cyrilzakka/clinical-trials huggingface dataset:
Development and Pilot Testing of a Multimodal Web-based Program to Address Heavy Drinking During Smoking Cessation

The overall objective of this project is to develop and pilot-test a web-based smoking cessation program that specifically addresses heavy drinking (HD). The project builds upon a well-established, free evidence-based smoking cessation website, BecomeAnEX.org ("EX"), which is supported by Truth Initiative, a national non-profit public health organization, and its research arm, the Schroeder Institute. Investigators will develop an alternative version of BecomenAnEX that will include detailed content on alcohol's relation to smoking relapse, health effects of alcohol (including moderate drinking recommendations) along with related worksheets, feedback materials, and links to resources for drinking. Once a version of BecomeAnEX is developed that specifically addresses HD (called EX-HD), the investigators will conduct a one-arm open pilot of the site with 30 HD smokers recruited from newly registered BecomeAnEX users. The study will gather participant feedback on the site as well as site use metrics (e.g., number of logins, number of pages viewed, use of interactive components) and will revise EX-HD in response to this feedback in preparation for Stage 1b work. Stage 1b will use the updated EX-HD version to run a small scale randomized clinical trial where 120 participants will be randomly assigned to the standard version of BecomeAnEX or to EX-HD.


Eligibility Criteria:
Inclusion Criteria:

1. current daily smoking of at least one cigarette per day
2. meeting NIAAA criteria for past month heavy or at-risk drinking (for women: drinking 8+ drinks per week or consuming 4+ drinks on one occasion at least once in the past month; for men: drinking 15+ drinks per week or consuming 5+ drinks on one occasion at least once in the past month)
3. age 18 or older
4. willingness to provide contact and mailing information following consent

Exclusion Criteria:

1. history of severe alcohol withdrawal as indicated by past alcohol-induced seizures or delirium tremens;
Closed Loop Programming Evaluation Using External Responses for Deep Brain Stimulation

The objective of this study is to evaluate the performance of novel DBS programming methods compared to traditional programming methods.


Eligibility Criteria:
Key Inclusion Criteria:

* Implanted bilaterally in STN or GPi with a Vercise™ DBS system for Parkinson's disease, including directional leads, for at least four months and programming optimized according to standard of care with no changes to electrode configuration of primary settings for at least four weeks.
* Able to understand the study requirements and the treatment procedures and provides written informed consent before any study-specific tests or procedures are performed.
* Be at least 18 years of age.
* Device must have been implanted on label or must be on label by the time the subject gets enrolled.

Key Exclusion Criteria:

* Any significant psychiatric problems, including unrelated clinically significant depression as determined by the investigator.
Validity of MNI and Its Relationship With HEI-2015

This study assessed the validity of the "My Nutrition Index" (MNI) and its relationship with the Healthy Eating Index-2015 (HEI-2015) in the Turkish population. A cross-sectional study of 498 participants aged 19-64 years was conducted, collecting demographic, anthropometric, and three-day food consumption data to calculate both indices. Pearson's correlation was used for analysis.

Introduction: Healthy eating is a crucial concept encompassing biochemical, physical, and psychosocial domains, and various nutritional indices and scales have been developed to assess the healthfulness of individuals' diets.

Objective: This study aimed to evaluate the validity of the "My Nutrition Index" (MNI) and examine its relationship with the Healthy Eating Index-2015 (HEI-2015) in the Turkish population.

Methods: This cross-sectional study included 498 participants aged 19-64 years. Demographic and anthropometric data were collected, and three-day food consumption records were obtained to calculate both the My Nutrition Index and the Healthy Eating Index-2015. Participants' nutritional data were analyzed, and the relationship between the two indices was examined using Pearson's correlation test. Data analysis was performed using the IBM SPSS Statistics 26 software package.

Eligibility Criteria:
Inclusion Criteria:

-Individuals aged 19-64 years

Exclusion Criteria:

* Individuals with physician-diagnosed psychological disorders.
* Individuals who regularly used medication or vitamin supplements.
* Individuals with alcohol or substance addiction.
* Pregnant or nursing women.
Time-effect of FEST+TST in the Upper-extremity Rehabilitation of Individuals with Traumatic SCI

The purpose of this study is to investigate whether the timing of delivery of functional electrical stimulation therapy in combination with task-specific training (FEST+TST) following spinal cord injury (SCI) influences functional and neurological recovery.


Eligibility Criteria:
Inclusion Criteria:

• Subacute stage (\<3 months) after traumatic, motor incomplete (AIS C or D), cervical SCI

Exclusion Criteria:

* Contraindications for neurophysiological tests
* Contraindications for FEST
* Medical conditions that can limit treatment protocols
* Other neurological diseases (i.e. peripheral neuropathies)
* Significant persisting mental illness;
* Learning disabilities;
* Substance abuse over 6 months prior to recruitment;
* Hearing and visual deficits sufficient to affect test performance;
* Contraindication to MRI scanning
Different Risk Stratification Models for Prediction of Lymph Node Involvement in Endometrial Carcinoma

Endometrial cancer is the most common malignant disease of the female genital tract and the seventh most common cause of cancer death in women in Western countries. Histological type, grade and depth of myometrial invasion are prognostic factors in early stage disease as well as risk factors for lymph node metastasis. Systematic lymphadenectomy has recently been questioned for stage I disease based on the results from two randomized trials


Eligibility Criteria:
Inclusion Criteria:

* Not virgin
* Not having congenital anomalies
* Early stage
* Body mass index less than 35

Exclusion Criteria:

* virgin
* advanced stage
* sever infection especially in the pelvis
* lymphadenopathy for any cause
* lymphadenectomy for any cause
* BMI more than 35
* Synchronous malignancies
The Use of Statins for Myocardial Death Prevention

The administration of high dose HMG-CoA reductase inhibitors (Statins) to patients with acute ST-elevation MI (hypoxia/ischemia) who are treated with primary PCI (reoxygenation/ reperfusion) will protect their cardiomyocytes from death and thus preserve LV ejection fraction.


Eligibility Criteria:
Inclusion Criteria:

1. Patients suffering from acute ST elevation resulting from myocardial infarction, Killip Classification 1 and 2 will be included at-random to either group. Included subjects should be able to give their informed consent to participate in this study.

Exclusion Criteria:

1. The impossibility to give the required informed consent.
2. Known allergy to Atorvastatin.
3. Base line serum creatinine of 1.4 mg/dL.
4. Killip Classification 3 and 4.
5. Persisting vomiting.
6. History of previous liver disease.
7. History of previous muscle disease or rabdomyolisis.
8. Treated already with high dose atorvastatin
9. Non Compliance.
Central Sensitization and Outcome of Endometriosis Surgery

This study will evaluate whether the degree of central sensitization as measured by the questionnaire "central sensitization inventory CSI" is related to the outcome of surgical endometriosis treatment


Eligibility Criteria:
Inclusion Criteria:

* Primary surgery because of pelvic/abdominal pain under suspected diagnosis of and with the aim to confirm endometriosis
* Elective abdominal surgery in women with pelvic/abdominal pain and confirmed endometriosis

Exclusion Criteria:

* Patient is unable to give consent
* Cognitive impairment
* Patient outcomes questionnaire is not available in a language that the patient knows.
* Secondary surgery due to complications
* Endometriosis Surgery due to infertility
Increasing Access to Breast Cancer Screening Among Immigrants

The investigators aim to test whether inviting immigrants to breast cancer screening with a letter in their mother tongue in addition to the standard letter in Norwegian changes screening uptake in these immigrant groups, compared with a comparable group who receive the invitation in Norwegian only,

Women in selected immigrant groups according to birth country will be invited to screening and randomized in a 1:1 ratio to receive the screening invitation and information material 1) in the major official native language in the country the invitee is born in addition to Norwegian (intervention group), or 2) only Norwegian (control). The 13 selected countries of origin are Poland, the Philippines, Pakistan, Somalia and Arabic speaking countries (Iraq, Syria, Morocco, Lebanon, Algeria, Egypt, Palestine, Sudan and Tunisia). The five intervention languages will thus be Polish, English, Urdu, Somali and Arabic.

Eligibility Criteria:
Inclusion Criteria:

* Invited to screening program during the study recruitment period (January 2021-June 2022)
* The registered country of birth of the invitee is one of the following; Poland, Pakistan, Philippines, Somalia, Iraq, Syria, Morocco, Lebanon, Algeria, Egypt, Palestine, Sudan and Tunisia

Exclusion Criteria:

* Not reached with the screening invitation letter because of wrong address or similar
Evaluation of Step-Based Care for Individuals at Clinical High Risk for Psychosis

The Ohio State University Early Psychosis Intervention Center is implementing a specialized clinical program to serve individuals who meet clinical high risk criteria for a psychosis. The purpose of this study is to evaluate the long-term outcomes among individuals participating in this clinical service.

The Ohio State University Early Psychosis Intervention Center (OSU EPICENTER) is implementing a specialized clinical program to serve individuals ages 12-25 who meet clinical high risk criteria for a psychosis (CHR-P). The purpose of this project is to evaluate (i) correlates of baseline characteristics among clinic participants; (ii) outcomes among individuals participating in this clinical service; and (iii) predictors and mediators of longitudinal outcomes among individuals participating in this clinical service.

Eligibility Criteria:
Inclusion Criteria:

* Male and female patients between ages 12-25
* Individuals meeting clinical high-risk criteria for psychosis as determined using the Structured Interview for Psychosis Risk. Inclusive of individuals meeting any of the three CHR syndromes assessed by the SIPS (i.e., attenuated psychotic symptoms; brief intermittent psychosis, and genetic risk and functional deterioration) and/or individuals at all four current status specifiers for the SIPS (i.e., progression, persistence, partial remission, and full remission) given evidence that future worsening of symptoms and/or progression to psychosis is possible for individuals in each current status specifier category.
* Subjects with no evidence of a pre-existing intellectual disability defined as a premorbid IQ \>70 as estimated using the Reading subtest of the Wide Range Achievement Test-4
* Fluent in English per self-report
Effect of Lithium Carbonate on Postoperative Sleep in Patients Undergoing Videoassisted Thoracic Surgery

It has been proved that lithium carbonate can prolong slow wave sleep with few or no side-effects. The aim of the present study is to evaluate postoperative sleep quality of patients undergoing video assisted thoracic surgery taken 250mg lithium carbonate 6 hours after surgery.

This study is a prospective, randomized, controlled (randomized, parallel group, concealed allocation), double-blinded trial. All patients undergoing video assisted thoracic surgery during morning will be randomized 1:1 to the treatment intervention with lithium carbonate 250mg (Baoqing, Hunan, China) or calcium carbonate 500mg (Reneed, Beijing, China) 6 hours after surgery. The objective of the trial is to evaluate the lithium carbonate 250mg on the first postoperative night sleep quality. The patients received standardized general anesthesia supplemented by paravertebral nerve block. The ultrasound-guided approach for paravertebral nerve block was used with the patient in the lateral decubitus position, and the paravertebral nerve block was administered at the T4-T6 level according to the incision protocol at our center. General anesthesia for maintenance of propofol anesthesia, total intravenous anesthesia was administered by using propofol (Fresenius Kabi, Austria GmbH) at a plasma target concentration (Marsh pharmacokinetic model software) of 2.5-4 μg/ml. Remifentanil (0.2-0.5 μg/kg/min, Renfu, Yichang, China) was given to all patients during the operation. All patients accepted patient-controlled intravenous analgesia with 1 μg ml-1 sufentanil (Renfu, Yichang, China). Duration of sleep was defined as the duration of all bispectral index data below 80 in the 12 hours of monitoring (from 20:00pm to 06:00am).

Eligibility Criteria:
Inclusion Criteria:

* • 1. ethnic Chinese;
* • 2. age, 18 to 75 years old;
* • 3. American Society of Anaesthesiologists (ASA) physical status I or II;
* • 4. required VATS for lung surgery and one lung ventilation

Exclusion Criteria:

* Cognitive difficulties
* • Partial or complete gastrectomy
* • Previous esophageal surgery
* • Previous treated by radiotherapy or surgery
* • Inability to conform to the study's requirements
* • body mass index exceeding 30 kg/m2
* • Deprivation of a right to decide by an administrative or juridical entity
* • Ongoing participation or participation in another study \<1 month ago
* • preoperative Pittsburgh Sleep Quality Index global scores higher than 6
* • recent (\< 3 months prior) use of antibiotics, probiotics, prebiotics, symbiotics, hormonal medication, laxatives, proton pump inhibitors, insulin sensitizers or traditional Chinese medicine
Safety Study of S.Flexneriza-S.Sonnei Bivalent Conjugate Vaccine in Healthy Volunteers Aged Above 3 Months

The purpose of this study is to evaluate safety of S.flexneriza-S.sonnei Bivalent Conjugate Vaccine in healthy volunteers aged above 3 Months.


Eligibility Criteria:
Inclusion Criteria:

* 3 months old and above healthy people.
* Subject or legal representative who consent and has signed written informed consent.
* Subject and parent/guardian who is able to comply with all study procedures.
* Subject who did't receive blood products within 30 days ,immune with any live vaccine within 14 days and inactivated vaccine within 7 days before vaccination.
* Axillary temperature ≤37.0 ℃.

Exclusion Criteria:

* Febrile illness (temperature ≥ 38°C) in the 3 days.
* Subject who are allergic to tetanus toxoid.
* Allergic history after vaccination.
* Immunodeficiency diseases patients who administered with immunosuppressive agents.
* In pregnancy or lactation or pregnant women.
* Subject who are suffering from serious chronic diseases, infectious diseases, active infection, cardiovascular disease,liver or kidney disease.
* Subject who have symptoms such as diarrhea, abdominal pain, and pus and bloody stools in the past 3 days.
* History of allergy，eclampsia, epilepsy,brain trauma,encephalopathy and mental disease or family disease.
* Subject who diagnosis of thrombocytopenia or other history of coagulopathy may cause intramuscular contraindication.
* Children with abnormal labor（pregnancy week\<37w,\>42w）,birth weight (\<2500g,\>4000g), asphyxia rescue history,congenital malformations or developmental disorders(Only applicable to 3-5 months old group)
* Blood routine, blood chemistry and urinalysis laboratory collection abnormalities and the severity of grade 2 and above before immunization.
* Subject who plan to participate in or is in any other drug clinical trial.
* Any condition that, in the judgment of investigator, may affect trial assessment.
Adjuvant Oophorectomy and Tamoxifen in Premenopausal Women With Hormone Receptor-Positive Breast Cancer

This trial tests surgical oophorectomy (removal of ovaries) plus Tamoxifen, done at different times in the menstrual cycle, as adjuvant therapy for invasive breast cancer in 510 premenopausal women with Hormone Receptor-positive Breast Cancer. This study is recruiting at hospitals in Philippines, Vietnam, and Morocco.


Eligibility Criteria:
Inclusion Criteria:

* Open for accrual in Asia only
* Female age 18-50,
* premenopausal with regular cycles (\>25-35 in length)
* fine-needle aspiration diagnosis
* Stage II-IIIA hormone receptor positive invasive breast cancer
* No prior radiation or chemotherapy
* Must be surgical candidate for bilateral oophorectomy
Analysis of the Mass Skiers' Injury in a Large Ski Resort in Chongli, China

This study takes the injury situation of a large ski resort in Chongli during the 2017-2018 and 2018-2019 snow seasons as an example, aiming to preliminarily understand the injury situation of mass skiing in ski resorts in China, and provide a basis for predicting the rapidly growing medical demand for treatment and treatment of ski injuries in the context of 2022 Winter Olympic Games.

Objective: To make a retrospective analysis of the injuries of skiing population in a large ski resort in Chongli, China and provide a basis for predicting the rapidly increasing medical needs for ski injuries in the context of the 2022 winter Olympic Games.

Methods: The basic data of all injured skiers who were treated in a medical station of a large ski resort in Chongli during the 2017-2018 and 2018-2019 snow seasons were collected. The number of skiers, the number of injuries, the causes of injuries, the types of injuries and the locations of injuries were compared.

Eligibility Criteria:
Inclusion Criteria:

* All of the injured in a snow season at a snow resort

Exclusion Criteria:

* None
Periodic Continuous Glucose Monitoring in Patients With Type 2 Diabetes

The aim of this randomised controlled trial is to investigate the effectiveness of periodic CGM (continuous glucose monitoring) to support a person-centered approach versus self-monitoring of blood glucose (SMBG) in adults with type 2 diabetes on glucose control and patient reported outcomes.

This is a 16-week prospective, multicenter, randomised, open-labelled, two-armed study in adults with type 2 diabetes conducted at primary care practices in Sweden.

Periodic CGM group- Intervention group:

The participants in the intervention group will be provided with FreeStyle Libre (Abbott Diabetes Care). Participants wear the sensor and check their glucose level for a period of 28 days (14 days X 2) during week 0-4 and week 10-13.Patient's measurement data from the FreeStyle Libre system 2 will be transferred to the OneTwo Analytics (DDA) analysis tool for an automated analysis and this Insight report will be presented to the participants at visit week 4 (digital) and at visit week 16 (clinical). The diabetes nurse and the patient reviews and discuss trends, patterns, and challenges to support the person's self-care management of their type 2 diabetes. This approach is intended to facilitate communication and patient participation and create the conditions for shared informed decisions and health planning.

Self-monitoring of blood glucose, SMBG and usual care - Control Group The participants in the control group perform SMBG testing as usual including fasting, pre- or post-prandial measurements. They also receive usual care which comprises consultation with physician diabetes specialist or diabetes nurse depending on individual health care needs.

Eligibility Criteria:
Inclusion Criteria:

* Adults aged 18-80 years
* Type 2 diabetes with a duration of \> 6 months
* HbA1c 45-70 mmol/mol
* Have a smartphone
* Experience of self-monitoring of blood glucose prior to the study start

Exclusion Criteria:

* Prandial insulin
* Pregnancy or planning pregnancy during the study
* Breastfeeding
* Renal disease with estimated glomerular filtration rate (eGFR) \<45 mL/ min/1.73 m2
* Active malignancy or under investigation for malignancy
* Severe visual impairment
* Severe skin allergy that inhibits the use of a continuous glucose monitoring device
* Glucocorticoids (systemic)
* Planned or currently using weight reduction medications, programs, or surgery
* Cognitively or psychologically unable to participate and read instructions
* Enrolled in other clinical trials
* Eating disorders
Retention, Stability and Performance Assessment of Denture Fixatives Versus no Fixative Control

This clinical investigation will evaluate the effectiveness, tolerability and safety of two denture fixative creams versus no fixative control

A single-centre, randomised, 3-way cross-over, clinical investigation comparing the performance of two denture fixative versus no denture fixative control in full denture wearers and an exploratory sub study in partial denture wearers. The study will assess the performance and tolerance of two denture fixative cream formulations (Paraffin based and Polydecene based) when applied to full dentures.

Eligibility Criteria:
Inclusion Criteria:

1. Participants with a completely edentulous maxillary \[UPPER\] arch restored with a conventional full acrylic-based complete denture and dentate, partial, or full edentulous mandibular \[LOWER\], which may be restored with a stable complete, partial or implant supported denture
2. For complete denture wearers, maxillary \[UPPER\] dentures must be completely removable standard acrylic dentures, which are at least moderately well-fitting at the screening visit (modified (Olshan) Kapur Index: retention score ≥2, stability score ≥2)
3. Male or female participants aged between 18 and 85 years at the time of signing the informed consent form
4. Participants must have been using dentures daily for at least 6 months prior to the screening visit
5. Dentures must have been made in the last 5 years;
6. Dentures must be well-made based on design and construction in the opinion of the clinician
7. No clinically significant and relevant abnormalities in medical history or upon oral examination

Exclusion Criteria:

1. Female participants who are pregnant as confirmed by a positive pregnancy test (urine) or are lactating (applicable to female participants of childbearing potential)
2. Daily doses of medication that might interfere with the ability to perform the study according to protocol or affect study assessments, for example, bisphosphonates (oral or intravenous) (as determined by the Investigator)
3. Known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients
4. Any clinically significant or relevant oral abnormality (e.g., temporomandibular joint \[TMJ\] problems), or recent (within last 6 months) oral surgery / intervention, or oral health concern that, in the opinion of the investigator, could affect the participant's participation in the study
5. Participants with maxillofacial defects covered by prosthetics
6. Self-reported and/or visual manifestations of severe dry mouth (xerostomia) that may affect denture retention in the opinion of the Investigator
7. Participants with oral soft tissue examination findings such as stomatitis, open sores, ulcers, lesions, redness or swelling or associated lymphadenopathy