intend to stay in this country for the duration of treatment, and
2. those who cannot fill in the questionnaires
Evaluating Edema and Range of Motion Using Negative Pressure Therapy vs. Standard Surgical Dressing in Bilateral TKA

This study will compare the effects of closed incision negative pressure dressing vs. standard of care silver dressing on lower limb swelling after bilateral primary total knee arthroplasty.


Eligibility Criteria:
Inclusion Criteria:

* is at least 22 years of age on the date of informed consent.
* can independently provide informed consent.
* requires and is scheduled to undergo a simultaneous, bilateral, primary TKA.
* is willing and physically capable of undergoing a simultaneous, bilateral, primary TKA with or without replacement of the patella.
* is willing and able to return for all scheduled study visits.

Exclusion Criteria:

* is pregnant or lactating.
* has signs of an infection in the area of either knee or has signs of a systemic infection at the time of surgery.
* is a chronic opioid user, defined per the CDC guidelines as opioid use for \>3 months, at the time of enrollment.
* has a current diagnosis of lymphedema in either leg.
* has signs, symptoms, or a current diagnosis of venous insufficiency in either leg, as determined by the investigator's review of the subject's medical history.
* has a history of clotting disorder or prior history of deep vein thrombosis
* will undergo a unilateral TKA.
* will undergo a staged, bilateral TKA.
* has had previous knee replacement surgery.
* has received a corticosteroid injection into either knee within 30 days of surgery.
* undergoes a simultaneous, bilateral TKA with a planned different incision type on each knee (eg, midline incision vs. medial parapatellar incision).
* has known sensitivity to the study product components (drape and/or dressing materials in direct contact with the closed incision or skin).
* has known sensitivity to silver.
* is enrolled in another interventional clinical study.
* has skin cancer localized at or in proximity to the incision site.
* does not have access to an electronic device (smartphone, iPad, or computer) on a daily basis to complete online assessments.
* has condition(s) that, in the opinion of the investigator, cause the subject to be an overall health risk that is unsuitable for the surgery.
* has condition(s) that, in the opinion of the investigator, will impact study endpoints (eg, hemophilia or autoimmune disorders) or the ability to comply with study procedures.

Intra-Op Exclusion Criteria:

* does not receive a "total" knee replacement for first knee. For example, a partial or uni-compartmental knee replacement is performed
* has a surgical incision that would preclude placement of either dressing onto the knee
* has a TKA resulting in a muscle flap
Investigation of Hypermobility, Biomarkers, and Pain Generators in Chronic Pain Patients

Observational study of axial spine pain and hyperflexibility. Patients will receive physical exam maneuvers (traditional straight leg raise, FABER, facet loading as well as Beighton's hypermobility score) and blood / urine / saliva collection. They will also be separated into pain groups based on their response to injections. A correlation between exam findings and procedure group will be measured.

This is an observational study of patients with neck and back pain followed by a pain management clinic. Patients with particular pain generators in the neck and back will be defined by a positive response to one of several targeted interventional pain procedures. Each patient may undergo a physical exam to determine whether they have hypermobile joints. The study will thus evaluate the rate of hypermobility for each pain generator. In addition blood, urine, or saliva samples may be taken for biomarkers for pain or rheumatologic factors.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of axial back pain (neck, mid-back, lower back) or pain radiating to the extremity, with suspected diagnosis of a specific pain generator amenable to a pain procedure, including disorders of the nerves, joints, and muscles as listed immediately below.
* Clinical decision to schedule patient for a pain procedure, including procedures targeting the following disorders:

  * Facet arthropathy: intra-articular facet joint injection, medial branch block, medial branch radiofrequency ablation
  * Sacroiliac joint dysfunction: sacroiliac joint injection, lateral branch block, lateral branch radiofrequency ablation
  * Myofascial pain syndrome: trigger point injection
  * Radiculopathy, spinal stenosis, or herniated nucleus pulposus: epidural steroid injection, selective nerve root block
  * Piriformis syndrome: piriformis injection
  * Greater trochanteric bursitis: greater trochanteric bursa injection
* Able to provide HIPAA authorization to share prior medical records/imaging.

Exclusion Criteria:

* Previous diagnosis of cancer.
* Currently pregnant.
* Previously enrolled for the same procedure or the same pain generator site. (For example, this would exclude a patient who had an intra-articular facet joint injection at the right L5/S1 if: 1) he had the same injection 3 months ago and was enrolled at that time, or 2) the patient was already enrolled for a medial branch block at the right L5 and sacral ala, as this targets the same facet joint.)
* Inability or unwillingness of subject or legal guardian/representative to give informed consent (e.g., ward of the state)
Effects of Renal Sympathetic Denervation on the Cardiac and Renal Functions in Patients With Drug-resistant Hypertension Through MRI Evaluation

This is a prospective, single centre clinical investigation looking at short (6 months) and long term (24 months) changes in cardiac function and renal function in patients with drug-resistant hypertension post renal sympathetic denervation.


Eligibility Criteria:
Inclusion Criteria:

* Subject must be able and willing to comply with the required follow-up schedule
* Therapeutic Goods Association approved indications for EnligHTN™ Renal Denervation System
* Subject is ≥ 18 years of age at time of consent Subject has office SBP ≥ 160 mmHg (except for subjects with Diabetes Mellitus who must demonstrate an office SBP of ≥ 150 mm Hg) within 14 days of the procedure ◦Subject is taking ≥ 3 antihypertensive medications concurrently at maximum tolerated dose (this must include one diuretic) or subject has a documented intolerance to at least 2 out of the 4 major classes of anti-hypertensives (ACE/ARB, CCB, Diuretics, Beta Blockers and is unable to take 3 antihypertensive drugs.

Exclusion Criteria:

* Standard CMR exclusions;

  * implanted cardiac device
  * intracranial metallic implants
  * claustrophobia -Gadolinium-specific: estimated GFR \<60 mls/min (usual clinical cut-off is \<30 mls/min).
* Adenosine-specific:

  * asthma / reactive airways disease
  * \>first degree atrioventricular block
  * concomitant use of dipyridamole or theophylline consumption of caffeine within 48 hours of proposed investigation
  * EnligHTN™ Renal Denervation System exclusion criteria:

Subject has an identified cause of secondary hypertension

* Subject has an estimated GFR \<45 mL/min per 1.73 m2 using the MDRD formula
* Subject has undergone prior renal angioplasty, indwelling renal stents, and/or aortic stent grafts
* Subject has haemodynamically significant valvular heart disease
* Subject has a life expectancy less than 12 months, as determined by the PI
* Subject is participating in another clinical study Subject is pregnant, nursing, or of childbearing potential and is not using adequate contraceptive methods
* Subject has renal arteries with diameter(s) \< 4 mm in diameter
Risperidone Treatment in Schizophrenia Patients Who Are Currently Taking Clozapine

This study will determine whether adding the drug risperidone (Risperdal®) is more effective than placebo in treating schizophrenic patients who are taking the drug clozapine.

Clozapine is the only antipsychotic drug that has been approved for treatment resistant patients with schizophrenia. However, up to 50% of patients treated with clozapine fail to respond and continue to exhibit clinically significant residual positive and negative symptoms and cognitive impairments. An emerging trend in treatment is the addition of a second antipsychotic drug. This study will determine if risperidone when given as adjunctive treatment is more effective than placebo in treating schizophrenic patients failing clozapine therapy.

Participants are randomly assigned to add either adjunctive risperidone or placebo to their current clozapine treatment in a single, daily dose for 16 weeks. Positive and negative symptoms, cognitive impairments, side effects of the treatment, anxiety, depression, hostility symptoms, and quality of life are assessed. Neurological tests, self administered questionnaires, and interviews are used to assess patients.

Eligibility Criteria:
Inclusion Criteria:

* DSM-IV criteria for schizophrenia or schizoaffective disorder
* Current clozapine treatment
* Moderate illness severity and inadequate positive symptom response to clozapine treatment
* 6 month period of clozapine treatment with documented clozapine blood level greater than or equal to 350 ng/ml or clozapine and norclozapine blood level greater than or equal to 450 ng/ml

Exclusion Criteria:

* Organic brain disorder
* Mental retardation
* Medical condition whose pathology or treatment could alter the presentation or treatment of schizophrenia or significantly increase the risk associated with the proposed treatment protocol
* Pregnancy
* DSM-IV criteria for current alcohol or substance dependence within the last 6 months or DSM-IV criteria for alcohol or substance abuse within the last month
* Previously received adjunctive risperidone (at doses greater than or equal to 8 mg/day) with their clozapine treatment for greater than or equal to 6 weeks
Transcranial Direct Current Stimulation Therapy for Bipolar Depression

Bipolar disorder is a severe and disabling disorder. The course of illness is often progressive but is highly heterogeneous between individuals and within the lifetime for an individual. The most common treatments are medications. However, for many individuals, combinations of medications are often required, and full recovery is infrequent.

The novel brain stimulation treatment, transcranial direct current stimulation (tDCS), is a potential first-line treatment for bipolar depression. The present research question is whether tDCS can be provided as a home-based treatment for bipolar depression for adults with bipolar disorder.

The novel brain stimulation treatment, transcranial direct current stimulation (tDCS), is a potential first-line treatment for bipolar disorder. tDCS generates a small electric current which modulates how easy it is for active brain cells to discharge. The device is a headband worn over the forehead with two electrodes, which are small metal discs, where the current comes from. tDCS does not directly stimulate brain cells to cause a seizure like electroconvulsive therapy (ECT) and it does not induce brain cells to discharge like transcranial magnetic stimulation (TMS).

Clinical studies have shown that tDCS treatment could help to improve the symptoms of depression. The main side effects have been redness, skin irritation or sensations (itching, tingling or burning) under the electrodes. Less commonly reported side effects include headache or tiredness. tDCS is a portable and safe treatment.

The studies to date have mostly looked at tDCS treatment which has been provided in a research setting. This is a problem because the treatment requires daily sessions for several weeks which could limit whether individuals would be able to go every day. As tDCS is a portable and safe treatment, it could be provided in the community.

The present study is a proof-of-concept trial to assess the efficacy, acceptability and safety of tDCS treatment for bipolar depression within a community-based setting.

Eligibility Criteria:
Inclusion Criteria:

* diagnosis of bipolar disorder based on DSM-5 criteria
* minimum score of 18 on the MADRS
* being on a stable dosage of mood stabilizing medication for a minimum of two weeks

Exclusion Criteria:

* comorbid psychiatric disorder
* significant risk of suicide or self harm
* any contraindications to tDCS, including implanted electronic medical devices
* history of epilepsy
Blood and Stool Sample Collection in Subjects With a Diagnosis of Colorectal Cancer or Colorectal Lesion: Act Fast

The primary objective of this study is to collect de-identified, clinically-characterized stool and whole blood specimens for use in developing and evaluating the performance of new biomarker assays for the detection of colorectal cancer (CRC).

Participants will be 40 years of age or older, with a diagnosis of CRC, at any stage, confirmed with a tissue biopsy or a colorectal lesion at least 1 cm in size suspicious for adenoma (including sessile serrated adenoma) or CRC on a pre-enrollment colonoscopy, sigmoidoscopy, or computed tomography (CT) colonography. Approximately 1500 participants will be enrolled.

Eligibility Criteria:
Inclusion Criteria:

1. Participant is 40 years of age or older.
2. Participant has a diagnosis of CRC, at any stage, confirmed with a tissue biopsy or a colorectal lesion at least 1 cm in size suspicious for adenoma (including sessile serrated adenoma) or CRC on a pre-enrollment colonoscopy, sigmoidoscopy, or CT colonography.
3. Postcolonoscopy, the residual lesion in the colon must be at least 1 cm in size as to require additional surgical excision or complex colonoscopic polypectomy.
4. Participant understands the study procedures and is able to provide informed consent to take part in the study and authorization for release of relevant protected health information to the study Investigator.

Exclusion Criteria:

1. Any previous cancer diagnosis (with the exceptions of basal cell or squamous cell skin cancers) and/or cancer related treatment (e.g., chemotherapy, immunotherapy, radiation, and/or surgery) within the past 5 years.
2. Less than 7 days between colonoscopy and blood and/or stool specimen collection.
3. IV contrast (e.g., CT or MRI) within 1 day \[or 24 hours\] before blood and/or stool collection.
4. Participant has any condition that in the opinion of the Investigator should preclude taking part in the study.
Hormone Replacement Therapy for Use in Postmenopausal Women for Relief of Hot Flushes and Urogenital Symptoms.

Multicenter, double-blind, controlled, parallel group, randomized study to compare the clinical benefit of Estradiol acetate tablets, estradiol tablets and conjugated equine estrogen tablets, each administered orally, once daily, to postmenopausal women.


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 40 years of age; bilateral oophorectomy ≥ 35 years of age.
2. Non-hysterectomized women:

   * Amenorrhea for ≥ 12 months or
   * Amenorrhea for ≤ 12 months, but longer than 6 months, and serum FSH (follicle stimulating hormone) levels \> 40 units/L and serum estradiol levels \< 20 pg /mL,

   Hysterectomized women:
   * Bilateral oophorectomy - subjects may enter the study 6 weeks after surgery or
   * History of removal of ovaries may be confirmed by - serum FSH levels \> 40 units/L and serum estradiol levels \< 20 pg/mL or via surgical report / ultrasound.
3. Seven or more moderate or severe hot flushes daily for 1 week or 60 or more moderate or severe flushes in 1 week during the 2 week screening period prior to study entry.

Exclusion Criteria:

1. Hormone therapy administered via the following routes and during the specified timeframes: oral within 8 weeks, vaginal (rings, creams, gels) within 1 week, transdermal within 4 weeks, intramuscular within 6 weeks, progestational implants, estrogen or estrogen/progestational injectable drug therapy within 3 months, estrogen pellet or progestational injectable within 6 months.
2. Abnormal Pap smear suggestive of low grade squamous intraepithelial lesion (LGSIL) or worse. Enrollment of subjects with an ASCUS (atypical squamous cells of undetermined significance) interpretation must be discussed with the sponsor prior to randomization.
3. Urinary tract infection
4. Congestive heart failure
5. Uncontrolled hypertension; sitting systolic BP ≥ 160 mmHg or diastolic ≥ 95 mmHg
6. History of stroke or transient ischemic attacks
7. Treatment with anticoagulants (heparin or warfarin).
8. Uncontrolled thyroid disorders.
9. Insulin-dependent diabetes mellitus.
10. Increase frequency or severity of headaches including migraines during previous estrogen therapy.
Clinical Effectiveness of Obturator Externus Muscle Injection in Chronic Pelvic Pain Patients

Obturator externus (OE) muscle has the possibility as a pain generator, considering its anatomical and functional aspects, but this muscle as a possible target for therapeutic intervention is currently understudied in pain practice.


Eligibility Criteria:
Inclusion Criteria:

* 1. 20-75 adults/ 2. Chronic pelvic pain patients who required the interventional procedures/ 3. patients with a localized tenderness on inferolateral side of the pubic tubercle

Exclusion Criteria:

* 1. Severe cardiovascular disease /2. Coagulation abnormality /3. Patient denial
A Comparison of Ropinirole Immediate Release With Ropinirole Prolonged Release in Patients With Advanced Parkinson's

This study was designed to compare the effectiveness and tolerability of a new prolonged release formulation of ropinirole with the currently marketed immediate release formulation which is prescribed in many countries. The new prolonged release formulation allows the drug to be taken once a day rather than three times a day. This study will also evaluate the side effects of the new prolonged release formulation of ropinirole


Eligibility Criteria:
Inclusion criteria:

* Patients with a diagnosis of advanced idiopathic Parkinson's disease (according to modified Hoehn \& Yahr criteria Stages II-IV) whose symptoms are not adequately controlled with L-dopa.

Exclusion criteria:

* Patients with late stage advanced Parkinson's disease with incapacitating dyskinesias on a stable dose of L-dopa.
* Current, or history of, (within the previous 3 months), significant and/or uncontrolled psychiatric, haematological, renal, hepatic, endocrinological, neurological, or cardiovascular disease or active malignancy.
* Recent history of severe dizziness or fainting on standing.
* Dementia, neurotic behaviour, crippling degenerative arthritis or limb amputations, or prior or current major psychosis.
* Recent history or current evidence of drug abuse or alcoholism.
* Use of a dopamine agonist within 4 weeks of starting the study.
* Personal or family history of an allergic reaction to ropinirole.
The Efficacy of Botulinum Toxin in Disabling Multiple Sclerosis (MS) Tremor

The incidence of tremor in Multiple Sclerosis (MS) has been estimated to affect up to 2/3rds of patients. Over half of the tremors involve the upper limb and frequently lead to further disability. Medical treatment of MS tremor is generally unrewarding, although carbamazepine, clonazepam, glutethimide, hyoscine, isoniazid, ondansetron, primidone, and tetrahydrocannabinol have been reported to have some beneficial effect but published evidence of effectiveness is very limited. The investigators' experience to date suggests that many of the upper limb tremors may potentially be responsive to Botulinum toxin injection therapy.

Aims:

1. The investigators aim to determine the efficacy of commonly used doses of BOTOX on the patients with symptomatic unilateral or bilateral arm tremor due to MS; and any side effects associated with this treatment.


Eligibility Criteria:
Inclusion Criteria:

* Relapsing-remitting MS or secondary progressive MS according to the Mc Donald criteria
* Age 18-80 years of age
* Competent to understand and sign informed consent
* Presence of symptomatic head and/or limb tremor

Exclusion Criteria:

* Treatment with botulinum toxin type A of any brand within the 4 months prior to enrollment
* A known contraindication to Botox injection
* Pregnancy
The Effect of Sleep Quality on Mental and Physical Health

This study aimed to explore the relationship between sleep quality and its impact on mental and physical health, particularly in the context of stress.

A mixed methods approach will be used including:

a pre-test questionnaire and physiological measurements that depend on scales for measuring to assess sleep patterns: DASS21, fatigue assessment scale, Epworth sleeping scale, and SF-12 health survey scoring.

All of that will highlight the importance of addressing sleep quality as a crucial factor in promoting overall well-being.

This study aims to explore the relationship between sleep quality and its impact on mental and physical health, particularly in the context of stress.

A mixed methods approach will be used including: a pre-test questionnaire and physiological measurements that depend on scales for measuring to assess sleep patterns: DASS21, fatigue assessment scale, Epworth sleeping scale, and SF-12 health survey scoring.

All of that will highlight the importance of addressing sleep quality as a key factor in promoting overall well-being.

In conclusion, understanding the intricate relationship between sleep quality, stress, and mental and physical health is vital for promoting holistic well-being, developing effective interventions, and improving health outcomes at individual, community, and societal levels. By recognizing the significance of this research, we can work towards creating a healthier and more resilient population.

Eligibility Criteria:
Inclusion Criteria:

-university students between the ages of 18 and 35.

Exclusion Criteria:

* People with diseases and conditions can significantly affect sleep quality, cause fatigue, and impact mental and physical health along with relevant medications that might exacerbate these issues:

Diseases and conditions:

* Restless Legs Syndrome (RLS)
* Bipolar Disorder
* Fibromyalgia:
* Parkinson's Disease
* Multiple Sclerosis (MS)
* Thyroid Disorders

Medication:

* Sleep aids
* antidepressants
* diuretics
* antihistamines
* hormonal medications
* blood pressure medications