louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00702208: Feasibility of Delphi Screener for Cervical Cytology
Official title: The Feasibility and Acceptability of Using the Delphi Screener for Cervical Cytology Testing Among Low Income Women in New York City
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Cervical Neoplasia
Keywords: cervical cytology
Pap smear
self-sampling
abnormal
normal
Lead sponsor: Columbia University
Sponsor class: OTHER
Collaborators: name: Delphi Devices BV
First posted: 2008-06-20
Enrollment: 198
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: The aim of this study is to see whether a new self-sampling device, the Delphi Screener (Delphi Devices, Scherpenzeel, Netherlands), can be used for cervical cancer screening. The results using the new device will be compared to results using the current gold standard. The gold standard is clinician-collected endo-cervical and ecto-cervical specimens (often referred to as a 'Pap smear'). Additionally, women will be asked about the acceptability of using the device and how easy it is to understand the user instructions.

The Delphi Screener is a sterile, plastic, syringe-like device containing buffered saline which allows a woman to collect her own vaginal lavage (to 'self-squirt'). The hypothesis is that the device may work well for cervical cytology and will be acceptable to the women in the study.


Eligibility criteria: Inclusion Criteria:

* Valid Pap smear in last 1-3 months obtained at participating clinic
* 18 years or older
* Self-report being able to read in English and/or Spanish
* Willing to sign informed consent

Exclusion Criteria:

* Used vaginal product (douche, spermicide, antifungal) in last 48 hours
* Last menses started ≤ 4 days prior to enrollment visit
* No uterus / history of hysterectomy
* Self-report currently pregnant
* Self-report currently breastfeeding

Primary outcomes:
measure: Sensitivity and Specificity
timeFrame: 1-3 months between 2 specimen collections
measure: Kappa Coefficient
timeFrame: 1-3 months between 2 specimen collections
Secondary outcomes:
measure: Outcome: Acceptability of Device
timeFrame: cross-sectional - asked at time of Screener use
Other outcomes:
Locations:
city: New York
country: United States
facility: Columbia University Presbyterian Hospital
state: New York
Study officials:
affiliation: Columbia University
name: Carolyn Westhoff, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Jones HE, Mansukhani MM, Tong GX, Westhoff CL. Validity and reliability of using a self-lavaging device for cytology and HPV testing for cervical cancer screening: findings from a pilot study. PLoS One. 2013 Dec 20;8(12):e82115. doi: 10.1371/journal.pone.0082115. eCollection 2013.
Clinical trial NCT05609708: Technological Development and Clinical Parallel Testing of PGT-G
Official title: Technological Development and Clinical Parallel Testing of Preimplantation Genetic Testing for Generalization
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Genetic Disease
Keywords: PGT
stLFR-WGS
Lead sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Sponsor class: OTHER
First posted: 2022-11-08
Enrollment: 55
Sex: ALL
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with genetic diseases undergoing PGT cycle

Brief summary: Preimplantation genetic testing (PGT) has three different testings according to the type of genetic disease, which was classified as PGT-M, PGT-SR and PGT-A. If the couple is tested for two different genetic diseases at the same time, it is necessary to customize the probe and adopt different detection methods, which increases the cost and cycle of testing. Advanced expert pre-experimental analysis is required for PGT-M in couples with monogenic disease. If the family members are unavailable, only the polar bodies, sperms or affected embryos can be used to analysis, which not only increases the risk of failure, but also increases the difficulty of detection. At present, BGI has developed a new single-tube complete Long fragment whole genome sequencing (stLFR-WGS) technology, which uses the same molecular tag on the short read sequencing fragments from the same long DNA molecule to achieve accurate short read sequencing to obtain long DNA information. Multiple genetic abnormalities such as gene variation, chromosome aneuploidy and chromosome structure rearrangement can be directly detected in embryos without pre-experiment of family members, so as to achieve universal normalization of the three PGT methods and solve the PGT detection needs of patients with multiple genetic diseases.


Eligibility criteria: Inclusion Criteria:

1. Patients undergoing PGT cycle;
2. Patients with balanced chromosomal structural rearrangement (reciprocal translocation, Robertsonian translocation, inversion, etc.) by conventional karyotype analysis;
3. Clearly diagnosed monogenic genetic disease, and the related genes and their mutations are judged to be pathogenic or likely pathogenic;
4. Chromosomal abnormalities in recurrent abortion tissues or in PGT-A embryos; The number of blastocysts was \>= 1, and the morphological classification was more than 4BC/4CB.

Exclusion Criteria:

1. Belonged to any contraindications of PGT;
2. Failed to embryo biopsy;
3. Failed to embryo WGA failure or abnormal quality control;
4. Failed to embryo sequencing, and the result was unknown.

Primary outcomes:
measure: diagnosis specificity
timeFrame: 1 day (the time of sequencing)
measure: diagnosis sensitivity
timeFrame: 1 day (the time of sequencing)
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Sun Yat-sen Memorial Hospital, Sun Yat-sen University
state: Guangdong Provicne
Study officials:
References:
Clinical trial NCT00095108: Study of Interleukin-21 for Metastatic Malignant Melanoma and Metastatic Kidney Cancer
Official title: A Phase 1 Open-Label Study of the Safety and Pharmacokinetics of Recombinant Human Interleukin-21 (rIL-21) in Subjects With Metastatic Melanoma or Metastatic Renal Cell Carcinoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Melanoma
Kidney Neoplasms
Metastases
Keywords: Metastatic Melanoma
Metastatic Renal Cell Carcinoma
Lead sponsor: ZymoGenetics
Sponsor class: INDUSTRY
First posted: 2004-11-01
Enrollment: 43
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study is being done to see if an experimental drug called recombinant interleukin-21 (rIL-21) when given to patients with stage 4 malignant melanoma or stage 4 kidney cancer is safe and has any effect on these types of cancers.

Detailed description: This is a phase 1 safety study. Everyone enrolled and eligible will be given rIL-21. The study has 2 parts, Part A will determine how high a dose of rIl-21 can be safely given to patients with these types of cancers. Part B will determine if the drug is of any benefit to patients with these types of cancers. Part A may have up to 7 different dose groups. Beginning with the lowest dose, 3 patients will be treated and will be watched for side effects. If the side effects are not severe, the next group of 3 patients will recieve a higher dose. This cycle is repeated until the highest tolerated dose group is found.

Eligibility criteria: Inclusion Criteria:

* 18 years and older with stage 4 metastatic malignant melanoma or stage 4 metastatic kidney cancer
* ECOG status of 0 or 1
* Patients must have adequate liver, kidney and bone marrow function

Exclusion Criteria:

* Known ocular melanoma
* Suspected or confirmed brain metastases
* Patient cannot have had a bone marrow transplant

Primary outcomes:
measure: To determine the maximum tolerated dose (MTD) of rIL-21
measure: To further characterize the safety of rIL-21 at the MTD
Secondary outcomes:
measure: Characterize pharmacokinetics of rIL-21
measure: Evaluate immunogenicity of rIL-21
measure: Identify clinical or biological parameters that may correlate with clinical efficacy
measure: Characterize anti-tumor effect of IL-21
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan Comprehensive Cancer Center
state: Michigan
city: Seattle
country: United States
facility: University of Washington/Seattle Cancer Care Alliance
state: Washington
Study officials:
affiliation: ZymoGenetics
name: Diana Hausman, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT06879808: The Effect of Color Therapy on Depression, Stress, Anxiety and Quality of Life in Hemodialysis Patients: A Randomized Controlled Study
Official title: The Effect of Color Therapy on Depression, Stress, Anxiety and Quality of Life in Hemodialysis Patients: A Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hemodialysis
Color Therapy
Keywords: Anxiety
Color Therapy
Depression
Hemodialysis
Nursing
Quality of Life
Stress
Lead sponsor: Erzincan Binali Yildirim Universitesi
Sponsor class: OTHER
First posted: 2025-03-17
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomization; participants were divided into two groups by using simple random numbers table, and then the first group which was drawn by lot method was named as the experimental group.
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study was conducted to examine the effect of color therapy on depression, stress, anxiety and quality of life in hemodialysis patients.

Detailed description: Many patients on hemodialysis treatment require hemodialysis, which requires hospitalization three times a week for four hours each dialysis session. Therefore, practices such as color therapy may be useful in the management of psychological symptoms in these patients.

Eligibility criteria: Inclusion Criteria:

* Be on hemodialysis treatment for at least 6 months,
* No sleeping pills or sedative medication,
* No physical or cognitive impairment that prevents them from understanding the education and no diagnosis of a psychiatric illness,
* The patient or someone living in the same household with the patient is literate,
* Patients have no vision problems,
* Patients must be 18 years of age or older.

Exclusion Criteria:

* Being on hemodialysis treatment for less than 6 months,
* Taking sleeping pills or sedative medication,
* Being diagnosed with a physical illness or cognitive impairment or psychiatric illness that prevents understanding the education provided,
* Illiteracy of the patient and relatives,
* Patients have vision problems,
* Refusing to participate in the research,
* Under 18 years of age

Primary outcomes:
measure: Depression Anxiety Stress-21 scale (DASS-21)
timeFrame: 8 week
measure: Short Form-12 (SF-12) Quality of Life Scale
timeFrame: 8 week
Secondary outcomes:
Other outcomes:
Locations:
city: Elazığ
country: Turkey
facility: Fırat University
state: Merkez
Study officials:
affiliation: Firat University
name: Gülcan Bahçecioğlu Turan, Associate Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Istanbul Sebahattin Zaim University
name: Zülfünaz Özer, Associate Professor
role: STUDY_DIRECTOR
affiliation: Erzincan Binali Yildirim Universitesi
name: Safiye Yanmış, Assistant Professor
role: STUDY_DIRECTOR
affiliation: Cumhuriyet University
name: Mukadder Mollaoğlu, Professor Doctor
role: STUDY_DIRECTOR
References:
Clinical trial NCT03254108: Clinical Pharmacology Trial to Investigate the Dose of OPC-61815 Injection Equivalent to Tolvaptan 15-mg Tablet in Patients With Congestive Heart Failure
Official title: A Multicenter, Double-blind, Randomized, Active-controlled, Parallel-group Comparison Clinical Pharmacology Trial to Investigate the Dose of OPC-61815 Injection Equivalent to Tolvaptan 15-mg Tablet in Patients With Congestive Heart Failure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Congestive Heart Failure
Lead sponsor: Otsuka Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2017-08-18
Enrollment: 61
Sex: ALL
Minimum age (years): 20
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The dose for intravenous administration of OPC-61815 achieving tolvaptan exposure equivalent to that for oral administration of tolvaptan 15-mg tablet will be investigated by administering OPC-61815 injection 2 to 16mg or tolvaptan 15-mg oral tablet to subjects with congestive heart failure.


Eligibility criteria: Inclusion Criteria:

1. Subjects who are currently on treatment with any of the following diuretics

   * Loop diuretics equivalent to furosemide tablet or fine granules at a dose of 40 mg/day or higher
   * Concomitant use of a loop diuretic and a thiazide diuretic (including thiazide analogs) at any dose
   * Concomitant use of a loop diuretic and an aldosterone antagonist or potassium-sparing diuretic agent at any dose
2. Subjects with congestive heart failure in whom lower limb edema, pulmonary congestion, and/or jugular venous distension due to volume overload is present
3. Subjects who are currently hospitalized or who are able to be hospitalized during the trial

Exclusion Criteria:

1. Subjects with acute heart failure
2. Subjects with a history of hypersensitivity to any of ingredients of OPC-61815 or tolvaptan
3. Subjects who are unable to sense thirst or who have difficulty with fluid intake

Primary outcomes:
measure: Maximum Plasma Concentration (Cmax) of OPC-41061 on Day 1
timeFrame: Baseline, 1, 1.5, 2, 4, 6, 12 24 hours after the start of administration of investigational drug
measure: Area Under the Concentration-time Curve From Time Zero to 24 Hours (AUC24h) on Day 1
timeFrame: Baseline, 1, 1.5, 2, 4, 6, 12 24 hours after the start of administration of investigational drug
Secondary outcomes:
Other outcomes:
Locations:
city: Kanto
country: Japan
Study officials:
affiliation: Otsuka Pharmaceutical Co., Ltd.
name: Hiroaki Ono
role: STUDY_DIRECTOR
References:
Clinical trial NCT05873608: Communication Issues in Patient and Provider Discussions of Immunotherapy
Official title: Communication Issues in Patient/Provider Discussions of Immunotherapy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hematopoietic and Lymphoid System Neoplasm
Malignant Solid Neoplasm
Lead sponsor: Emory University
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2023-05-24
Enrollment: 125
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: For aim 4, each participant is assigned to watch a video and comprehension is tested using a pre and post method
Primary purpose: OTHER

Brief summary: This trials studies communication issues in patient and provider discussions about immunotherapy. The goal of this study is to describe where patients have heard about immunotherapy, what the participants understand about it, how physicians and other healthcare workers describe immunotherapy, and how educational videos may support patient knowledge about immunotherapy.

Detailed description: PRIMARY OBJECTIVES:

I. To identify misestimations about the risks and benefits of immunotherapy resulting from media hype or other sources and assess if these misestimations persist post-provider conversation about immunotherapy.

II. To qualitatively describe patient reported misunderstandings and to assess patient understanding of technical terms and metaphors used in the immunotherapy conversation.

III. To identify provider and patient preferences for information to be communicated about immunotherapy.

IV. Develop videos that describe immunotherapy and test their efficacy in improving understanding using pre and post methodology.

OUTLINE:

Patients and their providers undergo observation during a conversation about immunotherapy. Then participate in an interview over 20 minutes. Understanding of educational videos is then tested.

Eligibility criteria: Inclusion Criteria:

* AIMS 1-3: All patients and providers who may have a discussion about immunotherapy at the Winship Cancer Institute
* AIM 4: Any cancer patient

Primary outcomes:
measure: Misestimations about the risks and benefits of immunotherapy resulting from media hype or other sources
timeFrame: Up to 4 years
measure: Qualitatively describe patient reported misunderstandings
timeFrame: Up to 4 years
measure: Provider and patient preferences for information to be communicated about immunotherapy
timeFrame: Up to 4 years
measure: Correct definition rates (pre- versus post-video)
timeFrame: Up to 4 years
Secondary outcomes:
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Emory University Hospital/Winship Cancer Institute
state: Georgia
city: Decatur
country: United States
facility: Atlanta VA Medical Center
state: Georgia
Study officials:
affiliation: Emory University Hospital/Winship Cancer Institute
name: Rebecca Pentz, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02823808: Effect of Alogliptin/Pioglitazone on the Preservation of Long-term Beta-cell Function
Official title: Effect of Alogliptin/Pioglitazone on the Preservation of Long-term Beta-cell Function After Early Intensive Diabetes Treatment
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Diabetes
Lead sponsor: Kyunghee University Medical Center
Sponsor class: OTHER
Collaborators: name: Takeda
name: Kyung Hee University Hospital at Gangdong
name: Bucheon St. Mary's Hospital
name: Korea University Guro Hospital
name: Ajou University School of Medicine
name: Inha University Hospital
name: Kangbuk Samsung Hospital
name: Seoul Medical Center
First posted: 2016-07-06
Enrollment: 96
Sex: ALL
Minimum age (years): 26
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: All subjects will be randomized as Alo/Pio combo group (intervention) or Glim/Met combo group (control) after intensive COAD treatment based on identical protocol.

* All subject will be managed with once daily, fixed dose, single tablet treatment based on the study protocol, and followed-up for 104 weeks.
* Any group of subjects who fail to reach glycemic target with single tablet treatment, subject will be treated with rescue medication and stopped regular observation.


Eligibility criteria: Inclusion Criteria:

* Type 2 Diabetes Mellitus patients
* Patient who had been diagnosed within the previous 12 months with HbA1c levels of 8.0-12.0%, did not have a medical history related to diabetes, and did not display proliferative retinopathy

Exclusion Criteria:

* The use of weight-lowering drugs, any investigational blood-glucose or lipid-lowering agent (other than statins or ezetimibe) within the past 3 months
* Previous treatment with systemic corticosteroids or a change in dosage of thyroid hormones in the previous 6 weeks
* The use of insulin within the 3 months prior to screening
* Others

Primary outcomes:
measure: Cumulative treatment failure (HbA1c≥7.0%) rate for glycemic control
timeFrame: 104 weeks from randomization
Secondary outcomes:
measure: Change in HbA1c
timeFrame: 104 weeks from randomization
measure: Change in Fasting Blood Sugar
timeFrame: 104 weeks from randomization
measure: Change in Glycoalbumin
timeFrame: 104 weeks from randomization
measure: Change in insulin sensitivity (HOMA2%S)
timeFrame: 104 weeks from randomization
measure: Change in insulin sensitivity (HOMA2%B)
timeFrame: 104 weeks from randomization
measure: Change in proinsulin
timeFrame: 104 weeks from randomization
measure: Change in glucagon
timeFrame: 104 weeks from randomization
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Kyunghee University Medical Center
Study officials:
affiliation: Kyung Hee University Hospital
name: Jeong-taek Woo
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01795508: Parent Management Training, Oregon
Official title: The Effect of Parent Management Training, Oregon, in Denmark
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Child Behavior Problems
Keywords: Parent training
Child behavior
Randomized Controlled Trials
Lead sponsor: VIVE - The Danish Center for Social Science Research
Sponsor class: OTHER
Collaborators: name: National Board of Social Services, Denmark
name: Ministry of Social Affairs, Denmark
First posted: 2013-02-20
Enrollment: 126
Sex: ALL
Minimum age (years): 3
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to examine the effects of Parent Management Training Oregon (PMTO) compared to treatment as usual (TAU) for parents with children aged 3 and 12 showing behavioral problems.

Detailed description: This project estimates the causal effect of Parent Management Training, Oregon (PMTO) in a Danish context. The study design is an RCT where PMTO is compared to Treatment As Usual (TAU). The target population is parents with children aged 3 and 12 showing behavioral problems. The primary outcome estimates changes in child behavior, and is measured three times: baseline, seven months follow-up, and 19 month follow-up.

Eligibility criteria: Inclusion Criteria:

* Families with children that are eligible for PMTO and at least one other type of family training program

Exclusion Criteria:

* The family does not want to participate

Primary outcomes:
measure: Strength and Difficulties Questionnaire (SDQ)
timeFrame: 7 months post baseline
measure: Brief Problem Monitor-Parent Form (BPM-P)
timeFrame: 7 months post baseline
Secondary outcomes:
measure: Parents Preference Test (PPT)
timeFrame: 7 months post baseline
measure: Sense of Coherence (SOC)
timeFrame: 7 months post baseline
measure: Parental Stress Scale (PSS)
timeFrame: 7 months post baseline
measure: Parenting Sense of Competence scale (PSOC)
timeFrame: 7 months post baseline
measure: Major Depression Inventory (MDI)
timeFrame: 7 months post baseline
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: SFI the Danish National Centre for Social Research
state: Copenhagen K
Study officials:
References: