louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06386367: Health Education by Buddhist Monks to Promote Malaria Knowledge and Preventive Practices in Rural Myanmar
Official title: Monastery-based Health Education by Buddhist Monks to Promote Malaria Knowledge and Preventive Practices in Rural Myanmar: A Quasi-experimental Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Buddhist Monks
Health Education
Malaria
Monastery-based
Myanmar
Preventive Practice
Lead sponsor: Myanmar Health Network Organization
Sponsor class: OTHER
Collaborators: name: Chulalongkorn University
name: Ministry of Health and Sports, Myanmar
First posted: 2024-04-26
Enrollment: 501
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Malaria is still a leading public health concern in Myanmar. However, people living in rural areas usually showed poor prevention practice despite residing in malaria hotspots. The majority in Myanmar are Buddhists who frequently visit the monastery and receive the speech delivered by the monks. In a malaria high burden township of the Sagaing Region from northern Myanmar, current study will first explore the difference in malaria preventive practices among people residing in different malaria-endemic villages through a mixed-methods approach. Next, this research will address the knowledge gaps by a monastery-based health education delivered by trained Buddhist monks using standardized health messages instruction for six consecutive months between August 2022 to January 2023. To test whether the intervention could balance those gaps among different groups, quantitative data of baseline, 3-month, and 6-month will be compared using descriptive statistics, chi-square test, T-test or repeated ANOVA, and the Difference-In-Differences (DID) analysis, as applicable.


Eligibility criteria: Inclusion Criteria:

For educational intervention; - voluntary participation

For questionnaire surveys;

* male or female household leaders or immediate family members
* aged \>18 years who had resided in the study villages for more than one year

Exclusion Criteria:

For questionnaire surveys;

- Individuals who were unable to communicate effectively or were under the influence of narcotics, including alcohol

Primary outcomes:
measure: Malaria knowledge and preventive practices
timeFrame: Pre intervention (July 2022), 3-month post-intervention (Dec 2022) and 6-month post-intervention (Mar 2023)
Secondary outcomes:
Other outcomes:
Locations:
city: Yangon
country: Myanmar
facility: Myanmar Health Network Organization
Study officials:
References:
Clinical trial NCT04728867: Comparison of Textbook Versus 3D Animation Versus Cadaveric Training Video in Teaching Laparoscopic Rectal Surgery
Official title: Comparison of Textbook Versus 3D Animation Versus Cadaveric Training Video in Teaching Laparoscopic Rectal Surgery: A Prospective Randomized Clinical Trial From Tertiary Care Center
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Educational Problems
Lead sponsor: Ankara University
Sponsor class: OTHER
First posted: 2021-01-28
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: prospective, randomized, blinded study
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Digital 3D animation and cadaveric videos have been increasingly used in surgical education and provide tremendous opportunity to develop new surgical educational tools, particularly during this Coronavirus-19 pandemic period.

This prospective, randomized, blinded study is designed to compare the educational effectiveness of various educational tools including the surgical textbook, animation, and cadaveric videos in laparoscopic rectal surgery among board-certificated surgeons. Initially, an electronic questionnaire assessing the knowledge about laparoscopic rectal surgery will be created and validated by the board-certificated colorectal surgeons. Exploratory and confirmatory factor analyses will be utilized to test the structure validity of the questionnaire. After the questionnaire will be sent to the graduates completing the general surgery residency program in Turkey, the volunteers will be then randomized into four groups based on the study material including a textbook, 3D animation, cadaveric video, and both 3D animation + cadaveric video. A step-by-step educational 3D animation and a cadaveric video will be prepared in order to teach the technical steps of laparoscopic rectal surgery. Volunteers in four groups were given 2 weeks to review their educational material. After the 2-weeks of the study period, the volunteers will be asked to answers the same electronic questionnaire imported in the edited live laparoscopic rectal surgery. Pre- and post-educational assessment of the questionnaire among the groups will be performed and compared.


Eligibility criteria: Inclusion Criteria:

* General surgeon who graduated at least 5 years ago from the residency
* General surgeon who is proficient to perform open rectal surgery
* General surgeon who was scrubbed in/assisted for laparoscopic rectal surgery
* General surgeon who is not able to perform laparoscopic rectal surgery by itself

Exclusion Criteria:

* None

Primary outcomes:
measure: Comparison of rectal cancer assessment scores among the groups before and after the education
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara University
Study officials:
affiliation: Ankara University
name: Cigdem Benlice
role: STUDY_DIRECTOR
References:
Clinical trial NCT03155867: Glycemic Response to Six Meal Replacements in Persons With Type 2 Diabetes Mellitus
Official title: Plasma Glucose and Insulin Response to Six Meal Replacements in Persons With Type 2 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes
Lead sponsor: Société des Produits Nestlé (SPN)
Sponsor class: INDUSTRY
First posted: 2017-05-16
Enrollment: 13
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief summary: This will be a randomized, cross-over design. Subjects will be randomized to one of six interventions on six separate study days, 1 week apart.


Eligibility criteria: Inclusion Criteria:

* Age 20-75 yrs
* Type 2 diabetes controlled with diet or diet and oral agent, with the exception of sulfonylureas such as glimepiride (Amaryl), glipizide (Glucotrol/Glucotrol XL) and glyburide (DiaBeta, Micronase, Glynase Prestabs); meglitinides such as reaglinide (Prandin) and nateglinide (Starlix); and alpha-glucosidase inhibitors such as acarbose (Precose) and miglitol (Glyset)
* Hemoglobin A1C less than 9.0%
* Fasting blood glucose less than 180 mg
* Hematocrit levels within normal limits

Exclusion Criteria:

* Abnormal thyroid function
* Creatinine \>2.0 mg/dL
* Potassium \<3.5 mEq/L
* Gastrointestinal disease: ulcer, gastritis, diarrhea, gastroparesis, vomiting
* Currently unstable diabetes or under treatment for cancer, heart disease, renal disease
* Unable to give informed consent or follow instructions
* Current insulin therapy or insulin therapy within the past month
* Patient who are pregnant
* Allergies to milk, soy or any component of the test product
* Patient who in the Investigators assessment cannot be expected to comply with treatment
* Currently participating or having participated in another clinical trial.
* Patients with Anemia

Primary outcomes:
measure: Area under the blood glucose curve (AUC 0-240)
timeFrame: Baseline, 10, 20, 30, 60, 90, 120, 150, 180, 210 and 240 minutes
Secondary outcomes:
measure: Area under the insulin curves (AUC 0-240)
timeFrame: Baseline, 10, 20, 30, 60, 90, 120, 150, 180, 210 and 240 minutes
measure: Insulinogenic index [Change in Ins30/Change in Glu30]
timeFrame: Baseline, 10, 20, 30, 60, 90, 120, 150, 180, 210 and 240 minutes
measure: AUC (0-30min) for insulin
timeFrame: Baseline, 10, 20, 30, 60, 90, 120, 150, 180, 210 and 240 minutes
Other outcomes:
Locations:
city: Tustin
country: United States
facility: Orange County Research Center
state: California
Study officials:
affiliation: Orange County Research Center
name: Joel Neutel, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00210067: A Study in Subjects With Retinal Detachment
Official title: A Double-Masked, Randomized, Dose-Ranging Study of a Single Intravitreal (IVT) Injection of INS37217 Intravitreal Injection in Subjects With Retinal Detachment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Retinal Detachment
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2005-09-21
Enrollment: 14
Standard ages: CHILD
ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this trial is to access the tolerability of INS37217 Intravitreal Injection when administered intravitreally in subjects with macula-on or macula-off rhegmatogenous retinal detachment (RRD).


Eligibility criteria: Inclusion Criteria:

* have macula-on or macula-off rhegmatogenous retinal detachment
* are eligible for pneumatic retinopexy, with identifiable retinal breaks
* are phakic or pseudo-phakic

Exclusion Criteria:

* have detachments not of a rhegmatogenous nature
* currently have blood in the vitreous, corneal opacity, or other conditions which limit the view of peripheral retina
* have evidence of intraocular inflammation (uveitis)
* have a history of current condition of uncontrollable, elevated IOP or open-angle glaucoma
* have breaks not conducive to a single procedure of pneumatic retinopexy treatment
* have proliferative vitreoretinopathy of type C or D
* have previously had a vitrectomy or require one
* have previously had a scleral buckle procedure

Primary outcomes:
measure: tolerability
Secondary outcomes:
measure: pharmacological activity
Other outcomes:
Locations:
Study officials:
name: Amy Schaberg, BSN
role: STUDY_DIRECTOR
References:
Clinical trial NCT05020067: Impact on Xerostomia for Nasopharyngeal Carcinoma Patients Treated With or Without Superficial Parotid Lobe-sparing Intensity-modulated Radiotherapy
Official title: Impact on Xerostomia for Nasopharyngeal Carcinoma Patients Treated With or Without Superficial Parotid Lobe-sparing Intensity-modulated Radiotherapy: a Prospective Phase II Clinical Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Nasopharyngeal Carcinoma
Radiation-induced Xerostomia
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2021-08-25
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This is a prospective phase II clinical randomized controlled study, the purpose of this study is to assess whether superficial parotid lobe-sparing intensity-modulated radiotherapy (SPLS-IMRT) can decrease the incidence of xerostomia versus conventional IMRT (C-IMRT) in NPC patients.


Eligibility criteria: Inclusion Criteria:1) newly diagnosed, histologically confirmed World Health Organization (WHO) type II-III NPC; 2) stage I-IVa (T1-4 N0-3M0) according to the staging system of the 8th American Joint Committee on Cancer/Union for International Cancer Control (AJCC/UICC); 3) no prior antitumor therapy; 4) no tumor involvement in salivary gland; 5) no parotid glands disorder and no history of parotid glands surgery; 6) ages between 18 and 70 years; 7) Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1, and 8) adequate organ function Exclusion Criteria: 1) used salivary stimulating or protecting agent; 2) metachronous or synchronous malignancy; 3) pregnancy or lactation; or 4) severe comorbidities. The pretreatment evaluation included a complete history and physical examination, nasopharyngoscopy, chest X-ray, complete blood count, liver and renal biochemistry, and magnetic resonance imaging (MRI) of the head and neck.

Primary outcomes:
measure: the incidence of xerostomia
timeFrame: 12 months
Secondary outcomes:
measure: xerostomia questionnaire score
timeFrame: 12 months
measure: Salivary flow rate
timeFrame: 12 months
measure: locoregional relapse-free survival
timeFrame: 36 months
measure: distant metastasis-free survival
timeFrame: 36 months
measure: overall survival
timeFrame: 36 months
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Sun Yat-sen University
state: Guangdong
Study officials:
References:
citation: Huang H, Miao J, Xiao X, Hu J, Zhang G, Peng Y, Lu S, Liang Y, Huang S, Han F, Deng X, Zhao C, Wang L. Impact on xerostomia for nasopharyngeal carcinoma patients treated with superficial parotid lobe-sparing intensity-modulated radiation therapy (SPLS-IMRT): A prospective phase II randomized controlled study. Radiother Oncol. 2022 Oct;175:1-9. doi: 10.1016/j.radonc.2022.07.006. Epub 2022 Jul 8.
Clinical trial NCT02694367: Expression of EPK in Recurrent Miscarriage
Official title: MAP Kinase Signaling Pathways Through ERK and p-ERK Protein in Human Placenta of Women With Recurrent Miscarriage
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Recurrent Miscarriage
Keywords: genetic basis
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2016-02-29
Enrollment: 39
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Women fulfilling the eligibility criteria had been tested and complete history and examination was done

Brief summary: The present study is based on hypotheses that some as yet unknown genetic factors may result in recurrent miscarriage (RM). Consequently, the main aim of this study was to gain new information about the underlying genetic causes of RM in the Egyptian population and to investigate the expression of ERK and p-ERK protein in human placenta and their corresponding tissue, to assess the significance of MAPK signal pathway in progression of recurrent miscarriage and PI3K-Akt Pathway.


Eligibility criteria: Inclusion Criteria:

1. Gestational age less than 12 weeks.
2. no uterine abnormalities (examined by ultrasonography or hysterosonogram)
3. previous history of RM, defined as two or more consecutive miscarriages

Exclusion Criteria:

1. Gestational age 12 weeks or more.
2. Endocrine etiology like (thyroid dysfunction, and uncontrolled diabetes mellitus).
3. Antiphospholipid syndrome, inherited thrombophilias, alloimmune causes.
4. Uterine anatomic anomalies

Primary outcomes:
measure: The levels of ERK and AKT in placenta
timeFrame: 48 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Ahmed Abbas
state: Cairo
Study officials:
References:
Clinical trial NCT05741567: Transobturator Repair by Vaginal Plastron
Official title: Transobturator Cystocele Repair by Vaginal Plastron
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anterior Prolapse Surgery Using the Transobturator Repair by Vaginal Plastron
Keywords: anterior prolapse
transobturator repair
vaginal plastron
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2023-02-23
Enrollment: 30
Sex: FEMALE
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: This study covers all patients who underwent surgery using the transobturator repair by vaginal plastron for correction of anterior prolapse between September 2020 and October 2022.

Brief summary: The autologous vaginal route consists of repairing the genital prolapse through the vagina using the patient's tissues without a prosthesis. Vaginal prostheses are actually currently prohibited in France \[1, 2\].

The autologous vaginal route is the quickest surgery and it can be done under spinal anesthesia, which constitutes arguments for offering it to elderly and fragile patients. The autologous vaginal approach gives functional and subjective results similar to promontofixation \[2\].

There are many surgical techniques that make it difficult to assess the recurrence rate in the literature. Autologous vaginal surgery provides a good degree of satisfaction for patients despite the risk of recurrence \[3\].

We propose to describe the results of the transobturator cystocele repair by vaginal plastron, a technique which seems reproducible and effective to us.


Eligibility criteria: Inclusion Criteria:

* women over 18
* patient who underwent surgery using the transobturator repair by vaginal plastron for correction of anterior prolapse requiring surgical correction of stage equal to or greater than II in the POP-Q classification
* intervention between September 2020 and October 2022
* person having expressed his non-opposition

Exclusion Criteria:

* inability to understand the information given
* person deprived of liberty
* person under guardianship

Primary outcomes:
measure: failed prolapse correction
timeFrame: at 1 month after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Lyon
country: France
facility: Hôpital Femme Mère Enfant
state: Bron
Study officials:
References:
Clinical trial NCT05624567: Symptoms and Quality of Life of Patients With Suspected Endometriosis
Official title: Symptoms and Quality of Life of Patients With Suspected Endometriosis - a Prospective Multi-center Observational Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Endometriosis
Surgery
Pain
Dysmenorrhea
Dyspareunia
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2022-11-22
Enrollment: 800
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women between 18 and 50 years of age undergoing surgery for suspected endometriosis.

Brief summary: All patients undergoing surgery due to suspected endometriosis in a previously selected 3-month period within the study period (between 12/2022 and 12/24) (each participating center will define the particular 3 months in question) will be asked to participate in this study. Upon inclusion, patients will be asked to fill out questionnaires regarding endometriosis-associated symptoms as well as a detailed patient history. Furthermore, patients will be asked to fill out 2 standardized questionnaires, one regarding quality of life (Endometriosis-Health Profile-30) and one regarding sexual function (Female Sexual Function Index). Six and 12 months after surgery, patients will again be asked to fill out these two standardized questionnaires as well as a questionnaire regarding postsurgical therapy and endometriosis-associated symptoms. The surgeon will be asked to fill out a form regarding the surgical procedure and possible surgical complications.

The primary endpoints of this multicenter observational study are to prospectively examine:

1. if the individual symptoms correlate with the individual compartments of the surgical #ENZIAN Endometriosis classification
2. if the surgical intervention has an effect on the quality of life in relation to the individual #ENZIAN compartments.


Eligibility criteria: Inclusion Criteria:

* Planned surgery for suspected endometriosis
* Age between 18 and 50
* signed informed consent

Exclusion Criteria:

* menopause
* current malignant disease

Primary outcomes:
measure: Symptom correlation with #ENZIAN
timeFrame: 12/2022-12/2024
measure: Endometriosis surgery and #ENZIAN - Correlation with quality of life?
timeFrame: 12/2022-12/2024
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05407467: KurCoSmart Effects on People With Type 2 DM
Official title: KurCoSmart Effects on People With Type 2 DM: a Randomized, Open Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Diabetes Mellitus, Type 2
Insulin Resistance
Inflammation
Body Weight
Keywords: curcumin
coconut oil
diabetes mellitus
Lead sponsor: Universitas Sebelas Maret
Sponsor class: OTHER
First posted: 2022-06-07
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The investigators aim to evaluate the effect of curcumin and virgin coconut oil extract supplementation on people with type 2 DM, including blood glucose, HbA1c levels, inflammation, body weight and insulin resistance evaluation

Detailed description: The investigators give Kurcosmart supplementation aside from diabetes standard treatment to evaluate its benefits on people with type 2 DM, considering its effect on controlling fasting and prandial blood glucose, reducing HbA1c level, controlling inflammation degree; and repairing insulin resistance

Eligibility criteria: Inclusion Criteria:

* Confirmed Type 2 DM
* Signing consent form

Exclusion Criteria:

* Pregnant or breastfeeding
* Multiple organ failure
* History of hypersensitivity reaction to curcumin and virgin coconut oil
* Cancer, renal insufficiency, hematological disease, acute heart failure, chronic liver disease

Primary outcomes:
measure: Blood glucose
timeFrame: Change of Blood glucose at 1 months
measure: Inflammation degree
timeFrame: Change of hs-CRP at 1 Months
measure: insulin resistance
timeFrame: Change of HOMA IR at 1 Months
measure: HbA1c
timeFrame: Change of HbA1C at 1 Months
Secondary outcomes:
measure: Body Mass Index
timeFrame: Change of BMI at 1 Months
measure: Blood Pressure
timeFrame: Change fof blood prssure at 1 Months
Other outcomes:
Locations:
city: Sukoharjo
country: Indonesia
facility: UNS Hospital
state: Central Java
Study officials:
References: