louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00599599: Stress-Reducing Interventions in HIV+ Patients: Pilot
Official title: Pilot Intervention for PTSD, Nonadherence, and HIV Risk
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stress Disorders, Post-Traumatic
HIV Infections
Keywords: Prolonged Exposure Therapy
Adherence to HIV Medications
Complementary Therapies
Lead sponsor: Kent State University
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
name: Summa Health System
First posted: 2008-01-24
Enrollment: 70
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: The primary aim of this project is to examine the efficacy of prolonged exposure (PE) therapy at reducing HIV-related PTSD symptoms, increasing adherence to antiretroviral medication regimens, and increasing health-related quality of life (QOL) in HIV+ patients.

Detailed description: HIV+ patients will be randomized to receive either PE therapy (up to 18 possible sessions) or weekly symptom monitoring (described below) and will complete measures of PTSD, adherence, and QOL pre- and post-intervention and at 3- and 6-month follow-up assessments. Secondary analyses will examine the impact of the intervention on disorders commonly comorbid with PTSD (i.e., anxiety, mood, and substance abuse/dependence disorders).

Eligibility criteria: Inclusion Criteria:

* Must be HIV+
* Must meet PTSD diagnostic criteria
* Must be taking HIV medications
* Must be able to read and write in English

Exclusion Criteria:

* Current or previous diagnosis of schizophrenia, any current diagnosis with psychotic features, or current suicidal ideation
* Being in a current abusive relationship or ongoing intimate relationship with one's assailant
* Mental retardation

Primary outcomes:
measure: PTSD symptoms
timeFrame: pre- & post-intervention, 3-month post, & 6-month post
Secondary outcomes:
measure: Adherence to HIV medications
timeFrame: pre- & post-intervention, 3-month post, & 6-month post
measure: Health-related Quality of Life
timeFrame: pre- & post-intervention, 3-month post, & 6-month post
Other outcomes:
Locations:
city: Akron
country: United States
facility: Violet's Cupboard
state: Ohio
city: Cleveland
country: United States
facility: AIDS Taskforce of Greater Cleveland
state: Ohio
Study officials:
affiliation: Kent State University
name: Douglas L Delahanty, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02206399: Non-Invasive Hemoglobin Study
Official title: Non-Invasive Hemoglobin Multi-Center Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anemia
Lead sponsor: Convergence Biometrics
Sponsor class: INDUSTRY
Collaborators: name: DRMiller Engineering
First posted: 2014-08-01
Enrollment: 237
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Whole Blood Donation Center Donors sample

Brief summary: The investigators clinical trials will be for a medical device that is non-invasive in nature. The investigators will be studying whether their non-invasive medical device gets data that is as good as, or better than, an FDA previously approved, blood analysis device. There is no study hypothesis for this study.


Eligibility criteria: Inclusion criteria for this study are:

1. Subject is capable of giving informed consent.
2. Subject has an anatomically intact digit capable of having a capillary sample taken and of being placed in the POCT device.

Exclusion criteria for this study are:

1. Age less than 18 years at time of research
2. Subject lacks the digits to place in the POCT device
3. Subject displays symptoms or has a history of Raynaud's disease
4. Subject has a neurological disorder resulting in an inability to hold the index finger steady for 20 sec.
5. Subject has a history of long term continuous decreased perfusion to either hand (\>30 days).
6. Subject has had surgery within the last 2 weeks on finger or hand that he wishes to use in the study
7. Subject's same day participation in this study
8. Capillary sample volume is not adequate to complete testing on the comparative device.
9. Cold agglutinin disease

Primary outcomes:
measure: Percentage of Hemoglobin in Blood At Time of Test
timeFrame: Up to 30 seconds
Secondary outcomes:
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: BloodSource
state: California
Study officials:
affiliation: BloodSource
name: Anne Igbokwe, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: BloodSource
name: Chris Gresens, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03979599: Safety and Efficacy of Magnesium Sulphate as an Adjuvant to Levobupivacaine in Ultra-sound Guided Transversus Abdominis Plan Block in Pediatric Abdominal Cancer Surgery
Official title: Safety and Efficacy of Magnesium Sulphate as an Adjuvant to Levobupivacaine in Ultra-sound Guided Transversus Abdominis Plan Block in Pediatric Abdominal Cancer Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Postoperative Pain
Keywords: TAP, magnisum sulphate
Lead sponsor: South Egypt Cancer Institute
Sponsor class: OTHER
First posted: 2019-06-07
Enrollment: 10
Sex: ALL
Minimum age (years): 1
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Group A (control group): patients will receive levobupivacaine 0.25% . Group B (magnesium sulphate group): patients will receive levobupivacaine 0.25% + MgSo4 .
Primary purpose: TREATMENT

Brief summary: To study the efficacy of magnesium sulphate as adjuvant to levobupivacaine in transversus abdominis plane (TAP) block in patient undergoing abdominal cancer surgery.

Detailed description: In this randomized study, patients with (ASA) Ӏ and ӀӀ, aged from 1 to 7 years old and their weight less than 30 Kg of both sex will undergo surgery will be enrolled.

A written informed consent from all parents are obtained

Eligibility criteria: Inclusion Criteria:

* patients with (ASA) Ӏ and ӀӀ physical status, aged from 1 to 7 years old and their weight less than 30 Kg of both sex will undergo surgery will be enrolled.

Exclusion Criteria:

* Children with infection, hemorrhagic disorders, hypersensitivity to the studied drugs, muscular disorders, central and peripheral neuropathy, organ dysfunction, cardiac problems and unconscious or mentally retarded patients will be excluded

Primary outcomes:
measure: postoperative pain management
timeFrame: one day
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: south Egypt cancer institute
Study officials:
References:
Clinical trial NCT04870099: Guided Self-help for Common Mental Disorders
Official title: Leveraging Computational Social Sciences and Natural Language Processing to Optimize Engagement and Response to Low-intensity CBT for Depression and Anxiety
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bibliotherapy
Lead sponsor: Indiana University
Sponsor class: OTHER
Collaborators: name: Indiana Clinical and Translational Sciences Institute
name: National Institutes of Health (NIH)
name: National Center for Advancing Translational Sciences (NCATS)
First posted: 2021-05-03
Enrollment: 141
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Guided self-help
Primary purpose: TREATMENT

Brief summary: Common mental disorders (CMDs) like depression and anxiety account for a large proportion of disability worldwide. Access to effective treatments like cognitive-behavioral therapy (CBT) is limited and has not reduced the public health burden of psychopathology. For patients with mild-moderate CMDs, lower-intensity treatments like guided self-help CBT (GSH-CBT) are effective and more scalable (e.g., via the internet). The advent of social media has opened avenues for dissemination of GSH-CBTs and allows for passive sensing of mood, thinking, behavior, and social networks. We propose to leverage a social media platform used by over a fifth of the United States (Twitter) as a recruitment tool to virtually screen over 150 individuals, recruit N=60 to a 5-week course of GSH-CBT, and extract social media data from individuals engaged in GSH-CBT. Sociodemographic and social media data will be used to predict engagement, outcomes, and processes in GSH-CBT.


Eligibility criteria: Inclusion Criteria:

* At least mild distress: K6 score ≥ 6
* Having reasonably regular access to the internet or a telephone

Exclusion Criteria:

- Suicidality: Patient Health Questionnaire-9 (PHQ9) item 9 ("thoughts that you would be better off dead, or of hurting yourself ") ≥ 2 ("more than half the days")

Primary outcomes:
measure: 6-week Change in Kessler 6 Psychological Distress Scale (K6)
timeFrame: Change from Baseline to Week 6
measure: 6-week Change in the WHO 5 Well-being Index (WHO-5)
timeFrame: Change from Baseline to Week 6
Secondary outcomes:
measure: 6-week Change in Emotion Regulation Scale (ERQ) - Reappraisal Subscale
timeFrame: Change from Baseline to Week 6
measure: 6-week Change in the Emotion Regulation Scale (ERQ) - Suppression Subscale
timeFrame: Change from Baseline to Week 6
measure: 3-month Change in Kessler 6 Psychological Distress Scale (K6; 0 - 24)
timeFrame: Change from Baseline to 3 Months post-treatment
measure: 3-month Change in the WHO 5 Well-being Index (WHO-5)
timeFrame: Change from Baseline to 3 Months post-treatment
Other outcomes:
Locations:
city: Bloomington
country: United States
facility: Indiana University
state: Indiana
Study officials:
References:
Clinical trial NCT02432599: Interest of the F18-choline as a Second Line of the Tracer for Detection of Parathyroid Adenomas
Official title: Interest of the F18-choline as a Second Line of the Tracer for Detection of Parathyroid Adenomas
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hyperparathyroidism
Keywords: F18-choline
Lead sponsor: Centre Francois Baclesse
Sponsor class: OTHER
First posted: 2015-05-04
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The rationale for the proposed pilot study is to investigate the ability of PET-CT with F18-choline to detect and locate the parathyroid adenoma in patients with primary hyperparathyroidism and negative or non-contributory MIBI (Tc-99m sestamibi) and cervical ultrasound, in order to avoid unnecessary bilateral cervical exploration.


Eligibility criteria: Inclusion Criteria:

* Patient aged 18 years or more;
* Patient with a primary hyperparathyroidism and witj a negative or non-contriburatory MIBI parathyroid scintigraphy and neck ultrasonography, for which surgical resection is planned;
* Confirmation of the diagnosis of primary hyperparathyroidism on laboratory tests
* Affiliate to a social security system;
* Patient written informed consent.

Exclusion Criteria:

* Patient deprived of liberty, under guardianship;
* Any medical or psychological condition witch could compromise the capacity of the patient to participate in the study;
* Pregnant or breastfeeding

Primary outcomes:
measure: Sensitivity (ability to identify and visualize the parathyroid adenoma)
timeFrame: Up to 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: Caen
country: France
facility: CHU
city: Caen
country: France
facility: Centre François Baclesse
Study officials:
References:
citation: Quak E, Blanchard D, Houdu B, Le Roux Y, Ciappuccini R, Lireux B, de Raucourt D, Grellard JM, Licaj I, Bardet S, Reznik Y, Clarisse B, Aide N. F18-choline PET/CT guided surgery in primary hyperparathyroidism when ultrasound and MIBI SPECT/CT are negative or inconclusive: the APACH1 study. Eur J Nucl Med Mol Imaging. 2018 Apr;45(4):658-666. doi: 10.1007/s00259-017-3911-1. Epub 2017 Dec 22.
Clinical trial NCT01460199: Safety & Tolerability Study of CTP-499 in Patients With Moderate Chronic Kidney Disease
Official title: A Multi Center, Double-Blind, Two-Arm,Placebo Controlled, Randomized Safety and Tolerability Study of CTP-499 in Non-Dialysis Patients With Stage 3 Chronic Kidney Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Stage 3 Chronic Kidney Disease
Lead sponsor: Concert Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2011-10-26
Enrollment: 33
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: This study is being conducted to evaluate the safety and tolerability of treatment with CTP-499 in non-dialysis patients associated with moderate chronic kidney disease.

Detailed description: This study will evaluate the safety and tolerability of treatment with CTP-499 starting with 600 milligrams (mg) once a day (QD) for 2 weeks followed by 600 mg twice a day (BID) for 2 weeks in non-dialysis patients associated with moderate chronic kidney disease defined as an estimated Glomerular Filtration Rate or eGFR that is 30-59 mL/min/1.73m2

Eligibility criteria: Inclusion Criteria:

* Patient has a diagnosis of chronic kidney disease
* If taking antihypertensive and antidiabetes medications, regimen must be stable for a minimum of 4 weeks
* Patient has systolic blood pressure less than or equal to 160 mm Hg and diastolic blood pressure less than or equal to 95 mm Hg

Exclusion Criteria:

* Patient has concurrent condition such as uncontrolled inflammatory disease, acute infection or clinically unstable autoimmune, endocrine, neurological, psychiatric, retinal, cardiovascular, bronchopulmonary, hepatic, gastrointestinal or musculoskeletal disorder
* Patient has acute, active and/or current unstable renal impairment disease
* Patient has been hospitalized for acute renal failure in the past year
* Patient has active malignancy or a history of neoplastic disease
* Patient has QTc interval \> 450 milliseconds
* Patient is currently on cytotoxic or other immunosuppressive therapy

Primary outcomes:
measure: Safety measures
timeFrame: 4 weeks
Secondary outcomes:
measure: Pharmacokinetic Profile
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Costa Mesa
country: United States
facility: West Coast Clinical Trials
state: California
city: Garden Grove
country: United States
facility: Southern California Clinical Research
state: California
city: Tustin
country: United States
facility: Orange County Research Center
state: California
Study officials:
affiliation: Concert Pharmaceuticals
name: James Shipley, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02648399: Prospective Study on the Clinical Prognosis of Bilateral Central Lymph Node Dissection in the Patients With Unilateral Thyroid Papillary Carcinoma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Thyroid Papillary Carcinoma
Keywords: thyroid carcinoma
center lymph node dissection
Lead sponsor: Fujian Medical University
Sponsor class: OTHER
First posted: 2016-01-07
Enrollment: 300
Sex: ALL
Minimum age (years): 15
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study recruit the patients with unilateral papillary thyroid cancer before operation,the patients agree to enter the test,and divided into experimental and control group.experimental group patients receive the surgery including unilateral thyroid lobectomy and bilateral central lymph node dissection.and control group receive the surgery including unilateral thyroid lobectomy and unilateral central lymph node dissection.last the investigators compare numbers of patient with tumor recurrence and metastasis rate of 5 years,numbers of metastatic lymph node,and numbers of participants with adverse events related to treatment between two groups in order to evaluate the significance of bilateral lymph node dissection.


Eligibility criteria: according by thyroid carcinoma TNM(tumor,lymph node, metastasis) staging of NCCN (National Comprehensive Cancer Network)

Inclusion Criteria:

* 1.Unilateral thyroid papillary carcinoma 2.TNM staging: T1\~2N0M0

Exclusion Criteria:

* 1.Bilateral thyroid papillary carcinoma 2.isthmus thyroid carcinoma 3.TNM staging: T3orT4 4.Clinic N1orM1

Primary outcomes:
measure: tumor recurrence
timeFrame: 5 years
measure: numbers of metastatic lymph node
timeFrame: 1 years
measure: adverse events related to treatment
timeFrame: 1 years
Secondary outcomes:
measure: relations between the lymph metastasis and TNM staging
timeFrame: 1 years
measure: relations between the lymph metastasis and tumor location
timeFrame: 1 years
Other outcomes:
Locations:
city: Fuzhou
country: China
facility: Fujian Medical University Union Hospital
state: Fujian
Study officials:
affiliation: Fujian Medical University Union Hospital
name: wenxin zhao, doctor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06145399: A Study of 1 8F-FDHT PET/MRIScans in Women With Breast Cancer
Official title: [18F]-Fluoro-2-Deoxy-D-Glucose and -[18F] Dihydro-Testosterone PET Imaging In Patients Advanced Breast Cancer
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: EARLY_PHASE1
Conditions: Breast Cancer
Breast Carcinoma
Metastatic Breast Cancer
Metastatic Breast Carcinoma
Female Breast Cancer
Keywords: Breast Cancer
Breast Carcinoma
Metastatic Breast Cancer
Metastatic Breast Carcinoma
AR+ breast cancer
Progressive metastatic breast cancer
21-299
Memorial Sloan Kettering Cancer Center
Female Breast Cancer
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2023-11-24
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to see whether 18F-FDHT PET/MRI scans are an effective way of identifying AR-positive breast cancer.


Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years
* ECOG performance score of 0-2
* Signed informed consent
* Histologically confirmed AR+ breast cancer

  * All participants under consideration for enrollment will have their tumor specimen tested centrally at MSK; nuclear AR staining ≥ 1% will be considered positive.
* Progressive metastatic breast cancer manifested as increase in evaluable disease OR the appearance of new sites of disease since the date of the last imaging study performed and under consideration for AR-targeted therapy
* Planning to undergo treatment with agents targeting the antiandrogen signaling pathway on a clinical trial

Exclusion Criteria:

* Life expectancy \< 3 months
* Pregnancy or lactation
* Participants who cannot undergo scanning because of

  * weight limits
  * devices or implants that are not MRI safe
  * allergies to contrast materials
* CNS only disease on recent imaging

Primary outcomes:
measure: Number of lesions that correlate 18F-FDHT uptake with IHC expression of AR
timeFrame: 8 weeks post treatment
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Maxine Jochelson, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05790499: LDL-c Level Variability and Trained Immunity
Official title: Continuous Atorvastatin Therapy Compared With Intermittent Atorvastatin Therapy for the Effect of LDL-c Level Variability and the Regulation of Trained Immunity
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cholesterol Variability
Trained Immunity
Lead sponsor: Wuhan Union Hospital, China
Sponsor class: OTHER
First posted: 2023-03-30
Enrollment: 12
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: Statin treatment significantly reduces the incidence of cardiovascular events. However, cholesterol variability is associated with the risk of adverse events such as mortality, myocardial infarction, and stroke. The previous research found that the inflammatory activity of peripheral blood mononuclear cells in mice fed with intermittent high-fat diet was significantly increased, and the cholesterol variability had an impact on the trained immunity of peripheral blood mononuclear cells, thus aggravating the atherosclerosis in mice.

We plan to compare the differences in serum LDL-C levels after intermittent atorvastatin treatment and continuous atorvastatin treatment, and investigate the impact of this difference on the trained immunity of peripheral blood mononuclear cells.


Eligibility criteria: Inclusion Criteria:

1. Voluntarily participate, understand and sign an informed consent form;
2. Age ≥ 18 years old, male or postmenopausal female (defined as amenorrhea over 2 years with relevant clinical characteristics, such as age over 55 years old or menopausal cardiovascular symptoms such as hot flashes, night sweats, palpitations, etc.). Women with hysterectomy and/or bilateral oophorectomy may also be considered for inclusion in the group;
3. Commit to complying with research procedures and cooperate in the implementation of the entire process of research; 4、LDL-c\>3.4mmol/L

Exclusion Criteria:

1. Previous cardiovascular history;
2. Statins should not be discontinued in high-risk groups for cardiovascular events;
3. Any known organ dysfunction;
4. Intolerance to statins;
5. Pregnant women, lactating women, or women of childbearing age who do not use effective contraception;
6. Participating in other clinical trials;
7. Unable to follow the study procedure.

Primary outcomes:
measure: Changes in LDL-C levels between baseline and atorvastatin treatment cycles
timeFrame: 16 weeks
Secondary outcomes:
measure: PBMCs subgroup percentage and activation status
timeFrame: 16 weeks
measure: PBMCs secreting cytokines
timeFrame: 16 weeks
measure: Differences in gene expression of PBMCs
timeFrame: 16 weeks
measure: The levels of hs-CRP, IL-6, IL-18, and sVCAM-1
timeFrame: 16 weeks
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Department of Cardiology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
state: Hubei
Study officials:
References: