louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05342363: Mechanical Cardiopulmonary Resuscitation During Treatment of Acute Respiratory Failure Through Extracorporeal Membrane Oxygenation.
Official title: Mechanical Cardiopulmonary Resuscitation During Treatment of Acute Respiratory Failure Through Extracorporeal Membrane Oxygenation.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiovascular Resuscitation
Venovenous Extracorporeal Membrane Oxygenation
Lead sponsor: Goethe University
Sponsor class: OTHER
First posted: 2022-04-22
Enrollment: 117
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients treated with veno-venous extracorporeal membrane oxygenation (vv-ECMO) for respiratory failure in acute respiratory distress syndrome (ARDS). And in addition required mechanical cardiovascular resuscitation treatment during existing therapy with veno-venous extracorporeal membrane oxygenation (vv-ECMO).

Brief summary: In-hospital cardiovascular arrest is associated with poor outcome despite prompt treatment and optimal on-site resources. The population of patients treated by venovenous extracorporeal membrane oxygenation (vv-ECMO) due to pulmonary failure is a very challenging group of patients. To date, the frequency, causes and outcome of cardiovascular arrest in these patients have not been studied. We are aiming to conduct a retrospective observational study of all vv-ECMO patients treated at our ARDS centre.


Eligibility criteria: Inclusion Criteria:

Patients treated with veno-venous extracorporeal membrane oxygenation (vv-ECMO) due to respiratory failure during acute respiratory distress syndrome (ARDS).

Exclusion Criteria:

Patients treated with veno-arterial extracorporeal membrane oxygenation (va-ECMO)

Primary outcomes:
measure: Survival of mechanical cardiovascular resuscitation
timeFrame: During the intensive care stay ( usually between 2 and 8 weeks)
Secondary outcomes:
measure: Incidence of cardiovascular resuscitation i
timeFrame: During the observation period 2019-2022
measure: Complications of resuscitation treatments
timeFrame: During the intensive care stay ( usually between 2 and 8 weeks)
Other outcomes:
Locations:
city: Frankfurt
country: Germany
facility: University Hospital Frankfurt
state: Hessen
Study officials:
References:
Clinical trial NCT04662463: Evaluation of Parturients With Anxiety
Official title: Evaluation of Parturients With Anxiety
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Anxiety
Lead sponsor: Harvard Medical School (HMS and HSDM)
Sponsor class: OTHER
First posted: 2020-12-10
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The primary objective of this study is to examine the effects of cognitive bias modification for interpretation (CBM-I) on prenatal anxiety in parturients. Half of the participants will receive CBM-I assignments, while the other half will receive placebo assignments.

Detailed description: Maternal prenatal anxiety has been shown to have implications on neonatal behavior and early childhood behavioral and emotional wellbeing. Recent studies found that adults using computer-assisted feedback-learning paradigms, referred to as Cognitive Bias Modification for Interpretation (CBM-I), experienced significant reductions in levels of social anxiety, trait anxiety, and depression. Our goal is to identify patients with prenatal anxiety and evaluate the effects of CBM-I on symptoms of prenatal anxiety and patient satisfaction with the labor and delivery experience.

Eligibility criteria: Inclusion Criteria:

* Age 18-45
* Women before 36-week gestation
* At least high school level education

Exclusion Criteria:

* They refuse
* Have impaired decision-making capacity
* Are blind or extremely visually impaired (excluding use of glasses)
* Cannot understand or read English
* Diagnosed with psychiatric disorder other than anxiety

Primary outcomes:
measure: Effects of Internet-Based Cognitive Bias Modification (CBM-I) on prenatal anxiety
timeFrame: 4 weeks (starting from 36-week gestation)
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Harvard Medical School (HMS and HSDM)
name: Jie Zhou, MD, MS, MBA
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lester KJ, Field AP, Muris P. Experimental modification of interpretation bias about animal fear in young children: effects on cognition, avoidance behavior, anxiety vulnerability, and physiological responding. J Clin Child Adolesc Psychol. 2011;40(6):864-77. doi: 10.1080/15374416.2011.618449.
citation: Bowler JO, Mackintosh B, Dunn BD, Mathews A, Dalgleish T, Hoppitt L. A comparison of cognitive bias modification for interpretation and computerized cognitive behavior therapy: effects on anxiety, depression, attentional control, and interpretive bias. J Consult Clin Psychol. 2012 Dec;80(6):1021-33. doi: 10.1037/a0029932. Epub 2012 Sep 10.
citation: O'Connor TG, Ben-Shlomo Y, Heron J, Golding J, Adams D, Glover V. Prenatal anxiety predicts individual differences in cortisol in pre-adolescent children. Biol Psychiatry. 2005 Aug 1;58(3):211-7. doi: 10.1016/j.biopsych.2005.03.032.
Clinical trial NCT00004663: Epidemiologic Study of Reproductive Outcome in Women With Systemic Lupus Erythematosus
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Systemic Lupus Erythematosus
Keywords: arthritis & connective tissue diseases
immunologic disorders and infectious disorders
rare disease
systemic lupus erythematosus
Lead sponsor: Office of Rare Diseases (ORD)
Sponsor class: NIH
Collaborators: name: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
name: Northwestern University
First posted: 2000-02-25
Enrollment: 480
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Time perspective: OTHER

Brief summary: OBJECTIVES: I. Evaluate whether pregnancy is an independent risk factor that affects disease activity in women with systemic lupus erythematosus.

II. Evaluate whether maternal disease activity is a risk factor for adverse pregnancy outcome.

Detailed description: PROTOCOL OUTLINE: This is a case-controlled study. Intensive data collection begins when a patient becomes pregnant.

Pregnant women are evaluated with interval pregnancy/exposure history and a clinical exam, including the Systemic Lupus Activity Measure (SLAM). Assessments are scheduled every 3 months as follows: visit 1 when the pregnancy is confirmed, visit 2 during the second trimester, visit 3 during the third trimester, visit 4 at 3 months postpartum, and visit 5 at 6 months postpartum. Visits 4 and 5 include an infant exam for growth and morphologic parameters; these visits occur on the same schedule if there is a miscarriage or stillbirth.

Patients not currently pregnant are randomly chosen to be followed as controls. These patients undergo a review of current pregnancy status and measures of disease activity, including SLAM, every 3 months for 5 visits.

Eligibility criteria: * Definite or probable systemic lupus erythematosus meeting American College of Rheumatology criteria

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Northwestern University
name: Rosalind Ramsey-Goldman
role: STUDY_CHAIR
References:
Clinical trial NCT03804463: The Multicentic Trial in Fertility-sparing Treatment and Ovarian Preservation Management for Early Endometrial Cancer
Official title: The Randomized Multicentic Prospective Controlled Trial in Fertility-sparing Treatment and Ovarian Preservation Management for Early Endometrial Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Endometrial Cancer
Keywords: Preservation of fertility surger
ovarian preservation
endometrial cancer
Lead sponsor: Shengjing Hospital
Sponsor class: OTHER
Collaborators: name: First Hospital of China Medical University
First posted: 2019-01-15
Enrollment: 170
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: Through multicenter, prospective, randomized, controlled clinical studies comparing different treatment options (fertility-sparing surgery and ovarian preservation surgery and radical surgery)therapeutic efficacy, safety and quality of life of patients, exploration of the best strategies and risks for the treatment of early endometrial cancer, and promotion and application.

Detailed description: Patients eligible for enrollment are selected and divided into three groups randomly, including fertility group,ovarian preservation group and endometrial cancer radical surgery group. Take interventions including fertility preservation surgery,ovarian preservation surgery and endometrial cancer radical surgery for patients in different groups respectively. Compare therapeutic efficacy, safety and quality of life of patients to evaluate three treatment and explore the best treatment for clinical application.

Eligibility criteria: Inclusion Criteria:

1. Premenopausal women, age ≤ 50 years
2. Surgical curettage / hysteroscopic pathology confirmed, endometrioid adenocarcinoma G1/G2 (including well-differentiated, high-medium and middle-differentiation);
3. Clinical consideration of IA (\<1/2 muscle infiltration);
4. First-time treatment
5. The subject (or his legal representative) must understand the nature of the study and sign an informed consent form.

Exclusion Criteria:

1. At the same time participate in other clinical trials;
2. Can not tolerate surgery;
3. Ovarian suspicious metastasis;
4. Have a family history of ovarian cancer;
5. Incorporate other malignant tumors;
6. Preoperative CA125 abnormal persons

Primary outcomes:
measure: Total survival Time
timeFrame: 6 months
Secondary outcomes:
measure: the change of Ovarian volume
timeFrame: 6 months, 1 year, 2 years, 3 years, 4 years, 5 years
measure: the change of endocrine function evaluation
timeFrame: 6 months, 1 year, 2 years, 3 years, 4 years, 5 years
measure: Progression Free Survival
timeFrame: 6 months
Other outcomes:
Locations:
city: Shenyang
country: China
facility: Shengjing Hospitaol of China Medical University
state: Liaoning
Study officials:
affiliation: Shengjing Hospital
name: Min Wang, PHD.
role: STUDY_DIRECTOR
References:
Clinical trial NCT02319863: Rapid Ligating the Corresponding Inflow and Outflow Vessels Without Hilus Dissection During Hepatectomy
Official title: A Simple Technique of Rapid Ligating the Corresponding Inflow and Outflow Vessels Without Hilus Dissection During Hepatectomy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cancer Progression
Keywords: hepatocellular carcinoma
prognosis
Lead sponsor: Huazhong University of Science and Technology
Sponsor class: OTHER
First posted: 2014-12-18
Enrollment: 600
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: This study examines the role of this simple technique on postoperative metastasis and long term survival.

Detailed description: The only hope of long-term survival for patients with primary hepatocellular carcinoma (HCC) is surgical resection or liver transplantation, the former of which is more feasible at present. However, postoperative recurrence or metastasis is an ominous feature for this disease. Innovation of the surgical procedure for improving prognosis is under emergency request. This study examines the role of this simple technique on postoperative metastasis and long term survival.

During the past 20 years, more 600 patients with primary HCC were performed hepatectomy with the new hemorrhage control technique, and prospective randomized controlled trial (RCT) was applied. We further applied a mice model ligating the pedicle of the lesion-located hepatic lobe before hepatectomy to imitate the clinic practice, and evaluated the role of the new technique on postoperative metastasis and survival.

Eligibility criteria: Inclusion Criteria:

* HCC patients who will perform left- or right- hemihepatectomy.

Exclusion Criteria:

1. contraindication for hepatectomy, including gastrointestinal hemorrhage, severe hemorrhagic disorders, explicit acute nonspecific infectious lesion, overt ascites, Child-Pugh Score C,indocyanine green retention rate at 15min (ICGR15)\>30%,serum hepatitis B virus (HBV)-DNA\>106 copies/ml and serum alanine aminotransferase (ALT)\>2×ULN, serum triglycerides\>2.0 mmol/L, circulatory shock, stroke, acute myocardial infarction, renal failure, coma of unknown cause;
2. pregnancy;
3. age of\<18y or\>65y

Primary outcomes:
measure: recurrence
timeFrame: 12 months
measure: metastasis
timeFrame: 12 months
measure: mortality
timeFrame: 1 month
Secondary outcomes:
measure: Prognosis
timeFrame: 5 years
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Tongji Hospital
state: Hubei
Study officials:
affiliation: Tongji Hospital
name: Xiaoping Chen, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chen XP, Qiu FZ. A simple technique ligating the corresponding inflow and outflow vessels during anatomical left hepatectomy. Langenbecks Arch Surg. 2008 Mar;393(2):227-30; discussion 231-4. doi: 10.1007/s00423-007-0224-z. Epub 2007 Nov 3.
Clinical trial NCT01581463: A Study of Sustained-Release Liothyronine Sodium (T3) in Healthy Subjects
Official title: Phase 1 Single-Dose Study of the Pharmacokinetics of Sustained-Release Liothyronine Sodium (T3) in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: pharmacokinetics of oral T3
Lead sponsor: Ipe, LLC
Sponsor class: INDUSTRY
First posted: 2012-04-20
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Liothyronine is indicated for the treatment of primary hypothyroidism. Between 6 and 10 Million in the United States and 80 Million patients world-wide are hypothyroid, usually the result of autoimmune thyroiditis called Hashimoto's Disease. Hypothyroid symptoms result from low levels of thyroid hormones (T4 and T3) in the blood due to inadequate thyroid hormone production by the thyroid gland. Every tissue in the body is a thyroid hormone target and hypothyroid symptoms can be debilitating.

BCT303 utilizes Liothyronine, Sodium as the active ingredient, the same Liothyronine salt utilized as the active ingredient in currently marketed products.

The current "gold standard" for treatment of hypothyroidism are products containing Levothyroxine (T4). T4 is known to be a pro-hormone, converted to the more active hormone T3 by deiodinases in various tissues. Patients on Levothyroxine therapy alone are occasionally not euthyroid as measured by clinical presentation, a condition hypothesized to result from low levels of T3 from inadequate T4 to T3 conversion. In addition, the efficiency of conversion of T4 to T3 is variable and dependent on the patho-physiologic state of the patient.

BCT303 contains Liothyronine, Sodium as the active ingredient. This product has a patented formulation and granulation procedure that solves multiple clinical and stability problems associated with T3-based products. Thus, BCT303 is designed to have:

1. Increased shelf stability to ensure the maintenance of claimed dosage.
2. A sustained-release profile to minimize side effects associated with spikes in serum T3 levels.
3. Uniformity of dose between production batches and between tablets.


Eligibility criteria: Inclusion Criteria:

* Healthy adults
* Must be able to swallow tablets

Exclusion Criteria:

* Hypothyroid Disease
* Pregnant Females

Primary outcomes:
measure: Serum Total T3
timeFrame: Four Days.
Secondary outcomes:
Other outcomes:
Locations:
city: Washington
country: United States
facility: Georgetown University Hospital
state: District of Columbia
Study officials:
References:
Clinical trial NCT04223063: Exercise-based Pre-habilitation in Bladder Cancer Patients Prior to Radical Cystectomy: a Feasibility Study
Official title: Exercise-based Pre-habilitation in Bladder Cancer Patients Prior to Radical Cystectomy: a Feasibility Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Bladder Cancer
Urothelial Carcinoma
Keywords: Bladder Cancer
Urothelial Carcinoma
Chemotherapy
Neoadjuvant
Exercise prehabilitation
Lead sponsor: Nova Scotia Health Authority
Sponsor class: OTHER
Collaborators: name: Nova Scotia Health Authority
First posted: 2020-01-10
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to explore the feasibility and efficacy of a 12-week, home-based exercise program in bladder cancer patients undergoing curative intent neoadjuvant chemotherapy and RC.

Detailed description: The investigators will seek to recruit 20 patients diagnosed with muscle invasive localized urothelial carcinoma of the bladder who are scheduled to receive neo-adjuvant chemotherapy prior to RC from the Queen Elizabeth Health Sciences center in Halifax, Nova Scotia. Participants will be randomly allocated to standard of care treatment versus standard of care plus a multimodal, home-based program including strength and endurance exercises. Outcomes measured will include feasibility data, patient outcomes, and post-surgical complications.

Eligibility criteria: Inclusion Criteria:

1. confirmed diagnosis of localized muscle invasive urothelial carcinoma of the bladder (clinical stages cT2-4a, N0-1, M0);
2. treatment plan includes the administration of cisplatin-based systemic neoadjuvant chemotherapy prior to anticipated RC (typically four, 3-week cycles of cisplatin-based chemotherapy);
3. English fluency;
4. physician approval; and
5. participant willingness to participate in a 12-week, home-based exercise intervention.

Exclusion Criteria:

1. unstable or symptomatic cardiac or pulmonary disease, musculoskeletal injury or co-morbid disease that precludes ability to exercise; and
2. significant cognitive limitations.

Primary outcomes:
measure: Health-related quality of life in patients with bladder cancer
timeFrame: 12 weeks
measure: Fatigue
timeFrame: 12 weeks
measure: Sleep quality
timeFrame: 12 weeks
Secondary outcomes:
measure: Post-surgical complications
timeFrame: 30 days post-surgery
measure: Post-operative length of stay
timeFrame: 30 days post-surgery
Other outcomes:
measure: Chemotherapy completion rates
timeFrame: 16 weeks
measure: Post-surgical readmission rates
timeFrame: 90 days post-surgery
Locations:
Study officials:
References:
Clinical trial NCT04343586: Blue Light Phototherapy
Official title: Development & Preliminary Clinical Validation Blue Light Phototherapy Systems for T-Cell
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Grover's Disease
Psoriasis Vulgaris
Lead sponsor: Northwestern University
Sponsor class: OTHER
Collaborators: name: T-Cellerate LLC
First posted: 2020-04-13
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study will use Blue-light Photo-therapy to treat patients with psoriasis vulgaris and Grover's Disease.


Eligibility criteria: Inclusion Criteria:

1. Patient's aged 18-89 at time of enrollment
2. Previous diagnosis of psoriasis vulgaris or Grover's disease

Exclusion Criteria:

1. All Groups: Subjects who are younger than 18 years of age or older than 90 years of age
2. Patients who have received topical or systemic treatment within the prior 2 weeks of planned phototherapy
3. Patients prescribed any of the following drugs for issues not related to their psoriasis or Grover's disease

   * topical steroids
   * calcineurin inhibitors
   * methotrexate
   * retinoids
   * biologic agents
4. Unable to schedule phototherapy sessions
5. We will not recruit the following populations: adults unable to consent, individuals who are not yet adults (infants, children, teenagers), pregnant women, prisoners and other vulnerable populations.

Primary outcomes:
measure: Efficacy of Blue Light Therapy for Patients With Grover's Disease
timeFrame: Time Frame: 5 weeks
measure: Assess User Experience With the Dermatology Life Quality Index (DLQI) Pre and Post-treatment.
timeFrame: Time Frame: 5 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern University Department of Dermatology
state: Illinois
Study officials:
affiliation: Northwestern University
name: Shuai Xu
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02717286: Restorative Treatment in First Molars Affected by Molar-Incisor Hypomineralization
Official title: Survival of Restorative Treatment in First Molars Affected by Molar-Incisor Hypomineralization
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Molar Incisor Hypomineralization
Lead sponsor: Universidade Federal do Paraná
Sponsor class: OTHER
First posted: 2016-03-23
Enrollment: 26
Sex: ALL
Minimum age (years): 6
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The restorative management of molars with Molar-Incisor Hypomineralization (MIH) represents a challenge in the clinical practice with high failure rate. Thus, this clinical trial aimed to evaluate the clinical survival of direct composite resin restorations in first permanent molars (FPMs) that are affected by MIH, comparing two adhesive systems.

Detailed description: For the research, it was selected first permanent molars (FPMs) with MIH from children aged 6-8 years. FPM fully erupted and with restorative treatment needed was the inclusion criteria. We excluded FPMs with destroyed crowns. The FPMs were randomly assigned to two groups: G1 (self-etching adhesive) and G2 (total-etching adhesive). Clinical evaluation was performed during 18 months according to the USPHS-Modified by a blinded examiner. The actuarial method was used to evaluate survival of the restorations and Fisher's exact test was used to compare differences between the groups (α=5%).

Eligibility criteria: Inclusion Criteria:

* children and/or parents who agree in participate of the study
* children were born and living in Araraquara, SP, Brazil
* presence of the first permanent molars totally erupted with defects classified as enamel post eruptive breakdown (PEB) or unsatisfactory atypical restoration (UATR), with or without carious lesions.

Exclusion Criteria:

* children and/or parents who do not agree in participate of the study
* first permanent molars with enamel malformation associated with syndromes,
* dental fluorosis,
* first permanent molars with destroyed crowns,
* imperfect amelogenesis
* fixed orthodontic appliances.

Primary outcomes:
measure: Survival rates of the direct restorative treatment
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Araraquara
country: Brazil
facility: UNESP - Univ. Estadual Paulista
state: SP
Study officials:
affiliation: UNESP- Univ Estadual Paulista
name: Rita de Cássia Loiola Cordeiro, PhD
role: STUDY_CHAIR
References: