louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04793490: Sphenopalatine Ganglion Block for Management of Post- Dural Puncture Headache in Obstetric Patients
Official title: Efficacy and Efficiency of Sphenopalatine Ganglion Block for Management of Post-dural Puncture Headache in Obstetric Patients-A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post-Dural Puncture Headache
Keywords: Sphenopalatine ganglion block
Post-Dural Puncture Headache
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2021-03-11
Enrollment: 40
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this trial is to study the efficacy and efficiency of sphenopalatine ganglion block for management of post dural puncture headache in obstetric patients

Detailed description: Background and objectives: Post dural puncture headache(PDPH) is a common complication of lumbar puncture, it is likely due to the loss of cerebrospinal fluid into the epidural space through the dural tear. The prevalence of PDPH is higher in pregnant women.Sphenopalatine ganglion block (SPGB) is a non-invasive intervention with minimal adverse effects, it is indicated in acute and chronic facial/head pain like cluster headache, trigeminal neuralgia, post herpetic neuralgia and pain due to head and neck cancer.SPGB can be performed by different approaches:transnasal,transoral ,sub zygomatic and lateral infratemporal.Transnasal is the easiest, least invasive approach which can be done at bedside.

The objective of this trial is to study the efficacy and efficiency of sphenopalatine ganglion block for management of post-dural puncture headache in obstetric patients.The following will be recorded: pain score will be assessed using the numeric rating pain scale(NRS),heart rate and mean arterial pressure, onset and duration of analgesia, total dose of ketorolac, duration of hospital stay and patient satisfaction

Eligibility criteria: Inclusion Criteria:

* Female patients ASA I or II post caesarean section
* Body weight between 60-100 kg
* Active PDPH within days after spinal anesthesia not relieved with standard treatment such as, intravenous fluids, bed rest and caffeine.

Exclusion Criteria:

* Patient refusal to participate in the study
* Body mass index \>35kg/m2
* Patients with :coagulopathy ,nasal septal deviation,polyp
* History of nasal bleeding
* Allergy to local anesthetic

Primary outcomes:
measure: Numeric rating pain score
timeFrame: First 24 hours after the procedure
Secondary outcomes:
measure: Total analgesic consumption
timeFrame: First 24 hours after the procedure
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams University Hospital
state: Abassia
Study officials:
affiliation: Ain Shams University
name: Marwa M Mowafi, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05858203: Inhibition of Che-1/AATF as a New Tool in Multiple Myeloma Treatment
Official title: Inhibition of Che-1/AATF as a New Tool in Multiple Myeloma Treatment
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Multiple Myeloma
Lead sponsor: Regina Elena Cancer Institute
Sponsor class: OTHER
First posted: 2023-05-15
Enrollment: 150
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: MM Patients

Brief summary: Multiple myeloma (MM) is a haematological malignancy characterized by the accumulation of proliferating antibody producing plasma cells in the bone marrow. In the last few years many studies have emphasized the biological complexity and heterogeneity of MM as a result of both genetic and epigenetic aberrations. Che-1/AATF (Che-1) is a transcriptional cofactor involved in cell cycle regulation, apoptosis, DNA damage and stress response. it can be hypothesized that Che-1 might contribute to the establishment of the MM malignant phenotype by sustaining global transcription through its ability to modulate chromatin accessibility.

The prospective study on MM human samples aims to understand the involvement of Che-1 in the transcriptional regulation and chromatin remodeling during the pathology. To this goal the main objectives are:

* Characterization of Che-1's role in chromatin remodeling and global gene expression
* Study in vivo and in vitro of Che-1 involvement in MM tumorigenesis
* Evaluation of Che-1 as a possible therapeutic target


Eligibility criteria: Inclusion Criteria:

* MM Patients

Exclusion Criteria:

* No exclusion criteria

Primary outcomes:
measure: Che-1 involvement in MM tumorigenesis
timeFrame: About 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Roma
country: Italy
facility: Regina elena Cancer Institute
city: Rome
country: Italy
facility: "Regina Elena" National Cancer Institute
Study officials:
References:
Clinical trial NCT04203303: Implications of the Human Microbiota for Health and Disease
Official title: Implications of the Human Microbiota for Health and Disease
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Human Microbiota
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2019-12-18
Enrollment: 5000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Eligible patients who are on the Mayo Clinic campus for clinic appointments or research study visits

Brief summary: The purpose of this study is to advance the understanding of human health and disease as it relates to environmental factors that may affect intestinal and non-intestinal microbiota.


Eligibility criteria: Inclusion Criteria:

* Age 18 years of age or older
* Able to provide informed consent

Exclusion Criteria:

* None

Primary outcomes:
measure: Microbiome Differences
timeFrame: 10 years
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Virend Somers, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06425003: Study of [14C] ABBV-CLS-7262 in Healthy Male Volunteers Following Single Oral Dose Administration
Official title: Mass Balance Study of [14C] ABBV-CLS-7262 in Healthy Male Volunteers Following Single Oral Dose Administration
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteer
Lead sponsor: Calico Life Sciences LLC
Sponsor class: INDUSTRY
Collaborators: name: AbbVie
First posted: 2024-05-22
Enrollment: 7
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to evaluate mass balance, pharmacokinetics and safety of \[14C\] ABBV-CLS-7262 in healthy, male volunteers following administration of a single oral dose.


Eligibility criteria: Inclusion Criteria:

* A condition of general good health, based upon the results of a medical history, physical examination, vital signs, laboratory profile and a 12-lead ECG.
* Body Max Index (BMI) is ≥ 18.0 to ≤ 32.0 kg/m2 after rounding to the tenths decimal at screening.

Exclusion Criteria:

* Considering fathering a child or donating sperm during the study and for 94 days after study drug administration, or is unwilling to comply with protocol recommended contraception recommendations.
* History of any clinically significant illness/infection/major febrile illness, hospitalization, or any surgical procedure within 30 days prior to the first dose of study drug.
* History of epilepsy, any clinically significant cardiac, respiratory (except mild asthma as a child), endocrine, metabolic, renal, hepatic, gastrointestinal, hematologic, endocrinologic or psychiatric disease or disorder, or any uncontrolled medical illness.
* Has had significant exposure to radiation for professional or medical reasons (e.g., serial x-rays or computed tomography scans, barium meal, current employment in a job requiring radiation exposure monitoring), except dental x-rays, within 12 months prior to study drug administration.

Primary outcomes:
measure: Number of Participants with Adverse Events (AEs)
timeFrame: Up to approximately 30 days from last dose.
measure: Maximum observed concentration (Cmax)
timeFrame: Up to approximately Day 15 from last dose
measure: Time to Cmax (peak time, Tmax)
timeFrame: Up to approximately 15 days from last dose
measure: Terminal phase elimination half-life (t1/2)
timeFrame: Up to approximately 15 days from last dose
measure: Area under the plasma concentration-time curve (AUC) from time 0 to the time of the last measurable concentration (AUCt)
timeFrame: Up to approximately 15 days from last dose
measure: Percent radioactivity excreted
timeFrame: Up to approximately 15 days from last dose
measure: Identification of metabolites excreted
timeFrame: Up to approximately 15 days from last dose
Secondary outcomes:
Other outcomes:
Locations:
city: Madison
country: United States
facility: Fortrea Clinical Research Unit Inc.
state: Wisconsin
Study officials:
References:
Clinical trial NCT05693103: The Effect of High-Intensity Focused Electromagnetic on Urinary Incontinence Symptoms
Official title: The Effect of High-Intensity Focused Electromagnetic on Urinary Incontinence Symptoms
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Urinary Incontinence, Stress Incontinence
Lead sponsor: Kaohsiung Medical University Chung-Ho Memorial Hospital
Sponsor class: OTHER
First posted: 2023-01-20
Enrollment: 30
Sex: FEMALE
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Collect 30 women with urinary incontinence symptoms (including: stress urinary incontinence, urge urinary incontinence)

Brief summary: This study is aimed at women's pelvic floor muscles, especially urinary incontinence caused by pelvic floor muscle relaxation or pelvic prolapse, to observe whether the use of (HIFEM) high-intensity focused magnetic energy chairs can help the pelvic floor muscles after this treatment Strengthening to improve the symptoms of urinary incontinence caused by the compression of the sacral nerve plexus caused by the downward movement of the uterus, thereby improving the social life and quality of life of the patient.


Eligibility criteria: Inclusion Criteria:

1. Women over 20 years old.
2. Symptoms of urinary incontinence (including: stress incontinence, urge incontinence).
3. Blood tests confirmed that the number of platelets was 150,000-450,000/UL, and the coagulation function (PT) index was normal.

Exclusion Criteria:

1. Pregnant and lactating women.
2. Patients with acute or chronic cardiovascular disease.
3. Patients with acute or chronic infectious diseases.
4. Patients with malignant tumors, uterine fibroids, and gynecological cysts, who have been evaluated by doctors as unsuitable.
5. Those who have undergone lower abdominal or genital-related surgery and have been evaluated by doctors as unsuitable.
6. Patients with pulmonary insufficiency.
7. People with metal and electronic implants (such as: pacemaker, defibrillator, neurostimulator).
8. Those with bleeding disorders or receiving anticoagulant therapy.
9. Use drug pumps.
10. People with skin allergies or skin diseases.
11. Those unable to sign the subject's consent form.

Primary outcomes:
measure: Urodynamic study
timeFrame: One hour
measure: Questionnaire
timeFrame: fifteen minutes
measure: Physiological parameter
timeFrame: five minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Medical University Chung-Ho Memorial Hospital
Study officials:
References:
Clinical trial NCT03015103: Safety Dermatological Assessment of Topical Use Product Through Dressings Predictive Studies for Evaluation of Photoirritation and Dermal Photosensitivity
Official title: Safety Dermatological Assessment of Topical Use Product Through Dressings Predictive Studies for Evaluation of Photoirritation and Dermal Photosensitivity
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Skin Irritability
Skin Sensitisation
Lead sponsor: Kley Hertz S/A
Sponsor class: INDUSTRY
First posted: 2017-01-09
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: The purpose of this study is to prove the product tested does not cause photoirritation or photosensitization reactions when exposed to sun light.


Eligibility criteria: Inclusion Criteria:

* Age between 18 to 70 years old;
* Skin types: I (light caucasian) or III (light brown);
* Intact skin where the product will be applied;
* Agreement to comply with the test procedures and attend the clinic in the days and fixed times for medical assessments and application and reading of dressings
* Signature of informed consent form

Exclusion Criteria:

* Pregnancy and lactation
* Use of anti-inflammatory and immunosuppressive from 30 days up to three months prior to selection;
* Diseases that cause immune suppression;
* Use of photosensitizing drugs;
* History or photodermatoses activities;
* Personal or family history of photoinduced skin cancer;
* Presence of precursor lesions of skin cancer, such as melanocytic nevi and actinic keratoses;
* Intense sun exposure in the experiment area Use of new drugs and/or cosmetics during the experiment;
* Previous participation in a study with the same product under test;
* Relevant medical history or current evidence of alcohol or other drugs abuse;
* Known historical or suspected intolerance to any ingredient of the product under study (product under test or comparator);
* Sponsor's employees involved in the study, or close family member of an employee involved in the study;

Primary outcomes:
measure: Photoirritation as measured through the use of dressings containing tested product and placebo
timeFrame: 5 days
measure: Photosensitization as measured through the use of dressings containing tested product and placebo
timeFrame: 32 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02051803: Women Engaging in Quitting Smoking Together (WE QUIT)
Official title: Distress Tolerance Treatment for Weight Concern in Smoking Cessation Among Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Smoking Cessation
Keywords: smoking cessation
women
Lead sponsor: Butler Hospital
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2014-01-31
Enrollment: 22
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The long-term goal of this program of research is to develop and disseminate an efficacious intervention for weight concern that will significantly increase smoking cessation rates among women. The overall objective of this project is to develop this intervention and modify it based on piloting and feedback to ensure its feasibility and acceptability. These objectives will be accomplished by pursuing the following specific aim: 1) develop a group-based distress tolerance treatment for weight concern (DT-W) in female smokers and a comparison health education (HE) program and pilot both treatments with three groups of 10 (total N = 30) female weight-concerned smokers (2 DT-W groups, 1 HE group).


Eligibility criteria: Inclusion Criteria:

* female
* 18 to 65 years of age
* smoke 10 or more cigarettes per day
* daily smoker for at least the past year
* report motivation to quit smoking in the next month of at least 5 on a 10 point scale
* report concern of at least 50 on at least one of two 100 point scales assessing weight concern
* able to travel to study location for study appointments

Exclusion Criteria:

* current use of other smoking cessation or weight loss therapies
* current use of other tobacco products at least weekly
* current diagnosis of depression
* diagnosis or treatment for non-nicotine substance use disorder with substance use during the past 6 months
* lifetime diagnosis or treatment of eating disorder, bipolar disorder, schizophrenia, or schizoaffective disorder
* current use of psychotropic medication except antidepressants
* score above established cut-offs on self-report screening measures of depressive symptomology, eating disorder symptomology, alcohol use disorder, or drug use disorder
* current suicidality or homicidality
* medical condition that is a contraindication for the use of transdermal nicotine patch
* lives at same address as current or past participant

Primary outcomes:
measure: Point prevalence abstinence from smoking
timeFrame: 6 months from smoking quit date
Secondary outcomes:
Other outcomes:
Locations:
city: Providence
country: United States
facility: Butler Hospital
state: Rhode Island
Study officials:
affiliation: Butler Hospital and Rhode Island Hospital
name: Erika L. Bloom, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03741803: Relationship Between Delayed Cord Clamping at Birth and Neonatal Bilirubin Levels in Parturients With a Prior Child Requiring Therapy for Neonatal Jaundice
Official title: Randomized Controlled Trial to Evaluate the Relationship Between Delayed Cord Clamping at Birth and Neonatal Bilirubin Levels in Parturients With a Prior Child Requiring Therapy for Neonatal Jaundice
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: NA
Conditions: Hyperbilirubinemia, Neonatal
Jaundice, Neonatal
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
First posted: 2018-11-15
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of the study is to determine if neonates (who already have an increased risk of hyperbilirubinemia due to mother's history of having previous neonate who received phototherapy for hyperbilirubinemia) have higher bilirubin levels 24 hours after birth with delayed cord clamping.


Eligibility criteria: Inclusion Criteria:

* mothers delivering at 35 weeks or greater
* mothers who have had at least 1 previous child that received phototherapy for hyperbilirubinemia
* multiple gestations can be included unless the neonate does not meet criteria for delayed cord clamping as described below or due to concerns about safety of delayed cord clamping for timing of delivery of the 2nd twin (ie: 2nd twin requires immediate delivery intervention)

Exclusion Criteria:

- Neonates who do not meet criteria for delayed cord clamping (any infant that any provider in the room felt needed evaluation by the neonatal transport team immediately so that the infant would be handed off for resuscitation. If the patient required delivery by cesarean section the delayed cord clamping protocol would be abandoned).

Primary outcomes:
measure: Neonatal bilirubin level
timeFrame: 24 hours after birth
Secondary outcomes:
measure: Number of neonates with hyperbilirubinemia
timeFrame: 24 hours after birth
measure: Number of neonates with a need for phototherapy
timeFrame: From birth to up to 1 week after birth
measure: Number of neonates with a need for exchange transfusion
timeFrame: From birth to up to 1 week after birth
measure: Number of neonates admitted to the neonatal intensive care unit (NICU)
timeFrame: From birth to up to 1 week after birth
measure: Number of mothers with postpartum hemorrhage
timeFrame: From birth to up to 1 week after birth
measure: Number of neonates re-hospitalized for jaundice
timeFrame: From birth to up to 1 week after birth
Other outcomes:
Locations:
city: Houston
country: United States
facility: The University of Texas Health Science Center at Houston
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Pamela D Berens, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00770003: Tolerability/PoP Study in Allergic Rhinitis After Intranasal Administration of AZD8848
Official title: A Double-blind, Placebo Controlled, Randomized, Parallel Group Study to Investigate the Tolerability, Safety, Pharmacodynamics and Pharmacokinetics of Repeated Weekly Doses of AZD8848 Administered Intranasally to Seasonal Allergic Rhinitis Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Allergic Rhinitis
Keywords: patients
allergic rhinitis
tolerability
safety
nasal symptoms
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2008-10-09
Enrollment: 103
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary purpose is to investigate tolerability/safety of repeated weekly doses of AZD8848 administered intranasally to seasonal allergic rhinitis patients.


Eligibility criteria: Inclusion Criteria:

* Patients with a history of birch and/ or timothy grass pollen induced seasonal allergic rhinitis for at least the previous 2 years (verified by a positive skin prick test)
* Patients with need of treatment for their nasal symptoms during the pollen season

Exclusion Criteria:

* Clinical relevant disease or abnormality (past or present) - other than allergic rhinitis
* Symptomatic perennial allergic or non-allergic rhinitis
* A history of asthma

Primary outcomes:
measure: Incidence/nature of adverse events,pulse, BP, body temperature, ECG parameters, lab assessments
timeFrame: During the study
measure: Nasal symptoms, peak nasal inspiratory flow
timeFrame: During the study
Secondary outcomes:
measure: Reflective Total Nasal Symptom Score, Peak Nasal Inspiratory Flow
timeFrame: During the study
measure: Blood biomarkers and nasal lavage biomarkers
timeFrame: During the study
measure: Pharmacokinetics
timeFrame: During the study
Other outcomes:
Locations:
city: Helsingborg
country: Sweden
facility: Research Site
city: Lund
country: Sweden
facility: Research Site
Study officials:
affiliation: Lund University Hospital
name: Lennart Greiff, MD PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: AstraZeneca
name: Leif T Eriksson, MD, PhD
role: STUDY_DIRECTOR
References:
citation: Greiff L, Ahlstrom-Emanuelsson C, Alenas M, Almqvist G, Andersson M, Cervin A, Dolata J, Lindgren S, Martensson A, Young B, Widegren H. Biological effects and clinical efficacy of a topical Toll-like receptor 7 agonist in seasonal allergic rhinitis: a parallel group controlled phase IIa study. Inflamm Res. 2015 Nov;64(11):903-15. doi: 10.1007/s00011-015-0873-2. Epub 2015 Sep 5.
citation: Greiff L, Cervin A, Ahlstrom-Emanuelsson C, Almqvist G, Andersson M, Dolata J, Eriksson L, Hogestatt E, Kallen A, Norlen P, Sjolin IL, Widegren H. Repeated intranasal TLR7 stimulation reduces allergen responsiveness in allergic rhinitis. Respir Res. 2012 Jun 22;13(1):53. doi: 10.1186/1465-9921-13-53.