cyrilzakka/clinical-trials huggingface dataset:
Detection of Early Lung Cancer by Serum Protein Expression Profiling

Promising new technology exists to examine small proteins that are shed by cancers into the blood stream. The purpose of this study is to see if there are differences in the proteins and protein levels in blood from individuals with early stage lung cancer compared to healthy adults.

A prospective longitudinal patient-based pilot study is proposed whereby surfaced enhanced laser desorption ionization time-of-flight mass spectroscopy (SELDI-TOF-MS) will be used to discover and validate serum proteomic expression profiles diagnostic of early lung cancer. A unique approach will be used to compare the serum proteomic expression profiles of patients with non-small cell lung cancer compared to healthy heavy smoking adults, as well as differences before and after anatomic pulmonary resection with curative intent. Discriminatory proteins will be selected by their differential expression before compared to after surgical removal of a tumor. The protein profile of blood obtained from the draining pulmonary vein at the time of resection will be used to identify materials potentially shed by the tumor that may serve as biomarkers in peripheral blood. The serum samples will be used to develop a training data set and then a test set for validation using a class prediction model. Candidate proteomic patterns will then serve as a basis for a larger prospective multi-centre clinical trial.

Eligibility Criteria:
Inclusion Criteria:

* Presence of early stage non-small cell lung cancer
* Elective surgical resection of lung lesion at Vancouver General Hospital (VGH)
* No preoperative chemoradiation therapy
* No previous cancer
* Ability to provide informed consent
The Influence of Baseplate Adhesive on the Degree of Leakage

The influence of the baseplate adhesive type, shape and application is investigated with regard to the degree of leakage.


Eligibility Criteria:
Inclusion Criteria:

1. Have given written informed consent and signed letter of authority
2. Be at least 18 years of age and have full legal capacity
3. Have had their ileostomy/colostomy for at least 3 months
4. Have a stoma with a diameter between 15 and 36 mm
5. Be able to handle the products themselves
6. Be able to use a custom cut product
7. Normally experience faeces under the base plate at least 3 times during 2 weeks
8. Currently using SenSura 1-piece flat, open or closed bag, pre-cut or custom-cut or SenSura Mio 1-piece flat, closed bag, pre-cut or custom cut
9. Be willing to test the test products without using paste and/or ring
10. Be willing to use minimum 1 test product every second day, i.e. maximum 48 hours wear time per prod-uct
11. Be suitable for participation in the investigation
12. Be able to present a negative result of a pregnancy test - for women of childbearing age

Exclusion Criteria:

1. Are currently receiving or have within the past 2 months received radio- and/or chemotherapy
2. Are currently receiving or have within the past month received local or systemic steroid treatment in the peristomal area
3. Are pregnant or breastfeeding
4. Are participating in other interventional clinical investigations or have previously participated in this investigation
5. Use irrigation during the investigation (flush the intestines with water)
6. Are currently suffering from peristomal skin problems, i.e. bleeding and/or broken skin (assessed by the investigator/investigator representative)
7. Have a loop stoma
8. Have known hypersensitivity towards any of the test products (including adhesive remover)
CARegiver BURden, Effectiveness and Other Health Care Measures on Functional Disability, in Patients Treated With Abobotulinumtoxin A for Upper Limb Spasticity

The aim of this study is to perform, in real world clinical practice, a three-dimensional assessment from patient's, caregiver's and physician's perspectives, of the impact of AboBoNT-A on caregiver burden, functional disability and other health care measures in patients affected with ULS due to acquired brain injuries.


Eligibility Criteria:
Inclusion Criteria:

1. The patient is able to comply with the protocol;
2. Male and female patients who are at least 18 years old;
3. The patient is supported by an identified caregiver (family member or other nonpaid adult

   - if the patient has more than one caregiver, the main caregiver will be selected) who provides daily supervision or direct assistance to the care recipient;
4. The patient has been diagnosed with ULS due to non-progressive acquired brain injuries (stroke, traumatic brain injury, surgical resection of non-progressive tumours, other) or due to non-progressive spinal cord injury with stability of spasticity of the upper limbs;
5. The decision to treat the patient with AboBoNT-A by the care provider will be made prior to, and independently from the decision to enrol the patient in the observational study;
6. The patient is covered by a healthcare insurance;
7. The cognitive and health status of the patient is compatible with the participation to the study.

For Caregivers :

(8) The caregiver is able to comply with the protocol; (9) Male and female caregivers who are at least 18 years old; (10) The cognitive and health status of the caregiver is compatible with the participation to the study.

Exclusion Criteria:

1. Contraindication to BoNT-A treatment;
2. Previously treated with BoNT-A in upper limbs within the last 12 months;
3. Patients and if applicable Legally Authorized Representative (LAR) of patient under curatorship or deprived of liberty who are opposed to their data collection
4. Caregivers who are opposed to their data collection;
5. Caregivers already included for another patient;
6. Current participation in any other interventional clinical study or have participated within the 12 weeks prior to the inclusion visit;
7. Non-ambulatory patients except for those who have been hospitalized for the purpose of their BoNT-A injection (maximum length of stay as per clinical judgment of the investigator);
8. Vulnerable patients (i.e. pregnant and/or lactating women, children, patient under curatorship or deprived of liberty).
Development and Implementation of Electronic Decision Aids for Genetic Testing in Inherited Cancer Syndromes

An electronic decision aid will be used to assist individuals in choosing a multi-gene panel with their medical oncologist instead of a genetic counselor. A decision aid may facilitate quality decisions around the selection of a specific multi-gene panel without a genetic counselor. Upon completion of the decision aid, participants will be asked to indicate their decision about whether to pursue genetic testing and which specific multi-gene panel to pursue. A survey will then be administered to assess participants' opinions on the decision aid.


Eligibility Criteria:
Inclusion Criteria:

* Adults (18 years of age or older)
* Diagnosed with malignant ovarian tumor or malignant pancreatic adenocarcinoma

Exclusion Criteria:

* Children (\<18 years of age)
* Unable to complete surveys
* Previous germline genetic testing
A Study to Test if TEV-50717 is Effective in Relieving Tics Associated With Tourette Syndrome (TS)

Standard placebo-controlled, double-blind study design (TEV-50717 \[low dose and high dose\] vs. placebo in a 1:1:1 ratio) was chosen to determine whether study drug treatment results in a statistically significant effect on the tics in participants with TS.


Eligibility Criteria:
Inclusion Criteria:

* Participant weighs at least 44 pounds (20 kg) at baseline.
* Participant meets the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5™) diagnostic criteria for TS and, in the opinion of the investigator, participant, and parent/legal guardian, the participant's active tics are causing distress or impairment.
* Participant has a TTS of 20 or higher on the YGTSS at screening and baseline.
* Participant is able to swallow study medication whole.
* -Additional criteria apply, please contact the investigator for more information

Exclusion Criteria:

* Participant has a neurologic disorder other than TS that could obscure the evaluation of tics.
* The participant 's predominant movement disorder is stereotypy (coordinated movements that repeat continually and identically) associated with autism spectrum disorder.
* Participant has clinically significant depression at screening or baseline.
* Participant has a history of suicidal intent or related behaviors within 2 years of screening
* Participant has a history of a previous actual, interrupted, or aborted suicide attempt.
* Participant has a first-degree relative who has completed suicide.
* Participant has a confirmed diagnosis of bipolar disorder, schizophrenia, or another psychotic disorder.
* Participant has received Comprehensive Behavioral Intervention for Tics for TS or Cognitive Behavioral Therapy for obsessive-compulsive disorder (OCD) within 4 weeks of screening.
* Participant has received treatment with deep brain stimulation, transmagnetic stimulation, or transcranial direct current stimulation within 4 weeks of the screening visit for reduction of tics.
* Participant has a history of torsades de pointes, congenital long QT syndrome, bradyarrhythmias, or uncompensated heart failure.
* Participant has participated in an investigational drug or device study and received investigational medicinal product (IMP)/intervention within 30 days or 5 drug half-lives of baseline, whichever is longer.
* Participant is a pregnant or lactating female, or plans to be pregnant during the study.
* -Additional criteria apply, please contact the investigator for more information
Clinical Studies of Kikuchi's Disease

Kikuchi-Fujimoto disease is a distinctive syndrome of necrotizing lymphadenitis which was formally described in 1972 by two Japanese pathologists, Kikuchi and Fujimoto. It is a benign, self-limited disease that predominantly occurs in young women. It was more common in Asian people, especially in Japanese. The most frequent clinical presentations are fever (30\~50%) and cervical lymphadenopathy, often tender in palpable. Other lymph node regions can be affected, and hepatosplenomegaly may be present. The laboratory findings include leucopenia with atypical lymphocytosis. ESR, transaminases and lactate dehydrogenase are often raised. The clinical features are easily confused with other conditions, particularly lymphoma. Therefore the diagnosis depends on the pathological findings. The typical findings are paracortical lesions consisting of patchy zones of eosinophilic fibrinoid necrosis and abundant karyorrhexis. In general, spontaneous resolution of symptoms and signs within a few months can be expected without treatment.For decades, the etiology of Kikuchi's disease has been speculated. Although the perforin and Fas pathways of cytotoxic T cells induce an abundance of apoptosis and thus induce necrotizing lesions, the trigger factor is unknown. Since the disease can precede or occur in association with a connective tissue disorder, especially SLE, the autoimmune contribution to the etiology has also been speculated. However, the clinical course of Kikuchi's disease, often sudden onset and spontaneous resolution, the frequent flu-like or upper respiratory prodrome, and the prominence of cervical lymphadenopathy, support a viral cause. Evidence for a viral cause also includes peripheral blood atypical lymphocytosis and elevated serum IFN-a or 2'-5' oligoadenylate synthetase levels. Several infectious agents have been suggested, including bacteria (e.g. Brucella, Yersinia), parasites (e.g. toxoplasmosis) and viruses (e.g. EBV, CMV, HHV6, HHV8, parvovirus B19, HTLV, HIV).The aim of this study is to collect cases of Kikuchi' disease in bureau of NHI and NTUH. We will analyze the incidence rate, age of onset, sex, season of onset and clinical course to see if there is any clustered cases, or nosocomial infection. Then we will study the etiology of Kikuchi's disease especially the infection causes by analyzing pathologic specimen and serology. We hope to find out the etiology of Kikuchi's disease and the new treatment.


Eligibility Criteria:
Inclusion Criteria:

* Kikuchi's disease
Application and Optimization of the International Study Group of Pancreatic Surgery (ISGPS) Definition and Grading Criteria for Postoperative Complications of Pancreatic Surgery in Laparoscopic Pancreatic Surgery

In recent years, with the continuous development of minimally invasive techniques, laparoscopic pancreatic surgery has also been widely used. Although the postoperative mortality rate of laparoscopic pancreatic surgery has been decreasing as the technology continues to improve and mature, the complication rate reported varies widely among centers.The definition and grading criteria of ISGPS on postoperative complications of pancreatic surgery are mostly proposed based on open pancreatic surgery, and most of the data of the later related studies are also for open pancreatic surgery, while the applicability of the definition and grading criteria in laparoscopic pancreatic surgery is still lacking in systematic The study The main purpose of this study is to investigate the applicability of the ISGPS definition and grading criteria for pancreatic fistula, postoperative bleeding and delayed gastric emptying in laparoscopic pancreatic surgery.


Eligibility Criteria:
Inclusion Criteria:

1. All patients underwent laparoscopic pancreatic resections at the Department of Pancreatic Surgery of West China Hospital of Sichuan University and the Department of Minimal Invasive Surgery of Shangjin Nanfu Hospital between January 2014 and July 2022.
2. All patients underwent laparoscopic pancreaticoduodenectomy (LPD), laparoscopic distal pancreatectomy (LDP), laparoscopic enucleation, laparoscopic middle pancreatectomy (LMP), laparoscopic duodenum-preserving resection of head of pancreas (LDPRHP), or laparoscopic Frey procedure.
3. Patients whose demographic parameters, perioperative clinical variables, postoperative follow-up outcomes for 3 months and total hospital costs can be collected completely.

Exclusion Criteria:

1. Patients converted to laparotomy
2. Patients underwent total pancreatectomy
3. Patients underwent pancreatic pseudocyst drainage management
4. Patients underwent pancreas biopsy
Evaluation of Safety and Efficacy of KPG-121 Plus Enzalutamide, Abiraterone or Apalutamide in CRPC Patients

This is a Phase 1, open-label, multicenter study of KPG-121 administered orally once daily (QD) in 28-day treatment cycles to adult subjects.

This Phase 1 study will comprise two parts: Part 1 will be a 3+3 dose escalation design to characterize the MTD and a RP2D, Part 2 will be an expansion cohort at RP2D.

Eligibility Criteria:
Inclusion Criteria:

1. Signed informed consent provided prior to any study-related procedure being performed;
2. Able to swallow and retain orally administered medication;
3. Male aged 18 years and older;
4. diagnosis of prostate carcinoma;
5. Men with either non-metastatic or metastatic CRPC are eligible;
6. Completed at least 4 or more weeks of prior continuous therapy with fixed stable dose enzalutamide, abiraterone or apalutamide prior to initiating study treatment (for Part 1), or with fixed stable dose enzalutamide (for Part 2), with no change in dose for at least 2 weeks prior to screening;
7. Serum testosterone level \<50 ng/dL (\<0.5 ng/mL, \<7.0 nmol/L).
8. ECOG performance status of 0 or 1;
9. Adequate baseline organ function;
10. Must have a QT interval corrected for heart rate according to Fridericia's formula (QTcF) \<470 milliseconds (msec) or \<480 msec with bundle branch block;
11. Male subject with a female partner of childbearing potential must have either had a prior vasectomy or agree to use effective contraception from time of screening until 3 months after the last dose of study medication;
12. Willing and able to comply with all protocol required visits and assessments.

Exclusion Criteria:

1. Prior chemotherapy, radiation;
2. Prior malignancy other than CRPC.
3. Uncontrolled hypothyroidism, or TSH \>2.0 x ULN at screening.
4. Current use of or anticipated requirement of prohibited medication(s);
5. Any unresolved ≥grade 2 (per CTCAE v5.0) toxicity from previous anti-cancer therapy;
6. Previous history of difficulty swallowing capsules;
7. Known active infection requiring intravenous (IV);
8. Presence of hepatitis B surface antigen (HBsAg), positive hepatitis C antibody test ;
9. History of seizure or any condition that may predispose subject to seizure (e.g., prior cortical stroke or significant brain trauma). History of loss of consciousness or transient ischemic attack within 12 months prior to the start of study medication;
10. Poorly controlled hypertension;
11. Have a known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs
12. History or evidence of cardiovascular risk; known cardiac metastases;
13. Previous major surgery within 30 days prior to the start of study medication;
Using Mobile Phone Text Messaging System to Improve Exclusive Breastfeeding Rate in a Resource-poor Caribbean Island

This study will evaluate whether sending educational and supportive mobile phone text messages to mothers of infants, from babies' day of birth until 6 months of age, increases the rate of exclusive breastfeeding in Roatan, Honduras.

Encouraging and educational text messages and animations were created based on barriers to breastfeeding found during preceding focus groups and a baseline survey. Messages were written in English and translated into Spanish, with back-translation to ensure accuracy. Mothers who plan to or are already breastfeeding will be recruited and invited to participate in the study in the post-partum ward after delivery at Public Hospital Roatán. Written informed consent will be obtained. Three animated videos will be shown to mothers at enrollment providing information regarding breastfeeding technique, breastfeeding encouragement and general breastfeeding information. SMS messages will start at time of enrollment and continue through six months after enrollment. Messages will be delivered through Telerivet, an SMS interactive platform designed to send the educational and motivational messages to mothers' cell phones.

The intervention group will be polled when infants turn two months, four months, and six months regarding their infant feeding practices through Telerivet via SMS messaging. The primary outcome of this study is exclusive breastfeeding at 2 months of age, as compared to the exclusive breastfeeding rate obtained in our baseline cross sectional survey. Exclusive breastfeeding will be defined as giving only mother's breastmilk in the 24 hours preceding the interview. Mothers will also be asked if they are breastfeeding at all, age of infant when they last gave breast milk, the incidence of diarrheal illness in the past two weeks, and any other foods / liquids given to infant.

Eligibility Criteria:
Inclusion Criteria:

* Recently delivered full term infants (\>37 weeks gestation, less than 72 hours old)
* 18 years of age or older, or emancipated minor, or if parent able to consent if \<18 years of age
* Intent to breastfeed
* Own a phone that can receive SMS messages
* Able to send SMS reply messages

Exclusion Criteria:

* Mothers who report they can not read in Spanish nor English
Multilevel Action Toward Colorectal Cancer and Hepatitis C Education and Screening

This innovative Multilevel Action Toward Colorectal Cancer (CRC) and Hepatitis C Virus (HCV) Education and Screening (MATCHES) intervention aims to promote concurrent HCV and CRC screening among FQHC patients ages 45-75.

While this is a multi-level intervention study, only information related to the patient-level intervention is being reported for the purposes ClinicalTrials.gov.

Eligibility Criteria:
Inclusion Criteria:

* Participants must be receiving care at one of the participating FQHC clinics.
* Participants must be 45-75 years of age.
* Participants must not be up to date with Colorectal Cancer (CRC) screening recommendations such as no colonoscopy in the past 10 years, occult blood test in the past 12 months.
* Participants must never have had Hepatitis C Virus (HCV) antibody screening.
* Participants must be able to read, write, and understand English or Spanish.
* Participants must have no personal history of CRC or current presumptive CRC symptoms such as unresolved rectal bleeding or abdominal pain/bloating.
* Participants must be at average risk for CRC (no hereditary CRC syndromes such as lower gastrointestinal (GI) bleeding, persistent diarrhea, bloating, or lower GI pain, no strong family history of CRC).
* Participants must be asymptomatic for HCV.
* Participants receiving intervention materials must be able and willing to complete surveys and receive the patient level intervention.
* Participants completing qualitative interviews must be willing to complete a remote interview via phone or teleconference software such as ZOOM.
* Participants completing qualitative interviews must be willing to be audio recorded.
* Participants recruited for qualitative interviews only (did not receive MATCHES intervention materials) must have a clinic visit within prior two months.
* All Participants must be able to provide informed consent.

Exclusion Criteria:

* Participants that do not meet all Inclusion Eligibility requirements will be excluded.
Efficacy and Safety Study of ZK219477 in Patients With Recurrent Ovarian Cancer

The purpose of this study is to determine if this epothilone leads to a response in patients with recurrent ovarian cancer that has progressed during, or in the last six months since a treatment of platinum-based chemotherapy. We also aim to look at the safety of the study drug and assess the impact of the infusion duration on tolerability.

The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been renamed to Bayer Schering Pharma AG, Germany.Bayer Schering Pharma AG, Germany is the sponsor of the trial.

Eligibility Criteria:
Inclusion Criteria:- Females aged 18 or over - Cancer of any of the following types: -- epithelial ovarian cancer -- peritoneal cavity cancer -- fallopian tube cancer - Up to 2 previous chemotherapies; the most recent must have been a platinum- containing therapy - Progression of disease or symptomatic relapse during, or within 6 months of previous therapy - 4 weeks or more since prior radiotherapy or chemotherapy - 3 weeks or more since prior immunotherapy - Adequate recovery from previous surgery, radiotherapy, and chemotherapy ( excluding alopecia) - Survival expectation of 3 months or more Exclusion Criteria: - More than 2 previous chemotherapies - Previous treatment with epothilones - Use of any investigational drug within 4 weeks of start of study treatment or inadequate recovery from any toxic effects of such therapy - Previous radiation to the whole pelvis - Symptomatic brain metastases requiring whole-brain irradiation - Active infection - Any other malignancy except: -- Non-melanoma skin cancer -- Carcinoma in situ of cervix -- Malignancy with treatment 5 or more years ago without relapse - Mixed mesodermal tumor - Prior hormone therapy for any malignancy in the previous month - Women of childbearing potential