louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02821819: Random-start Ovarian Stimulation in Egg-donors (ROSE)
Official title: Random-start Ovarian Stimulation in Egg-donors (ROSE) Trial: a Self-controlled Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Infertility
Keywords: ovarian stimulation
random
egg donation
antagonist
gnrh agonist trigger
Lead sponsor: Instituto Bernabeu
Sponsor class: OTHER
First posted: 2016-07-04
Enrollment: 15
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this prospective single-center study is to evaluate the laboratory outcome after random start ovarian stimulation in oocyte donors. The study will be performed in egg-donors but this type of treatment has the potential to be implemented in general infertility population.

Detailed description: The study group will start ovarian stimulation randomly in different moments throughout the menstrual cycle.

Randomization will take place on day 2-3 of the menstrual cycle, according to a list of random allocation of treatments and egg-donors will be assigned to random start ovarian stimulation: During follicular phase starting at day 5,7,9,11 or 13 of the menstrual cycle and during luteal phase starting at luteinizing hormone (LH) peak +3,+5,+7,+9 or +11.

Egg-donors will receive urinary follicle stimulating hormone (FSH) 150-225 IU/d in gonadotropin-releasing hormone (GnRH) antagonist protocol with cetrorelix acetate 0,25 mg/d starting five days after ovarian stimulation and a GnRH agonist trigger with triptorelin 0,2 mg to induce the final follicular maturation. Transvaginal ultrasound and serum analysis (estradiol, progesterone, LH and FSH) will be included for cycle monitoring.

Eligibility criteria: Inclusion Criteria:

* Premenopausal women
* 18-35 years old
* FSH levels \< 10 IU/liter
* Antral follicle count (AFC) \> 10
* Regular cycles
* Body Mass Index (BMI) \< 28
* Signed informed consent

Exclusion Criteria:

* Polycystic ovary syndrome (PCOS) patients
* Allergy to gonadotrophins
* Concomitant participation in other trial

Primary outcomes:
measure: Percentage of Mature Eggs
timeFrame: Up to 24 hours from the oocyte collection
Secondary outcomes:
measure: Fertilization Rate
timeFrame: 24 hours after day of oocyte collection
Other outcomes:
Locations:
city: Alicante
country: Spain
facility: Instituto Bernabeu
Study officials:
affiliation: Instituto Bernabeu
name: Juan C Castillo, Md. PhD.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04395118: STOP HCC: Mailed HCV Treatment Outreach Program for HCC Prevention for Elevated LFTs
Official title: STOP-HCC Evidence-Based Hepatocellular Cancer Prevention Through Treatment of Hepatitis C Virus Infection
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Hepatitis C
Hepatocellular Carcinoma
Lead sponsor: University of Texas Southwestern Medical Center
Sponsor class: OTHER
First posted: 2020-05-20
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: The investigators will conduct a randomized controlled trial comparing two strategies to promote HCV screening, follow-up testing, and treatment among Parkland patients who are 18 years or older who have elevated liver functioning test (LFT) results: in reach with electronic medical record alerts and provider education vs. combination of in reach and provider education plus mailed outreach and patient navigation.


Eligibility criteria: Inclusion Criteria:

* ages 18 or older
* elevated liver functioning tests (AST or ALT \>35 that are separated by at least one month)
* ≥ 1 outpatient visit during 12 months prior to randomization at Parkland
* no prior HCV screening (prior HCV antibody, viral load, or genotype).
* any active medical coverage
* speaks Spanish or English

Exclusion Criteria:

* a life expectancy less than one year including any history of metastatic cancer, and those who received a palliative care or hospice referral in the past year
* history of HCC.
* non-English or Spanish speakers
* no address or phone number on file

Primary outcomes:
measure: Hepatitis C Screening
timeFrame: 6 months
Secondary outcomes:
measure: Hepatitis C Screening
timeFrame: 12 months
measure: Hepatitis C Confirmation
timeFrame: 3 months
measure: Hepatitis C Linkage to Care
timeFrame: 6 months
measure: Cost Per Patient Screened
timeFrame: 3 months
measure: Cost Per HCV Diagnosis
timeFrame: 12 months
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Parkland Hospital
state: Texas
Study officials:
References:
Clinical trial NCT03058718: Procalcitonin-Guided Antibiotic Therapy in Bronchiectasis
Official title: Effectiveness of Procalcitonin-Guided Antibiotic Therapy in Acute Exacerbations of Bronchiectasis: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Procalcitonin
Bronchiectasis
Antibiotic Therapy
Lead sponsor: Qilu Hospital of Shandong University
Sponsor class: OTHER
First posted: 2017-02-23
Enrollment: 210
Sex: FEMALE
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: To explore effectiveness of procalcitonin-guided antibiotic therapy in acute exacerbations of bronchiectasis, and to explore the clinical value of procalcitonin in bronchiectasis.


Eligibility criteria: Inclusion Criteria:

1. Bronchiectasis was diagnosed by high-resolution computed tomography based on the criteria published by McShane PJ et al.
2. Acute exacerbations of bronchiectasis.
3. Aged \>= 18 years.
4. Procalcitonin been detected after admission.

Exclusion Criteria:

1. Associated with chronic obstructive pulmonary disease.
2. Associated with asthma.
3. Traction bronchiectasis caused by pulmonary fibrosis.
4. Rule out other possible cause procalcitonin increased diseases such as cancer, connective tissue disease, active tuberculosis, chronic liver disease and respiratory system than the bacterial infection.
5. Clinical data were incomplete.
6. Can not follow up with the person.

Primary outcomes:
measure: Antimicrobial prescription rate
timeFrame: 14 days
measure: Number of days of antimicrobial application
timeFrame: 14 days
measure: The number of days in hospital
timeFrame: 14 days
Secondary outcomes:
measure: Effective rate of clinical treatment
timeFrame: 14 days
measure: Quality of life score
timeFrame: 6 months
measure: Adverse reaction rate
timeFrame: 14 days
measure: Bacterial resistance rate
timeFrame: 14 days
measure: The incidence of complications
timeFrame: 14 days
measure: fungal infection rate
timeFrame: 14 days
measure: mortality rate
timeFrame: 14 days
measure: The proportion of patients with at least once acute exacerbation in 6 months
timeFrame: 6 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02073318: Effects of Balance Training in Older Adults With Dementia
Official title: Effects of Task-oriented Balance Training in Institutionalized Older Adults With Dementia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Dementia
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2014-02-27
Enrollment: 19
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Purpose -To investigate whether older adults with dementia who have balance and gait problems can improve their balance and gait function after an individualized 4-week tasks-oriented balance training with sensory manipulation.

Hypothesis

-There is significant difference of Timed Up and Go Test, Berg Balance Scale, walking speed, 30-s chair-stand test, Chair sit-and-reach test and Barthel Index between dementia patients who received tasks-oriented balance training and those didn't receive after 4-weeks training and one month follow-up.


Eligibility criteria: Inclusion Criteria:

* Patient provides oral consent, and written consent obtains from next of kin
* Older than 65 years
* Diagnosis of dementia, based on Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) or The International Statistical Classification of Diseases and Related Health Problems 10th Revision (ICD-10)
* Can follow order to complete the screening test(Timed Up and Go test)
* Has balance and gait problems
* Can standing independently with/without assistive device or can standing with minimal assistance

Exclusion Criteria:

* Newly developed cardiopulmonary disease and other exercise contraindications
* Other neuromuscular or musculoskeletal disease that might affect the outcome(ex. Recent stroke, fracture or orthopedic surgery)

Primary outcomes:
measure: Timed Up and Go test
timeFrame: baseline, post-treatment, 1-month follow up
measure: Berg Balance Scale
timeFrame: baseline, post-treatment, 1-month follow up
measure: walking speed
timeFrame: baseline, post-treatment, 1-month follow up
Secondary outcomes:
measure: 30-s chair-stand test
timeFrame: baseline, post-treatment, 1-month follow up
measure: chair sit-and-reach test
timeFrame: baseline, post-treatment, 1-month follow up
measure: Saint Louis University mental status examination
timeFrame: baseline, post-treatment, 1-month follow up
measure: Barthel index
timeFrame: baseline, post-treatment, 1-month follow up
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: The Catholic Foundation of Alzheimer's Disease and Related Dementia St. Joseph Home for Alzheimer's Disease and Related Dementia
Study officials:
affiliation: School of Physical Therapy, National Taiwan University
name: Ming-Hsia Hu, Ph.D.
role: STUDY_CHAIR
References:
Clinical trial NCT04116918: Efficacy and Safety of the Combination of Anlotinib and JS001 in EGFR-TKI Resistant T790M-Negative NSCLC
Official title: Efficacy and Safety of the Combination of Anlotinib and JS001 in EGFR-TKI Resistant T790M-Negative NSCLC
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: NSCLC Stage IV
EGFR T790M-negative
Anlotinib
JS001
Lead sponsor: Shanghai Changzheng Hospital
Sponsor class: OTHER
First posted: 2019-10-07
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: EGFR-TKI Resistant T790M-Negative NSCLC

Brief summary: This study is designed to evaluate the efficacy and safety of the combination of Anlotinb and JS001 in EGFR-TKI resistant T790M-negative NSCLC patients.

Detailed description: All EGFR mutation NSCLC patients with EGFR-TKIs eventually develop acquired resistance and in 40%-50% of these the resistance mechanism is based on the EGFR T790M mutation who could receive Osimertinib. Several alternative mechanisms of escape from EGFR-TKIs have been detected in NSCLC patients without the T790M, such as Met application, BRAF mutation, PIK3CA mutation, etc, who could receive the combination of EGFR-TKI with comparable target drug. Given the lack of targeted therapy for the majority of T790M-negative patients, platinum-doublet chemotherapy remains the standard of care with low effectiveness. In the present study, we aimed to evaluate the efficacy and safety of the combination of Anlotinb and JS001 in EGFR-TKI resistant T790M-negative NSCLC patients.

Eligibility criteria: Inclusion Criteria:

* Adult patients \>=18 years of age
* Inoperable locally advanced, recurrent, and/or metastatic NSCLC patients with EGFR sensitive mutation
* EGFR-TKI resistent
* EGFR T790M negative
* Expected survival ≥ 3 month;
* ECOG / PS score: 0-2;
* the main organ function to meet the following criteria: HB ≥ 90g / L, ANC ≥ 1.5 × 109 / L, PLT ≥ 80 × 109 / L,BIL \<1.5 times the upper limit of normal (ULN); Liver ALT and AST \<2.5 × ULN and if liver metastases, ALT and AST \<5 × ULN; Serum Cr ≤ 1 × ULN, endogenous creatinine clearance ≥50ml/min

Exclusion Criteria:

* EGFR-T790M positive
* with druggable gene alteration;
* Patient can not comply with research program requirements or follow-up;

Primary outcomes:
measure: Progression-Free Survival (PFS)
timeFrame: Evaluation of tumor burden based on RECIST criteria until first documented progress through study completion, an average of 2 months
measure: Objective Response Rate
timeFrame: Evaluation of tumor burden based on RECIST criteria through study completion, an average of 2 months
Secondary outcomes:
measure: Overall Survival
timeFrame: From date of treatment beginning until the date of death from any cause, through study completion, an average of 1 months
measure: Adverse Effect
timeFrame: Through study completion, an average of 1 months
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Changzheng Hospital
Study officials:
References:
Clinical trial NCT06806618: HAE Burden and Crisis Management
Official title: Survey Evaluating the Burden and Management of HAE Crises by Patients and Caregivers
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Hereditary Angioedema (HAE)
Keywords: survey
on-demand treatment
hereditary angioedema
burden
caregivers
quality of life
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
First posted: 2025-02-04
Enrollment: 300
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with HAE

Brief summary: The study has been designed as a French, multicentric survey study to obtain data to describe the burden of on-demand treatment for patients with hereditary angioedema (HAE). The online survey assesses various aspects of HAE and in particular the burden of HAE from the patients' and caregivers' perspectives.

Detailed description: The study has been designed as a French, multicentric survey study to obtain data to describe the burden of on-demand treatment for patients with hereditary angioedema (HAE). The study will also explore the burden related to the administration of intravenous or subcutaneous on-demand treatments. The study was designed to collect data concerning the burden of HAE in patients with HAE (during HAE attacks and between attacks) and in caregivers. The online survey will collect data to describe the characteristics of patients with HAE, the disease characteristics, details concern various aspects of HAE attacks, and the burden of HAE in patients and their caregivers.

Eligibility criteria: Inclusion Criteria:

For the patient population:

1. Patients with a confirmed diagnosis of HAE with a deficit in the C1 inhibitor.
2. Aged ≥12 years
3. Having consulted for HAE in the last 3 months and with a medical file.

For the caregiver population:

1. A person identified by the patient as part of their support group and who provides support with the management of the patients HAE (including family members, friends, spouse, etc.)

Exclusion Criteria:

For the patient population:

1. Opposes to participating in the study.
2. Patients is under guardianship or deprived of their liberty.

Primary outcomes:
measure: To describe the burden associated with the on-demand treatment of HAE attacks
timeFrame: The survey will focus on HAE attacks that have occurred within the last 12 months.
Secondary outcomes:
measure: Use of on-demand treatments for HAE attacks
timeFrame: The survey will focus on HAE attacks that have occurred within the last 12 months.
Other outcomes:
Locations:
city: Grenoble
country: France
facility: CHU Grenoble Alpes
Study officials:
References:
Clinical trial NCT00717418: Efficacy Study of Cyclosporine Ophthalmic Emulsion in Patients With Dry Eye Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Keratoconjunctivitis Sicca
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2008-07-17
Enrollment: 781
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients can either:

1. be newly diagnosed or changing therapies and require, in the judgment of the treating physician, a prescription treatment
2. have insufficiently controlled dry eye symptoms necessitating use of over-the-counter treatments

Brief summary: This study will evaluate the efficacy of cyclosporine ophthalmic solution vs. other non-prescription treatments in patients with dry eye disease. Patient and physician assessments completed at baseline, at each follow-up visit (follow-up visits are variable as per physician discretion) and at final follow-up visit.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of dry eye disease
* Currently using artificial tears daily
* Male or female of legal age of consent
* Normal lid position and closure

Exclusion Criteria

* Patients currently using cyclosporine ophthalmic emulsion 0.05%
* Participation in other investigational drug or device study
* Any current or previous topical ophthalmic or oral cyclosporine use within the last three years

Primary outcomes:
measure: Ocular Surface Disease Index (OSDI) Total Score at Baseline
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
measure: Schirmer's Test With and Without Anesthesia at Baseline
timeFrame: Baseline
Locations:
city: Wilson
country: United States
state: North Carolina
Study officials:
affiliation: Allergan
name: Medical Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT02647918: Study to Evaluate Sotagliflozin in Subjects With Varying Degrees of Renal Function
Official title: A Phase 1, Open-label, Parallel-group Study to Evaluate Sotagliflozin Safety and Pharmacokinetics in Subjects With Varying Degrees of Renal Function
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Renal Impairment
Healthy
Lead sponsor: Lexicon Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2016-01-06
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the effect of mild, moderate, or severe renal impairment, or end-stage renal disease (ESRD) requiring hemodialysis (HD), on the safety and tolerability of 1 or 2 single doses of sotagliflozin compared with healthy, demographically-matched subjects with normal renal function.


Eligibility criteria: Inclusion Criteria:

* Adult male and female subjects ≥18 to ≤75 years of age
* Body mass index ≥18.0 to ≤36.0 kg/m2, at Screening
* Subjects with mild, moderate, or severe renal impairment, or ESRD requiring HD
* Control group of matched healthy subjects
* Willing and able to provide written informed consent

Exclusion Criteria:

* Presence of clinically significant physical, laboratory, or ECG findings that may interfere with any aspect of study conduct or interpretation of results
* Existence of any surgical or medical condition that might interfere with the absorption, distribution, metabolism, or excretion of sotagliflozin
* History of any major surgery within 6 months
* History of hepatic disease, or significantly abnormal liver function test
* Women who are breastfeeding or are planning to become pregnant during the study

Primary outcomes:
measure: Number of treatment emergent adverse events
timeFrame: Day 1 to Day 8
Secondary outcomes:
measure: Plasma concentration of sotaglifozin to evaluate AUC
timeFrame: Day 1
Other outcomes:
Locations:
city: Miami
country: United States
facility: Lexicon Investigational Site
state: Florida
city: Orlando
country: United States
facility: Lexicon Investigational Site
state: Florida
city: Minneapolis
country: United States
facility: Lexicon Investigational Site
state: Minnesota
city: Saint Paul
country: United States
facility: Lexicon Investigational Site
state: Minnesota
Study officials:
affiliation: Lexicon Pharmaceuticals, Inc.
name: Suman Wason, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01068418: Vitamin D Supplementation Reduces Renin-Angiotensin System Activity in Obesity
Official title: Vitamin D Deficiency Augments Renin-Angiotensin System Activity in Obesity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Vitamin D Deficiency
Hypertension
Keywords: Obesity
Renin Angiotensin System
Vitamin D deficiency
Hypertension
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
First posted: 2010-02-15
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: Hypothesis: Vitamin D supplementation lower renin-angiotensin system activity in obesity.

Specific Aim: To investigate whether Vitamin D supplementation in obesity improves the vascular sensitivity to angiotensin II.

Detailed description: Vitamin D deficiency and obesity are international epidemics that have both been associated with increased activity of the renin-angiotensin system (RAS). Because increased RAS activity is associated with cardiovascular disease, interventions to lower RAS will have favorable public health impacts.

This study aims to evaluate whether the supplementation of Vitamin D in obese subjects will lower local tissue RAS activity. RAS activity will be evaluated by cross-sectional measurement of RAS components and by quantifying the vascular response to an infusion of angiotensin II. Subjects will be studied while Vitamin D deficient, and will return for repeat study following Vitamin D supplementation, for comparison.

Eligibility criteria: Inclusion Criteria:

* age \< 65,
* Cr \< 1.6,
* 25-hydroxyvitamin D \< 25 ng/mL,
* BMI \> 30 kg/m2,
* stage I hypertension.

Exclusion Criteria:

* diabetes,
* coronary heart disease,
* heart failure,
* renal failure,
* liver failure,
* hyperparathyroidism,
* granulomatous disease.

Primary outcomes:
measure: The Change in the Mean Arterial Blood Pressure in Response to an Infusion of Angiotensin II
timeFrame: baseline and 1 month following vitamin D3 therapy
Secondary outcomes:
measure: The Change in Renal Blood Flow in Response to an Infusion of Angiotensin II
timeFrame: baseline and 1 month following vitamin D3 therapy
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
Study officials:
affiliation: Brigham and Women's Hospital
name: Jonathan S Williams, MD, MMSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Brigham and Women's Hospital
name: Anand Vaidya, MD
role: STUDY_DIRECTOR
References: