louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06966024: Study of DCC-2812 in Participants With Advanced Genitourinary Cancers
Official title: An Open-label, Phase 1 Study of DCC-2812 Monotherapy in Participants With Advanced or Metastatic Renal Cell Carcinoma, Urothelial Cancer, or Castration-Resistant Prostate Cancer
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
Conditions: Renal Cell Carcinoma
Urothelial Carcinoma
Castration-resistant Prostate Cancer
Keywords: Advanced malignancies
Lead sponsor: Deciphera Pharmaceuticals, LLC
Sponsor class: INDUSTRY
First posted: 2025-05-11
Enrollment: 60
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: This is a multicenter clinical trial to evaluate the safety and preliminary activity of the selective general control nonderepressible 2 (GCN2) activator DCC-2812 as monotherapy in advanced/metastatic renal cell carcinoma (RCC), urothelial carcinoma, and castration-resistant prostate cancer.


Eligibility criteria: Key Inclusion Criteria:

* Have confirmed Advanced or Metastatic Renal Cell Carcinoma, Urothelial Cancer, or Castration-Resistant Prostate Cancer
* Able to take oral medication
* If a female is of childbearing potential, must have a negative pregnancy test prior to enrollment and all participants agree to follow the contraception requirements
* Adequate organ function and electrolytes

Key Exclusion Criteria:

* Received any prior anticancer therapy or any investigational therapy within a specified timeframe prior to first dose of DCC-2812
* Impaired cardiac function
* Major surgery within 28 days of the first dose of study drug

Primary outcomes:
measure: Number of Participants with Dose-limiting Toxicities (DLTs)
timeFrame: Cycle 1 (28 days)
measure: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
timeFrame: Up to 42 months
measure: Number of Participants With Dose Reduction, Interruption, or Discontinuation of Study Drug Due to TEAEs
timeFrame: Up to 42 months
Secondary outcomes:
measure: Radiographic Objective Response Rate (rORR) per RECIST v1.1
timeFrame: Up to 42 months
measure: Radiographic Duration of Response (rDOR) per RECIST v1.1
timeFrame: Up to 42 months
measure: PK: Maximum Observed Plasma Drug Concentration (Cmax)
timeFrame: Predose up to 24 hours postdose (up to 42 months)
measure: PK: Time to Reach Cmax (Tmax)
timeFrame: Predose up to 24 hours postdose (up to 42 months)
measure: PK: Area Under the Plasma Concentration-time Curve (AUC)
timeFrame: Predose up to 24 hours postdose (up to 42 months)
measure: PK: Trough Plasma Concentration (Ctrough)
timeFrame: Predose up to 24 hours postdose (up to 42 months)
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02937324: The CloudUPDRS Smartphone Software in Parkinson's Study.
Official title: The CloudUPDRS Smartphone Software in Parkinson's Study - a Pilot Dual-site, Open Label Study Comparing the Validity of Smartphone Software for Monitoring the Symptoms and Signs of Parkinson's Disease.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Parkinson's Disease
Lead sponsor: University College, London
Sponsor class: OTHER
First posted: 2016-10-18
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: This study compares the validity and usability of smartphone software for home monitoring of symptoms and signs in Parkinson's disease as compared to the current clinical gold standard - the Unified Parkinsons Disease Rating Scale.

Detailed description: Parkinson's Disease (PD) is a neurodegenerative condition, which when treated can result in fluctuating motor activity - sometimes too much movement, sometimes too little.

A series of tests, run on a smartphone, will be used to evaluate the motor signs of Parkinson's and related to a clinical evaluation based on the Unified Parkinson's Disease Rating Scale. 60 participants will be recruited.

Eligibility criteria: Inclusion Criteria:

1. Diagnosed with probable idiopathic Parkinson's Disease according to Brain Bank criteria (Gibb and Lees, 1988).
2. Over 18 years old.
3. Achieve \>20/30 on the Montreal Cognitive Assessment (MOCA).
4. They must have been on the current Parkinson's Disease medication schedule for at least a week and have no plans to change this during the period of testing.
5. They must have the capacity to consent to take part in the study.
6. They must be able to understand English to the level of being able to operate the phone software, follow its instructions and be able to answer the study questions.

Exclusion Criteria:

1. Acute medical illness.
2. Any other co-morbidity that in the opinion of the Investigator may preclude their participation in the study.
3. Unable to consent to the study.

Primary outcomes:
measure: Validity of smartphone software for home monitoring in Parkinson's disease
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
measure: Data exploration
timeFrame: 3years
Locations:
city: London
country: United Kingdom
facility: Ashwani Jha
Study officials:
affiliation: University College, London
name: Kailash Bhatia, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02656524: Stivarga Real Life Evidence in Hungary
Official title: Effectiveness of Stivarga (Regorafenib) for Patients With Metastatic Colorectal Cancer in the Hungarian Real World Setting
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colorectal Neoplasms
Keywords: Metastatic colorectal cancer
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2016-01-15
Enrollment: 400
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population will be all patients who met the criteria within the SmPC. Using the National Health Insurance Database, patients will be included in this retrospective data analysis if they had at least one dose of regorafenib treatment cycle.

Brief summary: The study aims to evaluate use of regorafenib in clinical practice in Hungary. The study should provide information about clinical characteristics of Hungarian regorafenib patients as well as information about safety and efficacy of regorafenib in Hungarian patients with metastatic colorectal cancer. This much needed data is required by the National Health Insurance Fund in order to accept regorafenib into the regular reimbursement system. This study is proposed to be based on patient data from the Hungarian National Health Insurance Fund's Database. Data to be analyzed includes patient demography and baseline tumor characteristics, overall survival, time to treatment failure, duration of treatment, average dose and dose modifications, and adverse events. Further, treatment costs will be estimated.


Eligibility criteria: Inclusion Criteria:

* Using the National Health Insurance Database, patients will be included in this retrospective data analysis if they had at least one dose of regorafenib treatment cycle (=28 days).

Exclusion Criteria:

* Not applicable

Primary outcomes:
measure: Length of treatment for each treatment episode
timeFrame: Retrospective analysis of 2 year period
measure: Progression Free Survival (PFS)
timeFrame: Retrospective analysis of 2 year period
measure: Overall Survival (OS)
timeFrame: Retrospective analysis of 2 year period
measure: Number of participants with treatment emergent adverse events as a measure of safety and tolerability
timeFrame: Retrospective analysis of 2 year period
Secondary outcomes:
measure: Resource utilization per patient
timeFrame: Retrospective analysis of 2 year period
Other outcomes:
measure: Time to treatment failure (TTF)
timeFrame: Retrospective analysis of 2 year period
measure: Time to progression (TTP)
timeFrame: Retrospective analysis of 2 year period
measure: Characteristics of patients with better response
timeFrame: Retropsective analysis of 2 year period
measure: Time frame between the baseline computed tomography and the first drug delivery
timeFrame: Retrospective analysis of 2 year period
Locations:
city: Budapest
country: Hungary
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT04974424: Early Warning Model of Susceptibility and High-risk Population of Cervical Cancer Related to HPV
Official title: Study on Early Warning Model of Susceptibility and High-risk Population of Cervical Cancer Related to HPV
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Uterine Cervical Neoplasm
Uterine Cervical Cancer
Cervical Cancer
Lead sponsor: Huazhong University of Science and Technology
Sponsor class: OTHER
Collaborators: name: Women's Hospital School Of Medicine Zhejiang University
name: Obstetrics & Gynecology Hospital of Fudan University
name: Qilu Hospital of Shandong University
name: Wuhan Central Hospital
name: Third Military Medical University
name: Xiangyang Central Hospital
name: Shenzhen Second People's Hospital
First posted: 2021-07-23
Enrollment: 20000
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Chinese population

Brief summary: Most uterine cervical high-risk human papillomavirus (HPV) infections are transient, with only a small fraction developing into cervical cancer. Family aggregation studies and heritability estimates suggest a significant inherited genetic component. Candidate gene studies and previous genome-wide association studies (GWASs) report associations between the HLA region and cervical cancer. Adopting a genome-wide approach, we aimed to establish an early warning model for a high-risk population of cervical cancer.


Eligibility criteria: Inclusion Criteria:

* (1) Case group a) Aged 25-75 years. b) Han nationality. c) Patients with cervical cancer or cervical precancerous lesions above CIN2 diagnosed by biopsy or postoperative pathological diagnosis.
* (2) Control group: a) Aged 25-75 years. b) Han nationality. c) No family history of cervical cancer or precancerous lesions. d) The results of TCT examination showed no abnormality.

Exclusion Criteria:

* (1) suffering from other neoplastic diseases.
* (2) pregnant women.
* (3) those with a history of bone marrow transplantation.

Primary outcomes:
measure: Significant loci of genetic variation
timeFrame: 2
Secondary outcomes:
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Tongji Hospital
state: Hubei
Study officials:
affiliation: Huazhong University of Science and Technology
name: Ding Ma, MD, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT01958424: In Vitro Fertilization Outcomes in Metabolic Syndrome
Official title: The Influence of Metabolic Syndrome on in Vitro Fertilization Treatment Outcome
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Metabolic Syndrome
Keywords: metabolic syndrome
in vitro fertilization
c reactive protein
over-weight women
ovarian stimulation
Lead sponsor: Meir Medical Center
Sponsor class: OTHER
First posted: 2013-10-09
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: women undergoing ivf treatment in "Meir" medical center in "Kfar-Saba, Israel

Brief summary: The purpose of this study is to examine the effect of metabolic syndrome in over-weight women on IVF treatment outcomes.

Detailed description: This porpuse of the study is to examine the physiology of CRP during the IVF cycle in and to evaluated the effect of CRP in patient with and without metabolic syndrome on IVF outcomes

Eligibility criteria: Inclusion Criteria:

* women undergoing ivf treatment

Exclusion Criteria:

* inflammatory disease
* acute conditions

Primary outcomes:
measure: success or failure of ivf treatment
timeFrame: within 1 year from intiation of ivf treatment
Secondary outcomes:
measure: blood levels of C-reactive protein
timeFrame: within 1 year from initiation of ivf treatment
measure: follicle liquid levels of C-reactive protein
timeFrame: within 1 year from initiation of ivf treatment
Other outcomes:
Locations:
city: Kfar-Saba
country: Israel
facility: Sapir Medical Center, Meir Hospital
Study officials:
affiliation: "Meir", Medical centere
name: Amir Waiser, M.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05849324: Intravascular Injection Rate During Lumbar Transforaminal Epidural Block Using Bent or Straight Needles
Official title: The Difference of Intravascular Injection Rate During Lumbar Transforaminal Epidural Block Using Bent Needle Compared to Straight Needle: a Prospective Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Analgesia, Epidural
Lead sponsor: Kyungpook National University Hospital
Sponsor class: OTHER
First posted: 2023-05-08
Enrollment: 260
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: SCREENING

Brief summary: The primary aim of this study was to compare intravascular injection rates during LTFESI between commonly used straight and bent chiba needles.

Detailed description: Lumbar transforaminal epidural steroid injection (LTFESI) is widely used in clinical practice to effectively deliver injectate into the ventral epidural space. Complications associated with intravascular injection such as spinal cord infarction and paraplegia can occur during LTFESI. The incidence of intravascular injection during LTFESI was known as 9.9% \~ 17.7%. To improve the safety of the procedure, avoidance of intravascular injection is crucial, for which appropriate needle selection is important. Currently, the most commonly used block needles in LTFESI are straight or bent chiba needles.

The primary aim of this study was to compare intravascular injection rates during LTFESI between commonly used straight and bent chiba needles.

Eligibility criteria: Inclusion Criteria:

* Patients with radiating pain from lumbar spinal stenosis and herniated nucleus pulposus.

Exclusion Criteria:

* Pregnancy, allergic to contrast media, patient refusal, and patients with persistent contraindication to nerve block such as coagulopathy and infection of the injection site.

Primary outcomes:
measure: Intravascular injection
timeFrame: During procedure
Secondary outcomes:
measure: Ventral epidural spreading
timeFrame: up to 24 weeks
measure: Medial epidural spreading
timeFrame: up to 24 weeks
measure: Procedure time
timeFrame: During procedure
Other outcomes:
Locations:
city: Daegu
country: Korea, Republic of
facility: Kyungpook national university hospital
Study officials:
affiliation: Kyungpook National University Hospital
name: Saeyoung Kim
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00787124: Transfusions and Nitric Oxide Level in Preterm Infants
Official title: Transfusions and Nitric Oxide Level in Preterm Infants
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Prematurity
Anemia
Necrotizing Enterocolitis
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: Children's Miracle Network
First posted: 2008-11-07
Enrollment: 8
Sex: ALL
Maximum age (years): 365
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Infants \< 28 weeks gestation at birth undergoing a packed red blood cell transfusion

Brief summary: The purpose of this study is to better understand S-nitrosohemeglobin (SNO-Hb) in transfused blood of extremely preterm infants. The long term goal of the project is to identify variation in the SNO-Hb between packed red blood cell units, and between and among individual preterm infants pre and post-transfusion. Duke investigators are developing methods to replenish SNO-Hb, which, if successful, would improve RBC deformation in addition to providing a vasodilatory stimulation to hypoxic tissue, and lead to a randomized clinical trial testing treated vs. untreated RBC transfusions in extremely premature infants.

AIM 1. Measure the Total Hemoglobin (Hb)-bound nitric oxide (NO), Hb \[Fe\] NO, SNO-Hb (a calculated value = (total Hb-NO - Hb \[Fe\] NO) in blood to be transfused in extremely preterm babies, and in samples pre and post- transfusion from the babies.

Hypothesis 1: Measures of NO and SNO-Hb will be low in blood used for transfusion in preterm infants and will be decreased in the post-transfusion samples from the infants compared with the pre-transfusion samples.

AIM 2. Collect clinical data about study participants, including oxygen saturation and measures of perfusion pre and post-transfusion.

Hypothesis 2: Measures of perfusion will be reduced by 20% post-transfusion in extremely preterm infants.


Eligibility criteria: Inclusion Criteria:

* Infant \< 28 weeks gestation at birth
* Undergoing PRBC transfusion with a volume ≥ 10 cc/kg
* Availability and willingness of the parent/legally authorized representative to provide written informed consent.

Exclusion Criteria:

* Any concomitant condition, which in the opinion of the investigator would preclude a patient's participation in the study
* Previous participation in the study.

Primary outcomes:
measure: SNOHgB Levels
timeFrame: beginning and end of study
Secondary outcomes:
measure: Oxygen Saturation and Measures of Perfusion Pre and Post-transfusion.
timeFrame: prior to, during, after transfusion
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
affiliation: Duke University
name: P Brian Smith, MD MHS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04116424: VIGIP-SEP2: Evaluation of the Impact of the Training of Patients by a Nurse on the Adverse Drug Reaction Reporting by RRMS Patient Via a Mobile Application: Randomized Real-life Study
Official title: VIGIP-SEP2: Evaluation of the Impact of the Training of Patients by a Nurse on the Adverse Drug Reaction Reporting by RRMS Patient Via a Mobile Application: Randomized Real-life Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Multiple Sclerosis
Lead sponsor: University Hospital, Caen
Sponsor class: OTHER
First posted: 2019-10-04
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The patient's reporting of adverse drug reactions (ADRs) is recognized as being of interest for post-marketing safety monitoring, but is still underdeveloped in France, with an average lower than the European average. A multidisciplinary team of the University Hospital of Caen, composed of neurologists and pharmacovigilants, has been carrying out since autumn 2017 a national study (VIGIP-SEP1) with 24 research centers in France (12 universitary hospitals, 6 general hospitals, and 6 private-practice neurologists) whose main objective was to evaluate the impact of multiple sclerosis (MS) patients' use of a mobile application (App) to report their ADRs. My eReport France® has been developed by the eVedrug company: ADR reports are sent by patients directly to the Regional Pharmacovigilance Centers, after analyze, clinical pharmacologist send it to the National Competent Authority. As part of VIGIP-SEP1, the accompaniment for the use of the App was carried out very simply by neurologists.

We designed a randomized controlled trial based on the assumption that a nurse training of the patient, after the initial prescription of an oral MS drug, with a telephone follow-up within 6 months, will increase by 3 times the number of patients who report ADRs compared to a simple information presented by the neurologist. The number of subjects required is 23 subjects per group.


Eligibility criteria: Inclusion Criteria:

* more than 18 years
* multiple sclerosis in initiation with a DMT
* patient informed and who gave informed consent

Exclusion Criteria:

* patient without mobile or tablet

Primary outcomes:
measure: number of patients who reported at least one ADR
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03445624: Abdominal Ultrasound With Doppler and Peripheral Hemogram in Assesment Inflammatory Bowel Disease
Official title: Abdominal Ultrasound With Doppler and Peripheral Hemogram in Assesment Inflammatory Bowel Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Inflammatory Bowel Diseases
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2018-02-26
Enrollment: 60
Sex: ALL
Minimum age (years): 15
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: all patients diagnosed inflammatory bowel disease (ulcerative colitis and crohns disease) at age(15 -60)

Brief summary: assessment of inflammatory bowel disease patients in activity and remission by abdominal ultrasound examine non-invasive and in physiological condition by measuring the colon wall thickness in diagnosis and follow up the patient also including extra intestinal features such as the splanchnic vessels,mesentery and lymph nodes . Doppler u.s can evaluate bowel wall vascularity In activity and remission . peripheral hemogram in relationship to activity inflammatory bowel disease asses anemia ,increase monocyte and decrease mean platelet volume( MPV) . also,the investigator will evaluate the outcome of different lines of treatment traditional and biologic therapy (response to treatment,times of activity and complications)

Detailed description: the participants will follow up the patient for 1 year in the first visit

All patients in this study will be subjected to:

1. Detailed history.
2. Careful physical examination
3. laboratory investigation

   1. complete blood picture.
   2. liver function
   3. kidney function
   4. Iron profile(serum iron ,serum ferritin
   5. ESR (erythrocyte sedimentation rate )

   g-CRP (C reactive protein) f-LDH (lactate dehydrogenase)
4. Abdominal us(the colon wall thickness,lymph nodes,mass,other organs)
5. Doppler us (mesenteric vessels)
6. colonoscopy after 1 year of treatment follow up every 3 months by abdominal US and peripheral hemogram and last visit after 1 year colonoscopy and biopsy for assessment response to treatment

Eligibility criteria: Inclusion Criteria

* patients diagnosed ulcerative colitis at age(15-60)
* patients diagnosed crohns disease at age(15-60)k

Exclusion criteria

* liver cirrhosis and portal hypertension
* spontaneous bacterial peritonitis
* Ischemic colitis

Primary outcomes:
measure: the role abdominal ultrasound in assessment inflammatory bowel disease
timeFrame: 2 year
Secondary outcomes:
Other outcomes:
measure: Assesment inflammatory bowel disease by complete blood picture
timeFrame: 2year
Locations:
city: Assiut
country: Egypt
facility: Hyam Fathy
Study officials:
affiliation: lecturer of internal medicine
name: ahmed ashmawy
role: STUDY_DIRECTOR
References: