louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06500572: Landmark Guided Intercostobrachial Nerve Block Versus Serratus Plane Block After Supraclavicular Plexus Block for Anesthesia in Creation of Arteriovenous Fistula in the Medial Side of the Arm
Official title: Ultrasound Guided, Landmark Guided Intercostobrachial Nerve Block Versus Serratus Plane Block After Supraclavicular Plexus Block for Anesthesia in Creation of Arteriovenous Fistula in the Medial Side of the Arm: A Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intercostobrachial Nerve Block
Serratus Plane Block
Supraclavicular Plexus Block
Arteriovenous Fistula
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2024-07-15
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study aims to compare the role of ultrasound-guided and landmark-guided intercostobrachial nerve block and serratus plane block after supraclavicular plexus block for anesthesia in the creation of an arteriovenous fistula in the medial side of the arm.

Detailed description: Brachial plexus block (BPB) is usually utilized for proximal arm arteriovenous access creation. It has been suggested that supraclavicular brachial plexus block (SCPB) could be an alternative and provide comparable effective anesthesia and postoperative analgesia for arm surgery, with a reduced incidence of adverse events, including hemidiaphragmatic paresis.

By performing SCPB, the inner part of the arm is not completely anesthetized because this part of the arm is innervated by the lateral cutaneous branch of the second intercostal nerve (intercostobrachial nerve (ICBN)) and the medial branch of the brachial cutaneous nerve.

Serratus plane block (SPB) was first defined in 2013 by Blanco et al. This block provides anesthesia and analgesia in the hemi-thorax, where it is applied to block the thoracic intercostal nerves, in addition to the axillary region and shoulder posteriorly.

Eligibility criteria: Inclusion Criteria:

* Age from 18 to 65 years.
* Both sexes.
* American Society of Anesthesiology (ASA) physical status I-II.
* Scheduled for creation of arteriovenous fistula in the medial side of the arm.

Exclusion Criteria:

* Allergy to local anesthetics.
* Drug addiction.
* Coagulation abnormalities.
* Body Mass Index (BMI)≥35 kg/m2.
* Upper extremity neuropathy.
* Vasculitis.
* Unstable hemodynamics.
* History of seizures or mental illness.
* Severe heart, kidney, and liver diseases.
* Pregnancy.

Primary outcomes:
measure: Percent of patients who needed local anesthetic supplementation
timeFrame: Intraoperatively
Secondary outcomes:
measure: Total amount of morphine consumption
timeFrame: 24 hours postoperatively
measure: Patient satisfaction
timeFrame: 24 hours postoperatively
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Tanta University
state: El-Gharbia
Study officials:
References:
Clinical trial NCT05859672: Ventilation and Esophageal Pressure Changes
Official title: A Study of Intraoperative Transpulmonary and Intrathoracic Pressure Changes Associated With Ventilator Management of Tidal Volume and Positive End-expiratory Pressure (PEEP)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Mechanical Ventilation
Lead sponsor: University of California, Davis
Sponsor class: OTHER
First posted: 2023-05-16
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Elective surgical patients

Brief summary: A study to observe the effect of variations in ventilator settings including tidal volume and PEEP on transpulmonary pressure monitored with an esophageal balloon catheter and to correlate intraoperative transpulmonary pressure variations and intraoperative stroke volume variation changes.

Detailed description: This study seeks to observe the effects of variations in ventilator settings on transpulmonary and intrathoracic pressures. More specifically, to observe the impact of variations in tidal volume from 6 mL/kg to 8 mL/kg and PEEP from 0 cm of water (H2O) to 5 cm H2O on transpulmonary and intrathoracic pressures monitored with an esophageal balloon catheter. The impact of this recommended decrease in tidal volume on the clinical utility of stroke volume variation (SVV) as a guide for fluid administration has not been previously examined.

Eligibility criteria: Inclusion Criteria:

* Patients scheduled for elective surgery requiring general anesthesia and endotracheal intubation.
* Age ≥ 18

Exclusion Criteria:

* Patients undergoing planned esophageal surgery
* Patients with significant nasal or esophageal pathology
* Adults unable to consent
* Individuals who are not yet adults (infants, children, teenagers)
* Pregnant women
* Prisoners

Primary outcomes:
measure: Intrathoracic Pressure
timeFrame: Intra-operative
Secondary outcomes:
measure: Stroke Volume Variation
timeFrame: Intra-operative
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: UC Davis Medical Center
state: California
Study officials:
affiliation: University of California, Davis
name: Neal Fleming, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04385472: Musculoskeletal Imaging of Runners
Official title: Musculoskeletal Imaging of Runners
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Musculoskeletal Injury
Lead sponsor: Royal National Orthopaedic Hospital NHS Trust
Sponsor class: OTHER
First posted: 2020-05-13
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: asymptomatic long-distance runners

Brief summary: The investigators aimed to assess the impact of long-distance running on musculoskeletal system of runners, by doing high resolution magnetic resonance imaging analysis before and after marathon running.

Detailed description: Rationale for the study: This research will examine a key modifiable risk factor for health and well- being: exercise. Regular exercise is highly recommended by healthcare professionals because the whole body benefits, including cardiorespiratory, musculoskeletal systems and mental wellbeing. Long-distance running is a popular physical activity with more than 30 million individuals running marathons each year. The increasing participation of first-time runners, including older people, has been linked to a rise in related injuries. The ideal dose of exercise is not known and overdosage affects some musculoskeletal tissues and joints more than others. Overdoing a specific amount of exercise and the presence of chronic injuries may pose a great risk on the joints, leading to serious conditions such as osteoarthritis, musculoskeletal injuries, tendinopathy. However, it is not yet clear whether a high dose of exercise such as marathon running damages the musculoskeletal system and there is a growing need for research in the area of running science to better understand this.

Aim: This research aims to do musculoskeletal imaging before and after long-distance running using 3 Tesla magnetic resonance imaging and to provide evidence on how much exercise people should undertake and how to minimise injury.

Eligibility criteria: Inclusion Criteria:

* no previous marathon participations
* no present or previous history of hip injuries or surgeries
* asymptomatic hip joints
* no contradindications to hip MRI scanning

Exclusion Criteria:

* pregnant or breastfeeding women
* individuals aged \<18 years
* claustrophobia
* history of anxiety or panic attacks
* known hip problems

Primary outcomes:
measure: Change in radiographic score after marathon running
timeFrame: up to 1 year
measure: Change in self-reported hip questionnaire after marathon running
timeFrame: up to 1 year
Secondary outcomes:
measure: Number of participants who finished the training for/and the marathon vs not finishing
timeFrame: up to 4 months
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Royal National Orthopaedic Hospital
Study officials:
References:
Clinical trial NCT06247072: TRK-3 Conformance to Standards for Tonometers
Official title: TRK-3 Conformance to Standards for Tonometers
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Glaucoma
Lead sponsor: Topcon Corporation
Sponsor class: INDUSTRY
First posted: 2024-02-07
Enrollment: 125
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Eyes with different range of IOP

Brief summary: To collect measurements of a new tonometer and show conformance to standards for tonometers.


Eligibility criteria: Inclusion Criteria:

1. Age at least 22 years at the time of the informed consent
2. Provide voluntary written consent for participation in the study

Exclusion Criteria:

1. Have only one functional eye
2. Have difficulty in ocular fixation or eccentric fixation in either eye
3. Have corneal scar or have a history of corneal surgery such as corneal laser surgery (cataract surgery is acceptable)
4. Have microphthalmia
5. Have buphthalmos
6. Wear contact lens (have used soft contact lenses within the last 3 months and/or hard contact lenses within the last 6 months)
7. Have dry eyes and taking prescription medication or using artificial tears daily
8. Have blepharospasm
9. Have nystagmus
10. Have keratoconus
11. Have corneal or conjunctival lesions or infections
12. Have a central corneal thickness of \<500μm or \>600μm
13. Have corneal astigmatism \>3D
14. Have known allergy to ophthalmic anesthetics
15. Have known allergy to sodium fluorescein

Primary outcomes:
measure: IOP
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: La Mesa
country: United States
facility: New View Optometric Center
state: California
city: Chicago
country: United States
facility: Illinois College of Optometry
state: Illinois
Study officials:
References:
Clinical trial NCT01446172: Longterm Outcome of Inpatient Cognitive and Behavioral Therapies for Agoraphobia
Official title: Longterm Outcome of Inpatient Cognitive and Behavioral Therapies for Panic Disroder and Agoraphobia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Agoraphobia
Keywords: Long term outcome
Lead sponsor: Modum Bad
Sponsor class: OTHER
First posted: 2011-10-05
Enrollment: 132
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients diagnosed with panic disorder with or without agoraphobia and/or agoraphobia without history of panic disorder who have accepted treatment at an inpatient psychiatric hospital

Brief summary: While cognitive therapy and exposure therapy are both proven to be effective for panic disorder and/or agoraphobia when outcome is assenssed up to one year after treatment (Gould et al., 1995) the scientific knowledge about long-term course of these disorders is still scanty. Although several long-term outcome studies have been conducted, the quality of these studies has been questioned.

The aim is to conduct a follow-up study of patients with either panic disorder with history of agoraphobia or agoraphobia without history of panic disorder. the patients were treated in a group format at Modum Bad during the years 1989 to 1997. Four subsamples will be included in the study. Subsample 1 (76 patients treated in 1989 and 1990) received combined cognitive and psychodynamic treatment. Subsample 2 and 3 (46 patients treated in 1992 - 1993) were allocated to either cognitive therapy or guided mastery treatment. Subsample 4 (45 patients treated in 1994 - 1996) received cognitive and schema focused therapy.

In the follow-up study the participants will be requested to complete the same self report measures as they completed at intake, discharge and at previous follow-up times. the participants will also be interviewed using the SCID-I and II as they were at the previous assessments.

The present sample is relatively unique in having received pure psychosocial experimental treatments. The very long term efficacy of cognitive therapy relative to behavioural treatmetns for agoraphobia can be evaluated, and the potential moderating effects of personality disorders can be assessed.


Eligibility criteria: Inclusion Criteria:

* Meet the DSM-IV kriteria for either panic disorder, panic disorder with agoraphobia or agoraphobia

Exclusion Criteria:

* psychosis
* dementia
* substance abuse

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Vikersund
country: Norway
facility: Modum Bad
Study officials:
References:
Clinical trial NCT04273672: Speech, Linguistic and Acoustic Markers in Parkinson's Disease
Official title: Speech, Linguistic and Acoustic Markers in Parkinson's Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Parkinson Disease
Cognitive Impairment, Mild
Speech
Lead sponsor: University of Massachusetts, Worcester
Sponsor class: OTHER
Collaborators: name: Boston University
name: VA Puget Sound Health Care System
name: National Institute on Deafness and Other Communication Disorders (NIDCD)
name: Massachusetts Institute of Technology/Lincoln Labs
First posted: 2020-02-18
Enrollment: 58
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults with Parkinson's Disease and mild cognitive impairment or normal cognition as well as controls

Brief summary: The Investigators aim to identify speech and language markers that provide information on cognitive function and predict cognitive decline in Parkinson's disease. The Investigators will administer speech tasks and cognitive assessments to participants with Parkinson's disease and healthy controls. The Investigators will also explore the associations between genetic factors and speech and cognitive status in Parkinson's disease.


Eligibility criteria: Inclusion Criteria:

* Parkinson's Disease (or healthy control)
* Disease duration ≥ 2 years
* Mild cognitive impairment or normal cognition

Exclusion Criteria:

* Diagnosis of dementia (MoCA \<21)
* Adults unable to consent
* Age \< 18
* Pregnant women
* Prisoners
* Non-English speakers
* Any neurological disorder other than PD
* Deep brain stimulator placement
* Severe, unstable psychiatric disorder
* Unintelligible speech due to effects of PD
* Visual acuity or color vision impairment that would interfere with cognitive testing
* Other voice, speech or swallowing disorders or history of surgery involving palate/nasopharynx/larynx/vocal cords

Primary outcomes:
measure: Mild Cognitive Impairment
timeFrame: baseline
measure: Mean Fundamental Frequency
timeFrame: baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Worcester
country: United States
facility: UMass Medical School/UMass Memorial Medical Center
state: Massachusetts
Study officials:
affiliation: UMass Medical School
name: Kara Smith, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01203072: A Phase 2b Study of DU-176b, Prevention of Venous Thromboembolism in Patients After Total Knee Arthroplasty
Official title: A Phase 2b, Randomized, Double-Blind, Multi-Dose Efficacy, Safety and Dose-finding Study of the Oral Factor Xa Inhibitor DU-176b Compared With Placebo for Prevention of Venous Thromboembolism in Patients After Total Knee Arthroplasty (STARS J-1)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Venous Thromboembolism
Deep Vein Thrombosis
Total Knee Arthroplasty
Keywords: prevention
venous thromboembolism
edoxaban
factor Xa
Lead sponsor: Daiichi Sankyo
Sponsor class: INDUSTRY
First posted: 2010-09-16
Enrollment: 523
Sex: ALL
Minimum age (years): 20
Maximum age (years): 84
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The objective of this study is to assess the efficacy, safety and dose-response relationship of DU-176b compared with placebo for the prevention of venous thromboembolism in patients after elective total knee arthroplasty.


Eligibility criteria: Inclusion Criteria:

* Patients undergoing unilateral total knee arthroplasty

Exclusion Criteria:

* risks of hemorrhage
* thromboembolic risks
* weight less than 40 kg
* pregnant, suspect pregnancy, or subjects who want to become pregnant

Primary outcomes:
measure: Proportion of Subjects With Venous Thromboembolism Events.
timeFrame: 2 weeks
Secondary outcomes:
measure: Incidence of Major Bleeding or Clinically Relevant Non-major Bleeding
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Osaka
country: Japan
city: Tokyo
country: Japan
Study officials:
affiliation: Osaka Koseinekin Hospital
name: Takeshi Fuji, Director
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05990972: Clinical Study of Fecal Microbiota Transplantation in the Treatment of Antibiotic-associated Diarrhea
Official title: To Investigate the Efficacy and Safety of Fecal Microbiota Transplantation (FMT) in the Treatment of Antibiotic-associated Diarrhea.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fecal Microbiota Transplantation
Antibiotic-associated Diarrhea
Lead sponsor: Shanghai 10th People's Hospital
Sponsor class: OTHER
First posted: 2023-08-14
Enrollment: 25
Sex: ALL
Minimum age (years): 21
Maximum age (years): 78
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Antibiotic-associated diarrhea (AAD) refers to the occurrence of other unexplained diarrhea symptoms after the use of antibiotics, often combined with abdominal pain, bloating and bloody stool. Fecal Microbiota Transplantation (FMT) is a therapeutic method to transplant the microbiota from the feces of healthy people into the intestinal tract of patients. To explore the overall efficacy and safety of FMT in the treatment of AAD.


Eligibility criteria: Inclusion Criteria:

* occurrence of antibiotic-associated diarrhoea; no response to standard therapy; agree to receive FMT and sign informed consent; willingness to provide stool samples.

Exclusion Criteria:

* non-antibiotic-associated diarrhea; did not accept FMT or did not sign informed consent; unwillingness to provide stool samples.

Primary outcomes:
measure: Changes in defecation frequency after FMT.
timeFrame: Baseline and three months after treatment
measure: Changes in gut microbiota after FMT.
timeFrame: Baseline and three months after treatment.
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Intestinal Microenvironment Treatment Center of General Surgery, Shanghai Tenth People's Hospital, Tenth People's Hospital of Tongji University
Study officials:
affiliation: Intestinal Microenvironment Treatment Center of General Surgery, Shanghai Tenth People's Hospital, Tenth People's Hospital of Tongji University
name: Le Wang
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01793272: Beneficial Effect of Adding Pentoxifylline to Processed Semen Samples on ICSI Outcome in Infertile Males
Official title: Beneficial Effect of Adding Pentoxifylline to Processed Semen Samples on ICSI Outcome in Infertile Males With Mild and Moderate Asthenozoospermia: Randomized Controlled Prospective Crossover Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pentoxifylline Allergy
Lead sponsor: Adam International Hospital
Sponsor class: OTHER
First posted: 2013-02-15
Enrollment: 120
Sex: ALL
Maximum age (years): 35
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To evaluate the effect of pentoxifylline used in preparation of semen samples that will be used for ICSI in infertile men complaining of mild and moderate asthenozoospermia (i.e. cases which does not need motility enhancement prior to ICSI) in comparison to semen samples without pentoxifylline preparation on the outcome of ICSI.

Detailed description: The primary outcome measures were the number of oocytes retrieved, the number of oocytes injected, number of oocytes fertilized, fertilization rate, number of embryos and their quality (G1: good embryos, G2: fair embryos and G3: bad embryos), number of embryos transferred (ET), number of embryo sacs, embryo implantation rate, pregnancy rate and abortion rate for all 3 groups and pregnancy rate and abortion rate for both group (I) and group (II).

Eligibility criteria: Inclusion Criteria:

* seeking ICSI for infertility

Exclusion Criteria:

* Pyospermia, presence of antisperm antibodies. Azoospermia, severe male factor, severe asthenozoospermia. Past history of orchitis. Patients who received empirical treatment for asthenozoospermia e.g. oral Pentoxifylline, l-carnitine or antioxidants during the past 3 to 6 month. Diabetics, hypertensives or patients with any other chronic systemic illnesses. Wife's age more than 35 years. Low antral count. Presence of any ovarian factor contributing to infertility e.g. polycystic ovaries.

Primary outcomes:
measure: ICSI outcome
timeFrame: from October 2010 to April 2011.
Secondary outcomes:
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Adam International Hospital
Study officials:
affiliation: M.Amer
name: Medhat Amer, MD
role: STUDY_DIRECTOR
References:
citation: Amer M, Metawae B, Hosny H, Raef A. Beneficial effect of adding pentoxifylline to processed semen samples on ICSI outcome in infertile males with mild and moderate asthenozoospermia: A randomized controlled prospective crossover study. Iran J Reprod Med. 2013 Nov;11(11):939-44.