louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00327223: Safety Study of Imexon Treatment of Patients With Metastatic or Disseminated Malignancy
Official title: A Phase 1 Trial of Amplimexon® (Imexon, Inj.) Administered Daily for 5 Days Every 3 Weeks to Patients With Metastatic Cancer or Disseminated Malignancy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Neoplasm Metastasis
Keywords: Metastatic cancer
Disseminated malignant disease
Lead sponsor: AmpliMed Corporation
Sponsor class: INDUSTRY
First posted: 2006-05-18
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: AMP-011 is a Phase 1 study designed to extend the understanding of the toxicity and pharmacology of imexon by investigating a schedule of daily treatment for 5 days every three weeks. The objective of the study is to determine the maximally tolerated dose, the pharmacokinetics, and the toxicity of the drug on the designated schedule.


Eligibility criteria: Inclusion Criteria:

* Previously treated malignant disease of any type.
* Prior treatment; at least one prior regimen required.
* Able to perform the activities of daily living.
* Off prior cancer therapy for at least 4 weeks.
* If female, neither pregnant nor nursing.
* Willing to use contraceptives to prevent pregnancy.
* No other serious illnesses.
* No other active malignancy.
* No serious infections.
* No other current drug therapy for the cancer.
* Blood counts and blood chemistries in or near normal range.
* Prior radiation is permitted.

Exclusion Criteria:

* No active brain metastases.

Primary outcomes:
measure: Determine the maximally tolerated dose
measure: determine the pharmacokinetics
measure: determine the toxicity of the drug on the designated schedule
Secondary outcomes:
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: US Oncology Indiana
state: Indiana
city: Albany
country: United States
facility: US Oncology Albany, New York Oncology
state: New York
city: Temple
country: United States
facility: Investigational Site 014
state: Texas
city: Tyler
country: United States
facility: US Oncology, Tyler Cancer Center
state: Texas
Study officials:
affiliation: AmpliMed Corporation
name: Evan Hersh, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00671723: Dornase Alpha Versus Hypertonic Saline for Lung Atelectasis in Non-Cystic Fibrosis Patients
Official title: Dornase Alpha Versus Hypertonic Saline for Lung Atelectasis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atelectasis
Keywords: Atelectasis
Lead sponsor: University of Oklahoma
Sponsor class: OTHER
First posted: 2008-05-05
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Despite the lack of trials proving the efficacy of DNase in non cystic fibrosis patients, it is currently heavily used in this population. In fact, per evidence of barcode scanning via Meditech computer system at OU Medical Center 93% of the DNase prescribed in 2005 was for non Cystic fibrosis patients with an estimated yearly cost of $341,968.15.In vitro studies showed that the effect of Dnase was minimal on sputum viscosity when compared to Hypertonic saline . Furthermore recent studies on hypertonic saline in cystic fibrosis patients showed that it is an inexpensive and safe therapy when preceded by a bronchodilator in patients with cystic fibrosis.

We hereby propose a prospective randomized trial to compare the efficacy of hypertonic saline, DNase, vs. normal saline in the treatment of atelectasis in non cystic fibrosis, mechanically ventilated patient.


Eligibility criteria: Inclusion Criteria:

1. Patient on invasive mechanical ventilation
2. New Onset (\<48 hours) lobar or multilobar lung atelectasis based on CXR

Exclusion Criteria:

1. Asthma
2. Severe COPD (FEV1\<30%)
3. Pneumothorax or massive pleural effusion, thought to be causing the atelectasis
4. Lobar atelectasis secondary to compressive tumor.
5. Severe hypoxemia (PaO2/FiO2 \< 75)
6. Hemodynamic Instability
7. Cystic fibrosis patients
8. Allergy to DNase
9. Patients on Acetylcysteine
10. Pregnant women

Primary outcomes:
measure: Change in the Chest X-ray Atelectasis Score
timeFrame: Baseline(Day 0) to Day 7
Secondary outcomes:
measure: Rate of Extubation
timeFrame: 7 days
Other outcomes:
Locations:
city: Oklahoma City
country: United States
facility: Presbyterian Hospital
state: Oklahoma
Study officials:
affiliation: University of Oklahoma
name: Jean Keddissi, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Youness HA, Mathews K, Elya MK, Kinasewitz GT, Keddissi JI. Dornase alpha compared to hypertonic saline for lung atelectasis in critically ill patients. J Aerosol Med Pulm Drug Deliv. 2012 Dec;25(6):342-8. doi: 10.1089/jamp.2011.0954. Epub 2012 Mar 13.
Clinical trial NCT02581423: A Study of Capecitabine (Xeloda) in the Adjuvant Treatment of Participants With Resected Colon Cancer
Official title: Phase IV Clinical Study of Safety and Tolerability of Oral Xeloda (Capecitabine) in Adjuvant Treatment of Resected Cancer of the Colon
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Colorectal Cancer
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2015-10-21
Enrollment: 63
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study will evaluate the safety and tolerability of capecitabine (Xeloda) in participants who have undergone surgery for colon cancer. Oral Xeloda will be administered twice daily in 3-week cycles for a total of up to 8 cycles. The anticipated time on study treatment is 24 weeks, and the target sample size is 70 individuals.


Eligibility criteria: Inclusion Criteria:

* Adults at least 18 years of age
* Curative surgery for Stage III colon cancer, performed 4 to 8 weeks before study entry

Exclusion Criteria:

* Macroscopic or microscopic residual tumor
* Evidence of metastatic disease including tumor cells in ascites
* Previous cytotoxic chemotherapy, radiotherapy, or immunotherapy for colon cancer
* Active cardiovascular disease
* Other malignancy within the last 5 years, other than curatively treated basal cell cancer of the skin or in situ cancer of the cervix
* Malabsorption syndrome or lack of physical integrity of the upper gastrointestinal tract

Primary outcomes:
measure: Incidence of adverse events (AEs)
timeFrame: Up to approximately 6 months
measure: Incidence of treatment discontinuation due to AEs
timeFrame: Up to approximately 6 months
Secondary outcomes:
measure: Incidence of toxocity-related dose reductions
timeFrame: Up to approximately 6 months
Other outcomes:
Locations:
city: Blagoevgrad
country: Bulgaria
city: Ruse
country: Bulgaria
city: Shumen
country: Bulgaria
city: Sofia
country: Bulgaria
city: Sofia
country: Bulgaria
city: Veliko Tarnovo
country: Bulgaria
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_CHAIR
References:
Clinical trial NCT03941223: Regional Anesthesia for Breast Surgery
Official title: A Prospective, Randomized Comparison Between Paravertebral and Pectoral Nerve Block on Postoperative Pain, Persistent Post Surgical Pain and Cancer Recurrence After Mastectomy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Breast Cancer
Keywords: breast cancer, regional anesthesia, cancer recurrence
Lead sponsor: Azienda USL Reggio Emilia - IRCCS
Sponsor class: OTHER_GOV
First posted: 2019-05-07
Enrollment: 150
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Patients scheduled for mastecotmy will be randomized to receive either an ultrasound-guided double space paravertebral block or a PECSII + parasternal block. In both groups, blocks will be performed with 20 ml of ropivacaine 0.75%, plus ropivacaine 0.375% 10 ml for parasternal block only.

Postoperative, all patients will receive a morphine PCA. They will follow at 6, 12, 24 months for persistent postoperative surgical pain (PPSP) and cancer recurrence.

Detailed description: Patients scheduled for mastecotmy with or without axillary dissection, will be randomized to receive preoperative either an ultrasound-guided double space paravertebral block or a PECSII + parasternal block. In both groups, blocks will be performed with 20 ml of ropivacaine 0.75%, plus ropivacaine 0.375% 10 ml for parasternal block only.

All the patients also received a general anesthesia induced by propofol and esmeron for endotracheal intubation and desflurane for maintaining.

Sensory block by ice and pinprick test application and maximum spread after 40' from LA injection will be registered.

Postoperative, all patients will receive a morphine PCA, ketorolac 30 mg/12h and paracetamol 1g each 8h.

Morphine consumption will be registered. Patients will follow at 6, 12, 24 months for persistent postoperative surgical pain (PPSP) and cancer recurrence.

Eligibility criteria: Inclusion Criteria:

* Patients scheduled for radical mastectomy for cancer.
* age \> 18 y-o
* Written informed consent

Exclusion Criteria:

* Bilateral surgery
* Opioids user
* BMI \> 35
* Postoperative Intensive care

Primary outcomes:
measure: Morphine requirement
timeFrame: 1 day
Secondary outcomes:
measure: postoperative pain
timeFrame: 2 days
measure: Persistent Postsurgical pain (PPSP)
timeFrame: 2 years
measure: cancer recurrence
timeFrame: 2 years
Other outcomes:
Locations:
city: Reggio Emilia
country: Italy
facility: AUSL IRCCS Reggio Emilia
Study officials:
affiliation: AUSL IRCCS Reggio Emilia, Italy
name: gianluca cappelleri, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05122923: Implementation of the S'TIM Serious-Game for Rehabilitation of Dysexecutive Disorders (S'TIM)
Official title: Implementation of the S'TIM Serious-Game for Rehabilitation of Dysexecutive Disorders
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Dysexecutive Syndrome
Serious Game
Lead sponsor: Ramsay Générale de Santé
Sponsor class: OTHER
Collaborators: name: European Clinical Trial Experts Network
First posted: 2021-11-17
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study proposes to improve the management of dysexecutive syndrome by a serious game (SG) in addition to the usual management including work in occupational therapy and neuropsychology.


Eligibility criteria: Inclusion Criteria:

* French-speaking male or female patient at least 18 years old
* Patient suffering from recent disorders (less than 6 months) of executive functions
* Patient with sufficient mobility of the upper limb (mobility of the dominant upper limb greater than 70 °) to interact with the device.
* Patient affiliated or beneficiary of a social security scheme
* Patient having signed the free and informed consent.

Exclusion Criteria:

* Patient participating in another clinical study
* Protected patient: adult under guardianship, curatorship or other legal protection, deprived of liberty by judicial or administrative decision,
* Pregnant or breastfeeding woman,
* Patient hospitalized without consent.
* Patient with unstable psychiatric disorders
* Patient with comprehension disorders (alexia, visual agnosia, illiteracy, not understanding the language, etc.)
* Patient with executive function disorders greater than 6 months
* Negligent hemi patient
* Patient not familiar with the French language
* Patient with major neuro-visual disorders.

Primary outcomes:
measure: The effect of using the serious-game S'TIM in terms of cognition
timeFrame: 6 weeks
measure: The effect of using the serious-game S'TIM at 6 weeks in terms of metacognition with the BRIEF-A
timeFrame: 6 weeks
measure: The effect of using the serious-game S'TIM at 6 weeks in terms of behavior with BRIEF-A
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Aubagne
country: France
facility: Clinique de Provence Bourbonne
Study officials:
References:
Clinical trial NCT00467623: Holotranscobalamin Remains Unchanged During Pregnancy
Official title: Holotranscobalamin Remains Unchanged During Pregnancy. Longitudinal Changes of Cobalamins and Its Binding Proteins During Pregnancy and Postpartum
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Vitamin B12 Deficiency
Keywords: Pregnancy
holotranscobalamin
cobalamin
vitamin B12 analogues
reference interval
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: University of Copenhagen
First posted: 2007-04-30
Enrollment: 150
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Time perspective: PROSPECTIVE

Brief summary: Background and objective: Plasma cobalamins decrease during pregnancy but it is not fully elucidated how this is reflected in the total and cobalamin saturated transport proteins, transcobalamin (total TC, holoTC) and haptocorrin (total HC, holoHC). TC transports cobalamin into the cells. The function of HC is unknown, but in contrast to TC it binds both cobalamins and cobalamin analogues.

Design and methods: Healthy pregnant women (N=141) had blood samples drawn at 18th, 32nd, 39th gestation week and 8 weeks postpartum. The protein moiety of TC and HC (total and holo) was measured by in-house ELISA methods.

Detailed description: Background and objective: Plasma cobalamins decrease during pregnancy but it is not fully elucidated how this is reflected in the total and cobalamin saturated transport proteins, transcobalamin (total TC, holoTC) and haptocorrin (total HC, holoHC). TC transports cobalamin into the cells. The function of HC is unknown, but in contrast to TC it binds both cobalamins and cobalamin analogues.

Design and methods: Healthy pregnant women (N=141) had blood samples drawn at 18th, 32nd, 39th gestation week and 8 weeks postpartum. The protein moiety of TC and HC (total and holo) was measured by in-house ELISA methods.

Eligibility criteria: Inclusion Criteria:

* Danish healthy Caucasian women \>18 years of age with previous uncomplicated pregnancies and deliveries and presently with a normal pregnancy.

Exclusion Criteria:

* \>4 cigarettes smoked per day,
* Treatment with vitamin B12, folic acid or acetyl salicylic acid,
* Impaired renal function and clinically significant vaginal haemorrhage before first visit as well as blood haemoglobin \<6.4 mmol/L at first visit.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Nils Milman
Study officials:
affiliation: University of Copenhagen
name: Nils Milman, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01482923: Tobacco Assessment and Intervention With Low-Income Persons Living With HIV-AIDS (PLWHA) in Community-Based AIDS Service Organizations
Official title: Feasibility of Tobacco Assessment and Intervention With Low-Income Persons Living With HIV-AIDS (PLWHA) in Community-Based AIDS Service Organizations
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Tobacco Cessation
HIV
AIDS
Keywords: Tobacco Use Assessment
smoke tobacco
quit smoking
tobacco cessation
HIV/AIDS
Community-Based Service Organizations
11-173
Low-Income Persons Living with HIV/AIDS
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
Collaborators: name: Gay Men's Health Crisis
name: The City College of New York
name: AIDS Center of Queens County
name: Bronx AIDS Services
name: North Jersey Community Research Initiative
First posted: 2011-12-01
Enrollment: 65
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: "Low-income smokers living with HIV/AIDS being served at community-based organizations."

Brief summary: "A treatment session especially for PLWHA to help them discuss and take action about their smoking may be useful."


Eligibility criteria: Inclusion Criteria:

* Age 18 years or older as per self-report;
* English speaking;
* New York or New Jersey State resident;
* HIV-positive serostatus direct referral from a CAB agency staff member, which verifies that the person is an HIV+ client, or by as verified by presentation of medical evidence (i.e.,confirmatory test result, ARV prescription, M11Q form, or lab results);
* Self-report of smoking \> or = to 20 cigarettes (\> or = to one pack) within the prior 7 days;
* To confirm smoking status, the carbon monoxide alveolar breath test must be \> or = to 10 ppm;
* To confirm cognitive functioning, score on the in-person BLESSED Exam must be \< or = to 10;
* Low income, defined by either: 1) Proof of Medicaid insurance, or 2) Self-report of income at 50% or below median income for New York State for New York State residents, or if a New Jersey resident, at or below 50% median income for New Jersey

Exclusion Criteria:

* Presence of current severe psychopathology that would limit study participation (e.g., unstable schizophrenia, bipolar disorder recent changes to medication noncompliance);
* Currently receiving smoking cessation treatment elsewhere.

Primary outcomes:
measure: Feasibility of a motivational tobacco cessation intervention
timeFrame: 2 years
Secondary outcomes:
measure: Estimate the differences between the experimental intervention
timeFrame: 2 years
Other outcomes:
Locations:
city: New York
country: United States
facility: City College of New York
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Jamie Ostroff, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03847623: Effect of Preoperative Curcumin in Breast Cancer Patients
Official title: Effect of Preoperative Curcumin in Breast Cancer Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Breast Cancer
Lead sponsor: University of Malaya
Sponsor class: OTHER
First posted: 2019-02-20
Enrollment: 30
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Effect of curcumin on modulation of immune and inflammatory parameters in pre-operative patients

Detailed description: Patients diagnosed with breast cancer will be supplemented with either curcumin or placebo for a minimum period of 2 weeks and may be extended up to 4 weeks prior to their surgery.

Eligibility criteria: Inclusion Criteria:

* Patients with operable breast cancer
* Life expectancy of at least 3 months
* Adequate organ function
* No allergy to curcumin
* Provides consent to participate in trial and adhere to the study protocol

Exclusion Criteria:

* Receiving concomitant radiotherapy, hormonal, immune therapy or other investigational drugs
* Uncontrolled concurrent illness
* Patient of anti platelet medications
* Pregnant / breast feeding
* Patients who are unable or unwilling to take curcumin, herbal remedies, or non-prescription medications
* Patients with bleeding tendency, bleeding disorders and abnormal bleeding/clotting profile

Primary outcomes:
measure: Tumour infiltrating lymphocytes (TILs)
timeFrame: For 2 to 4 weeks
Secondary outcomes:
measure: FOXP3
timeFrame: For 2 to 4 weeks
measure: CD68
timeFrame: For 2 to 4 weeks
Other outcomes:
Locations:
city: Kuala Lumpur
country: Malaysia
facility: University of Malaya Medical Center
Study officials:
affiliation: University of Malaya
name: Nur Aishah Taib, MBBS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06723223: Novel Combined Function Test for Patients on Peritoneal Dialysis
Official title: Clinical Validation of a Combined Equilibration Test in Patients on Peritoneal Dialysis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: End Stage Kidney Disease (ESRD)
Keywords: Peritoneal dialysis
Peritoneal equilibration test
CombiPET
Lead sponsor: Lund University
Sponsor class: OTHER
First posted: 2024-12-09
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Peritoneal membrane function tests such as the traditional peritoneal equilibrium test (PET) aid in the assessment of various peritoneal membrane functions, and are widely used in clinical practice to guide dialysis prescription, and also to monitor the integrity of the peritoneal membrane over time. Traditional tests do however have several shortcomings such as being time consuming, complex, and having a low reliability. Also, present functional tests often provide limited information such as small solute transfer rates, which means that other functional changes go unnoticed.

The present study investigates the reliability of a novel short (60 min) test, with the potential of replacing complex and time-consuming conventional tests. The novel test provides a comprehensive assessment on both water- and solute transfer across the peritoneal membrane, including the osmotic conductance to glucose (OCG), small solute diffusive conductance (in terms of the diffusive surface to diffusion length ratio, A0/Δx), and also macromolecular transport and apparent fluid absorption. In contrast to conventional tests, multiple fill volumes may be used and results are also applicable to all glucose strengths used in conventional peritoneal dialysis.


Eligibility criteria: Inclusion Criteria:

* Peritoneal dialysis treatment duration of at least 1 month
* No recent peritonitis (a minimum of 1 month since the last peritonitis)

Exclusion Criteria:

* Pregnancy
* Participant unable to provide informed consent
* Peritonitis
* Other acute infections

Primary outcomes:
measure: Reliability of the combined peritoneal equilibrium test
timeFrame: All interventions need to be completed within one month.
Secondary outcomes:
measure: Comparison of the Traditional vs. Combined Peritoneal Equilibrium Test
timeFrame: All interventions are performed within one month.
Other outcomes:
Locations:
city: Lund
country: Sweden
facility: Hemdialysmottagningen, Skånes Universitetssjukhus (SUS) Lund
Study officials:
affiliation: Lund University
name: Carl M Öberg, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: