louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01656512: Zometa Study in Pediatric Acute Lymphoblastic Leukemia
Official title: Analysis of Outcome of Bisphosphonate Use in Children With ALL- "Case Controlled Study"
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Osteoporosis
Keywords: ALL
zoledronic acid
Osteoporosis
Lead sponsor: Children's Cancer Hospital Egypt 57357
Sponsor class: OTHER
First posted: 2012-08-03
Enrollment: 95
Sex: ALL
Minimum age (years): 5
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Acute Lymphoblastic Leukemia (ALL) is the most common malignancy in children. It accounts for one fourth of all childhood cancers \& 74 % of childhood leukemia. Based upon drug registry data, children prescribed more than three courses of systemic glucocorticoids yearly faced a 20% increase in age-adjusted fracture rates. Rapid recovery occurred once glucocorticoids were discontinued, and fracture rates returned to expected for age by 1 year after treatment (Journal Of Clinical Endocrinology \& Metabolism 2009). The investigators will study the role of bisphosphonates in the prevention of secondary osteoporosis in children \& adolescents treated for ALL in the Children's Cancer Hospital -Egypt.


Eligibility criteria: Inclusion Criteria:

* Age above 5 \& below 18 years at the time of diagnosis.
* Newly diagnosed ALL patients.
* Not previously treated, previous steroid intake not more than 72 hours.
* Treated according to St Judy study XV protocol.

Exclusion Criteria:

* Previous steroid intake more than 72 hours.
* Less than 5 years

Primary outcomes:
measure: Measure the change in the Bone densitometry due to secondary osteoporosis
timeFrame: 1- At baseline ( not more than 48 hours of start of therapy with steroids) 2- At week 48 3- At end of treatment ( week 120 for girls ) & ( week 146 for boys) 4-As required clinically eg: fractures .
Secondary outcomes:
measure: - To assess the percentage change in lumbar spine BMD at wk 48 relative to baseline in both arms.
timeFrame: week 48 continuation phase
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Children's Cancer Hospital Egypt 57357
Study officials:
affiliation: Children's Cancer Hospital Egypt 57357
name: Shimaa Samir, MBBCH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01201512: CONDOR Temporomandibular Muscle and Joint Disorders (TMJD) Survey
Official title: Primary Care Management for TMJD Pain
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Temporomandibular Disorders
Keywords: TMJD pain
feasibility
Lead sponsor: Dental Practice-Based Research Network
Sponsor class: NETWORK
Collaborators: name: National Institute of Dental and Craniofacial Research (NIDCR)
name: HealthPartners Institute
name: Kaiser Permanente
name: Permanente Dental Associates Group, Oregon
First posted: 2010-09-14
Enrollment: 503
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The questionnaire was administered to all enrolled DPBRN dentist practitoner-investigators (general dentists or specialists), defined as those who had completed a DPBRN Enrollment Questionnaire who were 22 years or older.

Brief summary: The purpose of study was to characterize using an online questionnaire the feasibility of recruiting dentists in primary care dental practices in the practice-based research network and documenting their current initial care for their TMJD pain patients.

Detailed description: The overall goal of this project was to collect data to be used in preparing an application for a Clinical Trial Planning Grant and then in designing a subsequent Phase III clinical trial. The ultimate goal of this series of research projects is to determine the most practical approach to conduct a randomized clinical trial (RCT) to evaluate initial intervention for patients with painful temporomandibular muscle and joint disorders (TMJD) using NIDCR's Collaboration of Networked Dental and Oral Health Research (CONDOR) group consisting of three dental Practice-Based Research Networks: The Dental Practice-Based Research Network (DPBNR), Northwest Practice-Based Research Collaborative in Evidence-based Dentistry (PRECEDENT), and Practitioners Engaged in Applied Research and Learning (PEARL).

Eligibility criteria: Inclusion Criteria:

* DPBRN dentist practitioner-investigator (general dentists or specialists) who had completed a DPBRN Enrollment Questionnaire
* 22 years of age or older

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
Study officials:
affiliation: The University of Alabama at Birmingham
name: Gregg H Gilbert, DDS, MBA
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Minnesota
name: Eric Schiffman, DDS
role: STUDY_CHAIR
References:
Clinical trial NCT01499212: Effects of Different I:E Ratio on Intrapulmonary Shunt Fraction and Oxygenation During One Lung Ventilation in the Lateral Decubitus Position
Official title: Effects of Different Inspiratory to Expiratory Ratios on Intrapulmonary Shunt Fraction and Oxygenation During One Lung Ventilation in the Lateral Decubitus Position
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lung Cancer
Lung Lobectomy
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2011-12-26
Enrollment: 58
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to investigate effect of increasing inspiratory time (I:E ratio 1:1) on intrapulmonary shunt fraction and oxygenation during one lung ventilation in the lateral decubitus position.

Detailed description: Increasing inspiratory time(e.g. Inverse ratio ventilation) has been known that had advantage of alveolar recruitment, preventing of ateletasis. On the contrary, it has disadvantange of intrinsic PEEP, air trapping. There is few study on one lung ventilation in lateral decubitus position about this ventilation method. We were going to investigate effecf of this ventilation method.

Eligibility criteria: Inclusion Criteria:

* ASA physical status class I, II
* Use of Double lumen tube
* Unilateral lung lobectomy

Exclusion Criteria:

* COPD
* CAOD
* Unstable hemodynamic status
* Peak airway pressure \> 30mmHg (Two lung ventilation)

Primary outcomes:
measure: intrapulmonary shunt fraction
timeFrame: T1 (10min before one lung ventibation)T2 (30min after one lung ventilation started)T3 (60min after one lung ventilation started)T4 (10min after two lung ventilation)
Secondary outcomes:
measure: Respiratory dynamic parameters
timeFrame: T1,T2,T3,T4 (same as primary outcome measure)
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Department of Anaesthesiology and Pain Medicine, Anaesthesia and Pain Research Institute, Yonsei University College of Medicine
Study officials:
affiliation: Department of Anaesthesiology and Pain Medicine, Anaesthesia and Pain Research Institute, Yonsei University College of Medicine, Seoul, Korea
name: Young Jun Oh, MD,PhD
role: STUDY_CHAIR
References:
Clinical trial NCT03863912: Impact of Disney Movies During Chemotherapy on QOL of Gynecologic Oncology Patients
Official title: Impact of Disney Movies During Chemotherapy on QOL of Gynecologic Oncology Patients: A Prospective Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ovarian Cancer
Chemotherapy
Quality of Life
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2019-03-05
Enrollment: 56
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: To evaluate the impact of Disney movies on quality of life (QOL) of gynecologic oncology patients.

25 Patients are watching Disney movies on portable DVD players during chemotherapy, 25 patients are not allowed to watch TV.

EORTC QLQ-C30 and EORTC QLQ-FA12 surveys are given to the patients before and after the six chemotherapies.

Hypothesis: Disney movies can elevate patients QOL.


Eligibility criteria: Inclusion Criteria:

* planned 6 cycles of chemotherapy with carboplatin/paclitaxel or carboplatin/pegylated liposomal doxorubicin
* Age \>18 years

Exclusion Criteria:

* inadequate knowledge of the German language

Primary outcomes:
measure: Change of Quality of life during 6 cycles of chemotherapy
timeFrame: Measured before and after each chemotherapy (at baseline and on average after 3, 6, 9, 12, 15 weeks after inclusion in patients with carboplatin/paclitaxel or after 4, 8, 12, 16, 20 weeks after inclusion in patients with carboplatin/doxorubicin)
measure: Change of Fatigue during 6 cycles of chemotherapy
timeFrame: Measured before and after each chemotherapy (at baseline and on average after 3, 6, 9, 12, 15 weeks after inclusion in patients with carboplatin/paclitaxel or after 4, 8, 12, 16, 20 weeks after inclusion in patients with carboplatin/doxorubicin)
Secondary outcomes:
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Medical University of Vienna
Study officials:
affiliation: Medical University of Vienna, Department of General Gynecology and Gynecologic Oncology
name: Sophie Pils, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Pils S, Ott J, Reinthaller A, Steiner E, Springer S, Ristl R. Effect of Viewing Disney Movies During Chemotherapy on Self-Reported Quality of Life Among Patients With Gynecologic Cancer: A Randomized Clinical Trial. JAMA Netw Open. 2020 May 1;3(5):e204568. doi: 10.1001/jamanetworkopen.2020.4568.
Clinical trial NCT04485312: Chance to Avoid New Caries by Adding Chlorhexidine to the Preventive Protocol in Adolescent Special Needs
Official title: Chance to Avoid New Caries by Adding Chlorhexidine Containing Chemotherapeutic Agent to the Conventional Preventive Protocol for Patients With Special Needs
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Disabilities Multiple
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2020-07-24
Enrollment: 22
Sex: ALL
Minimum age (years): 13
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Adolescent Special need individuals are most need of easy forms of antibacterial agents, so in this study, using chemotherapeutic agents like the newly introduced varnish containing chlorhexidine seems to be a quite promising tool for local delivery to patients with special needs . Chlorhexidine is a wide spectrum very effective bactericidal used for years against the oral flora while fluorides are well known with their antibacterial ability. This may be an excellent way to reduce the risk assessment in adolescent special needs patients.

Detailed description: Participants will be divided into two groups according to the tested regimen, where (A1) represents participants exposed to risk based conventional protocol, (A2) represents participants exposed to chlorhexidine containing varnish and risk based conventional preventive protocol. The study will be carried over a period of 10 months (one academic year), the study will be divided into three phases Phase I: Information of the Cariogram parameters (caries experience, diet content, diet frequency, plaque amount, mutans streptococci, fluoride program, saliva secretion and saliva buffer capacity) will be collected, which will be used to generate the individual caries profile, based on which the participants will be divided into 2 risks groups. Phase II: Risk based preventive program will be implemented including the restorative part. Phase III: At the end of 10 months, caries profile will be generated again

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of disability like : autism and down syndrome.
* Must be able to open his/her mouth for varnish application

Exclusion Criteria:

* systemically unhealthy patients with fetal diseases
* Age below 13 and above 18

Primary outcomes:
measure: chance to avoid new caries
timeFrame: 10 months
Secondary outcomes:
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: School
Study officials:
affiliation: cairo U
name: katreen tawfik, master
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03210012: Bubbles, Stress, Diastole
Official title: Bubbles, Stress, Diastole
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Diastolic Dysfunction
Endothelial Dysfunction
Lead sponsor: Clinica ARS Medica
Sponsor class: OTHER
First posted: 2017-07-06
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healty volunteer divers

Brief summary: This is a monocentric pilot study to assess the safety profile of a 30-meter deep underwater diving using 3 different type of gas mixtures: AIR (21% O2 and 79% N2), NITROX 32 (32% O2 And 68% N2) and TRIMIX (21% O2, 44% N2 and 35% He).

Detailed description: The participants will be measured for vital parameters, blood samples and transthoracic cardiac ultrasound before diving (baseline).

Participants will be requested to perform recreational dive, which does not require particular decompression stops, at a depth of 30 meters with a 30 minutes botton time. 20 minutes after dive the same measurements as baseline will be repeated, once at rest and once after a physical effort by performing a series of 10 bending on the legs (squats). The day after dive, the participants will be interviewed by phone (FOLLOW-UP) by a physician. It will be required to report any unusual event, MDD symptom, or neurological complication.

Same procedure will be repeated with three different type of blends (AIR, NITROX, TRIMIX).

Eligibility criteria: Inclusion Criteria:

* Age 18 - 60
* healthy subjects
* body mass BMI \< a 30
* physical status ASA 1

Exclusion Criteria:

* subjects with significant clinical impairments such as important head trauma, general pain, low back pain, diabetes, asthma, cardiac and coagulation dysfunctions
* pregnant women
* participation in another study in the last 3 months
* use of drugs and alcohol
* smoking
* psychiatric disorder

Primary outcomes:
measure: Best gas mixture
timeFrame: 1 month
Secondary outcomes:
measure: diastolic function evaluation
timeFrame: 1 month
Other outcomes:
Locations:
city: San Nazzaro
country: Switzerland
facility: Salvataggio Sub Gambarogno
Study officials:
References:
Clinical trial NCT05452512: Medication Adherence Monitoring Trial Using Smart Clinical Trial Application and Smart Watch
Official title: An Open, Randomized and Parallel-design Exploratory Clinical Trial to Evaluate the Effect of Smart Medication Adherence Monitoring on the Medication Adherence and Blood Vitamin D Concentration
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Compliance, Medication
Keywords: smart device
compliance monitoring
vitamin D
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2022-07-11
Enrollment: 16
Sex: ALL
Minimum age (years): 19
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The study will investigate the effect of smart monitoring on medication adherence.

Detailed description: In this study, multiple medication monitoring procedures will be performed: self-reporting, pill counting, smart monitoring and concentration monitoring. Subjects will take vitamin D supplement on the market which enables validated concentration monitoring. The study will last for 3 months.

Eligibility criteria: Inclusion Criteria:

* Adults aged 19-64 years at the consent
* 25(OH) vitamin D \< 10 ng/mL
* Not taking vitamin D at the screening
* Fully understood the study procedures

Exclusion Criteria:

* Hypercalciuria, sarcoidosis
* Clinically significant hypersensitivity reaction to Vitamin D
* History of or current kidney stone
* One of the following findings:

  1. Serum calcium level \> upper limit of normal
  2. Estimated glomerular filtration rate \< 60 mL/min/1.73m\^2
* Galactose intolerance, Lapp lactase deficiency, Glucose-galactose malabsorption
* Unable to use smart clinical trial application or smart watch
* Expected to take vitamin D from 4 weeks before the first administration and until the last administration

Primary outcomes:
measure: The percentage of prescribed doses taken
timeFrame: 3 months
measure: The percentage of days with correct dosing
timeFrame: 3 months
Secondary outcomes:
measure: The percentage of days with correct dosing window
timeFrame: 3 months
measure: Days without medication intake during a time period longer than 24 h
timeFrame: 3 months
measure: Mean difference between administration time point and the mode of administration time point
timeFrame: 3 months
measure: Sum of deviations divided by the number of days
timeFrame: 3 months
measure: Serum concentration of vitamin D
timeFrame: 3 months (Day 1, 15, 29, 43, 57, 71, 85)
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital Clinical Trial Center
Study officials:
affiliation: Seoul National University Hospital Clinical Trial Center
name: Heejin Kim, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00902512: Study Of Bioavailability Of Two Sildenafil 100mg Oral Tablet Formulations
Official title: Relative Bioavailability Of Two Sildenafil 100mg Oral Tablet Formulations In Healthy Volunteers Under Fasting Conditions.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Healthy Males
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
Collaborators: name: Investigacion Farmacologica y Biofarmaceutica, S.A. de C.V.
First posted: 2009-05-15
Enrollment: 30
Sex: MALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: the pharmacokinetics of sildenafil following single doses of sildenafil CT administered with and without water is similar relative to the conventional oral tablet of sildenafil administered with water.


Eligibility criteria: Inclusion Criteria:

* Only healthy male volunteers in the 18-40 age range will be included.
* At the selection visit allowed normal range for vital signs will be: Blood pressure (with the subject sitting down) 90-130mm Hg systolic and 60-90
* The volunteers' health condition will be determined from their complete clinical history by doctors at the clinical research site and lab test results by certified clinical laboratories mm Hg diastolic, heart rate 55-100 bpm , respiratory rate 14-20 respirations per minute.

Exclusion Criteria:

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing) disease or clinical findings at Screening.
* Treatment with a PDE-5 inhibitor within the 4 days preceding the first dose of study medication
* History of hypersensitivity to sildenafil citrate or any components of its formulations

Primary outcomes:
measure: AUC0-T and Cmax of sildenafil
timeFrame: 28 days
Secondary outcomes:
measure: AUC0-inf of sildenafil
timeFrame: 28 days
measure: Tmax and half-life of sildenafil
timeFrame: 28 days
measure: Adverse events and vital signs
timeFrame: 28 days
Other outcomes:
Locations:
city: Col. Arenal Tepepan
country: Mexico
facility: Pfizer Investigational Site
state: Mexico D.F.
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT00504712: Testosterone for Peripheral Vascular Disease
Official title: A Randomised, Double Blind, Placebo Controlled, Parallel Pilot Study to Test the Effect of Testosterone Treatment on Peripheral Vascular Disease in Hypogonadal Men With Type 2 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hypogonadism
Peripheral Vascular Disease
Type 2 Diabetes
Keywords: Testosterone
Hypogonadism
Diabetes
PVD
RCT
Lead sponsor: Barnsley Hospital
Sponsor class: OTHER
First posted: 2007-07-20
Enrollment: 24
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: There is increasing evidence of the linkage of type 2 diabetes with low testosterone levels in men.

Detailed description: Testosterone treatment has shown beneficial effects on blood sugar control and obesity in pilot studies in men with type 2 diabetes. Beneficial effects have also been seen on angina- a disease related to atherosclerosis (narrowing of the arterial blood vessels). Peripheral vascular disease is also caused by atherosclerosis. We hypothesise that testosterone will have beneficial effects on peripheral vascualr disease in men with low serum testosterone and type 2 diabetes.

Eligibility criteria: Inclusion Criteria:

1. Type 2 diabetes mellitus.
2. Serum testosterone 12 nmol/L or less on two consecutive samples taken on different days and symptoms compatible with hypogonadism.
3. Peripheral vascular disease as defined by

   * previous diagnosis by a specialist vascular surgeon OR
   * ABPI less than 0.92 and ischaemic leg pain (claudication or rest pain) or distal complications (non-healing arterial foot ulcer or gangrene).
4. Agreement to maintain antihypertensive and antilipid treatments at prior doses during 3 month duration of study.
5. Ability to give written informed consent after verbal and written explanation in the English language.
6. Ability to comply with all study requirements.

Exclusion Criteria:

1. Current or previous breast cancer.
2. Current or previous prostate cancer.
3. Raised prostate specific antigen (PSA) or abnormal per rectal examination unless prostate cancer excluded after specialist urology opinion.
4. Severe symptoms of benign prostatic hypertrophy ('prostatism')
5. Treatment with testosterone in the 3 months prior to the trial.
6. Investigational drug treatment in the 3 months prior to the trial.

Primary outcomes:
measure: Change in Arterial Stiffness
timeFrame: Baseline, 12 weeks, and 26 weeks
Secondary outcomes:
measure: Change in IMT
timeFrame: Baseline, 12 weeks, and 26 weeks
Other outcomes:
Locations:
city: Barnsley
country: United Kingdom
facility: Barnsley Hospital NHS Foundation Trust
state: South Yorkshire
Study officials:
affiliation: Barnsley Hospital
name: Thomas H Jones
role: PRINCIPAL_INVESTIGATOR
References: