louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02941341: Observational Post-Authorisation Study on the Use of Bemfola® in Human Assisted Reproductive Techniques in Spain.
Official title: Ambispective Observational Post-Authorisation Study on the Use of Bemfola® in Human Assisted Reproductive Techniques in Spain.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Infertility
Keywords: Bemfola
r-hFSH
ART
Oocytes
OHSS
Pregnancy
Lead sponsor: Finox AG
Sponsor class: INDUSTRY
First posted: 2016-10-21
Enrollment: 1222
Sex: FEMALE
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: Women who have undergone oocyte retrieval after ovarian stimulation with Bemfola®, either as part of an in vitro fertilisation (IVF) cycle or with an intracytoplasmic sperm injection (ICSI), for reproductive purposes or for oocyte donation, and who are pituitary-suppressed with a GnRH antagonist.

Brief summary: Non-comparative, observational, ambispective post-authorisation study (EPA-SP).


Eligibility criteria: Inclusion Criteria:

* Women aged ≥ 18 years
* Currently undergoing an IVF or ICSI cycle or are oocyte-donors
* Have completed controlled ovarian stimulation
* Have received at least 5 doses of Bemfola®
* Are pituitary suppressed with a GnRH antagonist
* Have undergone oocyte retrieval
* Have signed the Informed Consent Form

Exclusion Criteria:

* Hypersensitivity to the active substance follitropin alfa, FSH or to any of the excipients listed
* Presence of tumours of the hypothalamus or pituitary gland

Primary outcomes:
measure: Total number of oocytes retrieved
timeFrame: 34-36 hours after hCG administration and after a maximum 16 days of r-hFSH treatment
Secondary outcomes:
measure: Number of fertilised oocytes
timeFrame: 1 day after ovum pick-up
measure: Quality of oocytes
timeFrame: At Day 4-5
measure: Number and quality of transferred embryos
timeFrame: Day of embryo transfer, either 2,3 or 5 days after oocyte retrieval
measure: Fertilization and implantation rate
timeFrame: 5 to 6 weeks after oocyte retrieval
measure: Incidence of serious adverse events, including moderate-to-severe OHSS
timeFrame: From Day 1 of stimulation
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: IVI Barcelona
Study officials:
affiliation: Director IVI Bilbao, Spain
name: Marcos Ferrando, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Jefe del Servicio de Medicina de la Reproducción,Hospital Universitari Quirón Dexeus, Barcelona, Spain
name: Buenaventura Coroleu Lletget, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Jefe de la Unidad de Reproducción, Hospital Clínico Universitario de Valladolid, Valladolid, Spai^n
name: Luis Rodríguez-Tabernero Martín, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ferrando M, Coroleu B, Rodriguez-Tabernero L, Barrenetxea G, Guix C, Sanchez F, Jenkins J; BIRTH study group. The continuum of ovarian response leading to BIRTH, a real world study of ART in Spain. Fertil Res Pract. 2020 Jul 29;6:13. doi: 10.1186/s40738-020-00081-4. eCollection 2020.
Clinical trial NCT04113941: Clinical Trial to Evaluate the Efficacy and Safety of MEDITOXIN® in Subject With Idiopathic Overactive Bladder
Official title: A Randomized, Double-Blind, Placebo-controlled, Multi-center, Phase 3 Study to Evaluate the Efficacy and Safety of MEDITOXIN® in Subject With Idiopathic Overactive Bladder
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Overactive Bladder
Lead sponsor: Medy-Tox
Sponsor class: INDUSTRY
First posted: 2019-10-03
Enrollment: 216
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is for patients who have idiopathic overactive bladder symptoms. This study will evaluate efficacy and safety of Neuronox® against placebo.


Eligibility criteria: Inclusion Criteria:

* Male and female subjects aged above 20
* Patient with overactive bladder symptoms lasting at least 6 months

Exclusion Criteria:

* Patient with a history of surgery or a disease that may affect bladder function.

Primary outcomes:
measure: The change in the daily average UI (Urinary Incontinence) episodes
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Konkuk University Hospital
Study officials:
References:
Clinical trial NCT05593419: Selecting Patients Who May Benefit From Immunotherapy by Tissue-based Biomarkers.
Official title: Selecting Patients Who May Benefit From Immunotherapy by Tissue-based Biomarkers
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Gastric Cancer Patients Received Immunotherapy
Lead sponsor: Peking University
Sponsor class: OTHER
First posted: 2022-10-25
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All patients in this study were enrolled by the Department of gastrointestinal oncology, Peking University Cancer Hospital \& Institute for conventional therapy or clinical trials

Brief summary: We have established a machine learning model based on effective TIIC signature which could select GC patients who may benefit from immunotherapy.

The current study aims to enroll 300 GC patients as a validation cohort to vertify the accuracy of TIIC signature in predicting immunotherapy efficacy


Eligibility criteria: Inclusion Criteria:

* Having signed informed consent
* Age:18-80 years old
* Histologically confirmed gastric adenocarcinoma
* Unresectable recurrent or metastatic gastric cancer
* Previous neo-adjuvant or adjuvant treatment for gastric cancer, if applicable, more than 6 months
* Measurable disease according to the RECIST criteria
* Karnofsky performance status ≥70
* Life expectancy of ≥3 month
* No prior radiotherapy except radiotherapy at non-target lesion of the study more than 4 weeks
* ALT and AST\<2.5 times ULN (≤5 times ULN in patients with liver metastases)
* Serum albumin level ≥3.0g/dL
* Serum AKP \< 2.5 times ULN
* Serum creatinine \<ULN, and CCr \< 60ml/min
* Bilirubin level \< 1.5 ULN
* WBC\>3,000/mm3, absolute neutrophil count ≥2000/mm3, platelet\>100,000/mm3, Hb\>9g/dl

Exclusion Criteria:

* Previous systemic therapy for metastatic gastric cancer
* Surgery (excluding diagnostic biopsy) within 4 weeks prior to study entry Contraindications of nuclear magnetic resonance image such as fitment of cardiac pacemaker , nerve stimulator, or aneurysm clip, and metallic foreign body in eye ball and so on.
* Allergic constitution or allergic history to protium biologic product or any investigating agents.
* Severe heart disease or such history as recorded congestive heart failure, uncontrolled cardiac arrhythmia, angina pectoris needing medication, cardiac valve disease, severe abnormal ECG findings, cardiac infarction , or retractable hypertension.
* Pregnancy or lactation period
* Other previous malignancy within 5 year, except non-melanoma skin cancer
* Legal incapacity

Primary outcomes:
measure: TIIC signature
timeFrame: Treatment baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University Cancer Hospital
Study officials:
References:
Clinical trial NCT05597319: ERAS in Liver Surgery
Official title: Enhanced Recovery After Surgery: Compliance to the Program in Liver Surgery and Factors Associated With Drop-out
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: ERAS
Lead sponsor: University of Milano Bicocca
Sponsor class: OTHER
First posted: 2022-10-28
Enrollment: 126
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 126 patients were consecutively enrolled from January 2019 to July 2021

Brief summary: Enhanced Recovery After Surgery (ERAS) Program (EP) is widely applied to obtain a reduction in post-operative length of hospital stay and a faster restoration of pre-operative patient conditions. However, in Western countries, adherence to EP in liver surgery is still difficult to achieve due to deep-rooted traditional practices. In our Institute, since 2019, EP has been applied pursuing 18/23 items identified by 2016 guidelines. At all consecutive patients who underwent elective liver surgery in our Institution, EP was proposed and their adherence to ERAS items was measured before, during and after surgery. Data were retrospectively collected and analysed, particularly focusing on EP items. Primary outcome was compliance to EP, defined as at least 80% of accomplished items per patient. Secondary outcome was adherence to each ERAS item, while tertiary outcome was detecting the variables associated with program drop out.


Eligibility criteria: Inclusion Criteria:

* patients candidates to surgery for benign or malignant liver disease
* liver resection with curative intent

Exclusion Criteria:

* refusal to participate at the EP
* incapability to acquire informed consent
* cognitive impairment that can prejudice the patient comprehension of the EP
* liver surgery with palliative or diagnostic intent or non-resective liver surgery
* emergency surgery

Primary outcomes:
measure: Compliance to ERAS program
timeFrame: 32 months
Secondary outcomes:
measure: Compliance to ERAS items
timeFrame: 32 months
measure: Drop-out factors
timeFrame: 32 months
Other outcomes:
Locations:
city: Monza
country: Italy
facility: Ospedale San Gerardo
state: MB
Study officials:
References:
Clinical trial NCT03647319: Noninvasive Dual-mode Stimulation Therapy for Neurorehabilitation in Post-stroke Cognitive Impairment
Official title: Investigation for Individualized Noninvasive Neuromodulation in Neurorehabilitation of Brain Disease: Longitudinal Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post-stroke Cognitive Impairment
Keywords: Noninvasive Brain Stimulation
Repetitive Transcranial Magnetic Stimulation
Transcranial Direct Current Stimulation
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2018-08-27
Enrollment: 29
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Repetitive transcranial magnetic stimulation (rTMS) or transcranial direct current stimulation (tDCS) has been used for the modulation of post-stroke cognitive impairment patients' cognitive function by altering the cortical excitability.

Recently, more challenging approaches, such as stimulation of two or more sites or use of dual modality have been studied in stroke patients. In this study, simultaneous stimulation using both facilitatory rTMS (10Hz) and anodal or cathodal tDCS (dual-mode stimulation) over bilateral dorsolateral prefrontal cortices (DLPFCs) was investigated to compare its modulatory effects with single facilitatory rTMS stimulation in post-stroke cognitive impairment patients.


Eligibility criteria: Inclusion Criteria:

* First-ever stroke patients
* Subacute stage (less than 4 weeks)
* Who can perform the 2-back verbal and non-verbal working memory task

Exclusion Criteria:

* K-MMSE score under 9
* Major active neurological disease or psychiatric disease
* A history of seizure
* Metallic implants in their brain

Primary outcomes:
measure: Accuracy of 2-back verbal working memory task
timeFrame: Change from Pre-intervention at 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
References:
Clinical trial NCT00445419: Phase I Hepatitis C Vaccine Trial of Virosome-formulated Peptides
Official title: A Phase I Single-blind Randomised Placebo Controlled Dose Escalating Study of One Virosome Formulated CD4 and Two Virosomes Formulated CD8 Hepatitis C Virus (HCV) Vaccine Components (PEV2A and PEV2B) Administered to Healthy Adult Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Chronic Hepatitis C
Keywords: Hepatitis C
Liver disease
Viral infection
Virosome
Vaccine
therapeutic vaccine
Chronic hepatitis C virus infection
Lead sponsor: Pevion Biotech Ltd
Sponsor class: INDUSTRY
First posted: 2007-03-09
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Pevion Biotech has designed a therapeutic vaccine to treat patients who suffer from chronic hepatitis C virus infection. The vaccine is based on a combination of the PeviPRO and PeviTER platforms using synthetic peptide antigens from the hepatitis C virus. Generally, a cellular immune response by cytotoxic T-lymphocytes (CTL) seems to be crucial in overcoming a hepatitis C virus infection. In-depth research in recent years has shown that the cellular immune response is even more effective when supported by helper T-cells. Pevion Biotech's HCV vaccine candidate utilizes this effect inducing specific CTL responses (PeviTER) together with a supportive helper T cell response (PeviPRO). This virosome-based technological combination in a single product represents a new generation of modular therapeutic vaccines.


Eligibility criteria: Inclusion Criteria:

* Healthy volunteers of both sexes
* Aged between 18 and 45 years
* Free of obvious health problems
* With a BMI between 18.5 and 29.9 are included if they give written informed consent

Exclusion Criteria:

* Chronic or acute illness
* Immunosuppression
* HCV and/or HBV infection
* history of allergic disease
* Pre-existing immune response against peptide of the vaccines

Primary outcomes:
measure: Incidence of adverse events
measure: Specific cellular immune response by Elispot and FACS
Secondary outcomes:
measure: Specific proliferative response
measure: Humoral immunity
Other outcomes:
Locations:
city: Lausanne
country: Switzerland
facility: Vaccine and Immunotherapy Center, CHUV
Study officials:
affiliation: Vaccine and Immunotherapy Center (VIC), Division of Immunology and Allergy, CHUV, Lausanne
name: Giuseppe Pantaleo, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01654419: Comparison of the Quantity of Distal Movement of the Upper Canine and Molar
Official title: Comparison of the Quantity of Distal Movement of the Upper Canine and Molar Using Class II Elastics With and Without Sliding Jig in a Period of 3 Months
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Malocclusion
Keywords: sliding jig
Class II malocclusion
Distalization mechanics
Intermaxillary elastics
Lead sponsor: Universidad de Antioquia
Sponsor class: OTHER
First posted: 2012-07-31
Enrollment: 30
Sex: ALL
Minimum age (years): 13
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: THE PURPOSE OF THE STUDY IS COMPARE THE QUANTITY OF DISTAL MOVEMENT OF THE UPPER CANINE AND MOLAR USING CLASS II ELASTICS WITH AND WITHOUT SLIDING JIG IN A PERIOD OF 3 MONTHS

Detailed description: To achieve a Class I canine relationship at the end of the alignment and leveling phase, different intraoral devices have been used. These include intermaxillary class II elastics, which retract the upper and protract the lower arch, generating extrusive forces at the anchorage sites. Its upper distalizing action is exerted to the canine bracket and transmitted through the posterior teeth where the upper molar does not receive a direct force. The sliding jig is an auxiliary addition that exerts force to the molar by an elastic hanged in a jig between the lateral and the canine in class II; such mechanism decreases the vertical adverse effects of the elastics wearing while directing the distalizing force to the molar.

A randomized, unblinded, clinical trial comparing 30 units of analysis (hemi arches) in which were placed sliding jig or stand alone elastics were perform.

Eligibility criteria: Inclusion Criteria:

* Class II dental malocclusion with alignment and leveling phase ended.
* Root completed not trauma
* Second molar erupted
* Third molar absent
* Dental and periodontal health

Exclusion Criteria:

* Root uncompleted
* Dental Trauma
* Dental Pathology

Primary outcomes:
measure: CT analysis for comparison of distal movement of upper canine and molar using class II elastics
timeFrame: 3 months
Secondary outcomes:
measure: CT analysis for comparison of distal movement of upper canine and molar using class II with Sliding Jig
timeFrame: 3 months
Other outcomes:
Locations:
city: Medellin
country: Colombia
facility: Faculty of Dentistry
state: Antioquia
Study officials:
affiliation: Universidad de Antioquia
name: Luis A Sanchez, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01664819: Antioxidants for Prevention of Cataracts Follow-up Study
Official title: Antioxidants for Prevention of Cataracts Follow-up Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cataract
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: Aravind Eye Hospitals, India
First posted: 2012-08-14
Enrollment: 576
Sex: ALL
Minimum age (years): 50
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Aravind Eye Hospital and the University of California, San Francisco (UCSF) Proctor Foundation collaborated on the Antioxidants for the Prevention of Cataract Study from 1997-2002. (1) In the study, 798 participants aged 35-50 years were enrolled from 5 rural villages, and randomized to thrice weekly antioxidants (vitamin C, 500 mg; beta carotene, 15 mg; and alpha-tocopherol, 400 IU) or placebo. After 5 years of supplementation, there was no significant difference in cataract formation between the antioxidant group and placebo. In this follow-up study, we will return to study villages to determine whether rates of cataract surgery are different in the 2 groups.

1. Gritz DC, Srinivasan M, Smith SD, et al. The Antioxidants in Prevention of Cataracts Study: effects of antioxidant supplements on cataract progression in South India. The British journal of ophthalmology 2006;90:847-51.


Eligibility criteria: Inclusion Criteria:

* participation in previous cataract study

Exclusion Criteria:

* refusal to participate

Primary outcomes:
measure: Cataract surgery
timeFrame: 15 years post-intervention
Secondary outcomes:
measure: Risk factors for cataract surgery
timeFrame: 15 years post-intervention
measure: All-cause mortality
timeFrame: 15 years post-intervention
Other outcomes:
Locations:
city: Madurai
country: India
facility: Aravind Eye Hospitals
state: Tamil Nadu
Study officials:
affiliation: University of California, San Francisco
name: Jeremy D Keenan, MD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Aravind Eye Hospitals
name: Muthiah Srinivasan, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gritz DC, Srinivasan M, Smith SD, Kim U, Lietman TM, Wilkins JH, Priyadharshini B, John RK, Aravind S, Prajna NV, Duraisami Thulasiraj R, Whitcher JP. The Antioxidants in Prevention of Cataracts Study: effects of antioxidant supplements on cataract progression in South India. Br J Ophthalmol. 2006 Jul;90(7):847-51. doi: 10.1136/bjo.2005.088104. Epub 2006 Mar 23.
citation: Nesemann JM, Srinivasan M, Ravindran RD, Edwards T, O'Brien KS, Kim UR, Wilkins JH, Whitcher JP, Lietman TM, Gritz DC, Keenan JD. Relationship Between Cooking Fuel and Lens Opacities in South India: A 15-Year Prospective Cohort Study. Am J Ophthalmol. 2022 Nov;243:66-76. doi: 10.1016/j.ajo.2022.06.021. Epub 2022 Jul 9.
Clinical trial NCT01014819: A Clinical Trial of Dermacorder for Detecting Malignant Skin Lesions
Official title: A Phase I Clinical Trial of Dermacorder for Detecting Malignant Skin Lesions
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Basal Cell Carcinoma
Keywords: Dermacorder
Electric field
basal cell carcinoma
Gorlin Syndrome
Lead sponsor: UCSF Benioff Children's Hospital Oakland
Sponsor class: OTHER
First posted: 2009-11-17
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Males and females with multiple basal cell carcinomas

Brief summary: The Dermacorder measures the electric field in the skin. Malignant skin lesions disrupt the skin's normal electric field and this abnormal electric field can be detected by the Dermacorder. Therefore the investigators are testing the hypothesis that the Dermacorder can provide useful data to guide in the diagnosis of skin disease.

Detailed description: The Dermacorder is a non-invasive medical device that scans a probe over the skin about 200 microns away from it and detects the electric field in the skin using capacitative coupling. Measurements of hundreds of malignant melanomas in mice indicated that these lesions generate an electric field that is easily detected. One previous clinical trial at the VA Medical Center in Hampton VA indicated an 80% reliability in predicting malignant lesions by their electric field. We have improved the Dermacorder over the past two years by enhancing its sensitivity and stability and must now determine if these improvements have improved its ability to detect malignant lesions. If the Dermacorder provides a reliable diagnosis of malignant lesions, its use could dramatically reduce the number of biopsies performed and this would significantly improve the quality of life for hundreds of thousands of Americans seeking the advice of dermatologists regarding suspicious lesions each year

Eligibility criteria: Inclusion Criteria:

* Study subjects must have had diagnosed at least one benign or malignant skin lesion;
* Subject is from 18-75 years of age, inclusive;
* Subject must sign and date all informed consent statements.

Exclusion Criteria:

* Subject is exhibiting signs of a bacterial or viral infection, including fever;
* Subject is unwilling to allow a biopsy of a malignant lesion for histological analysis.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Oakland
country: United States
facility: Childrens Hospital Oakland Research Institute
state: California
Study officials:
affiliation: UCSF Benioff Children's Hospital Oakland
name: Ervin Epstein, M.D.
role: PRINCIPAL_INVESTIGATOR
References: