louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01993784: Study of Nimotuzumab to Treat Esophageal Squamous Cell Carcinoma.
Official title: Phase IIa Study of Nimotuzumab in Second or Late- Line Treatment of Patients With Locally Advanced or Metastatic Esophageal Squamous Cell Carcinomas
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Esophageal Squamous Cell Cancer
Lead sponsor: Peking University
Sponsor class: OTHER
First posted: 2013-11-25
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Nimotuzumab is an IgG1 humanized monoclonal antibody that recognized an epitope located in the extra cellular domain of the human epidermal growth factor receptor (EGFR). Clinical efficacy has been shown in adult with head and neck cancer. The study assessed the safety and efficacy of different dosage of Nimotuzumab in second or late- line treatment of patients with locally advanced or metastatic esophageal squamous cell carcinomas.


Eligibility criteria: Inclusion Criteria:

* Histologically confirmed esophageal squamous carcinoma,failed to first or second line chemothrepay
* Age 18 to 75 years old
* Measurable disease according to the RECIST criteria(diameter of the lesion should be more than 10mm by spiral CT or MRI, more than 20mm by common CT, the date of image should be less than 15 days before enrollment)
* Life expectancy of ≥3 month
* Karnofsky performance status ≥80
* WBC\>3,000/mm3, absolute neutrophil count ≥1500/mm3, platelet\>100,000/mm3, Hb\>9g/dl，Bilirubin level \< 1.0 times ULN，Serum creatinine \<1.0 times ULN，ALT and AST\<2.5 times ULN ，AKP \< 2.5 times ULN ，(≤5 times ULN in patients with liver metastases)(within 7 days before enrollment)
* No sever complication, such as active gastrointestinal bleeding, perforation, jaundice, obstruction, non-cancerous fever\>38℃；
* Normal ECG/cardiac function
* Good compliance
* Having signed informed consent -

Exclusion Criteria:

* No previous systemic therapy for metastatic esophageal squamous carcinoma
* Known hypersensitivity to study drugs
* Tumor with length≥10cm, liver metastasis covers more than 50% of liver,or lung metastasis covers more than 25% of lung
* No measurable lesions, eg. pleural fluid and ascites
* Only with Other previous malignancy within 5 year, except non-melanoma skin cancer
* Heart failure or other sever organ dysfunction, eg. coronary artery disease, myocardial infarction within the last 6 months only Brain or bone metastasis
* Chronic diarrhea
* Mentally abnormal or disable cognition,including CNS metastasis
* Pregnancy or lactation period

Primary outcomes:
measure: Objective response rate
timeFrame: 6 weeks
Secondary outcomes:
measure: adverse events
timeFrame: during the treatment in the hosptital,an expected average of 1 week
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University Cancer Hospital
state: Beijing
Study officials:
affiliation: Peking Universtiy Cancer Hospital
name: Lin Shen, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02626884: Ibrutinib in Relapsed Nodular Lymphocyte-predominant Hodgkin Lymphoma (NLPHL)
Official title: Ibrutinib in Relapsed Nodular Lymphocyte-predominant Hodgkin Lymphoma (NLPHL)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Nodular Lymphocyte-Predominant Hodgkin's Lymphoma
Lead sponsor: University of Cologne
Sponsor class: OTHER
First posted: 2015-12-10
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this trial is to determine

1. Disease stabilization/response rate after six 21-day cycles of ibrutinib
2. Remission status after six, twelve and 20 21-day cycles of ibrutinib


Eligibility criteria: Inclusion Criteria (key criteria):

1. Histologically proven relapsed nodular lymphocyte-predominant Hodgkin lymphoma (NLPHL) as confirmed by expert review
2. Age at entry 18-99 years
3. ECOG status 0-2
4. Absolute leukocyte count \> 2.500/mm3
5. Absolute neutrophil count \> 1.000/mm3 independent of growth factor support
6. Platelet count \> 100.000/mm3 or \> 50.000/mm3 in case of bone marrow involvement independent of transfusion support in either situation
7. GPT and GOT ≤ 3 x upper limit of normal (ULN)

Exclusion Criteria (key criteria):

1. Classical HL (cHL) or composite lymphoma
2. Known central nervous lymphoma
3. Prior Btk inhibitor treatment
4. Life expectancy \< 3 months
5. Major surgery within 4 weeks of study inclusion
6. History of stroke or intracranial hemorrhage within 6 months prior to the first study drug
7. Current anticoagulation with warfarin or equivalent vitamin K antagonists

Primary outcomes:
measure: Response Rate
timeFrame: after 6 cycles (each cycle is 21 days) of Ibrutinib
Secondary outcomes:
measure: Remission status
timeFrame: Remission status after six, twelve and 20 21-day cycles of ibrutinib
Other outcomes:
Locations:
city: Cologne
country: Germany
facility: 1st Department of Medicine, Cologne University Hospital
Study officials:
affiliation: University Hospital of Cologne
name: Andreas Engert, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00006402: Lifestyle, Adiposity and Cardiovascular Health in Youths
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiovascular Diseases
Heart Diseases
Obesity
Lead sponsor: National Heart, Lung, and Blood Institute (NHLBI)
Sponsor class: NIH
First posted: 2000-10-13
Sex: ALL
Minimum age (years): 15
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no

Brief summary: To determine the influences of diet and physical activity (PA) on total body fatness and regional fat distribution and the relationship of these to risk factors of cardiovascular disease during adolescence.

Detailed description: BACKGROUND:

Adult studies have shown that adiposity, especially visceral adipose tissue, and cardiovascular (CV) fitness are key links between lifestyle factors like diet and exercise on one hand, and CV disease on the other. However, very little is known about these links during the juvenile years, when the processes leading to CV disease are at an early stage of development.

The study is in response to a Program Announcement issued in March 1998 on Diet and Cardiovascular Disease Risk in Children and Adolescents. The Program Announcement, jointly issued by the National Institute of Nursing Research and the NHLBI, sought to encourage research relevant to the development and/or testing of dietary interventions to improve the cardiovascular disease (CVD) risk profiles in children and adolescents, especially those at increased risk for CVD or for development of CVD risk factors because of genetics, family history, socioeconomic status (SES), race/ethnicity, levels of blood cholesterol or blood pressure, or other factors.

DESIGN NARRATIVE:

The study determines the relations of free-living diet and exercise to total body percent fat ( percent BF), visceral adipose tissue and CV fitness in black and white boys and girls of varying socioeconomic status (SES). The study also determines the relations of fatness and fitness to different CVD risk factors. A total of 800 15 to 18 year olds, 200 in each ethnic and gender subgroup will be recruited. Diet will be assessed with seven 24-hour recalls, and exercise with two seven-day recalls and heart rate monitoring. Percent body fat will be measured with dual-energy x-ray absorptiometry, visceral adipose tissue with magnetic resonance imaging and CV fitness with a multi-stage treadmill test. Measurements will be made of major fatness- and fitness-related CV disease risk factors (e.g., total cholesterol:HDL cholesterol ratio, insulin, systolic blood pressure, left ventricular mass indexed to height, fibrinogen). Multivariate and univariate analyses will be conducted to determine relationships.

Eligibility criteria: No eligibility criteria

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Augusta University
name: Paule Barbeau
References:
citation: Litaker MS, Barbeau P, Humphries MC, Gutin B. Comparison of Hologic QDR-1000/W and 4500W DXA Scanners in 13- to 18-Year Olds. Obes Res. 2003 Dec;11(12):1545-52. doi: 10.1038/oby.2003.206.
Clinical trial NCT00892502: Can Treatment With Bismuth Reduce Toxicity to Chemotherapy and Radiotherapy?
Official title: Can Treatment With Bismuth Reduce Toxicity to Chemotherapy and Radiotherapy? A Clinical, Prospective, Randomized, Blinded Examination of Patients Suffering From Hematological Malignancies Treated With Intensive Chemotherapy and/or Radiotherapy.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hematological Diseases
Hematological Malignancies
Blood Diseases
Malignant Lymphoma
Leukemia
Multiple Myeloma
Keywords: haematology
haematological
hematology
hematological
malignancy
lymphoma
myeloma
leukemia
blood diseases
malignant
bismuth
Lead sponsor: Copenhagen University Hospital at Herlev
Sponsor class: OTHER
First posted: 2009-05-04
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether treatment with Bismuth can reduce the toxicity of chemotherapy and radiotherapy in patients with malignant diseases of the blood.


Eligibility criteria: Inclusion Criteria:

* Patients of 18 years or over referred to the Department of Haematology L, Herlev Hospital, with a view to 'cytostatic'? treatment of or radiotherapy for haematological malignancy

Exclusion Criteria:

* Pregnant women and nursing mothers
* No informed consent from patient
* Known hyper sensitivity to bismuth or other tablet content
* Severe renal insufficiency with creatinin clearance below 25 ml/min.
* Patients receiving other treatment for protection of the mucous membrane except cryo treatment of the oral cavity (lumps of ice in the mouth)
* Other experimental treatment within past four weeks.

Primary outcomes:
measure: To evaluate a possible protective effect of bismuth on the mucous membranes during chemotherapy and radiotherapy
timeFrame: daily during treatment
Secondary outcomes:
measure: To identify the effect of bismuth on the regulation of metallothionein in tumour tissue and healthy tissue, respectively
timeFrame: 6 months
Other outcomes:
Locations:
city: Herlev
country: Denmark
facility: Department of Haematology L, Herlev Hospital, Herlev Ringvej 75
Study officials:
affiliation: Department of Haematology, Copenhagen University Hospital at Herlev
name: Per B Hansen, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01887002: Study to Evaluate the Effects of ONO-2952 on Pain Perception Produced by Rectal Distention in Female Subjects With Diarrhea-Predominant Irritable Bowel Syndrome (IBS-D)
Official title: A Phase 2, Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled Study to Evaluate the Effects of ONO-2952 on Pain Perception Produced by Rectal Distention in Female Subjects With Diarrhea-Predominant Irritable Bowel Syndrome (IBS-D) (RESTORE)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Irritable Bowel Syndrome (IBS)
Keywords: Irritable Bowel Syndrome
IBS
ONO-2952
Lead sponsor: Ono Pharmaceutical Co. Ltd
Sponsor class: INDUSTRY
First posted: 2013-06-26
Enrollment: 39
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective is to evaluate whether ONO-2952 modulates visceral pain perception produced by rectal distention in female patients with IBS-D


Eligibility criteria: Inclusion Criteria:

1. Female 18-65 years of age (inclusive)
2. Diagnosed with IBS based on the following criteria (Rome III criteria):

   * Symptom onset at least 6 months prior to diagnosis, and
   * Recurrent abdominal pain or discomfort at least 3 days per month for the past 3 months, and
   * Abdominal discomfort or pain associated with two or more of the following at least 25% of the time:
   * improvement with defecation
   * onset associated with a change in frequency of stool/defecation
   * onset associated with a change in form (appearance) of stool
3. Diagnosed with IBS-D, defined as loose/watery stools ≥ 25% and hard/lumpy stools ≤ 25% of defecations

Exclusion Criteria:

* Any structural abnormality of the gastrointestinal (GI) tract (other than esophagitis or gastritis)
* History of Chron's disease, ulcerative colitis, diabetes mellitus, lactose malabsorption, malabsorption syndromes, celiac sprue, or any upper GI symptoms that may impact the assessment of IBS symptoms

Primary outcomes:
measure: Change in pain intensity rating during rectal distention by using a numeric pain rating scale
timeFrame: 2 weeks
Secondary outcomes:
measure: Safety assessed through adverse events and clinical laboratory values
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston Clinical Site
state: Massachusetts
city: St. Louis
country: United States
facility: St. Louis Clinical Site
state: Missouri
city: Chapel Hill
country: United States
facility: Chapel Hill Clinical Site
state: North Carolina
city: Oklahoma
country: United States
facility: Oklahoma City Clinical Site
state: Oklahoma
Study officials:
affiliation: Ono Pharmaceutical Co. Ltd
name: Ono Pharma USA, Inc.
role: STUDY_DIRECTOR
References:
Clinical trial NCT03595202: Clinical Study of TS-143 in Healthy Adult Male Subjects (Multiple-Dose Administration)
Official title: Phase I Clinical Study of TS-143 in Healthy Adult Male Subjects (Multiple-Dose Administration)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Participants
Lead sponsor: Taisho Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2018-07-23
Enrollment: 24
Sex: MALE
Minimum age (years): 20
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: BASIC_SCIENCE

Brief summary: To investigate the safety, pharmacokinetics and pharmacodynamics of TS-143 when administered 3 times a day for 10 days to healthy Japanese adult males using placebo-controlled, double-blind, dose escalation study design.


Eligibility criteria: Inclusion Criteria:

* Subjects with a BMI of 18.5 to less than 25.0 at the time of the screening tests
* Subjects judged by the principal investigator or a subinvestigator to be appropriate for participation in the study based on the results of the screening tests and the tests conducted before the investigational drug treatment on Day 1
* Subjects capable of receiving an explanation of this study before participation, understanding the details, and providing written informed consent themselves

Exclusion Criteria:

1. Subjects meeting any of the following criteria in the results of screening tests, tests conducted on the day before the first investigational treatment (Day -1), and tests conducted before the investigational drug treatment on the morning of Day 1:

   * Red blood cell count: ≥535 × 10\^4 /μL
   * Hemoglobin: ≥16.2 g/dL
   * Hematocrit: ≥47.5%
   * Reticulocyte rate: Outside of the reference value range
2. Subjects meeting any of the following criteria in the screening tests:

   * Serum EPO concentration: Outside of the reference value range
   * Ferritin: ≤30 ng/mL or \>upper limit of the reference value
3. Subjects meeting any of the following criteria in the vital signs in the screening tests and the tests conducted before the investigational drug treatment on the morning of Day 1:

   * Blood pressure: Systolic blood pressure ≥140 mmHg, or diastolic blood pressure ≥90 mmHg
   * Pulse rate: \<40 bpm, or ≥100 bpm
   * Body temperature: ≥37.5°C

Primary outcomes:
measure: Incidence of subjects with adverse events
timeFrame: 18 days
measure: Plasma concentrations of unchanged form (ng/mL)
timeFrame: 13 days
measure: Urinary excretions of unchanged form (ng/mL)
timeFrame: 12 days
measure: Serum EPO concentration
timeFrame: 13 days
measure: Reticulocyte count
timeFrame: 13 days
measure: Plasma vascular endothelial growth factor (VEGF) concentration
timeFrame: 13 days
measure: Serum iron (μg／dL)
timeFrame: 13 days
measure: Total iron binding capacity（μg／dL）
timeFrame: 13 days
Secondary outcomes:
Other outcomes:
Locations:
city: Tokyo
country: Japan
facility: Taisho Pharmaceutical Co., Ltd selected site
Study officials:
affiliation: Taisho Pharmaceutical Co., Ltd.
name: Shigeru Okuyama
role: STUDY_DIRECTOR
References:
Clinical trial NCT03371602: Study of the Combined Influence of Sepsis and Mechanical Ventilation on the Human Diaphragm
Official title: Study of the Combined Influence of Sepsis and Mechanical Ventilation on the Human Diaphragm
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Respiration, Artificial
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2017-12-13
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The aim of this study is to study the combined impact of mechanical ventilation and sepsis on the human diaphragm in order to establish the neutral, protective or destructive character of mechanical ventilation by studying the diameter of the fibers, activation of proteolytic systems, inhibition of protein synthesis, tissue inflammation as well as contractile function.


Eligibility criteria: Inclusion Criteria:

* Patient at least 18 years of age, male or female requiring abdominal or thoracic surgery or multi-organ sampling;
* Affiliated to a social security or similar system;
* Not subject to legal protection;
* Having given consent to participate in the study (or consent from the trusted person)
* Control group (C): non-septic mesocolic programmed abdominal or thoracic surgery: gastrectomy, esophagectomy, pancreatectomy, hepatectomy
* Sepsis group (S): Abdominal or thoracic surgery in a septic context (peritonitis, mediastinitis, pleural abscess)
* Group Mechanical Ventilation (MV): Patient in brain death for which a multi organ sample is planned
* Mechanical Ventilation + Sepsis (S-MV) group: Patient under controlled mechanical ventilation to undergo abdominal or thoracic surgery in a septic context (peritonitis, mediastinitis, pleural abscess)

Exclusion Criteria:

* Pregnant woman (diagnosis of interrogation)
* severe and / or unbalanced chronic respiratory disease; severe malnutrition
* Long-term corticosteroids\> 5mg / day for more than 1 month
* Myopathy
* surgery by laparoscopic

By group:

* Control group: Sepsis, preoperative controlled mechanical ventilation and preoperative hemodynamic instability
* Mechanical Ventilation Group: Sepsis, duration of controlled mechanical ventilation \<24 hours or\> 7 days
* Sepsis Group: Preoperatively controlled mechanical ventilation
* Mechanical Ventilation - Sepsis Group: duration of controlled mechanical ventilation \<24 hours or\> 7 days

Primary outcomes:
measure: Assessment of atrophy of the myofibers of the human diaphragm
timeFrame: day 0 (day of the surgery)
Secondary outcomes:
Other outcomes:
Locations:
city: Lyon
country: France
facility: Croix Rousse Hospital
Study officials:
affiliation: Hospices Civils de Lyon
name: Céline Guichon
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00155402: The Application of Fibrin Glue in Ocular Surface Diseases
Official title: Phase 1 Study of Applying Fibrin Glue in Patients With Corneal Ulcer or Patients Requiring Wound Closure by Suture
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: Pterygium
Corneal Ulcer
Keywords: fibrin glue
corneal perforation
pterygium
conjunctiva
corneal ulcer
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2005-09-12
Enrollment: 30
Sex: ALL
Minimum age (years): 3
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This clinical trial tries to use tissue fibrin glues (Tisseel) to treat various ocular surface diseases or surgeries, which includes pterygium surgery, corneal melting/perforation, Gunderson's flap, conjunctival laceration, and muscle/clinical/filtering surgery.

Detailed description: This clinical trial tries to use tissue fibrin glues (Tisseel) to treat various ocular surface diseases or surgeries. The inclusion criteria are:

1. ocular surface disease which may need amniotic membrane transplantation (corneal pro epithelization, pterygium surgery, etc)
2. infectious or noninfectious corneal ulcer with perforation less than 3 mm
3. conjunctival transplantation/suture
4. corneal surgeries which can be treated by conventional suture technique or application with cyanoacrylic acid tissue glues.

Informed consents will be obtained from the patients before applications. After surgeries, topical steroids and antibiotics will be used, and therapeutic contact lens will be used. The patients will be followed up for at least three months.

Eligibility criteria: Inclusion Criteria:

* Ocular surface diseases, which are expected to be treated by tissue fibrin glues

Exclusion Criteria:

* Pregnancy
* Children younger than 3 years old

Primary outcomes:
measure: cure of the diseases
timeFrame: 1week, 2 weeks, 3 weeks, 4 weeks
Secondary outcomes:
measure: integrity of the ocular surface
timeFrame: 1week, 2 weeks, 3 weeks, 4 weeks
measure: visual acuity
timeFrame: 1week, 2 weeks, 3 weeks, 4 weeks
Other outcomes:
Locations:
city: Taiwan
country: Taiwan
facility: Wei-Li Chen
Study officials:
affiliation: National Taiwan University Hospital
name: Fung-Rong Hu, MD
role: PRINCIPAL_INVESTIGATOR
References: