cyrilzakka/clinical-trials huggingface dataset:
EC17 for Intraoperative Imaging for Parathyroidectomy

Primary hyperparathyroidism is a significant medical and public health problem in the world and affects approximately 100,000 new patients in the United States alone. If left untreated this can lead to renal stones, osteoporosis, fatigue, and depression. The best treatment for primary hyperparathyroidism is surgical parathyroidectomy. However surgical parathyroidectomy can be difficult due to the variant location of the parathyroid glands. Up to 5% of patients leave the operating room without surgical cure.

Primary hyperparathyroidism is an ideal disease to investigate intraoperative fluorescent imaging. This would allow surgeons to identify the parathyroid glands and resect the suspicious parathyroid glands. Folate receptor (FR) has been found to be over-expressed in parathyroid tissue and not thyroid issues. An ideal surgical treatment would combine FR-specific fluorescent tracers with intraoperative imaging. It is important to note that FR is expressed only in the proximal tubules of the kidneys, activated macrophages, and in the choroidal plexus. Thus, the false positive detection rate is expected to be extremely low.

A group well known to us in the Netherlands has completed a pilot study utilizing a folate-FITC conjugate in 12 patients with ovarian cancer. Another group of investigators in Mayo have subsequently performed this study on 20 more patients without any serious adverse events (personal communication). They report excellent sensitivity and specificity with this technique with only grade 1 side effects (allergic reaction). All side effects reversed when the injection was halted. Patients with a history of allergic reactions to insect bites should not participate (fluorescein is derived from the firefly insect, folate is an essential vitamin).

A fluorescent contrast agent (folate-FITC or EC17) will be used to determine if it will localize to the primary tumor nodule(s) or mass(es) of patients undergoing parathyroid surgery.


Eligibility Criteria:
Inclusion Criteria:

1. Adult patients over 18 years of age
2. Patients presenting with primary hyperparathyroidism presumed to be resectable on pre-operative assessment
3. Good operative candidate
4. Subject capable of giving informed consent and participating in the process of consent.

Exclusion Criteria:

1. Pregnant women as determined by urinary or serum beta hCG within 72 hours of surgery
2. Patients with a history of anaphylactic reactions to Folate-FITC or insects
3. Vulnerable patient populations

   1. Homeless patients
   2. Patients with drug or alcohol dependence
   3. Children and neonates
   4. Patients unable to participate in the consent process
Virtual Reality Training Program for Ambulatory Patients With Chronic Gait Deficits After Stroke

The purpose of this study is to examine the feasibility and efficacy of a virtual reality program for ambulatory patients with mild-to-moderate chronic gait deficits after stroke.

Virtual reality (VR) systems enable the learning of simple and complex skills in a controlled virtual environment; i.e., one in which the different components (constraints) of the environment can be displayed, graded, changed and monitored in a quantitative manner.

Small preliminary studies suggest that VR may be used to augment chronic stroke rehabilitation and may enhance cortical reorganization. Our aim is to examine the feasibility and efficacy of a virtual reality program for ambulatory patients with mild-to-moderate chronic gait deficits after stroke. Study design-a single center randomized controlled trial of an experimental group and a usual care group.

Eligibility Criteria:
Main Inclusion Criteria:

* Stroke within 3-72 months.
* Mild-to-moderate residual gait deficits after the index stroke with preserved capacity for ambulation without or with an assistive device (e.g., walker, cane) or orthotics (e.g. AFO).

Main exclusion Criteria:

* Unstable cardiac or other medical condition or aphasia, dementia or other significant neurological disease limiting ability to train.
Fluoride Metabolism, Bone Remodelling and Mineral Density in HIV Patients Treated With Tenofovir +/- Emtricitabine

HIV+ patients are considered at risk for excessive bone fragility. Several factors could contribute: age, male sex, low body mass index (BMI), HIV infection per se, vitamin D deficiency, using tenofovir/a protease inhibitor (time on and/or current use). Tenofovir is used in a backbone of nucleosides/nucleotides analogues with emtricitabine (FTC), licensed as TRUVADA®, or without this analogue, licensed as VIREAD®. FTC closely resembles lamivudine (3TC) but is 5-fluorinated, the daily intake of fluoride is \~15 mg. Fluoride induces bone formation by stimulating osteoblasts, of often impaired bone quality.

The aim of the study is to compare in a cross-sectional design fluoride levels, bone renewal, bone mineral density (BMD) in HIV+ male patients treated by TRUVADA® or VIREAD® for more than 60 months. The patients will be randomly selected, then matched according to age, ethnic origin, BMI.

Fluoride metabolism will be studied by measurement of fluoride in blood and in daily urine, bone remodelling by measurement of P1NP. Dual X-ray absorptiometry (DXA) will be used to determine the areal bone mineral density (aBMD) of the lumbar spine, femoral neck and distal radius. Volumetric BMD (v-BMD) and micro-architecture of distal radius and tibia will be studied using a HR-pQCT scan (Xtreme, Scanco).

Eligibility Criteria:
Inclusion Criteria:

* HIV+ patients
* male patients
* patients treated by tenofovir+emtricitabine(TRUVADA®) or tenofovir(VIREAD®) for more than 60 months.

Exclusion Criteria:

* chronic use of fluoroquinolones, antifungal agents, steroids
* malignancy (current or previous) requiring chemotherapy or radiotherapy
Efficacy of Acupuncture in Exercise Tolerance in Patients With COPD

Chronic Obstructive Pulmonary Disease (COPD) is nowadays the 4th cause of death in the world and it´s expected to become the 3rd cause of death in 2020 and the majority cause of morbidity. Besides that, in Portugal COPD patients become more dependents each day.

Acupuncture as a reflex therapy it´s carried out through a Traditional Chinese Medicine (TCM) diagnose that will allowed to identify the acupoints.

The investigators are interested in to assess acupuncture efficacy on physical exercise tolerance in COPD patients.An experimental, controlled, randomized, double blind study was done. Patients were recruited according TCM diagnose to optimize potential therapeutic effects.


Eligibility Criteria:
Inclusion Criteria:

* COPD GOLD III,IV;
* able to walk;
* Informed consent signed;
* stable medication during last 3 days
* exacerbation during 3 months;
* Chinese diagnose opening principle;
* blood pressure "90"180 mmhg/ "100mmhg; respiratory rate "10"30 cpm

Exclusion Criteria:

* smoker;
* metastasis;
* hepatic,
* renal or cardiovascular disease;
* pulmonary hypertension;
* COPD symptoms exacerbation during the therapy;
* previous acupuncture treatments;
* unstable vital signs;
* pulmonary rehabilitation in the last 6 months;
* needle phobia.
JUST BREATHE, Breathing Life Into Innovative Therapies for ARDS- Cohort B: Paridiprubart

This is a Phase 2 multicenter, randomized, double-blinded, placebo-controlled study that will evaluate the safety and efficacy of host-directed therapeutics in hospitalized adults diagnosed with Acute Respiratory Distress Syndrome (ARDS) utilizing a platform trial design.

Cohort B: Participants will be randomized to receive either a placebo or paridiprubart.

This record describes the default procedures and analyses for Cohort B. Please see NCT06703073 for information on the BP-ARDS-P2-001 Master Protocol.

This is a master protocol for a Phase 2 platform clinical trial to evaluate host-directed therapeutic candidates (i.e., investigational product, IP) for the treatment of hospitalized participants diagnosed with ARDS. The safety and efficacy of each IP will be studied within its own cohort (IP versus Placebo). All patients will continue to receive standard treatments for ARDS as per the investigator. An individual participant will complete the study in approximately 90 days. The study will include a screening period (\<24 hours from providing informed consent to treatment), in-hospital treatment period with IP/placebo starting on Day 1 through discharge from the hospital, and a follow-up period after discharge from the hospital through the end of study (Day 90 + 2 weeks). Outcome data will be assembled for each patient over time (such as ventilatory status, oxygenation, and survival). Functional status using the WHO Ordinal scale and Karnofsky scale will be collected. Resource utilization will be calculated (length of stay in a critical care setting, days intubated, and survival).

All participants will undergo a series of physical exams, laboratory assessments/biomarker collections, ECG, Chest X-ray or CT scan, and questionnaires through Day 90. Exploratory biomarkers will be evaluated over time to facilitate clinical learning. This record only includes information relevant to the paridiprubart cohort.

Eligibility Criteria:
Inclusion Criteria:

The following inclusion criteria are in addition to the exclusion criteria specified in the Master Protocol NCT06703073:

- ARDS Severity of moderate or severe based on PaO2/FiO2 or SpO2/FiO2 assessment at the time of randomization.

Exclusion Criteria:

The following exclusion criteria are in addition to the exclusion criteria specified in the Master Protocol NCT06703073.

-Participant has a known allergy or known hypersensitivity to paridiprubart or its excipients, including polysorbate 80
A Study to Evaluate the Safety & Effectiveness of a Nasal Spray to Treat Seasonal Allergies

The Purpose of this study is to determine if one allergy medication (0.15% azelastine hydrochloride) is more effective than Placebo alone


Eligibility Criteria:
Inclusion Criteria:

* Male and female patients 12 years of age and older with a 2 year history of moderate to severe seasonal allergic rhinitis
* Must be in generally good health
* Must meet minimum symptom requirements, as specified in the protocol
* Must be willing and able to provide informed consent and to participate in all study procedures
* Positive skin test to a prevalent fall allergen

Exclusion Criteria:

* On focused Nasal Examination, the presence of any nasal mucosal erosion, nasal ulceration, or nasal septal perforation at either the screening visit or randomization visit will disqualify the subject from the study.
* Other nasal disease(s)likely to affect deposition of intranasal medication, such as sinusitis, rhinitis medicamentosa, clinically significant polyposis, or nasal structural abnormalities.
* Nasal Surgery or sinus surgery within the previous year
* Chronic sinusitis-more than 3 episodes a year
* Planned travel outside of the study area during the study period
* The use of any investigational drug within 30 days prior to screening. No investigational products are permitted for use during the conduct of the study.
* Presence of any hypersensitivity to drugs similar to azelastine and to either sorbital or sucralose (Splenda brand sweetener)
* Women who are pregnant or nursing
* Women of childbearing potential who are not abstinent or not practicing medically acceptable method of contraception
* Respiratory tract infection within 14 days prior to screening
* Respiratory tract infections requiring antibiotic treatment 14 days prior to screening
* Asthma (with the exception of mild, intermittent asthma). Subjects with mild, intermittent asthma who only require short-acting inhaled bronchodilators (not for more often tha twice a week) and who do not have nocturnal awakening as a result of asthma are eligible for enrollment
* Significant pulmonary disease including COPD
* Clinically significant arrythmia or symptomatic cardiac conditions
* A known history of alcohol or drug abuse within the last 2 years
* Existence of any surgical or medical condition or physical laboratory findings, which in the opinion of the investigator or sponsor's medical monitor, might significantly alter the absorption, distribution, metabolism, or excretion of study drug; that might significantly affect the subject's ability to complete this trial; or their safety in this trial
* Clinically relevant abnormal physical findings which, in the opinion of the investigator, would interfere with the objectives of the study or that may preclude compliance with the study procedures.
Hormonal Contraception and Vaginal Health

The purpose of this study is to help determine if the route by which women receive hormonal contraception causes different changes to occur in the lining of the vagina. The investigators plan to compare an oral route (taking birth control pills) with a vaginal route (using a vaginal ring).

The investigators intend to conduct a prospective, randomized study at Oregon Health and Science University. This study will be conducted over six 28-day cycles. Subjects enrolled in the study will undergo baseline vaginal biopsy and then be randomized to receive either intravaginal ethinyl estradiol and etonogestrel (NuvaRing®) or oral ethinyl estradiol and desogestrel (Desogen®). Repeat vaginal biopsies will be obtained after three and six months of exposure to either oral or intravaginal hormonal contraception. These will be analyzed to measure the thickness of the vaginal epithelium and to quantify the presence of Langerhans cell, macrophages, T-lymphocytes and dendritic cells.

Eligibility Criteria:
Inclusion Criteria:

* Female
* 18-35 years
* In general good health
* With regular menses (every 28-32 days)
* Seeking contraception and willing to use a hormonal method for at least 6 months

Exclusion Criteria:

* Current or recent (within the past 8 weeks) vaginitis or pelvic inflammatory disease
* History of recurrent vaginitis (\> 2 episodes in one year, any type)
* Pregnancy
* Recent use of hormonal contraceptives
* Depot medroxyprogesterone: 6 months
* Progestin implants: 3 months
* Oral contraceptives: 3 months
* Hormone impregnated IUD: 3 months
* Contraindications to use of oral contraceptive pills or vaginal ring
* History of deep vein thrombosis
* Known coagulopathy or thrombophilia
* Unexplained vaginal bleeding
* Uncontrolled hypertension
* Diabetes with vascular changes
* Present or history of hepatic disease or liver tumors
* Migraines with neurologic changes
* Myocardial infection
* Pulmonary embolus
* Stroke
* Breast cancer
* Hypersensitivity or allergy to hormonal contraception
* Heavy Smoking ( ≥ 15 cigarettes per day)
An Intervention Effect Study of a Mobile Medical Supportive Care Program for Family Caregivers with Dementia Combined with Diabetes: a Randomized Controlled Trial

The purpose of this project is to evaluate the effectiveness of the clinical application of a mHealth supportive care program for family caregivers with dementia combined with diabetes based on the supportive care framework. The results of the study will provide family caregivers with more economical and efficient care guidance, thereby improving the quality of care and quality of life for people with dementia and diabetes in general.


Eligibility Criteria:
Inclusion Criteria:

Caregivers: ① caregivers and patients have legal kinship (such as spouses, children or siblings) and other non-costly caregivers such as babysitters, bellhops, etc.; ② caregiving work ≥ 8 hours / day, care for the patient ≥ 5 days a week, the care time ≥ 1 month; ③ conscious adults with a certain degree of reading and comprehension; ④ at least have a smart phone (with Internet access) and will be able to use it proficiently; ⑤ informed consent and voluntary participation in the study. Informed consent and voluntary participation in the study.

Targets: ① meet the diagnostic criteria of Alzheimer's disease; ② meet the diagnostic criteria of type 2 diabetes mellitus; ③ age ≥ 60 years old, permanent residents of the district.

Exclusion Criteria:

Caregivers: ① severe physical or mental illness; ② people with drug or alcohol dependence; ③ caregivers who are participating in a similar intervention study.

Caregivers: ① patients with severe physical illnesses, major illnesses, or terminal illnesses; ② patients with drug or alcohol dependence.
Pilot Study Comparing the Efficacy and Safety of a New Pain Patch and Placebo in Delayed Onset Muscle Soreness (DOMS)

The purpose of this study is to evaluate the analgesic efficacy and safety of a new pain patch compared to placebo and no treatment in subjects experiencing Delayed Onset Muscle Soreness (DOMS).


Eligibility Criteria:
Inclusion Criteria:

* Males or females, 18 to 40 years of age
* are in good general health, with a BMI less than or equal to 32, and able to perform the exercise regimen
* develops muscle pain/soreness within 24-48 hours of the end of the exercise regimen and have a baseline muscle pain/soreness with movement of greater than or equal to 5 on the Numerical Rating Scale (NRS) (numerical rating scale) and at least "moderate" on the categorical scale

Exclusion Criteria:

* has engaged in upper extremity exercise for a minimum of 6 months prior to study participation
* has been working heavy manual or physical labor jobs within 3 months prior to study participation.
* has a known history of allergic reaction or clinically significant intolerance to acetaminophen, aspirin, or any nonsteroidal anti-inflammatory drugs
* has skin lesions such as psoriasis at the application site
* has abnormal skin condition such as eczema, contact dermatitis, pigment anomaly, etc.
* has an allergy-related skin condition
A Post-marketing Surveillance to Assess Safety and Efficacy of Rosuvatatin/Ezetimibe

Post-marketing surveillance of Rosuvastatin/Ezetimibe

This study will collect clinical data, mainly focused on safety, in Korean population as per the requirement of MFDS for market authorization.

Eligibility Criteria:
Inclusion Criteria:

* The patient who is first prescribed and administered Rosuvastatin/Ezetimibe

Exclusion Criteria:

* The patients who are overreacting to this drug or its components
* The patients with severe renal impairment
Long-term Observational Study of Patients Treated With Inaticabtagene Autoleucel Injection

This clinical trial adopts an observational research method to conduct annual follow-up and monitoring of patients receiving treatment with Inaticabtagene Autoleucel Injection after its commercialization, in order to evaluate the delayed adverse events of Inaticabtagene Autoleucel Injection.

Patients treated with Inaticabtagene Autoleucel Injection (including registered clinical trial patients with different indications of this product and commercialized patients after market launch), would be included in this program for a maximum of 15 years of long-term follow-up (LTFU), and an informed consent form must be signed again. The research period was 15 years after Inaticabtagene Autoleucel infusion. The patient was followed up once a year for 15 years.

Eligibility Criteria:
Inclusion Criteria:

1. Agree to sign an informed consent form for long-term follow-up studies.
2. Registered clinical trial patients with different indications for this product who have received at least one infusion of Inaticabtagene Autoleucel Injection in the past, as well as post market commercialized patients.

Exclusion Criteria:

- None.
Clinical Outcome of Posterior Cruciate Ligament (PCL) Posterolateral Reconstruction

The purpose of this investigation is to determine the clinical outcome of surgical reconstruction of complete ruptures to the posterior cruciate ligament (PCL) and posterolateral structures of the knee joint. The outcome will be determined with validated and rigorous knee rating systems between 2 and 10 years postoperatively. The results will be determined by the analysis of subjective and functional factors, sports and occupational activity levels, a comprehensive physical examination, and a radiographic evaluation. We hypothesize that the appropriately indicated procedures will effectively restore normal knee stability and function in patients with isolated or combined injuries to these structures.

Because injuries to the PCL and posterolateral structures occur with less frequency than other structures in the knee joint (such as the anterior cruciate ligament and menisci), fewer studies are available to assist the surgeon and patient with appropriate decision-making regarding conservative versus surgical treatment. The majority of patients who sustain injury to these structures are treated conservatively. Unfortunately, several investigations describe noteworthy symptoms and functional limitations following conservative management, and a high percentage of patients develop knee osteoarthritis that can be disabling for both recreational and daily activities. The investigators of this study have nearly three decades of experience and have extensively studied the effects of this injury in both the laboratory and clinic settings. It is our opinion that surgical reconstruction provides significant benefit when appropriately indicated, as has been demonstrated in our previous studies. Especially in athletic individuals, PCL and posterolateral reconstructive procedures have advanced to the point where more predictable results can be expected to restore sufficient knee function. Studies have demonstrated, at least in the short-term, that the majority of patients with acute ligament ruptures treated with reconstruction are able to return to various levels of sports activities.12 Whether these procedures will decrease the risk of the patient developing future osteoarthritis is unknown and requires further study.

Eligibility Criteria:
Inclusion Criteria:

* Complete rupture to the posterior cruciate ligament, greater than 10 mm of increased posterior tibial translation
* Rupture to the posterolateral knee structures, greater than 5 mm of increased lateral tibiofemoral joint opening, greater than 10 degrees of increased external tibial rotation
* Patient willing to comply with postoperative rehabilitation program

Exclusion Criteria:

* Patient unwilling to participate