louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06034548: Diabetes and Hypertension Self Management Program
Official title: Diabetes and Hypertension Self Management Program
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Hypertension
Lead sponsor: West Virginia University
Sponsor class: OTHER
First posted: 2023-09-13
Enrollment: 74
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: RCT with wait-listed control
Primary purpose: OTHER

Brief summary: The purpose of this R15 project is to test the feasibility and effectiveness of a 12-week diabetes and hypertension self-management program using trained health coaches.

Detailed description: West Virginia has high prevalence of comorbid diabetes and hypertension. Most diabetes self-management programs are hospital or clinic based and none are tailored to address the unique needs of rural WV adults with comorbid diabetes (T2DM) and hypertension (HTN). There is a critical need for new and creative community-based, culturally appropriate self-management programs in this medically underserved state. This study will use a wait-listed randomized control trial (RCT) design, using evidence-based interventions, to improve patient self-management behaviors and health outcomes (HbA1c and BP). Eligible adults with comorbid T2DM and HTN will be randomized with a 1:1 ratio to the immediate diabetes and hypertension self-management program (DHSMP; n=35) or to 6-month wait-listed control group (N=35), based on an allocation sequence generated by the biostatistician using a randomly varying block randomization method to ensure equal distribution among treatment groups.

Eligibility criteria: Inclusion Criteria:

* English speaking adults \>= 18 years of age;
* co-occurring diagnosis of T2DM and HTN;
* body mass index \>= 25.0
* willing to be randomized and complete all assessments.

Exclusion Criteria:

* currently pregnant or breastfeeding;
* diagnosed with a severe mental illness;
* have any condition that requires physical activity limitations or is contraindicated for the Dietary Assessment to Stop Hypertension (DASH) diet;
* inability to complete the study protocol.

Primary outcomes:
measure: Clinical outcomes - A1c
timeFrame: 6 months after enrollment
measure: Clinical outcomes - BP
timeFrame: 6 months after enrollment
Secondary outcomes:
measure: Behavioral outcome - healthy eating plan; questions
timeFrame: 6 months after enrollment
measure: Behavioral outcome - exercise; questions
timeFrame: 6 months after enrollment
Other outcomes:
Locations:
city: Morgantown
country: United States
facility: West Virginia University
state: West Virginia
Study officials:
affiliation: West Virginia University
name: Ranjita Misra, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05474248: Diaphragmatic Breathing Training on Postpartum Anxiety
Official title: Effects of A Biofeedback-assisted Diaphragmatic Breathing Training on Postpartum Anxiety: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Postpartum Anxiety
Keywords: postpartum anxiety
biofeedback
diaphragmatic breathing
Lead sponsor: Ministry of Science and Technology, Taiwan
Sponsor class: OTHER_GOV
Collaborators: name: Taichung Tzu Chi Hospital
First posted: 2022-07-26
Enrollment: 128
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a two-group pretest-posttest, triple-blinded and randomized controlled trial examining the effects of a biofeedback-assisted diaphragmatic breathing training on postpartum anxiety. This study will include full-term postpartum women, aged from 20 to 49, who experienced anxious symptoms with State Anxiety Inventory (A-State) scored 40 or more at the first postpartum day. Participants will be randomly assigned to either an experimental group (n = 64) or a control group (n = 64). The experimental group will undergo the diaphragmatic breathing training assisted with StressEraser to breath slowly 4-6 times per minute and practice 15 minutes twice daily. Participants in the control condition receive postpartum usual care. The outcome measures include anxiety measured by State-Trait Anxiety Inventory (STAI) and the physiological parameters expressed by blood pressure (BP) and heart rate (HR). Measurements will be taken at the first postpartum day and one month postpartum. We except this breathing training design is able to improve women's postpartum anxiety, and in turn improve their physio-psychological health, breastfeeding and baby care skills.

Detailed description: Ditto

Eligibility criteria: Inclusion Criteria:

* full-term postpartum women
* aged from 20 to 49
* STAI-S scored 40 or more at the first postpartum day

Exclusion Criteria:

* newborn with severe illness or stillbirth
* maternal suicide or self-harm
* drug use: sedatives, hypnotics or antipsychotic drugs

Primary outcomes:
measure: Postpartum anxiety
timeFrame: Baseline: postpartum day 1-3
measure: Postpartum anxiety
timeFrame: Post-test: Change from baseline postpartum anxiety at 4 weeks postpartum
Secondary outcomes:
measure: Heart rate
timeFrame: Baseline: postpartum day 1-3
measure: Heart rate
timeFrame: Post-test: Change from baseline heart rate at 4 weeks postpartum
measure: Blood pressure
timeFrame: Baseline: postpartum day 1-3
measure: Blood pressure
timeFrame: Post-test: Change from baseline heart rate at 4 weeks postpartum
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Taipei Tzu Chi Hospital
state: Xindian Dist
Study officials:
References:
Clinical trial NCT01550848: A Phase II Study of Abraxane Gemcitabine Combination in Patients With Metastatic Breast Cancer
Official title: A Phase II Study of Abraxane Combined With Gemcitabine in the Patients With Metastatic Breast Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Metastatic Breast Cancer
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2012-03-12
Enrollment: 84
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the efficacy and toxicity of Abraxane combined with Gemcitabine in the patients with metastatic breast cancer.

Detailed description: This study is to investigate the efficacy and toxicity of Abraxane combined with Gemcitabine in the patients with metastatic breast cancer.

Eligibility criteria: Inclusion Criteria:

* Female between 18 and 70 years old;
* Patients with histologic proved metastatic breast cancer, unsuitable to be treated with surgery;
* ECOG (Eastern Cooperative Oncology Group) 0\~1;
* Normal functions with heart, liver,renal and bone marrow:WBC≥3.5×109/L；Hb≥90 g/L；plt≥100×109/L;
* Got ICF (Informed Consent Form) before enrollment;
* Life expectancy more than 12 weeks

Exclusion Criteria:

* Pregnant or breast-feeding women or positive serum pregnancy test;
* Uncontrolled brain metastases. Patients with brain metastases must be locally treated and the disease must be stable for at least one month at the time of enrolling;
* Participation in any investigational drug study within 4 weeks preceding treatment start;
* Concurrent other malignancy at other sites or previous other cancer within the last 5 years, with the exception of adequately treated in situ carcinoma of cervix uteri or basal or squamous cell carcinoma of the skin or a contralateral breast cancer;
* Serious uncontrolled intercurrent infections;
* Poor compliance

Primary outcomes:
measure: overall response rate
timeFrame: 8 weeks
Secondary outcomes:
measure: number of adverse events
timeFrame: 6 months
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Fudan University Cancer Hospital
Study officials:
affiliation: Fudan University
name: Xichun Hu, MD;PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Li Y, Zhao Y, Gong C, Xie Y, Hu X, Zhang J, Wang L, Zhang S, Cao J, Tao Z, Wang B. Cisplatin shows greater efficacy than gemcitabine when combined with nab-paclitaxel in metastatic triple-negative breast cancer. Sci Rep. 2019 Mar 5;9(1):3563. doi: 10.1038/s41598-019-39314-y.
citation: Zhao Y, Lv F, Chen S, Wang Z, Zhang J, Zhang S, Cao J, Wang L, Cao E, Wang B, Hu X. Caveolin-1 expression predicts efficacy of weekly nab-paclitaxel plus gemcitabine for metastatic breast cancer in the phase II clinical trial. BMC Cancer. 2018 Oct 22;18(1):1019. doi: 10.1186/s12885-018-4936-y.
Clinical trial NCT05136248: Comparison of the Effect of Intra Articular Steroid Injection and Pericapsular Nerve Group Block for Hip Osteoarthritis
Official title: Comparison of Ultrasound Guided Intra-articular Steroid Injection and Pericapsular Nerve Group Block (PENG) in Patients With Chronic Hip Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hip Osteoarthritis
Lead sponsor: Diskapi Teaching and Research Hospital
Sponsor class: OTHER
First posted: 2021-11-29
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The most common cause of hip joint dysfunction in the elderly is degenerative osteoarthritis of the hip. Innervation of the hip joint capsule is provided by the obturator nerve, the accessory obturator nerve, and the femoral nerve. With pericapsular nerve group block (PENG), by blocking the femoral nerve and the accessory obturator nerve, analgesia is successfully provided for the hip joint. Intra-articular injection of corticosteroids; It is used as an alternative to surgical interventions because it reduces inflammation and short-term pain and is a minimally invasive method. The investigators aim to compare and report patients who underwent ultrasound-guided intra-articular steroid injection and PENG block in terms of post-procedural pain scores and patient satisfaction.


Eligibility criteria: Inclusion Criteria:

* Hip pain NRS \> 4
* No pathologies in the laboratory and coagulation parameters

Exclusion Criteria:

* Rheumatological disease with hip involvement
* Systemic active infection
* Malignancy
* History of hip joint surgery
* History of traumatic hip injury
* Platelets values \< 150.000 / µl
* History of bleeding disorder

Primary outcomes:
measure: numerical rating scale (NRS) pain score
timeFrame: change from baseline to day 1, week 2, 4, 8 after the block
Secondary outcomes:
measure: Quality of Life (WOMAC)
timeFrame: baseline to 8 weeks
Other outcomes:
measure: Change in Harris Hip Score (HHS)
timeFrame: baseline to 8 weeks
Locations:
city: Ankara
country: Turkey
facility: Diskapi Yildirim Beyazit Training and Research Hospital
Study officials:
affiliation: Diskapi Teaching and Research Hospital
name: selin guven kose
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01400048: Aloe Vera in Irritable Bowel Syndrome
Official title: Aloe Vera Versus Placebo for Patients With Irritable Bowel Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Irritable Bowel Syndrome
Lead sponsor: Sahlgrenska University Hospital
Sponsor class: OTHER
Collaborators: name: Calmino group AB
First posted: 2011-07-22
Enrollment: 173
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the present study is to study the effect of aloe vera in the treatment of IBS patients in a randomized, double-blind placebo controlled study.

Detailed description: There is limited knowledge of the IBS pathophysiology, absence of biological markers and therefore few effective treatment options. IBS therefore contributes to difficulties in the management of the patients. Aloe vera has a long association with herbal medicine, from the Ebers Papyrus from 16th century BCE. It is alleged to be effective in treatment of wounds, to improve blood glucose levels in diabetics, and it may reduce symptoms and inflammation in patients with ulcerative colitis. Evidence of the effects of aloe vera in the treatment of IBS, is however limited and contradictory.

Eligibility criteria: Inclusion Criteria:

* IBS according to the Rome III criteria
* Adults

Exclusion Criteria:

* other GI disorders
* other medical conditions
* were pregnancy or breast-feeding
* food allergy or intolerance to other than lactose
* ongoing intake of aloe vera products

Primary outcomes:
measure: IBS symptoms
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Gothenburg
country: Sweden
facility: Mag-tarmlab, Dept of Internal Medicine, Sahlgrenska University Hospital
Study officials:
affiliation: Dept of Internal medicine, Sahlgrenska UH, Gothenburg, Sweden
name: Magnus Simrén, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ahluwalia B, Magnusson MK, Bohn L, Storsrud S, Larsson F, Savolainen O, Ross A, Simren M, Ohman L. Randomized clinical trial: Effects of Aloe barbadensis Mill. extract on symptoms, fecal microbiota and fecal metabolite profiles in patients with irritable bowel syndrome. Neurogastroenterol Motil. 2020 Aug;32(8):e13860. doi: 10.1111/nmo.13860. Epub 2020 Apr 20.
Clinical trial NCT00763048: Collection of Gingival Crevicular Fluid From Periodontitis Patients
Official title: Collection of Gingival Crevicular Fluid From Periodontitis Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Gingival Diseases
Lead sponsor: Colgate Palmolive
Sponsor class: INDUSTRY
First posted: 2008-09-30
Enrollment: 39
Sex: ALL
Minimum age (years): 26
Maximum age (years): 68
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To collect GCF (gingival crevicular fluid) samples from diseased patients suffering only from gingivitis and/or periodontitis.


Eligibility criteria: Inclusion Criteria:

* Be aged 18 to 65 years inclusive
* Have a minimum of 20 natural uncrowned teeth (excluding 3rd molars) present
* Give written informed consent
* Be in good general health
* No known history of allergy to personal care/consumer products or their
* ingredients, relevant to any ingredients in the test products as determined by the
* dental/medical professional monitoring the study

Exclusion Criteria:

* Medical condition which requires pre-medication prior to dental visits/procedures
* Advanced periodontal disease
* 5 or more decayed, untreated dental sites
* Diseases of the soft or hard oral tissues
* Orthodontic appliances
* Abnormal salivary function
* Use of prescription drugs.
* Use of antibiotics one (1) month prior to or during this study
* Use of any over the counter medications other than analgesics
* Erratic use of vitamin supplements
* Pregnant or breastfeeding.
* Participation in another clinical study in the month preceding this study
* Allergic to common dentifrice ingredients
* Immune compromised individuals (HIV, AIDS, immuno suppressive drug therapy)

Primary outcomes:
measure: Metabolite Associated With Inflammation (Cadaverine)
timeFrame: 6 weeks
measure: Metabolite Associated With Inflammation (Choline)
timeFrame: 6 weeks
measure: Metabolite Associated With Inflammation (Hypoxanthine)
timeFrame: 6 weeks
measure: Metabolite Associated With Inflammation (Inosine)
timeFrame: 6 weeks
measure: Metabolite Associated With Inflammation (Isoleucine)
timeFrame: 6 weeks
measure: Metabolite Associated With Inflammation (Leucine)
timeFrame: 6 weeks
measure: Metabolite Associated With Inflammation (Lysine)
timeFrame: 6 weeks
measure: Metabolite Associated With Inflammation (Phenylalanine)
timeFrame: 6 weeks
measure: Metabolite Associated With Inflammation (Putrescine)
timeFrame: 6 weeks
measure: Metabolite Associated With Inflammation (Xanthine)
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Forsyth Institute
state: Massachusetts
Study officials:
name: Riccardo Teles, DMD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04585048: The Efficacy of Integrated Behavioral Therapy for Selective Mutism
Official title: The Efficacy of Integrated Behavioral Therapy for Selective Mutism
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Selective Mutism
Lead sponsor: Rabin Medical Center
Sponsor class: OTHER
First posted: 2020-10-14
Enrollment: 60
Sex: ALL
Minimum age (years): 4
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: waiting list vs. treatment phase
Primary purpose: TREATMENT

Brief summary: This study examines the efficacy of the Integrated Behavioral Therapy for Selective Mutism protocol (Bergman et al., 2013). Participants are 60 children, aged 4-8 years, diagnosed with Selective Mutism (SM). The level of SM symptoms is assessed during first arrival to the SM unit of Schneider Children's Medical Center of Israel (Intake), at the first treatment session, at sessions 12, and at the end of treatment.

A secondary aim of this study is to assess the contribution of parent's characteristics (anxiety and depression levels, parenting style) to the childrens' SM symptoms level and to treatment achievements.

Detailed description: All study procedures have been approved by the Institutional Review Board of Schneider Children's Medical Center of Israel. Participants are recruited from the Selective Mutism unit at Schneider Children's Medical Center of Israel, during their first visit to the clinic. Both parents of eligible children sign informed consents. Each child is evaluated by a clinical psychologist, using a semi-structured interview (ADIS), designed to diagnose the child and to determine the level of symptom severity. The parents who are identified as the main-caregiving, complete questionnaires assessing the child's levels of SM symptoms and social anxiety (SMQ, SASC), the parents' levels of social anxiety (LSAS, SPIN) and depression (BDI), parent's authority style (PAQ), parental accommodation (FASA) and parental playfulness (PPQ). The child's teacher completes questionnaires assessing the child's SM levels (SSQ). Participants are than assigned either to the treatment or the waiting list group (by chance). The assessment of SM levels is repeated in both groups at 1 week from baseline, 12 weeks from baseline, and 24 weeks from baseline. participants of the waiting list group will commence treatment following the 24 weeks waiting period.

Eligibility criteria: Inclusion Criteria:

* Selective Mutism diagnosis (DSM-5)
* age 4-8 years

Exclusion Criteria:

* Autism Spectum Disorder
* Psychotic disorder
* Commenced other psychiatric or psychological treatment at the last month

Primary outcomes:
measure: Change in Selective Mutism Questionnaire
timeFrame: baseline, 1 week from baseline, 12 weeks from baseline, 24 weeks from baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Petach Tikva
country: Israel
facility: Schneider Childrens' Medical Center of Israel
Study officials:
affiliation: Schneider Children's Medical Center, Israel
name: Maayan shorer, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT05328765: A Global Record of Patients With Anal Squamous Cell Carcinoma With and Without HIV Infection
Official title: ACTION HIV (Anal Cancer TherapIes and Outcomes iNitiative for Patients Living With and Without HIV): A Global Record of Patients With Anal Squamous Cell Carcinoma With and Without HIV Infection
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Anal Squamous Cell Carcinoma
HIV Infections
Keywords: HIV Infections
Anal Squamous Cell Carcinoma
Lead sponsor: Latin American Cooperative Oncology Group
Sponsor class: OTHER
First posted: 2022-04-14
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Potentially eligible patients will be screened through the administrative lists of participating centres. Based on convenience and viability, we estimate to accumulate 300 patients with CCA with and without HIV infection.

Brief summary: Due to the scarcity of data on prognostic and predictive influence on CCA, epidemiological studies evaluating these factors need to be developed in patients with CCA. Therefore, the investigators want to evaluate the profile of patients in the real world and from various parts of the world, describing prognostic factors such as CD4 dosage, time of HIV infection, evaluation of viral load, diagnosis of AIDS, geographic region of diagnosis and treatment, clinical staging, medications concomitant with QRT (risk of drug interactions), comorbidities (possible impact on dose-intensity), use of HAART, time of use of HAART, radiotherapy modality (conventional 3D vs Modulated Beam Intensity \[IMRT\], response to Nigro vs CTII regimens, as well as comparing clinical outcomes with patients without HIV infection.


Eligibility criteria: Inclusion Criteria:

* Patients 18 years of age or older
* Confirmed histological diagnosis of anal canal squamous cell carcinoma. Basaloid subtype is accepted
* Have underundered serological test for HIV infection
* Any clinical stage

Exclusion Criteria:

* Lack of data on treatments and clinical outcomes

Primary outcomes:
measure: Median disease-free survival
timeFrame: 3 years
measure: Complete clinical response
timeFrame: 6 months
measure: Overall survival
timeFrame: From first date of treatment to date of death from any cause, assessed up to 3 years.
Secondary outcomes:
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: A.C. Camargo Cancer Center
Study officials:
affiliation: Brazilian Group of Gastrointestinal Tumors
name: Rachel Riechelmann
role: PRINCIPAL_INVESTIGATOR
References: