louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06677957: A Clinical Trial to Investigate the Clinical Drug-Drug Interaction of Divarasib With Probe Substrates of P-Glycoprotein and Breast Cancer Resistance Protein in Healthy Participants
Official title: A Phase I, Open-Label, Two-Period, One-Sequence, Crossover Study in Healthy Subjects to Evaluate the Clinical Drug-Drug Interaction of Divarasib With Probe Substrates of P-Glycoprotein (Digoxin) and Breast Cancer Resistance Protein (Rosuvastatin)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Participants
Lead sponsor: Genentech, Inc.
Sponsor class: INDUSTRY
First posted: 2024-11-07
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: This is a Phase 1, open-label, two-period, one-sequence, crossover drug-drug interaction study to assess the P-gp and BCRP inhibition potential of divarasib using digoxin and rosuvastatin as probe substrates, respectively, in healthy participants.


Eligibility criteria: Inclusion Criteria:

* Males or females of non-childbearing potential
* Within body mass index (BMI) range of 18.0 to 32.0 kg/m2, inclusive

Exclusion Criteria:

* Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal (GI), neurological, or psychiatric disorder
* History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the investigator
* Poor peripheral venous access

Primary outcomes:
measure: Maximum Observed Plasma Concentration (Cmax) of Digoxin and Rosuvastatin
timeFrame: Day 1 of Period 1 and Day 5 of Period 2
measure: Area Under the Plasma Concentration-Time Curve from Hour 0 to the Last Measurable Concentration (AUC0-t) of Digoxin and Rosuvastatin
timeFrame: Day 1 of Period 1 and Day 5 of Period 2
measure: Area Under the Plasma Concentration-Time Curve (AUC0-inf) of Digoxin and Rosuvastatin
timeFrame: Day 1 of Period 1 and Day 5 of Period 2
measure: Time to Cmax (Tmax) of Digoxin and Rosuvastatin
timeFrame: Day 1 of Period 1 and Day 5 of Period 2
Secondary outcomes:
measure: Percentage of Participants with Adverse Events (AEs)
timeFrame: From Day 1 until end of study participation (approximately 2 months)
Other outcomes:
Locations:
city: Daytona Beach
country: United States
facility: Daytona Beach Clinical Rsch Unit
state: Florida
Study officials:
affiliation: Genentech, Inc.
name: Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT00460057: The Change of Bone Markers After Low Dose Alendronate in Postmenopausal Women With Bone Loss
Official title: The Change of Bone Markers After Low Dose Alendronate in Postmenopausal Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Osteoporosis
Keywords: osteoporosis
alendronate
bone marker
Lead sponsor: Eulji University Hospital
Sponsor class: OTHER
First posted: 2007-04-13
Enrollment: 63
Sex: FEMALE
Minimum age (years): 50
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: High bone turnover with the bone resorption exceeding bone formation is a major mechanism of postmenopausal osteoporosis. Therefore, inhibition of bone resorption is a rational approach for the prevention. The Objective of the current study was to determine the short-term efficacy of once-weekly low dose alendronate in the prevention of bone loss in early postmenopausal Korean women with moderate bone loss via bone turnover markers.

This study was a 12-week, randomized, double-blind clinical trial compared the effects of placebo with alendronate 20 mg once weekly. All subjects received supplemental calcium 600 mg and vitamin D 400 IU daily. Fifty two postmenopausal women (the ages between 50-65 year) with lumbar spine BMD at least 2.0 SD below the peak young adult mean were recruited at Eulji University Hospital, Daejeon, Korea. BMD was measured by DXA at baseline and serum alkaline phosphatase, osteocalcin and C-terminal telopeptide of type I collagen was measured at baseline and 12 weeks after treatment.


Eligibility criteria: Inclusion Criteria:

* postmenopausal women (the ages between 50-65 year) with lumbar spine BMD at least 2.0 SD below the peak young adult mean

Exclusion Criteria:

* severe osteoporosis
* current medication of osteoposis
* metabolic bone disease
* cancer, stroke etc.

Primary outcomes:
measure: Changes of bone turnover markers
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Department of Family medicine, Eulji University Hospital
name: Hee-Jeong Choi, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06506357: A Single Group Study to Evaluate the Effects of a Probiotic Supplement on Vaginal Health.
Official title: A Single Group Study to Evaluate the Effects of a Probiotic Supplement on Vaginal Health.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vaginal Health
Women's Health
Keywords: Probiotic Supplement
Urinary Tract Health
Lead sponsor: Love Wellness
Sponsor class: INDUSTRY
Collaborators: name: Citruslabs
First posted: 2024-07-17
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This virtual single-group clinical trial aims to evaluate the effects of the Good Girl Probiotics supplement on vaginal health. Participants will take one capsule of the probiotic supplement daily for eight weeks. They will complete questionnaires at Baseline, after the first dose, and at the end of Weeks 2, 4, 6, and 8 to assess changes in vaginal pH, vaginal health, and urinary tract health.


Eligibility criteria: Inclusion Criteria:

* Female at birth.
* Aged 18+.
* Interested in supporting a balanced vaginal pH, vaginal health, and urinary tract health.
* Regularly experience symptoms of an unbalanced vagina, including an atypical smell, discharge, itching, swelling, irritation, pain during sex, and/or burning sensation while urinating.
* Willing to avoid using products or medications that target vaginal or urinary tract health infections.
* Willing to avoid other probiotics.
* Able to follow the study protocol.

Exclusion Criteria:

* Two or more bladder infections in six months or three or more infections in a year.
* Recent surgeries or invasive treatments within the last six months.
* Use of products or medications targeting vaginal or urinary tract health in the last 12 weeks.
* Known allergies to the product ingredients.
* Chronic health conditions impacting participation.
* Pregnant, breastfeeding, or trying to conceive.
* History of substance abuse.
* Current or former smoker within the past six months.
* Participation in another clinical trial.
* Diagnosed vaginal or pelvic conditions.
* Use of vaginal-related birth control (NuvaRing, IUD).
* Changes in hormonal birth control in the last three months.

Primary outcomes:
measure: Vaginal and Urinary Tract Health and Balance
timeFrame: Baseline, Week 2, Week 4, Week 6, Week 8
Secondary outcomes:
measure: Vaginal Environment and Odor
timeFrame: Baseline, Week 2, Week 4, Week 6, Week 8
Other outcomes:
Locations:
city: Santa Monica
country: United States
facility: Citruslabs
state: California
Study officials:
References:
Clinical trial NCT03015857: Phenylephrine and Noradrenaline for Post Spinal Anesthesia Hypotension
Official title: A Comparison Between Phenylephrine and Norepinephrine Boluses in Prevention of Post-spinal Hypotension During Cesarean Delivery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Adverse Anesthesia Outcome
Lead sponsor: Kasr El Aini Hospital
Sponsor class: OTHER
First posted: 2017-01-10
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Hypotension following spinal anesthesia for cesarean section is a serious problem. In this study we investigated the effect of the vasopressors phenylephrine and noradrenaline on postspinal hypotension.

Detailed description: On arrival to the operating room, an 18g cannula will be inserted and monitors will be applied (electrocardiography - pulse oximetry - non-invasive blood pressure monitor). Patients will receive spinal anesthesia with 500 ml rapid crystalloid co-load. Ten milligrams heavy bupivacaine in addition to 20 mcg fentanyl will be injected in L3-L4 or L4-L5 interspace using 25 g spinal needle in the sitting position.

After spinal block, patients will be randomly allocated into one of two groups:

* Phenylephrine group (n=100)
* Norepinephrine group (n=100)

Patients who shows SBP above 140 mmHg or heart rate below 55 bpm after the first vasopressor dose will not receive the infusion. The infusion will stop if the SBP was above 140 mmHg or if the heart rate was below 55 bpm. Patients will be positioned in the supine position with left lateral tilt. Block success will be assessed using pinprick, patients with failed block will be excluded from the study. The highest sensory block level will be assessed after 5 minutes from intrathecal injection. Co-hydration will be continued till maximum of 1.5 litres.

Eligibility criteria: Inclusion Criteria:

* full term singleton parturients
* elective cesarean sections

Exclusion Criteria:

* cardiac morbidities
* hypertensive disorders of pregnancy
* peripartum bleeding
* body mass index \> 35 will be excluded from the study

Primary outcomes:
measure: Incidence of post spinal hypotension (PSH) defined as percentage of patients with decreased systolic blood pressure less than 80% of the baseline reading during the period from intrathecal injection to delivery of the fetus)
timeFrame: 2 hours
Secondary outcomes:
measure: systolic and diastolic blood pressures measured in mm Hg
timeFrame: 2 hours
measure: heart rate measured in beats per minute
timeFrame: 2 hours
measure: nausea and vomiting measured in number of attacks
timeFrame: 2 hours
Other outcomes:
Locations:
Study officials:
affiliation: Lecturer of anesthesia Faculty of medicine Cairo university
name: Shereen Refaat, M.D.
role: STUDY_CHAIR
affiliation: Lecturer of anesthesia Faculty of medicine Cairo university
name: Tamer M Rook, M.D.
role: STUDY_CHAIR
References:
Clinical trial NCT03762057: Prevalence, Risk Factors, and Prognostic Factors of Intraabdominal Hypertension and Abdominal Compartment Syndrome in Critically Ill Surgical Patients in Ramathibodi Hospital
Official title: Prevalence, Risk Factors, and Prognostic Factors of Intraabdominal Hypertension and Abdominal Compartment Syndrome in Critically Ill Surgical Patients in Ramathibodi Hospital
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Intraabdominal Hypertension
Abdominal Compartment Syndrome
Keywords: Intraabdominal Hypertension
Abdominal Compartment Syndrome
Prevalence
Risk factors
ICU
Surgical
Lead sponsor: Ramathibodi Hospital
Sponsor class: OTHER
First posted: 2018-12-03
Enrollment: 303
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 postoperative adult patients admitted to institutional surgical ICUs.

Brief summary: To identified prevalence, risk factors, and prognostic factors of IAH and ACS in surgical critically ill patients in institutional hospital

Detailed description: Every postoperative patients admitted to surgical ICU who meet inclusion criteria will be asked for informed consent. After obtained, intraabdominal pressure (IAP) will be measured through already placed Foley's catheter simultaneously with patients's data record. If patients don't have IAH or ICS, IAP will be measured daily until discharge from ICU or removal of Foley's catheter. If patients have IAH or ACS, IAP will be measured every 6-8 hours until IAP is less than 12 mmHg then it will be measures daily until discharge from ICU or removal of Foley's catheter. After completion of data collection, data will be analyzed accordingly.

Eligibility criteria: Inclusion Criteria:

* Postoperative patient admitted to surgical ICU
* Age \>/= 18
* Foley's catheter in place

Exclusion Criteria:

* Patient refusal
* Underwent neo-bladder procedure
* Need continuous bladder irrigation

Primary outcomes:
measure: Prevalence of intraabdominal hypertension and abdominal compartment syndrome
timeFrame: Within 30 days of ICU admission
Secondary outcomes:
measure: Risk factors of intraabdominal hypertension and abdominal compartment syndrome
timeFrame: Within 30 days of ICU admission
measure: Prognostic factors of death after developing intraabdominal hypertension and abdominal compartment syndrome
timeFrame: Within 30 days of ICU admission
Other outcomes:
Locations:
city: Ratchathewi
country: Thailand
facility: Ramathibodi Hospital
state: Bangkok
Study officials:
affiliation: Faculty of medicine, Ramathibodi Hospital
name: Cherdkiat Karnjanarachata, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04627857: Effect of the Use of Specific Oral Hygiene Devices on Gingival Health Among Patients With Systemic Sclerosis
Official title: Effect of the Use of Specific Oral Hygiene Devices on Gingival Health Among Patients With Systemic Sclerosis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Scleroderma Systemic
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2020-11-13
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Systemic sclerosis is a rare multisystem connective-tissue disorder characterized by three major pathological hallmarks: widespread fibrosis, vasculopathy and immunological abnormalities. This condition has multiple effects on the orofacial region that is involved in approximately 80% of the patients with a significant impact on the quality of life.

The aim of this randomized single-blind study is to evaluate the impact of the use of a specific oral hygiene instrumentation (sonic toothbrush and water flosser with a large handle) compared to "standard" toothbrushing with a manual toothbrush on the gingival health among patients with systemic sclerosis.


Eligibility criteria: Inclusion Criteria:

* Adult male or female ≥ 18 years (18th birthday completed)
* Affiliation to a social welfare system
* Signed informed consent form
* More than 12 natural teeth suitable for evaluation
* Systemic sclerosis with cutaneous involvement with a diagnosis based on American College of Rheumatology (ACR) and LeRoy and Metzger criteria

Exclusion Criteria:

* Localized scleroderma or systemic sclerosis without cutaneous involvement ("sine scleroderma" limited form)
* Less than 12 natural teeth suitable for evaluation and/or mandibular/maxillary complete denture(s)
* Other progressive chronic illness /autoimmune disease other than systemic sclerosis (e.g. diabetes)
* Another cause of mucocutaneous sclerosis (e.g. radiotherapy involving the oro-facial region)
* Current use of sonic toothbrush and/or dental water flosser
* Severe manual handicap preventing the patient from holding a toothbrush with a large handle
* Oral antiseptics (e.g. chlorhexidin mouthwashes)
* Ongoing medical treatment inducing a significant modification of the gingival state (e.g. anti-epileptic drugs)
* Smoking (≥ 10 cigarettes per day)
* Impossibility to provide accurate information (e.g. emergency situation, comprehension difficulties)
* Individual under guardianship, curatorship or judicial protection

Primary outcomes:
measure: Changing of plaque index between baseline, week 2 and week 4
timeFrame: day 0, week 2 and week 4
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Service de parodontologie
Study officials:
References:
Clinical trial NCT04393857: The Temporo-spatial Dynamics of Genital Tract Microbiota - an Observational Study in Oocyte Donors
Official title: The Temporo-spatial Dynamics of Genital Tract Microbiota - an Observational Study in Oocyte Donors
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bacterial Vaginoses
Lead sponsor: Regionshospitalet Viborg, Skive
Sponsor class: OTHER
Collaborators: name: Instituto Bernabeu
First posted: 2020-05-19
Enrollment: 26
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Healthy oocyte donors

Brief summary: The investigators aim to examine the endometrium with state of the art sequencing techniques to investigate the endometrial microbiota. The endometrial microbiota has been perceived to be sterile, however, this seems incorrect from recent studies. Thus, the primary outcome is to compare the rate of ascending infection from the vagina to the endometrium and to investigate which bacteria are capable of inhabiting these environments in healthy oocyte donors. These results will be compared to equivalent samples of IVF patients.


Eligibility criteria: Inclusion Criteria:

Oocyte donors meeting local criteria for donation. Written informed consent. Regular cycle

Exclusion Criteria:

Antibiotics within 1 month Vaginal products other than for menstrual hygiene within 1 month Uterine malformations(Septum, polyps, adenomyosis, fibroids) HIV, Hepatitis B or C positivity. HPV CIN 2 or higher. Chlamydia trachomatis positivity.

Any uncontrolled concomitant disease (e.g. uncontrolled diabetes, uncontrolled hypertension etc.)

Primary outcomes:
measure: Rate of ascending infection/sharing of bacteria in the genital tract
timeFrame: This outcome data is measured at the 1 day of oocyte retrieval.
Secondary outcomes:
measure: Next generation sequencing techniques and qPCR will be used to assess the microbiota.I.e. measure of relative abundances and absolute abundances
timeFrame: This outcome data is measured at the 1 day of oocyte retrieval.
Other outcomes:
Locations:
city: Alicante
country: Spain
facility: Instituto Bernabeu
Study officials:
References:
Clinical trial NCT06987357: Comparison of the Effects of Sugammadex and Neostigmine on Early Extubation, Intensive Care Unit Admission and Length of Stay, and Hospital Costs in Adult Cranial Surgery
Official title: Comparison of the Effects of Sugammadex and Neostigmine on Early Extubation, Intensive Care Unit Admission and Length of Stay, and Hospital Costs in Adult Cranial Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Craniectomy
Sugammadex
Extubation
Recovery After Neuromuscular Block
Hospital Costs
Lead sponsor: Kanuni Sultan Suleyman Training and Research Hospital
Sponsor class: OTHER
First posted: 2025-05-23
Enrollment: 112
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Among the patients who underwent cranial surgery under sevoflurane anesthesia and whose neuromuscular blockade was provided with rocuronium, the patients whose neuromuscular blockade was antagonized with neostigmine or sugammadex and who were admitted to the intensive care unit postoperatively were evaluated.

Brief summary: The aim of this study was to retrospectively investigate the effects of sugammadex or neostigmine, which are routinely used after the completion of surgery to antagonize (reverse) neuromuscular blockade in adult patients undergoing cranial surgery under general anesthesia, on early extubation in the operating room, intensive care unit admission and length of stay, length of hospital stay, and hospital costs.


Eligibility criteria: Inclusion Criteria:

* Patients from the American Society of Anesthesiology (ASA) I-II-III group,
* over the age of 18,
* who underwent elective surgery,
* underwent general anesthesia with sevoflurane anesthesia from volatile anesthetics,
* used rocuronium as a neuromuscular blocking agent

Exclusion Criteria:

* Patients aged 18 and under,
* ASA IV and above,
* who underwent surgery under emergency conditions,
* who have incomplete follow-up form records and electronic media data,
* who were taken to the intensive care unit without neuromuscular blockade antagonism due to long surgery,
* who were treated with a neuromuscular blocking agent other than rocuronium,
* who were treated with a volatile anesthetic other than sevoflurane or with total intravenous anesthesia.

Primary outcomes:
measure: The amount of cost in the hospital process
timeFrame: through study completion, an average of 3 month
measure: Length of stay in the intensive care unit
timeFrame: through study completion, an average of 3 month
measure: Early extubation rate after two different neuromuscular blocking antagonist drugs
timeFrame: through study completion, an average of 3 month
Secondary outcomes:
Other outcomes:
Locations:
city: İstanbul
country: Turkey
facility: Kanuni Sultan Suleyman Training and Research Hospital
Study officials:
References:
Clinical trial NCT00248157: Extension Study of the Long-term Safety and Tolerability of Octreotide Acetate in Patients With Moderately Severe or Severe Non-proliferative Diabetic Retinopathy or Low Risk Proliferative Diabetic Retinopathy
Official title: An Open-label Extension Study to Evaluate the Long-term Safety and Tolerability of Octreotide Acetate in Microspheres in the Therapy of Patients With Moderately Severe or Severe Non-proliferative Diabetic Retinopathy (NPDR) or Low Risk Proliferative Diabetic Retinopathy (PDR)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Diabetic Retinopathy
Keywords: Diabetic retinopathy
Octreotide acetate in microspheres
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2005-11-03
Enrollment: 105
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This multicenter, open-label extension study will evaluate the long-term tolerability and safety for patients completing study CSMS995 0802. During this extension study, all patients will receive open-label treatment of octreotide acetate in microspheres every 4 weeks for 2 years for the treatment of moderately severe to severe NPDR and low risk PDR.


Eligibility criteria: Inclusion Criteria:

* written informed consent provided prior to participation in the extension study
* successful completion of study CSMS995 0804
* willingness to comply with all study requirements

Exclusion Criteria:

* more than 8 weeks interval since the completion of study CSMS995 0804
* premature discontinuation from study CSMS995 0804

Other protocol-defined inclusion/exclusion criteria may apply.

Primary outcomes:
measure: long-term safety and tolerability
Secondary outcomes:
measure: monitor long-term efficacy
Other outcomes:
Locations:
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: