louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00840138: A Comparison of Bile Duct Injuries Following Open Cholecystectomy Versus Laparoscopic Cholecystectomy
Official title: Comparison of Iatrogenic Common Bile Duct Injuries Following Open Cholecystectomy vs Laparoscopic Cholecystectomy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cholecystectomy
Common Bile Duct Diseases
Major Bile Duct Injury
Lead sponsor: Centre of Postgraduate Medical Education
Sponsor class: OTHER
First posted: 2009-02-10
Enrollment: 70
Sex: ALL
Minimum age (years): 21
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients treated for common bile duct injuries following laparoscopic and open cholecystectomy procedures.

Brief summary: In this prospective study the investigators compared common bile duct injuries (CBDI) following laparoscopic cholecystectomy (LC) and open cholecystectomy (OC) procedures, 35 patients in each group. To date, no detailed study concerning this matter has been published. LC - CBDI in comparison with OC - CBDI more often concerned young females with a narrow CBD, they were located closer to the liver hilus, and they were more extended.


Eligibility criteria: Inclusion Criteria:

* Major common bile duct injury

Exclusion Criteria:

* Minor common bile duct injury

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03678038: Comparison of Rotator Interval Injection Versus Intraarticular Hydrodilatation in Frozen Shoulder
Official title: Comparing the Efficacy of Rotator Interval Steroid Injection Versus Steroid Intraarticular Hydrodilatation in the Treatment of Frozen Shoulder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Adhesive Capsulitis
Keywords: adhesive capsulitis
Lead sponsor: Taipei Veterans General Hospital, Taiwan
Sponsor class: OTHER_GOV
First posted: 2018-09-19
Enrollment: 64
Sex: ALL
Minimum age (years): 35
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study was conducted to compare the efficacy of hydrodilatation with steroid via posterior approach versus rotator interval approach for treating patients with adhesive capsulitis.

Detailed description: Adhesive capsulitis is a common cause of shoulder pain, and the efficacy of most interventions is limited. This study was conducted to compare the efficacy of rotator interval injection with steroid with that of steroid hydrodilatatoin for treating adhesive capsulitis.

Design: a prospective, single-blinded, randomized, clinical trial

Patient and methods:

Patients with adhesive capsulitis were enrolled and randomly allocated into group 1 ( ultrasound guided rotator interval injection ) and group 2 (ultrasound guided steroid hydrodilatation). The patients were evaluated before treatment and were reevaluated 0, 6, and 12 weeks after the beginning of the treatment. Outcomes measures included a pain scale (visual analog scale), range of motion, Constant shoulder score, and Shoulder Pain And Disability Index.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of frozen shoulder by physical examination and ultrasonography

Exclusion Criteria:

1. other conditions involving the shoulder ( rheumatoid arthritis, Hill-Sachs lesions,osteoporosis, or malignancies in the shoulder region)
2. neurologic deficits affecting shoulder function in normal daily activities
3. shoulder pain caused by cervical radiculopathy
4. a history of drug allergy to xylocaine or corticosteroid
5. pregnancy or lactation;
6. received injection into the affected shoulder during the preceding 3 months
7. history of surgeries on the affected shoulders
8. Secondary frozen shoulder

Primary outcomes:
measure: Shoulder Pain And disability index
timeFrame: Change of the score between 6 weeks and baseline, and change of the score between 12 weeks and baseline
Secondary outcomes:
measure: pain intensity
timeFrame: Change of the score between 6 weeks and baseline, and change of the score between 12 weeks and baseline
measure: glenohumeral joint range of motion
timeFrame: Change at baseline, 6 weeks, 12 weeks
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital
Study officials:
References:
Clinical trial NCT00062738: Treatment of Depression in Parkinson's Disease Trial
Official title: Treatment of Depression in Patients With Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Parkinson Disease
Depression
Keywords: Parkinson's disease
Parkinson disease
depression
antidepressants
nortriptyline
paroxetine
Lead sponsor: Rutgers, The State University of New Jersey
Sponsor class: OTHER
Collaborators: name: GlaxoSmithKline
First posted: 2003-06-13
Enrollment: 52
Sex: ALL
Minimum age (years): 35
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this study is to evaluate the effectiveness and safety of two antidepressants--nortriptyline and paroxetine, compared to placebo in patients with Parkinson's disease and depression.

Detailed description: Depression is the most common neuropsychiatric disorder found in patients with Parkinson's disease (PD). It causes immense personal suffering and is associated with increased disability and caregiver burden.

Despite the adverse consequences of depression in patients with PD, there are virtually no empirical data to guide clinical treatment. This study will begin to answer some questions on the treatment of depression by testing a SSRI (selective serotonin reuptake inhibitor) antidepressant, paroxetine, a tricyclic antidepressant, nortriptyline, and placebo in a placebo-controlled trial.

A total of 75 patients with PD will be randomized to each of the three arms in a balanced design.

Eligibility criteria: inclusion criteria:

* Parkinson's disease without dementia.
* Depression.
* Males or females.

exclusion criteria:

* Psychosis
* Heart block

Primary outcomes:
measure: Hamilton Depression Scale
timeFrame: 8 weeks
Secondary outcomes:
measure: Percent Responders
timeFrame: 8 weeks
Other outcomes:
Locations:
city: New Brunswick
country: United States
facility: Robert Wood Johnson Medical School
state: New Jersey
Study officials:
affiliation: Rutgers, The State University of New Jersey
name: Matthew Menza, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Menza M, Dobkin RD, Marin H, Mark MH, Gara M, Buyske S, Bienfait K, Dicke A. A controlled trial of antidepressants in patients with Parkinson disease and depression. Neurology. 2009 Mar 10;72(10):886-92. doi: 10.1212/01.wnl.0000336340.89821.b3. Epub 2008 Dec 17.
citation: Dobkin RD, Menza M, Bienfait KL, Gara M, Marin H, Mark MH, Dicke A, Friedman J. Depression in Parkinson's disease: symptom improvement and residual symptoms after acute pharmacologic management. Am J Geriatr Psychiatry. 2011 Mar;19(3):222-9. doi: 10.1097/JGP.0b013e3181e448f7.
citation: Dobkin RD, Menza M, Bienfait KL, Gara M, Marin H, Mark MH, Dicke A, Troster A. The impact of antidepressant treatment on cognitive functioning in depressed patients with Parkinson's disease. J Neuropsychiatry Clin Neurosci. 2010 Spring;22(2):188-95. doi: 10.1176/jnp.2010.22.2.188.
Clinical trial NCT03932838: Descriptive Study of Multiligamentary Reconstruction of the Knee
Official title: Descriptive Study of Multiligamentary Reconstruction of the Knee: Clinical Results and Postoperative Laxity by Dynamic Radiography.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Injury, Knee
Lead sponsor: Versailles Hospital
Sponsor class: OTHER
First posted: 2019-05-01
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: Evaluation of clinical results and postoperative laxity after single-stage reconstruction of multiligamentous lesions of the knee. Comparison of two types of transplant: allograft versus autograft.

There is currently little data in the clinical outcome literature after allograft reconstruction. There is one study reporting postoperative laxity assessed by dynamic radiography in the four planes (anterior, posterior, varus, valgus). No study compares postoperative laxity after allograft versus autograft reconstruction.


Eligibility criteria: Inclusion Criteria:

* Patients operated for one-time allograft or autograft reconstruction of multiligamentous knee injury
* \>18 years old

Exclusion Criteria:

* Neurological or vascular injury during trauma.
* Fracture of the femur or both bones of the leg.
* Ligamentous lesion on the contralateral knee.
* History of surgery on the affected knee.

Primary outcomes:
measure: Joint mobility of both knees
timeFrame: 2 years
measure: Postoperative laxity in varus, valgus, anterior and posterior drawer
timeFrame: 2 years
measure: Postoperative knee function assessed by scores
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Le Chesnay
country: France
facility: CH de Versailles
Study officials:
References:
Clinical trial NCT01793038: Clomiphene Citrate Plus uFSH Versus Aromatase Inhibitor Plus uFSH in Clomiphene Resistant Infertile PCOS Women
Official title: Clomiphene Citrate Plus HPuFSH Versus Letrozole Plus HPuFSH in Clomid Resistant Infertile PCOS Women
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Polycystic Ovary Syndrome
Infertility
Keywords: PCOS
clomiphene citrate resistant PCOS
Aromatase inhibitors
Lead sponsor: Mansoura Integrated Fertility Center
Sponsor class: OTHER
First posted: 2013-02-15
Enrollment: 160
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 38
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Polycystic ovarian syndrome (PCOS) is a condition characterized by infertility, infrequent periods and amenorrhea or irregular bleeding plus anovulatory infertility. Clomid is the standard first drug of treatment for ovulation induction. Ovulation and conception will occur in approximately 75 and 30 percent of cases respectively. Cases not ovulating in response to doses of clomid up to 150 mg/day are known as clomid resistant PCOS.

Detailed description: To test whether CC co- treatment with chronic low dose HP uFSH versus lirizole plus chronic low dose HP uFSH in CC resistant PCOS will yield comparable results in terms of, ovulation rate, lower follicle number, lower HP uFSH dose, better outcome in terms of pregnancy rates, better cost-effectiveness ratio, lower multiple pregnancy rates, lower cycle cancellation.

Eligibility criteria: Inclusion Criteria:

* CC resistant PCOS
* Infertile
* Females
* Age 18-38

Exclusion Criteria:

* Hyperprolactinaemia
* Cushing syndrome
* Adult onset adrenal hyperplasia
* Age \> 38
* Other infertility factors in the couple than PCOS: male factor,tubal factor,edometriosis

Primary outcomes:
measure: ovulation rate
timeFrame: 30 days
Secondary outcomes:
measure: endometrial thickness
timeFrame: 4 weeks
measure: ongoing cycle pregnancy rate
timeFrame: 16 weeks
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Mansoura Integrated fertility center
state: Dekahlia
Study officials:
References:
citation: Abdellah MS. Reproductive outcome after letrozole versus laparoscopic ovarian drilling for clomiphene-resistant polycystic ovary syndrome. Int J Gynaecol Obstet. 2011 Jun;113(3):218-21. doi: 10.1016/j.ijgo.2010.11.026. Epub 2011 Apr 1.
citation: Palomba S, Falbo A, Zullo F. Management strategies for ovulation induction in women with polycystic ovary syndrome and known clomifene citrate resistance. Curr Opin Obstet Gynecol. 2009 Dec;21(6):465-73. doi: 10.1097/GCO.0b013e328332d188.
Clinical trial NCT00525538: Evaluation Conformal Radiotherapy for Gynecologic Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Radiation Therapy
Lead sponsor: Istanbul University
Sponsor class: OTHER
First posted: 2007-09-05
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Intervention model: PARALLEL

Brief summary: The purpose of this study is comparision conformal radiotherapy for gynecologic cancer


Eligibility criteria: Inclusion Criteria:

* Gynecologic cancer

Exclusion Criteria:

* Metastases

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Cerrahpasa Medical Faculty Department of Radiation Oncology
state: Fatih
Study officials:
affiliation: Cerrahpasa Medical Faculty Department of Radiation Oncology
name: filiz munzuroglu
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06519838: Effect of Pre-Warming of Local Anesthesia in Reducing Pain Perception During Injection in Children
Official title: Effect of Pre-Warming of Local Anesthesia in Reducing Pain Perception During Injection in Children: A Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Local Anesthesia
Dental Anesthesia
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2024-07-25
Enrollment: 72
Sex: ALL
Minimum age (years): 5
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of the current study was to evaluate the pain perception upon injection of pre-warmed dental anesthetic solution (at 370C and 400C) versus that at room temperature (Average 23 degrees) during Maxillary Infiltration and Mandibular Inferior Alveolar Nerve Block techniques in children


Eligibility criteria: Inclusion Criteria:

* Healthy patients with ASA 1 or 2 Classification.
* Patients with Frankl Behavior Classification 3-4.
* Patients having at least one carious primary molar that requires dental treatment under the effect of local anesthesia.
* Parents' willingness to participate through informed written consent.

Exclusion Criteria:

* Patients with previous negative dental experience.
* Patients complaining of cellulitis or infection spreading in the fascial spaces.
* Patients who have received analgesics within the previous 12 hours before receiving the required dental treatment.
* Patients with any Intellectual Impairment.
* Patients with a history of allergy from any of the components of the dental anesthetic carpule.

Primary outcomes:
measure: Heart rate (HR) monitoring
timeFrame: during local anesthesia administration
measure: Pain during injection using Sound, Eye, Motor (SEM) Scale
timeFrame: during local anesthesia administration
measure: Pain during injection using Face scale
timeFrame: during local anesthesia administration
Secondary outcomes:
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Faculty of Dentistry, Alexandria University
Study officials:
References:
Clinical trial NCT04928638: Educational Intervention for Asthmatic and Allergic Patients
Official title: Educational Intervention for Asthmatic and Allergic Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Asthma
Allergy
Lead sponsor: Universidad de Granada
Sponsor class: OTHER
First posted: 2021-06-16
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Despite its importance, there are few studies that implement the use of new technologies in the approach to patients with asthma and allergy. Therefore, the objective of this study is to evaluate the effectiveness of a telematic educational intervention in patients with allergies and / or asthma


Eligibility criteria: Inclusion Criteria:

* Asthmatic and allergic patients

Exclusion Criteria:

* Cognitive impairment.
* Diagnose of autism spectrum disorder or severe intellectual disability
* Physical or functional impairment that limits the performance of evaluation

Primary outcomes:
measure: Asthma knowledge questionnaire
timeFrame: Baseline
measure: Asthma knowledge questionnaire
timeFrame: 1month
measure: Allergic rhinitis knowledge questionnaire
timeFrame: Baseline
measure: Allergic rhinitis knowledge questionnaire
timeFrame: 1month
measure: Inhaler technique checklist
timeFrame: Baseline
measure: Inhaler technique checklist
timeFrame: 1month
measure: Knowledge of COVID
timeFrame: Baseline
measure: Knowledge of COVID
timeFrame: 1month
Secondary outcomes:
measure: Asthma control questionnaire
timeFrame: Baseline
measure: Asthma control questionnaire
timeFrame: 1month
measure: Allergic rhinitis control test
timeFrame: Baseline
measure: Allergic rhinitis control test
timeFrame: 1month
measure: Fear of COVID-19 Scale
timeFrame: Baseline
measure: Fear of COVID-19 Scale
timeFrame: 1month
measure: COVID-19 Anxiety Scale (CAS)
timeFrame: Baseline
measure: COVID-19 Anxiety Scale (CAS)
timeFrame: 1month
measure: COVID Stress Scales
timeFrame: Baseline
measure: COVID Stress Scales
timeFrame: 1month
measure: Feeling of Satisfaction with Inhaler
timeFrame: Baseline
measure: Feeling of Satisfaction with Inhaler
timeFrame: 1month
measure: Test of Adherence to Inhalers
timeFrame: Baseline
measure: Test of Adherence to Inhalers
timeFrame: 1month
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04335838: Age, Traumatic Brain Injury and Injury Severity as Independent Risk Factors for In-Hospital Mortality in Polytrauma Patients.
Official title: Age, Traumatic Brain Injury and Injury Severity as Independent Risk Factors for In-Hospital Mortality in Polytrauma Patients. Experiences From a Level I Trauma Center.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Polytrauma
Traumatic Brain Injury
Keywords: prognostic factors
New Berlin Definition
Polytrauma
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2020-04-06
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Retrospective analysis of polytrauma patients.

Brief summary: In this study patients who were admitted to our hospital with critical injuries were enrolled retrospectively from January 2012 to December 2015. Patients with an ISS\>16 points, an AIS \>3 in one body region and at least 2 different body regions affected were included. Possible prognostic factors were evaluated.


Eligibility criteria: Inclusion Criteria:

* ISS \>16 points
* AIS \>3 in one body region
* at least 2 body regions affected

Exclusion Criteria:

* patients younger than 18 years of age
* isolated traumatic brain injury
* minor injuries (AIS \<3 or ISS \<16 points)

Primary outcomes:
measure: In-hospital mortality in polytrauma patients.
timeFrame: January 1, 2012 to December 31, 2015
Secondary outcomes:
measure: Possible prognostic factors influencing the outcome of polytrauma patients.
timeFrame: Januar 1, 2012 to December 31, 2015
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Medical University of Vienna, Department of Traumatology
Study officials:
References:
Clinical trial NCT03096938: Cell-free DNA Methylation Markers for Cancer Screening
Official title: Cell-free DNA Methylation Markers for Cancer Screening
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cancer Screening
Keywords: cell-free DNA
methylation
markers
cancer
screening
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2017-03-30
Enrollment: 15000
Sex: ALL
Minimum age (years): 40
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SCREENING

Brief summary: The purpose of this study is to evaluate the role of cell-free DNA methylation markers in cancer screening.


Eligibility criteria: Inclusion Criteria:

1. Subject is average risk for development of cancer
2. Subject able and willing to undergo screening test within 90 days of enrollment
3. Subject is 40 to 74 years of age inclusive
4. Subject is able to comprehend, sign, and date the written informed consent document to participate in the study

Exclusion Criteria:

1. Subject has any condition which, in the opinion of the investigator should preclude participation in the study
2. Subject has a history of cancer
3. Participation in any "interventional" clinical study within the previous 30 days in which an experimental treatment is administered or might be administered through a randomized assignment of the subject to one or more study groups.

Primary outcomes:
measure: sensitivity (true positive rate)
timeFrame: 2 year
measure: Specificity (true negative rate)
timeFrame: 2 year
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Sun Yat-sen University Cancer Center
state: Guangdong
Study officials:
References:
citation: Imperiale TF, Ransohoff DF, Itzkowitz SH, Levin TR, Lavin P, Lidgard GP, Ahlquist DA, Berger BM. Multitarget stool DNA testing for colorectal-cancer screening. N Engl J Med. 2014 Apr 3;370(14):1287-97. doi: 10.1056/NEJMoa1311194. Epub 2014 Mar 19.
Clinical trial NCT01553838: A Prospective Study to Evaluate MRI Guided Biopsy Compared With Transrectal Ultrasound Guided Biopsy of the Prostate in Men With Increased PSA Values
Official title: A Prospective Study to Evaluate MRI Guided Biopsy Compared With Transrectal Ultrasound Guided Biopsy of the Prostate in Men With Increased PSA Values
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prostate Cancer
Keywords: prostate biopsy
MRI guided biopsy
TRUS guided biopsy
Lead sponsor: Heinrich-Heine University, Duesseldorf
Sponsor class: OTHER
First posted: 2012-03-14
Enrollment: 185
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Intervention model: CROSSOVER
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to determine whether MRI guided prostate biopsy achieves higher prostate cancer detection rates compared with transrectal ultrasound guided prostate biopsy in patients with increased PSA values \> 4.0 ng/ml.


Eligibility criteria: Inclusion Criteria:

* PSA \> 4.0 ng/ml
* written informed consent
* age \>18

Exclusion Criteria:

* patients with prostate cancer
* patients with prior prostate biopsy
* patients with contraindications against MRI or biopsy

Primary outcomes:
measure: Prostate cancer detection rate
timeFrame: 3 years
Secondary outcomes:
measure: Number of Participants with Adverse Events as a measure of Safety and Tolerability
timeFrame: 3 years
Other outcomes:
Locations:
city: Duesseldorf
country: Germany
facility: Department of Urology
Study officials:
affiliation: Department of Urology, University of Duesseldorf
name: Christian Arsov, MD
role: PRINCIPAL_INVESTIGATOR
References: