cyrilzakka/clinical-trials huggingface dataset:
Acupuncture for Prevention of Itch in Caesarean Section

This study aims to determine the effectiveness of using a commercially available acupuncture stud at the LI11 acupuncture point at reducing the severity of itch caused by intrathecal diamorphine in elective caesarean section.

Itch is a very common complication of diamorphine used in spinal anaesthesia for caesarean section with a local incidence of 78%. It ranges from irritating to distressing and difficult to treat and can adversely affect maternal satisfaction, wellbeing and bonding with their baby.

This trial aims to determine whether acupuncture using a commercially-available acupuncture stud at the LI11 point reduces the incidence and severity of post-operative itching in patients undergoing elective caesarean section under spinal anaesthesia with intrathecal diamorphine.

80 women having a planned caesarean section under spinal anaesthesia will be recruited by informed consent and randomised to the intervention group or the control group. The intervention group will receive an acupuncture stud at the LI11 point on either arm and the control group will receive acupuncture with a similar stud containing a smaller needle at a non-acupuncture point on either arm. The stud can be left in-situ until the followup visit the following morning or removed earlier at the participants discretion. All other care will be the usual clinical care including access to anti-itching drugs as required. Participants will be visited by a member of the research team at 3-5 hours following the start of their spinal anaesthetic and asked to mark their itch on an 11 point visual analogue scale (VAS). They will also be visited by a member of the research team the following morning, asked to rate their worst itch on the same scale and asked how troublesome they have found their itch (none, mild, moderate, severe). The administration of any anti-itch drugs will be recorded and if the acupuncture stud has not been removed it will be removed at this time.

If effective, acupuncture with an acupuncture stud would provide an acceptable, convenient, safe and cost-effective treatment.

Eligibility Criteria:
Inclusion Criteria:

* ASA1-3 patients with uncomplicated pregnancies undergoing elective caesarean section with a plan for spinal anaesthesia with intrathecal diamorphine.

Exclusion Criteria:

* Age under 18.
* Pre-existing itch or conditions associated with itch (eg cholestasis of pregnancy).
* Pre-existing use of H1 receptor antagonists, non-selective antihistamines or ursodeoxycholic acid.
* Severe perioperative complication or fetal death.
* Conversion to general anaesthesia.
* Unable to understand written and spoken English.
Habit Building Software Application to Increase Engagement of Vulnerable Populations in the National Diabetes Prevention Program (NDPP) Lifestyle Change Program (LCP)

The goal of this clinical trial is to learn whether a companion software application can improve program engagement in the National Diabetes Prevention Program in adults with prediabetes. The main question\[s\] it aims to answer \[is/are\]:

Do participants using the software application (the intervention group) have better engagement with the Diabetes Prevention Program than those who do not use the companion software application (the control group)? Are participants using the software application (the intervention group) more likely to stay in the Diabetes Prevention Program longer than those who do not use the companion software application (the control group)?

Participants are those who have signed up for their local Diabetes Prevention Program and agree to be in the study.


Eligibility Criteria:
Inclusion Criteria:

* is eligible for and enrolls in a live or distance LCP at a designated study site during the enrollment period of the study
* has a smartphone or other device able to engage with the FT LCP app
* can read basic 5th grade English, as used in the FT LCP app

Exclusion Criteria:

* Cohorts and sites enrolled in concurrent, similar health app-based studies
Safety of Insulin Detemir for the Treatment of Insulin Dependent Type 1 or Type 2 Diabetes Mellitus

This trial is conducted in North America. The aim of this trial is to evaluate the safety of insulin detemir for the treatment of diabetes.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with type 1 or type 2 diabetes
* Using a basal/bolus insulin regimen

Exclusion Criteria:

* Subjects who are unlikely to comply with protocol, e.g., uncooperative attitude, inability to return for the final visit
* Subjects who previously enrolled in this study
* Subjects with a hypersensitivity to insulin detemir or to any of the excipients
Study of Bortezomib and Dexamethasone With or Without Elotuzumab to Treat Relapsed or Refractory Multiple Myeloma

The purpose of the study is to determine whether the addition of Elotuzumab to Bortezomib/ Dexamethasone will prolong the time before myeloma worsens \[progression free survival (PFS)\].


Eligibility Criteria:
For additional information, please contact the BMS oncology clinical trial information service at 855-216-0126 or email MyCancerStudyConnect@emergingmed.com. Please visit www.BMSStudyConnect.com for more information on clinical trial participation.

Inclusion Criteria:

* Documented progression from most recent line of therapy
* Measurable disease
* 1 to 3 prior lines of therapy

  * Subjects may be proteasome inhibitor naive or have received prior proteasome inhibitor therapy provided all the following criteria are met:

    1. The subject did not discontinue any proteasome inhibitor due to intolerance or grade ≥ 3 toxicity
    2. The subject is not refractory to any proteasome inhibitor, defined as progression during treatment or within 60 days after the last dose
    3. The subject previously achieved a partial response (PR) or better to previous proteasome inhibitor (PI)

Exclusion Criteria:

* Monoclonal gammopathy of undetermined significance (MGUS), smoldering myeloma, or Waldenstrom's macroglobulinemia
* Active plasma cell leukemia
* Known Human immunodeficiency virus (HIV) infection or active hepatitis A, B, or C
A Study to Assess the Effect of Rho-Kinase Inhibitor AR-12286 Ophthalmic Solution 0.5% and 0.7% in Patients With Uncontrolled Advanced Glaucoma With Prior Failed Trabeculectomy or Tube Shunt

A. To evaluate the ocular hypotensive efficacy of the rho-kinase Inhibitor (AR-12286 0.5% and 0.7%) ophthalmic solutions in glaucoma patients with failed prior glaucoma filtering surgery and uncontrolled IOP who are facing further surgical intervention. Patients will be treated for 6 months in this initial trial.

B. To evaluate the efficacy of AR-12286 in enabling treated patients to delay or avoid the necessity of further surgical intervention.


Eligibility Criteria:
Inclusion Criteria:

1. Patients older than 18 years of either sex.
2. Patients with open-angle glaucoma with prior glaucoma filtering surgery.
3. IOP above the target range or visual field progression.
4. Have given written informed consent, prior to any investigational procedures.
5. Ability to attend for the 6-month duration of treatment.

Exclusion Criteria:

1. Closed angle glaucoma (primary or secondary).
2. Known hypersensitivity to any component of the formulation (benzalkonium chloride, etc.), or to topical anesthetics.
3. Ocular medication of any kind within 30 days of base-line visit, with the exception of ocular hypotensive medications and/or lubricating drops for dry eye (which may be used throughout the study).
4. Any abnormality preventing reliable applanation tonometry of the treated eye.
5. Clinically significant systemic disease (e.g., uncontrolled diabetes, myasthenia gravis, hepatic, renal, endocrine or cardiovascular disorders) which might interfere with the study.
6. Participation in any investigational study within the past 30 days.
7. Inability to perform reliable visual field testing.
8. Unwilling to sign the consent form approved by the Institutional Review Board (IRB) of the New York Eye and Ear Infirmary.
9. Self-reported poor compliance to treatment.
10. Reluctance to return for scheduled follow-up visits.
11. Patients not able to understand the nature of the study.
French Registry of Adult Patients With Immune Thrombocytopenia and Autoimmune Hemolytic Anemia

CARMEN is a national, real-world clinical registry of all adult patients with incident diagnosis of Immune thrombocytopenia (ITP) or Autoimmune Hemolytic anemia (AIHA) patients in France. It is aimed at describing ITP and AIHA clinical features, assessing the real-world risk-benefit ratio of treatments and adherence to guidelines for ITP and AIHA management.


Eligibility Criteria:
Inclusion Criteria:

* adult patients (18+ year-old)
* newly diagnosed for ITP/AIHA or initiation of FOSFAMATINIB

Exclusion criteria:

- opposition to data collection
Multiple Dose Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Efficacy of THDBH120 in Chinese Patients With Obesity

The aim of this trial is to investigate the safety, tolerability, pharmacokinetics, and efficacy of THDBH120 injection in participants with obesity. This study includes three multiple-ascending dose cohorts.


Eligibility Criteria:
Inclusion Criteria:

* Age between 18 and 65 years (inclusive), male or female;
* Body mass index (BMI) ≥ 28 kg/m²;
* Diet and exercise control for at least 3 months before screening visit, and less than 5% self-reported change within the last 3 months.

Exclusion Criteria:

* Type 1 diabetes, type 2 diabetes, gestational diabetes, or other types of diabetes;
* History of obesity attributable to endocrine diseases, monogenic mutations, or drug-induced causes, such as hypothalamic obesity, pituitary obesity, hypothyroid obesity, Cushing's syndrome, insulinoma, acromegaly, or hypogonadism; or weight gain resulting from increased non-fat mass (e.g., edema);
* Presence of uncontrolled hypertension at screening: systolic blood pressure ≥160 mmHg and/or diastolic blood pressure ≥100 mmHg;
* Prolonged QTcF interval on 12-lead ECG at screening (QTcF≥450 ms for males, \>470 ms for females), PR interval \>200 ms, or the presence of long QT syndrome, second- or third-degree atrioventricular block, left or right bundle branch block, Wolff-Parkinson-White syndrome, or any other clinically significant arrhythmias (except sinus arrhythmia).
Efficacy/Safety of Midurethral Sling

The trans-obturator tape (TOT), which exhibits a satisfactory cure rate and a relatively diminished invasiveness, has been increasingly accepted as a surgical treatment of stress urinary incontinence (SUI) patients. Nevertheless, in contrast to the well-recognized therapeutic benefit of the enhanced resistance to the bladder continence during urine storage, if the voiding function of the bladder adapts to the TOT-enhanced outlet resistance has not been adequately investigated. This study retrospectively assayed the voiding efficacy of each voiding cycle, to clarify if the thermodynamic efficacy of the bladder was modified in response to the TOT surgery.

The urodynamic study included free uroflowmetry, postvoid residual, filling and voiding cystometry, and a urethral pressure profile. The filling cystometry and urethral pressure profile were performed with 37 degrees C normal saline similar to body temperature at an infusion rate of 80 ml/min. All patients received a pre- and a post-operative urodynamic evaluation, in which pre-operative evaluation was conducted 1-4 weeks before TOT procedure, and post-operative evaluation was done at 4-6 weeks follow-up.

Complete multichannel urodynamic studies including free uroflowmetry, filling and voiding cystometry, and urethral pressure profile was performed in each patient. The urodynamic parameters measured were the maximum flow rate (Qmax), voided volume, post-void residual volume (PVR), and detrusor pressure at Qmax (Pdet. Qmax). The filling cystometry and urethral pressure profile were performed with 37 degrees C normal saline at an infusion rate of 80 ml/min. All data were recorded and analyzed using a Medical Measurement Systems (MMS UD-200, Enschede, The Netherlands). All data in this study will be expressed as mean ± SEM. After checking the normality and variance of data, two-way ANOVAs were used to assess the difference in values among testing groups and time points; and post hoc Student-Newman-Keuls tests were used to compare the means of groups when there was a significant difference between groups. Significance was set at p\<0.05.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of stress urinary incontience
* Have urodynamic investigations before and after operation.

Exclusion Criteria:

* Exclusion criteria will be a history of (1) cardiovascular, (2) neurological, or (3) other medical (such as diabetes or inflammation) problems as well as (4) patients who received a concomitant surgical procedure.
SMART Program Impact on Quality of Life in Inflammatory Bowel Diseases

This research study is being done to look at the impact of a Stress Management and Resilience Training (SMART) Program on the quality of life and healthcare utilization of patients with inflammatory bowel disease.


Eligibility Criteria:
Inclusion Criteria:

* History of IBD defined by a physician global assessment (PGA) of quiescent, mild, moderate, or severe disease.
* Access to internet/device such as smart phone, tablet, or computer
* Patient reports stress as a trigger to their GI symptoms

Exclusion Criteria:

* Corticosteroids in the previous 3 months
* Elicit substance use (including medical marijuana)
Individualized Physiotherapy and Activity Coaching for Multiple Sclerosis

Multiple Sclerosis (MS) is a chronic neurological disease that places a high burden on patients, families and society. Physical activity in MS is associated with improved fitness, symptoms, and function, fewer relapses, and fewer brain lesions on MRI. Saskatchewan has one of the highest rates of MS worldwide, and a recent survey estimated approximately 80% of persons living with MS are not sufficiently active for health benefits. Individuals living with MS recognize the importance of physical activity, but often indicate a lack support, including limited access to professionals knowledgeable about both MS and physical activity. There is a need to identify effective interventions for improving activity levels safely and appropriately. Behaviour change strategies target specific behaviours involved in increasing and maintaining physical activity. The primary objective of this project is to determine if individualized behaviour change strategies delivered by neurophysiotherapists increases physical activity in MS. Participants will be randomly assigned into two groups. The intervention group will receive individualized behaviour change strategies delivered through the support of neurophysiotherapists for 12 months. The wait-list control group will receive usual care for 12 months, and then be offered the intervention for a 6-month period at the end of the study period. The long-term goal of this research is to help decrease the burden of MS by identifying new opportunities for increasing physical activity.


Eligibility Criteria:
Inclusion Criteria:

* clinically definite MS (diagnosed by a neurologist)
* patient determined disease steps (PDDS) less than or equal to 6 (i.e. not wheel-chair bound)
* GLTEQ\<24 (not active enough for health benefits)

Exclusion Criteria:

* medical instability (PAR-Q moderate-high risk of exercise-related harm)
* persons unable to provide consent
* persons under the age of 18 years old
Sclerotherapy of Internal Spermatic Veins in Patients With Varicocele and Localized Prostate Cancer

Patients with varicocele in whon early prostate cancer will be found will undergo venographic embolization of both spermatic veins. The study hypothesis is that this procedure will induce a gradual regression of the prostate volume that may decrease prostate cancer cells. Close follow-up will ensure that necessary therapy will be provided if needed according to clinical criteria. Results in terms of prostate size PSA level and tumor size will be recorded.


Eligibility Criteria:
Inclusion Criteria:

* Males age 45-75
* Prostate cancer
* Presence of varicocele
* No contraindication for venography

Exclusion Criteria:

* Diseases or medications which prevent interventional vascular procedures
Pre-emptive Low-dose Doxycycline During Anti-EGFR Treatment

Up to 60% of patients with metastatic colorectal cancer can be treated with one of monoclonal antibodies targeted against epidermal growth factor receptor (EGFR). This treatment is associated with a specific spectrum of toxicity: acne-like rash from limited up to erythema, often with severe pruritus, sometimes combined with other types of skin toxicities (hair and nail changes). Previously in STEPP study investigators shown that pre-emptive treatment with oral doxycycline (200 mg daily), topical steroids and sun blockers reduces the number of more severe skin side effects of panitumumab.

The study is designed to described the profile of skin toxicity of EGFR blocking drugs combined with low-dose doxycycline (100 mg daily) used in the pre-emptive manner.

Patients with metastatic colorectal cancer treated with cetuximab or panitumumab usually develop the skin toxicity which can impair patients' quality of life as well as limit the treatment. We designed this trial to assess the effect of simplified protocol of pre-emptive treatment on the observed skin toxicities during cetuximab and panitumumab treatment of colorectal cancer.

The study is a cohort observational, single center study which should result in estimation of particular types of toxicities, especially occurence of more severe (grade 2 and 3) side effects and assess the tolerance of doxycyline in the prolonged administration.

The observation in the study is biweekly and is continued up to 8 weeks.

Eligibility Criteria:
Inclusion Criteria:

* diagnosis of metastatic colorectal cancer,
* previously qualified to either cetuximab or panitumumab,
* written consent.

Exclusion Criteria:

* previous administration of cetuximab or panitumumab,
* contradictions to receive oral doxycycline.
Scar Prevention Using Fractional Carbon Dioxide Laser Treatment

In this study the investigators intend to determine the impact of fractional CO2 laser treatment on the edges of a fresh wound during surgical area closure on thin skin (e.g. face, hands, arms, thorax, etc.) and on thick skin (abdominoplasty procedure) on scar formation. The investigators will also evaluate the effect of shallow fractional laser treatment versus deep parameters settings. If effective treatments could be performed at time of surgery, this would result in both time and cost saving to the patient and to the healthcare system and will improve patient's self-image post surgeries.


Eligibility Criteria:
Inclusion Criteria:

* Male or Females
* At least 18 and no more than 65 years old
* The surgical area closure in these subjects should be at least 4cm
* Type of surgery scheduled:

Site 1: Surgical area closure on thin skin, including areas that require motion (e.g. face, hands, arms, thorax, etc.) Site 2: Surgical area closure on thick skin (abdominoplasty procedure)

* Willing to comply with study dosing and complete the entire course of the study

Exclusion Criteria:

* Active bacterial, fungal, or viral infection in the treatment area
* Active cold sores, or herpes in the treatment area
* Recent excessive exposure to sunlight or artificial UV light (e.g.: use of tanning beds/booths and/or sunbathing) or expectations of tanning during the time of the study
* History of skin cancer, unless the surgical procedure of issue is for cancer treatment purposes.
* History of or the presence of any skin condition/disease that might interfere with the diagnosis or evaluation of study parameters (i.e., atopic dermatitis, eczema, psoriasis)
* Treatment with a systemic retinoid within the past year (e.g., Accutane®, Roche Dermatologics)
* History or presenting with a keloid scar
* Any current or recent treatment for cancer, unless the surgical procedure of issue is for cancer treatment purposes.
* Any uncontrolled systemic disease. A potential subject in whom therapy for a systemic disease is not yet stabilized will not be considered for entry into the study
* Significant history or current evidence of a medical, psychological or other disorder that, in the investigator's opinion, would preclude enrollment into the study.
* Subject planning any other cosmetic procedure to the study area during the study period, other than the treatments that will be performed by the investigator
* Female subject who is pregnant, nursing an infant or is less than 6 months after termination of breast feeding
* Small surgical closure (\<4cm)
HI-VISION Pilot Study

A prospective cohort pilot study of non-cardiac patients to determine the feasibility of recruiting 150 patients to undergo postoperative continuous hemodynamic monitoring for up to 3 days.

Patient will start wearing the Philips' hemodynamic and ECG monitor in the Post Anaesthesia Care Unit (PACU). This device will continuously measure heart rate, pulse oxymetry, and ST-segments. The device will measure blood pressure every hour from 7 am to 10 pm and every 2 hours from 10 pm to 7 am.

Patients will have postoperative Troponin I monitoring and telephone follow-up at 30 days postop.

Eligibility Criteria:
Inclusion Criteria: We will enroll patients aged 45 years or older undergoing noncardiac surgery who fulfilled 2 or more of the following risk factors:

* History of coronary artery disease
* History of stroke or transient ischemic attack (TIA)
* History of hypertension
* History of diabetes
* History of peripheral vascular disease
* History of congestive heart failure
* Preoperative creatinine \> 175 umol/L
* A planned admission for ≥48 hours
* Patients receiving a general or regional anesthetic

Exclusion Criteria:

* Patients unable to provide informed consent.
* Patients who undergo procedure performed under infiltrative or topical anesthesia.
* Patients previously enrolled in the HI-VISION Study.
* Patients who refuse 30-day follow-up.
Feasibility and Acceptability of Group Pain Reprocessing Therapy for Veterans With Chronic Neck/Back Pain

The investigators are conducting a trial that evaluates the feasibility of telehealth group pain reprocessing therapy (PRT), with no comparison group, for the treatment of chronic back pain in a population of veterans. PRT is a psychotherapy for chronic pain that aims to help patients reconceptualize their pain as a non-dangerous signal. It has been shown to be effective in a previous RCT (n=151).


Eligibility Criteria:
Inclusion Criteria:

* At least 6 months of back pain with last week average back pain at least 4/10
* Able to attend at least 7/8 telehealth group sessions
* Access to safe living space, quite room, reliable internet, and electronic device that can be used to attend telehealth therapy sessions.

Exclusion Criteria:

* Leg pain that is worse than back pain
* Suicide attempt, SI, HI, or inpatient psychiatric hospitalization in the past 5 years
* Not receiving/has not received disability or workers compensation related to back pain in the past 2 years.
* Is not currently involved in litigation regarding chronic back pain.
* Current misuse or overuse of alcohol or drugs
* Major surgery or other major medical events in the next 6 months
* Known vertebral/spinal fracture or tumor.
* Back surgery within last 2 years
* Difficulty controlling bowel movements
* Current or recent diagnosis of cancer
* Current or recent diagnosis of severe cardiovascular disease
* Unexplained or unintended greater than 20 pound weight loss in the past year
* Diagnosis of rheumatoid arthritis, polymyalgia rheumatica, scleroderma, Lupus, polymyositis, or other specific inflammatory disorders