louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02642497: Local Ketamine Instillation for Postoperative Analgesia
Official title: Efficacy of Postoperative Analgesia Offered by Local Ketamine Wound Instillation Following Total Thyroidctomy; a Randomized, Double-blind, Controlled-clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Postoperative Pain
Keywords: postoperative analgesia
ketamine
total thyroidectomy
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2015-12-30
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This study aims at exploring the analgesic efficacy, and safety of Ketamine instillation into the wound of total thyroidectomy compared to placebo,and to systemic ketamine administration (I.M. injection of the same dose) with respect to postoperative VAS, first request of analgesia, total opioid consumption, and with respect to possible side effects.


Eligibility criteria: Inclusion Criteria:

* patients with thyroid cancer scheduled for total thyroidectomy.

Exclusion Criteria:

1. BMI\>35
2. Unstable ischaemic cardiac disease
3. Increased intracranial pressure
4. Increased intraocular pressure
5. Hypersensitivity or allergy to ketamine, local anesthetic, morphine, or other drugs used in the study.
6. Severe psychiatric disease
7. Unwillingness or inability to use PCA-device
8. Inability to use VAS scale

Primary outcomes:
measure: total opioid consumption
timeFrame: 24 hours
Secondary outcomes:
measure: first request of analgesia
timeFrame: 24 hours
measure: VAS
timeFrame: 24 hours
Other outcomes:
measure: possible side effects
timeFrame: 24 hours
Locations:
Study officials:
References:
Clinical trial NCT04890197: Tahini and Dermatitis in Breast Cancer
Official title: The Effects of Tahini Consumption on Radiotherapy Induced Dermatitis in Breast Cancer - A Pilot Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Breast Cancer
Lead sponsor: National Nutrition and Food Technology Institute
Sponsor class: OTHER
First posted: 2021-05-18
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aimed to investigate the effect of tahini on acute radiation dermatitis in breast cancer (BC) patients undergoing radiotherapy (RT).

50 eligible BC patients will randomly assign to consume tahini 48 gr per day during and 1 week after RT or with no intervention (control group). The radiation dermatitis will be assessed weekly according to the Radiation Therapy Oncology Group/ European Organization for Research and Treatment of Cancer (RTOG/EORTC) scales.


Eligibility criteria: Inclusion Criteria:

* women with Brest Cancer undergoing adjutant Radiation therapy

Exclusion Criteria:

* previous history of RT, MRM,
* concomitant presence of two or more malignant tumors
* metastasis to other areas
* allergy or intolerance to tahini
* skin diseases and wounds
* severe liver and renal disease
* autoimmune diseases
* pregnant and lactating women
* those who treated with hypo fraction RT

Primary outcomes:
measure: severity of dermatitis
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04947397: Investigation of Pupillometry as Guide for Extubation Readiness in Anesthetized Children
Official title: Investigation of Pupillometry as Guide for Extubation Readiness in Anesthetized Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anesthesia
Laryngospasm on Emergence
Keywords: Pediatric
Anesthesia
Extubation
Pupillometry
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2021-07-01
Enrollment: 20
Sex: ALL
Minimum age (years): 2
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Investigation of pupillometry as guide for extubation readiness in anesthetized children.

Detailed description: Can a pupil metric be used to make extubation more safe in anesthetized children?

Eligibility criteria: Inclusion Criteria:

* Children undergoing general anesthesia and endotracheal intubation for surgery.
* American Society of Anesthesiologists Physical Status Class I and II patients.

Exclusion Criteria:

* Central nervous system abnormality.
* Ophthalmologic abnormality.

Primary outcomes:
measure: Extubation Success
timeFrame: Immediately after extubation
Secondary outcomes:
measure: Anesthetic Vapor Concentration at Extubation
timeFrame: At the time of extubation
Other outcomes:
measure: Breath-holding
timeFrame: Prior to extubation
Locations:
city: Oakland
country: United States
facility: UCSF Benioff Children's Hospital Oakland
state: California
Study officials:
affiliation: UCSF Benioff Children's Hospital Oakland
name: Daniel Abelson, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04015297: Raman Spectroscopy and Endometriosis
Official title: The Role of Raman Spectroscopic Analysis for Endometriosis Diagnosis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Endometriosis
Endometrioma
Keywords: endometriosis
raman analaysis
Lead sponsor: Acibadem University
Sponsor class: OTHER
First posted: 2019-07-10
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: We aimed to use Raman spectroscopy to detect differences between healthy controls and patients with surgically proven endometriosis.

Detailed description: Endometriosis is a chronic disease whose molecular basis is still unknown and diagnostic methods are controversial. The diagnosis is still invasive and there are no accepted ways which are molecular-based and noninvasive. Raman spectroscopy is a vibrational spectroscopy technique which can analyze specific spectral patterns, substances and molecular changes with high specificity. We aimed to use Raman spectroscopy to detect differences between healthy controls and patients with surgically proven endometriosis.

Eligibility criteria: Inclusion Criteria:

* proven endometriosis

Exclusion Criteria:

* having additional health conditions

Primary outcomes:
measure: diagnostic specificity
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Bahar Yuksel
Study officials:
affiliation: esenler maternity and children's hospital
name: Bahar Yuksel, md
role: STUDY_DIRECTOR
References:
citation: Lyng FM, Traynor D, Ramos IR, Bonnier F, Byrne HJ. Raman spectroscopy for screening and diagnosis of cervical cancer. Anal Bioanal Chem. 2015 Nov;407(27):8279-89. doi: 10.1007/s00216-015-8946-1. Epub 2015 Aug 16.
citation: Eberhardt K, Stiebing C, Matthaus C, Schmitt M, Popp J. Advantages and limitations of Raman spectroscopy for molecular diagnostics: an update. Expert Rev Mol Diagn. 2015 Jun;15(6):773-87. doi: 10.1586/14737159.2015.1036744. Epub 2015 Apr 15.
Clinical trial NCT06477497: The Application of Comprehensive Prevention and Treatment Strategy of Placenta Accreta Spectrum Disorders
Official title: The Application of Comprehensive Prevention and Treatment Strategy of Placenta Accreta Spectrum Disorders
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Placenta Accreta Spectrum
Keywords: placenta accreta spectrum disorders
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
Collaborators: name: National Key Research and Development Program of China
First posted: 2024-06-27
Enrollment: 33
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Pregnant women with placenta accreta spectrum disorders

Brief summary: Placenta accreta spectrum (PAS) disorders are pathological attachment of the placenta to myometrium, where trophoblastic cells invade the uterine placental interface. PAS can lead to severe postpartum hemorrhage or even maternal death. Prenatal diagnosis of PAS is essential for optimal obstetric management to improve the pregnancy outcomes. However, in some low resource regions in China, less than 20% PAS are detected before delivery.

To explore the feasibility and universality of the bundled prevention and treatment strategy for placenta accreta spectrum disorders in different levels of medical institutions, and to investigate its effectiveness in improving the specialized disease management capabilities of medical institutions at all levels. We will conduct a regional, cluster-randomized trial to assess a multicomponent PAS management strategy to improve the prepartum detection rate of PAS.


Eligibility criteria: Inclusion Criteria:

* Pregnant women who have regular prenatal examination at the research hospitals
* Pregnant women diagnosed with PAS before or after delivery

Exclusion Criteria:

* Pregnant women who have never been diagnosed with placental implantation disease throughout the pregnancy
* Pregnant women who were lost to follow-up during the study period

Primary outcomes:
measure: antepartum diagnosis rate of PAS
timeFrame: through study completion, an average of 1.5 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00204997: Preservation of Ovarian Function Via LOT in Squamous Cell Carcinoma of the Cervix
Official title: Preservation of Ovarian Function Via Laparoscopic Transposition in Patients With Locally Advanced Squamous Cell Carcinoma of the Cervix
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Cervical Cancer
Keywords: Cervical Cancer
Squamous Cell
Laparoscopy
Ovarian Function
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
First posted: 2005-09-20
Enrollment: 10
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the feasibility, safety and efficacy of laparoscopic ovarian transposition in women less than 40 years of age with locally advanced cervical squamous cell carcinoma


Eligibility criteria: Inclusion Criteria:

* Newly diagnosed Stages iB-iiiB squamous cell carcinoma of the cervix

Exclusion Criteria:

* Evidence of ovarian involvement on MRI
* Evidence of uterine involvement on MRI
* Evidence of distant mets on MRI

Primary outcomes:
measure: Menopause
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Madison
country: United States
facility: University of Wisconsin
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: David M Kushner, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05524597: Writing About Experiences and Health in Older Adults II
Official title: Writing About Experiences and Health in Older Adults II
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Social Psychology
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
First posted: 2022-09-01
Enrollment: 200
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trial
Primary purpose: BASIC_SCIENCE

Brief summary: UCLA researchers looking for healthy older adults (aged 65+) to participate in a study investigating how writing about experiences can affect your brain and body.

Once a week for 6 weeks, participants will write about their experiences and fill out online questionnaires. Participants will also come to the UCLA campus to complete a neuroimaging session (fMRI), provide a blood spot sample, and fill out questionnaires 2 times: once prior to the 6-week writing period and once immediately after the 6-week writing period.


Eligibility criteria: Inclusion Criteria:

* Healthy adults age 65 years and older

Exclusion Criteria:

1. current smokers
2. active, uncontrolled medical disorders
3. chronic infection (e.g., Hepatitis C, HIV)
4. use of certain medications (steroid use, opioid use)
5. psychiatric disorders (e.g., current major depression, bipolar disorder)
6. body mass index (BMI) greater than 35
7. left-handed
8. claustrophobic
9. metal in body

Other exclusion criteria may apply.

Primary outcomes:
measure: Change in Psychological Distress
timeFrame: Baseline, 6 weeks, 10 weeks
measure: Change in Social Support
timeFrame: Baseline, 6 weeks, 10 weeks
measure: Change in Social Participation
timeFrame: Baseline, 6 weeks, 10 weeks
measure: Change in Inflammatory Gene Expression
timeFrame: Baseline, 6 weeks, 10 weeks
measure: Change in Dorsal Anterior Cingulate Cortex (dACC) Activity in response to stress
timeFrame: Baseline, 6 weeks
measure: Change in Anterior Insula Activity in response to stress
timeFrame: Baseline, 6 weeks
measure: Change in Amygdala Activity in response to threat
timeFrame: Baseline, 6 weeks
measure: Change in Ventral Striatum Activity in response to prosocial behavior
timeFrame: Baseline, 6 weeks
measure: Change in Septal Area Activity in response to prosocial behavior
timeFrame: Baseline, 6 weeks
Secondary outcomes:
measure: Change in Memory
timeFrame: Baseline, 6 weeks, 10 weeks
measure: Change in Beliefs about Aging
timeFrame: Baseline, 6 weeks, 10 weeks
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Center for Cognitive Neuroscience
state: California
Study officials:
References:
Clinical trial NCT03587597: Socket Shield vs Conventional Immediate Implant
Official title: Esthetic Zone Socket Shield Technique With Immediate Temporization vs. Conventional Immediate Implant Placement With Immediate Temporization Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Preservation of the Labial Bone
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2018-07-16
Enrollment: 12
Sex: ALL
Minimum age (years): 25
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: eighteen implants will be placed in patients with non-restorable maxillary teeth in the aesthetic area.the recruited patients will be divided into two groups .group 1 will undergo socket shield technique with immediate temporization ,while group 2 will undergo conventional immediate implant placement with immediate temporization. to compare bone loss and aesthetic outcomes in the two techniques.


Eligibility criteria: Inclusion Criteria:

* Patients with non-restorable maxillary anterior teeth in the esthetic zone indicated for implant placement.
* Both sexes.
* No intraoral soft and hard tissue pathology
* No systemic condition that contraindicate implant placement

Exclusion Criteria:

* Heavy smokers more than 20 cigarettes per day.
* Patients with systemic disease that may affect normal healing.
* Psychiatric problems
* Disorders to implant are related to history of radiation therapy to the head and neck neoplasia

Primary outcomes:
measure: implant stability
timeFrame: immediately after implant placement
Secondary outcomes:
measure: Amount of bone loss
timeFrame: after 3 month from implant insertion.
Other outcomes:
measure: pink aesthetic score
timeFrame: immediately after implant placement and three month later
Locations:
city: Cairo
country: Egypt
facility: Faculty of Oral and Dental Medicine
Study officials:
References:
Clinical trial NCT01675297: Efficacy and Safety Study of Risedronate, Cholecalciferol Combination Tablet in Patients With Osteoporosis
Official title: For 12months, the Multi Center, Randomized, Open-label, Active Controlled Comparative Clinical Study to Assess the Efficacy and the Safety of Risedronate, Cholecalciferol Combination Tablet in Patients With Osteoporosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Osteoporosis
Keywords: Risedronate, cholecalciferol, BMD
Lead sponsor: Hanlim Pharm. Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2012-08-29
Enrollment: 1053
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the efficacy and the safety of Risedronate, cholecalciferol combination tablet in patients with Osteoporosis.

Detailed description: The purpose of this study is to evaluate the efficacy and the safety of Risedronate with and without cholecalciferol on vitamin D status, Bone Mineral Density (BMD) and bone markers.

Eligibility criteria: Inclusion Criteria:

1. Male osteoporosis patients over 19 years of age
2. Female osteoporosis patients with menopause

   * Definition of osteoporosis

     * They had a BMD T-score -2.5 or less at mean Lumbar spine(L1-L4), Femoral neck or total. Or evidence of at least one vertebral fracture
   * Definition of menopause(can be one of three condition)

     * For 12months spontaneous amenorrhea
     * For 6months spontaneous amenorrhea with serum FSH(Follicle stimulating hormone) is 40mlU/mL and over
     * 6weeks after bilateral ovariectomy whether hysterectomy or not.

Exclusion Criteria:

1. Patients with esophagus disorder (i.e:esophagostenosis)
2. Patients administered with osteoporosis therapy(except calcium, Vit.D medication)within the previous 3 Months
3. Patients with serum calcium concentrations 8.0mg under
4. Patients with severe nephropathy (CCr 30mL/min less)
5. Patients with unable to sit upright or stand for 30minutes

Primary outcomes:
measure: The Change of Bone Mineral Density (BMD) Value
timeFrame: baseline and 12 months
Secondary outcomes:
measure: The Change of 25OHD(25-hydroxyvitamin D)
timeFrame: baseline, 6months, 12months
measure: PTH(Parathyroid Hormone Value)
timeFrame: baseline, 6months, 12months
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Chung-ang university hospital
Study officials:
affiliation: Chung-Ang University Hosptial, Chung-Ang University College of Medicine
name: Hyoung-Moo Park, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03623997: Measuring Erythrocyte Iron Incorporation From Different Dosing Regimens in Anemic Women
Official title: Defining Systemic Control of Iron Absorption to Optimize Oral Iron Supplementation Regiemns for Women With Iron Deficiency Anemia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Iron Deficiency Anemia
Lead sponsor: Swiss Federal Institute of Technology
Sponsor class: OTHER
First posted: 2018-08-09
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Young women with iron-deficiency anemia

Brief summary: Iron-deficient anaemic subjects are likely to benefit most from oral iron supplements, but supplementation schedules vary widely in clinical practice, absorption is low and compliance is poor due to mild gastrointestinal side effects. The investigators will compare iron absorption from labeled oral iron doses of 100mg and 200mg administered either on two consecutive days or on alternate days in young anemic women.


Eligibility criteria: Inclusion Criteria:

* Ferritin \<15 µg/L
* Hb 8-11.9 g/dl
* BMI 18.5-24.9 kg/m2
* Body weight \<70 kg

Exclusion Criteria:

* Severe anemia (Hb \<8 g/dl)
* Elevated CRP \>5.0 mg/L
* Chronic disease
* Long-term medication, except contraception
* Consumption of Mineral and Vitamin supplements within the study period
* Therapeutic iron infusion over the past 6 months
* Pregnancy or breastfeeding
* Smoking

Primary outcomes:
measure: Fractional and total iron absorption
timeFrame: absorption will be measured 14days after the 100mg and 200mg cycle
measure: Serum hepcidin
timeFrame: right before the administration of an iron dose
measure: Serum EPO
timeFrame: right before the administration of an iron dose
Secondary outcomes:
measure: Serum ferritin
timeFrame: right before the administration of an iron dose
measure: Serum TfR
timeFrame: right before the administration of an iron dose
measure: Serum CRP
timeFrame: right before the administration of an iron dose
measure: Serum AGP
timeFrame: right before the administration of an iron dose
measure: Serum iron
timeFrame: right before the administration of an iron dose
measure: Total iron binding capacity
timeFrame: right before the administration of an iron dose
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: Human Nutrition Laboratory ETH Zurich
Study officials:
References:
citation: Stoffel NU, Zeder C, Brittenham GM, Moretti D, Zimmermann MB. Iron absorption from supplements is greater with alternate day than with consecutive day dosing in iron-deficient anemic women. Haematologica. 2020 May;105(5):1232-1239. doi: 10.3324/haematol.2019.220830. Epub 2019 Aug 14.
Clinical trial NCT05706597: Clinical Relevance of Small Airways Disease in Severe Asthma Patients Treated With Anti-InterLeukin-5 Therapy
Official title: Clinical Relevance of Small Airways Disease in Severe Asthma Patients Treated With Anti-InterLeukin-5 Therapy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Asthma
Lead sponsor: Frisius Medisch Centrum
Sponsor class: OTHER
First posted: 2023-01-31
Enrollment: 110
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population consists of all severe eosinophilic asthma patients in the MCL, treated with anti-IL5/5R therapy (i.e. mepolizumab, benralizumab, reslizumab) for at least 4 months.

Brief summary: The aim of this research is to investigate the extent and clinical relevance of small airways disease in severe eosinophilic asthma patients treated with anti-IL5/5R therapy.


Eligibility criteria: Inclusion Criteria:

* Severe asthma patients treated with anti-IL5/5R therapy (i.e. mepolizumab, benralizumab, reslizumab) for at least 4 months.

Exclusion Criteria:

* No information about lung function at baseline, or after both 4 months and 12 months.
* No information about clinical response (i.e. number of exacerbations, reduction of mOCS/ maintenance oral corticosteroid dose, ACQ, AQLQ) after both 4 months and 12 months.
* Treatment with another anti-IL5/5R therapy before

Primary outcomes:
measure: Is change in FEF25-75 during anti-IL5/5R treatment associated with change in asthma control (measured with the asthma control questionnaire -ACQ-) in severe eosinophilic asthma patients after 4 months and after 12 months treatment?
timeFrame: 4 months and 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Leeuwarden
country: Netherlands
facility: Medical Center Leeuwarden
Study officials:
References: