louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02717676: Prediction of Perineal Tears by Striae Gravidarum Score
Official title: Episiotomy for Prevention of Perineal Tears During Labor in Women With High Striae Gravidarum Score
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Normal Labor
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2016-03-24
Enrollment: 250
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Previous studies concluded that striae gravidarum assessment appears to predict the occurrence of perineal tears and recommend training the health personnel to calculate the total striae score which can help them decide if episiotomy is to be given or not. Episiotomy definitely seems to be preventive for perineal tears but giving episiotomy for the same is still debatable as episiotomy in itself is associated with morbidity. the hypothesis is episiotomy done in patients with high score will definitely protects against perineal tears. So, the aim of study is to determine whether assessment of striae gravidarum score could predict occurrence of tears during labor or not, and if episiotomy will prevent perineal tears in women with high score.


Eligibility criteria: Inclusion criteria:

1. Multipara
2. Singleton pregnancy
3. Full-term (37- 40 weeks)
4. Average size fetus (2500-4000 gm)
5. Cephalic-vertex presentation
6. Spontaneous onset of labor
7. No scarred uterus
8. No medical diseases as hypertension
9. No obstetric complications as obstructed labor
10. Women accepted to participate in the study

Exclusion criteria:

1. Multiple pregnancy
2. Women with Previous cesarean sections
3. Preterm labor
4. Malpresentation
5. Fetal macrosomia
6. Medical diseases as diabetes and hypertension
7. Women refuse to participate in the study

Primary outcomes:
measure: Rate of third and forth degree perineal tears
timeFrame: intraoperative
Secondary outcomes:
measure: Rate of first and second degree perineal tears
timeFrame: intraoperative
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Ahmed Abbas
state: Cairo
Study officials:
References:
Clinical trial NCT02153476: A Safety And Efficacy Study Of Alg-1001 In Human Subjects With Symptomatic Focal Vitreomacular Adhesion
Official title: A Safety And Efficacy Study Of Alg-1001 In Human Subjects With Symptomatic Focal Vitreomacular Adhesion
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Symptomatic Focal Vitreomacular Adhesion
Lead sponsor: Allegro Ophthalmics, LLC
Sponsor class: INDUSTRY
First posted: 2014-06-03
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Evaluate the safety and efficacy of ophthalmic intravitreal injection of ALG-1001 in human subjects with symptomatic focal vitreomacular adhesion


Eligibility criteria: Inclusion Criteria:

1. Symptomatic focal vitreomacular adhesion
2. Vitreomacular traction syndrome
3. Stage 1 and 2 macular holes, ≤ 350 µm
4. BCVA of 20/25 Early Treatment Diabetic Retinopathy Study (ETDRS) or worse in the study eye
5. BCVA of 20/800 ETDRS or better in the fellow eye
6. Male or female subjects, 18 years of age or older
7. Signed Informed Consent

Exclusion Criteria:

1. High myopes \> -8.0 D spherical equivalent
2. History of prior vitrectomy in the study eye
3. History of photocoagulation to the retina in the study eye
4. Macular hole in the study eye \> 350 µm
5. Subjects with epiretinal membranes in the study eye
6. Subjects with broad VMA, defined as VMA of \>1500 µm
7. Subjects with proliferative Diabetic Retinopathy (DR), neovascular Age-related Macular Degeneration (AMD), or retinal vascular occlusion in the study eye
8. Subjects with aphakia in the study eye
9. Subjects with uncontrolled glaucoma
10. Subjects with lenticular or zonular instability
11. Subjects with prior ocular surgery or intravitreal injection in the study eye within 90 days of study enrollment
12. Pregnant or nursing women

Primary outcomes:
measure: Release of Vitreo Macular Adhesion (VMA) by Optical Coherence Tomography (OCT)
timeFrame: 90 Days
Secondary outcomes:
Other outcomes:
Locations:
city: Beverly Hills
country: United States
facility: Retina-Vitreous Associates Medical Group
state: California
city: Santa Barbara
country: United States
facility: California Retina Consultants
state: California
city: Winter Haven
country: United States
facility: Center for Retinal and Macular Disease
state: Florida
city: Austin
country: United States
facility: Austin Retina Associates
state: Texas
city: Houston
country: United States
facility: Retina Consultants Houston
state: Texas
Study officials:
References:
Clinical trial NCT03335176: Feasibility of Telerehabilitation in HIV-patients
Official title: Feasibility and Benefit of a Telerehabilitation Program in Human Immunodeficiency Virus-infected Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Human Immunodeficiency Virus
Lead sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Sponsor class: OTHER
First posted: 2017-11-07
Enrollment: 25
Sex: ALL
Minimum age (years): 18
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 the feasibility and the effects of a 6-week telerehabilitation on the three domains of the International Classification of Functioning, Disability and Health in HIV-infected patients under highly active antiretroviral therapy (HAART).

HIV-infected patients were randomized either into an Endurance and Resistance Training Exercise (ERTE) group or a control (CON) group. Telerehabilitation was realized in a public fitness center, with online guidance and weekly telephone advice, 3 times per week for 6 weeks. Feasibility was determined by recruitment rate, retention rate and adverse events. Secondary outcomes were impact on body composition, inflammation and coagulation (C-reactive protein, D-dimer), physical fitness and quality of life (WHOQOL-HIV).


Eligibility criteria: Inclusion Criteria:

* 18 years or older
* under HAART treatment
* native French speaker

Exclusion Criteria:

* AIDS diagnosis
* physical and/or psychiatric impairments that seriously impaired physical activity
* pregnant
* Unstable (defined by any modification of health outcomes during the last 6 months).

Primary outcomes:
measure: Recruitment rate
timeFrame: At study completion (after 6 weeks)
measure: Retention rate
timeFrame: At study completion (after 6 weeks)
measure: Adverse events
timeFrame: At study completion (after 6 weeks)
Secondary outcomes:
measure: Weight
timeFrame: Assessments at baseline and at 6 weeks
measure: Lean body mass
timeFrame: Assessments at baseline and at 6 weeks
measure: Fat body mass
timeFrame: Assessments at baseline and at 6 weeks
measure: C-reactive protein
timeFrame: Assessments at baseline and at 12 weeks
measure: D-dimer
timeFrame: Assessments at baseline and at 12 weeks
measure: CD4+ T cell counts
timeFrame: Assessments at baseline and at 12 weeks
measure: Viral load
timeFrame: Assessments at baseline and at 12 weeks
measure: Functional exercise capacity
timeFrame: Assessments at baseline and at 6 weeks
measure: Flexibility
timeFrame: Assessments at baseline and at 6 weeks
measure: Lower body muscular strength
timeFrame: Assessments at baseline and at 6 weeks
measure: Upper limb strength
timeFrame: Assessments at baseline and at 6 weeks
measure: Quality of life
timeFrame: Assessments at baseline and at 6 weeks
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04518176: Bilateral Uterine Artery Ligation During the Cesarean Delivery of Twins
Official title: Clinical Outcomes of Bilateral Uterine Artery Ligation During the Cesarean Delivery of Twins: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cesarean Section Complications
Lead sponsor: Aswan University Hospital
Sponsor class: OTHER
First posted: 2020-08-19
Enrollment: 400
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized controlled study
Primary purpose: PREVENTION

Brief summary: Objective to assess the effectiveness of prophylactic bilateral uterine artery ligation (BUAL) in reducing the incidence of postpartum hemorrhage during cesarean delivery among women with twin pregnancy

Detailed description: A randomized clinical trial at Aswan University Maternity Hospital, Egypt. Women with twin pregnancy undergoing scheduled or emergency cesarean were randomized into two groups. In the BUAL group, women underwent BUAL before placental delivery; in the control group, women had cesarean delivery without BUAL. The primary outcome was the estimated blood loss during a cesarean

Eligibility criteria: Inclusion Criteria:

* women undergoing cesarean section
* twin pregnancy

Exclusion Criteria:

* Placenta previa.
* Ante-partum hemorrhage.
* patient refuse to participate

Primary outcomes:
measure: mean Blood loss after placental separation
timeFrame: 30 minutes
Secondary outcomes:
measure: Number of Participants with postpartum hemorrhage
timeFrame: 12 hours
measure: The number of participant needed for blood transfusion
timeFrame: 24 hours
Other outcomes:
Locations:
city: Aswan
country: Egypt
facility: Aswan University Hospital
Study officials:
affiliation: Aswan universirty
name: nahla w Shady, md
role: STUDY_CHAIR
References:
Clinical trial NCT04913376: Hilotherapy-study on Prevention of Oxaliplatin-induced Peripheral Neuropathy
Official title: Effectiveness of Hilotherapy for the Prevention of Oxaliplatin-induced Peripheral Neuropathy and Pain in the Treatment of Gastrointestinal Tumors: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Quality of Life
Chemotherapy-induced Peripheral Neuropathy
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
First posted: 2021-06-04
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomised controlled trial with stratification.
Primary purpose: PREVENTION

Brief summary: Effectiveness of hilotherapy for the prevention of oxaliplatin-induced peripheral neuropathy and pain in the treatment of gastrointestinal tumors: A randomized controlled trial.

Detailed description: This study investigates whether constant cooling of the hands and feet using Hilotherm ChemoCare devices reduces the incidence of (severe) oxaliplatin-induced peripheral neuropathy and pain compared to standard care (i.e. no hand and foot cooling) in patients with gastrointestinal tumors.

Eligibility criteria: Most important Eligibility Criteria:

Inclusion Criteria:

* 18 years or older
* Gastro-intestinal tumor, treated in UZ Leuven (University Hospitals of Leuven)
* Starting oxaliplatin-based treatment

Exclusion Criteria:

* Already grade 2 or higher peripheral neuropathy

For a more detailed list, see protocol.

Primary outcomes:
measure: Time until Grade 2 or higher patient-reported peripheral neuropathy after start of treatment in the first 12 weeks
timeFrame: 12 weeks
Secondary outcomes:
measure: Secondary Outcome Measures regarding peripheral neuropathy (pro-ctcae)
timeFrame: 24 weeks
measure: Secondary Outcome Measures regarding peripheral neuropathy (eortc-qlq-cipn20)
timeFrame: 24 weeks
measure: Secondary Outcome Measures regarding pain in hands and feet (pro-ctcae)
timeFrame: 24 weeks
measure: Secondary Outcome Measures regarding pain in hands and feet (eortc-qlq-cipn20)
timeFrame: 24 weeks
measure: Secondary Outcome Measures regarding comfort hilotherapy
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: UZ Leuven
state: Flemish-Brabant
Study officials:
affiliation: UZ Leuven
name: Annemarie Coolbrandt, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02895776: Risk Factors of Conversion From Local to General Sedation in Endovascular Stroke Therapy
Official title: Search for Risk Factors of Conversion From Local to General Sedation in Emergency Endovascular Therapy for Acute Stroke
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Acute Stroke
Lead sponsor: Fondation Ophtalmologique Adolphe de Rothschild
Sponsor class: NETWORK
First posted: 2016-09-12
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Endovascular Acute Stroke Therapy scheduled to be performed with local sedation and either performed under General Anesthesia (case), either actually performed under conscious sedation (control).

Endovascular Acute Stroke Therapy scheduled to be performed with conscious sedation and performed under General Anesthesia 3 control patients will be included per case, and matched with the moment of procedure (term of the year).

Brief summary: Thrombectomy is now the standard of care of revascularization in acute ischaemic stroke. Data tend to show that final neurologic outcome is superior if the thrombectomy procedure was performed under conscious sedation.

The Rothschild Foundation is a high output centre with more than 400 thrombectomy procedures every year.

We report a rate of 5% of these procedures requiring general anesthesia despite conscious sedation being the standard of care. This study aims to identify clinical factors associated with a risk of conversion of a conscious sedation to a general anesthesia.


Eligibility criteria: Inclusion Criteria:

* patients undergoing thrombectomy for ischemic stroke
* age ≥ 18 years old

Exclusion Criteria:

* patient already under general anesthesia
* general sedation required
* haemorrhagic softening diagnosed before the beginning of procedure
* patient refusal to participate in the study

Primary outcomes:
measure: factors associated with a conversion from conscious sedation to general anesthesia
timeFrame: during therapy (day 1)
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Fondation Ophtalmologique Adolphe de Rothschild
Study officials:
References:
Clinical trial NCT00541476: Non-Interventional Study In Patients With Peripheral Or Central Neuropathic Pain Treated With Lyrica
Official title: Non-Interventional Study In Patients With Peripheral Or Central Neuropathic Pain Undergoing Symptomatic Treatment With Lyrica
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Neuralgia
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2007-10-10
Enrollment: 746
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE

Brief summary: The purpose of this study is to obtain more data about efficacy and safety of the study drug Lyrica.


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of peripheral or central neuropathic pain

Exclusion Criteria:

* None. Patients recruited by physician decision. Patient's personal data are not collected.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT04320576: Clinical Comparison of Bulk-fill Restorative and Nano-fill Resin Composite
Official title: Long-term Clinical Comparison of Bulk-fill and Nano-fill Composite Restorations
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Dental Caries
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2020-03-25
Enrollment: 50
Sex: ALL
Minimum age (years): 24
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to evaluate the clinical performance of a nano-fill and a bulk fill resin composite in class II restorations.

Detailed description: In accordance with a split-mouth design, 50 patients will be received at least one pair of restorations, restored with a nanofill resin composite (Filtek Ultimate \[FU\]) and with a bulk fill resin composite (Tetric EvoCeram Bulk Fill \[TB\]). Each restorative resin will be used with its respective adhesive system according to the manufacturers' instructions. A total of 104 class II restorations will be placed by two operators. The restorations will be blindly evaluated by two examiners at baseline and at 1-, 2-, 3-, 4-, 5-, 6-, 7- and 8- year using modified US Public Health Service Ryge criteria. The comparison of the two restorative materials for each category will be performed with the chi-square test (a=0.05). The baseline scores will be compared with those at the recall visits using the Cochran Q-test.

Eligibility criteria: Inclusion Criteria:

* a need for at least two but not more than four posterior tooth-colored restorations
* the presence of teeth to be restored in occlusion
* teeth that were symptomless and vital
* a normal periodontal status
* a good likelihood of recall availability.

Exclusion Criteria:

* partly erupted teeth
* absence of adjacent and antagonist teeth
* poor periodontal status
* adverse medical history
* potential behavioral problems

Primary outcomes:
measure: Marginal adaptation
timeFrame: From baseline to 8 year the change of restorations will be evaluated
measure: Marginal discoloration
timeFrame: From baseline to 8 year the change of restorations will be evaluated
measure: Retention
timeFrame: From baseline to 8 year the change of restorations will be evaluated
measure: Anatomic form
timeFrame: From baseline to 8 year the change of restorations will be evaluated
measure: Color change
timeFrame: From baseline to 8 year the change of restorations will be evaluated
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Hacettepe University School of Dentistry
name: Ayse R Yazici, DDS, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02236676: Sleep Study Among Inpatients With TBI in an Acute Rehabilitation Hospital
Official title: Sleep, Procedural Learning & Therapeutic Engagement Among Inpatients With
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Motor Learning in TBI
Keywords: motor learning TBI
Lead sponsor: Kessler Foundation
Sponsor class: OTHER
Collaborators: name: New Jersey Commission on Brain Injury Research
First posted: 2014-09-10
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this research study is to better understand how a daytime nap after training on a motor skill after brain injury improves performance compared with the same amount of time after training spent awake and resting.


Eligibility criteria: Inclusion Criteria:

* Must have a Traumatic Brain Injury.
* Must have been a Kessler Institute for Rehabilitation inpatient for at least three days.

Exclusion Criteria:

* Bilateral arm fractures, cellulitis or other conditions that prevent safe wearing of the WatchPAT-200/actigragh.
* Movement disorder or spasticity affecting both upper extremities
* Patients who are ventilator-dependent.
* Patients who are on contact precautions for C.diff or other highly contagious diseases.
* Patients with neurological disorders other than TBI.

Primary outcomes:
measure: Improvement on Motor Functioning Test
timeFrame: Three Nights and Three Days
Secondary outcomes:
Other outcomes:
Locations:
city: West Orange
country: United States
facility: Kessler Foundation
state: New Jersey
Study officials:
References:
Clinical trial NCT04826276: Effects of Smoking State on Decision Making
Official title: Effects of Smoking State on Effort-based Decision Making
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Behavior
Keywords: Decision making
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2021-04-01
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Participants will be instructed to smoke as usual before one fMRI study visit (satiated state) and to abstain from using all tobacco/nicotine for 12 hours before the other fMRI study visit (abstinence and/or withdrawn state). The order of the satiated and abstinence/withdrawn study visits will be randomized and counterbalanced across participants.
Primary purpose: BASIC_SCIENCE

Brief summary: Adult smokers will be tested using behavioral and neuroimaging measures after smoking as usual and after overnight abstinence.


Eligibility criteria: Inclusion Criteria:

* Aged 18-55 years
* Smokes cigarettes or e-cigarettes
* Negative urine drug screen

Exclusion Criteria:

* Unstable or serious medical or mental health condition
* History of serious head trauma
* Pregnancy
* Unsuitable for MRI
* Weight \> 350 pounds (maximum allowed for MRI)

Primary outcomes:
measure: Effort based decision making
timeFrame: through study completion, an average of 1 year
measure: Distress tolerance behavior
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest University School of Medicine
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Merideth Addicott, PhD
role: PRINCIPAL_INVESTIGATOR
References: