cyrilzakka/clinical-trials huggingface dataset:
Clinical Significance of Circulating Tumor Cells (CTCs) in Blood of Patients With Advanced/Metastatic Gastric Cancer

To identify the correlation of CTCs with clinical prognosis in advanced/metastatic gastric cancer. Confirm the presence of CTCs are sensitive for monitoring response to chemotherapy.


Eligibility Criteria:
Inclusion Criteria:

* Having signed informed consent
* Age≥ 18 years old
* Histologically confirmed gastric adenocarcinoma
* Unresectable recurrent or metastatic disease
* Previous neo-adjuvant or adjuvant treatment for gastric cancer, if applicable, more than 6 months
* Previous chemotherapy with capecitabine or cisplatin, if applicable, more than 12 months.
* Measurable disease according to the RECIST criteria
* Karnofsky performance status ≥60
* Life expectancy of ≥2 month
* No prior radiotherapy except radiotherapy at non-target lesion of the study more than 4 weeks
* ALT and AST\<2.5 times ULN (≤5 times ULN in patients with liver metastases)
* Serum albumin level ≥3.0g/dL
* Serum AKP \< 2.5 times ULN
* Serum creatinine \<ULN, and CCr \< 60ml/min
* Bilirubin level \< 1.5 ULN
* WBC\>3,000/mm3, absolute neutrophil count ≥2000/mm3, platelet\>100,000/mm3, Hb\>9g/dl

Exclusion Criteria:

* Brain metastasis (known or suspected)
* Previous systemic therapy for metastatic gastric cancer
* Inability to take oral medication
* Previous therapy targeting at angiogenesis or vasculogenesis pathway or other targeted therapy
* Surgery (excluding diagnostic biopsy) within 4 weeks prior to study entry Contraindications of nuclear magnetic resonance image such as fitment of cardiac pacemaker , nerve stimulator, or aneurysm clip, and metallic foreign body in eye ball and so on.
* Allergic constitution or allergic history to protium biologic product or any investigating agents.
* Severe heart disease or such history as recorded congestive heart failure, uncontrolled cardiac arrhythmia, angina pectoris needing medication, cardiac valve disease, severe abnormal ECG findings, cardiac infarction , or retractable hypertension.
* Pregnancy or lactation period
* Any investigational agent within the past 28 days
* Other previous malignancy within 5 year, except non-melanoma skin cancer
* Previous adjuvant therapy with capecitabine+platinum,
* Pre-existing neuropathy\>grade 1
* Legal incapacity
Comparison of Insulin Pump and MDI for Pregestational Diabetes During Pregnancy

This study is investigating whether insulin treatment with the insulin pump or with multiple daily injections (MDI) gives better outcomes for mother and baby in pregnant women with pregestational diabetes. Participants will be randomized to use either the insulin pump or MDI.

Primary outcome is a composite of Cesarian section, instrumental delivery, maternal hypertension, LGA infant, neonatal hypoglycemia or SCN admission.

Eligibility Criteria:
Inclusion Criteria:

* subjects are attending the Diabetes Pregnancy Clinic at participating hospitals
* have had type 1 or type 2 diabetes for at least one year
* are in the first trimester or are actively attempting pregnancy
* have a singleton pregnancy
* are receiving intensive insulin therapy
* are judged by clinic staff to be capable of using an insulin pump
* are age 19 or older
* are willing to adhere to the study protocol including monitoring blood glucose levels
* are willing to take folic acid before pregnancy and during the first trimester
* are willing to discontinue any medication contraindicated in pregnancy prior to conception
* weigh less than 100 kg (220 lb) prior to becoming pregnant
* use less than 100 units of insulin per day

Exclusion Criteria:

* current or previous use of an insulin pump
* use of fertility treatments
* have a multiple pregnancy
* have had children born with major birth defects
* have experienced stillbirth or multiple early pregnancy losses
* have significant diabetes complications or a serious medical issue
Impact of Oximetry on Hospitalization in Acute Bronchiolitis

To determine, in previously healthy infants 6 weeks to 12 months of age, diagnosed with acute bronchiolitis and monitored by hourly oximetry, if the probability of hospitalization within 72 hours of arrival in those whose oxygen saturation display is manipulated 3 percentage points above the true measurements is significantly lower in comparison to those whose monitors display true saturations.

This is the first bronchiolitis study to examine the clinical and economic impact of making disposition decision on primarily clinical grounds, while blinding the physicians to oxygen saturations by providing them with either true saturation measurements or those which are 3 percentage points above the true values. Although physiologically insignificant and within the measurement error of the instrument, this difference has been shown to be perceived as clinically relevant and to have a major hypothetical impact on disposition, without any evidence to support this belief.

We hope to find out if children with oxygen saturations above or in the vicinity of the threshold recommended for initiation of oxygen therapy by the AAP can be safely discharged based on their clinical appearance rather than to have their hospitalization dictated by a locally defined number. This study will hopefully provide much needed evidence necessary to help us interpret the oximetry results more meaningful which may in turn lead to fewer hospitalizations, shorter length of hospital stay and lower health care costs.

Eligibility Criteria:
Inclusion Criteria:

* Acute bronchiolitis
* Age 4 weeks to 12 months
* Baseline Respiratory Disease Assessment Instrument (RDAI) ≥ 3 points
* Informed consent
* Availability of a telephone

Exclusion Criteria:

* Pre-existing pulmonary or cardiac distress, neuromuscular disease, congenital or acquired airway anomalies, hemoglobinopathies, or chronic hypoxia
* Severe respiratory distress, defined as the retraction component on the RDAI as 8 out of possible 9 points
* True baseline oxygen saturation less than 88% in room air
* Transfers from other institutions
Goal Directed Hemodynamic Management and Renal Outcome After Renal Transplant Surgery

This study is designed to compare the incidence of delayed graft function in patients following renal transplant surgery with different perioperative hemodynamic managements: a goal directed hemodynamic management group (using PiCCO) and a control group.

Volume assessment and management during renal transplantation is one of the most challenging problems the anesthetist has to deal with. It seems sensible that individualized volume management and hydration therapy during the operation and during the stay at the intensive care unit could improve perfusion of the transplanted organ resulting in a better transplant function. Aim of this study is to investigate the impact of a goal directed hemodynamic management on incidence of delayed graft function (DGF) after renal transplant surgery.

Therefore patients will be randomized in one of two groups, the PiCCO group with goal directed hemodynamic management during operation and during the ICU-stay and the control group with hemodynamic management performed according to heart rate, blood pressure and central venous pressure.

Eligibility Criteria:
Inclusion Criteria:

* Renal Transplant Surgery
* Age ≥ 65 years
* Written informed consent

Exclusion Criteria:

* Contraindications for an arterial line in the femoral artery:

  * stents
  * bypasses
  * severe peripheral artery occlusive disease
Effect of Levcromakalim in Individuals With Migraine Pretreated With Erenumab

An outstanding scientific question, that merits further investigation, is whether dilation of intracranial arteries is implicated in the pathogenesis of cephalic pain in migraine. Here, we hypothesize that experimentally-induced dilation of intracranial arteries using intravenous infusion of levcromakalim (a potent vasodilator) induces cephalic pain with migraine-like features in people with migraine, who prior to the infusion are administered erenumab (anti-calcitonin gene-related peptide (CGRP) receptor monoclonal antibody).


Eligibility Criteria:
Inclusion Criteria:

* Participant has provided informed consent prior to initiation of any study-specific activities/procedures.
* Age ≥18 years upon entry into screening.
* History of migraine without aura for ≥12 months with a frequency of 1-5 migraine attacks per month before screening according to the International Headache Society (IHS) Classification ICHD-3 (Headache Classification Committee of the International Headache Society, 2018), based on medical records and/or patient self-report.

Exclusion Criteria:

* History of any primary headache disorder other than migraine without aura, or tension-type headache with a frequency of ≥5 headache days per month before screening according to the International Headache Society (IHS) Classification ICHD-3 (Headache Classification Committee of the International Headache Society, 2018), based on medical records and/or patient self-report.
* History of any secondary headache disorder before screening according to the International Headache Society (IHS) Classification ICHD-3 (Headache Classification Committee of the International Headache Society, 2018) based on medical records and/or patient self-report.
* Intake of prophylactic migraine medication within ≤30 days or 5 plasma half-lives (whichever is longer) prior to screening.
* Prior intake of therapies targeting the CGRP signaling pathway, including anti-CGRP ligand monoclonal antibodies, anti-CGRP receptor monoclonal antibodies, and small molecule CGRP receptor antagonists.
* The participant is at risk of self-harm or harm to others as evidenced by past suicidal behavior.
* History or evidence of any other clinically significant disorder, condition, or disease (with the exception of those outlined above) that, in the opinion of the investigator will pose a risk to participant safety or interfere with the study evaluation, procedures or completion.
* Female participants of childbearing potential with a positive pregnancy test assessed at screening or day 1 by a urine pregnancy test.
* Female participants who are pregnant or breastfeeding or plan to become pregnant or breastfeed during participation in the study.
* Evidence of current pregnancy or breastfeeding per participant self-report or medical records.
* Participants likely to not be available to complete all protocol-required study visits or procedures, and/or to comply with all required study procedures to the best of the participants' and investigator's knowledge.
A Study to Explore the Role of Gut Flora in COVID-19 Infection

This study seeks to determine whether the virus which causes COVID-19, SARS-CoV-2, is shed in the stools of patients who are infected.

In this study the stool of patients who are being treated for COVID-19 will be tested during treatment and then again following treatment to determine if the virus is shed in the stool during infection, afterwards, or both.

Eligibility Criteria:
Inclusion Criteria:

1. Signed informed consent, demonstrating that the patient understands the procedures required for the study and the purpose of the study
2. Male or female of 18 years of age or older
3. Diagnosis of COVID-19 infection by RT- PCR within 1 week of Screening

Exclusion Criteria:

1. Refusal to sign informed consent form
2. History of bariatric surgery, total colectomy with ileorectal anastomosis or proctocolectomy.
3. Postoperative stoma, ostomy, or ileoanal pouch
4. Treatment with total parenteral nutrition
Joint Outcome Study

This study examines the progression of joint disease in children with hemophilia assigned to either standard treatment or enhanced therapy.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with hemophilia A
* factor level less than 2%

Exclusion Criteria:

* More than 2 bleeds into the same joint
An Observational Study to Evaluate the Effectiveness of Mircera Treatment for Renal Anemia in Pre-dialysis Participants With Chronic Kideny Disease (CKD)

This observational trial will examine the efficacy and safety of Mircera for renal anemia in participants with stage III-IV CKD in daily clinical practice. Mircera will be prescribed by treating physician and followed for approximately 36 months.


Eligibility Criteria:
Inclusion Criteria:

* Participants aged \> 18 years with CKD
* Participants who are eligible for Mircera treatment according to current guidelines and summary of product characteristics (SmPC)

Exclusion Criteria:

* Non-renal anemia
* Pregnancy and breast-feeding
* Uncontrolled hypertension
* Known hypersensitivity to methoxy polyethylene glycol-epoetin beta
* Administration of any other study drug within 30 days prior to study enrollment
A Multicentre Trial of Nerve-Spring Radical Hysterectomy vs. Radical Hysterectomy for Cervical Cancer

The investigators designed this multicentre randomized study to investigate the clinical benefits of nerve-spring radical hysterectomy for cervical cancer. Patients with FIGO stage Ia2, Ib1, IIa1 and FIGO stage Ib2, IIa2 after neoadjuvant chemotherapy are randomized to either nerve-spring radical hysterectomy or radical hysterectomy. The primary endpoint are urodynamic outcome including maximum flow rate, residual volume, maximum vesical compliace, cystomctric capacity at first desire, and maximum cystomctric capacity. A total 240 patients (120 per treatment arm) are planned to accrue for this study within 7 years.


Eligibility Criteria:
Inclusion Criteria:

1. FIGO(2009) stage Ia2, Ib1, and IIa1 Untreated cervical cancer OR FIGO(2009) stage Ib2 and IIa2 cervical cancer that possible to surgery after neoadjuvant chemotherapy
2. Possible to radical hysterectomy or nerve-spring radical hysterectomy
3. Age: 17 to 60 years
4. No complication during operation
5. Written informed consent

Exclusion Criteria:

1. patients who underwent radiotherapy
2. Pathologically diagnosed Pathologically diagnosed squamous carcinoma, Small Cell Carcinoma, Small Cell Carcinoma
3. Patients who have uncontrolled diabetes or uncontrolled hypertension
4. patients with neurogenic bladder dysfunction
5. patients with uterine prolapse
6. Patients with psychiatric illness
7. Patients who have active infection
8. Patients who have had heart failure, unstable angina, or myocardial infarction within the past 6 months
9. Patients who are unable to undergo radical hysterectomy for complication of excessive obesity, liver cirrhosis, or bleeding tendency
Resistance Exercise Program on the Functionality of Individuals With Chikungunya Fever

Common symptoms of chikungunya fever are persistent arthritis and arthralgia, such symptoms can lead to impairment in functionality. The objective of this study is to evaluate the efficacy of a resistance exercise protocol on the functionality of individuals with chronic musculoskeletal manifestations of Chikungunya fever. Quality of life, number of painful joints, intensity of pain, number of recurrence of exacerbation and thermography are secondary outcomes that will also be evaluated. The protocol uses elastic resistance to strengthen muscle groups that stabilize the main joints affected by Chikungunya Fever. The sessions will be 2 times a week for 12 weeks. The control group will not be submitted to the intervention during the 12 weeks, being contacted through telephone calls. After the reevaluation at the end of the 12 weeks the control group will perform the same protocol. The sample will be characterized and the effect size and the mean difference will be calculated. Intention-to-treat analysis and rate of adherence will also be calculated.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Chikungunya fever for more than three months
* Present musculoskeletal symptoms after infection (eg, arthritis or arthralgia)

Exclusion Criteria:

* Cognitive deficit that compromises the understanding and accomplishment of the protocol (MiniMental\<24);
* Self-reported disease that contraindicates the performance of research procedures (eg, unstable angina);
* Self-reported diagnosis of neurological disease;
* Prior self-reported diagnosis of other inflammatory or autoimmune rheumatic diseases or fibromyalgia;
* Pregnancy;
* Physical impairment that prevents arrival to the research site or execution of the exercises (eg, use of walking devices);
* Execution of other physiotherapeutic treatments during the research period;
* Regular practice of physical exercises in other places during the period of participation in the research.
Clinical and Pathologic Studies in Non-Hodgkin's Lymphoma and Hodgkin's Disease

The purpose of this study is to characterize the molecular and cell biology of the tumor cells in lymphoma.

This research involves the study of lymphoma cells in order to better understand how the disease grows and spreads. This study may lead to the development of special materials that could be used, in the future, to treat lymphoma or to follow the response of lymphoma to treatment.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Hodgkin's disease or non-Hodgkin's lymphoma, any cellular classification, any stage, any grade.
* Adult or pediatric patients receiving lymph node excision for purposes other than cancer therapy (i.e. tonsillectomy, sleep apnea).
* A routine procedure for tissue collection is planned.
* Ability to understand and the willingness to sign a written informed consent.

Exclusion Criteria:

* Patients without NHL or Hodgkin's disease
Diagnosis Accuracy of Hemoconcentration to Detect Hypovolemia During CRRT

The aim of the study is to analyze if blood protein concentration variation during continuous renal replacement therapy (CRRT) with fluid removal can predict a decrease of 15 % of cardiac index in intensive care unit (ICU) patients. Blood protein concentration, clinical data describing hemodynamic status (providing data from Pulsion medical system PiCCO2 ® monitoring), including preload dependency evaluation with passive leg raising, are collected at different times: before initiation of fluid removal, and after the first episode of hypotension or one hour after initiation of fluid removal.

The aim of the study is to analyze if blood protein concentration variation during continuous renal replacement therapy (CRRT) with fluid removal can predict a decrease of 15 % of cardiac index in intensive care unit (ICU) patients. Blood protein concentration, clinical data describing hemodynamic status (providing data from Pulsion medical system PiCCO2 ® monitoring), including preload dependency evaluation with passive leg raising, are collected at different times: before initiation of fluid removal, and after the first episode of hypotension or one hour after initiation of fluid removal.

Eligibility Criteria:
Inclusion Criteria:

* up to 18 years old
* continuous renal replacement therapy
* Suspicion of fluid overload
* Prescription of fluid removal by the intensivist
* PICCO2 monitoring

Exclusion Criteria:

* pregnancy
* intra abdominal hypertension
* Moribund patient
* Abdominal hypertension
A Phase IIIb Study Comparing Two Boosted Protease Inhibitor-based HAART Regimens in HIV-infected Patients Experiencing Their First Virologic Failure While Receiving an NNRTI-containing HAART Regimen

The purpose of this study is to compare the anti-HIV efficacy, safety and effect of serum lipids of two boosted protease inhibitor-based HAART regimens (ARV/RTV v. LPV/RTV) in HIV-1 infected subjects who have experienced their first virologic failure while receiving a NNRTI-containing HAART regimen.


Eligibility Criteria:
Inclusion Criteria:

* Patients ≥ 18 years of age infected with HIV
* Plasma HIV RNA ≥ 1000 copies/mL and CD4 cell count ≥ 50 cells/mm3
* Currently receiving a NNRTI-containing HAART regimen or not currently receiving a NNRTI-containing HAART regimen and have not been treated with an alternative regimen since the documented virologic failure (with genotype performed within 2 weeks of the discontinuation of the failing regimen and the genotype report is available)
* The failing NNRTI-containing regimen must be the patient's first virologic failure on treatment and contain a NNRTI and at least 2 NRTIs. The regimen must have been administered for at least 24 weeks and the patient must have documented virologic response to the regimen (HIV RNA \< 400 c/mL)

Exclusion Criteria:

* Pregnancy or breastfeeding
* Reported virologic failure to two or more antiretroviral regimens
* Active AIDS-defined opportunistic infection or disease
* Proven or suspected acute hepatitis within 30 days prior to study entry
A Study to Evaluate the Change in Weight After 24 Weeks Treatment With LIK066 in Obese or Overweight Adults

This was a dose-finding study that evaluated the change in weight after 24 weeks treatment with 8 different doses of LIK066 compared to placebo in obese or overweight adults, followed by 24 weeks treatment with 2 doses of LIK066 and placebo.


Eligibility Criteria:
Inclusion Criteria:

1. informed consent
2. (BMI\>=30) or (BMI\>=27 with history of CV disease, hypertension, dyslipidemia, pre-diabetes or type 2 diabetes mellitus, sleep-apnea syndrome)
3. willing to comply with life-style intervention and treatment during the full duration of the study (approximately 54 weeks)

Exclusion Criteria:

* Hypersensitivity to any of the study medications
* Pregnancy or lactating women
* History of malignancies
* Use of pharmacologically active weight loss products
* Bariatric surgery
* Ketoacidosis, lactic acidosis, hyperosmolar coma in the 6 months before the screening visit.
* HbA1c \>10% at the screening visit.
The Effect of the Mediterranean Diet on Fatty Acids in Biological Fluids of Women Undergoing Infertility Treatment

The aim of this study was to examine the effect of the Mediterranean diet, which is accepted as one of the adequate and balanced nutrition models today, as well as serum and follicular fluid fatty acid profile and implantation success in women with an age range of 19-40 (years) before infertility treatment. The study was conducted as a prospective and case-control study with a total of 32 volunteer women, 16 in the intervention group and 16 in the control group, who applied to Gazi University Hospital between February 2021 and February 2022.


Eligibility Criteria:
Inclusion Criteria:

Women diagnosed with infertility Women between the ages of 19-40 Women with BMI \<30 kg/m² women undergoing assisted reproductive treatment in which updated oocytes and semen be used Women undergoing assisted reproductive treatment (ART), IUI or one of the first 3 IVF/ICSI treatments (number of ART treatments ≤ 3)

Exclusion Criteria:

Women diagnosed with chronic diseases other than infertility Women who smoke and drink alcohol Women on ART who will use frozen eggs or semen Women with BMI \>30 kg/m2 at the first measurement Women experiencing communication breakdown/timeout, becoming pregnant, difficulty adhering to a diet program or ART while the intervention is ongoing