louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00643357: Study of the Efficacy and Safety of Kalinox® 170 Bar for the Performance of Care Procedures in Children With Burns
Official title: Study of the Efficacy and Safety of KALINOX® 170 Bar for the Performance of Care Procedures in Children With Burns
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Burns
Keywords: children with burns
Child between 5 and 15 years of age , burned for many days and who has to undergo at least 3 procedures of care
Lead sponsor: Air Liquide Santé International
Sponsor class: INDUSTRY
First posted: 2008-03-26
Enrollment: 0
Sex: ALL
Minimum age (years): 4
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the efficacy and the safety of Kalinox® 170 bar, over a period of three consecutive care procedures in burned children. It's a international (Spain, France, Tunisia and Belgium) study with 8 investigator centers.

Detailed description: Pain due to burns is one of the most intense and persistent types of pain. This pain consists of a permanent background pain, overlaid by episodes of temporary exacerbations triggered by treatment procedures or burn-care procedures.

Care procedures, such as changing the dressings or cleaning the wounds, make it necessary to handle the painful areas, and this causes transient intense pain.

Analgesia with a 50/50 mix of nitrous oxide and oxygen is a simple and effective technique, which induces a state of light sedation during which verbal contact is not lost, which is rapidly reversible and is devoid of any major side effects. This gas is used in paediatrics for carrying out painful procedures of a short duration, such as lumbar puncture and minor surgery.

The nitrous oxide/oxygen mix has also been used to treat the pain induced by care procedures in children with burns for more than 30 years.

The objective of our study is to obtain qualitative and quantitative data about the efficacy of Kalinox® 170 bar in care procedures in children with burns.

Eligibility criteria: Inclusion Criteria:

* Child between 5 and 15 years of age , burned for many days and who has to undergo at least 3 procedures of care

  * potentially mildly to moderately painful
  * lasting for at least 15 minutes and for less than 30 minutes
  * eligible to receive short-term prophylactic analgesic treatment
  * for whom the consent form has been signed (parent and child)

Exclusion criteria:

* Child treated under general anaesthesia
* Child physically or mentally incapable of responding to an assessment of his/her pain on a visual scale.
* Child suffering from moderate to severe pain when beginning the care procedure (FPSr \> 4)
* Exclusion criteria linked to the product

Primary outcomes:
measure: The intensity of the pain was assessed using the "Faces Pain Scale Revised"
timeFrame: Faces Pain Scale Revised
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02766348: Clinical Efficacy and Safety of Dendritic Cytotoxic Lymphocyte(DC-CTL) Cell Infusion in NSCLC Patients
Official title: Randomized, Controlled Study of the Safety and Efficacy of DC-CTL Immune Cell for Non-Small Cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: NSCLC
Keywords: DC-CTL, NSCLC
Lead sponsor: Shenzhen Hornetcorn Bio-technology Company, LTD
Sponsor class: INDUSTRY
First posted: 2016-05-09
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Patients in group A will receive DC-CTL treatment and chemotherapy. Patients in group B will receive only chemotherapy.

Detailed description: 60 patients with stage III-IV NSCLC will be randomly divided into group A (receive DC-CTL treatment with chemotherapy) or group B (Just receive chemotherapy), and the randomize ratio will be 1:1, patients in group A will receive 3 cycles of DC-CTL treatment (every 1 months) and 4 cycles of chemotherapy (every 2 weeks). Patients in group B will receive only 4 cycles chemotherapy(every 2 weeks).

Eligibility criteria: Inclusion Criteria:

* The patient who have signed the informed consent;
* Histologically confirmed with NSCLC at stage III-IV
* Expected survival time is more than 2 month;
* Eastern Cooperative Oncology Group(ECOG) performance status was 0-2

Exclusion Criteria:

* Hemoglobin \<8.0 g/dL, White blood cell \<3 x 10\^9/L; Platelet count \<75 x 10\^9/L; alanine aminotransferase(ALT), aspartate aminotransferase(AST), blood urea nitrogen(BUN) and Creatinine(CR) more than normal limits on 3.0 times;
* Known or suspected allergy to the investigational agent or any agent given in association with this trial;
* Pregnant or lactating patients;
* Known history of Human Immunodeficiency Virus (HIV), Hepatitis C Virus (HCV) or TreponemaPallidun (TP) infection;
* Patients who are suffering from serious autoimmune disease;
* Patients who had used long time or are using immunosuppressant;
* Patients who had active infection;
* Patients who are suffering from serious organ dysfunction;
* Patients who are suffering from other cancer;
* Other situations that the researchers considered unsuitable for this study.

Primary outcomes:
measure: Progress-free survival
timeFrame: 3 years
Secondary outcomes:
measure: Overall survival
timeFrame: 3 years
Other outcomes:
Locations:
city: Jingzhou
country: China
facility: Jingzhou Central hospital Immunotherapy center
state: Hubei
Study officials:
affiliation: Jingzhou Central Hospital
name: Zi L Zhang, researcher
role: STUDY_DIRECTOR
References:
Clinical trial NCT03630848: Effect of Protein Concentration on Human Embryo Development
Official title: Protein Concentration and Human Embryo Development
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Human Embryo Culture
Lead sponsor: Ibn Sina Hospital
Sponsor class: OTHER_GOV
Collaborators: name: Banon IVF Center Assiut, Egypt
First posted: 2018-08-15
Enrollment: 1536
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Protein Concentration in Human Embryo Culture Media remains assigned to the manufacturers with no clear evidence on which concentration is ideal.


Eligibility criteria: Inclusion Criteria:

* Intracytoplasmic sperm injection cycles

Exclusion Criteria:

-

Primary outcomes:
measure: Ongoing pregnancy rate
timeFrame: 12 weeks
Secondary outcomes:
measure: embryo development
timeFrame: two months
measure: Blastocyst Formation
timeFrame: two months
measure: Clinical pregnancy rate
timeFrame: 7 weeks
measure: Implantation rate
timeFrame: 7 weeks
measure: Miscarriage rate
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Banon Assiut
city: Sohag
country: Egypt
facility: IbnSina IVF Center
Study officials:
References:
Clinical trial NCT00477048: Efficacy and Safety of SQV in Patients Who Have Chronic IDV Nephrotoxicity
Official title: Efficacy and Safety of a Saquinavir Based Regimen in HIV-1 Infected Thai Patients Who Have Chronic IDV Associated Nephrotoxicity.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: IDV Associated Nephrotoxicity
Keywords: IDV nephrotoxicity
Lead sponsor: The HIV Netherlands Australia Thailand Research Collaboration
Sponsor class: OTHER
Collaborators: name: Roche Pharma AG
name: Ministry of Health, Thailand
First posted: 2007-05-22
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Efficacy and safety of a saquinavir (SQV) based regimen in HIV-1 infected Thai patients who have chronic indinavir (IDV) associated nephrotoxicity.

Detailed description: Primary objective:

To determine whether a switch to a SQV can cause improvements in renal function in patients with chronic IDV associated nephrotoxicity without improvement after IDV dose reduction.

Secondary objective:

1. To describe the pathophysiology of chronic IDV associated renal impairment through renal biopsies at baseline and week 48
2. To describe the pathophysiology of chronic IDV associated renal impairment through renal tubular function at baseline and week 48
3. To determine whether a switch to an SQV can cause improvements in renal pathophysiology in patients with chronic IDV associated nephrotoxicity through renal biopsies performed at baseline and at weeks 48
4. To determine whether a switch to an SQV results in improvements in hypertension, lipid profiles and cutaneous side effects

Eligibility criteria: Inclusion Criteria:

* IDV containing regimen for more than 1 year and have creatinine more than 1.4 at least 6 months/abnormal renal imaging/abnormal urinary examinations
* Viral load less than 50 copies

Exclusion Criteria:

* Saquinavir intolerance

Primary outcomes:
measure: Viral load less than 50 copies/ml Improvement of renal functions and renal imaging
timeFrame: 48 weeks
Secondary outcomes:
measure: Metabolic and cutaneous profile
timeFrame: 48 weeks
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: The HIV Netherlands Australia Thailand Research Collaboration (HIV-NAT)
Study officials:
affiliation: The HIV Netherlands Australia Thailand Research Collaboration (HIV-NAT)
name: Kiat Ruxrungtham, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03561948: Feasibility of Intraperitoneal Chemotherapy in the Surgical Treatment of Colon Cancer cT4
Official title: Feasibility of Intraperitoneal Chemotherapy in the Surgical Treatment of Colon Cancer cT4
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colon Cancer
Keywords: intraperitoneal chemotherapy
Peritoneal Carcinomatosis
Colonic Diseases
Lead sponsor: State Scientific Centre of Coloproctology, Russian Federation
Sponsor class: OTHER_GOV
First posted: 2018-06-19
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This is a randomised controlled study aims to determine the oncological effectiveness of adjuvant HIPEC, using intraperitoneal Mytomicin C following a curative resection of a cT4 Colon cancer in preventing the development of peritoneal carcinomatosis in addition to the standard adjuvant systemic treatment.

Detailed description: In the experimental group (50 patients) after laparotomy and revision of the abdominal cavity organs, peritoneal lavage will be performed followed by immunological examination. After performing the surgical intervention, the patient will undergo intraoperative intra-abdominal chemotherapy with mitomycin C. Further, lavage of the abdominal cavity will be repeated, followed by immunological examination.

In the control group (40 patients), after laparotomy and revision, peritoneal lavage will also be performed, followed by immunological examination. Patients of this group will not receive intraoperative intra-abdominal chemotherapy. After performing the surgical intervention, the patient will perform irrigation of the abdominal cavity with physiological saline. Further, lavage of the abdominal cavity will be repeated, followed by immunological examination.

Eligibility criteria: Inclusion Criteria:

1. Colon cancer which represent cT4N0-2 M0 on the basis of preoperative examination data (CT of the chest, abdominal and pelvic organs) in line with The American Joint Committee on Cancer: the 7th edition of the AJCC cancer staging manual:
2. Histologically verified adenocarcinoma of the colon.
3. Signed informed consent.

Exclusion Criteria:

1. Pregnancy or lactation.
2. The presence of synchronous or metachronous malignant tumors.
3. Distant metastases to the liver, lungs, peritoneal carcinomatosis and other organs.
4. Neoadjuvant chemotherapy.
5. Suspected Lynch syndrome.

Primary outcomes:
measure: Positive peritoneal lavage
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: State Scientific Centre of Coloproctology
Study officials:
References:
Clinical trial NCT02640248: Endotracheal Tube Intracuff Pressure and Leak Around the Cuff During Retractor Placement for Adenotonsillectomy
Official title: Endotracheal Tube Intracuff Pressure and Leak Around the Cuff During Retractor Placement for Adenotonsillectomy
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Otolaryngological Surgery
Lead sponsor: Nationwide Children's Hospital
Sponsor class: OTHER
First posted: 2015-12-28
Enrollment: 0
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Less than 18 years of age, undergoing otolaryngological surgery with endotracheal intubation

Brief summary: The investigators have devised a simple method to continuously measure the CP using an invasive pressure monitoring setup (IPMS), which is used routinely in the operating room to monitor arterial or central venous pressures. The investigators have previously confirmed both in vitro and in vivo (previous IRB approved protocol), a clinically applicable agreement of the IPMS readings with the values obtained from a standard manometer (gold standard). In the current study, we will prospectively evaluate the relationship between the patient's head position and CP in patients undergoing otolaryngological surgery and also measure the oxygen concentration in the oropharynx to determine the potential risk of an airway fire.


Eligibility criteria: Inclusion Criteria:

* Less than 18 years of age, undergoing otolaryngological surgery with endotracheal intubation

Exclusion Criteria:

* Patient who is intubated with an uncuffed endotracheal tube
* Patients who have a limitation for movement of the neck or concerns of the stability of the cervical spine.

Primary outcomes:
measure: Changes in intracuff pressure
timeFrame: during time of surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Nationwide Children's Hospital
state: Ohio
Study officials:
References:
Clinical trial NCT04027348: Palliative Management of Inoperable Malignant Bowel Obstruction
Official title: Palliative Management of Inoperable Malignant Bowel Obstruction: A Prospective, Open Label, Phase-2 Study at an NCI Comprehensive Cancer Center
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Malignant Bowel Obstruction
Keywords: bowel obstruction
Lead sponsor: Roswell Park Cancer Institute
Sponsor class: OTHER
First posted: 2019-07-22
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To identify the role of palliative medical management of inoperable malignant bowel obstruction (MBO) with Octreotide, Dexamethasone and Metoclopramide given together as triple therapy.


Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years of age.
* Diagnosis of partial bowel obstruction secondary to active or prior malignancy (primary or metastatic GI, GYN, and carcinomatosis) caused either by tumor itself or adhesions inthe setting of active malignancy.
* Cross-sectional imaging performed within 24 hours of clinical symptoms of bowel obstruction (nausea, vomiting, and constipation ± abdominal pain) during hospital admission.
* Patient must have an inoperable MBO
* Participant must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved writteninformed consent form prior to receiving any study related procedure.

Exclusion Criteria:

* Evidence of complete bowel obstruction by imaging.
* Bacteremia/septicemia with a documented positive blood culture: If a blood culture comes back positive after study enrollment, patient will be excluded.
* Patients already taking a steroid equivalent to 8 mg of dexamethasone per day prior to study enrollment.
* Patients undergoing bowel surgery or stent placement for bowel obstruction.
* Those patients with MBO in setting of incarcerated hernia.
* Known history of QT prolongation syndrome or if QTc is \> 450 msec in males or \> 470 msec in females on baseline EKG within 2 weeks of enrollment.
* Lack of decision making capacity/delirium.
* Pregnant or nursing female participants.
* Actively suicidal patients.
* Acute cholecystitis

Primary outcomes:
measure: Proportion of Patients With Obstruction Clearance
timeFrame: Within 7 days of starting protocol therapy
Secondary outcomes:
Other outcomes:
Locations:
city: Buffalo
country: United States
facility: Roswell Park Cancer Institute
state: New York
Study officials:
affiliation: Roswell Park Cancer Institute
name: Amy Case, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03626948: SK-1403 Long-term Treatment Study; Long-term Study in Patients With Secondary Hyperparathyroidism Receiving Hemodialysis
Official title: SK-1403 Long-term Treatment Study - Long-term Study in Patients With Secondary Hyperparathyroidism Receiving Hemodialysis -
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Secondary Hyperparathyroidism
Lead sponsor: Sanwa Kagaku Kenkyusho Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2018-08-13
Enrollment: 157
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To evaluate the safety and efficacy of treatment with SK-1403 for 52 weeks in patients with secondary hyperparathyroidism on maintenance hemodialysis.


Eligibility criteria: Inclusion Criteria:

* Serum PTH\>240 pg/mL at the screening
* Serum corrected Ca≥8.4 mg/dL at the screening
* Stable chronic kidney disease patients who undergo hemodialysis or hemodialysis filtration

Exclusion Criteria:

* Primary hyperparathyroidism
* Severe liver disease
* Severe cardiac disease
* History or family history of long QT syndrome
* Malignant tumor
* Uncontrolled diabetes mellitus
* Uncontrolled hypertension
* A history of severe drug allergy

Primary outcomes:
measure: Number of participants with adverse events or adverse drug reactions
timeFrame: 52 weeks
Secondary outcomes:
measure: Rate of participants who achieved a serum iPTH level of ≥ 60 pg/mL and ≤ 240 pg/mL at each time point
timeFrame: 52 weeks
measure: Measured values and Changes from baseline in serum PTH, Ca, ionized Ca, P, and serum Ca x P product
timeFrame: 52 weeks
Other outcomes:
Locations:
city: Tokyo
country: Japan
facility: Investigational site (there may be other sites in this country)
Study officials:
References:
Clinical trial NCT05142748: Study of Pulmonary Infections (Pneumonia) in Kidney Transplant Recipients Admitted to Hospital
Official title: Study of Pulmonary Infections (Pneumonia) in Kidney Transplant Recipients Admitted to Hospital
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Kidney Transplant Infection
Lead sponsor: CHU de Reims
Sponsor class: OTHER
First posted: 2021-12-03
Enrollment: 132
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with kidney transplant

Brief summary: The investigators aimed to identify prognosis factors associated with in-hospital complications and assess the epidemiology, management, and outcomes of community-acquired pneumonia in a kidney transplant recipients' cohort. The investigators intend to identify each stay by a national database. Then they will be consulted by 2 clinicians to assert CAP clinical definition. After that radiographic evidence will be reviewed to validate CAP diagnoses. Then clinical data are collected in each center.


Eligibility criteria: Inclusion Criteria:

* kidney transplant recipients
* at least 18 years
* admitted to hospital for CAP. Non-inclusion criteria were:

Exclusion Criteria:

* incomplete CAP definition
* hospital-acquired pneumonia
* another diagnosis explaining the symptoms
* patients with non-functional kidney graft

Primary outcomes:
measure: In-hospital complications
timeFrame: inhospital stay, an average of 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Reims
country: France
facility: Chu Reims
Study officials:
References:
Clinical trial NCT02943148: Prediction of Pelvic Adhesions at Repeat Cesarean Delivery
Official title: Predictive Value of Striae Gravidarum Severity and Cesarean Scar Characteristics for Pelvic Adhesions at Repeat Cesarean Delivery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Decrease Maternal Morbidity
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2016-10-24
Enrollment: 300
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: All Women who will be admitted to our Labor Ward for emergency or elective cesarean section will be invited to participate.

Brief summary: Several methods have been used to predict adhesions after abdominal operations. High-resolution ultrasonography, magnetic resonance imaging and scar healing properties were the methods that were evaluated in the English literature for this study. Estimating the likelihood of adhesions and related complications after prior surgery and assessing the severity of adhesion formation after surgery is not easy. Anticipating adhesions is very important to preventing complications by ensuring that the necessary preoperative preparations are in place and/or that appropriate cases are referred to a tertiary center.


Eligibility criteria: Inclusion Criteria:

1. Women with at least previous one cesarean
2. Full term (37- 41 weeks)
3. Women accepted to participate in the study

Exclusion Criteria:

1. History of pelvic inflammatory disease
2. History of endometriosis
3. Previous pelvic surgery other than cesarean
4. History of wound site infections
5. History of long corticosteroid use
6. Women with midline incisions
7. Women with placenta accreta
8. Women refuse to participate in the study

Primary outcomes:
measure: Rate of of abdominal adhesions in relation to striae scoring system
timeFrame: 30 min
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Ahmed Abbas
state: Cairo
Study officials:
References: