cyrilzakka/clinical-trials huggingface dataset:
A Trial to Evaluate the Safety and Efficacy of NCR102 in Subjects With aGVHD

Evaluate the safety and efficacy of NCR102 injection in the treatment of SR-aGVHD patients who have failed second-line therapy.

An open-label, dose-escalation and dose-expansion study to evaluate the safety, tolerability and preliminary efficacy of NCR102 injection in the treatment of SR-aGVHD patients who have failed second-line therapy.

Eligibility Criteria:
Inclusion Criteria:

* Age\>18 years and \<70 years old (including threshold), gender not limited；
* Grade II to IV gastrointestinal involvement acute graft-versus-host disease(aGVHD)；
* Subjects with Steroid-refractory Acute Graft-versus-host Disease(SR-aGVHD)；
* Failed to second-line aGVHD treatment;
* Subjects will receive NCR102 injection treatment within 3 days after enrollment;
* Voluntarily sign an informed consent form.

Exclusion Criteria:

* Subjects have lung disease, and investigators have determined that they are not suitable for the study;
* Subjects with severe hepatic vein occlusion disease or sinus vein occlusion syndrome;
* Subjects with signs/symptoms of chronic GVHD;
* Subjects who are clinically assessed by the investigator could not be ruled out as having diarrhea caused by cytomegalovirus (CMV) enteritis, transplant related thrombotic microvascular disease (TA-TMA), or digestive tract infection;
* Eastern Cooperative Oncology Group(ECOG)\>3；
* Subjects have other diseases or physiological conditions that may interfere with the evaluation results of this trial, or life-threatening complications；
* Subjects had active malignant solid tumors within the past 5 years；
* Subjects had a known history of severe allergies to blood products, or heterologous proteins.
Metachronic Brain Metastases After Esophagectomy for Esophageal Cancer (METABREC)

Esophagectomy is the cornerstone of the curative treatment of esophageal carcinoma. Despite this treatment, patients can suffer from locoregional or distant metastatic disease and only a very selected group of patients can be cured: mostly those with recurrence in one single organ.

Brain metastases are rare after esophagectomy for cancer, but they have a serious impact on survival. Agressive treatment is often moren difficult for brain metastases compared to other metastases and some risk factors have been identified earlier.

There is an impression that the incidence of brain metastases in esophageal cancer patients has increased since the introduction of neoadjuvant treatment schemes. However, this is not clear yet. A potential explanation could be that chemotherapy disturbs the blood-brain-barrier, hereby facilitating the migration of tumor cells to the brain.

The purpose of this study is to retrospectively analyze the incidence and potential risk factors of brain metastases in patients who underwent esophagectomy for esophageal cancer. Patients treated between 2000 and 2019 will be included and outcome parameters are Odds Ratio for brain metastases (comparison between primary surgery and neoadjuvant treatment followed by surgery), time to recurrence and risk factors, number and characteristics of the brain metastases.


Eligibility Criteria:
Inclusion Criteria:

* Patients receiving surgical treatment for esophageal cancer between 1 januari 2000 and 31 december 2019
* All types of neoadjuvant treatment followed by surgery, primary surgery or salvage surgery.
* Adenocarcinoma or squamous cell carcinoma histology

Exclusion Criteria:

* other histology type than adenocarcinoma or squamous cell carcinoma
* Hypopharyngeal carcinoma extending to the esophagus (requiring total laryngo-pharyngo-esophagectomy)
* Early esophageal carcinoma (cT IS-1a N0 M0)
* palliative esophagectomy
A Clinical Study of VA-CAG as Induction Therapy in Newly Diagnosed AML Patients

This study aims to assess the therapeutic efficacy and safety of venetoclax in combination with azacitidine and CAG(VA-CAG) as induction regimen in newly diagnosed young patients with acute myeloid leukemia(AML).

This is an open-label, multicenter, phase II clinical trial to assess the therapeutic efficacy and safety of venetoclax in combination with azacitidine (VA) and CAG (G-CSF priming, low dose cytarabine, and aclarubicin) as induction regimen in newly diagnosed patients with acute myeloid leukemia (AML).

The combination of venetoclax and azacitidine is the standard therapy for elderly (\> 60 year old) patients with newly diagnosed AML who are not eligible for intensive chemotherapy. Previous studies have shown that venetoclax plus intense chemotherapy represent promising efficacy in de novo AML patients with high complete remission rates and good tolerance. The preliminary results suggest that venetoclax in combination with azacitidine and CAG are well tolerated and effective for newly diagnosed young patients with AML. Thus, this phase II clinical trial is going to further explore its efficacy and safety. It is expected that about 100 patients will take part in this trial.

Eligibility Criteria:
Inclusion Criteria:

1. Patients ≥ 18 years old and ≤ 65 years old
2. Newly diagnosed as AML patients according to 2016 World Health Organization (WHO) classification;
3. Patients without receiving prior therapy for AML;
4. Eastern Cooperative Oncology Group (ECOG) Performance status score less than 3;
5. Liver function: Total bilirubin ≦2 upper limit of normal (ULN); aspartate aminotransferase (AST) ≦3 ULN; alanine aminotransferase (ALT)≦3 ULN
6. Renal function：Ccr（Creatinine Clearance Rate） ≧30 ml/min; Scr (serum creatinine) ≦2 ULN
7. Heart function: left ventricular ejection fraction ≧45%
8. Patients must participate in this clinical trial voluntarily and sign an informed consent form.

Exclusion Criteria:

1. Acute promyeloid leukemia；
2. AML with central nervous system (CNS) infiltration；
3. Patients have received prior hypomethylating agents (HMA) therapy for myelodysplastic syndrome (MDS) and progressed to AML；
4. Patients with a life expectancy \<3 months
5. Patients with uncontrolled active infection;
6. HIV infection;
7. Evidence of other clinically significant uncontrolled condition(s) including, but not limited to: a) Chronic hepatitis B virus (HBV) or hepatitis C (HCV) requiring treatment; b) An active second cancer that requires treatment within 6 months of study entry.
8. Female who are pregnant, breast feeding or childbearing potential.
9. Patients deemed unsuitable for enrollment by the investigator.
Trial of Efficacy and Safety of Pregabalin in Subjects With Neuropathic Pain Associated With Lumbo-Sacral Radiculopathy

Trial will evaluate the efficacy and safety of pregabalin in the treatment of subjects with neuropathic pain associated with lumbo-sacral radiculopathy.


Eligibility Criteria:
Inclusion Criteria:

* Pain consistent with a diagnosis of chronic lumbo-sacral radiculopathy due to spinal stenosis or disk herniation.
* Radicular pain must be present for at least 3 months and pain stable for at least 4 weeks.

Exclusion Criteria:

* Surgery for lumbo-sacral radiculopathy within previous 6 months and/or more than one previous spinal surgery for pain-radiculopathy.
* Epidural injection for lumbo-sacral radiculopathy within previous 6 weeks and/or anticipated need for treatment with opioid analgesics, anti-epileptic medications or tricyclic antidepressants to alleviate pain due to lumbo-sacral radiculopathy during the course of the study.
Effect of Cognitive Aid on Adherence to Perioperative Guidelines

The objective of this prospective randomized trial is to ascertain whether the use of a cognitive aid improves adherence to best published practices for the management of simulated patients regarding perioperative cardiac evaluation and management.


Eligibility Criteria:
Inclusion Criteria:

Any active resident or faculty member will be allowed to volunteer.

Exclusion Criteria:

There are no exclusion criteria (notably we will include residents on academic probation)
Wright Foot & Ankle Post-Market Observational Study

WRIGHT FOOT \& ANKLE POST-MARKET OBSERVATIONAL STUDY, Multi-Year, Multi-Site, Multi-Device, Post-Market Observational Study, 10 sites, a minimum of 40 patients per device

The selected design is a global, multi-center, non-randomized, prospective observational study. The study subjects included are those treated with one or more approved or cleared Wright Medical products included in this study.

Eligibility Criteria:
Inclusion Criteria:

* Willing and able to consent to participate (written, informed consent);
* Willing and able to attend/complete the requested follow-up visits;
* Considered for treatment with one or more approved or cleared Wright Medical products included in this study

Exclusion Criteria:

* Subjects determined, by the investigator, to be an inappropriate candidate for the procedure indicated;
* Unable to consent to participate (written, informed consent);
* Unable to attend/complete the requested follow-up visits
How Acupuncture Sensation Propagated to Effect the Energy of Channels

De-qi as an important factor to therapeutic effect of acupuncture for years, It's a concrete pathway to approach Qi, an abstract concept in Chinese medicine. However, all previous physicians and medical scientists have different interpretation to De-qi, and no objective principles for clinical practice, teaching and studies.

Qi propagated combined with acupuncture practice always be seen as De-qi , therefore, the study control "transmission or not" and "direction of sensation propagated" to compare what's different in human body. If the change happened as prediction based on acupuncture theories, it could define De-qi for operation.

The study will collect 60 subjects, from age 20 to 40, the same numbers of male and female. They will accept different manipulation in left hand HeGu(LI4), and assessed the variations in microcirculation, temperature of left forearm, and waxing/waning of yin-yang , Qi and blood in related meridian. We hope to understand if sensation propagated is primary factor of De-Qi and acupuncture effect .


Eligibility Criteria:
Inclusion Criteria:

* both male and female
* age:20-40 years old

Exclusion Criteria:

* to be afraid of acupuncture
* easily fainting
* right index finger has been injured recent one month
* had taken drugs can trigger vasodilatation or vasoconstriction recent three months
* systemic diseases
* pregnancy
Evaluation of the Effect of Telmisartan (Micardis® 80 mg/ MicardisPlus® 80/12.5 mg) on Blood Pressure and Cardiovascular Risk Factor Index in High Risk Hypertensive Patients

The study is designed to evaluate the effect of treatment with Micardis/MicardisPlus on blood pressure and its ability to reduce different indicated cardiovascular risks. Further on, the study will evaluate the current antihypertensive treatment pattern in the daily practice among the patient population at increased cardiovascular risk.


Eligibility Criteria:
Inclusion criteria:

* diagnosis of essential arterial hypertension (BP\>140/90 mm HG or BP\>130/80 mm Hg for diabetic patients)
* at least an additional cardiovascular risk factor

Exclusion criteria:

* hypersensitivity to the active substance or to any of the excipients in any ACE inhibitor or angiotensin receptor blocker (ARB) available on the local market
* pregnancy and lactation
* diseases involving biliary obstruction
* severe liver impairment
The Role of the Endocannabinoid System in Sweet Taste Intensity and Liking

The endocannabinoid (eCB) system, a neurochemical signalling system consisting of CB-receptors and their endogenous ligands, has been found to be involved in food intake of sweet and palatable foods. Activation of the eCB system increases food intake and vice versa. The mechanism behind this effect is still unknown and the current study aims at clarifying why sweet food intake increases. It is hypothesized that sweet taste intensity increases and that sweet taste is experienced as more pleasant.


Eligibility Criteria:
Inclusion Criteria:

* BMI: 18.5 - 25 kg/m2
* Incidental cannabis use for at least one year, at least four times per year, but less than once a week.
* Dutch-speaking
* Willing to comply with the study procedures
* Having given written informed consent

Exclusion Criteria:

* Not meeting the inclusion criteria
* Restraint eating (men: score \> 2.90)
* Lack of appetite
* Having difficulties with swallowing/eating
* Usage of an energy restricted diet during the last two months
* Weight loss or weight gain of 5kg or more during the last two months
* Stomach or bowel disease
* Diabetes, thyroid disease, other endocrine disorders
* Use of daily medication except paracetamol
* Having taste or smell disorders (self-report)
* Being allergic/intolerant for products under study
* Previously experienced an adverse reaction to cannabinoids (e.g. anxiety, paranoia, nausea)
* Having (had) a schizophrenia or other psychotic illness
* Having a family history of schizophrenia or other psychotic illness
* Working at the Division of Human Nutrition (WUR)
* Current participation in other research from the Division of Human Nutrition (WUR)
Combination Chemotherapy In Treating Patients With Advanced Cancer

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.

PURPOSE: Phase I trial to study the effectiveness of combining gemcitabine, fluorouracil-uracil and leucovorin in treating patients who have advanced cancer that has not responded to previous therapy.

OBJECTIVES:

* Determine the maximum tolerated doses of gemcitabine, fluorouracil-uracil (UFT), and leucovorin calcium in patients with advanced refractory cancer.
* Assess the toxicity of this combination regimen in this patient population.
* Evaluate this regimen in terms of response rate, response duration, and overall survival in these patients.

OUTLINE: This is a dose escalation study of gemcitabine and fluorouracil-uracil.

Patients receive gemcitabine IV over 30 minutes on days 1, 8, and 15. Patients receive oral leucovorin calcium immediately followed by oral fluorouracil-uracil (UFT) three times a day on days 1-21. Courses are repeated every 28 days. Treatment continues in the absence of disease progression or unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of gemcitabine and UFT until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose limiting toxicities.

PROJECTED ACCRUAL: A total of 36 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically or cytologically confirmed malignancy refractory to existing chemotherapy or for which no standard therapy exists
* Evaluable disease

PATIENT CHARACTERISTICS:

Age:

* 18 and over

Performance status:

* SWOG 0-2

Life expectancy:

* Greater than 3 months

Hematopoietic:

* Absolute neutrophil count greater than 1,500/mm3
* Platelet count greater than 100,000/mm3
* Hemoglobin greater than 8.0 mg/dL

Hepatic:

* Bilirubin less than 2.0 mg/dL
* AST less than 3.0 times upper limit of normal

Renal:

* Creatinine no greater than 2.0 mg/dL

Other:

* No active infection requiring antibiotics
* Not pregnant or nursing
* Fertile patients must use effective barrier contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

* Not specified

Chemotherapy:

* At least 3 weeks since prior systemic cytotoxic chemotherapy (including fluorouracil) and recovered
* No prior gemcitabine

Endocrine therapy:

* Prior hormonal therapy allowed
* No concurrent hormonal contraception

Radiotherapy:

* At least 3 weeks since prior radiotherapy to large areas of active bone marrow and recovered

Surgery:

* Prior major surgery allowed and recovered

Other:

* No prior or concurrent antiviral nucleosides
Study of Irofulven in Combination With Oxaliplatin in Patients With Advanced Solid Tumors

The purpose of this study is to determine the maximum tolerated dose (MTD) and to investigate the efficacy, safety and pharmacokinetics of irofulven combined with oxaliplatin in patients with advanced solid tumors.


Eligibility Criteria:
Inclusion Criteria:

1. Signed informed consent obtained prior to initiation of any study-specific procedures and treatment.
2. Malignant solid tumor confirmed by a biopsy sample.
3. Pancreatic, endometrial, gastric, and hepatocellular cancer patients that have exhausted standard treatment options.
4. Measurable disease according to RECIST.
5. 18 years of age or older.
6. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS): 0-1.
7. Life expectancy greater than 3 months.
8. Previous anticancer treatment must be discontinued at least 4 weeks prior to first dose of study treatment (6 weeks for mitomycin C, 8 weeks for bicalutamide).
9. Patients of reproductive age must be using effective contraceptive methods.
10. Negative pregnancy test for patients of reproductive potential.

Exclusion Criteria:

1. Prior therapy with irofulven or oxaliplatin.
2. Patients who have had radiation therapy to more than 30% of the bone marrow prior to entry into the study.
3. Prior chemotherapy with nitrosoureas or high dose carboplatin (AUC \> 6), prior mitomycin C cumulative dose greater than or equal to 25 mg/m², prior bone marrow transplant or intensive chemotherapy with stem cell support.
4. Presence of any serious concomitant systemic disorders incompatible with the study (e.g., uncontrolled congestive heart failure, active infection).
5. Any previous history of another malignancy (other than cured basal cell carcinoma of the skin or cured in-situ carcinoma of the cervix) within 5 years of study entry, unless the active malignancy can be unmistakably identified by evidence such as recent biopsies or tumor specific markers.
6. Treatment with any other investigational agent, or participation in another clinical trial within 28 days prior to study entry.
7. Pregnant or lactating patients or any patient with childbearing potential not using adequate contraception.
8. Patients with retinopathy or significant visual impairment not correctable by refractory lens will be enrolled on a case by case basis according to the expected benefit ratio, taking into account the malignant disease and the existence of an objective decreased visual acuity and its degree.

Please note: There are additional criteria that must be met in order to be eligible for this study.
A Questionnaire Survey for Biliary Tract Cancers

The purpose of this study is:

* To evaluate risk factors for cancers of the biliary tract by registering new patients and their counterparts in a multi-center program
* Development of programs by creating a multi-center biliary tract cancer registration system


Eligibility Criteria:
Inclusion Criteria:

* Study population :

  * Newly diagnosis of biliary tract cancers - Pathological or Radiological or other clinical diagnosis of biliary tract cancers
  * Informed consent
* Control :

  * with no previous cancer diagnosis
  * Informed consent

Exclusion Criteria:

* Previous diagnosis of bile duct cancer with resection operation, endoscopic resection, chemotherapy or radiation therapy
* Prior diagnosis of other cancer in 5 years or ongoing cancer treatment
* Patients' refusal
Usability and Performance Evaluation of the AutoLap System - a Feasibility Study

The main objectives of this study are to evaluate the ease of use and performance of the AutoLap system compared to human camera holder during general and bariatric laparoscopic surgeries.


Eligibility Criteria:
Inclusion Criteria:

1. Signed and dated Informed Consent Form (ICF).
2. Patients over 18 years who were scheduled for elective laparoscopic Cholecystectomy, Nissen fundoplication, paraesophageal hernia and sleeve surgery procedures

Exclusion Criteria:

1. Extensive adhesions that will preclude routine laparoscopic surgical approach.
2. Pregnancy
3. Patient participates in any other clinical study 60 days prior to the start of the study and throughout the study duration.
Influence of Injury to the Kaplan Fibers in Adult and Pediatric Patients With ACL Injury

The goal of this \[type of study: observational study\] is to \[detect concomitant KF and ALL injury in knees with ACL injury using MRI in both adult and pediatric patients and compare the effect of KF injury and multiple risk factors (concomitant injury to the ALL, medial collateral ligament \[MCL\], or anterior, central, or posterior part of the medial or lateral meniscus) on anterolateral rotatory laxity as measured by the pivot-shift test in a clinical setting.\].

The main question \[s\] it aims to answer are:

\[Does the main risk factor for a high-grade pivot shift after acute ACL injury differ between pediatric patients and adults?\] \[Does Concomitant KF injury significantly affect the pivot-shift phenomenon in pediatric patients with acute ACL injury?\] Researchers will compare \[71 pediatric patients and 469 adults\] to see if \[main risk factor for a high-grade pivot shift after acute ACL injury differs between pediatric patients and adults?\].


Eligibility Criteria:
Inclusion Criteria:

* unilateral acute primary ACL tear, considered when the patient reported knee injury occurring less than 2 weeks before the examination;
* bone bruising on the femoral condyles and tibial plateau identiﬁed on MRI.

Exclusion Criteria:

* concomitant ligament (posterior cruciate ligament and/or posterolateral complex) procedures or realignment procedures; contralateral knee injury;
* previous injury or surgery affecting the ipsilateral knee;
* insufficient data from the electronic medical record system;
* lack of KF visualization on MRI.
Processing of Salient Emotional Stimuli as a Function of Tetrahydrocannabinol (THC) and Cannabidiol (CBD)

Attentional blink refers to a phenomenon where the detection of the second of two target stimuli that are presented in Short succession within a stream of stimuli is impaired. This is explained by an insufficient availability of attentional resources. Additionally, emotionally salient stimuli, like for example pictures with a positive or negative content, are detected more often compared to neutral pictures during this attentional blink period.

Cannabinoids are involved in the modulation of cognitive, attentional, and emotional processes. Interestingly, data from animals suggests that THC and CBD, both active ingredients in the Cannabis sativa plant, have opposing effects on brain cannabinoid (CB1) receptors. CB1 receptors modulate the expression of emotionally salient conditioned association in rats, if salience processes in humans are modulated in the same way remains unclear.

Employing a task to detect salient stimuli, Bhattacharyya et al. (2012) showed that THC seems to make non-salient standard stimuli more salient. They showed decreased activation of the right caudate and increased right prefrontal cortex stimuli during processing of salient stimuli. Importantly, this was associated with decreased response times to standard relative to oddball stimuli. Generally, THC and CBD differentially modulate brain areas associated with attentional salience processing. For example THC seems to increase prefrontal and striatal activation whereas CBD seems to decrease it.

The investigators assume that THC increases the number of correctly detected emotional stimuli during the attentional blink period, whereas CBD has no effect. Additionally, the investigators assume that pictures of the positive category are detected with higher accuracy than negative ones under the influence of THC.


Eligibility Criteria:
Inclusion Criteria:

* male
* age between 18 and 65 years
* right-handed

Exclusion Criteria:

* consumption of cannabis more than 5 times
* substance abuse (apart from nicotine)
* psychiatric disorders
* epilepsy
* chronic diseases (e.g. diabetes)