louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00778011: Uncomplicated Nausea and Vomiting in the Emergency Department
Official title: Ondansetron 4 mg vs. 2 mg vs. Metoclopramide 10 mg for Nausea and Vomiting in the Emergency Department: A Randomized, Double-Blind Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Nausea
Vomiting
Keywords: Nausea
Vomiting
Ondansetron
Metoclopramide
Randomized
Double-Blind
nausea and vomiting in the emergency department
Lead sponsor: WellSpan Health
Sponsor class: OTHER
First posted: 2008-10-23
Enrollment: 137
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: Nausea and vomiting is a common complaint in the emergency department. Treatment is important for many reasons. In addition to patient comfort, there are adverse effects secondary to vomiting such as dehydration, metabolic alkalosis, Mallory-Weiss tears, and aspiration. Two mediations common used for nausea in ED patients include Ondanesetron and Metoclopramide.

Detailed description: This study will compare Ondansetron 4 mg vs 2 mg vs Metoclopramide 10 mg to look for efficacy in nausea and vomiting treatment for patients in the ED with many different causes. We will also look for cost effectiveness as well, since Metoclopramide is much less expensive than Ondansetron, which is less expensive at lower doses. There is little research about nausea medication in the ED literature even though these medications are used frequently in the ED for many causes of nausea.

Eligibility criteria: Inclusion Criteria:

* 18 years or older with nausea and at least 1 episode vomiting in the last 12 hours presenting to the York Hospital Emergency Department

Exclusion Criteria:

* Patients known to have hypersensitivity to the drugs ondansetron or metoclopramide
* gastrointestinal hemorrhage, mechanical obstruction or perforation
* patients with pheochromocytoma
* seizure disorder
* patients receiving other drugs which are likely to cause extrapyramidal reactions such as butapherones and phenothiazines
* patients experiencing hyperemesis gravidum
* patients unable to understand the informed consent (intoxicated, Spanish speaking)
* prior antiemetics within 12 hours
* inability to perform visual analog scale
* renal dialysis

Primary outcomes:
measure: To delineate whether a high vs low dose of Ondansetron in better as opposed to an alternate medication -- Metoclopramide in the ED setting for uncomplicated nausea and vomiting.
timeFrame: 30 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: York
country: United States
facility: York Hospital
state: Pennsylvania
Study officials:
affiliation: York Hospital Emergency Department Physician
name: Marc Pollack, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01680211: Safety and Efficacy Study of Herbal Supplements in Prediabetic and Mild to Moderate Hyperlipidemic Patients
Official title: Efficacy and Safety Study of Herbal Supplements (SR-L-01, SR-B-01 and SI-S-01) in the Management of Prediabetes and Mild to Moderate Hyperlipidemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prediabetes
Hyperlipidemia
Keywords: Blood Sugar,
Lipoproteins,
Salacia,
Sesame,
Prediabetes,
Hyperlipidemia,
Herbal supplement
Lead sponsor: Olive Lifesciences Pvt Ltd
Sponsor class: INDUSTRY
First posted: 2012-09-07
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: PARALLEL
Primary purpose: PREVENTION

Brief summary: Objective of this study is to determine the safety and efficacy of administration of herbal supplements (Salacia leaf extract, Salacia root extract and Sesame seed extract) for 6 weeks in the management of prediabetes and mild to moderate hyperlipidemia.


Eligibility criteria: Inclusion Criteria:

1. As per ATP III guidelines: Baseline LDL ranging 160-189 mg/dL, TC \>200 mg/dL and with no or one of the below risk factors

   * Current cigarette smoking
   * Family history of premature Coronary Heart Disease(CHD); in male first degree relative \<55 years; in female first degree relative \<65 years)
   * Hypertension (BP \>140/90 mmHg or on antihypertensive medication)
   * Low HDL-C (\<40 mg/dL)
   * Age (men \> 40 years)
2. Impaired glucose tolerance (2-hour post 75 g OGTT glucose levels in the range of ≥140 to ≤ 200 mg/dL)
3. Impaired fasting sugar (Fasting blood sugar levels in the range of ≥ 100 to ≤125 mg/dL)
4. Being mentally competent and able to understand all study requirements and sign the informed consent form.

Exclusion Criteria:

1. Patients with severe liver, renal, cardiac or brain diseases.
2. Pregnant or lactating women or women of child bearing potential whom are not practicing a reliable form of birth control (either with IUD or with stable usage of oral contraceptives).
3. Unable to complete follow up.
4. Subjects on any medication that would affect evaluation like Statins.

Primary outcomes:
measure: Change in Blood Sugar and lipid profiles
timeFrame: baseline and 6 weeks
Secondary outcomes:
measure: Clinical laboratory evaluations
timeFrame: 0 and week 6
Other outcomes:
Locations:
city: Bangalore
country: India
facility: Srinivasa Clinic & Diabetic Care Center
state: Karnataka
Study officials:
affiliation: Srinivasa Clinic & Diabetic Care Center
name: K R Raveendra, M.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05818111: Comparison of Different Volume of Steroid Hydrodilatation in Treating Patients With Adhesive Capsulitis
Official title: Comparison of Different Volume of Steroid Hydrodilatation in Treating Patients With Adhesive Capsulitis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Adhesive Capsulitis
Keywords: adhesive capsulitis
Lead sponsor: Taipei Veterans General Hospital, Taiwan
Sponsor class: OTHER_GOV
First posted: 2023-04-18
Enrollment: 86
Sex: ALL
Minimum age (years): 35
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 was conducted to compare the efficacy of low volume steroid hydrodilatation with high volume steroid hydrodilatation under ultrasonographic guidance for treating adhesive capsulitis

Detailed description: adhesive capsulitis is a common cause of shoulder pain, and the efficacy of most interventions is limited. This study was conducted to compare the efficacy of low volume steroid hydrodilatation with high volume steroid hydrodilatation under ultrasonographic guidance for treating adhesive capsulitis Design: a prospective, double-blinded, randomized, clinical trial

Patient and methods:

Patients with adhesive capsulitis for at least 3 months were enrolled and randomly allocated into group 1 (10cc steroid hydrodilatation under ultrasonographic guidance ) and group 2 (20cc steroid hydrodilatation). The patients were evaluated before treatment and were reevaluated 0, 6, and 12 weeks after the beginning of the treatment. Outcomes measures included a pain scale (visual analog scale), range of motion, Shoulder Pain And Disability Index

Eligibility criteria: Inclusion Criteria:

1) age 35-65 years (to prevent the inclusion of patients with secondary AC), 2) onset of shoulder stiffness since over a month, and 3) limitation in the passive range of motion (ROM) over 30° when compared with the contralateral side in at least two of these three movements: forward flexion, abduction, or external rotation.

Exclusion Criteria:

1. ultrasound findings of rotator cuff tears, 2) plain radiography findings of significant glenohumeral joint arthritis, 3) accompanying cervical radiculopathy, 4) systemic inflammatory joint disease, 5) intraarticular injection into the glenohumeral joint within the past 3 months, 6) history of surgery on the affected shoulders, 7) regular use of systemic non-steroidal anti-inflammatory drugs or corticosteroids, and 8) allergy to corticosteroid or lidocaine.

Primary outcomes:
measure: change in visual analog scale visual analog scale
timeFrame: at 6, 12 wk
Secondary outcomes:
measure: change in glenohumeral joint range of motion
timeFrame: at 6, 12 wk
measure: change in Shoulder Pain And disability index
timeFrame: at 6, 12 wk
measure: change in pain intensity
timeFrame: at 6, 12 wk
Other outcomes:
Locations:
city: Taipei City
country: Taiwan
facility: Taipei Veterans General Hospital
Study officials:
References:
Clinical trial NCT06778811: Clinical Study of Perioperative Sleep Disorders in Cardiac Surgery
Official title: Clinical Study of Perioperative Sleep Disorders in Cardiac Surgery
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Sleep Wake Disorders
Esketamine and the Quality of Recovery
Dexmedetomidine
Lead sponsor: Nanjing First Hospital, Nanjing Medical University
Sponsor class: OTHER
First posted: 2025-01-16
Enrollment: 180
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The aim of this clinical trial is to understand the effects of dexmedetomidine and esketamine on postoperative sleep in patients undergoing cardiac surgery. The main questions it aims to answer are:

Does dexmedetomidine or esketamine prevent the development of postoperative sleep disturbances? Which one works better? The researchers compared dexmedetomidine and esketamine with saline (a drug-free solvent) to see if dexmedetomidine and esketamine prevented the development of postoperative sleep disturbances.

Participants will:

1. Intraoperative continuous infusion of dexmedetomidine, esketamine or saline until the end of surgery
2. Postoperative sleep was assessed on the first and third postoperative days using a sleep rating scale


Eligibility criteria: Inclusion Criteria:

1. ASA class II-III, NYHA class I-III, EF ≥ 50%
2. Intended to perform cardiac surgery under extracorporeal circulation

Exclusion Criteria:

1. Patients undergoing second heart surgery
2. Patients with mental retardation, deafness, or other conditions that interfere with normal communication
3. Previous neurological or psychiatric disorders
4. Patients with a history of sleep disorders
5. Alcoholics, drug addicts, or psychotropic substance abusers
6. Significant hepatic or renal dysfunction affecting drug metabolism
7. Contraindication to the use of dexmedetomidine or esketamine.

Primary outcomes:
measure: Sleep Quality
timeFrame: 1, 3, 7days after surgery
Secondary outcomes:
measure: postoperative pain
timeFrame: 24 hours and 48 hours after surgery
measure: Record postoperative analgesic medications used and the amount used for postoperative pain
timeFrame: 24 hours and 48 hours after surgery
measure: anxiety and depression assessment
timeFrame: 1,3 days after surgery
measure: Postoperative complications
timeFrame: 48 hours after surgery
measure: Postoperative delirium
timeFrame: from 1 day to 7 days after surgery
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Nanjing First Hospital
state: Jiangsu
city: Nanjing
country: China
facility: Nanjing First Hospital，Nanjing Medical University
state: Jiangsu
Study officials:
References:
Clinical trial NCT04160611: What Amount of Stress is Enough for a Successful Conception?
Official title: Impact of Premedication With Midazolam in Aspiration Procedures On Stress Levels During IVF Procedures
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: In Vitro Fertilization
Stress
Midazolam Adverse Reaction
Stress, Emotional
Keywords: IVF
stress
midazolam
premedication
Lead sponsor: University Hospital Sestre Milosrdnice
Sponsor class: OTHER
First posted: 2019-11-13
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two randomized groups receiving midazolam/not receiving midazolam premedication before oocyte aspiration procedures as part of IVF procedures
Primary purpose: TREATMENT

Brief summary: The aim of the study is to determine whether premedication with midazolam before oocyte aspiration in IVF procedures affects the amount of (oxidative) stress in women undergoing IVF and whether stress is also transmitted to the follicular fluid of aspirated follicles. The primary endpoint is the impact of stress during aspiration on the success of medically assisted fertilization (IVF / ICSI in the stimulated cycle).

Detailed description: The procedure of in vitro fertilisation (IVF) is used to treat the infertility problems. The procedure includes ovary aspiration, to isolate oocytes. During the aspiration the patient is sedated with short-term intravenous aesthetic. Premedication is often used in anaesthesiology, and includes drugs application 30 minutes prior to procedure to sedate and treat the anxieties of the patient. One of the most often used drugs in premedication is midazolam. As the procedure is quite stressful for the patients, our aim is to investigate the influence of midazolam premedication on the stress release during the oocyte aspiration procedure, as well as its influence on the whole IVF procedure. Therefore, patients will be divided into two groups, control and midazolam. Blood samples will be taken before and during the procedure. Stress, antioxidant parameters (with glutathione and catalase) and oxidative status will be monitored in serum and follicular fluid.

The results will be correlated with subjective stress levels in the two groups in an effort to establish ties with IVF results.

Eligibility criteria: Inclusion Criteria:

* Informed consent, healthy women undergoing IVF procedures for the first time

Exclusion Criteria:

* Refusal to enroll, chronic endocrine and psychiatric illnesses that might affect baseline stress levels

Primary outcomes:
measure: Stress Levels in Premedicated Women
timeFrame: 3 hours post-surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Zagreb
country: Croatia
facility: University Hospital Center Sestre milosrdnice
Study officials:
affiliation: Department of Gynecology and Obstetrics, University Hospital Center Sestre milosrdnice, Zagreb, Croatia
name: Vesna Košec, MD, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT00281411: Follow-up of Endovascular Aneurysm Treatment - The FEAT Trial
Official title: Follow-up Study of Endovascular Abdominal Aortic Aneurysm Treatment
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Aortic Aneurysm, Abdominal
Keywords: Blood Vessel Prosthesis Implantation
Endovascular aneurysm repair
Magnetic Resonance Angiography
Computed Tomography Angiography
Endoleak
Lead sponsor: UMC Utrecht
Sponsor class: OTHER
First posted: 2006-01-24
Enrollment: 46
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient planned for endovascular abdominal aortic aneurysm repair

Brief summary: After endovascular abdominal aortic aneurysm repair, life-long follow-up is needed to monitor the effectiveness of exclusion of the aneurysm sac from blood flow. For this reason, aneurysm diameter and the presence of endoleaks is evaluated with CT angiography yearly after Endovascular Aneurysm Repair (EVAR).

The aim of this study is to investigate the value of MRA examinations for the follow-up of these patients. The advantages of MRA with respect to CTA are no use of ionizing radiation, use of less nephrotoxic contrast agents.

Detailed description: The FEAT trial (Follow-up of Endovascular Aneurysm Treatment) is designed as a prospective, single-center, follow-up study. 100 Patients will be enrolled in this study. These patients will undergo additional MRA-examinations the day before EVAR, the day after EVAR, 6 months and 1 year after EVAR. These patients also participate in the conventional CTA follow-up scheme which comprises a pre- and post-operative CTA and a CTA yearly thereafter. Coagulation parameters in the blood will be measured before and 1 year after EVAR.

Eligibility criteria: Inclusion Criteria:

* Patient is planned for endovascular abdominal aortic aneurysm repair

Exclusion Criteria:

* contraindication for MRI examination

  * claustrophobia
  * pacemaker
  * other non-MRI compatible implants

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Utrecht
country: Netherlands
facility: UMC Utrecht
Study officials:
affiliation: UMC Utrecht
name: W. Mali, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05170711: Hypotensive Anesthesia With Sleeve Gastrectomy
Official title: the Effect of Hypotensive Anesthesia With Sleeve Gastrectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity, Morbid
Lead sponsor: Minia University
Sponsor class: OTHER
First posted: 2021-12-28
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: to do sleeve gastrectomy under hypotensive anesthesia till compete stapling then hypertensive at the end

Detailed description: to do sleeve gastrectomy under hypotensive anesthesia till compete stapling then hypertensive at the end of the operation to check bleeding

Eligibility criteria: Inclusion Criteria:

* obese patients with BMI more than 40 or more than 35 with comorbidity
* patients fit for laparoscopic surgery
* give approval to share in the study

Exclusion Criteria:

* patients refused to share in the study
* patients unfit for surgery
* patients aged less than 18 and older than 50
* patients with BMI less than 35
* patient with previous upper abdominal surgery either for obesity or other diseases
* patients with GERD

Primary outcomes:
measure: operative time
timeFrame: 20-120 minutes
measure: intraoperative bleeding or oozing
timeFrame: 0-120 minute
Secondary outcomes:
measure: postoperative bleeding
timeFrame: 2-36 hours
Other outcomes:
Locations:
city: Minya
country: Egypt
facility: Faculty of medicine
Study officials:
References:
Clinical trial NCT01057511: Compare the Difference of P4 Concentration in Serum and Endometrium After Vaginal and IM P Administration
Official title: Investigation of the Differences of Progesterone Concentration in Serum and Endometrium After Administration With Vaginal and Intramuscular Progesterone
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Postmenopausal Endometrium
Keywords: Crinone
progesterone
endometrial progesterone concentration
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
Collaborators: name: Merck Serono International SA
First posted: 2010-01-27
Enrollment: 51
Sex: FEMALE
Maximum age (years): 55
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Crinone is a micronized progesterone gel which is administrated via vaginal route and targeted drug delivery to uterine (first uterine pass effect) with lower serum concentration. This study is to investigate the difference of progesterone concentration in serum and endometrium after administration with crinone and intramuscular progesterone.

The study will be conducted as a single centre, randomized, active controlled study. Recruitment duration will be 6-8 months long. Day 1 of Crinone administration will be the baseline. On Day 7 of Crinone administration endometrial tissue will be taken for P4 test. Last visit will be at 3-5 days after withdraw bleeding.


Eligibility criteria: Inclusion Criteria:

* Perimenopausal women aged \<55 years old with amenorrhea\>=2 months or reproductive aged women with amenorrhea \>= 6months due to premature ovarian failure or other reasons.;
* Serum progesterone level \< 1ng/mL
* Endometrial thickness ≥5mm
* No contraindication of progesterone administration;
* Informed consent is signed.

Exclusion Criteria:

* The other kind of progestin was applied 1 month before recruitment;
* Any serious diseases that does not allow to receive the progestin treatment;
* Under any vaginal treatment;
* Any vaginal infectious disease;
* Any other hormone treatment contraindications;
* drug abuse or untreated STD;
* Prior hypersensitivity to Crinone or one of their excipients.
* Pregnant women who indicate hCG positive.

Primary outcomes:
measure: Primary endpoint: progesterone level in endometrium and in serum
timeFrame: after 7 days of progesterone therapy
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospital
Study officials:
affiliation: Peking Union Medical College Hospital
name: AIJUN SUN, PhD, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00763711: Injectable Bulking Agent Needle Guide
Official title: Injectable Bulking Agent Needle Guide
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Urinary Incontinence
Intrinsic Sphincter Deficiency
Keywords: Urinary Incontinence
ISD
Lead sponsor: Carbon Medical Technologies
Sponsor class: INDUSTRY
First posted: 2008-10-01
Enrollment: 17
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the use of the Needle Guide as an assist in properly guiding an injection needle into the appropriate tissue plane during an injectable bulking agent procedure in women using a FDA approved injectable bulking agent. The injectable bulking agent will be Durasphere EXP.


Eligibility criteria: Individuals satisfying the "Indications" and "Contraindications" criteria in the Durasphere EXP Directions for Use may participate.

Primary outcomes:
measure: to evaluate the consistency of the location of the injection site and resulting location of bulking effect
timeFrame: at procedure
measure: Safety will be demonstrated through an analysis of morbidity and complication rates, (if any), associated with the use of the Needle Guide.
timeFrame: 1 week
Secondary outcomes:
measure: to evaluate the comparative ease of the injection procedure using the Bulking Agent Needle Guide as compared to the traditional transurethral or periurethral injection technique.
timeFrame: at procedure
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: Mayo Clinic Jacksonville
state: Florida
city: West Chester
country: United States
facility: Advanced Urogynecology
state: Ohio
Study officials:
affiliation: Carbon Medical Technologies
name: Dean Klein
role: STUDY_DIRECTOR
References: