louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01170884: Comparing Safety and Efficacy of Combigan® and Lumigan® With Lumigan® Alone in Glaucoma or Ocular Hypertension Subjects Treated With Xalatan®
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Glaucoma
Ocular Hypertension
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2010-07-27
Enrollment: 121
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: Comparing Safety and Efficacy of Combigan® and Lumigan® with Lumigan® Alone in Glaucoma or Ocular Hypertension Subjects Treated with Xalatan®.


Eligibility criteria: Inclusion Criteria:

* Diagnosed with glaucoma or ocular hypertension.
* Visual Acuity 20/100 or better in both eyes

Exclusion Criteria:

* Any active ocular disease
* History of any intraocular surgery or glaucoma laser surgery within 3 months
* Contraindication to pupil dilation
* Use of topical, periorbital, intravitreal, or systemic steroid within 3 months

Primary outcomes:
measure: Mean Diurnal Intraocular Pressure (IOP) at Week 12
timeFrame: Week 12
Secondary outcomes:
Other outcomes:
Locations:
city: Dallas
country: United States
state: Texas
Study officials:
affiliation: Allergan
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: Myers JS, Vold S, Zaman F, Williams JM, Hollander DA. Bimatoprost 0.01% or 0.03% in patients with glaucoma or ocular hypertension previously treated with latanoprost: two randomized 12-week trials. Clin Ophthalmol. 2014 Mar 27;8:643-52. doi: 10.2147/OPTH.S59197. eCollection 2014.
Clinical trial NCT04549584: Neoadjuvant Chemotherapy Response in Metaplastic Carcinoma of Triple Negative Breast Cancer
Official title: Neoadjuvant Chemotherapy Response in Metaplastic Carcinoma of Triple Negative Breast Cancer
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Metaplastic Breast Carcinoma
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2020-09-16
Enrollment: 3
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: * over 20 years old
* patients with triple negative breast cancer diagnosed Seoul National University Hospital

Brief summary: prospective study for response of neoadjuvant chemotherapy in metaplastic carcinoma of triple negative breast cancer

Detailed description: Vimentin/Pan CK staining will be performed on tissues of patient who visited Seoul National University Hospital and were diagnosed with triple negative breast cancer and decided to perform neoadjuvant chemotherapy under clinical judgement.

Histologically determined to be a metaplastic breast cancer or tested positive for vimentin/Pan CK patients decides as the metaplastic breast cancer. They evaluate the response rate of the neoadjuvant chemotherapy.

Patients with vimentin/Pan CK negative are diagnosed with non-metaplastic breast cancer and this group also confirms the response rate of neoadjuvant chemotherapy.

The group of metaplastic breast cancer will enroll 50 people, and the group of non-metaplastic breast cancer will enroll 100 people.

Eligibility criteria: Inclusion Criteria:

* over 20 years old
* patients with triple negative breast cancer diagnosed Seoul National University Hospital
* patients who decided to perform neoadjuvant chemotherapy under clinical judgement

Exclusion Criteria:

* not applicable

Primary outcomes:
measure: response rate of neoadjuvant chemotherapy
timeFrame: After neoadjuvant chemotherapy was finished. Average 6 month later.
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
state: Jongno-gu
Study officials:
affiliation: Seoul National University
name: Hyeong Gon Moon
role: PRINCIPAL_INVESTIGATOR
References:
citation: Satelli A, Li S. Vimentin in cancer and its potential as a molecular target for cancer therapy. Cell Mol Life Sci. 2011 Sep;68(18):3033-46. doi: 10.1007/s00018-011-0735-1. Epub 2011 Jun 3.
citation: Schwartz TL, Mogal H, Papageorgiou C, Veerapong J, Hsueh EC. Metaplastic breast cancer: histologic characteristics, prognostic factors and systemic treatment strategies. Exp Hematol Oncol. 2013 Nov 14;2(1):31. doi: 10.1186/2162-3619-2-31.
citation: Adams S. Dramatic response of metaplastic breast cancer to chemo-immunotherapy. NPJ Breast Cancer. 2017 Mar 29;3:8. doi: 10.1038/s41523-017-0011-0. eCollection 2017.
Clinical trial NCT00455884: A Post Marketing Surveillance Study for NutropinAq® in Adults With Growth Hormone Deficiency
Official title: International Cooperative Metabolic Study (iNCMS) of NutropinAq® [Somatropin (rDNA Origin) Injection] Replacement Therapy in Adults With Growth Hormone Deficiency
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Growth Hormone Disorders
Lead sponsor: Ipsen
Sponsor class: INDUSTRY
First posted: 2007-04-04
Enrollment: 546
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: Adult patients treated with NutropinAq in the specialised adult endocrinology centres in Germany, Italy, and UK.

Brief summary: This study is a multicenter, open-label, observational, post marketing surveillance program to collect information on the use of NutropinAq® in adults suffering from Growth Hormone Deficiency in Germany, Italy, and United Kingdom


Eligibility criteria: Inclusion Criteria:

* Patients with Growth Hormone Deficiency
* Patients treated with NutropinAq®
* Patients having completed growth (fused epiphyses)

Exclusion Criteria:

* Active neoplasia
* Pregnancy

Primary outcomes:
measure: Incidence of serious adverse events
timeFrame: when reported
Secondary outcomes:
measure: Incidence of targeted adverse events, including adrenal insufficiency, arthritis, carpal tunnel syndrome, intracranial hypertension, new onset and recurrence of leukemia & tumor, pancreatitis, peripheral edema requiring medical intervention and death
timeFrame: when reported
measure: Incidence of intercurrent cardiovascular events
timeFrame: when reported
measure: Incidence of fractures
timeFrame: when reported
Other outcomes:
Locations:
city: Slough
country: United Kingdom
facility: Ipsen Central Contact
state: Berkshire
Study officials:
affiliation: Ipsen
name: Ipsen Medical Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT03149484: Use of RM Technology in Pediatric BAI Recipients
Official title: Remote Microphone Technology in Pediatric Bone Anchored Implant Recipients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hearing Loss, Unilateral
Lead sponsor: University of Miami
Sponsor class: OTHER
First posted: 2017-05-11
Enrollment: 20
Sex: ALL
Minimum age (years): 5
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: English speaking pediatric conduction device users ages 5 to 18 and their parent/guardian will be included for study. These pediatric patients have a unilateral conductive hearing loss with a minimum of a 30 dB air-bone gap.

Brief summary: The purpose of this research study is to learn about the hearing outcomes of children with conductive hearing loss who are treated with bone conductive devices and their outcomes with remote microphone technology.

Detailed description: The purpose of this research study is to learn about the hearing outcomes of children with unilateral conductive hearing loss who are treated with bone conductive devices and their outcomes with remote microphone technology. It has been shown that the use of intervention (hearing aids, cochlear implants, bone conduction devices) alone does not alleviate the difficulties children with hearing loss encounter in noisy environments such as a classroom or restaurant. One of the most common methods to help children hear better in these types of environments is the use of a personal remote microphone (RM) system. This study will evaluate how much benefit children are getting from their bone conduction device alone compared to the bone conduction device with a personal RM system.

Eligibility criteria: Inclusion Criteria:

* English speaking
* unilateral conductive hearing loss with a minimum of a 30 dB air-bone gap and their parent/guardian

Exclusion Criteria:

* Do not meet inclusion criteria

Primary outcomes:
measure: Speech Understanding in Noise
timeFrame: 40 minutes
measure: Parent and Child Perception of Hearing Loss Questionnaire
timeFrame: 20 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Miami
country: United States
facility: University of Miami Department of Otolaryngology
state: Florida
Study officials:
affiliation: University of Miami
name: Hillary Snapp, AuD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04964284: Efficacy and Safety Study of rhTSH for Adjuvant Radioiodine Ablation Therapy in Patients With Differentiated Thyroid Cancer
Official title: A Randomized, Open-label, Multi-center, Controlled Phase Ⅲ Study to Evaluate the Safety and Efficacy of Recombinant Human Thryoid Stimulating Hormone（rhTSH） for Adjuvant Radioiodine Ablation Therapy in Postoperative Patients With Differentiated Thyroid Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Differentiated Thyroid Cancer
Lead sponsor: Suzhou Zelgen Biopharmaceuticals Co.,Ltd
Sponsor class: INDUSTRY
First posted: 2021-07-16
Enrollment: 328
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: This study was conducted in patients with differentiated thyroid cancer who had undergone total/near-total thyroidectomy. After surgery patients were randomized to one of two methods of performing thyroid remnant ablation. One group of patients who took thyroid hormone medicine and were euthyroid \[i.e. their thyroid stimulating hormone (TSH) levels are normal\], and received injections of rhTSH (0.9 mg daily on two consecutive days) followed by oral radioiodine. The second group of patients did not take thyroid hormone medicine so that they were hypothyroid (i.e. their TSH levels were high), and were given oral radioiodine.


Eligibility criteria: Inclusion Criteria:

* Subjects voluntarily sign the informed consent form (ICF).
* Age ≥ 18 years old, either male or female.
* Patients with diagnosed differentiated papillary or follicular thyroid carcinoma, including papillary-follicular variant, characterized as pT 1-3, N 0-1or Nx, and M0.
* Eastern Cooperative Oncology Group (ECOG) score of 0-2;
* Expected life expectancy is greater than 12 weeks;
* Patients with a total or near-total thyroidectomy within 12 months prior to randomized.
* Low iodine diet for two weeks prior to randomized.

Exclusion Criteria:

* patients with recent history of 131I whole body scan within 2 weeks prior to randomized.
* Pregnant or breast feeding women.
* patients with other malignancies (exception for in situ cervix uterine cancer, baso cellular skin cancer or breast cancer in remission)
* Subjects who are unsuitable to the trial in combination with other serious diseases, as identified by the investigator.
* Subjects who have participated in another clinical trial of a new drug or medical instrument within 1 months before screening.

Primary outcomes:
measure: The rate of successful postoperative thyroid ablation
timeFrame: 8 months later by a rhTSH stimulated radioiodine scan
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospital
state: Beijing
Study officials:
affiliation: Peking Union Medical College Hospital
name: Yansong Lin, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04884984: Anti-CLL1 CAR T-cell Therapy in CLL1 Positive Relapsed/Refractory Acute Myeloid Leukemia (AML)
Official title: Pilot Study of the Safety and Efficacy of Anti-CLL1 Chimeric Antigen Receptor Engineered T-Cells in the Treatment of CLL1 Positive Relapsed or Refractory Acute Myeloid Leukemia (AML)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Acute Myeloid Leukemia
Keywords: CLL1
CART
AML
Lead sponsor: The First Affiliated Hospital of Soochow University
Sponsor class: OTHER
First posted: 2021-05-13
Enrollment: 20
Sex: ALL
Minimum age (years): 6
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a single center, open-label phase 1/2 study to evaluate the safety and efficacy of anti-CLL1 chimeric antigen receptor engineered T cell immunotherapy (CART) in the treatment of CLL1 positive relapsed or refractory acute myeloid leukemia.

Detailed description: The patients will receive infusion of anti-CLL1 CAR T-cells to confirm the safety and efficacy of anti-CLL1 CAR T-cells in relapsed or refractory acute myeloid leukemia.

Eligibility criteria: Inclusion Criteria:

* CLL1 positive relapsed/refractory acute myeloid leukemia
* Age 6-65 years
* Left ventricular ejection fractions ≥ 0.5 by echocardiography
* Creatinine \< 1.6 mg/dL
* Aspartate aminotransferase/aspartate aminotransferase \< 3x upper limit of normal
* Total bilirubin \<2.0 mg/dL
* Karnofsky performance status ≥ 60
* Expected survival time ≥ 3 months (according to investigator's judgement)

Exclusion Criteria:

* Patients are pregnant or lactating
* Uncontrolled active infection
* Class III/IV cardiovascular disability according to the New York Heart Association Classification
* Active hepatitis B or hepatitis C infection
* Patients with HIV infection
* Patients with history of seizure
* Active central nervous system leukemia

Primary outcomes:
measure: Number of Adverse Events
timeFrame: 12 months
Secondary outcomes:
measure: Overall response rate (ORR)
timeFrame: 2 years
measure: overall survival (OS)
timeFrame: 2 years
measure: Event-free survival (EFS)
timeFrame: 2 years
measure: Cumulative incidence of relapse(CIR)
timeFrame: 2 years
Other outcomes:
Locations:
city: Suzhou
country: China
facility: The First Affiliated Hospital of Soochow University
state: Jiangsu
Study officials:
affiliation: The First Affiliated Hospital of Soochow University
name: Xiaowen Tang, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01157884: Change of Body Composition After Kidney Transplantation in Korea
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Kidney Transplantation
Keywords: body composition
obesity
kidney transplantation
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2010-07-07
Enrollment: 50
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: recieved kidney transplantation in the Seoul National University Hospital

Brief summary: The graft survival in kidney transplantation has been improving after the introduction of new immunosuppressive agents. Therefore, other complications after transplantation are concerned; one of those is obesity. Several factors are attributable to obesity in kidney transplant recipients.

The body composition such as fat mass and lean mass is important concept in overweight patients. Some studies have been conducted on the change of body composition in kidney transplants. However, all of them are studied among Caucasians or using dual energy X-ray absorptiometry (DEXA).

In this study, the investigators plan to study the body composition among Asian kidney transplant recipients using the bioelectrical impedance analysis (BIA).


Eligibility criteria: Inclusion Criteria:

* aged 20 years and over

Exclusion Criteria:

* history of previous transplantation
* co-transplantation with other organs
* neuropsychological problem with diet (such as anorexia nervosa, bulimia)

Primary outcomes:
measure: change of body composition
timeFrame: 2 weeks, 1/3/6/9/12 months after transplantation
Secondary outcomes:
measure: weight, waist circumference
timeFrame: 2 weeks, 1/3/6/9/12 months after transplantation
measure: cholesterol, CRP
timeFrame: 2 weeks, 1/3/6/9/12 months after transplantation
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Yon Su Kim, M.D., Ph.D.
role: STUDY_CHAIR
References:
Clinical trial NCT05746884: Haemostatic Gel Prophylaxis for Post Duodenal Endoscopic Resection Bleeding
Official title: Haemostatic Gel Prophylaxis for Post Duodenal Endoscopic Resection Bleeding
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Duodenal Bleeding
Lead sponsor: GCS Ramsay Santé pour l'Enseignement et la Recherche
Sponsor class: OTHER
Collaborators: name: Euraxi Pharma
First posted: 2023-02-28
Enrollment: 234
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Single-blind, controlled, comparative, randomized, multicentre, international post-marketing follow-up study of a CE marked medical device.
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to test whether prophylactic application of haemostatic gel will reduce the rate of clinically significant bleeding requiring intervention (such as blood transfusion, admission to hospital, other blood products) following endoscopic resection of advanced duodenal neoplasia compared to standard therapy.

Detailed description: This is a post-marketing follow-up study of a CE marked medical device, controlled, comparative, randomized, multicentre, international single-blind.

The main objective is to evaluate the efficacy and safety of PuraStat in duodenal endoscopic mucosal resection or ampullectomy.

This study will be carried out in France in 3 investigative centers. The duration of patient participation in the study is approximately 37 days depending on the time between the selection and the endoscopic intervention.

Eligibility criteria: Inclusion Criteria:

Ampullary lesions

* Single ampullary lesion ≥ 10mm
* Resection via hot ampullectomy, injection/Endoscopic mucosal resection of adjacent lateral spreading component Duodenal Lesions
* ≤ 2 lesions
* Lesion ≥15mm
* Resection via hot Endoscopic mucosal resection
* Morphology: 0-Is, 0-IIa/b/c or combination, submucosal lesions

Exclusion Criteria:

* Inability to provide informed consent (including people with cognitive impairment);
* Pregnant or breastfeeding women;
* Allergy to PuraStat®;
* "Cold" mucosal endoscopic resection;
* Patient under guardianship or curatorship, or under a regime of deprivation of liberty;
* Participating patient, or in a period of exclusion from another clinical trial;
* Patient not benefiting from a social security scheme.

Primary outcomes:
measure: Bleeding rate requiring further intervention within 30 days
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Lyon
country: France
facility: Hôpital Privé Jean Mermoz
Study officials:
References:
Clinical trial NCT02468284: Pharmacokinetics of Degarelix in Chinese Patients With Prostate Cancer
Official title: An Open-label, Multi-Centre Trial Investigating Pharmacokinetics of Degarelix After a Starting Dose of 240 mg (40 mg/mL) Followed by Six Maintenance Doses of 80 mg (20 mg/mL) in Chinese Patients With Prostate Cancer Requiring Androgen Deprivation Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Prostate Cancer
Lead sponsor: Ferring Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2015-06-10
Enrollment: 15
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this trial is to look at how much a new trial drug get into body, such as when the drug concentration in your body reaches peak and how high the peak value is.


Eligibility criteria: Inclusion Criteria:

* Has a histologically confirmed (Gleason graded) adenocarcinoma of the prostate (all stages), for which endocrine therapy (except for neoadjuvant hormonal therapy) is indicated
* Has a Prostate-specific Antigen (PSA) level ≥2.0 ng/mL at Screening
* Has a screening serum testosterone level \>150 ng/dL
* Has an Eastern Cooperative Oncology Group (ECOG) score of ≤2

Exclusion Criteria:

* Has had previous or is currently under hormonal management of prostate cancer. However, hormonal therapy for a maximum duration of 6 months is accepted. This treatment should have been terminated at least 6 months prior to the Screening Visit
* Is currently treated with a 5-alpha reductase inhibitor
* Is considered to be candidate for curative therapy, i.e. radical prostatectomy or radiotherapy
* Is in need of neoadjuvant hormonal therapy
* Has a history of bilateral orchiectomy, adrenalectomy, or hypophysectomy

Primary outcomes:
measure: Maximum plasma concentration observed (Cmax)
timeFrame: Day 0 - 196
measure: Time of Cmax after subcutaneous administration (Tmax)
timeFrame: Day 0 - 196
measure: Maximum plasma concentration observed (Cmax)
timeFrame: Day 0 - 28
measure: Maximum plasma concentration observed (Cmax)
timeFrame: Day 168 - 196
measure: Time of Cmax after subcutaneous administration (Tmax)
timeFrame: Day 0 - 28
measure: Time of Cmax after subcutaneous administration (Tmax)
timeFrame: Day 168 - 196
measure: Area under the plasma concentration-time curve during a drug dosing interval (AUC)
timeFrame: Day 0 - 28
measure: Area under the plasma concentration-time curve during a drug dosing interval (AUC)
timeFrame: Day 168 - 196
Secondary outcomes:
measure: Plasma trough levels of degarelix
timeFrame: At Days 28, 56, 168 and 196
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University Third Hospital (there may be other sites in this country)
Study officials:
affiliation: Ferring Pharmaceuticals
name: Clinical Development Support
role: STUDY_DIRECTOR
References: