louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04597944: Lanadelumab in Bradykinin Angioedema
Official title: Evaluation of the Efficacy of Kallikrein Inhibition by Lanadelumab for Patients With Bradykinin Angioedema: a Cohort Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Angioedema
Keywords: Kallikrein, Kininogen, Bradykinin, Lanadelumab
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
First posted: 2020-10-22
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Hereditary or Acquired Angiodema

Brief summary: A multicenter observational study aiming to evaluate the efficacy of kallikrein inhibition by lanadelumab in patients with bradykinin- angioedema

Detailed description: The bradykinin-angioedema (AE-BK) is characterized by recurrent and unpredictable episodes of swelling; it can be disabling and disfiguring and the attacks affecting the larynx can be life-threatening.

The clinical symptoms depend on accumulation of bradykinin (BK), a vasoactive peptide responsible for vasodilation and increase of vascular leakage. BK formation depends on activation of the kallikrein-kinin cascade leading to uncontrolled generation of plasma kallikrein and subsequent proteolysis of high molecular-weight kininogen (HK).

Lanadelumab is a fully human monoclonal antibody inhibitor of plasma kallikrein, thereby preventing BK production; it represents an attractive therapeutic strategy for BK-AE prophylaxis.

The aim of this study is to evaluate the kallikrein inhibition by assessing the levels of cleaved HK and the immunogenicity of the lanadelumab.

Eligibility criteria: Inclusion Criteria:

* Male/female \>18 years old
* Patient with hereditary or acquired angioedema
* Patient treated by lanadelumab
* Patient whose the biological explorations have been carried out or will be carried out at Laboratory of Immunology of CHUGA
* Informed consent is obtained from the participant

Exclusion Criteria:

* Absence of biological material at T0 and M3 (stored for routine analysis)
* Person under guardianship or curatorship
* Female who is pregnant, nursing

Primary outcomes:
measure: Evaluation of the efficacy of the kallikrein inhibition by lanadelumab in patients with bradykinin-angioedema
timeFrame: 3 months
Secondary outcomes:
measure: Evaluation of the efficacy of kallikrein inhibition by lanadelumab in patients with bradykinin-angioedema between T0 and the others visits
timeFrame: Day 7; 6, 12 and if possible 24 months
measure: Immunogenicity of lanadelumab
timeFrame: Months 3, 6, 12 (and 24 if possible)
measure: Evaluation of therapeutic escape
timeFrame: Months 3, 6, 12 and if possible 24
Other outcomes:
Locations:
city: Grenoble
country: France
facility: Chu Grenoble Alpes
city: Rouen
country: France
facility: CHU Rouen
Study officials:
affiliation: Grenoble Alpes University Hospital
name: Federica DEFENDI
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02320344: Partnerships to Improve Lifestyle Interventions (PILI) 'Ohana Dissemination Project Partners in Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes
Lead sponsor: University of Hawaii
Sponsor class: OTHER
Collaborators: name: Kula No Na Po'e Hawaii
name: Ke Ola Mamo
name: Hawai'i Maoli
name: Kokua Kalihi Valley
First posted: 2014-12-19
Enrollment: 47
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The 3-month face-to-face Partners in Care intervention will be community-based and community-led by trained community peer educators from these four partnering community organizations. The intervention involves 12 weekly, group lessons with each lesson lasting about 1 and 1/2 hours. Individuals with a hemoglobin A1c (HbA1c; average blood sugar levels) greater than or equal to 7% will be recruited for the study because they represent the most at-risk for diabetes-related complications. Over a 3-year accrual period, the community partners will recruit and enroll 150 eligible NHs and PPs, as well as deliver and evaluate the intervention in their respective community settings. The primary outcomes of our study are hemoglobin A1c and self-reported diabetes specific quality of life. Secondary outcomes are cholesterol levels (including HDL, LDL, total cholesterol, and triglycerides), blood pressure, body mass index, and psychosocial adaptation.


Eligibility criteria: Inclusion Criteria:

1. Adults age \>18 years of age,
2. English-speaking,
3. Physician-diagnosed type 2 diabetes, and
4. Baseline hemoglobin A1c \>7%.

Exclusion Criteria:

1. Survival less than 6 months,
2. Planning to move out of the community during the intervention study period,
3. Pregnancy,
4. Any co-morbid condition (physical and mental disabilities) that would prevent the individual from participating in the intervention protocol (i.e., major psychiatric illness).

Primary outcomes:
measure: Hemoglobin A1c
timeFrame: 3 months
measure: Problem Areas in Diabetes
timeFrame: 3 months
Secondary outcomes:
measure: Total Cholesterol (including HDL and LDL)
timeFrame: 3 months
measure: Triglycerides
timeFrame: 3 months
Other outcomes:
Locations:
city: Honolulu
country: United States
facility: Department of Native Hawaiian Health, University of Hawaii
state: Hawaii
Study officials:
References:
Clinical trial NCT05825144: Therapeutic Effects of Robotic Exoskeleton-Assisted Gait Re-habilitation and Predictive Factors of Significant Improvements in Stroke Patients
Official title: Therapeutic Effects of Robotic Exoskeleton-Assisted Gait Re-habilitation and Predictive Factors of Significant Improvements in Stroke Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stroke Sequelae
Keywords: robotic rehabilitation
stroke
quality of life
walking speed
Lead sponsor: Taichung Veterans General Hospital
Sponsor class: OTHER
First posted: 2023-04-24
Enrollment: 50
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Investigators aimed to examine the effectiveness of robotic exoskeleton-assisted gait training in stroke rehabilitation, and to determine predicting factors of significant improvements in post-stroke patients. Investigators hypothesized that robotic assisted gait training brings better strength recovery and functional improvement.


Eligibility criteria: Inclusion Criteria:

* patients aged from 30 to 80 years
* hemiparesis due to ischemic or hemorrhagic stroke in the last 6 months

Exclusion Criteria:

* with a significant history of pain or injury of lower limbs that affected their walking ability,
* with cardiopulmonary diseases that prohibited exercise training
* with impaired cognitive function
* unable to complete the timed up-and-go test
* able to complete the timed up-and-go test in \<20 seconds using walking device

Primary outcomes:
measure: Change from baseline distance walked in 6 minute walk test after entire rehabilitation program (4 weeks)
timeFrame: 4 weeks
measure: Change from baseline time needed to complete Timed-Up-and-Go test after entire rehabilitation program (4 weeks)
timeFrame: 4 weeks
measure: Change from baseline scores in 12-item short form survey after entire rehabilitation program (4 weeks)
timeFrame: 4 weeks
measure: Change from baseline Isokinetic strength after entire rehabilitation program (4 weeks)
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Taichung
country: Taiwan
facility: Taichung Veterans General Hospital
Study officials:
References:
Clinical trial NCT02745444: Prevention of Acute Kidney Injury - Molecular Mechanisms of Dietary Pre-conditioning in Human
Official title: Prevention of Acute Kidney Injury - Molecular Mechanisms of Dietary Pre-conditioning in Human
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Kidney Disease
Keywords: Living kidney transplantation
Chronic kidney disease
Acute kidney injury
Lead sponsor: University of Cologne
Sponsor class: OTHER
First posted: 2016-04-20
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The key objective of this pilot study is to assess the molecular mechanisms of renal pre-conditioning by a one-week low-calorie diet in humans.

The protective effect of the low-calorie diet and also of the protein-restriction in donor on transplant qualities and functions in receptor will also be investigated.

Analysis of transcriptome, lipidome, metabolome, epigenome, proteome und phosphoproteome through tissue samples as well as blood samples for comparison of low-calorie diet, protein-restriction and no-diet groups.


Eligibility criteria: Inclusion Criteria:

* Age ≥18 years
* Competent patients
* Planned living kidney transplantation
* Provision of informed consent
* BMI ≥ 18,5 kg/m²

Exclusion Criteria:

* None

Primary outcomes:
measure: Number of differentially regulated genes on a transcriptomic level
timeFrame: up to 1 year upon receipt of the last tissue sample
measure: Number of differentially regulated genes on a lipidome level
timeFrame: up to 2 years upon receipt of the last tissue sample
measure: Number of differentially regulated genes on a metabolome level
timeFrame: up to 2 years upon receipt of the last tissue sample
measure: Number of differentially regulated genes on a epigenome level
timeFrame: up to 2 years upon receipt of the last tissue sample
measure: Number of differentially regulated genes on a proteome level
timeFrame: up to 1 year upon receipt of the last tissue sample
measure: Number of differentially regulated genes on a phosphoproteome level
timeFrame: up to 2 years upon receipt of the last tissue sample
Secondary outcomes:
measure: Change of NGAL in urine
timeFrame: Preoperative from donor and receptor; 6h, 12h and 24h after renal transplantation from receptor.
measure: Cystatin C
timeFrame: Preoperative and up until 7 days after renal transplantation from receptor.
measure: Occurrence of acute kidney injury
timeFrame: Assessed up to approx. 30 days from date of renal transplantation until date of discharge, which is the end of observation.
measure: Maximum postoperative serum creatinine
timeFrame: Assessed up to approx. 30 days from date of renal transplantation until date of discharge, which is the end of observation.
Other outcomes:
Locations:
city: Cologne
country: Germany
facility: University Hospital of Cologne
Study officials:
affiliation: Principal Investigator
name: Volker Burst, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00066144: Use of Black Cohosh and Red Clover for the Relief of Menopausal Symptoms
Official title: Black Cohosh and Red Clover Efficacy for the Relief of Menopausal Symptoms
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hot Flashes
Menopause
Keywords: menopause
hot flashes
red clover
black cohosh
sexual dysfunction
Lead sponsor: National Center for Complementary and Integrative Health (NCCIH)
Sponsor class: NIH
Collaborators: name: Office of Dietary Supplements (ODS)
First posted: 2003-08-05
Enrollment: 112
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This Phase II study, a follow-up to a Phase I trial in normal volunteers, will determine the efficacy of black cohosh and red clover for the relief of menopausal symptoms. It will also assess the safety of chronic dosing (1 year) by evaluating uterine (endometrial biopsies), breast (mammography), and hematology parameters (CBC and chemistry lab values) at baseline and 1 year.


Eligibility criteria: Inclusion Criteria:

* Menopausal women with intact uterus
* Must be experiencing hot flashes
* No menstrual periods for at least 6 months and no longer than 3 years
* Non-smoker
* Must have intact uterus (no hysterectomy)

Exclusion Criteria:

* Contraindications for hormone replacement therapy
* Diabetes mellitus
* Pregnancy or breast-feeding
* Obese (BMI \>35 excluded)
* History of endometrial hyperplasia/neoplasia/malignancy
* History of breast or reproductive cancer
* History of severe recurrent depression, or severe psychiatric disturbance
* History of stroke/CVA, severe varicose veins, sickle cell anemia, myocardial infarction (heart attack), or arrhythmia (rhythm disturbance of the heart)
* History of abnormal vaginal bleeding of unknown cause
* Untreated or uncontrolled high blood pressure/hypertension
* Use of any medication or supplement containing estrogen, progestin, SERM, St. John's Wort, bisphosphonates, or phytoestrogens
* History of hormone-associated migraines
* History of deep vein thrombosis (blood clots), thrombophlebitis, or thromboembolic disorders
* Participation in a clinical trial within 30 days
* Abnormal endometrial biopsy or mammogram
* Abnormal transvaginal ultrasound defined as \>7mm thickness
* Vegan

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Illinois at Chicago
state: Illinois
Study officials:
affiliation: Department of Obstetrics and Gynecology University of Illinois, Chicago
name: Stacie Geller, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Geller SE, Shulman LP, van Breemen RB, Banuvar S, Zhou Y, Epstein G, Hedayat S, Nikolic D, Krause EC, Piersen CE, Bolton JL, Pauli GF, Farnsworth NR. Safety and efficacy of black cohosh and red clover for the management of vasomotor symptoms: a randomized controlled trial. Menopause. 2009 Nov-Dec;16(6):1156-66. doi: 10.1097/gme.0b013e3181ace49b.
Clinical trial NCT02029144: Observational Study of Dydrogesterone in Cycle Regularization
Official title: Dydrogesterone in Cycle Regularization in Abnormal Uterine Bleeding - Ovulation Dysfunction (AUB-O) Patients: A Prospective, Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Observational Study
Dydrogesterone
Irregular Menstrual Cycle
Abnormal Uterine Bleeding
Lead sponsor: Fudan University
Sponsor class: OTHER
Collaborators: name: Abbott
First posted: 2014-01-07
Enrollment: 114
Sex: FEMALE
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Chinese women who is suffering from irregular menstrual cycle for at least 3 months and has been diagnosed as AUB-O

Brief summary: Dydrogesterone has been widely used worldwide for various gynecological and obstetric indications:

* Dydrogesterone is effective in cycle regulation treatment.
* Dydrogesterone is recognized as none interference to hypothalamus pituitary ovary (HPO) axis in the recommended dosage.
* Dydrogesterone might have non-negative effect on glucose and lipid metabolic.

Detailed description: The current study is designed as a prospective, non-interventional, observational study. Patients with irregular cycle diagnosed as AUB-O will be prescribed dydrogesterone as per physician's clinical practice.

Eligibility criteria: Inclusion Criteria:

* Women aged 16 years or above with menses
* Patient who is suffering from irregular menstrual cycle for at least 3 months and has been diagnosed as AUB-O (irregular cycle is defined as cycle duration \< 21days or \>35 days)
* Physicians have decided to prescribe dydrogesterone 10mg for cycle regulation treatment, orally taking dydrogesterone 10mg twice daily, from day16 to day 25 of each cycle, being consecutive at least 3 cycles
* Patient who is willing to sign written authorization

Exclusion Criteria:

* Hyperprolactinemia and thyroid dysfunction.
* Patient took cycle regulation treatment including oral contraceptives, sex hormone or glucocorticoid in the past 1 month
* Women with estrogen deficiency related symptom
* Patient who meets the contraindications listed in Chinese label of dydrogesterone
* Pregnant and lactating patients
* Patient who is not suitable for the study according to physician's discretion

Primary outcomes:
measure: percentage of patients reporting a regular cycle (defined as cycle duration≥21 and ≤ 35 days) at the end of cycle 3
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Obstetrics and Gynecology Hospital of Fudan University
state: Shanghai
Study officials:
References:
Clinical trial NCT02927444: Immunogenicity and Safety Study of NBP606 in Healthy Toddlers
Official title: Multi-Center, Randomized, Double-Blind, Phase III Trial to Assess the Immunogenicity and Safety of Booster Vaccination With NBP606 in Healthy Toddlers (The Extension Study of NBP606_PCVI_III_2013)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pneumococcal Infections
Lead sponsor: SK Chemicals Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2016-10-07
Enrollment: 462
Sex: ALL
Minimum age (years): 12
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study will assess the immunogenicity and safety of booster vaccination with NBP606 compared to the existing commercial vaccine, when given concomitantly with routine pediatric vaccinations.


Eligibility criteria: Inclusion Criteria:

* Healthy infants who completed 3 doses of primary vaccination (NBP606_PCVI_III_2013), available for follow-ups during the study period.
* The LAR (Legally Authorized Representative) who understand the requirements of the study and voluntarily consent to participate in the study.

Exclusion Criteria:

* Administration of other vaccines, except the ones provided in this study, within 1month prior to booster study
* Known hypersensitivity to any components of the pneumococcal vaccine
* Any confirmed or suspected immunosuppressive or immunodeficient conditions
* Coagulation disorder contraindicating IM(intramuscular) vaccination
* Participation to another study

Primary outcomes:
measure: Proportion of subjects with the targeted antibody concentration
timeFrame: 1 month after the booster vaccination
Secondary outcomes:
measure: Geometric mean concentration ratio
timeFrame: 1 month after the booster vaccination
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Clinical Research Center
Study officials:
References:
Clinical trial NCT05480644: Circulating Biomarkers Repository in Adults Diagnosed With Primary and Metastatic Brain Tumors
Official title: Circulating Biomarkers Repository in Adults Diagnosed With Primary and Metastatic Brain Tumors
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Brain Tumor, Primary
Brain Metastases, Adult
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2022-07-29
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients diagnosed with primary or metastatic brain tumors and treated in the Department of Radiation Oncology at Duke

Brief summary: The purpose of this protocol is to create a repository of blood samples from patients diagnosed with primary and metastatic brain tumors who are being seen in the Department of Radiation Oncology at Duke Cancer Center.

Detailed description: Repository blood samples will be used to study the association of circulating biomarkers with radiation therapy outcomes.

Eligibility criteria: Inclusion Criteria:

* Have a confirmed diagnosis of primary or metastatic brain tumor (histology or imaging as appropriate)

Exclusion Criteria:

* None

Primary outcomes:
measure: Number of circulating immune cells in peripheral blood
timeFrame: 6 weeks post radiation therapy
Secondary outcomes:
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke Cancer Center
state: North Carolina
Study officials:
affiliation: Duke University Health System (DUHS)
name: Scott Floyd, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02095444: Using Human Menstrual Blood Cells to Treat Acute Lung Injury Caused by H7N9 Bird Flu Virus Infection
Official title: Phase1 Study of Recombinant Stem Cells That Repair Lung Injury in H7N9 Infected Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Acute Lung Injury
Acute Respiratory Distress Syndrome (ARDS)
Multiple Organ Failure
Lead sponsor: S-Evans Biosciences Co., Ltd.
Sponsor class: INDUSTRY
Collaborators: name: First Affiliated Hospital of Zhejiang University
First posted: 2014-03-24
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 human menstrual blood-derived stem cells are effective in the treatment of infection of H7N9 virus caused acute lung injury.

Detailed description: 1. recruiting volunteers of H7N9 infection: age \> 18; patients signed with the informed consent; APACHE II \> 20 score
2. patients infused with menstrual blood progenitor cells infusion dose: 1\~10×10\*7 cells/kg infusion frequency: 2 times a week, 2 weeks for infusion
3. test items and standard spirits lifted; pulmonary function improved; lung image injury improved

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of H7N9 infection
* must be critical injured for lung tissues

Exclusion Criteria:

* cancer diseases
* pregnancy
* mental disorder
* allergic constitution
* severe inflammation

Primary outcomes:
measure: The degree of lung injury
timeFrame: 14 days
Secondary outcomes:
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: State Key Laboratory for Diagnosis and Treatment of Infectious Diseases, the First Affiliated Hospital
state: Zhejiang
Study officials:
affiliation: State Key Laboratory for Diagnosis and Treatment of Infectious Diseases, the First Affiliated Hospital, School of Medicine, Zhejiang University
name: Charlie Xiang, Doctor
role: PRINCIPAL_INVESTIGATOR
References: