cyrilzakka/clinical-trials huggingface dataset:
Expanded Access Protocol of Verdiperstat in Patients With Multiple System Atrophy (MSA)

The purpose of this expanded access program is to provide access to the investigational drug verdiperstat in patients with Multiple System Atrophy (MSA). Expanded access allows patients with a serious or a life-threatening disease or condition access to an investigational drug when no satisfactory approved treatment options are available.


Eligibility Criteria:
Inclusion Criteria:

1. with a diagnosis of probable or possible MSA documented by a physician according to consensus clinical criteria,5 including patients with MSA of either subtype, MSA-P or MSA-C.
2. able to swallow whole tablets without crushing or chewing.
3. with established care with a physician at the specialized MSA center involved in the protocol and will maintain this clinical care throughout the duration of the EAP.
4. not eligible for an ongoing clinical study with verdiperstat and/or an ongoing EAP for MSA

Exclusion Criteria:

1. Based on the Physician's judgement, any condition (including history of a clinically significant or unstable medical condition or lab abnormality) that would interfere with the patient's ability to comply with the EAP instructions, visit schedule, requirements and/or procedures, place the patient at unacceptable risk, or confound/interfere with the adequate assessment/interpretation of data; including difficulty swallowing verdiperstat tablets or any other sound medical, psychiatric and/or social reason.
2. Presence of clinically significant thyroid disease despite treatment and/or TSH \>10 mIU/ L at Screening/Baseline, confirmed by repeat.
3. Patient is known to have acute or chronic liver disease that is clinically significant in the Prescriber's judgment
4. First or second dose of COVID-19 vaccination within 7 days of first dose of verdiperstat.
Cognition Intervention Study Dortmund- Glycemic Index (CogniDo GI)

The Cognition Intervention Study Dortmund (CogniDo) and the Cognition Intervention Study Dortmund PLUS (CogniDo PLUS) investigated the short-term effects of having school lunch versus skipping it on children's basal (CogniDo) and executive (CogniDo PLUS) cognitive functions in the afternoon. The The Cognition Intervention Study Dortmund Continued (Coco) connected this two previous studies and investigates the effect of having school lunch versus skipping it on children's basal and executive cognitive functions later in the afternoon. The present study the Cognition Intervention Study Dortmund- Glycemic Index (CogniDo GI) examines the influence of the gylcemic index of lunch on cognitive performance of school children in the afternoon.

Glucose is the main fuel of the human brain. However, which impact the glycemic index of lunch has on cognitive performance is not clear. A recently published review by Philippou and Constantinou suggested cautiously that a low-GI meal may favor cognitive functions in adults, but note that their findings are inconclusive due to differences in study design, study sample (e.g. size, age), time of testing and the cognitive domain being examined. Because of cerebral particularities, children may react highly sensitive to variations of glycose supply. Therefore, an optimised composition of meals at favourable mealtime should be considered for optimal cognitive performance. The increasing implementation of all-day schools in Germany requires the children's catering for lunch at school.

As prior intake of food can have an influence on the physiological effect of test meal, the children's dietary intake in the mid-morning is standardized. The intervention is integrated in everyday school life: 9.15 a.m. standardized snack within the frame of the regular break, 9.45 a.m. to 12.25 p.m. everyday school life, 12.25 p.m. lunch with a high GI-rice or a low GI-rice and a water beverage, 12.45 p.m. to 13.15 p.m. regular lunch break, 13.15 p.m. computerized tests of executive cognitive and basal (alertness) functioning.

Parameters of cognition with relevance to everyday school life are measured by a computerized test program developed by the Institute of Working Learning and Aging (ALA). Usual eating behaviour, sleep behaviour, physical activity and parental education were determined as control variables by questionnaires for children, parents.

Eligibility Criteria:
Inclusion Criteria:

* all fifth and sixth grade students of Gesamtschule Berger Feld with the consent of parents and child

Exclusion Criteria:

* Metabolic diseases or special diet
Polatuzumab, Rituximab and Orelabrutinib Combination Regimen (PRO) in the Treatment of Elderly Frail Patients with Treatment-naive Non-GCB DLBCL

This prospective, single-arm, multicenter clinical study aims to enroll 30 frail elderly patients with Non-GCB DLBCL. This study is to evaluate the preliminary efficacy and safety of the combination of Polatuzumab, Rituximab, and orelabrutinib in this population. The primary endpoint is CR rate after induction therapy.


Eligibility Criteria:
Inclusion Criteria:

* Patients with histopathologically confirmed DLBCL;

  * The sGA evaluation result of octogenarians or 60-79 years old is unfit or f RA il;

    * Non-germinal center (Non-GCB) type;

      * ECOG performance status score of 0-3 points; ⑤ No previous treatment for Lymphoma (unless glucocorticoid); 6 Radiographic Investigation to measurable disease, defined as the longest diameter with at least one Lymph node disorder \> 1.5 cm, or at least one extranodal lesion \> 1.0 cm in the longest diameter; ⑦ Adequate organ function;

        * Life expectancy ≥ 12 weeks; ⑨ Signed written informed consent.

Exclusion Criteria:

* Accompanied by uncontrolled cardiovascular and cerebrovascular diseases, Coagulopathy diseases, autoimmune diseases and severe Immunization diseases, etc.;

  * Laboratory abnormalities at screening (unless caused by Lymphoma) A) ANC \< 1.5 x 109/L, PLT \< 80 x 109/L b） Coagulation: INR greater than 1.5 x upper limit of normal; PT and APTT greater than 1.5 x upper limit of normal c） Liver function: ALT or AST 2 times higher than upper limit of normal, AKP and Bilirubin 1.5 times higher than upper limit of normal d） Renal function: Creatinine high 1.5 times the upper limit of normal, Creatinine clearance \< 60 mL/min (estimated by C OC kcroft-Gault formula); ③ HIV Infection;

    * HbsAg positive patients should be HBV DNA negative before enrollment; in addition, if the patients are HBsAg negative but HBcAb positive (regardless of HBsAb status), HBV DNA detection is still required; if the results are positive, antiviral therapy is required, and HBV DNA negative before enrollment;

      * Requires continuous treatment with strong and moderate CYP3A inhibitors or CYP3A Induction agents. Patients who have taken strong and moderate CYP3A inhibitors or CYP3A Induction agents (or have taken these agents within 5 half-lives) within 7 days prior to the first dose of study drug should not be enrolled; ⑥ Inability to swallow capsules or suffering from diseases that seriously affect gastrointestinal function, such as Syndrome malabsorption, gastric or Small intestinal resection, symptomatic Inflammatory bowel disease or partial or complete Intestinal obstruction; ⑦ Other concurrent and uncontrolled medical conditions that, in the opinion of the investigators, would affect the patients' participation in the study, including patients with Psychosis or other patients known or suspected to be unable to fully comply with the study protocol.
Isolation of Vitamin D Binding Protein Isoforms From Human Volunteers

The purpose of this study is to isolate genotype-specific DBP/Gc from homozygous human volunteers and use these purified proteins to cross-validate existing or novel assays for this serum protein and to evaluate the binding characteristics of these variants of DBP/Gc for different vitamin D metabolites.


Eligibility Criteria:
Inclusion Criteria:

* Generally healthy adults (≥ 18 years), non pregnant, with known DBP/Gc genotype

Exclusion Criteria:

* Inability to provide written informed consent
* No children or pregnant women
* Persons with known abnormal serum proteins
A Study of the Effect of Zinc-Hyaluronate on Ocular Surface Sensations in Patients With Dry Eye

Hyaluronic acid, a natural polymer, helps to maintain ocular surface hydration and can already be found in several artificial tears recommended to alleviate symptoms of dry eye. A recent hyaluronate modification involves zinc-hyaluronate complex formation by adding zinc-chloride to an aqueous sodium-hyaluronate resulting in a very stable molecular structure, which functions as both a mechanical barrier and a biocompatible film on the ocular surface. Apart from its beneficial elastoviscous characteristics, previous results indicate that hyaluronate can also reduce the excitability of the peripheral nociceptor endings underlying pain. Although hyaluronate is widely used in artificial tears to improve tear film stability, its effect on ocular surface sensitivity was not evaluated in patients with dry eye. The aim of this study is to investigate the characteristics of ocular surface sensations and corneal sensitivity in dry eye patients before and after long-term tear supplementation with zinc-hyaluronate.


Eligibility Criteria:
Inclusion Criteria:

* Patients who had been diagnosed as having dry eye symptoms for at least 3 months, with an OSDI score of ≥13 evaluated by the questionnaire of Ocular Surface Disease Index (OSDI)

Exclusion Criteria:

* Subjects with ophthalmic conditions other than dry eye or systemic disease including blepharitis, meibomitis, lid abnormalities as well as contact lens wearers
Role of Intrapulmonary Lymph Nodes in Patients With NSCLC and Visceral Pleural Invasion

Background: Lung cancer is the leading cause of cancer related death worldwide. More than 80% of all lung tumors are Non-Small Cell Lung Cancers (NSCLC). Lymph node staging has a prognostic value and is crucial to establish the optimal treatment strategy in individual patients. It remains unknown whether dissecting the intrapulmonary lymph nodes (stations 13 and 14) is necessary for accurate staging and prognostication. Although suggested by several guidelines, these peripheral lymph nodes are not routinely examined in clinical routine for several reasons. Moreover, the prognostic significance of the visceral pleural invasion is controversial. Some studies showed a negative impact on OS and DFS in patients with histologic proved visceral pleura invasion.

The mechanism to explain this negative effect is not fully understood. Given that the visceral pleura is very rich in lymphatic vessels, with an intercommunicating "network" arranged over the lung surface and penetrating into the lung parenchyma to join the bronchial lymph vessels with drainage to the various hilar nodes, we assume that the worse OS and DFS observed in these patients could be explained with the presence of metastatic lymph nodes (Station 13-14) that are not routinely examined. Methods: This is a prospective, multicenter study based on ad-hoc created prospectively database. The incidence of N1 lymph node metastasis overall and the incidence of metastasis to the different lymph node stations (Hilar 10/11, Lobar 12, Sublobar 13/14) will be calculated by dividing the number of the respective events by the patient years separately. To investigate the association between visceral pleural invasion and the presence of metastatic lymph nodes univariate and multivariate logistic regression models will be fitted to the data.

Discussion: The primary outcome is to investigate the incidence of N1 metastases (especially stations 12,13,14) and his relationship with visceral pleural invasion. The secondary outcomes is to evaluate the impact of N1 metastases and/or visceral pleural invasion on long-term outcomes (OS and DFS) along with incidence and pattern of recurrence. DFS is defined as the time of surgical intervention to tumor recurrence or death, and OS is defined as the time of surgical intervention to death


Eligibility Criteria:
Inclusion Criteria:

* Anatomical resection for NSCLC \<3 cm (lobectomy, bilobectomy, segmentectomy)
* Samples from the intrapulmonary stations 12, 13, and 14 lymph nodes
* Resection of lymphnodes station 10 and 11 during hilar separation.
* R0 resection

Exclusion Criteria:

* Prior or synchronous lung cancer
* pN2
* Pneumonectomy
* R1/R2 resection
* M1
* Neoadjuvant treatment
Pharmacokinetics of Imrecoxib in Subjects With Hepatic Insufficiency

This clinical research study will assess pharmacokinetics and the safety of Imrecoxib in patients with impaired hepatic function as compared to healthy volunteers.


Eligibility Criteria:
Inclusion Criteria:

All subjects:

* Between the ages of 18 to 70 years, with BMI 18\~ 29kg/m2.
* In good health as determined by past medical history, physical examination, vital signs, electrocardiogram, and laboratory test values(except for values related to hepatic insufficiency).

Hepatic impaired subjects:

* Hepatocirrhosis subjects verified by B-mode ultrasonography,CT ,MRI or Biopsy.
* A Child-Pugh Classification score clinically determined as Class B.

Exclusion Criteria:

All subjects:

* History of hypersensitivity to Imrecoxib or its components.

Subjects diagnosed with tumor.

* History of or current clinically important systemic illnesses, including but not limited to cardiovascular, pulmonary, renal, hematological, gastrointestinal, endocrinological, immunological, dermatological, or psychiatric diseases.
* Have used any drugs or substances (including herbal supplements) known to inhibit or induce cytochrome P450 enzymes including cytochrome P450 3A4, cytochrome P450 2C8 and cytochrome P450 2C9 within 28 days prior to the first dose and throughout the study.
* Have taken other investigational drugs or participated in any clinical trial within 90 days prior to first dose of study drug in this study.

Hepatic impaired subjects:

* Subjects with hepatic failure,or severe complications caused by Hepatocirrhosis.
Ibrutinib for Relapsed or Refractory Mantle Cell Lymphoma

To review the efficacy and the safety of ibrutinib in patients with relapsed or refractory mantle cell lymphoma (MCL).

# Background and Rationale Mantle cell lymphoma (MCL) is a rare subtype of lymphoma, accounting for about 3-6% of all non-Hodgkin's lymphoma. It is clinically prevalent in the elderly and men, commonly with gastrointestinal tract involvement. Since about 80% of patients present with advanced stage disease at diagnosis, the prognosis is very poor. Mantle cell lymphoma is less frequent in Korean than in Western countries, accounting for about 2% of all non-Hodgkin's lymphoma cases, with very poor treatment outcome as Western countries.

In Korea, the clinical information about patients with MCL is very scarce so far and does not reflect recent treatment patterns. Firstly, the incidence in Korea is relatively lower than that in Western countries, with only about 100 patients a year. Secondly, due to substandard national health insurance regulations in Korea, it was not until recently that ibrutinib for relapsed/refractory MCL was approved for coverage by the National Health Insurance. In this context, the study was designed to investigate the efficacy and safety of ibrutinib in patients with relapsed or refractory MCL in Korea.

Eligibility Criteria:
Inclusion Criteria:

* Patients with MCL diagnosed by a pathologist (based on the WHO 2017 classification)

  1. mantle cell lymphoma
  2. leukemic nonnodal mantle cell lymphoma
  3. in situ mantle cell neoplasia
* Aged ≥ 19 years
* Relapsed or refractory patients treated with ibrutinib, including relapse after autologous stem cell transplantation

Exclusion Criteria:

* Patients whose clinical and pathological data are not available
* Patients who were not treated with ibrutinib
Cold Snare Polypectomy Vs. Cold Forceps Polypectomy Using Narrow-band Imaging Endoscopy for Removal of Diminutive Colorectal Polyps

The purpose of this study is to compare cold snare polypectomy and cold forceps polypectomy using narrow-band imaging endoscopy for removal of diminutive colorectal polyps.

Previous study found Cold snare polypectomy a preferable technique in comparison to cold biopsy for diminutive polyps when assessed for completeness of resection. However, it is expected that cold biopsy polypectomy with advanced endoscopy, such as chromoendoscopy or narrow-band imaging endoscopy, increase completeness of resection. One study showed 90% of the diminutive polyps were completely resected using cold biopsy polypectomy with chromoendoscopy. However, no study compared cold snare polypectomy and cold biopsy polypectomy using Narrow-band Imaging endoscopy for Removal of Diminutive Colorectal Polyps.

The aim of this study is to compare cold snare polypectomy and Cold biopsy Polypectomy Using Narrow-band Imaging Endoscopy for Removal of Diminutive Colorectal Polyps

Eligibility Criteria:
Inclusion Criteria:

* patients over the age of 20 years undergoing routine colonoscopy (screening, surveillance, or diagnostic)

Exclusion Criteria:

* patients taking antiplatelet or anticoagulant therapy during the past 1 week of the procedure
* known coagulopathy
* history of inflammatory bowel diseases
* American Society of Anesthesiology class III or more
* pregnancy.
To Investigate the Efficacy and Safety of OPC-6535 in Chronic Obstructive Pulmonary Disease (COPD) Patients

To investigate the efficacy and safety of OPC-6535 in COPD patients, using the measurement of trough FEV1 over time as the primary endpoint.


Eligibility Criteria:
Inclusion Criteria:

* Age 40 to 75 years, inclusive, at the time informed consent is obtained
* Ability to provide own written informed consent
* Agree to use an appropriate method of contraception until 3 months after the last dose of the investigational medicinal product (IMP)
* A rating of 1 or higher on the Goddard scale in assessment of emphysema severity by chest CT scan at screening
* Ratio of forced expiratory volume in 1 second to forced vital capacity (FEV1/FVC) of less than 70% at screening
* Cigarette smoking history of at least 20 pack years at screening

Exclusion Criteria:

* Subjects with obstructive disorders due to bronchial asthma
* Subjects receiving long-term oxygen therapy
* Subjects with active tuberculosis or obvious bronchiectasis
* Complication of malignant tumor
* Uncontrolled cardiovascular, endocrine, blood, or nervous system disorders
* Uncontrolled condition with COPD exacerbation of level 2 or 3 within 8 weeks prior to the start of washout period (within 12 weeks prior to start of treatment period)
Effect of Darbepoetin in Contrast-induced Nephropathy

The purpose of this study is to determine whether the drug that produce red blood cells is effective in the prevention of kidney dysfunction after coronary angiography in patients with chronic kidney disease.

Use of radiocontrast agent is inevitable in computed tomography or angiography. However, contrast agent can aggravate kidney function. Contrast-induced nephropathy (CIN) refers to the clinical situation where decreased kidney function after use of contrast. CIN is the 3rd most common cause of acute kidney injury in the hospitals. There are a lot of reports that death rate is increased in patients with CIN.

Erythropoietin is an agent that treat anemia. It also has been reported to have a tissue-protective effect in the animal experiments.

In this study, we hypothesized that erythropoietin can reduce the incidence of CIN in patients with chronic kidney disease undergoing coronary angiography.

Eligibility Criteria:
Inclusion Criteria:

* age over 18 yr
* estimated glomerular filtration rate (GFR) \< 60 ml/min/1.73m2

Exclusion Criteria:

* Chronic renal replacement therapy (hemodialysis, peritoneal dialysis, continuous renal replacement therapy)
* Pregnancy or lactation
* Use of contrast agent within 1 week
* Emergent CAG or PCI
* Not recovered from AKI(acute kidney injury)
* Use of nephrotoxic drugs within 48 hr
* Cardiogenic shock (SBP(systolic blood pressure) \< 90 mmHg) or pulmonary edema
* Uncontrolled hypertension (SBP ≥ 200 mmHg or DBP(diastolic blood pressure) ≥ 130 mmHg)
* History of hypersensitivity to contrast agent
* Known allergy or hypersensitivity to EPO(erythropoietin)
* Use of EPO within 1 month
* Anemia (hemoglobin \< 9 g/dL)
* Ventilatory care
Changes and Associations Between Cervical Range of Motion, Pain, TMJ Range of Motion and Quality of Life in Migraineurs Applying Physical Therapy

The purpose of this study is to assess the effects of physiotherapy program and review the associations between neck movements, pain, temporomandibular joint (TMJ) movements and quality of life in individuals with migraine.

Migraine is one of the most common type of headaches in the world causing the greatest disability in individuals under 50 years of age. Many different health organizations (American Headache Society etc.) recommend regular physical activity and exercise for the treatment and prevention of migraine. However, the relationship between aerobic exercise and migraine is still not completely clear. Unfortunately, a research database to validate the benefits of exercise for people with migraine is still being developed.

The aim of this study is to assess the effects of physiotherapy program and review the associations between neck movements, pain, temporomandibular movements and quality of life in individuals with migraine.

The study was approved by Committee on Biomedical Research Ethics of Kaunas Region (2020-06-30 No.BEC-SR(M)-266).

Eligibility Criteria:
Inclusion Criteria:

* Individuals diagnosed with migraine 2 or more years ago
* Headache, occurring at least 6 times a year
* Individuals from 18 years of age
* Voluntary patient consent to participate in the study

Exclusion Criteria:

* Neurological or psychiatric disorder
* Visiting an orthodontist, taking muscle relaxants
* Head or neck injury, cervical spine hernia, facial or temporomandibular injury
Walking on Cognitive Function in Individuals With Mild Cognitive Impairment: A Pilot Project

Background: Many studies suggest physical activity reduces risk of dementia and improves global cognitive function in individuals with mild cognitive impairment (MCI). Using commercial wearable technology to measure daily steps is feasible in this population.

Objectives: The purpose of this pilot study was to explore whether 12 weeks of increased physical activity improved cognitive function in individuals with MCI. A wearable activity tracker was used to measure participants' daily steps as a quantifiable measure of daily activity level.

Design: This was a one-group pretest-posttest study.

Setting: Established memory clinic patients within a neurology department in Northern California during 2019.

Participants: 17 enrolled and 14 included for data analysis. There were 7 females and 7 males whose mean age was 76.21 (SD 2.69). 12 participants were White, which reflected the clinic population.

Intervention: Participants were asked to wear an activity tracker for approximately 12 hours a day for 12 weeks and to increase their physical activity as much as possible. They were provided twice a month telephone support.

Measurements: The Montreal Cognitive Assessment (MoCA) was used to measure pretest-posttest cognitive function. Timed Up and Go (TUG) was used to assess fall risk at enrollment. Cumulative step count for the study period was measured with an activity tracker.


Eligibility Criteria:
Inclusion Criteria:

* Participants had a score of 0.5 on the Clinical Dementia Rating and are on a stable medication regimen for 3 months prior to enrollment.

Exclusion Criteria:

* a diagnosis of dementia; receiving chemotherapy; unstable chronic diseases; surgery with general anesthesia in the prior 3 months; MRI-confirmed brain damage from trauma, stroke, or other neurological disorder; a myocardial infarction \< 1 year; a serious or non-healing wound, ulcer, or bone fracture; TUG ≥ 12 seconds; MoCA score \>26 or \<16; already using a wearable activity tracker; lacked access to the internet; or non-English speaking.