louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05210673: Enhanced Recovery for Patients Undergoing Radical Cystectomy.
Official title: Enhanced Recovery for Patients Undergoing Radical Cystectomy. A Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post Procedural Discharge
Lead sponsor: Menoufia University
Sponsor class: OTHER
Collaborators: name: Ezzeldin Saleh Ibrahim
name: asmaa mohamed hamza
name: asmaa ibrahim mohamed
name: mohamed marzouk abdallah
First posted: 2022-01-27
Enrollment: 50
Sex: ALL
Minimum age (years): 40
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Investigators hypothesize that with the use of enhanced recovery of surgery (ERAS), the postoperative hospital stay after radical cystectomy is reduced, and also postoperative complications are decreased.

Detailed description: Radical cystectomy (RC) is believed to be associated with high morbidity and prolonged length of hospital stay even with advances in perioperative medical care. Enhanced Recovery After Surgery (ERAS) pathways are multidisciplinary, multimodal evidence-based approaches to perioperative protocol by which patients are treated. The most important aims of this multimodal approach are modifying as many of the factors contributing to the morbidity of RC as possible, the improvement of patients' preoperative status, and the perioperative maintenance of homeostasis by minimizing stress response and inflammation to improve patient outcomes and decrease the length of inpatient hospital stay. The investigators hypothesize that with the use of enhanced recovery of surgery (ERAS), the postoperative hospital stay after radical cystectomy is reduced, and also postoperative complications are decreased.

Eligibility criteria: Inclusion Criteria:

* Age: 40-85 years.
* Adequate cognitive state (able to understand and collaborate)
* American society of anesthesia (ASA) I, II and III.

Exclusion Criteria:

* ASA IV

Primary outcomes:
measure: length of hospital stay
timeFrame: 1-15 days
Secondary outcomes:
measure: Onset of bowel movement
timeFrame: 1-5 days
measure: Onset of early mobilization
timeFrame: 1-15 days
measure: Postoperative analegesic consumption
timeFrame: 1-15 days
Other outcomes:
Locations:
city: Shibeen Elkoom
country: Egypt
facility: Ashraf Magdy Eskandr
Study officials:
affiliation: menoufia faculty of medicine
name: ashraf M eskandr
role: STUDY_DIRECTOR
References:
Clinical trial NCT00195273: Study Evaluating Sirolimus in Kidney Transplant Recipients
Official title: A Randomized Open-Label Study Comparing the Efficacy and Safety of Sirolimus Combined With Daclizumab, Mycophenolate and Corticosteroids vs Cyclosporine, Mycophenolate and Corticosteroids in Renal Allograft Recipients Receiving Kidneys From Older Donors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Graft vs Host Disease
Kidney Transplantation
Keywords: Kidney
Transplant
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2005-09-19
Enrollment: 61
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 purpose of this study is to compare the kidney function in patients who have received a transplanted kidney and were treated with the combination of sirolimus, daclizumab, mycophenolate and corticosteroids versus transplanted patients treated with cyclosporine, mycophenolate and corticosteroids.


Eligibility criteria: Inclusion Criteria:

* Kidney transplantation
* Donor must be at least 60 years old.

Exclusion Criteria:

* Current systemic infection
* Unstable angina or treatment for serious arrhythmia.
* Cancer within the previous 5 years.

Primary outcomes:
measure: Mean Creatinine Clearance Rate
timeFrame: 12 months
Secondary outcomes:
measure: Number of Patients With Acute Rejection
timeFrame: 3 and 12 months
measure: Patient and Graft Survival
timeFrame: 12 months
measure: Mean Creatinine Clearance Rate - 3 Months
timeFrame: 3 months
Other outcomes:
Locations:
city: Oslo
country: Norway
city: Gothenburg
country: Sweden
city: Uppsala
country: Sweden
Study officials:
affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
name: Medical Monitor, MD
role: STUDY_DIRECTOR
affiliation: For Norway, Sweden, MedInfoNord@wyeth.com
name: Trial Manager
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02093273: Evaluation on Immunogenicity and Safety Profile of Trivalent OPV (tOPV Bio Farma)
Official title: Phase II, Randomized, Double Blind, Prospective Intervention Study to Evaluate the Immunogenicity and Safety Profile of tOPV (Bio Farma) With Different Batch Numbers in Indonesian Infants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Healthy
Keywords: tOPV
Antibody response
Safety
Lead sponsor: PT Bio Farma
Sponsor class: INDUSTRY
First posted: 2014-03-20
Enrollment: 240
Sex: ALL
Minimum age (years): 1
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The objective of this study is to compare the antibody response 30 days after two doses of t OPV

Detailed description: The trial design is phase II, randomized, double blind, prospective intervention study. The subject study are 240 healthy, full term, newborn infants.

Eligibility criteria: Inclusion Criteria:

* Healthy, full term, newborns infants
* newborn residing within a relatively short and easily accessible distance A(\<30km) from the study clinic(s) and not planning to travel away during the entire study period
* Infant born after 37 weeks of pregnancy
* Infant weighing 2.5kg or more at birth (birth weight \>= 2.5kg)
* Healthy newborns, with no history of asphyxia or meconium aspiration
* Father, mother or legally acceptable representative properly informed about the study and having signed the informed consent form.
* Parents will commit themselves to comply with the indications of the investigator and with the schedule of the trial
* Mother at least elementary school graduate

Exclusion Criteria:

* Child concomitantly enrolled or scheduled to be enrolled in another trial
* Known history of congenital or acquired immunodeficiency (including HIV infection)
* Evolving moderate or severe illness, especially infectious diseases or fever (axillary temperature \>=37.5oC
* Newborns requiring hospitalization at birth
* Infant immunized with non-scheduled OPV or IPV during trial

Primary outcomes:
measure: To compare the antibody response 30 days after two doses of tOPV
timeFrame: 30 days
Secondary outcomes:
measure: To asses and compare the safety of tOPV
timeFrame: 30 days
Other outcomes:
measure: To describe the antibody response after two doses of tOPV
timeFrame: 30 days
Locations:
city: Bandung
country: Indonesia
facility: Garuda Primary Health Center
state: West Java
city: Bandung
country: Indonesia
facility: Ibrahim Adjie Primary Health Centre
state: West Java
city: Bandung
country: Indonesia
facility: Padasuka Primary Health Centre
state: West Java
city: Bandung
country: Indonesia
facility: Puter Primary Health Centre
state: West Java
Study officials:
affiliation: Department of Child Health of Medicine Padjadjaran University
name: Eddy Fadlyana, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06706973: Profiling and Targeting Epigenetic Marks to Improve Diagnosis and Therapeutic Approaches in Head and Neck Cancer
Official title: Profiling and Targeting Epigenetic Marks to Improve Diagnosis and Therapeutic Approaches in Head and Neck Cancer
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Head and Neck Cancer
Keywords: PROFILING AND TARGETING EPIGENETIC MARKS
HEAD AND NECK CANCER
Lead sponsor: European Institute of Oncology
Sponsor class: OTHER
Collaborators: name: AIRC (Italian Association for Cancer Research)
First posted: 2024-11-27
Enrollment: 60
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: patients that will undergo surgical tumor removal at the Otolaryngology - head and neck surgery unit of the IEO. Samples will be collected from at least 60 HNC primary tumors

Brief summary: Investigators have recently shown that epigenetic remodelling enzymes, such as HDAC inhibitors, are feasible drugs in HNC (8, 9). Preliminary data are indicating some deregulated epigenetics marks suggesting the corresponding histone modifiers as possible targets for the treatment of HNC, providing an attractive and feasible option to build upon. Our overarching hypothesis is that unique histone marks distinguish HPV+ and HPV- HNC and that specific histone modifiers are novel mediators of HNC tumorigenesis in an HPV specific manner

Detailed description: Head and neck cancer (HNC) is a highly heterogeneous disease, involving diverse anatomical sites including oral cavity, larynx and oropharynx. HNC risk factors include tobacco smoking and alcohol consumption and, especially for the subtype of oropharyngeal cancers (OPC), human papillomavirus (HPV) infection

Eligibility criteria: Inclusion Criteria:• Age: Adults aged ≥ 18 years diagnosed with HNC

* Sex: Both male and female
* Human papilloma virus (HPV) test: Both positive and negative.
* Tumor: primary tumors, treatment naïve, squamous cell carcinoma
* Cancer stage: I-IV
* Anatomic location: oral cavity, larynx, oropharynx
* Tumor fragments not required for diagnostics

Exclusion Criteria:

* Previous radiotherapy, chemotherapy or immunotherapy for HNC
* Unable to provide written informed consent

Primary outcomes:
measure: PROFILING AND TARGETING EPIGENETIC MARKS TO IMPROVE DIAGNOSIS AND THERAPEUTIC APPROACHES IN HEAD AND NECK CANCER
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Milan
country: Italy
facility: European Institute of oncology
state: MI
Study officials:
affiliation: Istituto Europeo di Oncologia
name: Susanna Chiocca
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00908973: Gut Hormone Response, Appetite and Intestinal Transit Time in Good and Poor Weight Responders After Gastric Bypass
Official title: Gut Hormone Response, Appetite and Intestinal Transit Time in Good and Poor Weight Responders 1-2 Years After Gastric Bypass
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obesity
Keywords: Obesity
Gastric bypass
Gut hormone
Intestinal transit time
Lead sponsor: Hvidovre University Hospital
Sponsor class: OTHER
Collaborators: name: University of Copenhagen
name: Novo Nordisk A/S
First posted: 2009-05-27
Enrollment: 46
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Case subjects are recruited from the outpatient clinic of endocrinology at Hvidovre University Hospital. Control subjects are recruited through announcement in local newspapers.

Brief summary: The aim of the study is to describe differences in meal-stimulated gut hormone response, appetite and intestinal transit time between good and poor responders 1-2 years after Gastric Bypass surgery for obesity.


Eligibility criteria: Inclusion Criteria:

* Age 20-60 years
* Completed laparoscopic gastric bypass surgery without complications (cases)
* No previous gastric bypass surgery (controls)

Exclusion Criteria:

* Diabetes
* Disease or treatment interfering with appetite or gastrointestinal motility
* Pregnancy or breastfeeding
* Excess weight loss 1 year after gastric bypass \> 50% and =\< 60% (cases)

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Hvidovre
country: Denmark
facility: Department of Endocrinology at Hvidovre University Hospital
state: Copenhagen
Study officials:
affiliation: Dept. of Endocrinology, Hvidovre University Hospital, Hvidovre, Copenhagen, Denmark
name: Carsten Dirksen, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06220773: A Study to Evaluate the Efficacy and Safety of BR1019A and BR1019B Combination Therapy
Official title: A Randomized, Double-blind, Multi-center, Phase 3 Study to Evaluate the Efficacy and Safety of BR1019A and BR1019B Combination Therapy in Patients With Essential Hypertension and Type 2 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Essential Hypertension
Type 2 Diabetes Mellitus
Lead sponsor: Boryung Pharmaceutical Co., Ltd
Sponsor class: INDUSTRY
First posted: 2024-01-24
Enrollment: 276
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of this clinical study is to Evaluate the Efficacy and Safety of BR1019A and BR1019B combination therapy in Patients with Essential Hypertension and Type 2 Diabetes Mellitus


Eligibility criteria: Inclusion Criteria:

* Those with type 2 diabetes mellitus \& essential hypertension
* Those who agree to discontinue existing antihypertensive and/or oral hypoglycemic drugs during the clinical trial
* Those who are judged medically reasonable by investigator to be able to discontinue existing antihypertensive and/or oral hypoglycemic drugs(except for Metformin) during the clinical trial

Exclusion Criteria:

* Those who meet the following criteria

  * Those with a history of secondary hypertension or suspected secondary hypertension; (Including but not limited to; e.g., renovascular disease, adrenal medullary and cortical hyperfunctions, coarctation of the aorta, primary hyperaldosteronism, unilateral or bilateral renal artery stenosis, Cushing's syndrome, pheochromocytoma and polycystic kidney disease, etc.)
  * Those with clinical significant orthostatic hypotension accompanied by symptoms
  * Those with diabetes mellitus taking renin inhibitors(Aliskiren) or moderate to severe renal impairment
  * Those with diabetic nephropathy taking ACE inhibitors
  * Those with type 1 diabetes mellitus, secondary diabetes mellitus, severe insulin-dependent diabetes, diabetic ketoacidosis or lactic acidosis
  * Those with uncontrolled, severe diabetic complications (Micro-vascular complications(e.g., nephropathy, retinopathy, neuropathy, etc.), Macro-vascular complications)
  * Diabetic coma or pre-coma

Primary outcomes:
measure: The change of mean sitting systolic blood pressure from baseline in BR1019A+BR1019B+BR1019C-1 at Week 12 compared to BR1019A-1+BR1019B+BR1019C-1
timeFrame: 12 weeks from Baseline Visit
measure: The change of HbA1c from baseline in BR1019A+BR1019B+BR1019C-1 at Week 12 compared to BR1019A+BR1019B-1+BR1019C-1
timeFrame: 12 weeks from Baseline Visit
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Severance Hospital
city: Seoul
country: Korea, Republic of
facility: Severance Hospital
Study officials:
References:
Clinical trial NCT04504773: Using Immersive Virtual Reality to Treat Pediatric Anxiety
Official title: Virtually Better: Using Immersive Virtual Reality to Treat Pediatric Anxiety
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Specific Phobia
Specific Phobia, Situational
Specific Phobia, Animal
Specific Phobia, Natural Environment
Childhood Anxiety Disorder
Keywords: Exposure Therapy
Virtual Reality
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
First posted: 2020-08-07
Enrollment: 3
Sex: ALL
Minimum age (years): 8
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Anxiety is a common and impairing problem for children. The principle treatment for pediatric anxiety involves facing a child's fears in a stepwise approach through a therapeutic exercise called exposures. While exposures are effective, some feared situations cannot be confronted in a clinician's office (e.g., heights, public speaking, storms). This poses a logistical challenge in treatment that: (1) takes time away from patient care, (2) leads clinicians to rely on imagined exposures, and/or (3) requires families to complete exposures outside of the therapy visits. This creates a burden for clinicians and families, and impedes treatment success. Immersive virtual reality (VR) presents an innovative solution that allows children to face fears without leaving the clinician's office. While VR has been used to distract children during painful medical procedures, it has not been well examined as a primary treatment for pediatric anxiety. This study proposes to examine the effectiveness and acceptability of using immersive VR exposures to treat children and adolescents with specific phobias.


Eligibility criteria: Inclusion Criteria:

* 8-17 years (inclusive),
* meet diagnostic criteria for one or more phobias on a structured diagnostic interview (ADIS-C/P). This specifically includes natural environments (e.g., storms, heights) and/or situational settings (e.g., airplanes, public speaking).
* be fluent in English.

Exclusion Criteria:

* unable to complete rating scales, or
* attend study visits.

Primary outcomes:
measure: Clinical Severity Rating (CSR) of Targeted Specific Phobia on Anxiety Disorder Interview Schedule for Children and Parents (ADIS-C/P)
timeFrame: 1 week after virtual reality exposure therapy session
Secondary outcomes:
measure: Screen for Childhood Anxiety and Related Disorders-Parent Report (SCARED-P)
timeFrame: 1 week after virtual reality exposure therapy session
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins University School of Medicine
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Joseph F. McGuire, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01412073: Control of Blood Loss During Caesarean Section
Official title: A Randomized Trial to Determine the Best Strategy for the Control of Blood Loss at Elective Caesarean Section
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Complications; Cesarean Section
Keywords: caesarean section, intrapartum haemorrhage
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2011-08-08
Enrollment: 600
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: trial of 3 protocols to determine the best one to control blood loss during caesarean section

Detailed description: The study population will be divided into 3 groups each containing 200 women:

Group (A): 200 patients will receive 5-IU oxytocin bolus over 3 minutes after delivery of the baby.

Group (B): 200 patients will receive 5-IU oxytocin bolus over 3 minutes and 30-IU oxytocin infusion in 500 ml 0.9 % saline over 4 hours after delivery of the baby.

Group (C): 200 patients will receive misoprostol 800 micrograms intrauterine, placed manually on the bottom of the uterine cavity after delivery of the placenta and cleaning of the cavity.

Operative blood loss will be estimated in theatre based on the volume in the suction bottle and the weight of swabs used. We will record blood loss up until the time the woman will be discharged from the theatre recovery ward.

Hemoglobin level and haematocrit value will be done as follow:-

1. After admission of each case in the pre-operative period.
2. Immediately post- operative.
3. 24 hours post- operative.

Eligibility criteria: Inclusion Criteria:

* Patients booked for elective cesarean section.
* Singleton pregnancies.
* Primigravida or multipara ,first cesarean section or previous .

Exclusion Criteria:

* Patients with obstetric hemorrhage.
* Uterine laceration.
* Placenta previa.
* Blood dyscrasias.
* Large fibroids.
* Multiple pregnancy.
* Pre-eclampsia.
* Marked maternal anemia.
* Previous history of PPH.

Primary outcomes:
measure: amount of blood loss
timeFrame: 12 month
Secondary outcomes:
measure: Haemoglobin % and haematocrit value
timeFrame: 12 month
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: faculty of medicine , Cairo University
Study officials:
affiliation: Lecturer of Obstetrics & Gynecology , Faculty of medicine, Cairo University
name: Waleed M El-khayat, M.D.
role: STUDY_DIRECTOR
References:
Clinical trial NCT06140173: Low-osmolar Water Soluble Contrast Agent in Management of Adhesive Small Bowel Obstruction
Official title: Randomized Controlled Trial of Low-osmolar Water Soluble Contrast Agent in Management of Adhesive Small Bowel Obstruction
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Small Bowel Adhesion
Small Bowel Obstruction
Lead sponsor: Queen Savang Vadhana Memorial Hospital, Thailand
Sponsor class: OTHER
First posted: 2023-11-18
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Adhesive small bowel obstruction (ASBO) is a condition that is commonly found in patients with history of abdominal surgery. The management for such condition can be controversial. In terms of conservative treatment, recent studies have shown conflicting outcomes on whether water soluble contrast would provide benefit in reducing number of patients needed for surgery. In addition, there are a limited number of literature that investigates the role of low-osmolar contrast in reducing operative need in patients diagnosed with ASBO.

The objective of this study is to compare the operative rate of patient diagnosed with ASBO between patients who were treated with low osmolar water soluble contrast (Iohexol) and patients who were treated traditionally.

Detailed description: This study is a randomized, controlled and double-blinded study, where participants who were diagnosed with ASBO will be randomly allocated into two groups:

(i) A contrast group (CG): Patients will be treated conservatively and received Omnipaque (Iohexol) via nasogastric tube

(ii) A traditional group (TG): Patients will be treated conservatively and received sterile water via nasogastric tube

After obtaining informed consent, the patient will be administered with either 100 mL of 350 mg Omnipaque or 100 mL of sterile water via nasogastric tube. The nasogastric tube will be clamped for 1 hour and patient will be positioned with 30 degree head elevation. In the contrast group (CG), surgery is indicated when contrast failed to reach the colon. Failure of conservative treatment is considered when there are no clinical improvements after 48 hours and the patient will then be proceeded for surgery.

Eligibility criteria: Inclusion Criteria:

* Patients who are presented with clinical manifestation of small bowel obstruction due to adhesion and require radiological investigations
* Patients who has history of abdominal surgery over 30 days

Exclusion Criteria:

* Patients with clinical signs and symptoms of bowel strangulation, ischemia, perforation or peritonitis
* Patients with clinical signs and symptoms of bowel obstruction from non-adhesive causes, including malignancy, herniation, inflammatory bowel disease, Crohn's disease, and others.
* Patients who has history of allergy to water soluble contrast agent

Primary outcomes:
measure: Rate of operative intervention
timeFrame: At 72 hour
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: