cyrilzakka/clinical-trials huggingface dataset:
Dry Eye Disease in the Vitamin D and Omega-3 Trial (VITAL)

The VITamin D and OmegA-3 Trial (VITAL; NCT 01169259) is a randomized clinical trial in 25,875 U.S. men and women investigating whether taking daily dietary supplements of vitamin D3 (2000 IU) or omega-3 fatty acids (Omacor fish oil, 1 gram) reduces the risk of developing cancer, heart disease, and stroke in people who do not have a prior history of these illnesses. This ancillary study is being conducted among participants in VITAL and will examine whether omega-3 fatty acids or vitamin D3, compared to placebo, reduce the incidence and/or progression of dry eye disease.

This ancillary study to VITAL will examine the efficacy of omega-3 fatty acids and vitamin D3 in prevention of dry eye disease. The primary aims are to test whether omega-3 fatty acid supplementation (1) reduces the incidence of dry eye disease, and (2) improves the natural history of dry eye disease by relieving symptoms and other impacts on quality of life. Secondary aims are to estimate the incidence of dry eye disease in the US, prospectively examine the natural history of dry disease, explore factors that could modify or influence the impact of omega-3 fatty acid supplementation, evaluate the interrelationship of dry eye disease and depression, and test for possible independent or joint effects of vitamin D3 supplementation in the incidence and natural history of dry eye disease.

Eligibility Criteria:
Inclusion Criteria:

* All participants in VITAL (NCT 01169259) are eligible to participate in this ancillary study.

Exclusion Criteria:

* None
Comparative Study of Lobaplatin and Paclitaxel in Advanced Gastric Cancer Patients With D2 Surgery Combined With Hyperthermic Intraperitoneal Chemotherapy

This study is a prospective, randomized, comparative clinical trial conducted by Wuhan Union Hospital and aim to compare the therapeutic effects of Lobaplatin and Paclitaxel in advanced gastric cancer patients with D2 surgery combined with hyperthermic intraperitoneal chemotherapy

Hyperthermic intraperitoneal chemotherapy (HIPEC) is traditionally used to treat peritoneal cancer combined with cytoreductive surgery (CRS). Further, there have been lots of randomized clinical trials assessing the efficacy of surgery + HIPEC for the treatment of locally advanced gastric cancer conducted. Nonetheless, to date, the kinds, doses, combinations of HIPEC drugs are not clearly been evaluate a criterion. Thus, This study aim to compare the efficacy of Lobaplatin and Paclitaxel in advanced gastric cancer patients with D2 surgery combined with HIPEC. We plan to recruit 231 patients and divide into 3 groups, 2 drug groups and 1 control groups, radomly. all patients with advanced gastric cancer receive D2 surgery + HIPEC + SOX/XELOX chemotherapy regimen. the mainly experimental variable is HIPEC drugs and three groups employ Lobaplatin, Paclitaxel and none respectively. the endpoints of study include peritoneal metastasis, overall survival, immune status and perioperative safety assessment.

Eligibility Criteria:
Inclusion Criteria:

1. No chemoradiotherapy or other anti-tumor therapy before clinical trial performed;
2. Aged 18-75 years;
3. Male or non-pregnant or lactating women;
4. Pathological diagnosis of gastric adenocarcinoma;
5. Clinical diagnosis of T3 stage or above without distant metastasis and can be given D2 radical resection (AJCC Version 8, 2018);
6. Normal function of major organs;
7. Routine blood examinations meeting the following criteria:

   A. HB ≥ 90 g/L; B. ANC ≥ 1.5 x 10 9 /L; C. PLT ≥ 125 × 10 9 /L;
8. Chemistry indexs meeting the following criteria:

   A. TBIL \< 1.5ULN; B. ALT and AST \< 2.5ULN; ALB \> 30 g/L C. serum Cr ≤ 1.25 ULN or endogenous creatinine clearance \> 50 ml/min (Cockcroft-Gault formula);
9. ECOG score 0-1;

Exclusion Criteria:

1. A history of other malignant tumors within 5 years;
2. Distant metastasis found during surgery;
3. Allergic to paclitaxel, lobaplatin and other related chemotherapeutic drugs;
4. Suffering from epilepsy or other mental illness, unable to control behavior;
5. Inability to tolerate surgery due to severe cardiac, pulmonary and vascular disease;
6. Pregnant or lactating women.
7. Receiving anti-cancer drug therapy from other clinical trials.
Aim 2 - Conversations Can Save Lives: TALKing About Buprenorphine & Methadone for Opioid Use Treatment Initiation

The increasing morbidity and mortality of the opioid epidemic has necessitated a reevaluation of current addiction treatment paradigms: medications for opioid use disorder, such as buprenorphine and methadone, are effective in decreasing one's risk of death and disability from opioid use, but are underutilized and often difficult to access. The 5000 Emergency Departments (EDs) in the US are potential additional locales for medication initiation, but currently only a small minority of ED patients with opioid use disorder are started on medications. This study will refine and pilot an intervention called Talk About It which aims to foster patient-centered care, 'meet patients where they are' for addiction treatment, and increase treatment initiation and adherence via facilitating Shared Decision-Making in the ED around these potentially life-saving options.

Participants (ED patients with untreated opioid use disorder) will be enrolled and followed prospectively before and after an ED-wide intervention training clinicians to use "Talk About It," a paper-based conversation aid designed to foster shared decision-making about the decision to start methadone and buprenorphine.

Outcomes will include the initiation of medications, treatment adherence, and patient-reported outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 16 and older
* presenting with indications for Medications for Opioid Use Disorder (MOUD) initiation (opioid overdose, opioid withdrawal, complications of injection opioid use, untreated OUD)
* not currently on buprenorphine or methadone (in the past 7 days).

(Buprenorphine is FDA approved for patients aged 16 and older, so 16- and 17-year-olds may be included with parental consent.)

Exclusion Criteria:

* No Opioid Use Disorder (OUD)
* already on MOUD
Strengthening Inspiratory and Oropharyngeal Muscles in Moderate Obstructive Sleep Apnea Hypopnea Syndrome

The Obstructive Sleep Apnea hypopnea Syndrome (OSAS), whose prevalence is 4% of the French population, can lead to serious health consequences (risk of road accidents, onset of cardiovascular disease, etc.). OSAS corresponds to a certain number of interruptions (apneas) or reductions (hypopneas) of ventilation during sleep. The weakening of the tone of the inspiratory and oropharyngeal muscles is one of the main causes of upper airways obstruction during the inspiratory phase.

For patients with moderate OSAS, with few or no symptoms, without associated cardiovascular comorbidities, there is no recommended treatment. Rehabilitate the inspiratory and oropharyngeal muscles through muscle strengthening seems to be an alternative to this problem. Therefore, this study proposes a complete rehabilitation care evaluating the effectiveness of the strengthening of inspiratory and oropharyngeal muscles in subject with moderate OSAS.

Eligibility Criteria:
Inclusion Criteria:

* Moderate SAHOS (15 ≤ AHI ≤30);
* Body Mass Index (BMI) \< 35 ;
* Patient affiliated or entitled to a social security scheme;
* Patient having signed a consent to participate in the study.

Exclusion Criteria:

* Excessive daytime sleepiness: Epworth sleepiness score \> 10 ;
* Professional driving and history of accidents related to sleepiness;
* Severe obstructive or restrictive ventilatory disorders of neuromuscular origin authenticated by respiratory function tests;
* Patients undergoing treatment for OSAS or requiring immediate initiation of continuous positive airway pressure (CPAP) or a mandibular advancement orthosis;
* Patients who have stopped CPAP or orthosis treatment in less than one month;
* Patients undergoing cardiorespiratory exercise rehabilitation or starting regular physical training;
* Uncompensated heart failure, thoracic sternotomy surgery \< 4 months;
* Marked osteoporosis with history of rib fractures;
* History of spontaneous pneumothorax;
* Severe asthma;
Ultrasound-guided Axillary Artery vs Femoral Artery Cannulation.

The main purpose of the study is to compare two ultrasound-guided arterial cannulation procedures: in-plane infraclavicular axillary artery cannulation and out-of-plane femoral artery cannulation.


Eligibility Criteria:
Inclusion Criteria:

mechanically ventilated critically ill patients with indications for artery cannulation:

* in whom radial artery cannulation is unable to perform or
* in order to conduct hemodynamic monitoring using transpulmonary thermodilution

Exclusion Criteria:

* age less than 18 years
* trauma and hematoma at the catheterization site
* clinically significant coagulation disorders
* infection at the catheterization site
* lack of patients or closest relatives contents
* precedent surgery operation into the femoral and axillary arteries
* clinically significant ischemia of the limb at the cannulation side
ANRS 12406 EvvA Study

ANRS 12406 EvvA is an observational, longitudinal and monocentric study evaluating the virological success rate in HIV-infected adolescents on antiretroviral therapy in Cameroon.

The main objective of the study is to estimate the rate of virological suppression among adolescents on antiretroviral therapy for more than 6 months in Cameroon

At the end of 2017, HIV-AIDS affects more than 36 million people worldwide, more than three-quarters of whom live in sub-Saharan Africa, and a quarter of the infections are among young people and adolescents. Every hour, 4 adolescents (aged 15-19) are newly infected with HIV in the world, and 3 of them are adolescents. Three infections occur in sub-Saharan Africa, and for five adolescents living with HIV, there are seven girls (aged 10 to 19) in the same situation. This gender disparity increases when adolescents reach adulthood. This group of the population may well deserve the term "key and vulnerable population". In the era of international commitment to end the AIDS epidemic by 2030, especially to stop new infections, it is essential not to neglect part of the epidemic because it would effectively represent a reservoir for maintaining the epidemic and make these eradication goals impracticable. Data on virological success among adolescents on antiretroviral treatment are generally scarce and this is much more striking in Central Africa. Also, information on the frequency of emergence of resistant viruses and the consequences for the effectiveness of available treatments is rare. However, in the absence of such data, it is difficult, if not impossible, to take the right decisions to improve the care and monitoring of adolescents. In addition, the few available data indicate high virological failure rates and high frequencies of drug resistance, which may indicate a need to further investigate virological failure events in this population.

This study will be conducted in Cameroon among 289 adolescents during 9 months, where access to biological monitoring is a major challenge, especially with low access to viral load testing. The results of this project will inform on the current state of success of ARV treatments in this population. Moreover, the other goal of this study is to conclude on the need to conduct a larger study at the national or regional level according to the results obtained

Eligibility Criteria:
Inclusion Criteria:

* Being adolescent (aged 10 to 19) on antiretroviral therapy and followed at the Laquintinie Hospital (Douala Cameroon)
* HIV-1 infection
* Duration of antiretroviral therapy ≥ 6 months regardless of antiretroviral regimen
* For emancipated adolescents: obtaining informed consent signed by the adolescent
* For unemancipated adolescents:
* Obtaining informed consent signed by the legal representative (parent(s) or guardian(s))
* Obtaining the assent of adolescents able to understand the study (maturity and knowledge of HIV status)

Exclusion Criteria:

* Infection with HIV-1 or HIV-1/HIV2 co-infection
The Effect of Psychodrama for Treating Fear of Childbirth

This study is a randomized controlled study. This research was carried out with the aim of determining the effect of psychodrama-based pregnancy education program on fear of childbirth (FOC). The population of the study consisted of 18-45 years old pregnant who with high fear of childbirth. The sample of the study was determined as 150 pregnant with confidence level of 95% and theoretical power of 95%. The pregnant women were divided into two groups of 75 pregnant. In addition to routine pregnancy training, a 90-minute psychodrama study was carried out to the experimental group. Data were collected using the information form, Wijma Delivery Expectancy/ Experience Questionnaire Version A (W-DEQ), Wijma Delivery Expectation / Experience Questionnaire Version B (W-DEQ), City Birth Trauma Scale and Edinburgh Postpartum Depression Scale. The data obtained were assesment using the SPSS (Version 21.0) package program on the computer.

The pregnant women were divided into two groups of 75 pregnant. In addition to the 6-week routine pregnancy training, a 90-minute psychodrama study was conducted to the experimental group. The experimental group was divided into 6 subgroups and trained (min = 9, max = 14). The control group was divided into 6 subgroups and trained (min = 11, max = 14). Prenatal psychodrama is held by psychodrama psychotherapists in individual and group therapy sessions. In these sessions the pregnant mother encounters herself, her baby, her partner, her mother, her fear of childbirth and the moment of birth; she may act as protagonist in some scenes and in this way she closes any unfinished business from the past and rehearses the future in a safe therapeutic environment.Data were collected using the information form, Wijma Delivery Expectancy/ Experience Questionnaire Version A (W-DEQ), Wijma Delivery Expectation / Experience Questionnaire Version B (W-DEQ), City Birth Trauma Scale and Edinburgh Postpartum Depression Scale. The data obtained were assesment using the SPSS (Version 21.0) package program on the computer.

Eligibility Criteria:
Inclusion Criteria:

* willing to participate in the study voluntarily,
* non-disabled (hearing, seeing, understanding),
* having 38 or more points from Wijma Birth Experience / Expectation Scale A,
* living with his wife,
* primipary,
* not diagnosed with risky pregnancy and
* women with suitable weeks of gestation (between 20-30 weeks) were included in the study.

Exclusion Criteria:

* those who were diagnosed with risky pregnancy during the training,
* did not attend the first week of the pregnancy training program,
* were absent for more than a week,
* had difficulty following group studies,
* completed the forms incompletely, and
* did not want to continue working / gave up from the study.
A Phase 3 Safety and Efficacy Study of Fovista® (E10030) Intravitreous Administration in Combination With Either Avastin® or Eylea® Compared to Avastin® or Eylea® Monotherapy

The objectives of this study are to evaluate the safety and efficacy of intravitreal administration of Fovista® administered in combination with either Avastin® or Eylea® compared to Avastin® or Eylea® monotherapy in subjects with subfoveal choroidal neovascularization secondary to age-related macular degeneration (AMD).

Subjects will be randomized in a 1:1 ratio to the following two arms per study design:

* Fovista® 1.5 mg/eye + Avastin® 1.25 mg/eye or Eylea® 2 mg/eye
* Fovista® sham + Avastin® 1.25 mg/eye or Eylea® 2 mg/eye

Subjects will be treated for up to 24 months with active Fovista® or sham, in combination with either Avastin® or Eylea® with the primary endpoint at 12 months.

Approximately 622 subjects will be randomized into one of the two treatment groups (311 patients per dose group), and the efficacy analysis will be based on the data from these two groups as per the SAP

Eligibility Criteria:
Inclusion Criteria:

* Subjects of either gender aged ≥ 50 years
* Active subfoveal choroidal neovascularization (CNV) secondary to AMD
* Presence of sub-retinal hyper-reflective material (SD-OCT)

Exclusion Criteria:

* Any prior treatment for AMD in the study eye prior to the Day 1 visit, except oral supplements of vitamins and minerals
* Any prior intravitreal treatment in the study eye prior to the Day 1 visit, regardless of indication (including intravitreal corticosteroids)
* Any intraocular surgery or thermal laser within three (3) months of trial entry. Any prior thermal laser in the macular region, regardless of indication
* Subjects with subfoveal scar or subfoveal atrophy are excluded
* Diabetes mellitus
Measuring Volume Using a 3D Scanner and iPad to Grade the Swelling of Legs

We used a new and easy-to-measure iPad 3D scanner to measure swelling in lower limbs because current technology is not easily available or affordable. We want to see how reliable the measurements are and what might affect how consistent they are.

Twenty limbs from ten healthy volunteers were scanned using an iPad-based Structure Sensor and software. Initial scans followed standard manufacturer instructions, but high variance rendered data unsuitable for clinical use. To improve accuracy, a standardized scanning protocol was developed, incorporating anatomical calibration, scanning distance standardization, and scanning time control. A 254-mm calf segment was defined using a 3D marker placed on the medial malleolus to ensure consistent volume measurement. The scanning distance was fixed between 50-59 cm to reduce zoom parallax errors, and scans were conducted after 3 PM to minimize diurnal volume fluctuations. Multiple technicians performed repeat scans on the same limb to assess intra-observer and inter-observer scan reliability.

Eligibility Criteria:
Inclusion Criteria:

* The people in this study will be symptom free volunteers.

Exclusion Criteria:

* Pre-existing diseased limbs
Camrelizumab Plus Apatinib as Maintenance Therapy in Extensive-stage Small-cell Lung Cancer

This single-arm, Phase II study was designed to evaluate the safety and efficacy of Camrelizumab (anti-programmed death-receptor 1 \[PD-1\] antibody) combination with Apatinib in participants with ES-SCLC who was response or stable disease after firstline standard chemotherapy. Participants will be receive camrelizumab +apatinib on 21-day cycles until progressive disease (PD) as assessed by the investigator using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1). Treatment can be continued until persistent radiographic PD or symptomatic deterioration.


Eligibility Criteria:
Inclusion Criteria:

* Male or female patients aged 18 and 75 years old;
* Signed the informed consent form prior to patient entry;
* Eastern Cooperative Oncology Group performance status of 0 or 1;
* Expected Survival Time: Over 3 months;
* Pathological or cytologically proven extensive-Stage small cell lung cancer(according to Veterans Administration Lung Study Group)and without progression after Cycles 4-6 21-day cycles of first-line Standard chemotherapy(Evaluation was CR /PR/SD based on RECIST1.1);
* If prophylactic cranial irradiation (PCI) was not planned,informed consent was required to be written between 3 weeks and 5 weeks after day 1 of the last cycle of chemotherapy. If PCI was planned or already performe, informed consent was required to be written between 3 weeks and 8 weeks after day 1 of the last cycle of chemotherapy.

Exclusion Criteria:

* Has prior therapy with anti-programmed cell death (PD)-1, anti-PD-L1,anti Cytotoxic T lymphocyte-associated Antigen(CTLA)-4 or other Drugs that target T cells;
* Has prior therapy with angiogenesis inhibitors,Such as sunitinib, bevacizumab, apatinib, anlotinib;
* Has active or untreated central nervous system (CNS) metastases and/or cancerous meningitis;
* Imaging (CT or MRI) shows that tumor invades large blood vessels or the boundary with blood vessels is unclear;
* Has spinal cord compression which was not cured or relieved through surgery and/or radiotherapy, or diagnosed spinal cord compression after treatment showed no clinical evidence of disease stabilization prior to allocation ≥1 week;
* Within the past 2 weeks have used high dose antibiotics;
* According to the judgement of the researchers, there are other factors that may lead to the termination of the study.
Dynamic PET CT as a Tool for Treatment Efficacy Monitoring in Lung Cancer

The purpose of this study is to evaluate the use of Dynamic PET/CT as a tool to assess disease response to anti-cancer therapy in Lung Cancer patients.

Background:

Lung cancer is a devastating disease in which the response for first line therapy is only 30%. Evaluating response is performed normally by a CT or PET-CT scans after 2-3 cycles of therapy, thus, lack of response is been evaluated only after the patient has been treated following significant amount of therapy, which is inefficient in 70% of cases.

Therefore, there is an urgent need to develop tools that might predict response to therapy during the early course of therapy; Most valuable will be before or after the first cycle of therapy. For that reason, the investigators aim in this study to evaluate the use of Dynamic PET-CT as a tool to assess disease response to anti-cancer therapy in Lung Cancer patients.

Objectives:

1. To assess the feasibility of baseline Dynamic PET-CT as a tool for assessing response for anti-cancer therapy in Lung Cancer patients.
2. To predict early response to treatment as soon as after 1 cycle of therapy by dynamic and static PET-CT.
3. To correlate Dynamic PET-CT with survival/disease free survival

Method:

200 advanced lung cancer patients will be enrolled over 3 years in a single institute, single arm study at Rabin Medical Center, Beilinson Hospital.

Patients will be evaluated by a Dynamic PET-CT protocol: before initiation of therapy, 7-14 days after the first therapy cycle, 3 months after initiation of therapy and 6 months after the first therapy cycle. In addition, non-invasive biomarkers that are routinely measured including protein markers (CEA- Carcinoembryonic Antigen, CYFRA21- Cytokeratin 19 Fragment, NSE- Neuron Specific Enolase) will be assessed in this trial.

Disease response will be evaluated by Response Evaluation Criteria In Solid Tumors (RECIST criteria).

Additional PET-CT will not increase radiation dose significantly. The mean estimated radiation dose for a limited CT of the chest is about 14 mSv (i.e., 7mSv for limited diagnostic CT and FDG (\[18F\]-fluorodeoxyglucose), each). The dynamic stage will add radiation dose of about 0.3mSv. Of note, the significance of adding radiation dose is less of importance with regard to treatment of patients with aggressive cancer.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years.
* Lung cancer, stage 4
* Patients are planned to be treated by a systemic anti-cancer therapy.
* A define lesion for imaging.
* Able and willing to sign an informed consent form.
* First line therapy or at least 6 weeks after previous line of therapy

Exclusion Criteria:

* Pregnant or lactating women.
* Anti cancer therapy within the last 6 weeks before enrollment.