cyrilzakka/clinical-trials huggingface dataset:
Efficacy and Safety of Lanreotide 120 Milligram (mg) as a Palliative Treatment of Clinical Symptoms Associated With Malignant Intestinal Obstruction in Inoperable Patients

The primary objective of this study is to assess the efficacy of Lanreotide 120 mg for the relief of clinical symptoms due to malignant bowel obstruction in inoperable patients. This effect will be evaluated by the percentage of responder patients 7 and 14 days after one administration of lanreotide 120 mg.

(A responder patient will be defined either as a patient experiencing \< or= 1 vomiting episode per day during at least three consecutive days or as a patient in whom NGT has been removed without any vomiting recurrence during at least three consecutive days)

The total number of visits will depend on the clinical situation, 5 visits are obligatory: Day(D)-3/-0,Day 1,Day 7,Day 14,Day 28

Inclusion visit (D-3/-0): eligibility, PIC, obstruction history, clinical exam, vital signs, diary cards, VAS scale, cc medication, blood sample

Visit D1: injection Visit D7/D14/28: clinical exam, nutrition procedure, result of biochemical analyse, adverse events, cc medication

In between the visits, the patient will keep and fill out his diary and VAS scale


Eligibility Criteria:
Inclusion Criteria:

* PIC
* \>= 18 years at time of enrolment
* Diagnosis of a digestive obstruction of malignant origin
* Diagnosis of peritoneal carcinomatosis confirmed by a ct scan within the previous 3 months
* Inoperability as decided after surgical consultation

Exclusion Criteria:

* Operable obstruction
* Bowel obstruction that can be explained by a non malignant cause
* Signs of bowel obstruction
* Prior treatment with somatostatin analogues within the previous 60 days
* Known hypersensitivity to any of the test materials or related compounds
* Previous enrolment in this study
A New Parameter Derived From DSA to Evaluate Cerebral Perfusion

This observational study focus on a new parameter of cerebral perfusion derived form digital substraction angiography.

Ischemic cerebrovascular disease is an important cause of death and disability in the world. Digital Subtraction Angiography (DSA) is the golden index for evaluating cerebral blood vessels. We introduced a new parameter derived from DSA to evaluate the perfusion to predict the outcomes in acute stroke with large vessel occlusion.

To study the possible relationship between the new parameter of cerebral perfusion derived from DSA and outcomes in cerebral ischemia（modified Rankin Scale）, we intend to retrospectively analyze the images derived from patients who undergone the DSA and follow-up outcomes（modified Rankin Scale）.

Eligibility Criteria:
Inclusion Criteria:

1. Cerebral ischemia
2. patients undergone DSA

Exclusion Criteria:

1.cerebral hemorrhage
Comparison of Hyaluronic Acid and Corticosteroid Intra-articular Injections for the Treatment of Osteoarthritis of the Hip

Abstract Background: The effect of intra-articular treatment of hip osteoarthritis with hyaluronic acid in the hip joint is not based on large randomized controlled trials. Hyaluronic acid is a well established treatment for osteoarthritis of the knee.

Methods: Randomized controlled trial with three-armed parallel-group design. The patients meeting the inclusion criteria will be randomized into one of the following groups: infiltration of the hip joint with hyaluronic acid, with corticosteroids or with bupivacaine 0,125%.

Pain VAS, Harris Hip Score and HOOS were scored during follow-up. The patients will be asked to determine their situation as worse, stabile or better then at the time of enrollment. There will be asked if they use painkillers and if they have complications/adverse events. These outcome measure instruments will be used at the time of enrollment in the study prior to any injection, and then again at six weeks, 3 and 6 months after the initial injection. The six-month follow-up period begins for all patients on the date the first injection will be administered.


Eligibility Criteria:
Inclusion Criteria:

1. an age between 30 and 70years
2. radiographic evidence of OA of the hip (Kellgren-Lawrence grading scale 1-3)
3. chronic pain for at least 3 months prior to study entry (day 0)
4. dissatisfaction with prior attempts at non-operative management including nonsteroidal anti-inflammatory drugs.

Exclusion Criteria:

1. Kellgren and Lawrence grade 4
2. an intra-articular hip injection (with any corticosteroid, hyaluronic acid preparation or other) within the previous three months
3. non compliance to the study procedures and or non completion of the study according to investigator's judgment
4. rapid destructive hip.
5. a history of crystalline arthropathy or inflammatory arthritis, neuropathic arthropathy
6. a current other problem in the affected extremity
7. contra-indications for the use of corticosteroids (gastrointestinal ulcer, severe osteoporosis, psychiatric anamnesis, herpes simplex or zoster (viremic stadium), varicella, 8 weeks before and 2 weeks after immunization, systemic mycosis, poliomyelitic except of bulbar encephalitic form lymphadenitis after BCG-vaccination, parenteral depot medication, closed- and wide-angle glaucoma)
8. allergy or hypersensitivity to any of the study medications or to contrast solutions.
Comparison of Non-invasive Methods of Lung Ventilation in Patients With Respiratory Failure After Cardiac Surgery

Comparison of the effectiveness of three methods of non-invasive ventilation in patients with mild and moderate respiratory failure in the early postoperative period after cardiac surgery

The study includes the comparison of the three methods of non-invasive ventilation: non-invasive mask ventilation, high-flow oxygen therapy through a nasal cannula (high-flow nasal oxygenation) and non-invasive ventilation with a helmet in patients with mild and moderate respiratory failure in the early postoperative period after cardiac surgery. It assumes 90 randomized patients:30 patients in three study groups male and female aged 30 to 60 years of age inclusive, with mild or moderate respiratory failure.The study will be randomized, single-center, prospective.

Eligibility Criteria:
Inclusion Criteria:

1. Age from 30 years to 60 years inclusive
2. Decreased oxygenation function of the lungs (SpO2 less than 90%, PaO2/FiO2 less than 300, BH less than 25 per minute)
3. By data CT/x-ray examination of hypoventilation zones (pneumonia, atelectasis)
4. Consent the patient to participate in this study

Exclusion Criteria:

1. Tracheal intubation, absence of independent breathing
2. Unstable hemodynamics or hemodynamically significant rhythm disturbances
3. Acute violation of the cerebral blood supply
4. Shocks of various etiologies
5. Impossibility provide respiratory protection , high risk of aspiration
6. Lack of productive contact with the patient
7. Patient's refusal to participate in this study
Dutch Multidomain Lifestyle Intervention in Older Adults at Risk of Cognitive Decline

FINGER-NL is a multi-center, randomized, controlled, multidomain lifestyle intervention trial among 1,206 older adults at risk for cognitive decline with a duration of 24 months. Participants are randomized in a 1:1 ratio to a personalized multi-domain lifestyle intervention (high-intensity intervention group) versus online access to general lifestyle-related health information (low-intensity intervention group). After the intervention period, participants are invited for a 24 month extension of follow-up.


Eligibility Criteria:
Inclusion Criteria:

* 60-79 years of age at pre-screening;
* Adequate fluency in Dutch to understand the informed consent and complete questionnaires;
* Providing informed consent to all study procedures;
* Internet access at home;
* Presence of ≥3 self-reported risk factors for cognitive decline (must contain at least 2 modifiable risk factors and 1 non-modifiable riskfactor).

Exclusion Criteria:

* Diagnosis of dementia or mild cognitive impairment at baseline (self-reported);
* Significant cognitive impairment assessed using the Modified Telephone Interview for Cognitive Status battery (TICSm score\<23);
* Conditions affecting safe and continuous engagement in the intervention (e.g. under treatment for current malignant diseases, major psychiatric disorders (e.g. major depression, psychosis, bipolar disorder), neurological disorders (e.g. Parkinson's disease, multiple sclerosis), symptomatic cardiovascular disease (e.g. stroke, angina pectoris, heart failure, myocardial infarction), re-vascularization within three months, severe loss of vision, hearing or communicative ability, severe mobility impairment, other conditions preventing co-operation) as judged by the local study nurse or consulted physician at the local study site;
* Coincident participation in any other intervention trial at time of pre-screening.
* Coincident participation of spouse in FINGER-NL trial.
AMD 3100 for Treatment of Myelokathexis

This is an initial study to determine if CXCR4 inhibitor AMD 3100 or plerixafor may be a potential treatment for neutropenia due to CXCR4 mutations, the myelokathexis or WHIM (warts, hypogammaglobulinemia, immunodeficiency and myelokathexis) syndrome. This is the initial study of this concept and will involve up to 6 patients to receive increasing doses of plerixafor administered subcutaneously or on an alternate day basis. It is unknown if these patients will be highly sensitive to a blockade of CXCR4 activity and release more white blood cells than normal volunteers or cancer patients given the same dose of this drug. Therefore doses will begin at a level 12 fold less than currently used to mobilize stem cells and will be increased stepwise to achieve an acceptable circulating level of neutrophils.

This is an open label, single Center, phase I study to examine the hematological effects, pharmacokinetics and safety of plerixafor in patients with myelokathexis attributable to mutations of CXCR4, utilizing serial, escalating doses of plerixafor administered on days 1, 3, 5, 8, and 10. Five intrapatient escalating dose levels, 20 micrograms per kilogram (mcg/kg), 40 micrograms/kilogram(mcg/kg), 80 micrograms/kilogram(mcg/kg), and 240 micrograms/kilogram (mcg/kg)will be examined. The subjects will be patients at the University of Washington General Clinical Research Center for up to 10 days; the study requires subject be available for up to 14 days. Patients will be monitored for hematological effects of plerixafor and observed for adverse effects. If a normal blood neutrophil count is achieved and maintained for at least 24 hours prior to the highest dose, we will stop at that level.

Eligibility Criteria:
Inclusion Criteria:

* age over 18 years, WBC (white blood count) less than 3.0 x 10\^9 per Liter,
* Absolute neutrophil count less than 2.0 x 10\^9 per Liter,
* platelets greater than 100 x 10\^6 per Liter, creatinine less than 2.0/milligrams per/deciliter,
* Creatinine clearance \> 60 ml/min calculated,
* Aspartate Aminotransferase-GOT (SGOT), Alanin Aminotransferase-GPT (SGPT), bilirubin \< 2.5 upper limit of normal,
* Eastern Cooperative Oncology Group (ECOG) status 0 or 1,
* mutation identified and confirmed in CXCR4,
* on no granulocyte-colony stimulating factor (G-CSF), granulocyte-macrophage-colony stimulating factor (GM-CSF) within 3 weeks of the study drug
* patient signs consent, accepts contraception

Exclusion Criteria:

* greater than 18 years of age,
* sensitivity to plerixafor,
* pregnant,
* prisoner,
* decisionally impaired,
* judged unlikely to comply,
* illness that may interfere with interpretation of results,
* leukemia,
* malignancy,
* active infection requiring antibiotics within one week of study drug administration,
* history of cardiac conduction or electrocardiogram (EKG) abnormality,
* previous experimental therapy within one week.
Hemodynamic Effects of Negative Pressure Ventilation in Chronic Obstructive Pulmonary Disease

Negative pressure ventilation (NPV) is a non-invasive ventilation mode which provide better lung expansion. The major complication of NPV is decrease blood pressure and affects the hemodynamics. The effects of NPV on chronic obstructive pulmonary disease (COPD) patients with pulmonary rehabilitation program remains unknown.

Both of NPV or positive pressure ventilation (PPV) has impact of hemodynamics. NPV with cuirass ventilator increases venous return and leads to ventricular filling and increases cardiac output (CO); In contrast to NPV, the effect of PPV in most situations is a decreased venous return and leads to decreased CO. NPV improving ventilation and work of breathing in patients with chronic obstructive pulmonary disease (COPD).

Eligibility Criteria:
Inclusion Criteria:

* Patients with COPD who received pulmonary rehabilitation program with NPV treatment

Exclusion Criteria:

* Recent exacerbation within 3-months
* Existing of tracheostomy
* Absence of NPV used
* Required of oxygen supplement during NPV
* Diagnosed of neuromuscular disease
Point-of-Care Testing in Outpatient Diabetes Care

Using a point-of-care (POC) platform, the investigators will investigate the effects of POC testing for glycated hemoglobin (HbA1c) and cystatin C at out-patient clinics on long-term diabetes outcomes.

Laboratory testing for HbA1c and cystatin C is time-consuming, and healthcare providers often do not have update results when they evaluate outpatients with diabetes. A POC testing platform may help address this issue, and the investigators aim to examine its effects on diabetes outcomes.

Eligibility Criteria:
Inclusion Criteria:

-Adults aged 18 to 80 receiving treatment and follow-up for diabetes at outpatient clinics of Taichung Veterans General Hospital, Taichung, Taiwan.

Exclusion Criteria:

1. Past medical history of hemolytic anemia, hemoglobinopathies (sickle cell anemia HbS, fetal hemoglobin HbF), iron deficiency anemia, thalassemia, pernicious anemia, recent blood transfusions, acute bleeding requiring erythropoiesis-stimulating agents.
2. Chronic liver disease, cirrhosis, hyperbilirubinemia, asplenia (splenomegaly, splenectomy).
3. Hypertriglyceridemia (over 500 mg/dl), or alcoholism.
4. Thyroid dysfunction, active malignant tumors under treatment, HIV infection.
5. Long-term use (over three months) of steroids or cyclosporine.
6. Severe proteinuria (e.g., nephrotic syndrome), or a baseline eGFR \<60 ml/min/1.73 m².
Restless Leg Syndrome and Severe Preeclampsia

Restless Leg Syndrome is a common but not well recognized central nervous system disorder. It is more prevalent during pregnancy and, if present before pregnancy, can develop an exacerbation of symptoms. In some of the hypothesis trying to explain this syndrome, the physiopathology can also explain hypertensive disorders of pregnancy. So far, no study has been done trying to link both disorders.


Eligibility Criteria:
Inclusion Criteria:

* Gestational age between 24-34 weeks
* Severe preeclampsia

Exclusion Criteria:

* Neurological disorders (central nervous system)
Improved Language Acquisition With Levodopa

The purpose of this study is to determine whether the non-daily administration of levodopa is effective in boosting semantic language acquisition in healthy subjects.

Our prior work using a between-subject design shows that daily administration of d-amphetamine or the dopamine precursor levodopa over the course of five days markedly improves word learning success in healthy subjects. In this randomized, placebo-controlled, double-blind clinical trial, we probe whether the effect can be replicated using a within-subject design, with administration of levodopa and placebo on alternate days for a total period of 10 days.

The expected scientific results will strengthen the basis for transferring neuromodulatory interventions from the laboratory to stroke patients with language dysfunctions. Because of the heterogeneity of stroke patients, only a within-subject design can be used to probe the effects of pharmacological adjuncts to language therapy.

Eligibility Criteria:
Inclusion Criteria:

* Healthy subjects
* 20-35 years old
* Right handedness

Exclusion Criteria:

* Neurological/psychiatric/metabolic/cardiac disorders
* Asthma
* Known allergic reactions to one of the experimental drugs
* Other drugs affecting the central nervous system
* Leisure drug ingestion during the past 4 weeks (urine test)
* Smoking cessation during the past 2 weeks
* \> 6 cups of coffee or energy drinks per day
* \> 10 cigarettes per day
* \> 50 grams of alcohol per day
SDC for Lung Cancer Patients Treated With Curative Primary or Postoperative Radiotherapy or Chemoradiation

Introducing standardized data collection (SDC) for lung cancer patients to improve the performance of the prediction models.

All patients planned for curative primary or postoperative radiotherapy can be included. Patients will be treated according to the institutional protocol. It is optional to collect a saliva sample for genetic profiling.

Follow up at five time points:

* 2 weeks after RT
* 3 months after RT
* 6 months after RT
* 12 months after RT
* 24 months after RT

At these time points, toxicity will be assessed. In addition, patients will receive a short questionnaire by mail at eight time points.

Eligibility Criteria:
Inclusion Criteria:

* All patients planned for curatively intended radiotherapy or postoperative radiotherapy
* Recurrent disease

Exclusion Criteria:

* All patients planned for palliative radiotherapy
The Effect of Central Sensitization and Neuropathic Pain After Total Knee Arthroplasty

It has been well known that central sensitization (CS) is a risk factor for inferior outcomes following total knee arthroplasty (TKA). However, there are still insufficient studies on the relationship between CS and neuropathic pain (NP), and the effects of CS and NP on the patient-reported outcome measures (PROMs) of patients who underwent TKA. The purpose of this study was to investigate the relationship between CS and NP and whether CS and NP were associated with PROM in patients undergoing TKA.

A total of 312 patients who underwent primary TKA for end stage knee OA were enrolled. CS was defined as a patient with a score of 40 or higher using central sensitization inventory (CSI). NP was defined as a patient with a score of 12 or more using pain detect questionnaire (PDQ). PROMs were also evaluated based on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score preoperatively and at postoperative 1 year. The patients were divided into 4 groups, group 1 with CS and NP positive, group 2 with only CS positive, group 3 with only NP positive, and group 4 with CS and NP negative, and PROM was compared between the groups.

Eligibility Criteria:
Inclusion Criteria:

* Primary knee degenerative osteoarthritis
* Patients for total knee arthroplasty over the age of 60
* Patients with 2 year postoperative medical records

Exclusion Criteria:

* Rheumatoid arthritis
* Other inflammatory arthritis
* Neuropsychiatric patients
* Hepatic insufficiency
* Renal insufficiency
* Allergy or intolerance to study medications
* Patients with an acetylsalicylic acid of IV (angina, congestive heart failure, dementia, cerebrovascular accident)
* Chronic opioid use (taking opioids for longer than 3 months)
* Alcohol, drug abuser
* Narcotics addiction
Clinical Trial to Evaluate the Influence of Genotype on the Pharmacokinetics/Pharmacodynamics of Clopidogrel

This study has an open-label, five-period, single-sequence design. The purpose of this study is as follows;

1. Primary

   * To evaluate the influence of genotype of drug metabolizing enzyme or transporter on the pharmacokinetics/pharmacodynamics of clopidogrel
   * To evaluate the influence of aspirin on the pharmacokinetics/pharmacodynamics of clopidogrel
2. Secondary

   * To explore the representative biomarkers for the variable pharmacokinetics/pharmacodynamics of clopidogrel
   * To evaluate the influence of genotype of drug metabolizing enzyme or transporter on the drug-drug interactions between aspirin and clopidogrel
   * To explore the representative biomarkers for the drug-drug interactions between aspirin and clopidogrel


Eligibility Criteria:
Inclusion Criteria:

* 1. Healthy male subjects aged 20 - 45 years.
* 2. A body weight in the range of 50 kg (inclusive) - 90 kg (exclusive) and a body mass index (BMI) in the range 18.5 kg/m2 (inclusive) - 27 kg/m2 (inclusive).
* 3. Sufficient ability to understand the nature of the study and any hazards of participating in it. Provide written informed consent after being fully. informed about the study procedures.

Exclusion Criteria:

* 1. Presence or history of hypersensitivity or allergic reactions to drugs including investigational product (clopidogrel or aspirin)
* 2. Clinically relevant abnormal medical history that could interfere with the objectives of the study.
* 3. A subject with history of gastrointestinal disease or surgery (except simple appendectomy or repair of hernia), which can influence the absorption of the study drug.
* 4. A subject whose lab test results are as follows; Platelet count or PT, aPTT \< 0.9 x lower limit of reference range of \> 1.1 x upper limit of reference range.
* 5. A subject whose SBP is over 160 mmHg or below 90 mmHg and DBP is over 100 mmHg or below 50 mmHg.
* 6. Presence or history of drug abuse or positive result in urine drug screening test.
* 7. Participation in other clinical trial within 2 months before first dose.
* 8. Use of CYP inducer (ex. rifampin) within 4 weeks before first dose.
* 9. Use of a prescription medicine, herbal medicine within 2 weeks or over-the-counter medication or vitamin substances within 1 week before first dose.
* 10.Use of grapefruit juice within 1 week before first dose.
* 11. Blood donation during 2 months or apheresis during 1 month before the study.
* 12. Use of alcohol over 21 units/weeks
* 13. Smoking of more than 10 cigarettes/days within 3 months before first dose.
* 14. Subject judged not eligible for study participation by investigator.
Lifei Xiaoji Wan Treatment's of Early-stage NSCLC and Its Impact on the Tumor Microenvironment

This study evaluated the relationship between the clinical efficacy, histopathological changes and tumor microenvironment of the pharmacopharmacologic Lifei Xiaoji Wan in the treatment of early stage lung adenocarcinoma, and improved high-level clinical evidence and action targets for the prevention and treatment of early stage lung cancer by traditional Chinese medicine

Lung cancer is a malignant tumor with the highest morbidity and mortality. The microenvironment of tumor plays an important role in its occurrence and development.Traditional Chinese medicine has great advantages in the prevention and treatment of ground glass pulmonary nodules, but there is a lack of high-level clinical evaluation evidence and precise mechanism of action.Lifei Xiaoji Wan is a prescription based on the theory of "gas accumulation causing cancer". It has good curative effect in treating non-small cell lung cancer.

In this study, a single-center randomized controlled study was used to set up a treatment group and a control group to observe and evaluate the clinical efficacy of Lifeixiaoji pills on patients with early stage lung adenocarcinoma of ground glass nodules. Flow cytometry, PCR array and multiple fluorescence immunofluorescence were used to detect the tumor microenvironment in lung cancer tissues. To investigate the effect of Lifeixiaoji pill on tumor microenvironment and its mechanism of action on early lung adenocarcinoma.

Eligibility Criteria:
Inclusion Criteria:

* It met the diagnostic criteria of non-small cell lung cancer and was confirmed by pathology, cytology and other relevant examinations.
* Preoperative thin-slice CT showed pure ground glass pulmonary nodules with a size of 10mm-30mm. Intraoperative and postoperative pathology indicated adenocarcinoma, and the tumor stage (TNM) was stage Ia.
* Age: 18-75 years old
* Expected survival \>5 years
* Informed consent and sign informed consent

Exclusion Criteria:

* Patients who have undergone surgery
* Patients with serious dysfunction of heart, liver, lung, kidney and other important organs
* Patients with mental illness who were unable to complete the study