louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00062608: Written Self-disclosure for Youth Abdominal Pain
Official title: RCT of Written Self-disclosure for Youth Abdominal Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Abdominal Pain
Keywords: Abdominal
Lead sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Sponsor class: NIH
First posted: 2003-06-12
Enrollment: 160
Sex: ALL
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The aims are to evaluate: (1) the effectiveness of written self-disclosure (WSD) on health status of youth ages 12-18 with functional recurrent abdominal pain (RAP); (2) whether effectiveness of WSD is similar for younger (12-14) and older (15-18) youth with functional RAP; and (3) the feasibility and acceptability of WSD when extended to the pediatric health care setting.We will implement a randomized, controlled trial (RCT) designed to compare health status in 140 youths (ages 12-18) with functional RAP assigned either to standard medical care (SMC) or WSD provided in the health care setting in addition to SMC. Health status will be measured at Baseline and 3- and 6-months thereafter. Primary measures of health status are symptom severity and episode frequency, consistent with the definition of RAP. Secondary measures of health are functional health, psychological distress, health-related quality of life, and health care utilization. Total use and diagnostic tests will index health care utilization, collected for the 6-mos prior to and following Baseline. Mixed model ANOVA or MANOVA will be used to test directional hypotheses corresponding to the specific aims.


Eligibility criteria: * Ages 12-18.
* Diagnosis of RAP by the examining pediatric gastroenterologist using Apley's (1975) criteria: (a) 3 episodes of abdominal pain, (b) severe enough to interrupt activities and occurring, (c) over a period of at least 3 months, (d) without an identifiable organic cause (If an organic cause is identified during participation in protocol, then participant is withdrawn from database prior to analysis).
* Free of a known chronic health condition.
* Physical and mental ability to complete the procedures, as judged by Dr. Madan-Swain.
* Consents to complete the protocol over the next 6 months.
* Parent(s) consents to participate and agrees to support the youth in completing the protocol.
* Access to a phone on the days writing sessions are to be completed at home.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
Study officials:
References:
Clinical trial NCT04854408: Evaluation of the Effect of Coronavac Vaccine (Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2 Vaccine) on Healthcare Workers' Menstrual Patterns
Official title: the Effect of Coronavac Vaccine (Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2 Vaccine) on Healthcare Workers' Menstrual Patterns
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Covid19
Vaccine Reaction
Coronavirus
Menstrual Problem
Endometrium
Lead sponsor: Kanuni Sultan Suleyman Training and Research Hospital
Sponsor class: OTHER
First posted: 2021-04-22
Enrollment: 300
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: It includes female healthcare workers between the ages of 8 and 45. For participation, 1 or 2 doses of vaccine should be administered and at least one menstrual period after the match.

Brief summary: Coronavac, one of the vaccines developed within the scope of combating the COVID-19 pandemic that has surrounded the world for a year, started to be applied in the first healthcare workers in our country. In this important step taken to end the pandemic, information on vaccines is still limited. Most vaccines, including the Coronavac vaccine, are applied with approval for emergency use before phase 3 studies are fully completed. While investigating the effect of the vaccine on the virus, possible side effects should also be considered. In this context, it is not known whether the vaccine has an effect on the menstrual cycle, especially of women of reproductive age.

Our primary aim in our study is to evaluate the effect of the vaccine on the menstrual cycle and if the vaccine has any effect on the menstrual cycle, what kind of changes this effect causes.

Detailed description: The survey contains 20 questions aimed at obtaining information about the menstrual cycles of health workers before and after vaccination. Demographic data of the participants are also taken.

Eligibility criteria: Inclusion Criteria:

* be positive for covid-19 (severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2 )
* Having 1 or 2 doses of vaccine
* have menstruation
* Being a female health worker
* not using drugs that can affect menstruation

Exclusion Criteria:

* be negative for covid-19(severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2 )
* have no menstruation
* Being a male health worker

Primary outcomes:
measure: Possible effects of Coronavac vaccine (severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2 vaccine) on menstrual cycle
timeFrame: 40 days
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Pinar Yalcin Bahat
state: İ̇stanbul
Study officials:
References:
Clinical trial NCT02077608: Hyaluronan in Embryo Transfer Media
Official title: Effect of Hyaluronan Enriched Embryo Transfer Media on IVF Outcome
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Infertility
Keywords: In vitro fertilization
Embryotransfer
Hyaluronan
Pregnancy rate
Implantation rate
Lead sponsor: Semmelweis University
Sponsor class: OTHER
First posted: 2014-03-04
Enrollment: 580
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 48
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients entering in vitro fertilization and embryo transfer treatment

Brief summary: Prospective randomized double blind comparison of hyaluronan enriched embryotransfer media and conventional embryotransfer media in human IVF treatments. Embryos selected for transfer are incubated in a culture media containing high concentration of hyaluronan or low concentration of hyaluronan.

Primary outcome: implantation and pregnancy rates


Eligibility criteria: Inclusion Criteria:

* Infertile patients
* entering in vitro fertilization treatment
* at least 1 embryo transferred

Exclusion Criteria:

* IVF treatment with donated oocytes
* No embryo available for transfer

Primary outcomes:
measure: Clinical pregnancy rate
timeFrame: 5 weeks after embryo transfer
measure: Implantation rate
timeFrame: 5 weeks after embryotransfer
Secondary outcomes:
measure: Multiple pregnancy rate
timeFrame: 5 weeks after embryotransfer
measure: Delivery rate
timeFrame: 40 weeks after embryo transfer
Other outcomes:
Locations:
city: Budapest
country: Hungary
facility: Semmelweis University First Department of Obstetrics and Gynecology
Study officials:
affiliation: Semmelweis University First Department of Obstetrics and Gynecology
name: Peter Fancsovits, Ph.D.
role: STUDY_CHAIR
affiliation: Semmelweis University First Department of Obstetrics and Gynecology
name: Janos Urbancsek, MD, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Semmelweis University First Department of Obstetrics and Gynecology
name: Adam Lehner, MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bontekoe S, Heineman MJ, Johnson N, Blake D. Adherence compounds in embryo transfer media for assisted reproductive technologies. Cochrane Database Syst Rev. 2014 Feb 25;2014(2):CD007421. doi: 10.1002/14651858.CD007421.pub3.
Clinical trial NCT01449708: Effect of Intraoperative Anesthetic Management on Postoperative Nausea and Vomiting in Bariatric Surgery
Official title: Effect of Intraoperative Anesthetic Management on Postoperative Nausea and Vomiting (PONV) in Bariatric Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Postoperative Nausea and Vomiting
Keywords: Bariatric Surgery
TIVA
PONV
non-opioid
OSA
Lead sponsor: Coastal Anesthesiology Consultants
Sponsor class: OTHER
First posted: 2011-10-10
Enrollment: 124
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Morbidly obese patients are at high risk for Postoperative Nausea and Vomiting (PONV) after surgery and general anesthesia. The results of our observational study indicate that 42.7% of patients require medication to treat PONV in the first 24 hours after bariatric surgery despite our aggressive perioperative approach with triple prophylaxis. Common risk factors for PONV are the use of intraoperative narcotics and anesthetic gases.

Preliminary results of multimodal postoperative analgesia in the first 24 hours lead to a reduction of narcotic consumption, desaturations and use of antiemetic medication.

Our study hypothesis is that different types of anesthetics reduce PONV further.

Patient would be randomly assigned to receive either our current intraoperative management or a narcotic free, total intravenous general anesthetic (TIVA).

The investigators hope to improve patients' satisfaction by reducing PONV in the postoperative period.

Detailed description: See above

Eligibility criteria: Inclusion Criteria:

* All patients scheduled for bariatric surgery at Flagler Hospital will be included after written and informed consent.

Exclusion Criteria:

* Patients will be excluded from the study if they don't consent to participate in the study. Patients allergic to any of the study medication will be excluded. Patients with second or third degree heart block will be excluded.

Primary outcomes:
measure: PONV During the First 24 Hours After Bariatric Surgery
timeFrame: 24 hours
Secondary outcomes:
measure: Number of Patients Requiring Antiemetic Rescue Medication (AERM)
timeFrame: 24hours
measure: PONV Between Different Surgical Procedures (Percentage of Participants)
timeFrame: 24 hours
Other outcomes:
Locations:
city: St. Augustine
country: United States
facility: Flagler Hospital
state: Florida
Study officials:
affiliation: Coastal Anesthesiology
name: Patrick Ziemann-Gimmel, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ziemann-Gimmel P, Goldfarb AA, Koppman J, Marema RT. Opioid-free total intravenous anaesthesia reduces postoperative nausea and vomiting in bariatric surgery beyond triple prophylaxis. Br J Anaesth. 2014 May;112(5):906-11. doi: 10.1093/bja/aet551. Epub 2014 Feb 18.
Clinical trial NCT01226108: The Akloma Tinnitus Patch in Patients With Manifested Tinnitus
Official title: The Akloma Tinnitus Patch in Patients With Manifested Tinnitus (the Aktin Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tinnitus
Lead sponsor: Akloma Bioscience AB
Sponsor class: INDUSTRY
First posted: 2010-10-21
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: OBJECTIVES:

Primary Objective The primary objective will be a decrease of inconvenience with at least 10% for at least 50% of the subjects.

Secondary Objectives

The secondary objective will be to:

To evaluate if the patch can improve the tinnitus patient's quality of life and sleep quality.

METHODOLOGY

Study Design:

An open safety and performance clinical investigation of the antinitus patch in patients with manifested tinnitus.

Treatment Duration:

1 patch per day for 3 weeks

Primary Endpoint:

Tinnitus severity questionnaire (TSQ)

Performance Parameters:

Tinnitus severity questionnaire (TSQ) and numerical rating scale (NRS) measuring tinnitus annoyance.

Quality of life and sleep quality

Safety Parameters: Adverse Reactions


Eligibility criteria: Inclusion Criteria:

* Adults of both sexes \> 18 years of age
* Signed informed consent
* Patients who have suffered from tinnitus for ≥ 4 weeks before study entry
* Manifested tinnitus grade II or above on the Klockhoff-Lindblom tinnitus severity grading scale.
* Tinnitus score of 5 or above (numerical rating scale for tinnitus annoyance)
* Pure tone averages better than 40 dB in the worse hearing ear.

Exclusion Criteria:

* Pregnant or lactating women
* Malignancy or other serious medical conditions
* Skin disease
* Simultaneous or previous (within 30 days prior to study entry) participation in a clinical study using experimental drugs or devices.
* Severe psychiatric disorder
* Serious suicidal risk
* Patients who have started treatment or made changes in treatment with drugs known to influence tinnitus within 6 weeks before study start.
* Patients with untreated high blood pressure ≥140/90 mmHg
* Other tinnitus treatment within 6 weeks before study entry.
* Previous use of the Antinitus patch
* Known allergy or sensitivity to any of the compounds in the Antinitus or the placebo patches.

Primary outcomes:
measure: Number of Participants with Adverse Events as a Measure of Safety and Tolerability
timeFrame: 7 weeks
measure: Tinnitus severity questionnaire score as a measure of efficacy
timeFrame: 3 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Nacka
country: Sweden
facility: Sickla ÖNH-center, Atlashuset Planiavägen 5
Study officials:
affiliation: Sickla ÖNH-center / Supramed AB
name: Peter Åhnblad
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01263808: Cardiac Safety of Indacaterol
Official title: A Randomized, Multiple-dose, Placebo- and Positive-controlled Parallel Group Study to Evaluate the Effects of Indacaterol on Cardiac Safety in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Chronic Obstructive Pulmonary Disease
Keywords: Indacaterol
Moxifloxacin
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2010-12-21
Enrollment: 404
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study compares the cardiac safety of inhaled indacaterol with that of placebo and oral moxifloxacin.


Eligibility criteria: Inclusion Criteria:

* Healthy, non-smoking
* Body mass index (BMI) 18.5-32 kg/m2
* Body weight at least 50 kg

Exclusion Criteria:

* Recent/concurrent use of concomitant medications (except acetaminophen)
* Recent participation in other clinical trials
* Recent donation or loss of blood
* History/presence of a range of medical conditions, including electrocardiographic (ECG) abnormalities, diabetes mellitus, hyperthyroidism and impaired renal function

Other protocol-defined inclusion/exclusion criteria may apply

Primary outcomes:
measure: Change from baseline in QTc interval (Fridericia's)
timeFrame: Change from baseline (prior to the first dose) to Day 14
Secondary outcomes:
measure: Change from baseline in uncorrected QT interval
timeFrame: Change from baseline (prior to the first dose) to Day 14
Other outcomes:
Locations:
city: Miami
country: United States
facility: Novartis investigative site
state: Florida
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
citation: Khindri S, Sabo R, Harris S, Woessner R, Jennings S, Drollmann AF. Cardiac safety of indacaterol in healthy subjects: a randomized, multidose, placebo- and positive-controlled, parallel-group thorough QT study. BMC Pulm Med. 2011 May 26;11:31. doi: 10.1186/1471-2466-11-31.
Clinical trial NCT05214508: Serum Interleukin 6 in Chronic Obstructive Pulmonary Disease
Official title: Serum Interleukin 6 in Chronic Obstructive Pulmonary Disease Patients and Its Relation to Severity and Acute Exacerbation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Obstr Lung Disease
Lead sponsor: Beni-Suef University
Sponsor class: OTHER
First posted: 2022-01-28
Enrollment: 90
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The aim of this study is to estimate level of IL 6 in COPD patients and its relation to COPD severity and acute exacerbation.

Detailed description: 1. A detailed clinical history was be carried out for every patient. In the clinical history, duration of COPD with a history of exacerbation and treatment will be elicited. History of the presence of risk factors such as smoking, exposure to fumes (biomass), and the presence of any other chronic disease were be inquired.
2. Thereafter, the detailed physical examination also had been carried out.
3. Pulmonary function test was performed by master screen NO : 781040 (care fusion) Measurements were obtained for FVC,FEV1,Ratio between them, PEF,FEF25%,FEF50% ,and FEF75% (The readings for FEV1 and Ratio were the ones included in the statistical analysis as indices for obstructive pattern of respiration).
4. Labs including Complete blood count, urea, and serum creatinine ,ESR was done for all patients
5. Exercise capacity by six minutes' walk test.
6. Dyspnea score by MMRC score.
7. Health state assessment by CAT score

3- 8- Determination of IL 6 serum levels. by sandwich enzyme-linked immunosorbent assay (ELISA). The detection range (0.2 ng/L- 8ng/L)

Eligibility criteria: Inclusion Criteria:

1. All patients aged \>40 years and \<80 years, of both gender
2. Diagnosed to have COPD according to GOLD 2019 by spirometry
3. Given the consent for participation in the study

Exclusion Criteria:

1- Any patient with systemic inflammation as

1. Bronchial asthma,
2. rheumatoid arthritis.

Primary outcomes:
measure: measure level of IL-6
timeFrame: 9 monthes
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Beni Suef university
Study officials:
affiliation: Beni Suef faculty of medicine
name: Laila Anwar Sharawy
role: STUDY_DIRECTOR
References:
Clinical trial NCT01419808: Vascularized Versus Non-Vascularized Bone Grafts in Treating Proximal Pole Scaphoid Non Unions
Official title: Vascularized vs. Non-vascularized Bone Grafting in the Treatment of Proximal Pole Scaphoid Non Unions: A Prospective Randomized Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Scaphoid Non-Unions
Keywords: Scaphoid
Non-Union
Proximal pole
Bone Graft
Vascularized
Non-Vascularized
PREE
Lead sponsor: Hand and Upper Limb Clinic, Canada
Sponsor class: NETWORK
First posted: 2011-08-18
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to investigate whether treatment of scaphoid non-unions with a vascularized bone grafts improves patient reported pain and disability compared to treatment with a non-vascularized bone graft. Secondary objectives are to examine if there is any difference in the overall rate and time to union, range of motion, grip strength, or complication rates between the two groups.

In addition, this is the first prospective randomized study to directly compare the two techniques. This is also the first study to use standardized methods of assessing union (based on computerized tomography), standardized methods of collecting objective patient data, and utilizing validated patient questionnaires to assess pain and disability.


Eligibility criteria: Inclusion Criteria:

* The primary inclusion criterion is any scaphoid waist or proximal pole non-union in a patient receiving a recommendation for operative treatment. Non-union is defined as \<10% bony union across the fracture site on sagittal computerized tomography (CT) after at least 16 weeks of appropriate non-operative treatment or morphologic features on plain x-ray and CT (resorption and sclerosis at the fracture site, significant cyst formation) confirming non-union.

Exclusion Criteria:

* radiologic evidence of significant scaphoid non-union advanced collapse (SNAC) wrist arthritis
* fragmentation of the proximal pole

Primary outcomes:
measure: Patient Rated Wrist Evaluation
timeFrame: Change in PRWE score at time of Surgery (day 1) compared to two years post operation.
Secondary outcomes:
measure: Objective Measures
timeFrame: Change in strength, ROM, and Dexterity from time of surgery (day 1) compared to two years post operation.
Other outcomes:
Locations:
city: London
country: Canada
facility: Hand and Upper Limb Centre, St Joseph's Health Care
state: Ontario
Study officials:
affiliation: Hand and Upper Limb Centre, St. Joseph's Health Care
name: Ruby Grewal, MD, FRCSC
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02781623: Quantifying Quadriceps Atrophy Following Tibial Plateau Fracture
Official title: Quantifying Quadriceps Atrophy Following Tibial Plateau Fracture
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atrophy
Keywords: Quadriceps
Tibial Plateau
Fracture
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2016-05-24
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who opt for surgical treatment or non-operative treatment of their fracture.

Brief summary: This study will quantify and examine the extent to which the quadriceps femoris muscle group atrophies following tibial plateau fractures and the length of time that atrophy affects function. The study will also look at the effects of tibial plateau fractures on the quadriceps muscle and the effect this atrophy has on functional outcome. Quadriceps atrophy will be measured both clinically and by using MRI scans taken pre-operatively, 3 months post operatively, and 1 year post-operatively. The injured leg and the non-injured leg will be scanned in order for the non-injured leg to serve as the control. In this way muscle volume can be estimated from the muscle thickness at specific locations in the thigh. The muscle strength of the quadriceps will also be assessed at the 3 month and 1 year visit by measuring isokinetic knee-extension torque, and functional assessment questionnaires will be completed at each study visit.


Eligibility criteria: Inclusion Criteria:

* All racial and ethnic groups
* Diagnosis of tibial plateau fracture
* Patients who opt for surgical treatment or non-operative treatment of their fracture
* Patients who consent to undergoing 3 MRI scans
* Patients who are willing to follow-up for a minimum of 52 weeks

Exclusion Criteria:

* Patients younger than 18 years old or older than 65
* Patients who may be pregnant or may become pregnant in the 52 weeks following injury
* Patients who have electric, magnetic, or mechanical devices currently implanted
* Patients who have abnormal ECG results
* Diagnosis of any additional lower extremity fractures other than tibial plateau
* Patients who fit the definition of a vulnerable population

Primary outcomes:
measure: Cross-sectional area (CSA) calculations
timeFrame: 1 Year
measure: Quadriceps muscle strength
timeFrame: One Year
measure: Muscle Volume
timeFrame: One Year
measure: Pain Level
timeFrame: One Year
Secondary outcomes:
measure: Isokinetic Knee-Extension Strength Test
timeFrame: One year
Other outcomes:
Locations:
city: New York
country: United States
facility: New York University Langone Medical Center
state: New York
Study officials:
affiliation: NYU Langone Health
name: Kenneeth Egol, MD
role: PRINCIPAL_INVESTIGATOR
References: