louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00171769: Atrial Fibrillation Feasibility Certoparin Trial - AFFECT
Official title: An Open Label, Multi-center Trial to Evaluate the Feasibility and Safety of Short-term Treatment With Subcutaneously Injected Certoparin (8000 U Anti-Xa Twice Daily) in Patients With Persistent Nonvalvular Atrial Fibrillation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Persistent Nonvalvular Atrial Fibrillation
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2005-09-15
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This trial is designed to provide data about feasibility and safety of short-term treatment with the low-molecular-weight heparin certoparin in patients with persistent nonvalvular atrial fibrillation


Eligibility criteria: Inclusion Criteria:

* persistent AF (electrical cardioversion is planned)
* written informed consent

Exclusion Criteria:

* acute clinical signs of venous thromboembolism
* current oral anticoagulation
* indication for medical cardioversion

Primary outcomes:
measure: Safety measures including reporting of serious adverse events and adverse events, including vascular and neurological events
Secondary outcomes:
Other outcomes:
Locations:
city: East Hanover
country: United States
facility: Novartis Pharmaceuticals
state: New Jersey
city: Investigative Centers
country: Germany
Study officials:
affiliation: Novartis Pharmaceuticals
name: novartis pharmaceuticals
role: STUDY_DIRECTOR
References:
citation: Tebbe U, Oeckinghaus R, Appel KF, Heuer H, Haake H, Eggers E, Seidel K, Adams J, Harenberg J. AFFECT: a prospective, open-label, multicenter trial to evaluate the feasibility and safety of a short-term treatment with subcutaneous certoparin in patients with persistent non-valvular atrial fibrillation. Clin Res Cardiol. 2008 Jun;97(6):389-96. doi: 10.1007/s00392-008-0644-y. Epub 2008 Mar 5.
Clinical trial NCT06493669: Study on the Correlation Between Treg Immune Cells on the Muscle Content and Cognitive Functions of the Elderly
Official title: Study on the Correlation Between Treg Immune Cells on the Muscle Content and Cognitive Functions of the Elderly
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cognitive Disorder Patients and Cognitive Assessment
Lead sponsor: Fifth Affiliated Hospital, Sun Yat-Sen University
Sponsor class: OTHER
First posted: 2024-07-10
Enrollment: 100
Sex: ALL
Minimum age (years): 40
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Cognitive decline patient

Brief summary: In order to explore the impact of the level of the elderly Treg immune cells and the effects of different fat distribution and muscle content, the impact of the level of Treg immune cells on cognitive functions is explored. The correlation between visceral fat content, subcutaneous fat content and cognitive function.


Eligibility criteria: Inclusion Criteria:

- aged 40-90 years old

Exclusion Criteria:

- previous diagnosis of dementia (including Alzheimer's disease, Lewy body dementia, Parkinson's disease, or other dementias) were excluded.

Primary outcomes:
measure: Cognitive function decline
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Zhuhai
country: China
facility: The Fifth Affiliated Hospital of Sun Yat-sen University
state: Guangdong
Study officials:
References:
Clinical trial NCT05279469: D-Dimer as Predictor of Disease Outcome in Intensive Care Unit in COVID-19m Patients
Official title: D-Dimer as Predictor of Disease Outcome in Intensive Care Unit in SARS-COV-2 Patients: A Retrospective Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Critical Illness
Pneumonia, Viral
Keywords: D dimer
SARS-COV-2
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2022-03-15
Enrollment: 465
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients in SARS.COV.2 patients in ICU with positive PCR and needing oxygen therapy

Brief summary: Evaluating value of D-Dimer blood level of icu admitted patients on admission and 48 hours later as outcome predictor in SARS.COV.2 patients.

Detailed description: Evaluating value of D-Dimer blood level of icu admitted patients on admission and 48 hours later as outcome predictor in SARS.COV.2 patients.

It has been reported that COVID 19 is associated with hemostatic abnormalities and elevated D-Dimer level, so its level is used to predict severity of disease.

Eligibility criteria: Inclusion Criteria:

* patients of both sex admitted in icu
* positive PCR
* requiring oxygen therapy

Exclusion Criteria:

* ward patients
* negative PCR

Primary outcomes:
measure: 28 days mortality
timeFrame: 1 month
Secondary outcomes:
measure: length of stay and mechanical ventilation
timeFrame: during ICU stay
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain shams university hospitals
city: Cairo
country: Egypt
facility: Faculty of medicine, Ain Shams University
Study officials:
References:
Clinical trial NCT02032069: Pneumoproteins Expression in the Organ Donor
Official title: Pneumoproteins Expression in the Organ Donor
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Primary Graft Dysfunction
Lead sponsor: University Hospital of Mont-Godinne
Sponsor class: OTHER
First posted: 2014-01-09
Enrollment: 20
Sex: ALL
Minimum age (years): 5
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Organ donors and lung recipients

Brief summary: Primary graft dysfunction, a form of reperfusion pulmonary edema that occurs early after lung transplantation, shares key clinical and pathological features with acute lung injury and its more severe form, the acute respiratory distress syndrome. However, in contrast to acute lung injury/acute respiratory distress syndrome, in which biomarkers in plasma, urine and lung edema fluid have prognostic and pathogenetic value, the role of biomarkers in primary graft dysfunction has been less thoroughly explored. We will try in this study de determine the rule of pneumoproteins in the donor organ on the pulmonary edema in the recipient.


Eligibility criteria: Inclusion Criteria:

All the organ donors for lung grafts.

Exclusion Criteria:

none

Primary outcomes:
measure: Number of Recipient with primary graft dysfunction
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
city: Yvoir
country: Belgium
facility: CHU Mont-Godinne
state: Namur
Study officials:
References:
Clinical trial NCT06045169: The Effects of Muscle Energy Techniques on Pain and Quality of Life in Young Females With Primary Dysmenorrhea
Official title: The Effects of Muscle Energy Techniques on Pain and Quality of Life in Young Females With Primary Dysmenorrhea
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Primary Dysmenorrhea
Lead sponsor: Foundation University Islamabad
Sponsor class: OTHER
First posted: 2023-09-21
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Quasi Experimental Pre-test Post-test design
Primary purpose: TREATMENT

Brief summary: This study will be a quasi experimental study in which females aged 18 - 30 years with primary dysmenorrhea will be recruited in single group. They will be given a total of 3 sessions of treatment during a period of one menstrual cycle (One Week). Before and after the introduction of intervention pain and quality of life of participants will be assessed.

Detailed description: Primary Dysmenorrhea is one of the most prevalent gynecological conditions which impacts the quality of life of young females.Primary dysmenorrhea is defined as cramping like pain during menstruation cycle without the presence of any pelvic pathology it is associated with symptoms like headache,vomitting and irritability.The aim of our study is to determine the effects of muscle energy technique in young females with primary dysmenorrhea in terms of pain and quality of life.This study will be a Quasi Experimental study.It will be conducted at Foundation university college of physical therapy.Paticipants will complete WALIDD scale,NPRS and WHOQOL at baseline and then after intervention.All participants will receive post isometric relaxation of global muscles of core commonly involved in primary dysmenorrhea(Gluteus Maximus,Illiopsoas and Piriformis).Post isometric relaxation technique will be applied to all the participants with participants using 20% of their maximum voluntary contractio with held time of 6-10 seconds followed by 15 to 30 seconds stretch,rest time of 5 seconds between each repetitions and 3-5 repetions.There will be a total of 3 sessiond of treatment(1st on second day of menstruation,2nd on fourth day of menstruatio and 3rd on seventh day of menstruation)during a period of one week (one menstraul cycle).

Eligibility criteria: Inclusion Criteria:

* Female aged 18 - 30
* Primary Dysmenorrhea
* Unmarried

Exclusion Criteria:

* Not on any contraceptive medicine for treatment of pelvic pathology
* Secondary Dysmenorrhea and other issues such as endometriosis, Pelvic inflammatory disease, Ovarian cyst

Primary outcomes:
measure: Pain intensity
timeFrame: 1 week
Secondary outcomes:
measure: Quality of life of participant
timeFrame: 1 week
measure: WALIDD
timeFrame: 1 week
Other outcomes:
Locations:
city: Rawalpindi
country: Pakistan
facility: Foundation University College of Physical Therapy
state: Punjab
Study officials:
References:
Clinical trial NCT06520969: Prevelance of Uterine Vein and Uterine Vein System Variations
Official title: Prevelance of Uterine Vein and Uterine Vein System Variations
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Uterine Vein Injury Left
Uterine Vein Injury Right
Lead sponsor: Istanbul University
Sponsor class: OTHER
First posted: 2024-07-25
Enrollment: 100
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Endometrium and cervical cancer patients that will be operated in Istanbul University School of Medicine, Dept. of Obstetrics and Gynecology, Division of Oncology will be included. Anatomic details such as the presence, number of superficial and deep uterine veins, calibers, anatomical relationships with hypogastric arteries and veins, ureters, vesicouterine ligaments will be described systematically and bilaterally for every consenting women after pelvic spaces are opened before pelvic lypmhadenectomy and hysterectomy. All regarding information will be photographed for every patient bilaterally and recorded on data sheet.
Primary purpose: OTHER

Brief summary: Contrary to the uterine arterial system, our knowledge about superficial and deep uterine vein prevalence and anatomic variations are limited. The present study aims to deepen and clarify our knowledge on superficial and deep uterine vein anatomy, prevalence and relationship with other neighbouring structures which may be helpful in uterine transplantation and radical hysterectomy operations.

Detailed description: Despite that two veins draining the uterus, superficial and deep, are described, their true anatomy, number, calibers, trajectories, relationships with sympathetic and parasympathetic nerves and internal iliac vasculature and ureters are quite limited. Additionally, variations of these vasculature are much less described. The aim of this study is to increase the our current knowledge about these anatomical information and also to calculate the prevalence of superficial and deep uterine veins which may potentially decrease the possible complications such as bleeding in uterine transplantation surgery and nerve sparing radical hysterectomy for cervical cancer.

Eligibility criteria: Inclusion Criteria:

Endometrium and cervical cancer patients that will be operated -

Exclusion Criteria:

Any women in whom uterine vascular anatomy that might be changed for a specific disease such as myomas, uterine infections, etc.

-

Primary outcomes:
measure: To describe the prevalence of uterine vein and uterine vein system variations
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul University Medical Faculty Dept. of Obstet Gynecol, Division of Gynecologic Oncology
state: Istanbul / Turkey
Study officials:
affiliation: Istanbul Univrsity
name: Samet Topuz, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01388569: Biomarkers in Blood Samples From Patients With Stage IV Melanoma Previously Treated With Sargramostim
Official title: Immune Counter-Regulation in Melanoma Patients Vaccinated With GM-CSF
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Melanoma (Skin)
Keywords: stage IV melanoma
Lead sponsor: Eastern Cooperative Oncology Group
Sponsor class: NETWORK
Collaborators: name: National Cancer Institute (NCI)
First posted: 2011-07-06
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Samples from patient enrolled on E4697 from whom samples were submitted for research

Brief summary: RATIONALE: Studying samples of blood from patients treated with sargramostim in the laboratory may help doctors learn more about the effects of sargramostim on cells. It may also help doctors understand how patients respond to treatment.

PURPOSE: This research trial studies biomarkers in blood samples from patients with stage IV melanoma previously treated with sargramostim.

Detailed description: OBJECTIVES:

Primary

* To correlate circulating myeloid-derived suppressor cells (MDSC) and Treg frequencies with clinical outcome.

Secondary

* To correlate circulating anti-sargramostim (GM-CSF) antibody levels with clinical outcome.

OUTLINE: Archived peripheral blood mononuclear cells and serum samples are analyzed for circulating myeloid-derived suppressor cells, Treg (CD3+/CD4+/CD25hi/FOXP3+) frequency, and anti-sargramostim (anti-GM-CSF) antibody levels by flow cytometry and anti-GM-CSF neutralizing antibody assay.

Eligibility criteria: DISEASE CHARACTERISTICS:

* Diagnosed with melanoma

  * Stage IV disease
  * HLA-A2\^+ and A2\^+
* Received sargramostim on clinical trial ECOG-4697
* Specimens collected at baseline and either day 43 or day 85 (based on most consistent availability) from long-term survivors and patients with poor survival

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics

Primary outcomes:
measure: Overall and disease-free survival
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Pittsburgh
name: Lisa Butterfield, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02960269: Interprofessional Management of Chronic Back Pain in Rural and Remote Setting: Use of Telehealth vs. Secure Laptop-based Videoconferencing
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Back Pain Lower Back Chronic
Keywords: rural health
telehealth
physiotherapy
interprofessional
Lead sponsor: University of Saskatchewan
Sponsor class: OTHER
Collaborators: name: Kelsey Trail Health Region
First posted: 2016-11-09
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This pilot study will evaluate the impact and overall experience of an interprofessional chronic low back pain patient care approach for people in rural and remote areas using Telehealth technology compared to secure laptop based videoconferencing (Vidyo).

Detailed description: People with chronic low back pain will be recruited to participate in a team assessment with a local rural nurse practitioner and an-urban based physiotherapist linking through telehealth. The assessment will include a detailed history, physical examination and jointly-delivered education and recommendations for further community-based management. Pre and post measures of self-reported pain, back-specific function, quality of life, and satisfaction will be completed 2-4 weeks after the assessment. Comparison of short-term outcomes will be made with a group of participants from another study using the a different telehealth technology (secure laptop based videoconferencing) same inclusion criteria, measures and health care providers (Clin Trials.gov NCT02225535). The health care providers will be interviewed to get feedback on their preference and experience using the different type of telehealth technology.

Eligibility criteria: Inclusion Criteria:

chronic low back pain localized below costal margins and above gluteal folds and/or related leg pain, which is bad enough to limit their usual activities or daily routine and has been present for at least 3 months

Exclusion Criteria:

* People with: third party payer insurance (i.e.worker's compensation board) for their back related complaints, with primarily neck or thoracic pain, and/ or with language, reading or comprehension barriers that would limit their ability to adequately complete the required study paperwork will be excluded from participating in the study.

Primary outcomes:
measure: Patient experience with telehealth
timeFrame: 2-4 weeks after assessment
measure: Pain
timeFrame: 2-4 weeks after assessment
measure: Back-specific function
timeFrame: 2-4 weeks after assessment
measure: Participant satisfaction
timeFrame: 2-4 weeks after assessment
Secondary outcomes:
measure: Health care provider experience
timeFrame: within 2 weeks of completion of all assessments
Other outcomes:
Locations:
city: Saskatoon
country: Canada
facility: University of Saskatchewan
state: Saskatchewan
Study officials:
References:
Clinical trial NCT01271569: A Study to Assess the Efficacy and Safety of Fospropofol Disodium
Official title: A Phase 1,Open, Dose-escalation Study to Assess the Efficacy and Safety of Fospropofol Disodium Injection in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Drug Safety
Lead sponsor: West China Hospital
Sponsor class: OTHER
First posted: 2011-01-06
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The aim of this study was to evaluate the pharmacodynamics, safety, and tolerability of Fospropofol disodium up to a dose producing maximal hypnotic effect as defined by electroencephalogramderived assessment (Bispectral Index \[BIS\]) and to compare the dynamic properties of PropofolF to those of Propofol.

Detailed description: After local ethics committee (West China Hospital, Sichuan University, Chengdu, China) approval and written informed consent were obtained, 80 healthy volunteers (40 males and 40 females) aged between 18 and 45 yr were included. For 1 week before the study, subjects were to follow a diet with limited amounts of alcohol and caffeine. Ingestion of caffeine, alcohol, products containing aspartame (aspartame may increase formate concentrations), or use of paracetamol within 24 h before study drug administration resulted in ineligibility. Exclusion criteria included hypersensitivity to any anesthetic; known or suspected serious disorders and/or significant dysfunction; an abnormal, clinically significant ECG finding; participation in an investigational drug study within the previous month; known or suspected pregnancy; anatomical malformations expected to produce a difficult intubation and known or suspected history or family history of malignant hyperthermia.

Eligibility criteria: Inclusion Criteria:

* After local ethics committee (West China Hospital, Sichuan University, Chengdu, China) approval and written informed consent were obtained, 80 healthy volunteers (40 males and 40 females) aged between 18 and 45 yr were included. For 1 week before the study, subjects were to follow a diet with limited amounts of alcohol and caffeine.

Exclusion Criteria:

* Exclusion criteria included hypersensitivity to any anesthetic; known or suspected serious disorders and/or significant dysfunction; an abnormal, clinically significant ECG finding; participation in an investigational drug study within the previous month; known or suspected pregnancy; anatomical malformations expected to produce a difficult intubation and known or suspected history or family history of malignant hyperthermia.

Primary outcomes:
measure: BIS
timeFrame: 2hr after administration
Secondary outcomes:
measure: Modified OAA/S Score
timeFrame: 2hr after administration
Other outcomes:
Locations:
city: Chengdu
country: China
facility: West China Hospital, Sichuan University
state: Sichuan
Study officials:
affiliation: West China Hospital
name: Jin Liu, MD
role: STUDY_CHAIR
References: