louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01344785: The Effect of Loss of Offset After Pertrochanteric Fracture Treated With a Intramedullary Nail
Official title: The Effect of Loss of Offset After Pertrochanteric Fracture Treated With a Intramedullary Nail
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Intertrochanteric Fractures
Keywords: Intertrochanteric Fractures
Intramedullary nailing
Hip function
Pain
Lead sponsor: Danderyd Hospital
Sponsor class: OTHER
First posted: 2011-04-29
Enrollment: 100
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 100 consecutive patients with an intertrochanteric fracture presenting at the Orthopaedic depertment of Danderyd Hospital, Sweden

Brief summary: The purpose of this study is determine the relationship between pain and protrusion of the implant after surgery for a intertrochanteric fracture.

Detailed description: Intertrochanteric fractures are common fractures in which severe complications such as non-union, implant cut-out and postoperative wound-infections occur at very low rates with modern surgical techniques. While severe complications are rare, the patient reported outcome is less satisfactory with roughly half of the patients complain of thigh pain and others failing to regain their walking ability. The current leading methods for osteosynthesis of intertrochanteric fractures are intramedullary (IM) nails and sliding hip screws (SHS).

Over the period 1998 to 2007 the use of IM nails for pertrochanteric fractures increased from 5% to 20% in Sweden, at the expense of the use of SHS (5). IM nailing has also become more common at our clinic where we since February 2008 use the 3rd generation of the Gamma nail. In this study we investigate if the increased pain after IM nailing, reduced hip function and life quality may correlate to the compression over the fracture and the lateral protrusion of the intramedullary nail.

Eligibility criteria: Inclusion Criteria:

* Intertrochanteric Fracture
* Age over 55
* Intramedullary nailing

Exclusion Criteria:

* Severe cognitive impairment
* Substance abuse

Primary outcomes:
measure: Hip function
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Danderyd Hospital
Study officials:
affiliation: Danderyd Hospital
name: Max Gordon, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05551585: Transcranial Pulse Stimulation for Depression
Official title: A Randomized, Double-blind, Sham-controlled Clinical Trial of Transcranial Pulse Stimulation for the Treatment of Major Depression
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Major Depression
Keywords: Transcranial pulse stimulation
Brain stimulation
Major depression
Lead sponsor: The Hong Kong Polytechnic University
Sponsor class: OTHER
First posted: 2022-09-22
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: Transcranial pulse stimulation (TPS) is a newly developed brain stimulation therapy from Austria \& Germany with highly promising applicability in neuropsychiatric disorders. Major depressive disorder (MDD) is the world's leading cause of disability. Novel treatment approaches are urgently needed given that a significant fraction of patients does not sufficiently respond to standard antidepressant treatments. Our open-label pilot study using TPS in MDD indicates preliminary efficacy. However, experimental control is necessary to infer reliable scientific evidence for the efficacy of TPS. Here, we propose a randomized, double-blind, sham-controlled clinical trial to probe the utility of TPS as a modern antidepressant treatment.


Eligibility criteria: MDD group

Inclusion Criteria:

* Age 18 to 60;
* A clinical diagnosis of a MDD and a HAMD17 score ≥14;
* Treatment naivety or stable (≥4 weeks) psychopharmacological medication.

Exclusion Criteria:

* Severe internal diseases including blood clotting disorders;
* Neurological disorders including bleeding prone micro-pathologies or a history of severe head injuries;
* Current psychiatric comorbidities, including addiction;
* Pregnancy;
* Common NIBS exclusion criteria, such as a history of brain surgery, cardiac pacemaker, deep brain stimulation and intracranial metallic particles.

Primary outcomes:
measure: Change in depressive symptoms after the treatment
timeFrame: four weeks of treatment
Secondary outcomes:
measure: Change in depressive symptoms in the follow-up stage
timeFrame: at 3 months follow-up
measure: Change in depressive symptoms
timeFrame: four weeks of treatment and at 3 months follow-up
measure: Change in depressive symptoms
timeFrame: four weeks of treatment and at 3 months follow-up.
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: The Hong Kong Polytechnic University
Study officials:
affiliation: The Kong Kong Polytechnic University
name: Georg S. Kranz, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00906685: Bevacizumab for Central Retinal Vein Occlusion Study
Official title: A Prospective, Randomized, Controlled Study on Intravitreal Bevacizumab (Avastin) for Central Retinal Vein Occlusion (CRVO)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Central Retinal Vein Occlusion
Keywords: CRVO
anti-VEGF
Macular edema
Lead sponsor: St. Erik Eye Hospital
Sponsor class: OTHER
First posted: 2009-05-21
Enrollment: 60
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Central retinal vein occlusion is a leading cause of severe visual impairment. Until now, no treatment has been available to improve visual acuity. The present study intends to investigate if intravitreal bevacizumab can improve visual acuity as compared to sham-treated control patients.


Eligibility criteria: Inclusion Criteria:

* CRVO with duration \< 6 months
* Visual acuity of 20/800 to 20/50

Exclusion Criteria:

* CRVO with duration of \> 6 months
* previous treatment with anti-angiogenic drugs

Primary outcomes:
measure: The proportion of patients gaining 15 ETDRS letters or more
timeFrame: 6 months
Secondary outcomes:
measure: Change in foveal thickness
timeFrame: 6 months
measure: Cases of neovascular glaucoma
timeFrame: 6 months
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: St Eriks Eye Hospital
Study officials:
affiliation: St Eriks Eye Hospital
name: Anders Kvanta, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03309085: Functional Respiratory Imaging of Airways in ARDS
Official title: Functional Imaging With Computational Fluid Dynamics to Evaluate the Airways in Patients With Acute Lung Injury
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: ARDS, Human
Lead sponsor: University Hospital, Antwerp
Sponsor class: OTHER
First posted: 2017-10-13
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This is a prospective single-center cohort trial to compare regional bronchial recruitment, bronchial distention and alveolar recruitment in 6 patients with acute respiratory distress syndrome (ARDS). The investigators used CT scan images as the imaging modality, and the subjects were scanned on end-expiratory lung volume with different positive end-expiratory pressures. Those images were post-processed to evaluate the airways.


Eligibility criteria: Inclusion Criteria:

* mechanically ventilated
* moderate or severe ARDS, as defined by the Berlin criteria

Exclusion Criteria:

* pregnancy
* hemodynamic instability
* obesity (BMI \>30)

Primary outcomes:
measure: Regional bronchial recruitment
timeFrame: Through study completion, within 24 hours after inclusion
measure: Regional bronchial dilation
timeFrame: Through study completion, within 24 hours after inclusion
measure: Regional alveolar recruitment
timeFrame: Through study completion, within 24 hours after inclusion
Secondary outcomes:
measure: Correlation between parenchymal recruitment and bronchial recruitment
timeFrame: Through study completion, within 24 hours after inclusion
Other outcomes:
Locations:
city: Edegem
country: Belgium
facility: Antwerp University Hospital
state: Antwerp
Study officials:
References:
Clinical trial NCT04849585: Evaluation of the Impact of Hospitalization in Intensive Care for COVID-19 Infection
Official title: Evaluation of the Impact of Hospitalization in Intensive Care for COVID-19 Infection
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Covid19
Lead sponsor: Tourcoing Hospital
Sponsor class: OTHER
First posted: 2021-04-19
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients hospitalized in intensive care at CH Dron for a COVID 19

Brief summary: To evaluate the psychological, physical, social, professional and family impact of a hospitalization in intensive care for a covid 19 by analysis of the verbatim during a semi-structured interview.


Eligibility criteria: Inclusion Criteria:

* All patients hospitalized in intensive care at CH Dron for a COVID 19 who have given their agreement during their follow-up consultation

Exclusion Criteria:

* Minor patient
* Patient does not speak French
* Refusal to participate

Primary outcomes:
measure: Psychological impact of hospitalization in intensive care for a covid 19.
timeFrame: At day 1
measure: Physical impact of hospitalization in intensive care for a covid 19.
timeFrame: At day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Tourcoing
country: France
facility: CH Tourcoing
Study officials:
affiliation: CH TOURCOING
name: Pauline THILL, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05105685: Effectiveness of Recombinant Human Growth Hormone Therapy for Children With PMS
Official title: Effectiveness of Recombinant Human Growth Hormone Therapy for Children With Phelan-McDermid Syndrome: An Open-label, Cross-over, Preliminary Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Phelan-McDermid Syndrome
Growth Hormone Treatment
Keywords: Phelan-McDermid Syndrome
Growth Hormone Treatment
cross-over
Placebo-controlled
Lead sponsor: Affiliated Hospital of Jiangnan University
Sponsor class: OTHER
First posted: 2021-11-03
Enrollment: 6
Sex: ALL
Minimum age (years): 1
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: In summary, this piot study with 6 participants shown that recombinant human growth hormone (rhGH) has a positive effect on the treatment with PMS. In addition, This study indicated that rhGH can improve PMS symptoms via increase the level of serum insulin-like growth factor-1 (IGF-1) and insulin-like growth factor binding protein 3 (IGFBP-3). RhGH may be low cost, more accessible, alternative treatment for PMS.

Detailed description: Compared with the placebo, rhGH treatment significantly decreased the total scores and subscale scores of GDS (P \<0.05), while the total scores and subscale scores of SC-ABC significantly decreased (P \< 0.05) following three-months rhGH treatment. The similar results were also observed in comparison with baseline. Compared with the baseline, the level of serum IGF-1 and IGFBP-3 increased significantly (P \< 0.05) following three-months rhGH treatment, while the placebo group had no significant impact on serum IGF-1 and IGFBP-3 (P \> 0.05). One participant developed skin allergy the day after the first rhGH treatment, which were resolved later.

Eligibility criteria: Inclusion Criteria:

* Patients diagnosed with PMS aged from 1years to 5 years

Exclusion Criteria:

- active or suspected tumour, intracranial hypertension, chronic kidney disease, acute proliferative or severe nonproliferative diabetic retinopathy, allergy to rhGH or severe comorbidity

Primary outcomes:
measure: level of serum IGF-1 and IGFBP-3
timeFrame: 3 months
measure: Chinese version of the Gesell Development Scale (GDS)
timeFrame: 3 months
measure: Simplified Chinese version of the Aberrant Behavior Checklist (SC-ABC)
timeFrame: 3 months
measure: Adverse events
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Wuxi
country: China
facility: Affiliated Hospital of JiangNan University, Department of Pediatrics
state: Jiangsu
Study officials:
affiliation: Affiliated Hospital of Jiangnan University
name: YueYing Liu, Phd
role: STUDY_DIRECTOR
References:
Clinical trial NCT01966185: Establishing Learning Curves in Virtual Simulation Training of Mastoidectomy
Official title: Establishing Learning Curves in Virtual Simulation Training of Mastoidectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: User-Computer Interface
Clinical Skills
Motor Skills
Temporal Bone
Students
Keywords: virtual simulation
temporal bone
surgical training
medical education
self-directed learning
final product assessment
cognitive load
reaction time
skills training
simulator metrics
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2013-10-21
Enrollment: 43
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The purpose of this study is to establish learning curves of mastoidectomy training in virtual surgical simulation training, to establish the long-term effect of repeat simulation training and to explore the transfer of skills, the roles of an integrated tutor function, self-directed learning and cognitive load.

Detailed description: Repeat surgical simulation training is known to provide better learning and long-term transfer. The learning curves for the mastoidectomy procedure have not been intensively studied. The only study conducted on learning curves in mastoidectomy to date found a plateau in performance for 4 medical students after about 4 mastoidectomy procedures on separate occasions. The participants were however assessed using an unvalidated, unestablished simulator integrated overall performance score. There is therefore a need for establishing learning curves and plateau using established objective assessment scales, which could have implications for future studies and on a larger scale for the future organization of temporal bone dissection courses.

The long-term effect on learning of deliberate repeat simulator training of the mastoidectomy procedure has not previously been studied. The role of cognitive load in learning complex surgical technical skills in simulation has not been studied in great detail. The relationship between time and progress/performance assessment using Final Product Analysis (FPA) has not been studied.

We have previously suggested that a tutor-function with volumetric approach with green lighting of the procedural steps could have an effect on performance. The effect of the tutor function could however not be isolated.

Eligibility criteria: Inclusion Criteria:

* medical students
* informed written consent

Exclusion Criteria:

* prior training on the Visible Ear Simulator

Primary outcomes:
measure: Change in Final Product Assessment Score
timeFrame: 4 months
Secondary outcomes:
measure: Change in simulator metrics
timeFrame: 4 months
measure: Change in reaction time
timeFrame: 4 months
Other outcomes:
measure: Background data
timeFrame: At recruitment
Locations:
city: Copenhagen
country: Denmark
facility: Rigshospitalet
Study officials:
affiliation: Rigshospitalet, Denmark
name: Steven AW Andersen, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01275885: Vitamin D Intervention in Infants - Pilot
Official title: Vitamin D Intervention in Infants - Pilot
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Vitamin D
Supplementation
Keywords: cholecalciferol
infant
bone mineral density
Lead sponsor: Helsinki University Central Hospital
Sponsor class: OTHER
Collaborators: name: University of Helsinki
First posted: 2011-01-13
Enrollment: 113
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The aims of the present study are to evaluate the concentrations of vitamin D in the plasma and of calcium in the plasma and in the urine as well as to evaluate bone mineral density using peripheral quantitative computed tomography (pQCT), after supplementation of vitamin D with 30µg (1200 IU) and 40µg (1600 IU), in comparison with currently recommended supplementation of vitamin D with 10µg (400 IU). In this pilot study supplementation is given to infants from 2 weeks of age to 3 months of age.

Detailed description: Vitamin D deficiency is common around the world. In Finland vitamin D levels are low in all age groups. Especially infants are predisposed to vitamin D deficiency. Partly this is due to low exposure to sunlight but mainly it is due to low dietary intake of vitamin D. Vitamin D prophylaxis was introduced in Finland in the 1950´s to overcome rickets. However, the recommended dose has decreased from 50µg (2000 IU) in the 1960´s to 10µg (400 IU) from beginning of the 1990´s. The serum concentration of 25-hydroxyvitamin D (S-25OHD) is used as a marker of vitamin D status in the body. Although there is no consensus of optimal concentration of S-25OHD, it has been proposed that concentrations lower than 50 nmol/l indicate deficiency. According to recent findings on 25-OHD concentrations in Finnish children, currently recommended intake of vitamin D is inadequate.

Eligibility criteria: Inclusion Criteria:

* healthy Caucasian women with an uneventful pregnancy
* healthy infants born at term and appropriate for gestational age

Primary outcomes:
measure: S-25OHD concentration after vitamin D supplementation to infants
timeFrame: after 10 weeks of supplementation
Secondary outcomes:
measure: concentration of calcium in the plasma and in the urine
timeFrame: after 10 weeks of supplementation
measure: bone mineral density
timeFrame: after 10 weeks of supplementation
Other outcomes:
Locations:
city: Helsinki
country: Finland
facility: Hospital for Children and Adolescents, Helsinki University Central Hospital
Study officials:
affiliation: Helsinki University Central Hospital
name: Sture Andersson, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01582685: Exercise in Breast Cancer Survivors
Official title: Exercise in Breast Cancer Survivors: Analysis of Angiogenic Profile
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Breast Cancer
Obesity
Keywords: Breast Cancer
Obesity
Exercise
Angiogenesis
Lead sponsor: University of Mississippi Medical Center
Sponsor class: OTHER
First posted: 2012-04-23
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The investigators hypothesize that exercise in postmenopausal breast cancer survivors will result in an increase in the plasma concentrations of angiostatic factors and a decrease in the plasma concentrations of angiogenic factors. Exercise is expected to result in a circulating angiostatic phenotype that inhibits adipose tissue mass, growth of breast cancer tumor, growth of microscopic residual disease after breast cancer resection, decreases rates of local-regional recurrence, decreases rates of distant recurrence, and increases survival.


Eligibility criteria: Inclusion Criteria:

* \> 18 years of age and \< 65 years of age
* Female
* BMI \> 25
* Weight \< 350 pounds
* English as a primary language
* Postmenopausal
* Invasive ER-positive cancer on biopsy and subsequent definitive surgical therapy
* Received and Completed standard of care adjuvant therapy (Concurrent endocrine therapy acceptable)
* 6-12 months after completion of therapy (excluding adjuvant endocrine therapy) at time of randomization

Exclusion Criteria:

* Recurrent breast cancer
* DCIS only (no invasive component)
* Taking a Beta Blocker or Verapamil
* Pregnant
* Wheelchair bound
* Unable to ambulate independently
* Concurrent uncontrolled medical or psychiatric disorder
* Open wound
* Stage IV breast cancer
* Progression of disease
* Bilateral mastectomies

Primary outcomes:
measure: Number of participants that complete the study as a measure of feasibility of an exercise intervention in obese breast cancer survivors.
timeFrame: 12 months
Secondary outcomes:
measure: IGF-1, endostatin, and VEGF levels in obese breast cancer survivors undergoing an exercise intervention as a measure of angiostatic phenotype:
timeFrame: 12 months
measure: Amount of adipose tissue mass as measured on CT scans in obese breast cancer survivors before and after exercise intervention as a measure of weight loss
timeFrame: 12 months
Other outcomes:
Locations:
city: Jackson
country: United States
facility: University of Mississippi Health Care
state: Mississippi
Study officials:
affiliation: University of Mississippi Health Care
name: Natale Sheehan, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05454085: Could Bisphenol-A Have a Role in the Etiology of Neural Tube Defects
Official title: Could Bisphenol-A Have a Role in the Etiology of Neural Tube Defects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neural Tube Defects
Bisphenol-A
Keywords: Bisfenol A
amniocentesis
neural tube defect
Lead sponsor: Sanliurfa Mehmet Akif Inan Education and Research Hospital
Sponsor class: OTHER
Collaborators: name: Bursa Yuksek Ihtisas Education and Research Hospital
First posted: 2022-07-12
Enrollment: 92
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Our aim in this study is in patients with a diagnosis of neural tube defect; is the measurement of BPA levels in maternal blood and amniotic fluid.

Detailed description: This prospective observational study was conducted with 92 patients aged 18 - 45 years who had amniocentesis at 15 - 22 weeks of gestation at Bursa Yüksek İhtisas Training and Research Hospital between April 15, 2021 and April 15, 2022. Patients were divided into two groups according to amniocentesis indications. Group 1: patients with abnormal maternal serum screening test or prenatal diagnosis test, patients with abnormal ultrasonography findings (45 patients), Group 2: patients with pre-diagnosis of NTD (47 patients). During the amniocentesis procedure, the first 5cc amniotic fluid and maternal serum samples were collected from the patients. The obtained samples were stored at -80°C until the end of the study. After all samples were collected, BPA values were measured by ELISA method.

Eligibility criteria: Inclusion Criteria:

* Patients who had a single pregnancy, had a pre-diagnosis of neural tube defect or had amniocentesis between 15 and 22 weeks of age with other indications
* patients had an uncomplicated pregnancy before the procedure
* patients had no vaginal infection

Exclusion Criteria:

* Multiple pregnancies,
* pregnant women who developed complications due to amniocentesis
* pregnant women with known infective or autoimmune diseases before pregnancy
* those whose spouses or themselves worked in the plastics industry
* patients who could not obtain enough amniotic fluid despite meeting the study criteria during the study

Primary outcomes:
measure: BPA levels
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Bursa
country: Turkey
facility: Nefise Nazlı YENIGUL
Study officials:
References: