louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01408511: HPA Axis Study in Adults
Official title: A Multicenter, Open Label Study to Evaluate the Adrenal Suppression Potential of Mapracorat 0.1% Ointment in Adults With Atopic Dermatitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Atopic Dermatitis
Eczema
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2011-08-03
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: A multicenter, open-label study to evaluate the adrenal suppression potential of Mapracorat 0.1% ointment in adults with atopic dermatitis.

Detailed description: Assessment of safety, efficacy, pharmacokinetics and adrenal suppression potential of Mapracorat 0.1% ointment in adults with atopic dermatitis.

Eligibility criteria: Inclusion Criteria:

* Signed written informed consent
* Male or female subject aged \>= 18 years
* Diagnosis of atopic dermatitis according to Hanifin and Rajka Criteria
* Investigator's Global Assessment (IGA) score of 3 (moderate) to 4 (severe) at baseline
* Normal ACTH response before start of treatment

Exclusion Criteria:

* Pregnancy or lactation
* Clinically relevant disease, which could interfere with the study conduct or the evaluation and interpretation of the study results
* Concomitant medical or dermatological disorder(s), which could interfere with the study conduct or the evaluation and interpretation of the study results
* Clinically manifest immunosuppressive disorder or known history of malignant disease

Primary outcomes:
measure: HPA axis response to Cosyntropin: Number of subjects with adrenal suppression
timeFrame: measured after 4 weeks of therapy
Secondary outcomes:
Other outcomes:
Locations:
city: Bloemfontein
country: South Africa
facility: PAREXEL Bloemfontein
city: George
country: South Africa
facility: PAREXEL George
city: Port Elizabeth
country: South Africa
facility: PAREXEL Port Elizabeth
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT05081011: Managing Insulin With a Voice AI
Official title: Using an AI-based Voice Assistant to Manage Insulin in Diabetes: a Randomized-Control Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Medication Adherence
Keywords: Voice Assistant
Medication Management
Insulin Management
Smart Speaker
AI
Artificial Intelligence
Autonomous Prescriptions
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2021-10-18
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study randomizes participants to have their basal insulin titrated either through standard of care or by receiving prompts through interactions with an AI-enabled smart speaker device. The primary objective of this study is to investigate the feasibility of an AI-enabled smart speaker device and whether such a device facilitates insulin titration management, increases insulin adherence and decreases time to optimal insulin dose. The secondary objective of the study is to explore whether the device improves glycemic control as defined by improvements in fasting blood sugar.


Eligibility criteria: Inclusion Criteria:

* Patients with Type 2 Diabetes
* Patients clinically indicated to be taking daily long-acting insulin
* Patients currently taking long-acting insulin but necessitating active dose adjustments

Exclusion Criteria:

* Patients who do not speak English
* Patients who do not own a smart phone
* Patients who do not have stable wireless internet connection at home

Primary outcomes:
measure: Time to Optimal Insulin Dose
timeFrame: 8 weeks
measure: Insulin Medication Adherence
timeFrame: 8 weeks
measure: Attitudes Toward Diabetes
timeFrame: Baseline and 8 weeks
measure: Attitudes Toward Health Technology
timeFrame: Baseline and 8 weeks
measure: Attitudes Toward Medication Adherence
timeFrame: Baseline and 8 weeks
Secondary outcomes:
measure: Percentage of Participants Who Achieved Glycemic Control
timeFrame: 8 weeks
measure: Glycemic Improvement
timeFrame: Day 3 and 8 weeks (assessed at the end of each 3 day period)
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University
state: California
Study officials:
affiliation: Stanford University
name: Kevin Schulman, MD, MBA
role: PRINCIPAL_INVESTIGATOR
affiliation: Stanford University
name: Ashwin Nayak, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Stanford University
name: Sharif Vakili, MD, MS, MBA
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05049811: Effects of Mobile Medicine on Cancer Patients
Official title: An Overall Solution for Full-course Oral Anti-tumor Drug Services Based on Mobile Medicine
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cancer Pain
Keywords: mini program
self management
cancer pain
Lead sponsor: Fujian Cancer Hospital
Sponsor class: OTHER_GOV
First posted: 2021-09-20
Enrollment: 200
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: With the existing medical system and insufficient medical resources in China, we developed a mini program. a pain management mini app can be useful and appreciated by patients and health care professionals, making it a good choice for the management of cancer pain in our country . our study want to develop and test the mini program for pain management among Chinese cancer patients in or discharged from hospital treatment.

Detailed description: Healthcare interventions delivered via personal mobile device have been shown to be acceptable to users, who have identified benefits such as convenience, access to personalized information, greater awareness of own health. Integrating mini program into the cancer pain care may be an effective strategy to improve cancer pain patients self-management.

To design, construct, and test the mini program in patients managing cancer pain, evaluate the total remission rate of pain and the improvement in medicine compliance to improve pain management for cancer pain patients, and assess patient acceptance of the mini program.

Eligibility criteria: Inclusion Criteria:

* Patients aged 18 years or older;
* Be able to read Chinese and use a mobile phone;
* Histologically or cytologically confirmed solid tumor;
* Diagnosed chronic cancer pain
* Could understand the study process and evaluation, agreed to participate in the trial, and signed the informed consent form.

Exclusion Criteria:

* Illiterate person;
* Incompetence;
* Inability to complete the pain assessment;
* Participation in any other therapies or other study protocols that may have an impact on pain intensity, which were the main outcomes of this study.

Primary outcomes:
measure: Change in pain score
timeFrame: Change from baseline at four weeks after discharge
Secondary outcomes:
measure: Change in medication adherence
timeFrame: Change from baseline at four weeks after discharge
measure: Incidence of adverse events
timeFrame: Up to four weeks after discharge
measure: Change in quality of life
timeFrame: Change from baseline at four weeks after discharge
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02469311: Prospective, Randomized Study Evaluating The Efficacy of Chlorhexidine Gluconate Impregnated No-Rinse Cloths.
Official title: Prospective, Randomized Study Evaluating The Efficacy of Chlorhexidine Gluconate Impregnated No-Rinse Cloths in Reducing Surgical Site Infections for Total Hip and Knee Arthroplasty.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Osteoarthritis
Infection
Keywords: infection; arthroplasty; chlorhexidine; hip; knee
Lead sponsor: LifeBridge Health
Sponsor class: OTHER
First posted: 2015-06-11
Enrollment: 539
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Subjects in the study were randomized to a treatment group using Chlorhexidine cloths or a standard-of-care group who only had a bath with antibacterial soap and water. Both groups received standard infection control practices during admission.

Detailed description: Between March 2012 and November 2012, patients scheduled for total hip arthroplasty (THA) or total knee arthroplasty (TKA) were randomized (539 patients; 554 arthroplasties) at the time of their preoperative clinic visit. Patients in the chlorhexidine protocol group (275 arthroplasties) applied 2% chlorhexidine gluconate-impregnated cloths to their skin the night before and the morning of surgical admission. Patients in the standard of care group (279 arthroplasties) took a bath with soap and water the night before surgical admission. Both groups were subject to standard infection control practices during admission. The primary outcome was periprosthetic infection incidence within one year of surgery, and secondary outcomes included the potential influence of risk factors for periprosthetic infection and incidence of adverse events.

Eligibility criteria: Inclusion Criteria:

* Joint replacement surgery for any reason
* 18 years or older

Exclusion Criteria:

* unable to comply with study requirements
* were pregnant
* were under the age of 18 years
* medical history of immunosuppression or systemic disease e.g. human immunodeficiency virus, status-post organ transplantation
* received greater than 10 milligrams of prednisone equivalent for more than 10 days within 90 days prior to enrollment;
* chronic hepatitis B or C infection
* had an infection in or around the joint requiring surgery.

Primary outcomes:
measure: The incidence of periprosthetic infection.
timeFrame: One year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Director, Rubin Instituted for Advanced Orthopedics and Joint Preservation and Replacement
name: Michael A Mont, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00488111: Fluid Management for Cesarean Section
Official title: Fluid Management With Ringer's and 6% Starch for Cesarean Section After Epidural or Spinal Anesthesia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cesarean Section
Keywords: Regional anesthesia
Fluid Therapy
Hemostasis, Surgical
Lead sponsor: Nanjing Medical University
Sponsor class: OTHER
Collaborators: name: HRSA/Maternal and Child Health Bureau
First posted: 2007-06-19
Enrollment: 850
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Cesarean section-associated hypotension is one of the pivotal factors to influence the Apgar Score of children and related with the stable hemostasis during the whole process of labor. How to keep circulation in a consistent stability is yet to be known. The investigators hypothesized that different fluids, crystalloids or colloids, can produced varying effects in keeping the physiological environment of labor from significant fluctuating.


Eligibility criteria: Inclusion Criteria:

* 21-40 yr
* First time of delivery
* ASA status I-II
* No premature
* No genetic and infectious diseases
* Chinese

Exclusion Criteria:

* \< 21 yr
* \> 40 yr
* Subjects with cardiac and pulmonary disorders
* Dislocation of placenta
* Pregnant hypertension
* Allergy to local anesthetics
* Unwilling to cooperation
* Need intraoperative administration of vascular active agents
* With significant delivery side effects

Primary outcomes:
measure: Total volume of colloid Total volume of crystalloid Total fluid volume
timeFrame: 6 months
Secondary outcomes:
measure: Percentage reduction in hematocrit, Days in hospital
timeFrame: 6 months
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Nanjing Maternal and Child Care Hospital
state: Jiangsu
Study officials:
affiliation: Nanjing Medical University
name: XiaoFeng Shen, MD
role: STUDY_CHAIR
References:
Clinical trial NCT06147011: 3D Thyroid Education Model for Student
Official title: Development of 3D Printing High-Fidelity Thyroid Fine Needle Aspiration Exam Medical Education Model to Facilitate Student Learning and Practice
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Satisfaction, Personal
Keywords: 3D printing
medical education model
high-fidelity simulation
thyroid
fine needle aspiration
Lead sponsor: Fu Jen Catholic University
Sponsor class: OTHER
First posted: 2023-11-27
Enrollment: 50
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The purpose of our study is to develop a high-fidelity thyroid education model, that can be utilized for medical students/ PGY doctors/ residents training. This model can help them better understand the structure of thyroid, learn about what are thyroid nodules, and practice thyroid fine needle aspiration examination with the model. The investigators would also evaluate the efficacy of using this model in student teaching.

Detailed description: Background： Thyroid nodular disorder is prevalent in Endocrine clinics, and while thyroid fine needle aspiration examination is crucial for evaluating nodules, conveying the procedure to students is challenging. The investigators propose a high-fidelity 3D model to enhance education, especially for hands-on practice. Our study aims to assess the model's education efficacy.

Study Design： This is a prospective study.

Methods： In our study, 3D scanning and 3D printing technology will be used to create the thyroid high-fidelity model. The investigators plan to choose 3D printing materials that enable the practice of thyroid fine needle aspiration produce with No.22 or No.23 needles.

Effect： The investigators hope to assist students understand the structure of thyroid and thyroid nodules better. And students will be able to practice thyroid fine needle aspiration examination with the 3D high-fidelity model. The outcome of our study may be utilized in medical schools or hospitals to facilitate student education.

Key words： 3D printing; medical education model; high-fidelity simulation; thyroid; fine needle aspiration

Eligibility criteria: Inclusion Criteria:

* Medical students, medical interns, PGY physicians, and resident physicians training at Fu Jen Catholic University Hospital

Exclusion Criteria:

* Refused to participate in the study

Primary outcomes:
measure: Patient education effectiveness questionnaire
timeFrame: immediately after the intervention
Secondary outcomes:
Other outcomes:
Locations:
city: New Taipei City
country: Taiwan
facility: Fu Jen Catholic University Hospital, Fu Jen Catholic University
Study officials:
affiliation: Fu Jen Catholic University Hospital
name: Ke-Yun Chao, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02414711: Validation of the French Translation of the Scale HSCL25 in the Diagnosis of Depression in Primary Care
Official title: Validation of the French Translation of the Scale HSCL25 in the Diagnosis of Depression in Primary Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Keywords: Depression
Primary care
General Practitioners
Lead sponsor: University Hospital, Brest
Sponsor class: OTHER
First posted: 2015-04-13
Enrollment: 1128
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP

Brief summary: Depression has emotional consequences, social and important business. Reaching at least 7.5% of French aged 15 to 85 years. General Practitioners are the first professional consulted in terms of frequency of consultations. Indeed, in primary care, 10 to 25% of patients with depression that General Practitioners are often alone to support and follow. But General Practitioners are faced with diagnostic difficulties facing the diagnosis of depression, because if the patient does not engage itself, no tool is validated in France to help them in their diagnosis. However, standardized questionary exist that allow to overcome this difficulty. Questionary used in other european countries. Among them, the HSCL25 scale was selected by a systematic review of literature and a RAND UCLA type of consensus procedure. This HSCL25 scale is the most efficient for the diagnosis of depression in terms of efficiency tool, reproducibility and ergonomics. However, it remains necessary to confirm its validity in terms of the French translation and in terms of efficiency.


Eligibility criteria: Inclusion Criteria:

* Adult (18 and over) consultant in primary care

Exclusion Criteria:

* Child or young person under 18
* Women with a declared pregnancy to prevent puerperal depression whose support is different.
* Adult consultant to obtain a medical certificate
* Psychotic patients and\\or requiring immediate care

Primary outcomes:
measure: To validate the French translation of the HSCL25 scale
timeFrame: 1 month
measure: To assess the HSCL25 scale diagnosis efficacy of depression in primary care ambulatory practice
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Brest
country: France
facility: Cabinet médical en zone urbaine
city: Lanmeur
country: France
facility: Cabinet médical en zone rurale - Pôle Santé Universitaire
city: Plounéour Trez
country: France
facility: Cabinet médical en zone semi-rurale
Study officials:
affiliation: GP department
name: Patrice NABBE, GP
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06241911: Transcutaneous Auricular Vagus Nerve Stimulation in Patients With Narcolepsy Type 1
Official title: Safety and Efficacy of Transcutaneous Auricular Vagus Nerve Stimulation in Patients With Narcolepsy Type 1: A Double-blind, Randomized, Sham-controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Narcolepsy Type 1
Fmri
Keywords: transcutaneous auricular vagus nerve stimulation
Lead sponsor: Xijing Hospital
Sponsor class: OTHER
First posted: 2024-02-05
Enrollment: 60
Sex: ALL
Minimum age (years): 12
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study aimed to examine the efficacy and safety of tVNS as a complementary approach for NT1 by conducting a double-blind, randomized, sham-controlled trial. The specific objectives of the study were as follows: To evaluate the effects of complementary tVNS on the ability to maintain wakefulness, severity of narcolepsy, mood and quality of life in patients with NT1


Eligibility criteria: Inclusion Criteria:

1. Age ≥ 12 years old with the ability to understand and complete the self-reported questionnaires
2. The patients met the international classification of sleep disorders third edition (ICSD-3) for NT126
3. Local residence for more than 3 months
4. Willingness to follow the trial plan as scheduled

Exclusion Criteria:

1. History of a clinically defined neurological or sleep disorders other than NT1
2. Any psychiatric disorder involving a history of psychosis
3. Any chronic condition affecting the ability to read or comprehend written instructions
4. Any substances abuse within the past 12 months
5. Pregnant or nursing
6. Metallic implants or devices contraindicating tVNS

Primary outcomes:
measure: maintenance of wakefulness test (MWT)
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Xi'an
country: China
facility: Liu Yonghong
state: Shaanxi
Study officials:
References:
Clinical trial NCT03378011: UVA1 Phototherapy in Acral Vitiligo
Official title: The Role of Long Wavelength UVA1 Phototherapy in Acral Vitiligo
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acral Vitiligo
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2017-12-19
Enrollment: 20
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: evaluate the effect of UVA1 phototherapy in the treatment of acral vitiligo.


Eligibility criteria: Inclusion Criteria:

* Patients with acral vitiligo.
* Patients more than 12 years old.

Exclusion Criteria:

* Patients less than 12 years old.
* Patients with any other skin diseases or autoimmune diseases.
* Patients taking medical treatment or phototherapy for vitiligo.

Primary outcomes:
measure: effect of medium dose UVA1 phototherapy in treatment of acral vitiligo
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Maha Fathy Elmasry
Study officials:
affiliation: Cairo University
name: Maha Elmasry
role: PRINCIPAL_INVESTIGATOR
References: