cyrilzakka/clinical-trials huggingface dataset:
Combined Buprenorphine and Behavioral Treatment With and Without Contingent Reinforcement on Opioid and Cocaine Abstinence. - 22

The purpose of this study is to test combined buprenorphine and behavioral treatment with and without contingent reinforcement on opioid and cocaine abstinence.


Eligibility Criteria:
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Ischemia Reperfusion: Prostaglandins and Antioxidants

The purposes of this study are two-fold. The first purpose is to determine the effect of taking vitamins on the recovery of an artery (blood vessel) following an induced temporary injury. The second purpose is to determine whether a specific vasodilator is less abundant after the injury and whether this contributes to increased constriction or after the injury. Finally, does vitamin consumption have an effect on the recovery from the injury if one of the substances in the blood that causes vessels to enlarge (dilate) is stopped?


Eligibility Criteria:
Inclusion Criteria:

* Healthy males
* Healthy females

Exclusion Criteria:

* Smokers
* Cardiovascular disease
* Peripheral vascular disease
* Neurological deficits
* Diabetes Type I or II
* Pregnant women
* Adverse reactions to Ibuprofen
Prospective Study of Pregnancy in Women with Cystic Fibrosis

In this study, the investigators aim to evaluate changes in lung function in women with cystic fibrosis (CF) during pregnancy and for 2 years after pregnancy based on exposure to highly effective cystic fibrosis transmembrane conductance regulator (CFTR) modulators.

Advances in medical treatment, including the use of highly effective CFTR modulators have greatly increased life expectancy in women with CF, but the effects of pregnancy on women with CF are yet unknown. It is anticipated that over 90% of the CF population will be on CFTR modulators in the next few years. More knowledge about the effects of CFTR modulators in pregnancy is needed.

This is a prospective, multi-center, observational study to follow pregnant women with CF, conducted at 40 US sites. Women are enrolled in the first trimester of pregnancy and assessed every 3 months during pregnancy and during the first year after delivery, then every 6 months for an additional year. Changes in lung function over the course of pregnancy will be evaluated based on cumulative CFTR modulator use while pregnant while accounting for other factors that may influence changes in pulmonary function: baseline lung function, genotype, history of exacerbations, and pre-existing co-morbid conditions.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant, intending to continue pregnancy, enrolled in the Cystic Fibrosis Foundation Patient Registry (CFFPR)

Exclusion Criteria:

* None
Comparing Functional Outcomes in Individuals Using Micro-processor Controlled Orthosis Versus Stance Control Orthosis

The study will specifically evaluate the potential of the C-Brace to improve the functional mobility and quality of life in individuals with lower extremity impairments due to neurologic or neuromuscular disease, orthopedic disease or trauma, as compared to the stance control orthosis.


Eligibility Criteria:
Inclusion Criteria:

* Lower extremity functional impairment due to neurologic or neuromuscular disease, orthopedic disease or trauma.
* Prior active and compliant use of unilateral Knee-ankle-foot orthosis (KAFO) or Stance control orthosis (SCO).
* Age 18 - 80 years.
* Demonstrate a reciprocal gait pattern using the SCO and C-Brace trial tools.
* Cognitive ability to understand and the willingness to sign a written informed consent.
* Subjects must be able to demonstrate the ability to turn the global positioning sensor (GPS) and Actigraph units on and off and sufficient memory ability to wear the devices each day during use of the orthoses.

Exclusion Criteria:

* Passive ankle range of motion (PROM) of the lower extremity requiring the knee-ankle-foot orthosis (KAFO) of less than 2 degrees.
* Body weight \>275 pounds.
* Unstable neurological or cardiovascular/pulmonary disease, cancer.
* Knee flexion contracture resulting in the inability to actively use C-Brace or SCO.
* Participating in physical therapy currently or within 1 month of starting protocol, specific to orthotic use and gait training.
Discussion on the Effectiveness of Tea on Blood Pressure, Body Composition and Vision Problems in College Students

Background:

Tea is a universal beverage and one of the most popular drinks around the world. Some cell and animal experiments have pointed out that drinking tea may be related to hypotension, body composition and vision problems, and there are more and more related advertisements, especially for hibiscus tea, which is rich in anthocyanins. However, there is a lack of literature on the effectiveness of hibiscus tea drinks in preventing and treating blood pressure, body composition and vision problems in college students.

Purposes:

This study used a randomized human trial to evaluate the effects of drinking hibiscus tea on the control and reduction of blood pressure, body composition, and near vision problems. 100 subjects were divided into 2 groups: the hibiscus tea group and the boiled water drinking group, and they continued to drink it for 10 weeks. At the beginning of the trial (week zero), the second week, the sixth week, and the tenth week after stopping drinking, the visual fatigue scale, blood pressure, and body composition were examined respectively. At the initial stage (0th week) and at the 10th week after stopping drinking, visual acuity examinations were performed.

Expected results:

1. To explore the effect of hibiscus tea drinks on subjects' myopia.
2. To explore the effect of hibiscus tea drinks on visual fatigue of subjects.
3. To explore the effect of hibiscus tea drinks on the blood pressure of subjects.
4. To explore the impact of hibiscus tea drinks on the body composition of subjects.
5. To explore the effect of hibiscus tea drinks on body fat of subjects.


Eligibility Criteria:
Inclusion Criteria:

* The inclusion criteria are college students aged 15 to 22 years old. -

Exclusion Criteria:

* hemodialysis patients who need to limit their water intake
* those with a history of gastric ulcers
* those allergic to anthocyanins
* those who have long-term consumption or consumption of beverages, foods or health products containing high anthocyanins that may interfere with the study after evaluation, for example: foods or health foods such as cranberries, blueberries, cherries and grapes.
A Study in Healthy Male Subjects Designed to Assess the Mass Balance Recovery and Pharmacokinetics of 14C TZP-101

A study to investigate the mass balance recovery and pharmacokinetics of 14C TZP-101.


Eligibility Criteria:
Inclusion Criteria:

* Healthy Males
* 35-65 years of age
* Body Mass Index (BMI) of 18-32 kg/m2 or, if outside the range, considered not clinically significant by the investigator
* Body weight of 75-90kg
* Must be willing and able to communicate and participate in the whole study
* Must provide written informed consent
* Subject must agree to use adequate methods of contraception

Exclusion Criteria:

* Participation in a clinical research study within the previous 3 moths or more than 3 studies within the previous 12 months
* Participation in an ADE study within the previous 12 months
* History of any drug or alcohol abuse in the past 2 years
* Regular alcohol consumption \>21 units per week
* Current smokers and those who have smoked within the last 12 months, or a breath carbon monoxide (CO) reading of greater than 10ppm at screening
* Radiation exposure from clinical studies, including that from the present study, excluding background radiation including diagnostic X-rays and other medical exposures, exceeding 5 mSv in the last twelve months or 10 mSv in the last 5 years. No occupationally exposed worker, as defined in the Ionising Radiation Regulations 1999, shall participate in the study
* Clinically significant abnormal biochemistry, haematology or urinalysis at screening as judged by the investigator
* Clinically significant abnormal physical findings, ECG or vital signs measurements at screening
* PR interval 220 ms at screening or on admission
* QTcB \>450 ms at screening or on admission
* Existence of any surgical or medical condition that might interfere with the absorption, distribution, metabolism or excretion of the IMP
* History or presence of significant cardiovascular, respiratory, gastrointestinal (especially peptic ulcer disease), neurological, psychiatric, metabolic, hepatic or renal problems as judged by the investigator
* Positive drugs of abuse test result
* Positive HBV, HCV or HIV results
* Use of prescription or non prescription drugs, including vitamins, herbal and dietary supplements (including St. John's Wort) within 14 days of the planned IMP administration unless in the opinion of the PI the medication will not interfere with study procedures or compromise study safety
* Serious adverse reaction or serious hypersensitivity to any drug or the formulation excipients
* Presence or history of allergy requiring treatment (seasonal allergic rhinitis (hayfever) is allowed unless it is active)
* Donation or loss of greater than 400 mL of blood within the previous three months
* Subjects receiving or requiring prohibited medication as described in Section 11
* Failure to satisfy the Investigator of fitness to participate for any other reason
* Poor venous access
Anti-OX40 Antibody in Head and Neck Cancer Patients

The purpose of this study is to test the safety of the anti-OX40 antibody, MEDI6469, given prior to surgery in patients with advanced head and neck squamous cell carcinoma.

This phase Ib clinical trial uses MEDI6469 at various dose intervals prior to definitive surgical resection of patients with stage III and IV Oral Head and Neck Squamous Cell Carcinoma (OHNSCC) with the primary objective of determining the safety and feasibility of preoperative MEDI6469 administration. In addition, tumor tissue and peripheral blood will be obtained for exploratory immunologic end points including measurements of tumor infiltrating immune cell populations based on flow cytometry and immunohistochemistry as well as circulating immunological parameters that may correlate with changes induced by MEDI6469 administration.

Eligibility Criteria:
Inclusion Criteria:

* Patients with treatment naive, resectable, stage III or IV squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx or larynx who are candidates for definitive surgical resection followed by standard risk adapted adjuvant therapy.
* Histologic or cytologic diagnosis of a primary OHNSCC with no radiological evidence of metastatic disease is acceptable. Patients with bone or cartilage invasion and any T or N stage are acceptable.
* Patients with oral cavity primaries will be managed using conventional transoral or transcervical techniques; oropharynx or hypopharynx tumor will be managed with transoral robotic surgery; and larynx tumors (T3/T4 with thyroid cartilage invasion) will be managed by either total laryngectomy or larynx preservation surgery.
* Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2
* Laboratory values (performed within 28 days prior to enrollment) within protocol defined range
* Ability to give informed consent and comply with the protocol. Patients with a history of psychiatric illness must be judged able to understand the investigational nature of the study and the risks associated with the therapy.
* No active gastrointestinal bleeding.
* Anticipated lifespan greater than 12 weeks.

Exclusion Criteria:

* Locoregionally unresectable or Metastatic disease (stage IVB)
* Active infection.
* Active autoimmune disease including patients with Inflammatory Bowel Disease as determined by an autoimmune questionnaire.
* Previous treatment with mouse monoclonal antibodies
* Need for chronic maintenance oral steroids \> 5mg prednisone daily equivalent.
* Any medical or psychiatric condition that in the opinion of the investigator would preclude compliance with study procedures.
The Health Effects of a Blueberry Enriched Diet on Obese Children

The purpose of this study to determine if adding blueberries to obese children's diet will improve weight status and other medical testing. We would also like to determine if a larger research study involving blueberries is possible.

Ten children aged 12 to 17 years of age who have a BMI \> 95th percentile for age and who are patients of the Center for Better Health and Nutrition will be recruited for this 12 week study.

Group 1 (Standard Therapy): Participants will be asked not to consume berries during the study so as not to confound the effects of eating blueberries. They will, however, be encouraged to consume other fruits consistent with nutrition guidelines for the Healthy Eating Plan (HEP: reduced glycemic load diet).

Participants will be instructed and receive educational handout materials on implementing HEP. In addition participants will be introduced to the use of behavioral tools (e.g. goal setting, daily tracking when goals are met, and incentives provided by the family) to help them stay on track with HEP. Participants will be seen by the dietitian at monthly intervals consistent with programmatic standard of care to review adherence to HEP, use of behavioral tools, and change in weight status.

Participants will be encouraged to attend group exercise classes five days per week or a minimum of four days per week. At the end of each exercise session, participants will receive a "sham smoothie" which contains no blueberries. The children will be directly observed by a study worker when consuming the smoothies to ensure compliance and measure how much of the smoothie was consumed.

Group 2 (Blueberry Enhanced): All the features of Group 1 with the exception that the participants will be given a smoothie that contain 1 1/2 cups of freeze-dried whole blueberries crushed into a powder per serving.

Eligibility Criteria:
Inclusion Criteria:

* Children 12 to 17 years old at the time of enrollment
* Children with a BMI ≥ 95th percentile for age
* Children participating in a weight management program at the CBHN.

Exclusion Criteria:

* Children/parents/guardians who appear unable to understand the study
* Children/parents appear unable to meet the requirements of participating, specifically not missing more than 1 consecutive week during the 12 week intervention
* Children who have a medical condition or development impairment that precludes them from participating in an exercise program
* Children who have type 2 diabetes
* Children who have been diagnosed with hypertension
* Children who are taking a statin
* Children who are pregnant or have given birth within 6 months
* Children with a history of significant cardiac disease leading to cardiovascular instability
* Children who have food allergies or are lactose intolerant
* Children who are unable to finish at least half of the smoothie while they taste it after the consent/assent process or decide after tasting the smoothie that they are no longer interested in participating.
Radicle Relief 1: A Study of Health and Wellness Products on Pain and Other Health Outcomes

A randomized, blinded, placebo-controlled study assessing the impact of health and wellness products on pain and other health outcomes

This is a randomized, blinded, placebo-controlled study conducted with up to 300 adult participants per study arm, age 21 and older and residing in the United States.

Eligible participants will (1) endorse a desire for less pain, (2) indicate an interest in taking a health and wellness product to potentially help relieve their pain, and (3) express acceptance in taking a product and not knowing its formulation until the end of the study.

Participants with known liver or kidney disease, heavy drinkers, and those who report they are pregnant, trying to become pregnant, or breastfeeding will be excluded. Those taking certain medications will be excluded.

Self-reported data are collected electronically from eligible participants over 5 weeks. Participant reports of health indicators will be collected during baseline, throughout the active period of study product use, and in a final survey. All study assessments will be electronic; there are no in-person visits or assessments for this real-world evidence study

Eligibility Criteria:
Inclusion Criteria:

* Adults, 21 years of age and older at the time of electronic consent, inclusive of all ethnicities, races, genders and/or gender identities
* Resides in the United States
* Endorses pain as a primary issue (desire for less pain)
* Selects their desire for less pain and/or reduce reliance on medications as a reason for their interest in taking a health and wellness product
* Expresses a willingness to take a study product and not know the product identity (active or placebo) until the end of the study

Exclusion Criteria:

* Reports being pregnant, trying to become pregnant, or breastfeeding
* Unable to provide a valid physical shipping address
* Reports a diagnosis of liver or kidney disease
* Reports being a heavy drinker (defined as drinking 3 or more alcoholic beverages per day)
* Unable to read and understand English
* Lack of reliable daily access to the internet
* Reports taking anticoagulants, any medication that warns against grapefruit consumption, corticosteroids at doses greater than 5 mgs per day, or MAOIs
* Reports current or recent (within 3 months) use of chemotherapy, immunotherapy, or oral anti-infectives (antibiotics, antifungals, antivirals) to treat an acute infection
A Study to Evaluate Efficacy and Safety of Macrolane VRF30 for Volume Restoration and Contouring of the Buttocks

The purpose of the study is to evaluate the efficacy and safety of Macrolane for volume restoration and shaping of the buttocks.


Eligibility Criteria:
Inclusion Criteria:

* ≥ 20 years old
* willing to undergo augmentation therapy of the buttocks where a maximum total injected volume of 400 ml of the study product is judged by the Investigator to be enough to achieve full correction
* understand and comply with the requirements of the study
* be willing to understand and comply with the requirements of the study
* be willing to abstain from esthetic surgery and esthetical augmentation procedures (other than the study treatment) between the umbilicus and the knees.
* be a male or non-pregnant, non breast-feeding female.
* give written informed consent to participate in the study

Exclusion Criteria:

* Active skin disease, inflammation or related conditions Tumors or pre-malign tissue disorder near or on the area to be treated
* scar tissue in the area to be treated
* subjects seeking corrections for other body parts then the buttocks anywhere between the umbilicus and the knees
* subjects with human immunodeficiency virus (HIV) associated lipodystrophy
* subjects having undergone liposuction within 6 months prior to inclusion
* BMI \<20 or expected instable weight
* insufficient tissue cover in the area to be treated
* excessive skin laxity in the area to be treated
* other injectable implant or permanent implant near or in the area to be treated
* previous radiation therapy of tumors near or in the area to be treated
* concomitant anticoagulant therapy, anti-platelet therapy or a history of bleeding disorders.
* a presence or history of connective tissue diseases
* ongoing immunosuppressive therapy
* known allergies or hypersensitivity reactions towards anesthetics
* previous inflammatory or hypersensitivity reactions towards products containing Hyaluronic acid
* any condition which in the opinion of the investigator makes the subject unsuitable for inclusion use of any investigational drugs or devices within 30 days prior to inclusion.
Determining the Presence of RAP in Orthognathic Patients and Its Effect on Root Resorption by Biomarkers

A prospective clinical trial to what extent inflammatory biomarkers are affected by the medication after orthognathic surgery in early surgical cases and whether these biomarkers affects the amount of maxillary or mandibular incisor root resorption.

To conduct a prospective clinical trial to what extent inflammatory biomarkers such as OPG, RANKL, IL-1, IL-6, and CRP are affected by the medication after orthognathic surgery in early surgical cases and whether these biomarkers affects the amount of maxillary or mandibular incisor root resorption.

Eligibility Criteria:
Inclusion Criteria

1. Have skeletal Cl III malocclusion
2. Wisdom teeth are absent or extracted at least 6 months before the surgery
3. Need of orthognathic surgery through Le Fort I osteotomy of the maxilla and bilateral sagittal split osteotomies (BSSO) of the mandible.
4. Undergo fixed orthodontic treatment before and after the orthognathic surgery
5. Have available orthopantomograms with adequate quality
6. Have healthy periodontal tissue without inflammation or bleeding before and after the surgery.
7. Maintain the same medication protocol during and after the surgery.

Exclusion Criteria:

1. ongoing use of regular medication
2. smoking
3. known penicillin allergy,
4. any immune disorder,
5. musculoskeletal diseases,
6. syndromes,
7. cleft lip-palate,
8. systemic diseases affecting root resorption,
9. periodontal and gingival disorders,
10. missing teeth among upper or lower incisors,
11. poor oral hygiene.
Ablation or Surgery for Atrial Fibrillation (AF) Treatment

The purpose of this study is to compare 2 invasive strategies for Atrial Fibrillation treatment, Endocardial catheter ablation isolation of the Pulmonary veins versus minimally invasive thoracoscopic surgical epicardial isolation. Both strategies are in use for several years now, and have been reported as a successful strategy with success rates of 60-90%. However, it is not known which technique is preferable in a given patient population in terms of efficacy to cure AF, safety, or patient discomfort. Therefore, in the present trial a randomized study is proposed to provide more insight into the relative merits of both techniques

Atrial Fibrillation is the most common cardiac arrhythmia, affecting millions of people around the world. It is a large burden on health care resources and may even lead to a shorter life expectancy. Drug treatment has been found insufficient and sometimes even hazardous to the pt. Traditionally, there was only one invasive approach available, being MAZE 3 procedure by means of full open chest cardiac surgery. This was a very invasive approach, limited to only a few skilled surgeons, with insufficient options to treat large pt volume.

With the discovery that AF often is initiated and maintained by electrical instability inside and around the Pulmonary Veins, catheter ablation is now a widely accepted early invasive strategy to cure AF. Success rates of 60% to 90% have been reported, depending on technique employed and the type of AF (Resp, chronic versus paroxysmal)

Eligibility Criteria:
Inclusion Criteria:

* Patient has a history of symptomatic paroxysmal and/or persistent atrial fibrillation for at least 12 months
* Patient is refractory to or intolerant of at least one antiarrhythmic drug
* Patient has an enlarged atrium \>40 mm and/or Patient has a failed previous catheter ablation and/or Patient has additional risk factors such as hypertension, increasing age
* Patient is between 30 and 70 years of age
* Patient is mentally able and willing to give informed consent

Exclusion Criteria:

* Cardiac ablation or surgical cardiac procedure in the last 3 months
* Previous cardiac tamponade
* Previous stroke or TIA
* Left atrial thrombus
* Left atrial size \>65 mm
* Left ventricular ejection fraction \<45 %
* Active infection or sepsis
* Pregnancy
* Unstable angina
* Myocardial infarction (MI) within previous 3 months
* Atrial fibrillation is secondary to electrolyte imbalance, thyroid disease, or other reversible or non-cardiovascular cause
* History of blood clotting abnormalities
* Known sensitivity to heparin or warfarin
* Life expectancy is less than 12 months
* Patient is involved in another clinical study involving an investigational drug or device
* Pleural adhesions
* Prior thoracotomy
* Prior cardiac surgery
* Elevated hemi diaphragm