louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02137746: Study to Allow for Second Treatment Cycle of DCVAC in Patients With Localized Prostate Cancer
Official title: Open-label, One-arm, Multi-centre Phase II Clinical Trial Treated With Second Cycle of Active Cellular Immunotherapy With DCVAC/PCa in Patients With Localized Prostate Cancer After Primary Radical Prostatectomy Without Objective Progression
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Prostate Cancer
Keywords: Prostate Cancer
Radical Prostatectomy
Lead sponsor: Sotio Biotech Inc.
Sponsor class: INDUSTRY
First posted: 2014-05-14
Enrollment: 24
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the safety of the second cycle of DCVAC/PCa in patients who completed the first cycle of DCVAC/PCa in the clinical trial SP003 without an objective progression of the disease.

Detailed description: Same as brief summary

Eligibility criteria: Inclusion Criteria:

* Male 18 years and older
* Histologically confirmed prostate adenocarcinoma Stage pathological tumor-2 (pT2)
* Post radical Primary Prostatectomy
* Completion of DCVAC/PCa arm in Study SP003, without objective progression of the disease

Exclusion Criteria:

* Prior androgen deprivation therapy for prostate cancer
* Peripheral neuropathy of Common Toxicity Criteria (CTC) grade 2 or greater
* Other uncontrolled intercurrent illness
* Treatment with immunotherapy against PCa
* Clinically significant cardiovascular disease
* Active autoimmune disease requiring treatment

Primary outcomes:
measure: Safety evaluation of the second cycle of DCVAC
timeFrame: 52 weeks
Secondary outcomes:
measure: Time to Prostate Specific Antigen (PSA) Doubling Time
timeFrame: 52 weeks
Other outcomes:
Locations:
city: Hradec Kralove
country: Czechia
city: Jablonec nad Nisou
country: Czechia
city: Novy Jicin
country: Czechia
city: Olomouc
country: Czechia
city: Prague 4
country: Czechia
city: Prague 5
country: Czechia
city: Uherske Hradiste
country: Czechia
city: Usti nad Labem
country: Czechia
Study officials:
affiliation: Sotio Biotech Inc.
name: Tomas Scheiner, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02972346: Availability Study of ACTH to Treat Children SRNS/SDNS
Official title: Availability and Safety Study of ACTH to Treat Children SRNS/SDNS
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Proteinuria
Lead sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Sponsor class: OTHER
First posted: 2016-11-23
Enrollment: 42
Sex: ALL
Minimum age (years): 3
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Primary nephrotic syndrome(NS) is a common children renal disease.About 20% primary nephrotic syndrome are steroid-dependent and steroid-resistant.Low serum cortisol is one of the main relapse reasons.Adrenocorticotropic hormone(ACTH)-induced steroidogenesis improve serum cortisol and also direct melanocortin receptors(MCRs) mediated protective effect on kidney cells. To investigate the efficacy and safety of ACTH to treat NS, total 42 children steroid resistant or steroid dependent NS is enrolling in this multicenter, prospective case series of prescription based treatment with ACTH for NS.

Detailed description: Primary nephrotic syndrome(NS) is a common children renal disease.About 20% primary nephrotic syndrome are steroid-dependent and steroid-resistant.Low serum cortisol is one of the main relapse reasons.Adrenocorticotropic hormone(ACTH) can stimulates the adrenal cortex and its production of corticosteroids.ACTH also direct melanocortin receptors(MCRs) mediated protective effect on kidney cells. To investigate the efficacy and safety of ACTH to treat NS, total 42 children steroid resistant or steroid dependent NS is enrolling in this multicenter, prospective case series of prescription based treatment with ACTH for NS.

Eligibility criteria: Inclusion Criteria:

1. age:3-12 years old
2. primary nephrotic syndrome
3. SRNS or SDNS
4. Minor lesion or minimal change disease
5. Signed informed consent

Exclusion Criteria:

1. Second nephrotic syndrome
2. allergic to ACTH
3. Refuse to signed informed consent
4. have had ACTH treatment
5. serious complication

Primary outcomes:
measure: 24-hour proteinuria excretion
timeFrame: 1.5 years
Secondary outcomes:
measure: times of relapse
timeFrame: 1.5 years
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Xinhua Hospital
state: Shanghai
Study officials:
affiliation: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
name: Yufeng Li, Ph.D.
role: STUDY_DIRECTOR
References:
Clinical trial NCT05617846: Application of Antiosteoporosis Therapy in Osteolysis
Official title: Efficacy and Safety of Antiosteoporosis Therapy in Patients After Bone Tumor Resection: a Multicenter, Real-world Prospective Cohort Observational Study
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Limb; Fusion
Complication
Lead sponsor: Henan Cancer Hospital
Sponsor class: OTHER_GOV
First posted: 2022-11-16
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients receiving antiosteoporosis therapy for osteolysis after surgery for bone tumors in the extremities

Brief summary: To report the postoperative complications and limb function of patients with osteolysis after surgery for bone tumors of the extremities who received anti-osteoporosis therapy in Henan Cancer Hospital in the next 10 years.

Detailed description: A total of 100 patients with osteolysis after surgery for bone tumors of the four extremities who received anti-osteoporosis treatment in Henan Cancer Hospital in the next 10 years were reported. The basic information, treatment methods, postoperative complications and limb function of these patients were collected.

Eligibility criteria: Inclusion Criteria:

1. No age restriction, male or female.
2. A subtype of bone tumor (including benign, malignant, and metastatic cancer) was confirmed in the pathology department of the research institution.
3. Received excision of bone tumor in research institution.

Exclusion Criteria:

Not applicable.

Primary outcomes:
measure: Complications
timeFrame: Collected from the beginning of treatment to 24 months after treatment.
measure: Limb function
timeFrame: Collected from the beginning of treatment to 24 months after treatment.
Secondary outcomes:
Other outcomes:
Locations:
city: Zhengzhou
country: China
facility: Department of Bone and Soft Tissue ,Henan Cancer Hospital
state: Henan
Study officials:
References:
Clinical trial NCT04039646: ERAS in Patients With Perforated Peptic Ulcer Disease Who Underwent Laparoscopic Repair
Official title: Enhanced Recovery After Surgery in Patients With Perforated Peptic Ulcer Disease Who Underwent Laparoscopic Repair, a Randomised Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hospital Stay
Hospital Cost
Keywords: Perforated peptic ulcer
Enhanced recovery after surgery
Laparoscopic repair
Complications
Lead sponsor: Beijing Chao Yang Hospital
Sponsor class: OTHER
First posted: 2019-07-31
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Perforated peptic ulcer (PPU) is a frequent emergency condition worldwide with associated mortality up to 30%. Open procedures have in the most part been replaced by laparoscopic techniques. The standard postoperative management of PPUD patients is predominantly based on traditional practices. The aim of this randomized controlled clinical trial was to investigate the feasibility of enhanced postoperative recovery pathways in patients who underwent laparoscopic repair for Perforated peptic ulcer.

Detailed description: Perforated peptic ulcer (PPU) is a frequent emergency condition worldwide with associated mortality up to 30%. Open procedures have in the most part been replaced by laparoscopic techniques. The standard postoperative management of PPUD patients is predominantly based on traditional practices. Randomization will be made at the end of the surgical procedure. Patients will be included in groups 1 or2. Group 1 is the control group and will receive standard postoperative care, and group 2 is the ERAS group.The aim of this randomized controlled clinical trial was to investigate the feasibility of ERAS in patients who underwent laparoscopic repair for Perforated peptic ulcer.

Eligibility criteria: Inclusion Criteria:

1. Perforated ulcer less than 10 mm in size
2. Patients received laprascopic repair

Exclusion Criteria:

-

1. refusal to join the study or sign the informed consent form 3. age younger than 18 years 3.the presence of any psychiatric or neurologic disease 4. class 3 and 4 surgical patients according to the classification of The American Society of Anesthesiologists 5. septic shock on admission 6. pregnancy 7. multiple perforated peptic ulcers 8. spontaneously sealed-off perforated ulcers that were diagnosed either preoperatively or during surgery and that did not require surgical repair 9.conversion to open technique 10. perforated ulcers that were not amenable to Graham patch repair because of size or technical considerations

Primary outcomes:
measure: Hospital stay
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Chaoyang Hospital, Capital Medical University
state: Beijing
Study officials:
affiliation: Ethics center, Beijing Chaoyang Hospital
name: Li Hua Tian
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02867046: The Incidence of the Intravascular Injection During S1 Transforaminal Epidural Steroid Injection in Two Approaches: Medial vs Lateral in Anteroposterior View
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lumbosacral Radicular Pain
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2016-08-15
Enrollment: 165
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Lumbosacral transforaminal epidural steroid injection (TFESI) is helpful for the treatment of lumbosacral radicular pain, but in case of intravascular injection, infrequently serious complication can be developed. Against this backdrop, if there is any difference of frequency of intravascular injection incidence during S1 (sacrum 1) TFESI between method using medial approach and method using lateral approach in anteroposterior view, the result can be crucial factor in selecting the approach. In addition, appropriate volume of injection will be checked in each approach.


Eligibility criteria: Inclusion Criteria:

1. Adult patients (20-80 years of age) who were scheduled to receive S1 transforaminal epidural steroid injection for lumbosacral radicular pain at pain management clinic

Exclusion Criteria:

1. pregnancy
2. coagulopathy
3. systemic infection
4. any active infection at the injection site
5. history of allergy to contrast media, local anesthetics, corticosteroid
6. patients unable to communicate or patients with cognitive dysfunction

Primary outcomes:
measure: the incidence of intravascular injection in the medial approach group in S1 foramen
timeFrame: 5 seconds after injection of contrast media via block needle.
measure: the incidence of intravascular injection in the lateral approach group in S1 foramen
timeFrame: 5 seconds after injection of contrast media via block needle.
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, Yonsei University College of Medicine
Study officials:
References:
Clinical trial NCT03237546: The Use of Serratus Block for Cardiac Surgery
Official title: The Use of Serratus Block for Cardiac Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiac Surgery
Keywords: Robotic Cardiac Surgery
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2017-08-02
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this randomized, un-blinded study is to determine if serratus blocks or Patient Controlled Analgesia (PCA)-alone (no block) offer patients adequate pain relief. This study will compare two standard of care pain management options and the patients narcotic requirements in the immediate postoperative period.


Eligibility criteria: Inclusion Criteria:

* Patients over the age of 18 years of age undergoing robotic cardiac surgery.

Exclusion Criteria:

* Patients who are not candidates for serratus block

Primary outcomes:
measure: Amount of intravenous opiates used during the immediate postoperative period
timeFrame: 24 Hours
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: New York University School of Medicine
state: New York
Study officials:
affiliation: NYU Langone Health
name: Jennie Ngai, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT07001046: Impact of Mobile App-Based Exercises on Rectus Diastasis in Women Undergoing Cesarean Birth
Official title: Effect of Mobile App-Based Exercises on Diastasis Rectus Abdominis in Post-Cesarean Mothers: A Quasi-Experimental Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diastasis Recti and Weakness of the Linea Alba
Lead sponsor: South Valley University
Sponsor class: OTHER
First posted: 2025-06-03
Enrollment: 40
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Diastasis recti abdominis, or rectus diastasis, is the separation of the two parts of the rectus abdominis muscle along the midline of the linea alba, without any visible defect in the fascia.

Diastasis recti abdominis is most frequent during pregnancy and postpartum especially, after cesarean birth.

Detailed description: Cesarean births were linked to significant post-operative changes in the thickness of abdominal fasciae and muscles when compared to vaginal births and these changes may be involved in the higher rates of diastasis recti post-cesarean births.

Managing diastasis recti abdominis begins with its diagnosis, followed by targeted interventions.

Diagnosis usually involves manual palpation to estimate the gap between the rectus abdominis muscles along the tendinous sheet of the linea alba. Updated imaging techniques, such as magnetic resonance imaging (MRI) and ultrasound, are now more frequently used for diagnosis.

Treatment either surgical or conservative; emphasizes physical therapy and personalized exercise programs. This method targets strengthening specific core muscles, such as the transverse abdominis and the pelvic floor.

Eligibility criteria: Inclusion Criteria:

* First-time mothers who delivered by a cesarean birth
* Post-cesarean women between 25 and 35 years old
* Women with a Diastasis Recti of at least 1 cm separation above the umbilicus and at least 0.5 cm separation below the umbilicus

Exclusion Criteria:

* First-time mothers who delivered by a vaginal birth
* Multiparous mothers
* Those who have not a Diastasis Recti
* Mothers under 25 years old and those above 35 years old

Primary outcomes:
measure: Inter-recti Separation
timeFrame: Assessment was done pre treatment sessions and immediately after 8 weeks of treatment sessions
Secondary outcomes:
measure: Abdominal muscle strength
timeFrame: Assessment was done pre treatment sessions and immediately after 8 weeks of treatment sessions
measure: Girth measurements
timeFrame: Assessment was done pre treatment sessions and immediately after 8 weeks of treatment sessions
measure: Satisfaction level
timeFrame: Assessment was done immediately after 8 weeks of treatment sessions
Other outcomes:
Locations:
city: Qinā
country: Egypt
facility: Faculty of physical therapy, South Valley University
state: Qena
Study officials:
References:
Clinical trial NCT00092846: A 6-Month Consumer Behavior Study of a Self-Management System (0803-084)(COMPLETED)
Official title: A Consumer Use Study of OTC Lovastatin (CUSTOM): A 6-Month Consumer Behavior Study of the Lovastatin OTC Self-Management System
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hypercholesterolemia
Keywords: High Blood Cholesterol Levels
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2004-09-28
Enrollment: 1000
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to evaluate the ability of patients with intermediate risk of heart disease to appropriately use a Self-Management System.

Detailed description: The duration of treatment is 6 months.

Eligibility criteria: Inclusion Criteria:

* Must be able to read and understand English without assistance.
* For Males: Minimum age 45 years and Maximum age N/A (No limit).
* For Females: Minimum age 55 years and Maximum age N/A (No limit).

Exclusion Criteria:

* Pregnant or nursing
* Drug allergy

Primary outcomes:
measure: Percentage of patients who make appropriate decision for self-management.
Secondary outcomes:
measure: Percentage of patients who make appropriate decision to discontinue therapy or consult with a physician; the incidence of adverse experiences.
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Melin JM, Struble WE, Tipping RW, Reynolds JM, Vassil TC, Levy SJ, Petrohoy TM, Midgette P, Hemwall EL, Levine JG, Irvin JD. A Consumer Use Study of Over-The-Counter lovastatin (CUSTOM). Am J Cardiol. 2004 Nov 15;94(10):1243-8. doi: 10.1016/j.amjcard.2004.08.007.
Clinical trial NCT02530346: Is Colostomy Closure Without Mechanical Bowel Preparation Safe in Pediatric Patients? Randomized Clinical Trial.
Official title: Is Colostomy Closure Without Mechanical Bowel Preparation Safe in Pediatric Patients? Randomized Clinical Trial.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Colostomy
Surgical Anastomosis
Lead sponsor: Hospital Infantil de Mexico Federico Gomez
Sponsor class: OTHER
First posted: 2015-08-21
Enrollment: 130
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will help determine wether mechanical bowel preparation before a colostomy closure is necessary in pediatric population, in order to avoid surgery related complications (surgical site infection and anastomosis leakage).

Half of the population will go through the mechanical bowel prep before colostomy closure and the other half won´t. Complications rate will be compared among both groups.

Detailed description: Mechanical bowel preparation is based on administering osmotic laxatives and enemas through the stomas, in order to diminish solid stool and bacterial load on the colon prior to a colostomy takedown. This was thought to decrease the surgery related complications.

However mechanical bowel preparation can cause discomfort in patients as well as other complications like hydro electrolyte imbalance.

Studies in adult population have shown that there is not a significant difference in the presence of surgery related complications in patients that received bowel prep and those who did not.

There is not enough evidence in pediatric patients that this affirmation is also true.

Eligibility criteria: Inclusion Criteria:

* Pediatric patients who are to be submitted to a colostomy closure

Exclusion Criteria:

* patients with more than 3 abdominal surgeries
* patients with primary or acquired immunodeficiencies (including malnourishment)
* Patients in which the distal intestine is closed in a Hartmann´s pouch

Primary outcomes:
measure: Surgery Related Complications
timeFrame: up to 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Mexico City
country: Mexico
facility: Hospital Infantil de Mexico Federico Gomez
Study officials:
References:
Clinical trial NCT04649346: The Difference of Oropharyngeal Leak Pressure and Sealing Pressure Between New Supraglottic Airway Devices
Official title: The Difference of Oropharyngeal Leak Pressure and Sealing Pressure Between New Supraglottic Airway Devices
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Oropharyngeal Leak Pressure
Keywords: Supraglottic airway (SGA) devices
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2020-12-02
Enrollment: 90
Sex: FEMALE
Minimum age (years): 20
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: All general anesthesia patients who use SGA.

Brief summary: The difference of oropharyngeal leak pressure and sealing pressure between new supraglottic airway devices.

Detailed description: In this clinical study, investigators want to discuss the issue that oropharyngeal leak pressure and sealing condition with different SGA including air-Q、i-gel、LMA-supreme、AMBU auragain 、ProSeal LMA and other new SGAs.

In the perioperative period, investigators documented respiratory function data including oropharyngeal leak pressure and peak airway pressure in these randomly selected SGA. Oropharyngeal leak pressure was measured by closing the expiratory valve of the circle system at fixed O2 flow 3L/min and noting the airway pressure at which the dial on a calibrated aneroid manometer reached equilibrium.

investigators wanted to compared the respiratory function between air-Q、i-gel、LMA-supreme、AMBU auragain、ProSeal LMA and other new SGAs during surgery and postoperative care unit.

Eligibility criteria: Inclusion criteria:

1. 20-80 years old.
2. ASA physical status I or II .
3. Without major organ dysfunction like heart, liver, brain, lung, kidney function failure.

Exclusion criteria:

1. BMI\> 35 kg/m2.
2. Risk of aspiration(NPO clear water\> 2 hours, solid foods \> 8 hours).
3. Difficult airway like head and neck tumor or airway tumor.
4. Limited mouth opening (\<2cm).
5. major organ dysfunction including heart, liver, brain, lung, kidney function failure.
6. Major surgery including open heart surgery, laparotomy general surgery, open chest surgery.

Primary outcomes:
measure: Oropharyngeal leak pressures
timeFrame: 10 minutes
Secondary outcomes:
measure: 1. The participant's head and neck position 2. The number of attempts required for SGA insertion 3. Ease of gastric tube placement 4. The ventilation score
timeFrame: 180 minutes
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: visiting staff
name: Liu Chih Min
role: PRINCIPAL_INVESTIGATOR
References: