louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06993610: Tibulizumab Skin Healing and Inflammation Evaluation for Lasting Defense
Official title: A Phase 2, Multi-Center Study Consisting of a Randomized, Placebo-Controlled Period, Followed by an Open-Label Extension Period to Assess the Efficacy, Safety, and Tolerability of Tibulizumab in Adults With Hidradenitis Suppurativa
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Hidradenitis Suppurativa (HS)
Keywords: Hidradenitis Suppurativa
HS
Tibulizumab
Hidradenitis Suppurativa clinical response
HiSCR
Skin Diseases
Inflammatory Skin Disease
Chronic Skin Condition
Sweat Gland Disease
Skin Diseases Bacterial
Suppurative Hidradenitis
Hidradenitis
Acne
Acne inversa
Inversa
Lead sponsor: Zura Bio Inc
Sponsor class: INDUSTRY
First posted: 2025-05-29
Enrollment: 180
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: The study is a Phase 2, multi-center, randomized, double-blind, placebo-controlled study to evaluate the effects of tibulizumab over 16 weeks (Period 1) in adults with hidradenitis suppurativa, followed by a 16-week open-label extension period in which all participants will receive tibulizumab (Period 2)


Eligibility criteria: Inclusion Criteria:

* Male or female, 18 to 70 years of age
* ≥6-month history of Hidradenitis suppurativa (HS)
* Total AN (abscesse and inflammatory nodule) count ≥5
* HS lesions in ≥2 distinct anatomical areas, at least one of which is Hurley Stage II or III

Exclusion Criteria:

* Draining tunnel count \>20
* Presence of another inflammatory condition or a skin condition that may interfere with study assessments
* Known to have immune deficiency or is immunocompromised
* Evidence or suspicion of active or latent tuberculosis
* History of opportunistic, chronic, or recurrent infection requiring chronic antibiotic use, serious or life-threatening infection within 2 months, or had an infection requiring systemic antibiotics within 2 weeks
* Has active systemic candidiasis
* Unable to tolerate subcutaneous drug administration

Primary outcomes:
measure: [Period 1] Percent change from baseline in abscess and inflammatory nodule (AN) count at 16 weeks
timeFrame: Week 16
Secondary outcomes:
measure: [Period 1] Achieving HiSCR50 at Week 16
timeFrame: Week 16
measure: [Period 1] Achieving HiSCR75 at Week 16
timeFrame: Week 16
measure: [Period 1] Absolute change from baseline in Dermatology Life Quality Index (DLQI) score at Week 16
timeFrame: Week 16
measure: [Period 1] Absolute change from baseline in Patient's Global Assessment of Hidradenitis Suppurativa (HS-PtGA) score at Week 16
timeFrame: Week 16
measure: [Period 1] Absolute change from baseline in Skin Pain Numeric Rating Scale (NRS) at Week 16
timeFrame: Week 16
measure: [Period 1] Safety and tolerability of tibulizumab
timeFrame: Week 16
Other outcomes:
Locations:
city: Baton Rouge
country: United States
facility: DelRicht LLC
state: Louisiana
Study officials:
References:
Clinical trial NCT05490810: Effects of Trunk Stabilization Versus Activation Exercises on Pain and Disability in Postpartum Lumbo-pelvic Pain
Official title: Effects of Trunk Stabilization Versus Activation Exercises on Pain and Disability in Postpartum Lumbo-pelvic Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pelvic Pain
Keywords: Lumbo-pelvic Pain
Postpartum
Stabilization Exercises
Trunk Activation Exercises
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2022-08-08
Enrollment: 30
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To compare the Effects of trunk stabilization versus activation exercises on pain and disability in postpartum lumbo-pelvic pain.

Detailed description: Effects of stabilizing exercises on postpartum pelvic floor muscle function, lumbo-pelvic pain and disability. In results, stability exercises can help women with LPP enhance the function of their PFMs. Pregnancy and childbirth weakens PFMs and disrupts the load-transfer system in the lumbo-pelvic area. The use of PFMs in the right pattern can help these muscles operate better. Local stabilizing muscles are targeted during stabilization exercises, which increase pelvic motor control and stability.

As per researcher knowledge there was limited evidence present on the comparison of trunk stabilization and trunk activation exercises. Therefore, this study was conducted to find the effectiveness of trunk stabilization versus activation exercises on disability and pain in postpartum women with lumbo-pelvic pain.

Eligibility criteria: Inclusion Criteria:

* Age 20-40
* Female after postpartum
* Two or more positive posterior provocation test
* Active straight leg raises
* Pain onset during pregnancy

Exclusion Criteria:

* Orthopedic or rheumatologic disorders
* Intervertebral disc pathology
* Neoplasm or previuos surgery of spine
* History of fracture.

Primary outcomes:
measure: Visual analogue scale
timeFrame: 2 weeks
Secondary outcomes:
measure: Oswestry disability index
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Jinnah hospital
state: Punjab
Study officials:
affiliation: Riphah International University
name: Hafiza Neelam Muneeb, MS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06924710: Adaptive Therapy for Resected Stage ⅠB-Ⅱ NSCLC Patients With Undetectable MRD
Official title: A Prospective Multicenter Randomized Controlled Study of Adaptive Therapy in Resected Stage ⅠB-Ⅱ NSCLC Patients With Undetectable MRD
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: NSCLC
Keywords: MRD
ctDNA
Lead sponsor: Peking University Cancer Hospital & Institute
Sponsor class: OTHER
Collaborators: name: Tianjin Chest Hospital
name: Peking University First Hospital
name: The First Hospital of Jilin University
name: Beijing Friendship Hospital
name: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
name: Liaoning Cancer Hospital & Institute
name: Geneplus-Beijing Co. Ltd.
First posted: 2025-04-11
Enrollment: 286
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: It is a prospective, multicenter, randomized controlled trial to investigate the predictive value of MRD on adjuvant therapy. Stage IB-II resected EGFR/ALK negative NSCLC patients will undergo two-round MRD tests after surgery, first in 3-7 days and second in 1 month after surgery. And patients who confirm two-round landmark undetectable MRD will be enrolled and randomly assigned to the conventional treatment group or the adaptive therapy group . Patients in the the adaptive therapy group will undergo closely MRD and imaging monitoring without adjuvant therapy if the MRD was negative.


Eligibility criteria: Inclusion Criteria:

* Stage IB-II non-small cell cancer patients who after complete resection.
* EGFR/ALK negative
* Two-round MRD tests confirm landmark undetectable MRD
* Expected survival ≥24 months
* ECOG PS 0-1
* Willing to accept MRD monitoring every 3 months for a total of 2 years after surgery

Exclusion Criteria:

* Patients who had previously undergone radiotherapy or chemotherapy or any other anti-tumor therapy
* Patients with a history of other malignancies in the past 5 years
* Any unstable systemic disease (eg, active infection, high-risk hypertension, unstable angina, congestive heart failure, etc.) or other conditions that investigators considered would limit the ability of the patient to participate in the study

Primary outcomes:
measure: Two-years disease free survival rates
timeFrame: 2 years
Secondary outcomes:
measure: Use of adjuvant therapy
timeFrame: 2 years
measure: Questionnaire on Quality of Life
timeFrame: 2 years
measure: Five-years disease free survival rates
timeFrame: 5 years
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University Cancer Hospital & Institute
state: Beijing
Study officials:
affiliation: Peking University Cancer Hospital & Institute, Beijing 100142, China
name: Shaohua Ma, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04082910: Metoprolol Treatment for Cytokine Release Syndrome in Patients Treated With Chimeric Antigen Receptor T Cells
Official title: Metoprolol for the Treatment of Cytokine Release Syndrome in Patients Treated With Chimeric Antigen Receptor T Cells
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Solid Tumor
Hematological Malignancy
Keywords: Metoprolol
cytokine release syndrome
chimeric antigen receptor T cells
Lead sponsor: Chinese PLA General Hospital
Sponsor class: OTHER
First posted: 2019-09-10
Enrollment: 30
Sex: ALL
Minimum age (years): 16
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this prospective study is to evaluate the feasibility and efficacy of metoprolol, a beta-1 adrenergic receptor blocker, in the treatment of cytokine release syndrome (CRS) caused by chimeric antigen receptor T (CAR T) cell infusions, its effects on the serum levels of Interleukin-6 (IL-6) and other cytokines.


Eligibility criteria: Inclusion Criteria:

* Patients with lymphoma, leukemia or other malignant diseases who were enrolled for CAR T cell therapy.

Exclusion Criteria:

Patients with contraindications indicated in metoprolol instruction, including:

* Significant bradycardia (heart rate \< 45/min)
* Cardiogenic shock
* Severe or acute heart failure
* Poor peripheral circulation perfusion
* Grade II or III atrioventricular block
* Sick sinus syndrome
* Severe peripheral vascular disease

Primary outcomes:
measure: Safety and tolerability of metoprolol in patients treated by CAR T infusions.
timeFrame: 2-4 weeks
measure: Safety and tolerability of metoprolol in patients treated by CAR T infusions.
timeFrame: 2-4 weeks
Secondary outcomes:
measure: Efficacy of metoprolol for CRS control
timeFrame: 2-4 weeks
measure: Efficacy of metoprolol for CRS precaution
timeFrame: 2-4 weeks
Other outcomes:
Locations:
city: Beijing
country: China
facility: Biotherapeutic Department of Chinese PLA General Hospital
state: Beijing
Study officials:
References:
Clinical trial NCT00095810: Aripiprazole in Patients With Psychosis Associated With Parkinson's Disease
Official title: An Open-Label Study of Aripiprazole to Evaluate the Safety and Tolerability in Patients With Psychosis Associated With Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Parkinson's Disease
Psychoses
Keywords: Psychosis, Parkinson's Disease
Lead sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Otsuka America Pharmaceutical
First posted: 2004-11-09
Enrollment: 50
Sex: ALL
Minimum age (years): 50
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 clinical research study is to assess the safety and tolerability of aripiprazole in patients with psychosis associated with Parkinson's disease.


Eligibility criteria: Inclusion Criteria:

* Primary diagnosis of idiopathic Parkinson's disease.
* Psychosis related to Parkinson's disease.

Exclusion Criteria:

* Psychosis present prior to diagnosis of Parkinson's disease.

Primary outcomes:
measure: Tolerability
Secondary outcomes:
measure: Safety Assessments
Other outcomes:
Locations:
city: Albany
country: United States
facility: Local Institution
state: New York
Study officials:
References:
citation: Friedman JH, Berman RM, Goetz CG, Factor SA, Ondo WG, Wojcieszek J, Carson WH, Marcus RN. Open-label flexible-dose pilot study to evaluate the safety and tolerability of aripiprazole in patients with psychosis associated with Parkinson's disease. Mov Disord. 2006 Dec;21(12):2078-81. doi: 10.1002/mds.21091.
Clinical trial NCT05592210: Influence and Mechanism of Dyadic Coping on Parenting Stress and Parenting Self-Efficacy in Parents of Preterm Infant
Official title: Influence and Mechanism of Dyadic Coping on Parenting Stress and Parenting Self-Efficacy in Parents of Preterm Infant
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Premature Infant Disease
Keywords: Premature Infant
Parental self-efficacy
Parenting Stress
Dyadic Coping
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2022-10-24
Enrollment: 308
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The parents of premature infants admitted to Peking University Shenzhen Hospital from November 2022 to November 2023.

Brief summary: The goal of this observational study is to investigate the parenting stress, parenting self-efficacy and dyadic coping of preterm parents and explore the influence and pathway analysis of dyadic coping between parenting stress and parenting self-efficacy.

Detailed description: For now, there is a lack of investigation and research on parenting stress, parenting self-efficacy and dyadic coping of co-parenting for discharged premature infants in the literature, and the mediating effect of dyadic coping between parenting stress and parenting self-efficacy of preterm parents has not been verified yet. This study aims to provide a theoretical basis for effective intervention for preterm parents with high parenting pressure and insufficient parenting self-efficacy in clinical work.

Eligibility criteria: Inclusion criteria for parents

* Parents of hospitalized preterm infants with a gestational age of less than 37 weeks;
* Both parents are at least 18 years old;
* Able to read and communicate in Chinese, able to complete the questionnaire independently or with the help of the investigator;

Inclusion criteria for Infants

* Gestational age less than 37 weeks;
* admitted to the NU or NICU and discharged after treatment

Exclusion criteria for parents

* Single-parent family;
* Parents diagnosed with severe anxiety and depression;

Exclusion criteria for Infants

* for birth defects cannot be cured and affect the quality of life;
* infants who were given up treatment due to illness or family reasons;
* transferred or death;

Primary outcomes:
measure: Karitane parenting confidence scale
timeFrame: baseline
measure: Parental Stressor Scale: Neonatal Intensive Care Unit (PSS:NICU)
timeFrame: baseline
measure: Dyadic Coping Inventory
timeFrame: baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Shenzhen
country: China
facility: Peking University Shenzhen Hosipital
Study officials:
affiliation: Sun Yat-sen University
name: Wei Xia, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02212210: Maternal Epidural Steroids and Hyperthemia
Official title: Maternal Epidural Steroids to Prevent Neonatal Exposure to Hyperthermia and Inflammation
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: EARLY_PHASE1
Conditions: Fever
Labor Pain
Complication of Anesthesia During Pregnancy, Unspecified
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
First posted: 2014-08-08
Enrollment: 135
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to look to see if adding steroids to an epidural reduces the chances of having a fever in labor, and protects the baby from exposure to inflammation.

Detailed description: The association between epidural analgesia and increased maternal intrapartum temperature has been well documented in multiple randomized controlled trials. The exact mechanism for this elevation in temperature is unknown; however the most likely cause appears to be non-infectious inflammatory stimulation. Fetal exposure to maternal fever in utero has been linked with increased antibiotic treatment, increased neonatal sepsis evaluation, and longer length of stay for neonates. In addition there is evidence to suggest intrapartum fevers may lower the threshold for fetal hypoxic brain injury and increase the risk of cerebral palsy. The risk of neonatal encephalopathy in infants born to febrile mothers is 1% compared to 0.1% to afebrile mothers. Safe interventions are needed to prevent adverse fetal outcomes.

Eligibility criteria: Inclusion criteria:

* Nulliparity
* Age\>=18
* Patient requests epidural analgesia
* GA \>= 37 weeks

Exclusion criteria:

* No prenatal care
* Temperature \>99.4 at decision for epidural placement
* Cervical dilation \>4cm
* Diabetes (pre-gestational or gestational)
* Autoimmune condition
* Pre-eclampsia
* Maternal heart disease
* Current steroid use
* Active infection (bacterial or viral)
* Wet Tap (CSF on placement of epidural)
* Pre-gestational diabetes
* Known systemic infection (bacterial, viral, fungal or tubercular)
* Known allergy to steroids
* Heart failure
* Hypertensive crisis
* History of active epilepsy

Primary outcomes:
measure: Rate of maternal fever
timeFrame: delivery
Secondary outcomes:
measure: Rate of funisitis
timeFrame: delivery
Other outcomes:
measure: IL-6 level
timeFrame: delivery
Locations:
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
Study officials:
affiliation: Medical University of South Carolina
name: Christopher G Goodier, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01716910: Effect of Synbiotic on Composition of Human Gut Microbiota and Production of Short and Branched-chain Fatty Acids
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Synbiotics
Healthy Humans
Composition of Gut Microbiota
Short and Branched-chain Fatty Acids
Lead sponsor: University of Copenhagen
Sponsor class: OTHER
First posted: 2012-10-30
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: This is a randomized, double-blind, placebo controlled, cross-over, single centre, 14 week clinical trial on healthy volunteers. Following a two week run-in-period, subjects were randomized, and treatment with synbiotic or placebo for 21 days was given, followed by a 3-week wash-out period before the second treatment period, followed by a another wash-out period. Volunteers completed questionnaires for each period on overall health and well being, stool frequency and consistency and gastrointestinal symptoms. The subjects were asked to collect fecal samples for investigation of microbiological and microbial metabolites before and after three treatment periods. The primary objective of the study is tan increase in fecal butyrate concentration. Secondary objectives are changes in microbiota composition and short-chain fatty acids.


Eligibility criteria: Inclusion Criteria:healthy individuals between 18-50 years of age who had not used antibiotics three months prior to the trial

-

Exclusion Criteria:

* chronic illness
* regular intake of medication (except birth-control pills)
* post-menopausal women

Primary outcomes:
measure: increase in fecal butyrate concentration
timeFrame: 12 weeks (2x 3 week intervention periods which each were followed by a 3 week wash-out period, sampling at the end of each period)
Secondary outcomes:
measure: changes in composition of microbiota
timeFrame: 12 weeks (2x 3 week intervention periods which each were followed by a 3 week wash-out period, sampling at the end of each period)
measure: changes in short-chain fatty acids
timeFrame: 12 weeks (2x 3 week intervention periods which each were followed by a 3 week wash-out period, sampling at the end of each period)
Other outcomes:
Locations:
city: Frederiksberg C
country: Denmark
facility: Department of Food Science, Food Microbiology, Faculty of Science, University of Copenhagen
Study officials:
affiliation: Department of Food Science, Food Microbiology, Faculty of Science, University of Copenhagen, Denmark
name: Gabriella C. van Zanten, PhD student
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Food Science, Food Microbiology, Faculty of Science, University of Copenhagen, Denmark
name: Gabriella C van Zanten, PhD student
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03029910: Eccentric Training and Cryotherapy Vs Eccentric Training and Whole Body Vibration in Achilles Tendinopathy
Official title: Eccentric Training and Cryotherapy Vs Eccentric Training and Whole Body Vibration in Achilles Tendinopathy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Achilles Tendon
Tendinopathy
Keywords: Eccentric exercise
Whole body vibration
Cryotherapy
Lead sponsor: Universidad Europea de Madrid
Sponsor class: OTHER
First posted: 2017-01-24
Enrollment: 132
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the effectiveness of eccentric exercise combined with vibration or cryotherapy in Achilles tendon pathology.

The investigators hypothesis is that the combined eccentric exercise is better than the results presented by the exclusive eccentric exercise.

This intervention differs from the classic studies in that we maintain the intensity throughout the treatment.


Eligibility criteria: Inclusion Criteria:

* Sports people
* Positive initial ultrasound diagnosis
* Presence of degenerative changes at achilles mid portion
* Chronic Achilles tendon pain, (3/10 VAS)
* Pain when walking or running of Achilles tendon, (3/10 VAS)
* Pain in load in plantar flexion of Achilles tendon, 3/10 VAS)
* Pain in palpation of Achilles, (3/10 VAS)
* Morning Stiffness

Inclusion Criteria Healthy pople:

* Sports people
* Negative initial ultrasound diagnosis
* No syntomp of achilles tendinophaty

Exclusion Criteria:

* Receive physical, orthotic or physiotherapeutic treatment
* Asociated low back pain, ankle/knee/hip injury that may affect the study
* Previous injury or surgery of Achilles tendon.
* Pathologies that may limit the joint of ankle
* Pregnancy
* Obesity
* Patients with diabetes and/or other endocrine or metabolic pathologies or neurologic pathologies
* Patients diagnosed with cardiovascular disease
* Subjets diagnosed with familiar hypercholesterolemia and/or presence of xanthomas or with hyperuricemia
* Patients who have received renal transplantation
* Subjects who have suffered retinal detachment
* Subjects who have received oral contraceptives, statins, corticoids or hormone replacement therapy in the last six months
* Subjects who have received treatment wiht fluoroquinolones in the last two years
* Subjects who have received treatment with AINE's in the last four weeks

Primary outcomes:
measure: Change at Achilles Tendon Cross Sectional Area
timeFrame: 3 months
measure: Change at Achilles Tendon Thickness
timeFrame: 3 months
Secondary outcomes:
measure: Differences between healthy volunteers and volunteers with Achilles tendinopathy
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Universidad Europea
Study officials:
References: