louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00002119: A Phase I/II Clinical Study of WF 10 IV Solution ( TCDO ) in Patients With HIV Infection
Official title: A Phase I/II Clinical Study of WF 10 IV Solution ( TCDO ) in Patients With HIV Infection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: HIV Infections
Keywords: Acquired Immunodeficiency Syndrome
AIDS-Related Complex
Antiviral Agents
Lead sponsor: NIH AIDS Clinical Trials Information Service
Sponsor class: INDUSTRY
First posted: 2001-08-31
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: To evaluate the clinical toxicity, safety, and MTD of WF 10 ( TCDO ) intravenous solution administered to patients with HIV infection. To evaluate the potential anti-HIV activity of TCDO.


Eligibility criteria: Inclusion Criteria

Concurrent Medication:

Required:

* Aerosolized pentamidine (300 mg monthly) as prophylaxis for PCP only in patients with CD4 count \<= 200 cells/mm3.

Allowed:

* PCP prophylaxis with aerosolized pentamidine in patients with CD4 count \> 200 cells/mm3, only at the discretion of the treating physician.

Patients must have:

* HIV positivity.
* Absolute CD4 count of 150 - 500 cells/mm3.
* At least 6 months of prior zidovudine therapy.
* No active opportunistic infection requiring ongoing therapy.
* Life expectancy of at least 6 months.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

* Neoplasm other than basal cell carcinoma of the skin.
* Clinically significant cardiac disease.
* Abnormal neurological status by a standardized assessment including strength, reflex testing, and sensory testing.
* Unwilling to comply with protocol requirements.

Patients with the following prior conditions are excluded:

History of myocardial infarction or arrhythmias.

Prior Medication:

Excluded within 2 weeks prior to study entry:

* Antiretroviral agent or interferon.
* Systemic biologic response modifiers, corticosteroids, cytotoxic chemotherapeutic agents, or other drugs that can cause neutropenia or significant nephrotoxicity.
* Rifampin or rifampin derivatives.
* Systemic anti-infectives.

Required:

* At least 6 months of prior zidovudine. Active drug or alcohol abuse.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: Oncol Med Associates
state: Texas
Study officials:
References:
citation: Busch HW, Christensen S, Reichelt D, Jahn S, Zidek W. Treatment of HIV-infected patients with advanced symptomatic disease with WF10 solution (TCDO). Int Conf AIDS. 1994 Aug 7-12;10(1):204 (abstract no PB0245)
citation: Kahn JO, McGrath MS, Ching OM, Kuhne FW. A single center, phase 2 study evaluating the effects of WF10. Int Conf AIDS. 1998;12:349 (abstract no 22423)
citation: Raffanti SP, Schaffner W, Federspiel CF, Blackwell RB, Ching OA, Kuhne FW. Randomized, double-blind, placebo-controlled trial of the immune modulator WF10 in patients with advanced AIDS. Infection. 1998 Jul-Aug;26(4):202-7. doi: 10.1007/BF02962364.
Clinical trial NCT02326519: Electrical Signal Collection From a 20 Pole Catheter During Routine Cardiac Procedures
Official title: Electrical Signal Collection From a 20 Pole Catheter During Routine Cardiac Procedures
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiac Arrhythmias
Lead sponsor: Medtronic Cardiac Rhythm and Heart Failure
Sponsor class: INDUSTRY
First posted: 2014-12-29
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: Routine data collection will be conducted during normal sinus rhythm and AV synchronous pacing for approximately 20 minutes. The data collected will then be processed and the P, R and T wave amplitudes will be measured.

Detailed description: The purpose of this study is to collect atrio-ventricular electrograms using a sequence of tip-ring spacings in patients undergoing routine cardiac procedures (EP study, pacemaker/ICD/CRT implant). To collect these signals, a 20 pole catheter (Medtronic StableMapr intracardiac steerable electrode catheter) will be acutely placed in the RV apex during a routine cardiac procedure.

Routine data collection will be conducted during normal sinus rhythm and AV synchronous pacing for approximately 20 minutes. The data collected will then be processed and the P, R and T wave amplitudes will be measured.

Eligibility criteria: Inclusion Criteria:

* Subjects aged 18 or above, or of legal age to give consent specific to the national law of the countries in which the study is being conducted

  * Subjects who are undergoing a cardiac procedure where routine placement of cardiac catheter can be performed
  * Subjects are willing to provide Informed Consent

Exclusion Criteria:

* • Subject has exclusion criteria per local law and regulations (e.g. age, breast feeding, etc)

  * Any condition which precludes the subject's ability to comply with the study requirements
  * Subject has physical conditions that contraindicate the use of the device per approved labeling, including but not limited to active sepsis, known sensitivity to heparin, cannot undergo standard anticoagulation protocol for cardiac procedure, blood clotting abnormalities or a recent coagulopathy or embolic event, venous filtering device (Greenfield Filter) and obstructed or damaged vessel

Primary outcomes:
measure: The electrical signal mean amplitude (mv) during AV synchronous pacing.
timeFrame: 2 minutes during the procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Linz
country: Austria
facility: Allgemeines Krankenhaus der Stadt Linz
city: Bordeaux
country: France
facility: Hôpital Cardiologique du Haut-Lévêque
Study officials:
References:
Clinical trial NCT02749019: Dual Integrin αvβ3 and GRPR Targeting PET Imaging in Breast Cancer Patients
Official title: 68Ga-NOTA-BBN-RGD PET/CT in Breast Cancer Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Breast Cancer
Keywords: BBN-RGD
GRPR
integrin αvβ3
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
Collaborators: name: National Institute for Biomedical Imaging and Bioengineering (NIBIB)
First posted: 2016-04-22
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This is an open-label positron emission tomography/computed tomography (PET/CT) study to investigate the diagnostic performance and evaluation efficacy of 68Ga-NOTA-BBN-RGD in breast cancer patients. A single dose of 111-148 Mega-Becquerel (MBq) 68Ga-NOTA-BBN-RGD will be injected intravenously. Visual and semiquantitative method will be used to assess the PET/CT images.

Detailed description: Gastrin-releasing peptide receptor (GRPR) is a member of the G protein-coupled receptor family of bombesin receptors, which is over-expressed in various types of cancer cells, including prostate cancer, breast cancer, colorectal cancer, pancreatic cancer, glioma, lung cancer, ovarian cancers, endometrial cancers, renal cell cancer and gastrointestinal stromal tumors. BBN(7-14), with the amino acid sequence of Gln-Trp-Ala-Val-Gly-His-Leu-Met-NH2, has been extensively used for the development of molecular probes for the imaging of GRPR. On the other hand, the RGD moiety binds with integrin αvβ3 receptor, also plays an important role in the regulation of tumor growth, angiogenesis, local invasiveness, and metastatic potential in human breast cancer. To target both receptors, a heterodimeric peptide BBN-RGD was synthesized from bombesin(7-14) and c(RGDyK) through a glutamate linker and then labeled with 68Ga. An open-label whole-body PET/ CT study was designed to investigate the safety and dosimetry of 68Ga-NOTA-BBN-RGD and diagnostic performance of 68Ga-NOTA-BBN-RGD PET/CT in breast cancer patients.

Eligibility criteria: Inclusion Criteria:

* Neoplasm identified by X-ray, ultrasound or MRI as breast cancer
* To provide basic information and sign the written informed consent.

Exclusion Criteria:

* Consisted of conditions of mental illness;
* Severe liver or kidney disease with serum creatinine \> 3.0 mg/dl (270 μΜ) or any hepatic enzyme level 5 times or more than normal upper limit;
* Severe allergy or hypersensitivity to IV radiographic contrast
* Claustrophobia to accept the PET/CT scanning
* Pregnancy or breast feeding

Primary outcomes:
measure: Standardized uptake value of 68Ga-NOTA-BBN-RGD in breast cancer
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospital, Chinese Academy of Medical Science and Peking Union Medical College
state: Beijing
Study officials:
References:
Clinical trial NCT00506519: Recombinant Human Antithrombin (ATryn®) in the Treatment of Patients With DIC Associated With Severe Sepsis
Official title: Exploratory Efficacy and Safety, Pharmacokinetics and Dose Finding Study of ATryn® (Antithrombin Alfa) in Patients With Disseminated Intravascular Coagulation Associated With Severe Sepsis
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Disseminated Intravascular Coagulation
Keywords: DIC associated with severe sepsis
Lead sponsor: LEO Pharma
Sponsor class: INDUSTRY
First posted: 2007-07-25
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary objective of the study is to explore the efficacy and safety of ATryn® (antithrombin alfa) for the treatment of disseminated intravascular coagulation (DIC) associated with severe sepsis, when administered by continuous intravenous (IV) infusion over five days.


Eligibility criteria: Inclusion Criteria:

* Signed informed consent has been obtained from the patient or his/her legally acceptable representative
* Severe sepsis
* Disseminated intravascular coagulation

Primary outcomes:
measure: Patients Alive on Day 28, Having Had an Improvement in the DIC Score (Overt or Non-overt) by at Least 2 Points Between Baseline and Day 6 and Having Had no Worsening of the SOFA Score Between Baseline and Day 6.
timeFrame: Day 28
Secondary outcomes:
measure: Mortality at Day 28
timeFrame: Day 28
measure: Mortality at Day 90
timeFrame: Day 90
measure: Change From Baseline to Day 6 in SOFA Score Among Survivors on Day 6
timeFrame: Baseline to Day 6
measure: Change From Baseline to Day 6 in DIC Score Among Survivors on Day 6
timeFrame: Baseline to Day 6
measure: Days Alive and Out of ICU Day 28
timeFrame: Baseline to Day 28
measure: Days Alive and Out of Hospital Day 28
timeFrame: Baseline to Day 28
measure: Days Alive and Free of Inotrope/Vasopressor Support Day 28
timeFrame: Baseline to Day 28
measure: Days Alive and Off Ventilator Day 28
timeFrame: Baseline to Day 28
measure: Days Alive and Free of Need for Renal Replacement Therapy Day 28
timeFrame: Baseline to Day 28
measure: Change From Baseline to Day 6 in Inflammation Marker IL-6
timeFrame: Baseline to Day 6
measure: Change From Baseline to Day 6 in Inflammation Marker Procalcitonin
timeFrame: Baseline to Day 6
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02045719: Phase II Clinical Trial of Uncaria Tomentosa (Cat´s Claw) in Patients With Advanced Solid Tumors
Official title: Phase II Clinical Trial of Uncaria Tomentosa (Cat´s Claw) in Patients With Advanced Solid Tumors
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Solid Tumors
Keywords: cat´s claw
uncaria tomentosa
quality of life
no further therapeutic options
Lead sponsor: Faculdade de Medicina do ABC
Sponsor class: OTHER
First posted: 2014-01-27
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: Cat's claw (Uncaria tomentosa) is a native amazonic plant that exhibits anti-inflammatory and antitumor properties. Patients and methods: This prospective phase II study will assess the effects of a 100-mg dose of a dry extract of U. tomentosa three times per day on individuals with advanced solid tumors, with no further therapeutic options and with at least 2 months life expectancy. In addition, several biochemical and inflammatory parameters will be analyzed.


Eligibility criteria: Inclusion Criteria:

* individuals with advanced solid tumors, with no further therapeutic options and with at least 2 moths life expectancy
* individuals 18 years of age and older
* creatinine levels up to twice the upper limit of normal (ULN)
* alanine (ALT) and aspartate (ASP) transaminase levels up to twice the ULN and direct bilirubin (DB) levels up to 1.5 times the ULN
* in cases with pre-existing liver disease, the ALT, ASP and DB levels could be up to 2.5 times the ULN

Exclusion Criteria:

* pregnant and breastfeeding women
* individuals using chemotherapy or other tumor-targeting antineoplastic treatments, except for antalgic radiotherapy
* severe kidney or liver failure
* known hypersensitiveness to the components of the medication used
* past history of emotional disorders that could interfere with the data collection.

Primary outcomes:
measure: assessment of benefits on quality of life after treatment during two months
timeFrame: two months
Secondary outcomes:
Other outcomes:
Locations:
city: Santo André
country: Brazil
facility: Centro de Estudos e Pesquisa em Hematologia e Oncologia
state: São Paulo
Study officials:
References:
Clinical trial NCT04687319: RHEology of the Pulmonary MUcus
Official title: Protocol for the Collection of Lung Mucus Samples From Care for a Rheology Research Programme
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Bronchial Mucus in COPD and Cystic Fibrosis
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
Collaborators: name: University Grenoble Alps
First posted: 2020-12-29
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient consulting or hospitalised in the pneumology department and for whom an emission of bronchial mucus is planned as part of the treatment

Brief summary: Patients for whom bronchial mucus collection has been performed as part of the treatment will be offered the opportunity to participate in the study.

* A rheology measurement will be carried out shortly after the collection of fresh bronchial mucus samples.
* Another part will be done on frozen bronchial mucus samples


Eligibility criteria: Inclusion Criteria:

* Male or female over 18 years of age.
* Patient consulting or hospitalised in the pneumology department and for whom an emission of bronchial mucus is planned as part of the treatment (mucus from respiratory physiotherapy sessions for patients with cystic fibrosis or COPD, bronchial aspirations from the bronchial fibroscopy programme).

Exclusion Criteria:

* Patient being opposed to the use of his mucus samples and data for this research.
* Patient protected by law (guardianship or curatorship), subject deprived of liberty

Primary outcomes:
measure: Reproducibility of the rheology parameters studied
timeFrame: Day 1
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03623919: FallSensing Multiplayer Games for Fall Risk Prevention in Senior Care Centers
Official title: FallSensing Multiplayer Games for Fall Risk Prevention in Senior Care Centers
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Accidental Fall
Lead sponsor: Escola Superior de Tecnologia da Saúde de Coimbra
Sponsor class: OTHER
Collaborators: name: Sensing Future Technologies
name: Fraunhofer Portugal Research Center for Assistive Information and Communication Solutions
First posted: 2018-08-09
Enrollment: 30
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: Fall prevention programs should include strength and balance training, home hazard assessment and intervention, vision assessment and referral and also medication review with modification/withdrawal. Evidence exists that a tailored exercise program can reduce falls by as much as 54%.

The FallSensing games software include 3 mini-games to be played by two teams with up to 3 players each will compete against each other alternately.

The players will perform an initial evaluation with FallSensing screening tool, 16 sessions of group games (2 times a week/8weeks) with FallSensing multiplayer games and a final evaluation also with FallSensing screening tool.

Both initial and final evaluation include six functional tests (Grip Strength, Timed Up and Go, 30 seconds Sit-to-Stand, Step test, 4 Stage Balance test "modified" and 10 meters Walking Speed) and a questionnaire concerning self-efficacy for Exercise.


Eligibility criteria: Inclusion Criteria:

* adults aged 50 years or over;
* Community-dweller;
* independent to be standing and walking, with or without walking aids;
* interest to participate in the study.

Exclusion Criteria:

* individuals with severe sensorial impairments (deafness or blindness)
* individuals with cognitive impairments which precludes the ability to comprehend the questionnaire, functional tests and exercises included in the protocol.

Primary outcomes:
measure: 30 seconds Sit-to-Stand
timeFrame: Change from baseline 30 seconds Sit-to-Stand score up to 8 weeks
measure: 4 Stage Balance Test "Modified"
timeFrame: Change from baseline 4 Stage Balance Test "Modified" score up to 8 weeks
measure: Self-efficacy for Exercise
timeFrame: Change from baseline Self-efficacy for exercise score up to 8 weeks
Secondary outcomes:
measure: Timed Up and Go
timeFrame: Outset and up to 8 weeks
measure: Grip Strength
timeFrame: Outset and up to 8 weeks
measure: Step Test
timeFrame: Outset and up to 8 weeks
measure: 10 meters Walking Speed
timeFrame: Outset and up to 8 weeks
Other outcomes:
Locations:
city: Coimbra
country: Portugal
facility: Escola Superior de Tecnologia da Saúde de Coimbra
Study officials:
References:
Clinical trial NCT00357019: Study of the Clinical and Biological Efficacity of NAAXIA SINE® in Vernal Keratoconjunctivitis
Official title: Study of the Clinical and Biological Efficacity of NAAXIA SINE® in Vernal Keratoconjunctivitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Keratoconjunctivitis, Vernal
Lead sponsor: Laboratoires Thea
Sponsor class: INDUSTRY
First posted: 2006-07-27
Sex: ALL
Minimum age (years): 4
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To assess the clinical and biological efficacity of preservative free NAAGA eyes drops in vernal keratoconjunctivitis

Detailed description: The objective of this pilot study is to evaluate the clinical and biological efficacy of preservative free NAAGA eyedrops in VKC -by in particular the levels of ECP and MPO in tears- comparatively to the activity of levocabastine eyedrops.

Eligibility criteria: Inclusion Criteria:

* Patients with vernal keratoconjunctivitis,
* mild or moderate : clinical score \>3 and \<= 14, calculated from 4 major symptoms (itching, tearing, photophobia, foreign body sensation) and 6 major clinical signs (conjunctival erythema, conjunctival chemosis, discharge, papillae, limbal infiltrates and corneal epithelial disease)
* age \>= 4 years old

Exclusion Criteria:

* no occurrence of ocular trauma or infection (within the 3 months preceding the study),
* no ocular medical treatment (topical or not) within the 5 days preceding the study,
* no ocular laser (within the 3 previous months),
* no ocular surgery (within the previous year),
* patient who signs the informed consent form (or his/her parents or legal guardian in the case of underage patient).

Primary outcomes:
measure: ECP tear concentration
Secondary outcomes:
measure: Tolerance
Other outcomes:
Locations:
Study officials:
affiliation: Clinica Oculistica, Padova (Italy)
name: Andréa LEONARDI, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Leonardi A, Bremond-Gignac D, Bortolotti M, Violato D, Pouliquen P, Delval L, Grouin JM, Fregona IA. Clinical and biological efficacy of preservative-free NAAGA eye-drops versus levocabastine eye-drops in vernal keratoconjunctivitis patients. Br J Ophthalmol. 2007 Dec;91(12):1662-6. doi: 10.1136/bjo.2007.117515. Epub 2007 Jun 21.
Clinical trial NCT02004119: Phase 2 Study of KHK4577
Official title: Randomized Double-blind Placebo-controlled Study of KHK4577 in Patients With Atopic Dermatitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Atopic Dermatitis
Lead sponsor: Kyowa Kirin Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2013-12-06
Enrollment: 93
Sex: ALL
Minimum age (years): 20
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is an randomized double-blind placebo-controlled study to evaluate the efficacy and the safety of oral KHK4577 for 6 weeks in patients with atopic dermatitis. Pharmacokinetics of KHK4577 will also be assessed.


Eligibility criteria: Inclusion Criteria:

* Subject has signed voluntarily the written informed consent form to participate in this study.
* Subject has been diagnosed as atopic dermatitis according to Guidelines for Management of Atopic Dermatitis (2009).
* Rajka \& Langeland criteria of \>/= 4.5 at screening visit
* Investigator's Global Assessment (IGA) score of \>/= 3 at screening visit

Exclusion Criteria:

* Evidence of skin disorders/conditions that would interfere with the assessment of the effect of the study drug.
* Subject received photochemotherapy or systemic immunosuppressants within 2 weeks prior to informed consent.
* Subject has any active infectious disease(except localized infection) which needs to treat with systemic antibiotics(eg. antibacterial, antifungal or antiviral drugs) within 4 weeks prior to informed consent.
* Subject has complications / history of drug abuse or alcoholism.
* Subject has drug allergy or history of allergic reaction to a drug medicine.
* Subject has a significant concurrent medical conditions as defined in the study protocol.
* Subject is breast-feeding, pregnant or planning to become pregnant in this study period.

Primary outcomes:
measure: Percent improvement from baseline in Eczema Area and Severity Index (EASI)
timeFrame: Pre-dose, Week 1,2,4 and 6
Secondary outcomes:
measure: Change from baseline in Investigator's Global Assessment score
timeFrame: Pre-dose, Week 1,2,4 and 6
measure: Dermatology Life Quality Index
timeFrame: Pre-dose, Week 1,2,4 and 6
measure: Visual Analog Scale (itching)
timeFrame: Pre-dose, Week 1,2,4 and 6
measure: Incidence of patients with adverse events
timeFrame: From Day 1 through Week 6
measure: Profile of pharmacokinetics of plasma KHK4577 concentration
timeFrame: pre-dose, Week 1,2,4 and 6
Other outcomes:
Locations:
city: Sapporo
country: Japan
facility: For additional information regarding investigative sites for this trial, contact Kyowa Hakko Kirin
state: Hokkaido
Study officials:
References: