cyrilzakka/clinical-trials huggingface dataset:
Effects of Interscalene Brachial Plexus Nerve Blocks on the Hand and Forearm

Research study to determine the proportion of cases in which an interscalene brachial plexus nerve block produces hand and forearm anesthesia.

This is a research study to prospectively determine the proportion of cases in which an interscalene brachial plexus nerve block produces hand and forearm anesthesia. The investigators will investigate this issue in patients having shoulder and not hand/forearm surgery. We will test hand grip strength and sensation to determine if the hand and forearm are responding to the anesthesia.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* unilateral orthopedic shoulder surgery
* already desiring an interscalene brachial plexus nerve block for postoperative analgesia with the anesthetic plan including a preoperative interscalene nerve block with mepivacaine

Exclusion Criteria:

* any known contraindication to study medications or testing hand grip strength pre/post-op
* insulin-dependent diabetes mellitus
* neuropathy of any etiology in the affected extremity
* any anticipated incision site apart from the shoulder
* Obesity
* Pregnancy
* Incarceration
* inability to communicate with the investigators and hospital staff
Alveolar Ridge Preservation Using Amniotic Chorion Membrane

the present study is to compare the amniotic chorion membrane (ACM) alone versus the amniotic chorion membrane combined with xenograft for their efficacy in alveolar ridge preservation procedures regarding volumetric changes assessed by cone beam computed tomography (CBCT).


Eligibility Criteria:
Inclusion Criteria:

* Patients require extraction of a non-restorable (premolar or anterior tooth) located in the maxillary arch and needs implant restoration.
* Type two sockets will be selected as revealed by Cone beam computed tomography(CBCT)
* Absence of any systemic disease or drugs that contraindicate oral surgery using Modified Cornell Medical Index
* Male and female within age range of 20-45 years.

Exclusion Criteria:

* Smokers.
* Patients with poor oral hygiene or non-compliant patients who are not willing to perform oral hygiene measures.
* Pregnant and breast-feeding females.
* Patients with acute peri-apical infection or sinus tract.
* Vulnerable group of patients as handicapped patients, orphans,prisoners,etc
Safety, Tolerability and Pharmacokinetics of Single Rising Doses of BIIB 722 CL and HPβCD in Young Healthy Male Volunteers

Study to assess safety, tolerability and pharmacokinetics (PK) of single intravenous (i.v.) doses of BIIB 722 CL


Eligibility Criteria:
Inclusion Criteria:

* Healthy males
* 21 to 50 years of age
* Broca index \>= -20% and \<= +20%
* Written informed consent according to Good Clinical Practice (GCP) and local legislation

Exclusion Criteria:

* Any finding of the medical examination (including blood pressure, pulse rate and Electrocardiogram (ECG)) deviating from normal and of clinical relevance
* History or current gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunologic or hormonal disorders
* Diseases of the central nervous system or psychiatric disorders or neurological disorders
* History of orthostatic hypotension, fainting spells or blackouts
* Chronic or relevant acute infections
* History of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator
* Intake of drugs with a long half-life (\> 24 hours) within at least one month or less than ten half-lives of the respective drug before enrolment in the study
* Use of any drugs, which might influence the results of the trial within two weeks prior to administration or during the trial
* Participation in another trial with an investigational drug (\<= two months prior to administration or during trial)
* Smoker (\> 10 cigarettes or \> 3 cigars or \> 3 pipes/day)
* Inability to refrain from smoking on study days
* Alcohol abuse (\> 60 g/day)
* Drug abuse
* Blood donation (\>= 100 mL within four weeks prior to administration or during the trial)
* Excessive physical activities (within the last week before the study)
* Any laboratory value outside the reference range of clinical relevance
Turmeric and Turmeric-containing Tablets and Sebum Production

A noticeably increasing number of patients are asking for naturally based extracts and ingredients as supplementary dermatologic remedies. Patients are seeking natural and cost-effective skin care alternatives in place of prescription medications and procedures. This study will isolate the effects of oral turmeric and assess a combination tablet that includes turmeric on sebum production in healthy subjects.

Turmeric (Curcuma longa) is a spice that has been shown to exhibit anti-inflammatory, antimicrobial, antioxidant, anti-neoplastic properties, and even potential to improve mental illnesses. In western herbalism, Turmeric is primarily used as an anti-inflammatory agent. In India, turmeric is used in Ayurvedic medicine for the treatment of acne. It has been used both internally and externally.

Curcumin is a phytochemical derived from turmeric and believed to be one of the key active components of turmeric. Curcumin is reported to have activity as an antibacterial and anti-inflammatory agent and has been used as a paste for skin eruptions and infections. Previous basic science work by Dr. Raja Sivamani's lab has shown that both turmeric and curcumin inhibit lipid synthesis in human sebocytes, the cells responsible for the production of sebum

The goal of this study is to evaluate how ingestion of turmeric and tablets that have a combination of herbs including turmeric may modulate sebum production.

Eligibility Criteria:
Inclusion Criteria:

1. Age 18 to 50 years of age, and
2. Subject must be able to read and comprehend study procedures and consent forms.

Exclusion Criteria:

1. Subject should be generally healthy and have no smoking history in the past one year, and must have no history of diabetes, metabolic syndrome, known cardiovascular disease, malignancy, kidney disease, or chronic steroid use.
2. Subjects who consume more than 6 servings of caffeine per day, such as coffee and energy drinks (example - Red Bull).
3. Subjects with known allergies to herbal ingredients.
4. Subjects with known EKG changes.
5. Those who used topical medications in the past two weeks or systemic antibiotics within one month of starting the study.
6. Subjects who are postmenopausal
7. Those who are pregnant or breastfeeding.
8. Those that are prisoners or cognitively impaired.
Photoacoustic Endoscopy of Barrett's Esophagus

Endoscopy is an important technique in medicine to diagnose internal organs. Video endoscopy has been the most common technique providing clear, real time video images of organs' surfaces. However, this technique only images the surface and cannot effectively diagnose diseased tissues that develop in endothelial tissues. Endoscopic ultrasound (EUS) has been developed to overcome this limitation, and it is widely utilized in diagnosing GI diseases. This technique can image very deep areas of organs, up to several centimeters; however, it suffers from speckle artifacts and cannot adequately provide early diagnosis of tissue abnormalities that do not show mechanical properties that differ significantly from those of normal tissues.

The investigators propose that photoacoustic endoscopy (PAE), an endoscopic embodiment of the rapidly growing photoacoustic tomography (PAT) technology, can fulfill the aforementioned need.


Eligibility Criteria:
Inclusion Criteria:

* Aged 18 years and older.
* Patients with Barrett's esophagus scheduled for esophageal surgery.
* Patients with GERD, but without Barrett's esophagus, scheduled for esophageal surgery.
* Subjects must be able to understand and willing to sign a written informed consent form.

Exclusion Criteria:

* Inability to give informed consent.
* Pregnancy.
* Age less than 18 years
* Previous esophageal procedure (surgery, photodynamic therapy, argon plasma coagulation, endoscopic mucosal resection).
* Acute GI bleeding.
* Coagulopathy.
Efficacy and Safety of Short-term Postoperative Anticoagulant Therapy to Prevente Thrombosis in Arterovenous Fistula

Many guidelines at home and abroad advocate that arteriovenous fistula should be the first choice of permanent vascular access, but it is easy to form thrombus in a short time after arteriovenous fistula molding, resulting in internal fistula stenosis or occlusion. In this study, the investigators plan to screen the patients with arteriovenous fistula in the blood purification center of our hospital. Through the study design of random grouping and open label, the investigators will discuss the use of low molecular weight heparin or warfarin to prevent thrombosis in a short period of time after arteriovenous fistula operation. According to the research results, the investigators will understand efficacy and safety of short-term postoperative anticoagulant therapy to prevente thrombosis in arterovenous fistula.


Eligibility Criteria:
Inclusion Criteria:

* After AVF formation or balloon dilation surgery, there were no significant signs of oozing or bleeding at the surgical incision and operative site observed within 12-24 hours.
* The patient is willing to accept short-term anticoagulant therapy after the surgery, bear related risks, and sign an informed consent form.
* The patient is willing to cooperate with this study, undergo data collection related to the research, and relevant clinical examinations.

Exclusion Criteria.

* Age \>80 years;
* Concurrent hematologic diseases that can affect coagulation function;
* Concurrent comorbidities that can affect the patient's bleeding or coagulation functions, such as liver cirrhosis;
* Concurrent active bleeding disorders, such as active gastrointestinal ulcers or active lupus;
* History of major organ bleeding (e.g., intracranial or gastrointestinal) or surgery within the past six months;
* Unwillingness to participate in this study.
CoROnary SinuS Reducer implantatiOn for ischemiA reDuction

Patients with refractory angina pectoris have low quality of life and reduced exertional capacity. Studies have shown that the coronary sinus reducer (CSR) implantation improves the quality of life. However, to date there are no firm objective data on improvement of exertional capacity. Studies have shown a large influence of placebo effect after interventional procedures, which is even more pronounced than in medically treated patients. As angina pectoris presents entirely subjective perception of chest discomfort, its improvement may be influenced by this effect in up to 30 %. The investigators will study weather the CSR implantation improves aerobic exertional capacity in comparison to optimal medical therapy alone. Further, the investigators will explore the extent of myocardial reversible ischemia reduction and possible influence on hrECG markers of left ventricular arrhythmogenicity. 40 patients with refractory angina CCS class (Canadian cardiovascular society) II-IV and confirmed reversible ischemia will be included. Patients will be randomized into two groups. The first group will undergo CSR implantation procedure. The second group will present a sham control group with placebo procedure. At inclusion and after 6 months the investigators will perform cardiopulmonary exercise test (CPET), single photon emission tomography for detection of reversible ischemia (SPECT), high resolution ECG (hrECG), echocardiography and asses the subjective burden of angina according to CCS score and the quality of life according to the Seattle angina Questionnaire (SAQ).


Eligibility Criteria:
Inclusion Criteria:

* angina pectoris CCS class II-IV
* receiving optimal medical therapy for at least one month
* confirmed reversible myocardial ischemia in left anterior descending coronary artery (LAD) and/or left circumflex coronary artery (LCX) territory by SPECT
* not candidate for percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG)

Exclusion Criteria:

* recent non stable angina pectoris (within 1 months)
* recent acute coronary syndrome (within 3 months)
* recent successful PCI and/or CABG (within 6 months)
* decompensated heart failure and/or recent (within 3 months) hospitalization due to heart failure
* severe heart valve(s) disease
* advanced chronic obstructive pulmonary disease (COPD) or poorly managed asthma
* peripheral arterial disease, musculoskeletal disorder or central nervous system disease which preclude exercise testing
To Study the Efficacy and Safety of TIPS (Trans Intrahepatic Portosystemic Shunt) Versus Self Expanding Metallic Stent (SEMS) in the Management of Refractory Variceal Bleed in Cirrhotics.

A total of 50 patients will be enrolled and will be randomized into either Group A(TIPS) or Group B (SEMS).

Primary end point of the study will be to compare efficacy of TIPS versus SEMS for survival at 6 week or Early re Bleed. All enrolled patients will also undergo HVPG measurement at baseline to stratify risk of failure to control bleed or early re-bleed.

Patient will be monitored for 5 days for re bleed, complications of therapy, worsening of Liver function tests and scores and efficacy of either treatment modality over other. Patient will be followed for 6 weeks to see for the primary end point.


Eligibility Criteria:
Inclusion Criteria:

- Consecutive patients of cirrhosis aged 18-70 years presenting with acute variceal Bleeding, who on endoscopy fail to control bleed or rebleeds within 5 days will be randomized.

Exclusion Criteria:

* Bleeding from non-variceal source
* Coagulopathy related bleed
* Bleeding from Gastric varices
* Any malignancy including HCC
* Main Portal vein thrombosis
* Patients in refractory shock
* Patients with severe cardiopulmonary disease
* Grade 4 Hepatic encephalopathy
* MELD \> 25
* Multiorgan failure
* Active sepsis
* Pregnancy
* Failure to give consent
A Brain Imaging Study of Nicotine Release in Cigarette Smokers

Tobacco Smoking is the most prevalent addiction in society today causing directly major health hazards and sharing morbidity with other psychiatric disorders. Nicotine binds to acetylcholine receptors and thus elevates DA release and inhibits DA transport. There are few studies using advanced brain imaging techniques to investigate how nicotine releases dopamine in humans. These studies utilized dopamine displacement paradigms with \[11C\] Raclopride binding to D2 receptor in Positron Emission Tomography (PET). There is evidence that smokers (particularly those who enjoyed smoking) showed decreased \[11C\] Raclopride binding in the caudate/nucleus accumbens and putamen after smoking cigarettes. These results also indicated that the effects of nicotine on dopaminergic neurotransmission are mediated by pleasure and craving. We propose to investigate the effects of smoking a cigarette ad lib on dopamine release by using dopamine competition paradigm with \[I123\] IBZM in SPECT. Secondly, we will test the hypothesis that dopamine deficiency is a major vulnerability factor for smoking. This may provide further evidence that dopamine deficiency in some smokers pre-disposes them to enjoy and desire smoking cigarettes more than others.


Eligibility Criteria:
Inclusion Criteria:

* Chronic smokers and healthy non-smokers.

Exclusion Criteria:

* Pregnant and breast feeding women.
* Age below 20.
* Neurological disorders.
* Others drugs.
Single-center, Feasibility Study to Evaluate the Use and Safety of the Percutaneous Ultrasound Gastrostomy Technique

This is a single-center, non-randomized, non-blinded feasibility study to evaluate the performance, safety and tolerability of the Percutaneous Ultrasound Gastrostomy (PUG) procedure that utilizes a novel device in conjunction with widely available ultrasound technology. The procedure will be performed in 40eligible subjects. Patients will be followed for 2 days following performance of PUG to assess for potential complications. If the patient remains hospitalized they will be assessed through Day30 for potential complications.


Eligibility Criteria:
Inclusion Criteria:

* •Written informed consent must be obtained before any study-specific assessment is performed •Male or female ≥18 years of age•BMI between 20 and 30•Indication for gastrostomy tube placement determined to be present by the primary clinical care team•Patient determined to be an appropriate candidate for PEG or PUG by the study team•Women of childbearing potential must have negative serum or urine pregnancy test duringthe current hospitalization

Exclusion Criteria:

* •BMI \<20 or \> 30•Temperature ≥ 38 C •Systolic BP \< 100 or \> 180 mmHg•Heart Rate \< 50 or \> 110•Presence of a contraindication to being in proximity to a magnet (e.g. pacemaker).•History of prior gastrostomy or gastrectomy (partial or complete).•Patients with hematocrit \<25%, or a history of blood transfusion within the 14 days prior to screening, or active life-threatening GI bleeding. •Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test. •Involvement in other investigational trials within 30 days prior to screening.•Any other medical condition(s) that may putthe patient at risk or influence study results in the investigator's opinion, or that the investigator deems unsuitable for the study.
Phase II Evaluation of Exhaled Nitric Oxide (NO)

The goal of this clinical research study is to learn if the level of nitric oxide you breathe out may relate to the amount of breathing complications that you may experience due to radiation treatment.

Nitric Oxide Breathing Test:

If you agree to take part in this study, you will have a nitric oxide breathing test performed before, during and after radiation therapy. You will you will have a nitric oxide breathing test 1 week before you complete radiation therapy, when you complete radiation therapy, and at each follow-up visit for 6 months.

To complete this test, you will breathe out into a device called a nitric oxide breath analyzer for 10 seconds. You will repeat this test 3 times. The results of this test will give researchers information about possible inflammation in your lungs. The results of this test will be compared with any breathing symptoms you may experience during the same time period.

For your first breath testing session and any session when your nitric oxide level is at least 1 ½ times higher than the first session, you will repeat the test for up to 5 different "breathe out rates". This additional testing will allow the researchers to find where in your lungs the nitric oxide increase is coming from.

Breathing Symptoms Questionnaire:

On the day of each breathing test, you will complete a questionnaire about your breathing and any symptoms you may be experiencing. This should take about 10 minutes. After radiation therapy is complete, some of the monthly questionnaires will be completed by the data coordinator using telephone interviews.

Length of Study:

Your participation in this study will be over after you complete the last breath testing session.

This is an investigational study. The nitric oxide breath analyzer used in this study is FDA approved and commercially available for measuring breathed out nitric oxide levels in patients with asthma. Its use to predict lung inflammation caused by radiation therapy is investigational.

Up to 150 patients will take part in this study. All will be enrolled at MD Anderson.

Eligibility Criteria:
Inclusion Criteria:

1. Patients will sign consent for the study.
2. Patients with pathologic diagnosis of esophagus or lung cancer.
3. Patient plans to receive radiation treatment at MD Anderson.
4. Patient will receive \>/= 5 weeks of thoracic radiotherapy.
5. Patients \>/= 18 years of age.

Exclusion Criteria:

1. Patients who have asthma.
2. Women of childbearing potential (A woman of child-bearing potential is a sexually mature woman who has not undergone a hysterectomy or who has not been naturally postmenopausal for at least 24 consecutive months \[i.e., who has had menses at any time in the preceding 24 consecutive months\]) must practice effective contraception (oral, injectable, or implantable hormonal contraceptive; tubal ligation; intra-uterine device; barrier contraceptive with spermicide) throughout the study.
Efficacy and Safety Study on Menatetrenone in the Treatment of Postmenopausal Osteoporosis Women

To determine the effect and safety of menatetrenone on treatment of postmenopausal osteoporosis comparing with alfacalcidol.


Eligibility Criteria:
Inclusion criteria :

* Postmenopausal women with menopause duration more than 5 years and with age between 45-75 years old (menopausal age ≥40), or if hysterectomy operated before natural menopause, the age of women between 60-75 years old.
* Subject with BMD (L2-4 or neck of femur) being more than 2 Standard Deviation (SD) below the young female adult mean (According to the standard of each center)
* BMI between 18 kg/m2-30 kg/m2.
* The anatomic structure of lumbar spine must be available for Dual-energy X-ray Absorptiometry (DEXA) examination, patient with serious scoliosis, bone trauma or sequela after orthopedics surgery, which makes BMD measurement difficult, should be excluded
* Subject who have given informed consent prior to participation in the trial and who undertake to comply with the protocol.

Exclusion Criteria

* Subject with conditions that are considered to effect osteoporosis, such as clear definite diabetes mellitus, rheumatoid arthritis, rheumatoid arthritis, hyperparathyroidism or other bone metabolic diseases.
* Subjects who have received treatment with active-type vitamin D3 preparation, other vitamin D preparations (\>1000IU per day）, calcitonin, corticosteroid hormone, androgen, estrogen, other hormone, vitamin K preparation, in the 3 months prior to inanition of this study; Subjects who have received treatment with bisphosphonate preparation or Sodium Fluoride in the 1 year prior to inanition of this study; Subjects who have received treatment with Selective Estrogen Receptor Modulator (SERM) in the 6 months prior to inanition of this study
* Concurrent serious renal disease, hepatic disease, uncontrolled hypertension （≥150/100mmHg）, symptomatic ischemic heart disease, cerebral infarction or arteriosclerosis obliterans.
* Cancer history within 5 years.
* Subjects who take antacid containing aluminum in the preparation, warfarin or thrombolytic agents.
* Subject with any known abnormality in laboratory tests, which is deemed to be clinically significant by the investigator, which include:
* Serum alkaline phosphatace (ALP) \> upper normal limit 10% (calculated according to the range of normal values of each center);
* Glutamic Oxalacetic Transaminase (AST)/ Glutamic Pyruvic Transaminase (ALT) \> upper normal limit 50％(calculated according to the range of normal values of each center);
* Serum creatinine \>1.5mg/dL (133μmol/L);
* Blood-fasting sugar ≥ 7mmol/L (126mg/L)
* Inability of subject to return for scheduled visits or to comply with any other aspect of the protocol.
* Subject who, in the opinion of the investigator, are poor medical candidates or pose any other risk for therapy with an investigational drug.