louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04373083: Anti-PD-1 Antibody Treatment With Cemiplimab and Radiotherapy in Early-stage Classical Hodgkin Lymphoma
Official title: Anti-PD-1 Antibody Treatment With Cemiplimab and Radiotherapy in Early-stage Favorable Classical Hodgkin Lymphoma (CARHL) - A Randomized Phase II Trial
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Hodgkin Lymphoma
Keywords: Early Stage
Favorable
Classical
classical Hodgkin lymphoma (cHL)
Lead sponsor: Regeneron Pharmaceuticals
Sponsor class: INDUSTRY
Collaborators: name: Sanofi
First posted: 2020-05-04
Enrollment: 0
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: The primary objective is to estimate the efficacy of experimental treatment with the anti-PD-1 antibody cemiplimab (REGN2810) in combination with simultaneous or subsequent radiotherapy (RT) in early-stage favorable classical Hodgkin lymphoma (cHL).

Secondary objectives are to assess the safety and feasibility of the 2 experimental strategies.


Eligibility criteria: Key Inclusion Criteria:

* Histologically proven classical HL
* First diagnosis, no previous treatment
* Stage I-II without risk factors as defined in the protocol

Key Exclusion Criteria:

* Composite lymphoma or nodular lymphocyte-predominant Hodgkin lymphoma (NLPHL)
* Prior malignancy within the previous 5 years (except for locally treatable cancers that have been apparently cured by complete resection)
* Prior chemotherapy or radiation therapy
* Concurrent disease precluding protocol treatment as defined in the protocol
* Pregnancy or breast-feeding
* Non-compliance as defined in the protocol

Note: Other protocol-defined Inclusion/Exclusion criteria apply

Primary outcomes:
measure: Progression-free survival (PFS) at 1 year
timeFrame: From randomization up to 1 year
Secondary outcomes:
measure: PFS at 2 and 3 years
timeFrame: From randomization up to 3 years
measure: Overall survival (OS) at 1, 2, and 3 years
timeFrame: From randomization up to 3 years
measure: Incidence of acute toxicities
timeFrame: Up to 90 days after study treatment
measure: Rate of patients with long-term fatigue using EORTC-QLQ-FA12
timeFrame: 12-18 months after randomization
measure: Rate of patients with long-term fatigue using EORTC-QLQ-C30
timeFrame: 12-18 months after randomization
measure: Quality of life (QoL) using EORTC-QLQ-30
timeFrame: Up to 3 years
measure: Rate of early discontinuation of study treatment
timeFrame: From first dose to up to 19 weeks
measure: Frequency of lymphoma treatment administered in addition to study treatment
timeFrame: From randomization up to 3 years
measure: Types of lymphoma treatment administered in addition to study treatment
timeFrame: From randomization up to 3 years
Other outcomes:
Locations:
Study officials:
affiliation: Regeneron Pharmaceuticals
name: Clinical Trial Management
role: STUDY_DIRECTOR
References:
Clinical trial NCT00226083: Study of Blood Platelets in Sickle Cell Disease
Official title: Studies of Large Platelets in Patients With Sickle Cell Disease
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Sickle Cell Disease
Lead sponsor: Rockefeller University
Sponsor class: OTHER
Collaborators: name: Icahn School of Medicine at Mount Sinai
name: Schneider Children's Hospital of North Shore
First posted: 2005-09-26
Enrollment: 0
Sex: ALL
Minimum age (years): 7
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults and children with sickle cell disease (Hb SS)

Brief summary: We are studying if sickle cell disease blood platelets are larger than normal and how they may cause obstruction of blood vessels. We are also trying to study the reasons why large platelets are found in patients with sickle cell disease.

Detailed description: Research volunteers are seen in the Outpatient Research Center by the Principal Investigator or another physician. A detailed history is obtained, a physical examination is performed, and blood (usually 4 tablespoons) is obtained for additional tests. The research volunteer's previous medical records will be requested. Upto 5 additional blood samples may be obtained in a subgroup of patients.

Eligibility criteria: Inclusion Criteria:

* Adults and children \> 7 years of age with sickle cell disease (Hb SS) who are not taking hydroxyurea and are not receiving routine blood transfusion therapy.

Exclusion Criteria:

* Current hydroxyurea therapy or,
* Hydroxyurea use within the past 3 months
* Blood transfusion or exchange transfusion within the past 3 months
* Current treatment with aspirin or clopidogrel

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Rockefeller University Hospital
state: New York
Study officials:
affiliation: Rockefeller University
name: Arun Shet, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00996983: Safety and Activity Study of Intrathecally Administered Ziconotide for Neuropathic Pain in Patients With Cancer
Official title: Phase II Study of Intrathecal Ziconotide for the Treatment of Neuropathic Pain in Patients With Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Pain
Neuropathic Pain
Intractable Pain
Cancer
Lead sponsor: National Cancer Institute, Naples
Sponsor class: OTHER
First posted: 2009-10-16
Enrollment: 16
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: Neuropathic pain is difficult to control because it is only partially sensitive to opioid analgesics, and requires the addition of other therapies such as antidepressants and epileptics. Ziconotide is a drug that is used to treat neuropathic pain in patients who have had inadequate pain control with prior combination of medicines.

Detailed description: The purpose of this study is to evaluate the effects and the tolerability of intrathecal ziconotide in cancer patients suffering from severe neuropathic pain not controlled by previous therapies.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of neoplasm
* Neuropathic pain level VASPI \> or = 6 (0-10 scale)
* Inadequate pain relief with opioid analgesics and adjuvants
* Age \> or = 18 years
* Performance status ECOG 0-2
* Life expectancy at least one month
* Adequate contraception in women of child-bearing potential
* Signed Informed Consent

Exclusion Criteria:

* Use of experimental drugs within previous 30 days
* Pregnancy or lactation
* Contraindication to the use of intrathecal analgesics, including active infection or conditions that could alter the circulation of cerebrospinal fluid
* Presence of cerebral metastasis
* INR \> 2
* Contraindication to the use of ziconotide
* Unable or unwilling to provide informed consent

Primary outcomes:
measure: Response rate (> 30% reduction in VASPI)
timeFrame: 48 hours after completion of titration phase
Secondary outcomes:
measure: toxicity
timeFrame: daily during drug titration, weekly thereafter
measure: duration of analgesic response
timeFrame: weekly
Other outcomes:
Locations:
city: Napoli
country: Italy
facility: Istituto Nazionale dei Tumori , Unita Terapia Antalgica
Study officials:
affiliation: NCI Naples, Division of Pain Therapy
name: Arturo Cuomo, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: NCI Naples, Division of Pain Therapy
name: Gennaro Russo, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: NCI Naples, Clinical Trials Unit
name: Alessandro Morabito, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00036283: Chemoprevention of Oral Premalignant Lesions
Official title: Clinical Protocol For A Phase II Double-Blind, Placebo-Controlled, Randomized Study Of Celecoxib (Sc-58635) In Oral Premalignant Lesions, Investigator IND
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Precancerous Conditions
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2002-05-09
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Reduction in size and number of oral premalignant lesions


Eligibility criteria: Inclusion Criteria:

* 8mm oral premalignant lesion that has not been biopsied in the past 6 months

Exclusion Criteria:

* Taking \>100mg daily dose of NSAIDS (Non-steroidal anti-inflammatory drugs)

Primary outcomes:
measure: To evaluate the efficacy of celecoxib in subjects with Early or Advanced oral premalignant lesion (OPL)
measure: by both clinical response (reduction in size of all lesions,
measure: prevention of growth in the index lesion and of any new lesions)
measure: and histological response (change in histological grade).
measure: To evaluate the safety of chronic multiple dosing of celecoxib in this patient population.
Secondary outcomes:
measure: To evaluate the treatment effects in modulating the expression of genomic and proliferative markers after 12 weeks of treatment with study drug, followed by 12 weeks off study drug.
Other outcomes:
Locations:
city: Farmington
country: United States
facility: Pfizer Investigational Site
state: Connecticut
city: Shreveport
country: United States
facility: Pfizer Investigational Site
state: Louisiana
city: Ann Arbor
country: United States
facility: Pfizer Investigational Site
state: Michigan
city: Minneapolis
country: United States
facility: Pfizer Investigational Site
state: Minnesota
city: New York
country: United States
facility: Pfizer Investigational Site
state: New York
city: Houston
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Seattle
country: United States
facility: Pfizer Investigational Site
state: Washington
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT04453683: Airway Management in Morbidly Obese Patients: A Comparison of Intubating Laryngeal Mask Fastrack and Air Q as a Conduit for Fiberoptic Intubation
Official title: Airway Management in Morbidly Obese Patients: A Comparison of Intubating Laryngeal Mask Fastrack and Air Q as a Conduit for Fiberoptic Intubation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intubation; Difficult or Failed
Lead sponsor: Zagazig University
Sponsor class: OTHER_GOV
First posted: 2020-07-01
Enrollment: 80
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: To compare air Q versus ILMA intubation in obese adult paralyzed patient

Detailed description: Evaluate the process of endo-tracheal intubation through Air Q compared to through ILMA regarding number and duration of attempts, laryngeal view grade, time to removal of device over tube without dislodgement and any complication

Eligibility criteria: Inclusion Criteria:All morbidly obese patient defined as BMI \>40 kg/m2 scheduled for an elective surgery requiring general anesthesia with tracheal intubation were enrolled on the day of their surgery.

ASA physical status (I-II)

Exclusion Criteria physical status of IV or V or had a history of impossible tracheal intubation or awake fibreoptic intubation or if preoperative evaluation showed limited mouth aperture \<3.5 cm or showed evidence that an awake fiberoptic intubation or rapid sequence induction would be required patients at increased risk for aspiration of gastric contents, coagulopathy or those with unstable cervical spines or requiring nasal route for tracheal intubation

-

Primary outcomes:
measure: success rate of tracheal intubation through each device.
timeFrame: Within a maximum of 5 minutes to confirm success of tracheal intubation through each supraglottic airway devices
Secondary outcomes:
measure: Insertion time of supraglottic airway devices
timeFrame: It is about 13-19 second for insertion of supraglottic airway devices
Other outcomes:
Locations:
city: Zagazig
country: Egypt
facility: Zagazig University
Study officials:
affiliation: Zagazig University
name: Heba M EL-Asser, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Zagazig University
name: Khadiga M El Hossiney, MD
role: STUDY_CHAIR
affiliation: Zagazig University
name: Amani A Aly
role: STUDY_CHAIR
References:
citation: Frappier J, Guenoun T, Journois D, Philippe H, Aka E, Cadi P, Silleran-Chassany J, Safran D. Airway management using the intubating laryngeal mask airway for the morbidly obese patient. Anesth Analg. 2003 May;96(5):1510-1515. doi: 10.1213/01.ANE.0000057003.91393.3C.
citation: Karim YM, Swanson DE. Comparison of blind tracheal intubation through the intubating laryngeal mask airway (LMA Fastrach) and the Air-Q. Anaesthesia. 2011 Mar;66(3):185-90. doi: 10.1111/j.1365-2044.2011.06625.x.
Clinical trial NCT02889783: Urethral Sensory Profile: a New Technique to Evaluate Urethral Sensation Prospective Evaluation in Patients With or Without Neurological Disorders
Official title: Urethral Sensory Profile: a New Technique to Evaluate Urethral Sensation Prospective Evaluation in Patients With or Without Neurological Disorders
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Urethral Cyst
Keywords: urodynamics
urethral sensation
urethral pain
Lead sponsor: Groupe de Recherche Clinique en Neuro-Urologie
Sponsor class: OTHER
First posted: 2016-09-07
Enrollment: 183
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients consulting for an urodynamic study in our tertiary care unit.

Brief summary: This is a routine evaluation of urethral sensation during urodynamic studies. The record has been realized retrospectively. The investigators propose a new way to represent urethral sensation, in a simple and non-invasive way.

Detailed description: All patients consulting for urodynamics were included. During the introduction of the urinary catheter for urodynamic evaluation, patients were asked to report pain and/or desire to void felt at every centimeter (cm)of insertion, on an analogic visual scale graded from 0 to 10. The USP was defined by the graphic representation of the successive values of these sensations , from the urinary meatus, to the urinary bladder.

Eligibility criteria: Inclusion Criteria:

* patients consulting in our department for a urodynamic study

Exclusion Criteria:

* chronic pelvic pain
* difficulties for understanding or for communicating

Primary outcomes:
measure: Urethral Sensitive profile
timeFrame: mars 2015
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Weglinski
Study officials:
affiliation: UPMC, Sorbonne Université, Univ Paris 6, service neuro-urologie, hôpital TENON, Paris
name: Gerard Amarenco, MD PHD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06073483: Exploratory Study of Toumai Endoscopic Surgery System for Remote Gastrectomy
Official title: Exploratory Study of Toumai Endoscopic Surgery System for Remote Gastrectomy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Gastric Cancer
Lead sponsor: Hebei Medical University
Sponsor class: OTHER
First posted: 2023-10-10
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This clinical study was a prospective, single-center, single-arm exploratory study. Subjects who meet the inclusion criteria will be enrolled in this study, where surgeons will perform 5G remote gastrectomy on subjects using the Toumai endoscopic surgery system, and explore and evaluate the safety and efficacy of this clinical application.


Eligibility criteria: Inclusion Criteria:

1. 18 years old ≤ actual age ≤80 years old.
2. Patients requiring gastrointestinal endoscopic surgery.
3. Willing to cooperate with and complete the study follow-up and related examinations.
4. Voluntarily participate in the study and sign the informed consent in person.

Exclusion Criteria:

1. Have serious cardiovascular or circulatory disease and cannot tolerate surgery.
2. Participated in other clinical trials within the last 3 months.
3. Inability to understand trial requirements, or inability to complete the study follow-up plan.
4. Researchers believe that there are other circumstances that are not suitable for inclusion.

Primary outcomes:
measure: The rate of intraoperative complications
timeFrame: The day of surgery
measure: The rate of postoperative complications
timeFrame: Postoperative 30 days
Secondary outcomes:
measure: Intraoperative system failure rate
timeFrame: The day of surgery
measure: Surgical completion rate
timeFrame: The day of surgery
measure: Intraoperative blood loss
timeFrame: The day of surgery
measure: Operation time
timeFrame: The day of surgery
measure: Preoperative device assembly time
timeFrame: The day of surgery
measure: Intraoperative instrument operation error rate
timeFrame: The day of surgery
Other outcomes:
Locations:
city: Shijiazhuang
country: China
facility: Department of General Surgery
state: Hebei
Study officials:
References:
Clinical trial NCT06371183: A Comparative Study of Clinical, Endoscopic and Histopathological Features of Colitis in Children
Official title: A Comparative Study of Clinical, Endoscopic and Histopathological Features of Colitis in Children
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Role of Ileoscopy in Diagnosis of Colitis
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2024-04-17
Enrollment: 196
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Patients who complaining of lower GI manifestations
Primary purpose: DIAGNOSTIC

Brief summary: A Comparative study of clinical, endoscopic and histopathological features of colitis in children

Detailed description: To find out the role of ileoscopy in diagnosis of colitis and compare clinical , endoscopic and histopathological manifestations of colitis

Eligibility criteria: Inclusion Criteria:

* 1. All patients diagnosed as colitis during the study period. 2. Age from 1 month to 18 years.

Exclusion Criteria:

1. Patients with lower gastrointestinal manifestations and weren't diagnosed as colitis during colonoscope.
2. Patients less than one month and more than 18 years.

Primary outcomes:
measure: Is ileoscopy indicated for all children complaining of colitis on 196 patient
timeFrame: 2years
Secondary outcomes:
measure: To correlate clinical manifestations by colonoscopic picture
timeFrame: 2years
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00761683: Non-Interventional Study to Evaluate Effect of Zoladex In EndometrioSIS
Official title: Non-Interventional Study to Evaluate Effect of Zoladex In EndometrioSIS
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Endometriosis
Keywords: Endometriosis
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2008-09-29
Enrollment: 105
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The programme will include the patients diagnosed with endometriosis that the doctors have already decided to treat with Zoladex within the last month, before inclusion in this program.

Brief summary: To observe the effect of goserelin 3,6mg sc depot injection by assessment of the mean percent reduction scores for symptoms: dysmenorrhoea, dyspareunia and pelvic pain; to observe the effect of goserelin 3,6mg sc depot injection by assessment of the mean percent reduction scores for pelvic tenderness and indurations; to observe the reduction in the proportion of patients requiring analgesics for the relief of pelvic pain for 6 months in patients treated with Zoladex 3.6 mg.


Eligibility criteria: Inclusion Criteria:

* patients diagnosed with endometriosis that the doctors have already decided to treat with Zoladex within the last month, before inclusion in this program, according to Romanian approved goserelin 3,6 mg

Exclusion Criteria:

* patients who have a known hypersensitivity to goserelin (Zoladex) or any of its excipients or any other GnRH analogue, pregnancy, according to Romanian approved goserelin 3,6 mg SmPC

Primary outcomes:
measure: Biberoglu and Bergham Scale
timeFrame: monthly/ at every clinic visit- 6 times for symptoms: dysmenorrhoea, dyspareunia and pelvic pain
Secondary outcomes:
measure: Biberoglu and Bergham Scale
timeFrame: twice/first and last clinic visit for pelvic tenderness and indurations
Other outcomes:
Locations:
city: Bucuresti
country: Romania
facility: Research Site
city: Cluj-Napoca
country: Romania
facility: Research Site
city: Timisoara
country: Romania
facility: Research Site
Study officials:
affiliation: AstraZeneca Romania
name: Cristina Pentiuc
role: STUDY_DIRECTOR
References:
Clinical trial NCT00709683: Observational Study to Evaluate the Safety of NovoMix® 30 FlexPen®
Official title: An Observational Study Evaluating the Safety and Efficacy of the Treatment With Biphasic Insulin Aspart (NovoMix® 30 FlexPen®) in the Treatment of Type 2 Diabetics After Failing on Basal/ Intermediate Mono or Combination Therapy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes
Diabetes Mellitus, Type 2
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2008-07-03
Enrollment: 216
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Type 2 diabetic patients

Brief summary: This study is conducted in Africa. The aim of this observational study is to evaluate the incidence of adverse events while using NovoMix® 30 FlexPen® under normal clinical practice conditions.


Eligibility criteria: Inclusion Criteria:

* Type 2 diabetes having failed on basal insulin with or without OAD
* HbA1c greater than 7.0%

Exclusion Criteria:

* Subjects being unlikely to comply with protocol requirements
* Subjects who previously enrolled in this study
* Subjects with hypersensitivity to biphasic insulin aspart or any of the excipients
* Women who are pregnant, breast feeding and women in child bearing capacity who are not using reliable contraceptive method

Primary outcomes:
measure: Incidence of major hypoglycaemic events reported as serious adverse drug reactions
timeFrame: during 26 weeks of treatment
Secondary outcomes:
measure: Number of serious adverse drug reactions
timeFrame: during 26 weeks of treatment
measure: Number of serious adverse events
timeFrame: during 26 weeks of treatment
measure: Number of all major (daytime and nocturnal) hypoglycaemic events
timeFrame: during 26 weeks of treatment
measure: Number of all minor (daytime and nocturnal) hypoglycaemic events
timeFrame: during 26 weeks of treatment
measure: Weight (BMI) change from baseline
timeFrame: At the end of the study
measure: HbA1c change from baseline
timeFrame: At the end of the study
measure: Percentage of patients reaching the target of HbA1c of less than or equal to 7.0%
timeFrame: At the end of the study
measure: Average (mean) fasting plasma glucose level
timeFrame: At the end of the study
measure: Average post-breakfast (90-120 mins), post-lunch (90-120 mins), post-dinner (90-120 mins) plasma glucose level
timeFrame: At the end of the study
Other outcomes:
Locations:
city: Tunisia
country: Tunisia
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References: