louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06807827: Pharmacist-Led Cognitive Behavioral Intervention for Diabetic Patients: a Randomized Interventional Trial to Evaluate the Impact on Medication Adherence and Quality of Life
Official title: Pharmacist-Led Educational Intervention for Diabetic Patients: a Randomized Interventional Trial to Evaluate the Impact on Medication Adherence and Quality of Life
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Diabete Mellitus
Keywords: Educational Intervention
Cognitive behavioral therapy
Pharmacist
Medication Adherence
Quality of life
Lead sponsor: Hamdard University
Sponsor class: OTHER
First posted: 2025-02-04
Enrollment: 385
Sex: ALL
Minimum age (years): 25
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This interventional study will to assess the impact of pharmacist-led educational intervention along with cognitive behavioral intervention in diabetic patients. Participants of this study will be provided regular counselling or cognitive behavioral intervention and educational material as part of their routine pharmacy visit. Researchers will compare the two groups to see which of the two groups improve in term of medication adherence and quality of life.

Detailed description: The purpose of the study is to investigate whether incorporating pharmacist-led educational interventions along with Cognitive Behavioral Therapy (CBT) can result in better outcomes for diabetic patients. Effective diabetes management requires proper education and adherence to medication. Missed doses or irregular medication use can lead to poor glycemic control and increased complications. The study will examine if educational interventions along with Cognitive Behavioral Therapy (CBT) can have a favorable effect on various aspects of diabetes management coping techniques, Medication beliefs, reduction in hypo and hyperglycemic frequency, HbA1c and medication related problems (MRPs) medication adherence and overall quality of life of diabetic patients.

Eligibility criteria: Inclusion Criteria:

All confirmed Type II diabetic patients who visit endocrinology OPD Clinic during study duration.

Patients having HbA1c \>8%. Follow up as well as new patients were included subjects willing to participate in the study with or without other severe co-morbidities were included in the study.

Exclusion Criteria:

GDM diabetic patients Patients with Central Obesity Type I DM Patients Patients with inadequate medical history Patient having HbA1c \<8% Patient who are not interested in the study are excluded.

Primary outcomes:
measure: Medication adherence score
timeFrame: 3 months
measure: Quality of life Score
timeFrame: 3 months
Secondary outcomes:
measure: Incidence of Drug-Drug Interactions
timeFrame: 3 months
measure: HbA1c %
timeFrame: 3 months
Other outcomes:
Locations:
city: Islamabad
country: Pakistan
facility: Shifa International Hospital
state: ICT
Study officials:
References:
Clinical trial NCT03400527: The Effects of Self Directed Exercise on People With Fibromyalgia
Official title: The Effects of Self Directed Exercise on People With Fibromyalgia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Fibromyalgia
Lead sponsor: Shenandoah University
Sponsor class: OTHER
First posted: 2018-01-17
Enrollment: 10
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: The purpose of this study is to determine the effects of self directed exercise on pain and function reported in patients with Fibromyalgia both in the short term and long term. Previous studies have shown that patients with fibromyalgia respond better to a single session of self directed exercise compared to prescriptive exercise. To the investigator's knowledge, no studies have examined the impact on pain and function after multiple sessions of self directed exercise in this patient population.

This study hoes to be a case series exploring the effects of self directed exercise on participants with fibromyalgia. Participants will be encouraged to exercise 8-12 times in a 4 week time frame at a self selected pace and intensity on a stationary bicycle. Outcome measures such as the Fibromyalgia Impact Questionnaire, SF-36 and Numeric Pain Rating Scale will be used prior to study participation as well as 4 and 8 weeks following the start of participation.


Eligibility criteria: Inclusion Criteria:

* over the age of 18
* a medical diagnosis of Fibromyalgia
* sedentary level of activity prior to entry. Sedentary level of activity is defined as: no participation in regular physical activity more strenuous than slow paced walking for a maximum of 2 times per week for the 4 months prior to study entry.
* signed release from their physician stating that they are able to participate in the study.

Exclusion Criteria:

* presence of an acute or chronic medical condition such as cancer
* infection, cardiovascular or respiratory disease (that would limit their exercise participation), metabolic or musculoskeletal or neurologic condition (systemic lupus or rheumatoid arthritis, or other pain disorders)
* already participating or plan on participating in a regular aerobic exercise program 6 months prior to the study
* ongoing or planned Physical Therapy treatment
* drug dependency

Primary outcomes:
measure: Change in Fibromyalgia Impact Questionnaire
timeFrame: 0, 4 and 8 weeks
Secondary outcomes:
measure: Change in Numeric Pain Rating Scale
timeFrame: 0, 4 and 8 weeks
measure: Change in Short Form (SF) - 36
timeFrame: 0, 4 and 8 weeks
Other outcomes:
Locations:
city: Woodstock
country: United States
facility: Woodstock Rehab & Fitness
state: Virginia
Study officials:
References:
citation: Ellingson LD, Stegner AJ, Schwabacher IJ, Koltyn KF, Cook DB. Exercise Strengthens Central Nervous System Modulation of Pain in Fibromyalgia. Brain Sci. 2016 Feb 26;6(1):8. doi: 10.3390/brainsci6010008.
Clinical trial NCT06377527: Establishing a Tumor Registry of Patients With Mesonephric-like Adenocarcinoma (MLA)
Official title: Establishing a Tumor Registry of Patients With Mesonephric-like Adenocarcinoma (MLA)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Mesonephric-like Adenocarcinoma
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
First posted: 2024-04-22
Enrollment: 2000
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: MD Anderson

Brief summary: To develop a database of medical information about patients with MLA in an effort to increase our understanding of the characteristics of MLA, which is the rarest form of endometrial carcinoma.

Detailed description: Primary Objectives

1. To collect, both prospectively and retrospectively, data on participants characteristics, disease characterization, pathology and molecular data, treatment, and outcomes for participants with gynecologic mesonephric-like adenocarcinoma (MLA).

Secondary Objectives

1. To organize clinical information to support multifaceted queries of participant characteristics, treatment, and disease outcome data and to facilitate correlation of these characteristics with participant outcome.
2. To have a single data repository kept on a secure platform that will integrate clinical information and research findings and serve as an archive for future research.

Eligibility criteria: Inclusion Criteria:

1. Adult patients with a diagnosis of gynecologic mesonephric-like adenocarcinoma (MLA).
2. Patients can also be diagnosed with mesonephric adenocarcinoma (MA) or patients with mesonephric and mesonephric-like carcinosarcomas.
3. Patients who are receiving or have received treatment at any facility, including but not limited to MD Anderson Cancer Center are eligible.
4. Patients may be residents of any country and be of any ethnic background.
5. Patients who request to participate in the registry, regardless of the method by which they learned of it, are eligible to participate.
6. Patients who do not speak English can be eligible if accompanied by an institutional interpreter.

Exclusion Criteria:

1. Patients with other subtypes of EACs.

Primary outcomes:
measure: Tumor Registry
timeFrame: Through study completion; an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: MD Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Jeffrey How, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04055727: Sepsis at Södersjukhuset-Adherence to Treatment Guidelines
Official title: Sepsis at Södersjukhuset-Adherence to Treatment Guidelines
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Sepsis
Keywords: treatment
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
First posted: 2019-08-14
Enrollment: 11000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients admitted to the emergency department at Södersjukhuset

Brief summary: A retrospective single-center study with patients with suspected sepsis admitted to the Emergency Department at Södersjukhuset during a period of two years. The aim is to describe the association between adherence to treatment guidelines, gender, incidence and mortality for patients with sepsis.

Detailed description: In this single-center study, patients with suspected sepsis admitted to the Emergency Department at Södersjukhuset during a period of two years will be included. About 11,000 patients will be included. Patient data including described sepsis symptoms will be drawn from the electronic medical record, TakeCare and Clinisoft. Logistic regression analysis will adjust for age, gender, comorbidity according to Charlson score, vital signs, with preliminary focus of infection (pneumonia, urinary tract infection, abdominal, other, unknown). The Surviving Sepsis guidelines for the time period are: 3-hour bundle including lactate measurement, obtaining blood culture, fluid treatment if hypotensive and administration of broad-spectrum antibiotics. The 6-hour bundles with administration of vasopressors if needed, remeasure lactate if elevated, with persistent hypotension re-asses volume status and tissue perfusion. Time zero is defined as the admission time to the emergency department. The aim is to describe the association between adherence to treatment guidelines, gender, incidence and mortality for patients with sepsis.

Eligibility criteria: Inclusion criteria:

• Patients admitted to the Emergency Department at Södersjukhuset with suspicion of sepsis defined as blood cultures taken and intravenous antibiotics of type beta-lactam or aminoglycoside prescribed within 48 hours of admission.

Exclusion criteria:

• Patients transferred from other hospitals or treatment clinics.

Primary outcomes:
measure: Gender differences in 90-day mortality
timeFrame: 90 days
Secondary outcomes:
measure: Association between adherence to treatment guidelines and mortality
timeFrame: 90 days
measure: Incidence of sepsis
timeFrame: 90 days
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Södersjukhuset
Study officials:
affiliation: Karolinska Institutet
name: Katarina Bohm, Ass Prof
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00047827: Trial of Micafungin (FK463) in Combination With Liposomal Amphotericin B (AmBisome) for Aspergillosis
Official title: A Phase 2, Open-Label, Non-Comparative Trial of Micafungin (FK463) in Combination With Liposomal Amphotericin B (AmBisome) as First-Line Therapy in the Treatment of Invasive Aspergillosis
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Aspergillosis
Keywords: Aspergillus
Aspergillosis
Anti-Fungal
AmBisome
Micafungin
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2002-10-24
Enrollment: 2
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the safety and effectiveness of micafungin in combination with AmBisome as first-line therapy in the treatment of invasive aspergillosis.


Eligibility criteria: Inclusion Criteria

* Have proven or probable systemic infection with Aspergillus species and have received no more than 96 hours of prior therapeutic doses of systemic antifungal therapy

Exclusion Criteria

* Has abnormal liver test parameters, e.g., AST or ALT \> 10 times upper limit of normal
* Has allergic bronchopulmonary aspergillosis, aspergillomas, or with sinus aspergillosis or external otitis who do not have evidence of tissue invasion
* Has life expectancy of less than five days

Primary outcomes:
measure: Incidence of treatment response defined as complete or partial response
timeFrame: Day 28, end of combined therapy and Day 84
Secondary outcomes:
measure: Clinical Response
timeFrame: Day 28, end of combined therapy and Day 84
measure: Radiological Response
timeFrame: Day 28, end of combined therapy and Day 84
measure: Mycological Response
timeFrame: Day 28, end of combined therapy and Day 84
measure: Survival at Day 84
timeFrame: Day 84
Other outcomes:
Locations:
city: Washington
country: United States
state: District of Columbia
city: Atlanta
country: United States
state: Georgia
city: Ann Arbor
country: United States
state: Michigan
city: Detroit
country: United States
state: Michigan
city: St. Louis
country: United States
state: Missouri
city: Memphis
country: United States
state: Tennessee
city: Houston
country: United States
state: Texas
Study officials:
affiliation: Astellas Pharma US, Inc.
name: Central Contact
role: STUDY_DIRECTOR
References:
Clinical trial NCT03665727: Psychosocial Support for Pre-operative Pain and Distress
Official title: Psychosocial Support for Pre-operative Pain and Distress
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Pain
Lead sponsor: University of Utah
Sponsor class: OTHER
First posted: 2018-09-11
Enrollment: 727
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 purpose of this randomized study is to determine the impact of three different types of psychosocial support delivered by mental health professionals to pre-operative joint replacement patients. This study will examine the differential effects of brief mindfulness training, hypnostic suggestion, and cognitive behavioral pain psychoeducation for pre-operative patients, with a supplemental nonrandomized usual care comparison group.


Eligibility criteria: Inclusion Criteria:

* English-speaking males or females
* 18 years old or older
* patients within the University of Utah Hospital system
* patients attending the Joint Replacement Academy to prepare for either hip or knee replacement surgery

Exclusion Criteria:

* Altered mental status due to delirium, psychosis, or pharmacological sedation as determined by clinical assessment.

Primary outcomes:
measure: Pain Intensity Numeric Rating Scale
timeFrame: Immediately prior to and following intervention
measure: Pain Unpleasantness Numeric Rating Scale
timeFrame: Immediately prior to and following intervention
Secondary outcomes:
measure: Pain Medication Desire Numeric Rating Scale
timeFrame: Immediately prior to and following intervention
measure: Anxiety Numeric Rating Scale
timeFrame: Immediately prior to and following intervention
measure: Postoperative Patient Reported Outcomes Measurement Information System (PROMIS) Physical Functioning Item Bank, v2.0
timeFrame: During the 6 weeks prioir to surgery and at the 6-week outpatient follow-up appointment.
measure: Nondual Awareness Dimensional Assessment - State
timeFrame: Immediately prior to and following intervention
measure: Sensation Manikin Body Sensation Report
timeFrame: Immediately prior to and following intervention
Other outcomes:
measure: Present Moment Awareness Numeric Rating Scale (Manipulation Check)
timeFrame: Immediately prior to and following intervention
measure: Decentering Numeric Rating Scale (Manipulation Check)
timeFrame: Immediately prior to and following intervention
Locations:
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
Study officials:
References:
citation: Hanley AW, Gililland J, Garland EL. To be mindful of the breath or pain: Comparing two brief preoperative mindfulness techniques for total joint arthroplasty patients. J Consult Clin Psychol. 2021 Jul;89(7):590-600. doi: 10.1037/ccp0000657. Epub 2021 Jun 24.
Clinical trial NCT05523427: Probiotics as Adjuvant Therapy in the Management of Irritable Bowel Syndrome
Official title: Two Lactobacilli Strains as Adjuvant Therapy in the Management of Irritable Bowel Syndrome: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Irritable Bowel Syndrome
Irritable Bowel Syndrome With Diarrhea
Keywords: IBS
IBS-D
Abdominal pain
Abdominal distention
Probiotic
Lactobacilli
Mucus
L. plantarum
L. acidophilus
Lead sponsor: University of Mosul
Sponsor class: OTHER
First posted: 2022-08-31
Enrollment: 100
Sex: ALL
Minimum age (years): 16
Maximum age (years): 55
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Studying the effects of adding probiotics to the drug regimen of patients with diarrhea predominant IBS

Detailed description: Irritable bowel syndrome (IBS) is a common highly prevalent functional gastrointestinal (GI) disorder that places an enormous burden on resource-challenged healthcare systems. Although many drugs have been advocated in the treatment of IBS, including psychotropic agents, antispasmodics, bulking agents, and 5-HT receptor antagonists. However, in the vast majority of instances, these medications have failed to provide adequate symptom alleviation, presumably due to the disease's diverse pathophysiology. Probiotics are "live bacteria that confer a health benefit on the host when administered in suitable doses". In IBS, a decrease in Bifidobacterium and Lactobacillus species, as well as an increase in Gamma-proteobacteria species (a family of pathogens), has been described in IBS studies. Therefore, the ability of probiotics to repair dysbiosis (qualitative and quantitative changes in the microbiota) or stabilize the host microbiota is the reason for their use in the treatment of IBS.

Eligibility criteria: Inclusion Criteria:

1. Age 16-55
2. Both genders
3. Patients diagnosed clinically with IBS based on Rome's criteria
4. IBS-Diarrhea only with pain \& distention
5. Duration of symptoms 6 months

Exclusion Criteria:

1. Age \> 55
2. Celiac disease
3. Inflammatory bowel disease (ulcerative colitis \& Crohn's)
4. Thyroid disease
5. Colonic CA
6. Lactose intolerance
7. Alarming features (anemia, blood in the stool, weight loss, abdominal masses, dysphagia, family history of GIT malignancy)
8. Preexisting use of antibiotics in the previous 3 months.
9. Preexisting systemic diseases

Primary outcomes:
measure: The change in bowel habits (based on the IBS-SSS) after treatment with a multi-strain probiotic or standard treatment, and compared with baseline.
timeFrame: Three months
Secondary outcomes:
Other outcomes:
Locations:
city: Mosul
country: Iraq
facility: University of Mosul
state: Ninevah
Study officials:
References:
Clinical trial NCT05537727: Robotic MIS With Dexter
Official title: Robotic Minimally Invasive Gynecological, Urological, and General Surgery With Dexter
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hysterectomy
Partial Nephrectomy
Right Colectomy
Lead sponsor: Distalmotion SA
Sponsor class: INDUSTRY
First posted: 2022-09-13
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population will consist of the modified intent-to-treat (mITT) sample. This is defined as the set of patients who were enrolled in the trial and on whom robotic-assisted surgery with Dexter was at least started.

Brief summary: The purpose of this study is to confirm the perioperative and early postoperative safety and clinical performance of the Dexter Robotic System (Dexter Surgical System, Model DM-L6).


Eligibility criteria: Inclusion Criteria:

* Aged ≥ 18 years
* Patient agrees to perform the 30-day follow-up assessment
* Able to provide signed Informed Consent, according to local regulation

Exclusion Criteria:

* Morbidly obese patients.
* Any and all relative and absolute contraindications to endoscopic surgical technique applicable to the use of conventional endoscopic surgical instruments.
* Bleeding diathesis.
* Pregnancy.
* Patients with pacemakers or internal defibrillators.
* Any planned concomitant procedures.
* Patient deprived of liberty by administrative or judicial decision or under legal guardianship.
* Participation in another interventional clinical trial.

Primary outcomes:
measure: occurrence of serious (Clavien - Dindo grades III-V), device related adverse events.
timeFrame: perioperatively up to 30 days
measure: successful completion of the Dexter-assisted procedure, i.e. free of any device related permanent conversion to an open or fully laparoscopic surgical approach.
timeFrame: intraoperative
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Hopital Paris Saint-Joseph
city: Saintes
country: France
facility: Centre Hospitalier de Saintes
city: Kiel
country: Germany
facility: UKSH
city: Bern
country: Switzerland
facility: Inselspital
city: Lausanne
country: Switzerland
facility: CHUV
Study officials:
affiliation: CHUV
name: Dieter Hahnloser, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02114827: Efficacy of a Patient Education Video
Official title: Efficacy of a Patient Education Video
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Leukemia, Not Otherwise Specified
Malignant Neoplasm
Keywords: Multiple Myeloma
Lead sponsor: Virginia Commonwealth University
Sponsor class: OTHER
First posted: 2014-04-15
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Patients in the intervention arm will view the 23-minute video depicting the Hematopoietic stem cell transplantation (HSCT) experience. Patients in the control arm will receive HSCT frequently asked questions (FAQ) sheet developed by the National Cancer Institute (NCI) at the National Institutes of Health (NIH).

Detailed description: The study's overall goals are 1) to improve outcomes; and 2) to increase satisfaction with the physician consultation.

Patients will be randomized to intervention or control and data will be collected at three time points (before treatment, 30 days post-HSCT and 12 months post-HSCT).

Eligibility criteria: Inclusion Criteria:

* Cancer patients scheduled for HSCT

Exclusion Criteria:

* Patients who have received HSCT previously
* Patients who do not speak English

Primary outcomes:
measure: Change in emergency department visits
timeFrame: Up to 12 months after HSCT
measure: Change in number of hospitalizations
timeFrame: Up to 12 months after HSCT
Secondary outcomes:
measure: Perception of satisfaction with the physician consultation
timeFrame: Up to 12 months after HSCT
Other outcomes:
Locations:
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
Study officials:
affiliation: Virginia Commonwealth University
name: Robin K Matsuyama, PhD
role: PRINCIPAL_INVESTIGATOR
References: