louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00259649: Prospective Survey of Menstrual Migraine & Prevention With Eletriptan
Official title: Assessment and Prevention of Menstrual Migraine: Phase 1-prospective Survey of Self-identified Menstrual Migraine. Phase 2-prevention of Menstrual Migraine With Relpax
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Migraine
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: Pfizer
First posted: 2005-11-29
Enrollment: 71
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: Women are followed prospectively for 3 months, recording headaches, other symptoms, and menstrual periods. Those with menstrual migraine are treated perimenstrually with eletriptan for 3 months.

Detailed description: Women are followed prospectively for 3 months, recording headaches, other symptoms, and menstrual periods. Those with menstrual migraine are treated perimenstrually with eletriptan for 3 months.

Eligibility criteria: Inclusion Criteria:

* age 18-45 healthy menstruating female

Exclusion Criteria:

* cardiac or other conditions precluding use of eletriptan

Primary outcomes:
measure: Change in Mean Headache Index Score Among Patients
timeFrame: baseline to approximately three months
Secondary outcomes:
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: University of Pittsburgh
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Dawn Marcus, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03907449: Preview Rapid Strep A Test Method Comparison Study
Official title: Preview Rapid Strep A Test Method Comparison Study
Study type: OBSERVATIONAL
Overall status: SUSPENDED
Conditions: Strep Throat
Lead sponsor: Guangzhou Wondfo Biotech Co., Ltd
Sponsor class: INDUSTRY
First posted: 2019-04-09
Enrollment: 320
Sex: ALL
Minimum age (years): 3
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Approximately 320 patients to be tested, expecting 50-100 positive for Strep A collected from patients of any age and gender from two CLIA waived or waivable sites. Children will be enrolled in this study due to the high prevalence of Strep A infections in minors and the intention to market this investigational device for use for all ages following FDA clearance.

Brief summary: This study is designed to determine the accuracy of the Preview Rapid Strep A Test compared to a laboratory reference method for Group A Streptococcal infection and to determine the precision of the Preview Rapid Strep A test.


Eligibility criteria: Inclusion Criteria:

* Any patient presenting with symptoms of pharyngitis

  * Fever
  * Sore throat
  * Swollen lymph nodes in neck
  * Redness of throat/tonsils
  * White/yellow patches on tonsils
  * Not currently on antibiotics
* ≥3 years or older
* Ability to read, understand and sign a consent form, in English, or for parent(s) to sign an assent form providing permission to include children under the age of 18.

Exclusion Criteria:

* Currently taking antibiotics
* Previously enrolled in this study

Primary outcomes:
measure: Accuracy of Preview Strep A Rapid Test
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Johnson City
country: United States
facility: UHSH Microbiology
state: New York
city: Liverpool
country: United States
facility: Summerwood Pediatrics
state: New York
Study officials:
affiliation: UHSH Microbiology
name: Paul Granato, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: UHSH Microbiology
name: Jagmohan Sidhu, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03204149: Evaluation of Safety of Low Level Laser Device Treatment in Chronic Wounds
Official title: Evaluation of Safety of Low Level Laser MC-8XL Device Treatment in Chronic Wounds
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Diabetic Foot Ulcer
Lead sponsor: Medical Coherence LLC
Sponsor class: INDUSTRY
First posted: 2017-06-29
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: This is a randomized, double blind, placebo-controlled study to evaluate the safety of the low level laser MC-8XL device treatment in subjects with an unsuccessfully treated Diabetic Foot Ulcer (DFU) that has been present for at least 3 months.

Eligible subjects will be randomized to either Treatment group or Control group, following which, treatment of each subject will be provided by a qualified nurse at the clinic or in the home setting, everyday for up to 16 weeks.

Study assessments and adverse events monitoring will be also performed throughout the study.


Eligibility criteria: Inclusion Criteria:

* Provide signed and dated Informed Consent Form
* Willing to comply with all study procedures and be available for the duration of the study
* Male or female, aged 18 to 90
* Having a DFU of at least 3 months duration that had not improved after prior standard wound treatments
* HbA1c of \<11.0
* Size of wounds: 1-10 cm2
* Having DFU of grades 2 or 3 according to Wagner's classification

Exclusion Criteria:

* Immeasurable wounds or wounds that are unsuited to this laser treatment (usually due to the wound's location, e.g. in the area between the toes).
* Uncontrolled Diabetes defined as an HbA1c of \> 11.0
* Arterial insufficiency, Doppler vascular assessment (if needed- Ankle Brachial Index (ABI) \< 0.6)
* Osteomyelitis in the bone.
* Photosensitivity
* Pregnancy
* Presence of any suspicious pre-cancerous or cancerous lesions, or having cancer.
* Being on medications that are immunosuppressive, may affect peripheral blood flow or may affect normal wound healing.
* Being on medications that might cause photosensitivity.
* Participation in any other clinical trial testing a device or drug.

Primary outcomes:
measure: Safety
timeFrame: On a weekly basis until the end of the 16 week treatment period
Secondary outcomes:
measure: Wound Healing
timeFrame: On a weekly basis until the end of the 16 week treatment period or until complete wound closure
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Northern District Trauma & Wound Clinics Division, Maccabi Health Care Services
Study officials:
References:
Clinical trial NCT05606549: Effect of MSD on FCR Among Gastric Cancer Survivors
Official title: Effect of Marital Self Disclosure Intervention on Fear of Cancer Recurrence and Dyadic Coping Ability Among Gastric Cancer Survivors and Their Spouse
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stomach Cancer；Clinical Control Trial
Keywords: Cancer Survivors；Stomach；Marital Therapy
Lead sponsor: University of Malaya
Sponsor class: OTHER
Collaborators: name: Jiangsu Taizhou People's Hospital
name: Jingjiang People's Hospital
First posted: 2022-11-04
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The goal of this clinical trial is to explores the effect of marital self disclosure intervention on fear of cancer recurrence and dyadic coping ability in gastric cancer survivors and their spouses. The main questions are: What is the level of fear of cancer recurrence among gastric cancer survivors and their spouse? What is the level of dyadic coping ability among gastric cancer survivors and their spouse?What is the effect of marital self-disclosure intervention on fear of cancer recurrence and dyadic coping ability in the gastric cancer survivors and their spouses? Participants will accept the intervention of marital self disclosure for 4 times (4 cycles of chemotherapy) with different topics. Researchers will compare with control group to see if the level of fear of cancer recurrence and dyadic coping ability will be improved.


Eligibility criteria: Inclusion Criteria:

* The disease meets the diagnostic criteria of "Guidelines for Diagnosis and Treatment of Gastric Cancer"(Department of Medical Affairs, 2019), the preoperative gastroscopy and pathological diagnosis are advanced gastric cancer, and the postoperative pathological classification is type II, III or IV
* Age ≥ 18 years
* Able to write and oral communicate effectively by themself
* The main caregiver is their spouse
* Clear consciousness, no understanding barriers
* Agree to participate in this study

Exclusion Criteria:

* History of receiving a structured psychological intervention from a psychiatrist or a psychologist
* Cognitive disorders or psychiatric disorders (according to the DSM-V)
* Severe visual, hearing and speech impairment
* With previous or concurrent malignant tumors
* With severe complications, such as gastrointestinal obstruction, perforation, etc.

Primary outcomes:
measure: Fear of Progression Questionnaire-Short form (FoP-Q-SF) for Patients
timeFrame: 4 months
measure: Fear of Progression Questionnaire-Short form (FoP-Q-SF) for Partners
timeFrame: 4 months
Secondary outcomes:
measure: Dyadic Coping Inventory(DCI)
timeFrame: 4 months
Other outcomes:
Locations:
city: Taizhou
country: China
facility: Jingjiang people's Hospital
state: Jiangsu
Study officials:
References:
Clinical trial NCT03114449: Auricular Acupuncture vs. Sham Procedure for Pain Control After Knee Arthroplasty
Official title: Auricular Acupuncture (AA) vs. Sham AA Procedure for Pain Control After Elective Knee Arthroplasty - a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Pain
Lead sponsor: University Medicine Greifswald
Sponsor class: OTHER
Collaborators: name: Naemi-Wilke-Stift Guben Hospital - Anesthesia Services
First posted: 2017-04-14
Enrollment: 150
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Aim of the study To investigate whether auricular acupuncture (AA) will reduce postoperative pain and analgesic requirement in comparison with sham AA in patients after elective knee arthroplasty

Design Prospective randomized controlled blinded clinical trial

Participants:

* Patients \< 80 und \> 50 years old
* scheduled for knee arthroplasty under general anesthesia with \< 120 minutes duration
* Without previous opioid medication
* Able to give informed consent

Outcome measures

* Postoperative analgesic requirement
* Incidence of side effects
* Physiological parameters


Eligibility criteria: Inclusion Criteria:

1. Patients with an American Society of Anesthesiologists physical status of I to III scheduled for elective knee arthroplasty under general anesthesia
2. Surgery time does not exceed 120 minutes
3. Patients without previous opioid medication
4. Patients ranged 50-80 years old
5. Patients who have given written informed consent

Exclusion Criteria:

1. Recidivist alcoholics
2. Local auricular skin infection
3. Age \< 50 and \> 80 years
4. Surgery time more than 120 minutes
5. Intraoperative complications (bleeding, required blood transfusion more than 6 units of packed cells, cardiovascular instability, required catecholamines)
6. Patients who consumed opioid medication at least 6 months before surgery
7. Patients with prosthetic or damaged cardiac valves, intracardiac and intravascular shunts, hypertrophic cardiomyopathy and mitral valve prolaps (risk of bacterial endocarditis according to guidelines of AHA)
8. Patients who are unable to understand the consent form
9. History of psychiatric disease

Primary outcomes:
measure: Postoperative requirement of analgesic tilidine (measured in mg)
timeFrame: Six days following surgery
Secondary outcomes:
measure: Side effects of analgesics
timeFrame: Six days following surgery
measure: heart rate
timeFrame: 12 hours after surgery
measure: blood pressure
timeFrame: 12 hours following surgery
measure: Patients' satisfaction with the treatment of postoperative pain using NRS-5 (where 1=excellent; 5=very bad)
timeFrame: 12 hours following surgery
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02931149: Evaluation of the Efficacy of Platelet-rich Plasma (PRP) on Advanced Endoscopic Resection Techniques
Official title: Evaluation of the Efficacy of Platelet-rich Plasma (PRP) on Advanced Endoscopic Resection Techniques
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Platelet-rich Plasma
Endoscopic Mucosal Resection
Endoscopic Submucosal Dissection
Keywords: platelet-rich plasma
endoscopic mucosal resection
endoscopic submucosal dissection
Lead sponsor: Germans Trias i Pujol Hospital
Sponsor class: OTHER
First posted: 2016-10-12
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: To avoid complications secondary to advanced endoscopic resection techniques (Endoscopic Mucosal Resection -EMR- or Endoscopic Submucosal Disection -ESD-) the endoscopists have to avoid deep thermal damage and increase mucosal healing. Platelet-rich plasma (PRP) has demonstrated efficacy in preclinical endoscopic resection models.

Detailed description: Background:To avoid complications secondary to advanced endoscopic resection techniques (Endoscopic Mucosal Resection -EMR- or Endoscopic Submucosal Disection -ESD-) the endoscopists have to avoid deep thermal damage and increase mucosal healing. Platelet-rich plasma (PRP) has demonstrated efficacy in preclinical endoscopic resection models.

Aim: Evaluate the efficacy of PRP on participants submitted to advanced endoscopic resection techniques: EMR or ESD.

Material and Methods: The investigators have evaluated a prospective clinical study. The investigators have included 12 participants submitted to EMR or ESD. Patients were informed and accepted to participate with a written consent. Prior to endoscopy PRP was obtained from autologous blood with a comercial kit. Submucosal injection with PRP were performed prior to resection. Resection was performed with standard technique. Participants were followed-up after the procedure.

Eligibility criteria: Inclusion Criteria:

* Endoscopic lesion higher than 40mm in diameter submitted to endoscopic resection (EMR or eSD)

Exclusion Criteria:

* Ineligibility to endoscopic resection

Primary outcomes:
measure: Prevention of delayed bleeding: percentage of participants with delayed bleeding
timeFrame: 28 days after resection
measure: Prevention of coagulation syndrome (or postpolipectomy syndrome): percentage of participants with coagulation syndrome
timeFrame: 5 days after resection
Secondary outcomes:
Other outcomes:
Locations:
city: Badalona
country: Spain
facility: Endoscopy Unit. University Hospital Germans Trias
state: Barcelona
Study officials:
affiliation: University Hospital Germans Trias
name: Vicente Lorenzo-Zúñiga García, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lorenzo-Zuniga V, Boix J, Moreno de Vega V, Bon I, Marin I, Bartoli R. Efficacy of platelet-rich plasma as a shielding technique after endoscopic mucosal resection in rat and porcine models. Endosc Int Open. 2016 Aug;4(8):E859-64. doi: 10.1055/s-0042-109170. Epub 2016 Aug 10.
Clinical trial NCT01640249: A Study of LY3006072 in Healthy Participants
Official title: A Single Ascending Dose, Safety, Tolerability, Pharmacokinetic, and Pharmacodynamic Study of LY3006072 in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Healthy Volunteers
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2012-07-13
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to evaluate how safe LY3006072 (study drug) is and whether it causes any side effects. The study will also measure how much of the study drug gets into the blood stream and how long it takes the body to get rid of the study drug. The study drug will be given in the morning or evening with or without a meal.

This is the first time that this study drug is being given to humans. This study is for research purposes only and is not intended to treat any medical condition.

Detailed description: This study has two parts:

Part A - single ascending dose of LY3006072 administered to healthy participants in 3 of 4 study periods (placebo in 1 of 4 periods).

Part B - morning and evening doses of LY3006072 given to healthy participants in fed and fasted states in 2 or 3 of 3 study periods (placebo in 1 of 3 periods for some participants).

Eligibility criteria: Inclusion Criteria:

* Overtly healthy males or females, as determined by medical history and physical examination
* Male participants with a partner of childbearing potential must agree to use barrier protection during sexual intercourse while in the study and for 3 months after the last dose of study drug
* Women must not be pregnant or nursing and must be of non-childbearing potential, due to either surgical sterilization or menopause
* Body mass index between 19.0 and 30.0 kilograms per square meter (kg/m\^2), inclusive

Primary outcomes:
measure: Number of Participants With One or More Drug Related Adverse Events (AEs) or Any Serious AEs
timeFrame: Baseline, up to 21 days
Secondary outcomes:
measure: Pharmacokinetics: Maximum Concentration (Cmax) of LY3006072
timeFrame: Predose, 0.25, 0.5, 1, 2, 3, 5, 8, 12, 16, 24, 36, 48 and 96 hours postdose
measure: Pharmacokinetics: Area Under the Concentration Curve (AUC) of LY3006072
timeFrame: Predose, 0.25, 0.5, 1, 2, 3, 5, 8, 12, 16, 24, 36, 48 and 96 hours postdose
Other outcomes:
Locations:
city: Evansville
country: United States
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
state: Indiana
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: STUDY_DIRECTOR
References:
Clinical trial NCT02621749: Cerebral Microembolism in the Critically Ill With Acute Kidney Injury
Official title: Cerebral Microembolism in the Critically Ill With Acute Kidney Injury: A Prospective Multi-Center Randomized Controlled Trial Comparing Continuous With Intermittent Renal Replacement Therapy.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Cerebral Embolism
Lead sponsor: Insel Gruppe AG, University Hospital Bern
Sponsor class: OTHER
First posted: 2015-12-03
Enrollment: 66
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: The primary objective of this study is to investigate the impact of continuous renal replacement therapy and intermittent renal replacement therapy on microbubble / cerebral microemboli generation in a cohort of critically ill patients with dialysis-dependent acute kidney injury.


Eligibility criteria: Inclusion Criteria:

* \> 18 yrs.
* Signed IC

Exclusion Criteria:

* Heart disease (PFO, ASD, VSD, severe valvular disease)
* Atrial fibrillation
* Cerebrovascular pathology
* Missing temporal bone window
* Allergy to plastic contained in the investigative device (transcranial Doppler)
* Chronic kidney disease
* Pregnancy
* Participation in another study

Primary outcomes:
measure: Cerebral Microembolic Load detected by Transcranial Doppler Ultrasound
timeFrame: During hemodialysis therapy
Secondary outcomes:
Other outcomes:
Locations:
city: Bern
country: Switzerland
facility: University Hospital Bern
Study officials:
affiliation: University of Berne
name: Gabor Erdoes, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Erdoes G, Uehlinger DE, Kobel B, Stucki MP, Wiest R, Stueber F, Fankhauser N, Jakob SM, Schefold JC. Cerebral microembolism in the critically ill with acute kidney injury (COMET-AKI trial): study protocol for a randomized controlled clinical trial. Trials. 2018 Mar 21;19(1):189. doi: 10.1186/s13063-018-2561-3.
Clinical trial NCT06270849: Validity and Reliability of ICIQ-FLUTS LF in Thai Version and Correlation With IPSS
Official title: Validity and Reliability of the Translated International Consultation on Incontinence Questionnaire - Female Lower Urinary Tract Symptoms Long Form (ICIQ-FLUTS-LF) in Thai Version and Correlation With the IPSS
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Validity of Thai Version of the ICIQ-FLUTS LF Questionnaire
Reliability of Thai Version of the ICIQ-FLUTS LF
Lead sponsor: Thammasat University Hospital
Sponsor class: OTHER
First posted: 2024-02-21
Enrollment: 130
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Females with lower urinary tract symptoms who can read and understand Thai language.

Brief summary: The investigators recruited participants, who were female with LUTS 50 participants for known group validity and 80 normal control females to evaluate for construct validity and test for reliability by statistical analysis.

Detailed description: 50 females with LUTS will completed the ICIQ-FLUTS and IPSS and then again at 2 weeks apart to test for convergent validity and test-retest validity.

The normal control group 80 women will completed ICIQ-FLUTS LF for test of construct validity.

Eligibility criteria: Inclusion Criteria:

* age at or over 18 years old
* can read and understand Thai language
* have lower urinary tract symptoms

Exclusion Criteria:

* those who have a diagnosis of calculi, urinary tract cancer

Primary outcomes:
measure: How well the ICIQ-FLUTS LF questionnaire in the Thai version can differentiate between females with LUTS and normal females, was assessed by the construction validity.
timeFrame: 10-12 months
measure: The correlation between items within a subscale of the ICIQ-FLUTS LF questionnaire assessed by internal consistency.
timeFrame: 10-12 months
measure: The consistency of the repeated measurements by the Thai version of the ICIQ-FLUTS LF was assessed by the test-retest reliability.
timeFrame: 10-12 months
Secondary outcomes:
measure: The correlation between the IPSS questionnaire and ICIQ-FLUTS LF questionnaire was assessed by convergent validity.
timeFrame: 10-12 months
Other outcomes:
Locations:
city: Khlong Luang
country: Thailand
facility: Thammasat University Hospital
state: Pathumthani
Study officials:
affiliation: Thammasat University Hospital
name: Valeerat Swatesutipun, MD
role: PRINCIPAL_INVESTIGATOR
References: