louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05277792: Dosage of Tacrolimus Metabolites in Blood and Bile for Prediction of Its Side Effects in Liver Transplant Recipients
Official title: Dosage of Tacrolimus Metabolites in Blood and Bile for Prediction of Its Side Effects in Liver Transplant Recipients
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Blood Concentration of Tacrolimus Metabolites
Keywords: Tacrolimus, metabolites, liver transplantation
Lead sponsor: Rennes University Hospital
Sponsor class: OTHER
First posted: 2022-03-14
Enrollment: 48
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: Liver transplant patients

Brief summary: The purpose of this study is to evaluate if concentration of tacrolimus metabolites is increased in patients presenting tacrolimus (TAC) side effects.

Detailed description: The study will evaluate whether the blood concentration of TAC metabolites (13-O-desmethyl-tacrolimus, 15-O-desmethyl-tacrolimus and 31-O-desmethyl-tacrolimus), measured between Day1 and Day5 of its introduction, is increased in patients with TAC toxicity.

A blood test will be performed daily from Day1 to Day5 for the measurement of TAC concentration and TAC metabolites concentration.

Eligibility criteria: Inclusion Criteria:

* Adult patients (\> 18 years) of both sexes,
* Candidates for liver transplantation or retransplantation, whatever the etiology and severity of the underlying disease,
* Not having expressed their opposition to participation in the study

Exclusion Criteria:

* Associated transplantation of another organ
* Contraindications to TAC administration
* Delayed introduction of TAC (beyond the 5th postoperative day) whatever the cause.

Primary outcomes:
measure: Comparison of blood concentration of TAC metabolites between patients presenting TAC related side effects or not.
timeFrame: Day 5
Secondary outcomes:
Other outcomes:
Locations:
city: Rennes
country: France
facility: CHU Rennes
Study officials:
References:
Clinical trial NCT01639989: Doppler Assesment of Blood Flow in the Spiral Arteries
Official title: Pilot Study Which is Aiming at the Feasibility of Performing Doppler Studies of the Spiral Arteries
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Early Pregnancy
Keywords: Doppler, Pregnancy
Lead sponsor: Hillel Yaffe Medical Center
Sponsor class: OTHER_GOV
First posted: 2012-07-13
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 52
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pregnant women at 1st trimester

Brief summary: In this study we will try to show that performing Doppler of the Spiral arteries is doable. No outcome will be followed at this stage

Detailed description: This will only be a pilot study to show that we can acurately perform Doppler studies of the spiral arteries

Eligibility criteria: Inclusion Criteria:

* Pregnancy 1st trimester

Exclusion Criteria:

* Not willing to participate

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Hadera
country: Israel
facility: Hillel Yaffe Medical Center
Study officials:
affiliation: Hillel Yaffe Medical Center
name: Alon Shrim, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03437889: Gravity Flow Technique to Validate Proper Location of Epidural Needle Tip on Obese Parturients
Official title: Gravity Flow Technique to Validate Proper Location of Epidural Needle Tip on Obese Parturients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Epidural/Anesthesia
Keywords: epidural
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2018-02-19
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: Pregnant women, with a Body Mass Index (BMI) greater than 30 kg/m2, who receive epidural analgesia/anesthesia for childbirth will have epidural catheter placement per our standard procedure, which includes using the gravity flow technique to confirm that the tip (aperture) of the epidural needle is indeed located within the epidural space. The study procedure will be to use a cold stimulus (ice) to assess the subjects for hypesthesia the dermatomes of the lower abdomen between 10 and 30 minutes after the epidural catheter is inserted. Hypesthesia to cold will be taken a sign of successful lumbar epidural block.

Detailed description: The purpose of this study is to quantify the reliability of the gravity flow technique to accurately validate the position of the epidural needle tip when performing lumbar epidural analgesia/anesthesia for childbirth (vaginal and cesarean delivery) in women with a BMI greater than 30 kg/m2.

Eligibility criteria: Inclusion Criteria:

* Patients requesting epidural analgesia/anesthesia for childbirth
* American Society of Anesthesiologists (ASA) physical status I to III
* Ability to speak and read English to fully comprehend the consent process
* BMI greater than 30 kg/m2

Exclusion Criteria:

* Combined spinal-epidural anesthesia
* Coagulopathy
* History of lumbar spine surgery
* Allergy or contraindication to any of the study medications
* Contraindication to epidural analgesia
* ASA physical status \>III
* BMI less than 30 kg/m2

Primary outcomes:
measure: Measure of bilateral decrease of sensation to cold with ice
timeFrame: 30 Minutes Post Intervention
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: New York University School of Medicine
state: New York
Study officials:
affiliation: NYU Langone Health
name: Gilbert Grant, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03947489: Bioavailability Study of Two Formulations of Sarpogrelate HCl 300mg Tablets Under Fasting Conditions
Official title: A Single-dose, Comparative Bioavailability Study of Two Formulations of Sarpogrelate HCl 300mg Tablets Under Fasting Conditions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Daewoong Pharmaceutical Co. LTD.
Sponsor class: INDUSTRY
First posted: 2019-05-13
Enrollment: 38
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: A Single-dose, Comparative Bioavailability Study of Two Formulations of Sarpogrelate HCl 300mg Tablets Under Fasting Conditions

Detailed description: To evaluate the bioequivalence of two formulations of Sarpogrelate HCl 300mg after a single oral dose administration in healthy volunteers under fasting conditions

Eligibility criteria: Inclusion Criteria:

* Healthy, non-smoking, male and female subjects, 19 years of age or older
* BMI ≥ 18.0 and ≤ 30.0 kg/m2.
* Females who participate in this study will be of childbearing or non- childbearing potential

Exclusion Criteria:

* Know history or presence of clinically significant neurologic, hematologic, endocrine, oncologic, pulmonary, immunologic, genitourinary, psychiatric, or cardiovascular disease or any other condition which, in the opinion of the investigator, would jeopardized the safety of the subject or impact the validity of the study results

Primary outcomes:
measure: Maximum Plasma Concentration
timeFrame: 0~24hours
measure: Area under the plasma concentration versus time curve
timeFrame: 0~24hours
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Daewoong pharmatceutical
Study officials:
References:
Clinical trial NCT05099692: CHD Patient's Concern on Cardiac Rehabilitation
Official title: CHD Patient' s Concern on Primary Cardiac Rehabilitation and Its Social Associated Factors
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Coronary Heart Disease
Cardiac Rehabilitation
Keywords: cardiac rehabilitation
coronary heart disease
social-psychological factor
Lead sponsor: Shenyang Northern Hospital
Sponsor class: OTHER
First posted: 2021-10-29
Enrollment: 3000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with coronary heart disease eligible for the study must be at least 18 years of age or greater, able to participate in cardiac rehabilitation after medical judgments by the physicians for the first time and provide the written informed consent. Moreover, the participants must understand the questionnaire content and complete it.

Brief summary: Our study focuses on the question about primary cardiac rehabilitation (CR) patients with coronary heart disease are concerned about demonstrating the association between the patients' view of CR and social associated factors. In our study, all participants are invited to choose at least 1 question in 15 questions or provide their questions regarding their doubt about the CR after filling in their personal information. The selectable questions can be categorized into five titles: the content or purpose of CR, the method of CR, the advantage of CR, the adverse effect of CR, and the expenditure of CR.


Eligibility criteria: Inclusion Criteria:

* age \>18 years old
* patients diagnosed as coronary heart disease
* able to participate in cardiac rehabilitation after medical judgments for the first time
* understand the questionnaire content
* agree to participant in the study and provide the written informed consent

Exclusion Criteria:

* unable to complete the questionnaire
* patients who aren't willing or refuse to participate in the trial

Primary outcomes:
measure: The total number of different selected questions
timeFrame: 5 minutes
measure: The variety of different selected questions
timeFrame: 5 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Shenyang
country: China
facility: Qiang Hu
state: Liaoning
Study officials:
References:
Clinical trial NCT06099392: The Effect of Transcutaneous Electrical Acustimulation on Small Bowel Preparation for Capsule Endoscopy
Official title: The Effect of Transcutaneous Electrical Acustimulation Combined With Polyethylene Glycol-electrolyte on the Quality of Small Bowel Preparation for Capsule Endoscopy
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Quality of Small Bowel Preparation
Lead sponsor: Shanghai Changzheng Hospital
Sponsor class: OTHER
Collaborators: name: RenJi Hospital
First posted: 2023-10-25
Enrollment: 166
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Transcutaneous elctroacupuncture(TEA) at ST36 can improve gastrointestinal motility. Therefore,the investigators hypothesized that if TEA is applied to the preparation of small bowel capsule endoscopy, the small bowel peristalsis of patients can be regulated by electrical stimulation at (ST36). On the one hand, it can be used in combination with compound polyethylene glycol electrolyte powder, which is conducive to the discharge of small bowel contents and improve the imaging quality. On the other hand, it can improve the diagnostic rate by adjusting the intestinal transit time, And the completion rate of the examination can be improved by accelerating the gastric emptying time of capsule endoscopy.

Therefore, in order to explore the effect of TEA stimulation at ST36 combined with polyethylene glycol powder on preparation for small bowel capsule endoscopy, the investigators designed this study.


Eligibility criteria: Inclusion Criteria:

Agree to sign an informed consent form; Aged 18 to 75 years old Plan to undergo small bowel capsule endoscopy;

Exclusion Criteria:

Clinical diagnosis of gastrointestinal stricture, bowel obstruction, gastrointestinal fistula, intestinal resection; Clinical diagnosis of dysphagia; Those who require fasting or parenteral nutrition support treatment; Individuals with gastrointestinal motility disorders; Oral administration of gastrointestinal motility drugs within 1 week; Implanting medical electronic devices; Those who are allergic to compound polyethylene glycol electrolyte powder and dimethicone oil and cannot tolerate oral laxatives for intestinal preparation; Skin diseases that affect electrode fixation; Pregnant, preparing to conceive, or breastfeeding patients; Familiar with acupuncture and moxibustion treatment, acupoint selection or meridians; Researchers believe that it is not suitable for participants.

Primary outcomes:
measure: The rate of "adequate" cleansing of the small intestine
timeFrame: one year
Secondary outcomes:
measure: Diagnostic rate of video capsule endoscopy
timeFrame: one year
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06286189: Trazodone on OSA Endotypes
Official title: Effect of Trazodone on Obstructive Sleep Apnea Endotypes and Severity
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: Obstructive Sleep Apnea
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
First posted: 2024-02-29
Enrollment: 18
Sex: ALL
Minimum age (years): 21
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Obstructive sleep apnea (OSA) is common and has major health implications but treatment options are limited. Some OSA patients with low arousal threshold wake up prematurely during an obstructive event and do not have time for spontaneous upper airway (UA) dilator muscle recruitment. As a consequence they are exposed to apnea and hypopnea cycling. In this protocol the investigators will test the effect of trazodone administered before sleep on OSA traits and OSA severity during sleep.

Detailed description: Two overnight home sleep studies will be performed: a drug night and a placebo night. The patient will breath spontaneously (without CPAP) for both nights. On the study nights, subjects be instrumented with a full polygraphy for monitoring sleep, and respiratory events. Trazodone 100 mg will be given 30 min before lights out. At least four hours of sleep with high quality signal acquisition will be required for a study to be judged adequate. After the first overnight study is completed, there will be a one-week washout period prior to crossing over to the other treatment.

Eligibility criteria: Inclusion Criteria:

* Moderate-to-severe OSA (AHI ≥ 15 events/hr)

Exclusion Criteria:

* All participants will be healthy and without major organ system disease that would preclude undergoing the physiological measurements.
* Use of medications expected to stimulate or depress respiration (including opioids, barbiturates, acetazolamide, doxapram, almitrine, theophylline, 4-hydroxybutanoic acid).
* Use of SNRIs/SSRIs.
* Conditions likely to affect OSA physiology: neuromuscular disease or other major neurological disorder, heart failure (also below), or any other unstable major medical condition.
* Sleep disordered breathing or respiratory disorders other than obstructive sleep apnea:
* Other sleep disorders: periodic limb movements (periodic limb movement arousal index \> 10/hr), narcolepsy, or parasomnias.
* Hypersensitivity to the study drug (angioedema or urticaria)
* Contraindications to DAW2020
* Use of medications that lengthen QTc interval
* Hypokaliemia, hypomagnesemia, uncontrolled thyroid disease
* Severe claustrophobia.

Primary outcomes:
measure: Effect of trazodone on arousal threshold (%eupnea)
timeFrame: 1 night
Secondary outcomes:
measure: Effect of trazodone on apnea hypopnea index (events/h)
timeFrame: 1 night
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
Study officials:
References:
Clinical trial NCT02627989: An Observational Study Investigating the Treatment Satisfaction of Atopic Dermatitis Patients Who Have Switched to Ointment (W/O Emulsion) Formulation of Very Strong Class Topical Corticosteroids
Official title: An Observational Study Investigating the Treatment Satisfaction of Atopic Dermatitis Patients Who Have Switched to Ointment (W/O Emulsion) Formulation of Very Strong Class Topical Corticosteroids
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dermatitis, Atopic
Lead sponsor: LEO Pharma
Sponsor class: INDUSTRY
Collaborators: name: Bayer
First posted: 2015-12-11
Enrollment: 55
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients will be recruited by the investigator who will also be the treating physician. As an observational study, only patients who the investigator plans on switching to the ointment (W/O emulsion) from fatty ointment formulation will be eligible to participate. Patients will be recruited for each seasonal phase and same patients may not necessarily be observed between the two seasonal phases.

Brief summary: This study intends to investigate patient satisfaction of treatment with Ointment (W/O emulsion) formulations of Potency Class II topical corticosteroids (TCs) for atopic dermatitis (AD) patients in Japan. Objectives include measuring patient satisfaction, treatment adherence, itchiness, and AD severity scores.


Eligibility criteria: Inclusion Criteria:

* Female and male patients with a diagnosis of atopic dermatitis who are treated with Fatty Ointment Potency Class II (Very strong class) TCs
* Patients who are scheduled to change the formulation of the Potency Class II TC from Fatty Ointment to Ointment (Water in Oil; Water per Oil emulsion) as per investigator's routine treatment practice
* Patients who are aged over 20
* Patients who are able to understand and sign a written informed consent

Exclusion Criteria:

-Patients participating in an investigational program with interventions outside of routine clinical practice

* Patients with any contraindication to TCs
* Patients who are regarded as ineligible by the investigator
* Patients who are pregnant or breastfeeding
* For Period 2 (Spring-Summer), patients enrolled in the Period 1

Primary outcomes:
measure: Treatment satisfaction measured by Treatment Satisfaction Questionnaire for Medication (TSQM-9)
timeFrame: 10 months
Secondary outcomes:
measure: Treatment adherence measured by Morisky Medication Adherence Scale (MMAS-8-Item)
timeFrame: 10 months
measure: Itchiness according to Visual Analogue Scale (VAS)
timeFrame: 10 months
measure: Severity Scoring of Atopic Dermatitis (SCORAD)
timeFrame: 10 months
measure: Eczema Area and Severity Index (EASI)
timeFrame: 10 months
Other outcomes:
Locations:
city: Tsu
country: Japan
state: Mie
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT00170989: Valsartan/Hydrochlorothiazide Combination in Hypertensive Patients Not Controlled With Valsartan Alone
Official title: Comparison of the Combination of Valsartan 320 mg Plus Hydrochlorothiazide 12.5 mg and Valsartan 320 mg Plus Hydrochlorothiazide 25 mg to Valsartan 320 mg in Mild to Moderate Hypertensive Patients Not Adequately Controlled With Valsartan 320 mg
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hypertension
Keywords: hypertension
high blood pressure
valsartan
hydrochlorothiazide
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2005-09-15
Enrollment: 2714
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will test the effectiveness and safety of a combination treatment in patients whose blood pressure is not controlled with a single medication.


Eligibility criteria: Inclusion Criteria:

* Patients with mild to moderate hypertension

Exclusion Criteria:

* Severe hypertension
* History of stroke, myocardial infarction, heart failure, chest pain, abnormal heart rhythm
* Liver, kidney, or pancreas disease
* Insulin dependent diabetes
* Allergy to certain medications used to treat high blood pressure

Other protocol-defined exclusion criteria may apply.

Primary outcomes:
measure: Change from baseline in diastolic blood pressure from baseline after 8 weeks
Secondary outcomes:
measure: Change from baseline in systolic blood pressure from baseline after 8 weeks
measure: Change from baseline in standing systolic and diastolic blood pressure after 8 weeks
measure: Diastolic blood pressure less than 90 mmHg or at least a 10 mmHg decrease in diastolic pressure after 8 weeks
measure: Diastolic blood pressure less than 90 mmHg after 8 weeks
measure: Adverse events and serious adverse events at 8 weeks
Other outcomes:
Locations:
city: Investigative Centers
country: Germany
city: Basel
country: Switzerland
facility: Novartis Pharmaceuticals
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
Clinical trial NCT00667589: Sorafenib-induced Hand- Foot Skin Reaction Treatment
Official title: Four-arm Study to Evaluate Urea 40% Cream, Fluocinonide 0.05% Cream, Tazarotene 0.1% Cream, and an Emollient Cream for the Treatment of Hand-foot Skin Reaction Related to the Use of Multi-targeted Tyrosine Kinase Inhibitor Sorafenib.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Hand-foot Skin Reaction
Rash
Keywords: sorafenib
rash
hand foot skin reaction
Lead sponsor: Northwestern University
Sponsor class: OTHER
Collaborators: name: Bayer
First posted: 2008-04-28
Enrollment: 6
Sex: ALL
Minimum age (years): 18
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 treatments for a rash caused by sorafenib.

Detailed description: This study will compare compare the effectiveness of four creams (urea 40% cream, fluocinonide 0.05% cream, tazarotene 0.1% cream, and Udderly smooth® Udder Cream) in treating hand-foot skin reaction (HFSR), a rash caused by sorafenib.

Eligibility criteria: Inclusion Criteria:

* Patients receiving sorafenib as monotherapy or in combination if other agents are not known to cause HFSR.
* Subjects must be 18 years or older.
* Patients must provide written informed consent to participate in the study.
* Women of childbearing potential and men must be willing to use an effective method of contraception while participating in this study and for at least two weeks after completing treatment in the study.
* Women in this study need to have a negative urine pregnancy test before starting study medications.

Exclusion Criteria:

* Patients simultaneously taking another anti-cancer agent or combination of anti-cancer agents known to cause hand foot syndrome (pegylated doxorubicin, 5-fluorouracil, cytarabine).
* Patients with an active dermatological condition due to previous chemotherapy or biologic therapy affecting the hands.
* Patients with pre-existing dermatological condition affecting the hands or feet.
* Women who have a positive pregnancy test or are lactating.

Primary outcomes:
measure: Change in Skindex-16 Total Score Between Baseline and 8 Weeks
timeFrame: baseline and 8 weeks
Secondary outcomes:
measure: Change in Skindex-16 Total Score Between Baseline and 2 Weeks
timeFrame: baseline and 2 weeks
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern University Feinberg School of Medicine, Department of Dermatology
state: Illinois
Study officials:
affiliation: Northwestern University
name: Dennis West, PhD
role: PRINCIPAL_INVESTIGATOR
References: