louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03588338: Paracetamol on Postoperative Nausea and Vomiting
Official title: The Effect of Paracetamol on Postoperative Nausea and Vomiting Following Maxillofacial Surgery: a Prospective, Randomised, Double-blind Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Postoperative Nausea and Vomiting
Keywords: PONV
Paracetamol
Lead sponsor: Aydin Adnan Menderes University
Sponsor class: OTHER
First posted: 2018-07-17
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The drugs with both high potency and low side effects are preferred in the prevention of postoperative nausea and vomiting (PONV) which is a common problem. This prospective randomized study aimed to compare the efficacy of paracetamol on PONV in adults undergoing maxillofacial surgery.

Detailed description: One hundred-twenty patients are randomly divided into two groups; the paracetamol group who received the IV infusion of paracetamol (1.5 ml/kg); and the metoclopramide group who received the IV infusion of saline (1.5 mg/kg). The presence of vomiting and the actions indicative of nausea, such as repeated gagging or spitting, within 24h following general anesthesia are defined as PONV. All PONV episodes and postoperative pain scores are recorded during 24h postoperatively. The postoperative 0-4h and 4-24h are defined as early and late postoperative period, respectively. Intravenous 4 mg ondansetron as rescue antiemetic drug is administered in case of two or more vomiting episodes.

Eligibility criteria: Inclusion Criteria:

* ASA (the classification of the American Society of Anesthesiologists) physical status I-II
* Patients who scheduled for elective maxillofacial surgery under general anesthesia

Exclusion Criteria:

* Patients with a history of allergy to any of the study medications (opioid, general anesthetic agents or paracetamol)
* History of opioid use, hepatic or renal disease, coronary, psychotic and neurologic diseases
* Use of antiemetic, antihistaminic, analgesic or corticosteroid 24 hours (h) prior to surgery

Primary outcomes:
measure: Preventing of postoperative nausea and vomiting
timeFrame: First 24 hours postoperatively
Secondary outcomes:
Other outcomes:
Locations:
city: Aydin
country: Turkey
facility: Ozlem Kocaturk
Study officials:
affiliation: Aydin Adnan Menderes University
name: Adnan Menderes University
role: STUDY_DIRECTOR
References:
citation: Cok OY, Eker HE, Pelit A, Canturk S, Akin S, Aribogan A, Arslan G. The effect of paracetamol on postoperative nausea and vomiting during the first 24 h after strabismus surgery: a prospective, randomised, double-blind study. Eur J Anaesthesiol. 2011 Dec;28(12):836-41. doi: 10.1097/EJA.0b013e32834c580b.
Clinical trial NCT05059938: MyFitnessPal Pilot Study
Official title: Promoting the Use of Free Smartphone App (MyFitnessPal) for Weight Loss by Primary Care Provider in Overweight Patients: A Randomized Controlled Pilot Study
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Weight Reduction
Lead sponsor: Geisinger Clinic
Sponsor class: OTHER
First posted: 2021-09-28
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This project is studying whether patients who use MyFitnessPal as an aid to weight loss have more success than patients who are only given traditional medical guidance from the patient's physician.

Detailed description: Patients will be given a survey determining the patient's eligibility to be part of the study. Based on the results patients will be consented and then randomized into two arms. The intervention group will download MyFitnessPal onto the patient's smartphone and given guidance on how to use the application in order to help with weight loss. The control group will receive traditional weight loss counseling from the physician. Both groups will have measurement recorded for weight, blood pressure, and waist circumference at the patient's initial visit. All patients will be asked to return to the clinic at no cost to the patient to have measurements recorded for the patient's weight, blood pressure, and waist circumference at 1 month, 3 months, and 6 months after the patient's initial visit. At the conclusion of the study, patients who were in the intervention group will be asked to take a final survey regarding the patient's use of the MyFitnessPal application.

Eligibility criteria: Inclusion Criteria:

* BMI\>/= 25
* Have a smart phone
* Patient is willing to lose weight

Exclusion Criteria:

* Do not have a smart phone
* pregnant (current, planned, or previous pregnancy within 6 months)
* have already seen a nutritionist
* on weight loss medication
* using outside weight loss programs
* lack interest in weight loss
* hemodialysis patient
* has a life expectancy less than 6 months

Primary outcomes:
measure: Rate of Weight Loss
timeFrame: 1-6 months
Secondary outcomes:
measure: Change in Waist Circumference
timeFrame: 1-6 months
measure: Change in Blood Pressure
timeFrame: 1-6 months
Other outcomes:
measure: Pre-Screen survey
timeFrame: First visit
measure: Post intervention survey
timeFrame: 3 to 6 months
Locations:
Study officials:
References:
Clinical trial NCT06873438: The Effect of Probiotics on the Improvement of Intestinal and Immune Function
Official title: A Study on the Safety and Effectiveness of Lactobacillus Delbrueckii Subsp. Bulgaricus LB42 in Improving Intestinal and Immune Functions
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Intestinal and Immune Function Improved
Lead sponsor: Wecare Probiotics Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2025-03-12
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Evaluate the effectiveness and safety of Lactobacillus delbrueckii subsp. bulgaricus LB42 as a food supplement compared to a placebo in improving intestinal and immune functions in healthy adults.


Eligibility criteria: Inclusion Criteria:

1. Age 18-45 years
2. Willing to undergo 3 follow-up visits during the intervention period
3. Willing to provide 2 blood, urine, and stool samples during the intervention period
4. Willing to self-administer one of the probiotics/placebo once daily during the intervention period
5. Good eyesight, able to read and write, and can wear glasses
6. Have good hearing and be able to hear and understand all instructions during the intervention

Exclusion Criteria:

1. Suffering from digestive disorders, mainly gastrointestinal disorders (celiac disease, ulcerative colitis, Crohn's disease)
2. Has a severe neurological condition (epilepsy, stroke, severe head trauma, meningitis within the past 10 years, brain surgery, brain tumor, prolonged coma - excluding general anesthesia)
3. Has received/is receiving treatment for the following psychiatric disorders: alcohol/drug/substance abuse dependence, schizophrenia, psychosis, bipolar disorder
4. Take medication for depression or low mood
5. Suffering from internal organ failure (heart, liver, or kidney failure, etc.)
6. Radiotherapy or chemotherapy in the past
7. Surgery/procedure under general anesthesia within the past three years, or planned to undergo a procedure/procedure under general anesthesia within the next 3 months during this trial
8. Have had hepatitis (hepatitis B, hepatitis C), HIV or syphilis in the past

Primary outcomes:
measure: Change in the concentration of LL-37 in feces before and after intervention.
timeFrame: Week 0 and Week 8
Secondary outcomes:
measure: Change in the composition of fecal microbiota before and after intervention.
timeFrame: Week 0 and Week 8
measure: Change in the concentration of calprotectin in feces before and after intervention.
timeFrame: Week 0 and Week 8
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05903638: A Pilot RCT: the Impact of a Virtual MBSR Course on Women With Primary Infertility
Official title: A Pilot RCT: the Impact of a Virtual MBSR Course on Women With Primary Infertility Seeking Fertility Treatment at a Single Centre
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Primary Infertility
Mental Health Issue
Quality of Life
Lead sponsor: One Fertility
Sponsor class: OTHER
First posted: 2023-06-15
Enrollment: 24
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Single-blinded pilot randomized control trial with control arm and intervention (virtual MBSR course).
Primary purpose: SUPPORTIVE_CARE

Brief summary: We plan to perform a pilot study in which women with primary infertility seeking an initial fertility consultation will be randomized into either a standard treatment group or an 8-week virtual Mindfulness-Based Stress Reduction (MBSR) program. Primary outcomes included retention and survey completion rates. Secondary outcomes included Beck Depression Inventory (BDI), Beck Anxiety Inventory (BAI), Perceived Stress Score (PSS), Fertility Problem Index (FPI), pregnancy rates, intention to pursue treatment and % pursuing treatment.


Eligibility criteria: Inclusion Criteria:

-Primary infertility and no prior fertility treatment

Exclusion Criteria:

* No internet access
* Non-English speaking
* History of suicidal ideation/intent, psychotic disorder, eating disorder, substance abuse or dependence, PTSD
* Psychotropic medication change in the previous month
* Previously seen at another fertility clinic
* Previous MBSR course
* Previous mindfulness meditation retreat

Primary outcomes:
measure: MBSR course participation rate
timeFrame: 8-weeks of MBSR course
measure: Survey completion rate
timeFrame: Randomization to 3-months after course completion
Secondary outcomes:
measure: Beck Depression Inventory
timeFrame: Randomization to 3-months after course completion
measure: Beck Anxiety Inventory
timeFrame: Randomization to 3-months after course completion
measure: Perceived Stress Scale
timeFrame: Randomization to 3-months after course completion
measure: Fertility Problem Inventory
timeFrame: Randomization to 3-months after course completion
measure: % involvement in fertility treatment
timeFrame: 3-months after course completion
measure: Pregnancy rates
timeFrame: 3-months after course completion
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: ONE Fertility
state: Ontario
Study officials:
affiliation: McMaster University, ONE Fertility
name: Mehrnoosh Faghih, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05813938: Assessment of Accuracy and Safety of LabTest Checker
Official title: Assessment of Accuracy and Safety of LabTest Checker - Clinical Evaluation of a Patient-centered Clinical Decision Support System Based on AI
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Abnormalities in the Blood Test Results
Keywords: laboratory test interpretation
artificial intelligence
clinical decision support system
clinical implementation
Lead sponsor: Labplus Sp. z o.o.
Sponsor class: INDUSTRY
First posted: 2023-04-14
Enrollment: 101
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 goal of this study is to assess performance of a new clinical decision support system named LabTest Checker in a cohort of adult patients reporting to the internal ward's emergency department. The main question it aims to answer is:

• how accurate and safe is LabTest Checker.

A set of blood laboratory tests will be ordered for each participant. Participants will use LabTest Checker to obtain an interpretation of their test results. The interpretation provided by LabTest Checker will then be compared with the interpretation given by an internal medicine specialist to assess the accuracy and safety of the tool.


Eligibility criteria: Inclusion Criteria:

* adult
* requires laboratory test investigation

Exclusion Criteria:

* under 18 years old
* pregnant
* no need for laboratory test investigation

Primary outcomes:
measure: accuracy
timeFrame: 7 days
measure: sensivity to emergency
timeFrame: 7 days
measure: sensivity to urgency
timeFrame: 7 days
measure: safety
timeFrame: 7 days
Secondary outcomes:
measure: reduction of unnecessary visits
timeFrame: 7 days
Other outcomes:
Locations:
city: Katowice
country: Poland
facility: Oddział Chorób Wewnętrznych i Chemioterapii Onkologicznej, Samodzielny Publiczny Szpital Kliniczny im. Andrzeja Mielęckiego Śląskiego Uniwersytetu Medycznego w Katowicach
Study officials:
References:
Clinical trial NCT00668538: Uptake of the Antifungal Miconazole and Effect on Estrogen Metabolizing Enzymes in Humans
Official title: Uptake of the Antifungal Miconazole and Effect on Estrogen Metabolizing Enzymes in Humans
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: Miconazole
CYP1A2
CYP3A4
Women
Healthy Subjects
Lead sponsor: University of Southern Denmark
Sponsor class: OTHER
Collaborators: name: Odense University Hospital
First posted: 2008-04-29
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study, is to study the uptake of the pharmaceutical antifungal miconazole when used as a vaginal suppository in young women. The investigators want to know if the uptake is big enough to cause a biological effect (effect on CYP1A2 and CYP3A4 activity).


Eligibility criteria: Inclusion Criteria:

* Woman
* Age 18-45 years
* Healthy
* Signed consent
* Written authority to the GCP-unit

Exclusion Criteria:

* Pregnancy
* Breast-feeding
* Hypersensitivity to miconazole
* Hypersensitivity to sodium ethyl parahydroxybenzoic acid(E219)
* Hypersensitivity to sodium propyl parahydroxybenzoic acid (E217)
* Using contraceptives with hormones
* Daily consumption of alcohol
* Daily use of medicine
* Participated in a clinical trial within the last 3 months

Primary outcomes:
measure: CYP1A2 and CYP3A4 activity measured as metabolite ratios of caffeine and quinidine, respectively
timeFrame: urine and blood collected day 4 and 8
Secondary outcomes:
measure: Detection of miconazole or metabolites in blood and urine
timeFrame: Blood and urine collected day 8
Other outcomes:
Locations:
city: Odense
country: Denmark
facility: Institute of Public Health, Clinical Pharmacology, University of Southern Denmark
Study officials:
References:
citation: Kjaerstad MB, Nielsen F, Nohr-Jensen L, Zwisler S, Brosen K, Andersen HR. Systemic uptake of miconazole during vaginal suppository use and effect on CYP1A2 and CYP3A4 associated enzyme activities in women. Eur J Clin Pharmacol. 2010 Dec;66(12):1189-97. doi: 10.1007/s00228-010-0906-2. Epub 2010 Oct 6.
Clinical trial NCT06530238: Comparative Study Between Russian And Exercise in Subjects With Flexible Flatfoot
Official title: Comparative Study Between Russian And Exercise in Subjects With Flexible Flatfoot
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Flat Feet
Lead sponsor: Deraya University
Sponsor class: OTHER
First posted: 2024-07-31
Enrollment: 30
Sex: ALL
Minimum age (years): 20
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The prevalence of flexible flat foot was 13.6% in adults a cross-sectional Study (for males-12.8%; for females-14.4%).18-21-year-old Indian adults. This trial aims to compare between the effects of Russian current for tibialis posterior muscle and comprehensive exercise alone in subjects suffering from flexible flat foot on quality of life, ROM, strength of tibialis posterior and foot posture


Eligibility criteria: Inclusion Criteria:

* The patient's age ranges from 20 to 25 years.
* Both genders.
* patients suffering from symptomatic flat foot

Exclusion Criteria:

* Rigid flatfoot.
* Pregnancy and lactation.
* recent fracture and fixation.
* genu valgus.
* cardiac pacemaker.
* inflammatory disorders / rheumatoid arthritis.

Primary outcomes:
measure: ROM (inversion and eversion).
timeFrame: 4 weeks
measure: Foot Posture Index (FP1-6)
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Minya
country: Egypt
facility: Deraya university
Study officials:
References:
Clinical trial NCT02641938: Effect of Intraoperative Dexmedetomidine on Development of Acute Kidney Injury
Official title: Effect of Intraoperative Dexmedetomidine on Development of Acute Kidney Injury Following Cytoreduction and Hyperthermic Intraperitoneal Chemotherapy: a Double-blind Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Malignant Tumor
Lead sponsor: Gangnam Severance Hospital
Sponsor class: OTHER
First posted: 2015-12-30
Enrollment: 38
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: To investigate the renal protective effect of dexmedetomidine in patients undergoing cytoreduction and hyperthermic intraperitoneal chemotherapy

Detailed description: A cytoreductive surgery and hyperthermic intraperitoneal chemotherapy may lead to the renal hypoperfusion, systemic inflammatory response, and oxidative stress. Dexmedetomidine has been known to protect the kidney against inflammation and oxidative stress in diverse clinical settings. It may also enhance a renal perfusion by inhibition of renal sympathoexcitation. We hypothesized administration of dexmedetomidine might protect the kidney in patients undergoing cytoreduction and hyperthermic intraperitoneal chemotherapy.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of malignant tumor with peritoneal metastasis
* Scheduled for elective cytoreduction and hyperthermic intraperitoneal chemotherapy

Exclusion Criteria:

* Preoperative chronic kidney disease stage ≥4 defined by KDOQI ( eGFR \< 30 mL/min/1.73m2)
* Congestive heart failure
* Atrioventricular block \> 1st degree
* Bradycardia \< 45 beat per minute
* History of myocardial infarction within 3 months
* Pregnancy

Primary outcomes:
measure: Change of Creatinine clearance from baseline
timeFrame: Postoperative day 1,2,3,4,5,6,7
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: GangnamSH
Study officials:
affiliation: Yonsei University Medical College Gangnam Severance Hospital
name: Ji-Young Kim, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Song Y, Kim DH, Kwon TD, Han DW, Baik SH, Jung HH, Kim JY. Effect of intraoperative dexmedetomidine on renal function after cytoreductive surgery and hyperthermic intraperitoneal chemotherapy: a randomized, placebo-controlled trial. Int J Hyperthermia. 2019;36(1):1-8. doi: 10.1080/02656736.2018.1526416. Epub 2018 Oct 25.
Clinical trial NCT00803738: Safety and Equivalence of a Terconazole Vaginal Suppository (Test Product) Compared to the Reference Terconazole Vaginal Suppository in the Treatment of Vulvovaginal Candidiasis
Official title: A Multi-center, Randomized, Investigator-blinded, Parallel-group Study, Designed to Evaluate the Safety and Clinical Equivalence of Terconazole Vaginal Suppositories, 80 mg (Test Product) and Terconazole Vaginal Suppositories, 80 mg (Reference Product) in the Treatment of Vulvovaginal Candidiasis Caused by Candida Species
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vulvovaginal Candidiasis
Keywords: Vulvovaginal Candidiasis
Terconazole
Lead sponsor: Padagis LLC
Sponsor class: INDUSTRY
First posted: 2008-12-08
Enrollment: 572
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objectives of this study were to demonstrate comparable safety and efficacy of Terconazole Vaginal Suppositories, 80 mg(Test Product) and Terconazole Vaginal Suppositories, 80 mg(Reference Product) in the treatment of subjects with vulvovaginal candidiasis in order to establish bioequivalence.


Eligibility criteria: Inclusion Criteria:

* Female at least 18 years of age
* Presented with symptomatic vulvovaginitis consistent with a diagnosis of moniliasis
* Willing and able to read and sign an IRB approved ICF, which included agreement to comply with all study requirements as indicated in the protocol.

Exclusion Criteria:

* History of hypersensitivity or allergy to imidazoles
* Female who was pregnant or lactating
* Was menstruating or expected the onset of menses during the treatment days
* Had evidence of any bacterial, viral or protozoal infection
* Had a history of alcoholism, drug abuse, or problems that would likely have made the subject unreliable for the study
* Had any condition or used any medication that, in the opinion of the Investigator, might have interfered with the conduct or results of the study or placed the prospective subject at increased risk
* Had participated in any investigational study within 30 days prior to study enrollment

Primary outcomes:
measure: Proportion of Subjects in Each Treatment Group With Therapeutic Cure
timeFrame: Visit 3: Day 22-31
Secondary outcomes:
measure: Proportion of Subjects With Mycological Cure
timeFrame: Visit 3: Day 22-31
measure: Proportion of Subjects With Clinical Cure
timeFrame: Visit 3: Day 22-31
Other outcomes:
Locations:
Study officials:
References: