cyrilzakka/clinical-trials huggingface dataset:
Effect of Nalbuphine and Naloxone on Experimentally Induced Skin Sensitivity

In previous clinical studies of post-surgical pain the investigators found that nalbuphine (Nubain), a narcotic pain killer, relieves pain more effectively when combined with low-dose naloxone (Narcan), a drug that is used to treat narcotic overdose. This finding was particularly true in men. The purpose of this study is to find out if nalbuphine combined with naloxone is more effective in relieving experimentally produced pain than either drug alone. A second reason for this study is to find out if study medications work more effectively in women or in men. Subjects will come to the University of California at San Francisco (UCSF) Clinical Research Center (CRC) for 4 study visits. The first visit will be a 2-hour screening to assess the subject for study eligibility. During the other three visits, the investigators will use a thermal stimulating device to produce temporary, non-injurious skin sensitivity that subjects will feel as painful. Changes in pain will be measured following the intravenous (i.v.) administration of study drugs. Three drug combinations will be administered, a different one each visit: 1) nalbuphine 5 mg and naloxone 0.4 mg , 2) naloxone 0.4 mg and saline (an inactive solution), nalbuphine 5 mg and saline. These drug combinations will be administered in random order; all subjects will receive all three combinations.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 - 40
* In stable health
* Speak, read, understand English language
* If female, must be non-lactating and not pregnant

Exclusion Criteria:

* Heat pain detection thresholds above 47 ºC/116.6 ºF
* Inability to develop secondary hyperalgesia from the heat and capsaicin stimulation performed at the screening visit
* Serious psychiatric psychopathology (psychotic disorder, substance abuse)
* Tattoos in the area of measurements
* Allergy to study drugs (nalbuphine, naloxone, or capsaicin)
* Current or recent use opioids
A Study to Evaluate Safety and Effectiveness of G-POEM for Gastroparesis

The purpose of this research is to evaluate the 12-month treatment effect of peroral endoscopic pyloromyotomy (G-POEM) vs. sham surgery in patients with gastroparesis that is not helped by medications and to analyze factors that may predict the outcome of the surgery.


Eligibility Criteria:
Inclusion Criteria:

* Symptoms of chronic nausea or vomiting compatible with gastroparesis (idiopathic or diabetic) must be present for at least one year (does not have to be contiguous) prior to registration.
* Must have a mean total Gastroparesis Cardinal Symptom Index (GCSI) score of ≥ 3 at screening visit.
* Refractory gastroparesis, defined using our previously published data5, as a failure to improve over the last 6 months, despite an adequate trial of one or more standard prokinetics (metoclopramide, erythromycin, prucalopride), antinauseants (5-HT3 antagonists, promethazine, prochlorperazine, dronabinol), or neuromodulators (mirtazapine, buspirone).
* Moderate to severe delay in gastric emptying, defined as \> 25% solid retained at 4 hours or \> 75% retained at 2 hours. The qualifying gastric emptying scintigraphy must be performed within 18 months prior to registration or can be the baseline gastric emptying.
* No evidence of mechanical obstruction based on upper GI endoscopy or upper GI series in their medical history.

Exclusion Criteria:

* Another active disorder which could explain symptoms in the opinion of the investigator.
* Gastric retention of solids at 4 hours \< 25% or \< 75% at 2 hours.
* Ongoing use of prokinetic agents (e.g., metoclopramide, erythromycin, prucalopride) GLP -1 analog or agonists, or drugs that slow down gastric emptying (narcotics). Neuromodulators such as tricyclic antidepressants (amitriptyline or nortriptyline) or others that are being used at stable doses for a month prior to randomization may continue at the discretion of the care provider.
* Significant systemic illness such as chronic renal failure (adjusted for age) or liver disease as defined by Child-Pugh score of 10 or greater.
* Poorly controlled diabetes with HbA1c of greater than 10% at time of screening.
* New medications for gastroparesis-related symptoms started within 1 month prior to registration.
* Pregnancy or nursing.
* Failure to give informed consent.
* Any other condition, which in the opinion of the investigator would impede compliance or hinder completion of the study.
* Botox injection into the pylorus within 3 months prior to registration.
* Allergy to eggs or Egg Beaters and Ensure.
Project FIRST - Financial Incentives to Reduce Substance Use and Improve Treatment

This study will test whether contingency management (monetary vouchers contingent on abstinence from drugs) that reinforces one behavior (achieving abstinence from drugs) leads to improved outcomes in other related behaviors (achieving HIV viral load suppression). In a randomized controlled trial, the investigators propose to test whether an abstinence-reinforcing contingency management intervention improves viral load suppression in HIV-infected drug users.

Using a randomized controlled study design, the investigators will test the efficacy of an abstinence-reinforcing contingency management intervention compared with a control condition (Performance Feedback) on HIV viral load suppression. The investigators will enroll 202 opioid-dependent HIV-infected individuals who are receiving opioid agonist treatment with buprenorphine or methadone, who continue to use opiates, oxycodone or cocaine (drugs that are consistently associated with poor HIV treatment outcomes), and who are prescribed antiretroviral medication, but with suboptimal viral load suppression. The contingency management group will have the potential to receive compensation in vouchers over the 16-week intervention based on drug-free urine. Participants will be followed for 28 weeks, with research visits occurring twice weekly during the Baseline Period (weeks 1-4) and Intervention Period (weeks 5-20), then every two weeks during the Post-Intervention Period (weeks 21-28). Data sources will include blood tests (viral load and CD4 count), urine toxicology tests, questionnaires, pill counts, and medical records. The primary outcome will be change in HIV viral load, and secondary outcomes will include CD4 count, antiretroviral adherence, and abstinence.

Eligibility Criteria:
Inclusion Criteria:

* at least 18 years old
* English or Spanish fluency
* HIV-infected
* Currently taking highly active antiretroviral therapy
* a) opioid use disorder and receiving opioid agonist treatment with methadone or buprenorphine, or b) cocaine use disorder
* urine toxicology positive for cocaine, oxycodone, or opioids during the run-in period
* detectable viral load while prescribed highly active antiretroviral therapy in the prior 6 months
* self-reported adherence to HAART \<100%

Exclusion Criteria:

* inability to give informed consent
* inability to follow the research protocol (e.g., visits twice weekly)
* frequent hospitalizations (\>2) in the prior 6 months
* currently with a chronic pain condition in which the participant has been prescribed opioid analgesics for longer than the past month
Effect Of PF-06305591 On Capsaicin And Capsaicin/Heat-Induced Neurogenic Flare

The purpose of this study is to examine the effect of PF-06305591 on capsaicin and capsaicin/heat-induced neurogenic flare.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male Caucasian subjects with skin type I-III inclusive (Fitzpatrick Scale), between the ages of 18 and 55 years, inclusive (Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12 lead ECG and clinical laboratory tests).
* An informed consent document signed and dated by the subject.
* Subjects must have a distance from base of scaphoid to antecubital fossa equal of greater to 26 cm on their forearms.
* Subjects who demonstrate a capsaicin -mediated neurogenic flare with a value \>200 on the arbitrary Laser Doppler output at any of the time points 30, 40, 50 or 60 minutes following administration of capsaicin at Screening.

Exclusion Criteria:

* Evidence or history of clinically significant hematological (ie, abnormalities due to prolonged exposure to altitude), renal), endocrine or dismetabolic, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic or pain condition, dermatological or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
* Subjects with scars or tattoos on the forearms, or with evidence of sunburn, or excessively hairy volar forearms.
* History of febrile illness within 5 days prior to dosing.
Effects of Scapular Stabilization Exercises Combined With Post Facilitation Stretch in Patients With Upper Cross Syndrome: A Randomized Control Trial

Upper Cross Syndrome is characterized by the postural deviation of head , neck , shoulders and altered muscular muscular activation which included weakness of rhomboids , middle and lower trapezius and serratus anterior and tightness of upper trapezius , pectorallis and levator scapulae . It is a combinaton of scapular dyskinesia , forward head posture , rounded shoulder and thoracic kyphosis.This study aims to assess the enduring effects scapular stabilization exercises along with post facilitation stretch on Upper Cross Syndrome with the goal of preventing its reoccurrence over time, If there are improved results by the combination of both treatments than any of them alone , then it can used in combination for better results on patients


Eligibility Criteria:
Inclusion Criteria

* Aged 18 to 45 with neck pain for more than 3 months
* Both genders males and females
* NPRS scoring of greater than or equal to 4 points
* No History of serious pathology or recent neck trauma
* Diagnosed Upper Cross Syndrome cases using Janda approach

Exclusion Criteria

* Known Scapular or shoulder pathology
* Cervical and thoracic fractures , dislocations or surgeries or whiplash injury
The Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Study of HEC83518 Tablets in Chinses Healthy Subjects

The Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Study of HEC83518 Tablets in Chinses Healthy Subjects


Eligibility Criteria:
Inclusion Criteria:

1. Subjects who are willing and are able to provide a written informed consent to participate in the study.
2. Without Plann for pregnancy or pregnant within 3 months after enrollment throughout the trial.
3. Subjects aged between 18 and 45 (both inclusive) years old.
4. Healthy volunteers has a body weight ≥50 kg (for male) or ≥ 45kg (for female) and body mass index ≥18 and ≤28 kg/m2 at screening.
5. Subjects, who are healthy, as having no clinically significant abnormalities in vital signs, physical examination, clinical laboratory test results, Chest X-ray and 12-lead electrocardiogram (ECG).

Exclusion Criteria:

1. Subjects with a positive serology for human immunodeficiency virus (HIV) antibodies, hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibodies and/or TP antibodies at screening.
2. Subjects with history of digestive system,urinary system, liver,central nervous system, blood system, endocrine system,respiratory system,immune system,cardiovascular system,and/or malignant tumor or others medical conditions (such as history of mental illness, etc.) that are not suitable for clinical trial participation;Subjects with history of stroke, epilepsy, bipolar disorder/mania, high intraocular pressure, or acute angular-closure glaucoma.
3. Subjects with history of sleep-related illness.
4. Subjects with history of severe involuntary hypoglycemia
5. Known allergic reactions or hypersensitivity to any excipient of the drug formulation(s) ,or anaphylaxis physique.
6. Use of any prescription or non-prescription medications within 14 days prior to initial dosing,or Use of any medications known to inhibit or induce cytochrome P enzyme drug metabolism within 28 days prior to initial dosing.
7. Consume foods or beverages containing caffeine, xanthine, alcohol, and grapefruit within 48 hours prior to initial dosing.
8. Positive results from urine drug screen test.
9. History of alcoholism or drink regularly within 3 months prior to the study(defined as Alcohol consumption of \> 21 units/week), or positive results from alcohol breath test.
10. Regular smoking of more than 10 cigarettes per day within 3 months before administration of study drug.
11. Donate blood or lose blood 400 mL or more within 1 month prior to initial dosing.
12. Subjects who plan to receive or have had organ transplants.
13. Females who are lactating/breastfeeding, or positive result from pregnancy test for women of child-bearing potential.
14. Subjects who participated in another clinical trial within 3 months prior to initial dosing.
15. Any other condition with in the opinion of the investigator would render the patient unsuitable for inclusion in the study.
Single-arm Study of Photodynamic Laser Therapy Using Foscan for Non-curatively-resectable Bile Duct Carcinoma

The purpose of this study is to assess efficacy and safety of Foscan (temoporfin) photodynamic therapy in the treatment of locally advanced perihilar bile duct carcinoma without distant metastases.


Eligibility Criteria:
Inclusion Criteria:

* bile duct carcinoma proven by histology in advanced or non-operable stage or tumor extension:

  1. Bismuth type III or IV ( not resectable with R0-margins )
  2. Bismuth type I or II, if resective surgery is contraindicated for old age or poor surgical risk of patient
* sufficient general condition to undergo PDT (Karnofsky status \> 30%)
* age \> 19 years
* access to common bile duct (either via endoscopy after sphincterotomy or percutaneously after transhepatic drainage),
* informed written consent

Exclusion Criteria:

* porphyria or other diseases exacerbated by light
* known intolerance or allergies to porphyrin derivatives
* a planned surgical procedure within the next 30 days
* coexisting ophthalmic disease likely to require slit lamp examination within the next 30 days
* impaired kidney or liver function (creatinine \> 2.5x elevated, INR \> 2.2 on vitamin K),
* leukopenia ( WBC \< 2000/cmm ) or thrombopenia ( \< 50000/cmm ),
* cytotoxic chemotherapy within the past 4 weeks.
* pregnancy ( and safe contraception for 6 months after PDT )
* accompanying/complicating disease with very poor prognosis (expected survival \< 6 weeks),
* proven advanced peritoneal carcinomatosis ( PET scan imaging, ascites positive for tumor cells)
Assessing eFficacy and Safety of DEXTENZA 0.4 mg inseRt, Following Cataract Surgery

Assessing eFficacy and Safety of DEXTENZA 0.4 mg inseRt, Following Cataract Surgery

Assessing eFficacy and Safety of DEXTENZA 0.4 mg inseRt Treating Pain, and inflamMation Following Cataract Surgery Compared to Topical Prednisolone Acetate 1%.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with clinically significant cataract and are planning to undergo non-complicated Clear Cornea Incision Cataract Extraction with Posterior Capsule IntraOcular Lens in one or both eyes
* Are willing and able to comply with clinic visits and study related procedures
* Are willing and able to sign the informed consent form

Exclusion Criteria:

* Under the age of 18 at the time of signing the Informed Consent Form
* Pregnant or planning to become pregnant during the trial period
* Have visual acuity potential of less than 20/30 as recorded by a Retinal Acuity Meter or Potential Acuity Meter glare testing
* Have active infectious systemic disease
* Have active infectious ocular or extraocular disease
* Have punctal plug in the study eye
* Have obstructed nasolacrimal duct in the study eye(s) (dacryocystitus)
* Have known hypersensitivity to dexamethasone or are a known steroid responder
* Have a history of ocular inflammation or macular edema
* Has history of Laser Vision Correction (LASIK, PhotoRefractive Keratectomy) in the operated eye
* Are currently being treated with immunomodulating agents in the study eye
* Are currently being treated with immunosuppressants and/or oral steroids
* Are currently being treated with corticosteroid implant (i.e Ozurdex)
* Have a history of herpes simplex virus keratitis or present active bacterial, viral, or fungal keratitis in either eye
* Have a history of complete punctal occlusion in one or both punctum
* Currently using topical ophthalmic steroid medications
* Are unwilling or unable to comply with the study protocol
* Are determined by the Investigator to not be included for reasons not already specified (e.g., systemic, behavioral, or other ocular disease/abnormality) if the health of the subject or the validity of the study outcomes may be compromised by the subject's enrollment
CardiAQ-Edwards™ Transcatheter Mitral Valve Replacement (TMVR) Study

Clinical study to evaluate the safety and performance of the CardiAQ-Edwards™ Transcatheter Mitral Valve

The study is a multi-center, prospective, single-arm, and non-randomized study designed to evaluate the safety and performance of the CardiAQ-Edwards™ Transcatheter Mitral Valve with transapical and transseptal delivery systems in patients with degenerative or functional/ischemic mitral regurgitation.

Eligibility Criteria:
Inclusion Criteria:

* NYHA ≥ II
* Moderate/severe or severe mitral regurgitation
* Prohibitive risk for open-heart surgery
* Meets anatomical criteria

Exclusion Criteria:

* Unsuitable anatomy
* Need for emergent or urgent surgery
* Prior mechanical aortic valve replacement
* Any prior surgical or transcatheter repair (excluding balloon valvuloplasty) or replacement of the mitral valve
* Preexisting device in the left ventricular apex
* Clinically significant, untreated coronary artery disease
* Limited life expectancy (\< 12 months)
* Active infection
Multicenter Study on Rehabilitation Medical Data for Pediatric Big Brain Development

Retrospective study for development of imaging-genetics (brain imaging/genome big data) models and algorithms that are clinically explainable and have high predictive performance in brain research on pediatric developmental disorders

Retrospective study for development of imaging-genetics (brain imaging/genome big data) models and algorithms that are clinically explainable and have high predictive performance in brain research on pediatric developmental disorders

Eligibility Criteria:
Inclusion Criteria:

* Healthy subjects and patients 20 years old or younger who underwent imaging examinations performed at the Department of Rehabilitation Medicine at our hospital from January 2010 to December 2023 (patients who underwent brain MRI tests to determine the cause of developmental delay)

Exclusion Criteria:

* None
Whole Body Vibration Exercise for Elderly With Cognitive Impairments

The whole body vibration exercise group will have significantly more improvement in mobility, muscle strength, balance, balance confidence, and cognitive function with a lower fall rate than the control group.


Eligibility Criteria:
Inclusion Criteria:

* a diagnosis of mild or moderate dementia, with a Clinical Dementia Rating (CDR) of 1 to 2, and a Cantonese Mini-mental State Examination (CMMSE) score at 10 or above but below the local cutoff for dementia (18-22, depending on education level)
* able to stand for at least 1 minute with or without hand support
* living in the community
* having an informed consent (from the primary caregiver)

Exclusion Criteria:

* significant musculoskeletal conditions (e.g. amputations)
* metal implants in the lower extremity
* recent fracture in the lower extremity
* vestibular disorders
* peripheral vascular disease
* other serious illnesses or contraindications to exercise.
A Study to Assess the Short Term Efficacy of Intravenous Ibandronate (Bondronat) in Participants With Metastatic Bone Pain Due to Breast Cancer

This study will assess the short term efficacy of ibandronate (6 mg intravenous \[IV\]) in participants with breast cancer and malignant bone disease, with moderate to severe pain. All participants will receive an IV infusion of ibandronate on Days 1, 2, and 3, and pain response will be measured on Days 1-7. The anticipated time on study treatment is 3 days, and the target sample size is 182 individuals.


Eligibility Criteria:
Inclusion Criteria:

* Female participants greater than or equal to (\>=) 18 years of age
* Breast cancer with bone metastases
* Pain score of \>=4 on Worst Pain scale of Brief Pain Inventory (BPI)
* Stable analgesic regimen.

Exclusion Criteria:

* Participants who have received a bisphosphonate within 3 weeks of start of trial
* Radiotherapy to bone within 4 weeks of enrolment
* Hypersensitivity to ibandronate
* Central nervous system (CNS) or meningeal metastases
Assessment of Sublingual Immunotherapy in Children Allergic to House Dust Mites

The purpose of the trial is to asses the efficacy and safety of sublingual annual immunotherapy in children with bronchial asthma and/or allergic rhinitis allergic to house dust mites.

Allergen immunotherapy is currently the only one method of cause treatment of the IgE-dependent allergic diseases. Sublingual immunotherapy (SLIT) is the method which allows to give allergens via alternative oral route in patients home. Due to possibility of avoiding injection this therapy offers better relationship with pediatric patient. However efficacy and safety of sublingual immunotherapy are still important issues, especially in asthmatic children. The purpose of the trial is to asses the efficacy and safety of sublingual annual immunotherapy in children with bronchial asthma and/or allergic rhinitis allergic to house dust mites.

Eligibility Criteria:
Inclusion Criteria:

* patients with bronchial asthma and/or allergic rhinitis allergic to house dust mites first diagnosed at least 2 years before the study

Exclusion Criteria:

* active respiratory tract infection requiring antibiotic treatment within 4 weeks before the study
* hospitalisation due to asthma exacerbation during the 3 months before the first visit
* known contraindications of SIT according to the EAACI
* previous allergen immunotherapy
* use of systemic corticosteroids
* other clinically significant pulmonary, hematologic, hepatic, gastrointestinal, renal, endocrine, neurologic, cardiovascular, and/or mental diseases or malignancy that either put the patient at risk when participating in the study or could influence the results of the study