louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06633120: In Vitro Maturation of Human Eggs
Official title: In Vitro Maturation of Human Eggs
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Healthy
PCOS
PCOS (Polycystic Ovary Syndrome)
Ovarian Reserve
Infertility
Infertility Female
Infertility of Tubal Origin
Infertility Poly Cystic Ovary
AMH
In Vitro Maturation
IVM
IVF
Keywords: IVM
Infertility
PCOS
IVF
Lead sponsor: Colorado Center for Reproductive Medicine
Sponsor class: OTHER
First posted: 2024-10-09
Enrollment: 50
Sex: FEMALE
Maximum age (years): 38
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: CCRM Fertility, a global pioneer in fertility treatment, research and science, is seeking participants for a new study on in vitro maturation (IVM). IVM requires less hormones to stimulate the ovaries than IVF, making it more affordable than IVF with fewer side effects. Participants that qualify for the study will receive a free cycle of IVM treatment at CCRM Fertility and including a new patient consultation, fertility testing, preimplantation genetic testing for aneuploidies (PGT-A), anesthesia and some medication

Detailed description: Patients will undergo a complete IVF workup to qualify for study. Once passing their baseline appointment patients will undergo a three day low dose stimulation followed by egg retrieval 18-22 hours post last medication dosage. Immature oocytes will be retrieved from the ovaries via ultrasound guided TV aspiration and matured overnight in the laboratory. Mature oocytes will be fertilized via ICSI the following day and cultured to the blastocyst stage. Biopsy of the first 14 blastocysts are included with this package, patients have the option biopsy additional embryos if available. Biopsies will be sent for PGTA testing. This study also includes preparation for and the first frozen embryo transfer. Some FET medication is included as well as testing through the first pregnancy test.

Eligibility criteria: Inclusion Criteria:

* Infertile women diagnosed with PCOS or polycystic ovaries, or infertile women with good ovarian reserve
* Antral follicle count (AFC) greater than 24
* AMH greater than 3.5 ng/ml
* Body Mass Index less than 35
* Accept to have embryos biopsied for PGT
* Intend to perform embryo transfer within 4 months after completing the IVM cycle
* Paternal (or donor) age \&lt;45, ejaculated sperm collection only (partner frozen and donor sperm acceptable), sperm morphology (strict criteria) \&gt;1%, motility \&gt; 20% and sperm count \&gt; 10 million per ml (so samples can be prepared through standard procedure)

Exclusion Criteria:

* More than 2 failed IVF cycles

Primary outcomes:
measure: Oocyte maturation
timeFrame: 27 hours
measure: Embryo fertilization and development
timeFrame: 7 days
measure: Pregnancy
timeFrame: 6 months
Secondary outcomes:
measure: Live Birth
timeFrame: 12 months
Other outcomes:
Locations:
city: Lone Tree
country: United States
facility: Colorado Center for Reproductive Medicine
state: Colorado
Study officials:
References:
Clinical trial NCT01505920: Lidocaine Spray Compared With Submucosal Injection During LEEP: a Randomized Controlled Trial
Official title: Lidocaine Spray Compared With Submucosal Injection in Reducing Pain During Loop Electrosurgical Excision Procedure: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Uterine Cervical Dysplasia
Lead sponsor: Chiang Mai University
Sponsor class: OTHER
First posted: 2012-01-09
Enrollment: 101
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Loop Electrosurgical Excision Procedure (LEEP) is a widely used minor surgical procedure for diagnosis and treatment of cervical intraepithelial neoplasia. During the procedure, several methods have been proposed to reducing pain including submucosal block, paracervical block, and oral analgesics. Submucosal (underneath the lining of the cervix) injection of lidocaine appeared to be the most common methods used. However, from the investigators experience, there is significant pain associated with the injection itself.

Lidocaine spray is an effective measure for pain control during minor gastrointestinal and otolaryngological procedures. It is simple without pain related to application.

An objective of this study is to examine effectiveness of lidocaine spray versus lidocaine submucosal injection by comparing pain scores at various stages of the LEEP procedure.


Eligibility criteria: Inclusion Criteria:

* Any degrees of cervical dysplasia detected from cervical cytology or histology
* Need to have loop electrosurgical excision procedure (LEEP) for diagnosis and/or treatment

Exclusion Criteria:

* Allergy to lidocaine
* Pregnancy
* Previous history of cervical operation including conization, LEEP, laser therapy and cryotherapy
* Cardiac arrhythmia
* Neural disease with impaired sensation
* Lower urinary tract cancer
* Coagulation defect
* Drug dependence
* Lower genital tract infection
* Obvious invasive disease of the cervix

Primary outcomes:
measure: Visual analog pain scores immediately after the excision
timeFrame: Immediately after the excision
Secondary outcomes:
measure: Visual analog pain scores at the time of anesthetic application
timeFrame: At the time of anesthetic application
measure: Visual analog pain scores at 30 minutes after the procedure
timeFrame: At 30 minutes after the procedure
Other outcomes:
Locations:
city: Chiang Mai
country: Thailand
facility: Department of OB-GYN, Faculty of Medicine, Chiang Mai University
Study officials:
affiliation: Chiang Mai University
name: Kittipat Charoenkwan, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Chiang Mai University
name: Asama Vanichtantikul, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Vanichtantikul A, Charoenkwan K. Lidocaine spray compared with submucosal injection for reducing pain during loop electrosurgical excision procedure: a randomized controlled trial. Obstet Gynecol. 2013 Sep;122(3):553-7. doi: 10.1097/AOG.0b013e31829d888e.
Clinical trial NCT00142220: The Benefit of Adding Fish Oil to the Nutrition of Critically Ill Patients
Official title: Comparison Between Two Different Proportions of Omega-3- and Omega-6-Fatty Acids in the Parenteral Nutrition of Critically Ill Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Sepsis Syndrome
Lead sponsor: University Medicine Greifswald
Sponsor class: OTHER
Collaborators: name: Fresenius AG
First posted: 2005-09-02
Enrollment: 160
Sex: ALL
Minimum age (years): 0
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: We study whether an increased proportion of omega-3-fatty acids (contained in fish oil) in the nutrition of critically ill patients reduces systemic inflammation.


Eligibility criteria: Inclusion Criteria:

* indication for parenteral nutrition

Exclusion Criteria:

* hypertriglyceridemia
* coagulation disorder
* decompensated liver cirrhosis or acute liver failure

Primary outcomes:
measure: level of IL-6 in serum
measure: HLA-expression on monocytes
Secondary outcomes:
measure: number of nosocomial infections
measure: days on mechanical ventilation
measure: duration of ICU stay
measure: mortality
measure: SOFA score
Other outcomes:
Locations:
city: Greifswald
country: Germany
facility: Internistische ITS
Study officials:
affiliation: University Medicine Greifswald
name: Sigrun Friesecke, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03728920: Screening Muscle Strength in Arthroscopic Surgery of the Hip
Official title: Screening Muscle Strength in Arthroscopic Surgery of the Hip
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Femoroacetabular Impingement
Lead sponsor: Cambridge University Hospitals NHS Foundation Trust
Sponsor class: OTHER
First posted: 2018-11-02
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Young adult patients suffering with femoroacetabular impingement, prior to the development of arthritis

Brief summary: Hypothesis We hypothesise that hip muscle strength can predict the outcome of hip arthroscopy. A relationship between strength and outcome can improve the success of the procedure and avoid unnecessary and potentially harmful surgery.

Objectives The primary objective is to evaluate the relationship between hip muscle strength and outcomes of hip arthroscopy. The secondary objective is to determine a 'threshold strength' above which the operation becomes successful. If this relationship is established, it would launching a randomised control trial with targeted physiotherapy as the intervention.

Background Hip arthroscopy is key-hole surgery to the hip joint which is performed for femoroacetabular impingement; a condition which describes a shape mismatch between the ball-and-socket hip joint. The number of procedures is increasing, however, studies have shown success in only half of patients undergoing the procedure.

Several factors have been linked with outcomes; however, the influence of muscle strength has never been investigated. We performed a systematic review of this topic, revealing that muscles around affected hips are significantly weaker. We also developed a standardised protocol for the measurement of muscle strength.

Plan Patients awaiting hip arthroscopy will undergo muscle strength testing pre- and post-operatively. There will be no deviation of treatment from their NHS care. Validated outcome measure questionnaires will be completed at five months post-operatively. Magnetic resonance imaging and electromyography tests will be performed on a subset of patients post-operatively.


Eligibility criteria: Inclusion Criteria:

* Patients aged 18-45 years with evidence of FAI on MRI scan (the standard method of imaging of the condition in the NHS)
* Competent to consent to study participation

Exclusion Criteria:

* Established osteoarthritis with evidence of osteophytes (Tonnis grade \>2)
* Patient with hip dysplasia (centre-edge-angle \<20 degrees)
* Patients with full thickness cartilage (chondral) lesions
* Previous diagnosis of mental health disorder
* Failure to comply with Addenbrooke's hospital post-operative rehabilitation exercises tailored to hip arthroscopy

Primary outcomes:
measure: Hip Outcome Score
timeFrame: 6 months post-operatively
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00948220: Influence of Antiviral Therapy on Bone Mineral Density and Metabolism in Patients With Chronic Hepatitis C
Official title: Non-randomized Prospective Study on the Effect of Antiviral Therapy With Peginterferon Alfa-2a and Ribavirin on Bone Mineral Density and Metabolism in Patients With Chronic Viral Hepatitis C Genotype 1
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hepatitis C, Chronic
Liver Diseases
Virus Diseases
Keywords: HCV
hepatitis C virus
CHC
chronic hepatitis c
interferon
ribavirin
DEXA
BMD
bone mineral density
osteoporosis
osteopenia
osteodystrophy
osteodensitometry
Bone Density
Hepatitis, Viral, Human
Anti-Infective Agents
peginterferon alfa-2a
Lead sponsor: University of Ulm
Sponsor class: OTHER
Collaborators: name: Hoffmann-La Roche
First posted: 2009-07-29
Enrollment: 26
Sex: MALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: One single study has suggested that bone mineral density (BMD) is reduced in patients with non-cirrhotic chronic viral hepatitis C. Antiviral combination therapy with standard interferon and ribavirin may further decrease BMD. The aim of this study is to systematically investigate the effect of chronic hepatitis C genotype 1 infection alone and current standard therapy with peginterferon alfa-2a/ribavirin on BMD and bone metabolism.


Eligibility criteria: Inclusion Criteria:

* proven chronic hepatitis C
* aged between 18 and 65
* male patients

Exclusion Criteria:

* high grade liver fibrosis (Grade 3 - 4)
* renal disease
* hyperparathyroidism
* hypogonadism
* malignant disease
* use of any other drug known to effect bone mineral metabolism
* use of alcohol
* organ transplant
* any form of thyroid disease
* any medical condition known to be associated with bone loss

Primary outcomes:
measure: Change of the bone mineral density of the lumbar spine and right hip measured by DEXA in patients with chronic hepatitis C with or without antiviral combination treatment with peginterferon and ribavirin
timeFrame: 96 weeks
Secondary outcomes:
measure: Change in markers of bone formation and resorption over time during antiviral therapy and after cessation of therapy.
timeFrame: 96 weeks
Other outcomes:
Locations:
city: Ulm
country: Germany
facility: University Hospital Ulm
Study officials:
affiliation: University of Ulm
name: Michael Fuchs, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06184620: Correlation Between Angle Closure Glaucoma Data and Lens Zonule Status
Official title: Correlation Between Angle Closure Glaucoma Data and Lens Zonule Status
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Primary Angle Closure Glaucoma
Keywords: primary angle closure glaucoma
UBM
lens zonule
Lead sponsor: Qianfoshan Hospital
Sponsor class: OTHER
First posted: 2023-12-28
Enrollment: 263
Sex: ALL
Minimum age (years): 47
Maximum age (years): 91
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: From December 2020 to January 2022, patients with primary angle-closure glaucoma and normal control patients were diagnosed for the first time and intended to undergo cataract surgery in the ophthalmology department of the First Affiliated Hospital of Shandong First Medical University (Shandong Qiandfo Hospital).

Brief summary: The goal of this observational study is to discuss the correlation between primary angle-closure glaucoma and the state of the suspended ligament of the lens and the pathogenesis of PACG by measuring the biological data of primary angle-closure glaucoma and observing its anatomical changes.

Detailed description: Patients clinically diagnosed with Primary angle-closure glaucoma (PACG) and normal control patients from December 2020 to January 2022 were enrolled in this study.

Eligibility criteria: Inclusion Criteria:

* The depth of the anterior chamber is normal, and the whole corner of the chamber is open;
* The cup-to-plate ratio is less than 0.5;
* No family history of glaucoma.

Exclusion Criteria:

* Previous history of trauma or internal eye surgery in both eyes or one eye;
* Used "pilocarpine", "atropine" and other drugs to change the size of the pupil and the shape of the chamber Angle within 1 week;
* Combined with other eye diseases affecting the Angle and suspension ligament, such as uveitis, ciliary cyst, high myopia, retinal diseases, etc.;
* Can not cooperate with UBM and Angle scopy;
* Refuse to participate in this researcher.

Primary outcomes:
measure: Axial Length (AL), Lens Thickness (LT),Lens Vault (LV), Pupil Diameter (PD),
timeFrame: before operation
measure: Anterior Chamber Depth (ACD) in seat and rectum position, White To White (WTW), pupil vault (LV), pupil diameter (PD), The Lens Zonular Length (LZL) and Angle Opening Distance at 500μm (AOD500) in the upper, lower, nasal and temporal directions
timeFrame: before operation
Secondary outcomes:
Other outcomes:
Locations:
city: Jinan
country: China
facility: guangfu Dang
state: Shandong
Study officials:
References:
Clinical trial NCT01130220: Study of the Health Information Needs of Brain Cancer Patients
Official title: Informed Brain Cancer Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Brain Tumor
Keywords: Brain Tumor
Brain Neoplasm
Lead sponsor: University of Florida
Sponsor class: OTHER
First posted: 2010-05-25
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants will be recruited during routine interactions with the investigators.

Brief summary: The purpose of this research is to explore the factors involved in brain cancer health care literacy needs.

Detailed description: A mere subset of the reasons behind unmet health care literacy needs include the health care systems' increasing complexity, increased time constraints, profound treatment decision making requirements, decreased financial resources, fracturing social networks and diversifying educational and cultural needs.

This project will use focus groups to explore the factors involved in brain cancer health care literacy from the perspectives of patients and those involved in their care. Hypothesis generated from this project will be directly applied toward future projects. The overarching goals are improved access and adequacy of health care literacy information through the eventual development of validated, useful, reliable health care literacy information tools for brain cancer patients and those involved in their care.

Eligibility criteria: Inclusion Criteria:

BRAIN TUMOR PATIENTS:

* 18 to 89 years of age
* Have or have had any type of brain tumor
* Ability to communicate in English
* Willingness to participate in a 30-60 minute focus group

HEALTH CARE PROVIDERS:

* 18 to 89 years of age
* Be a health care provider who cares for any type of brain tumor
* Ability to communicate in English
* Willingness to participate in a 30-60 minute focus group

Exclusion Criteria:

* None

Primary outcomes:
measure: Explore the factors involved in health care literacy from the perspective of brain cancer patients.
timeFrame: 1 Year
Secondary outcomes:
measure: Explore the factors involved in health care literacy from the perspective of health care providers.
timeFrame: 1 Year
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: University of Florida
state: Florida
Study officials:
affiliation: University of Florida
name: Erin M Dunbar, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06289920: A Study to Compare the Pharmacokinetics and the Safety Between a Fixed-dose Combination Administration of "BR3005" and Co-administration of "BR3005-1" and "BR3005-2" Under Fasting Conditions in Healthy Adult Volunteers
Official title: An Open Label, Randomized, Fasting, Single Dose, 2-sequence, 2-period, Crossover Study to Compare the Pharmacokinetics and the Safety Between a Fixed-dose Combination Administration of "BR3005" and Co-administration of "BR3005-1" and "BR3005-2" in Healthy Adult Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Type 2 Diabetes Mellitus
Lead sponsor: Boryung Pharmaceutical Co., Ltd
Sponsor class: INDUSTRY
First posted: 2024-03-04
Enrollment: 47
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The objective of this clinical study is to compare the pharmacokinetics and the safety between a fixed-dose combination administration of "BR3005" and co-administration of "BR3005-1" and "BR3005-2" under fasting conditions in healthy adult volunteers


Eligibility criteria: Inclusion Criteria:

* Those who have body mass index (BMI) within the range of 18.0 to 30.0kg/m² at screening visit

  * In case of a male subject, Those who weigh 50 kg or more
  * In case of a female subject, Those who weigh 45 kg or more
* Those who sign written consent spontaneously after listening to and understanding sufficient explanation of the purpose and contents of this clinical trial, characteristics of the Investigational products, expected adverse events, etc.

Exclusion Criteria:

* Those who have taken drugs that induce and inhibit metabolizing enzymes such as barbiturate within 30 days prior to the first day of administration or have taken drugs concerned about affecting this clinical trial within 10 days prior to the first day of administration. (however, participation is possible considering pharmacokinetics and pharmacodynamics such as Interaction of investigational products, half-life of concomitant drugs, etc.)
* Those who have participated in other clinical trials(including bioequivalence tests) and administered their investigational products within 6 months prior to the first administration date.(However, the termination for participation in other clinical trials are based on the last administration date of their investigational products)
* Those who have a medical history of gastrointestinal surgery or gastrointestinal diseases that may affect the absorption of drugs. (Except for simple appendectomy, hernia surgery)
* In the case of a female subject, those suspected pregnancy, pregnant woman, lactating woman.

Primary outcomes:
measure: AUCτ
timeFrame: 0~48 hours after administration
measure: Cmax
timeFrame: 0~48 hours after administration
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Clinical Research Center, H PLUS Yangji Hospital
state: Gwanakgu
Study officials:
References:
Clinical trial NCT00534820: Cytogenetic Analysis of Bone Marrow Specimen Prior to High Dose Chemotherapy and Autologous Stem Cell Transplantation in Patients With Non-Hodgkin's Lymphoma or Hodgkin's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lymphoma, Non-Hodgkin
Hodgkin Disease
Keywords: Cytogenetic Analysis of Bone Marrow Specimen in Non-Hodgkin's Lymphoma or Hodgkin's Disease
Lead sponsor: King Faisal Specialist Hospital & Research Center
Sponsor class: OTHER
First posted: 2007-09-26
Enrollment: 450
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: Cytogenetic Analysis of Bone Marrow Specimen Prior to High Dose Chemotherapy and Autologous Stem Cell Transplantation in Patients with Non-Hodgkin's Lymphoma or Hodgkin's Disease


Eligibility criteria: Inclusion Criteria:

* Patients with Non-Hodgkin's Lymphoma or Hodgkin's Disease

Primary outcomes:
measure: Efficacy
timeFrame: 6 years
Secondary outcomes:
Other outcomes:
Locations:
city: Riyadh
country: Saudi Arabia
facility: KFSH&RC
Study officials:
affiliation: KFSH&RC
name: Syed Akhtar, MD
role: PRINCIPAL_INVESTIGATOR
References: