louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01532193: The Effect of Embryo Culture Under Low Oxygen Tension on Pregnancy Rates
Official title: A Randomized Controlled Trial Evaluation the Effect of Low Oxygen Tension on the Pregnancy Rate After Day 3 Embryo Transfer in an Egg Donation Programme.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Low Oxygen Tension
Lead sponsor: Instituto Valenciano de Infertilidad, IVI VALENCIA
Sponsor class: OTHER
First posted: 2012-02-14
Enrollment: 380
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will determine whether the use of low oxygen tension during "in vitro" embryo culture may increase the pregnancy rates in women undergoing egg donation.

Detailed description: As far as oxygen (O2) tension is concerned, both oocytes and embryos from different mammalian species included the human are normally surrounded by values which are much less than half of atmospheric O2, ranging from high (8.7% O2) in the rabbit oviduct, rabbit and hamster uterus, to as low as 11 mm Hg (1.5% O2) in the monkey uterus. Even in the preovulatory follicle, oocytes are bathed within follicular fluids containing oxygen that range from \> 1 to 5.5 % The aim of this study was to evaluate the impact the effect of low oxygen tension after day-3 embryo transfer in our egg donation programme on pregnancy and implantation rates.

Eligibility criteria: Inclusion Criteria:

* Women aged 25-45 years of age;
* In good mental and physical health;
* First or second of egg-recipient treatment;
* Embryo transfer on Day 3.
* One to three embryos will be transferred.
* BMI between 18-25 kg/m2.

Exclusion Criteria:

* Uterine pathology or hydrosalpinx
* Recurrent miscarriage
* No chronic illnesses

Primary outcomes:
measure: Clinical pregnancy rates per cycle
timeFrame: one month
Secondary outcomes:
Other outcomes:
Locations:
city: Valencia
country: Spain
facility: Ivi Valencia
Study officials:
References:
citation: Rendon Abad M, Serra V, Gamiz P, de Los Santos JM, Remohi J, Navarro AT, de Los Santos MJ. The influence of oxygen concentration during embryo culture on obstetric and neonatal outcomes: a secondary analysis of a randomized controlled trial. Hum Reprod. 2020 Sep 1;35(9):2017-2025. doi: 10.1093/humrep/deaa152.
Clinical trial NCT05881993: Study of CBP-4888 in Healthy, Non-Pregnant Female Subjects
Official title: A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of CBP-4888 in Healthy, Non-Pregnant Female Subjects
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: EARLY_PHASE1
Conditions: Healthy Volunteer Study
Lead sponsor: Comanche Biopharma
Sponsor class: INDUSTRY
First posted: 2023-05-31
Enrollment: 15
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a Phase I, first-in-human, single-center, randomized, double-blind, placebo-controlled, single ascending dose study to evaluate the safety, tolerability, and PK of ascending doses of CBP-4888.

Detailed description: This study will involve female subjects meeting all inclusion criteria and no exclusion criteria. Cohorts of CBP-4888 are planned to be investigated in a sequential dose-escalation manner. Each cohort of subjects will be randomized to CBP-4888 to placebo and administered a single subcutaneous dose.

Eligibility criteria: Inclusion Criteria:

* Healthy non-pregnant female subjects
* Body mass index (BMI) ≥ 18.5 and ≤ 35.0 kg/m2
* Medically healthy, defined as having no clinically significant abnormal screening results including clinical laboratory evaluations, medical history, vital signs, ECG, and physical examination as deemed by the Investigator.

Exclusion Criteria:

* Screening blood pressure \< 100/60 mmHg or \> 140/90 mmHg
* Screening heart rate that is \< 40 bpm or \> 99 bpm
* Clinically significant ECG abnormality at screening
* Used prescription medication within 14 days prior to dosing
* Used over the counter (OTC) medications (including herbal products, nutritional supplements, dietary supplements, and/or vitamins) within 7 days prior to dosing
* Donated blood or had significant blood loss within 56 days prior to dosing

Primary outcomes:
measure: Adverse Events
timeFrame: 30 days
measure: Pain at Site of Injection
timeFrame: 30 days
measure: Tenderness at Site of Injection
timeFrame: 30 Days
measure: Erythema at Site of Injection
timeFrame: 30 days
measure: Swelling at Site of Injection
timeFrame: 30 Days
Secondary outcomes:
measure: Cmax of CBP-4888
timeFrame: 30 days
measure: AUC of CBP-4888
timeFrame: 30 days
measure: Tmax of CBP-4888
timeFrame: 30 days
Other outcomes:
measure: Pharmacodynamics
timeFrame: 30 days
Locations:
city: San Antonio
country: United States
facility: Comanche Biopharma Clinical Research Site #1
state: Texas
Study officials:
affiliation: Chief Medical Officer
name: Allison August, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT06281093: Radiofrequency Fields in Neonatology: Exposure and Impact on the Nervous System
Official title: Radiofrequency Fields in Neonatology: Exposure and Impact on the Nervous System
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Preterm Newborn
Keywords: preterm newborn
radiofrequencies
central and peripheral nervous systems
Lead sponsor: Centre Hospitalier Universitaire, Amiens
Sponsor class: OTHER
Collaborators: name: University Hospital, Brest
name: Hospices Civils de Lyon
name: University Hospital, Strasbourg, France
name: University Hospital, Toulouse
First posted: 2024-02-28
Enrollment: 200
Sex: ALL
Minimum age (years): 1
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: Previously, the investigators showed that preterm newborns are exposed chronically to very low radiofrequency levels in average while hospitalized in NICUs. Most of the infants were nevertheless frequently exposed to transient values above 1 V/m. The investigators also showed that an increase in RF exposure is likely to alter the activity of some neurophysiological functions and their regulatory systems in preterm newborns. The investigators hypothesize that above results are extremely specific to the location of the previous study and may be different in other NICU environments.

This study will aim at quantifying RF levels to which preterm newborns are exposed during their stay in several NICUs spread across the French territory, and assessing its impact on the central and peripheral nervous systems. The first step of this study will be to quantify the precise, continuous and individual levels of daily RF exposure to which each recruited neonate is subjected during his stay in the different NICUs from birth to 1 week postnatal life. Infants' clinical data (medical history, nutrition, morphology...) will also be continually monitored. At 1 week postnatal life, the investigators will investigate cerebral activity (EEG) and autonomic nervous system activity (ECG, heart rate variability). The impact of RF will be evaluated by analyses of the relationship between exposure levels and the various parameters extracted from the neurophysiological investigation phase.


Eligibility criteria: Inclusion Criteria:

* preterm newborns born between 26-34 weeks of gestational age

Exclusion Criteria:

* infants infected,
* suffering from neurological disorders,
* serious heart, respiratory, digestive or metabolic diseases;
* infants born from mothers aged less than 18 years old or deprived of their parental rights

Primary outcomes:
measure: Variation of the spectral power in the α band (8-12 Hz) of the EEG
timeFrame: one week
Secondary outcomes:
measure: variation of the spectral power in the delta (δ, 0.5-4 Hz) of the EEG
timeFrame: one week
Other outcomes:
Locations:
city: Amiens
country: France
facility: Amiens University Hospital
state: Picardie
Study officials:
References:
Clinical trial NCT05638893: Metformin as Adjuvant Therapy in Obese Knee Osteoarthritis Patients
Official title: Metformin as Adjuvant Therapy in Obese Knee Osteoarthritis Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Knee Osteoarthritis
Keywords: Metformin
knee osteoarthritis
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2022-12-06
Enrollment: 50
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aims to evaluate the possible efficacy and safety of addition of metformin to celecoxib in patients with knee osteoarthritis.

Detailed description: Metformin is a safe, well-tolerated oral biguanide widely used as first-line therapy for type 2 diabetes for over 50 years. In addition to its glucose-lowering effects, metformin modulates inflammatory and metabolic factors resulting in weight loss and reduced inflammation and plasma lipids. Data from animal studies suggest that metformin could limit OA development and progression, possibly through activating AMPK.

Retrospective cohort study of participants with OA and type 2 diabetes reported that patients receiving a combination of cyclooxygenase-2 inhibitors and metformin therapy had a lower risk of joint replacement than those receiving cyclooxygenase-2 inhibitors alone .

These findings shed light on possible therapeutic potential of metformin in treatment of OA.

Eligibility criteria: Inclusion Criteria:

* Patients have symptomatic and radiological evidence of OA in one or both knee joints.
* Age ≥ 45 years.
* Both obese male and female will be included (BMI ≥ 30 kg/m²).

Exclusion Criteria:

* Patients with inflammatory rheumatic diseases, crystal deposition arthritis or infection-induced OA.
* Patient with hypertension or diabetes mellitus.
* Patient with hepatic or renal impairment.
* Patients who have active peptic ulcer.
* Patients with positive malignancy.
* Steroid injection into the affected knee joint within 3 months of recruitment for the study.
* Pregnant or lactating female patients.

Primary outcomes:
measure: Western Ontario and McMaster Universities Arthritis Index (WOMAC)
timeFrame: 12 weeks
measure: Weight (Kg)
timeFrame: 12 weeks
Secondary outcomes:
measure: Cartilage Oligomeric Matrix Protein (COMP)
timeFrame: 12 weeks
measure: C-terminal crosslinked telopeptide of type I collagen (CTX-1)
timeFrame: 12 weeks
measure: Interleukin 1-beta (IL-1β)
timeFrame: 12 weeks
measure: Adverse drug events
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Tanta university
state: Gharbia
Study officials:
affiliation: Tanta University
name: Sahar M El-Haggar, Professor
role: STUDY_CHAIR
affiliation: Tanta University
name: Amal M El-Barbary, Professor
role: STUDY_CHAIR
References:
Clinical trial NCT00000293: Effect of Nefazodone on Relapse in Females With Cocaine Abuse - 10
Official title: Effect of Nefazodone on Relapse in Females With Cocaine Abuse
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Cocaine-Related Disorders
Keywords: cocaine dependence
Lead sponsor: National Institute on Drug Abuse (NIDA)
Sponsor class: NIH
Collaborators: name: University of Minnesota
First posted: 1999-09-21
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the effect of nefazodone on relapse to cocaine use in depressed and non-depressed females with cocaine abuse/dependence.

Detailed description: The purpose of this study is to determine the effect of nefazodone on relapse to cocaine in women and if a greater effect will be seen in the dependent condition. A relapse and coping skills questionnaire will be utilized to determine the various factors important to the relapse process.

Eligibility criteria: Inclusion Criteria:

Female, ages 18-55, cocaine abuse/dependence, use of cocaine 7 days of the last 30 days or of the 30 days prior to current abstinence, less than 90 days current abstinence, at least an 8th grade education.

Exclusion Criteria:

Unstable medical conditions; current use of Hismanal, Seldane, or Propulsid; dx of MR, OBS, bipolar, schizophrenia.

Primary outcomes:
measure: Retention
measure: Primary drug use
measure: Depression (secondary)
measure: Relapse
Secondary outcomes:
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: Dorothy Hatsukami, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02157493: Evaluation of an Entrepreneurship Program for American-Indian Youth
Official title: Evaluation of an Entrepreneurship Program on Psychosocial, Behavioral Health, Educational and Economic Outcomes Among American-Indian Youth
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depressive Symptoms
Substance Use
Keywords: American Indian
Adolescents
Entrepreneurship
Paraprofessional
Life skills
Lead sponsor: Johns Hopkins Bloomberg School of Public Health
Sponsor class: OTHER
Collaborators: name: Native American Research Center for Health
First posted: 2014-06-06
Enrollment: 449
Sex: ALL
Minimum age (years): 13
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study will use a randomized controlled design to evaluate whether a youth entrepreneurship/life-skills intervention for reservation-based American Indian adolescents (ages 13-15) improves psychosocial, behavioral health, educational, and economic outcomes from baseline for up to 3 years follow-up as compared to a recreational sports league control condition.

Detailed description: Intervention activities will be held over a 3 night/4 day residential camp and 6 weekend workshops during the academic year. The control condition will consist of a recreational sports league held on 3 Saturdays, also during the academic year.

Eligibility criteria: Inclusion Criteria:

* American Indian ethnicity and primary residence within the Fort Apache Indian Reservation.
* Participants must be 13-15 years old, enrolled as a student at one of the participating high schools, and must have parent/guardian consent for participation in the study.

Exclusion Criteria:

* Youth that are currently enrolled in foster care will not be eligible to participate in the study.
* Those unable to participate in any of the evaluation assessments or intervention components will also be excluded.

Primary outcomes:
measure: Decreased substance use as measured by Youth Risk Behavior Survey (YRBS) in treatment vs. control group at 24 months follow-up
timeFrame: 24 months follow-up
Secondary outcomes:
measure: Decreased depressive symptoms on Patient Health Questionnaire-9 (PHQ-9) in treatment vs. control group at 24 months follow-up
timeFrame: 24 months follow-up
measure: Increased academic achievement as measured by school records and Across Time Orientation measure in treatment vs. control group at 24 months follow-up
timeFrame: 24 months follow-up
Other outcomes:
Locations:
city: Whiteriver
country: United States
facility: Johns Hopkins Center for American Indian Health - Whiteriver Office
state: Arizona
Study officials:
affiliation: Johns Hopkins Center for American Indian Health
name: Allison Barlow, PhD, MPH, MA
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02940093: Pipeline Integrating Gut Metagenome Data, Host Immunogenetic Characteristics and Clinical Gut Inflammatory Biomarkers
Official title: Implementation of a Pipeline Integrating Gut Metagenome Data, Host Immunogenetic Characteristics and Clinical Gut Inflammatory Biomarkers for Stratified Clinical Management
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Stem Cell Transplantation
Lead sponsor: University Hospital Tuebingen
Sponsor class: OTHER
First posted: 2016-10-20
Enrollment: 60
Sex: ALL
Minimum age (years): 3
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing stem cell transplantation due to hematological malignancies Allogeneic stem cell donors

Brief summary: The combined analysis of microbiome, immunological parameters and host genetics in patients has potential for applying personalized approaches of prevention, diagnostics or therapy in the future. However, the acquisition and analysis of these patient characteristics in a scientifically sound, technically reliable, cost-effective, practicable and future-oriented fashion are a far from trivial task. Therefore the objectives of the study are (i) to optimize a sample and data acquisition and analysis pipeline that fulfills these criteria (using samples from healthy volunteers); (ii) validate the pipeline in a cohort of children undergoing stem cell transplantation, yielding information on host immuno-genetics, gut immune function and the human gut microbiome; (iii) deduct the most critical parameters for host-microbiome interplay from this complex dataset.


Eligibility criteria: Inclusion Criteria:

* Patient (stem cell recipient) with hematological malignancies, age 3-18
* Healthy allogeneic stem cell donor (identical or non-identical related donor)

Exclusion Criteria:

* Patients \<3 years of age
* Patient who are unable to provide urine, stool or blood samples due to their medical condition

Primary outcomes:
measure: Immune system - intestinal microbiota co-re-emergence after myeloablative conditioning and antibiotics treatment, respectively.
timeFrame: through study completion, anticipated after 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Tübingen
country: Germany
facility: University Children's Hospital Tübingen
Study officials:
affiliation: University Hospital Tuebingen
name: Alexander NR Weber, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00002293: A Study of Nystatin in the Prevention of Fungal Infections of the Mouth in Patients With AIDS or AIDS-Related Syndromes
Official title: Nystatin Pastille for the Prophylaxis of Oral Candidiasis in Patients With AIDS or AIDS Related Syndromes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Candidiasis, Oral
HIV Infections
Keywords: Nystatin
AIDS-Related Opportunistic Infections
Acquired Immunodeficiency Syndrome
AIDS-Related Complex
Candidiasis, Oral
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2001-08-31
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: To determine a safe, effective, and convenient dosing schedule for nystatin pastilles in the prophylaxis of oral candidiasis in patients with AIDS or AIDS related syndromes (group III or IV, CDC classification)


Eligibility criteria: Inclusion Criteria

Concurrent Medication:

Allowed:

* Experimental drugs (IND drugs) which are targeted specifically against the AIDS virus or which stimulate the immune system.
* Systemic or oral antibiotics.

Patients must have AIDS or AIDS-related syndromes (HIV infection:

* Group III or IV, CDC classification) and not have been treated for oral candidiasis during the past year.
* Patients can be entered into the study who have:
* Other oral lesions due to Kaposi's sarcoma, herpes zoster, and herpes simplex.
* A positive or negative oral culture for Candida.
* Must be able to follow instructions regarding the use of a pastille.

Exclusion Criteria

Co-existing Condition:

Patients with the following are excluded:

* Oral lesions diagnostic of oral candidiasis or systemic candidiasis.
* Suspected or proven candidal esophagitis.

Patients with the following are excluded:

* Oral lesions diagnostic of oral candidiasis or systemic candidiasis.
* Receiving any effective antifungal agent orally or intravenously within 72 hours of study entry.
* Not expected to survive for at least 6 months.
* Unable to voluntarily maintain a pastille in the buccal cavity for approximately 20 minutes twice a day.
* Known hypersensitivity to nystatin.
* Suspected or proven candidal esophagitis.

Prior Medication:

Excluded within 72 hours of study entry:

* Any oral or intravenous antifungal agent.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Birmingham Veterans Administration Med Ctr / Univ of Alabama
state: Alabama
city: Princeton
country: United States
facility: Bristol - Myers Squibb Co
state: New Jersey
Study officials:
References:
citation: MacPhail LA, Hilton JF, Dodd CL, Greenspan D. Prophylaxis with nystatin pastilles for HIV-associated oral candidiasis. J Acquir Immune Defic Syndr Hum Retrovirol. 1996 Aug 15;12(5):470-6. doi: 10.1097/00042560-199608150-00005.
Clinical trial NCT01633593: Treatment of Delirium in the Elderly With Donepezil: a Double-blind, Randomized, Placebo-controlled Clinical Trial
Official title: Treatment of Delirium in the Elderly With Donepezil: a Double-blind, Randomized, Placebo-controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Elderly
Delirium of Unknown (Axis III) Etiology
Intensive Care (ICU) Myopathy
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2012-07-04
Enrollment: 19
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Nowadays features for the diagnosis of delirium are:

1. Disturbance of consciousness (i.e. reduced clarity of environment awareness) with reduced ability to focus, sustain or shift attention;
2. A change in cognition (such as memory deficit, disorientation, language disturbance) or the development of a perceptual disturbance that is not better accounted for by a pre-existing or evolving dementia;
3. The disturbance develops over a short period of time (usually hours to days) and its severity fluctuates during the course of the day;
4. There is evidence from the history, physical examination, or laboratory findings that the disorder is caused by the direct physiological consequences of a general medical condition, substance intoxication or substance withdrawal.

Treatment of underlying clinical disease is important to remit the delirium. However, these procedures alone are not enough to remit the delirium early and to prevent sequels. There is a need for a specific and faster strategy to treat the delirium.

The investigators want to test the hypothesis that an Anticholinesterase Inhibitor (donepezil) can reduce the duration of the delirium.


Eligibility criteria: Inclusion Criteria:

* Over 60 year old
* Delirium according to the CAM-ICU (Confusion Assessment Method for Intensive Care Unit)
* informed consent (legal representatives)

Exclusion Criteria:

* unable to swallow pills
* previous allergy to donepezil
* Atrioventricular block of 2nd and 3nd degree

Primary outcomes:
measure: reduction of the duration of delirium in elderly patients treated with donepezil
timeFrame: 2 weeks
Secondary outcomes:
measure: Severity of delirium (as measured by the DSR-98-R) may influence the response to donepezil
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Marilia
country: Brazil
facility: FAMEMA
state: Sao Paulo
Study officials:
affiliation: University of Sao Paulo
name: Mario R Louza, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: