louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01402349: Chronic Rhinosinusitis in a Danish Population: Evaluation of Causes of Disease, Progress and Treatment
Official title: Chronic Rhinosinusitis in a Danish Population: Evaluation of Causes of Disease, Progress and Treatment
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Rhinosinusitis
Keywords: Chronic rhinosinusitis, SNOT 22, Quality of life
Lead sponsor: Odense University Hospital
Sponsor class: OTHER
First posted: 2011-07-26
Enrollment: 5000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: As part of Ga2len (Global Asthma and Allergy European Network) a questionnaire on CRS was posted to 5000 residents on Funen. From the completed and returned questionnaires self reported CRS was evaluated. Respondents were invited for clinical examination. Patients diagnosed with CRS were invited for a 1 year and 2 year follow up.

Brief summary: Introduction: Chronic Rhinosinusitis (CRS) is defined as inflammation of the nose and the paranasal sinuses. It is a very common disorder increasing in both incidence and prevalence with significant impact on quality of life and substantial health care costs. In this study we evaluate the prevalence of CRS in Denmark and there is a need for consensus about diagnosing this disease. Different questionnaires and different tests used for examination are evaluated together with the patients compliance and days lost through illness.

Methods: As part of Ga2len (Global Asthma and Allergy European Network) a questionnaire on CRS was posted to 5000 residents on Funen. From the completed and returned questionnaires self reported CRS was evaluated. Respondents were invited for clinical examination including spirometry, skin prick test, bloodsample and an ENT examination including nasal endoscopy, acoustic rhinometry, peak nasal inspiratory flow and smell test. Questionnaire on quality of life (EQ-5D) and symptom severity (SNOT-22) was completed. Medical diagnosed CRS was diagnosed according to the definition on CRS stated by EPOS (European Position Paper on Rhinosinusitis and Nasal Polyps 2007). CRS is defined as inflammation in the nose and paranasal sinus and should be characterized by two or more symptoms one of which should be either nasal blockage/obstruction/congestion or nasal discharge, +/- facial pain/pressure, +/- reduction or loss of smell. Endoscopic signs should be present and symptoms must have been present \> 12 weeks. Patients diagnosed with CRS were invited for a 1 year and 2 year follow up where examination and questionnaires were repeated and treatment compliance and days lost through illness were evaluated.


Eligibility criteria: Inclusion Criteria:

* residents on Funen aged 18-75 years

Exclusion Criteria:

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Department of Otorhinolaryngology, Odense University Hospital
name: Bibi Lange, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00364806: Prochlorperazine vs Metoclopramide
Official title: Prochlorperazine Verus Metoclopramide for the Treatment of Acute Migraine in the Emergency Department Setting
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Migraine
Keywords: Migraine
Headache
Lead sponsor: Montefiore Medical Center
Sponsor class: OTHER
Collaborators: name: Albert Einstein College of Medicine
First posted: 2006-08-16
Enrollment: 76
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: Migraine headaches are a common reason for patients to present to an emergency department. We are comparing two different medications to see which one is better for patients who present ot an emergency room with a migraine headache.

Detailed description: One-third of the five million headache patients who present to US Emergency Departments (ED) annually have a migraine headache. The anti-emetic dopamine receptor antagonists have proven efficacy for migraines, are at least as well-tolerated as triptans, and enjoy wide-spread use in North American EDs. However, it is not yet clear which medication within this class and which dosage is optimal. Therefore, we propose a randomized clinical trial to compare the efficacy and tolerability of two standard medications for migraine.

Specific Aim: To compare the efficacy of metoclopramide versus prochlorperazine for the emergency department treatment of migraine headaches. Both of these medications will be combined with diphenhydramine to prevent extra-pyramidal side effects.

Patients will be enrolled as participants if they present to one of the participating EDs and consent to participate. Medications will be administered as an intravenous drip over 15 minutes. Rescue medication will be administered, if needed, after one hour. A follow-up phone call will be conducted 24 hours after the ED visit.

Eligibility criteria: Inclusion Criteria:

* Present to the Ed with an acute migraine headache

Exclusion Criteria:

* secondary headache
* if the patient is to receive a lumbar puncture in the ED
* maximum temperature greater than 100.3 degrees
* new objective neurologic abnormality at the time of physical exam
* allergy or intolerance to a study medication
* pregnancy
* previous enrollment

Primary outcomes:
measure: One hour pain scores
Secondary outcomes:
measure: One hour, two hour and 24 hour pain, functional disability scores, and side effect profiles.
Other outcomes:
Locations:
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
Study officials:
affiliation: Albert Einstein College of Medicine
name: Benjamin W Friedman, MD, MS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00568906: Microarray Analysis of Gene Expression and Identification of Progenitor Cells in Lung Carcinoma
Official title: Microarray Analysis of Gene Expression and Identification of Progenitor Cells in Lung Carcinoma
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Carcinoma, Giant Cell
Carcinoma, Non-Small-Cell Lung
Lung Cancer
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2007-12-06
Enrollment: 129
Sex: ALL
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: Patients who agree to participate in this study will be those who are undergoing wedge resection, lobectomy on pneumonectomy for clinically diagnosed lung carcinoma or metastatic tumors to the lung, or who are undergoing therapeutic or diagnostic thoracentesis for malignant pleural effusion.

Brief summary: This study will help us understand the gene expression profiles of lung cancer. We will identify genes related to lung cancer development, their growth and metastasis to the lung. In addition, we will examine the role nicotine in the development and progression of lung tumors of smokers, ex-smokers, non-smokers on supplemental nicotine and non smokers with no exposure to nicotine.


Eligibility criteria: Inclusion Criteria:Adults with non small cell lung cancer Exclusion Criteria:NA

Primary outcomes:
measure: identify genes related to lung cancer development, their growth and metastasis to the lung.
timeFrame: day one
Secondary outcomes:
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University School of Medicine
state: California
Study officials:
affiliation: Stanford University
name: Daya Upadhyay
role: PRINCIPAL_INVESTIGATOR
affiliation: Stanford University
name: Glenn D. Rosen
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04345406: Angiotensin Converting Enzyme Inhibitors in Treatment of Covid 19
Official title: Randomized Trial of ACEIs in Treatment of COVID-19
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE3
Conditions: COVID
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2020-04-14
Enrollment: 60
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: ACEIs as treatment for COVID19

Detailed description: ACEIs as suggested treatment for COVID19

Eligibility criteria: Inclusion Criteria:

* Patients infected with covid 19

Exclusion Criteria:

* allergy or contraindications to the drug

Primary outcomes:
measure: number of patients with virological cure
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Tanta University
Study officials:
affiliation: Tanta University Faculty of medicine
name: Sherief Abd-Elsalam, ass. prof.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04774406: Arterial Hypertension Related to PARP Inhibitors (ArteRIB)
Official title: Arterial Hypertension With PARP Inhibitors in Cancer Patients: an Observational and Retrospective Study Using the WHO Pharmacovigilance Database (ArteRIB)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cancer
Lead sponsor: University Hospital, Caen
Sponsor class: OTHER
First posted: 2021-03-01
Enrollment: 2336
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Cancer patients treated with PARPi and experiencing hypertension.

Brief summary: Although PARP inhibitors (PARPi) have proved effective in treating many cancers, few patients receiving PARPi may experience rare but serious (or not) adverse events such as hypertension whose data are scarce.

The objective was to investigate reports of hypertension related to PARPi, including olaparib, rucaparib, niraparib, talazoparib, veliparib, pamiparib, and fluzoparib using the World Health Organization's (WHO) pharmacovigilance database: VigiBase.

Detailed description: Here, investigators use the World Health Organization's (WHO) database of individual safety case reports, to identify cases of hypertension AE related to PARPi.

Eligibility criteria: Inclusion Criteria:

* case reported in the World Health Organization (WHO) database (VigiBase) of individual safety case reports at the time of the extraction,
* patients treated with at least 1 PARPi (with ATC classification system): olaparib (ATC L01XX46), niraparib (ATC L01XX54), rucaparib (ATC L01XX55), talazoparib (ATC L01XX60), veliparib, pamiparib, fluzoparib (none).

Exclusion Criteria:

-chronology not compatible between the PARPi and adverse event

Primary outcomes:
measure: hypertension reports related to PARPi.
timeFrame: From inception to 16 Feb, 2023
Secondary outcomes:
Other outcomes:
Locations:
city: Caen
country: France
facility: Alexandre Joachim
state: Basse Normandie
Study officials:
References:
Clinical trial NCT04007406: DP13 - A Phase II Study in Patients With Primary Aldosteronism
Official title: DP13 - A Phase II Study in Patients With Primary Aldosteronism to Evaluate the Efficacy, Safety and Tolerability of DP13, Over an 8-week Treatment Period
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Primary Aldosteronism
Keywords: Hyperaldosteronism
Lead sponsor: Damian Pharma AG
Sponsor class: INDUSTRY
First posted: 2019-07-05
Enrollment: 35
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: The purpose of the present phase II study is to determine whether DP13 displays the clinical safety and efficacy profile to support further development in patients with primary aldosteronism.

Detailed description: A phase II, multi-centre, randomized, parallel group, baseline-and withdrawal-controlled study in patients with primary aldosteronism to determine the dose-dependent efficacy, safety and tolerability of DP13 after a 2-week single-blind placebo run-in period followed by a randomized 8-week double-blind treatment period. After an additional single-blind, 2-week DP13 placebo withdrawal period, patients are switched to standard of care.

Eligibility criteria: Inclusion Criteria:

Patients with a guideline-recommended diagnosis of primary aldosteronism

Exclusion Criteria:

Patients with primary aldosteronism and

* hyperkalemia
* prolonged QT intervals
* refusal of special contraception measures

Primary outcomes:
measure: Change in Aldosterone-to-renin Ratio
timeFrame: 8 weeks
measure: Change in Ambulatory Systolic Blood Pressure
timeFrame: 8 weeks
Secondary outcomes:
measure: Change in Potassium
timeFrame: 8 weeks
measure: Change in Ambulatory Diastolic Blood Pressure
timeFrame: 8 weeks
measure: Change in 24-hour Urinary Tetrahydroaldosterone Content (uTHA)
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Torino
country: Italy
facility: Ospedale Molinette
Study officials:
affiliation: University of Torino, Torino, Italy
name: Paolo Mulatero, Prof
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00516906: Clinical Performance of a Chlorhexidine Antimicrobial Dressing
Official title: Clinical Performance of a Chlorhexidine Antimicrobial Dressing
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Catheterization
Lead sponsor: Solventum US LLC
Sponsor class: INDUSTRY
Collaborators: name: University of Nebraska
name: 3M
First posted: 2007-08-16
Enrollment: 68
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: Evaluate the clinical performance of a new IV Dressing in Comparison to a standard IV Dressing

Detailed description: Prospective, controlled, randomized, clinical trial comparing the 3M™ TegadermTM CHG (Chlorhexidine Gluconate) IV Securement Dressing (3M Healthcare, St Paul, MN) to a standard transparent dressing.

Eligibility criteria: Inclusion Criteria:

* Males or Females over 18 years of age
* Patients with an existing, or newly inserted, central venous catheter
* Patients who require the catheter for at least 3 days

Exclusion Criteria:

* Sensitivity to chlorhexidine

Primary outcomes:
measure: Clinician Overall Satisfaction With Catheter Securement
timeFrame: Daily up to 7 Days (average 3-7 days of wear)
Secondary outcomes:
measure: Clinician Overall Satisfaction With Dressing
timeFrame: Daily up to 7 Days (average 3-7 days of wear)
measure: Rating of Skin Condition
timeFrame: Daily up to 7 Days (average 3-7 days of wear)
Other outcomes:
Locations:
Study officials:
affiliation: Nebraska Medical Center
name: Mark E Rupp, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02539706: Menstrual Cycle on Injection Pain of Rocuronium
Official title: The Impact of the Menstrual Cycle on Injection Pain of Rocuronium
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain, Menstrual
Lead sponsor: Aydin Adnan Menderes University
Sponsor class: OTHER
First posted: 2015-09-03
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: This study evaluates the effects of rocuronium injection pain to menstrual cycle phases.Half of participants will receive follicular phase, while the other half will receive luteal phase.

Detailed description: Menstrual period includes a spectrum of emotional and somatic symptoms observed in luteal phase of menstrual cycle, which are disappeared after menstruation.

During menstrual cycle, fluctuation in sexual hormones results in attitude change and alteration in pain perception.

Different studies reported some interactions between sex hormones and central nervous system, which might be linked to activity of serotonin and beta-endorphin in the brain.

Pain perception differs during menstrual cycle.

It has been recommended that estrogens might have an influence on somatic sensory process.

Some studies reported a significant effect of pain sensitivity with higher levels of progesterone and some other studies reported similar patterns for pain perception.

There are reports of more complaint of pain in luteal phase of menstruation, which is suggested as the reason for functional changes in women during menstrual cycle.

Eligibility criteria: Inclusion Criteria:

* American Society of Anesthesiology Classification (ASA) I-II
* 18-45 years
* Regular menstrual cycle

Exclusion Criteria:

* Irregular menstrual cycles
* Patients receiving hormones or drugs affecting the ovulatory cycle
* Amenorrhea
* Pregnancy
* Climacteric patients

Primary outcomes:
measure: Pain measure
timeFrame: 10 second
Secondary outcomes:
Other outcomes:
Locations:
city: Aydın
country: Turkey
facility: Adnan Menderes University Training and Research Hospital
Study officials:
affiliation: Adnan Menderes University,Faculty of Medicine, Department of Anesthesia
name: Adnan Menderes Univercity Medicine Faculty
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06017206: Intraopertive Hypotension and Postoperative Cardiovascular Complications Among Chinese Elderly Patients Undergoing Oncardiac Surgery : a Retrospective Cohort Study
Official title: Intraopertive Hypotension and Postoperative Cardiovascular Complications Among Chinese Elderly Patients Undergoing Oncardiac Surgery : a Retrospective Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypotension
Lead sponsor: Chinese PLA General Hospital
Sponsor class: OTHER
First posted: 2023-08-30
Enrollment: 35262
Sex: ALL
Minimum age (years): 65
Maximum age (years): 90
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: age ≥65 years old patients

Brief summary: To explore the relationship of intraoperative hypotension and perioperative cardiovascular complications in elderly noncardiac surgical patients


Eligibility criteria: Inclusion Criteria:

* Patients over 65 years
* Undergoing general anesthesia
* Inpatients who had noncardiac surgery between January 1, 2012 and August 31, 2019

Exclusion Criteria:

* ASA grade V
* Low-risk surgery (hysteroscopic and body surface surgery)
* Length of surgery ≤30 min
* Short operation interval (less than 3 days between procedures)
* Without intraoperative blood pressure value at 30s intervals
* Missing data on patient characteristics.

Primary outcomes:
measure: postoperative cardiovascular complications
timeFrame: 2012-1~2019-8
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06343506: Ankle Dorsiflexion Changes With Assisted Stretching Device
Official title: Ankle Dorsiflexion Changes With Assisted Stretching Device
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Physical Therapy Modality
Lead sponsor: Montana State University
Sponsor class: OTHER
First posted: 2024-04-02
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: Ankle range of motion is an important degree of freedom for performing activities of daily living. Limited range of ankle motion has been related to Achilles tendonitis, lower limb injury, and abnormal gait leading to overuse injury. While stretching and massage can help increase range of motion the amount and frequency of manual manipulation needed to affect range of motion is not accessible to an individual in their home. A new device has been developed to allow deep stretching of the ankle and surrounding muscles to help increase ankle dorsiflexion. This device can be used in an individual's home, without assistance, allowing more frequent stretching without increased visits to physical therapy. The goal of this study is to determine the effect of using this device during a course of treatment to improve ankle dorsiflexion in individuals with decreased ankle range of motion.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of limited ankle range of dorsiflexion by physical therapist

Exclusion Criteria:

* Inability to perform testing activities as described in the consent form by self-report
* Inability to perform daily stretching with the device by self-report

Primary outcomes:
measure: Ankle Range of Motion
timeFrame: Following 3 Weeks of Device Use
Secondary outcomes:
measure: Ankle Strength
timeFrame: Following 3 Weeks of Device Use
Other outcomes:
Locations:
city: Bozeman
country: United States
facility: Neuromuscular Biomechanics Laboratory
state: Montana
Study officials:
affiliation: Montana State University
name: Corey Pew, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06285006: Desmopressin Monotherapy for Monosymptomatic Nocturnal Enuresis
Official title: Predictors of Success and Relapse After Desmopressin Monotherapy for Monosymptomatic Nocturnal Enuresis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Nocturnal Enuresis
Keywords: Nocturnal enuresis
Desmopressin
Monotherapy
Lead sponsor: Al-Azhar University
Sponsor class: OTHER
First posted: 2024-02-29
Enrollment: 50
Sex: ALL
Minimum age (years): 7
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Nocturnal Enuresis (NE) is defined as the involuntary passage of urine during sleep past the age of usual control, which is considered a developmental age of 5 to 7 years.

NE is a common problem that causes distress to both children and their families. It has an adverse impact on behavior and social life, affects self-esteem, and can result in poor emotional well-being. In Egypt, the prevalence of NE in primary school children is about 15.4%. The family history was seen to have had a markedly significant impact on the occurrence of NE in the studied children. The mainstay of treatment is urotherapy with information and psychoeducation about normal lower urinary tract function, the underlying cause of MNE, disturbed bladder dysfunction in the child with NMNE, and instructions about therapeutic strategies. Alarm therapy and desmopressin are effective in randomized trials. Children with NMNE first need treatment of the underlying daytime functional bladder problem before treatment of nocturnal enuresis.


Eligibility criteria: Inclusion Criteria:

* School age group (from 7 to 14 years)
* Primary monosymptomatic nocturnal enuresis

Exclusion Criteria:

Patients with one or more of the following will be excluded from the study.

* Diurnal enuresis
* Urinary tract infection within the preceding 3 months
* Diabetes mellitus
* History of renal disease, hypertension or genitourinary abnormality, neurological disease, or psychological disease.
* Post-micturition residual urine \>1/3 expected bladder capacity.
* Each patient will be subjected to the following.

Primary outcomes:
measure: The number of episodes per week after desmopressin treatment
timeFrame: After the end of the treatment for one month.
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Alazhar university
Study officials:
References: