louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01317888: Access Protocol for MAB-425 Radiolabeled With I-125 for High Grade Gliomas
Official title: An Access Protocol for Continued Use of Anti-Epidermal Growth Factor Receptor-425 (Anti-EGFr-425) Monoclonal Antibody Radiolabeled With 1-125 for High Grade Gliomas
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Glioblastoma Multiforme
Astrocytoma Anaplastic Foci
Keywords: high grade gliomas of the brain
anti-body treatment
survival
Lead sponsor: Drexel University
Sponsor class: OTHER
First posted: 2011-03-17
Enrollment: 11
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: The purpose of this access protocol is to allow patients with brain tumors who had previously received 125I-MAB 425 to receive additional course(s) of 125I-MAB 425 until their brain tumor begins to grow, they develop side effects to the treatment, or their medical condition changes (e.g., you become pregnant, become infected with human immunodeficiency virus (HIV) or develop another cancer).


Eligibility criteria: Inclusion Criteria:

* 18 Years or Older
* Previous treatment with at least one course of 125I-MAB 425 (one course = 3 infusions)
* Karnofsky performance status \> 70%
* Hemoglobin \> 10.0 g/dL, White Blood Cells \> 4,000/mm3, Platelets \> 100,000/mm3, BUN \< 25 mg/dL, Creatinine \< 1.5 mg/dL
* Signed informed consent
* Pathologic confirmation of GBM or AAF
* A negative beta hCG test for women of childbearing potential
* Negative HAMA test

Exclusion Criteria:

* Metastases or Second Primary Cancer
* Iodine allergy
* Inability to tolerate oral intake of Lugol's solution
* HIV Infection
* Positive HAMA test
* Pregnancy
* Uncontrolled Seizures

Primary outcomes:
measure: Prevention of disease progression
timeFrame: 3 months after first course with follow-up
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02604888: Efficacy Study of a Cosmetic Lotion in the Treatment of Alopecia Areata in Males and Females
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Alopecia Areata
Keywords: Baldness
Alopecia Areata
Alopecia
Hair loss
Lead sponsor: Mexis George
Sponsor class: OTHER
First posted: 2015-11-16
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether the Hair Loss Prevention Lotion named MEXIS, M.P.A.F., M6S PATENT is effective in the treatment of Alopecia Areata.

Detailed description: This study verifies whether the tested product has any efficacy in the treatment of Alopecia Areata.

* The evaluated product (Hair Loss prevention Lotion) is called: MEXIS, MPAF, M6S PATENT.
* 20 volunteers both men and women suffering from hair loss both in parties and over the entire scalp with age between 18 and 70 years will be selected for this test .
* Samples of the product have been applied following their usual use: as they are.
* On the selecting volunteers will be used:

A polarized light video-camera to check the redness of the scalp and to have a picture of hair and scalp.

* Volunteers will also be asked about:
* Fluffiness
* Sheen
* Itching
* Presence of scales on scalp
* Oily hair
* Product's acceptability
* The readings will be taken at 0 time (basal value), after 15 days (t15), 30 days (t30), 45 days (t45), 45 days (t45), 60 days (t60) and 90 days (t90) by the experimenter in the medical studio. Then they analyzed and reported in a graph.
* Summarizing tables and graphs of the data will be taken during experimentation.

Eligibility criteria: Inclusion Criteria:

* Good state of general health
* Suffering from Alopecia Areata
* No pharmacological treatment in progress
* Promise not to change the usual daily routine
* No atopy in the anamnesis

Exclusion Criteria:

* Illness
* Good state of hair
* Pharmacological treatment in progress
* Denial of the continuance of the usual daily routine
* Atopy in the anamnesis

Primary outcomes:
measure: Change of the Density of the Hair measured with a camera
timeFrame: baseline and 180 days
Secondary outcomes:
measure: Change of the Amount of Hair Loss
timeFrame: baseline and 180 days
Other outcomes:
Locations:
city: Athens
country: Greece
facility: George Mexis
Study officials:
affiliation: 401 General Military Hospital of Athens, Dermatology clinic
name: Markos Papakonstantis, Monitor
role: STUDY_CHAIR
References:
Clinical trial NCT04144088: Traditional Chinese Medicine in the Treatment of Patients With Hyperuricemia.
Official title: Traditional Chinese Medicine in the Treatment of Patients With Hyperuricemia. A Randomized Placebo-Controlled Double-Blinded Clinical Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hyperuricemia
Lead sponsor: Chung Shan Medical University
Sponsor class: OTHER
First posted: 2019-10-30
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: To testify the efficacy and safety of traditional Chinese formulae, "Wu-Ling San" and "Yin-Chen Wu-Ling San" for patients with hyperuricemia.

Detailed description: The prevalence of hyperuricemia and gout is increasing in Taiwan. It is probably contributed by adapting to Western diet and lifestyle. Previous studies have demonstrated the relationship between hyperuricemia with hypertension, metabolic syndrome, cardiovascular disease and chronic renal disease. While Western medicine shows promising effects in treating hyperuricemia and gout, we are searching for an alternative in traditional Chinese medicine with both safety and efficacy in treating hyperuricemia.

We conducted a randomized double-blinded placebo-controlled clinical trial in adults with hyperuricemia. Sixty patients with serum uric acid level more than 8 mg/dl were enrolled. Patients were then randomized into three arms: Traditional Chinese Medicine formulae: "Wu-Ling San", "Yin-Chen Wu-Ling San" or placebo for 4 weeks. Efficacy and safety were evaluated at Week 2, 4 and 8. Primary endpoint was the serum uric acid\<6 mg/dL at Week 4. Secondary endpoints were the differences between groups in serum uric acid at Week 2 and 8, serum SGPT, SGOT, creatinine, total cholesterol, triglycerides, HDL, LDL, fasting blood glucose, body weight, blood pressures and frequency of gouty attack at Week 4.

Eligibility criteria: Inclusion Criteria:

* serum uric acid \> 8 mg/dL

Exclusion Criteria:

* 1. gout attack within 2 weeks before baseline 2. drug for control urine acid must be stable dose within 2 weeks before baseline (e.g.allopurinol、benzbromarone、probenecid、sulfinpyrazone) 3. subject taking the drug involved azathioprine、aspirin (\>325 mg)、atorvastatin、fenofibrate、losartan、thiazide、systemic corticosteroid、estrogen、oral contraceptive pills 4. serum creatinine \> 3.0 mg/dL 5. GPT \> 100 mg/dL 6. Pregnant or breast-feeding women 7. Chemotherapy or radiation therapy in cancer patients

Primary outcomes:
measure: Serum Uric Acid<6 mg/dL at Week 4
timeFrame: week 4
Secondary outcomes:
measure: Change From Baseline Serum Uric Acid at Week 2
timeFrame: week 0, week 2
measure: Change From Baseline Serum Uric Acid at Week 8
timeFrame: week 0, week 8
measure: Change From Baseline Blood Sugar at Week 4
timeFrame: week 0, week 4
Other outcomes:
Locations:
Study officials:
affiliation: Chung Shan Medical University
name: Cheng Ching Wei, Ph. D.
role: STUDY_DIRECTOR
References:
Clinical trial NCT04150588: The Correlation Between MMCR and Phenylephrine Test
Official title: The Correlation Between Müller's Muscle-Conjunctival Resection and Phenylephrine Test
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: the Correlation Between Erin Test and Müller's Muscle-Conjunctival Resection
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
First posted: 2019-11-05
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with ptosis over 18 YO that react to efrin test

Brief summary: The propose of the study is the examine the association between the amount that the eyelid rise 3 months after surgery and the reaction to Efrin test before surgery


Eligibility criteria: Inclusion Criteria:

* patients with ptosis
* patients that react to Efrin test

Exclusion Criteria:

* Other eye diseases
* other eye surgeries

Primary outcomes:
measure: The reaction to efrin test before surgery
timeFrame: 15 minutes
Secondary outcomes:
measure: The amount that the eyelid rise after surgery
timeFrame: 3 MONTHS postoperatively
Other outcomes:
Locations:
city: Ramat Gan
country: Israel
facility: Sheba Medical Center
Study officials:
References:
Clinical trial NCT01113788: Tricuspid Isthmus Imaged by CARTOsound, Patients With Typical Atrial Flutter
Official title: Tricuspid Isthmus Architecture as Imaged by CARTOsound, Determines Ablation Times in Patients With Typical Atrial Flutter
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Atrial Flutter
Keywords: atrial flutter, tricuspid isthmus, ablation
Lead sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Sponsor class: OTHER
Collaborators: name: Johnson & Johnson
First posted: 2010-04-30
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with typical atrial flutter

Brief summary: The investigators propose a third hypothesis based on the anatomic observations made in pathological studies. The investigators hypothesize that the anatomic architecture determines the functional properties of the TV-IVC isthmus. As a result,

• Muscular bundles are preferential routes of conduction through the TV-IVC isthmus. The isthmus acts like a series of discreet conduction routes rather than as a sheet of tissue.

The muscular bundles form selective targets for ablation and therefore the entire anatomic line need not be ablated. This has direct implications for ablation of the isthmus.

Detailed description: Patients undergoing atrial flutter ablation will have cartosound imaging done during procedure to determine if this will shorten ablation times.

Eligibility criteria: Inclusion Criteria:

* Patients must be over 18 years of age provided written informed consent documented atrial flutter by ECG , holter monitor or TTM

Exclusion Criteria:

* previous atrial flutter ablation non isthmus dependent atrial flutter prior right atrial surgery

Primary outcomes:
measure: observational including ablation lesion number, ablation time in minutes, fluoroscopic
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: London
country: Canada
facility: London Health Sciences Center
state: Ontario
Study officials:
affiliation: London Health Sciences Centre
name: Allan Skanes, MD, FRCPC
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00944788: A Structured Qi-gong Program for Hospitalized Older Adults
Official title: Feasibility and Impact on Quality of Life and Depressive Symptoms of a Structured Qi-gong Program for Hospitalized Older Adults. A Pilot Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Quality of Life
Behavioral Symptoms
Patient Compliance
Keywords: physical activity
aging
inpatients
quality of life
depression
Lead sponsor: Fundacio Salut i Envelliment UAB
Sponsor class: OTHER
First posted: 2009-07-23
Enrollment: 58
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to test the effects on a number of health outcomes and the feasibility of a structured program of qi-gong, a form of tai-chi which has been previously tested in older populations, in older hospitalized patients. In particular, this pilot study aims to assess changes in quality of life and depressive symptoms after 4 weeks of treatment, with the hypothesis that this intervention will have a positive impact on these two domains, compared to usual care. Adherence will be also monitored in the intervention arm.


Eligibility criteria: Inclusion Criteria:

* \>=50 years old
* Preserved ability to move inside the house (also using walking aids or chair)
* Estimation of at least one month of hospitalization (convalescence or rehabilitation)
* Ability and willing to sign informed consent

Exclusion Criteria:

* Moderate to severe cognitive impairment (SPMSQ \>= 4)

Primary outcomes:
measure: Quality of life
timeFrame: 4 weeks
Secondary outcomes:
measure: Depressive symptoms
timeFrame: 4 weeks
measure: Adherence
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Parc Sanitari Pere Virgili
Study officials:
affiliation: Fundació Institut Català de l'Envelliment
name: Marco Inzitari, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rogers CE, Larkey LK, Keller C. A review of clinical trials of tai chi and qigong in older adults. West J Nurs Res. 2009 Mar;31(2):245-79. doi: 10.1177/0193945908327529.
citation: Martinez N, Martorell C, Espinosa L, Marasigan V, Domenech S, Inzitari M. Impact of Qigong on quality of life, pain and depressive symptoms in older adults admitted to an intermediate care rehabilitation unit: a randomized controlled trial. Aging Clin Exp Res. 2015 Apr;27(2):125-30. doi: 10.1007/s40520-014-0250-y. Epub 2014 Jun 14.
Clinical trial NCT04808388: Using MRI in Patients With Non-dystrophic Myotonia to Access Muscle Contractility
Official title: Using MRI to Quantify Fatty Infiltration in Muscle Tissue, and Compare it to Isometric Muscle Strength Measurements and (2) Use Questionnaires, Systemic Interview and Simple Myotonic Bed-side Tests to Describe the Phenotype.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Paramyotonia Congenita
Nondystrophic Myotonia
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2021-03-22
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Paramyotonia congenita (prevalence 50-100)

Brief summary: The aim of this project is (1) to investigate whether or not structural muscle abnormalities could be a consequence of the disorder and (2) to provide further clinical description of this rare phenotype. To do so, the investigators will (1) use Dixon MRI to quantify fatty infiltration in muscle tissue and compare it to muscle strength measurements from isometric dynamometry in order to access contractility and (2) describe the myotonic phenotype with simple squeeze test and questionnaires.

Detailed description: Non-dystrophic myotonias are rare genetic diseases in which the membrane excitability is altered by mutations in genes encoding muscle ion channels.

Patients suffer from myotonic stiffness, pain, fatigue and sometimes paralysis. Non-dystrophic myotonia is distinct from myotonic dystrophies with the absence of muscle degeneration.

Paramyotonica congenita is characterzied by paradoxial myotonia, which, in contrast to the more common myotonia congenita, is myotonic stiffness that worsens with activity. Typically, the first few contractions seem normal, whereas repetition leads to severe stiffness. Our hypophysis is that these patient might also suffer from muscle degeneration.

Eligibility criteria: Inclusion Criteria:

* 18 years of age
* Diagnosed with non-dystrophic myotonia

Exclusion Criteria:

* MRI contraindications

Primary outcomes:
measure: Contractile properties
timeFrame: 1 year
Secondary outcomes:
measure: Muscle strength
timeFrame: 1 year
measure: Cross sectional area (CCSA)
timeFrame: 1 year
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Neuromuscular Center Rigshospitalet
Study officials:
References:
Clinical trial NCT05674188: AR vs In Person Simulation for Medical Workplace Training
Official title: The Physiologic and Emotional Effects of Augmented Reality Simulation Versus In Person Simulation - A Noninferiority, Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Augmented Reality
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2023-01-06
Enrollment: 111
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: This study will evaluate the physiologic and emotional effects of an augmented reality (AR) simulation versus an in-person simulation. This is a single institution, non-inferiority, randomized controlled trial. The target enrollment will be 100 participants in each group for a total of 200 participants. One group will wear an AR headset and participate in an AR medical crisis scenario and the other group will participate in the same scenario with a traditional, mannequin based in situ simulation.


Eligibility criteria: Inclusion Criteria:

* Hospital providers, including nurses, physician assistants, physicians, physician trainees, and other healthcare workers at Lucile Packard Children's Hospital (LPCH) and affiliated facilities who communicate with patients daily will be included

Exclusion Criteria:

* Participants with reported severe motion sickness
* Nausea
* Seizure disorder
* Currently using chronotropic heart medications, such as β blockers

Primary outcomes:
measure: Parasympathetic response indexed by RSA
timeFrame: Duration of simulation (15-20 minutes)
Secondary outcomes:
measure: Sytem Usability Scale (SUS)
timeFrame: Post-simulation (5 minutes)
measure: ISO 9241-400
timeFrame: Post-simulation (5 minutes)
measure: Simulation Design Scale (SDS)
timeFrame: Post-simulation (5-10 minutes)
measure: Learning effectiveness
timeFrame: 5 months-post simulation (5 minutes)
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Lucile Packard Children's Hospital Stanford
state: California
Study officials:
affiliation: clinical professor
name: Thomas J Caruso, MD, MEd
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05483088: Urine Sample Processing Study
Official title: Urine Sample Processing Study: Analysis of Fresh Versus Frozen Urine Samples From ICU Subjects
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Kidney Injury
Lead sponsor: Astute Medical, Inc.
Sponsor class: INDUSTRY
First posted: 2022-08-01
Enrollment: 110
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult ICU patients with KDIGO stage 2 or 3 AKI.

Brief summary: The objective of the study is to collect and process urine samples from Intensive Care Unit (ICU) subjects with moderate to severe (Stage 2 or 3) acute kidney injury (AKI) for use in assessing the effects of urine sample freezing and various storage conditions on NEPHROCLEAR™ CCL14 Test results. This study is observational and will have no impact on the medical management of the subject.


Eligibility criteria: Inclusion Criteria:

1. Males and females 21 years of age or older;
2. Receiving care in an intensive care unit;
3. Expected to remain in the ICU for at least 48 hours after enrollment;
4. Use of indwelling urinary catheter as standard care at the time of enrollment;
5. Subject must have acute kidney injury (KDIGO Stage 2 or Stage 3) at the time of sample collection;
6. Urine sample must be collected within 36 hours of meeting KDIGO Stage 2 criteria;
7. Written informed consent provided by patient or legally authorized representative (LAR).

Exclusion Criteria:

1. Prior kidney transplantation;
2. Comfort-measures-only status;
3. Already receiving dialysis (either acute or chronic) or in imminent need of dialysis at the time of enrollment;
4. Known infection with human immunodeficiency virus (HIV) or active hepatitis (acute or chronic);
5. Special populations, pregnant women, prisoners or institutionalized individuals.

Primary outcomes:
measure: Stability of CCL14 in urine samples
timeFrame: Up to 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: University of Maryland, Baltimore
state: Maryland
Study officials:
References:
Clinical trial NCT04948788: SHR1459 in Combination With YY-20394 in Recurrent and Refractory B-cell Non-Hodgkin's Lymphoma
Official title: A Phase I/ II Study of SHR1459 in Combination With YY-20394 in Recurrent and Refractory B-cell Non-Hodgkin's Lymphoma in Adults
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Recurrent and Refractory B-cell Non-Hodgkin's Lymphoma
Lead sponsor: Jiangsu HengRui Medicine Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2021-07-02
Enrollment: 102
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel Assignment
Primary purpose: TREATMENT

Brief summary: The study is evaluating the efficacy, and safety of SHR1459 combined with YY-20394 for Recurrent and refractory B-cell non-Hodgkin's lymphoma in adults.


Eligibility criteria: Inclusion Criteria:

1. Histologically confirmed diagnosis of B-cell NHL such as DLBCL, FL and MCL
2. Patients received at least 2 lines of systemic therapy
3. Previously received anti- CD20 treatment
4. Patients in stage II should also be unsuitable or unwilling to receive allogeneic hematopoietic stem cell transplantation
5. Patients must have an acceptable organ function

Exclusion Criteria:

1. Previously treated with PI3K inhibitors or BTK inhibitors
2. Unresolved toxicity of CTCAE grade \> 1 from prior anti-lymphoma therapy
3. Chemotherapy or other investigational therapy within 28 days (or 5 times the half-life time, whichever is shorter) before starting cycle 1
4. Significant concurrent medical disease or condition which according to the investigators' judgement
5. Active hepatitis B, C or HIV infection
6. Infection requiring treatment 2 weeks prior to the first dosing

Primary outcomes:
measure: Stage 1: MTD （Maximum tolerated dose）or RP2D（Recommended Phase II Dose) of SHR1459 and YY-20394;
timeFrame: Minimum observation period is 28 days for the maximum dose cohort
measure: Stage 2: Overall response rate (ORR)
timeFrame: 8 weeks after last patient first visit (LPFV)
Secondary outcomes:
measure: Incidence of Adverse Events
timeFrame: At every treatment and follow up visit until disease progression. Expected to be for up to 6 months
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Ruijin Hospital Affiliated to The Shanghai Jiao Tong University Medical School
state: Shanghai
Study officials:
References: