louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02736370: Early Weight Bearing for Ankle Fractures
Official title: Early Weight Bearing for Bimalleolar and Trimalleolar Ankle Fractures Without Syndesmotic Disruption
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Broken Ankle
Lead sponsor: Spectrum Health Hospitals
Sponsor class: OTHER
First posted: 2016-04-13
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients that present with bimalleolar or trimalleolar ankle fractures

Brief summary: The purpose of this observational study is to assess the rate of return to work, rate of return to activities, functional outcome measures and pain scores in operatively repaired rotational Bimalleolar and Trimalleolar (AO/OTA Classification of 44A and 44B) ankle fractures not requiring fixation of the syndesmosis and allowed early weight bearing on or before the first post-operative visit.


Eligibility criteria: Inclusion Criteria:

* Men and women ages of 18 and up
* Closed, low-energy Bimalleolar and Trimalleolar rotational ankle fractures
* Orthopaedic Trauma Association (OTA) classification of 44A and 44B
* English speaking
* Able and willing to consent

Exclusion Criteria:

* Open fractures
* OTA classification of 43 and 44C
* Patients with diabetes mellitus
* No other lower extremity injuries that would affect functional outcomes
* Previous use of walking aides
* Patients with paralysis or hemiplegia
* Ankle fractures requiring syndesmotic repair
* Ankle fractures requiring fixation of the posterior malleolar
* Associated neurovascular injury
* Problems maintaining follow up (homeless or not willing to return for follow up)
* Pathological fractures
* Prisoners
* Patients not allowed to bear weight before the 6 week post-operative follow up visit

Primary outcomes:
measure: Functional Outcome Scores
timeFrame: 12 months post operatively
Secondary outcomes:
measure: Return to work
timeFrame: up to 12 months
measure: Fracture Healing
timeFrame: up to 12 months
measure: Pain Scores
timeFrame: 12 months post operatively
measure: Post operative complications
timeFrame: up to 12 months
Other outcomes:
Locations:
Study officials:
affiliation: Spectrum Health Hospitals
name: Blake W Miller, DO
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06919770: Use of a Taurolidine Containing Antimicrobial Wash to Reduce Prosthetic Device Infection After Trauma Surgery
Official title: Use of a Taurolidine Containing Antimicrobial Wash to Reduce Prosthetic Device Infection After Trauma Surgery
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Osteosynthesis
Infection Prevention
Lead sponsor: University of Kiel
Sponsor class: OTHER
First posted: 2025-04-09
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: trimalleolar farcture lower extremity, requiring osteosynthesis and external fixation undergoing revision to internal fixation; osteosynthesis of upper extremity undergoing revision to receive inverse shoulder prosthesis

Brief summary: A taurolidine-based antimicrobial solution, was evaluated for its safety and efficacy in preventing infections associated with prosthetic materials, such as joint replacements, plates, nails, and screws. This prospective observational study compared Taurolidine to infection rates from scientific literature.

Detailed description: During any invasive procedure involving prosthetic materials at the corresponding author's institution, the surgical site was irrigated, and all accessible hardware (including nails, screws, plates, and prosthetic joint replacement therapy devices) was wiped with Taurolidine. Only procedures performed between 01/01/2022 and 01/10/2023, where Taurolidine was applied, were included in the analysis.

Patients who underwent multiple procedures were censored for the last treatment group and reassigned at the next procedure. Preoperative antibiotic prophylaxis was administered according to institutional guidelines, and no additional intraoperative antimicrobial agents were used aside from Taurolidine.

The primary endpoint was the occurrence of a major infection within three months post-procedure, defined as:

1. Infection necessitating revision procedure,
2. A requirement for prolonged antibiotic therapy, or
3. Infection leading to mortality. Secondary endpoints included infections beyond three months, adverse events potentially related to the antimicrobial solution, procedural complications (i.e., hematoma formation, nerval lesions, etc), and mortality during all follow-up.

Eligibility criteria: Inclusion Criteria:

* requires osteosynthesis with placement of prosthetic materials

Exclusion Criteria:

* minor, can't or won't sign PIC, can't undergo surgical procedure

Primary outcomes:
measure: Infection
timeFrame: 3 months
Secondary outcomes:
measure: AE all grades, infections and all cause mortality during total follow up
timeFrame: 36 months
Other outcomes:
Locations:
city: Cuxhaven
country: Germany
facility: Helios Cuxhaven
Study officials:
References:
Clinical trial NCT01891370: Median Study for Biochemical Serum Markers in First Trimester of Pregnancy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pregnancy
Lead sponsor: PerkinElmer, Wallac Oy
Sponsor class: INDUSTRY
First posted: 2013-07-03
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: women in first trimester of pregnancy coming to antenatal assessment

Brief summary: The purpose of this study is to get initial values (normal medians) for certain biochemical serum markers for pregnancy weeks 10-13. Also initial values for mean arterial blood pressure measurement and certain ultrasound measurement may be established.


Eligibility criteria: Inclusion Criteria:

* written informed consent
* maternal age 18 - 45 years
* gestational age 10 -13 (+6 days)verified by ultrasound

Exclusion Criteria:

* mental retardation or other mental disorders that impose doubts regarding the true subject's willingness to participate in the study
* lack of needed demographic data

Primary outcomes:
measure: levels of biochemical serum markers
timeFrame: 10-13 wks gestation
Secondary outcomes:
Other outcomes:
Locations:
city: Seremban
country: Malaysia
facility: Hospital Tuanku Jaafar
city: Caloocan City
country: Philippines
facility: MCU-FDT Medical Foundation
city: Khon Kaen
country: Thailand
facility: Khon Kaen University
Study officials:
References:
Clinical trial NCT02724670: Study of MR-based IGRT for Prostate Cancer
Official title: Single-arm Phase II Study of MR(Magnetic Resonance Imaging)-Based Image-guided Radiotherapy for Prostate Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Prostate Cancer
Lead sponsor: University Hospital Tuebingen
Sponsor class: OTHER
First posted: 2016-03-31
Enrollment: 78
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: MR (Magnetic Resonance Imaging) - based IGRT (image-guided radiotherapy) for patients with prostate carcinoma.

Detailed description: Single arm, phase II study, MR (Magnetic Resonance Imaging) - based IGRT (Image-guided radiotherapy) of prostate cancer.

Primary endpoint: Grade 2+ GI (gastrointestinal) and genitourinary (GU) toxicity after 2 years.

Eligibility criteria: Inclusion Criteria:

* histologically proven prostate cancer
* indication for curative treatment
* ECOG performance scale 0-2
* Informed consent

Exclusion Criteria:

* contraindications for curative treatment
* age\<18year
* previous pelvic radiotherapy or prostatic treatment like TURP (transurethral resection of prostate), HIFU (high intensity focused ultrasound)
* serious comorbidity leading to inability for IGRT (image-guided radiotherapy)
* contraindications for MRI (Magnetic Resonance Imaging)

Primary outcomes:
measure: G2+gastrointestinal and genitourinary toxicity at 2 years
timeFrame: Total trial treatment duration: 4 years, Duration for individual patient:Study treatment 9 months, Follow-up: 2 years for primary endpoint
Secondary outcomes:
measure: Long-term GU-GI toxicity
timeFrame: 10 years after treatment
Other outcomes:
Locations:
city: Tübingen
country: Germany
facility: Müller Arndt-Christian
Study officials:
affiliation: Department of Radiation Oncology, University of Tübingen
name: Arndt-Christian Müller, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04631770: Mediastinal Lymph Node Dissection Versus Spared Mediastinal Lymph Node Dissection in Stage I GGN NSCLC
Official title: Mediastinal Lymph Node Dissection Versus Spared Mediastinal Lymph Node Dissection in Stage IA Non-small Cell Lung Cancer Presented as Ground-glass Nodules: Study Protocol of a Phase III, Randomized, Multi-center Trial (MELDSIG) in China
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Lung Neoplasms
Lymph Node Excision
Keywords: Non-small cell lung cancer
Mediastinal lymph node dissection
Ground-glass nodules
Lead sponsor: Tianjin Medical University Cancer Institute and Hospital
Sponsor class: OTHER
First posted: 2020-11-17
Enrollment: 1362
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Lung cancer is the leading cause of cancer related death worldwide. Lobectomy or sub-lobectomy with mediastinal lymph node dissection is the standard surgery. About 50% lung nodules are pure ground-glass or part-solid nodules. Non-solid nodules rarely develop mediastinal lymph node metastasis. The present study is a prospective, multicenter and randomized clinical trial, comparing the overall survival and disease-free survival of whether performing mediastinal lymph node dissection in non-small cell lung cancer with ground-glass nodule CT features.

Detailed description: The study is a non-inferior statistical comparison, with 681 patients in each group. The anticipated enroll period is 3 years, followed by observation period of 5 years.

Eligibility criteria: Inclusion Criteria:

* Thin-slice HRCT shows single GGN with C/T ≤ 0.5 and no lymph node metastasis;
* Clinical stage IA NSCLC (TNM 8th classification) diagnosed prior or in surgery;
* No history of malignancies within past 5 years or lung surgery;
* No anti-cancer treatment prior to surgery.

Exclusion Criteria:

* Simultaneous or metachronous (within the past 5 years) double cancers;
* Active bacterial or fungous infection;
* Interstitial pneumonitis, pulmonary fibrosis, or severe pulmonary emphysema;
* Systemic steroidal medication;
* Uncontrollable diabetes mellitus; (vi) Uncontrollable hypertension or history of severe heart disease, heart failure.

Primary outcomes:
measure: Overall survival
timeFrame: 5 years
Secondary outcomes:
measure: Relapse-free survival
timeFrame: 5 years
measure: Proportion of local recurrence
timeFrame: 5 years
measure: Duration of hospitalization
timeFrame: 1-60 days
measure: Duration of chest drainage tube placement
timeFrame: 1-60 days
measure: Operation time
timeFrame: 20-180 minutes.
measure: Blood loss
timeFrame: 1-60 days
Other outcomes:
Locations:
city: Tianjin
country: China
facility: Ethics review board of Tianjin Medical University Cancer Institute and Hospital
state: Tianjin
Study officials:
affiliation: Tianjin Medical University Cancer Institute and Hospital
name: Zhenfa Zhenfa, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03180970: Different Lugol's Solution Concentration for Image Quality of Esophageal Lesions in Chromoendoscopy With Iodine Staining
Official title: Different Lugol's Solution Concentration for Image Quality of Early Esophageal Squamous Neoplasia in Chromoendoscopy With Iodine Staining
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Image Quality of Early Esophageal Squamous Neoplasia
Endoscopists'Subjective Assessments
Lead sponsor: Shandong University
Sponsor class: OTHER
First posted: 2017-06-08
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to assess whether lower Lugol's solution concentration can perceive the same image quality of early esophageal squamous neoplasia.

Detailed description: Chromoendoscopy using Lugol's solution is effective for the detection of early esophageal squamous neoplasia. However, this modality may cause severe chest pain and discomfort owing to mucosal irritation.

This study was to test whether a lower concentration of Lugol's solution can provide satisfied image quality of early esophageal squamous neoplasia and has lower mucosal irritation.

Eligibility criteria: Inclusion Criteria:

Patients with early esophageal squamous neoplasia who underwent endoscopic submucosal dissection.

Exclusion Criteria:

After esophageal surgery or endoscopic treatment ; Known esophageal radiotherapy or chemotherapy ; Esophageal stenosis; Acute bleeding; A known allergy to iodine; Coagulopathy (prothrombin time \<50% of control, partial thromboplastin time \>50 seconds); Having food retention; Severe hepatic ,renal, cardiovascular or metabolic dysfunction ; Being pregnant or lactating.

Primary outcomes:
measure: Image Quality of Esophageal Lesions
timeFrame: seven months
Secondary outcomes:
measure: Questionnaire of endoscopists' subjective assessments
timeFrame: intraoperative
measure: Complete resection/R0 resection rate
timeFrame: 1 month
measure: Mucosal change of the stomach in white-light endoscopy after Lugol's solution sprayed.
timeFrame: intraoperative
measure: The amount of Lugol's solution
timeFrame: intraoperative
measure: Severe adverse events (allergic reactions, esophageal burns, spasms and even perforation)
timeFrame: 1 month
Other outcomes:
Locations:
city: Jinan
country: China
facility: Qilu Hospital, Shandong University
state: Shandong
Study officials:
affiliation: Qilu Hospital of Shandong University
name: Xiuli Zuo, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02720770: Growth Hormone Treatment in Children With Hypophosphatemic Rickets
Official title: Proposition Pour un Traitement Par Hormone de Croissance Des Enfants Atteints de Rachitisme Hypophosphatemique Familial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: X Linked Hypophosphatemic Rickets
Keywords: growth hormone
Lead sponsor: Bicetre Hospital
Sponsor class: OTHER
First posted: 2016-03-28
Enrollment: 19
Sex: ALL
Minimum age (years): 3
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study evaluates the effect on height of a two year treatment with growth hormone in 19 children with X linked hypophosphatemic rickets.


Eligibility criteria: Inclusion Criteria:

* clinical, biochemical and genetic diagnosis of XLH
* height SDS \< 2
* at least two years of treatment with oral phosphate and calcitriol

Exclusion Criteria:

* uncontrolled rickets (ALP\>600 IU)
* growth hormone deficiency
* hyperparathyroidism, nephrocalcinosis, renal insufficiency
* associated disease
* previous treatment with growth hormone

Primary outcomes:
measure: change from baseline in height SDS (standard deviation score)
timeFrame: at year one and year two from baseline
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Rothenbuhler A, Esterle L, Gueorguieva I, Salles JP, Mignot B, Colle M, Linglart A. Two-year recombinant human growth hormone (rhGH) treatment is more effective in pre-pubertal compared to pubertal short children with X-linked hypophosphatemic rickets (XLHR). Growth Horm IGF Res. 2017 Oct;36:11-15. doi: 10.1016/j.ghir.2017.08.001. Epub 2017 Aug 15.
Clinical trial NCT03106870: Adding Metformin to Insulin in Controlling Pregestational and Gestational Diabetes Mellitus
Official title: Adding Metformin to Insulin in Controlling Pregestational and Gestational Diabetes Mellitus and Improving Neonatal Outcome Regarding Birth Weight
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gestational Diabetes Mellitus in Pregnancy
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2017-04-11
Enrollment: 62
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Group I: pregnant women who received oral metformin in addition to insulin therapy.

Group II: pregnant women who received insulin therapy only.
Primary purpose: TREATMENT

Brief summary: The purpose of the study to prove benefits of adding metformin to insulin for controlling presentational and gestational diabetes mellitus and improving neonatal outcome.

Detailed description: The current study was conducted at Ain Shams university maternity hospital during the period between June 2016 to December 2016.

All patients were subjected to:

1. History taking:
2. General and Abdominal Examination:

   With particular emphasis on :
   * Body mass index
   * Blood pressure.
   * Fundal height .
   * Estimated fetal weight .
3. Insulin and metformin doses :

   Insulin dose:

   0.7 IU/Kg (at the second trimester of pregnancy). 0.8 IU/Kg (at the third trimester of pregnancy). Insulin dose was raised at a rate of 1 IU for every 10 mg/dl higher than the target blood glucose concentration.

   Metformin dose :

   Oral metformin at a dose of 1500 mg divided into three doses, were taken with meals, in addition to insulin.

   If the target blood glucose concentrations were not attained, the dose of metformin was raised to 2000 mg per day.
4. Investigations:

Fasting and two hours postprandial blood glucose levels were measured in two groups of pregnant women:

1. Group I: pregnant women who received oral metformin in addition to insulin therapy.
2. Group II: pregnant women who received insulin therapy only.

Eligibility criteria: Inclusion Criteria:

1. Age 20 - 35 years.
2. Gestational age: 20- 36 weeks gestation.
3. Singleton pregnancy.
4. Women with pregestational or gestational diabetes mellitus

Exclusion Criteria:

1. Pregnant women with secondary diabetes (e.g. those on chronic steroid therapy).
2. Hypertensive patients.
3. Women with impaired liver or renal function
4. Non-compliant patients.

Primary outcomes:
measure: Number of Participants With Glycemic Control Over Period From 20 Weeks to 36 Weeks Gestation
timeFrame: from 20 weeks to 36 weeks gestation
Secondary outcomes:
measure: Number of Participants With a Macrosomic Baby
timeFrame: 24 hours after delivery
measure: Number of Participants With Neonates Who Were Hypoglycemic
timeFrame: 24 hours after delivery
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05376670: Patient Satisfaction and Long-term Safety of Intravesical Aminoglycoside Instillations in UTI Prevention
Official title: Patient Satisfaction and Long-term Safety of Intravesical Aminoglycoside Instillations in UTI Prevention
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Urinary Tract Infections
Recurrent Urinary Tract Infection
Keywords: Intravesical treatment
Lead sponsor: Leiden University Medical Center
Sponsor class: OTHER
First posted: 2022-05-17
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population will include adult male and female patients receiving IAI for recurrent UTI at the infectious diseases outpatient clinic of the Leiden University Medical Centre. A proportion of study participants will have urological and/or neurological comorbidities and a history of other prophylactic treatments for recurrent UTI.

Brief summary: Antimicrobial prophylactic treatment of recurrent UTI is limited by emerging resistance, antibiotic allergies and intolerances. Intravesical aminoglycoside instillations (IAI) have been shown to reduce recurrence rate, without a short-term decline in kidney function or hearing. Thus far, treatment satisfaction has not yet been assessed, while this may play an important role in treatment adherence and persistence. Moreover, there is no data on the long-term safety of IAI, e.g. regarding the development of (pre)malignant bladder lesions.


Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years
* Currently receiving or having received (no minimal duration) continuous or post-coital IAI (gentamicin, tobramycin or amikacin) for recurrent UTI prophylaxis and treatment

Exclusion Criteria:

* Exclusively receiving IAI for 'on-demand' treatment of UTI and not prophylactic purposes
* Receiving IAI as suppressive therapy for chronic prostatitis
* Presence of a chronic indwelling catheter
* Patient has objected to the use of his/her data
* Inability to provide informed consent

Primary outcomes:
measure: Treatment satisfaction regarding intravesical aminoglycoside instillations (IAI)
timeFrame: 1 year
Secondary outcomes:
measure: Time to first UTI recurrence after initiation of IAI
timeFrame: First 6 months of IAI
measure: Number of UTI recurrences
timeFrame: First 6 months of IAI
measure: Number of UTI recurrences that are treated with IAI alone (no systemic antimicrobial therapy)
timeFrame: First 6 months of IAI
measure: Number of patients that wish to (dis)continue IAI
timeFrame: 6 months after initiation of IAI
measure: Proportion of patients that have a UTI episode caused by the same MDRO uropathogen as before start of IAI
timeFrame: 6 months after initiation of IAI
Other outcomes:
Locations:
city: Leiden
country: Netherlands
facility: Leiden University Medical Center
state: South Holland
Study officials:
affiliation: Leiden University Medical Center
name: Manu Bilsen, MD
role: PRINCIPAL_INVESTIGATOR
References: