cyrilzakka/clinical-trials huggingface dataset:
Paclitaxel-binding Albumin and Cisplatin as Neoadjuvant Chemotherapy in Patients With Muscle-Invasive Bladder Cancer

This is a phase II study of Paclitaxel-binding albumin, Cisplatin as neoadjuvant chemotherapy in patients with muscle-invasive urothelial carcinoma of the bladder. Patients with muscle invasive urothelial carcinoma who are candidates for radical cystectomy will be enrolled.


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 years.
2. Patients must have histologically confirmed resectable（stage T2，T3 and T4a） urothelial carcinoma following 2017 V8 AJCC，including renal pelvic carcinoma，ureteral carcinoma，bladder carcinoma and urethral carcinoma.
3. There was at least one measurable tumor lesion following RECIST 1.1.
4. Treatment naïve.
5. Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
6. Left ventricular ejection fraction≥50%.
7. Absolute neutrophil count (ANC) ≥ 1.5 × 109/L，platelets (PLT) ≥ 100 × 109/L，hemoglobin (Hb) ≥ 90 g/L，leucocyte ≥ 3.0 × 109/L.
8. Total bilirubin (TBIL) ≤ 1.5 ×institutional upper limit of normal (ULN)， Alanine aminotransferase (ALT) (serum glutamic pyruvate transaminase \[SGPT\]) /Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \[SGOT\]≤ 2.5 ×ULN ，Creatinine (CRE) ≤ 1.5 ×ULN.
9. Signed informed content obtained prior to treatment.

Exclusion Criteria:

1. Patients who are pregnant or may be pregnant or nursing.
2. Patients with Coagulation dysfunction or active internal hemorrhage.
3. Patients with uncontrolled active infection，HIV，viral hepatitis.
4. Peripheral nerve lesion≥grade 1 following NCI-CTC 5.0.
5. Patients with serious cardiovasculardisease including history of cerebral vascular accident ， myocardial infarction，hypertension，angina，heart failure（NYHA grade 2-4） within the last 6 months.
6. History of allergic reactions attributed to compounds of similar chemical or biological composition to drugs used in this study.
7. Patients was involved in another study within the last 30 days.
8. Patients was mental disorders.
9. Any other patients deemed by the attending physician to be unsuitable to allow the feasible for this study.
Examining the Effect of the Nicotine Patch in Male and Female Smokers - 3

Treatment studies have demonstrated that current smoking cessation techniques are less effective for women. The purpose of this study is to determine the role that gender plays in the effectiveness of nicotine replacement therapy. In addition, the purpose of this study is to determine whether men and women differ in their response to smoking-related stimuli (e.g., taste or smell of a lit cigarette). Conclusions drawn from this study may help to improve cessation interventions for all smokers, particularly women.

Currently,about 70 percent of smokers who try to quit by using smoking cessation treatments are unsuccessful. Treatment studies have demonstrated that current smoking cessation techniques are less effective for women. There is no clear explanation for this difference, but it may involve a differential response to nicotine replacement treatments (NRTs) and/or smoking-related stimuli. For women, NRT may be less effective at suppressing withdrawal or blunting the effects of smoking during a quit attempt. Women may also be more sensitive to smoking-related stimuli, suc has the taste, sight, or smell of cigarette smoke. Tailoring treatments to the separate needs of smoker subgroups , such as men and women, my produce better cessation outcomes. The purpose of this study is to assess whether men and women differ in the their response to NRT (i.e., transdermal nicotine) and smoking-related stimuli.

Participants in this double-blind, dose-comparison study will complete separate sessions in random order.

Each session will last approximately 6.5 hours and will correspond to a transdermal patch dose (0 or 21mg) and cigarette type (denicotinized and nicotinized). Objectively verified cigarette abstinence will be required before each session. Sessions will occur at least 48 hours apart to avoid carryover. At the beginning of each session a patch will be placed on the participant's back and at 4, 5, and 6 hours after patch application the participant will smoke a cigarette (all identifying marking on the cigarette will be covered for blinding purposes). Physiological, subjective, cognitive, and smoking behavior outcomes will be collected during study visits.

Eligibility Criteria:
Inclusion Criteria include, but are not limited to:

18-50 years of age Smokes 15 cigarettes/day for at least 2 years Healthy (as determined by a brief study physical with medical doctor) Displays understanding of cognitive tasks.

Exclusion Criteria include, but are not limited to:

History of chronic health problems or psychiatric conditions History of cardiovascular disease, low or high blood pressure, seizures, head injuries requiring hospital care, peptic ulcer, or diabetes Pregnancy (tested by urinalysis) Scores greater than 17 on the Beck Depression Inventory Lack of a high school degree or GED
Survey Study on Barrett's Esophagus Screening

The goal of this study is to optimize Barrett's Esophagus (BE) screening to reduce the incidence, morbidity, and mortality of Esophageal Adenocarcinoma (EAC).

The initial step to achieve this goal is to study shortcomings of the current BE screening referral processes in the United States. These shortcomings will be identified through completion of two synergistic aims that assess:, (1) provider knowledge, attitudes, and barriers to BE screening referral and (2) patient knowledge, attitudes, and barriers to completion of BE screening. The central hypothesis is that there are patient- and provider-level factors that can be modified to improve BE screening adherence. This hypothesis was formulated based on strong preliminary data demonstrating significant single-mindedness among gastroenterologists regarding BE screening criteria.

Eligibility Criteria:
1. Patient Eligibility Criteria

   Inclusion Criteria:
   * Patients identified by ICD-10 codes for GERD (K21.0 and K21.9) AND
   * Have had at least one outpatient clinic visit at a participating site

   Exclusion Criteria:
   * Prior diagnosis of BE/EAC
   * Non-English speaking
2. Provider Eligibility Criteria

Inclusion Criteria:

* Provider must be a PCP and/or gastroenterologist AND
* Must be at a participating site
The Effect of Oral Hypotonic Hydration in Isolated Oligohydramnios

OBJECTIVE: The primary objective of our study is to compare the effects of routine hydration with additional 2 liters of normal water versus orally 2 liters of distilled water on the amount of amniotic fluid.

HYPOTHESIS: İsolated oligohydramnios, secondary to depleted maternal intravascular volume, can be reversed better with orally hypotonic water.

BACKGROUND: Olygohydramniosis is a condition in which amniotic fluid levels are lower than expected for gestational age. It is typically diagnosed by ultrasound examination and may be described qualitatively (e.g., reduced amniotic fluid volume) or quantitatively (e.g., amniotic fluid index ≤5 cm, single deepest pocket \<2 cm). Water hydration aims to decrease maternal osmolality and sodium concentration, increase water flow osmotically from maternal blood to fetal amniotic fluid, and improve uteroplacental perfusion.

A meta-analysis comparing maternal hydration's effect reported that maternal intravenous hydration had good results on AFI in pregnancies with isolated oligohydramnios and hypotonic solutions were more effective than isotonic fluids(1). Maternal oral hydration may slightly increase amniotic fluid and is safer than intravenous fluid administration or amnioinfusion.

Reducing the osmolality in maternal blood with oral hypotonic and isotonic fluids helps to direct the placental water passage towards the fetus, to improve uteroplacental perfusion, and as a result, to increase the amount of amniotic fluid in pregnant women with isolated oligohydramnios. Osmolality is further reduced by maternal oral hypotonic fluid, thus improving the amount of amniotic fluid.

The study protocol was approved by the Local Ethics Committee, and written informed consent will be taken from patients entering the study. The sample size was calculated based on the "Maternal hydration increases amniotic fluid index" study of Kilpatrick et al.(2). When 1.5 cm increase in AFI is considered significant, with 90% power and type 2 error (alpha): 0.05, the sample size is 20 for each group, and it is planned to include 40 pregnant women in total.

I

Eligibility Criteria:
Inclusion Criteria:

* Singleton pregnancy
* Gestational age (GA) 28-39 weeks (based on the last menstrual period and confirmed by the results of ultrasound or determined through early pregnancy sonography)
* Isolated oligohydramnios cases
* Amniotic fluid index ≤ 5
* No pregnancy complications such as preeclampsia, gestational hypertension
* Intact fetal membranes.

Exclusion Criteria:

* Presence of fetal complications (membrane rupture, presence of fetal anomaly, intrauterine growth restriction)
* Presence of maternal systemic disease (nephropathy, cardiac disease)
* Multiple pregnancies
* Conditions in which the amount of amniotic fluid cannot be accurately assessed (morbid obesity)
High On-treatment Platelet Reactivity Identified by Multiple Platelet Function Assay

High on-treatment platelet reactivity to adenosine diphosphate was a important reason to cause ischemic events in antiplatelet therapy. Using single testing to definite HPR may miss the "true HPR" or over estimate HPR, which may lead to randomized trials failed. It is not known whether combined multiple platelet function testing could assist to ensure"ture"HPR and improve clinical outcomes.

This was a single-center, randomized, prospective study. ACS patients undergoing PCI treated with clopidogrel and aspirin were included. in the 3-5th day after prescription of clopidogrel, platelet function were tested simultaneously by three methods: MPAADP by Light transmittance aggregometry（LTA）, MAADP by Thrombelastography (TEG) ,and CTP2Y by Innovance PFA-200 . According to three result（Two of three or all three results higher than cutoff value was identified as HPR, MPALTA\>50%;MAADP\>47mm;CTP2Y\<106s）.Patients was defined as HPR(n=125) or unHPR(n=232), HPR patients were divided into HPR-Ticagrelor(HPR-T)and HPR-Clopidogrel(HPR-C) randomized. HPR-T group(n=77) patients' antiplatelet agents changed to ticagrelor, both unHPR and HPR-C groups keep unchanged(Clopidogrel). The major adverse cardiovascular events (MACE) were recorded during 1 year Follow-up.

Eligibility Criteria:
Inclusion Criteria:

* ACS patients（UAP;USTEMI,STEMI）
* Undergoing PCI
* Oral antiplatelet therapy

Exclusion Criteria:

* Stable CAD
Postoperative Pain in Scheduled Craniotomy

Postoperative pain after craniotomy is frequent, with moderate-severe intensity. The fear to the side effects of opioids (nausea and vomiting and sedation), and NSAIDs (bleeding) makes it difficult to obtain adequate analgesic control in these patients. Preoperative anxiety may be associated with a poorer postoperative analgesic control, hindering the adequate postoperative evolution and increasing hospital stay and adverse effects. In this observational study, the investigators aimed to assess the postoperative analgesic management in patients undergoing scheduled craniotomy following routine clinical practice and to relate preoperative anxiety with the postoperative analgesic evaluation in this population.

Postoperative pain after craniotomy is frequent, with moderate-severe intensity. The fear to the side effects of opioids (nausea and vomiting and sedation), and NSAIDs (bleeding) makes it difficult to obtain adequate analgesic control in these patients. On the other hand, preoperative anxiety may be associated with a poorer postoperative analgesic control and hinder the adequate postoperative evolution. The main outcome is to assess the postoperative analgesic management in patients undergoing to craniotomy. Secondary objectives are to evaluate the appearance of postoperative side effects related to the analgesics and to assess the relationship between preoperative anxiety and postoperative pain

Eligibility Criteria:
Inclusion Criteria:

* Patients over 18 years old undergoing scheduled form for supratentorial craniotomy.
* Signed informed consent.

Exclusion Criteria:

* Mini Mental State Examination with a score less than or equal to 24 points.
* Patients suffering from disabilities.
* Patients who can not collaborate in the postoperative clinical assessment.
* Patients who can not be assessed during the postoperative period by the Acute Pain Unit.
Real-life Second-line Epirubicin-Paclitaxel Regimen as Treatment of Relapsed Small-Cell Lung Cancer : EpiTax Study.

Initial chemosensitivity is known concerning SCLC but relapse is almost systematic, especially at a metastatic stage. Brain metastasis are identified around 40 to 50% during the evolution of the disease. Concerning the efficacy of epirubicin combined with paclitaxel from the second-line treatment, data is lacking more particularly about specific response on brain metastasis.

In this retrospective multicentric observational study in real life conditions, we try to evaluate systemic and specific cerebral efficacy and safety of a regimen combining epirubicin and paclitaxel in patients treated between 2010 and 2020 for a small cell lung carcinoma from the second-line treatment.


Eligibility Criteria:
Inclusion Criteria:

* Adults (age ≥18 years)
* Histologically or cytologically SCLC diagnosis
* Treated with epirubicin-paclitaxel doublet between January 2010 and December 2020

Exclusion Criteria:

* Opposition to participate registered
* Patients under legal protection
* Patients afflicted by another subtype of lung carcinomas
* SCLC not treated with the epirubicin-paclitaxel doublet
High-resolution 7 Tesla MRI of C-spine - Comparison with 3 Tesla MRI

High-resolution MRI (7 Tesla) of the cervical spine is capable to differentiate osseous spurs from discus-material and better depict the compressed nerve in the neuroforamen compared to 3T MRI.

Provide the surgeon with a detailed high-resolution anatomical image before surgery and potential no need for CT (if the bony anatomy is of crucial importance).


Eligibility Criteria:
Inclusion Criteria:

* Informed consent as documented by signature (Appendix Informed Consent Form)
* \>18 years old
* Patients with cervical back pain (radiculopathy) and scheduled surgery for foraminal stenosis or central stenosis or cervical periradicular injection therapy (PRT)

Exclusion Criteria:

* previous surgery
* tumor patients
* pregnancy or breast feeding
* any MRI contra-indications
Healthcare Seeking Behaviour of Primary Caregivers for Acute Otitis Media (AOM) in Children Aged 6 Months to Less Than 30 Months in Panama

The study is a survey aiming to describe the healthcare seeking behaviour of primary caregivers when their child aged 6 months to less than 30 months was suspected to have an episode of acute otitis media in Panama.

The study is a cross sectional survey in which primary caregivers will be asked if they recall having observed an ear infection in the child in the age range 6 months to less than 30 months in the last 6 months. During the interview, the primary caregivers will be asked what they did for the child during that episode and whether they sought medical care or not. They will be also asked about the demographic characteristics (such as age range) of the child who experienced that episode and the household environment of the child at the time of the episode (such as number of household members), etc.

No questions will be asked about the episode itself if the primary caregiver does not recall that the child had one in the last six months.

Approximately 1300 primary caregivers will be interviewed in multiple clinics / well-baby clinics in Panama.

The clinics will be stratified into 'former clinical trial sites' and 'non-clinical trial sites' in urban areas of Panama, based on participation in the COMPAS trial. Both 'former clinical trial sites' and 'non-clinical trial sites' will include private and public facilities. Sites will be selected by convenience sampling and eligible subjects will be enrolled on an on-going basis, in proportion to the population coverage of each site. The participating sites have thus been stratified to be able to assess whether the healthcare seeking behaviour of primary caregivers enrolled at former clinical trial sites are different from those enrolled at non clinical trial sites.

Eligibility Criteria:
Inclusion Criteria:

* Subjects who the investigator/interviewer believes can and will comply with the requirements of the protocol (e.g. availability of time for completion of the interview).
* Signed informed consent obtained from the subject.
* Subjects aged 18 years or above, being the primary caregiver of at least one child aged 6 months to less than 30 months, visiting a clinic.

Note:

i. Although the child will most likely be present at the time of interview, his/her presence is not required.

ii. If more than one primary caregiver fulfilling the inclusion criteria is present per child, only one will be enrolled in this study.

Exclusion Criteria:

• Subjects having previously participated in this survey.
Effect of the InsuPatch on Automated Closed-loop Glucose Control in Type 1 Diabetes

This research study designed to look at how well adolescents' and young adults' blood sugars can be controlled with a "closed loop artificial pancreas" using a continuous glucose sensor, an insulin pump, and a computer program that automatically determines how much insulin to give based on the glucose level. The investigators will also study the effect of wearing a small heating patch, the InsuPatch, at the site of insulin infusion, on the ability of the closed loop system to control the blood sugar levels and to reduce the rise in glucose levels after meals.

This is an open-label, single-center, randomized crossover study evaluating the performance of a closed-loop (CL) insulin delivery system using a subcutaneous glucose sensor and an external insulin pump comparing the peak post-prandial glucose levels and the post-prandial glucose AUC during either CL control alone or CL control with the InsuPatch in an inpatient hospital research unit (HRU) setting. The closed loop visit consists of approximately 67 hours over 4 days and 3 nights.

Eligibility Criteria:
Inclusion Criteria:

1. age 12-40 years
2. clinical diagnosis of type 1 diabetes
3. duration of type 1 diabetes ≥ 1 year
4. HbA1c ≤ 9 %
5. Treated with pump therapy for at least 3 months
6. Body weight \> 40 kg

Exclusion Criteria:

1. Insulin resistant (defined as requiring \> 1.5 units/kg/day at time of study enrollment
2. Presence of any medical or psychiatric disorder that may interfere with subject safety or study conduct
3. Use of any medications (besides insulin) known to blood glucose levels, including oral or other systemic glucocorticoid therapy. Inhaled, intranasal, or rectal corticosteroid use is allowed along as not given within 4 weeks of admission. Use of topical glucocorticoids is allowable as long as affected skin area does not overlap with study device sites. Subjects using herbal supplements will be excluded, due to the unknown effects of these supplements on glucose control
4. History of poor wound healing, heat sensitivity, or diminished skin integrity.
5. History of hypoglycemic seizure within last 3 months
6. Anemic (low hematocrit), or evidence of renal insufficiency (elevated serum creatinine)
7. Female subjects who are pregnant, lactating, or unwilling to be tested for pregnancy
8. Subjects unable to give consent / permission / assent
Environmental Pollutants and Their Effects on Respiratory Allergy

In Latin America and the Caribbean, more than 100 million people are exposed to higher levels of pollution than those recommended by WHO. The objective of the study is to determine the relationship between exposure to environmental pollutants and the prevalence and exacerbation of respiratory allergy. It is an observational, prospective, longitudinal and descriptive study that will include subjects older than 6 years who come to the consultation of the Regional Center for Allergy and Clinical Immunology with a diagnosis of respiratory allergy, positive skin tests and who live in Monterrey and its metropolitan area. After verbal assent, the subject's address and work area will be registered, the Rhinitis Control Assessment Test and the Asthma Control Test as well as spirometry will be made. The geolocation of industries and avenues near the address and work area of subjects will be carried out, as well as the determination of pollutants and pollens by the Integral Monitoring System (SIMA) and the Pollen Sense device. Subsequently, the correlation between exposure to pollutants and respiratory allergy will be analyzed. Dispersion models will be built considering pollutants and climatic factors (precipitation, wind speed, humidity and temperature). By carrying out this project, it will be possible to contribute to the identification of the factors that lead to the development and exacerbation of allergic respiratory diseases and subsequently propose the implementation of measures for their control and recommendations for prevention to the population.


Eligibility Criteria:
Inclusion Criteria:

* Subjects over 6 years of age who attend the the Regional Center of Allergy and Clinical Immunology of the University Hospital "Dr. José Eleuterio González "with a diagnosis of respiratory allergy (allergic rhinitis and asthma) and type I immunological hypersensitivity demonstrated by skin tests by an allergist; and who live in the city of Monterrey and its metropolitan area.

Exclusion Criteria:

* Subjects for whom it is not possible to perform a pulmonary function test or who have concomitant diseases such as COPD, heart disease or some other pathology that, in the opinion of the investigator, may cause confusion with respiratory symptoms. Patients with negative skin tests to aeroallergens.
Superficial Cervical Plexus Block With Either Clavipectoral Fascial Plane Block or Interscalene Brachial Block for Clavicle Surgeries Anesthesia

This study aims to evaluate and compare the efficacy and safety of ultrasound guided superficial cervical plexus block (SCPB) with either clavipectoral fascial plane block (CPB) or interscalene brachial plexus block (ISBP) as an anesthetic technique for clavicle surgeries.

Clavicular fracture is the most common injury in the shoulder, it occurs in 35% of shoulder girdle fractures. Clavicle surgeries often involve addressing fractures, dislocations, or corrective procedures, and they generally require precise and effective pain control.

Traditional superficial cervical plexus block (SCPB) combined with interscalene brachial plexus block (ISBP) can be used in the operation of clavicle fracture.

The SCPB targets the cervical plexus, providing sensory anesthesia to the skin overlying the cervical and upper thoracic regions. It is often used in conjunction with other blocks to enhance analgesia in the upper shoulder and clavicle area.

The ISBP block involves the administration of local anesthetic at the level of the brachial plexus, typically performed between the anterior and middle scalene muscles. This approach provides comprehensive analgesia for the shoulder, upper arm, and part of the clavicular area.

Clavipectoral fascial plane block (CPB) is a new regional nerve block and can be used in anesthesia and postoperative analgesia for clavicle fracture surgery. CPB provides analgesia to the clavicular region and the upper shoulder.

Eligibility Criteria:
Inclusion Criteria:

* Aged 18 to 65 years.
* Both sexes.
* American Society of Anesthesiologists (ASA) physical status I, II.
* Patients with unilateral clavicular fractures undergo elective internal fixation of clavicle fractures.

Exclusion Criteria:

* Coagulopathy.
* Patients with infection at block site.
* Allergy to local anesthetics.
* Patient with morbid obesity (body mass index \>35 kg/m2).
* Pre-existing neurological disease.
* Difficult communication.