cyrilzakka/clinical-trials huggingface dataset:
802NP302 Efficacy and Safety Study of BIIB074 in Participants With Trigeminal Neuralgia

The primary objective of the study is to evaluate the efficacy of BIIB074 in treating pain experienced by participants with trigeminal neuralgia (TN).

The secondary objectives are to investigate the safety and tolerability of BIIB074 in participants with TN and to evaluate the population pharmacokinetic(s) (PK) of BIIB074.


Eligibility Criteria:
Key Inclusion Criteria:

* A diagnosis of trigeminal neuralgia (TN) for at least 3 months based on International Headache Society (IHS) diagnostic criteria.
* Participant must have failed at least 1 prior standard of care pharmacologic treatment for TN (defined as an inadequate response or intolerance to treatment), as determined by the Investigator based on medical history.
* Age ≥18 years at the time of informed consent.
* Participants must have recorded their pain score in their eDiary on at least 5 days during the run-in period (Days -7 to -1).
* Allowed concomitant medications must have been stable for at least 4 weeks prior to Day 1 of the dose-optimization period. The maximum dosage of carbamazepine allowed on Day 1 is 400 mg/day (or 600 mg/day for oxcarbazepine).

Key Exclusion Criteria:

* History or positive test result at Screening for hepatitis C virus antibody or current hepatitis B infection (defined as positive for hepatitis B surface antigen \[HBsAg\] and/or hepatitis B core antibody \[HBcAb\]).
* Positive history of human immunodeficiency virus (HIV) or a positive HIV test at Screening.
* Participants with facial pain other than TN.
* Personal or family (first-degree relative) history of seizures (except for simple febrile convulsions) or clinically significant head injury.
* Positive drug screen for drugs of abuse at Screening (amphetamine \[methamphetamines and 3,4-methylenedioxymethamphetamine\], phencyclidine, barbiturates, benzodiazepines, cocaine, opioids) except if explained by use of allowed prescription medicines. Prospective subjects with a positive screen for tetrahydrocannabinol must agree to discontinue use upon study enrollment and for the duration of the study.
* Known hypersensitivity to BIIB074 or components of the BIIB074 formulation or matching placebo.

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply
Weight Bearing Status Post-hip Arthroscopy

This study is being proposed to examine weight bearing precautions following hip arthroscopic labral repair, femoroplasty, and capsular closure. Standard post operative protocols limit weight bearing for 2-6 weeks depending on individual surgeons. Cadaveric studies demonstrate that minimal force during weight bearing is distributed through labrum. Therefore, progressing weight bearing earlier in these patients post operatively may help progress faster and improve outcomes. Data collected will include demographic information, radiological data, operative procedures and PRO data.

The study will be conducted at UPMC St. Margaret's Hip Preservation Program. Consented patients who undergo acetabular labral repair and femoroplasty will be included in randomization of weight-bearing status. Two separate protocols will be created to indicate weight bearing status, either WBAT immediately post-op or FFWB immediately post-op, to distribute to rehabilitation staff to ensure compliance. Immediately after the surgical procedure, the surgeon will be blinded and a randomized pamphlet with post-operative instructions with weight bearing education will be given to PACU nursing staff to educate patients and fit crutches.

Eligibility Criteria:
Inclusion Criteria:

* Age\>= 12 years
* Diagnoses: femoroacetabular impingement and hip labral tears.
* Surgical procedures performed: Hip arthroscopy with femoroplasty and labral repair.
* Surgery completed at UPMC Children's or UPMC St. Margaret's Hospital
* unilateral and bilateral hip patients

Exclusion Criteria:

* MSK tumor-related FAI or dysplasia
* generalized hypermobility
* revision surgeries
TAP Block Versus Local Anesthesia Wound Infiltration for Postoperative Pain Relief After Appendicectomy in Children

When performing laparoscopic appendectomy in children, regional anesthetic techniques are rou-tinely used concomitantly with general anesthesia. These techniques include local infiltration of the trocar wounds or transverse abdominal plane block (TAP block). In 2018, a position paper of the European Society of Pediatric Anaesthesiology advised for TAP block over local infiltration of the trocar wounds. However, there is no randomized study comparing both techniques in children. The aim of this study is to compare morphine consumption during the first 24 postoperative hours in children undergoing laparoscopic appendectomy and randomly allocated to either local infiltration of the trocar wounds or TAP block.

This is a double blind randomized study with two parallel groups. Children between 3 and 15 years of age with indication of laparoscopic appendectomy will be approached for inclusion in this trial. Informed consent will be asked for from the parents and the child. Before surgery, patients will be randomized to either local infiltration of the trocar wounds or TAP block using sequentially numbered sealed envelope each with a random number inside. Patients with peritonitis will be excluded. A standardized analgesia protocol within the first 24 post-operative hours will be applied and the primary outcome is nalbuphine consumption during this time frame. Secondary outcomes include postoperative pain (FLACC assessment tool) and postoperative nausea and vomiting.

Eligibility Criteria:
Inclusion Criteria:

* Age betwween 3 and 15 years
* Weight \< or = 50 kg
* indicaction of coelioscopic appendicectomy
* ASA 1,2 or 3
* consent of the children and the holder of parental autority

Exclusion Criteria:

* Age\<3 years or \> 15years or weight \> 50kg
* refusal of the children and the holder of parental autority
* ASA 4
* Peritonitis
* Patients with long term morphinic traitment
* Epilepsy
* Hepato-cellular insuffisiancy
* local anesthesia allergy or nalbuphine allergy
* coagulation abnomrmality
* exclusion of health insurance
Breast Reconstruction and Body Map : Assessment by Functional MRI (REMASCO)

Breast reconstruction is an integral part of the management of patients with breast cancer and treated by total mastectomy. The aim of breast reconstruction is to get a satisfying aesthetic and functional result (sensitivity) and that would enable the patient to appropriate the reconstructed breast. Patient satisfaction assessed subjectively by questionnaires would be better in autologous reconstructions than in reconstructions by prosthesis.

The aim of our trial is to use functional MRI (fMRI) as an objective evaluation tool to describe the brain functional changes of sensory projections after immediate or secondary breast reconstruction.

Patients responding criteria for selection and not objecting to participate in this trial will address a quality of life questionnaire at baseline. Then the study procedures differ depending on which group the patient belongs to.

Immediate breast reconstruction group : Six months after surgery (or six months after the implantation of the definitive prosthesis in case of use of a tissue expander), a postoperative fMRI will be performed and patients will be asked to complete a quality of life form and a satisfaction form.

Secondary breast reconstruction group :

* In the two months preceding the surgery, a preoperative fMRI will be performed.
* Six months after surgery (or six months after the implantation of the definitive prosthesis in case of use of a tissue expander), a postoperative fMRI will be performed and patients will be asked to complete a quality of life form and a satisfaction form.

Eligibility Criteria:
Inclusion Criteria:

1. Patient with an indication of unilateral total mastectomy with immediate breast reconstruction for initial breast cancer or recurrence, Or patient undergoing a unilateral secondary breast reconstruction
2. WHO performance status less than or equal to 2
3. Age ≥ 18 years
4. For patients of childbearing age, use of an effective contraceptive method for the duration of the study
5. Patient having been informed and having signed an informed consent form for the study.

Exclusion Criteria:

1. Patient undergoing a breast reconstruction by exclusive lipomodelling
2. Contraindication to MRI : claustrophobia, intra-orbital metallic fragment, pregnancy, cochlear implants, incompatible metallic foreign body such as certain pacemaker and mechanical valves
3. Patient with an indication of preoperative radiotherapy or adjuvant chemotherapy according to regional and/or national standards
4. History of brain surgery
5. History of contralateral breast surgery
6. History of prophylactic total mastectomy
7. Reconstruction techniques using a mixed procedure (autologous + prosthesis)
8. Patient on medication that may alter the BOLD signal in MRI
9. Pregnant or breastfeeding women
10. Patient under tutorship or guardianship
Methotrexate as a Steroid-sparing Agent in Idiopathic Retroperitoneal Fibrosis: a Randomised, Multicenter Trial

Chronic periaortitis is a clinico-pathological entity encompassing idiopathic retroperitoneal fibrosis and perianeurysmal retroperitoneal fibrosis. The treatment of this disease is generally based on the use of glucocorticoids, which are often effective. However, prolonged steroid treatments are usually needed to achieve a sustained remission; additionally, patients frequently develop disease relapses following treatment discontinuation, therefore they may be exposed to high cumulative doses of glucocorticoids.

Preliminary data reported in the literature show that methotrexate may be effective in combination with prednisone for retroperitoneal fibrosis. In addition, methotrexate is often used as a steroid-sparing agent in different inflammatory diseases.

The aim of this study is to evaluate whether a treatment with low-dose prednisone plus methotrexate is non-inferior to conventional dose-prednisone in achieving remission in retroperitoneal fibrosis patients.


Eligibility Criteria:
Inclusion Criteria:

* New diagnosis of idiopathic retroperitoneal fibrosis or chronic periaortitis; written informed consent

Exclusion Criteria:

* Secondary forms of retroperitoneal fibrosis (e.g. drugs, surgery, neoplasms, infections)
* Previous medical therapy for retroperitoneal fibrosis
* Renal failure with creatinine \>2 mg/dl which proved not to be reversible after ureteral decompression
* Hypersensitivity to the study drugs
* Pregnancy
* Active infections or malignant neoplasms
Randomized Trial of Culture Directed Versus Empiric Antibiotics for Urinary Tract Infections in Older Women

To evaluate the feasibility of recruiting eligible subjects into a randomized trial of a culture-directed versus empiric antibiotic strategy for patient-reported UTI symptoms in older women and the adherence to study procedures.

To evaluate A) the feasibility of recruiting eligible subjects into a randomized trial of a culture-directed versus empiric antibiotic strategy for patient-reported UTI symptoms in older women and B) the adherence to study procedures. We will recruit and enroll women with a history of rUTI from the Women's Center for Bladder and Pelvic Health and the University of Pittsburgh's Clinical and Translational Science Institute (CTSI) Pitt+Me® Research Registry. Once enrolled and randomized, women will be followed for a total of 28 days to document both clinical resolution at day 7 from symptom onset and adverse events. H1) Enrolling a total of 70 subjects in \<1 year (at least 10% of eligible patients) will demonstrate feasibility of recruitment and H2) Documenting at least 70% patient compliance with study procedures will confirm patient adherence to study protocol. Exploratory Aim: To explore the safety of a culture-directed UTI treatment strategy and preliminary secondary outcomes of assigned treatments. H1) There will be an overall low number of adverse events and H2) Preliminary outcome data will help power future trial.

Eligibility Criteria:
Inclusion Criteria:

* Female biologic Sex
* Age ≥65 years old
* History of recurrent UTI per patient report of greater than 2 UTIs in the last 6 months or 3 UTIs in the last year
* Patient reported UTI defined as:

  * Dysuria, increased urinary urgency/frequency and/or suprapubic pain

Exclusion Criteria:

* Male biologic sex
* Age \<65 years old
* History of augmentation cystoplasty or cystectomy
* Currently performing clean intermittent self-catheterization
* Current indwelling foley catheter
* Urinary tract instrumentation (i.e., cystourethroscopy, foley catheter placement) in the last 30 days
* Undergoing treatment for malignancy
* History of either confirmed or patient reported pyelonephritis and/or urosepsis
* Cirrhosis and/or end stage liver disease
* Chronic kidney disease with most recent estimated glomerular filtration rate \<50 ml/min
* Dementia and/or currently reside in skilled nursing facility
* Current high-dose chronic steroids (\>20mg/day of prednisone)
* Previous solid organ transplant
* Provider concern for pyelonephritis and/or sepsis (i.e., fevers)
* Unwilling or unable to comply with study procedures
Inflammatory Responses to Acute and Chronic Opioid Exposure in Humans

We aim to examine the extent to which inflammation is affected by acute and chronic opioid exposure.

We are interested in learning how the immune system and the inflammation process is effected by acute and chronic opioid exposure. Preliminary evidence in animal models show that acute opioid exposure leads to decreased inflammatory responses, while chronic opioid exposure causes increased inflammatory responses, as measured by local cytokine release at the site of injury. Translating these findings to humans will lead to important new mechanistic knowledge that may ultimately improve our ability to treat pain.

Eligibility Criteria:
Inclusion Criteria:

* 18-60 years old
* Healthy volunteer
* Not allergic to remifentanil

Exclusion Criteria:

* Patients younger than 18 or older than 70
* Patients unwilling or unable to follow study instructions
* Patients who don't speak English
* Patients who are taking prescription opioid medications (e.g. vicodin, percocet) or are unwilling to refrain from taking anti-inflammatory medications such as Advil or Naproxen during 2 weeks prior to and during the 1 month study
4-Week, Multiple-dose, Dose-escalating Study In Patients With Type 2 Diabetes

This is a dose-escalating study in patients with Type 2 diabetes on metformin. Participants will receive an investigational product or placebo for 28 days.


Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes treated with a stable dose of metformin at least 500 mg
* HbA1c value between 7.0 and 10.5%

Exclusion Criteria:

- Type 1 diabetes or secondary forms of diabetes
Does Activity Feedback Increase ICD Patient Activity Levels?

Medical device technology for use by patients is gaining popularity. Modern cardiac disease management seeks to integrate multiple device technologies and capabilities to optimize health outcomes. Fitbit, Inc. manufactures a line of wireless-enabled activity, wearable trackers that are used in conjunction with a mobile device. The Fitbit trackers use three-dimensional accelerometers to sense and record movement. This technology represents a new frontier for patients and their health care providers to understand and track physical activity in real time. The primary aim of the current project is to assess whether activity feedback using FitBit technology affects implantable cardioverter defibrillator (ICD) patient activity level as measured by the ICD accelerometer. The investigators will also examine the perceived added value of Fitbit technology to an ICD patient user experience.

Approximately 50 participants will be recruited. Participants in the experimental group (n = 25) will use the Fitbit device for 12 weeks. The experimental group will receive fitness goals (number of steps per day) to increase activity from a baseline value to a minimum of 7000 steps per day by week 9 of the intervention. Both groups will receive weekly texts messages to encourage activity. Feedback about technology satisfaction, cardiac anxiety, cardiac self-care, and health care utilization will be elicited from patients at multiple time points. Additional information will be gained about patient decision-making as participants may elect to continue Fitbit use beyond the study period; this will allow for behavioral evidence of the perceived value of adding this technology.


Eligibility Criteria:
Inclusion Criteria:

* has a Medtronic ICD
* access to a smartphone, tablet, or computer with internet access
* English speaking

Exclusion Criteria:

-
Breast Fractionation Study - Standard Versus Investigational Fractionation Trial - Nodal Radiation

The purpose of this study is to investigate the difference in fatigue, quality of life and radiation morbidity between hypofractionated and conventional radiation to the breast, chest wall and regional lymph nodes post mastectomy or lumpectomy

Breast cancer is the most commonly diagnosed cancer in Australia. Radiotherapy to the breast, chest wall and regional lymph nodes for breast cancer after surgery can reduce the risk of local recurrence by 50% and reduce breast cancer mortality. Traditionally, radiotherapy is delivered in a large number of small doses i.e. 25 treatment sessions over 5 1/2 weeks. Another approach is to give a lower number of larger doses i.e. 15 sessions over 3 1/2 weeks (hypofractionated radiotherapy).

Several studies in Europe and Asia have investigated hypofractionated radiotherapy to the chest wall, breast and regional lymph nodes following surgery for breast cancer, and found that it is equally effective to standard treatment, with similar side effects. These two approaches have not been directly compared in Australia.

This trial is to compare these two approaches, to determine whether hypofractionated radiotherapy is better tolerated by patients.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 years and older
* ECOG performance status 0-2
* Ability to understand and willingness to sign a written informed consent document
* Stage pT1-3, pN0-3, M0 histologically proven breast cancer no matter the status of ER/PR/HER2 receptor testing
* Managed with either mastectomy or breast conserving surgery
* Suitable for radiation therapy to the breast/chest wall and regional lymph nodes
* Neoadjuvant and adjuvant systemic therapy with chemotherapy, endocrine therapy and anti-HER2 therapy is accepted
* Neoadjuvant radiotherapy (reverse sequencing) accepted
* Breast implants and expanders are accepted
* Patients with connective tissue disease are allowed if the treating radiation oncologist finds radiation therapy indicated
* Life expectancy minimum 10 years
* Patients with non-breast malignancies are accepted if the patient has been disease free for five years and/or has a low risk of recurrence as estimated by the treating radiation oncologist (to be determined at initial patient appointment)

Exclusion Criteria:

* Prior radiotherapy to the ipsilateral breast or chest wall
* Pregnancy or lactation
* Radiosensitivity syndrome
* Permanent pacemaker/defibrillator within radiotherapy field
* Oncoplastic surgery where boost volume unacceptable (clinician discretion)
* Conditions indicating that the patient cannot go through radiation therapy or follow up, or a condition where the treating oncologist thinks the patient should not participate in the trial (for example, language barriers)
Intensive Cholesterol-Lowering and CD8+ T Cells in Prostate Cancer

To test the hypothesis that intensive cholesterol lowering (iCL) therapy has anti-tumor immune modulating activity, the investigators will conduct an open-label, single-arm phase II trial in prostate cancer patients who are in active surveillance and undergoing a planned surveillance biopsy in 3-6 months. Eligible patients will initiate iCL with Vytorin®(group 1, 2, and 3), an FDA-approved combination of ezetimibe and simvastatin used to lower atherogenic low density lipoprotein cholesterol (LDL-C) or Ezetimibe (group 4). Starting dose will be determined by current statin use and LDL-C levels. Dose modifications of VYTORIN will be employed with the goal of achieving LDL-C \<70 mg/dl. Dose adjustment is not allowed for ezetimibe.


Eligibility Criteria:
Inclusion Criteria:

1. Provision of signed and dated informed consent form.
2. Stated willingness to comply with all study procedures and availability for the duration of the study.
3. At least one Atherosclerotic Cardiovascular Disease (ASCVD) risk factor, such as:

   1. ≥ 50 years of age
   2. Hypertension
   3. Hypercholesterolemia
   4. Diabetes
   5. Current or former smoker
   6. First-degree family history of any cardiovascular heart disease
   7. BMI \> 25
   8. On hypertension treatment, statin, and/or aspirin therapy
4. Patients with clinically localized prostate cancer. That is Low or intermediate risk prostate cancer deﬁned as:

   1. Pre-operative PSA (Prostate Specific Antigen) ≤ 20.0 ng/ml
   2. Clinical stage T1c or cT2
   3. Gleason score 3+3 or 3+4 or 4+3
5. Patients on AS with plans for surveillance biopsy
6. No previous treatment for prostate cancer with radiotherapy, chemotherapy, or hormonal therapy
7. Ability to take oral medication and be willing to adhere to once daily, oral Vytorin or ezetimibe.
8. Agree to avoid consumption of grapefruit and grapefruit juice ≥ one quart per day throughout study duration.

Exclusion Criteria:

1. Current use of medications contraindicated for use with a statin such as strong CYP3A4 inhibitors (e.g., itraconazole, ketoconazole, posaconazole, erythromycin, clarithromycin, telithromycin, HIV protease inhibitors, and nefazodone).
2. Current use of medications contraindicated for use with ezetimibe (i.e., gemfibrozil, cyclosporine, or danazol).
3. History of allergic or severe reaction to a either study agent.
4. History of moderate or severe myalgia with statin use.
5. Acute liver failure or decompensated cirrhosis
6. Already on maximum VYTORIN dose (10/80)
7. Already on medication(s) known to interact with Vytorin or Ezetimibe that may prevent protocol-based escalation of cholesterol-lowering therapy from pre-enrollment baseline.
8. Already on a PCSK9 inhibitor
Participant Reported Outcomes With Use of Trifarotene 50 μg/g Cream in the Treatment of Moderate Facial and Truncal Acne Vulgaris

Participant Reported Outcomes with use of Trifarotene 50 μg/g Cream in participants with Moderate Facial and Truncal Acne Vulgaris

There was no formal hypothesis to be tested. Approximately 50 subjects would be enrolled to evaluate the subject reported outcomes (quality of life and satisfaction survey). The sample size was not based on any formal hypothesis testing.

Eligibility Criteria:
Inclusion Criteria:

* The participant was a male or female, 9 years of age or older, at Screening visit.
* The participant had moderate acne at Screening and Baseline.
* The participant was a female of non childbearing potential.
* The participant was a female of childbearing potential with a negative pregnancy test and who was strictly abstinent or who agreed to use an effective and approved contraceptive method for the duration of the study and at least 1 months after the last study drug application.

Exclusion Criteria:

* The participant had severe forms of acne (e.g., acne conglobate, acne fulminant) or secondary acne form (e.g., chloracne, drug induced acne, etc.).
* The participant had any uncontrolled or serious disease or any medical or surgical condition that may either interfere with the interpretation of the trial results and/or put the participant at significant risk (according to the Investigator's judgment) if the participant took part to the trial.
* The participant had been exposed to excessive ultraviolet (UV) radiation within one month prior to the Baseline visit or the participant was planning intense UV exposure during the study (i.ed, occupational exposure to the sun, sunbathing, tanning salon use, phototherapy, etc.).
* The participant was unwilling to refrain from use of prohibited medication during the Clinical Trial.