louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05255861: An Exploratory Study of HRD Score in Chinese Ovarian Cancer Patients Benefiting From PARP Inhibitor Targeted Therapy
Official title: An Exploratory Study of HRD Score in Chinese Ovarian Cancer Patients Benefiting From PARP Inhibitor Targeted Therapy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Ovarian Cancer
Keywords: Homologous Recombination Deficiency Score
Lead sponsor: Obstetrics & Gynecology Hospital of Fudan University
Sponsor class: OTHER
First posted: 2022-02-25
Enrollment: 300
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Chinese women with ovarian cancer

Brief summary: This project intends to evaluate the sensitivity of different Homologous Recombination Deficiency (HRD) score to Poly(ADP-ribose) polymerase inhibitor (PARPi) by retrospectively analyzing the tissue samples of patients with ovarian cancer using PARPi, and to determine the cut off value of the HRD score algorithm suitable for the Chinese population, so as to provide evidence for the role of PARPi in ovarian cancer. The screening of the beneficiaries of maintenance therapy provides precise guidance and can be used as a reference for other cancer types.


Eligibility criteria: Inclusion Criteria:

1. age ≥ 18 years;
2. high-grade serous/endometrioid epithelial ovarian cancer, fallopian tube cancer or primary peritoneal cancer;
3. FIGO stage III or IV;
4. at least 6 cycles and no more than 9 cycles First-line platinum-containing chemotherapy;
5. CR or PR after chemotherapy;
6. ECOG 0-1;
7. sufficient biological samples for HRD score detection;
8. patients signed informed consent;
9. good bone marrow function.

Exclusion Criteria:

1. incomplete follow-up records of survival information;
2. unqualified biological sample quality control

Primary outcomes:
measure: Homologous Recombination Deficiency score
timeFrame: After the ovarian tissue is obtained, an average of 3 year
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: The Obstetrics and Gynecology Hospital of Fudan University
state: Shanghai
Study officials:
affiliation: The Obstetrics and Gynecology Hospital of Fudan University
name: Xin Wu, PHD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00783861: Dermacyd Femina (Lactic Acid) Pocket BR - Compatibility
Official title: Study for Dermatological Evaluation of Topic Compatibility (Primary and Accumulated Dermical Irritability, Dermical Sensitivity) of Dermacyd Femina Pocket BR.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hygiene
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2008-11-02
Enrollment: 54
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: To demonstrate the absence of irritation potential (primary dermic irritability and cumulated dermic irritability) and allergy (sensibilization) of the product Dermacyd Femina (Lactic Acid) Pocket BR.


Eligibility criteria: Inclusion criteria:

* Age between 18 and 60 years old;
* Phototype Skin I,II, III e IV
* Integral skin test in the region;
* Willingness in following the study procedures and to be present in the clinic at the days and scheduled time for medical evaluations and for application of occlusion;

Exclusion criteria:

* Lactation or gestation
* Use of Antiinflammatory and/or immunosuppression drugs one month before the study;
* Personnel history of atopy;
* History of sensitivity or irritation for topic products;
* Active cutaneous disease;
* Use of new drugs or cosmetics during the study;

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Primary outcomes:
measure: The absence of primary and accumulated dermical irritability and dermical sensitivity will be evaluated using International Contact Dermatitis Research Group (ICDRG) scale.
timeFrame: Throughout the study
Secondary outcomes:
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Sanofi-Aventis Administrative Office
Study officials:
affiliation: Sanofi
name: Jaderson Lima
role: STUDY_DIRECTOR
References:
Clinical trial NCT05862961: Better Classification of Respiratory Amyloidosis
Official title: Towards a Better Classification of Respiratory Amyloidosis. Contribution of Proteomic Analysis Based on Tandem Mass Spectrometry
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Amyloidosis
Keywords: respiratory amyloidosis
proteomic analysis
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2023-05-17
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with respiratory amyloidosis

Brief summary: The B-AR project is based on a retrospective analysis of amyloidosis typing and the identification of their amylogenic protein.This work should be able to unite many clinicians, including pulmonologists and pathologists around a rare disease that still suffers from insufficient data.

Detailed description: The B-AR study will highlight the interest of proteomic analysis of amyloidosis compared to their identification by immunostaining. The objective is to reduce diagnostic wandering and to improve patient management. The typing of respiratory amyloidosis will allow a better characterization of the disease and thus, to propose a dedicated therapeutic management.

Eligibility criteria: Inclusion Criteria:

* Adult patient \> to 18 years with amyloidosis on a histological sample of the tracheobronchial or pulmonary tree.

Exclusion Criteria:

* Subject receiving state medical aid
* Subject deprived of freedom, or under a legal protective measure (example: patients under guardianship or curators)

Primary outcomes:
measure: Number of cases with identification of the amylogenic protein in respiratory amyloidosis.
timeFrame: 1 day (at inclusion)
Secondary outcomes:
measure: Distribution and severity of amyloidosis
timeFrame: 1 day (at inclusion)
Other outcomes:
Locations:
Study officials:
affiliation: APHP Hôpital Avicenne
name: Yurdagül UZUNHAN, Pr,MD, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00763061: Travatan Versus Timoptic in Treating Open-angle Glaucoma or Ocular Hypertension
Official title: A Twelve-Week, Double Masked, Parallel Group, Study of Travoprost 0.004% Compared to Timolol 0.5% in Patients With Open-Angle Glaucoma or Ocular Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Glaucoma
Keywords: Glaucoma
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2008-09-30
Enrollment: 111
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To evaluate the Intraocular Pressure (IOP) lowering efficacy and safety of Travoprost 0.004% compared to Timolol 0.5% in patients with open-angle glaucoma (OAG) or ocular hypertension (OH). The study structure is a parallel design. The patients will receive treatment for 12 weeks.

Detailed description: To evaluate the IOP lowering efficacy and safety fo Travoprost 0.004% compared to Timolol 0.5% in patients with open-angle glaucoma (OAG) or ocular hypertension (OH). The study structure is a parallel design. The patients will receive treatment for 12 weeks.

Eligibility criteria: Inclusion Criteria:

* ≥18 years;
* IOP=16-30mmHg
* OH or OAG with visual filed abnormality:

  1. ≥3 adjacent points in 24 degrees field on the same side of the horizontal meridian, that have p \<5% on the prepapillary diameter plot, one of which must have p \<1%,
  2. Glaucoma Hemifield Test outside normal limits,
  3. Corrected Pattern Standard Deviation with p \<5%

Exclusion Criteria:

* Previous damage of anterior chamber angle;
* ocular inflammation or ocular surgery within the past 3 months; Best Corrected Visual Acuity (logMAR) \<1.0;
* contact lens wearer;
* severe central field loss;
* uncontrolled cardiovascular, hepatic or renal disease;
* any medication within past 1 month.

Primary outcomes:
measure: Mean Intraocular Pressure (IOP) at 9 AM
timeFrame: At Week 12 - At the 9 AM time point for the patient's worse eye.
measure: Week 12 - Mean IOP At 4 PM
timeFrame: At the 4 PM time point for the patient's worse eye.
Secondary outcomes:
measure: Mean IOP Change From Baseline at 9 AM
timeFrame: Baseline to Week 12 - at 9 AM
measure: Mean IOP Change at 4 PM
timeFrame: Baseline to Week 12 - at 4 PM
Other outcomes:
Locations:
city: Fort Worth
country: United States
facility: Alcon Call Center
state: Texas
Study officials:
References:
Clinical trial NCT05194761: Normal Saline Nebulization on Prevention of Extubation Failure in Neonates
Official title: Normal Saline Nebulization in Prevention of Extubation Failure in Neonates
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Neonatal Respiratory Failure
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2022-01-18
Enrollment: 60
Sex: ALL
Maximum age (years): 2
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: this study is about evaluating the effect of using normal saline nebulization in preventing re-intubation in extubated neonates , provided that the cause of intubation is mainly due to respiratory cause

Detailed description: Using nebulization is of great debate in neonates especially post extubation as neonates have physiological characteristics such as difficult airway maintenance and clearance, smaller airway caliber, compliant chest wall, poor airway stability, and lower functional residual capacity that account for the diminished delivery of inhaled aerosol.

Nebulized normal saline has historically been used as a placebo typically in studies examining bronchodilator medications and sputum expectorants or used as a carrier to medications. Nowadays, normal saline is a method of enhancing mucociliary clearance has become a clinically accepted adjunct to physiotherapy in the treatment of many chronic lung conditions .

the effect of whether or not nebulization really improves the lung condition is evaluated by lung ultrasound ,It is not only useful in predicting failure of non-invasive ventilation and the need for invasive ventilation, but also has a great value in anticipating extubation success In general, patients with lower lung ultrasound scores show a better chance of extubation success. Each lung will be divided into 3 areas (upper anterior, lower anterior, and lateral) and will be examined using a linear microprobe through both transverse and longitudinal scans. For each lung area, a 0- to 3-point score was given (total score ranging from 0-18).

Eligibility criteria: Inclusion Criteria:

* Ventilated babies with primary respiratory disease as the provisional and primary cause of intubation immediately post-extubation.

Exclusion Criteria:

* Neurological, cardiac, surgical or metabolic problems affecting their respiration.

Upper obstructive air way disease that might affect the success of extubation.

Primary outcomes:
measure: Reintubation by 72 hours post-extubation
timeFrame: within 72 hours
Secondary outcomes:
measure: Lung ultrasound score
timeFrame: 72 hours
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: AinShams University Hospitals
Study officials:
affiliation: Ain Shams University
name: Rania ElFarrash, Prof.
role: STUDY_CHAIR
affiliation: Ain Shams University
name: Ibrahim Abuseif, Prof.
role: STUDY_CHAIR
References:
Clinical trial NCT01604161: Non-interventional Study of Patients Using Norditropin® for Growth Hormone Deficiency or Turner Syndrome
Official title: A Multicentre, Open Label, Non-interventional Study to Evaluate on Long-term Safety and Efficacy of Norditropin® Formulation in Child Patients With GHD or Turner Short Stature Without Closure of Epiphyseal Discs.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Growth Hormone Disorder
Growth Hormone Deficiency in Children
Genetic Disorder
Turner Syndrome
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2012-05-23
Enrollment: 2016
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: Patients from normal practice who have been deemed appropriate to receive somatropin ( Norditropin®) as part of routine out-patient care by the prescribing physician.

Brief summary: This study is conducted in Japan. The aim of this study is to collect information about the efficacy and safety of Norditropin® (somatropin) in the long-term treatment of short stature with GHD (Growth Hormone Deficiency) where epiphysial discs are not closed and short stature with Turner Syndrome where epiphysial discs are not closed.


Eligibility criteria: Inclusion Criteria:

* Growth hormone deficiency or short stature due to Turner Syndrome where the epiphyseal discs are not closed

Exclusion Criteria:

* Diabetic
* Patients with malignant tumors
* Women who are either pregnant or likely to be pregnant
* Known or suspected allergy to study product(s) or related products

Primary outcomes:
measure: Change from baseline in height
timeFrame: Week 0, Month 36, final height is reached
measure: Incidence of adverse reactions (ADRs)
timeFrame: 36 months, accumulation of study period
Secondary outcomes:
Other outcomes:
Locations:
city: Tokyo
country: Japan
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
Clinical trial NCT05692661: A Dose Escalation Study of Proton and Carbon Ion Irradiation for HER2 Positive and Triple Negative Breast Cancer
Official title: A Dose Escalation Study of Proton and Carbon Ion Irradiation for HER2 Positive and Triple Negative Breast Cancer After Breast Conserving Surgery
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Triple Negative Breast Cancer
HER2-positive Breast Cancer
Keywords: Breast Cancer
HER2 Positive
Triple Negative
Proton and Carbon Ion
Dose Escalation
Lead sponsor: Shanghai Proton and Heavy Ion Center
Sponsor class: OTHER
First posted: 2023-01-20
Enrollment: 24
Sex: FEMALE
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: Adjuvant radiotherapy is the standard treatment for early breast cancer after breast conserving surgery. Molecular subtypes was significantly associated with the risk of local recurrence of breast cancer. Nguyen et al found that the overall 5-year cumulative incidence of local recurrence was 0.8% for luminal A, 1.5% for luminal B, 8.4% for HER2 positive, and 7.1% for triple negative breast cancer after lumpectomy and radiotherapy. Her2 positive and triple negative breast cancers may be inherently radioresistant.

Therefore, for HER2 positive and triple negative breast cancer with high local recurrence and radiation resistance, proton combined with carbon ion is proposed after breast conserving surgery.


Eligibility criteria: Inclusion Criteria:

* Histologically confirmed HER2 positive or Triple Negative invasive breast carcinoma.(HER2 positive: immunohistochemistry \[IHC\] 3+ and or fluorescence in situ hybridization \[FISH\] amplified; Triple Negative: estrogen receptor \[ER\] and progesterone receptor \[PR\] \< 1%, HER2 negative \[IHC 1+ or 2+ FISH non-amplified\])
* Age ≥ 18 years and ≤ 80 years.
* The primary tumor must be excised via breast conserving surgery.
* Stage p T1-2 N0 M0
* ECOG performance status ≤2.

Exclusion Criteria:

* Invasive breast cancer not confirmed by pathology.
* Distant metastasis
* Prior thoracic radiation.
* Pregnancy or lactating.

Primary outcomes:
measure: Acute toxicity
timeFrame: 3 months after the completion of CIRT
Secondary outcomes:
measure: Local regional recurrence
timeFrame: within 5 years after radiotherapy.
measure: Cosmetic outcome as measured by Breast Cancer Treatment Outcomes Scale
timeFrame: within 5 years after radiotherapy.
measure: Cosmetic outcome as measured by BCCT.core software
timeFrame: within 5 years after radiotherapy.
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Proton and Heavy Ion center
Study officials:
References:
Clinical trial NCT05673161: Retrospective Evaluation of the Effect of Iron (Fe) Infusion on Complications in Anemic Patients Undergoing Thoracotomy
Official title: Retrospective Evaluation of the Effect of Iron (Fe) Infusion on Complications in Anemic Patients Undergoing Thoracotomy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Iron Deficiency Anemia
Iron Deficiency Anemia Treatment
Lead sponsor: Ankara University
Sponsor class: OTHER
First posted: 2023-01-06
Enrollment: 220
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients undergone thoracotomy

Brief summary: In patients who underwent thoracotomy due to lung malignancy; It is desired to investigate whether there is a difference in terms of postoperative results between those with and without anemia, and those with iron deficiency anemia (IDA) who underwent intravenous iron replacement and those who did not, according to the hemoglobin value in their preoperative examinations.


Eligibility criteria: Inclusion Criteria:

* thoracotomy patients

Exclusion Criteria:

* emergency cases

Primary outcomes:
measure: number of patients who had postoperatiive complication
timeFrame: 3 days
measure: number of patients who received blood products
timeFrame: 3 days
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara University
Study officials:
affiliation: Ankara University
name: CIGDEM YILDIRIM GUCLU
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01182961: The Use of Virtual Reality for the Gait Training of Elderly Fallers
Official title: Gait Training Intervention to Evaluate the Efficacy of Using Virtual Reality to Decrease Fall Risk in the Elderly Population
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Elderly
Keywords: Gait
Falls
Virtual reality
Lead sponsor: Tel-Aviv Sourasky Medical Center
Sponsor class: OTHER_GOV
First posted: 2010-08-17
Enrollment: 60
Sex: ALL
Minimum age (years): 65
Maximum age (years): 85
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study aims to investigate the efficacy of gait training using virtual reality to decrease the risk of falls in elderly idiopathic fallers. The investigator hypothesize that training with virtual reality would increase the ability to perform in the "real world" environment and decrease the risk of falls in elderly adults.

Detailed description: The study is a prospective single-blinded randomized control study with repeated measures at pre intervention, post intervention and follow up at 3 and 6 months post intervention. For six months after termination of the intervention, all subjects will fill out a log book in which they will write the occurrence and date of falls. total time of participation in the study will be 8 months.

Eligibility criteria: Inclusion Criteria:

* between the ages of 65-85
* independent in activities of daily living
* able to walk without assistance for at least 10 minutes
* cognitively intact (Mini Mental State Exam ≥24)
* reported 2 or more falls within 6 months prior to the beginning of the study

Exclusion Criteria:

* any neurological, orthopedic or any other impairment likely to impact gait.
* severe visual impairments
* major depression as defined by the Diagnostic and Statistical Manual of Mental Disorders (DSM) criteria

Primary outcomes:
measure: Gait dynamics
timeFrame: one week after training
Secondary outcomes:
measure: cognitive function
timeFrame: one week after training
Other outcomes:
Locations:
city: Tel Aviv
country: Israel
facility: Tel Aviv Sourasky Medical Center
Study officials:
affiliation: Tel Aviv University
name: Nir Giladi, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04127461: Endoscopic Harvesting in Coronary Artery Bypass Grafting.
Official title: Endoscopic Harvesting of the Radial Artery and Saphenous Vein Grafts in Coronary Artery Bypass Surgery.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Bypass Stenosis
Graft Infection
Lead sponsor: Queen's University
Sponsor class: OTHER
Collaborators: name: Medtronic
First posted: 2019-10-15
Enrollment: 773
Sex: ALL
Minimum age (years): 19
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This is a retrospective data collection looking at patients who received either an endoscopic vessel harvesting procedure versus the conventional open procedure. Besides looking at cost variables in the 2 groups, other outcomes of interest include length of hospital stay, rates of infection, medication use, re-admissions and compilations.

Detailed description: Since April 2018, the study database has been updated with all patients (currently there are 340 patients per group) and variables - both reflecting effectiveness of the procedure and cost. Preoperative variables being captured include comorbidity factors and variables relating to the Society of Thoracic Surgery (STS) score , which is a pre-procedure assessment of surgical risk.

The postoperative data collection includes a variety of complications and comorbidities the patient could experience during their hospital stay. These variables will provide us with information regarding procedure effectiveness, patient recovery and further costs associated with the procedure. Medications and antibiotics provided during the stay are also being captured. Total hospital costs will include any costs associated with ward stay, separated per level of care: Intensive Care Unit (ICU), Cardiac Surgical Unit (CSU), and regular ward.

The two follow up periods are 30 days and 6 months. Both look at the same effectiveness variables, any emergency room (ER) visits, re-admissions, and their respective reasons. Quality of life will be obtained by looking at the number of complications the patient experienced during these periods. The frequency of home care services provided to each patient, if any, are also being tracked. Cost calculations will be done by obtaining the time, length and number of visits to the ER, re-admissions and clinic visits.

Eligibility criteria: Inclusion Criteria:

* any patient at the KHSC undergoing a CABG procedure requiring a vein graft.

Exclusion Criteria:

* undergoing a simultaneous procedure.

Primary outcomes:
measure: cost analysis
timeFrame: 6 months
Secondary outcomes:
measure: Length of stay
timeFrame: 2 days
measure: infection
timeFrame: 6 months
Other outcomes:
Locations:
Study officials:
References: