cyrilzakka/clinical-trials huggingface dataset:
IBI334 in Subjects With Unresectable, Locally Advanced or Metastatic Solid Tumors

The primary objective of this study to evaluate the safety and tolerability of IBI334 and determine the maximum tolerated dose (MTD) and the recommended Phase 2 Dose (RP2D) of IBI334.


Eligibility Criteria:
Inclusion Criteria：

1. Male or female subjects ≥ 18 years old;
2. Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1;
3. Anticipated life expectancy of ≥ 12 weeks;
4. Adequate bone marrow and organ function;

   Criteria for dose escalation phase only:
5. Has a documented (histologically- or cytologically-proven), unresectable, locally advanced or metastatic solid tumor that is refractory to or intolerable with standard treatment, or for which no standard treatment is available (mainly focused on non-small-cell lung cancer, head and neck squamous cell carcinoma and RAS-wildtype colorectal cancer);
6. At least 1 evaluable lesion per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1;

   Criteria for dose expansion phase only:
7. Has a documented (histologically- or cytologically-proven), unresectable, locally advanced or metastatic non-small-cell lung cancer, head and neck squamous cell carcinoma or RAS-wildtype colorectal cancer that is refractory to or intolerable with standard treatment, or for which no standard treatment is available;
8. At least 1 measurable lesion per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.

Exclusion Criteria：

1. Participate in any other interventional clinical research except observational (non-interventional) study or in the follow-up phase of the interventional study;
2. Received live vaccines within 4 weeks prior to first dose of the study drug or plan on receiving any live vaccine during the study;
3. Received total pelvic radiotherapy;
4. Pyloric obstruction and/or persistent recurrent vomiting (≥ 3 times in 24 hours);
5. Uncontrolled diseases;
6. History of endotracheal or gastrointestinal stent implantation;
7. Multiple concurrent malignant tumors within 5 years (except non-melanoma skin cancer, carcinoma in situ or non-invasive tumor that were cured);
8. Women who are pregnant, have positive results in pregnancy test or are lactating;
9. Not eligible to participate in this study at the discretion of the investigator.
Effect of Low Dose ColchiciNe on the InciDence of POAF

The prior End-AF study by the same group showed that 1 mg of colchicine didn't decrease the incidence of AF after cardiac surgery. The current study, End-AF Low Dose Study, will test 0.5 mg colchicine vs. placebo in preventing AF after cardiac surgery.

AF after cardiac surgery leads to excess mortality and morbidity. Colchicine was used in several studies to lower the incidence AF but the results were generally disappointing. There was no benefit in reducing AF and there was a high incidence of GI side effects especially diarrhea, often leading to stopping the medication. However, a recently published meta-analysis showed that colchicine reduced AF, but again warned of the high incidence of GI side effects. The maintenance dose of colchicine used in these studies was 1 mg daily it is hypothesized that low dose colchicine (0.5 not 1 mg colchicine) might lower AF after cardiac surgery without the prohibitive GI side effects Patients will be randomized to colchicine vs. placebo started the day before surgery and continued until hospital discharge.

The primary efficacy endpoint will be the incidence of AF. The primary safety endpoint will be the GI side effects

Eligibility Criteria:
Inclusion Criteria:

* All patients aged 18 years or above undergoing elective cardiac surgery.
* Sinus rhythm and no previous AF
* Agreed to sign informed consent.

Exclusion Criteria:

* Known severe liver disease or current transaminases \>1.5 times the upper normal limit
* Current serum creatinine \>2.5 mg/dL
* Known myopathy or elevated baseline preoperative creatine kinase
* Known blood dyscrasias or significant gastrointestinal disease
* Pregnant and lactating women
* Known hypersensitivity to colchicine
* Current treatment with colchicine for any indications
* Emergency surgery
Tissue and Clinical Characterisation of Temporomandibular Joint Diseases

Temporomandibular joint (TMJ) diseases or dysfunctions affects many patients. Surgical treatment is planned when non-invasive interventions have failed. Still, much is not known regarding aetiology of TMJ diseases and how and why the disease develops over time. The study aims to investigate synovial tissue, synovial fluid and clinical characteristics for patients with TMJ diseases or dysfunctions designated for surgery. Patient samples and clinical variables will be analysed in relation to TMJ diagnosis and related to surgical outcome. The study is a cohort observational study.

TMJ disc displacement is common, affecting 20-30% of the population. Some of these patients will eventually need health-care attention. Patients with TMJ osteoarthritis (OA) or chronic inflammatory arthritis (CIA) are not that common, prevalence numbers are lacking. These TMJ diseases or dysfunctions can severely affect the patients' well-being because of local pain, chewing problems, psychosocial impact, amongst others. Treatment is primarily non-invasive to its character where orthotic splint, physiotherapy, medication, or other treatments can be evaluated. Patients who do not respond to these efforts might have surgery. Arthroscopy is a minimal invasive intervention with a described success rate from 50-90%. From the patients', the society and the surgeons' point of view, better individual pre-operative prognostication is valuable. TMJ disc displacement, OA and CIA is not fully characterised in terms of aetiopathogenesis. There are studies investigating components of extra cellular matrix and cytokines TMJ. The multitude of proteins still not studied may contribute in an unknown fashion to new insights in aetiology and to new treatment opportunities. The aim of the study is to characterise synovial tissue, synovial fluid, and clinical parameters and relate them to the specific TMJ diagnosis but also to each others. A secondary aim is to relate the outcome of surgery to both clinical and tissue variables in order to determine if there are factors that might function as predictors of outcome. A tertiary aim is to investigate if patients who suddenly develops disc displacement without reduction (DDwoR) without any prior signs or symptoms from the TMJ differs in their tissue or clinical characteristics compared to patients who develops DDwoR after having prior signs or symptoms from the TMJ.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 or older
* diagnosis DDwoR, DDwR, OA, or CIA
* conservative treatment (i.e. orthotic split, physiotherapy, medication) tried for at least 3-6 months without success

Exclusion Criteria:

* earlier TMJ surgery
* age under 18 years
* patients not able to give informed consent
Post-Marketing Surveillance (Special Use-results Surveillance) on Long-term Use With Ozempic®

The purpose of this study is to assess the safety of long-term treatment with Ozempic® in patients with type 2 diabetes mellitus. People will get Ozempic® as prescribed by their doctor. People will be in this study about 3 years. People above the age of 18 will be asked to fill in the quality of life (QOL) questionnaire (the QOL questionnaire is for the assessment of the influence of diabetes treatment on people's life). There is a possibility that people's blood sample would be provided to Novo Nordisk from their doctors in case of severe allergic reaction that might be caused by Ozempic®.


Eligibility Criteria:
Inclusion Criteria:

* Signed consent obtained before any study-related activities (study-related activities are any procedure related to recording of data according to the protocol).
* The decision to initiate treatment with commercially available Ozempic® has been made by the patient/Legally Acceptable Representative (LAR) and the treating physician before and independently from the decision to include the patient in this study.
* Patients with Diabetes Mellitus, Type 2 (T2DM) who the physician has decided to start treatment with Ozempic®.
* Male or female, no age limitation.

Exclusion Criteria:

* Previous participation in this study. Participation is defined as having given informed consent in this study.
* Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation.
* Patients who fall under contraindications to the label.
* Patients who are or have previously been treated with Ozempic®.
* Female who is pregnant, breast-feeding or intends to become pregnant.
Guided Meditation to Decrease Perioperative Anxiety and Increase Patient Intraoperative Compliance in Vascular Surgery

The primary purpose of this clinical trial is to test the feasibility of implementing a perioperative guided meditation program for patients undergoing peripheral vascular interventions that are performed under procedural sedation and analgesia.

This is a prospective, randomized, controlled study involving 30 adult patients undergoing peripheral vascular interventions. Patients will be randomized to two arms: an intervention arm where patients will participate in perioperative guided meditation, and a control arm where patients will receive standard of care without any meditation intervention.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* Undergoing an endovascular procedure for peripheral vascular disease
* Anesthesia plan for procedural sedation and analgesia

Exclusion Criteria:

* Pre-existing psychiatric disorder such as anxiety, panic disorder, depression, psychosis, or bipolar disorder
* Non-English speaking
* Prior history of ipsilateral lower extremity amputation
* Urgent or Emergent Surgery
* Anesthesia plan for general anesthesia
* Undergoing a hybrid procedure (simultaneous endovascular and open surgery)
Effectiveness of a Multifactorial Intervention to Improve Diet and Physical Activity in Diabetics From Primary Care

This is a randomized, clinical trial aimed at diabetics between 25-70 years (with no cardiovascular disease) selected at urban primary care health clinics in Salamanca (Spain). It is aimed at assessing the effects of adding an ICT (information and communication technology) tool, developed for the Smartphone application and group activities of healthy food and cardio-health rides in support of behavioral and educational recommendations in the increased physical activity and adaption to the Mediterranean dietary pattern.

Objective:

The main objective of this study is to evaluate the effect of adding a multifactorial intervention (ICT tool for Smartphone, cardio-health rides and a standardized advice about eating habits) to the usual care in the increase of the physical activity, in order to reach the international recommendations and in the Increased adherence to the Mediterranean diet in type 2 diabetic patients. Secondary objectives will be to evaluate the effect of intervention in improving dietary patterns, cardiovascular risk factors and metabolic control.

Design and setting:

A randomised controlled clinical trial, with two parallel groups, aimed at assessing the effects of adding an ICT tool and group activities on healthy food and cardio-health rides (intervention), in support of behavioral and educational recommendations (control) in the increased physical activity and adaption to the Mediterranean dietary pattern.

Study setting:

Primary Care Health Area of Salamanca in the Research Unit of La Alamedilla, belonging to the Spanish Network for Preventive Activities and Health Promotion (redIAPP) and Salamanca Institute for Biomedical Research (IBSAL).

Study population:

200 patients with Diabetes Mellitus Type 2, aged between 25-70 years, of both sexes, who meet selection criteria and signed informed consent.

Each participant will make three visits: baseline, three and twelve months post-intervention.

Measuring the effect of the intervention:

The validated 14-point Mediterranean Diet Adherence Screener, the International Physical Activity Questionnaire (IPAQ), pedometer, laboratory values including glucose and glycosylated hemoglobin, and quality of life questionnaire (SF -12).

Eligibility Criteria:
Inclusion Criteria:

* Subjects with Diabetes Mellitus Type 2 since 25 to 70 years.

Exclusion Criteria:

* Older than 70 years are excluded, due to difficulties in the use of ICTs.
* History of cardiovascular events (acute myocardial infarction, stroke, etc).
* Diagnosis of clinically demonstrable neurological and/or neuropsychological disease.
* Muscular-skeletal pathology that inhibit mobility.
* Those with any other circumstance that the investigators consider could interfere with the study procedures.
Tenapanor in Synucleinopathy-Related Constipation

Investigation of tenapanor as a potential treatment for synucleinopathy-associated constipation

Randomized, double-blind, placebo controlled trial of tenapanor vs. placebo for treating synucleinopathy-associated constipation in Parkinson\&#39;s disease.

Eligibility Criteria:
Inclusion Criteria

1. Age 50-89 years.
2. Diagnosis of PD within Hoehn and Yahr stages 1-3, confirmed by a neurologist per International Parkinson and Movement Disorder Society criteria.
3. Average weekly stool frequency of ≤5 spontaneous bowel movements (SBMs) and ≤2 complete spontaneous bowel movements (CSBMs) over the past 6 months. These criteria will be verified during a 2-week screening period.
4. Stool consistency ≤3 on the Bristol Stool Form Scale (BSFS). This criterion will be verified during a 2-week screening period.
5. Agreement to use contraception, if applicable.

Exclusion Criteria

1. Functional diarrhea or IBS-D/M based on Rome IV Criteria.
2. Symptomatic structural GI abnormalities or inflammatory bowel disease.
3. Significant hepatic (ALT or AST ≥ 2.5x the upper limit of normal) or renal (serum creatinine \>2mg/dl) dysfunction.
4. Pregnancy or lactation.
5. Diagnosis of primary dyssynergic defecation by anorectal manometry.
Effect of Cyanobacteria Patients With Chronic Hepatitis B Surface Antigen Quantitative Concentration

Hepatocellular carcinoma (HCC) is a very severe disease in Taiwan caused 7,000 deaths per year, and majorly about 70% is caused by the chronic hepatitis B virus infection. A repeat, long-term, and severe chronic hepatitis would be more possible progressed into liver cirrhosis and HCC. As previous records, there might be 2% of chronic HBV patient would progress to liver cirrhosis, and 5% of the liver cirrhosis's patients would develop to HCC. In some cases, the HBV patient also might directly develop to HCC without liver cirrhosis phase.

Hepatocellular carcinoma (HCC) is a very severe disease in Taiwan caused 7,000 deaths per year, and majorly about 70% is caused by the chronic hepatitis B virus infection. A repeat, long-term, and severe chronic hepatitis would be more possible progressed into liver cirrhosis and HCC. As previous records, there might be 2% of chronic HBV patient would progress to liver cirrhosis, and 5% of the liver cirrhosis's patients would develop to HCC. In some cases, the HBV patient also might directly develop to HCC without liver cirrhosis phase.

Spirulina platensis is a kind of ancient livings for a 3.5 billions years, and had been recognized as a kind of space food by National Aeronautics and Space Administration(USA) because of containing numerous nutrients, especially vitamin B and beta-carotene. Beta-carotene would convert into vitamin A and help keep health vision, skin, and mucosa. With a rich source of vitamins B, especial B12 which is almost only in meals (animal livers), 1.2 grams of Spirulina platensis daily uptake would be sufficient for a human daily need, and also be a very good source for vegetarians. The investigators add the B12 test in this trial as a secondary endpoint to help monitor the absorption rates of the Spirulina platensis in human. Otherwise, the plant pigments in Spirulina platensis would also have many bioactivities on human healthy. Among these bio-activities of Spirulina platensis would contain anti-virus, anti-cancer, immune modulation, anti-inflammation, anti-oxidant, improve liver abnormality, and liver cirrhosis abilities. As previous small scale of clinical trial results in HBV patients provided by Far East Bio-Tec Company, lamivudine combined with oral Spirulina platensis would also improve the sero-conversion rates of HBeAg.

Eligibility Criteria:
Inclusion Criteria:

* In patients with chronic hepatitis B of taking oral antiviral drugs , and the virus has been detected is less than the amount (HBV DNA \<20 IU / ml), aged between 20 years to 75 years .

Exclusion Criteria:

* Patients were allergic to seafood.
Studying a Quality of Life Questionnaire in Patients With Colorectal Cancer

RATIONALE: Collecting information about the quality of life of patients with colorectal cancer may help doctors learn more about the disease.

PURPOSE: This clinical trial is studying the European Organization of Research for the Treatment of Cancer (EORTC) quality-of-life-questionnaire in patients with colorectal cancer.

OBJECTIVES:

* To test the reliability and clinical and psychometric validity of the European Organization of Research for the Treatment of Cancer (EORTC) quality of life questionnaire (QLQ-CR29) in an international sample of patients with colorectal cancer.

OUTLINE: This is a multicenter study. Patients are stratified into predetermined clinically distinct groups (colon cancer after surgery vs colon cancer undergoing adjuvant chemotherapy vs rectal cancer undergoing neoadjuvant radiotherapy vs rectal cancer after anterior resection with temporary stoma vs rectal cancer after abdominoperineal excision of rectum vs colorectal cancer undergoing palliative chemotherapy).

Quality-of-life data is collected alongside standard outcomes in patients undergoing treatment for colorectal cancer. Patients complete the European Organization of Research for the Treatment of Cancer (EORTC) quality of life questionnaire (QLQ-C30), the revised colorectal cancer module (QLQ-CR29), case report forms for clinical and sociodemographic data, and a debriefing questionnaire at different time points before, during, and after treatment. Some patients complete more sets of the same questionnaire at later time points to assess sensitivity to change over time and test-retest reliability. Reliability, and clinical and psychometric validity of the questionnaires are assessed by correlation analyses, exploration of known group comparisons, and responsiveness to clinical changes.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically confirmed adenocarcinoma of the colon or rectum
* No brain metastases or intracranial tumor extension with cognitive impairment

PATIENT CHARACTERISTICS:

* No limit on performance status
* Able to understand the language of the questionnaire
* No psychological, familial, sociological, or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
* No other concurrent malignancies except basal cell carcinoma of the skin

PRIOR CONCURRENT THERAPY:

* No prior participation in this study (in a different subgroup)
* No concurrent participation in other quality of life studies that might interfere with this study
Nasotracheal Intubation Over a Bougie

The purpose of this study is to determine whether nasal intubation over a bougie placed via a nasal trumpet will decrease nasal trauma when compared to the conventional technique of blind nasal endotracheal tube passage.

Conventional nasotracheal intubation techniques (or "Conventional Videolaryngoscopic Techniques," CVT) are known to be associated with significant trauma to the patient's nares and the endotracheal tube itself. The investigators propose an alternative technique (Nasotracheal intubation over a bougie placed via a subsequently removed nasal trumpet, or NIB) which involves using Seldinger technique over a bougie placed via a nasal trumpet which promises to not only be less traumatic to the patient and the endotracheal tube, but also to take less time to perform and have a higher first-attempt success rate than conventional methods. The investigators propose a randomized prospective interventional study comparing this new technique with conventional technique to see if a significant difference exists.

Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled for elective surgery with an anesthetic plan including asleep nasotracheal intubation

Exclusion Criteria:

* Patients needing emergent airway protection
* Patients undergoing emergency surgery
* Patients whom are known to be pregnant
* Patients whom are currently anticoagulated (including daily aspirin use)
* Patients whose anesthetic includes the use of nitrous oxide
* Patients whom are currently incarcerated
* Patients 7 years of age or younger
* Mentally incompetent adults
* Patients whom refuse involvement in the study
Telehealth Rapid Intervention for Externalizing Behaviors in ASD

The purpose of this research study is to evaluate a time-limited version of Parent Child Interaction Therapy (PCIT) delivered via telehealth for young children with autism spectrum disorder (ASD) and disruptive behavior problems. Families will be randomly assigned to receive 10 sessions of Tele-PCIT or Treatment as Usual. Families will complete a baseline assessment, a post-treatment assessment, and a 3-month follow-up.


Eligibility Criteria:
Inclusion Criteria:

1. Be between 2:0 -6:11 years old
2. Have elevated levels of disruptive behavior problems as defined by the Eyberg Child Behavior Inventory
3. Have a diagnosis of ASD based on a positive Autism Diagnostic Observation Schedule (ADOS-2), a semi-structured parent interview, record review, and an ASD DSM-5 criteria checklist.
4. Have a receptive language age equivalent of at least 24 months as defined by the Peabody Picture Vocabulary Test
5. Are of low SES background defined by having primary Medicaid

Exclusion Criteria:

1. Presence of severe self-injurious behavior
2. Children who are receiving psychotropic medication and are not stable on their current medication regimen. Children receiving psychotropic medications who are on a stable regimen for one month will not be excluded.