cyrilzakka/clinical-trials huggingface dataset:
Pilot Trial of Opioid Taper Support

The proposed research will develop, demonstrate the feasibility of, and pilot test in a randomized controlled trial a prescription opioid taper support intervention. This intervention aims to prevent opioid misuse and adverse events among patients receiving chronic opioid therapy for chronic non-cancer pain without evidence of current substance abuse.

The project will yield information essential to planning a future, larger-scale RCT designed to evaluate: 1) the efficacy of the intervention in preventing prescription opioid abuse, misuse, overdose and other adverse events among patients receiving chronic opioid therapy for chronic non-cancer pain, 2) the effects of the intervention on opioid use, pain, pain related activity interference, and mood. Participants in our pilot study will be limited to those without current opioid abuse or other substance abuse, but past substance abuse will be allowed. This will provide a sample of patients at risk for opioid abuse, misuse and overdose, but who may be able to taper their opioids successfully. Hypothesis: Patients receiving chronic opioid therapy for chronic non-cancer pain who are randomized to the opioid taper support intervention, as compared with patients randomized to usual opioid prescribing care, will have lower opioid average daily doses at 22 and 34 weeks.


Eligibility Criteria:
Inclusion Criteria:

* age 18-80 years;
* CNCP, defined as pain on more than half the days in the past six months, where indicated diagnostic workup is complete and treatment is focused on pain;
* currently on COT, defined as self-report of prescribed oral opioid medication use on a daily or near-daily (\>90% of days) basis for 90 days or more;
* mean daily opioid dose in the past 30 days of 25 mg MED or greater;
* willing to participate in the study arm to which they are randomly assigned (including opioid taper in-person sessions if randomized to that group);
* able to read, speak, and write English.

Exclusion Criteria:

* currently receiving treatment for cancer (other than non-melanoma skin cancer);
* medical comorbidity with life expectancy less than a year (based on medical record review by the PI);
* recent use (past month) of parenteral, transdermal, or transmucosal opioids,
* currently residing in nursing home;
* currently using intrathecal pump for pain control;
* any current substance abuse according to the DSM-IV checklist (nicotine and marijuana will be allowed since Washington State allows medical marijuana for pain control);
* presence of illicit drug metabolite in baseline urine drug test,
* psychotic symptoms, psychiatric hospitalization or suicide attempts in the past year;
* current suicidal ideation with specific plan or intent;
* significant cognitive impairment (on 6-item screener Scale).
Ultrasound Guided Versus Conventional Arthrocentesis in Treatment of Temporomandibular Joint Internal Derangement.

The use of Ultrasound as a guide in arthrocentesis of tempromandibular joint versus conventional anatomically guided arthrocentesis in treatment of temporomandibular joint internal derangement: A randomized clinical trial.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients aged 16 to 45 years of age having temporomandibular joint internal derangement.
* Patients free from any systemic conditions and bone metabolic diseases that might interfere with the surgical intervention, soft tissue or hard tissue healing.
* ASA 1-2 patients with no contraindications for GA
* Patients who did not respond to conservative treatment.

Exclusion Criteria:

* Patient with uncontrolled systemic diseases precluding administration of general anesthesia.
* Handicaps and special needs patients.
* Prisoners.
Serratus Anterior Plane (SAP) Block vs SAP Block Combined With Transverus Thoracic Plane (TTP) Block, for Post-mastectomy Pain Control.

a comparison shall be conducted between Serratus anterior plane block, on one hand, and transversus thoracic plane block combined with Serratus anterior plane block, on the other hand for management of post-mastectomy pain. VAS "Visual Analogue Scale" score will be compared in both case, and control groups.

Breast cancer is one of the most common cancers in women all over the world. In the united states, according to the CDC "Center of Disease Control", it's the second most common cancer occurring in women. Perioperative pain after breast surgeries remains to be taken lightly due to the minimal invasiveness of breast surgeries. However, it is estimated that 25-60% of patients undergoing breast cancer related surgeries develop chronic pain. Acute post-operative pain remains an important risk factor in developing chronic post-mastectomy pain; about 40% of women will have acute post-operative pain, on the other hand, 50% will have chronic pain. Different regional anaesthesia techniques have achieved better management of post-breast surgery acute pain and subsequently less frequent chronic pain. Add to that, effective regional anaesthesia will decrease both the surgical stress response and the requirements of general anaesthetics and opioids, which will keep the function of the immune system intact. A lot of regional anaesthesia techniques have been used to control anterior chest wall pain as the pectoral nerves (PECs) block, paravertebral block, intercostal nerve blocks, thoracic epidural analgesia, serratus anterior plane block. The breast receives its innervation through the anterior and lateral cutaneous branches of the 2nd to the 6th intercostal nerves. Targeting the serratus plane is a safer and a simpler procedure than multiple intercostal or paravertebral blocks. As a setback for the serratus anterior plane block, it only blocks the lateral cutaneous branches of the intercostal nerves with minimal if any effect on the anterior cutaneous branches. The serratus anterior plane block, being unable to block the anterior cutaneous branches of the intercostal nerves, have to be combined with another technique, transversus thoracic plane block, which can block them. The investigators here are trying to measure the efficacy of the combined serratus anterior plane block and tranversus thoracic plane block on the management of post-mastectomy pain.

Eligibility Criteria:
Inclusion Criteria:

* Adult female patients \> 30 years old, ASA "American Society of Anaesthesiologists" physical status I or II undergoing any unilateral mastectomy.

Exclusion Criteria:

* Patient's refusal.
* Known contraindications to regional blocks, including local skin infections,and coagulopathy.
* Allergies to the local anaesthetics used.
Effect of HSV-2 Suppressive Therapy on Sexual Behavior

The purpose of this study is to determine what effect suppressive therapy has on sexual behavior and quality of life among persons with genital herpes (HSV) who have multiple sex partners.

Study terminated; investigator relocated and study funding ended. Results were never analyzed because data were not collected.

We plan to conduct a randomized controlled trial of chronic suppressive acyclovir, 400 mg orally twice daily (standard dose) versus episodic acyclovir for treatment of genital herpes recurrences. We will enroll 500 HSV-2 seropositive single persons (250 per arm), stratified by gender and history of symptomatic genital herpes, and prospectively follow them for 1 year to assess sexual behavior, adherence to therapy, and herpes-related quality of life. These outcomes will be measured by self-report in a confidential, computer-based assessment. We plan to use data from this trial to model the effect that increasing the proportion of sexually-active HSV-2 infected persons taking suppressive therapy will have on population-level incidence and prevalence of HSV-2.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 years or older
* HSV-2 seropositive by Western blot OR documented culture positive for HSV-2 from anogenital site
* 2 or more vaginal or anal sex partners in the past 12 months
* Not currently in a monogamous sexual relationship of \>= 6 months duration
* Willing and able to be randomized and comply with the study protocol

Exclusion Criteria:

* Pregnancy or intention to become pregnant within the next year
* Suppressive therapy with acyclovir, valacyclovir, or famciclovir within 2 weeks of enrollment/randomization
* 6 or more symptomatic herpes recurrences in the prior 12 months or in the 12 months prior to starting suppressive therapy if on suppressive therapy during the prior 12 months
* HIV seropositive or known immunocompromising medical condition. HIV negative test must be performed within 60 days of Visit 1 (enrollment/randomization). For current or former participants in HIV vaccine clinical trials for whom HIV vaccine-induced seropositivity potentially leading to vaccine study unblinding may be a concern, a report from the Seattle HVTU documenting that the participant is HIV uninfected based on HIV testing done within 60 days of Visit 1 will be accepted in lieu of HIV testing done at our clinic.
* Intention to move from the Seattle area within the next year
* Known allergy, intolerance, or medical contraindication to acyclovir
* Inability to understand, speak, and read English
Intraoperative Dual-modality Imaging in Renal Cell Carcinoma

Intraoperative tumor localization and resection can be enhanced using intraoperative fluorescence imaging and radiodetection. Girentuximab specifically recognizes carbonic anhydrase IX expressed on \> 95% of renal cell carcinoma (RCC). Therefore Indium-111-DOTA-girentuximab-IRDye800CW is a perfect dual-labeled antibody for dual-modality image-guided surgery in RCC.

The aim of this study is to assess the feasibility and safety of intraoperative dual-modality imaging with Indium-111-DOTA-girentuximab-IRDye800CW in renal cell carcinoma patients.

In oncologic surgery complete tumor resection is important for treatment outcome and patient survival. Intraoperative tumor localization and resection can be enhanced using intraoperative imaging techniques (e.g. targeted radioguided or fluorescence guided surgery). A powerful synergy can be achieved by combining radiotracers (e.g. Indium-111) and optical tracers (e.g. IRDye 800CW) conjugated to an antibody against a tumor-associated antigen. Girentuximab specifically recognizes carbonic anhydrase IX expressed on \> 95% of renal cell carcinoma (RCC). Therefore Indium-111-DOTA-girentuximab-IRDye800CW is a perfect dual-labeled antibody for dual-modality image-guided surgery in RCC. The concept has been shown in preclinical studies with mice and the investigators will translate this to the clinic.

Eligible patients with renal cell carcinoma scheduled for (partial) nephrectomy will receive dual-labeled girentuximab 7 days before surgery. At day 4 or 5 a SPECT/CT of the abdomen will be obtained. Surgery at day 7 will be extended with the use of a near-infrared fluorescence camera and a gamma probe.

The aim of this study is to assess the feasibility and safety of intraoperative dual-modality imaging with Indium-111-DOTA-girentuximab-IRDye800CW in renal cell carcinoma.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of clear cell renal cell carcinoma planned for surgery, (partial) nephrectomy
* Performance status: Karnofsky 70 %
* Being fit for surgery
* Minimum age 18 years
* Signed informed consent

Exclusion Criteria:

* A known subtype other than clear cell RCC
* Any medical condition present that in the opinion of the investigator will affect patients' clinical status.
* Administration of a radioisotope within 10 physical half lives prior to study enrollment
* Pregnancy and lactation
Prospective Use of Awake Endoscopy for Inspire Activation

The aim of this study is to examine a new method of device configuration for the Inspire upper airway stimulator. First, the investigators will attempt to determine optimal configuration by quantifying changes in upper airway size with different implant configurations using awake nasal endoscopy. The configuration/voltage that results in the greatest increase in upper airway size and is tolerated by the patient will be selected. Participants will then undergo a sleep study so that increased airway size may be correlated with changes in sleep study parameters including AHI and oxygen desaturation index (ODI). Airway size and sleep study parameters using the standard device configuration (+-+)/voltage will be compared to airway size and sleep study parameters using the test, or "optimal," configuration/voltage to determine the usefulness of awake endoscopy in activation of the Inspire device.


Eligibility Criteria:
Inclusion Criteria:

* Patients with moderate to severe OSA who have undergone Inspire UAS implantation by the principal investigator
* Must have symptoms of OSA prior to Inspire implantation
* AHI between 15 and 65, where central and mixed apnea is 25% or more, and the level of collapse is in the soft palate area BMI less than 32
* Age 18 or above

Exclusion Criteria:

* Significant central sleep apnea
* Presence of other sleep disorders
* History of neurologic or neuromuscular disease
* Historical or present substance abuse
* Bleeding disorders
* Autoimmune diseases that increase risk of nasal trauma such as Wegener's, Sarcoidosis, etc.
* Pregnancy
7.5F Versus 9.2F Flexible Ureteroscopy for the Treatment of 1-2cm Renal Calculi on Postoperative Infection

Ureteroscopic lithotripsy (RIRS) is the first-line treatment for 1-2 cm upper urinary tract stones, and the stone clearance rate can reach 81.4% - 92.5%. Fever after RIRS is the most common infection after RIRS, and its incidence is up to 20%. The incidence rate of systemic inflammatory response syndrome is 6.5% - 10.3%, sepsis 0.1% - 4.3%, with the infection progressed. If there is no timely and effective intervention in the early stage of urogenic sepsis, it can progress to septic shock, and the mortality can be as high as 30% - 40%. High intrarenal pressure is an important risk factor for postoperative infection. American Urological Association (AUA) guidelines point out that controlling intrarenal pressure at an appropriate level is particularly important to prevent postoperative infection.

The use of ureteroscopic sheath in ureteroscopic surgery can effectively reduce the intrarenal pressure, which is an important measure to reduce the incidence of postoperative infection. Theoretically, the larger the space, the better the reflux effect and the lower the incidence of postoperative infection. The study showed that the incidence of ureteral sheath infection was significantly lower than that of ureteral sheath infection after operation. When using the same caliber ureteroscopic sheath, use a smaller caliber ureteroscopy to increase the space between the ureteroscopy and the ureteral sheath, promote reflux, reduce intrarenal pressure and reduce the incidence of postoperative infection. However, there is still a lack of relevant research on the effect of different caliber ureteroscopy in the treatment of renal calculi on postoperative infection.


Eligibility Criteria:
Inclusion Criteria:

1. Agree to receive ureteroscopy
2. Aged 18-70 years. 3.1-2cm kidney stones

Exclusion Criteria:

1. Combined with middle and lower ureteral calculi, surgical operation other than RIRS is required;
2. Patients with abnormal anatomical structure, ureteral stenosis and urinary diversion, such as ectopic kidney, horseshoe kidney and duplicate kidney;
3. Patients who have undergone nephrostomy;
4. Severe cardiopulmonary insufficiency;
5. Pregnant women.
Comparison of Azathioprine to Methotrexate in Combination Therapy With Adalimumab in Crohn's Disease: an Open-label Randomized Controlled Trial

Combination therapy, the association of an anti-Tumor Necrosis Factor (TNF) to an immunosuppressant, is recognized as the most effective treatment during Crohn's disease (CD). Several mechanisms have been proposed to explain the superiority of combination therapy over monotherapy, the additive effect of two effective drugs or the prevention of anti-TNF immunogenicity. As the best combination therapy is unknown, both azathioprine (AZA) and methotrexate (MTX) are used. Some retrospective studies suggest a higher effectiveness of AZA. MTX may have an advantage in terms of safety.

The investigators hypothesize that AZA is more effective than MTX as combination therapy with adalimumab to improve short-term endoscopic, clinical and pharmacological outcomes in CD patients.


Eligibility Criteria:
Inclusion Criteria:

* Male or female patients with age \> 18 years
* Crohn's disease for at least 6 weeks,
* Clinically active with CDAI \> 150
* Active inflammation by endoscopy (CDEIS \> 4) at baseline
* Not responder to conventional therapy or are intolerant to or have medical contraindications for such therapies and initiating treatment with adalimumab
* Patient followed in a center belonging to the GETAID network
* Fertile men and women of childbearing potential included in the protocol should use adequate methods of contraception according to study drug SMPCs.
* Written consent

Exclusion Criteria:

* Short bowel syndrome, ostomy, symptomatic stricture, abscess, recent history of abdominal surgery (\<3 months)
* Non-passable colonic stricture
* Previous intolerance to thiopurines or MTX
* Previous exposition to adalimumab
* Contra-indication to immunosuppressants or anti-TNF
* Others serious simultaneous illness that could interfere with study participation
* Planning pregnancy, pregnancy or lactation or absence of contraception
* Known substance abusers
* Use of any investigational drug within 30 days
* Adults protected by law
The Effect of Rebox Current in Pain Management

This post-marketing monocentric double-blind sham controlled crossover study will assess the efficacy of Rebox electrotherapy in the treatment of pain. Totally 72 patients will be treated with both real and sham Rebox device in a crossover design with a 1:1 ratio over a 6-week period. The degree of pain intensity reduction after the real Rebox stimulation will be evaluated in comparison with the sham stimulation. Moreover, differences in multidimensional aspects of pain will be compared between the real and sham stimulation.


Eligibility Criteria:
Inclusion Criteria:

* Patient with pain based on the following diagnoses:

  * Myofascial musculoskeletal pain
  * Vertebrogenic algic syndrome in the cervical, thoracic and lumbosacral regions
  * Sacroileitis with sacroiliac joint block
  * Cervicocranialgia
  * Frozen shoulder syndrome
  * Arthrosis
  * Epicondylitis
  * Pain in tendons, ligaments and other enthesopathies
  * Postoperative pain
  * Post-traumatic pain
  * Postherpetic neuralgia
* Duration of pain (de novo or exacerbation of chronic pain) prior to study inclusion ranges from 2 weeks to 3 months
* The average pain intensity in a given period of 2 weeks to 3 months prior to study inclusion must be NRS (Numerical Rating Scale) \>3
* The patient may be concurrently treated with analgesics and may be undergoing manual physiotherapy (rehabilitation)

Exclusion Criteria:

* Age \<18 years
* Local contraindications:

  * Impaired skin integrity at the site of application (open wound, skin ulcer, burns), Note: the area around the postoperative scar is not an exclusion criterion
  * Acute inflammation of the skin or subcutaneous tissue at the application site
  * Deep vein thrombosis (diagnosed or suspected)
* General contraindications:

  * Implanted electrical device (pacemaker, implantable cardioverter-defibrillator, deep brain stimulator, cochlear implant, etc.)
  * Pregnancy
  * Epilepsy
  * Malignant cancer (diagnosed or suspected)
  * Acute potentially life-threatening conditions
* Concomitant other physical therapy (electrotherapy, magnetotherapy, laser therapy, ultrasound therapy, mechanotherapy, etc.)
* The Rebox device was administered to the subject for any indication in the last 12 months prior to the study inclusion date
* A recent change in analgesic medication (i.e., new agent or change in agent dose less than 1 week prior to the first stimulation session) or a planned change in analgesic medication during the course of the study (change in agent, change in dose), Note: modification of analgesic medication during the study is possible but must be recorded
* Ongoing acute infection, surgery or trauma during the study
* Concurrent subject participation in another clinical study
* Subject is unable to sign informed consent
Bariatric Atrial Restoration of Sinus Rhythm

The objective of this study is to determine whether bariatric surgery followed by Atrial Fibrillation (AF) catheter ablation is superior to AF catheter ablation alone in the management of atrial fibrillation in patients with morbid obesity.

This will be a multicenter, randomized, controlled, 1:1 allocation trial comparing Atrial Fibrillation (AF) catheter ablation only (Group A) to those undergoing bariatric surgery six months prior to AF catheter ablation (Group B) in patients with paroxysmal or persistent AF who also have morbid obesity.

Participants will be followed for 12 months after their protocol-assigned catheter ablation. Scheduled visits Group A will be at baseline, 3, 6, and 12 months post AF ablation. Scheduled visits in Group B will be baseline, clinical visit prior AF ablation, and at 3, 6, and 12 months post AF ablation. At each post ablation visit the following data will be collected:

AT/AF recurrence determined by ambulatory monitoring, clinic visit, or hospitalization; Physical Exam (weight, height, vitals); 12 lead ECG; Medication Regimen; AF Symptom Severity Scale (AFSS); Quality of Life (AFEQT); Laboratory Testing; and Adverse Events

Eligibility Criteria:
Inclusion Criteria:

* Symptomatic persistent or paroxysmal AF refractory to at least one antiarrhythmic agent
* EF \> 40%
* BMI \> 40 or BMI \> 35 and at least one of the following co-morbidities:

  * Type 2 Diabetes Mellitus (by American Diabetes Association diagnostic criteria).
  * Systolic blood pressure of 130 mmHg and/or diastolic blood pressure 80 mmHg or higher despite medical treatment with maximal doses of three antihypertensive medications).
  * Refractory hyperlipidemia (acceptable levels of lipids unachievable with diet and maximum doses of lipid lowering medications).
  * Obesity-induced cardiomyopathy.
  * Clinically significant obstructive sleep apnea.
  * Obesity-related hypoventilation.
  * Pseudotumor cerebri (documented idiopathic intracerebral hypertension).
  * Severe arthropathy of spine and/or weight-bearing joints (when obesity prohibits appropriate surgical management of joint dysfunction treatable but for the obesity).
  * Hepatic steatosis without evidence of active inflammation.
  * Hypertriglyceridemia
  * Polycystic Ovary Syndrome (PCOS)
  * Asthma
  * Coronary Artery Disease (CAD)

Exclusion Criteria:

* Prior bariatric surgery
* Prior AF catheter ablation
* BMI \> 65 kg/m2
* Contraindication to bariatric surgery or AF ablation
* Contraindication to therapeutic anticoagulation
* Sustained AF lasting more than 3 years
* Left atrial diameter of greater than or equal to 60 mm or LA volume greater than or equal to 60 ml/m2