louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02835079: Treatment Effect of Tamoxifen on Patients With DMD
Official title: Treatment Effect of Tamoxifen on Patients With DMD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Duchenne Muscular Dystrophy
Keywords: Duchenne Tamoxifen
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
First posted: 2016-07-15
Enrollment: 19
Sex: MALE
Minimum age (years): 5
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Duchenne muscular dystrophy (DMD) is a progressive devastating disease that affects mainly boys, with an incidence of about 1:3,500 live births. The pathology of DMD is a result of non-repaired muscle damage that leads to muscle-tissue replacement by scar tissue, a process known as fibrosis. Currently, there is no effective treatment for the disease. The only therapy offered to these boys are steroids which slightly delayed the disease progression. The boys lose their ability to walk at around the age of 12, and die in the 4th decade of life from severe heart and lung problems.

In this study investigators will test the efficacy of Tamoxifen treatment in ambulatory DMD boys. Tamoxifen is a drug used for palliative treatment of breast cancer patients and has an outstanding safety profile. In addition, Tamoxifen was tested in the past in boys, for other pediatric indications, and showed an excellent safety with no side effects.

Tamoxifen is being tested in this study, as a therapy for DMD, for the following reasons:

(i) it was shown to have anti-fibrotic effect in multiple in-vivo systems; (ii) it assists in the repair of damaged muscles.

In other words, Tamoxifen is expected to have a synergistic effect on DMD patients, due to its dual mechanism of action. Indeed, Tamoxifen was shown to have significant beneficial effects in the mdx mouse model of DMD. Also, a small compassionate cohort of 3 boys, treated for 6 months with Tamoxifen, yielded very encouraging results.


Eligibility criteria: Inclusion Criteria:

* Ambulatory

Exclusion Criteria:

* Non Ambulatory

Primary outcomes:
measure: 6-minute walk distance (6MWD)
timeFrame: The six minute walk distance will be tested during the 36 months of the trial. For the first 12 months, the 6 minute walk test will be tested every 3 months and for the follow up period of 24 months,will be done every 6 months.
Secondary outcomes:
measure: North Star assesment(NSAA)
timeFrame: The NSAA will be tested during the 36 months of the trial. For the first 12 months, the NSAA will be tested every 3 months and for the follow up period of 24 months,will be done every 6 months.
Other outcomes:
Locations:
Study officials:
References:
citation: Tsabari R, Simchovitz E, Lavi E, Eliav O, Avrahami R, Ben-Sasson S, Dor T. Safety and clinical outcome of tamoxifen in Duchenne muscular dystrophy. Neuromuscul Disord. 2021 Sep;31(9):803-813. doi: 10.1016/j.nmd.2021.05.005. Epub 2021 Jun 5.
Clinical trial NCT00002479: Tretinoin in Treating Patients With Mycosis Fungoides or Sezary Syndrome
Official title: Phase II Trial of Tretinoin (TRA) in Patients With Mycosis Fungoides/Sezary Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Lymphoma
Keywords: stage I cutaneous T-cell non-Hodgkin lymphoma
stage II cutaneous T-cell non-Hodgkin lymphoma
stage III cutaneous T-cell non-Hodgkin lymphoma
stage IV cutaneous T-cell non-Hodgkin lymphoma
Lead sponsor: Northwestern University
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2004-08-23
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of tretinoin in treating patients who have any stage mycosis fungoides or Sezary syndrome.

Detailed description: OBJECTIVES: I. Determine the efficacy of tretinoin (TRA) in patients with mycosis fungoides/Sezary syndrome. II. Evaluate the spectrum of toxicity of TRA in this patient population.

OUTLINE: Nonrandomized study. Single-agent Chemotherapy. Tretinoin, All-trans-Retinoic Acid, TRA, NSC-122758.

PROJECTED ACCRUAL: If 1 or more of the first 15 evaluable patients experience an objective response, then 20 additional patients will be entered. It is anticipated that the accrual rate will be 1-2 patients per month.

Eligibility criteria: DISEASE CHARACTERISTICS: Biopsy-proven mycosis fungoides/Sezary syndrome Stage I-IV disease No CNS involvement At least 1 measurable lesion required (skin, lymph nodes, visceral lesion, or peripheral blood counts)

PATIENT CHARACTERISTICS: Age: Over 18 Performance status: ECOG 0-3 Hematopoietic: WBC at least 3,000/mm3 Platelet count at least 75,000/mm3 Hepatic: Bilirubin no more than 2.0 mg/dL Transaminases no more than 2 x normal Alkaline phosphatase no more than 2 x normal Renal: Creatinine no more than 2.0 mg/dL Other: No active systemic infection No significant organ failure uncontrolled with medication No pregnant or lactating women Effective contraception required of fertile women

PRIOR CONCURRENT THERAPY: Biologic therapy: At least 4 weeks since prior systemic therapy Chemotherapy: At least 4 weeks since prior topical chemotherapeutics or systemic therapy Endocrine therapy: At least 4 weeks since prior topical (including steroid) therapy or systemic therapy Radiotherapy: Not specified Surgery: Not specified

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Robert H. Lurie Comprehensive Cancer Center, Northwestern University
state: Illinois
Study officials:
affiliation: Robert H. Lurie Cancer Center
name: Timothy M. Kuzel, MD
role: STUDY_CHAIR
References:
citation: Siegel RS, Martone B, Guitart J, et al.: Phase II trial of all-TRA in the treatment of relapsed/refractory mycosis fungoides. 94(1 suppl): A423, 96a, 1999.
Clinical trial NCT05696379: Angiography Derived Index of Microcirculatory Resistance in Patients With Acute Myocardial Infarction
Official title: Angiography Derived Index of Microcirculatory Resistance in Patients With Acute Myocardial Infarction
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Myocardial Infarction (AMI)
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
Collaborators: name: Shengjing Hospital
name: RenJi Hospital
First posted: 2023-01-25
Enrollment: 5000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients admitted with a diagnosis of acute myocardial infarction underwent successful percutaneous coronary intervention.

Brief summary: Coronary microcirculatory dysfunction has been known to be prevalent even after successful revascularization of acute myocardial infarction (AMI) patients, and has been shown to be associated with poor prognosis. Angiography derived index of micro-circulatory resistance (Angio-IMR) is a novel pressure-wire free approach to assess coronary microvascular disease with great diagnostic performance. The current study will further investigate the prognostic value of Angio-IMR in patients with AMI in multicenter retrospective cohort.


Eligibility criteria: Inclusion Criteria:

* Acute myocardial infarction patients who underwent successful percutaneous coronary intervention

Exclusion Criteria:

* No appropriate coronary angiography images (inferior image quality, image loss, severe arteries overlap, or significant artifact)
* Previous coronary artery bypass graft

Primary outcomes:
measure: Cardiac death or readmission for heart failure in 1 month
timeFrame: 1 month
measure: Cardiac death or readmission for heart failure in 6 months
timeFrame: 6 month
measure: Cardiac death or readmission for heart failure in 1 year
timeFrame: 1 year
measure: Cardiac death or readmission for heart failure in 2 years
timeFrame: 2 year
Secondary outcomes:
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Second Affiliated Hospital, School of Medicine, Zhejiang University
state: Zhejiang
Study officials:
References:
Clinical trial NCT06361979: SHR-A1811 Combined With Bevacizumab in HER2-positive Breast Cancer With Brain Metastases
Official title: A Single-arm, Exploratory Clinical Study of SHR-A1811 Combined With Bevacizumab in the Treatment of HER2-positive Breast Cancer With Brain Metastases
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Breasr Cancer
Lead sponsor: Tongji Hospital
Sponsor class: OTHER
First posted: 2024-04-12
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study aimed to evaluate the use of SHR-A1811 and bevacizumab in HER2-positive Breast Cancer with brain metastases


Eligibility criteria: Inclusion Criteria:

1. ≥18 years old;
2. Pathologically confirmed HER2-positive breast cancer;
3. At least one measurable intracranial lesion according to RANO-BM criteria, which had not received local treatment;
4. More than 2 weeks from last systemic treatment; patients with new brain lesions after craniocerebral surgery were admitted if no radiotherapy was performed.
5. Prior HER2-target treatment, endocrine therapy and chemotherapy was allowed;
6. Adequate function of major organs-

Exclusion Criteria:

1. Previous treatment with trastuzumab deruxtecan (DS-8201a) or any other antibody drug conjugate (ADC) which consists of an exatecan derivative that is a topoisomerase 1 inhibitor;
2. Previous treatment with bevacizumab;
3. Participated in other drug clinical trials within 4 weeks before admission;
4. History of clinically significant lung disease；
5. Other malignant tumors, excluding cured cervical carcinoma in situ, skin basal cell carcinoma or skin squamous cell carcinoma, have been diagnosed in the past five years.
6. According to the judgement of the researchers, there are concomitant diseases that seriously endanger the safety of patients or affect the completion of research (including, but not limited to, severe hypertension, severe diabetes, active infections, etc.).
7. Any other conditions that researchers believe that patients are unsuitable for this study.

   -

Primary outcomes:
measure: CNS-ORR
timeFrame: Up to 2 years
Secondary outcomes:
measure: PFS
timeFrame: up to 2 years
measure: ORR
timeFrame: Up to 2 years
measure: AE
timeFrame: Up to 2 years
Other outcomes:
Locations:
Study officials:
affiliation: Tongji Hospital Affiliated of Tongji Medical College Huazhong University of Science and Technology
name: Xiong huihua
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02183779: PORH and Response to Cold in Raynaud's Phenomenon.
Official title: Rôle Des Acides Epoxy-eicosatriénoïques et du Monoxyde d'Azote Dans l'hyperhémie Post-occlusive cutanée Digitale et la réponse cutanée au Froid Dans le phénomène de Raynaud Primaire
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Raynaud Disease
Hyperemia
Cold
Keywords: post-occlusive hyperaemia
laser-speckle contrast imaging
epoxyeicosatrienoic acid
nitrous oxide
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
First posted: 2014-07-08
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The main objective of the study is to determine if implication of epoxy-eicosatriénoïc acids (EETs) and NO during cutaneous post-occlusive hyperemia differs between patients with Raynaud phenomena and healthy volunteers, by studying hyperaemic postocclusive response after microinjection of fluconazole and L-NMMA at the dorsal side of the fingers.

Detailed description: The main objective of the study is to determine if implication of epoxy-eicosatriénoïques acids (EETs) and NO during cutaneous post-occlusive hyperemia differs between patients with Raynaud phenomena and healthy volunteers, by studying hyperaemic postocclusive response after microinjection of fluconazole and L-NMMA at the dorsal side of the fingers.

Healthy controls and patients will undergo 3 visits

Eligibility criteria: Inclusion Criteria:

* Neither raynaud's phenomenon or chronic disease for healthy volunteers
* Raynaud's phenomenon without connective tissue disease for patients in the group "Raynaud"

Exclusion Criteria:

* History of axillary dissection , trauma or surgery
* History of thromboembolic disease or thrombophilia
* Minor or law-protected major
* Exclusion period in another study
* No affiliation to medicare
* Pregnant, parturient or breasting woman
* Concomitant serious disease: progressive cancer, liver failure, history of myocardial infarction less than 5 years, angor
* Smoking in the 6 last months
* Person deprived of liberty by a legal or administrative decision, person under legal protection
* Maximal annual indemnification reached.

Primary outcomes:
measure: post occlusive hyperemia amplitude
timeFrame: day 1
Secondary outcomes:
measure: post occlusive hyperemia amplitude with anesthetic treatment
timeFrame: day1
measure: cold-induced vasoconstriction amplitude
timeFrame: day 2
measure: cold-induced vasoconstriction amplitude with anesthetic treatment
timeFrame: day 2
Other outcomes:
Locations:
city: GRENOBLE cedex9
country: France
facility: Centre d'investigation clinique CIC1406
Study officials:
affiliation: INSERM + University Hospital Grenoble
name: Jean-Luc CRACOWSKI, MD-PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03191279: First Aid by Laypersons - Effect on Mortality and Length of Stay
Official title: Førstehjelp Gjort av Lekfolk-effekt på dødelighet og behandlingsforløp (First Aid by Laypersons - Effect on Mortality and Length of Stay)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Wounds and Injury
First Aid
Bystander
Trauma
Keywords: Wounds and injury
Trauma
First aid
Bystander
Laypersons
Lead sponsor: University of Tromso
Sponsor class: OTHER
Collaborators: name: University Hospital of North Norway
name: Norsk Folkehjelp
name: Nasjonal kompetansetjeneste for traumatologi (NKT-Traume)
First posted: 2017-06-19
Enrollment: 1400
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients who has sustained an injury and where the EMS has been alerted and initiated an emergency response

Brief summary: The study aims to assess the effect of first aid from bystanders on survival, admission length, and need of ICU-stay for trauma victims.

Detailed description: All ambulance services in Norway will be invited to participate. In the participating ambulance services, the personnel of first unit to reach the scene of accident for any emergency response to trauma will register what first aid measures (if any) are indicated and have been performed by the bystanders on the scene up til the point where the ambulance arrives. Hospital data for each case will be retrieved. Those patients who did receive correct first aid will then be compared to those patients who did not receive first aid, and those where first aid was attempted but not correct for differences in share of survivors, length of hospital stay, and need for admission to ICU.

Eligibility criteria: Inclusion Criteria:

* All emergency response calls to trauma (drownings and hangings included)

Exclusion Criteria:

* No injury to patient
* Non-traumatic condition
* Poisonings

Primary outcomes:
measure: Admission length
timeFrame: 3 months after inclusion
measure: Survival
timeFrame: 1 month after inclusion
measure: Need of ICU stay
timeFrame: 3 months after inclusion
Secondary outcomes:
measure: Length of ICU stay
timeFrame: 3 months after inclusion
Other outcomes:
measure: Whether patients received first aid from bystanders
timeFrame: At time of inclusion
measure: Whether first aid measures were indicated for the patient
timeFrame: At time of inclusion
Locations:
city: Tromso
country: Norway
facility: UNN Tromsø
Study officials:
References:
Clinical trial NCT01749579: Comparison of Propofol-fentanyl and Midazolam-fentanyl for Conscious Sedation
Official title: Comparison of Propofol-fentanyl and Midazolam-fentanyl for Conscious Sedation in Painful Procedures
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Emergencies
Keywords: propofol
midazolam
duration of recovery
emergency procedure
Lead sponsor: Tehran University of Medical Sciences
Sponsor class: OTHER
First posted: 2012-12-13
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Sixty patients who refer to the emergency ward and need any painful procedure in the ward are randomized into 2 groups. One group is sedated before the procedure using propofol-fentanyl and the other with midazolam-fentanyl, with the same depth of sedation. The two groups will be compared regarding recovery time and other parameters described below.


Eligibility criteria: Inclusion Criteria:

* age more than 18
* candidate for a painful procedure
* negative past history of a serious medical condition
* ASA score 0 and 1

Exclusion Criteria:

* deep sedation making the patient unable to answer the questions
* pregnancy
* allergy to drugs
* hemodynamic instability
* failure to consent

Primary outcomes:
measure: Recovery time
timeFrame: Within one hour after sedation
Secondary outcomes:
measure: Patients' Pain perception
timeFrame: Within one hour after sedation
Other outcomes:
measure: Blood pressure
timeFrame: Within one hour after sedation
measure: Oxygen saturation
timeFrame: Within one hour after sedation
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Imam Khomeini Hospital
Study officials:
affiliation: Tehran University of Medical Sciences
name: Mohammad Jalili, MD
role: STUDY_CHAIR
References:
Clinical trial NCT03390179: Hyperglycemic Response and Steroid Administration After Surgery (DexGlySurgery)
Official title: Hyperglycemic Response to Steroid Administration After Noncardiac Surgery in Patients With and Without Diabetes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes
Healthy
Keywords: diabetes
anesthesia
surgery
glucose
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2018-01-04
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Diabetes (non insulin) or healthy patient scheduled for surgery under anesthesia

Brief summary: The hyperglycemic response to surgery and the added effect of low-dose steroids (dexamethasone 4 to 8mg), and whether these differ in diabetics and nondiabetics remain unclear. Therefore, we prospectively evaluate the intraoperative and postoperative serum glucose concentrations in diabetics and nondiabetics that received intravenous steroid administration. This multicentre study include \> 250 patients.Primary endpoiunt was glucose concentration at H6 after surgery. Secondary endpoints were glucose concentration at H12 and at H24 and effect of anesthesia (regional anesthesia)


Eligibility criteria: Inclusion Criteria:

* elective surgery under anesthesia

Exclusion Criteria:

* \< 50 kg
* emergency
* insulin therapy
* cardiac surgery
* refusal
* hyperglycemia\> 2g/L

Primary outcomes:
measure: glucose concentration
timeFrame: 6-8 hour
Secondary outcomes:
measure: glucose concentration
timeFrame: 12 hour
measure: glucose concentraion
timeFrame: 24 hour
Other outcomes:
Locations:
city: Nîmes
country: France
facility: Cuvillon
state: Gard
Study officials:
References:
Clinical trial NCT05737979: Modified Rekovelle and Menopur Combination Protocol to Avoid Monitoring Before Day 10 of Stimulation
Official title: Modified Rekovelle and Menopur Combination Protocol to Avoid Monitoring Before Day 10 of Stimulation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Infertility
IVF
Lead sponsor: Clinique Ovo
Sponsor class: INDUSTRY
First posted: 2023-02-21
Enrollment: 772
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women consulting the clinic for fertility issues that require in vitro fertilization

Brief summary: Follitropin delta (Rekovelle) algorithm established by Ferring provides personalized gonadotrophin doses based on each patient's weight and AMH. As a result, risks of stimulation failure or ovarian hyperstimulation syndrome (OHSS) during an in vitro fertilization (IVF) cycle are minimized.

As a standard practice for OHSS prevention at clinique ovo, women undergoing IVF will have a scheduled ultrasound and blood test on the sixth day of their stimulation treatment. However, with the determination of the Rekovelle and Menopur algorithm, the risks of OHSS before the tenth day have been considerably minimized.

Detailed description: The purpose of this study is to evaluate the necessity of programming an ultrasound and blood test prior to the tenth day of ovarian stimulation when women are on personalized doses of Rekovelle and Menopur duting an antagonist IVF cycle. Based on the results of the analysis, we will assess the economic impact that programming an ultrasound and blood test at day 10 might have.

Eligibility criteria: Inclusion Criteria:

* Women of 18 years of age or older having provided consent to chart access for scientific publication in the IVF consent form
* Antagonist IVF cycle using combination of Rekovelle and Menopur for stimulation according to the modified protocol employed at clinique ovo without deviation
* Presence of both ovaries

Exclusion Criteria:

* Second cycle of Duo-Stim IVF

Primary outcomes:
measure: Identify the population where a simplified IVF monitoring is conceivable
timeFrame: Up to 3 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Montréal
country: Canada
facility: Clinique Ovo
state: Quebec
Study officials:
affiliation: Clinique Ovo
name: Jacques Kadoch, MD
role: PRINCIPAL_INVESTIGATOR
References: