louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03794908: Light Treatment to Improve Symptom Management of Fibromyalgia Syndrome
Official title: Bright Light Treatment at Home to Improve Symptom Management of Fibromyalgia Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fibromyalgia
FMS
Keywords: Circadian timing
Pain
Light
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: National Institute of Nursing Research (NINR)
First posted: 2019-01-07
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to determine the effect a morning light treatment has on improving physical function, pain intensity, and pain sensitivity in people with fibromyalgia syndrome (FMS).


Eligibility criteria: Inclusion Criteria:

• Meet criteria for Fibromyalgia syndrome (FMS)

Exclusion Criteria:

* Significant chronic disease
* Severe hearing or memory problems
* Pending medical leave applications at workplace
* Current pregnancy, breastfeeding, or actively trying to get pregnant
* Night work or travel outside the eastern time zone within 1 month of the study
* Other research participation
* Frequent number of special events during study period (weddings, concerts, exams, etc).

Primary outcomes:
measure: Fibromyalgia Impact Questionnaire, Revised (FIQ-R) Score
timeFrame: Baseline (1 week), Mid-Treatment (2 weeks post-baseline), Post-Treatment (4 weeks post-baseline)
Secondary outcomes:
measure: Heat Pain Threshold Assessed by the Heat Pain Sensitivity Test
timeFrame: Baseline (1 week), Mid-Treatment (2 weeks post-baseline), Post-Treatment (4 weeks post-baseline)
measure: Heat Pain Tolerance Assessed by the Heat Pain Sensitivity Test
timeFrame: Baseline (1 week), Mid-Treatment (2 weeks post-baseline), Post-Treatment (4 weeks post-baseline).
measure: Patient Reported Outcomes Measurement Information System (PROMIS) Pain Intensity Score
timeFrame: Baseline (1 week), Mid-Treatment (2 weeks post-baseline), Post-Treatment (4 weeks post-baseline).
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: The University of Michigan
state: Michigan
Study officials:
affiliation: University of Michigan
name: Helen Burgess
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00880308: Dose Finding and Safety of Oral LDE225 in Patients With Advanced Solid Tumors
Official title: A Phase I, Multicenter, Open-label, Dose-escalation Study of Oral LDE225 in Patients With Advanced Solid Tumors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Advanced Solid Tumor Cancers
Medulloblastoma
Basal Cell Carcinoma
Keywords: Advanced tumors
hedgehog
smoothened inhibitor
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2009-04-13
Enrollment: 103
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 first-in-human dose-escalation study is to characterize the safety, tolerability, pharmacokinetics and pharmacodynamics of LDE225 given orally on a daily dosing schedule in patients with advanced solid tumors.


Eligibility criteria: Inclusion Criteria:

* confirmed diagnosis of advanced solid tumor (including •medulloblastoma and basal cell carcinoma)
* blood work criteria

Exclusion Criteria:

* patients with history of brain tumor (except recurrent medulloblastoma) or brain metastases
* positive HIV, hepatitis B or C
* impaired intestinal function
* impaired heart function
* pregnant or breast-feeding women

Other protocol-defined inclusion/exclusion criteria may apply

Primary outcomes:
measure: determine maximum tolerated dose of single agent LDE225
timeFrame: 28 day cycles
Secondary outcomes:
measure: characterize safety and tolerability
timeFrame: 28 day cycles
measure: characterize pharmacokinetics (PK) of single and repeated doses of LDE225
timeFrame: 28 day cycles
measure: assess preliminary anti-tumor activity
timeFrame: every other 28-day cycle
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center SC
state: Pennsylvania
city: San Antonio
country: United States
facility: Cancer Therapy & Research Center / UT Health Science Center InstituteForDrugDevelopment(5)
state: Texas
city: Barcelona
country: Spain
facility: Novartis Investigative Site
state: Catalunya
city: Zürich
country: Switzerland
facility: Novartis Investigative Site
city: Leicester
country: United Kingdom
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
Clinical trial NCT01648608: Efficacy and Safety of TAC and Exemestane as Neoadjuvant Chemotherapy in the Postmenopausal Women With Breast Cancer
Official title: Study to Assessment the Efficacy and Safety of Joint TAC and Exemestane as Neoadjuvant Chemotherapy in the Postmenopausal Women With Operable Breast Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Breast Cancer
Lead sponsor: Tianjin Medical University
Sponsor class: OTHER
First posted: 2012-07-24
Enrollment: 600
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Select the postmenopausal patients with breast cancer who is confirmed by core needle biopsy and at the clinical stage T2-4N0-2M0.Treat them with 4 cycles of TAC as neoadjuvant chemotherapy (Docetaxel was 75mg/m2, the EPI 60mg/m2 and the CTX 600mg/m2,21day/cycle).At the same time give daily oral exemestane 25mg for 12 weeks.Then assess the efficacy and safety of TAC and Exemestane.

Detailed description: The investigators select the postmenopausal patients with breast cancer who is confirmed by core needle biopsy and at the clinical stage T2-4N0-2M0.Treat them with 4 cycles of TAC as neoadjuvant chemotherapy (Docetaxel was 75mg/m2, the EPI 60mg/m2 and the CTX 600mg/m2,21day/cycle).At the same time give daily oral exemestane 25mg for 12 weeks.Then assess the efficacy and safety of TAC and Exemestane.

Eligibility criteria: Inclusion Criteria:

1. Karnofsky ≥ 70
2. Provision of informed consent
3. Pathological confirmation of invasive ductal carcinoma and estrogen receptor is positive
4. Tumor stage(TNM):T2-4bN0-3M0
5. Premenopausal woman
6. Not previously received treatment with bisphosphonate
7. Laboratory criteria:

   * PLT ≥ 100\*109/L
   * WBC ≥ 4000/mm3
   * HGB ≥ 10g/dl
   * GOT,GPT,ALP ≤ 2\*ULN
   * TBIL,DBIL,CCr ≤ 1.5\*ULN

Exclusion Criteria:

1. Pregnant or lactation woman
2. History of organ transplantation
3. With mental disease
4. With severe infection or active gastrointestinal ulcers
5. With severe liver disease (such as cirrhosis), kidney disease, respiratory disease or diabetes
6. Disease-free period of other malignant tumor is less than 5 years(except cured basal cell skin cancer and cervical carcinoma in situ)
7. With heart disease
8. Experimental drug allergy

Primary outcomes:
measure: therapeutic assessment
timeFrame: 6 months
Secondary outcomes:
measure: Adverse reactions and disease-free survival
timeFrame: 2 years
Other outcomes:
measure: Recurrence or death
timeFrame: 5 years
Locations:
city: Tianjin
country: China
facility: Tianjin Cancer Hospital
state: Tianjin
Study officials:
affiliation: Tianjin Cancer Hospital
name: jin Zhang, Professor
role: STUDY_CHAIR
References:
Clinical trial NCT00188708: Effect of Casodex on Tumour Hypoxia - Prostate Cancer
Official title: A Study of the Effect of Neoadjuvant Bicalutamide (Casodex) on Tumour Hypoxia in Patients With Clinically Localized Prostate Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prostatic Neoplasms
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
Collaborators: name: Canadian Cancer Trials Group
name: Princess Margaret Hospital, Canada
First posted: 2005-09-16
Enrollment: 30
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Prostate cancers, in common with many other tumours, are often hypoxic; that is, they have low levels of oxygen. It is thought that tumour hypoxia may hasten the progression of cancers and make them more resistant to treatment. One previous study has suggested that hormone therapy, such as Casodex, may improve the prostate oxygen level. This study is designed to test that finding.


Eligibility criteria: Inclusion Criteria:

* Men with histologically proven prostatic carcinoma, stage cT2, N0, M0, receiving neoadjuvant bicalutamide plus conformal radiotherapy in study 9907, who have previously participated in the prostate cancer hypoxia project
* informed consent

Exclusion Criteria:

* Coagulopathy

Primary outcomes:
measure: To determine the effect of neoadjuvant anti-androgen therapy on oxygenation of prostatic tumours
timeFrame: 8 weeks
measure: Correlate level of tumor oxygenation with PSA level
timeFrame: 8 weeks
measure: Correlate level of tumor oxygenation with hemoglobin level
timeFrame: 8 weeks
measure: Correlate level of tumor oxygenation with prostate volume
timeFrame: 8 weeks
Secondary outcomes:
measure: To study of the effect of neoadjuvant anti-androgen therapy on prostate tumour histopathology and gene expression, and correlation of these effects with changes in oxygenation.
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Princess Margaret Hospital
state: Ontario
Study officials:
affiliation: Princess Margaret Hospital, Canada
name: Michael Milosevic, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01373008: Inhaled Extra-fine Hydrofluoalkane-beclomethasone (QVAR) in Premature Infants With Bronchopulmonary Dysplasia (BPD)
Official title: Inhaled Extra-fine Hydrofluoalkane-beclomethasone (QVAR) in Premature Infants With Bronchopulmonary Dysplasia (BPD); Prospective, Double Blind, Randomized Placebo-control, Multi-center Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Bronchopulmonary Dysplasia
Keywords: Inhaled steroids
bronchopulmonary dysplasia
Infants with moderate to severe BPD
Lead sponsor: Bnai Zion Medical Center
Sponsor class: OTHER_GOV
Collaborators: name: Tel-Aviv Sourasky Medical Center
name: Schneider Children's Medical Center, Israel
name: Meir Hospital, Kfar Saba, Israel
name: Kaplan Medical Center
name: Barzilai Medical Center
name: Laniado Hospital
name: HaEmek Medical Center, Israel
First posted: 2011-06-14
Enrollment: 60
Sex: ALL
Minimum age (years): 3
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Premature infants with chronic lung disease (bronchopulmonary dysplasia \[BPD\]) are commonly treated with inhaled steroids, an optional treatment according to textbooks and guidelines . However, the evidence supporting this treatment in spontaneously breathing infants is limited, and based on only two randomized, placebo-controlled trials (RCT) with relative small number of infants . The Cochrane review concluded that these studies do not allow firm conclusions with regard to the efficacy of inhaled steroids in non-ventilated infants . Thus, there is no doubt that there is a need for more RCT in order to ascertain the role of inhaled steroids in infants with BPD. Because of its physical properties that theoretically make QVAR an attractive therapy in infants and studies showing it to be as effective as and with similar safety profile as other inhaled steroids in children, the investigators hypothesized that inhaled QVAR will be an effective therapy in infants with BPD.


Eligibility criteria: Inclusion Criteria:

1. Preterm infants with moderate to severe BPD, defined as oxygen \<30%, or \>30% or with positive pressure support at 36 weeks corrected gestational age, respectively
2. Parents signed an informed consent
3. The parents will comply with the 3 months study follow-up requirements, as judged by the site principal investigator.

Exclusion Criteria:

1. Congenital malformation
2. Cardiac disease (including active PDA)
3. Intraventricular hemorrhage grade III-IV
4. Unstable conditions such as sepsis, apneas, ets. at time of enrollment.

Primary outcomes:
measure: The primary outcome will be to compare the rate of readmissions to the hospital for BPD exacerbation during the study period between infants treated with QVAR vs. placebo.
timeFrame: 4 months
Secondary outcomes:
measure: Clinical outcomes at each visit
timeFrame: 4 months
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Bnai Zion Medical Center
Study officials:
References:
Clinical trial NCT06276608: Iron Deficiency in Pediatric Heart Surgery
Official title: Iron Deficiency in Pediatric Heart Surgery: Impact on Anemia, Transfusion and Complications, a Retrospective Cohort Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Iron Deficiencies
Iron Deficiency Anemia
Cardiac Surgical Procedures
Congenital Heart Disease in Children
Lead sponsor: Queen Fabiola Children's University Hospital
Sponsor class: OTHER
First posted: 2024-02-26
Enrollment: 300
Sex: ALL
Maximum age (years): 16
Standard ages: CHILD
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients who underwent pediatric cardiac surgery at our institution between January 1, 2019 and December 31, 2023

Brief summary: The prevalence of iron deficiency in pediatric cardiac surgery patients is not very well known. Iron deficiency can lead to anemia, higher transfusion rates and possibly higher complication rates. In this retrospective study, the iron status of all patients undergoing pediatric cardiac surgery at our institution between January 2019 and december 2023 will be analyzed. Together with iron status, transfusion requirements as well as complications will be recorded. Iron status will be reported with descriptive statistics, patients with or without iron deficiency will be compared using non-parametric tests.


Eligibility criteria: Inclusion Criteria:

* All patients who underwent pediatric cardiac surgery at our institution between January 1, 2019 and December 31, 2023

Exclusion Criteria:

* Incomplete medical charts
* Patients who did not consent to the use of their medical data

Primary outcomes:
measure: Prevalence of preoperative iron deficiency (%)
timeFrame: 24 hours
measure: Complications
timeFrame: 28 days
Secondary outcomes:
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: H.U.B - Hôpital Universitaire des Enfants Reine Fabiola
Study officials:
References:
citation: Gao P, Wang X, Zhang P, Jin Y, Bai L, Wang W, Li Y, Liu J. Preoperative Iron Deficiency Is Associated With Increased Blood Transfusion in Infants Undergoing Cardiac Surgery. Front Cardiovasc Med. 2022 Jun 2;9:887535. doi: 10.3389/fcvm.2022.887535. eCollection 2022.
citation: Sidhu S, Kakkar S, Dewan P, Bansal N, Sobti PC. Adherence to Iron Chelation Therapy and Its Determinants. Int J Hematol Oncol Stem Cell Res. 2021 Jan 1;15(1):27-34. doi: 10.18502/ijhoscr.v15i1.5247.
citation: Temel HH, Kumbasar U, Buber E, Aksoy Y, Cavdar S, Dogan R, Demircin M, Pasaoglu I. Comparison of antioxidant reserve capacity of children with acyanotic & cyanotic congenital heart disease. Indian J Med Res. 2020 Dec;152(6):626-632. doi: 10.4103/ijmr.IJMR_2215_18.
citation: Christen S, Finckh B, Lykkesfeldt J, Gessler P, Frese-Schaper M, Nielsen P, Schmid ER, Schmitt B. Oxidative stress precedes peak systemic inflammatory response in pediatric patients undergoing cardiopulmonary bypass operation. Free Radic Biol Med. 2005 May 15;38(10):1323-32. doi: 10.1016/j.freeradbiomed.2005.01.016.
Clinical trial NCT04673708: H - Test Usage in Identification of Sexual Orientation Among People.
Official title: Using H - Test to Identify the Sexual Orientation and Applying the Test in Medical and Forensic Fields
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sexual Behavior
Sexual Orientation Conflict Disorder
Sexual Arousal Disorder
Sexual Orientation
Sexual; Orientation, Relationship Disorder
Lead sponsor: University of Baghdad
Sponsor class: OTHER
First posted: 2020-12-17
Enrollment: 55
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Using of H - test in identifying the sexual behavior of the human.

Detailed description: The test using videos and in the same time watching the vital signs of the participant to identify any changes in them align with the vides.

These videos contain +18 contents that can excite them and make them sexually active. So we can determine with type of vides that more excited to the human and select his or her sexual behavior type.

Eligibility criteria: Inclusion Criteria:

* All the people can be included

Exclusion Criteria:

* Have a psychological disorder
* Have a sexual disorder

Primary outcomes:
measure: An observatory stimulation test of sexual orientation (Straight, gay, lesbian, bisexual) by using videos stimulation
timeFrame: 1 week
Secondary outcomes:
Other outcomes:
Locations:
city: Nasiriyah
country: Iraq
facility: No name
state: Thi Qar
Study officials:
affiliation: University of Thi-Qar
name: Talib Manea, MD
role: STUDY_CHAIR
References:
Clinical trial NCT00706108: Adaptive Coordination in Anaesthesia Teams and Its Relationship to Clinical Performance.
Official title: Adaptive Coordination in Anaesthesia Teams and Its Relationship to Clinical Performance. (Cooperative Project ETHZ, OAT, Prof. G. Grote, and IfA/USZ; Founding by Swiss National Science Foundation to Both Institutions)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anesthesia Team Coordination
Lead sponsor: University of Zurich
Sponsor class: OTHER
Collaborators: name: Swiss Federal Institute of Technology
First posted: 2008-06-27
Enrollment: 161
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Anesthesia personnel (nurse anesthetists, anesthesia residents, staff anesthetists, OR attendants, other members of anesthesia / perioperative team)and patients as seen on video; all if informed consent was obtained

Brief summary: The impact of different coordination patterns on team performance during anesthesia inductions are analyzed using videotapes. These records are examined using various categorization systems (ETHZ), focussing on changes of coordinative behaviour with shifting situational requirements. A rating system comprising multiple categories is used to evaluate team performance. An integrated simulator study facilitates validation of the rating system.

Detailed description: Video tapes and vital parameter readings are recorded with a setup allowing synchronized recordings. Thus, exact timing between events on different data channels can be determined. Data are analyzed for unforeseen events, technical performance, and team coordination / non-technical performance.

Eligibility criteria: Inclusion criteria:

* Anesthesia personnel with at least 3 months practical anesthesia experience
* Patients undergoing surgical procedures

Exclusion criteria:

* Not meeting inclusion criteria
* Lack of consent

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: Institute of Anesthesiology, University Hospital Zurich
Study officials:
affiliation: UniversitaetsSpital Zuerich
name: 01 Studienregister MasterAdmins
role: STUDY_DIRECTOR
affiliation: Institute of Anesthesiology, University Hospital Zurich
name: Donat R. Spahn, Prof., MD
role: STUDY_DIRECTOR
affiliation: Institute of Anesthesiology, University Hospital Zurich
name: Johannes Wacker, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Swiss Federal Institute of Technology ETH Zurich, OAT
name: Gudela Grote, Prof., PhD
role: STUDY_CHAIR
References:
citation: Kunzle B, Zala-Mezo E, Wacker J, Kolbe M, Spahn DR, Grote G. Leadership in anaesthesia teams: the most effective leadership is shared. Qual Saf Health Care. 2010 Dec;19(6):e46. doi: 10.1136/qshc.2008.030262. Epub 2010 May 14.
Clinical trial NCT04780308: Pediatric Type III Supracondylar Humeral Fracture
Official title: How Many K Wires do we Need in the Surgical Treatment of Pediatric Type III Supracondylar Humeral Fracture?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Supracondylar Humerus Fracture
Pediatric Fractures
Keywords: pediatric
supracondylar humeral fracture
k wires
closed reduction
pin configuration
Lead sponsor: Bakirkoy Dr. Sadi Konuk Research and Training Hospital
Sponsor class: OTHER_GOV
First posted: 2021-03-03
Enrollment: 100
Sex: ALL
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients under 16 years.

Brief summary: The purpose of this study was to compare pin configuration effects on early secondary displacement in the surgical treatment of pediatric supracondylar humeral fractures (SCHF).

Detailed description: The study consisted of 100 (68M, 32F) children who underwent surgery between 2010 and 2013 for Gartland Type 3 (SCHF). The patients divided into five groups according to the top in configurations (crossed 1 lateral 1 medial, crossed 2 lateral 1 medial, crossed 1 lateral 2 medial, 2 lateral divergent, and 3 lateral divergent). The average age at the time of injury was 7.34 (between 2 and 14 years). Bauman angle (BA), Humerocapital angle (HCA), Anterior humeral line (AHL), flexion range, extension range, and Carrying angle (CA) were compared at preoperative, postoperative 1st-day, postoperative last control, and non-operated side. The mean follow-up time 24,96±11,06 with a range of 12-54 months.

Eligibility criteria: Inclusion Criteria

* Pediatric Gartland Type 3 supracondylar humeral fracture
* Patients operated between 2010-2013
* Patients under 16 years old

Exclusion Criteria:

* Pathological fractures
* Conservative treated supracondylar fractures
* Less than the 1-year follow-up
* Patients with incomplete postoperative follow-up
* Patients older than 16 years
* Pediatric Gartland Type 1 and 2 supracondylar humeral fracture

Primary outcomes:
measure: Baumann Angle
timeFrame: postoperative 1. day, 1. month and 12. month
measure: Anterior Humeral Line
timeFrame: postoperative 1. day, 1. month and 12. month
measure: Humero-Capital Angle
timeFrame: postoperative 1. day, 1. month and 12. month
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: