louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00587847: Campath Maintenance in Chronic Lymphocytic Leukemia
Official title: Maintenance Alemtuzumab in Refractory Chronic Lymphocytic Leukemia
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Chronic Lymphocytic Leukemia
Keywords: leukemia
Lead sponsor: Northwell Health
Sponsor class: OTHER
Collaborators: name: Bayer
First posted: 2008-01-08
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a study designed to test whether giving campath (also known as alemtuzumab) on a maintenance schedule will prolong the time until the patient requires chemotherapy.

Detailed description: This is an open-label, single arm, proof-of-principle study of Campath (also known as alemtuzumab) maintenance therapy administered subcutaneously at varying intervals for up to 1 year. Ongoing prophylactic anti-infectives will be provided. Patients will be assessed for response every 2 months and for quality of life every 3 months while on treatment. Patients achieving a presumptive complete response will receive no further treatment but will be followed for response. Non-responding patients, with confirmed progressing disease following a minimum of 8 doses will be discontinued from treatment and followed for survival. Responding patients or patients with stable disease will undergo confirmatory assessment 2 months following their end-of-treatment assessment. If remission has occurred, patients will be followed off treatment until documented disease progression.

Eligibility criteria: Inclusion Criteria:

* Enrollment in this study is open to patients 18 years of age with confirmed chronic lymphocytic leukemia, a clinical response of stable disease or better to previous treatment, and an Eastern Cooperative Oncology Group performance status of 0-2

Exclusion Criteria:

* Treatment failure in more than 3 prior regimens
* Active secondary malignancy
* Central nervous system involvement with CLL
* History of significant allergic reaction to antibody therapies that required discontinuation of the antibody therapy
* History of HIV positivity
* Hepatitis C virus (HCV) positivity based upon core antigen testing
* Active infection, requiring treatment with antibiotic, antiviral, or antifungal agents
* Pregnancy or lactation
* Other severe, concurrent diseases or mental disorders

Primary outcomes:
measure: Time to Progression (Months)
timeFrame: Every 8 weeks
Secondary outcomes:
measure: Rate of Infections
timeFrame: Weekly then every 2 weeks then every 3 weeks
Other outcomes:
Locations:
city: New Hyde Park
country: United States
facility: Long Island Jewish Medical Center
state: New York
Study officials:
affiliation: Long Island Jewish Medical Center
name: Kanti R. Rai, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02151747: Testing BRCA 1/2 Mutation Using Next Generation Sequencing
Official title: Pilot Study of Validation of Testing BRCA 1/2 Mutation Using Next Generation Sequencing
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Neoplasms
Breast Cancer
Keywords: breast neoplasms, BRCA1, Sanger, NGS, Next generation sequencing
Lead sponsor: Severance Hospital
Sponsor class: OTHER
First posted: 2014-05-30
Enrollment: 12
Sex: ALL
Minimum age (years): 19
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with breast cancer

Brief summary: Testing BRCA 1/2 mutation is important for patients with breast cancer, and Sanger sequencing is a standard method to identify BRCA 1/2 mutation. Next generation sequencing (NGS) is a high-throughput parallel sequencing that can provide genetic information with high accuracy. NGS is a faster and cost-effective method to detect gene mutations compared to Sanger sequencing. In this study, we evaluated the clinical role of NGS testing for BRCA 1/2 compared to Sanger sequencing.


Eligibility criteria: Inclusion Criteria:

* Age \> 18
* Breast or ovarian cancer history in 2nd degree family members
* Male breast cancer
* Bilateral breast cancer
* Patient with breast cancer under 40 year of age
* Simultaneous breast and ovarian cancer
* Patients with epithelial ovarian cancer
* Breast cancer with other simultaneous extramammary malignancy

Exclusion Criteria:

-Patients who do not agree with testing BRCA 1/2 mutation

Primary outcomes:
measure: Overall Accuracy
timeFrame: 1 year
Secondary outcomes:
measure: Sensitivity, Specificity
timeFrame: 1 year
Other outcomes:
measure: False negative and false positive rates
timeFrame: 1 year
Locations:
city: Seoul
country: Korea, Republic of
facility: Yonsei University College of Medicine
Study officials:
affiliation: Yonsei University
name: Seung IL Kim, MD, phD
role: STUDY_DIRECTOR
affiliation: Yonsei University
name: JH Sohn, MD,phD
role: STUDY_DIRECTOR
affiliation: Yonsei University
name: Hyung Seok Park, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01686347: Epidural Analgesia and Troubles of Fetal Cardiaq Rythm : Effect of the Systemic Transfer of Ropivacaine and Sufentanil
Official title: Epidural Analgesia and Troubles of Fetal Cardiaq Rythm : Effect of the Systemic Transfer of Ropivacaine and Sufentanil
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Fetal Cardiac Rhythm Abnormalities
Keywords: epidural analgesia
fetal cardiac rythm
ropivacaine
sufentanil
Lead sponsor: University Hospital, Rouen
Sponsor class: OTHER
First posted: 2012-09-18
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The aim of the investigators study is to demonstrate the association between fetal cardiac rhythm abnormalies after epidural analgesia and the maternal systemic transfer of ropivacaine and/or sufentanil.


Eligibility criteria: Inclusion Criteria:

* 18 years old or more
* nulliparous

  _ one fetus
* head first
* spontaneous labor
* epidural analgesia
* no fetal cardiac rhythm abnormalies before the epidural analgesia
* no active management of labor during 30 minutes after the epidural analgesia induction
* at term
* signature of the consent form

Exclusion Criteria:

* pathological pregnancy
* low maternal blood pressure during the 30 minutes after the epidural analgesia
* uterin contraction which last for 5 minutes or more
* more than 6 uterin contractions during a 10 minutes period
* Ropivacaine contraindication
* sufentanil contraindication

Primary outcomes:
measure: Plasmatic concentrations compared maternal ropivacaine based on the presence of abnormal fetal heart rate
timeFrame: 1 day
Secondary outcomes:
measure: Plasmatic concentrations compared maternal sufentanil based on the presence of abnormal fetal heart rate
timeFrame: 1 day
Other outcomes:
Locations:
city: Rouen
country: France
facility: centre hospitalier universitaire de Rouen, Hopital Charles Nicolle
Study officials:
References:
Clinical trial NCT05813847: Herniorrhaphy for Postoperative Pain
Official title: A Randomized, Double-Blind, Placebo- and Active-Controlled Study to Evaluate the Efficacy and Safety of CPL-01 in the Management of Postoperative Pain After Open Inguinal Herniorrhaphy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Hernia, Inguinal
Lead sponsor: Cali Pharmaceuticals LLC
Sponsor class: INDUSTRY
First posted: 2023-04-14
Enrollment: 504
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: Subjects receive either CPL-01, positive control, or negative control after herniorrhaphy and are then followed.


Eligibility criteria: Inclusion Criteria:

* Able to sign Informed Consent
* Scheduled to have inguinal hernia repair
* Be a reasonably healthy adult 18 - 75 years of age
* Body mass index ≤ 39 kg/m2
* If biologically female, not pregnant or planning to become pregnant
* If biologically male, using acceptable birth control
* Be willing and able to complete study procedures

Exclusion Criteria:

* Previously inguinal herniorrhaphy
* Concurrent painful condition that may require analgesic treatment
* History or clinical manifestation of significant medical, neuropsychiatric, or other condition, significant abnormal clinical laboratory test value, or known bleeding abnormality that could preclude or impair study participation
* Clinically significant existing arrhythmia, bundle branch block or abnormal ECG, myocardial infarction, or coronary arterial bypass graft surgery within the prior 12 months
* History of malignant hyperthermia or glucose-6-phosphate dehydrogenase deficiency.
* Impaired liver function (e.g., alanine aminotransferase \[ALT\] \> 3 × upper limit of normal \[ULN\] or total bilirubin \> 2 × ULN), active hepatic disease, or cirrhosis.
* Impaired renal function (e.g., creatinine \> 1.5 × ULN).
* Malignancy in the past year
* Known or suspected daily use of opioids for 7 or more consecutive days within the previous 6 months.

Primary outcomes:
measure: Pain control
timeFrame: 72 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: Todd Bertoch
state: Utah
Study officials:
affiliation: Cali Biosciences
name: Erol Onel
role: STUDY_DIRECTOR
References:
Clinical trial NCT01656447: Scleroderma Registry & Repository At the Hospital for Special Surgery
Official title: The Scleroderma Registry & Repository
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Scleroderma
Keywords: Scleroderma
Scleroderma Registry
Hospital for Special Surgery Scleroderma
Lead sponsor: Hospital for Special Surgery, New York
Sponsor class: OTHER
First posted: 2012-08-03
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All individuals older than 18 years of age who have Scleroderma

Brief summary: The overall objective of the Scleroderma Registry is to support and promote the basic science and clinical research of this complex rheumatic disease at the Hospital for Special Surgery (HSS). The registry facilitates our understanding of the clinical features, pathobiology, genetics of Scleroderma. This will ultimately lead to a potential treatment for this currently untreatable condition.

Detailed description: What will be asked of you:

* Completion of 2 health questionnaires
* Donation of research bloods. This is optional, but encouraged (if possible).
* We also encourage patients who come for initial visits to return so follow-up data can be collected.

Benefits to Patients:

* The HSS Scleroderma Registry gives patients the opportunity to participate in observational research with the goal of improving the lives of patients in the future.
* By donating research bloods and providing clinical information, patients will help generate new knowledge about Scleroderma that can guide the treatment and care of patients afflicted with this rare disease.
* Patients will also receive a comprehensive, medical evaluation from an HSS physician who specializes in treating Scleroderma. He or she will provide guidance on treatment options and recommendations for current or upcoming clinical trials.
* Physicians will also make patients aware of the resources available to them, including support groups and educational programs.

Eligibility criteria: Inclusion Criteria:

* Individuals older than 18 years of age with Scleroderma

Exclusion Criteria:

* Individuals younger than 18 years of age
* Individuals older than 18 years of age without Scleroderma

Primary outcomes:
measure: Modified Rodnan Skin Score
timeFrame: Baseline & follow-up visits during regularly scheduled appointments for up to 5 years
Secondary outcomes:
measure: Scleroderma Health Assessment Questionnaire
timeFrame: Baseline & follow-up visits during regularly scheduled appointments for up to 5 years
measure: Short Form-36
timeFrame: Baseline & follow-up visits during regularly scheduled appointments for up to 5 years
Other outcomes:
Locations:
city: New York
country: United States
facility: Hospital for Special Surgery
state: New York
Study officials:
affiliation: Hospital for Special Surgery, New York
name: Robert F Spiera, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital for Special Surgery, New York
name: Jessica K Gordon, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06833047: Does Boredom Affect Mechanical Pain Thresholds
Official title: Does Boredom Affect Mechanical Pain Thresholds
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain Threshold
Healthy
Keywords: Pain Thresholds
Pain
Boredom
Lead sponsor: Linnaeus University
Sponsor class: OTHER
First posted: 2025-02-18
Enrollment: 120
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: PARALLEL
Intervention model description: Participants will be randomized to different conditions.
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to investigate if the feeling of boredom could influence mechanical pain thresholds.

Detailed description: Participants will be randomized into 3 different groups watching different short video-clips (2.30 min). The boredom group will watch a boring video about ploughing, the distraction control group will watch a positively valenced video, the control group will just wait for 2.30 min, without any instructions about what to think about. Pressure pain thresholds will be measured with an algometer before and after the video-clip interventions.

Eligibility criteria: Inclusion Criteria:

* No pain at the test session
* Swedish fluency.

Exclusion Criteria:

* Pain anywhere in the body during the test session
* known neurological disease.

Primary outcomes:
measure: Pressure pain thresholds
timeFrame: 30 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Växjö
country: Sweden
facility: Linnaeus University
Study officials:
References:
Clinical trial NCT04079647: Immune Checkpoint Inhibitor Therapy- Induced Endocrinopathy
Official title: Immune Checkpoint Inhibitor Therapy- Induced Endocrinopathy and Metabolic Diseases -a Case Series of Taiwanese Patients
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Endocrinopathy
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2019-09-06
Enrollment: 200
Sex: ALL
Minimum age (years): 20
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who receive immunotherapy in NTUH and develop endocrinopathy after therapy

Brief summary: To review cases from NTUH who developed endocrinopathy and metabolic diseases after immunotherapy, and statistically analyzed their age, clinical presentation, image findings, treatment and its response.

Detailed description: Immune checkpoint blockade-based immunotherapy is a new modality of cancer treatment with a unique mechanism that has gained increased numbers of indication and is now used in several cancer types. However, immune-related adverse events (irAEs) emerge as a new entity of diseases involving one or multiple organ systems. irAEs could result in interruption of immunotherapy, morbidities of patients or even death. Among various manifestations of irAEs, endocrinopathy and metabolic diseases are rare but important, and require prompt diagnosis and treatment to avoid life-threatening conditions.

Thus, we intend to review cases from NTUH who developed endocrinopathy and metabolic diseases after immunotherapy, and statistically analyzed their age, clinical presentation, image findings, treatment and its response. We will also review literatures to evaluate the difference and similarity from previous diagnostic and treatment experience.

Eligibility criteria: Inclusion Criteria:

* Patients who receive immunotherapy in NTUH and develop endocrinopathy after therapy

Exclusion Criteria:

* Patients less than 20 years old. Patients who are pregnant

Primary outcomes:
measure: Changes of endocrine profiles
timeFrame: 10 year
Secondary outcomes:
measure: Treatment response of the cancer after immunotherapy
timeFrame: 10 years
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Shyang-Rong Shih
Study officials:
affiliation: National Taiwan University Hospital
name: Shyang-Rong Shih, MD, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02423447: Comparison of the Airway Clearance Efficacy of Electro Flo 5000 and the G5 Flimm-Fighter in Patients With CF
Official title: Comparison of the Airway Clearance Efficacy of Electro Flo 5000 and the G5 Flimm-Fighter in Patients With Cystic Fibrosis (CF)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cystic Fibrosis
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2015-04-22
Enrollment: 25
Sex: ALL
Minimum age (years): 8
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: It is the goal of the proposed study to compare the efficacy, as assessed primarily by sputum weight, of these two different devices (the Electroflo 500 and the G5 Flimm-Fighter) for airway clearance (AC) in CF patients with mild to moderate lung disease, who have stable lung health and perform AC at home as part of their routine therapeutic regimen.

Detailed description: The investigators hope to enroll 25 patients with cystic fibrosis (with daily sputum production) in this study. It is the goal of the proposed study to compare the efficacy, as assessed primarily by sputum weight, of these two different devices (the Electroflo 500 and the G5 Flimm-Fighter) for airway clearance (AC) in CF patients with mild to moderate lung disease, who have stable lung health and perform AC at home as part of their routine therapeutic regimen.

Eligibility criteria: Inclusion Criteria:

1. Diagnosis of CF established by standard criteria (sweat chloride \> 60 mmol/L and/or two alleles affected by gene mutations know to be associated with CF).
2. Age older than 8 years.
3. Known to consistently produce sputum.
4. Currently on a home therapeutic regimen that includes some form of AC performed at least 1 time daily.
5. FEV1 \> 30%-predicted, and with stable lung function

Exclusion Criteria:

1. Hospitalization for CF pulmonary complications in the 1 months preceding enrollment.
2. Hemoptysis \> 60 cc in a single episode in the 4 weeks preceding enrollment.
3. Chronic chest pain.
4. Participation in another interventional clinical trial in the previous 30 days.

Primary outcomes:
measure: Wet Sputum Weight
timeFrame: End of study visit per intervention
measure: Dry Sputum Weight
timeFrame: End of study visit per intervention
measure: Pulmonary Function Measured as a Percent Predicted AFTER Therapy With Either ElectroFlo 5000 / G5.
timeFrame: End of study visit per intervention
Secondary outcomes:
measure: Pulmonary Function Measured as a Percent Predicted BEFORE Therapy With Either ElectroFlo 5000 / G5.
timeFrame: End of study visit per intervention
measure: PRO (Patient-reported Outcome)
timeFrame: End of study visit per intervention
Other outcomes:
Locations:
Study officials:
affiliation: Stanford University
name: Carlos Milla, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01857947: Prognosis Value of Pro-adrenomedullin in Acute Exacerbations of COPD in ER
Official title: Usefulness of Pro-adrenomedullin (MR proADM)as a Predictor of Outcome in Acute Exacerbations of COPD Visiting the Emergency Room
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pulmonary Disease, Chronic Obstructive Patients Admitted in Emergency Department for Acute Exacerbation
Keywords: AECOPD Mr ProADM Biomarkers ER Outcome
Lead sponsor: ThermoFisher Scientific Brahms Biomarkers France
Sponsor class: INDUSTRY
Collaborators: name: Assistance Publique - Hôpitaux de Paris
First posted: 2013-05-20
Enrollment: 370
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to determine whether pro-adrenomedullin (Mr proADM)in addition to clinical evaluation is effective to predict outcome of acute exacerbations of COPD patients visiting the emergency room(ER).

Detailed description: Acute exacerbation of COPD (AECOPD)are usual and frequent cause of admission in emergency room (ER). No validated clinical or biological predictor of evolution are available.

The main objective is to determine the prognosis value of Mr proADM in addition to the clinical risk stratification for AE COPD patients in ER.

Patients presenting with a AECOPD diagnosis in ER will have a blood sample collected and freezed at their admission. Mr proADM will be assessed at the end of the study. Clinicians in charge of patients will not have the result during the management of their patients. This study implies no change in the patients' management.

Data related to the patients'demographic,current exacerbation and basic COPD characteristics will be collected.

Eligibility criteria: Inclusion Criteria:

* patients \> 40 years old
* Acute exacerbation of COPD

Exclusion Criteria:

* Medico social conditions not allowing home discharge
* Other causes of Dyspnea: Pneumothorax, pulmonary embolism, pulmonary oedema, lung cancer
* Pneumonia on chest ray
* acute respiratory distress requiring immediate ICU transfer

Primary outcomes:
measure: composite outcome measure
timeFrame: at Day 30
Secondary outcomes:
measure: composite outcome
timeFrame: at Day 7 of ER admission
measure: correlation between Mr proADM and patients Severity
timeFrame: at Day 7 and Day 30 of ED admission
Other outcomes:
Locations:
city: Paris
country: France
facility: Hôpital Lariboisière
city: Paris
country: France
facility: Pitié Salpétrière Hospital
Study officials:
affiliation: Hotel Dieu Hospital Paris
name: Nicolas Roche, MD PHD
role: STUDY_CHAIR
affiliation: Hopital Bicêtre Le Krémlin Bicêtre
name: Martin Dres, MD
role: STUDY_DIRECTOR
affiliation: Pitié Salpétrière Hospital Paris
name: Pierre Hausfater, MD PHD
role: PRINCIPAL_INVESTIGATOR
References: