louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01514955: An Initial Feasibility Study to Integrate MRI Based Brachytherapy and CT/MR Fused INRT in Treatment of Advance Cervical Cancer
Official title: An Initial Feasibility Study to Integrate High-precision, Image Guided, Radiotherapy(MRI Based Brachytherapy and CT/MRI Fused Dynamic IMRT Planning) in the Treatment Planning of 10 Patients With Locally Advanced Carcinoma of the Cervix
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: Integrated MRI Based RT as Standard of Care
Locally Advanced Cervical Cancer
Lead sponsor: AHS Cancer Control Alberta
Sponsor class: OTHER
Collaborators: name: Cross Cancer Institute
First posted: 2012-01-23
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Main cause of mortality in cervix cancer is local relapse in the pelvis. Since distant metastasis is quiet rare, increasing local control in the pelvis can directly translate into improvement in survival. Obstacles in front of this approach is the dose limitation to normal organs located in the pelvis adjacent to the tumor. 3-D MRI based EBRT and Brachytherapy will grant safe delivery of more conformal higher doses of radiation to the tumor and allowing sparing of the normal structures.

Detailed description: A total of 10 patients with a diagnosis of locally advanced cervical carcinoma will be enrolled. After diagnosis and written informed consent, patients will undergo investigations prior to treatment planning, including CT imaging as per standard of care. In addition, patients will have an MRI of the pelvis + PET scan + EUA and gold seeds insertion to verify pelvic organs movement and EB-IMRT with daily cone beam CT. Brachytherapy treatment planning will be based on MRI imaging with the applicator in situ.

Eligibility criteria: Inclusion Criteria:

* Cancer of the uterine cervix considered suitable for curative treatment with definitive radio-chemo-therapy including MRI guided BT. (stage IB2 bulky disease-stage IVa)
* Staging according to FIGO and TNM guidelines
* Positive biopsy showing squamous cell carcinoma, adenocarcinoma or adeno-squamous cell carcinoma of the uterine cervix
* No pelvic nodes \> 2cm
* MRI of pelvis at diagnosis
* MRI of the retroperitoneal space and abdomen at diagnosis
* MRI with applicator in place at time of BT
* Age 18-70 years
* Patient informed consent

Exclusion Criteria:

* Pelvic nodes \> 2cm
* Previous pelvic or abdominal radiotherapy
* Previous total or partial hysterectomy
* Combination of preoperative radiotherapy with surgery
* Patients receiving neo-adjuvant chemotherapy
* Patients receiving BT only
* Contraindications to MRI

Primary outcomes:
measure: Feasibility parameters
timeFrame: One year
Secondary outcomes:
measure: Response rate, acute and late toxicity, local control rate, survival
timeFrame: Five years
measure: Dosimetric comparison between 2D and 3D Brachytherapy treatment planning
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02606955: Probing the Dry Weight by Bioimpedance: The Resistance Stabilization Test
Official title: Probing the Dry Weight (DW) by Bioimpedance (BIA): Which is the Gold Standard Between Clinical DW and BIA DW?
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Uremia
Keywords: Bioimpedance
Dry weight
Hemodialysis
Resistance
Lead sponsor: Miulli General Hospital
Sponsor class: OTHER
First posted: 2015-11-17
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Clinical methods are fundamental in probing the DW. They must be supported by strict BIA protocols. REST appears to be a (the) brilliant solution in solving the old problem of DW in HD patients

Detailed description: Probing the dry weight (DW) was largely dependent on clinical subjective estimates until recently. New bedside non-invasive tools have been developed with the aim of providing more objective information on volume status and guiding physicians in the quest for DW. Among them, bioimpedance (BIA) appears to be very promising.

Very recently, a BIA test aimed at assessing DW in hemodialysis (HD) patients has been developed, the "REsistance Stabilization Test" (REST). It is called BIA DW. Its rationale is based on the achievement of the flattening of the curve of the ratio R0/Rt (R0 is resistance at time 0 and Rt is resistance at a given time t during the HD session) of less than + 1% over 20 minutes in the presence of ongoing ultrafiltration.

Study protocol: the Clinical DW is the gold standard by definition. It is determined under strict clinical surveillance by the same attending physician. She/he will be helped by a clinical score of volume state about symptoms and signs of hypo- or hypervolemia. Then, this Clinical DW will be compared with BIA DW, as obtained after performing REST

Eligibility criteria: Inclusion Criteria

* stable uremic patients
* thrice weekly hemodialysis treatment
* start of hemodialysis treatment since at least 3 months

Exclusion Criteria

* overt edema
* liver cirrhosis
* cardiac failure
* serum albumin \< 3g/dl
* pregnancy
* metallic implants or a pacemaker
* limb amputation

Primary outcomes:
measure: Assessment of the gold standard method for the measurement of DW (in kg) through the comparison of clinical DW (as determined by means of a validated clinical score) and BIA DW (measurement of the resistance in kilohertz).
timeFrame: up to 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Acquaviva delle Fonti
country: Italy
facility: Nephrology and dialysis unit Miulli General Hospital
state: Bari
city: Solofra
country: Italy
facility: Divisionof Nephrology
Study officials:
affiliation: Mulli General Hospital
name: Carlo Basile, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Basile C, Libutti P, Lisi P, Rossi L, Lomonte C. Probing the dry weight by bioimpedance: the resistance stabilization test. J Nephrol. 2015 Aug;28(4):517-20. doi: 10.1007/s40620-014-0159-8. Epub 2014 Dec 6.
Clinical trial NCT03397355: Monitoring the Changes of Tumor-related Biomarkers Before and After Pulmonary Nodule Biopsy.
Official title: Changes of Tumor-related Biomarkers Before and After Pulmonary Nodule Biopsy and Their Clinical Implications.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Lung Cancer
Keywords: Pulmonary Nodule; Lung Cancer; Biopsy; Biomarker.
Lead sponsor: China-Japan Friendship Hospital
Sponsor class: OTHER
First posted: 2018-01-12
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with pulmonary nodules (single or multiple) by CT scans.

Brief summary: In the past few years, circulating tumor cells (CTCs), circulating tumor DNA (ctDNA), microRNAs, autoantibodies, and T-cell receptor repertoire are new biomarkers of liquid biopsy in cancer, which has been demonstrated to have a great value in diagnostics, treatment evaluation, and prognosis prediction. However, most of previous data were based on late stage tumor patients. This study plans to utilize the minimally invasive method to detect the changes of numbers of CTCs, ctDNA hot spot mutations and methylation signals, microRNAs, autoantibodies, and T-cell receptor repertoire in early stage lung cancer patients before and after pulmonary nodule biopsy, during therapeutic and follow-up periods, in order to evaluate the clinical values of above tumor-related biomarkers.


Eligibility criteria: Inclusion Criteria:

* Confirmed as suspected lung cancer patients with pulmonary nodules (single or multiple) by CT scans, and the maximum diameter of nodule is between 8mm and 3cm;
* Male or female, with age of 18\~80 years;
* Agree to take the pulmonary nodule biopsy, and sign the Informed Consent.

Exclusion Criteria:

* With severe comorbidities and unable to participate in this study;
* Diagnosed with acute respiratory tract infection, for instance fungus, mycobacterium tuberculosis or other bacteria, virus, etc., one month prior to the study recruitment;
* Pregnant or maternal women;
* Diagnosed with other carcinoma, and the pulmonary nodules suspected of stemming from other sites;
* Unable for regular follow-ups according to the research protocol;
* Blood sample is not qualified for biomarker testing.

Primary outcomes:
measure: Death or survival
timeFrame: Baseline and every three- or six-month follow-up within two years for each patient.
measure: Disease progress
timeFrame: Baseline and every three- or six-month follow-up within two years for each patient.
measure: Reasons of study termination
timeFrame: Baseline and every three- or six-month follow-up within two years for each patient.
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: China-Japan Friendship Hospital
state: Beijing
Study officials:
affiliation: China-Japan Friendship Hospital
name: Chen WANG, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01249755: International Validation of a Delirium Prediction Model for ICU Patients
Official title: International Validation of a Delirium Prediction Model for ICU Patients (PRE-DELIRIC) in ICUs; a Multicentre Trial.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Delirium
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
First posted: 2010-11-30
Enrollment: 2000
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: Adult patients admitted to the ICU

Brief summary: Recently our ICU research group developed and validated a delirium prediction model in the NetherlandsThis. This model has a high predictive value. We want to examine what the predictive value is in ICUs of other European countries.

Detailed description: Delirium is a serious and common disorder in ICU patients. It is increasingly recognized that screening of ICU patients is a valuable tool for early detection and treatment of delirium, which may reduce its incidence, severity and duration. Apart from treatment of delirium, delirium prevention (pharmacological and nursing interventions)is an important issue. However, it is time consuming to take preventive measures in all ICU patients. The recently developed prediction model facilitates the conduct of preventive measures focused on high risk groups. This prediction model is developed and validated in the Netherlands. The aim of our study is to investigate the predictive value of the model in ICUs in other countries.

Eligibility criteria: Inclusion Criteria:

* patients 18 years or older

Exclusion Criteria:

* delirious state within the first 24hours after ICU admission
* sustained comatose during complete ICU stay
* admission duration less than twelve hours;
* serious auditory or visual disorders
* unable to understand the language of the included centre
* severely mentally disabled
* serious receptive aphasia
* or if there are missing or incomplete delirium screenings during admission to the ICU

Primary outcomes:
measure: delirium
timeFrame: during admission at the critical care
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Radboud University Medical Center
name: Mark van den Boogaard, MSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02359955: Comparison of Masticatory Efficiency Between Complete Denture With Zero-degree Teeth and Anatomic Teeth in Patients With Severely Resorbed Ridge
Official title: Comparison of Masticatory Efficiency and EMG Activity Between Complete Denture With Zero-degree Teeth and Anatomic Teeth in Patients With Severely Resorbed Ridge
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Edentulous
Lead sponsor: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Sponsor class: OTHER
First posted: 2015-02-10
Enrollment: 20
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This study aims to evaluate masticatory efficiency of the zero-degree teeth complete denture in treatment of edentulous patients of severely resorbed ridge.Patients will be crossed over to be treated with zero-degree teeth complete denture and anatomic teeth complete denture. For each patient, the masticatory efficiency and electromyography with different denture will be recorded and analysis.


Eligibility criteria: Inclusion Criteria:

* complete edentulism for at least three months class Ⅳ ridge

Exclusion Criteria:

* neuromuscular dysfunction, psychiatric disorder,

Primary outcomes:
measure: EMG (Masseters EMG Are Recorded After Patient Wears Complete Denture for Three Months)
timeFrame: three months
measure: EMG (Masseters EMG Are Recorded After Patient Wears Complete Denture for Three Months)
timeFrame: three month
Secondary outcomes:
measure: Masticatory Efficiency Index
timeFrame: three months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04823455: Results Following Fresh-frozen Humeral Head Osteochondral Allograft Reconstruction for Reverse Hill-Sachs Lesion
Official title: Results Following Fresh-frozen Humeral Head Osteochondral Allograft Reconstruction for Reverse Hill-Sachs Lesion
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Shoulder Dislocation Closed Traumatic
Keywords: shoulder dislocation, humeral allograft, locked posterior dislocation
Lead sponsor: Istituto Ortopedico Rizzoli
Sponsor class: OTHER
First posted: 2021-03-30
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Locked posterior glenohumeral dislocations with a reverse Hill-Sachs impaction fracture involving less than 30% of the humeral head are most frequently treated with lesser tuberosity transfer into the defect, whereas those involving more than 50% undergo humeral head arthroplasty. Reconstruction of the defect with segmental femoral osteochondral allografts has been proposed to treat patients between these two ranges, but the medium-/long-term outcomes of this joint-preserving procedure are controversial.

Detailed description: Twelve patients with a unilateral locked posterior shoulder dislocation and at least 30% (mean 31%) impaction of the humeral head were treated with segmental reconstruction of the defect with fresh-frozen humeral head osteochondral allografts. Patients were assessed clinically, radiographically and with computed tomography (CT) at a medium follow-up of 66 months (range, 24-225).All twelve shoulders presented a slight limitation in anterior elevation

Eligibility criteria: Inclusion Criteria:

- Diagnosis of an acute non-reducible posterior gleno-humeral dislocation with an associated McLaughlin lesion affecting more than 30% of the cartilaginous circumference of the humeral head.

Exclusion Criteria:

- Patients with associated injuries to the affected upper limb, with neuromuscular or psychomotor disorders or with disorders affecting connective tissues.

Primary outcomes:
measure: Western Ontario Shoulder Instability index (WOSI)
timeFrame: 2 months
measure: American Shoulder and Elbow Surgeons Shoulder Score (ASES)
timeFrame: 2 months
measure: Constant-Murley score (CS)
timeFrame: 2 months
Secondary outcomes:
measure: Samilson-Prieto score
timeFrame: 2 months
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: IRCCS Istituto Ortopedico Rizzoli
Study officials:
References:
citation: Marcheggiani Muccioli GM, Rinaldi VG, Lullini G, Ritali A, Mosca M, Romagnoli M, Guerra E, Zaffagnini S. Mid-Term outcomes following fresh-frozen humeral head osteochondral allograft reconstruction for reverse Hill Sachs lesion: a case series. BMC Musculoskelet Disord. 2021 Sep 8;22(1):768. doi: 10.1186/s12891-021-04657-z.
Clinical trial NCT00935155: Effectiveness of Acupuncture as an Adjunct to Rehabilitation After Knee Arthroplasty
Official title: Effectiveness of Acupuncture as an Adjunct to Rehabilitation After Knee Arthroplasty. A Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Total Knee Replacement
Keywords: exercise therapy
Knee arthroplasty
Acupuncture Analgesia
Arthroplasty, Replacement, Knee
rehabilitation
Lead sponsor: Back and Rehabilitation Center, Copenhagen
Sponsor class: OTHER_GOV
First posted: 2009-07-08
Enrollment: 170
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: No randomized trials have tested the effectiveness of acupuncture as a supplement to rehabilitation after total knee replacement. Studies from related fields, however, have shown reduction of symptoms as a result of acupuncture treatment in patients with knee pain caused by severe osteoarthritis in the knee. Furthermore, studies have reported that the need of pain medication was lower when acupuncture treatment was performed immediately after knee surgery.

The aim of this study is to test whether acupuncture can reduce pain and improve disability as a supplement to rehabilitation after total knee replacement.

One hundred and seventy patients will be allocated by drawing lots to either a treatment group receiving exercise therapy and acupuncture or a group receiving exercise therapy alone. Treatment will start 3 weeks after surgery at the latest.

Outcome of treatments will be measured at completion of treatment and at 3 months follow-up by pain- and disability questionnaires as well as the recording of walking capacity.


Eligibility criteria: Inclusion Criteria:

* Hemi- or total knee arthroplasty.
* 18 - 70 years of age.

Exclusion Criteria:

* Concurrent diseases that compromises treatment, i.e.hip disease, rheumatoid arthritis, migraine).
* Bleeding disorders.
* Heart disease or use of pacemaker.
* Lack of patient cooperation, i.e. psychological disorders, alcoholism, problems with language).
* Infection.

Exclusion criteria during intervention:

* Infection.
* Cicatrice-burst.

Primary outcomes:
measure: pain
timeFrame: 3 months after treatment
Secondary outcomes:
measure: disability
timeFrame: 3 months after treatment
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Back and Rehabilitation Center Copenhagen
Study officials:
affiliation: Back and Rehabilitation Center, Copenhagen
name: Tom Petersen, PT, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01452555: Video-Based Delivery of HIV Test Information for Spanish-Speaking Latinos
Official title: Video-Based Delivery of HIV Test Information for Spanish-Speaking Latinos
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: HIV
AIDS
Keywords: HIV
HIV Prevention
HIV testing
HIV Rapid Test
Lead sponsor: Rhode Island Hospital
Sponsor class: OTHER
First posted: 2011-10-17
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to determine if a Spanish-language HIV and HIV test information video is as effective in delivering basic information regarding HIV and HIV tests to primarily Spanish-speaking HIV test recipients as an in-person presentation with an HIV test counselor.


Eligibility criteria: Inclusion Criteria:

* 18-64 years of age
* Self-identify as Latino
* Able to give informed consent
* Spanish speaking

Exclusion Criteria:

* Intoxicated
* Being treated for acute psychiatric illness
* Mental incapacitation
* Significant visual or hearing impairment
* Prisoner or under home confinement
* Participating in HIV vaccine trial
* Critically ill

Primary outcomes:
measure: Effectiveness of an educational video regarding HIV and HIV testing for Spanish speaking Latinos
Secondary outcomes:
Other outcomes:
Locations:
city: Providence
country: United States
facility: Rhode Island Hospital
state: Rhode Island
Study officials:
affiliation: Rhode Island Hospital
name: Dr. Roland Merchant, MD, MPH, ScD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Merchant RC, Clark MA, Santelices CA, Liu T, Cortes DE. Efficacy of an HIV/AIDS and HIV testing video for Spanish-speaking Latinos in healthcare and non-healthcare settings. AIDS Behav. 2015 Mar;19(3):523-35. doi: 10.1007/s10461-014-0889-6.
Clinical trial NCT03997955: Myofascial Induction Effects on Plantar Pressures and Stabilometry
Official title: Myofascial Induction Effects on Plantar Pressures and Stabilometry Variables. A Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Foot Diseases
Myofascial Pain
Lead sponsor: Universidad de León
Sponsor class: OTHER
First posted: 2019-06-25
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective is to determine the effectiveness of myofascial Induction effects on plantar pressures and stabilometry variables. Forty healthy subjects (28 females and 12 males) will be recruited for a simple blind clinical trial. All subjects will be randomly distributed in two different groups: control group (sham treatment of myofascial Induction) and experimental group (myofascial Induction). Outcome measurements will be foot plantar pressure area (footprint) and center of pressure area (stabilometry) by the Balance Evaluation Systems test. Two trials will be recorded for each condition.


Eligibility criteria: Inclusion Criteria:

* Healthy individuals without pain.

Exclusion Criteria:

* Previous lower extremities surgery
* History of lower extremities injury with residual symptoms within the last year
* Evidence of a leg-length discrepancy of more than 1 cm
* Evidence of balance deficits

Primary outcomes:
measure: Foot plantar pressure area
timeFrame: Change from foot plantar pressure area at 2 minutes
Secondary outcomes:
measure: Center of pressure area
timeFrame: Change from center of pressure area at 2 minutes
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Eva María Martínez
Study officials:
References:
citation: Martinez-Jimenez EM, Becerro-de-Bengoa-Vallejo R, Losa-Iglesias ME, Diaz-Velazquez JI, Palomo-Lopez P, Rodriguez-Sanz D, Calvo-Lobo C, Lopez-Lopez D. Pressure and Traction Technique Improves Postural Control More Than Tactile Stimulation in Foot Plantar Fascia: A Randomized Single-Blind Trial. Arch Phys Med Rehabil. 2020 Jun;101(6):978-984. doi: 10.1016/j.apmr.2020.01.017. Epub 2020 Feb 28.