cyrilzakka/clinical-trials huggingface dataset:
Continuation Protocol to Protocol BBCO-001

This will be a multi-center, randomized withdrawal, open-label, non-treatment concurrent control, parallel group study. Patients completing protocol BBCO-001 will be offered the opportunity to enter into this 12-month randomized withdrawal protocol.

This will be a multi-center, randomized withdrawal, open-label, non-treatment concurrent control, parallel group study. Patients completing protocol BBCO-001 will be offered the opportunity to enter into this 12-month randomized withdrawal protocol.

Eligible patients will be randomized to one of the following treatment arms:

* Treatment Arm 1: active treatment; continuation of 30 g IV Cabaletta once a week over an additional 52 weeks.
* Treatment Arm 2: no-treatment concurrent control; discontinuation of IV Cabaletta and follow-up over 52 weeks.

IV Cabaletta will be administered once a week to patients in Treatment Arm 1. All patients, regardless of treatment arm allocation, will undergo the same safety and efficacy assessments during the monthly site visits.

Eligibility Criteria:
Inclusion Criteria:

1. Adult men and women who participated and completed study BBCO-001
2. Clinical and genetic diagnosis of OPMD
3. Able to provide written informed consent to participate in this study
4. Able to understand the requirements of the study and willing to comply with the requirements of the study

Exclusion Criteria:

1. Pregnant or lactating
2. Currently receiving anticoagulant treatment (e.g., warfarin)
3. Any life-threatening illness, medical condition or organ system dysfunction which, in the investigator's opinion, could compromise the subject's safety
4. Known hypersensitivity to any ingredient in the Cabaletta IV infusion
5. Currently participating in another clinical trial (other than BBCO-001) or have completed an interventional trial less than 30 days prior to the planned treatment start date
Study Evaluating LXR-623 in Healthy Subjects

To evaluate the safety and tolerability of a single dose of LXR-623 in healthy subjects.


Eligibility Criteria:
Inclusion:

* Healthy, men or women, aged 19-50 years

Exlcusion:

* Use of any investigational or prescription drug within 30 days before study start
* Any clinically imprtant medical disease or abnormal laboratory test results
A Screening Study to Collect Samples for TAA, HLA & HLA Loss of Heterozygosity in Patients With Metastatic Solid Tumors

TScan Therapeutics is developing cellular therapies across multiple solid tumors in which autologous participant-derived T cells are engineered to express a T cell receptor that recognizes cancer-associated antigens presented on specific Human Leukocyte Antigen (HLA) molecules. The purpose of this screening study is to collect samples to conduct HLA genotyping, HLA Loss of Heterozygosity (LOH) and expression of Tumor-associated Antigens (TAA) testing. These results will be used to determine if participants meet the eligibility criteria for these parameters and could potentially be enrolled in a TScan clinical treatment study.

This multicenter screening study will be conducted to determine a participant's tumor antigen expression profile, HLA genotype and loss of HLA for TScan sponsored clinical treatment study(s). No treatment intervention will occur as part of this screening study.

Participants will be required to provide a buccal swab to assess their HLA status. If they are positive for certain types of HLA, participants will provide saliva sample to assess HLA loss of heterozygosity. In parallel, archival tissue (less than 8 months old) will be needed to assess for tumor antigen expression. If archival tissue is older than 8 months, a fresh tumor biopsy will be required at the time of the subsequent visit.

If eligible, participants will be referred to appropriate available interventional trial(s) at the discretion of the Investigator.

Eligibility Criteria:
Inclusion Criteria:

* Willing and able to provide written informed consent.
* Male or female aged ≥18 years at the time of signing the informed consent.
* Have one of the following histologically or cytologically confirmed locally advanced (unresectable) or metastatic solid tumor:
* Head and neck cancer
* Cervical cancer
* Non-small cell lung cancer
* Melanoma
* Ovarian cancer
* HPV positive anogenital cancers
* Other cancers with a reasonable likelihood of expressing 1 or more antigens included in a TScan clinical trial, following approval by the TScan Medical Monitor or their delegate.
* Willing to provide a buccal swab for HLA testing
* Willing to provide a saliva sample to use as a normal control for the LOH assay
* Have access to an FFPE tumor block that is \<8 months old or is willing to provide a fresh core-needle biopsy.

Exclusion Criteria:

• Participants undergoing anticancer therapy with curative intent such as tumor surgical resection with or without neoadjuvant/adjuvant therapy, or definitive chemoradiation, unless they have locoregionally advanced disease and are expected to have a high risk of relapse after their curative intent therapy as determined by the treating investigator.
Mobile Smoking Treatment for Hispanic Individuals Who Smoke

The specific aims of the project are to develop and test a mobile application for smoking cessation for Hispanic individuals who smoke called Impacto.

A total of 56 Hispanic individuals who smoke will be recruited for this project. Six (6) participants will complete usability/functionality testing of Impacto 2.0 in the English language for both iOS and Android. Following usability/functionality testing, a field test with 50 adult Hispanic individuals who smoke (50% English-speaking and 50% Spanish-speaking) will be recruited nationally and will receive Impacto 2.0 (50% Android and iOS platforms).

Eligibility Criteria:
Inclusion Criteria:

* 1) being Hispanic, 2) at least 18 years of age, 2) currently smoking (i.e., at least 5 cigarettes/day) biochemically verified by a CO \&gt; 7, 3), meeting criteria for high AS (cut-off score of 5 on the Short Scale Anxiety Sensitivity Index), 4) motivation to quit \&gt; 5 on a 10 pt. scale, 5) able to provide informed consent, 6) has daily access to their own iPhone or Android smartphone, and 7) is a fluent English or Spanish speaker.

Exclusion Criteria:

* 1) current participation in substance abuse treatment, 2) in psychotherapy for anxiety or depression, 3) concurrent use of medication for anxiety or depression, 4) active suicidality (ideation, intent, and/or plan), or 5) current psychosis.
Mirikizumab Real World Protocol

The goal of this observational study is to learn about how effective mirikizumab (Omvoh) is when treating patients with ulcerative colitis (UC)

Does mirikizumab (Omvoh) lead to a reduction in symptoms at intervals throughout one year?

Participants being prescribed mirikizumab (Omvoh) as part of their regular medical care for UC will answer online survey questions about their bowel habits for 1 year.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients, age 18 years or older, with UC, who within 2 weeks have been started on mirikizumab therapy for moderate to severe UC or who plan to begin this therapy within the next 2 weeks. The start of the mirikizumab treatment must have been or be initiated in the setting of standard-of-care therapy.
* Anticipation that the patient will be followed by the participating center for the next 12 months.
* Diagnosis of UC must be established based on standard clinical, radiographic, endoscopic, and histologic criteria as described below.

Criteria for diagnosis of UC The following diagnostic criteria were developed by the NIDDK IBD Genetics Consortium and are provided as guidelines to complete documentation on individuals with Ulcerative Colitis.

A) Symptoms including one or more: diarrhea, rectal bleeding, abdominal pain, fever, extraintestinal manifestations, weight loss, or failure to thrive.

AND

B) Symptoms on two or more occasions separated by at least 8 weeks or ongoing symptoms of at least 6 weeks duration.

AND

C) Endoscopic Findings compatible with UC:

* Superficial inflammation and/or ulceration (involving only the mucosa and submucosa) of the colon, which is continuous from the rectum extending proximally without skip lesions or complete rectal sparing (relative rectal sparing is allowed for patients receiving topical, rectal therapy; patchiness of endoscopic inflammation may be observed in patients with partially treated ulcerative colitis).
* In patients with proctitis or left-sided ulcerative colitis, there may be an area of inflammation in the cecum, usually surrounding the appendiceal orifice.
* No inflammation of the small intestine ("backwash ileitis" is allowed - non-stenotic superficial inflammation of the terminal ileal mucosa associated with severe pancolitis, which resolves following medical or surgical treatment of the colitis).
* No features of Crohn's disease listed above. There is no minimum length of extension of UC required for inclusion in this study.

Exclusion Criteria:

Patients will be excluded if they meet any of the following criteria:

* Inability to provide informed consent.
* Non-English speaking.
* Patients presenting for a one-time consultation.
The Effect of Lactate Clearance Oriented Haemodynamic Therapy on the Outcome of Patients With Septic Shock

The purpose of this study is to explore and assess possible outcome benefits of lactate clearance\>30% vs ScvO2 ≥70% in 6 hours as the protocol goal that evaluated adequacy of during early resuscitation of septic shock through a single-center randomized controlled study. The investigators anticipate to collect 300-400 qualified patients with septic shock who were selected from critically ill patients admitted to the Department of Critical Care Medicine. The participants can be randomized divided into lactate clearance group and SCVO2 group. The investigators compared the treatment and the relevant parameters changed after different target. 28-day mortality, ICU and hospital lengths of stay, ventilator-free days, and new emerged organ failure were collected and compared. 28-day survival curves were drew between these two group. And the adverse events of the treatment have also been compared. Through this study, the investigators want to answer that whether lactate clearance-oriented therapy can reduce the mortality in patients with septic shock, compared with ScvO2-oriented protocolised therapy.


Eligibility Criteria:
Inclusion Criteria:

* Patients with septic shock were assessed for inclusion, which required that patients be older than 18 years with confirmed or presumed infection, met two or more criteria for systemic inflammatory response syndrome \[16\], and evidence of refractory hypotension or a serum lactate level above 4 mmol per liter.
* Refractory hypotension was defined as a systolic blood pressure lower than 90 mm Hg, or a mean arterial pressure of less than 65 mm Hg , after an intravenous fluid challenge of 20 ml or more per kilogram of body weight.
* Patients had to be enrolled in the study within 2 hours after the earliest detection of septic shock and within 12 hours after arrival ICU.

Exclusion Criteria:

* The patients were excluded if they meet any one of follows: an age of less than 18 years, pregnancy, an acute cerebral vascular event (Glasgow coma score \< 5), acute myocardial infarction or acute coronary syndrome, massive pulmonary embolism, status asthmaticus, a primary diagnosed cardiac dysrhythmias, contraindication to central venous catheterization, active gastrointestinal hemorrhage, massive intra abdominal infective focus without drainage, severe bronchopleural fistula, seizure, during chemotherapy or immunosuppressive therapy, or end stage of the diseases.
A Post-market Clinical Study to Evaluate the Safety and Performance of the Carbon Fibre Reinforced Polyetheretherketone Metatarso-Phalangeal (MTP) Plate (CoLink® PCR MTP Plate) for the Treatment of Hallux Rigidus

The clinical study involves the routine treatment of skeletally mature patients who have been diagnosed with hallux rigidus (stiffness of the first metatarso-phalangeal joint in the foot due to arthritis and degeneration of cartilage).

It follows standard practice surgery to treat this condition. This type of degenerative arthritis affects the joint of the big toe (hallux) which is attached to the foot. Taking part in this research will involve collecting data of the surgery to remove damaged cartilage and fix the two bones together with screws and a plate (called the CoLink® PCR MTP Plate).


Eligibility Criteria:
Inclusion Criteria:

1. Subjects aged 18 years of age or older (\> 18 years) and are skeletally mature.
2. Subjects who require surgical treatment for hallux rigidus and have been evaluated as appropriate candidates for treatment with the CoLink® PCR MTP Plate by the Investigator.
3. Subjects who, in the opinion of the Investigator, are able to understand this clinical study, co-operate with the procedures and are willing to return to the hospital for all the required post-operative follow-ups.
4. Subjects who are able to give voluntary, written informed consent to participate in this clinical study and from whom consent has been obtained.

Exclusion Criteria:

1. Subjects who have previously undergone MTP fusion surgery or implant arthroplasty in the foot to be treated.
2. Subjects who require bi-lateral MTP fusion surgery.
3. Subjects with evidence of tumour and/or malignant disease with resultant life expectancy of less than two years.
4. Subjects with a known allergy to the material used in the instrumentation.
5. Subjects with evidence of an active infection and/or with any condition that would compromise their participation and follow-up in this clinical study.
6. Subjects who have any conditions outlined as contraindicated in the Instructions for Use.
7. Female subjects who are pregnant or lactating.
8. Subjects who are known drug or alcohol abusers, or with a baseline opioid use greater than 30 mg of morphine equivalent/day, or with psychological disorders that could affect follow-up care or treatment outcomes.
9. Subjects who are current smokers or have stopped smoking less than 6 months ago.
10. Subjects who are currently enrolled in a clinical study.
Safety and Efficacy of Empiric Levothyroxine (LT4) Dose Increase Versus Individualized LT4 Dose Increase in Hypothyroid Women During Pregnancy

In women who require thyroid hormone replacement medication, the investigators will compare 2 ways to adjust thyroid medication during pregnancy to determine superiority in maintaining optimal blood levels of thyroid hormone. Thyroid hormone requirements increase significantly in pregnancy and it is important that blood levels of thyroid hormone remain normal so the fetus, which cannot make its own thyroid hormone has enough for early prenatal development. This trial compares 2 methods for adjusting thyroid medicine during pregnancy in women with known thyroid disease. Pregnant women (age 18 to 45) who take thyroid medication will be randomized to either 1) a 2-dose per week increase in thyroid medicine once pregnancy is confirmed, followed by dose adjustments every 2-4 weeks, or 2) adjustments in thyroid medication every 2-4 weeks in micrograms per day based on results of blood tests. The investigators will compare thyroid hormone levels throughout pregnancy between the groups of mothers to determine which method is superior in meeting the increased thyroid hormone requirements during pregnancy.


Eligibility Criteria:
Inclusion Criteria:

* Female between ages of 18-45 who takes thyroid hormone replacement medicine AND pregnant or plan to become pregnant in the near future.

Exclusion Criteria:

* Males
* Younger than 18 or older than 45 years old
* More than 10 weeks pregnant at enrollment
* Iodine deficient
* Pregnant with more than one baby (i.e., twins, triplets, etc.)
* NOT taking thyroid hormone medicine before becoming pregnant
* Levels of thyroid hormone in blood have been too low or too high in the past 6 months
* Treated with radioactive iodine in the past year.
Pain Sensitivity Questionnaire and Postoperative Opioid Requirement

This study aims to investigate the potential association between pain sensitivity questionnaire score, the severity of postoperative pain, and postoperative analgesic requirement in patients with open colorectal cancer surgery. This information may be used to guide the optimal postoperative pain management, and ultimately improve patient's quality of life.

We plan to investigate the predictive ability of the PSQ as well as experimental parameters of pain sensitivity using electronic algometer and other known risk factors for postoperative pain in 100 patients scheduled for open colorectal cancer surgery.

The following items are investigated before surgery; Age, sex, level of education, type of surgery, past surgical history, presence of chronic pain, the expected maximal pain score (VAS) after surgery, Pain catastrophizing scale, anxiety scale (HADS-A), Pain sensitivity questionnaire, and pain threshold measured by electronic algometer.

The total opioid consumption is investigated for 24 and 48 hours after surgery. In addition, the severity of postoperative pain is measured by the 11-point VAS at 24 and 48 hours after surgery. Patient satisfaction with postoperative pain control is also investigated at 48 hours after surgery using the 7-point patient's satisfaction scale.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 years or above
* Patients scheduled for open colorectal cancer surgery under general anesthesia
* ASA status I-III
* Ability to read and understand the information sheet, questionnaires, and the - consent form
* Patients scheduled for using IV-PCA after surgery

Exclusion Criteria:

* Unable to read and understand the information sheet, questionnaires, and the consent form
* Severe medical or psychological diseases
* Patients with preoperative chronic pain
Psychosocial Aspects of Multiple Endocrine Neoplasia (MEN) Syndromes

The specific aims of the study include:

1. Profile the demographic, health-related, psychosocial and behavioral characteristics of adults with MEN1 or MEN2.
2. Evaluate MEN-specific distress as well as adherence to surveillance regimens among adults with MEN1 or MEN2, and identify associated with those outcomes.

The proposed cross-sectional study is intended to obtain information regarding current surveillance behaviors and other psychosocial outcomes among persons affected by the multiple endocrine neoplasia (MEN) 1 or MEN2, which are inherited conditions.

Study participants will include patients who have been seen previously at MDACC for evaluation of MEN1 or MEN2. Because this is the first time investigators are contacting these patients to invite them to participate in psychosocial research, the proposed study also will help determine the feasibility of conducting similar studies in the future.

Investigators anticipate that data gathered from this study will enhance existing knowledge about the psychological and behavioral aspects of the MEN syndromes, and will inform future research efforts directed toward this understudied population.

Eligibility Criteria:
Inclusion Criteria:

1. Adults age 18 years or older, with a clinical or genetic diagnosis of MEN1 or MEN2
2. Spouse, Significant Other, or Family Member who is at least 18 years of age and who is related to an individual who is a patient at MDACC and who has been diagnosed with MEN1.
3. Ability to read and write English

Exclusion Criteria:

1) Inability to be contacted via mail (i.e., no contact information on record, incorrect address)
Severe Acute Respiratory Infections (SARI) in Belgium (2011-2020)

The Belgian Severe Acute Respiratory Infections network (BELSARI-net) was implemented during the influenza season 2011-2012 following the recommendations of the World Health Organization (WHO) to monitor severity of influenza viruses in hospitals. The network is composed of 6 hospitals throughout the country, two in each administrative region (Flanders, Wallonia and Brussels-Capital), and operates during the influenza epidemic period (from the last week of December or first/second week of January to the third/last week of April, depending on when influenza virus circulation is detected by the general population, based on the Influenza-like illness (ILI) network of general practitioners).

Enrollment is performed for all cases matching the SARI case definition (based on WHO's case definition) and accepting to take part. A respiratory specimen is sampled systematically from each participant, and detailed clinico-epidemiological data, such as information on age, sex, symptoms and potential risk factors such as pregnancy or comorbidities (chronic respiratory diseases, asthma, chronic cardiovascular diseases, renal insufficiency, obesity, diabetes, hepatic or renal insufficiency, immunodeficiency, neuromuscular disease, pregnancy) is also collected. Participants are followed up during hospitalization for the occurrence of complications (detection of pneumonia based on chest radiography, development of acute respiratory distress syndrome (ARDS), requirement for respiratory assistance and/or for extracorporeal membrane oxygenation (ECMO), admission in intensive care unit (ICU)), or death (all-cause death).

The current project includes all the samples received by the Belgian National Influenza Centre (NIC) during the influenza seasons 2011-2012 till 2019-2020.


Eligibility Criteria:
Inclusion Criteria:

* All pediatric and adult patients admitted to one of the 6 sentinel hospitals during the active surveillance and fulfilling the case definition of acute respiratory infection with onset within the last ten days, with history of fever or measured fever of ≥38°C, with cough and/or dyspnea, and overnight hospitalization.

Exclusion Criteria:

* nosocomial infection, i.e. symptoms appearing after admission
Treatment of Perianal Crohn's Disease, Combining Medical and Surgical Treatment.

This study is aimed to assess the hypothesis that instillation of fibrin glue with the induction of local conditions using Infliximab, may be useful in the treatment of perianal Crohn's disease.

Patients with perianal fistulae of Crohn's disease will be prospectively enrolled and receive 3 doses of Infliximab. If reduction of fistula associated discharge of at least 50% will be recorded, commercially available fibrin glue will be instilled into the fistula tract using standard surgical techniques. The patients will be followed for 6 months for fistula healing and complications.

Eligibility Criteria:
Inclusion Criteria:

* Perianal fistula of Crohn's dis

Exclusion Criteria:

* More then 2 fistulae perianal sepsis known contraindication to infliximab or glue