louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00231504: Study of Follicle Stimulating Hormone (FSH) Receptor in Women With Low Antral Follicle Count
Official title: Study of Follicle Stimulating Hormone (FSH) Receptor in Women With Low Antral Follicle Count
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Antral Follicle Deficit
Fertility
Keywords: Polymorphism P1
Polymorphism P2
FSH Receptor
Antral follicle count
FSH receptor polymorphism
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2005-10-04
Enrollment: 82
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: YOUNG WOMAN

Brief summary: The deficit in the total number of antral follicles is associated with a reduction of the ovarian fertility potential in young women.

The principal objective of this study is to evaluate the relationship between FSH receptor polymorphism and antral follicle count.

The investigators have designed a study of FSH receptor polymorphisms P1 and P2 as an association with a low antral follicle count in the ovary.

Detailed description: The present study will compare the prevalence of FSH receptor polymorphisms P1 and P2 in women having reduced follicle count (1 to 9 antral follicles) or normal follicle count (13 to 20 antral follicles) determined by ultrasound scans.

Eligibility criteria: Inclusion Criteria:

* 18 to 35 years old
* 1 to 9 or 13 to 20 antral follicles
* Caucasian, occidental Europe
* Presence of both ovaries
* Informed consent

Exclusion Criteria:

* Ovarian anomalies
* Menopause
* Pregnancy
* Other diseases

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Antoine Beclere Hospital, Obstetrics and Gynaecology and Reproduction Medicine Service
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Renato FANCHIN, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03709004: Pacifiers and Breastfeeding Among Mothers at Risk for Postpartum Depression
Official title: Effect of Hospital Pacifier Distribution on Breastfeeding Among Mothers at High Risk for Postpartum Depression
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Breastfeeding
Postpartum Depression
Keywords: Pacifier
Lead sponsor: University of California, Davis
Sponsor class: OTHER
Collaborators: name: Benedictine University
name: Yale University
First posted: 2018-10-17
Enrollment: 0
Sex: ALL
Minimum age (years): 12
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: We will enroll 40 mother-infant dyads in a randomized trial exploring the effect of distribution of pacifiers during the birth hospitalization to mothers at high risk for postpartum depression on pacifier use, infant feeding, and maternal stress.

Detailed description: This study is a pilot a randomized controlled trial to determine if pacifier distribution affects breastfeeding among mothers at high risk for postpartum depression. We will recruit 40 mothers of healthy singleton births in a U.S. hospital who are at high risk of postpartum depression and randomly assign them to receive a pacifier or not. We will ascertain pacifier use, maternal stress, and infant feeding behaviors with web-based surveys at 2, 4, 6, 12, 18, and 24 weeks. Mothers will also wear a wristband to detect maternal heart rate variability throughout the first 6 weeks as a marker of maternal stress.

Eligibility criteria: Inclusion Criteria:

* Breastfeeding mother/infant dyad, receiving postpartum care at UC Davis Medical Center, maternal personal or family history of depression or postpartum depression, mother 18-45 years of age, infant 12-72 hours of age

Exclusion Criteria:

* infant without congenital anomalies that could affect feeding (cleft lip/palate, chromosomal anomaly, micro or retrognathia), infant preterm (born prior to 37 weeks' gestation), mother unable to participate in English, infant admitted to the neonatal intensive care unit, No smart phone

Primary outcomes:
measure: Infant Feeding - Breastfeeding Status
timeFrame: up to 24 weeks
measure: Infant Feeding - Breastfeeding Duration
timeFrame: up to 24 weeks
Secondary outcomes:
measure: Pacifier Use
timeFrame: 2, 4, and 6 weeks
Other outcomes:
measure: Maternal Stress
timeFrame: 2, 4, 6, 12, 18, and 24 weeks
measure: Infant Feeding Efficiency
timeFrame: 2 and 6 weeks
Locations:
city: Sacramento
country: United States
facility: University of California Medical Center
state: California
Study officials:
References:
Clinical trial NCT02994004: Exploring Medical Decisions Using Functional MRI
Official title: Medical Decision-making Under Budgetary Constraint: an fMRI Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: F-MRI Brain Imaging Data
Keywords: Hospital, medical decision-making, role conflict, f-MRI
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2016-12-15
Enrollment: 34
Sex: ALL
Minimum age (years): 25
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Hospital physicians

Brief summary: Hospital physicians are increasingly facing budgetary constraints that might have an impact on individual medical decisions (i.e. diagnostic or therapeutic decisions). This might translate into role conflict and ambiguity. We explore the medical decision-makingprocess of physicians usingfunctional MRI. Twenty hospital physicians will be asked to make simulated medical decisions during fMRI acquisitions, with and without explicit budgetary constraints. We will compare the fMRI data between the 2 modalities.


Eligibility criteria: Inclusion Criteria:

* Hospital physicians
* working in the CHU of Montpellier

Exclusion Criteria:

* Contra indication to f-MRI

Primary outcomes:
measure: Brain activation patterns measured by Functional magnetic resonance imaging
timeFrame: up to study completion, usually 2 weeks
Secondary outcomes:
measure: Level of role conflict, measured by the Kahn questionnaire (Kahn et al., 1964)
timeFrame: up tu study completion, usually 2 weeks
Other outcomes:
Locations:
Study officials:
affiliation: University Montpellier Hospital
name: Gregoire MERCIER, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03359304: The Neurofibromatosis-associated Tumor Biobank
Official title: Establishment of Neurofibromatosis-associated Tumours Biobank for Future Genomic-based Research Aiming at Improved Outcome Prediction
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Neurofibromatoses
Keywords: bone tumor
Lead sponsor: Peking University People's Hospital
Sponsor class: OTHER
First posted: 2017-12-02
Enrollment: 300
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: FAMILY_BASED
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Asia

Brief summary: Neurofibromatosis-associated Tumor is very rare bone tumor. The investigator set up the biobank to ensure every patient has the chance to participate in future research

Detailed description: Samples of blood and other stored material such as slides,frozen tissues or leftover diagnostic material.

Questionnaire information, including health history, growth and development, physical activity and family medical history information.

If patients have been diagnosed with a neurofibromatosis-associated tumor or another condition the investigator is interested in， the investigator will ask the patient to release medical record information relating to diagnosis and treatment of neurofibromatosis-associated tumor, other cancers, blood disorders, and similar conditions.

Eligibility criteria: Inclusion Criteria:

Proband Inclusion criteria: A diagnosis or suspected diagnosis of neurofibromatosis-associated tumor Family member inclusion criteria: Biological parents and full biological siblings of a case diagnosed with neurofibromatosis-associated tumor

Exclusion Criteria:

non-asian

Primary outcomes:
measure: Detected NF-1 gene expression pattern in neurofibromatosis-asociated tumor
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Peking University People's Hospital
name: Tingting Ren, phD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02281604: In-line Filters on ICU
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Micropore Filters
Lead sponsor: Johann Wolfgang Goethe University Hospital
Sponsor class: OTHER
First posted: 2014-11-02
Enrollment: 3281
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients, which will be treated on the anaesthesiological/surgical ICU of the University Hospital Frankfurt between 2013 - 2014

Brief summary: The purpose of this study is to determine whether the use of 0.2/1.2 microliter in-line filter reduces the incidence of severe vasoplegia comparing to the 5 microliter filter.


Eligibility criteria: Inclusion Criteria:

* all patients

Exclusion Criteria:

* Younger than 18 years

Primary outcomes:
measure: Incidence of severe vasoplegia
timeFrame: participants will be followed for the duration of intensive care unit stay, an expected average of 1 week
Secondary outcomes:
measure: Organ dysfunction
timeFrame: participants will be followed for the duration of intensive care unit stay, an expected average of 1 week
measure: Inflammation
timeFrame: participants will be followed for the duration of intensive care unit stay, an expected average of 1 week
measure: Duration of ICU and hospital stay
timeFrame: participants will be followed for the duration of intensive care unit/ hospital stay, an expected average of 1 or 4 week (s), respectively
measure: In-hospital mortality
timeFrame: participants will be followed for the duration of hospital stay, an expected average of 4 weeks
measure: Morbidity
timeFrame: participants will be followed for the duration of hospital stay, an expected average of 4 weeks
Other outcomes:
Locations:
Study officials:
affiliation: University Hospital Frankfurt. Department of Anesthesiology, Intensive-Care Medicine and Pain Therapy.
name: Kai Zacharowski, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Schmitt E, Meybohm P, Herrmann E, Ammersbach K, Endres R, Lindau S, Helmer P, Zacharowski K, Neb H. In-line filtration of intravenous infusion may reduce organ dysfunction of adult critical patients. Crit Care. 2019 Nov 22;23(1):373. doi: 10.1186/s13054-019-2618-z.
Clinical trial NCT04882904: Continuous Measurement of Activity in Patients with Muscle Pathology and in Control Subjects. ActiSLA Part.
Official title: Continuous Measurement of Activity in Patients with Muscle Pathology and in Control Subjects
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Amyotrophic Lateral Sclerosis
Keywords: Actimyo
Accelerometry
Daily living
Lead sponsor: Centre Hospitalier Universitaire de Liege
Sponsor class: OTHER
Collaborators: name: SYSNAV
name: Centre Hospitalier Régional de la Citadelle
First posted: 2021-05-12
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: All patients undergo clinical evaluation and wear Actimyo device in daily living to evaluate their evolution.
Primary purpose: OTHER

Brief summary: ActiSLA is a monocentric academic study. Patients with amyotrophic lateral sclerosis may be included on a voluntary basis. The investigators plan to include a group of approximately 20 patients with ALS.

The investigators have planned to assess patient every three months for a year. On each visit, participants will undergo a clinical examination with MRC sum score and Ashworth scores.

They will perform few tests ( 6-minutes walk test (6MWT), dynamometric measure, electromyography, Edinburgh Cognitive and Behavioural ALS Screen ) and will answer to some questionaires (dysphagia handicap scale, ALS-SFR-r).

After each visit, participants will wear Actimyo for one month daily.


Eligibility criteria: Inclusion Criteria:

* Clinically defined or probable diagnosis of ALS according to El Escorial criteria revised with Awaji's electro-diagnostic algorithm.
* Over 18 years old.
* Signed informed consent
* If patient on Riluzole, the dosage should be stable for 1 month and continued throughout the study period.

Exclusion Criteria:

* Patients with excessive cognitive disorders, limiting the understanding of task or with apparent communication difficulties hindering data collection.
* Any other previous or present pathology having an impact on motor function.
* Recent surgery or trauma (less than 6 months) in the upper or lower limbs.
* Prior neurological, endocrine, infectious, allergic, or chronic or acute inflammatory pathology in the three weeks preceding inclusion.
* Patients participating in an interventional clinical trial.

Primary outcomes:
measure: 95th centile of stride velocity
timeFrame: 1 year
measure: 50th centile of stride velocity
timeFrame: 1 year
measure: 95th centile of stride length
timeFrame: 1 year
measure: 50th centile of stride length
timeFrame: 1 year
Secondary outcomes:
measure: Upper limb function evolution in patient with ALS
timeFrame: 1 year
Other outcomes:
Locations:
city: Liège
country: Belgium
facility: CHR Citadelle
Study officials:
affiliation: CHR Citadelle-CHU liège
name: Margaux Poleur, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05274204: Individual Patient Expanded Access to CA102N
Official title: Expanded Access to CA102N in One Patient Who Completed at Least 12 Cycles of Combination Therapy of CA102N Plus Lonsurf in Clinical Study Number of HS-CA102N-101
Study type: EXPANDED_ACCESS
Overall status: TEMPORARILY_NOT_AVAILABLE
Conditions: Advanced or Metastatic Colorectal Cancer (mCRC)
Lead sponsor: Holy Stone Healthcare Co., Ltd
Sponsor class: INDUSTRY
First posted: 2022-03-10
Standard ages: CHILD
ADULT
OLDER_ADULT

Brief summary: This study is an individual patient expanded access protocol that the subject enrolled had completed the combination treatment of CA102N plus Lonsurf for at least 12 cycles.

Detailed description: In the individual patient expanded access, the subject who was enrolled in Phase 1 trial (Study Number: HS-CA102N-101) Part 2 (dose expansion) and had completed at least 12 treatment cycles with CA102N combined with trifluridine /tipiracil (LONSURF) will be provided access to treatment with CA102N (0.72 mg/kg Nimesulide Equivalent of CA102N).

Eligibility criteria: Inclusion Criteria:

-

Exclusion Criteria:

-

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01733004: A Phase 1 Study of MM-141 in Patients With Advanced Solid Tumors
Official title: A Phase 1 Study of MM-141 in Patients With Advanced Solid Tumors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Hepatocellular Carcinoma
Keywords: Cancer
Hepatocellular Carcinoma
Oncology
Phase I
ErbB3
IGF-1R
Everolimus
Gemcitabine
Abraxane
Lead sponsor: Merrimack Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2012-11-26
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is a Phase 1 and pharmacologic open-labeled dose-escalation trial using a "3+3" design, evaluating MM-141 at varying dose levels and frequencies.


Eligibility criteria: Inclusion Criteria:

* Advanced malignant solid tumors for which no curative therapy exists that has recurred or pgrogressed following standard therapy
* Eighteen years of age or above
* Able to understand and sign an informed consent (or have a legal representative who is able to do so)
* Measurable disease according to RECIST v1.1
* ECOG Performance Score of 0 or 1
* Adequate bone marrow, hepatic, renal and cardiac function
* Willing to abstain from sexual intercourse or to use an effective form of contraception during the study and for 90 days following the last dose of MM-141

Exclusion Criteria:

* Active infection or fever \> 38.5°C during screening visits or on the first scheduled day of dosing
* Symptomatic CNS disease
* Received other recent antitumor therapy
* Pregnant or breast feeding

Primary outcomes:
measure: Severity and number of adverse events related to escalating doses of MM-141
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Marietta
country: United States
state: Georgia
city: Boston
country: United States
state: Massachusetts
city: Detroit
country: United States
state: Michigan
city: Villejuif
country: France
Study officials:
affiliation: Merrimack Pharmaceuticals
name: Chrystal Louis, MD, MPH
role: STUDY_DIRECTOR
References:
Clinical trial NCT02316704: Fixation of OsseoTi™ Porous Structure Versus PPS (Porous Plasma Spray) Coating on the G7™ Acetabular Component for Primary Total Hip Arthroplasty
Official title: Fixation of OsseoTi™ Porous Structure Versus PPS (Porous Plasma Spray) Coating on the G7™ Acetabular Component for Primary Total Hip Arthroplasty: A Single-Blinded Randomized Controlled Trial Evaluating Implant Migration, Acetabular Liner Wear, and Patient Reported Outcome
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Osteoarthritis
Lead sponsor: Hvidovre University Hospital
Sponsor class: OTHER
First posted: 2014-12-15
Enrollment: 98
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary objective of this project is to investigate, using RSA, acetabular implant migration of the OsseoTi™ G7 acetabular cup in comparison to conventional PPS coated G7 acetabular cup, and compare liner wear of thinnest available E1™ liner, allowing for the largest possible femoral head (36mm-44mm) to E1™ liner holding a 32mm femoral head in the G7 acetabular system with endpoint assessment being performed at the 2 year follow-up.


Eligibility criteria: Inclusion Criteria:

* • Participants with primary hip osteoarthritis set to receive a primary unilateral uncemented total hip arthroplasty.

  * Participants must be 18-75 years of age.
  * Participants must be able to speak and understand Danish (or depending on country where patient is enrolled).
  * Participants must be able to give informed consent and be cognitively intact.
  * Participants must be expected to be able to complete all postoperative controls.
  * Participants must not have severe comorbidities, ASA-score ≤ 3.

Exclusion Criteria:

* Terminal illness.
* Rheumatoid arthritis.
* Previous fracture of the hip.
* Osteonecrosis of the hip.
* Previous infection of the hip.
* Severe bony deformity warranting the use of non-standard implants.
* Metastasis in the periarticular bone or proximal femur.
* Female patients that are pregnant or planning pregnancy during follow-up period
* If bone stock or femoral canal type, assessed on preoperative x-ray, warrants the use of cemented fixation.
* Documented osteoporosis with patient in active medical treatment.
* Comorbidity with altered pain perception (e.g. DM with neuropathy).
* Participants that develop deep infection in the follow-up period are excluded from the project.

Primary outcomes:
measure: RSA migration in 3 dimentions of the acetabular components as measured by Radiostereometric analysis, RSA.
timeFrame: 2 year
Secondary outcomes:
Other outcomes:
Locations:
city: Hvidovre
country: Denmark
facility: Dept. of Orthopaedic Surgery, Copenhagen University Hospital Hvidovre
city: Gothenburg
country: Sweden
facility: Sahlgrenska University Hospital, Department of Orthopedics,
Study officials:
References:
Clinical trial NCT02164604: Lucentis to Treat Retinopathy of Prematurity (ROP) 3 Plus Disease
Official title: Intravitreal Ranibizumab to Treat Retinopathy of Prematurity Stage 3 Plus Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Retinopathy of Prematurity
Keywords: ranibizumab
intravitreal therapy
ROP
Plus disease
stage 3 plus
Lead sponsor: Kantonsspital Aarau
Sponsor class: OTHER
Collaborators: name: Insel Gruppe AG, University Hospital Bern
First posted: 2014-06-16
Enrollment: 6
Sex: ALL
Minimum age (years): 32
Maximum age (years): 40
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Retinopathy of prematurity (ROP) is a neovascular retinal disorder of premature born children, characterized by the development of retinal neovascularisation, macular dragging and eventually retinal detachment. ROP is a leading cause for childhood blindness, especially in developing countries. Vascular endothelial growth factor (VEGF) plays an important role in the development of the disease. Recently, the BEAT ROP study tested the efficacy of intravitreal bevacizumab for stage 3 plus ROP in a prospective, controlled, randomized, stratified, multicenter trial. Authors found that bevacizumab showed a significant benefit for Zone I but not Zone II disease, with continuation of peripheral retinal vessel growths after treatment. The authors also concluded that safety could not be assessed due to the small sample size. Other authors raised concerns regarding the results of the BEAT ROP study and the safety of bevacizumab.

The investigators suspected a better safety profile for ranibizumab to treat stage 3 plus ROP. Here we present the outcome of 6 eyes with ROP stage 3 plus treated with a single injection of ranibizumab.

Detailed description: The outcome of six eyes with ROP stage 3 plus treated with one single intravitreal injection of ranibizumab is presented. Safety issues and side affects are discussed. Follow up was 6 months.

Eligibility criteria: Inclusion Criteria:

* ROP stage 3 plus disease

Exclusion Criteria:

* Severe systemic co-morbidity that did not allow systemic sedation for injection, or were antiVEGF (vascual endothelial growth factor) therapy was contra-indicated

Primary outcomes:
measure: number of eyes with ocular side effects due to intravitreal ranibizumab
timeFrame: 6 months
Secondary outcomes:
measure: number of patients with systemic side effects of intravitreal ranibizumab
timeFrame: 6 months
measure: efficacy of intravitreal ranibizumab to treat ROP stage 3 plus
timeFrame: 6 months
Other outcomes:
Locations:
city: Bern
country: Switzerland
facility: Department of Ophthalmology, Inselspital
Study officials:
References:
citation: Menke MN, Framme C, Nelle M, Berger MR, Sturm V, Wolf S. Intravitreal ranibizumab monotherapy to treat retinopathy of prematurity zone II, stage 3 with plus disease. BMC Ophthalmol. 2015 Mar 8;15:20. doi: 10.1186/s12886-015-0001-7.