louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00847431: Mapping Mood in the Subthalamic Nucleus in Parkinson's Disease (PD)
Official title: Mapping Mood in the Subthalamic Nucleus in PD
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Parkinson's Disease
Depression
Anxiety
Keywords: Subthalamic Nucleus
Deep Brain Stimulation
Depression
Anxiety
Parkinson's Disease
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Institute of Neurological Disorders and Stroke (NINDS)
First posted: 2009-02-19
Enrollment: 81
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: PD patients with and without STN DBS

Brief summary: The goal of this study is to determine the vulnerability of mood-related neurocircuitry in Parkinson Disease (PD) using deep brain stimulation of the subthalamic nucleus (STN DBS).


Eligibility criteria: Inclusion Criteria for STN-DBS subjects:

* Age 40 or older
* DBS STN Surgery in past 2 to 36 months
* Ability to tolerate turning off Stimulators
* Ability to read and comprehend questions
* English speaking

Exclusion Criteria for STN-DBS subjects:

* Other severe complications post surgery: stroke, seizure, major loss of consciousness, other brain trauma/surgery, or head injuries(i.e. near drowning), encephalitis, or hydrocephalus, blindness, deafness
* Clinically determined Dementia ( Most recent MMSE score of \>24)

Inclusion Criteria for Control subject:

* Age 40 or older
* Ability to read and comprehend questions
* English speaking

Exclusion Criteria for Control subject:

* Other severe complications post surgery: stroke, seizure, major loss of consciousness, other brain trauma/surgery, or head injuries(i.e. near drowning), encephalitis, or hydrocephalus, blindness, deafness
* Clinically determined Dementia ( Most recent MMSE score of \>24)
* Plans to have DBS STN surgery in the next 24 months

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: St. Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: Cincinnati
country: United States
facility: University of Cincinnati, Movement Disorder Center
state: Ohio
Study officials:
affiliation: Washington University School of Medicine
name: Tamara G Hershey, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06176573: Pre-operative Versus Post-operative Vaginal Cleansing With Chlorhexidine Solution in Prevention Post-Cesarean Section Infection
Official title: Pre-operative Versus Post-operative Vaginal Cleansing With Chlorhexidine Solution in Prevention of Post-Cesarean Section Infectious Morbidity at a Teaching Hospital in a Resource Poor Setting: A Randomized Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post Cesarean Infectious Morbidity
Lead sponsor: Federal Teaching Hospital Abakaliki
Sponsor class: OTHER_GOV
First posted: 2023-12-19
Enrollment: 120
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 44
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Maternal infectious morbidity is a common complication of cesarean delivery, especially in a poor recourse setting like ours. This study was done to compare the effectiveness of preoperative vaginal cleansing with immediate postoperative vaginal cleansing with chlorhexidine solution in preventing post-cesarean infectious morbidities. Randomized trial involving 120 consented women who had elective or emergency cesarean sections at term, 60 in each group. Group 1 had preoperative while group 2 had postoperative vaginal cleansing with 1% chlorhexidine.

Detailed description: Background: Maternal infectious morbidity is a common complication of cesarean delivery, especially in a poor recourse setting like ours. This study was done in a tertiary hospital in Abakaliki, Ebonyi State, Southeast Nigeria over a period of 5 months. The State is inhabited mainly by rural farmers and petty traders. Literacy is low and poverty is common with poor maternal health indices.

Aim: To compare the effectiveness of preoperative vaginal cleansing with immediate postoperative vaginal cleansing with chlorhexidine solution in preventing post-cesarean infectious morbidities.

Method: Randomized trial involving 120 consented women who had elective or emergency cesarean sections at term, 60 in each group. Group 1 had preoperative while group 2 had postoperative vaginal cleansing with 1% chlorhexidine. Research Randomizer software was used to generate 120 numbers. Sixty numbers were randomly generated from a pool of 120 numbers and were assigned to group 1 while the remaining 60 numbers were automatically assigned to group 2. Both groups received antibiotics and anterior abdominal wall scrubbing. There were monitored for symptoms and signs of endometritis, wound infection and pyrexia till discharge.

Eligibility criteria: Inclusion Criteria:

* Those that gave consent
* Term pregnancy

Exclusion Criteria:

* Refusal of consent
* Antepartum hemorrhage
* Cord prolapse
* Fetal distress
* Anemia in pregnancy
* Presence of fever and chorioamnionitis

Primary outcomes:
measure: infectious morbidity
timeFrame: six (6) weeks.
Secondary outcomes:
Other outcomes:
Locations:
city: Abakaliki
country: Nigeria
facility: Alex Ekwueme Federal University Teaching Hospital
state: Ebonyi
Study officials:
References:
Clinical trial NCT06451731: Rehabilitation of Post-stroke Aphasia by Targeting Phonological, and Lexico-semantic Deficits With Speech Output Tasks
Official title: Rehabilitation of Post-stroke Aphasia by a Single Protocol Targeting Phonological, Lexical, and Semantic Deficits With Speech Output Tasks: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aphasia, Acquired
Stroke
Anomia
Lead sponsor: Istituto Auxologico Italiano
Sponsor class: OTHER
First posted: 2024-06-11
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Aphasia in brain-damaged adult patients refers "to the more or less complete loss of the ability to use language" resulting from acquired brain damage, typically of the left hemisphere. The defective spoken output of persons with aphasia (PWA) has anomia as a main clinical manifestation. Improving anomia is a main goal of any language treatment.

The present randomized controlled study assessed the effectiveness of a novel, two-week, rehabilitation protocol (PHOLEXSEM), focused on PHonological, SEmantic, and LExical deficits, aiming at improving lexical retrieval, and, generally, spoken output.

The effects of the PHOLEXSEM treatment were compared to those of a control treatment, i.e., a Promoting Aphasics Communicative Effectiveness (PACE) protocol.

Finally, we studied the effects of age, education, disease duration, brain lesion volume, and functional independence (Functional Idependence Measure, FIM) on the treatment-induced linguistic improvements.


Eligibility criteria: Inclusion Criteria:

* acquired brain-damage
* presence of aphasia

Exclusion Criteria:

* global aphasia
* undergoing another treatment for aphasia

Primary outcomes:
measure: Change from baseline in the Neuropsychological Examination of Language (ENPA)
timeFrame: At baseline and immediately after the intervention.
measure: Change from baseline in phonemic fluency
timeFrame: At baseline and immediately after the intervention.
measure: Change from baseline in semantic fluency
timeFrame: At baseline and immediately after the intervention.
measure: Change from baseline in syntagma repetition
timeFrame: At baseline and immediately after the intervention.
measure: Change from baseline in the auditory digit span
timeFrame: At baseline and immediately after the intervention.
measure: Change from baseline in the word repetition span
timeFrame: At baseline and immediately after the intervention.
measure: Change from baseline in the Token Test
timeFrame: At baseline and immediately after the intervention.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01441531: Efficacy of Gabapentin in Prevention of Tourniquet Pain and Hypertension
Official title: Efficacy of Gabapentin in Prevention of Tourniquet Pain and Hypertension During Orif of Tibia Fracture Under General Anesthesia
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: EARLY_PHASE1
Conditions: Tourniquet-induced Pain
Tourniquet-induced Hypertension
Keywords: narcotic use
Other Acute Pain
Lead sponsor: Baylor College of Medicine
Sponsor class: OTHER
First posted: 2011-09-27
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to find out if taking a dose of gabapentin 600 mg by mouth (po) before surgery will help prevent the development of tourniquet pain and hypertension while the tourniquet is inflated during orif of tibia fracture.


Eligibility criteria: Inclusion Criteria:

* Patient ages 18-64
* ASA physical status 1-3
* Schedule for orif tibia fracture with use of pneumatic tourniquet

Exclusion Criteria:

* Allergy to study medications
* polytrauma
* lower extremity crush injury
* chronic opioid use
* sickle cell disease or trait
* peripheral vascular disease
* poorly controlled hypertension
* history of DVT/PE
* morbid obesity (BMI \> 35)
* patient or surgeon refusal
* patient inability to properly describe postoperative pain to investigators

Primary outcomes:
measure: Incidence of tourniquet-induced hypertension
timeFrame: During the tourniquet inflation time period
Secondary outcomes:
measure: Postoperative pain
timeFrame: 24 hours
measure: Narcotic use
timeFrame: 24 hours
Other outcomes:
Locations:
city: Houston
country: United States
facility: Ben Taub General Hospital
state: Texas
Study officials:
affiliation: Baylor College of Medicine
name: Jaime Ortiz, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06770231: Peri-implant Bone Behaviour Using Two Drilling Techniques in Posterior Maxilla
Official title: Peri-implant Bone Behavior After Single Drilling Technique Versus Undersized Technique of Immediately Loaded Implant in Posterior Maxilla: A One-year Prospective Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Implant
Keywords: Implant stability
Immediate loading
Single drilling technique
Posterior maxilla
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2025-01-13
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Two different drilling techniques in posterior maxilla immediate loading implant

Detailed description: One of the surgical techniques used to enhance the primary stability of implant in low density bone was the undersized drilling technique, which has been introduced to locally optimize poor density of bone by using a final drill diameter considerably smaller compared with the implant diameter.

On the other hand, a novel hollow drill with a single drilling systems was designed. Single drilling technique shortens surgical times, removes the smallest amount of bone during implant site preparation, reduces bone damage and micro fractures, and speeds up the healing process. Additionally, because of the hollow shape, bone core may be harvested and used as an autogenous bone grafting material.

Eligibility criteria: Inclusion criteria:

1. Patients with missing single or multiple teeth in posterior maxilla.
2. Age more than 18 years.
3. 10 mm or more vertical bone height is present.
4. Good oral hygiene.
5. Patients willing to be present during the study follow up intervals.
6. Patients free from any systemic diseases.
7. 6 mm or more ridge width is present.
8. Crown height space of at least 8 mm.
9. Patients without any para-functional habits (bruxism and clenching).

Exclusion criteria:

1. Patients with any pathological lesion or root tips at the planned surgical site.
2. Patients with inadequate bone height and thickness.
3. Smoking more than 14 cigarettes per day.14
4. Alcohol or drug abuse.
5. Patients with systemic diseases that absolutely contraindicate implant placement.

Primary outcomes:
measure: Implant stability
timeFrame: 12 months
measure: Modified Sulcus Bleeding Index (mBI)
timeFrame: 12 months
measure: Peri-implant probing depth
timeFrame: 12 months
measure: Marginal Bone Loss
timeFrame: 12 months
measure: Bone Density Recordings
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Mansoura University
state: Dakahlia
Study officials:
References:
Clinical trial NCT01320631: Male Sexual Experience and Its Impact on Quality of Life Before and After Their Sexual Partners Undergo Polypropylene Mesh Augmented Pelvic Floor Reconstruction
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sacral Colpopexy
Pelvic Organ Prolapse
Keywords: uterine prolapse
vaginal prolapse
Lead sponsor: Atlantic Health System
Sponsor class: OTHER
First posted: 2011-03-22
Enrollment: 80
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Male sexual partners of women who are sexually active and are scheduled to undergo a mesh augmented repair for pelvic organ prolapse referred to the Division of Urogynecology and Reconstructive Pelvic Surgery

Brief summary: The correction of the pelvic organ protrusion is aimed at restoring the pelvic floor functional status and ultimately improving the patient's quality of life. There are a few studies that have explored the effect of pelvic reconstructive surgery on female sexual function (1,2) but no studies have evaluated the male partner's sexual experience. The investigators intend to use a newly psychometrically validated questionnaire to capture this aspect. The sexual experience questionnaire (SEX-Q) is the first questionnaire to solely and exclusively combine functional and quality of life concepts (erection, individual satisfaction, and couple satisfaction domains) in a brief questionnaire, which allows a more focused and less burdensome evaluation of the sexual experience in men (3). Another issue is the density of the mesh material and if it can be felt vaginally even if it is not eroded and to what degree this might bother the male partner during intercourse.


Eligibility criteria: Inclusion Criteria:

1. Sexually active couple at the time of pre-operative visit
2. Female partner scheduled to undergo a mesh augmented repair

Exclusion Criteria:

1. Not sexually active
2. Use of other graft material than polypropylene mesh
3. Contraindications to surgery based on existing medical conditions
4. Pregnancy
5. Desire for pregnancy in the future

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Morristown
country: United States
facility: Atlantic Health System
state: New Jersey
Study officials:
References:
citation: Culligan PJ, Haughey S, Lewis C, Priestley J, Salamon C. Sexual Satisfaction Changes Reported by Men After Their Partners' Robotic-Assisted Laparoscopic Sacrocolpopexies. Female Pelvic Med Reconstr Surg. 2019 Sep/Oct;25(5):365-368. doi: 10.1097/SPV.0000000000000574.
Clinical trial NCT04649931: Differences in Exhaled Breath by Using Ion Mobility Spectrometry (IMS) in Subjects Tested for SARS-CoV-2 Infection (COVID-19 Disease)
Official title: Study to Evaluate Whether Differences in Exhaled Breath Can be Identified Using Ion Mobility Spectrometry (IMS) in Subjects Tested Positive for SARS-CoV-2 Infection and Subjects Tested Negative
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: SARS (Severe Acute Respiratory Syndrome)
Covid19
Lead sponsor: B. Braun Melsungen AG
Sponsor class: INDUSTRY
Collaborators: name: CeGaT GmbH
First posted: 2020-12-02
Enrollment: 450
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adult patients with suspected or diagnosed SARS-CoV-2 infection.

Brief summary: Breath gas analysis is the evaluation of exhaled breath. It aims to evaluate the volatile organic compounds (VOCs) in exhaled breath.

In this feasibility study it is intended to find specific peaks/pattern in exhaled breath indicating an infection with SARS-CoV-2 (severe acute respiratory syndrome coronavirus 2).


Eligibility criteria: Inclusion Criteria:

* PCR (= Polymerase Chain Reaction) testing for SARS CoV-2 will be/has been performed in a timely manner of sampling exhaled breath or PCR test for SARS-CoV-2 was performed within 96 hours, but preferably within 48 hours before sampling exhaled breath and PCR test result is already available
* Subject must be able to comply with study-specific procedures, e.g.is able to comply with breathing commands

Exclusion Criteria:

* Previous (history) SARS-CoV-2 infection, independent of the current episode
* Participation in a therapeutic study prior to breath analysis which could influence the result of the breath analysis

Primary outcomes:
measure: SARS-CoV-2 related volatile organic compounds (VOC)
timeFrame: 1 hour after breath gas sampling
Secondary outcomes:
measure: To compare the SARS-CoV-2 specific VOC with the clinical symptoms of COVID-19 (Corona Virus Disease 2019)
timeFrame: within 1 hour
Other outcomes:
Locations:
city: Marburg
country: Germany
facility: University Hospital Gießen and Marburg (UKGM), site Marburg
Study officials:
affiliation: University Hospital Marburg, Zentrum für unerkannte und seltene Erkrankungen (ZusE)
name: Juergen Schaefer, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02690831: Effects of Manual Therapy and Respiratory Muscle Training on the Maximal Inspiratory Pressure in Patients With Asthma
Official title: Effects of Manual Therapy and Respiratory Muscle Training on the Maximal Inspiratory Pressure in Patients With Asthma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Manual Therapies
Respiratory Muscle Training
Exercise Therapy
Inspiratory Capacity
Asthma
Keywords: Asthma
Inspiratory Muscle Training
Manual Therapies
Lead sponsor: Universidad Autonoma de Madrid
Sponsor class: OTHER
First posted: 2016-02-24
Enrollment: 40
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: TREATMENT

Brief summary: The aim of this study is to assess if an intervention of manual therapy and motor control exercises combined with an inspiratory muscle training program is more effective than an inspiratory muscle training program alone in increasing the maximum inspiratory pressure in patients with asthma. In addition, the study pretends to evaluate the changes caused by the intervention regarding possible postural changes and thoracic diameter.


Eligibility criteria: Inclusion Criteria:

* Asthmatics subjects aged between 18 and 65 years

Exclusion Criteria:

* Were excluded participants who presented neurologic, psychiatric or cognitive pathologies which difficult the cooperation, inflammatory disease of the cervical spine and/or severe orthopedic problems that difficult the daily activities, history of thoracic surgery, vertebral fracture, abnormal thorax radiography, spinal and thoracic structured musculoskeletal disorders and to present any contraindication of treatment techniques (e.g. ostheophorosis). In case of exacerbation of asthma, missing more than one treatment session and/or to appear any contraindication to continue the treatment routine during the six weeks of the study the patient also were excluded.

Primary outcomes:
measure: Maximum Inspiratory Pressure
timeFrame: Change from Baseline in Maximum Inspiratory Pressure at 6 weeks
Secondary outcomes:
measure: Head posture
timeFrame: Change from Baseline in Head Posture at 6 weeks
measure: Thoracic kyphosis
timeFrame: Change from Baseline in Thoracic kyphosis at 6 weeks
measure: Forced Vital Capacity (FVC)
timeFrame: Change from Baseline in Volumes and lung capacities at 6 weeks
measure: Forced Expiratory Volume at the First second (FEV1)
timeFrame: Change from Baseline in Volumes and lung capacities at 6 weeks
measure: Peak Expiratory Flow (PEF)
timeFrame: Change from Baseline in Volumes and lung capacities at 6 weeks
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Centro Superior de Estudios Universitarios La Salle
Study officials:
References:
Clinical trial NCT03303131: SAM: Discharge Based on the Use of a MUAC-based Criterion to
Official title: Discharge From Community-based Management of Severe Acute Malnutrition Using Mid Upper Arm Circumference
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Severe Acute Malnutrition
Lead sponsor: Epicentre
Sponsor class: OTHER
Collaborators: name: Medecins Sans Frontieres, Netherlands
First posted: 2017-10-05
Enrollment: 50841
Sex: ALL
Minimum age (years): 6
Maximum age (years): 59
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All children admitted to the MSF therapeutic feeding program in Yako and Titao districts from September 2007 to December 2011

Brief summary: Retrospective analysis of routine program data of children aged 6 to 59 months admitted to the MSF therapeutic feeding program with MUAC ≤ 118 mm in Yako and Titao districts of Burkina Faso from 2007-2011.

Detailed description: Comparison of patient characteristics and treatment outcomes was conducted between two groups: 1) children discharged as recovered from September 2007 to March 2009 with at least 15% of their weight at admission (Period A); and 2) children discharged as recovered from April 2009 to December 2011 with MUAC ≥ 124 mm (Period B).

A total of 50,841 children were admitted with MUAC ≤ 118 mm to the MSF therapeutic feeding program and were included in this analysis: 24,792 children in Period A (2007-2009) and 26,049 children in Period B (2009-2011).

Overall, 89% of admissions were directly into outpatient care and the majority (53%) entered with a MUAC 116-118mm; 48% of children were male and 80% of children \< 2 years of age (Table 1).

Compared to children admitted in Period A, children admitted in Period B were statistically more likely to be female, younger, and of better anthropometric status (e.g. higher mean MUAC, WHZ and HAZ).

There was a greater proportion of children admitted directly to inpatient care in Period B than in Period A (10.6% vs 8.0%).

Eligibility criteria: Inclusion Criteria:

* 6 to 59 months old
* presence of bipedal pitting edema or MUAC ≤ 118 mm

Exclusion Criteria:

* \< 6 months old or \> 59 months old
* absence of bipedal pitting edema or MUAC ≥ 118 mm

Primary outcomes:
measure: MUAC based criterion
timeFrame: 52 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: