louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01282840: Bladder Wall Blood Perfusion Pattern and Sexual Dysfunction in Female Patients With Lower Urinary Tract Symptoms, and the Association of That Perfusion Pattern and Therapeutic Efficacy of Antimuscarincs for Female Overactive Bladder Syndrome.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lower Urinary Tract Symptoms
Keywords: LUTS
Lead sponsor: Far Eastern Memorial Hospital
Sponsor class: OTHER
Collaborators: name: National Science and Technology Council, Taiwan
First posted: 2011-01-25
Enrollment: 676
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Overactive bladder syndrome (OAB) affects around 17 % of female population. However, the etiology of OAB is complicated and unclear in many aspects. Bladder wall thickness had been reported to be strongly associated with OAB, but its use as a screening tool remains controversial. Besides, few studies reported patterns of sexual dysfunction in female patients with lower urinary tract symptoms (LUTS). Therefore the aims of our study were to analyze the bladder wall blood perfusion pattern in female LUTS patients, the association of between the bladder wall blood perfusion pattern and the efficacy of anti-muscarinic treatment for female OAB, and the patterns of sexual dysfunction in the female LUTS patients.


Eligibility criteria: Inclusion Criteria:

* all cases are female patients with lower urinary tract symptoms

Exclusion Criteria:

* nil

Primary outcomes:
measure: Blood flow pattern after antimuscarinics
timeFrame: 12 weeks
Secondary outcomes:
measure: Blood flow patterns between different LUTS subgroups
timeFrame: 1 day
Other outcomes:
Locations:
city: New Taipei
country: Taiwan
facility: Far Eastern Memorial Hospital
state: Banqiao
Study officials:
References:
Clinical trial NCT03466840: Comparison of Coronally Advanced Lingual Flap to Modified MPI for Flap Advancement in Partially Edentulous Patients
Official title: Clinical Assessment of Coronally Advanced Lingual Flap to Modified Periosteal Releasing Incision for Flap Advancement in Partially Edentulous Patients Undergoing Guided Bone Regeneration Using Titanium Mesh.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Alveolar Bone Loss
Keywords: Ridge Augmentation
Titanium mesh
Flap advancement
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2018-03-15
Enrollment: 7
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Comparison of cronally advanced lingual flap to modified periosteal releasing incision (MPRI)

Detailed description: Clinical Assessment and Comparison of Coronally Advanced Lingual Flap to Modified Periosteal Releasing Incision for Flap Advancement in Partially Edentulous Patients Undergoing Guided Bone Regeneration Using Titanium Mesh: A Randomized Clinical Trial

Eligibility criteria: Inclusion Criteria:

* Partially edentulous patients in the mandibular posterior region.
* Patients with healthy systemic condition.
* Insufficient ridge width (\< 5mm).
* Presence of proper inter-arch space for placement of the implant prosthetic part.
* Adequate soft tissue biotype (≥ 2 mm).

Exclusion Criteria:

* Patients with systemic conditions that may interfere with the results of the study.
* Patients with local pathological defects related to the area of interest.
* Unmotivated, uncooperative patients with poor oral hygiene.
* Patients with habits that may jeopardize the implant longevity and affect the results of the study such as smoking, alcoholism or para-functional habits.

Primary outcomes:
measure: Flap advancement
timeFrame: "10 minutes"
Secondary outcomes:
measure: Postoperative Pain
timeFrame: 1 Week
measure: Postoperative membrane exposure
timeFrame: 12 Weeks
measure: bone density
timeFrame: 12 Weeks
measure: postoperative swelling
timeFrame: "1 week"
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Noha Diab
Study officials:
affiliation: Cairo, Egypt, 02
name: Egypt Recruiting
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00909740: A Study of the Safety and Pharmacokinetics of MEGF0444A Administered to Patients With Advanced Solid Tumors
Official title: A Phase I, Open-Label, Dose-Escalation Study of the Safety and Pharmacokinetics of MEGF0444A, Administered Intravenously to Patients With Advanced Solid Tumors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Solid Cancers
Keywords: Solid Tumor
Cancer
Lead sponsor: Genentech, Inc.
Sponsor class: INDUSTRY
First posted: 2009-05-28
Enrollment: 30
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: This is a Phase I, first-in-human, open-label, dose-escalation study of MEGF0444A administered by IV infusion to patients with advanced solid tumors for whom standard therapy either does not exist or has proven to be ineffective or intolerable.


Eligibility criteria: Inclusion Criteria:

* Histologically or cytologically documented, incurable, or metastatic solid malignancy that has progressed on, or failed to respond to regimens or therapies known to provide clinical benefit

Exclusion Criteria:

* Inadequate hematologic and organ function
* Anti-cancer therapy within 4 weeks prior to initiation of study treatment
* Adverse events from prior anti-cancer therapy that have not resolved to Grade ≤ 1, except for alopecia
* Active infection or autoimmune disease
* Pregnancy (positive pregnancy test) or lactation

Primary outcomes:
measure: Incidence and nature of dose-limiting toxicities (DLTs)
timeFrame: Days 1-21 of cycle 1
measure: Incidence, nature, relatedness, and severity of adverse events
timeFrame: Day 1 to study completion
Secondary outcomes:
measure: Pharmacokinetic parameters including total exposure, minimum and maximum serum concentration, clearance, and volume of distribution
timeFrame: Following administration of study drug
Other outcomes:
Locations:
Study officials:
affiliation: Genentech, Inc.
name: Louie Naumovski, M.D., Ph.D.
role: STUDY_DIRECTOR
References:
Clinical trial NCT04954040: Prevention and Treatment With Hydroxychloroquine + Azithromycin of Acute Respiratory Syndrome Induced by COVID-19
Official title: Clinical Trial for the Prevention and Treatment With Hydroxychloroquine + Azithromycin of Acute Respiratory Syndrome Induced by COVID-19
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Acute Respiratory Distress Syndrome
Covid19
Keywords: acute respiratory syndrome
SARS-CoV-2
COVID19
hydroxychloroquine
azithromycin
COVID19 symptoms
Lead sponsor: Maimónides Biomedical Research Institute of Córdoba
Sponsor class: OTHER
First posted: 2021-07-08
Enrollment: 132
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: TREATMENT

Brief summary: Multi-centered, randomized, open label clinical trial to study the safety and effectivity of hydroxychloroquine + azithromycin to treat COVID-19 symptoms in primary care patients.

Detailed description: In the patient group treated with hydroxychloroquine + azithromycin we expect to find a diminution of 20% or more regarding the evolution of acute respiratory syndrome, as opposed to patients who have not been treated with these medicines.

To date, there is no shown effective treatment regime for acute respiratory distress caused by COVID-19.

Eligibility criteria: Inclusion Criteria:

* Patients with positive semi-quantitative PCR and COVID19 symptoms (fever, cough, diarrhea, dyspnoea, loss of smell).
* Signed informed consent

Exclusion Criteria:

* Retinal degeneration.
* Congenital or acquired long QT syndrome.
* Advanced liver failure.
* Renal insufficiency (incompatible with creatinine clearance less than 50 mL /minute).
* Allergic to hydroxychloroquine or azithromycin.
* Serious interaction with the drugs used.
* Pregnant or breastfeeding.
* Men and women in fertile and sexually active periods, who do not accept a highly effective contraceptive method.
* Inability to follow study procedures.

Primary outcomes:
measure: Hospitalization
timeFrame: From randomization until patient's hospitalization happens, assessed up to 28 days.
measure: ICU admission
timeFrame: From date of randomization until ICU admission as a result of COVID19, assessed up to 28 days.
measure: Death
timeFrame: From randomization until death by any cause related to COVID19, assessed up to 28 days.
Secondary outcomes:
measure: Clinical Evolution
timeFrame: From randomization until healing, hospitalization or death. Symptoms will be evaluated every 24 hours for a minimum of 10 days and a maximum 28 days.
Other outcomes:
Locations:
city: Priego de Córdoba
country: Spain
facility: Centro de Salud Priego de Córdoba
state: Córdoba
Study officials:
References:
Clinical trial NCT00423540: Exploring the Role of Magnesium in Rest Cramps
Official title: Magnesium Status & Effect of Magnesium Infusions on Rest Cramps
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rest Cramps
Keywords: magnesium infusion
magnesium sulfate
rest cramps
nocturnal leg cramps
muscle cramps
fractional urinary excretion
urinary excretion
24 hour urine
serum magnesium
magnesium deficiency
family practice
general practice
richmond
cramp frequency
magnesium status
urinary magnesium
cramp diary
sf 36
Lead sponsor: University of British Columbia
Sponsor class: OTHER
Collaborators: name: Vancouver Coastal Health Research Institute
First posted: 2007-01-18
Enrollment: 54
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study sets out to show whether infusions of magnesium can lessen the frequency of rest cramps and to determine whether rest cramp sufferers have a deficiency in magnesium.

Detailed description: Subjects will be randomized to receive 5 days of 4 hour IV infusions of D5W either with or without 20 mmol magnesium sulfate added. Twenty four hour urinary excretion of magnesium will be determined on the first day of infusions to assess whether magnesium deficiency is present. Ten normal controls will also undergo a single infusion and collection of urine to serve as a comparison group for the urinary excretion data.

Eligibility criteria: Inclusion Criteria:

* ≥2 leg or foot cramps per week in a 4 week run-in diary

Exclusion Criteria:

* eGFR\<50
* Neurologic disease
* Pregnancy
* Heart block
* Bradyarhythmia without pacemaker
* Digoxin use
* Liver disease
* Addison's disease
* History of MI
* CHF
* Absence of detectable reflexes

Primary outcomes:
measure: Change in the frequency of leg cramps per week (active versus placebo) over the first 30 days post infusions compared to the 30 days prior to randomization (as recorded in patient diaries).
timeFrame: See above
Secondary outcomes:
measure: Assessment of magnesium status at trial entry as determined by 24 hour fractional excretion of magnesium on day 1 of infusions.
measure: Subjective assessment as to whether cramps were unchanged, more, or less frequent /painful/"bothersome" over the 3 months. following infusions.
timeFrame: See above
measure: Overall quality of life changes as measured by an SF36 questionnaire.
Other outcomes:
Locations:
city: Richmond
country: Canada
facility: Richmond Hospital
state: British Columbia
Study officials:
affiliation: University of British Columbia
name: Garrison Scott, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02803840: Low-dose Radiotherapy for Diffuse Large B-cell Lymphoma
Official title: A Phase II Trial of Low-Dose Radiotherapy for the Palliation of Patients With Diffuse Large B-cell Lymphoma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Lymphoma
Keywords: Large B-Cell
Diffuse
Lead sponsor: Centro di Riferimento Oncologico - Aviano
Sponsor class: OTHER
First posted: 2016-06-17
Enrollment: 25
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: Patients with Diffuse Large B-cell Lymphoma with indication for palliative radiotherapy are treated with low-dose radiation (2 x 2 Gy) to the symptomatic sites only. The primary endpoint of the study is the response rate and Quality of Life of the patients (QoL).

Detailed description: Response is planned at 21-day after completion of the treatment. Response assessment is based on the standard definitions of the World Health Organization using complete response (CR), partial response (PR), stable disease (SD), and progressive disease (PD) as response assessment criteria. The efficacy of the treatment consisted of a reduction greater than 50% of the maximum diameter of the radiated mass (PR + CR). QoL is evaluated using the European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 3.0 version questionnaire. The QLQ-C30 questionnaire is self administered to the patients at baseline and at 21 days after treatment.

Eligibility criteria: Inclusion Criteria:

* Patients with histologically proven diagnosis of DLBCL with indication for palliative radiotherapy

Exclusion Criteria:

* None

Primary outcomes:
measure: Response rate
timeFrame: Clinical response up to 21 days after treatment
Secondary outcomes:
measure: Quality of life according to the EORTC QLQ-C30 questionnaire
timeFrame: The QLQ-C30 questionnaire is administered at baseline and at 21 days after treatment
Other outcomes:
Locations:
city: Aviano
country: Italy
facility: Centro di Riferimento Oncologico
state: Pordenone
Study officials:
affiliation: Centro di Riferimento Oncologico - Aviano
name: Carlo Furlan, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04336540: Increasing Availability of Lower Energy Meals vs. Menu Energy Labelling on Food Choice
Official title: Socioeconomic Position and the Impact of Increasing Availability of Lower Energy Meals vs. Menu Energy Labelling on Food Choice in Virtual Full-service Restaurants: Two Randomized Control Trials
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nutrition Poor
Obesity
Diet, Healthy
Food Selection
Lead sponsor: University of Liverpool
Sponsor class: OTHER
First posted: 2020-04-07
Enrollment: 2091
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Two randomized control trials examining human food choice (i.e. selection of high energy 'unhealthy' foods vs. selection of healthier foods). Interventions: In a between-subjects design, participants (recruitment stratified by socioeconomic position) made food choices (main dish, plus optional sides and desserts) in the absence vs. presence of menu energy labelling and from menus with baseline (10%) vs. increased availability (50%) of lower energy main dishes. Main outcome measures: Average energy content (kcal) of main dish chosen and average total energy content of all food ordered, including optional sides and desserts.

Detailed description: See attached protocol documents.

Eligibility criteria: Inclusion Criteria:

* Participants were eligible to participate if they were US residents, aged of 18 or above, fluent in English, had access to a computer with an internet connection and had no dietary restrictions

Exclusion Criteria:

* See above.

Stratification Criteria:

- We aimed to recruit a sample stratified by gender (approx. 50/50) and highest educational qualification (approx. 40% high school or less, 60% above high school) to be broadly representative of US adults.

Primary outcomes:
measure: Energy ordered from main menu
timeFrame: 15-20 minutes (the time frame denotes time taken to make the menu order and there is no follow up
Secondary outcomes:
measure: Total energy ordered
timeFrame: 15-20 minutes (the time frame denotes time taken to make the menu order and there is no follow up
Other outcomes:
Locations:
city: Liverpool
country: United Kingdom
facility: University of Liverpool
state: Merseyside
Study officials:
affiliation: University of Liverpool
name: Eric Robinson, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Marty L, Reed SM, Jones AJ, Robinson E. Increasing availability of lower energy meals vs. energy labelling in virtual full-service restaurants: two randomized controlled trials in participants of higher and lower socioeconomic position. BMC Public Health. 2021 May 25;21(1):975. doi: 10.1186/s12889-021-11007-0.
Clinical trial NCT01272440: A Drug Monitoring Study on PEG-asparaginase Treatment in Children Diagnosed Acute Lymphoblastic Leukaemia
Official title: PEG-asparaginase Treatment in the NOPHO ALL-2008 Protocol: Antibody Formation, Pharmacokinetics, Pharmacodynamics and Side Effects.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Acute Lymphoblastic Leukaemia
Keywords: PEG-asparaginase
children
pharmacokinetics
antibodies
acute lymphoblastic leukaemia
adverse effects
Lead sponsor: Aarhus University Hospital
Sponsor class: OTHER
First posted: 2011-01-07
Enrollment: 200
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children aged between 1 and 18 years old, diagnosed ALL and treated according to the NOPHO-ALL 2008 protocol

Brief summary: Asparaginase is an important drug i the treatment of childhood leukaemia.

The aim of this project is to study the pharmacokinetics, pharmacodynamics and antibody development and hypersensitivity reactions during prolonged PEG-asparaginase treatment.

Study part 1) Asparaginase pharmacokinetics and pharmacodynamics during prolonged PEG-asparaginase treatment: A NOPHO ALL-2008 study

Study part 2) Asparagine depletion in cerebrospinal fluid: A NOPHO ALL-2008 study

Study part 3) A characterization of PEG-asparaginase hypersensitivity in children treated according to the NOPHO ALL 2008 protocol

Perspectives: New knowledge about PEG-asparaginase treatment regarding dosing, dosing interval, adverse effects and EFS, which may lead to improved future therapy

Patients: Children diagnosed with acute lymphoblastic leukaemia in the Nordic Countries


Eligibility criteria: Inclusion Criteria:

Children aged between 1 and 18 years old, diagnosed ALL and treated according to the NOPHO-ALL 2008 protocol and who have accepted to participate in this study

Exclusion Criteria:

Children that does not attend the NOPHO-ALL 2008 protocol but receives standard treatment

Primary outcomes:
measure: Asparagine depletion
timeFrame: Up to 30 weeks of treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Paediatric department, Skejby University hospital
Study officials:
affiliation: Aarhus University Hospital
name: Louise T Henriksen, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02424240: Growth Hormone (GH) Deficiency & Insulin Like Growth Factor 1 (IGF-I)/ Insulin Like Growth Factor Binding Protein 3 (IGFBP-3) Ratio
Official title: The Emerging Role of Serum IGF-I/IGFBP-3 Ratio in the Diagnosis of Children With Growth Hormone Deficiency
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diagnosis of GHD With IGF-I/IGFBP-3 Ratio
Lead sponsor: University of Jordan
Sponsor class: OTHER
First posted: 2015-04-22
Enrollment: 134
Sex: ALL
Minimum age (years): 4
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: yes
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 192 children presented to JUH outpatient endocrinology clinic for the evaluation of short stature (SS). The target population of our study was male and female children, aged 4-16 years, with short stature.

Brief summary: A 35-month cross-sectional observational study was conducted at an outpatient university hospital in Amman, Jordan. We obtained a comprehensive medical and laboratory evaluation for 134 short-statured children (64 boys and 70 girls, aged 4-16 years). Complete and partial growth hormone deficincy (GHD) were defined as peak forwth hormone (GH) response of 5 and 7 ng/ml \[IRMA/ DiaSorin®\], respectively in both clonidine stimulation and insulin tolerance tests. Serum IGF-I, IGFBP-3 and IGF-I/IGFBP-3 ratio were determined for all participants.


Eligibility criteria: Inclusion Criteria:

* children presented to Jordan Univeristy Hospital (JUH) outpatient endocrinology clinic for the evaluation of short stature (SS)

Exclusion Criteria:

(i) their parents could not provide written consent for them; (ii) they were lost to follow up; (iii) they could not perform clonidine stimulation tests (CST) or insulin tolerance test (ITT) due to a medical contraindication (e.g. cardiac disorder, seizure disorder); (iv) they had received GH therapy in the past; (v) they were known to have pituitary diseases, hypothyroidism, hypogonadism or discovered to have panhypopituitarism or (vi) they have malnutrition, diabetes mellitus, liver disease, or other chronic illnesses.

Primary outcomes:
measure: Serum IGF-1/IGFBP-3 ratio
timeFrame: 33 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: