cyrilzakka/clinical-trials huggingface dataset:
Prepare to Quit - A Clinical Trial to Help People Quit Smoking in a Community Dental Clinic Setting

The objectives of this study are:

1. To determine the effect that an intensive, community dental clinic centered, stop-smoking program using a motivational interviewing approach has upon cessation rates for interested, smoking inner-city dental patients.
2. To determine the effect that providing a tooth whitening incentive, in a community dental clinic stop-smoking program, has upon cessation rates for interested, smoking inner-city dental patients.

See above

Eligibility Criteria:
Inclusion Criteria:

* current smoker
* dental clinic patient
* interested in quitting smoking

Exclusion Criteria:

* minors
* those unable to provide own consent
Study of Nitazoxanide Tablets in the Treatment of Mild to Moderate Active Crohn's Disease

The primary objective of this study is to evaluate the efficacy and safety of nitazoxanide compared to a placebo in reducing the signs and symptoms of mild to moderate active Crohn's disease in adults.

There is a significant need for a safe and effective treatment of Crohn's disease. It is recognized that bacteria in the gut lumen may have a role in the etiology and/or symptoms of this disease. Antimicrobials have often been used in treating Crohn's disease although their effectiveness has not been well established. Pro-inflammatory cytokines are also believed to play an important role in this disease. Nitazoxanide, a thiazolide anti-infective, is active in vitro against a broad spectrum of anaerobic bacteria, and it inhibits secretion of pro-inflammatory cytokines including IL-2, -4, -5, -6, -8, -10 and TNF alpha. The drug is also highly concentrated in the gastrointestinal tract. With these characteristics, nitazoxanide offers a unique approach to treatment of Crohn's disease.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years.
* Diagnosis of Crohn's disease with colonic or perianal involvement confirmed by endoscopic, histologic and/or radiologic data.
* CDAI score ≥200 and ≤400.

Exclusion Criteria:

* Subjects known to have stool positive for Clostridium difficile toxin A or B, bacterial enteric pathogens, rotavirus, Cryptosporidium species (spp.), and/or ova/parasites.
* Evidence of bowel obstruction.
* Females that are pregnant, breast-feeding or not using birth control and are sexually active.
* Serious systemic disorders incompatible with the study.
* History of hypersensitivity to nitazoxanide or any inactive ingredient in the formulation.
* Uncontrolled gastro-intestinal bleeding.
* Evidence of intestinal abscess, non-perianal fistula or stricture.
* Patients who have received antibiotics in the past 7 days.
* Patients receiving \>20 mg of prednisone, or its equivalent.
* Patients receiving Anucort-HC or rectal steroids.
* Patients receiving immunosuppressive therapy that has not been stabilized.
* Patients who have received TNF-alpha inhibitor treatments such as infliximab or other biological agents within three months prior to start of treatment.
* Patients with Crohn's disease confined to the esophagus, stomach and small bowel.
Gait Modifications and Cutaneous Stimulation

The purpose of this study is to quantify differences in joint mechanics between different types of walking in healthy individuals and individuals with knee pathology. The investigators will determine how modifying gait through feedback and/or cutaneous stimulation changes joint loading.


Eligibility Criteria:
Inclusion Criteria:

* BMI \< 35 kg/m\^2
* For knee pathology subjects: Diagnosis of knee pathology (e.g. knee osteoarthritis, ACL injury, etc) and/or knee pain
* Full weight-bearing status

Exclusion Criteria:

* Non-ambulatory
* Use of walking aid
* For healthy volunteers - history of surgical intervention at any joint of the lower extremity
* Inability to cooperate with study protocol due to medical or psychiatric reasons
* Inability to provide informed consent
* For healthy subjects: Any diagnosis of knee osteoarthritis or knee pain
A Safety Study of ARRY-403 in Patients With Type 2 Diabetes

This is a Phase 1 study, involving a 1-day dosing period, designed to test the safety of investigational study drug ARRY-403 in patients with Type 2 diabetes. Approximately 36 patients from the US will be enrolled in this study.


Eligibility Criteria:
Key Inclusion Criteria:

* Male or female with willingness and ability to use protocol-specified methods of contraception, except females of nonchildbearing potential.
* Diagnosis of Type 2 diabetes less than 5 years prior to study start.
* HbA1c ≥ 6.5% and ≤ 10%.
* BMI ≥ 25 and ≤ 40.0 kg/m2.
* Additional criteria exist.

Key Exclusion Criteria:

* Recent history (i.e., less than 6 months) or concomitant/ongoing clinically significant hematologic, renal, pulmonary, gastrointestinal, hepatic, psychiatric, neurologic, dermatologic, or allergic disease (including drug allergies that are clinically significant and not remote, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).
* Significant cardiac disease, myocardial infarction within 6 months of study start, unstable angina, congestive heart failure, known arrhythmias of ventricular etiology, unexplained syncope or syncope/seizures related to arrhythmia.
* History of gastric surgery, vagotomy, bowel resection, or any surgical procedure that might interfere with gastrointestinal motility, pH, or absorption.
* Active infectious diseases including hepatitis B, hepatitis C, or human immunodeficiency virus (HIV). Past history and inactive hepatitis B and C, as confirmed by serological testing, are allowed.
* A positive test for drugs or alcohol.
* Women who are pregnant or breastfeeding.
* Donation or loss of ≥ 550 mL of blood (including plasmapheresis) or receipt of a transfusion of any blood product within 8 weeks prior to first dose of study drug.
* Additional criteria exist.
Focal Ablative STereotactic Radiosurgery for Cancers of the Kidney

This study is evaluating the activity and efficacy of Stereotactic Ablative Body Radiotherapy (SABR) for the treatment of kidney cancers.

Who is it for?

* Age \> 18 years old
* All patients must have a biopsy confirmed diagnosis of renal cell carcinoma with a single lesion within a kidney
* ECOGperformance of 0-2 inclusive.
* Life expectancy \> 9 months
* Either medically inoperable, technically high risk for surgery or decline surgery.
* Multidisciplinary decision for active treatment

Study Details:

Definitive external beam radiotherapy (EBRT) is often used to treat medically inoperable patients with cancers in many different organs, including the kidneys. However, renal cell carcinoma (RCC) is conventionally considered "radioresistant" to fully fractionated EBRT. In an effort to overcome the perceived "radioresistance" of RCC, severely hypofractionated EBRT in the form of stereotactic radiotherapy has renewed interest in the management of renal cell carcinoma with radiotherapy. This study will be evaluating the safety and effectiveness of Stereotactic Ablative Body Radiotherapy (SABR) for the treatment of cancers of the kidney.

Participants in this study will be allocated to receive either multi-fraction SABR (3 fractions over 2 weeks) or single fraction SABR (1 fraction only).

All participants will be assessed at regular intervals post treatment in order to estimate the activity and efficacy of the technique, evaluate tolerability, estimate survival, estimate distant failure rate, and renal function change after SABR.

The follow-up visits occur at 4 weeks and every 3 months in the 1st year post treatment, then every 6 months in the second year and then yearly until study closure (2 years after the last participant finishes study treatment).

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years old
* All patients must have a biopsy confirmed diagnosis of renal cell carcinoma with a single lesion within a kidney
* Eastern Cooperative Oncology Group (ECOG) performance of 0-2 inclusive.
* Life expectancy \> 9 months
* Either medically inoperable, technically high risk for surgery or decline surgery.
* Multidisciplinary decision for active treatment

Exclusion Criteria:

* Pre-treatment estimated glomerular filtration rate \< 30 mls/min
* Cytotoxic chemotherapy within 3 weeks of commencement of treatment, or concurrently with treatment. Delivery of targeted agents (such as sunitinib) are allowable only when at least 7 days separate the delivery of the proposed agent and the delivery of the stereotactic radiotherapy.
* Previous high-dose radiotherapy to an overlapping region
* Tumours of larger than 8cm is size
Prostaglandins Before Caserean Section

The aim of our study is to assess the value of administration of prostaglandins before cesarean section to reduce the amount of blood loss

160 full term pregnant patients candidate for elective cesarean section were randomly allocated into 2 groups ,80 patients will receive 200mcg of rectal prostaglandins before cesarean section and 80 patients are used as control receiving placebo

Eligibility Criteria:
Inclusion Criteria:pregnant patients full term elective cesarean section

-

Exclusion Criteria:

* medical disorder with pregnancy
Comparative Study of Mesh Versus No Mesh in Prolapse Surgery

Hypothesis / aims of study A RCT has shown that results of prolapse repair via vaginal approach could be improved when a polypropylene mesh is used as tissue support (1). However, non protected heavy-weight meshes were associated with a high rate of local complications such as vaginal erosions and dyspareunia (2). The aim of this multicentre study is to evaluate anatomical and functional results of an innovative low-weight polypropylene mesh protected by an absorbable hydrophilic film in the prolapse repair by vaginal route, in comparison by the standard anterior colporrhaphy.

Study design, materials and methods This study involves 15 centres in French Private or Public Hospital. Patients will be randomly allocated to be operated by a standard anterior colporrhaphy or by an anterior repair reinforced by a specially designed mesh: UgytexTM (Sofradim, France). Ugytex is a low-weight (38g/m²) and highly porous (average porosity: 89%, pores over 1.5mm) polypropylene monofilament mesh offering tissue ingrowth and connective differentiation for a stable and long-term support. The mesh is coated with a hydrophilic film composed of atelocollagen, polyethylene glycol and glycerol. The absorbable coating protects delicate pelvic viscera from the risk of acute inflammation during the healing's inflammatory peak. Prolapse severity will be evaluated using the POP-Q system. In order to evaluate the patient's quality of life, the validated PFDI and the PFIQ questionnaires will be used preoperatively and during follow-up (3), as well as a validated questionnaire on sexual problems. The difference on one-year cure rate should be 15% (80% for the anterior colporrhaphy and 95% for the mesh repair). Then the estimated number of patient is 97 in each arm.


Eligibility Criteria:
Inclusion Criteria:

* Patients older than 60 years-old
* Anterior vaginal wall prolapse of stage 2 or more (POP-Q system)
* Symptomatic prolapse
* Informed consent signature obtained

Exclusion Criteria:

* Patient not able to read French language
* Patient with a anterior prolapse of stage 1
* Urinary of vaginal infection
* Hepatopathy with ascitis
* Diabetes uncontrolled
* Treatment by corticosteroids
* Previous pelvic irradiation
* Intraoperative bladder injury
Effect of Weight Loss and Lactation (the EVA-trial)

A randomized controlled trial aiming to investigate the effects and possible interactions of diet induced weight loss and lactation on cardiometabolic profile


Eligibility Criteria:
Inclusion Criteria:

* Pregnant women in gestational week \<32, with a pre-pregnant BMI 25-35 kg/m2
* Residence in Oslo/Bærum and surrounding area
* Intention to breastfeed their child
* Able to read and write in Norwegian.

Exclusion Criteria:

* Medication that influences lipid or glucose metabolism
* Chronic disease that influences lipid or glucose metabolism (e.g. diabetes (World Health Organization, WHO, 2006) or diabetes in pregnancy (WHO 2013))
* Premature birth (before week 36)
* Preeclampsia
* Previous breast reducing surgery
Physiologic Performance Response to Salbutamol

This project aims to investigate the individual physiological response to beta2-adrenergic stimulation with salbutamol on performance-related outcomes


Eligibility Criteria:
Inclusion Criteria:

* 18 to 45 years of age
* Trained individuals with maximal oxygen uptake above 55 mL/kg/min for men and 50 mL/kg/min for women
* Body mass index lower than 26

Exclusion Criteria:

* Allergy towards study drug
* Unacceptable side effects of the study drug
* Chronic disease deemed by the MD to impose a risk or severely confound the study outcomes
* Current smokers
* Use of prescription medicine
* Pregnancy
Enhancing Psychiatric Nursing Skills in Auditory Hallucination Assessment Via AR/VR and Virtual OSCE

The purpose of this study is to develop and evaluate AI-based virtual reality teaching resources aimed at enhancing nursing students' competencies in assessing, communicating with, and managing patients experiencing auditory hallucinations. Specifically, this study seeks to improve the ability of nursing students to effectively assess auditory hallucinations, facilitate better communication with patients experiencing such disturbances, and strengthen their skills in managing these symptoms through the implementation of virtual reality-based educational scenarios.

This study employs a quasi-experimental design and uses a convenience sampling method to select senior students from a university nursing program as participants. The study aims to recruit 150 nursing students. The research involves two institutions, with participants being divided into groups within each institution. The students will be randomly assigned by computer into two groups: an experimental group and a control group. The experimental group will receive AR/VR technology-based group training within a virtual clinical environment during their practicum, while the control group will watch educational videos and participate in a general discussion group focused on auditory hallucinations.

Data will be collected using Google Forms at two time points: baseline and post-intervention. The research instruments include:

1. A self-assessment questionnaire on confidence in auditory hallucination assessment and intervention;
2. A scale measuring nursing students' knowledge, attitudes, and perceived empathy toward auditory hallucinations;
3. The Auditory Hallucination Situational Involvement and Empathy Scale;
4. An OSCE (Objective Structured Clinical Examination) evaluation form that assesses auditory hallucination assessment skills, empathy toward auditory hallucinations, communication skills, and the ability to manage auditory hallucinations." Data will be analyzed using IBM SPSS 24.0 for descriptive statistics and for comparing outcomes between the experimental group and the control group.

Eligibility Criteria:
Inclusion Criteria:

* Nursing students who are about to undertake their psychiatry practicum.
* Those who are willing to join the study and sign the consent form.
* Those who are willing to bring a smartphone to connect with VR360 and watch the video.
* Those who are willing to use their smartphone for research purposes (a smartphone will be provided by the research team if needed).

Exclusion Criteria:

* Individuals with hearing or vision impairments
Which Parameters of Short-term Blood Pressure Variability Best Predict Early Outcomes in Acute Ischemic Stroke

Previous studies on the association between blood pressure variation (BPV) in acute ischemic stroke and functional outcomes yield conflicting result. The obscured definition and measurement of BPV engenders considerable confounding factors, making it difficult to interpret. We aim to investigate the predictive role of 24-hour BPV on early outcomes in acute non-cardiogenic ischemic stroke.

This is a perspective registered cohort study. Patients with acute non-cardiogenic ischemic stroke are included into the study. During the first 24 hours after admission, the 24 hours blood pressure monitoring is to be taken and used to calculate various parameters of hour-to-hour blood pressure variability, including standard deviation(SD), coefficient of variation (CV), variation independent of mean(VIM) and average real variability (ARV) of systolic blood pressure (SBP) and diastolic blood pressure (DBP). The demographic and clinical data are also recorded. This is an observational sturdy, thus the caring physician make clinical decisions according to individual patient's condition. The endpoints are defined as early neurological deterioration, functional outcome(modified Rankin scale\<3 as good outcome) at discharge and 3 months.

Eligibility Criteria:
Inclusion Criteria:

* acute ischemic stroke

Exclusion Criteria:

* cardiogenic cerebral embolisms due to atrial fibrillation, pronounced heart valve diseases or valve replacement operation;
* isolated sensory symptoms, isolated visual changes, isolated dizziness, or vertigo, without explicit MRI-DWI evidence for acute cerebral infarcts;
* coexisting severe systematic diseases on admission such as acute coronary syndrome, malignant tumor, plasma dialysis therapy for renal failure, cirrhosis, rheumatic disease which would influence patients' independent functions .
Quantitative Analysis of Global Proteome in Bone Samples From Patients With Osteoporotic and Nonosteoporotic Fracture

RATIONALE: Collecting and storing bone samples from patients with osteoporotic and nonosteoporotic fracture to quantitatively analyze the differentially expressed proteins to further explain the relationship between bone iron content and bone mineral density (BMD).

PURPOSE: This research study is looking at changes of iron content and differentially expressed proteins in bone samples from patients with osteoporotic and nonosteoporotic.

fracture.

OBJECTIVES:

1. Establish the iron content in bone specimen in patients with hip fracture.
2. Explore the correlation of BMD and differentially expressed proteins.

OUTLINE:

1. Collect human bone specimens from patients with osteoporotic and nonosteoporotic Fracture.
2. Provide a repository for storage of tissue and make these specimens available for approved projects by laboratory-based investigators.
3. Collect clinical data on these patients including bone mineral density.
4. To examine the bone iron content using ICP/MS.
5. Investigate the differentially expressed proteins through quantitative analysing the global proteome of osteoporotic and nonosteoporotic fracture bone specimens.

Eligibility Criteria:
Inclusion Criteria:

1. Ages Eligible for Study: 55-90 Years
2. Genders Eligible for Study: Woman
3. Accepts Healthy Volunteers: NO
4. Study Population: Female patients with hip fracture.

Exclusion Criteria:

1. Malignancy or benign ovarian cysts
2. Known chronic or systemic diseases
3. Hormone therapy in the previous 3 months
4. Bone metabolism and drug therapy
Steroid Hormones, TH1/TH2 Cytokines and Reproductive Status

This study is designed to evaluate blood Th1 and Th2 immunoregulatory cytokine production and hormonal levels associated with the third trimester of pregnancy and the postpartum state. Cytokine and hormone levels will be assessed in blood specimens obtained from healthy pregnant and postpartum females and compared to levels from premenopausal non-pregnant and non-postpartum females. Blood samples obtained at 30-36 weeks of gestation and 2-6 weeks postpartum will be the primary study points. Samples will also be obtained from pregnant, postpartum, and non-pregnant, non-postpartum, premenopausal female patients with rheumatoid arthritis. Additional data will be generated from samples from normal males, which will be compared with data from females.

We expect to find that pregnancy is associated with enhanced Th2 cytokine expression and that the postpartum state is associated with enhanced Th1 cytokine expression. We expect to see differences in cytokine expression between males and females as well. We seek to gather data supporting the view that distinct hormonal environments regulate these contrasting immunological states.

This study is designed to evaluate blood Th1 and Th2 immunoregulatory cytokine production and hormonal levels associated with the third trimester of pregnancy and the postpartum state. Cytokine and hormone levels will be assessed in blood specimens obtained from healthy pregnant and postpartum females and compared to levels from premenopausal non-pregnant and non-postpartum females. Blood samples obtained at 30-36 weeks of gestation and 2-6 weeks postpartum will be the primary study points. Samples will also be obtained from pregnant, postpartum, and non-pregnant, non-postpartum, premenopausal female patients with rheumatoid arthritis. Additional data will be generated from samples from normal males, which will be compared with data from females.

We expect to find that pregnancy is associated with enhanced Th2 cytokine expression and that the postpartum state is associated with enhanced Th1 cytokine expression. We expect to see differences in cytokine expression between males and females as well. We seek to gather data supporting the view that distinct hormonal environments regulate these contrasting immunological states.

Eligibility Criteria:
No current medications or hormone therapy within the last 3 months.
SOX Regimen as Neoadjuvant Chemotherapy for AJCC Stage II-III Gastric Cancer

This is a randomized, multicenter, controlled trial to prove efficacy of S-1 and Oxaliplatin as Neoadjuvant Chemotherapy for Advanced Gastric Cancer Patients who undergo D2 gastrectomy.

The primary endpoint is three-year free disease and the second primary includes five-year overall survival, safety and R0 resection rate.


Eligibility Criteria:
Inclusion Criteria:

1. Histologically confirmed gastric adenocarcinoma
2. Gastroesophageal junction tumour type II or III(NCCN 2009) can be enrolled
3. All patients must undergo EUS,CT(or PET-CT) and laparoscopy to evaluate tumor stage classification (TNM), and only stage II or III (AJCC 7th) gastric cancer patients can be enrolled
4. planning to undergo gastric cancer D2 surgery after neoadjuvant chemotherapy
5. KPS \> 60; ECOG performance status 0-2
6. Life expectancy \> 6 months
7. Age: 20 to 75 years
8. No other severe disease and life expectancy less than five years
9. 7 days before enrolled, baseline data should be finished including:

   * Granulocyte count ≥ 1.5×109/L;
   * platelet count ≥ 100×109/L;
   * Hemoglobin ≥ 90g/L;
   * hepatic \< 1.5×ULN;
   * total bilirubin ≤ 1.0×ULN;
   * creatinine \< 1.5×ULN;
   * PT-INR/PTT \< 1.7× ULN
10. Disease had to be measurable by the Response Evaluation Criteria in Solid Tumors (RECIST1.1) criteria
11. Written informed consent and able to comply with the protocol

Exclusion Criteria:

1. Patient cannot undergo surgery or chemotherapy because of other severe disease
2. Be allergic to chemotherapy drugs
3. Patients receiving any chemotherapy or drugs involved in this trial in four weeks before enrolled
4. Patients received cytotoxic chemotherapy, targeted therapy, immunotherapy or radiotherapy for gastric cancer
5. Within the last 5 years in patients with a history of other malignant diseases
6. Pregnant or breast-feeding women
7. Severe heart disease like symptoms of coronary heart disease, New York Heart Association (NYHA) grade II or worse congestive heart failure or cardiac arrhythmia having medications or myocardial infarction within the last 12 months
8. Patients with upper gastrointestinal obstruction or absorption anomaly; patient in obstruction of the Helicobacter pylori failure like effect S-1 to take and absorb
9. Patients with a history of peripheral nerve disease
10. Patients who get organ transplant
11. lack of dihydropyrimidine dehydrogenase (DPD)
12. Infection or other disease failure to control