louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01818843: The Safety and Adverse Reaction Study of Neonatal to Inhaled Carbon Monoxide
Official title: Phase 1 Study of Inhaled Carbon Monoxide on the Effectiveness of Neonatal Pulmonary Hypertension
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Miscellaneous Disorders in the Fetus or Newborn
Keywords: Carbon monoxide
safety
Adverse Reaction
newborn
Lead sponsor: Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
Sponsor class: OTHER
Collaborators: name: Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
First posted: 2013-03-27
Enrollment: 24
Sex: ALL
Minimum age (years): 1
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Based on the study about carbon monoxide in human inflammatory and other beneficial physiological function , now we'll be going to research its application in neonates .Phase 1 Study as a foundation for the further test is, the safety and Adverse reaction study of newborn to inhaled CO

Detailed description: Previous studies have demonstrated that, carbon monoxide has showed the effectiveness such as in inflammation ,apoptosis as well as relaxation of smooth muscle of the body. Now we have a hypothesis to use carbon monoxide in pulmonary hypertension of the newborns, to observe whether it will decrease pulmonary artery hypertension on newborns. Phase 1 study is ,the safety and Adverse reaction study of newborn to inhaled CO , after this,we can master the application of carbon monoxide dose

Eligibility criteria: Inclusion Criteria:

* The newborn whose physiological function is healthy or close to healthy

Exclusion Criteria:

* Clinical considerations cannot survive or no treatment value of newborn Diagnosis of congenital or hereditary diseases, or children with heart diseaseCentral pulmonary vascular malformations in children

Primary outcomes:
measure: Number of participants with adverse events
timeFrame: up to 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: ChongQing
country: China
facility: Daping Hospital
state: Chongqing
Study officials:
References:
Clinical trial NCT05805943: Study of IMM0306 in Patients With Relapsed or Refractory CD20-positive B-cell Non-Hodgkin's Lymphoma
Official title: Phase I/II Study of IMM0306 in Patients With Relapsed or Refractory CD20-positive B-cell Non-Hodgkin's Lymphoma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: CD20-positive B-cell Non-Hodgkin's Lymphoma
Lead sponsor: ImmuneOnco Biopharmaceuticals (Shanghai) Inc.
Sponsor class: OTHER
First posted: 2023-04-10
Enrollment: 154
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 Phase I/II, Single-Arm, Open-Label, Multicentre Study to Evaluate the Safety and Efficacy of IMM0306 in Patients with Relapsed or Refractory B-Cell Non- Hodgkin's Lymphoma (R/R B-NHL).


Eligibility criteria: Inclusion Criteria:

* Relapsed or refractory CD20-positive B-cell non-Hodgkin's lymphoma (B-NHL) that has been diagnosed, including but not limited to diffuse large B-cell lymphoma (DLBCL) Follicular lymphoma (FL), mucosal lymphoma (MALT-L), small lymphocytic lymphoma (SLL) / chronic lymphocytic leukemia (CLL).
* At least one measurable or assessable tumor lesion.
* Adequate organ and hematologic function.
* Eastern Co-operative Oncology Group (ECOG) score 0 to 2.
* All adverse events from prior treatment must be CTCAE v5.0 grade \<= 1

Exclusion Criteria:

* Active central nervous system (CNS) lymphoma.
* Systemic steroid therapy (dose equivalent to \> 10 mg prednisone / day).
* History of severe allergic reactions to macromolecular protein preparations/monoclonal antibodies and any test drug components (CTCAE v5.0 grade \>=3).
* Have evidence of severe uncontrollable active infection.
* Subjects have deep vein embolism or pulmonary embolism within 6 months before screening.

Primary outcomes:
measure: Dose-limiting toxicity
timeFrame: Evaluated for DLTs during the first 28-day cycle
measure: Complete response rate
timeFrame: up to 52 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Cancer Hospital Chinese Academy of Medical Sciences
Study officials:
References:
Clinical trial NCT04278443: Fertility After Prostate Brachytherapy
Official title: A Single Site Prospective Descriptive Study on the Effect of Brachytherapy Monotherapy for Prostate Cancer on Male Fertility
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Prostate Cancer
Lead sponsor: East and North Hertfordshire NHS Trust
Sponsor class: OTHER_GOV
Collaborators: name: BXTAccelyon Ltd
First posted: 2020-02-20
Enrollment: 40
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Men undergoing brachytherapy for prostate cancer

Brief summary: Although brachytherapy toxicity data on erectile dysfunction, urethral dysfunction and bladder and bowel impact has been collected for a number of years, there is limited information on its effect on male fertility. This study aims to investigate the effect of brachytherapy on fertility

Detailed description: Brachytherapy is a commonly employed technique in the treatment of all prostate cancer risk groups. It delivers a high radiation localised to the prostate gland. The effects of this on fertility have not been systematically studied. An increasing number of younger men for whom fertility is an issue are being diagnosed with prostate cancer and may be offered brachytherapy amongst their treatment choices. This study therefore addresses this issue with a systematic evaluation of sperm count and quality before and after both high dose rate and low dose rate brachytherapy.

