louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00002153: Topical Use of 4,4'-Dihydroxybenzophenone-2,4-Dinitrophenylhydrazone (A-007) in the Treatment of Advanced Malignancies Including Kaposi's Sarcoma and Lymphoproliferative Disorders
Official title: Topical Use of 4,4'-Dihydroxybenzophenone-2,4-Dinitrophenylhydrazone (A-007) in the Treatment of Advanced Malignancies Including Kaposi's Sarcoma and Lymphoproliferative Disorders
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Sarcoma, Kaposi
HIV Infections
Lymphoproliferative Disorders
Keywords: Skin Neoplasms
Sarcoma, Kaposi
Acquired Immunodeficiency Syndrome
Antineoplastic Agents
Lead sponsor: NIH AIDS Clinical Trials Information Service
Sponsor class: INDUSTRY
First posted: 2001-08-31
Enrollment: 25
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: To evaluate topical A-007 in patients with advanced malignancies including Kaposi's sarcoma and lymphoproliferative disorders.


Eligibility criteria: Inclusion Criteria

Concurrent Medication:

Allowed:

* Maintenance antihormones, hormones, and glucocorticoids.

Patients must have:

* Histologically proven metastatic cancer including Kaposi's sarcoma and lymphoproliferative disorders to the skin or cutaneous sites. NOTE:
* Primary basal or squamous cell cancer of the skin is allowed.
* Failed both primary and secondary chemotherapy and/or immunotherapy protocols.
* Measurable skin or cutaneous lesions. 4 Life expectancy of at least 20 weeks.

Prior Medication:

Required:

* Prior therapy for cutaneous lesions from Kaposi's sarcoma or lymphoproliferative disorders.

Allowed:

* Prior maintenance steroids and hormone/antihormone therapy.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

* Active infections other than medically stable HIV infection.
* Active congestive heart failure, any persistent arrhythmia or transient serious arrhythmia (ventricular tachycardia, sinoatrial arrest, etc.), or progressive cardiomyopathy.
* Unstable blood pressure.
* Seizures or other CNS disorders.
* Severe unstable diabetes mellitus.
* Coagulopathies.
* Thrombotic disease.
* Any other medical conditions that would prevent completion of study or produce significant risk to patient.

Concurrent Medication:

Excluded:

* Concomitant chemotherapy or immunotherapy.
* Ongoing corticosteroid therapy (unless maintenance).

Patients with the following prior conditions are excluded:

* History of active cardiopulmonary or respiratory disease.
* History of sun hypersensitivity and photosensitive dermatoses.
* History of allergy or hypersensitivity to cosmetics, toiletries, or other dermatological products.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: New Orleans
country: United States
facility: DEKK - TEC Inc
state: Louisiana
Study officials:
References:
Clinical trial NCT03202953: Comparison of Volume Controlled Ventilation With 1:1 Inspiratory to Expiratory Ratio and Autoflow-volume Controlled Ventilation in Robot-assisted Laparoscopic Radical Prostatectomy With Steep Trendelenburg Position and Pneumoperitoneum
Official title: Comparison of Volume Controlled Ventilation With 1:1 Inspiratory to Expiratory Ratio and Autoflow-volume Controlled Ventilation in Robot-assisted Laparoscopic Radical Prostatectomy With Steep Trendelenburg Position and Pneumoperitoneum
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Robot Assisted Laparoscopic Prostatectomy
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2017-06-29
Enrollment: 78
Sex: MALE
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 1. 1:1 I:E ratio VCV group
2. autoflow VCV group
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to compare the 1: 1 I: E ratio VCV and the autoflow VCV in patients undergoing robot assisted laparoscopic prostatectomy


Eligibility criteria: Inclusion Criteria:

1. adult (20-80 years old)
2. patients undergoing robot assisted laparoscopic prostatectomy

Exclusion Criteria:

1. history of COPD
2. decreased heart function (EF \<50%)
3. BMI\>30
4. patients who cannot read the consent form (e.g., blind, foreigner)

Primary outcomes:
measure: PaO2
timeFrame: 30 minutes after trendelenburg position
Secondary outcomes:
measure: PaO2
timeFrame: 10 minutes after induction (T1), 30 minutes after trendelenburg position (T2), 60 minutes after trendelenburg position (T3), 10 minutes after supine position (T4)
measure: End tidal CO2
timeFrame: 10 minutes after induction (T1), 30 minutes after trendelenburg position (T2), 60 minutes after trendelenburg position (T3), 10 minutes after supine position (T4)
measure: peak airway pressure
timeFrame: 10 minutes after induction (T1), 30 minutes after trendelenburg position (T2), 60 minutes after trendelenburg position (T3), 10 minutes after supine position (T4)
measure: blood pressure
timeFrame: 10 minutes after induction (T1), 30 minutes after trendelenburg position (T2), 60 minutes after trendelenburg position (T3), 10 minutes after supine position (T4)
measure: Arterial blood gas analysis
timeFrame: 10 minutes after induction (T1), 30 minutes after trendelenburg position (T2), 60 minutes after trendelenburg position (T3), 10 minutes after supine position (T4)
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine
Study officials:
References:
Clinical trial NCT00872053: Effect of Robot-assisted Training on Foot Drop in Multiple Sclerosis
Official title: Effect of Robot-assisted Training on Foot Drop in Multiple Sclerosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: MS (Multiple Sclerosis)
Keywords: robot
treadmill
foot drop
rehabilitation
gait
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2009-03-31
Enrollment: 18
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 primary aim of this study is to:

1. Collect pilot data on the effect of task-specific lower extremity training using the Anklebot on subjects with Multiple Sclerosis (MS) and who have foot drop;
2. Collect pilot data on the use of combination therapy on improving gait in subjects with MS. This therapy will use both Anklebot training and robot-assisted gait training.

Hypothesis: Both trainings will result in improved walking performance, but the combination therapy will result in greater gains than ankle training alone.


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of MS by McDonald criteria (McDonald, Compston et al. 2001). EDSS level between 3.5-5.5, who report ambulation problems.
* Presence of unilateral foot drop that is clinically apparent to the PI or PI designate.
* Must be able to ambulate 25 feet without an assisting device.

Exclusion Criteria:

* Cardiovascular: recent MI \< 4 wk, uncontrolled HTN \>190/110 mmHg.
* History of uncontrolled diabetes.
* Symptoms of orthostasis when standing up.
* Circulatory problems, history of vascular claudication or pitting edema.
* Unable to fully understand instructions in order to use the equipment or the process of the study.
* Body weight over 150 kg.
* Lower extremity injuries that limit range of motion or function.
* Joint problems (hip or leg) that limit range of motion or cause pain with movement despite treatment.
* Unstable fractures.
* Pressure sores with any skin breakdown in areas in contact with the body harness or Lokomat apparatus.
* Chronic and ongoing alcohol or drug abuse.
* Pre-morbid, ongoing depression or psychosis.
* Ongoing physical therapy.
* Pregnancy (self-reported)
* PI's determination of inability to complete the test protocol

Primary outcomes:
measure: Ankle accuracy and stiffness
timeFrame: At inclusion, after 8 sessions, after 16 sessions
Secondary outcomes:
measure: Gait assessments (e.g., 6-Minute Walk, Timed 25-Foot Walk)
timeFrame: At inclusion, after every 4 sessions
measure: Functional assessments (EDSS, MS Functional Composite)
timeFrame: At inclusion, after 8 sessions, after 16 sessions
Other outcomes:
Locations:
city: Providence
country: United States
facility: Providence VA Medical Center
state: Rhode Island
Study officials:
affiliation: Providence VA Medical Center
name: Albert Lo, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01412853: Spectro-IRM and Evaluation Response to Prostatic Radiotherapy
Official title: Evaluation of the Response to Irradiation With MR-Spectroscopy for Localised Prostate Cancer Patients (The ERIS Trial)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prostate Cancer
Keywords: localized
Lead sponsor: Centre Georges Francois Leclerc
Sponsor class: OTHER
First posted: 2011-08-09
Enrollment: 90
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Context:

Prostate cancer is the most common non-cutaneous cancer and the second most common cause of cancer-related deaths in European and North-American men.

After external radiotherapy or brachytherapy, the Prostate Specific Antigen (PSA) value is often fluctuating and PSA nadir may only be reached after 2 years or more and may remain detectable several years after the completion of radiation. Moreover, PSA bounces and blips render patients and physicians very anxious about any possibility of a relapse. In this context, biomarkers that could predict the response to radiation earlier than PSA for patients with prostate cancer appear long overdue.

Magnetic Resonance Spectroscopy at 3 Tesla without endorectal coil is a non invasive procedure which allows quantification of metabolites such as Choline, Creatine, Polyamines and Citrate within the prostate gland.

Objectives:

The investigators are conducting a French prospective study on the Evaluation of the Response to Irradiation with MR Spectroscopy (ERIS). Their purpose is to monitor the early response of radiation with 3D MR Spectroscopy during the first year after completion of radiation and its impact on biochemical control. Therefore, the ERIS trial aims to investigate whether or not there could be a correlation between the time course of PSA and that of Choline and Citrate.


Eligibility criteria: Inclusion Criteria:

1. Patients with a biopsy-proven prostatic adenocarcinoma
2. Gleason score between 4 and 10
3. Maximal baseline PSA \< 50 ng/ml
4. Age over or = to 18 yr
5. Exclusive radiotherapy and/or brachytherapy with or without androgen deprivation therapy
6. Written informed consent from the patient

Exclusion Criteria:

1. lymph-node metastases
2. Bone metastases
3. Maximal baseline PSA ≥ 50 ng/ml
4. Prior radical prostatectomy
5. Contra-indications for MRI (Pace-maker, hip prothesis...)

Primary outcomes:
measure: PSA value compare to Choline and Citrate levels as measured with MR-spectroscopic imaging as predictive factor of the response to treatment
timeFrame: up to 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Dijon
country: France
facility: Centre Georges François Leclerc
Study officials:
References:
Clinical trial NCT01515553: Bioequivalence of Two Liraglutide Formulations in Healthy Volunteers
Official title: A Randomized, Double-blind, Single-centre, Two-period, Cross-over Trial in Healthy Subjects Investigating the Bioequivalence Between the Phase 3a Formulation of Liraglutide (Formulation 4) and the Planned Phase 3b Formulation (Final Formulation 4)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Diabetes
Healthy
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2012-01-24
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This trial is conducted in Europe. The aim of this trial is to test for bioequivalence of the phase 3a formulation of liraglutide (formulation 4) and the liraglutide formulation planned for phase 3b trials (final formulation 4).


Eligibility criteria: Inclusion Criteria:

* Good general health as judged by the investigator, based on medical history, physical examination including 12-lead ECG (electrocardiogram), vital signs and blood and urinary laboratory assessments
* BMI (Body Mass Index) of 18.0-27.0 kg/m\^2, both inclusive

Exclusion Criteria:

* History of any clinically significant renal, hepatic, cardiovascular, pulmonary, gastrointestinal, metabolic, endocrine, haematological, neurological, psychiatric disease or other major disorders that may interfere with the objectives of the trial, as judged by the Investigator
* Impaired renal function
* Any clinically significant abnormal ECG, as judged by the Investigator
* Active hepatitis B and/or active hepatitis C
* Positive human immunodeficiency virus (HIV) antibodies
* Known or suspected allergy to trial product(s) or related products
* Pregnant, breast-feeding or the intention of becoming pregnant or not using adequate contraceptive measures
* History of alcoholism or drug abuse, or positive results in alcohol or drug screens
* Smoking of more than 5 cigarettes per day, or the equivalent for other tobacco products
* Habitual excessive consumption of methylxanthine-containing (theophylline, caffeine or theobromine) beverages and foods (coffee, tea, soft drinks such as red bull, cola, chocolate) as judged by the Investigator
* Excessive consumption of a diet deviating from a normal diet as judged by the Investigator

Primary outcomes:
measure: Area under the curve (0-t)
measure: Cmax, maximum concentration
Secondary outcomes:
measure: Area under the curve (0-infinity)
measure: Relative bioavailability
measure: Time to reach maximum (tmax)
measure: Terminal elimination half life (t½)
measure: Terminal elimination rate constant
measure: Adverse events
Other outcomes:
Locations:
city: Lund
country: Sweden
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
Clinical trial NCT04910477: Nebulized Dexmedetomidine Versus Neostigmine/Atropine in Postdural Puncture Headache
Official title: Comparative Effects of Nebulized Dexmedetomidine Versus Neostigmine / Atropine in Treating Postdural Puncture Headache After Cesarean Section: A Double Blind Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Postdural Puncture Headache
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2021-06-02
Enrollment: 90
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In our study, we will compare a new route of nebulization for effectiveness between dexmedetomidine, neostigmine/atropine and saline placebo for females complained of postdural puncture headache (PDPH) after cesarean section.

Detailed description: A written informed consent will be taken from the patients. The study will involve female adults (age 18-40years) of American society of anesthesiologists (ASA) I-II who are listed for elective cesarean section under spinal anesthesia and suffer from postoperative postdural puncture headache (PDPH). Patients will be assigned randomly to three groups (30 subjects each) after PDPH diagnosis was established. First 90 patients developed PDPH will be assessed for study eligibility.

Group D (patients will receive ultrasonic nebulization of dexmedetomidine (1 mg/kg diluted in 4 mL saline) twice daily for three days. Group N (patients will receive nebulization of 20 µ/kg neostigmine and 10 µ/kg atropine mixed in 4 ml) twice daily for three days. Group S (patients will receive nebulization of saline placebo in 4 ml) twice daily for three days.

Eligibility criteria: Inclusion Criteria:

- Clinical diagnosis of postdural puncture headache (PDPH) after elective cesarean section under spinal anesthesia.

Exclusion Criteria:

* Hypersensitivity of dexmedetomidine, neostigmine or atropine
* Overactive thyroid gland
* Myasthenia gravis
* Closed angle glaucoma
* High blood pressure and coronary artery disease.
* withdrawal of consent

Primary outcomes:
measure: visual analog scale score (VAS) ≤3 within 72 hour.
timeFrame: 3 days
Secondary outcomes:
measure: Need for Epidural blood patch
timeFrame: Day 4
measure: Occurence of neck stiffness
timeFrame: 3 days
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut university hospital
Study officials:
affiliation: Omar makram
name: Omar Soliman
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00443677: Treatment of Advanced Hodgkin's Disease (Stages IIB-III-IV)
Official title: Treatment of Advanced Hodgkin's Disease (Stages IIB-III-IV)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Advanced Hodgkin Disease
Lead sponsor: Gruppo Italiano Studio Linfomi
Sponsor class: OTHER
First posted: 2007-03-06
Enrollment: 307
Sex: ALL
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 purpose of this study is to compare the toxicities of the COPPEBVCAD vs BEACOPP vs ABVD regimens.


Eligibility criteria: Inclusion Criteria:

* Histologically confirmed diagnosis of Hodgkin disease
* Clinical stage IIB, III, IV
* No prior treatment for Hodgkin disease or other malignancy
* Age 18-65 year
* Good cardiac, pulmunar, renal and hepatic function
* Performance status 0-3 (Karnofsky 100- 40)
* Written Informed Consent

Exclusion Criteria:

* HIV positivity
* Large cell, anaplastic, CD30+ lymphoma

Primary outcomes:
measure: To compare the toxicity of the COPPEBVCAD vs BEACOPP vs ABVD regimens
Secondary outcomes:
measure: To compare the results in terms of response, failure free survival and relapse free survival of the three regimens
Other outcomes:
Locations:
city: Modena
country: Italy
facility: Centro Oncologico Modenese
Study officials:
affiliation: GISL
name: Paolo Gobbi, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: GISL
name: Emilio Iannitto, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: GISL
name: Giuseppe Polimeno, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06120777: Clinical Validation for SpO2 Function of Masimo INVSENSOR00069
Official title: Clinical Validation for SpO2 Function of Masimo INVSENSOR00069
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Lead sponsor: Masimo Corporation
Sponsor class: INDUSTRY
First posted: 2023-11-07
Enrollment: 89
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: Assess the accuracy of INVSENSOR00069's peripheral oxygen saturation (SpO2) against contemporaneous measurement from arterial blood gas (ABG) analysis.


Eligibility criteria: Inclusion Criteria:

Influenced by study design:

* Subject is 18 to 50 years of age.
* Subject weighs a minimum of 110 lbs.
* Hemoglobin value ≥ 11 g/dL.
* Baseline heart rate ≥ 45 bpm and ≤ 90 bpm.
* Systolic blood pressure ≤ 140 mmHg and ≥ 90 mmHg and diastolic blood pressure ≤ 90 mmHg and ≥ 50 mmHg. If systolic blood pressure is lower than 100 mmHg and/or diastolic blood pressure is lower than 60 mmHg, subject passes an orthostatic blood pressure test.
* CO value ≤ 3.0% FCOHb.
* Subject is comfortable to read and communicate in English\*. \*This is to ensure the subject can provide informed consent (as study materials are currently available in English only) and can comply with study procedures.

Exclusion Criteria:

Influenced by device warning labels:

* Subjects with a skin condition affecting the digits, where the sensor is applied, which would interfere with the path of light (e.g., psoriasis, vitiligo, eczema, angioma, scar tissue, burn, fungal infection, substantial skin breakdown, etc.).
* Subjects with nail polish or acrylic nails on the digits where sensor needs to be applied, who opt not to remove them.
* Subject has hemoglobinopathies or synthesis disorders (e.g., thalassemia, sickle cell disease).
* Subject has a peripheral vascular or vasospastic disease (e.g., Raynaud's disease).

Influenced by study design/environment:

* Subjects who do not pass the health assessment for safe participation in the study procedures.
* Difficulty inserting an intravenous line in the subject's hand or arm and/or an arterial line in the radial artery of the subject's wrist.

Primary outcomes:
measure: SpO2 Accuracy of Masimo INVSENSOR00069
timeFrame: 1-3 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Irvine
country: United States
facility: Masimo Corporation
state: California
Study officials:
References:
Clinical trial NCT05371977: Deep Sclerectomy Versus Trabeculectomy in Normal Tension Glaucoma
Official title: Deep Sclerectomy Versus Trabeculectomy in Normal Tension Glaucoma
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Normal Tension Glaucoma
Lead sponsor: Helsinki University Central Hospital
Sponsor class: OTHER
First posted: 2022-05-12
Enrollment: 80
Sex: ALL
Minimum age (years): 55
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess whether deep sclerectomy is as effective in lowering intraocular pressure (IOP) as trabeculectomy in patients with normal tension glaucoma.

Detailed description: Subjects with normal tension glaucoma that is unstable with current medication needing filtration surgery are recruited in the study. All patients meeting the inclusion criteria and giving informed consent will be randomized to whether having deep sclerectomy or trabeculectomy.

Eligibility criteria: Inclusion Criteria:

* Signed Informed Consent
* Normal Tension Glaucoma with typical nerve fiber layer defects in red-free photographs and/or optical coherence tomography (OCT) and possible equivalent visual field defects, IOP never more than 21 mmHg, and open anterior chamber angle
* Glaucoma unstable with current medication assessed by a glaucoma specialist

Exclusion Criteria:

* Secondary Glaucoma e.g. due to previous injury or uveitis
* Exfoliation syndrome
* Pigment dispersion syndrome
* Previous transscleral or endoscopic cyclophotocoagulation
* Previous other glaucoma surgery
* Previous retinal detachment
* Previous intraocular surgery like vitrectomy and other retinal surgery
* Wet age-related macular degeneration
* Diabetic retonopathy
* Previous corneal transplant or previous refractive surgery
* Fuchs' dystrophy and other abnormalities compromising corneal clarity like scars
* The patient does not want to participate in the study
* The patient does not speak Finnish, Swedish or English
* Dementia
* Only eye with vision worse than 20/200 or loss of central visual field

Primary outcomes:
measure: Success Rate
timeFrame: One year
Secondary outcomes:
measure: Success Rate
timeFrame: 5 years
Other outcomes:
Locations:
city: Helsinki
country: Finland
facility: Helsinki University Central Hospital
Study officials:
References: