louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01359345: Nephrogenic Systemic Fibrosis With Gadollinum
Official title: The Prevalence and Severity of Nephrogenic Systemic Fibrosis in Patients Whom Underwent Imaging With Gadollinium(MRI/MRA) in University Hospital of Tehran Heart Center in 2003-2008
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Nephrogenic Systemic Fibrosis
Renal Failure
Keywords: NSF
ESRD
MRA
MRI
occurrence of NSF
Use of Gadollinum
Lead sponsor: Imam Khomeini Hospital
Sponsor class: OTHER
Collaborators: name: Tehran Heart Center
First posted: 2011-05-24
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: Recently there is increasing reports of NEPHROGENIIC SYSTEMIC FIBROSIS(NSF) in patients with severe renal failure mainly in patients under dialysis in whom gadollinum is being used.

The investigators will evaluate the prevalence and severity of NSF in patients with different degree of renal failure whom underwent imaging with Gadolinum.

Detailed description: NSF is a progressive and potentially fatal disease reported mainly in End Stage Renal Disease (ESRD) patients in whom Gadolinume been used as contrast agent. Skin is the main organ of involvement but other vital organs like myocard,lung,liver may also be involved.Gadollinum is known as a safe contrast in renal disease patients in comparison with conventional nephrotoxic radiocontrast agents,but with increasing reports of NSF with Gadollinum the use of this agent in renal failure patients is under question.

We will retrospectively evaluate the occurrence of this complication in all patients with different degree of renal failure whom underwent MRA or MRI with Gadollinum in Tehran Heart Center since 2003 till now and we will describe the severity and distribution pattern of lesions and the relation of this complication to the severity of renal failure.

Eligibility criteria: Inclusion Criteria:

* Renal Failure
* Use of Gadollinum

Exclusion Criteria:

* No consent
* Age under 18

Primary outcomes:
measure: occurrence of fibrosis
timeFrame: after 2 month of exposure with gadollinum
Secondary outcomes:
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Tehran Heart Center
Study officials:
affiliation: TUMS
name: Mohammad R Khatami, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05908045: Have Physical Therapists Attitudes and Beliefs Towards Vital Assessment Changed Following the COVID-19 Pandemic?
Official title: Have Physical Therapists Attitudes and Beliefs Towards Vital Assessment Changed Following the COVID-19 Pandemic?
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Vital Signs
Keywords: vital sign
physical therapy
assessment
covid-19
Lead sponsor: Youngstown State University
Sponsor class: OTHER
Collaborators: name: Duke University
First posted: 2023-06-18
Enrollment: 500
Sex: ALL
Minimum age (years): 23
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Physical Therapists who are currently working in clinical practice that have a minimum of 5 years experience (based on ability to identify practice patterns prior to the COVID-19 pandemic).

Brief summary: Previous studies prior to the COVID-19 pandemic show that cardiovascular and blood pressure assessment by physical therapists is inadequate or lacking despite prior training. Since the COVID-19 pandemic, assessment of cardiovascular and respiratory function may become more critical as the manifestation of long COVID has become a concern. The purpose of this study is to determine whether physical therapists' attitudes and beliefs towards vital sign assessment have changed following the COVID-19 pandemic.


Eligibility criteria: Inclusion Criteria:

1. Must be a licensed Physical Therapist
2. Must be actively be involved in clinical practice
3. Must have ≥ 5 years of experience practicing in a clinical setting as a Physical Therapist

Exclusion Criteria:

(1) Did not provide informed consent

Primary outcomes:
measure: KAP Survey
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Youngstown
country: United States
facility: Youngstown State University
state: Ohio
Study officials:
affiliation: Youngstown State University
name: Edmund C Ickert, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Severin R, Wang E, Wielechowski A, Phillips SA. Outpatient Physical Therapist Attitudes Toward and Behaviors in Cardiovascular Disease Screening: A National Survey. Phys Ther. 2019 Jul 1;99(7):833-848. doi: 10.1093/ptj/pzz042.
citation: Albarrati AM PT, PhD. Outpatient physical therapy cardiovascular assessment: Physical therapist perspective and experience. Physiother Theory Pract. 2019 Sep;35(9):843-850. doi: 10.1080/09593985.2018.1458355. Epub 2018 Mar 29.
citation: Faletra A, Bellin G, Dunning J, Fernandez-de-Las-Penas C, Pellicciari L, Brindisino F, Galeno E, Rossettini G, Maselli F, Severin R, Mourad F. Assessing cardiovascular parameters and risk factors in physical therapy practice: findings from a cross-sectional national survey and implication for clinical practice. BMC Musculoskelet Disord. 2022 Aug 4;23(1):749. doi: 10.1186/s12891-022-05696-w.
citation: Frese EM, Richter RR, Burlis TV. Self-reported measurement of heart rate and blood pressure in patients by physical therapy clinical instructors. Phys Ther. 2002 Dec;82(12):1192-200.
Clinical trial NCT06191445: Comparison of the Efficacy of Conventional Landmark, Ultrasound-Assisted, and Real-Time Ultrasound-Guided Techniques in Spinal Anesthesia for Obese Patients
Official title: Does the Use of Ultrasound Increase Spinal Anesthesia Success for Obese Patients?: Evaluation of the Success of Spinal Anesthesia Administered with Real-Time Ultrasound-Guided, Ultrasound-Assisted and Conventional Landmark Techniques
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Spinal Anesthesia
Ultrasound
Keywords: Anesthesia
Spinal Anesthesia
Obesity
Ultrasonography
Lead sponsor: Uludag University
Sponsor class: OTHER
First posted: 2024-01-05
Enrollment: 126
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Spinal anesthesia is frequently administered using the conventional landmark technique. Ultrasound is a non-invasive and safe approach. Neuroaxial anesthesia procedures can be conducted using two different ultrasound techniques; Real-Time Ultrasound Guided (USRTG) and Ultrasound-Assisted (USAS). The primary objective of this study is to compare the successes of spinal anesthesia applications using USRTG, USAS, and conventional landmark techniques on the first attempt in obese patients undergoing orthopedic surgery.

Detailed description: Patients included in the study will be those undergoing lower extremity orthopedic surgery, with a body mass index (BMI) 30 kg/m² and above, and classified as American Society of Anesthesiologists (ASA) class I-III. Patients will be randomized into 3 groups. In the Conventional Landmark group, spinal anesthesia will be administered using the conventional technique. In the Ultrasound-Assisted group, the spinal space will be marked with ultrasound before proceeding. For the Real-Time Ultrasound-Guided group, the spinal space and the advancement of the needle for the injection will be visualized simultaneously with ultrasound during the application of spinal anesthesia. The primary outcome is to compare the success rates on the first attempt. The secondary outcomes are to compare the number of skin punctures, needle redirections, procedure times, complications, and patient satisfaction

Eligibility criteria: Inclusion Criteria:

* 18 years and older
* Patients who will undergo lower extremity orthopedic surgery
* ASA I-II-III patients
* BMI 30 kg/m² and above

Exclusion Criteria:

* BMI \< 30 kg/m²
* ASA IV-V patients
* Severe cardiovascular disease
* Patients with a known or suspected allergy to local anesthetics
* Contraindications of spinal anesthesia (eg, coagulopathy, puncture site infection)

Primary outcomes:
measure: Success rates on the first attempt.
timeFrame: Preoperatively
Secondary outcomes:
measure: Number of skin punctures, needle redirections, procedure times, complications, and patient satisfaction
timeFrame: Preoperatively
Other outcomes:
Locations:
city: Bursa
country: Turkey
facility: Bursa Uludag University Faculty of Medicine
Study officials:
References:
Clinical trial NCT05997745: Enteral Nutrition in Acute Generalized Peritonitis
Official title: Effects of Early Enteral Nutrition With a Locally Produced Protein-energy Ration Versus a Marketed Nutritional Solution in Patients Operated on for Acute Generalized Peritonitis
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Enteral and Supplement Feeds Adverse Reaction
Peritonitis; Acute
Lead sponsor: Université Evangélique enAfrique
Sponsor class: OTHER
First posted: 2023-08-18
Enrollment: 76
Sex: ALL
Minimum age (years): 2
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Hospitals in South Kivu always have problems supplying artificial enteral nutritional products because of their high cost and low availability in our areas. While the Province has cereals, knowing their nutritional composition would enable the formulation of a nutritional product based on local protein-energy products. Hence the questions below: Can a local cereal-based protein-energy ration be used instead of a costly imported artificial nutritional solution to improve the nutritional status of patients operated on for PAG? What is the tolerance of this early enteral nutrition on the healing and functional recovery of patients compared with an artificial nutritional solution? To answer these questions, a randomized clinical trial has been designed with the following objectives:

* To formulate an enteral diet using cereals available in our environment with a protein-calorie composition superimposable on the artificial enteral ration,
* Evaluate the tolerance and advantages of early enteral nutrition with a locally manufactured protein-caloric ration vs. a commercially available artificial nutritional solution in patients undergoing surgery for PAG.


Eligibility criteria: Inclusion Criteria:

* patient operated for peritonitis with intestinal suture during treatment
* have a q-SOFA score of 1 to 2
* surgeon's agreement to enteral feeding
* at risk of malnutrition (BMC)

Exclusion Criteria:

* q SOFA score \> 2
* patients with tare (diabetes, HIV, renal failure)

Primary outcomes:
measure: Tolerability of feeding
timeFrame: 10 days after surgery
Secondary outcomes:
measure: nutritional surveillance
timeFrame: 2 days after, 5 days after, 10 days after feeding
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06815445: Postoperative Pain and Blood Loss of Non-use Compared to Partial-use of a Tourniquet in Bilateral Total Knee Replacement
Official title: Postoperative Pain and Blood Loss of Non-use Compared to Partial-use of a Tourniquet in Bilateral Total Knee Replacement: A Randomized- Control Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain, Postoperative
Total Knee Replacement
Tourniquet
Lead sponsor: Queen Savang Vadhana Memorial Hospital, Thailand
Sponsor class: OTHER
First posted: 2025-02-07
Enrollment: 20
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: This study divided into 2 groups. This study was designed to compare the effect of NTU vs BOO in the patients underwent bilateral TKA.

It is a crossover design to compare each knee in each group.
Primary purpose: TREATMENT

Brief summary: Postoperative pain and blood loss of non-use compared to partial-use of a tourniquet in bilateral total knee replacement: A Randomized- Control Trial This study aimed to compare the effects of non-use (NTU) and partial-use (before osteotomy to skin closure; BOO) of a tourniquet in bilateral total knee arthroplasty (TKA) on postoperative pain and complications.

Detailed description: Despite numerous meta-analyses, and randomized-control trials (RCTs), there is still no conclusive evidence on the most effective, and efficient method of using a tourniquet.

There is gap of knowledge of method of tourniquet usage. Hence this study will provide the best method to apply tourniquet.

Eligibility criteria: Inclusion Criteria:

* patients with over 50 years of age and diagnosed with bilateral severe knee osteoarthritis undergoing bilateral TKA

Exclusion Criteria:

* patients having undergone previous knee surgery
* patients being subject to uncontrolled hypertension, coagulopathy, or recent knee sepsis
* patients with an ASA physical status grade \> 2,
* inability to use patient-controlled analgesia (PCA), such as communication, or cognitive issues, or those patients who were allergic to medications used in the treatment process.

Primary outcomes:
measure: Postoperative pain
timeFrame: At postoperative Day1,2,3,4
Secondary outcomes:
measure: Blood loss
timeFrame: At postoperative Day1,2,3,4
Other outcomes:
Locations:
city: Chon Buri
country: Thailand
facility: Thada Wipatasinlapin
state: Sriracha
Study officials:
affiliation: Queen Savang Vadhana Memorial Hospital, Thailand
name: Thada Wipatasinlapin, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01146145: Efficacity, Safety and Cost of Intravenous Morphine Titration Alone or Combined to Ketamine
Official title: Efficacity, Safety and Cost of Intravenous Morphine Titration Alone or Combined to Ketamine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Pain
Keywords: postoperative
pain
analgesia
morphine
titration
ketamine
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2010-06-17
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a randomised, controlled, double blinded study comparing in the postoperative setting the analgesic efficacy, the safety and the cost in two groups of patients receiving in the postanesthesia care unit either intravenous morphine titration alone or intravenous morphine titration combined to ketamine.

Detailed description: Randomised, controlled, double blinded study comparing in the postoperative setting the analgesic efficacy, the safety and the cost in two groups of patients receiving in the postanesthesia care unit either intravenous morphine titration alone or intravenous morphine titration combined to ketamine

Eligibility criteria: Inclusion Criteria:

* Age \> 18 yrs
* scheduled surgery
* General anesthesia
* ASA I to III
* Able to use a VAS
* No psychological disorders, able to speak french

Exclusion Criteria:

* Age \< 18 yrs
* Locoregional anesthesia or analgesia
* Allergia to morphine or ketamine
* Morphine or ketamine contraindication
* Pregnancy or breast-feeding

Primary outcomes:
measure: analgesic efficacy
timeFrame: 24 h
Secondary outcomes:
Other outcomes:
Locations:
city: Colombes
country: France
facility: Hopital Louis Mourier
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Hawa Keita
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05251545: Randomized Trial: High Power Short Duration Versus Ablation Index
Official title: Pulmonary Vein Isolation Using High Power - Short Duration Versus Ablation Index: a Prospective Randomized Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Atrial Fibrillation Paroxysmal
Catheter Ablation
Lead sponsor: Robert Bosch Medical Center
Sponsor class: OTHER
First posted: 2022-02-22
Enrollment: 88
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The single procedure success rates of durable pulmonary vein isolation (PVI) for paroxysmal atrial fibrillation (PAF) varies between 80 and 90 %.

This prospective, randomized study investigated the efficacy of pulmonary vein isolation with RF-energy following the CLOSE protocol with standard energy application (30 Watts) versus PVI with RF-energy with high power settings (45 Watts).

Detailed description: A total number of 176 patients undergoing de-novo catheter ablation for paroxysmal AF are planned to be randomized to two different treatment arms. In group-A patients, PVI was performed with RF-energy with standard power settings of 30 Watts in a temperature-controlled mode.

The ablation procedure in group B was performed with RF-energy with higher power settings of 45 Watts. In both groups the ablation is performed with ablation index (AI) and following the CLOSE protocol (AI and ≤ 6 mm interlesion distance using a surround flow catheter, Biosense Webster Thermocool STSF).

A total of 88 patients are planned to be randomized into each group, the follow-up period will be 12 months after the first procedure.

The primary endpoint is freedom of all atrial arrhythmias after one procedure. The secondary endpoint is procedural time. The third endpoint is safety.

Eligibility criteria: Inclusion Criteria:

* Paroxysmal atrial fibrillation
* written informed consent

Exclusion Criteria:

* inability to obtain written informed consent
* persistent atrial fibrillation

Primary outcomes:
measure: Single procedure success rate, identified by 48-hours Holder-ECGs every three months
timeFrame: 1 year
Secondary outcomes:
measure: Procedural data
timeFrame: 1 year
Other outcomes:
Locations:
city: Stuttgart
country: Germany
facility: Robert Bosch Medical Center
Study officials:
affiliation: Robert Bosch Medical Campus
name: Peter Ong, Prof
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01280045: Influence of Aromatase Inhibitors and GnRH Analogs to Treat Uterine Leiomyoma by Vaginal Hysterectomy
Official title: Influence of the Aromatase Inhibitor Anastrozole and GnRH Analog Goserelin Acetate as Preoperative Treatment of Vaginal Surgical Treatment of Uterine Leiomyoma: Analysis of Intra and Immediate/Late Postoperative Patterns
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: UTERINE LEIOMYOMA
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2011-01-20
Enrollment: 5
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: We woudl be comparing aromatase inhibitors versus GnRH analogs
Primary purpose: TREATMENT

Brief summary: The investigators aimed to assess if use of aromatase inhibitors could decrease volume of uterine leiomyoma and cause same percentage of adverse effects during its use compared to GnRH analogs.

Detailed description: Uterine leiomyoma is the most prevalent benign gynecologic tumor in women. Standard treatment is surgical (hysterectomy or myomectomy), and depends of many variables. If these tumors are large, preoperative assessment with clinical treatment may be useful in order to decrease its volume, improve hematologic patterns and modify surgical approach (vaginal or abdominal). It is well know that GnRH analogs can cause these goals; however, aromatase inhibitors are new promising drugs which are being used for reducing uterine leiomyoma's volume and few observational studies have shown this fact. The investigators are aiming to compare both treatments in a randomized controlled trial and see if it both treatments are similar or not in decreasing uterine leiomyoma's volume, influencing operative time, blood loss during surgery.

Eligibility criteria: Inclusion Criteria:

* WOMEN OVER 40 YEARS, UTERINE VOLUME HIGHER THAN 300 ML, MINIMAL ANATOMIC CONDITIONS FOR VAGINAL SURGERY

Exclusion Criteria:

* ACTIVE GYNECOLOGIC MALIGNANCY

Primary outcomes:
measure: Operative Time
timeFrame: Intra-operative
Secondary outcomes:
measure: Uterine Leiomyoma Volume
timeFrame: 3 Months After Treatment, During Surgery
Other outcomes:
Locations:
Study officials:
References:
citation: Parsanezhad ME, Azmoon M, Alborzi S, Rajaeefard A, Zarei A, Kazerooni T, Frank V, Schmidt EH. A randomized, controlled clinical trial comparing the effects of aromatase inhibitor (letrozole) and gonadotropin-releasing hormone agonist (triptorelin) on uterine leiomyoma volume and hormonal status. Fertil Steril. 2010 Jan;93(1):192-8. doi: 10.1016/j.fertnstert.2008.09.064. Epub 2009 Jan 9.
Clinical trial NCT05898347: Nevoid Basal Cell Carcinomas in Gorlin Syndrome
Official title: Nevoid Basal Cell Carcinomas in Young People With Gorlin Syndrome
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Basal Cell Carcinoma
Gorlin Syndrome
Keywords: Dermatoscopy
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
First posted: 2023-06-12
Enrollment: 10
Sex: ALL
Minimum age (years): 6
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Children aged six to seventeen years with Gorlin syndrome and nevoid basal cell carcinomas living in Norway.

Brief summary: The overall aim of the project is to gain knowledge about the expected course of nevoid basal cell carcinomas and the usefulness of dermatoscopy in young individuals with Gorlin syndrome.

Clinical experience and some case-reports suggest that nevoid basal cell carcinomas have an indolent course with slow growth and that they can sometimes regress. However, no systematic research has previously been performed.

Increased knowledge about nevoid basal cell carcinomas and the use of dermatoscopy could be of great clinical value in the follow-up and treatment of individuals with nevoid basal cell carcinoma syndrome.


Eligibility criteria: Inclusion Criteria:

* The individual has Gorlin syndrome (clinically and/or genetically diagnosed)
* The individual is minimum 6 years and maximum 17 years
* The individual has at least three skin lesions clinically compatible with nevoid basal cell carcinomas

Exclusion Criteria:

* The patient has a psychiatric disorder not compatible with completion of the study examinations
* The patient has received topical treatment (imiquimod, 5-fluorouracil, photodynamic therapy and/or cryotherapy) of nevoid basal cell carcinomas during the last three months

Primary outcomes:
measure: Nevoid basal cell carcinoma size increase
timeFrame: Two years
measure: Dermatoscopy findings
timeFrame: Two years
Secondary outcomes:
measure: Nevoid basal cell carcinoma histology
timeFrame: Two years
Other outcomes:
measure: Clinical manifestations associated with nevoid basal cell carcinomas
timeFrame: Two years
measure: Mutation burden in nevoid basal cell carcinomas analyzed by next-generation sequencing
timeFrame: Two years
Locations:
city: Oslo
country: Norway
facility: Oslo University Hospital
Study officials:
affiliation: Oslo University Hospital
name: Kristin Hortemo, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: