cyrilzakka/clinical-trials huggingface dataset:
A Stepped Care Approach to Treating Tobacco Use in Rural Veterans

Tobacco use remains prevalent among Veterans. Although effective smoking cessation interventions exist, long-term term quit rates remain sub-optimal. The project will investigate the feasibility of a stepped care approach to treating tobacco use that includes enhancements based on initial response to treatment to augment the investigators' existing tailored tobacco treatment intervention.

Rural tobacco users (cigarette smokers, smokeless tobacco users, and users of other forms of tobacco) from the Iowa City VA Health Care System will be proactively recruited using information obtained from the electronic medical record. All participants will receive the investigators' tailored, six session smoking cessation intervention developed over a series of projects funded by ORH. This includes a counseling protocol tailored to tobacco users' individual needs and associated risk factors as well as pharmacotherapy selected using shared decision making. Participants who are unable to quit initially will be provided with enhanced counseling based on self-monitoring and scheduled reduced smoking. Those who are able to quit using tobacco during the initial treatment phase will be given an extended, four-session counseling protocol that incorporates new content based on established interventions from positive psychology in an effort to reduce relapse.

Eligibility Criteria:
Inclusion Criteria:

* Use tobacco (cigarettes, smokeless tobacco, pipes, cigars, hookah) on a daily basis
* Be willing to make a quit attempt in the next 30 days
* Able to provide informed consent
* Have access to a telephone
* Have a stable residence,

Exclusion Criteria:

* Planning to move within the next 6 months
* Terminal illness
* Unstable psychiatric disorder (e.g., acute psychosis)
The Constitution and Efficacy of Chinese Medicine of Infertility Male, Female, and Pregnant Female

The project aims to conduct a retrospective study to assess the impact of Traditional Chinese Medicine (TCM) on improving pregnancy rates and preventing miscarriages. It will include patients with infertility issues or a history of miscarriage. The study will analyze demographic and physiological data, TCM constitution, basal body temperature, reproductive history for females, and semen analysis for males, to determine the effectiveness of TCM care in enhancing fertility outcomes.

The present project plans to conduct a retrospective study based on the data of the National Health Insurance Traditional Chinese Medicine Enhancement Quality of Maternity Care Plan.

Analysis Methods: The collected data was archived using SPSS software, and the following testing methods were employed for statistical analysis among different datasets:

1. Paired-t Test: Examining differences in temperature and duration between follicular and luteal phases in females before and after treatment.
2. Chi-Square Test: Assessing the relationship between traditional Chinese medicine constitution and pregnancy outcomes.
3. McNemar Test: Testing the significance of changes in traditional Chinese medicine constitution before and after treatment.
4. Logistic Regression: Conducting multivariate analysis to explore factors associated with pregnancy status.

The purpose of this project is to figure out after conducting proper Chinese medical care, whether it will improve the target patients' pregnancy rate and miscarriage prevention rate. Those data will conduct a biological analysis to compare the difference between pregnancy and miscarriage prevention rates between different patients.

Eligibility Criteria:
Inclusion Criteria:

* Fertility Assistance: For male and female patients who have been married for over a year with regular sexual activity but are unable to conceive.
* Miscarriage Prevention: For females who have had miscarriages, non-natural conception, conception through fertility assistance, and are prone to miscarriage.

Exclusion Criteria:

* Fertility Assistance:

  1. Incomplete demographic data for males/females
  2. Incomplete Traditional Chinese Medicine constitution determination data for males/females
  3. Incomplete information on the follicular/luteal phase for females
  4. Incomplete semen analysis data for males
* Miscarriage Prevention:

  1. Incomplete demographic data
  2. Incomplete physiological examination data
  3. Incomplete data on related disease records
Efficacy and Safety of a Preparation Containing an Antibiotic and Anti-Inflammatory Agent in Acne Vulgaris

The concept behind our study was to combine an effect of antibiotic and anti-inflammatory agents for a more efficient acne therapy directed at the factors involved in the pathophysiology of the disease. For this purpose we evaluated a combination of clindamycin phosphate and salicylic acid in a non-irritating carrier.


Eligibility Criteria:
Inclusion Criteria:

* mild to moderate acne vulgaris;
* at least 5 lesions on the face;
* a one-month wash-out period was established for any topical or systemic drug use for treatment of acne vulgaris.

Exclusion Criteria:

* acne that was primarily truncal, nodular, or due to secondary causes/internal disease;
* pregnancy, breastfeeding, or intention to become pregnant;
* another dermatological disease of the face;
* significant systemic disease;
* any drug/alcohol addiction;
* interacting medication;
* known hypersensitivity to study medications;
* history of chronic disease treated with medications which might affect acne condition and treatment outcome (e.g. corticosteroids, lithium, isoniazid, anti-androgens, phenytoin, phenobarbital) in the preceding month
Endotracheal Tube Intracuff Pressure and Leak Around the Cuff During Retractor Placement for Adenotonsillectomy

The investigators have devised a simple method to continuously measure the CP using an invasive pressure monitoring setup (IPMS), which is used routinely in the operating room to monitor arterial or central venous pressures. The investigators have previously confirmed both in vitro and in vivo (previous IRB approved protocol), a clinically applicable agreement of the IPMS readings with the values obtained from a standard manometer (gold standard). In the current study, we will prospectively evaluate the relationship between the patient's head position and CP in patients undergoing otolaryngological surgery and also measure the oxygen concentration in the oropharynx to determine the potential risk of an airway fire.


Eligibility Criteria:
Inclusion Criteria:

* Less than 18 years of age, undergoing otolaryngological surgery with endotracheal intubation

Exclusion Criteria:

* Patient who is intubated with an uncuffed endotracheal tube
* Patients who have a limitation for movement of the neck or concerns of the stability of the cervical spine.
Long Thoracic Nerve Blockade for Pain Treatment After Video-Assisted Thoracoscopic Surgery

Video-assisted thoracoscopic surgery (VATS) provides an opportunity to penetrate the thoracic cavity by video through an incision into the chest wall and facilitate surgical operation of lung pathologies.Various regional methods of anesthesia are currently being used to achieve this goal.

The aim of the study was to assess the effectiveness of Long thoracic nerve bloc on postoperative VATS analgesia.


Eligibility Criteria:
Inclusion Criteria:

* Patients who were in the American Society of Anesthesiologists (ASA) I-III class and underwent video-assisted thoracoscopic surgery (VATS).

Exclusion Criteria:

* Previous history of opioid use preoperatively,
* Allergy to local anesthetics,
* The presence of any systemic infection,
* Uncontrolled arterial hypertension,
* Uncontrolled diabetes mellitus.
Acupuncture Study on Rheumatoid Arthritis, Monitoring Microbiome and Blood

Acupuncture is used and recommended by the WHO for the treatment of Rheumatoid Arthritis.

The molecular bases of this recommendation are not known, the investigators want to compare with the usage of high-throughput molecular technologies the variations occurring in patients treated with acupuncture and conventional treatment with the ones treated with conventional treatment only. The investigators observe the variations in blood and in the gut microbiome.


Eligibility Criteria:
Inclusion Criteria:

* The patient should be diagnosed as the first or second stage of rheumatoid Arthritis (RA) and checked with X ray for additional diagnose.
* diagnosed for RA according to ACR(1987)
* the patient should be in the active stage of the disease, defined as：

  1. swollen joints \>3
  2. tender joints \> 5
  3. any one of the following： (c1.) morning stiffness lasting more than 45 minutes (c2.) Erythrocyte Sedimentation Rate (ESR) \>= 28mm/h (c3.) C-reactive protein (CRP)\>= 12mg/L
* Should not be resistant to MTX nor leflunomide
* Blood test should satisfy:

  1. Hemoglobin (Hb)\>=85g/L
  2. White cell \>=3.5 10+9/L
  3. Platelets \>= 100 10+9/L
  4. Liver function: serum alanine aminotransaminase (ALT), aspartate transaminase (AST) and total bilirubin (TBil) should be less than 1.5 times the upper limit of normal (ULN)
  5. Kidney function: Serum creatinine (Cr) level should be less than ULN.
  6. Pregnancy test should be negative
* should be positive for anti-cyclic citrullinated protein antibodies (anti-CCP).
* should agree to sign the informed consent

Exclusion Criteria:

* Serious diseases affecting liver, kidney, heart and lung, or diseases related to hematologic，endocrine and nervous systems. .
* Be treated by MTX or Leflunomide in the last 3 months.
* Be treated with cortical hormone （could be intramuscular injection, intravenous injection or injection to articular cavity） in the last 4 weeks.
* Be treated with biological agents, such as antagonist of TNF-alpha,IL-6, and CD20 mono antibody in the last 3 months.
* Be treated by chronic medicine, such as immunosuppressive agent, Penicillamine, chloroquine and gold based Disease-modifying antirheumatic drugs (DMARDs) in the last 3 months.
* Pregnant and breast-feeding woman
* Having history of serious drug allergy
* In the acute or chronic phase of infection (such as lung diseases)
* Easy bleeding patients or patients with local skin infection (only for acupuncture)
* The patients cannot accept acupuncture (only for acupuncture)
* Be treated with acupuncture in the past 3 months（only for acupuncture）.
* No pregnant and breast-feeding woman.
* No history of serious drug allergy.
Food-related Differences in Human Metabolite Profiles

Many population studies include food questionnaires (recording the normal food intake or the food intake of the study day). This is necessary, because diet is an important lifestyle factor, although food questionnaires are time-consuming and expensive. Moreover, mis-reporting is a very common problem. We therefore seek for a tool to validate food protocol.

The hypothesis is to find biochemical marker for animal protein, fruit intake and grape consumption in urinary metabolic profiles after specific food consumption. Furthermore we want to specify biomarkers for different animal protein sources, fish and beef.

Volunteers are asked to follow a diet plan over the whole course of the study. Every newly introduced food (in this study the dinner on days 2-5) will cause a change in biochemical marker excretion with urine. To monitor the kinetics of biomarker excretion it is necessary to collect urine several times a day; we will ask volunteers to collect the first morning urine, before lunch, before dinner and before going to bed. Urine sampling will start with the first morning urine on day 1 and end with first morning urine on day 7.

As test food, we propose a fruit salad (apples, grapes, orange and grapefruit) on day 2, fish on day 3, grapes on day 4, beef on day 5 and again fish for lunch on day 6.

From day 0 (run-in day) to day 6 the basic diet will always be bread and cheese for breakfast, coffee in the morning, a ham sandwich for lunch, and pasta and tomato sauce for dinner. As beverages only water will be allowed (although wine is permitted on day 4 if the subject wishes but this is not a protocol requirement). The test foods will be consumed in addition to that.

All urine samples will then be analysed using high resolution NMR spectroscopy and mass spectrometry. Mathematical data analyses as well as the visual examinations of the NMR spectra will also be carried out to identify new food biomarkers.

Eligibility Criteria:
Inclusion Criteria:

* healthy individuals
* male/female
* aged 18-45 years
* non-smoker
* BMI 18-25 kg/m2

Exclusion Criteria:

* regular drug intake
* regular food supplements intake
* antibiotics intake in the last 3 months
* not willing to eat one or more items of the foods listed in the diet plan
Pleth Variability Index (PVI) to Predict Fluid Responsiveness

Interventional data collection study to evaluate the ability of pleth variability index (PVI) to predict fluid responsiveness in comparison with other dynamic parameters including pulse pressure variation (PPV) and stroke volume variation (SVV).

No subjects were enrolled into the validation portion of this study.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* Scheduled for elective surgery requiring general anesthesia and mechanical ventilation
* Arterial line and Swan-Ganz catheter placement indicated as part of the scheduled surgical procedure

Exclusion Criteria:

* Patients with surgeries at or around site of sensor placement or skin abnormalities affecting the sensor placement area such as psoriasis, eczema, angioma, scar tissue, burn, fungal infection, substantial skin breakdown, nail polish, or acrylic nails that would prevent monitoring of pulse-oximeter physiological parameters during the study
* Patients with cardiac arrhythmias
* Patients with intracardiac shunts
RALOX as Second Line Treatment for Advanced Malignant Biliary System Tumor

The purpose of this study was to explore the safety and efficacy of raltitrexed combined with oxaplatin as second line treatment for advanced malignant biliary system tumor.

The purpose of this study was to explore the safety and efficacy of raltitrexed combined with oxaplatin as second line treatment for advanced malignant biliary system tumor. Single arm，phase II study for patients with cholangiocarcinoma or gallbladder carcinoma after first line treatment failure to explore effection and safety of raltitrexed combined with oxaplatin as second line treatment；Sample size：50.

Eligibility Criteria:
Inclusion Criteria

1. 18-75 years old.
2. Patients with unresectable advanced advanced Gallbladder carcinoma or Cholangiocarcinoma confirmed by histology or cytology.
3. First-line chemotherapy failure (toxic side effects can not be tolerated, disease progression during treatment or relapse after treatment) ;Or the disease recurred within 6 months after completion of adjuvant chemotherapy.
4. At least one measurable lesion according to RECIST1.1 criteria.
5. ECOG: 0 \~ 1.
6. Life expectancy ≥ 12 Weeks.
7. The major organs were functioning normally, and the laboratory examination results within 1 week met the following conditions before enrollment:①Absolute neutrophil count (ANC)≥1.5×109/L ②Platelet count（PLT）≥80.0 × 109/L ③Hemoglobin concentration（HB） ≥90g/L④ Total bilirubin（TB）≤1.5×ULN ⑤ Serum creatinine （Cr）≤l.5×ULN ，Endogenous creatinine clearance \>60ml/min（Cockcroft-Gault Formula ）⑥Aspartate aminotransferase (AST), Alanine aminotransferase (ALT), Alkaline phosphatase(AP): ≤3 ×ULN (≤5 ×ULN for metastases to liver).
8. Sign the informed consent voluntarily.

Exclusion Criteria

1. Allergic to any research drug and its excipients.
2. Prior use of raltitrexed or oxaliplatin.
3. History of other malignancies, except cured Basal cell or squamous Cell Carcinoma of the skin and carcinoma in situ of the cervix.
4. There is a history of brain metastases.
5. History of psychotropic drug abuse and cannot quit or has a mental disorder.
6. Uncontrolled chronic infectious and non-infectious diseases.
7. Active or clinically poorly controlled severe infection
8. Other conditions that the researchers think should be ruled out.
Heart Matters: The Effectiveness of Heart Health Education in Regions at Highest-risk.

The aim of the study is to evaluate whether providing a targeted heart health education campaign to regions at high risk of heart attacks will improve ACS patient's symptom recognition and response.

The intervention will be will be evaluated according to a cluster randomized, stepped wedged design. The clusters are eight local government areas (LGAs) in Victoria, Australia. The main primary outcome will be assessed in consecutive patients presenting to emergency departments from the six LGAs throughout the study period with an ED diagnoses of acute coronary syndrome.

Primary objectives:

To determine if targeted heart health education will:

1. Increase ambulance use in ACS patients (main primary outcome);
2. Decrease patient and prehospital delay times in ACS patients;
3. Increase awareness of personal cardiovascular risk and associated factors in adult community members; and
4. Increase cardiovascular knowledge and confidence to act to heart attack warning signs in adult community members.

Secondary objectives

1. To determine if targeted heart health education:
2. Reduces the incidence of out-of-hospital cardiac arrest;
3. Improves survival in OHCA patients;
4. Improves survival in ACS patients;
5. Improves survival and ACS patients;
6. Increases presentations to ED for ACS and unspecified chest pain; and
7. Increases the rates of calls to ambulance for chest pain and non-chest pain.
8. Increases the rate of Heart Health Checks.

Intervention: To meet the objectives of the study, we will employ HM coordinators for each of the eight high-risk LGAs to organise and deliver our HM education program using HM materials and Partner resources.

Design: The stepped-wedge design is a uni-directional cross-over design - where the randomisation element is when the cluster crosses-over to the intervention following a control period.

Over the 16-month study period, the eight LGAs will move into the intervention phase at two month intervals. As four LGAs are in close proximity, these LGAs will switch from control to intervention periods at the same time to avoid possible contamination.

Eligibility Criteria:
Inclusion Criteria: Adult residents of the eight local government areas -

Exclusion Criteria: Adults not residing in the eight local government areas.

-
Observational Study of Complications Related to Use of Peripherally Inserted Central Catheters

The purpose of this study is to determine the rate and timing of interventions and complications related to the use of peripherally inserted central venous catheters in adult patients.


Eligibility Criteria:
Inclusion Criteria:

* Male or Female Age \> 18 years requiring central venous access
* Ability to comply with study requirements
* Written Informed Consent

Exclusion Criteria:

* Previous enrollment in study
* Current or recent upper extremity thrombosis, occlusion or stenosis
* Previous axillary lymph node dissection
* Skin inflammatory condition or rashes within 15 cm from insertion site
* Pre-existing history of hypercoagulability unrelated to malignant disease
* Participating in trial involving antithrombotic, anticoagulant or anti- infective drug therapies
* Positive blood culture within 48 hours from planned PICC placement
* Known, renal insufficiency with chronic creatinine levels \> 1.7 mg/dl
Pilot Study of a Homeopathic Therapy in Combination With Cyclosporin (Restasis) in the Treatment of Dry Eye Disease

The purpose of this study is to determine whether a homeopathic therapy in combination with cyclosporin (Restasis) is more effective than cyclosporin (Restasis) alone in the treatment of dry eye disease.

Dry eye disease affects millions of people world-wide, and presents with symptoms of blurred vision, discharge from the eyes, eye discomfort, burning, redness, sandy and gritty feeling in the eyes, and sensitivity to light. Topical eye drops for eye lubrication (i.e., artificial tear solutions) and controlling ocular inflammation through the use of topical immunomodulatory agents (i.e., cyclosporine \[Restasis\]) have been shown to be effective for treating dry eye syndrome, but are not curative. Recently, we have evaluated a few patients who had discontinued using Restasis as they had obtained better relief of their dry eye symptoms with a homeopathic therapy.

Potential participants will undergo an eye examination consisting of medical history and physical examination (i.e., visual acuity, pupillary exam, examination of the lids, slit-lamp examination of the conjunctiva, cornea, anterior chamber, iris, and lens, and funduscopic examination). Participants qualifying for the study will then stop all eye medications and will use a common artificial tear solution for 2 weeks prior to the baseline examination. We will evaluate 4 measures of dry eyes at baseline and after 6 weeks of therapy: 1) tear film to break-up; 2) staining of the cornea by fluorescein stain; 3) measurement of tear production over 5 minutes by Schirmer's test; and 4) the Ocular Surface Disease Index (OSDI).

Eligibility Criteria:
Inclusion Criteria:

* diagnosis of moderate to severe dry eye syndrome with or without Sjögren's syndrome
* receiving treatment with topical cyclosporine (Restasis)
* experience one or more moderate dry eye-related symptoms, including dryness, foreign body sensation, burning, blurred vision, photophobia, and soreness or pain

Exclusion Criteria:

* history of ocular disorder including non-dry eye ocular inflammation, glaucoma, contact lens use
* trauma or surgery, including punctal plug insertion within the prior 3 months
* any uncontrolled systemic disease or significant illness
* use of topical ophthalmic medications that could affect dry eye syndrome
* pregnancy, lactation, or considering a pregnancy
Does Teriparatide (rhPTH 1-34) Promote Fracture Healing in Proximal Humeral Fractures?

40 postmenopausal women, with a non-operated proximal humeral fracture, will be randomized to standard treatment (physiotherapy) or standard treatment + Forsteo (rhPTH 1-34) during 4 weeks. Follow-up will be at 7 weeks and 3 months including x-ray and DASH score (The Disabilities of the Arm, Shoulder and Hand) measuring physical function, and pain on a visual analoge scale (VAS).

Two doctors, blinded to the treatment, will judge the callus formation and healing on the x-rays and guess the treatment. The DASH score and the pain score will be compared between the treatment groups.

The investigators hypotheses are that callus formation and healing will be more pronounced and that patients have less pain and better function in the rhPTH 1-34 group.


Eligibility Criteria:
Inclusion Criteria:

* proximal humeral fracture
* postmenopausal woman 50 years or older
* non-surgical treatment

Exclusion Criteria:

* dementia or psychiatric disorder
* known malignancy \< 5 years prior to fracture
* calcium above reference value
* signs of liver disease
* creatinine over ref. value
* inflammatory joint disease
* alcohol or drug abuse
* oral corticosteroid medication
* long-term NSAID-treatment (=\> 3 months prior to fracture)