louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04120259: Effect of Apple Cider Vinegar and Metformin Combination vs Metformin Alone in Type 2 Diabetics
Official title: Effect of Apple Cider Vinegar and Metformin Combination vs Metformin Alone in Type 2 Diabetics:A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Ziauddin University
Sponsor class: OTHER
First posted: 2019-10-09
Enrollment: 126
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: 'This study aims to compare the effect of Metformin alone vs Metformin plus Apple Cider Vinegar in newly diagnosed Type 2 Diabetic Patients

Detailed description: Diabetes Mellitus is one of the oldest diseases known to men and has been treated with multiple agents,organic and with the current pharmacological advancement,with multiple synthetic drugs as well.

Metformin has been considered first line for the treatment of Type 2 Diabetes, however presents itself with a side effect profile of GI distress, Vitamin B12 deficiency,to name a few.

Vinegar has been used as therapeutic agent for centuries for multiple ailments including diabetes. This study aims to evaluate the combined effects of drug and natural therapy and compare it with conventional therapy.

Eligibility criteria: Inclusion Criteria:

* Recently diagnosed Type 2 diabetic patients taking metformin 750 mg daily as the oral antidiabetic agent
* Patients with Hemoglobin A1c in the range of 6.5 to 7.5%

Exclusion Criteria:

* All newly diagnosed Diabetic Patients requiring a dosage other than 750 mg per day
* Patients on Insulin Therapy or any drugs for diabetes other than Metformin
* Pregnant and Lactating women
* Patients with food allergies to either apple or any source of vinegar
* Patients unable to communicate efficiently\\mentally challenged
* Type 2 Diabetic patients with any of the complications of long standing uncontrolled diabetes

Primary outcomes:
measure: BMI (Anthropometric Measurement)
timeFrame: 12 weeks
measure: Measurement of Hemoglobin A1c
timeFrame: 12 weeks
measure: Measurement of Fasting Blood Sugar
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Karachi
country: Pakistan
facility: Ziauddin University
state: Sindh
Study officials:
affiliation: Ziauddin University
name: Dr Momina Abid, MBBS,M Phil (ongoing)
role: PRINCIPAL_INVESTIGATOR
affiliation: Ziauddin University
name: Dr Zahida Memon, MBBS,M Phil,PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05742659: Effects of Developing a Mobile-based Interactive Simulation Scheme for Assisting the Personalized Hands-on Learning of Nasogastric Tube Insertion
Official title: Effects of Developing a Mobile-based Interactive Simulation Scheme for Assisting the Personalized Hands-on Learning of Nasogastric Tube Insertion: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nasogastric Tube Insertion
Lead sponsor: National Cheng-Kung University Hospital
Sponsor class: OTHER
First posted: 2023-02-24
Enrollment: 73
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: A mobile-based interactive simulation scheme (MISS) was proposed and developed to investigate its effects on facilitating hands-on learning of nasogastric tube insertion in undergraduate medical students.


Eligibility criteria: Inclusion Criteria:

* fifth-year undergraduate medical students
* at least 20 years old
* without any practical clinical experience

Exclusion Criteria:

Primary outcomes:
measure: The 10-item evaluation questionnaire on Nasogastric tube insertion knowledge
timeFrame: one week
measure: The self-confidence scale (C-scale)
timeFrame: one week
Secondary outcomes:
measure: System Usability Scale (SUS)
timeFrame: one week
measure: The NASA-TLX (Task load index)
timeFrame: one week
measure: The overall learning satisfaction
timeFrame: one week
measure: The OSCE (Objective Structured Clinical Examination) test
timeFrame: one week
Other outcomes:
Locations:
city: Tainan
country: Taiwan
facility: National Cheng Kung University Hospital
Study officials:
References:
Clinical trial NCT04849559: Effects of Tradipitant on Satiation, Gastric Volume, Gastric Accommodation, and Gastric Emptying in Healthy Volunteers
Official title: VP-VLY-686-1301: A Single Center, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Effects of Tradipitant on Satiation, Gastric Volume, Gastric Accommodation and Gastric Emptying in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Healthy Volunteer
Keywords: tradipitant
NK-1 antagonist
neurokinin 1 receptor
Lead sponsor: Vanda Pharmaceuticals
Sponsor class: INDUSTRY
Collaborators: name: Mayo Clinic
First posted: 2021-04-19
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A single center, randomized, double-blind, placebo-controlled study to evaluate the effects of tradipitant on satiation, gastric volume, gastric accommodation and gastric emptying in healthy volunteers
Primary purpose: BASIC_SCIENCE

Brief summary: To evaluate the effects of tradipitant relative to placebo on satiation, gastric volume, gastric accommodation, and gastric emptying in healthy volunteers.


Eligibility criteria: Inclusion Criteria:

* Able to provide written consent
* Body Mass Index (BMI) of 18-35 kg/m2
* No medical problems or chronic diseases

Exclusion Criteria:

* Diagnosis of gastrointestinal diseases
* Structural or metabolic diseases that affect the GI system
* A positive test for drugs of abuse at screening

Primary outcomes:
measure: Fasting Gastric Volume as Measured by Single Photon Emission Computed Tomography (SPECT)
timeFrame: 9 Days
measure: Accommodation Volume as Measured by SPECT
timeFrame: 9 Days
measure: Satiation Expressed as Volume to Fullness as Measured by Satiation Test
timeFrame: 9 Days
measure: Gastric Emptying Half-time of Solids as Measured by Scintigraphy
timeFrame: 9 Days
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Vanda Investigational Site
state: Minnesota
Study officials:
affiliation: Vanda Pharmaceuticals
name: Vanda Pharmaceuticals
role: STUDY_DIRECTOR
References:
citation: Khanna L, Zheng T, Atieh J, Torres M, Busciglio I, Carlin JL, Xiao M, Harmsen WS, Camilleri M. Clinical trial: a single-centre, randomised, controlled trial of tradipitant on satiation, gastric functions, and serum drug levels in healthy volunteers. Aliment Pharmacol Ther. 2022 Jul;56(2):224-230. doi: 10.1111/apt.17065. Epub 2022 May 29.
Clinical trial NCT03844659: Music's Effects on Anxiety During Epidural Placement
Official title: A Randomized Controlled Trial of Playing "The Most Relaxing Song in the World" During Labor Epidural Placement and Its Effects on Anxiety and Satisfaction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety
Satisfaction
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
First posted: 2019-02-18
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The objective of the study is to determine if playing the song "Weightless" by Marconi Union during labor epidural placement, decreases laboring parturient anxiety and improves satisfaction with the experience.


Eligibility criteria: Inclusion Criteria

* Females ages 18 years and older committed to delivery by the obstetrical team (natural labor or induction of labor)
* English speaking
* Able to give informed consent
* Having an epidural placed Exclusion Criteria
* Patient refusal
* Intrauterine fetal demise
* Imminent delivery
* Existing music use

Primary outcomes:
measure: Mean Score of Anxiety Before Epidural Placement
timeFrame: Immediately prior to procedure
measure: Mean Score of Anxiety After Epidural Placement
timeFrame: Immediately after procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
Study officials:
References:
Clinical trial NCT06109259: Bioequivalence Study for the Safety and the Pharmacokinetics of DWJ1567 in Healthy Adult Volunteers
Official title: An Open-label, Randomized, 2x4 Crossover Study to Compare the Pharmacokinetics and Safety Following Administration of DWJ1567 and DWC202312 in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Healthy Volunteers
Lead sponsor: Daewoong Pharmaceutical Co. LTD.
Sponsor class: INDUSTRY
First posted: 2023-10-31
Enrollment: 44
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This study aims to compare the pharmacokinetics and safety following administration of DWJ1567 and DWC202312 in healthy volunteers

Detailed description: The study design is a Randomized, Open-label, Oral, Single-dose, Four-way crossover study. The patients were randomly assigned to each group. Primary endpoint was Cmax and AUCt of DWJ1567 and DWC202312. Secondary endpoints were AUCinf, Tmax, t1/2 of DWJ1567 and DWC202312.

Eligibility criteria: Inclusion Criteria:

* Over 19 year old

Exclusion Criteria:

* Galactose intolerance
* Lapp lactase deficiency

Primary outcomes:
measure: Cmax,ss of DWJ1567 and DWC202312
timeFrame: At pre-dose (0 hour), and post-dose 0 to 72 hour.
measure: AUCt of DWJ1567 and DWC202312
timeFrame: At pre-dose (0 hour), and post-dose 0 to 72 hour.
Secondary outcomes:
measure: AUCinf of DWJ1567 and DWC202312
timeFrame: At pre-dose (0 hour), and post-dose 0 to 72 hour
measure: Tmax of DWJ1567 and DWC202312
timeFrame: At pre-dose (0 hour), and post-dose 0 to 72 hour
measure: AUCt/AUCinf of DWJ1567 and DWC202312
timeFrame: At pre-dose (0 hour), and post-dose 0 to 72 hour
measure: t1/2 of DWJ1567 and DWC202312
timeFrame: At pre-dose (0 hour), and post-dose 0 to 72 hour
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: H Plus YANGJI Hospital
Study officials:
References:
Clinical trial NCT06014359: Preoperative Nebulized Dexmedetomidine on Hemodynamic Changes in Laparoscopic Bariatric Surgery.
Official title: Effect of Preoperative Nebulized Dexmedetomidine on Hemodynamic Changes in Morbidly Obese Patients Undergoing Laparoscopic Bariatric Surgery.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Dexmedetomidine
Hemodynamics
Laparoscopic Bariatric Surgery
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2023-08-28
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This randomized study aims to evaluate the effect of preoperative dexmedetomidine nebulization on blunting hemodynamic response for laryngoscope, intubation and pneumoperitoneum in morbidly obese patients undergoing laparoscopic bariatric surgery.

Detailed description: Dexmedetomidine is an α -2 adrenergic agonist that has been proven to attenuate the hemodynamic response to intubation and pneumoperitoneum along with dose sparing effect on opioids and propofol .It has been used in multiple routes such as intravenous, intramuscular, oral, nasal, or intrathecal routes .Inhalation of nebulized drug is noninvasive and associated with high bioavailability .Nebulized Dexmedetomidine may offer an attractive alternative to both intravenous as well as intranasal routes of administration because drug deposition following nebulization takes place over nasal, buccal, as well as respiratory mucosa.

Eligibility criteria: Inclusion Criteria:

* This study will include 90 adult morbidly obese patients of both sex with BMI (40-50), (ASA) III physical status, aged between 18 -50 years scheduled for elective laparoscopic bariatric surgery under general anesthesia.

Exclusion Criteria:

1. Patient's refusal.
2. Decompensated hepatic or renal or cardiac disease.
3. Expected difficult airway management.
4. Uncontrolled hypertension.
5. Psychiatric disease.
6. Sever pulmonary disorders.
7. Patients on opioid, alcohol, beta-blockers or allergy to any of the study drugs.

Primary outcomes:
measure: Hemodynamic response to laryngoscope, and pneumoperitoneum.
timeFrame: Intraoperative
Secondary outcomes:
measure: Degree of sedation
timeFrame: Just after nebulization
measure: Amount of opioid consumption
timeFrame: 24 hours postoperative
measure: Amount of fentanyl consumption
timeFrame: Intraoperative
measure: Postoperative pain
timeFrame: 24 hours postoperative
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Tanta University
state: ElGharbia
Study officials:
affiliation: Resident of Anesthesiology, Surgical Intensive Care and Pain Medicine, Faculty of Medicine, Tanta University, Tanta, Egypt.
name: Abdelhamed I Badreldin, MBBCH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05642559: Study for the Development and Validation of Chronic Cough Patient Perspective Questionnaire
Official title: Retrospective and Prospective Observational Study for the Development and Validation of Chronic Cough Patient Perspective Questionnaire
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Cough
Lead sponsor: Ospedale Policlinico San Martino
Sponsor class: OTHER
First posted: 2022-12-08
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients (\>18 years) suffering from RCC (Residual Cough VAS:\>10/100 mm)

Brief summary: Starting from Chronic Cough Impact Querstionnaire (CCIQ), of which we are the authors and copyright holders, it will be developed and validated a shortened version with psychometric properties allowing the use in the evaluation of single patient (Chronic Cough Patient Perspective).

The CCPP will allow to unmask the problem, reduce underdiagnosis, increase awareness on chronic cough, measure the impact of the chronic cough and its treatments on the patient's life.


Eligibility criteria: Inclusion Criteria:

diagnosis of RCC (Residual Cough VAS:\>10/100 mm) according to ERS guidelines

Exclusion Criteria:

difficulty in understanding the italian language in both spoken and written form

Primary outcomes:
measure: Chronic Cough Impact Questionnaire (CCIQ)
timeFrame: february 2023
Secondary outcomes:
measure: Chronic Cough Impact Questionnaire (CCIQ)
timeFrame: August 2023
Other outcomes:
Locations:
city: Genova
country: Italy
facility: IRCCS San Martino
Study officials:
References:
Clinical trial NCT02133859: Adaptive Servo-ventilation Monitoring Study
Official title: Feasibilty of Respiratory Monitoring With Adaptive Servoventilation (PaceWave™) to Predict Worsening of Heart Failure in Patients With Severe Heart Failure and Sleep-disordered Breathing
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Heart Failure
Lead sponsor: ResMed
Sponsor class: INDUSTRY
First posted: 2014-05-08
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Chronic Heart Failure patients using adaptive servo ventilation

Brief summary: Sleep disordered breathing is very common in patients with chronic heart failure with reported prevalence rates of 50-75%. Adaptive Servo-Ventilation (ASV) can be used to treat sleep apnea in these patients. This is an observational study to document changes in respiratory parameters in HF patients using ASV for a period of 12 months.


Eligibility criteria: Inclusion Criteria:

More than 18 years old Chronic heart failure (at least 12 weeks since diagnosis) according to the currently applicable guidelines NYHA Class III or IV at the time of inclusion with at least one hospitalization for heart failure in the last 12 months Moderate to severe sleep apnea (AHI ≥ 15/hour). Already using or willing to use ASV-therapy and able to tolerate the mask treatment

Exclusion Criteria:

Planned or scheduled heart valve interventions and/or CABG Untreated or therapy refractory Restless Leg Syndrome Patients for whom the use of positive airway pressure therapy may be contra-indicated because of symptomatic hypotension or significant intravascular volume depletion or pneumothorax or pneumomediastinum Pregnancy

Primary outcomes:
measure: Correlation of hypoxemia, as measured by overnight pulse oximetery, with worsening heart failure
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Bad Oeynhausen
country: Germany
facility: Sleep Laboratory, Ruhr University of Bochum
state: North Rhine-Westphalia
Study officials:
affiliation: Ruhr University of Bochum
name: Olaf Oldenburg, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01424059: Induction of Women With Fear of Labor
Official title: Planned Induction of Women With Fear of Labor and Evaluation of the Experience of Delivery
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Fear
Keywords: fear
labor
induction
amniotomy
WEDQ-B
parous
cesarean section
Lead sponsor: Uppsala University Hospital
Sponsor class: OTHER
First posted: 2011-08-26
Enrollment: 250
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Parous women with cercvical status allowing amniotomy as method for induction. Parous women planned for cesarean section.

Brief summary: The purpose of this study is to evaluate the experience of labor in parous women induced because of fear of labor and, to compare the experience of parous women induced without fear of labor. A comparison with the experience of women delivered with elective cesarean section because of fear of labor is done.

In the induced labors, the induction method is amniotomy. Between groups the experience of delivery is evaluated with a questionnaire: Wijma Delivery Expectancy Questionnaire(WEDQ-B).

Groups are also compared with regard to time from induction to delivery and rate of operative delivery.

Hypotheses:

* there is no difference in experience of delivery
* there is no difference in time to delivery or rate of operative deliveries


Eligibility criteria: Inclusion Criteria:

* parous
* induction or cesarean section
* amniotomy

Exclusion Criteria:

* non proficiency in the Swedish language

Primary outcomes:
measure: experience of delivery
timeFrame: Within 48 hours after delivery
Secondary outcomes:
measure: Operative delivery
timeFrame: within 48 hours
Other outcomes:
Locations:
city: Uppsala
country: Sweden
facility: Department of Obstetrics and Gynecology, Akademiska hospital
Study officials:
References:
Clinical trial NCT03200470: The Utility of Next-generation Sequencing for the Diagnosis of Periprosthetic Joint Infection
Official title: The Utility of Next-generation Sequencing for the Diagnosis of Periprosthetic Joint Infection
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Prosthetic Joint Infection
Lead sponsor: Rothman Institute Orthopaedics
Sponsor class: OTHER
First posted: 2017-06-27
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Samples will be collected from subjects undergoing revision for suspected infection. Data analysis will occur on samples collected

Brief summary: This is a prospective multicenter study. All patients presenting for revision hip or knee arthroplasty for all indications under the respective surgeon's care may be eligible. Per standard of care preoperatively, all patients must have blood drawn for erythrocyte sedimentation rate(ESR), C-reactive protein(CRP) and D-dimer. Aspiration of the joint in question may be performed at the discretion of the treating surgeon and results documented. Intraoperative samples will also be collected and sent for NGS analysis

Detailed description: Pre-operative D-dimer testing should be performed if this is in keeping with the local institutional standard of care. Otherwise, D-dimer testing will be omitted from the pre-operative panel of tests collected.

NGS results will be made available to the Investigator. Treatment will remain within keeping with the Investigator's standard of care. NGS results may be used at the discretion of the treating surgeon in guiding patient treatment.

Eligibility criteria: Inclusion Criteria:

1. Patients undergoing primary total hip or knee arthroplasty with no history of prior surgery
2. Patients undergoing revision hip or knee arthroplasty for septic or aseptic indication.

Exclusion Criteria:

1. Patients undergoing second stage re-implantation surgery for PJI.

Primary outcomes:
measure: NextGeneration Sequencing analysis concordance with Muskuloskeletal Infection Society (MSIS) criteria for defining infection
timeFrame: Immediate post-operative period (usually within 5 days following surgery)
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Rothman Institute
state: Pennsylvania
Study officials:
affiliation: Rothman Institute
name: Tiffany Morrison, MS, CCRP
role: STUDY_CHAIR
References: