louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03148548: Substudy - Evaluation of Patients With Iliac Vein Thrombosis
Official title: Iliofemoral Thrombosis and Postthrombotic Syndrome: Registration and Analysis Within the Frankfurt Thrombophilia Registry
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Iliac Vein Thrombosis
Keywords: VTE
thrombophilia screening
patients
risk factors
post-thrombotic syndrome
Lead sponsor: Cardioangiologisches Centrum Bethanien
Sponsor class: OTHER
First posted: 2017-05-11
Enrollment: 85
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects with previous iliofermoral thrombosis, which has been proven by objective measurements (Duplex sonography, phlebography, CT/MRT)

Brief summary: Patients with previous diagnosis of iliac vein thrombosis are enrolled in this registry. Using standardized questionnaire, clinical data detailing venous thromboembolism and contributing VTE risk factors are recorded. Results of technical and laboratory investigations including screening of thrombophilic disorders were additionally entered into the database.


Eligibility criteria: Inclusion Criteria:

* \>18 years
* subjects with iliofermoral thrombosis, which has been proven by objective measurements (Duplex sonography, phlebography, CT/MRT) later than 1996

Exclusion Criteria:

* \<18 years
* \> 80 years
* surface or deep vein thrombosis without affection of pelvis

Primary outcomes:
measure: Incidence and severity of postthrombotic Syndrome after iliofemoral thrombosis
timeFrame: up to 20 years after occurrence of iliofemoral thrombosis
Secondary outcomes:
measure: Distribution of gender in Iliofemoral thrombosis
timeFrame: since 1996
measure: Distribution of affected side in Iliofemoral thrombosis
timeFrame: since 1996
measure: Disease-specific quality of life instrument for use in venous diseases of the leg (VEINES-QOL)
timeFrame: 1 year
measure: Incidence of venous claudication
timeFrame: 1 year
Other outcomes:
Locations:
city: Frankfurt/Main
country: Germany
facility: Cardioangiologisches Centrum Bethanien
state: Hessen
Study officials:
affiliation: Cardioangiologisches Centrum Bethanien
name: Edelgard Lindhoff-Last, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02533830: Gum Chewing And Bowel Motility in Patients Undergoing Cesarean Section. Kasr el Ainy Experience
Official title: Gum Chewing And Bowel Motility in Patients Undergoing Cesarean Section. Kasr el Ainy Experience.A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Gum Chewing
Bowel Function
Lead sponsor: Kasr El Aini Hospital
Sponsor class: OTHER
First posted: 2015-08-27
Enrollment: 162
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of the present study was to evaluate the effect of chewing gum on the recovery of bowel function after cesarean section in women.

Detailed description: This study Will Be conducted on 162 Patients Undergoing caesarean section in The Obstetrics \& Gynecology Department "kasr el ainy teaching hospital".

Methods:

Women Were Randomized into Two Groups: Group A (81 Women) Who Received One Stick of Sugarless Gum (Samara for food \& Chocolates Product Company)"S.A.E." , for 15 Minutes Every 2 hours After Surgery Tell Defecation , Group B (81 Women) had Traditional Management (Oral Intake of Clear Fluid Allowed After Passage of Flatus and Regular Diet With The Passage of Bowel Movement.

Each Women in Both Groups Was Examined Abdominal Using A Stethoscope Detect The Intestinal Movement Every 4 Hours And Asked to Report Immediately The Time of Either Passing Flatus or stool .

Eligibility criteria: Inclusion Criteria:

1. Age between 18 - 35 Years.
2. Spinal Anesthesia.
3. Pfannenstiel incision.

Exclusion Criteria:

1. History of Drug Consumption Especially Opioids.
2. Water and Electrolyte Disturbances.
3. Pancreatitis.
4. Peritonitis.
5. History of Abdominal Surgery except Cesarean Section.
6. No Willingness to Cooperative.
7. Intra and Sever Post-Operative Complications.
8. Inability to Chew Gum with Drawl.
9. Diabetes.
10. Pre-eclampsia
11. Prolonged Rupture of Membranes.
12. Hypothyroidism.
13. Muscular and Neurological Disorders.

Primary outcomes:
measure: the first audible bowel sound in hours
timeFrame: 4 months
Secondary outcomes:
measure: patient satisfaction
timeFrame: 4 months
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Mohamed Abdel Aziz El Sharkawy
city: Cairo
country: Egypt
facility: Mohqmed El Sharkawy
Study officials:
affiliation: kasr el ainy street,cairo,egypt
name: Kasr El Ainy
role: STUDY_CHAIR
References:
Clinical trial NCT01540448: Role of CT Angiography With Three-dimensional Reconstruction of Mesenteric Vessels in Planning and Performing of Laparoscopic Colorectal Resections
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Colorectal Laparoscopic Resection
Lead sponsor: University of Roma La Sapienza
Sponsor class: OTHER
First posted: 2012-02-28
Enrollment: 100
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 evaluate if the prior knowledge of the individual mesenteric vascular anatomy of patients represents an advantage in performing laparoscopic colorectal resections. The investigators want demonstrate that the three-dimensional reconstruction of colonic vascular anatomy, acquired with a CT angiography, may lead to a more effective and less extensive dissection and to a fewer intraoperative and postoperative complications.


Eligibility criteria: Inclusion Criteria:

* need of colorectal resection
* absence of preoperative CT scan

Exclusion Criteria:

* contraindications to laparoscopy
* ASA IV
* BMI \> 40 Kg/m2
* need of non standard colonic resection

Primary outcomes:
measure: Surgical Performance (operative time)
timeFrame: within the first 4 hours
Secondary outcomes:
measure: complex identification of mesenteric vessels performing laparoscopic colorectal resection
timeFrame: within the first 4 hours
measure: Iatrogenic vascular or visceral injuries
timeFrame: within the first 10 postoperative days
measure: intraoperative bleeding
timeFrame: within the first 4 hours
measure: Postoperative complications
timeFrame: within the first 15 postoperative days
measure: lymph nodes harvesting
timeFrame: within first 4 hours
measure: Anatomical variations of mesenteric vessels
timeFrame: Within 24 hours before surgical procedure
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Azienda Ospedaliera Sant'Andrea
Study officials:
References:
citation: Mari FS, Nigri G, Pancaldi A, De Cecco CN, Gasparrini M, Dall'Oglio A, Pindozzi F, Laghi A, Brescia A. Role of CT angiography with three-dimensional reconstruction of mesenteric vessels in laparoscopic colorectal resections: a randomized controlled trial. Surg Endosc. 2013 Jun;27(6):2058-67. doi: 10.1007/s00464-012-2710-9. Epub 2013 Jan 5.
Clinical trial NCT05341648: Aerobic Exercise and Covid-19 Survivors With Post-Intensive Care Syndrome (Pics)
Official title: Effects of Aerobic Exercise Program in Covid-19 Survivors With Post-Intensive Care Syndrome (Pics)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: COVID-19
Post Intensive Care Syndrome
Keywords: Aerobic exercise
COVID-19 Survivors
Post Intensive Care Syndrome
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2022-04-22
Enrollment: 60
Sex: ALL
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To investigate the effects of aerobic exercise program on physical activity, aerobic capacity, anxiety\& depression in Covid-19 survivors discharged from Intensive Care Unit. There is evidence in the literature that post-intensive case survivors who have been mechanically ventilated will likely experience short- and medium-term consequences in the form of Post Intensive Care Syndrome (PICS).

Detailed description: The notion that patients surviving intensive care and mechanical ventilation for several weeks can be discharged home without further medical attention is a dangerous illusion. Post-Intensive Care Syndrome and other severe conditions will require not only adequate screening but early rehabilitation and other interventions. So, this focused control trial will contribute particularly to determining the Effects of the Aerobic Exercise Program in Covid-19 Survivors with Post-Intensive Care Syndrome.

Eligibility criteria: Inclusion Criteria:

* Patients undergo mechanical ventilation in the ICU.
* Recovered from Covid-19 \& Discharged from ICU within the past 2 months.
* Hospital Anxiety and Depression Scale (HADS)\>8.
* Scale≥ 2 on MRC Dyspnoea Scale.
* Subjects consenting to participate in the study.

Exclusion Criteria:

* Positive Covid-19 Test.
* COPD and other respiratory diseases.
* Pre-existing psychotic dementia-type illness.
* Acute neurologic diseases (meningitis, ischemic hemorrhagic stroke).
* Patients with chronic systemic disease.

Primary outcomes:
measure: Hospital Anxiety and Depression
timeFrame: 6 weeks
measure: 6 min walk test: Distance (meters)
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Rawalpindi
country: Pakistan
facility: Allama Iqbal International Hospital & Mega Medical Complex.
state: Punjab
Study officials:
affiliation: Riphah International University
name: Mehwish Waseem, MSPT(CPPT)
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00761930: Compare the Clinical Efficacy of Prototype Toothpastes.
Official title: Compare the Clinical Efficacy of Prototype Toothpastes.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Gingival Diseases
Lead sponsor: Colgate Palmolive
Sponsor class: INDUSTRY
First posted: 2008-09-30
Enrollment: 103
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Evaluate clinical efficacy of a prototype toothpaste on control of dental plaque gingival inflammation


Eligibility criteria: Inclusion Criteria:

* Male or female volunteers 18-65 years of age
* Good general health
* Must sign informed consent form
* Minimum of 16 natural uncrowned teeth (excluding third molars) must be present.
* No history of allergy to personal care consumer products, or their ingredients,
* relevant to any ingredient in the test products as determined by the dental/medical
* Professional monitoring the study.
* Dental Selection Criteria: Average full mouth GI score should be in the range of
* - 2.0. heavy plaque formers should be avoided. Target a full mouth PI
* (Quigley-Hein) to be in the range of 1.5-3.0
* If of child bearing potential and on birth control (diaphragm, birth control pills,
* Birth control implants, IUD (Intrauterine device), condoms)

Exclusion Criteria:

* Subjects unable or unwilling to sign the informed consent form.
* Medical condition which requires pre-medication prior to dental visits/procedures
* Moderate or advanced periodontal disease
* 2 or more decayed untreated dental sites at screening.
* Other disease of the hard or soft oral tissues.
* Impaired salivary function (e.g. Sjogren's syndrome or head and neck irradiation).
* Use of medications that are currently affect salivary flow.
* Use of antibiotics or antimicrobial drugs within 30 days prior to study visit #1.
* Pregnant or nursing women.
* Participation in any other clinical study within 1 week prior to enrollment into this
* study.
* Use of tobacco products
* Subjects who must receive dental treatment during the study dates.
* Current use of Antibiotics for any purpose.
* History of allergy to common dentifrice ingredients
* Presence of an orthodontic appliance which interferes with plaque scoring.
* History of allergy to natural remedies, such as herbal ingredients
* Immune compromised individuals (HIV, AIDS, immuno suppressive drug therapy)
* Smoker

Primary outcomes:
measure: Dental Plaque
timeFrame: 6 weeks
measure: Gingivitis Score
timeFrame: 6 weeks
measure: Bleeding Index (EIBI)
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Eastman Dental Center - University of Rochester
state: New York
Study officials:
name: Yanfang Ren, DDS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02419430: Mindfulness Based Resilience Training
Official title: Mindfulness Based Resilience Training for Employees at Mayo Clinic
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress, Psychological
Keywords: well-being
stress
resilience
self-compassion
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: Arizona State University
First posted: 2015-04-17
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The investigators aim to evaluate the Mindfulness Based Resilience Training (MBRT) intervention for Mayo Clinic employees in order to provide evidence for improved ability to cope with stress and decreased work-related burnout and stress-related symptoms as a result of MBRT training. In addition, the investigators aim to compare the effects of MBRT + smartphone sleep feedback, a smartphone resilience intervention + smartphone sleep feedback, or waitlist control +smartphone sleep feedback in a randomized clinical trial in a sample of 75 Mayo Clinic employees.

Detailed description: The investigators aim to compare the effects of MBRT + smartphone sleep feedback, a smartphone resilience intervention + smartphone sleep feedback, or waitlist control +smartphone sleep feedback in a randomized clinical trial in a sample of 75 Mayo Clinic employees. Specific self-report outcomes include: well-being, stress, anxiety, depression, fatigue, resilience, self-compassion, and burn-out, assessed at pre-, post- and 3-month followup. Objective outcomes, derived from smartphone-driven self-monitoring, include sleep quality and emotional experiencing, assessed throughout the six-week intervention period. The investigators will explore whether changes in objectively measured sleep quality and emotional experiencing will mediate treatment effects on self-report outcomes. The investigators will also explore whether treatment effects are more robust in self-selected versus randomized groups by drawing on the investigators' existing data.

Eligibility criteria: Inclusion:

1. Stress subscale of the DASS-21 needs to be a score 5 or greater and
2. Must have a smart Phone, and
3. Ability to attend at least 5 complete sessions.

Exclusion :

1. Stress subscale of the DASS-21 less than 5.
2. Must have a smart Phone.

Primary outcomes:
measure: Changes in scores using the DASS-21(Depression Anxiety and Stress Scales) questionnaire
timeFrame: Baseline to 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Mayo Clinic in Arizona
state: Arizona
Study officials:
affiliation: Mayo Clinic
name: Cynthia Stonnington, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03420430: Expanded Access to Provide GL-ONC1 for the Treatment of Advanced Cancers With No Standard of Care
Official title: Use of GL-ONC1 in Patients With Advanced Cancers With No Standard of Care
Study type: EXPANDED_ACCESS
Overall status: NO_LONGER_AVAILABLE
Conditions: Advanced Stage Cancer (Solid Tumor Disease for 4 Patients)
Acute Myeloid Leukemia (6 Patients)
Lead sponsor: Genelux Corporation
Sponsor class: INDUSTRY
First posted: 2018-02-05
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT

Brief summary: GL-ONC1 expanded access is for patients who are ineligible for an ongoing GL-ONC1 clinical trial. Expanded access is intended to treat individual patients with advanced stage cancers, including blood cancer, with no standard of care options for treatment. Potential patients will be evaluated individually depending on GL-ONC1 product supply.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of advanced cancers with no standard of care option for treatment.
* Willing and able to provide written, signed informed consent.
* Use of adequate contraception.
* Negative pregnancy test.

Exclusion Criteria:

* Have not recovered from severe adverse events from prior therapy.
* Major surgery occurred within 28 days prior to treatment.
* Known immune system disorders such as HIV, or active hepatitis B or C infection.
* Clinically significant cardiac disease (New York Heart Association Class III or IV).
* Have received prior therapy with an oncolytic virus of any type.
* Be receiving antiviral agent active against vaccinia virus (e.g., cidofovir, vaccinia immunoglobulin, imatinib, ST-246).
* Have known allergy to ovalbumin or other egg products.
* Have clinically significant dermatological disorders (e.g., eczema, psoriasis, or any unhealed skin wounds or ulcers) as assessed by the treating physician.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Orlando
country: United States
facility: Florida Hospital Cancer Institute
state: Florida
Study officials:
References:
Clinical trial NCT00932230: The Effect of Kinesio Taping on Ankle Proprioception
Official title: The Effect of Kinesio Taping on Ankle Proprioception
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sprains and Strains
Lead sponsor: Logan College of Chiropractic
Sponsor class: OTHER
First posted: 2009-07-03
Enrollment: 40
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study examines the effect of kinesiology tape on proprioception and postural control in subjects with sub-acute and chronic ankle sprains/strain.

Detailed description: The a priori hypothesis of this study is that proprioception (knee repositioning error) and balance (sway velocity and center of pressure) will improve significantly after intervention (Kinesiotape) in participants with a history of acute or chronic ankle sprains/strains.

Eligibility criteria: Inclusion Criteria:

* Logan student, staff, or faculty
* Between the ages of 20 and 65
* Previous history of ankle instability/sprains
* A score of 6 out of 10 questions answered yes on the Functional Ankle Instability form will qualify the candidate

Primary outcomes:
measure: Joint Position sense testing and postural control (sway velocity center of pressure)
timeFrame: Day 1, Day 2 and Day 3 of Study
Secondary outcomes:
measure: VAS
timeFrame: Day 1, Day 2 and Day 3 of Study
Other outcomes:
Locations:
city: St. Louis
country: United States
facility: Logan University, College of Chiropractic
state: Missouri
Study officials:
References:
Clinical trial NCT04264130: Effect of Artemisinin-based Combination Therapies on Schistosomiasis on Malaria Co-infection
Official title: Evaluation of the Effect of Artemisinin-based Combination Therapies on Urinary Schistosoma Haematobium When Administered for the Treatment of Malaria Co-infection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Schistosomiasis Haematobia
Lead sponsor: Centre de Recherche Médicale de Lambaréné
Sponsor class: OTHER
First posted: 2020-02-11
Enrollment: 54
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Open labelled, non randomized study to evaluate the effects of Artemisinin based Combined Therapies(ACTs) on schistosomiasis since Praziquantel (PZQ) which is presently the drug of choice for treating Schistosomiasis (STS), is ineffective on immature stages and there is known parasite resistance. ACTs when combined with PZQ, targeting different stages of the life cycle has shown some effectivity.

Detailed description: Study population included all subjects in study area who signed a written Informed Consent Form diagnosed with Malaria- STS co-infection. Those excluded were treated with PZQ prior 6 weeks, have drug intolerance or pregnant. At Inclusion, Basic Demographic data was recorded and urine samples analysed. During the follow up visits, urine samples were collected on D28 and D42 (6 weeks post treatment). Post treatment assessment was done on urine samples collected on at least two consecutive days and at the end of follow up, all subjects were treated with a single dose pf PZQ (40 mg/kg) as recommended by WHO.

Eligibility criteria: Inclusion Criteria:

* Malaria infection diagnosed by Rapid Diagnostic Tests (RDTs) or thick blood smear
* Urinary schistosomiasis diagnosed by presence of Schistosoma haematobium eggs in the urine before malaria treatment
* Written informed consent

Exclusion Criteria:

* Patients treated with PZQ during the previous 6 weeks
* Known intolerance /allergy to any study drug
* Pregnancy

Primary outcomes:
measure: Egg Reduction Rate (ERR)
timeFrame: Day 28
measure: Egg Reduction Rate (ERR)
timeFrame: Day 42
Secondary outcomes:
measure: Cure Rate (CR)
timeFrame: Day 28
measure: Cure Rate (CR)
timeFrame: Day 42
Other outcomes:
Locations:
city: Lambaréné
country: Gabon
facility: Centre de Recherches Medicales de Lambarene
Study officials:
affiliation: Centre de Recherches Medicales de Lambarene, Lambarene, Gabon
name: Rella Zoleko Manego
role: PRINCIPAL_INVESTIGATOR
References:
citation: Zoleko-Manego R, Okwu DG, Handrich C, Dimessa-Mbadinga LB, Akinosho MA, Ndzebe-Ndoumba WF, Davi SD, Stelzl D, Veletzky L, Kreidenweiss A, Nordmann T, Adegnika AA, Lell B, Kremsner PG, Ramharter M, Mombo-Ngoma G. Effectiveness of antimalarial drug combinations in treating concomitant urogenital schistosomiasis in malaria patients in Lambarene, Gabon: A non-randomised event-monitoring study. PLoS Negl Trop Dis. 2022 Oct 31;16(10):e0010899. doi: 10.1371/journal.pntd.0010899. eCollection 2022 Oct.