cyrilzakka/clinical-trials huggingface dataset:
The Prognostic Value of the Degree of Pathological Response of Induction Chemotherapy for NPC

This study aims to explore the prognostic value of pathological remission after one cycle of induction chemotherapy in locally advanced nasopharyngeal carcinoma, and the change of immune micro-environment after one cycle induction chemotherapy, including the density of immune cells infiltration and tertiary lymphoid structures.


Eligibility Criteria:
Inclusion Criteria:

1. Ability to sign informed consent
2. Age \> 18 years at time of study entry
3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 (amend based on specific study)
4. Histological confirmation of NPC (regardless if EBER positive or negative)
5. Locally advanced NPC, UICC stage III-IVa
6. Subject is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up.

Exclusion Criteria:

1. Concurrent enrolment in another clinical study, unless it is an observational (non-interventional) clinical study or during the follow-up period of an interventional study
2. Distant metastases
3. Prior systemic anti-cancer therapy (chemotherapy, immunotherapy, endocrine therapy, targeted therapy, radiotherapy, biologic therapy, tumour embolization, monoclonal antibodies) of the locally advanced NPC.
4. History of another primary malignancy
5. Female patients who are pregnant
6. Known allergy or hypersensitivity to any drugs
7. Judgment by the investigator that the patient is unsuitable to participate in the study and the patient is unlikely to comply with study procedures, restrictions and requirements.
Study of Emu Oil vs. Placebo for Vulvar Pain in Women.

The goal of this study is to determine if vulvar (external female genitalia) pain is decreased with emu oil over a similar placebo oil (no active ingredient) by using measurement devices, examinations, and questionnaires. Topical emu oil has not been scientifically studied for this condition yet, but related reports show no significant side effects or potential benefits.

A total of 30 women will participate in the study at William Beaumont Hospital, Royal Oak.

* Women of all ages with vulvar pain may participate in this trial.
* Women will be randomized into 2 groups--a treatment group or placebo group for the 1 month study.
* At the end of the study, those in the placebo group may choose to participate in a 1 month follow-up evaluation using emu oil.

Eligibility Criteria:
Inclusion Criteria:

* Women with vulvar pain upon q-tip exam of \> 3/10 at 2 or more sites tested.
* Age 18 or older.
* Capable of giving informed consent.
* Capable and willing to follow all study procedures.

Exclusion Criteria:

* Pregnant women or those intending to become pregnant during the study period.
* Vaginitis (may be treated, then tested later).
* Vulvar disease (other than vulvodynia)-lichen planus, lichen sclerosis, neoplasia, tissue damage due to radiation.
* The subject is deemed unsuitable for enrollment by the investigators based on their history or physical examination.
* Neuropathy.
* Currently in pelvic floor physical therapy.
Descartes-11 in Patients With Relapsed/Refractory Multiple Myeloma

This Phase I study will test the safety and anti-myeloma activity of ascending doses of Descartes-11 (autologous CD8+ T-cells expressing an anti-BCMA chimeric antigen receptor) in eligible patients with active multiple myeloma.


Eligibility Criteria:
Inclusion Criteria:

* Active multiple myeloma that is refractory after at least 2 prior lines of therapy;
* measurable disease;
* adequate vital organ function; and
* no active infection.
Long Term Follow up of the DVR-A Locking Plate

The surgical treatment of wrist fractures (distal radius bone) has been changed by the introduction of a new plate design, the locking plate. This results in improved fixation and stabilisation of the fracture fragments allowing early movement.

This type of plate has been increasingly used throughout the world but questions have been raised regarding the potential complications of the surgery, particularly nerve and tendon injury. The Norfolk and Norwich Hospital has treated over 250 distal radial fractures with this type of plate. The investigators plan to recall these patients to asses their long term function, general satisfaction and radiological results.


Eligibility Criteria:
Inclusion Criteria:

* Treatment between Jan 2005 and March 2009

Exclusion Criteria:

* Under 16
* Unable to consent
* Pregnant
Tailored Web and Peer Email Cessation Counseling for College Smokers

The RealU2 is a randomized controlled trial to determine the efficacy of an online health and wellness program for young adults with the addition of individualized peer health coaching.

The RealU addresses smoking in a young adult population of occasional and daily smokers.

Aim 1. To determine the efficacy of providing individually tailored smoking cessation messages as part of a general interest website for young adults.

Aim 2. To determine the efficacy of providing individually tailored smoking cessation messages plus peer email, phone and online support as part of a general interest website for young adults.

Participants were recruited via direct emails sent to undergraduate and graduate students at the University of MI as well as direct emails sent to participants from Survey Sampling International and National Data Group. Individuals were invited to complete an online survey about health and hope in young adults. Participants eligible for the full intervention were invited to join the RealU Study.

Participants were asked to complete an online enrollment survey and consent form. Eligible, enrolled participants were randomly assigned to one of the following three study arms:

* an untailored general interest/lifestyle website
* an individually tailored web intervention about health and lifestyle
* an individually tailored web intervention about health and lifestyle with coaching from peers, including video, phone, and email

Assessments were conducted at 7 weeks and 12 weeks post-enrollment. The primary outcome measure is self-reported 30-day abstinence at 12 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-35
* Able to read English
* Internet access for the next 3 months
* Self-reported internet use of more than once per week
* Smoked at least one puff of a cigarette in the past 30 days

Exclusion Criteria:

* Use of smokeless tobacco in the past 30 days
Zinc Bioavailability From Amaranth-enriched Maize Tortillas

Young children in Guatemala are at risk for nutrient deficiencies due to plant-based diets and poor sanitation. Stunting, frequent diarrhea, and respiratory infections are common. Supplementation of Zn to children during diarrhea episodes has been shown to diminish duration and severity of illness. Poor Zn absorption due to high fiber and phytate in this diet might play a role in these processes. Supplementation of this micronutrient in the diet might be beneficial. The investigators will compare absorption of Zn from white maize tortillas enriched with 20% amaranth to traditional white corn tortillas in preschool children in Guatemala.

This is a randomized cross-over study of zinc absorption in young children living in the Western Highlands of Guatemala. Absorption of zinc will be measured from maize tortillas and maize tortillas fortified with 20% amaranth as the major food staple which provides at least 70% energy and at least 90% zinc and phytate of the diet. Participants will be randomized as to which type of tortilla they receive on the first and second day. Fractional absorption of zinc (FAZ) from all meals in one day for one type of tortilla and one day for the other will be measured by extrinsic labeling with stable isotopes of zinc. FAZ will be measured by a dual isotope tracer ratio (DITR) technique based on ratio of urine enrichment of orally versus intravenously administered zinc stable isotopes. Measurement of total zinc in duplicate diets on test days allow for determination of quantities of this micronutrient absorbed.

Eligibility Criteria:
Inclusion Criteria:

* 2-3 years of age
* apparently healthy
* eats \>2-3 tortillas at each meal of the day.

Exclusion Criteria:

* Chispitas or macrovital supplementation
* breastfeeding
* birth weight \< 2,500 g
* birth defect affecting growth and development
* chronic infection
* twin or triplet
* sibling enrolled in study
Hemodynamic Effects of Changes in Transpulmonary Pressure During Recruitment Maneuver in Patients Under Pressure Supported Mechanical Ventilation

According to the anatomical proximity of the heart temporarily elevated intrathoracic pressures may have direct and indirect effects on the cardiovascular system. Undesirable hemodynamic effects of a recruitment maneuver primarily arise from the transiently increased airway pressure, manifesting in decreased right heart filling, increased pulmonary vascular resistance, a drop in left ventricular systolic transmural pressure, right and left heart ventricular interactions and subsequent changes in cardiac index. These effects can be more pronounced in patients suffering from ARDS, a condition commonly accompanied by hemodynamic instability. The complex pathophysiological changes account for why routine intensive care monitoring, such as invasive arterial blood pressure or central venous pressure monitoring is insufficient to follow hemodynamic changes under recruitment maneuver.

Previous studies by the same research team confirmed that the alveolar recruitment maneuver improves oxygenation in patients with moderate-to-severe hypoxemic respiratory failure under pressure supported ventilation. Following recruitment maneuver, arterial oxygenation increased in 74 % of all patients. However, there is lack of information regarding the actual degree of changes in transpulmonary pressure and the consequent hemodynamic alterations.

The primary aim of the study is to evaluate precisely the transpulmonary pressure changes during recruitment in patients with severe hypoxemic respiratory failure ventilated in pressure support mode following insertion of a balloon-catheter into the esophagus. In the meantime, hemodynamic changes are monitored by PiCCO and transthoracic echocardiography, and lung field aeration by electric impedance tomography.


Eligibility Criteria:
Inclusion Criteria:

* orotracheal intubation
* pressure supported ventilation
* moderate-to-severe hypoxemic respiratory failure according to ARDS Berlin Criteria Moderate: 100 Hgmm ≤ PaO2/FiO2 ≤ 200 Hgmm, PEEP ≥ 5 cmH2O Severe: PaO2/FiO2 ≤ 100 Hgmm, PEEP ≥ 5 cmH2O

Exclusion Criteria:

* age \< 18 years
* pregnancy
* previous pulmonary resection, pulmonectomy
* clinically verified, end-stage COPD
* severe hemodynamic instability (i.e. refractory shock to vasopressors)
* severe emphysema and/or spontaneous pneumothorax in past medical history
* contraindications of a balloon-catheter (e.g. esophageal abscess, esophageal perforation, esophageal diverticulosis, esophagus tumor, esophagus varix, recent esophagus or gastric surgery, severe coagulopathy)
Relationships Among FVIII, t-PA/PAI-1, and MMP-9 Levels and Intracranial Hemorrhage Complications After Thrombolysis With Alteplase in Patients With Acute Ischemic Stroke: Protocol for a Multicenter Retrospective Study

The primary aim of the study is to investigate the relationships among FVIII, t-PA/PAI-1, MMP-9 levels, and intracranial hemorrhage after thrombolysis with alteplase using a combined analysis.

Patients with acute ischemic stroke treated with alteplase within 4.5 hours after the onset of stroke symptoms will be recruited in this study. All participants will be divided into two groups according to whether intracranial hemorrhage occurred within 3 days after treatment with alteplase for analysis. Differences in FVIII, t-PA/PAI-1, and MMP-9 levels before and after thrombolytic therapy will be examined in both groups. This study will be conducted at Zhujiang Hospital of Southern Medical University, Nanfang Hospital of Southern Medical University, and the First Affiliated Hospital of Jinan University.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of ischemic stroke and within the time window of thrombolysis (Onset of symptoms no more than 4.5 hours )
* 18 y age 85 y•
* Symptoms of neurological deficits caused by cerebral infarction
* Informed consent form to confirm thrombolytic therapy have signed by patients or their family.

Exclusion Criteria:

* A history of major head trauma or stroke in the past 3 months
* Suspicious subarachnoid hemorrhage
* Arterial puncture at noncompressible site in the last week
* History of intracranial hemorrhage
* Intracranial neoplasm, arteriovenous malformation, or aneurysm
* Recent intracranial or intraspinal surgery
* Elevated blood pressure (systolic \>185 mm Hg or diastolic \>110 mm Hg)
* Active internal bleeding or Acute bleeding diathesis
* Platelet count \<100×109·L-1
* Heparin received within 48 h resulting in aPTT above the upper limit of normal
* Current use of anticoagulant with INR \>1.7 or PT \>15 s
* Current use of thrombin inhibitors or factor Xa inhibitors
* Abnormal laboratory tests (eg, aPTT, INR, platelet count, ECT, TT, or appropriate factor Xa activity assays)
* Blood glucose concentration \> 2.7 mmol/L
* CT demonstrates multilobar infarction (hypodensity \>1/3 cerebral hemisphere)
* Mild cerebral infarction or rapid improvement of symptoms of cerebral infarction
* Symptoms of neurological impairment after seizures
* Major surgery or severe trauma in the past 2 weeks
* Gastrointestinal or urinary bleeding in the past 3 weeks
* History of myocardial infarction in the past 3 months
* Combine diseases that may affect outcomes,such as Anemia, hemophilia
* History of autoimmune disease or organ transplantation
* Pregnancy or breastfeeding women
POASAC Study (Preoperative Anemia Severity and Classification Study)

The goal of this observational study focuses on the effect of different preoperative anemia status on perioperative complications in patients under moderate- to high-risk surgery. Different anemia types conclude iron-deficiency anemia(IDA), anemia of chronic disease/anemia of inflammation(ACD/AI), and combined anemia.The main question it aims to answer is whether there is a difference in the incidence of complication related to oxygen supply and demand imbalance in patients with IDA, ACD/AI or combined anemia.

Patients without preoperative anemia will be recruited as the control group for secondary outcome analysis, which is whether there is a difference in the incidence of complication related to oxygen supply and demand imbalance in patients with or without anemia.

The investigators aim to screen patients according to including and excluding criteria. According to the hemoglobin level, if the patient is anemia, the investigators will offer some lab tests for serum iron, transferrin saturation, C-reactive protein to classify different anemia status. Besides, the investigators will include patients without anemia in a 2:1 ration of anemia to non-anemia. The perioperative assessment and follow-up are the same for all the included patients.

Eligibility Criteria:
Inclusion Criteria:

* age 18 years or older
* scheduled for elective moderate- to high-risk surgery other than intracranial and cardiac surgery
* predicted surgery time longer than 1 hour and hospital stay longer than 24 hours
* understand and agree to participate

Exclusion Criteria:

* pregnant
* live at areas higher than 2,500 meters above sea level
* with hematological diseases other than anemia
* with severe comorbidities that might interfere outcome assessment, like uremia, dementia, and so on
* can't cooperate or communicate, or reject to sign informed consent form
Role of Frozen Section in Categorization of Thyroid Follicular Neoplasm

The goal of this prospective study is to assess the effectiveness of frozen section in distinguishing between benign and malignant tumors in the category of follicular thyroid neoplasm to prevent over-surgery for benign follicular neoplasm (lobectomy Vs total thyroidectomy).

The main questions, it aims to answer are:

The follicular neoplasm is benign or malignent? how far is FNAC valid and accurate? Researchers will compare the results of frozen section and paraffin embedded sections to evaluate the validity and accuracy of FNAC.

Thyroid tumors are the most common endocrine neoplasms, with their incidence steadily rising over the past few decades, reaching approximately 8.7 cases per 100,000 people annually in Europe. The majority of thyroid tumors are benign accounting for over 90% of cases, whereas malignant thyroid tumors are relatively less common. Thyroid cancer represents 1-2% of all newly diagnosed malignancies worldwide, with papillary thyroid carcinoma (PTC) being the most prevalent (80%) followed by follicular thyroid carcinomas (FTC) (15%). Fine needle aspiration cytology (FNAC) is the primarily diagnostic tool for thyroid nodule. However, its accuracy in distinguishing between benign and malignant follicular neoplasms is limited, necessitating further histopathological evaluation. The Bethesda system classifies FNAC results into six categories, with follicular neoplasm/suspicious for follicular neoplasm (category IV) carrying a moderate risk of malignancy. Differentiating between benign and malignant follicular neoplasms requires assessing capsular and vascular invasion. Intraoperative frozen section (FS) has been used for decades to provide rapid histologic assessment guiding the extent of surgery (lobectomy Vs total thyroidectomy). However, its utility remains controversial due to variability in diagnostic accuracy and cost-effectiveness. The recent 5th edition of the WHO classification (2023) categorizes follicular-derived thyroid tumors into benign, low-risk and malignant neoplasms, further refining diagnostic criteria. This study aims to evaluate the accuracy of FNAC and FS in diagnosing follicular thyroid neoplasms, optimizing surgical decisions and reducing unnecessary total thyroidectomies in benign cases.

Eligibility Criteria:
Inclusion Criteria:

* Cases presented with a thyroid nodule, diagnosed as "follicular neoplasm" (Bethesda category IV) by fine needle aspiration cytology, and underwent hemi-thyroidectomy.

Exclusion Criteria:

* Cases with thyroid nodule and diagnosed by fine needle aspiration cytology as non-neoplastic lesions, suspicious for malignancy or as malignant.
Radioembolisation and Chemotherapy in Liver Metastatic Breast Cancer Patients

The goal of this multicentre clinical pilot study is to investigate the feasibility of the addition of Ho-166 radioembolization to chemotherapy in patients with liver metastastic breast cancer.

Participants will receive a mapping angiography and Ho-166 radioembolization. Chemotherapy will be stopped 2-5 prior to radioembolization and continuation of chemotherapy will be evaluated at 2 weeks post-radioembolization.


Eligibility Criteria:
Inclusion Criteria:

* Women \>18 years
* Patients with hormone positive and HER2 negative liver metastatic breast cancer
* No extra-hepatic disease progression at evaluation of at least second line systemic chemotherapy
* Suitable for TARE evaluated after the mapping angiography
* Measurable target tumors in the liver according to RECIST 1.1
* Liver tumor burden \<50 %
* ECOG performance score 0 to 1
* Laboratory parameters: neutrophils \>1000/μL; thrombocyte count \>1000000 μL; eGFR \>45/mL/min/1.73 m2; albumin \> 3.0 g/dl, bilirubin \< 1.5x ULN (unless Gilbert syndrome); aminotransferase (ALAT/ASAT) \<3.0 ULN
* Able to read Dutch

Exclusion Criteria:

* Life expectancy ≤3 months
* Patient eligible for other curative local liver therapy (ea. surgery, ablation)
* Brain, pleural, peritoneal or extensive extra-hepatic visceral metastases
* Other life-threatening disease (i.e. Dialysis, unresolved diarrhea, serious unresolved infections (HIV, HBV, HCV etc.))
* Contraindication for angiography or MRI
* Significant toxicities due to prior cancer therapy that have not resolved before the initiation of the study, if the investigator determines that the continuing complication will compromise the safe treatment of the patient
* Prior or planned embolic intra-arterial liver directed therapy (TACE, TAE, TARE)
* Prior or planned external or internal radiation therapy of the liver
* Cirrhosis or portal hypertension
* Main portal vein thrombosis
* Intervention for, or compromise of, the Ampulla of Vater
* Ascites (except minor focal ascites)
* Baseline use of analgesics for abdominal pain
* Pregnancy (Women at childbearing potential need at least one form of birth control) and breastfeeding
* Flow to extra hepatic vessels not correctable by reposition or embolization
* Estimated dose to the lungs greater than 30 Gy in a single administration or 50 Gy cumulatively
* Target tumoral absorbed dose of \< 90Gy or an absorbed dose to the normal liver parenchyma of \>50Gy (in case of whole liver treatment)
Transperineal Ultrasonography and Premature Rupture of Membranes

This study's aim is to evaluate diagnostic accuracy of transperineal ultrasound assessment compared with speculum examination, nitrazine and placental micro globulin-1 tests.

Women with early and late preterm pregnancies with a complaint of fluid leakage are enrolled in the study. Prior to speculum examination, sagittal view of the birth canal and transverse view of cervix and fornices are obtained with transperineal technique and images are stored. Then speculum examination for pooling, nitrazine test and placental microglobulin-1 tests are performed and results are recorded. Ultrasound images are analysed by an observer blind to physical examination findings. Hypoechogenic fluid appearance of adequate size around the cervix and in the fornices are considered positive. Placental microglobulin-1 test is used as reference. Sensitivity and specificity values are calculated for each test.

Eligibility Criteria:
Inclusion Criteria:

* Women with early and late preterm pregnancies, (i.e., women above 24th and below 37th week of gestation)
* Pregnant women with a complaint of fluid leakage

Exclusion Criteria:

* Women with term pregnancies (i.e., women above 37th week of gestation)
* Women with unviable pregnancies (i.e., women below 24th week of gestation)
* Women in active labor (i.e., cervical dilatation above 4cm during admission)
* Women with vaginal bleeding
Treatment Development for Glucose Transporter Type I Deficiency Syndrome (G1D)

The purpose of this trial is to determine if an alternative energy source will impact brain metabolism in a disorder characterized by glucose metabolism failure in the brain.

The central hypothesis tested in this investigation is whether circumventing impaired glucose metabolism is feasible, safe and potentially promising by supplying anaplerotic precursors through metabolism of odd-carbon fatty acids that can enter the citric acid cycle (CAC) through alternative metabolic pathways.

Triheptanoin, a nutritional supplement long used in other metabolic disorders and also added to foods and cosmetics, will be used to complement any diet that G1D patients may be receiving at enrollment with the exception of the ketogenic diet.

Eligibility Criteria:
Inclusion Criteria:

* Male or Female
* Ages 1 month to \<21 years of age
* Diagnosed with glucose transporter type I deficiency.
* Age matched (within 1 year) controls not diagnosed with G1D.

Exclusion Criteria:

* All subjects carrying body metal implants incompatible with the exposure to a magnetic field
* Subjects unable to tolerate the MRI and MRS procedures due to anxiety
* Subjects receiving oxygen supplementation or those confined to a bed or stretcher
* Subjects currently receiving a ketogenic diet, due to a high risk of seizure recurrence while transitioning off ketosis.
* Patients behaviorally unable to hold still for imaging procedures (rather than limited by seizure activity) will be excluded.