cyrilzakka/clinical-trials huggingface dataset:
The STEPP Study: Sensors To Evaluate Physical Performance

This study assesses the association between digital functional measures of physical and patient-reported standard onocological assessments, like Karnofsky Performance Score (KPS).

This study assess the association between digital functional measures from physical monitoring devices (devices like a watch tracking steps, a heart rate monitor) and patient-reported standard oncological assessments. The study will also test the feasibility of obtaining the measures in clinic and at home from the monitoring devices in participants with cancer. Participants will be asked to spend 1 hour in clinic performing simple tasks such as walking and standing with 7 digital devices recording movement data. The participants will also be asked to fill out survey data regarding their health. At-home data will be collected for 14 days. During this time participants will wear a watch to collect movement and step data, and a lumbar belt to collect movement data.

Primary Objective:

1. Assess the association of 5 main digital physical functional measures (mean steps per day, mean sedentary activity time, light activity time, moderate activity time, and vigorous activity time (in minutes) per day) recorded at home with patient-reported standard oncological assessment (e.g. KPS)

Eligibility Criteria:
Inclusion Criteria:

1. All genders aged ≥ 18 years of age
2. Patients being seen at UNCCH for treatment of cancer.
3. English-speakers
4. Able to understand and cooperate with study procedures.
5. Patients with solid tumors or hematological malignancies, and self-reported KPS ≤70 to ≥ 100.

Signed and dated informed consent and HIPPA.

Exclusion Criteria:

1. Subjects using investigational/experimental products.
2. Has dementia, altered mental status, or any psychiatric or co-morbid condition prohibiting the understanding or rending of informed consent.
3. Unable or unwilling to complete physical performance assessments including the at-home wearable device for 14 days.
4. Unable to speak English.
5. Subjects who report any other medical condition, recreational substance use, or medication use which would prevent them from completing study tasks or impair the providing of informed consent.
6. Subjects who are allergic to silicone or adhesives. Subjects with cardiac pacemakers, electronic pumps or any other implanted medical devices.
Clinical and Multiomics Study of First-line Chemotherapy for Advanced Pancreatic Cancer

The early symptoms of pancreatic cancer are not obvious, and the early diagnosis rate is low. For most patients with pancreatic cancer,palliative chemotherapy is the only choice .At present, The guidance of NCCN guidelines on the selection of chemotherapy regimens for patients with advanced pancreatic cancer is only based on the physical condition(the ECOG score), which is one of the important reasons for the poor efficacy of chemotherapy in patients with advanced pancreatic cancer.Therefore, it is urgent to group pancreatic cancer patients according to tumor molecular typing and heterogeneity of response to chemotherapy drugs accurately,so as to guide the personalized treatment of patients.

Based on the limitations of existing studies and the needs of clinical patients, the investigators chose two time points: after the diagnosis of pancreatic cancer (before the first-line chemotherapy), and after chemotherapy evaluation in this study, to obtain in situ samples of pancreatic cancer tissues by EUS-FNA.The samples are detected by dynamic multi-omics study before and after treatment(including genomics, transcriptomics, proteomics, metagenomics, etc.).Combined with the drug reaction and clinical outcome of patients, a comprehensive model is established to predict the clinical outcome of patients with PDAC and the choice of chemotherapy regimens, so as to screen the pancreatic cancer patients who are most likely to benefit from different chemotherapy regimens, and lay the foundation for the development of individual chemotherapy for advanced pancreatic cancer.

Eligibility Criteria:
Inclusion Criteria:

1. Age \> 18 years old, male or female;
2. Locally advanced or metastatic pancreatic ductal adenocarcinoma confirmed by histopathology / cytology of the primary and / or metastatic lesions and not suitable for surgical resection, and don't receive chemotherapy;
3. According to the evaluation criteria of solid tumor efficacy(RECIST 1.1), there should be at least one measurable lesion (non nodular lesion with the longest diameter of 210 mm, or nodular lesion with the shortest diameter of more than 15 mm);
4. Patients voluntarily participate in this study, sign informed consent, have good compliance, and cooperate with follow-up.

Exclusion Criteria:

If any of the following criteria is met, the patient should be excluded:

1. Pancreatic ductal adenocarcinoma is diagnosed without histopathology / cytology;
2. The target lesion has received local non-drug therapy (including radiotherapy, physical and / or chemical ablation, etc.), and there is no imaging progression;
3. If the central nervous system metastasis is known, MRI should be performed to exclude it.
Use of Sublingual Microcirculation and FloTrac Monitoring During Major Vascular Surgery and Its Effect on Hospital LOS

the aim of this study is to determine whether an intraoperative optimization protocol using the enhanced flow-based hemodynamic parameters of the FloTrac/Vigileo device in combination with intraoperative measurement of the sublingual microcirculation with the Cytocam-IDF device would result in an improvement in outcome in high-risk patients undergoing major vascular surgery, measured by the hospital LOS in comparison with intraoperative FloTrac/Vigileo monitoring alone.

The FloTrac/Vigileo device only needs standard arterial access for enhanced, flow-based hemodynamic monitoring. It is reported to be easy to use and easy to set up and calculates the stroke volume (SV) on the basis of the arterial waveform in combination with demographic data. Cardiac index (CI), stroke volume index (SVI) as an indicator for fluid status and stroke volume variation (SVV) as an indicator for fluid responsiveness during mechanical ventilation and sinus rhythm will be continuously measured during major vascular procedures, including carotid endarterectomy (CEA), open abdominal aortic aneurysm (AAA) repair , endovascular aneurysm repair (EVAR), thoracic endovascular aneurysm repair (TEVAR) and fenestrated endovascular aneurysm repair (FEVAR).


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Males and females
* ASA III classification
* Written informed consent obtained by the patient
* Elective hospital admission for major vascular surgery procedures (CEA, open AAA, EVAR, TEVAR, FEVAR)

Exclusion Criteria:

* Age \< 18 years
* Presence of permanent cardiac arrythmias
* Weight \< 55kg and \> 140kg
* Pregnancy
* Emergency surgery
* Minor vascular procedures
* Refusal or inability to provide written informed consent (language barrier, mental retardation, dementia)
IL17 Rate and Spondyloarthritis

There are, to date, no validated biomarkers or head-to-head RCTs of biologics to guide choice of biologic agent in axSpA. While there are now two head-to-head studies of a TNF inhibitor (TNFi) vs an IL-17 inhibitor (IL-17i) in psoriatic arthritis. Recommendations refers to biological DMARDs (bDMARDs) including TNFi and IL-17i for patients with high disease activity despite the use (or intolerance/contraindication) of at least two non-steroidal anti-inflammatory drugs (NSAIDs) in axial SpA (axSpA) and in failure of a strategy including methotrexate for psoriatic arthritis. A tool to help us to decide which bDMARDs to use is necessary.

In SpA, the method of determination of IL17 seems to be questionable.

The determination of cytokines after stimulation of immune cells in patients with active SpA requiring a biological treatment could provide us with a tool to assist in the choice of therapy.

The aim of the study was to show the feasibility of cytokine assay following lymphocyte stimulation in active SpA requiring biological treatment. And secondly, to show the predictive character of this expression on the therapeutic response at three months after the implementation of a biological treatment.


Eligibility Criteria:
Inclusion criteria

* Patients with spondyloarthritis meeting the ASAS criteria
* Patients who were to benefit from the implementation of a biological treatment after failure of at least two NSAIDs.
* Patients having an active disease defined by a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) higher than four,

Exclusion criteria

* No predominant axial manifestation,
* Having received a previous biological treatment
* Patients presenting contraindication to the implementation of these treatments.
Study of Pharmacodynamic Effects of VAY736 in Patients With Primary Sjögren's Syndrome

This study consists of three consecutive parts. Part 1 in primary Sjögren's syndrome (pSS) patients (n=2-6) and Part 2 in healthy voluteers (n=3) are feasibility studies to assess if the selected \[Zr-89\]-rituximab PET/CT method is a valid method to assess B cells in salivary glands of pSS patients. In Part 1 and Part 2 no IMP will be applied to the subjects. In Part 3, pSS patients (n=12) will receive the IMP, VAY736. Posted information will be focused on Part 3.

The overarching purpose of this study is to test a new drug (VAY736) for the treatment of pSS. In pSS, the salivary glands (the glands that produce saliva) and other organs are affected by inflammation. A certain type of white blood cells called B cells prominently infiltrate the salivary glands in pSS, whereas they are not present in healthy salivary glands. Scientific evidence suggests that B cells may be involved in the disease process in pSS and that eliminating B cells may benefit patients with pSS. This study will test a new imaging method and a new treatment for pSS. Both the imaging method and the treatment are specific for B cells.


Eligibility Criteria:
Part 1 and 3:

Inclusion Criteria:

* Fullfilled consensus criteria for primary Sjögren's syndrome
* Patients must have elevated serum levels for some Sögren Syndorme specific parameters such as antinuclear antibodies (ANA), rheumatoid factor (RF) etc.

Exclusion Criteria:

* Patients that are suffering from Secondary Sjögren's syndrome.
* Patients previously treated with monoclonal antibody treatments such as rituximab, infliximab, adalimumab, etc.

Part 2

Inclusion criteria:

- healthy male and female people 18-75 years of age

Exclusion criteria:

* Use of other investigational drugs at the time of enrollment
* Exposure to a sizeable degree of radiation (≥ 5 mSv) in an investigational research study in the past year prior to this study
Evaluation of the Frequency of Limitation of Activity in Patients With Persistent Asthma

Evaluation of the frequency of limitation of activity, depending on gender and age-group, in patients with persistent asthma consulting a general practitioner


Eligibility Criteria:
Inclusion Criteria:

* persistent asthma receiving long-term maintenance treatment with inhaled steroids (alone or in combination with other drugs)

Exclusion Criteria:

* Patients with a diagnosis of COPD
The Efficacy and Safety of Adjuvant Immunotherapy After Pathological Complete Response Following Neoadjuvant Chemoimmunotherapy in Patients with Resectable NSCLC

This is a prospective, observational, multicenter real-world study aiming to investigate the efficacy and safety of NSCLC patients with or without adjuvant immunotherapy who have achieved pathologic complete remission after neoadjuvant immunotherapy.


Eligibility Criteria:
Inclusion Criteria:

1. 18 years ≤ age ≤ 80 years;
2. Histologically or cytologically confirmed NSCLC;
3. Resectable stage IB, II, IIIA, or IIIB (N2) NSCLC according to the staging criteria of the American Joint Committee on Cancer (8th edition);
4. Eastern Cooperative Oncology Group (ECOG) performance status score 0-1 at baseline;
5. With measurable or evaluable diseases according to the Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST 1.1) at baseline;
6. Achieving pathological complete response (pCR) after three cycles of neoadjuvant chemoimmunotherapy, which was assessed by independent pathological examination of surgical specimens;
7. With or without adjuvant immunotherapy postoperatively;
8. Signed and dated written informed consent provided by the patient prior to admission to the study.

Exclusion Criteria:

1. EGFR or ALK aberrations positive;
2. With primary/secondary immunodeficiency diseases or symptomatic interstitial lung diseases;
3. With a condition requiring systemic treatment with either corticosteroids (\> 10 mg daily prednisone or equivalents) or other immunosuppressive medications within 14 days of study drug administration;
4. With other active malignant tumors currently receiving cancer therapy (chemotherapy, radiation therapy, immunotherapy, or biologic therapy) or investigational anti-cancer drugs;
5. Receipt of other investigational drugs during the observation period;
6. Unable to follow the procedures required in the protocol due to any medical, mental or psychological conditions.
Efficacy of Lactose-free Milk in Treating Acute Gastroenteritis in Infants

The purpose of this study is to determine whether lactose-free milk will change diarrhea duration and severity in formula-fed infants with acute gastroenteritis presenting to pediatric wards.

More than 525 000 children die each year due to diarrheal disease, the second leading cause of death among children under five. Children from Asian countries, including Vietnamese children, frequently have lactose intolerance. In addition, gastroenteritis, specifically rotavirus-induced gastroenteritis, temporarily impairs lactase enzymes in the intestines. In a recent Cochrane review of 33 randomized and quasi-randomized trials, lactose-free diets reduced diarrhea among children younger than 5 years old. These trials, however, involved inpatients in middle-or high-income countries. Neither patient was from a developing country, where diarrheal diseases often cause significant morbidity and mortality. The purpose of this study is to determine whether lactose-free milk will change the duration and severity of diarrhea in Vietnamese infants with acute gastroenteritis.

Eligibility Criteria:
Inclusion Criteria:

* Children 2- 24 months old on artificial milk formula
* Acute diarrhea (3 or more loose or liquid stools per day)

Exclusion Criteria:

* Used antibiotics within 3 days before admission
* Breastfeeding
* Severe dehydration, defined by a need of IV rehydration
* Malnutrition (weight/height\< -3SD)
* Chronic underlying disease, immunocompromised condition or systemic infection
Semi-automatic Download of Prostate Biopsy Cores While Keeping the Orientation, Unfolding and Unity of the Sample

Performance evaluation of a novel, semi-automated device and method for needle core biopsy download compared to standard methods in terms of:

1. Biopsy core length obtained (i.e. collecting all tissue fragments)
2. Biopsy core yield (i.e. percent of tissue loss during the pathologic processing)
3. Pathologist interpretability
4. Processing time
5. Prostate cancer detection.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 years or older
* Planned for radical or open prostatectomy operation or Planned for TRUS prostate biopsy procedure.
* Signed informed consent.

Exclusion Criteria:

* Patient's unwilling to participate.
Management of Anal Fistula of Crohn Disease

The management of anal fistula in Crohn Disease is complex. In aim to obtain the healing of the anal fistula, different approaches can be proposed but the best strategy is not yet determined. The aim was to describe the therapeutic management of anal fistula in Crohn Disease.

Patients with anal fistula with Crohn disease and needed anal fistula drainage will be included. Medical and surgical treatments will be recorded. The management will be described and the best approaches will be identified.

Eligibility Criteria:
Inclusion Criteria:

* Patient over 18 years of age
* Crohn's disease with fistulizing anoperineal lesion
* Operated at least once for this reason

Exclusion Criteria:

* Adult person protected under the Public Health Code
* Minor person
4-valent HPV Vaccine to Treat Recurrent Respiratory Papillomatosis in Children

Recurrent respiratory papillomatosis in children caused by HPV 6,11 can be a life threatening condition resulting in surgical interventions. The maturing and disintegrating papillomas are the sources for the subsequent HPV relapses and immunization might slow down or even prevent this ongoing process.

After an initial immunological and ear-nose-throat (ENT) assessment children with at least 3 relapses in their patient history will be vaccinated with 4-valent HPV vaccine according to the following schedule: 0., 2., 6. months. It will be followed by an immunological and 3 ENT examinations to assess response to vaccination.

1. Enrollment

   * ear-nose-throat (ENT) examination + oesophagoscopy
   * immunological assessment

     * assessment of selected humoral (antibodies) and
     * cellular immune response parameters(INF gamma and granzyme B testing)
     * in vitro and in vivo stimulation of PMBCs with the HPV-4 vaccine
2. Immunization with 4-valent HPV vaccine at 0,2,6 months
3. Follow up

   * 1 month after 3rd vaccine dose - immunological assessment (same tests as in the enrollment phase)
   * 6, 12 and 18 months after the 3rd vaccine dose - ENT + oesophagoscopy

Eligibility Criteria:
Inclusion Criteria:

* respiratory papillomatosis
* at least 3 relapses in patient history
* HPV 6 and/or 11 positive papillomas
* able to mount neutralizing antibodies

Exclusion Criteria:

* other chronic underlying condition
* other HPV type
* no antibody response
Study to Assess the EffectiVeness of exIsting Anti-vascular Endothelial groWth Factor (Anti-VEGF) Treatment Regimens in Patients With Wet Age-related Macular Degeneration

Retrospective, non-interventional, observational multi-center field study. Patients diagnosed with wet Age-related macular degeneration (wAMD) and having started treatment with ranibizumab between January 1, 2009 and December 31, 2009 must be consecutively screened and, if eligible, enrolled. Patients will be followed up at maximum until December 31, 2011. Switch to any other Anti vascular endothelial growth factor (anti VEGF) treatment will be documented. For each patient, demographics, medical history, administered treatments, results of ocular and visual assessments and other tests (where available) will be documented.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of wet Age-related Macular Degeneration
* Start of anti-VEGF therapy with ranibizumab (Lucentis) between January 1, 2009 and December 31, 2009
* Informed consent form signed

Exclusion Criteria:

- Participation in an investigational study during anti-VEGF therapy (from start up to December 31, 2011) that involved treatment with any drug or device
Assessment of a Novel Fixed-dose Combination (FDC) Drug VR-AD-1005 for the Treatment of Acute Watery Diarrhea in Cholera

Cholera still remains a global public health concern affecting both children and adults, and patients can succumb in quick time if remain untreated. Cholera is a secretory diarrhea and is generally treated with oral or intravenous rehydration therapy to compensate for the fluid loss. However, antimicrobial treatment is given to patients with moderate to severe diarrhea. The consistent emergence of multidrug-resistant bacteria is a major concern for the management of infectious diseases including cholera. No antisecretory drug has so far been proven successful. In a phase II clinical trial, the investigators will assess the effectiveness of a novel antisecretory drug VR-AD-1005 for treating cholera. Changes in stool volume and rehydration therapy will be assessed for VR-AD-1005 in comparison with placebo. If successful, this will be a huge advance in managing cholera and other secretory diarrhea. The introduction of the antisecretory drug can minimize the hospital stay and reduce antibiotic use, which in turn can reduce the emergence of antibiotic resistance among pathogens


Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent.
* Adults, both genders aged 18-65 years.
* Acute watery diarrhea (defined as passage of three or more liquid stools within the 24 hours before admission) with severe dehydration on arrival.
* Detection of V. cholerae by rapid diagnostic assay (e.g. dark field microscopy).

Exclusion Criteria:

* Known or suspected hypersensitivity to trial product(s) or related products.
* Subjects with passage of bloody stools or muco-purulent stools.
* Subjects with chronic diarrhea (\>4 weeks of Diarrhea).
* Clinically significant concomitant systemic disease (i.e. cardiovascular diseases including heart failure, acute kidney injury, sepsis or life-threatening malignant cancer).
* Mental incapacity, unwillingness, or language barriers, precluding adequate understanding or cooperation.
* History of receiving antimicrobial or antidiarrheal drugs within 6 hours prior to admission.
* Positive urine pregnancy test for all female patients
* Failure to obtain informed consent.
* Failure to definitively diagnose cholera via culture or RT-PCR
Use of a Remifentanil-propofol Mixture in Patients Undergoing Breast Cancer Surgery

Co-administration of propofol and remifentanil is considered to be an ideal total intravenous anesthesia technique, which is widely used in induction and maintenance of general anesthesia. Remifentanil and propofol can be mixed in polypropylene syringes for one hour with a remaining concentration of 91% in small concentrations of remifentanil. However, delivery of remifentanil-propofol mixture by target-controlled infusion(TCI) for general anesthesia in surgical procedure has not been described. Breast cancer surgery ( including modified radical mastectomy and breast-conserving surgery) is a less time-consuming procedure for patients with breast cancer with one-hour duration in our hospital. This pilot study was to examine the merit of remifentanil-propofol mixture as a GA regimen for breast cancer surgery.

Previous studies has described the feasibility and safety of remifentanil-propofol mixture use in sedation of pediatric patients undergoing magnetic resonance imaging or flexible fiberoptic bronchoscopy.

Eligibility Criteria:
Inclusion Criteria:

* ASA II or III
* age more than 18 years
* scheduled for breast cancer surgery under general anesthesia.

Exclusion Criteria:

* previously allergic to propofol or remifentanil
* combining other surgical procedure leading to extended operative time
Cervical Laminoplasty Versus Laminectomy and Fusion: the Long-term Results Comparison

The objective of this study is to retrospectively analyze and compare the long-term clinical and radiographic results of multi-level laminoplasty to multi-level laminectomy and fusion for the treatment of patients with cervical myelopathy or myeloradiculopathy.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged at least 18 years
* The patient has the diagnosis of degenerative cervical myelopathy
* The myelopathy or myeloradiculopathy requires a posterior cervical decompression of the spinal canal involving two or more contiguous intervertebral levels including and between C3 and C7
* More than five years of follow-up time

Exclusion Criteria:

* Presence of primary focal anterior compression of the cervical spinal cord
* Previous surgery of the cervical spine
* Tumor, infection, or trauma of the cervical spine or cord
* Patients with ankylosing spondylitis
* Patients with neurodegenerative diseases, or any neuropathies