cyrilzakka/clinical-trials huggingface dataset:
Health Effects of Biodiesel Exhaust Exposure

Urban air pollution is a major contributor to greenhouse gases and has been shown to increase cardiovascular mortality and morbidity. This century has seen a rebirth of biofuel marketing and research, with biodiesel emerging as one of the strongest contenders within international markets. The pursuit of alternative renewable fuels is incredibly complex and has powered research in agriculture, biotechnology, production, transportation, feedstocks, ecology and biomass manufacturing. In spite of this, health effects have been an almost completely overlooked aspect. The purpose of this study is to investigate whether 100% biodiesel exhaust exposure in healthy volunteers leads to cardiovascular and inflammatory responses. Further investigations into the chemical composition of biodiesel exhaust will also be performed.


Eligibility Criteria:
Inclusion Criteria:

Non-smoking, healthy male subjects. All subjects undergo a general health examination and are required to have normal clinical examination, ECG, blood tests and lung function.

Exclusion Criteria:

* Diabetes Mellitus
* Cardiovascular disease
* Asthma
* Respiratory infection within 2 weeks of the study
* Antioxidant- and/or vitamin supplementation within 1 week prior to, as well as during the course of the study. (incl vitamin C, Acetylcysteine)
* Smokers or regular snus usage
Deep Marginal Acquisition With Thermacut Bur Vs. Functional Crown Lengthening in Deep Carious Lesions

this clinical trial is conducted to compare between deep marginal acquistion by the means of thermacut bur Vs. functional crown lengthening in exposing deep subgingival interproximal cervical lesions

Deep subgingival margins pose a great difficulty during restorative work with composite restorations. Exposing cavity margins is paramount in order to attain proper isolation, matrix adaptation and composite placement.

Several methods have been proposed to overcome the problem of exposing deep margins; functional crown lengthening is considered the gold standard of care regarding exposure of deep margins.

However, functional crown lengthening can pose many problems including the risk of root exposure, furcation involvement and compromising crown root ratio, besides risk of thread exposure if it is done beside implant, removal of bone from adjacent teeth and from buccal and lingual walls in order to create smooth bone architecture, and the complications of surgery such as post-operative pain, inflammation and edema and the risk of excessive bleeding.

Deep marginal acquisition and deep marginal extension (DMA \& DME) are considered as a viable option in treating deep subgingival extended margins.

Several methods regarding deep marginal acquisition have been proposed including the use of diode laser and Electrosurgery, there is another protocol for exposing the gingival seat by the use of thermacut bur.

The rationale behind conducting this research is to propose an easy and predictable way to expose deep subgingival margins, without the need to perform surgical intervention.

The technique is done by clinicians with good outcomes, but never been tested or validated, this study is performed to verify whether this test should be validated or not.

Eligibility Criteria:
Inclusion Criteria:

- Subject not less than 18 years of age

1. Males or females
2. Community-dwelling
3. Have at least one deep subgingival interproximal carious lesion.
4. Can comply to oral hygiene measures or with good oral hygiene
5. Have sufficient cognitive ability to

5- Understand consent procedures.

Exclusion Criteria:

1. Patients less than 18 years old.
2. Disabilities:
3. Systemic diseases or severe medically compromised. (Cardiovascular disorder, diabetes, hypertensive, epileptic).
4. Lack of compliance.
5. Gingival hyperplasia, blood disorder.
6. Cognitive impairment.
7. Attachment loss signs of periodontal disease.
Efficacy and Safety of TQB2618 Injection Combined With Toripalimab Injection in Patients With Advanced Melanoma

This study is an open, single-center, multi-cohort phase Ib exploratory study, and 50 subjects are planned to be enrolled to observe the objective response rate of each subject. The safety evaluation of this study adopts common terminology criteria for adverse events version (CTCAE) 5.0 to evaluate the adverse events of drugs. Efficacy was evaluated using response evaluation criteria in solid tumors version (RECIST) 1.1 for immune-based therapeutics criteria.


Eligibility Criteria:
Inclusion Criteria:

* 1 Age: 18-75 years old;ECOG PS score: 0\~1;The expected survival is over 3 months
* 2 Patients with advanced melanoma diagnosed histologically and/or cytologically
* 3 At least one measurable lesion was confirmed according to RECIST 1.1 criteria
* 4 Major organs are functioning normally
* 5 Female subjects of reproductive age should agree to use contraceptive methods (such as intrauterine devices, birth control pills, or condoms) during the study period and for 6 months after the end of the study;Negative serum pregnancy/urine pregnancy test within 7 days prior to study enrollment and must be non-lactating subjects;Male subjects should agree to use contraception during the study and for six months after the end of the study period

Exclusion Criteria:

* 1 Present or present with other malignant tumors within 3 years prior to first use
* 2 Unalleviated toxicity above CTCAE grade 1 due to any prior treatment
* 3 Major surgical treatment and significant traumatic injury were performed within 28 days prior to initial administration
* 4 A wound or fracture that has not healed for a long time
* 5 Those who have a history of psychotropic drug abuse and can't get rid of it or have mental disorders
* 6 Subject with any severe and/or uncontrolled disease
* 7 Prior chemotherapy within 3 weeks prior to initial drug use, and prior radiotherapy or other antineoplastic drugs within 2 weeks prior to initial drug use
* 8 Those who have participated in and used other antitumor clinical trials within 4 weeks prior to the first drug use
West Virginia WISEWOMAN Project

To provide low-income, under- or uninsured 40- to 64-year-old women with the knowledge, skills, and opportunities to improve diet, physical activity, and other lifestyle behaviors to prevent, delay and control cardiovascular and other chronic diseases.


Eligibility Criteria:
Inclusion Criteria:

* NBCCEDP

Exclusion Criteria:

-
Managing Fear of Cancer Progression Metacognition-based Vs Supportive-expressive Based Approaches

The present study aims to conduct a randomized controlled trial to assess the effect of CALM intervention and ConquerFear intervention on fear of cancer progression among Chinese patients diagnosed with advanced cancer.

A randomized controlled trial will be conducted to assess the effect of CALM intervention and ConquerFear intervention on fear of cancer progression among Chinese patients diagnosed with advanced cancer.

The aims are to test:

1. the direct effect of CALM intervention or ConquerFear intervention on fear of cancer progression, and
2. the indirect effect of ConquerFear intervention on fear of cancer progression through its effect on maladaptive metacognition.

Primary hypothesis:

1. Patients receiving CALM intervention or ConquerFear intervention, compared to those receiving a basic cancer care intervention will show a reduction in fear of cancer progression.
2. Both CALM intervention and ConquerFear intervention will be equally effective in reducing fear of cancer progression.
3. Given ConquerFear intervention aims to modify unhelpful metacognitive beliefs, there will be an indirect effect of ConquerFear intervention on fear of cancer progression through its effect on maladaptive metacognition.

Eligibility Criteria:
Inclusion Criteria:

* Cantonese- or Mandarin-speaking Chinese patients recently diagnosed with advanced or metastatic (i.e. stage III or IV) cancer
* are the age of 18 years or above

Exclusion Criteria:

* Patients with major communication difficulties
* are being unwilling or unable to commit 6 psychotherapy sessions
Comparison of Drug Eluting Stent and Covered Metal Stent in Malignant Biliary Obstruction (MIRA III)

The purpose of this study is to compare the effectiveness and safety of Niti-S Mira-Cover III Biliary Stent with Comvi Biliary Covered Stent for the treatment of malignant biliary obstruction.

In patients with malignant biliary obstruction, endoscopic placement of biliary stents offers similar technical success rates. Endoscopic retrograde cholangiography (ERCP)-guided stent placement has become the preferred approach to palliate malignant biliary obstruction. The major mechanisms of self-expandable metallic stent (SEMS) occlusion are tumor ingrowth, tumor overgrowth, and epithelial hyperplasia. These mechanisms provide the rationale for developing a drug-eluting stent in order to improve stent patency. Limited data exist regarding outcomes of paclitaxel-eluting stents in malignant biliary obstruction. This study is to prospectively compare the effectiveness and safety of paclitaxel-eluting covered metal stent and covered metal stent for the treatment of malignant biliary obstruction.

Eligibility Criteria:
Inclusion Criteria:

* Age greater than or equal to 19 years of age
* Malignant mid or distal biliary obstruction
* Unresectable cancer
* Estimated survival greater than or equal to 3 months (Karnofsky score ≥ 60)
* Patient willing to provide written informed consent and comply with follow-up requirements

Exclusion Criteria:

* Patients who had undergone surgical biliary drainage
* Severe bleeding disorder (e.g. coagulopathy)
* Polypoid lesion or intra-abdominal abscess
* Female of child-bearing potential who are unable to take adequate contraceptive precautions, are known to be pregnant, or are currently breastfeeding an infant.
Dry Needling and Exercises in Shoulder Pain

Shoulder pain is highly prevalent in the society. The role of muscle tissues in this pathology has received increasing interest. Some studies have proposed the role of myofascial trigger points in this population. The purpose of the current clinical trial is to compare the effects of physiotherapy treatment consisting of an eccentric exercise protocol versus the same physical therapy program plus the addition of trigger point dry needling (TrP-DN) on pain and function in patients suffering from unspecific shoulder pain.


Eligibility Criteria:
Inclusion Criteria:

* Unilateral non-traumatic shoulder pain
* Shoulder pain from at least 3 months
* Shoulder pain of more than 4 points on a NPRS

Exclusion Criteria:

* bilateral shoulder symptoms
* younger than 18 or older than 65 years
* history of shoulder fractures or dislocation
* cervical radiculopathy
* previous interventions with steroid injections
* fibromyalgia syndrome
* previous history of shoulder or neck surgery
* any type of intervention for the neck-shoulder area during the previous year
Cervical Interlaminar Versus Transforaminal Epidural Steroid Injection

compare cervical interlaminar epidural injection of betamethasone (9mg) and cervical transforaminal epidural injection of dexamethasone (15 mg) for cervical radicular pain

This study will compare one route of epidural steroid injection (interlaminar) using a particulate steroid to another route of epidural steroid injection (transforaminal) using a different non-particulate steroid dexamethasone. Repeat injections may be allowed.

All injections will be done with image guidance. Patients will be evaluated for improvements in pain and function.

Eligibility Criteria:
Inclusion Criteria:

* - aged \>18, capable of understanding and providing consent in English, capable of complying with the outcome instruments used, capable of attending all planned follow up visits
* unilateral cervical radicular pain as defined by arm pain or shoulder girdle pain/periscapular pain with or without neck pain of at least 2 weeks.
* 7 day average of numeric pain rating score (NPRS) for arm pain or shoulder girdle/periscapular pain of at least 5/10 at baseline evaluation
* MRI (or CT if MRI not available) shows one or two level cervical disc herniation(s) or disc osteophyte complex(es) between levels C4-T1, corresponding in location with unilateral radicular pain, with or without neurological deficits. MRI or CT may show degenerative changes at other levels.
* Patient consents to treatment with epidural injection in a shared decision-making process with the treating physician.
* Pain duration of at least 2 weeks or more.

Exclusion Criteria:

* - Neck pain is greater than arm pain or shoulder girdle/periscapular pain based on 7 day average NPRS
* Those receiving remuneration for their pain treatment (e.g., disability, worker's compensation).
* Those involved in active litigation relevant to their pain.
* Those unable to read English and complete the assessment instruments.
* Those unable to attend follow up appointments
* The patient is incarcerated.
* Spondylolisthesis at the involved or adjacent segments.
* History of prior cervical surgery
* Progressive motor deficit, and/or clinical signs of myelopathy.
* Prior cervical epidural steroid injections.
* Prior epidural steroid injection within the prior 12 months in any location within the spine.
* Possible pregnancy or other reason that precludes the use of fluoroscopy.
* Allergy to contrast media or local anesthetics.
* BMI\>35.
* Systemic inflammatory arthritis (e.g., rheumatoid arthritis, ankylosing spondylitis, lupus).
* Active infection or treatment of infection with antibiotics within the past 7 days.
* Medical conditions causing significant functional disability (e.g., stroke, COPD)
* Chronic widespread pain or somatoform disorder (e.g. fibromyalgia).
* Addictive behavior, severe clinical depression, or psychotic features.
Preoperative Focused Cardiac Ultrasound in Hip Fracture Surgery (PrEcho)

The primary objective of this study is to investigate the impact of preoperative focused transthoracic ultrasound (FOCUS) on intraoperative hypotension and postoperative complications in hip fracture surgery. Our hypothesis is that a preoperative FOCUS along with a hemodynamic optimization protocol will reduce the occurrence of intraoperative drops in blood pressure and post-operative complications.

Hip fracture surgery is a common procedure, and despite progress in perioperative management, cardiac complications are common, and the post-operative mortality remains high. In this geriatric patient population, cardiac disease as well as varying degrees of dehydration is common, and preoperative knowledge of these conditions have a key role in enabling a proactive perioperative hemodynamic management. However, clinical assessment is surprisingly unreliable and has been shown to easily fail to identify significant cardiac disease and lack of venous return.

Transthoracic echocardiography (TTE) is a well-established and non-invasive investigation that can identify cardiac disease and aberrations in volume status prior to surgery. In a preoperative practice, the use of focused cardiac ultrasound (FOCUS) enables an individualized anesthesia management and has been demonstrated to influence anesthesiologist decision making. Furthermore, measurements of inferior vena cava used as a surrogate for venous return have been shown to be a predictor of intraoperative hypotension.

Patients scheduled for daytime hip fracture surgery will be screened for eligibility.

Random allocation (1:1 allocation ratio) of patients to receive standard care (control group) or standard care + preoperative focused cardiac ultrasound with a preoperative hemodynamic optimization (intervention group). Registration of pre- and intraoperative blood pressure, as well as post-operative complications and mortality will be conducted.

Primary outcome measure: Intraoperative hemodynamic instability defined as MAP \< 60 mmHg.Secondary outcome measures: Time to surgery, length of hospital stay, renal failure, cardiac complications (myocardial ischemia, heart failure, post-operative atrial fibrillation, pulmonary edema, pulmonary embolism), 7-,30- and 90-day mortality.

Eligibility Criteria:
Inclusion Criteria:

* Patients ≥ 65 years of age, with American Socieity of Anesthesiologists (ASA) physical status classification 2-4, that are scheduled for acute hip fracture surgery (ICD-codes s72.0, s72.00, s72.01, s72.1, s72.2)

Exclusion Criteria:

* Metastatic cancer and/or suspect pathological fracture.
* Concurrent other fracture/surgery.
* Reoperation within 72 hours from primary operation.
* Severe dementia.
* Preoperative echocardiography for other reason than participation in the study.
Effect of Celecoxib on Perioperative Inflammatory Response in Colon Cancer

The proposed study aims to investigate how the administration of a drug known to reduce inflammation in humans, Celecoxib, will effect the peri-operative inflammatory response of a patient undergoing primary tumor resection surgery for colon cancer. The proposed project is an exploratory study, and will use data from blood samples and tumor samples to attempt to elucidate the immune and inflammatory response in colon cancer patients undergoing primary resection of their tumors.

This study is the first to assess the perioperative time course of systemic inflammation and immunity in colon cancer patients and evaluate the effect of anti-inflammatory treatment with celecoxib on this response. In addition, evaluation of the effect of short-term preoperative administration of celecoxib on tumor immunogenicity will help us to understand how tumor-enhancing inflammation and anti-tumor immunity can be differentially affected by COX-2 inhibitors. The knowledge gained as a result of this research will help us to set up the infrastructure for a method to monitor the immunoinflammatory status of colon cancer patients with a longer term goal of designing interventions to suppress tumor-enhancing inflammation and vitalize anti-tumor immunity in the perioperative period. The long-term objective is to use these novel tools in order to improve cancer-specific survival in patients with colon cancer after primary tumor resection.

Eligibility Criteria:
Inclusion Criteria:

- Colon cancer patients with no evidence of metastasis in distant organs (i.e., TNM stage I-III), who are

* between 18 and 75 years old,
* have a body mass index (BMI) between 18 and 35 kg/m\^2,
* and are eligible for laparoscopically-assisted colectomy for primary tumor resection.
* Patients must have the ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

- A history of allergic-type reactions to celecoxib or sulphonamides,

* a history of asthma, skin reactions or other allergic reactions to aspirin or other NSAIDs,
* a history of thromboembolic event (cerebrovascular accident, transient ischemic attack,
* unstable angina, myocardial infarction, deep vein thrombosis, or pulmonary embolism),
* renal insufficiency (defined by a serum creatinine level \> 1.5 mg/dL or blood urea nitrogen level \> 22 mg/dL),
* active gastrointestinal bleeding in the 60 days before surgery,
* alcohol or drug abuse, and
* previous chemotherapy or abdominal/pelvic radiation therapy.
* After randomization, other exclusion criteria will include a surgical procedure longer than 6 h, inability to extubate the trachea within 4 h after operation, evidence of a new postoperative myocardial infarction, abnormal postoperative mental status or any new neurologic deficit, significant postoperative bleeding (with a hemoglobin level \< 7.5 g/dL), requiring blood transfusion, or a urine output of less than 30 mL/h.
A Comparative Study of an Integrated Pharmaceutical Care Plan and a Routine Care in Bronchial Asthma

The aim of the study is to compare the effect of asthma care by clinical pharmacist intervention versus routine care on asthma control.


Eligibility Criteria:
Inclusion Criteria:

* patient with clinical diagnosis of bronchial asthma
* responsible for administering their own asthma medications.

Exclusion Criteria:

* patients who were not responsible for administering their own asthma medications.
* patients with cognitive defects, other pulmonary disease e.g. Chronic Obstructive Pulmonary Disease (COPD), experiencing illness with asthma-like symptoms e.g. Congestive Heart Failure, evidence of fixed airway obstruction
* patients unavailable for 2-month follow-up.
* patients who did not provide written informed consent.
Glucagon Use in Colonoscopies

The investigators believe that glucagon therapy will have a positive impact on key parameters of colonoscopy such as cecal intubation time, withdrawal time, total procedure time, adenoma detection rate, endoscopist's assessment of the difficulty of the procedure, patient comfort, and patient's willingness to undergo a repeat colonoscopy.

Glucagon transiently decreases peristalsis of smooth muscle in the gastrointestinal tract. It is widely used by radiologists to improve diagnostic yields of upper and lower GI barium contrast examinations. Glucagon is also routinely administered intravenously for all endoscopic retrograde cholangiopancreatography (ERCP) throughout the United States to facilitate canulation of the duodenal papilla and sphincterotomy. Glucagon has been used at the dose of 1-3 mg intravenously by Dr. John Cello in over 5000 ERCP examinations. The role of glucagon in facilitating colonoscopy remains controversial however and is not considered "routine". Several studies have evaluated the effect of glucagon on colonoscopy with varying results. No large scale randomized controlled trial has been performed to conclusively establish the effect of routine glucagon administration prior to colonoscopy. The investigators plan to carry out a randomized double blind, placebo controlled trial that studies key parameters of a colonoscopy such as cecal intubation time, withdrawal time, total procedure time, adenoma detection rate, endoscopist's assessment of the difficulty of the procedure, patient comfort, and patient's willingness to undergo a repeat colonoscopy.

Eligibility Criteria:
Inclusion Criteria:

* Any subject who has already been already cleared for and scheduled to undergo colonoscopy at SFGH endoscopy center.

Exclusion Criteria:

1. Refusal to give informed consent.
2. Age \<18 or \>70.
3. Prior intra-abdominal surgery
4. Diabetes
5. Pheochromocytoma
6. Insulinoma
7. Liver disease (Child-Pugh Score \>6)
8. Pregnancy