louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02723058: The Integrated Care Model for Homeless Mothers
Official title: The Integrated Care Model for Homeless Mothers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Keywords: Depression
Homelessness
Primary care
Lead sponsor: University of Massachusetts, Worcester
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2016-03-30
Enrollment: 67
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to pilot test an adapted collaborative care model for homeless mothers with depression.

Detailed description: Homeless mothers are more vulnerable to Major Depressive Disorder (MDD) than comparable groups of impoverished mothers, with rates in recent community studies approaching 50%. Even though primary care offers an ideal venue to identify and manage depression among women who commonly fail to receive needed mental health services, rigorously tested primary care-based treatment strategies that address the needs of homeless mothers with depression are lacking. This study reports results on a pilot test and feasibility findings of a new intervention, the Integrated Care Model for Homeless Mothers (ICMHM), adapted from the collaborative care model for depression (CCM) to address unique aspects of care for homeless mothers who screened positive for depression during a shelter-based primary care visit.

Eligibility criteria: Inclusion Criteria:

* Mothers who are residing in emergency shelter
* 18 years of age or older
* Screen positive for depression
* Speak English or Spanish

Exclusion Criteria:

* Not pregnant
* Not currently receiving depression treatment
* Not currently psychotic

Primary outcomes:
measure: Change in The Hopkins Depression Symptom Checklist -Depression Scale 20 (Williams et al, 2004)
timeFrame: The primary end point is 6 months
Secondary outcomes:
measure: Number of visits to the care manager and primary care physician
timeFrame: The primary end point is 6 months
measure: New antidepressant medication prescriptions
timeFrame: The primary end point is 6 months
measure: Patient Reactions Assessment (Galassi et al, 1992)
timeFrame: The primary end point is 6 months
measure: Helping Alliance Questionnaire (Luborsky et al, 1985)
timeFrame: The primary end point is 6 months
Other outcomes:
Locations:
Study officials:
References:
citation: Weinreb L, Upshur CC, Fletcher-Blake D, Reed G, Frisard C. Managing Depression Among Homeless Mothers: Pilot Testing an Adapted Collaborative Care Intervention. Prim Care Companion CNS Disord. 2016 Apr 21;18(2):10.4088/PCC.15m01907. doi: 10.4088/PCC.15m01907. eCollection 2016.
Clinical trial NCT02037958: Laryngeal Mask Airway Supreme Versus the Tracheal Tube as an Airway Device in Elective Laparoscopic Cholecystectomy
Official title: The Laryngeal Mask Airway Supreme (TM) is an Effective Alternative to Laryngoscope-guided Tracheal Intubation for Patients Undergoing Elective Laparoscopic Cholecystectomy-- A Prospective Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cholecystitis
Choledocholithiasis
Lead sponsor: Changi General Hospital
Sponsor class: OTHER
First posted: 2014-01-16
Enrollment: 76
Sex: ALL
Minimum age (years): 21
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: We hypothesise that the use of the LMA-Supreme provides greater ease of insertion and reduced haemodynamic variability during insertion compared to the tracheal tube, whilst still maintaining a patent airway to facilitate elective laparoscopic cholecystectomy in selected patients.

Detailed description: The Laryngeal Mask Airway Supreme(LMA-S) has been used successfully to maintain a patent airway for laparoscopic surgery. Our study compares the use of LMA-S with that of the tracheal tube (ETT) with respect to the ease of insertion and potential haemodynamic disturbance during insertion.

Eligibility criteria: Inclusion Criteria:

* American Society of Anesthesiologists (ASA) Physical Status 1 and 2
* Undergoing elective laparoscopic cholecystectomy

Exclusion Criteria:

* BMI \> 30
* Known gastro-oesophageal reflux disease
* predicted or documented difficult airway
* contraindications to drugs in the standardized anaesthesia protocol

Primary outcomes:
measure: Time to Effective Airway
timeFrame: Baseline
Secondary outcomes:
measure: Number of attempts taken for successful placement of airway device
timeFrame: Baseline
measure: Number of attempts taken for successful placement of gastric tube
timeFrame: Baseline
measure: Haemodynamic response to insertion of airway device
timeFrame: Baseline, 1 min, 5 min
measure: Peak airway pressure during pneumoperitoneum
timeFrame: Assessed intra-operatively, during the period of pneumoperitoneum
measure: Incidence of post-operative sore throat
timeFrame: Assessed 1 hr after the surgery, at the Recovery Area
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Changi General Hospital
Study officials:
affiliation: Changi General Hospital
name: Kelvin Quek, MMED (Anaes)
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00410358: A Dose Escalation of Gimatecan Administered Orally to Japanese Patients With Advanced Solid Tumor.
Official title: A Phase I Dose Escalation Study of LBQ707 (Gimatecan) Administered Orally 5 Consecutive Days to Japanese Patients With Advanced Solid Tumor.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Advanced Solid Tumors
Keywords: Gimatecan
topoisomerase I inhibitor
advanced solid tumors
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2006-12-12
Enrollment: 19
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study assesses the tolerability, safety, efficacy and pharmacokinetics of gimatecan in Japanese patients. Gimatecan is administered orally for five consecutive days, every 28 days, to adult patients with advanced solid tumors who have progressed despite standard therapy or for whom standard systemic therapy does not exist.


Eligibility criteria: Inclusion Criteria:

* Patients with histological or cytological confirmed advanced solid tumors, which have progressed despite standard therapy or for whom no standard therapy exists.
* Life expectancy of at least 3 months
* Adequate hematological parameters
* No major impairment of renal and hepatic function

Exclusion Criteria:

* Gastrointestinal dysfunction, such as gastrectomy and malabsorption syndrome that could alter absorption.
* Patients who have received any investigational compound within the past 28 days.
* Patients with other antineoplastic therapy within the last 28 days.
* Patients known to be HIV or hepatitis virus positive, or patients with the presence of active or suspected acute or chronic uncontrolled infection
* Patients with a history of allergies to the camptothecin family drug.

Other protocol-defined inclusion/exclusion criteria may apply

Primary outcomes:
measure: Estimated Maximum Tolerated Dose of gimatecan
timeFrame: 1.8 years
Secondary outcomes:
measure: Safety assessed by adverse events
timeFrame: 1.8 years
measure: Characterization of the pharmacokinetic profile of gimatecan
timeFrame: 1.8 years
measure: Anti-tumor activity assessed by RECIST
timeFrame: 1.8 years
Other outcomes:
Locations:
city: Chiba Prefecture
country: Japan
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
Clinical trial NCT02845258: Treatment of Pancreatic Pseudocysts by Endoscopic Ultrasound-guided Drainage
Official title: Treatment of Pancreatic Pseudocysts by Endoscopic Ultrasound-guided Drainage
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pancreatic Pseudocyst
Drainage
Lead sponsor: Sahlgrenska University Hospital
Sponsor class: OTHER
First posted: 2016-07-27
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients \>18 years referred to the Sahlgrenska University hospital for the performance of an EUS-guided pancreatic pseudocyst drainage

Brief summary: Patients may evolve pseudocysts of the pancreas secondary to a severe pancreatitis. In case of a symptomatic or infected pseudocyst, a therapeutic drainage of the cyst is indicated. In modern medicine the preferred way to perform such a drainage is by the means of endoscopic ultrasound (EUS). It is not precisely elucidated how this EUS-procedure should be performed in different scenarios. The cyst appearance and the drainage stents and/or technique may impact the clinical outcome.

This study is a prospective, single-center observational study on the outcome after EUS-guided drainage of pancreatic pseudocysts.

Detailed description: Patintes referred to Sahlgrenska University hospital for an EUS-guided drainage of a pseudocyst are eligible for inclusion. The drainage is performed at the discretion of an experienced endosonographer. Thus, the equipment and the technique used may vary among patients but no randomization is done before the procedure. Intraprocedural variables are registered as well as data and outcome parameters from the clinical follow up according to below.

Eligibility criteria: Inclusion Criteria:

* All patients \>18 years referred to the Sahlgrenska University hospital for the performance of an EUS-guided pancreatic pseudocyst drainage

Exclusion Criteria:

* Patients unwilling to participate or unable to understand or sign the informed consent
* Patients with no need for pseudocyst drainage as assessed by the endosonographer

Primary outcomes:
measure: Short time complication rate
timeFrame: Uo to 48 hours
measure: Repeated drainage frequency
timeFrame: Up to 3 months
Secondary outcomes:
measure: Hospital stay
timeFrame: Up to 30 days
measure: Long time complication rate
timeFrame: Up to 6 months
Other outcomes:
Locations:
city: Gothenburg
country: Sweden
facility: Endoscopy Department GEA, Sahlgrenska university Hospital
Study officials:
affiliation: Sahlgrenska University Hospital, Gothenburg
name: Riadh Sadik, Ass Prof
role: STUDY_DIRECTOR
References:
Clinical trial NCT04613063: Proximal Intestinal Obstruction Syndrome (PIOS) in a Patient With Cystic Fibrosis: A New Syndrome
Official title: Proximal Intestinal Obstruction Syndrome (PIOS) in a Patient With Cystic Fibrosis: A New Syndrome
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cystic Fibrosis
Bowel Obstruction
Distal Intestinal Obstruction Syndrome
Lead sponsor: Tecnologico de Monterrey
Sponsor class: OTHER
First posted: 2020-11-03
Enrollment: 1
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 45 years old patient with cystic fibrosis

Brief summary: A case of a patient with cystic fibrosis with bowel obstruction due to a proximal intestinal obstruction syndrome (PIOS) is presented.This syndrome can be diagnosed with the DIOS definition, with the only distinction of a more proximal location in the gastrointestinal tract, such as the stomach, the duodenum, or the jejunum.

Detailed description: Distal Intestinal Obstruction Syndrome is a rare complication in cystic fibrosis patients characterized by the accumulation of viscid fecal material, combined with sticky mucous secretions located in the distal ileum, adhered to the intestinal wall. Only few cases have been reported in the literature.

Eligibility criteria: Inclusion Criteria:

* Adult \>18 years
* Cystic fibrosis
* Bowel obstruction

Exclusion Criteria:

* Pediatric patient \<18 years
* Unknown cause of bowel obstruction

Primary outcomes:
measure: Bowel obstruction in a patient with cystic fibrosis
timeFrame: 3-6 days
Secondary outcomes:
Other outcomes:
Locations:
city: Monterrey
country: Mexico
facility: Escuela Nacional de Medicina, Tecnologico de Monterrey
state: Nuevo Leon
Study officials:
References:
Clinical trial NCT00826163: Innate Immune Responses in Chronic Obstructive Pulmonary Disease (COPD) Patients
Official title: Innate Immune Responses in Chronic Obstructive Pulmonary Disease Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chronic Obstructive Pulmonary Disease
Lead sponsor: Mahidol University
Sponsor class: OTHER
Collaborators: name: National Science and Technology Development Agency, Thailand
First posted: 2009-01-21
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: We hypothesize that ongoing and more severe airway inflammation in COPD may result from the impairment in activation of innate immune response


Eligibility criteria: Inclusion Criteria:

* clinical diagnosis of COPD or asthma
* a ratio of prebronchodilator FEV1 to forced vital capacity (FVC) equal to or less than 0.70
* postbronchodilator FEV1 \> or = 50% predicted

Exclusion Criteria:

* Exacerbation
* systemic corticosteroids
* DM, HIV and autoimmune disease
* immunosuppressive therapy

Primary outcomes:
measure: Sputum IL-8, IL-17
timeFrame: 2 WEEKS
Secondary outcomes:
measure: The expression of NF-kappa B in sputum macrophages
timeFrame: 2 WEEKS
Other outcomes:
Locations:
city: Bangkoknoi
country: Thailand
facility: Kittipong Maneechotesuwan
state: BKK
Study officials:
affiliation: Mahidol University
name: Kittipong Maneechotesuwan, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06436963: Exploring the Application of Narrative Medicine Combined With Case-Based Learning in the Standardized Training of General Practice Residents
Official title: Narrative Medicine Combined With Case-Based Learning
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Narrative Medicine
Case-based Learning
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
First posted: 2024-05-31
Enrollment: 45
Sex: ALL
Minimum age (years): 24
Maximum age (years): 28
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: This was a prospective, longitudinal, single-center nonrandomized controlled study. A total of 36 first- and second-year general practice residents of Zhejiang University School of Medicine were voluntarily enrolled in the experimental group. The remaining 9 residents served as a control group. The experimental group received narrative medicine training combined with CBL training. The control group received normal CBL training. None of the participants had previously had any training in narrative medicine. Teaching evaluation scores were measured for all subjects at baseline and 1 year after the training.


Eligibility criteria: Inclusion Criteria:

* first- and second-year general practice residents of Zhejiang University School of Medicine

Exclusion Criteria:

* third-year general practice residents of Zhejiang University School of Medicine

Primary outcomes:
measure: Satisfaction Survey of Residents in the Experimental Group
timeFrame: 12 months
measure: Comparison of the SEGUE scale scores Between the Experimental Group and the Control Group
timeFrame: 12 months
measure: Comparison of the JSE-S scale scores Between the Experimental Group and the Control Group
timeFrame: 12 months
measure: Comparison of the SEGUE scale in Different Grades Before and After Training in the Experimental Group
timeFrame: 12 months
measure: Comparison of the JSE-S scale in Different Grades Before and After Training in the Experimental Group
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Second Affiliated Hospital, School of Medicine, Zhejiang University
state: Zhejiang
Study officials:
References:
Clinical trial NCT06374563: Tackling Pressure Ulcer Via Bee Venom Phonophoresis
Official title: Tackling Chronic Pressure Ulcer Via Bee Venom Phonophoresis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bee Venom
Pressure Ulcers
Phonophoresis
Keywords: phonophoresis
bee venom
Lead sponsor: Badr University
Sponsor class: OTHER
First posted: 2024-04-18
Enrollment: 30
Sex: ALL
Minimum age (years): 40
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aimed to investigate the efficiency of topical Bee Venom gel versus phonophoresis of Bee Venom gel to accelerate healing of chronic pressure ulcer

Detailed description: In this study, the Bee Venom gel was prepared in a gel formula. Patients with chronic pressure ulcers were enrolled randomly into two different groups. Group 1 received a topical application of Bee Venom gel, 3 times per weeks. While group 2 received phonophoresis of Bee Venom gel using low frequency ultrasound, 3 times per week. The treatment lasted for 8 consecutive weeks. The Image J Software is used to measure the wound surface area before and after treatment.

Eligibility criteria: Inclusion Criteria:

- Patients with stage II and III chronic neuropathic ulcers.

Exclusion Criteria:

* Patients with chronic cardiac,
* Patients with renal, and
* Patients with hepatic diseases and
* Diabetic patients. Additionally,
* Patients with immunosuppressive diseases,
* Patients with HIV, and
* Anemia Patients

Primary outcomes:
measure: wound surface area wound surface area
timeFrame: Before starting treatment and after 8 weeks of treatment
measure: wound volume
timeFrame: Before starting treatment and after 8 weeks of treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Badr University in Cairo
Study officials:
affiliation: Badr University in Cairo
name: Ashraf Hassan, professor
role: STUDY_DIRECTOR
References:
Clinical trial NCT04518163: Bakri Balloon Plus Tranexamic Acid During Cesarean Delivery for Placenta Previa
Official title: Bakri Balloon Tamponade Plus Intravenous Tranexamic Acid During Cesarean Delivery for Placenta Previa: a Randomized Double-blind Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Placenta Previa
Lead sponsor: Aswan University Hospital
Sponsor class: OTHER
First posted: 2020-08-19
Enrollment: 140
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: Double blind randomized controlled trial
Primary purpose: PREVENTION

Brief summary: Objective to investigate the effect of adjunctive intravenous tranexamic acid (TA) on blood loss during cesarean section (CS) in patients with placenta previa undergone Bakri balloon tamponade

Detailed description: Placenta previa (PP) is an obstetric condition that is closely linked with massive obstetric hemorrhage with a varied incidence about once in every 200 live births. It is considered one of the causes of the increased need for blood transfusion and cesarean hysterectomy. PPH due to PP typically starts during cesarean section (CS) in the placental bed, at the lower uterine segment mostly after placental separation. Proceeding for cesarean hysterectomy can be the only effective line of management in spite of the associated high morbidity rate.

Tranexamic acid is a lysine analog which acts as an antifibrinolytic via competitive inhibition of the binding of plasmin and plasminogen to fibrin. The rationale for its use in the reduction of blood loss depending on the implication of the coagulation and fibrinolysis processes implicated in the control of PPH. However, concerns about possible thromboembolic events with parenteral administration of TA have stimulated increasing interest in its topical use.

Eligibility criteria: Inclusion Criteria:

* women undergoing elective cesarean delivery for complete placenta previa which not respond uterotonic and simple hemostatic maneuvers like placental bed hemostatic sutures

Exclusion Criteria:

* patients with the high possibility of morbid adherent placenta
* those presented with severe antepartum hemorrhage
* Patients with cardiac, hepatic, renal, or thromboembolic disease;
* hypersensitivity or contraindications of use of tranexamic acid
* patient refuses to consent

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 of extra surgical maneuvers
timeFrame: 30minutes
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: