louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04929093: Novel Dose Adjustment Schedule for Late Injection in SCIT in AR
Official title: Comparative Study of Novel and Conventional Dose Adjustment Schedules for Late Injection of More Than 16 Weeks in Subcutaneous Immunotherapy in Allergic Rhinitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Allergic Rhinitis
Immunotherapy
Lead sponsor: Beijing Tongren Hospital
Sponsor class: OTHER
First posted: 2021-06-18
Enrollment: 102
Sex: ALL
Minimum age (years): 5
Maximum age (years): 53
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Allergen specific immunotherapy is currently the only curative intervention for allergic rhinitis (AR). Subcutaneous immunotherapy (SCIT) need to be reinstituted with an interruption of more than 16 weeks in maintenance period, leading to increased time and economic cost burden and difficulties for continuing further treatment for patients. The aim of present study was to develop a novel dose adjustment schedule for such situation and to compare the clinical efficacy and adverse reactions between novel and conventional schedules for dust mite (DM) SCIT of AR subjects.


Eligibility criteria: Inclusion Criteria:

* (1) aged 18 to 60 years;
* (2) only had a positive response to Der p and Der f but no other inhalant allergens based on EUROline Allergy Diagnostics (Beijing Oumeng Biotechnology Co., Ltd., Beijing, China). Meanwhile at least Der p -specific IgE (sIgE) in serum of was ≥ 0.7 kU/l (CAP Pharmacia, Uppsala, Sweden) using ImmunoCAP system (Pharmacia, Uppsala, Sweden) regardless of the result of Der p -specific IgE in serum;
* (3) had reached cluster SCIT maintenance period and the overall treatment time was more than 1 year but less than 2 years;
* (4) hope to continue to complete the entire treatment and have good compliance.

Exclusion Criteria:

* (1) diagnosed as asthma based on the guidelines of the Global Initiative for Asthma(13);
* (2) had Grade II or above systemic adverse reactions occurred in the past SCIT period.

Primary outcomes:
measure: The change of Combined Symptom and Medication Score
timeFrame: baseline, week 3, week 6, week 26.
Secondary outcomes:
measure: The change of total nasal symptom scores
timeFrame: baseline, week 3, week 6, week 26.
measure: The change of medication score
timeFrame: Baseline, week 26.
measure: Adverse reactions
timeFrame: week 26.
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Tongren Hospital
state: Beijing
Study officials:
affiliation: Beijing Tongren Hospital, China
name: Luo Zhang
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06448793: Patient and Physician Preference Study in Resectable, Non-small Cell Lung Cancer Treatments
Official title: Patient and Physician Preferences for Potentially Resectable, Non-metastatic Non-small Cell Lung Cancer Treatments
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Non-small Cell Lung Cancer (NSCLC)
Keywords: Non-small Cell Lung Cancer (NSCLC)
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2024-06-07
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults participants with a diagnosis of resectable NSCLC and physicians treating patients with resectable NSCLC residing in US, Germany or Japan.

Brief summary: The purpose of this study is to investigate the perspectives and preferences of patients and healthcare professionals (medical oncologists, pneumologists, thoracic surgeons) regarding treatment options in the resectable non-small cell lung cancer (NSCLC) setting


Eligibility criteria: Inclusion Criteria:

Patients

* Aged ≥18 years at the time of enrollment in the study
* Resident of the US, Germany, or Japan
* Able to read, speak, and understand English, German or Japanese
* Diagnosed with resectable phase II to IIIB non-small cell lung cancer (NSCLC)

Physicians

* Resident of the US, Germany, or Japan
* Lung cancer-treating physician specialized in one of the following medical areas: oncology, pneumonology, thoracic surgery, or radiology
* Treated at least three new patients with resectable NSCLC in the past year

Exclusion Criteria:

Patients

* Appears to have sensory and/or cognitive impairment(s) that could interfere with their ability to provide online and/or verbal consent, or complete any other interview activities (based on screener judgment)
* Being diagnosed with another malignancy alongside NSCLC
* Not willing to be audio-recorded during the interview

Physicians

* Appears to have sensory and/or cognitive impairment(s) that could interfere with their ability to provide online and/or verbal consent, or complete any other interview activities (based on screener judgment)
* Not willing to be audio-recorded during the interview

Primary outcomes:
measure: Responses to qualitative interview questions
timeFrame: Day 1
measure: Patient sociodemographic
timeFrame: Day 1
measure: Patient clinical characteristics
timeFrame: Day 1
Secondary outcomes:
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Evidera
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
Clinical trial NCT01471093: Safety Study of OPC-12759 Ophthalmic Solution
Official title: Safety Study of OPC-12759 Ophthalmic Solution in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Dry Eye Syndromes
Lead sponsor: Otsuka Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2011-11-11
Enrollment: 100
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the safety of OPC-12759 ophthalmic solution in healthy subjects.


Eligibility criteria: Inclusion Criteria:

* BMI : {body weight (kg) / \[height (m)\] 2 } must be 17.6 or greater, and less than 26.4 kg/m2

Exclusion Criteria:

1. Presence of ocular disorder
2. Intraocular pressure of 21mmHg or higher
3. Corrected visual acuity of less than 1.0
4. Dysfunction of nasolacrimal duct or history of surgery related to nasolacrimal duct or eye lid which affects the nasolacrimal outflow
5. History of refractive surgery
6. History of other ocular surgeries within 12 months
7. Those who cannot discontinue the use of contact lenses from the 1st dose to 5-hour-post-dose

Primary outcomes:
measure: Number of Subjects With Blurred Vision After Instillation
timeFrame: The first and second instillation
measure: Number of Subjects With Bitter Taste
timeFrame: The first and second instillation
Secondary outcomes:
Other outcomes:
Locations:
city: Osaka
country: Japan
facility: Kansai region
Study officials:
affiliation: Director of Division of Dermatologicals and Ophthalmologicals, Otsuka Pharmaceutical Co., Ltd.
name: Eiji Murakami
role: STUDY_CHAIR
References:
Clinical trial NCT00336193: Competency Training, Staff Performance, & Family Outcomes
Official title: University of Colorado Health Sciences Center: Competency Training, Staff Performance, & Family Outcomes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Child Abuse
Keywords: home visitation
family outcomes
competency training
Lead sponsor: Centers for Disease Control and Prevention
Sponsor class: FED
First posted: 2006-06-13
Enrollment: 1075
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This proposal examines the impact of an augmented competency based approach to training of home visitors and supervisors for delivery of the Nurse Family Partnership (NFP) on staff performance, fidelity to the program model, and family outcomes relative to child maltreatment and early behaviors associated with youth violence. The central premise underlying the proposed study is that the augmented competency based curriculum and clinical consultation to supervisors will improve nurses' knowledge and skills in working with families, which in turn, will lead to greater fidelity to the home visit guidelines (i.e., quality implementation), which in turn, will result in better maternal and child health outcomes.

Detailed description: A two group experimental design will be used to examine the impact of an augmented competency-based curriculum for NFP home visitors and supervisors coupled with structured clinical consultation by NFP National Office professional development staff, as compared against the standard curriculum currently used, on quality of program implementation and family outcomes.

Eligibility criteria: Inclusion Criteria:

* First time mothers (enrolled during pregnancy) and their children

Exclusion Criteria:

* See above. No other exclusion criteria will be used.

Primary outcomes:
measure: Assessment of children's home environment
timeFrame: 12 and 24 months
measure: Children's emergency room visits/hospitalizations
timeFrame: 6, 12, 18, and 24 months
measure: Children's adjustment and behavior
timeFrame: 21-22 months
measure: Children's language development at 21 months
timeFrame: 21 months
measure: Referrals to child protective services 6, 12, 18, and 24 months
timeFrame: 6, 12, 18, and 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Denver
country: United States
facility: University of Colorado Denver Health Sciences Center
state: Colorado
Study officials:
affiliation: University of Colorado Denver Health Sciences Center
name: Ruth A O'Brien, RN PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02578693: Follow up of IFN Vs DAAs HCV SVR (IFDACS Study)
Official title: Long Term Follow-up for Subjects With Chronic Hepatitis C Infection Who Received Interferon-based Therapy or Direct-acting Antiviral Agents (DAAs)-Based Therapy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Hepatitis C Infection
Lead sponsor: Humanity and Health Research Centre
Sponsor class: OTHER
Collaborators: name: Beijing 302 Hospital
name: Nanfang Hospital, Southern Medical University
name: Yamanashi Prefectural Central Hospital
First posted: 2015-10-19
Enrollment: 1210
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects infected with hepatitis C virus (HCV) who received interferon-based therapy or direct-acting antiviral agents (DAAs)-based therapy.

Brief summary: The study is designed to provide long term clinical and virologic follow up in subjects infected with hepatitis C virus (HCV) who received interferon-based therapy or direct-acting antiviral agents (DAAs)-based therapy. This long term follow up study is observational and no treatment is provided for HCV infection.


Eligibility criteria: Inclusion Criteria:

* Patients with chronic hepatitis C treated with interferon-based therapy or direct-acting agents (DAAs)-based regimen;
* Provide written, informed consent;
* Be willing and able to comply with the visit schedule and protocol-mandated procedures.

Exclusion Criteria:

* Individuals planning to start a new course of hepatitis C therapy including any investigational drug or device during the course of the follow-up time frame;
* History of clinically significant illness or any other major medical disorder that may interfere with follow up, assessments, or compliance with the protocol.
* Inability to provide written informed consent.

Primary outcomes:
measure: Sustained virological response (SVR)
timeFrame: 36 months
Secondary outcomes:
measure: Treatment persistence
timeFrame: 36 months
measure: Virological breakthrough
timeFrame: 36 months
measure: Liver disease progression
timeFrame: Post treatment 10 years
measure: Proportion of participants who develop hepatocellular carcinoma (HCC) through Year 10 by treatment regimen
timeFrame: Post treatment 5 years
Other outcomes:
Locations:
city: Beijing
country: China
facility: Liver Fibrosis Diagnosis and Treatment Centre, 302 Hospital
state: Beijing
city: Hong Kong
country: China
facility: Humanity and Health GI and Liver Centre
state: Hong Kong
city: Kofu-city
country: Japan
facility: Yamanashi Prefectural Central Hospital
state: Yamanashi
Study officials:
affiliation: Humanity & Health Medical Centre
name: George Lau, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01149993: Attenuating Ischemia Reperfusion Injury After Living Donor Renal Transplantation
Official title: Attenuating Ischemia Reperfusion Injury After Living Donor Renal Transplantation
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Kidney Transplantation
Renal Transplantation
Reperfusion Injury
Keywords: living donation
kidney transplantation
delayed graft function
ischemia reperfusion injury
Lead sponsor: Georgetown University
Sponsor class: OTHER
Collaborators: name: Novartis
First posted: 2010-06-24
Enrollment: 0
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: Patients undergoing living donor renal transplant will be asked to participate to determine whether pre-operative dosing of immunosuppressive medication, and the donor organ receiving an additional dose of antibody induction therapy helps to alleviate potential damage to the transplanted organ post-transplant. A number of lab tests will be done post-transplant to determine how well the kidney is functioning.


Eligibility criteria: Inclusion Criteria:

1. Must be able to provide written informed consent.
2. All recipients of a kidney from a living donor only, either a de novo transplant, or re-transplant
3. All patients evaluated and listed with the United Network for Organ Sharing (UNOS) who are eligible to receive a kidney transplant under GUH's standard protocol.
4. Patients between 18-80 years of age

Exclusion Criteria:

1. Recipients of multi-organ transplant
2. Patients with known allergies of hypersensitivities to any of the drugs used in this protocol
3. Recipients of kidneys from a deceased donor
4. Recipients who are co-infected with Hepatitis B, Hepatitis C or HIV
5. Women who are pregnant
6. Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, including women whose career, lifestyle or sexual orientation precludes intercourse with a male partner unless they agree to avoid pregnancy throughout the duration of the trial and for 3 months following the trial.

Primary outcomes:
measure: reduction in ischemia reperfusion injury
timeFrame: one year
Secondary outcomes:
measure: secondary outcomes
timeFrame: one year
Other outcomes:
Locations:
Study officials:
affiliation: Georgetown University Hospital
name: Joseph K Melancon, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06083493: Neuromodulation of Conscious Perception: Investigating Thalamic Roles Through Ultrasonic Stimulation
Official title: Neuromodulation of Conscious Perception: Investigating Thalamic Roles Through Ultrasonic Stimulation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Thalamus
Keywords: Perception
Lead sponsor: University of Michigan
Sponsor class: OTHER
First posted: 2023-10-16
Enrollment: 61
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to evaluate the role that the thalamus (the egg-shaped structure in the middle of your brain) plays in perception using a low-intensity ultrasound pulsation (LIFUP) device. The researchers expect to observe differential changes in the perceptual outcomes based on the LIFUP stimulation of different thalamic areas


Eligibility criteria: Inclusion Criteria:

* Must be right-handed.
* Must have normal or corrected-to-normal vision (while wearing contact lenses). Please note: persons who need eyeglasses to achieve 20/20 vision cannot be included in this study as eyeglasses cannot be worn during the study visit.
* Must not be on any medications for any neurological, psychological, or psychiatric conditions.
* Must be English speaking.
* Must be capable of giving written informed consent.

Exclusion Criteria:

• Vision that is not 20/20, or vision that is not corrected to 20/20 while wearing contact lenses.

Please note: persons needing eyeglasses to achieve 20/20 vision cannot be included in this study as eyeglasses cannot be worn during the study visit.

* History of significant head injury with loss of consciousness.
* Learning disability or other developmental disorder.
* Medication use for any neurological, psychological, or psychiatric conditions.
* Any impairment (sensory or motor loss), activity, or situation that in the judgment of the study coordinator or Principal Investigators would prevent satisfactory completion of the study protocol.

Primary outcomes:
measure: Change in Sensitivity Derived From the Signal Detection Theory (SDT)
timeFrame: Up to 60 minutes after intervention
measure: Change in Perceptual Criterion Derived From the Signal Detection Theory (SDT)
timeFrame: Up to 60 minutes after intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
affiliation: University of Michigan
name: Zirui Huang
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Michigan
name: Anthony Hudetz
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02342093: Contraceptives Containing Drospirenone and Blood Pressure
Official title: Effects of Two Contraceptives Containing Drospirenone on Blood Pressure in Normotensive Women: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Blood Pressure
Contraception
Keywords: Ambulatory Blood Pressure Monitoring
Drospirenone
Oral contraceptive
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
Collaborators: name: Conselho Nacional de Desenvolvimento Científico e Tecnológico
First posted: 2015-01-19
Enrollment: 44
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: Background: Drospirenone (DRSP) seems to have a favorable effect on blood pressure (BP); however, when associated with ethinylestradiol (EE), this effect does not seem to occur. This study has the objective to assess possible differences in BP associated with the use of COCs containing DRSP with different doses of ethinylestradiol.

Materials and methods: This open-label parallel-group randomized clinical trial involved women randomized to use either 30 mcg of EE+DRSP (n=22) or 20 mcg of EE+DRSP (n=22). Daytime, nighttime and 24-hour BP were evaluated by ambulatory blood pressure monitoring (ABPM) at the beginning of the trial and six months after drug therapy.


Eligibility criteria: Inclusion Criteria:

* sexually active women who did not wish to become pregnant,
* aged between 18 and 35,
* with menstrual cycles lasting between 24 and 32 days,
* body mass index (BMI) between 18.0 and 29.9 kg/m2

Exclusion Criteria:

* smoking,
* use of drugs and/or alcohol,
* clinical and/or laboratory signs of hyperandrogenism,
* use of hormonal contraception within six months before the initiation of the study,
* presence of chronic and/or acute inflammatory processes,
* use of medications with endothelial effects (e.g., statins),
* breastfeeding or having stopped breastfeeding within two months before the initiation of the study,
* medical conditions classified as category 3 or 4 according to the WHO medical eligibility criteria for contraceptive prescription

Primary outcomes:
measure: Blood pressure
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Ribeirão Preto
country: Brazil
facility: University of Sao Paulo
state: SP
Study officials:
affiliation: University of Sao Paulo
name: Carolina S Vieira, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02860793: Role of PTK-7 in Acute Myeloid Leukemias
Official title: Role of PTK-7 in Acute Myeloid Leukemias: Impact of PTK7 Serum Marker and ex Vivo Studies to Decipher the Role of PTK7
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Myeloid Leukemia
Keywords: PTK7
Acute Myeloid Leukemia
Lead sponsor: Institut Paoli-Calmettes
Sponsor class: OTHER
First posted: 2016-08-09
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The pseudo tyrosine kinase receptor 7 (PTK7) is an orphan tyrosine kinase receptor assigned to the planar cell polarity pathway. PTK7 is expressed in normal myeloid progenitors and CD34(+) CD38(-) bone marrow cells in humans. It is also expressed in acute myeloid leukemia (AML) and is mostly assigned to granulocytic lineage differentiation. In AML, PTK7 seems to convey promigratory and antiapoptotic signals into the cell and represents an independent prognosis factor of survival in patients treated with induction chemotherapy. This study aims at:

* evaluating the impact of PTK7 expression on primary AML cells ex vivo
* evaluating the diagnostic and prognostic value of a soluble form of PTK7


Eligibility criteria: Inclusion Criteria:

* Age\> 18 years
* AML at diagnosis, not previously treated
* Treatment by induction chemotherapy
* Signed informed consent
* Affiliation to the French social security system

Exclusion Criteria:

* pregnant woman(or of childbearing potential) or breastfeeding woman
* emergency
* patients deprived of liberty or placed under the authority of a tutor

Primary outcomes:
measure: Evaluation PTK7+ and PTK7- AML cells hematopoietic homing abilities in xenografted mice by in vivo bioluminescence imaging
timeFrame: 1 day
measure: Soluble PTK7 measurement in the serum
timeFrame: 12 years
Secondary outcomes:
Other outcomes:
Locations:
city: Marseille
country: France
facility: Institut Paoli Calmettes
state: Bouches du Rhone
Study officials:
affiliation: Institut Paoli-Calmettes
name: Norbert VEY, MD
role: PRINCIPAL_INVESTIGATOR
References: