louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00254774: Efficacy and Safety of Quetiapine Compared With Valproate in the Treatment of Patients With Bipolar Disorder and Rapid Cycling
Official title: Pilot Study of the Efficacy and Safety of Quetiapine Compared With Valproate in the Treatment of Patients With Bipolar Disorder and Rapid Cycling: an Open Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Bipolar Disorder
Keywords: Bipolar Disorder I or II with Rapid Cycling
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2005-11-17
Enrollment: 44
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 purpose of the study is to evaluate the efficacy of quetiapine compared to valproate during a 12 month treatment period in subjects with Bipolar Disorder I or II with Rapid Cycling.


Eligibility criteria: Inclusion Criteria:

* Signed informed consent, men and women aged ³18 to £65 years with diagnosis of DSM-IV criteria for bipolar I or II disorder, most recent episode manic, hypomanic, mixed or depressive with Rapid Cycling.

Exclusion Criteria:

* Substance or alcohol dependence, female patients who are pregnant, lactating or at risk of pregnancy, diagnosis of schizophrenia or borderline personality disorder or antisocial personality disorder, history of seizure disorder, acute suicidal or external aggressive behaviour, legal incapacity or indication for treatment against the will of the patient by law.

Primary outcomes:
measure: Number of clinically relevant recurrences of depression or mania. Recurrence is defined by a change in LCM-C/P to moderate or severe or by 2 or more steps. End of an episode is defined as reduction to mild or baseline or by 2 or more steps.
Secondary outcomes:
measure: Absolute change from baseline on the (recalculated) HAM-D, YMRS, MADRS, total score. Absolute change from baseline on the CGI-BP severity score per dimension (mania, depression, overall bipolar illness).
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Research Site
city: Freiburg
country: Germany
facility: Research Site
city: München
country: Germany
facility: Research Site
Study officials:
affiliation: AstraZeneca
name: AstraZeneca Germany Medical Director, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT03148574: Intrauterine Misoprostol Versus Intravenous Oxytocin Infusion During Cesarean Delivery
Official title: Intrauterine Misoprostol Versus Intravenous Oxytocin Infusion During Cesarean Delivery to Reduce Intraoperative and Postoperative Blood Loss: A Randomized Clinical Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Post Partum Hemorrhage
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2017-05-11
Enrollment: 240
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Bleeding is still the major cause of mortality and morbidity in postpartum period. World health organization has reported 585000 deaths for pregnancy each year. Twenty five percent of cases die from post-partum bleeding. Mean amount of blood lost is 500 ml during normal vaginal delivery, 1000 ml in cesarean section, and 3500 ml during cesarean section with emergency hysterectomy


Eligibility criteria: Inclusion Criteria:

1-Uncomplicated pregnancy, 2-Had no hypersensitivity or contraindications to prostaglandins.

3-Had no history of coagulopathy. 4-Accepting to participate in the study.

Exclusion Criteria:

\\1-women with anemia (Haemoglobin \<8 gram ). 2 placental abnormality (e.g placenta previa,placenta abruption ) 3. History of complications at previous pregnancy especially postpartum hemorrhage. 4- Maternal hypertension , current or previous history of heart disease ,liver ,Renal disorders or known coagulopathy

Primary outcomes:
measure: amount of intraoperative blood loss
timeFrame: 30 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut Faculty of Medicine
Study officials:
References:
Clinical trial NCT06590974: A Study of Freeze-dried Human Protein C Concentrate (TAK-662) in Participants with Congenital Protein C Deficiency
Official title: Special Drug Use Surveillance Study of Ceprotin for Intravenous Injection 1000IU (All-Case Surveillance)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Protein C Deficiency
Keywords: Ceprotin/Protein C Deficiency
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2024-09-19
Enrollment: 7
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The population of this study are all participants who meet the inclusion/exclusion criteria.

Brief summary: This study is conducted in Japan of Freeze-dried Human Protein C Concentrate (TAK-662) used to treat participants with congenital protein C deficiency.

The main aim of the study is to evaluate for adverse events and effectiveness of congenital protein C deficiency (TAK-662).

During the study, participants with congenital protein C deficiency will be administered with TAK-662 intravenous injection in under routine normal practice. The investigators will evaluate adverse events due to TAK-662 for 12 months. For participants who will be administered in long-term supplementation of TAK-662 after acute treatment or short-term supplementation, the investigator will evaluate for 24 months as a maximum. The study sponsor will not be involved in how the participants are administered but will be recorded what happens during the study.


Eligibility criteria: Inclusion Criteria:

- All participants with congenital protein C deficiency who are administered with Freeze-dried Human Protein C Concentrate (TAK-662).

Exclusion Criteria:

- None

Primary outcomes:
measure: Number of Participants who Experience at Least One Treatment-Emergent Adverse Events (TEAE)
timeFrame: Up to 12 months (For participants who will be administered in long-term supplementation of TAK-662 after acute treatment or short-term supplementation, up to 24 months as a maximum)
Secondary outcomes:
measure: Number of Participants who Experience at Least One TEAE of Venous Thromboembolism
timeFrame: Up to 12 months (For participants who will be administered in long-term supplementation of TAK-662 after acute treatment or short-term supplementation, up to 24 months as a maximum)
measure: Number of Participants who Experience at Least One TEAE of Purpura Fulminans
timeFrame: Up to 12 months (For participants who will be administered in long-term supplementation of TAK-662 after acute treatment or short-term supplementation, up to 24 months as a maximum)
Other outcomes:
Locations:
city: Tokyo
country: Japan
facility: Takeda selected site
Study officials:
affiliation: Takeda
name: Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT06012474: Effect Of Power Breath Device On Arterial Blood Gases And Diaphragmatic Excursion After Valve Surgery
Official title: Effect Of Power Breath Device On Arterial Blood Gases And Diaphragmatic Excursion After Valve Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Valve Diseases
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2023-08-25
Enrollment: 50
Sex: ALL
Minimum age (years): 25
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The aim of this study is to evaluate the effect of power breath device on arterial blood gases, diaphragmatic excursion and the 6 min walk test after cardiac valve surgery.

Detailed description: No more studies have been done on the effect of IMT by power breath on valvular surgery, So, this study will see the effect of power breath device on arterial blood gases, diaphragmatic excursion and six minute walk test after valve surgery to know enhanced recovery protocols in valvular surgery that accelerate the functional recovery, minimize the length of the hospital stay and decrease cost of treatment.

Eligibility criteria: Inclusion Criteria:

* Female patients with valve surgery (valve replacement or repair with median sternotomy procedure).
* Age between 25 to 35 years old.
* BMI is between 18.5 to 24.5 kg/m2.

Exclusion Criteria:

The participants will be excluded if they meet one of the following criteria:

* Uncontrolled hypertension (systolic blood pressure\>230 mm Hg and diastolic blood pressure\>120 mm Hg)
* Patients with coronary artery disease or heart failure.
* Need for mechanical ventilation for \>24 h or reintubation.
* Renal and hepatic disorders.
* Infected or unstable sternum.
* patient with pneumothorax after surgery.
* Metabolic disorders.
* Pregnant woman.
* Lactating mother.
* Smokers
* Stroke patient

Primary outcomes:
measure: Assessing the change in diaphragmatic excursion
timeFrame: within 24 hours after 1 week of intervention
measure: Assessing the change in Arterial Blood gases
timeFrame: within 24 hours after 1 week of intervention
measure: Assessing the change in capacity to perform daily activities
timeFrame: within 24 hours after 1 week of intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Dokki
country: Egypt
facility: Outpatient clinic faculty of physical therapy cairo university
Study officials:
affiliation: Cairo University
name: Hend Mahdy
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02337374: Predictive Role of Urodynamics on Mid-urethral Sling Failure
Official title: Do Urodynamics Superior to 25 Years of Clinical Expertise Predict Mid-Urethral Sling Failure?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Urinary Incontinence, Stress
Keywords: Urodynamics
Midurethral sling
Transobturator tape (TOT)
Tension free vaginal tape (TVT)
Lead sponsor: Kanuni Sultan Suleyman Training and Research Hospital
Sponsor class: OTHER
First posted: 2015-01-13
Enrollment: 242
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Women with stress urinary incontinence and who desired surgical correction of their incontinence

Brief summary: Purpose The aim of this study is to investigate the contribution of preoperative urodynamics to mid-urethral slings (MUS) success for developing an algorithm that uses conventional and easily accessible tools Methods Women with stress urinary incontinence and who desired surgical correction of their incontinence were included in the study. The selection of the procedure was according to an algorithm used in an institution developed by a chief of urogynecology department who had 25 years of urogynecology experience. Urodynamic and baseline factors that may be associated with surgery failure were analyzed in MUS failure.


Eligibility criteria: Inclusion Criteria:

* Documented pure or predominant SUI symptoms for at least 3 months, along with a positive standardized urinary stress test

Exclusion Criteria:

* prior incontinence surgery, post-void residual volumes of greater than 100 ml, a history of chronic inguinal or vulvar abscess, hidradenitis suppurativa, genitourinary fistula or urethral diverticulum, reversible cause of incontinence (i.e., drug effect), or any contraindication to surgery

Primary outcomes:
measure: Mid urethral sling surgery failure
timeFrame: after june 2010
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06953674: Saline Versus Balanced Crystalloid in Traumatic Brain Injury
Official title: Saline vs. Balanced Crystalloid in Traumatic Brain Injury
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Traumatic Brain Injury (TBI) Patients
Lead sponsor: University of Louisville
Sponsor class: OTHER
Collaborators: name: Kentucky Spinal Cord and Head Injury Research Board
First posted: 2025-05-01
Enrollment: 600
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 goal of this clinical trial is to determine which crystalloid (saline or balanced) should be used in the critical management of Traumatic Brain Injury (TBI) in moderate or severe TBI patients. This trial will determine whether the use of saline or balanced crystalloids is associated with improved outcomes in TBI patients.

Participants will

1. be given fluids through the veins, either saline or balanced fluid will be given.
2. From the first day to the day 14 of the hospitalization (or discharge, whichever comes first), vital signs, laboratory values, treatments given, and other medical data will be collected from the medical record.
3. Six months later, your final disability, if any, will be assessed during your follow-up with a doctor. It involves answering a short survey that will take about 5 minutes or less.


Eligibility criteria: Inclusion Criteria:

* Trauma patients presenting to the Emergency Room for initial care
* Glasgow Coma Scale ≤ 12
* Head CT with skull fracture(s) and/or hemorrhage(s) (\>1cm in any single dimension) with a reported mechanism of trauma

Exclusion Criteria:

* Severe visceral trauma dictating mortality (visceral injury severity score \> brain injury severity score)
* Non-survivable brain injury based on the treating physician's judgment
* Emergent visceral operative intervention before complete trauma assessment
* Concern for ruptured intracranial vascular malformation
* Patients who are transferred from another facility

Primary outcomes:
measure: Neurological Outcomes
timeFrame: 6 months post injury
Secondary outcomes:
measure: Inpatient mortality
timeFrame: randomization to hospital discharge typically 2 weeks.
Other outcomes:
measure: To compare delayed interventions to treat Intracranial pressure (ICP).
timeFrame: randomization to hospital discharge, typically 2 weeks.
Locations:
city: Louisville
country: United States
facility: University of Louisville Hospital
state: Kentucky
Study officials:
affiliation: Assistant Professor Term
name: Akshitkumar Mistry, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT07008274: Laparoscopic Sleeve Gastrectomy-Induced Decline in Plasma Asprosin and Its Association With Metabolic Recovery
Official title: Laparoscopic Sleeve Gastrectomy-Induced Decline in Plasma Asprosin and Its Association With Metabolic Recovery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obesity, Morbid
Keywords: bariatric surgery
asprosin
Lead sponsor: Northern Jiangsu People's Hospital
Sponsor class: OTHER
First posted: 2025-06-06
Enrollment: 85
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CROSSOVER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults with obesity (BMI ≥37.5 kg/m², or ≥32.5 kg/m² with metabolic comorbidities such as type 2 diabetes, hypertension, or dyslipidemia), aged 18-65 years, undergoing laparoscopic sleeve gastrectomy at a single tertiary hospital in China. Healthy normal-weight controls (BMI 18.5-23.9 kg/m²) without metabolic disorders were also recruited for baseline comparison.

Brief summary: the present study aimed to systematically assess the changes in plasma asprosin levels at 3, 6, and 12 months after LSG, to explore the relationships between asprosin dynamics and key metabolic parameters, including body mass index (BMI), fasting glucose, insulin resistance assessed by the homeostasis model (HOMA-IR), and lipid profiles, and to compare asprosin concentrations between bariatric patients and healthy normal-weight controls.


Eligibility criteria: Inclusion Criteria:

1. age between 18 and 65 years;
2. body mass index (BMI) ≥37.5 kg/m², or BMI ≥32.5 kg/m² with at least one obesity-related comorbidity;
3. availability of complete clinical data and stored plasma samples at preoperative baseline and at 3, 6, and 12 months postoperatively.

Exclusion Criteria:

1. history of prior bariatric or gastrointestinal surgery;
2. active malignancy, chronic inflammatory or infectious disease, or severe hepatic or renal dysfunction;
3. pregnancy during the study period;
4. incomplete clinical or biochemical data.

Primary outcomes:
measure: Plasma asprosin levels at 3, 6, and 12 months
timeFrame: 1 year
Secondary outcomes:
measure: BMI at 3, 6, and 12 months
timeFrame: 1 year
Other outcomes:
measure: Insulin resistance (HOMA-IR) at 3, 6, and 12 months
timeFrame: 1 year
Locations:
city: Yangzhou
country: China
facility: Shuai Zhao
state: None Selected
Study officials:
References:
Clinical trial NCT04222374: Uro-DNA Collection for Expanded Genome-Wide Association Study (GWAS) of Renal Cell Carcinoma (RCC)
Official title: Uro-DNA Collection for Expanded Genome-Wide Association Study (GWAS) of Renal Cell Carcinoma (RCC) (Uro-DNA - GWAS)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Kidney Cancer
Keywords: Renal Cell Carcinoma
Expanded Genome-Wide Association
Lead sponsor: University Hospital, Bordeaux
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2020-01-10
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient with kidney cancer included in the UroCCR project and coming for a regular consultation visit.

Brief summary: In the last decade, investigators from the Department of Cancer Epidemiology and Genetics (National Cancer Institute, USA) have conducted genome-wide association (GWAS) studies of renal cell carcinoma.

Dr. Mark PURDUE and Dr. Stephen CAHNOCK (Department of Epidemiology of Cancer and Genetics, NCI) propose to expand their genome-wide association study (Expanded GWAS) by genotyping approximately 10,000 additional cases of kidney cancer patients, in collaboration with US institutions, South-American and European.

This study describes the participation of the French Kidney Cancer Research Network (UroCCR) in the Expanded GWAS research, under the coordination of Professor BERNHARD (Bordeaux University Hospital).

Detailed description: The aim of the Expanded GWAS study is to better understand the role of common genetic variants in susceptibility to renal cell carcinoma (RCC).

The participation of the French UroCCR network consists in completing the bio-collection of the UroCCR cohort by preserving constitutional DNA and to provide DNA samples to the US NCI team.

This will increase the number of samples for meta-analysis and contribute to better identify clear cell kidney cancer susceptibility loci.

Eligibility criteria: Inclusion Criteria:

* Patients over 18,
* Confirmed cases of renal cell carcinoma (any RCC histology) of European or African origin,
* Patients included in the UroCCR study,
* Free, informed, written and signed consent by the participant and the investigator (at the latest on the day of inclusion and before any investigation required by the research) for specific blood collection for the purpose of DNA extraction,
* Programmed or ongoing management for kidney tumor,
* Constitutional DNA available (whole blood) for selected cases,
* Affiliated person or beneficiary of a social security scheme.

Exclusion Criteria:

* Patients below 18,
* Refusal of consent or participation.

Primary outcomes:
measure: Identification of new clear cell Renal Cell Carcinoma (ccRCC) risk loci
timeFrame: Inclusion Visit
Secondary outcomes:
Other outcomes:
Locations:
city: Talence
country: France
facility: Centre Hospitalier Universitaire de Bordeaux
Study officials:
References:
Clinical trial NCT02636374: Guided Imagery: Reducing Stress and Improving Well-being in Pregnant Adolescents
Official title: Guided Imagery: Reducing Stress and Improving Well-being in Pregnant Adolescents
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress, Psychological
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
First posted: 2015-12-21
Enrollment: 35
Sex: FEMALE
Minimum age (years): 13
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to examine the effects of a guided imagery intervention on perceived stress in pregnant adolescents.

Detailed description: Pregnant adolescents attending a local alternative education program will be subjects of this study. Students will participate in four, 15 minute guided imagery sessions over about a 4-6 week period. They will complete a pregnancy specific stress questionnaire before beginning and after completion of the guided imagery protocol. The students will also complete a short 9-question stress measure before and after each of the individual guided imagery sessions.

The specific aims are:

1. to evaluate whether a guided imagery intervention reduces perceived stress in pregnant adolescents; and
2. to evaluate whether a guided imagery intervention enhances well-being in pregnant adolescents.

The hypotheses are that the intervention will reduce perceived stress and enhance well-being in these subjects. The purpose of this study is to assess whether employing a guided imagery intervention with pregnant teens and education will reduce perceived stress levels and improve well-being.

Eligibility criteria: Inclusion Criteria:

* All pregnant students ages 13-21 enrolled in the alternative education program for parenting teens were eligible to participate

Exclusion Criteria:

* Participants were excluded from the study if they delivered their babies prior to completing four sessions of guided imagery intervention.

Primary outcomes:
measure: Change in Psychological Stress Measure-9 (PSM-9) score
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Wisconsin, Madison
name: Karla Ausderau, PhD, OTR/L
role: PRINCIPAL_INVESTIGATOR
References: