louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00504270: A Study of R3421 in Patients With Moderate to Severe Chronic Plaque Psoriasis.
Official title: A Randomized, Placebo-controlled Dose-ranging Pilot Study to Assess the Effect on Clinical Response, and the Safety and Tolerability of R3421 in Patients With Moderate to Severe Chronic Plaque Psoriasis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Psoriasis
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2007-07-19
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will investigate the safety, efficacy and pharmacokinetics of R3421 in patients with moderate to severe chronic plaque psoriasis. Patients will be randomized to one of 3 treatment groups to receive once daily oral treatment with a)R3421 20mg, b)R3421 120mg, or c)placebo. The anticipated time on study treatment is \<3 months, and the target sample size is \<100 individuals.


Eligibility criteria: Inclusion Criteria:

* adult patients, 18-70 years of age;
* medically stable, moderate to severe chronic plaque psoriasis.

Exclusion Criteria:

* any skin condition which may interfere with evaluation of the effect of study medication on plaque lesions;
* confounding or concomitant condition or treatment.

Primary outcomes:
measure: Adverse events (AEs), laboratory parameters, pharmacokinetics
timeFrame: Throughout study
Secondary outcomes:
measure: Change from baseline in static physician global assessment (PGA) score, Psoriasis Area and Severity Index (PASI) and exploratory biomarkers
timeFrame: Throughout study
Other outcomes:
Locations:
city: Hot Springs
country: United States
state: Arkansas
city: Little Rock
country: United States
state: Arkansas
city: Santa Monica
country: United States
state: California
city: Alpharetta
country: United States
state: Georgia
city: East Windsor
country: United States
state: New Jersey
city: Albuquerque
country: United States
state: New Mexico
city: New York
country: United States
state: New York
city: New York
country: United States
state: New York
city: Stony Brook
country: United States
state: New York
city: Winston-Salem
country: United States
state: North Carolina
city: Providence
country: United States
state: Rhode Island
city: Nashville
country: United States
state: Tennessee
city: Galveston
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: Webster
country: United States
state: Texas
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_CHAIR
References:
Clinical trial NCT01052870: Association of Polymorphisms in the Androgen Receptor Gene and Finasteride Response in Women With Androgenetic Alopecia
Official title: Study Evaluating the Association of CAG Repeat Polymorphisms and Finasteride Response in Women With Androgenetic Alopecia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Androgenetic Alopecia
Keywords: pharmacogenomics, androgen receptor gene, androgen sensitivity, CAG repeats, androgenetic alopecia
Pharmacogenomics in treatment for androgenetic alopecia in women
Lead sponsor: HairDx, LLC
Sponsor class: INDUSTRY
First posted: 2010-01-20
Enrollment: 12
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Previous studies of finasteride treatment in women with hair loss have failed to show positive results, yet, some women have responded anecdotally. Given that polymorphisms of the androgen receptor gene which confer androgen sensitivity impact male response to finasteride therapy, it was hypothesized that the same polymorphism in women may identify the group that will respond. This study is designed to test the impact of finasteride therapy on hair loss in postmenopausal women.

Detailed description: Androgen sensitivity in the cell is determined by the number of Cytosine-Adenine-Guanine repeats in the Androgen Receptor gene. Lower CAG repeats have been associated in previous studies with androgenic conditions such as acne, hirsutism and hair loss in men and women. Keeping this in mind, we tested women with hair loss in the frontal or vertex area, for their AR genotype. Patients were randomized to placebo or 1 mg finasteride therapy for 6 months. Global photographs and 2 tatooed areas of 1cm2 each were measured monthly to assess global appearance and hair counts for medication impact.

Eligibility criteria: Inclusion Criteria:

* women with hair loss

Exclusion Criteria:

* pre menopausal,
* metabolic or medication or non-androgenetic causes of hair loss,
* diffuse hair loss

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: HairDx, LLC
name: Sharon A Keene, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04146870: Nutritional Status of Patients After Hematopoietic Stem Cell Transplantation
Official title: A Survey of Nutritional Status of Patients After Hematopoietic Stem Cell Transplantation
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Nutrition
Hematopoietic Stem Cell Transplantation
Lead sponsor: The First Affiliated Hospital of Soochow University
Sponsor class: OTHER
First posted: 2019-10-31
Enrollment: 200
Sex: ALL
Minimum age (years): 15
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients who have received hematopoietic stem cell transplantation in the First Affiliated Hospital of Soochow University

Brief summary: The main objectives of this study were :(1) to comprehensively and systematically evaluate the nutritional status of patients after hematopoietic stem cell transplantation. (2) to explore the effect of nutritional factors on the prognosis of patients treated by hematopoietic stem cell transplantation.

Detailed description: This study is devised to investigate nutritional status in patients who have undergone hematopoietic stem cell transplantation in the First Affiliated Hospital of Soochow University. Evaluation time points include the day before receiving conditioning regimen, post-transplantation 180 days, the nutritional status of patients were systematically evaluated from the aspects of food intake, physical activity level, body composition, blood biochemistry, etc. Also, the effect of nutritional factors on prognosis of hematopoietic stem cell transplantaion patients will be evaluated.

Eligibility criteria: Inclusion Criteria:

* Patients who undergo hematopoietic stem cell transplantation in the First Affiliated Hospital of Soochow University.
* Having a life expectancy of more than 3 months

Exclusion Criteria:

* Not willing to participate in the investigation
* Age less than 15 years old or more than 80 years old

Primary outcomes:
measure: Change from Baseline fat free mass at 6 months
timeFrame: 6 months
measure: Change from Baseline fat mass at 6 months
timeFrame: 6 months
measure: Change from Baseline food intake at 6 months
timeFrame: 6 months
measure: Change from Baseline albumin level in blood at 6 months
timeFrame: 6 months
Secondary outcomes:
measure: Overall survial
timeFrame: 3 years
measure: Event free survival
timeFrame: 3 years
Other outcomes:
Locations:
city: Suzhou
country: China
facility: The first affiliated hospital of suzhou university
state: Jiangsu
Study officials:
References:
Clinical trial NCT06190470: Effects of Marijuana on Neuropathic Pain and Spasticity in Spinal Cord Injury Patients
Official title: Effects of Marijuana on Neuropathic Pain and Spasticity in Spinal Cord Injury Patients
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: PHASE1
Conditions: Spinal Cord Injury
Keywords: Cannabis
Marijuana
Spinal cord injury
Pain
Spasticity
Lead sponsor: Khon Kaen University
Sponsor class: OTHER
First posted: 2024-01-05
Enrollment: 20
Sex: ALL
Minimum age (years): 25
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to compare effects of marijuana or cannabis on neuropathic pain and spasticity in spinal cord injury patients. The main question is: Does the cannabis product from KhonKaen University reduce neuropathic pain and spasticity in spinal cord injury patients? The research design is a crossover study. The participants will be randomly into 2 groups: group 1 and group 2. The participants received either cannabis or placebo for 2 weeks. After completing treatment, participants were swapped to the other group for 2 weeks, a wash-out period is 2 weeks. The outcome measurements are pain and spasticity.


Eligibility criteria: Inclusion Criteria:

* Spinal cord injury more than 6 months
* Neuropathic pain
* Pain score \> 3
* Do not response to standard medical treatment
* Given inform consent

Exclusion Criteria:

* Allergy to cannabis
* Unstable cardiovascular and pulmonary diseases
* Chronic kidney and liver diseases
* Psychological disease
* Pregnancy or breastfeeding

Primary outcomes:
measure: Pain score
timeFrame: 2 weeks
Secondary outcomes:
measure: Spasticity
timeFrame: 2 weeks
measure: Activities of daily living
timeFrame: 2 weeks
measure: Quality of life score
timeFrame: 2 weeks
measure: H-reflex
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Khon Kaen
country: Thailand
facility: Faculty of Medicine Khon Kaen University
Study officials:
affiliation: Rehabilitation Medicine Department, Faculty of Medicine, KhonKaen University
name: Nuttaset Manimmanakorn, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04933370: Neuromodulation Parameter Efficacy
Official title: Evaluating the Efficacy of Different Stimulation Paradigms in Neuromodulation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Chronic Pain
Lead sponsor: Alberta Health Services, Calgary
Sponsor class: OTHER
First posted: 2021-06-21
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The objective of this study is to determine the efficacy of neuromodulation using various stimulation paradigms in the treatment of several disorders including chronic pain.

Detailed description: Different stimulation parameters will be tried in a blinded fashion to compare efficacy.

Eligibility criteria: Inclusion Criteria:

* Patients who are candidates for, and have been consented for, implantation of a neuromodulation device.

Exclusion Criteria:

* Non-English speaking

Primary outcomes:
measure: Change in baseline pain measures
timeFrame: 6 months
Secondary outcomes:
measure: Effect of stimulation on quality of life
timeFrame: 6 months
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: University of Calgary
state: Alberta
Study officials:
References:
Clinical trial NCT05086770: Comparison of Pain After Uterine Artery Embolization Using Gelatin Microsphere or Tris-acryl Gelatin Microsphere
Official title: Comparison of Pain After Uterine Artery Embolization Using Gelatin Microsphere or Tris-acryl Gelatin Microsphere in Patients With Symptomatic Fibroids: A Prospective, Randomized Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Uterine Myoma
Uterine Fibroid
Lead sponsor: Next Biomedical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2021-10-21
Enrollment: 60
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is a prospective and randomized investigation planned to compare pain after uterine artery embolization using Gelatin microsphere or tris-acryl gelatin microsphere in 60 patients with symptomatic fibroids.

Detailed description: This investigational study is designed to compare pain after uterine artery embolization using Gelatin microsphere or tris-acryl gelatin microsphere in patients with symptomatic fibroids.

The primary end-points will be evaluated by assessing the maximum Visual Analogue Scale (VAS) score obtained for each time points within 24 hours after embolization.

Secondary end-points consist of evaluating six items: 1) fentanyl and analgesic usage within 24 hours, 2) comparison of symptom severity score and health-related quality of life score, 3) comparison of postoperative inflammation, 4) assessment of tumor necrosis degree in Magnetic Resonance Imaging, 5) fluoroscopy and procedure time comparison, and 6) assessment of residual ovarian function before and after surgery (Serum AMH).

This study included patients between the ages of 20 and less than 60 years of age who were diagnosed with uterine myoma and planned to undergo uterine artery embolization.

Eligibility criteria: Inclusion Criteria:

* A patient aged between 20 and under 60 who decided to undergo uterine artery embolization for symptomatic uterine myoma.

Exclusion Criteria:

* Bradycardia on electrocardiogram (\< 45 bpm)
* Ventricular conduction abnormalities
* Liver failure
* Kidney failure
* Uncontrolled high blood pressure
* Obesity (BMI ≥ 30 ㎏/㎡)
* Patients who are allergic to drugs
* Patients who cannot read consent forms such as illiterate or foreigners
* Pregnant woman

Primary outcomes:
measure: Pain intensity by numerical rating scale
timeFrame: 0-24 hours after embolization
Secondary outcomes:
measure: Fentanyl and analgesic usage volume
timeFrame: 24 hours
measure: Symptom severity score
timeFrame: 3 months
measure: Postoperative inflammation
timeFrame: 24 hours
measure: Tumor necrosis degree
timeFrame: 3 months
measure: Fluoroscopy and procedure time
timeFrame: procedure time
measure: Serum Anti-Mullerian Hormone (AMH)
timeFrame: 3 months
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Severance Hospital
Study officials:
affiliation: Severance Hospital
name: Man Deuk Kim, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00695370: Evaluation of Pegfilgrastim for Stem Cell Mobilization in Children
Official title: Hematopoietic Progenitor Cell Mobilization in Children With Malignancies: Evaluation of Pegfilgrastim at 300µg/kg in Hematological Steady State
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Solid Malignancies
Keywords: Children
cancer
Bone marrow transplantation
Mobilization
G-CSF
Children with solid malignancies
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
Collaborators: name: Amgen
First posted: 2008-06-11
Enrollment: 30
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Primary purpose: TREATMENT

Brief summary: Hypothesis: pegfilgrastim at 300 µg/kg in hematological steady state provides an efficient stem cell mobilization in children with malignancies

Design: phase 2 study.

Judgment criterion: percentage of children achieving at least 5x10e6 CD34 cells with a standard apheresis (less than 2 blood volume processed)

Detailed description: Patients: consecutively referred for HSC mobilization. At least 17 days after the previous chemotherapy. No hematological growth factor during the 8 previous days.

Mobilization: one sc injection of 300 µg/kg pegfilgrastim (Neulasta, Amgen)

Evaluation during the study: CD34 circulating cells from day 2 to day 7 ; AE recording

Judgment criterion: percentage of children achieving at least 5x10e6 CD34 cells with a standard apheresis (less than 2 blood volume processed)

Analysis: sequential Bayesian study

Eligibility criteria: Inclusion Criteria:

* 0 to 18 years
* solid malignancy
* Lansky score \>70%
* more than 17 days since the beginning of the last chemotherapy cycle
* absolute neutrophil count (ANC) greater than 1×109/l
* no administration of any hematopoietic growth factor in the previous 8 days

Exclusion Criteria:

* clinical or biological conditions precluding the mobilization or collection procedure

Primary outcomes:
measure: percentage of children achieving at least 5x10e6 CD34 cells with a standard apheresis (less than 2 blood volume processed)
Secondary outcomes:
measure: Side effects Number of apheresis required to achieved a graft of at least 5x10e6 CD34 cells
Other outcomes:
Locations:
Study officials:
affiliation: University Hospital, Clermont-Ferrand
name: Etienne Merlin, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03629470: Effectiveness of Nerve Glide Exercises on Cubital Tunnel Syndrome
Official title: Effectiveness of Nerve Glide Exercises on Cubital Tunnel Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cubital Tunnel Syndrome
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2018-08-14
Enrollment: 2
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: TREATMENT

Brief summary: The objective of this study is to determine if nerve glide exercises in patients with cubital tunnel syndrome can improve pain, paraesthesias and reduce the need for future surgery. Cubital tunnel syndrome is a common form of peripheral neuropathy caused by compression of the ulnar nerve at the elbow. Surgical intervention is typically reserved for those with severe symptoms, but many cases can be treated with non-operative measures. This study will look at the efficacy of nerve glide exercises in the management of cubital tunnel syndrome. 70 subjects with cubital tunnel syndrome will be enrolled and randomized into groups receiving either standard conservative measures or standard measures in addition to nerve glide exercises. Outcomes will be measured 6 months after initiation of treatment with questionnaires on clinical symptoms and function to see if there is a difference between the two groups.


Eligibility criteria: Inclusion Criteria:

* Patients diagnosed with cubital tunnel syndrome on physical exam

Exclusion Criteria:

* Patients with diagnosed or self-reported cognitive dysfunction
* Patients who are unable to understand or follow commands
* Any patient that the investigators feel unsafe or cannot comply with all study related procedures
* Patients who had previous ulnar nerve release at the elbow
* Patients with documented cervical spine pathology
* Patients with clinical signs of other nerve pathology
* Patients with palpable subluxation of the ulnar nerve at the elbow

Primary outcomes:
measure: Clinical Scoring
timeFrame: 1 Month
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: New York University School of Medicine
state: New York
Study officials:
affiliation: NYU Langone Health
name: Louis Catalano, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00858299: The Change of Urinary Angiotensinogen Excretion After Valsartan Treatment in Patients With Persistent Proteinuria
Official title: The Change of Urinary Angiotensinogen Excretion After Valsartan Treatment in Chronic Kidney Diseases Patients With Persistent Proteinuria
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Chronic Kidney Disease
Proteinuria
Keywords: proteinuria
chronic kidney disease
renin-angiotensin system
angiotensinogen
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2009-03-09
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This study is a multicenter, prospective, interventional study. It does not have a control group. All participants will receive 160 mg valsartan for 8 weeks. Among them, the patients with persistent proteinuria (defined as proteinuria more than 1 g/g after 8 weeks treatment of valsartan) will receive 320 mg valsartan for further 16 weeks. Participants who did not receive any ACEI or ARB previously will have a titration period for 4 weeks (80 mg for 4 weeks, 160 mg for 4 weeks, and then 320 mg for 16 weeks).

The investigators will evaluate the change of urinary angiotensinogen excretion between at baseline, at 8 weeks, and 24 weeks.


Eligibility criteria: Inclusion Criteria:

* Chronic kidney disease patients with

  * proteinuria of 1 - 10 g/day,
  * stable and controlled blood pressure (100/60 mmHg - 160/100 mmHg),
  * stable renal function with GFR ≥ 30 mL/min/ m2,
  * diabetes or non-diabetes

Exclusion Criteria:

* Uncontrolled diabetes (defined as HbA1c \> 9.0%)
* Immunosuppressive treatment within 6 months
* Intractable edema
* Hyperkalemia (\>5.5 mEq/L) or Hypokalemia (\< 3.5 mEq/L)

Primary outcomes:
measure: The percent change of urinary angiotensinogen excretion between at baseline and at 24 weeks after valsartan treatment.
timeFrame: 4 weeks of screening periods + 24 weeks of treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Division of Nephrology, Samsung Medical Center
Study officials:
affiliation: Division of Nephrology, Samsung Medical Center
name: Yoon-Goo Kim, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00628199: Study to Create Potential Cell-Based Therapies to Treat Human Disease and Disability
Official title: Derivation of Primary Donor Cell Lines for Human Cell Reprogramming
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Metabolic Diseases
Infertility
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2008-03-04
Enrollment: 60
Sex: ALL
Minimum age (years): 1
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with specific disease or infertility with potential for stem cell therapy

Brief summary: This is a research study in which your cells will be used for somatic cell nuclear transfer (SCNT), and/or genetic reprogramming research which may result in the production of stem cell lines. This study does not provide treatment.

Detailed description: It is thought that studies of genetic reprogramming and SCNT using human cells have the potential to give us new basic knowledge about human development. Current work will focus on developing this basic knowledge. In the future, human embryonic stem cell lines (hESC) derived from genetic reprogramming and SCNT may also have the potential to develop into cell types that are useful for cell-based therapies to treat human disease and disability.

Eligibility criteria: Inclusion Criteria:1. Donors with a degenerative disease phenotype or genetic disorders such as Type I Diabetes, heart disease, or infertility (azoospermia and premature ovarian failure)

Exclusion Criteria:1. Unable to read or understand English. 2. Unable to provide skin biopsy sample due to skin condition in the underarm area.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University School of Medicine
state: California
Study officials:
affiliation: Stanford University
name: Marius Wernig, MD
role: PRINCIPAL_INVESTIGATOR
References: