cyrilzakka/clinical-trials huggingface dataset:
Controlled Trial to Reduce Secondhand Smoke Exposure at Homes in Armenia

This study was designed to test the hypothesis whether a novel intervention that uses motivational interviewing along with immediate feedback and follow-up counseling calls is effective in educating the household members about the health hazards of smoking and secondhand smoke exposure and reducing children exposure to secondhand smoke at households in Armenia.

The study was a randomized control trial with two arms: intervention and control groups.

The sample population for the study included households with a non-smoking mother and at least one child 2 to 6 years of age residing with at least one daily smoker. The study team recruited the households through pediatrician's offices in polyclinics (primary healthcare facilities) utilizing multistage random sampling. Trained interviewers made two baseline (one week apart) and two 4-month follow-up household visits to conduct measurements, interviews and intervention. Measurements included surveys, air nicotine monitoring in homes and hair samples from children to assess changes in nicotine concentration over time.

SHS concentration was estimated by sampling vapor-phase nicotine using a filter badge treated with sodium bisulfate. Airborne nicotine monitors were used in all homes to measure SHS concentration at baseline and 4 month follow-up. At least one monitor was used in each home, preferably in the main room in which the family congregates.

Personal exposure to SHS in 2-6 years old children was assessed using biological samples of hair. A small sample of hair (approximately 30 - 50 strands, 2-3 cm) was cut near the hair root from the back of the scalp where there is the most uniform growth pattern between individuals which minimizes the variability of the results.

The intervention included an in-person counseling session with distribution of a tailored educational brochure and demonstration/feedback measurement of indoor PM2.5 (at second baseline visit); it also included one and two months follow-up counseling calls. The control group received only a brief educational leaflet on the hazards of second-hand smoke exposure.


Eligibility Criteria:
Inclusion Criteria:

* At least one child 2 to 6 years of age
* Non-smoking mother
* At least one daily smoker
* Child's exposed to second smoke of at least 1 cigarette per day

Exclusion Criteria:

* Mother's pregnancy
* Child's hair less than 2 cm in length after stretching out
* Residing out of Yerevan
Sensitivity and Specificity of Leucocytes Subpopulation Versus Platelet Indices in Prediction of Clinical Outcome for Candidates With Sepsis. A Bi-centric Observational Clinical Trial

Leucocyte subpopulation and platelet indices analysis can predict clinical outcome


Eligibility Criteria:
Inclusion Criteria:

* Adult population of both sex, aged 20 or older admitted to the ICU with a diagnosis of sepsis were screened for inclusion within 48 h of presentation to the hospital. Sepsis was defined as per the Sepsis-3 definition, 6 ie, the presence of suspected or documented infection with organ dysfunction determined by an acute increase of sequential organ failure assessment (SOFA) score by 2 or more points

Exclusion Criteria:

* Patient refusal.
* History of surgery in the last 7 days from admission.
* Immunocompromised population ( post-transplantation, steroid use \> 5 mg per day, malignancy, HIV, on chemotherapy).
* Population with history of thrombocytopenia ( ITP, aplastic anemia, drug induced)
* History of thrombocytosis ( idiopathic thrombocytosis, post-splenectomy)
* History of platelet transfusion one week before admission.
* Bone marrow transplanted population .
* Chronic liver and kidney disease.
* Von-Willebrand disease.
* Patients on antiplatelet therapy ( Aspirin, clopidogrel).
* Thrombocytopenic population ( ITP, TTP,HELLP) .
* Myelodysplastic or proliferative patients.
* Blood dyscarsiasis
* Obestetric parturients.
Marginal Bone Loss Around Mandibular Implant-retaining Overdentures and Implant Supported Fixed Hybrid Prosthesis

Few if any studies have compared marginal bone loss (MBL) around implant-retaining overdentures (2 implants with locators) versus implant supported fixed hybrid prosthesis (over 4 implants) in the mandible.

Material and Methods: Patients of the saint Joseph university dental clinics, who have already in their records peri-apical radiographs of the implants post loading, will be divided in 2 groups depending on the prosthetic treatment that they have had for 5 years in mouth, and will be recalled for a check-up session during which the investigators will take new peri-apical X-rays by means of the parallel long-cone technique for the implants that are supporting/retaining the prosthesis. A total of minimum 50 implants placed in a minimum of 19 patients will be examined. The mean mesial and distal radiographic MBL and bone to implant contact (BIC) will be recorded by comparing the two X-rays for each implant.

the investigators will also investigate the possibly related factors that may have contributed to this marginal bone loss such as the medical history, smoking habits, oral hygiene, compliance, presence of keratinized tissue and possibility of proper cleaning.

Results: the investigators aim to find a statistically significant difference in the Marginal bone loss around implants assisting these two types of prosthesis and a possible correlation with some risk and modifying factors.

Eligibility Criteria:
Inclusion Criteria:

* Patients treated with mandibular implant-retaining overdentures (2 implants)
* Patients treated with mandibular implant-supported fixed hybrid prosthesis (4 implants)
* Patients having in their records a post-loading peri-apical radiograph for the implants
* Patients who have had their prosthesis for 5 years in mouth

Exclusion Criteria:

* Patients treated with mandibular implant-retaining overdentures with more or less than 2 implants
* Patients treated with mandibular implant-supported fixed hybrid prosthesis with more or less than 4 implants Patients treated with any other prosthetic option on implants Patients who don't have a post-loading peri-apical radiograph in their records
Paclitaxel in Treating Patients With Unresectable Locally Advanced or Metastatic Pancreatic Cancer

RATIONALE: Drugs used in chemotherapy, such as paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.

PURPOSE: This phase II trial is studying how well paclitaxel works in treating patients with unresectable locally advanced or metastatic pancreatic cancer.

OBJECTIVES:

* Determine the time to progression and time to treatment failure in patients with unresectable locally advanced or metastatic epithelial carcinoma of the pancreas treated with paclitaxel loaded polymeric micelle (Genexol\^®-PM).
* Determine the best overall response rate and duration of response in patients treated with this drug.
* Determine the overall survival of patients treated with this drug.
* Determine the clinical benefit and safety of this drug in these patients.

OUTLINE: Patients receive paclitaxel loaded polymeric micelle (Genexol\^®-PM) IV over 3 hours on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

PROJECTED ACCRUAL: A total of 43 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically or cytologically confirmed epithelial carcinoma of the pancreas

  * Unresectable\* locally advanced or metastatic disease NOTE: \*Documented by high-quality contrast-enhanced CT scan
* No known or clinical evidence of CNS metastasis

PATIENT CHARACTERISTICS:

Age

* 18 and over

Performance status

* ECOG 0-1

Life expectancy

* Not specified

Hematopoietic

* Absolute neutrophil count ≥ 1,500/mm\^3
* Platelet count ≥ 100,000/mm\^3

Hepatic

* SGOT or SGPT ≤ 2.5 times upper limit of normal (ULN)
* Bilirubin ≤ 1.5 times ULN

Renal

* Creatinine ≤ 1.5 times ULN

Other

* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No other malignancy within the past 5 years except curatively treated nonmelanoma skin cancer or carcinoma in situ
* No unstable or serious medical condition
* No psychiatric disorder that would preclude giving informed consent

PRIOR CONCURRENT THERAPY:

Biologic therapy

* Not specified

Chemotherapy

* No prior chemotherapy for pancreatic cancer

  * Prior fluorouracil as a radiosensitizer allowed

Endocrine therapy

* Not specified

Radiotherapy

* More than 6 weeks since prior radiotherapy for pancreatic cancer

  * Disease must have progressed after completion of radiotherapy

Surgery

* More than 14 days since prior major surgery and recovered

Other

* More than 30 days since prior investigational agents
Tianjin Diabetes and Health Cohort Study

The goal of this observational study is to reveal the natural history of diabetes and the occurrence and development patterns of its complications, to evaluate the effectiveness of diabetes interventions, and to assess the health and medical burdens caused by diabetes in Tianjin, based on the medical records and health big data in Tianjin and correspondingly constructed diabetes-specific cohort.

This study was based on the University-enterprise joint Laboratory for Diabetes Epidemiology Research of Tianjin Medical University. Medical records and health big data of about 400,000 patients with diabetes treated in secondary and tertiary hospitals in Tianjin from 2009 to 2024 was recruited to construct a diabetes population cohort. Multi-dimensional data such as electronic health records, medical images and wearable device data were analyzed using in-depth mining technology.

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with diabetes
* Patients with three or more recorded visits
* The following information was complete at the first visit: age, sex, blood sugar or hemoglobin A1C

Exclusion Criteria:

* none
HO-1/CREB3 Modulates Golgi Stress in Patients With Sepsis

This study was an ambispective observational cohort study that included sepsis patients hospitalized in the Intensive care unit (ICU) of the Nankai Hospital. All patients met the consensus criteria of sepsis-3. The purpose of this study is to investigate the valuable biomarkers for the severity of sepsis and predictors of 30-day mortality for patients with sepsis.

All patients met the consensus criteria of sepsis-3. The purpose of this study is to investigate the valuable biomarkers for the severity of sepsis and predictors of 30-day mortality for patients with sepsis.

Eligibility Criteria:
Inclusion Criteria:

1. Males or females over the age of 18;
2. Sepsis was diagnosed within 48h which meets SPESIS 3 criteria;
3. Capable of understanding the purpose and risk of the study;
4. Patients or proxy must give written informed consent before any assessment is performed.

Exclusion Criteria:

1. Pregnancy, lactation or perinatal period;
2. Breast carcinoma;
3. HIV seropositive or Syphilis seropositive;
4. Any clinical-relevant condition that might affect study participation and/or study results;
5. Participation in any other intervention trial;
6. Unwillingness or inability to following the study protocol in the investigators opinion.
Study to Evaluate Safety, Tolerability and Pharmacodynamics of KP104 in Participants With Thrombotic Microangiopathy Secondary to Systemic Lupus Erythematosus

This study will evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and efficacy of KP104 in participants with systemic lupus erythematosus (SLE)-Thrombotic microangiopathy (TMA). The study consists of 2 parts: Part 1 (Dose Optimization) and Part 2 (Proof of Concept). All participants will receive KP104 in combination with standard of care (SOC) for SLE-TMA.


Eligibility Criteria:
Inclusion Criteria:

* Meets criteria for SLE per the 2019 European League Against Rheumatism (EULAR)/American College of Rheumatology (ACR) criteria.
* Decrease in platelet count to less than (\<)150,000/microliters (mcL).
* Abnormal renal function.
* Females of childbearing potential with negative pregnancy test and males must agree to practice effective contraception from Screening until 28 days after the End of study (EOS) visit.
* Willing and able to provide informed consent.
* Evidence of microangiopathic hemolytic anemia

Exclusion Criteria:

* Diagnosis of other TMA syndromes.
* A renal biopsy within 7 days of screening that shows exclusively chronic changes of TMA.
* Positive Coombs test at the time of TMA diagnosis.
* Active or unresolved Neisseria meningitidis infection at screening.

Only key inclusion and exclusion criteria have been included.
Smoking Termination Opportunity for inPatients

The Smoking Termination Opportunity for inPatients, (STOP) project is designed to capture the opportunity that is provided by admission for acute smoking related illness, to assist patients through withdrawal by use of a combination of:

* the new medication Champix with
* best practice counselling
* initiated in an inpatient setting

to achieve:

* sustained smoking abstinence
* reduced hospital bed and health service utilisation
* reduced inpatient smoking and craving prior to discharge

A national standard in public hospitals for the management of smoking in patients admitted with smoking related acute illnesses is lacking. Where such patients have continued to smoke up until the time of admission, it can be assumed that "primary" prevention has failed.

Once admitted, there is a vastly under-utilised opportunity, by use of a structured and systematic approach, to intervene with a secondary prevention attempt. This takes advantage of the synergy of:

1. the smoker is a "captive audience" and may be receptive to considering lifestyle factors that have lead to the admission, and
2. best practice medication and counselling can be initiated prior to discharge. If proven to be cost-effective in our analysis, a systematic roll-out of this secondary prevention initiative would be advocated. ie translation of research into practice.

Eligibility Criteria:
Inclusion Criteria:

* Smoker of at least 10 cigarettes per day on average over the past 12 months
* Inpatient with an anticipation admission of at least one day
* Willingness to quit smoking
* Aged between 20 and 75 years
* A plan of discharge to go home
* Acute hospital admission with cardiovascular, cerebrovascular, peripheral vascular diseases or airways (asthma and/or Chronic Obstructive Pulmonary disease

Exclusion Criteria:

* Subject preference to use an alternative pharmacotherapy for smoking cessation
* Respiratory patient being considered for home oxygen
* Pregnancy
* Breast feeding
* Acute or pre-existing severe psychiatric illnesses
* Past history of psychosis or suicidal ideation
* Renal impairment with creatinine clearance \<30ml/min
Evaluation of Sunscreen During Exercise Under Conditions of Profuse Sweating (821/2016)

To visually evaluate the retention of coverage of the Test Product(s) (TP) on the face after exercise compared to the full coverage observed prior to exercise


Eligibility Criteria:
Inclusion Criteria:

Subjects may be male or female, of an age of 18-55 years inclusive. Subjects must be capable of understanding and providing written informed consent.

Subjects must sign a written confidentiality agreement including a photography release form.

Subjects must be in good general health as judged by a specified licensed physician, who will indicate their suitability to participate in this study.

Exclusion Criteria:

Subjects must not have received or used an Investigational New Drug within the last 30 days.

Subjects must not have been active participants in another clinical or subjective TP performance study within the last 30 days unless authorized by this Sponsor. Subjects must not have a known physical or medical condition that would preclude vigorous exercise Subjects must not have a five-minute resting pulse rate greater than 80 bpm.
Duration of Silicone Oil Tamponade on Foveal and Parafoveal Thickness in Rhegmatogenous Retinal Detachment

Our study observes and analyses the influence of the duration of tamponade with silicone oil on the foveal and parafoveal thickness.

Retrospective Cohort study Retrospective review of records of eyes with Rhegmatogenous Retinal Detachment (RRD, for whom pars plana vitrectomy and silicone oil had been performed, in the period between January 2019 and December 2021.

After checking inclusion and exclusion criteria; we will enroll all the cases.

We shall observe the duration of silicone oil tamponade, and then divide the cases; accordingly; into 2 groups (Cohort).

* Group A: 3 months SO Tamponade
* Group B: 6 months SO Tamponade

Eligibility Criteria:
Inclusion Criteria:

* • Silicone oil (SO) tamponade ( up to 6 months)

  * Attached retina under SO
  * Attached retina 3 months after Silicone oil Removal (SOR)
  * Normal fellow eye ( no retinal detachment or macular disease)
  * OCT scan performed for the operated eyes (before SOR, and 3 months after SOR), and for the fellow eye (at any time during the study)

Exclusion Criteria:

* • Rhegmatogenous Retinal Detachment (RRD) with other tamponades ( e.g.: Gas, Densiron)

  * SO tamponade less than 3 months, or more than 6 months
  * Recurrent RD under SO
  * Recurrent RD within 3 months after SOR
  * One eyed
  * Vitrectomized fellow eye
  * Retinal detachment, or macular disease in the fellow eye.
  * Posterior staphyloma
  * Anisometropia (history, refraction if possible, spectacles prescription)
  * Absence of any of the OCT scans performed for the operated eyes (before SOR, and 3 months after SOR), and for the fellow eye (at any time during the study)
Women's Knowledges About Gynaecological Aftercare

The hypothesis of the investigators is that women don't have all the needfull knowledge to understand the importance of a regular gynaecological aftercare.

The main objective is to assess women's knowledge's about gynaecological aftercare.

The second objective is to identify barriers that prevent women of a regular gynaecological aftercare


Eligibility Criteria:
Inclusion Criteria:

* women aged over eighteen years old
* women who are able to read and write French

Exclusion Criteria:

* women aged under eighteen years old
* women who aren't able to read or write French
Outcome of Surgical Fixation of Multiple Fractured Ribs at Sohag University Hospital

The ribs are rigid and flexible structures that make up the chest skeleton and are a set of twelve paired bones. After Blunt trauma rib fractures incidence is about 30 to 40% \[1\].

Due to trauma, (4th -9th) ribs are often affected and the fracture point of the ribs is often on the midaxillary line. In ( 1st\&2nd) ribs fractures subclavian vessels and brachial plexus damage may occur. In fractures in the lower ribs (8th-12th ribs), intra-abdominal organs injury such as liver, spleen and kidney should be investigated. 11-12. ribs fractures are rare because the ribs are more flexible (floating).

Pain is the most important symptom indicating rib fracture, and it usually increases with coughing, breathing, and movement. Broken rib ends can be felt with palpation with sever tenderness at the site of fracture. Pneumothorax and/or hemothorax may develop as a result of the sharp end of the broken rib causing lung parenchymal damage\[2\].


Eligibility Criteria:
Inclusion Criteria:

* multiple fractured ribs pre ventilation

Exclusion Criteria:

-
An Evaluation of the Safety of CSF-1 in Presbyopic Subjects

This is a multi-center, double-masked, vehicle-controlled study. The purpose of the study is to evaluate the safety of CSF-1 compared with vehicle in presbyopic subjects. Subjects will be treated for at least 6 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Subjects must have presbyopia

Exclusion Criteria:

* Have any contraindications to the study medications or diagnoses that would confound the study data
Ameparomo Capsules 250 mg Drug Use Investigation

This Study is intended to evaluate the safety and effectiveness of Ameparomo Capsules 250 mg under actual medical practice.


Eligibility Criteria:
Inclusion Criteria:

* Patients with no history of using this product

Exclusion Criteria:

* No exclusion criteria are set out in this study.
Acute Appendicitis in Foreign Workers of Northern Israel

To Compare the outcome to acute appendicitis in foreign workers to the native patients.

This is a retrospective case-control study. The investigators identified all patients aged 18-50 who were admitted to our institution between January 1st, 2013 and October 31st, 2018, with the diagnosis of acute appendicitis. The study group included all foreign workers and the control group was age, sex, and co-morbidities matched group from the local population. The investigators compared time to presentation, admission parameters and disease outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18-50 who were admitted to our institution between January 1st, 2013 and October 31st, 2018, with the diagnosis of acute appendicitis

Exclusion Criteria:

* Pregnant women
* Patient whose pathology report of the appendix was normal
Circulating Fetal Cells and Breast Cancer

After pregnancy, fetal cells remain in a woman's body for years. These cells may be involved in different physiological situations (e.g. wound healing) and diseases (e.g. cancer).The study will evaluate the level of circulating fetal immune cells in patients with breast cancer vs controls with benign breast tumors, and further characterize these fetal cells. Patients participation will be limited to accepting that an additional blood sample is collected on the day of their preop consultation and blood test.

Breast cancer is the most common cancer in the female population. The protective mechanism associated with pregnancy is not fully understood.

During pregnancy fetal cells cross the placental barrier and may remain in the maternal circulation even for up to 30 years after childbirth. This phenomenon is called fetal microchimerism.

The presence of circulating fetal cells would have a protective role against breast cancer. However, their phenotype and role in the anti-tumor response is not explored.

The objective of the study is to identify the sub-population (s) of circulating fetal immune cells that may have an impact on the processes of carcinogenesis in breast cancer, in the context of fetal microchimerism.

Eligibility Criteria:
Inclusion Criteria:

* women aged 18-50
* having had a male child
* informed and not having objected to participating in the research.

Patients:

- having a diagnosis of breast cancer

Controls:

* operated on for benign breast tumors
* cancer free

Exclusion Criteria:

* autoimmune disease
* immunomodulatory treatment
* history of cancer other than breast cancer
* ongoing hormonal treatment
* women not affiliated to the social security
* under AME (state medical aid)
* under tutorship / curatorship