cyrilzakka/clinical-trials huggingface dataset:
Efficacy and Safety of Ojeok-san on Korean Patients With Cold Hypersensitivity in the Hands and Feet

The Purpose of this trial is to investigate the efficacy and safety of Ojeok-san(OJS) on Korean Patients With Cold Hypersensitivity in the Hands


Eligibility Criteria:
Inclusion Criteria:

1. Female subjects aged 19 to 59 years have a complaint of CHH.
2. Patients must include at least one or more of the following symptoms:

   * Those who have the symptoms of CHH in normal temperature which most individuals feel no cold;
   * Those who have the symptoms of extremely cold hands in cold temperature exposure;
   * Those who are on the return to a warmer environment, the symptoms of cold hands is not completely rewarmed;
3. Those who have 4 cm or greater of VAS CHH score;
4. A thermal differences between the palm (PC8) and the upper arm (LU4) may be higher than 0.3℃;
5. Those who can comply with all study-related procedures, medications, and evaluations;
6. Given a written informed consent form.

Exclusion Criteria:

1. Patients with calcium antagonists or beta-blockers with the purpose of treating CHH;
2. Those who have one or more finger gangrene or ulceration;
3. Those who are diagnosed by hypothyroidism or currently medicated to thyroid drugs;
4. Those who are diagnosed by autoimmune disease or have a positive ANA test result;
5. Those who are diagnosed by carpal tunnel syndrome or have a positive Tinel and Phalen's tests;
6. Those who are diagnosed with cervical disc herniation or (malignant) tumor disease;
7. Those who are diagnosed with diabetes;
8. Those who are currently medicated to drugs that may affect to CHH symptoms, such as anticoagulants etc;
9. Those who have moderate level of liver dysfunction (each of AST, ALT greater than 100 IU/L) or kidney dysfunction (Cr 2.0mg/dL);
10. Those who do not (cannot) abide by treatment and follow up due to the mental illness such as behavior disorder, depression, anxiety neurosis, schizophrenia, or serious mental illness;
11. Those who are Diagnosed with moderate anemia and hematologic disorders (adult non-pregnant women hemoglobin (Hgb) level less than 7g/dL, hematocrit (Hct) level less than 26%, white blood cell (WBC) level greater than 11,000/mm3);
12. Those whose systolic blood pressure (SBP) 180mmHg or diastolic blood pressure (DBP) is greater than 100 mmHg based on average value of at least 2 measurements;
13. Those who are suspected arrhythmia that showing up on ECG, or diagnosed by heart diseases, such as, ischemic heart disease and so on;
14. Those who are addicted to alcohol or drugs;
15. Those who are pregnant (positive urine-HCG) or lactating or have the chances of pregnancy;
16. Those who are diagnosed with malignant tumor
17. Those who are currently participated in other clinical trials;
18. Those who are unable to understand and speak Korean;
19. Those who are judged to be inappropriate for the clinical study by the researchers.
Phase 1b Study of CAR2Anti-CEA CAR-T Cell Hepatic Infusions for Pancreatic Carcinoma Patients With CEA+ Liver Metastases

This study is an open-label, single arm phase 1b safety study of CAR2 Anti-CEA CAR-T cell hepatic arterial infusions for pancreatic carcinoma patients with carcinoembryonic antigen positive (CEA+) liver metastases resistant to standard therapy who meet all other eligibility criteria.

Patients will receive weekly 3 doses of CAR2 Anti-CEA CAR-T cells in each 28-day cycle by hepatic arterial infusions using a Pressure Enhanced Delivery Device (PEDD) with low dose systemic IL-2 support. Patients may receive up to 3 cycles of CAR2 Anti-CEA CAR-T cell hepatic arterial infusions, per discretion of the investigator.

All patients who receive investigational CAR-T therapy will be included in the analyses and summaries of safety, efficacy, pharmacokinetic, and pharmacodynamic assessments.

Eligibility Criteria:
Inclusion Criteria:

* Must have documented CEA+ pancreatic adenocarcinoma liver metastases and have failed greater than or equal to 1 line of conventional systemic therapy.
* Must have at least evaluable liver metastases.
* Must have a life-expectancy at least 12 weeks.
* Patients must be willing and able to comply with the study schedule and all other protocol requirements.
* Females of childbearing potential must have 2 negative pregnancy tests, agree to pregnancy tests during the study, and sexually active female and male patients must be willing to use an effective birth control method to avoid pregnancy.

Exclusion Criteria:

* Subjects who have received an investigational study drug within 14 days of leukapheresis or 28 days before receiving first dose of study drug.
* Subjects who have received any approved anticancer medication within 14 days of leukapheresis or 14 days before receiving the first dose of study drug.
* Have any unresolved toxicity greater than Grade 2 from previous anticancer therapy.
* Have a history of confirmed metastases outside the peritoneal cavity, lungs, or liver.
* More than 50% replacement of one or both liver lobes with tumor.
* Has tumor causing biliary obstruction not amenable to stenting.
* Have a high volume of lung or peritoneal metastases.
* Has received any CAR cell line therapies.
* Has any clinically significant low baseline lab results for hemoglobin, platelet counts, and neutrophil counts at screening.
* Has untreated or ongoing intra-abdominal infection or bowel obstruction.
* Has any clinically significant elevated baseline lab results for serum creatinine, AST, and total bilirubin (except for patients in whom hyperbilirubinemia is attributed to Gilbert's syndrome), and alkaline phosphatase at screening regardless of causality.
* Known HIV or acquired immunodeficiency syndrome-related illness, acute or history of chronic hepatitis B or C.
* Female patients who are pregnant or breastfeeding.
* Have active bacterial, viral, or fungal infections.
* Has any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent study participation.
* Left ventricular ejection fraction (LVEF) \< 40%.
Effects of HIV and Hepatitis C Virus on the Brain

This study will determine the effects that HIV and hepatitis C virus have on thinking abilities and whether the viruses affect brain chemistry.

Hepatitis C is a liver disease that is caused by the hepatitis C virus (HCV). It can be successfully treated with 6 to 12 months of medication in both HIV infected and HIV uninfected people. Among HIV infected people, HCV infection is a common co-morbidity, and is more serious when it occurs in this population than others because it leads to liver damage more quickly. HIV is known to cause neurological deficits, and studies suggest that HCV may do so, as well. Knowledge about how to treat these deficits, however, is limited. More information about the nature of the neurological problems and their causes is needed to develop effective treatments. This study will determine the effects that HIV and HCV have on thinking abilities, such as memory, attention, and problem-solving, and whether the viruses affect brain chemistry.

Participants in this 4-year, observational study will undergo a series of tests and interviews. Participants may choose to complete all procedures over 2 days or three appointments. Procedures will include a 20-minute medical interview, a 4-hour neuropsychological evaluation, a 5-minute functional ability questionnaire, blood and urine collection (approximately 15 minutes), and a 1-hour magnetic resonance imaging (MRI) test of the head. The neuropsychological evaluation will test participants' memory, concentration, reasoning, and speed of thinking. All procedures will be completed over approximately 6 hours.

Eligibility Criteria:
Inclusion Criteria:

* CD4 count is greater than 200
* Hepatitis C infected or uninfected
* Speaks English

Exclusion Criteria:

* Currently receiving interferon treatment for hepatitis C
* History of neurological illness
* Any psychotic spectrum disorder (e.g., schizophrenia or manic depression/bipolar disorder)
* History of learning disability
* History of head injury that entailed a loss of consciousness for more than 30 minutes
* Any metal in body
Early Versus Delayed Rehabilitation Intervention in Patients With Lung Cancer

In Italy, the incidence of lung cancer for the year 2020 has been estimated at about 41.000 new diagnoses. Patients with lung cancer experience debilitating symptoms caused by the disease itself and cancer treatments, such as dyspnea and fatigue, which reduce physical function and quality of life (QoL). It is estimated that 90% of patients undergoing chemotherapy and 57% of patients undergoing lung resection suffer of Cancer-Related Fatigue (CRF).

Previous studies have shown that educational interventions and aerobic and resistance exercise are effective in improving CRF and QoL in patients with lung cancer. However, to date the optimal dose, mode and timing to deliver the intervention during the care pathway for lung cancer patients is unknown. Tolerability and frequency of cancer treatment could be a barrier to adherence to the intervention. Therefore, this study aims to evaluate the feasibility of a rehabilitation intervention aimed at improving CRF with respect to timing of delivery: early vs delayed rehabilitation in lung cancer patients.

The primary outcome of the study is to evaluate the feasibility of the experimental pulmonary rehabilitation (RP) program combining the exercise component with the educational component for patients with lung cancer undergoing chemotherapy and/or radiotherapy and/or immunotherapy, delivering RP at different points in the course of their care pathway. The secondary outcome is to evaluate the impact of the intervention on several health outcomes (CRF, physical performance, and QoL) by assessing any differences between early and delayed RP.

The early RP intervention will be delivered in the first three months of cancer treatment, while the same delayed RP intervention will be delivered three months after the start of treatment. Finally, considering the potential beneficial role that exercise on survival of patients with cancer, this study also aims to evaluate this outcome at 12 months after enrollment.

Eligibility Criteria:
Inclusion Criteria:

* Newly diagnosed of stage II and III lung cancer (NSCLC) candidates for anticancer therapies (chemotherapy, radiotherapy, immunotherapy, or combinations thereof), associated or not with surgery. In the last case, patients will be included at least 30 days after surgery.
* Prognosis ≥ 12 months
* At least 18 years old
* Recruited from the pneumology, oncology, radiotherapy, and physical medicine and rehabilitation unit of the Azienda Unità Sanitaria Locale - IRCCS of Reggio Emilia
* Willing and able to give written informed consent

Exclusion Criteria:

* Clinical disorders that contraindicate participation in a moderate exercise program (e.g. preexisting severe physical disabilities, major cognitive or sensory deficits, severe psychiatric disorders, language barrier, etc.).
* NSCLC stage IV
* Patients who are candidates for surgery alone
* Patients who are candidates for neoadjuvant therapy
Effects of Verbal Instructions on Fear Extinction and Extinction Retrieval

The goal of this study is to examine if verbal instructions can improve fear extinction learning and extinction retrieval in patients with anxiety disorders (AD) and healthy controls.

Patients with anxiety disorders (AD) and highly anxious individuals show accelerated fear conditioning and diminished fear extinction learning (Duits et al., 2015). The aim of the current study is to investigate how verbal instructions impact fear extinction learning and extinction retrieval in AD patients and healthy controls. Using a 3-day fear conditioning paradigm, fear acquisition will take place on the first, extinction training on the second, and extinction retrieval and reinstatement on the third day (i.e., all phases are on consecutive days). Part of the participants will receive explicit instructions such that the unconditioned stimulus (UCS) won't be presented anymore, either before and/or after extinction training. Participants will be randomly assigned to four conditions: (1) no explicit instructions at all, (2) explicit instructions before extinction, (3) explicit instructions after extinction or (4) explicit instructions before and after extinction.

Eligibility Criteria:
Inclusion Criteria:

* For the patient group: DSM-5 anxiety disorder diagnosis via a structured clinical interview for diagnosing mental disorders (DIPS)
* For the healthy controls: no psychological disorder according to the Mini-DIPS

Exclusion Criteria:

* smoking
* alcohol abuse
* drug consumption
* current and chronic physical and neurological diseases
* for the patient group: anxiety not the primary diagnosis, psychological comorbidities e.g. schizophrenia, bipolar disorder, mental retardation, acute drug or alcohol addiction, personality disorder, currently in psychotherapy
* for the healthy controls: a diagnosis of psychological disorder at any point in life, ever been in psychotherapy, current and/or regular intake of medicine (incl. psychopharmaceutic medicine), current or past cognitive or neurological disorder
* for women: pregnancy, nursing period
* previous experience with fear conditioning paradigm
Pro-permeability and Pro-fibrosis Factors in the Aqueous of Patients With Retinal Diseases

This study will examine potential factors in the aqueous humor that may contribute to the development or progression of macular edema or fibrosis (due to any underlying disease) in patients suffering from these conditions.

The primary purpose of this study is to determine the correlation of pro-permeability and pro-fibrosis factor levels and downstream receptor/signaling molecule activation with disease activity in patients with macular edema or fibrosis secondary to any underlying disease.

120 patients will be enrolled from both the clinic and OR, with the latter patients undergoing surgery for proliferative diabetic retinopathy, rhegmatogenous retinal detachment with Proliferative vitreoretinopathy (PVR), rhegmatogenous retinal detachment without PVR, macular pucker, or macular hole. Clinic patients must be receiving an intraocular injection of a steroid as part of standard of care for macular edema or progressive fibrosis.

Surgical patients will receive an anterior chamber (AC) tap at the beginning of surgery, while clinic patients will receive an AC tap prior to the intraocular injection of steroid with a second AC tap at a follow-up visit 6 +/- 2 weeks after the first injection. The aqueous sample will then be analyzed by measuring the levels of various pro-permeability and pro-fibrosis factors and/or their downstream receptor/signaling molecule activation.

We will also determine the correlation between reductions in foveal thickness or improvements in visual acuity with changes in the aqueous levels of pro-permeability and pro-fibrosis factors from baseline to week 6 in the clinic group.

Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent and authorization of use and disclosure of protected health information
* Age \>= 18 years
* Undergoing surgery as part of standard care for one of the following conditions: (1) Proliferative Diabetic Retinopathy (PDR), (2) rhegmatogenous retinal detachment with PVR, (3) rhegmatogenous retinal detachment without PVR, (4) macular pucker, (5) macular hole OR receiving as part of standard care, an intraocular injection of a steroid for macular edema or progressive fibrosis.

Exclusion Criteria:

* Previous use of an anti-Vascular Endothelial Growth Factor (VEGF) drug within 1 month of study entry
* Any condition that the investigator believes would pose a significant hazard to the subject if standard study procedures were conducted.
* Inability to comply with study or follow up procedures
* Patients with active or suspected ocular or periocular infection, including most viral diseases of the cornea and conjunctiva, including active epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, varicella, mycobacterial infections, and fungal diseases.
* Pregnant patients.
The Design and Evaluation of an Active Intervention for the Prevention of Non-contact ACL Injury

The overall goal of this project is to reduce the risk for anterior cruciate ligament injuries by designing a targeted intervention that will alter the known kinematic and kinetic risk factors associated with ACL injuries.

This study will address the following specific aims: 1) To optimize a wearable, targeted, active training feedback device to reduce the risk of ACL injury among healthy subjects by inducing patterns of movement that alter the known kinematic and kinetic risk factors associated with ACL injuries. 2) To evaluate the efficacy of the active device and determine if the device reduces the risk of ACL injury among healthy subjects by effectively inducing patterns of movement that alter the known kinematic and kinetic risk factors associated with ACL injuries.

Eligibility Criteria:
Inclusion Criteria:The ages would range from 18 to 65. Both male and female subjects will be enrolled, and ethnic backgrounds would be mixed. Exclusion Criteria:(i) chronic lower body pain (ii) recent surgery of the lower or upper body (limitation of range of motion) (iii) previous history of ligament, meniscal, or chondral injury requiring surgery to the lower limb (iv) inability to complete jumping tasks
Effectiveness of The Health Care CEO App for T1D

The present study aims to evaluate the intervention effectiveness of the Healthcare Chief Executive Officer mobile application(Healthcare CEO app) in patients with type 1 diabetes transitioning from adolescence to early adulthood.

Aim:The present study aims to evaluate the intervention effectiveness of the Healthcare Chief Executive Officer mobile application in patients with type 1 diabetes transitioning from adolescence to early adulthood.

Design: A 9-month two-arm, parallel-group, single-blind, randomized controlled trial Methods: Ninety-six Type-1 diabetes patients, aged 16-25 years, are expected to participate in this study. Participants will be randomly assigned to the experimental or control group by central randomization. The Healthcare Chief Executive Officer app, which consists of the following functions: data recording, knowledge, communication skills, food swap guide, exercise recommendations, chatroom, reminders, and SOS, will be used as the intervention measure. We will compare the differences in disease control outcomes, confidence in self-management, self-care behaviors, emotional distress, quality of life, and specific diabetes-related knowledge between the two groups before intervention and at 3, 6, and, 9 months post-intervention. The differences within the experimental group pre- and post- intervention will also be analyzed. This study design was approved by the ethics committee of the researcher's affiliation in March 2021.

Eligibility Criteria:
Inclusion Criteria:

* a confirmed diagnosis of T1D by an endocrinologist before the age of 16 and a disease duration of \>6months
* patients aged 16-25 years
* mean HbA1C level ≥7.5% one year before inclusion
* ability to communicate in Chinese or Mandarin
* patients who own smartphones with internet access
* patients who agreed to voice recording during a session explaining the treatment process
* patients who signed the informed consent form prior to participation; for minors, a legal representative must provide consent and sign the informed consent form.

Exclusion Criteria:

･ T1D patients with other concomitant metabolic diseases, chromosomal aberrations, major illnesses, and cognitive impairment will be excluded from this study.
Psycho-Social Well Being Following Stroke

Multicenter randomized controlled trial (RCT) testing the effect of a dialogue-based psychosocial intervention for stroke acute survivors in primary care one to six months poststroke. Primary outcome is psycho-social health and wellbeing, measured by GHQ28 (primary outcome) and SAQoL (secondary outcome). 400 stroke survivors are randomized into intervention group or control group. Patients are followed up for 12 months.


Eligibility Criteria:
Inclusion Criteria:

* being adults (over 18 years old),
* suffered an acute stroke within the last month,
* medically stable,
* sufficient cognitive functioning to participate (assessed by their physician/stroke team and acceptable Raven's score (see below),
* interested in participating,
* able to understand and speak Norwegian, and
* able to give informed consent.

Exclusion Criteria:

* moderate to severe dementia or other serious disease.

Persons with aphasia will be examined by a speech therapist and excluded if they have significant impressive aphasia or severe expressive aphasia inconsistent with participating in the dialogues.
Preoperative Immunonutrition in Laparoscopic Total D2 Gastrectomy

Immunonutrition (IN) appears to reduce infective complications and in-hospital length of stay (LOS) after gastrointestinal surgery. More specifically, it seems to be beneficial also in gastric cancer surgery. Potential benefits of combining preoperative IN (PIN) with protocols of enhanced recovery after surgery (ERAS) in reducing LOS in laparoscopic total gastrectomy are yet to be determined.


Eligibility Criteria:
Inclusion Criteria:

* Age \>18 years
* Primary gastric cancer
* Preoperative staging I-III
* Eligible for laparoscopic D2 total gastrectomy

Exclusion Criteria:

* Acquired or congenital immunodeficiency
* Malnutrition (MNA-SF score \< 12)
* Preoperative infection
* Previous gastric surgery
* ASA IV
* Emergency setting
* Para-aortic node involvement
* Intraoperative evidence of distant metastasis or peritoneal carcinosis
* Conversion to open surgery
Noninvasive Measurement of Cardiac Output in Pulmonary Hypertension Using Inert Gas Rebreathing

The study hypothesis is that accuracy of CO measurement by IGR does not differ from classical CO measurement methods such as thermodilution or direct Fick method. This is why the study aims to determine whether non invasive cardiac output (CO) measurement using inert gas rebreathing (IGR)is a suitable method in patients with pulmonary hypertension. In order to examine this, the IGR method will be used in patients undergoing diagnostic or follow-up right heart catheterization.

Inert Gas Rebreathing method enables non invasive measurement of cardiac output (CO) using the single rebreathing method. A mixture of blood soluble (N2O) and blood insoluble gas (SF6) and environmental air is inhaled and the amount of N2O, SF6, O2 and CO2 is measured by a photoacoustic analysator. The length of a measurement is about 1 minute.

As the gold standard measurement of CO is performed invasively, there is an urgent need for the development of non-invasive tools like IGR.

Eligibility Criteria:
Inclusion Criteria:

* Written informed consent
* Patients who undergo right heart catheterization

Exclusion Criteria:

* Missing written informed consent