Eligibility criteria: Inclusion Criteria:

* Male
* 18 years or older
* Receiving brachytherapy monotherapy; High or Low dose rate
* Ability to ejaculate
* Able to provide written informed consent

Exclusion Criteria:

* History of infertility or vasectomy
* Previous chemotherapy or pelvic radiotherapy
* Prior use of androgen deprivation therapy
* 5 alpha-reductase inhibitors within the last 4 months
* Alpha blockers within 7 days of semen collection

Primary outcomes:
measure: To define effect of prostate brachytherapy on male fertility.
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Northwood
country: United Kingdom
facility: East and North Hertfordshire NHS Trust
state: Middlesex
Study officials:
References:
Clinical trial NCT04325243: Sildenafil Citrate and Intrapartum Fetal Distress
Official title: Efficacy of Sildenafil Citrate to Reduce the Rate of Cesarean Section for Intrapartum Fetal Distress During Induction of Labor
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Fetal Distress
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2020-03-27
Enrollment: 410
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Induction of labour (IOL) is done for 20% of pregnancies for various maternal and fetal indications and nearly 20% of labour inductions end up in caesarean section. The most common causes are failed induction and intrapartum fetal distress. In spite of significant advances in methods of IOL and intrapartum fetal monitoring, no interventions are proven to reduce the development of intrapartum fetal distress


Eligibility criteria: Inclusion Criteria:

1. Singleton pregnancy.
2. Pregnant ≥ 37 weeks gestation.
3. Fetus with longitudinal lie and vertex presentation.
4. Healthy fetus with EFW\>2500 gm

Exclusion Criteria:

1. Patients with previous cesarean delivery or uterine surgery.
2. Antepartum hemorrhage.
3. Cephalopelvic disproportion.
4. Category II or III non-stress test.
5. Medical disease as hypertension, cardiac, renal and hepatic disorders
6. Intrauterine fetal death.
7. Fetal growth restriction.
8. Fetuses with major congenital malformations.
9. Women taking any anti-hypertensive medication, alpha-adrenergic blocking agents, calcium channel blockers (verapamil), nitrates, medications used to treat pulmonary arterial hypertension, and other phosphodiesterase type 5 inhibitors.
10. Women with a contra-indication to sildenafil treatment such as hypersensitivity to sildenafil.

Primary outcomes:
measure: The rate of cesarean section for intrapartum fetal distress
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Ahmed Abbas
state: Cairo
Study officials:
References:
Clinical trial NCT00872443: Interest of Occlusion of Permeable Foramen Ovale After a Cryptogenic Cerebrovascular Accident (CVA)
Official title: Interest of Occlusion of Permeable Foramen Ovale After a Cryptogenic Cerebrovacular Accident.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Permeable Foramen Ovale
Cerebrovascular Accident
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2009-03-31
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patient who had an occlusion of POF after CVA, younger than 55 years and without thromboembolic events.

Brief summary: Facing the lack of recommandations of Neurology and cardiology societies, the investigators decided in 2002 some Good Medical Practices to define a specific and precise population for whom the closure of permeable oval formaen after a first CVA seem to be necessary. Current survey of these patients after implantation of a prothesis in interauricular septum is defined by a consultation at 1, 3 and 6 months after surgery for a clinical exam and an echocardiography. One year after implantation, the investigators systematically realized a control by MRI associated to a contrast echography.

In the aim of evaluating the investigators' medical practice, the investigators decided to do an observational study which will permit us to judge of the interest or lack of interest of our "Good medical practice" before the publication of prospective and randomised clinical studies.


Eligibility criteria: Inclusion Criteria:

* less than 55 years old
* occlusion of FOP after cryptogenic CVA

Exclusion Criteria:

* characterized thromboembolic event
* patients who have a surgery after transitory ischemic accident

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Nantes
country: France
facility: Nantes University Hospital
Study officials:
References:
Clinical trial NCT05756543: Counterfactual Thinking and Decision-making in Parkinson's Disease
Official title: Counterfactual Thinking About Clinical Decision and Decision-making in the Context of the Parkinson's Disease.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Parkinson Disease
Keywords: counterfactual thinking
decision-making
neuropsychological assessment
clinical setting
Lead sponsor: Istituto Auxologico Italiano
Sponsor class: OTHER
Collaborators: name: Istituti Clinici Scientifici Maugeri SpA
First posted: 2023-03-06
Enrollment: 102
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants with Parkinson's Disease will be consecutively recruited at the beginning of a diagnostic recovery or rehabilitation treatment in the involved institutions.

Brief summary: The aim of this research is to verify the ability of counterfactual thinking about medical decisions in individuals affected by Parkinson's Disease when compared to healthy individuals.


Eligibility criteria: Inclusion criteria:

• Diagnosis of Parkinson's disease, according to the medical assessment performed by trained neurologists.

Exclusion Criteria:

* Diagnosis of Obstructive Sleep Apnea Syndrome, according to the clinical assessment;
* Concurrent neurological, neurodevelopmental (e.g., autism), motor, and/or psychiatric disorders;
* Dementia, according to the clinical/neuropsychological assessment.

Primary outcomes:
measure: CIT score
timeFrame: Baseline
Secondary outcomes:
measure: Decision-making index
timeFrame: Baseline
Other outcomes:
Locations:
city: Piancavallo
country: Italy
facility: IRCCS Istituto Auxologico Italiano - Ospedale San Giuseppe
state: VCO
Study officials:
affiliation: IRCCS Istituto Auxologico Italiano
name: Sofia Tagini, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05366543: Errors of Refraction Among Primary School Children
Official title: Errors of Refraction: Prevalence and Compliance of Wearing Correction Among Primary School Children
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Error, Refractive
Lead sponsor: Minia University
Sponsor class: OTHER
First posted: 2022-05-09
Enrollment: 150
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Primary school student less than 12 years with no sensory defects in their eyes

Brief summary: This study will include primary school children to evalute their refraction and follow those who will wear glasses to detect their compliance.

Visual acuity will be measured using autorefractometer after cycloplegic eye drops 3 times and glasses will be prescribed for those who are needed. Follow up of the students to detect their compliance of wearing correction.


Eligibility criteria: Inclusion Criteria:

* Primary school student less than 12 years.
* No sensory defect in those children.

Exclusion Criteria:

* Corneal opacity.
* Abnormal fundus lesion.

Primary outcomes:
measure: Visual acuity improvement
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Minya
country: Egypt
facility: Faculty of Medicine
state: Minia
Study officials:
References:
Clinical trial NCT00651443: Mechanism of Action of Galiximab in Subjects With Previously Untreated Follicular Non-Hodgkin's Lymphoma
Official title: A Phase I, Open Label Study to Evaluate the Mechanism of Action of Galiximab in Subjects With Previously Untreated Follicular Non-Hodgkin's Lymphoma
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Lymphoma, Non-Hodgkin's
Keywords: galiximab
Untreated NHL
antibody
open-label
Lead sponsor: Biogen
Sponsor class: INDUSTRY
First posted: 2008-04-02
Enrollment: 20
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: The purpose of the study is to evaluate the mechanism(s) of action of galiximab in subjects with previously untreated follicular NHL.


Eligibility criteria: Inclusion Criteria:

* Written informed consent (signed and dated).
* Age equal or greater than 18 at the time of consent.
* Histologically confirmed follicular NHL according to the Revised European American Lymphoma (REAL)/ World Health Organization (WHO) classification (from initial diagnosis) Grades 1,2, or 3a.
* At least 2 malignant lymph nodes of similar size (\>1 cm in minimal dimension) and location that are readily accessible for excisional biopsy at the time of study entry.
* Consent to 1 pretreatment and 1 post-treatment excisional biopsy of accessible tumor.
* Acceptable hematologic, hepatic, and renal function parameters.
* WHO Performance Status equal or less than 2.
* Subjects of reproductive potential must agree to follow accepted birth control methods.

Exclusion Criteria:

* Presence of lymphoma in CNS.
* Previous systemic anticancer treatment for NHL (including but not limited to radiation, myeloablative, or investigational therapy).
* Concurrent treatment with systemic steroids within 14 days of Day 1.
* Evidence of transformed lymphoma.
* Presence of malignancies within 3 years of Study Day 1 (except for adequately treated carcinoma in situ of the cervix, ductal carcinoma in situ (DCIS) of breast, or basal or squamous cell skin cancer).
* History of HIV infection or AIDS.
* Serious nonmalignant disease.
* Pregnant.
* Inability to comply with study and follow-up procedures.
* Any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding that contraindicates the use of an investigational drug.

Primary outcomes:
measure: Mechanism of action of galiximab given as a single agent in previously untreated subjects with follicular NHL.
timeFrame: 24 months
Secondary outcomes:
measure: 1) Safety and tolerability of Galiximab when administered as a single agent in an extended dosing regimen in previously untreated subjects with follicular NHL. 2) Evaluation of preliminary clinical activity of galiximab.
timeFrame: 48 months
Other outcomes:
Locations:
city: Buffalo
country: United States
facility: Research Site
state: New York
Study officials:
References:
Clinical trial NCT04041843: Oral Anticoagulant Apixaban for Treatment of Venous Thromboembolism
Official title: A Pilot Study of an Oral Anticoagulant "Apixaban" for theTreatment of Venous Thromboembolism in Children and Adolescents
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Venous Thromboembolism
Lead sponsor: New York Medical College
Sponsor class: OTHER
First posted: 2019-08-01
Enrollment: 25
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Patients who have developed a venous thrombosis will receive apixaban to treat and prevent a secondary thromboembolism.


Eligibility criteria: Inclusion Criteria:

* Children and adolescents with a newly diagnosed primary VTE.
* Treatment with apixaban has to begin within 72 hours of the diagnosis of VTE.
* Patients who have received heparin at the beginning of their diagnosis and are willing to switch to apixaban, are allowed to do so within 72 hours of their treatment. Patients who are switched to apixaban are not allowed to receive any other systemic anticoagulant therapy.
* VTE confirmed by diagnostic imaging.
* Children with body weight of ≥ 40 kg and are able to tolerate medication by mouth or administered via an NG or GT tube.
* Adequate liver function: AST and/or ALT \<5 times ULN, and/or Direct bilirubin \<2 times ULN
* Platelet count of at least ≥ 30,000/ul.
* Adequate renal function: \>30% of GFR for age
* Female subjects of childbearing potential must not be nursing or pregnant with negative urine pregnancy test within 72 hours prior to dosing with study medication.
* Signed written informed consent

Exclusion Criteria:

* Current or recent (within 3 months) apixaban administration.
* Patient is unable to tolerate medications by oral route or by n/g administration, peptic ulcer disease, intestinal obstruction, toxic megacolon, typhlitis, or short gut syndrome.
* History of primary bleeding disorder and first degree family history of bleeding disorder.
* Active bleeding or high risk of bleeding at the time of study entry.
* History of significant head injury and/or any history of intracranial hemorrhage.
* Conditions predispose to intracranial bleed; e.g. brain tumor, brain metastasis.
* Uncontrolled Grade 3 or 4 severe hypertension.
* History of allergy to apixaban or factor Xa inhibitors.

Primary outcomes:
measure: venous thromboembolism (VTE) formation
timeFrame: 7-90 days
Secondary outcomes:
measure: Doppler ultrasound vein imaging
timeFrame: day 8-15
Other outcomes:
Locations:
city: Valhalla
country: United States
facility: New York Medical College
state: New York
Study officials:
affiliation: New York Medical College
name: Oya Tugal, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00927043: Study Evaluating Renal Cell Carcinoma Risk Factors
Official title: Prospective, Multicenter, Epidemiological Study To Determine The Clinical, Molecular And Genetic Factors Associated To The Prognosis Of Patients With Advanced Renal Cell Carcinoma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Carcinoma, Renal Cell
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2009-06-24
Enrollment: 145
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Treatment naive patients with proven advanced RCC

Brief summary: This is an epidemiological, prospective, multicenter study designed to identify the pre-treatment clinical, molecular and genetic prognostic factors associated with progression free survival in patients naïve to renal cell carcinoma (RCC) treatment.

Detailed description: invitation to volunteer

Eligibility criteria: Inclusion Criteria:

* Treatment naïve patients with proven advanced RCC will be evaluated. (Except surgery or radiotherapy)
* =18 years, any gender.
* Patients with advanced Renal Cell Carcinoma and treatment naïve.

Exclusion Criteria:

* Patients who have already initiated any kind of specific therapy for the treatment of RCC.2.
* Patients with other neoplasias different from RCC (current or past).

Primary outcomes:
measure: Progression-free survival
timeFrame: 12 months
Secondary outcomes:
measure: Response rate.
timeFrame: 12 months
measure: Overall survival.
timeFrame: 12 months
Other outcomes:
Locations:
city: Pamplona
country: Spain
facility: Pfizer Investigational Site
state: Navarra
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: