louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06417047: Effect of Hand Holding on Pain and Anxiety
Official title: Effect of Hand Holding on Reducing Intramuscular Injection-Induced Pain and Anxiety: A Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain and Anxiety
Lead sponsor: Necmettin Erbakan University
Sponsor class: OTHER
First posted: 2024-05-16
Enrollment: 104
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel Assignment
Primary purpose: SUPPORTIVE_CARE

Brief summary: It was aimed to examine the effect of the hand holding method applied during intramuscular injection on pain and anxiety.

Detailed description: This study was designed as a pre-test-post-test regular parallel group, randomized controlled experimental design. The research will be carried out in the Adult Emergency Service of the Ministry of Health of the Republic of Turkey, Konya City Hospital. Patients will be randomly divided into two groups: handholding (52) and control group (52). For the Hand Holding Group: After the patient is positioned appropriately, the patient's hand will be held by the researcher. Once the intramuscular injection is completed, the patient's hand holding will be stopped. For the Control Group: No application will be made during intramuscular injection in the control group. The primary outcome of this study is to determine patients' pain scores during the intramuscular injection procedure. The secondary outcome is to determine the anxiety levels of patients.

Eligibility criteria: Inclusion Criteria:

* Having vitamin B 12 1000 mcg/ml (1 ml ampoule) intramuscular treatment,
* Being literate,
* Are between the ages of 18-65,
* No visual, hearing, sensory or motor loss or cognitive impairment,
* Not using centrally or peripherally acting analgesics or sedatives,
* There is no scar tissue, incision, lipodystrophy or signs of infection on the skin of the injection area,
* Having a body mass index between 18.5 and 29.5,
* Injected into the ventrogluteal area,
* Individuals who agree to participate in the research will be included.

Exclusion Criteria:

* Those with chronic pain,
* Having a psychiatric disorder,
* Foreign nationals,
* Patients with contact-communicable diseases will be excluded from the study.

Primary outcomes:
measure: Numerical Pain Scale
timeFrame: It will be filled within 1 minute after the intramuscular injection is completed.
Secondary outcomes:
measure: State Anxiety Scale
timeFrame: It will be filled immediately before the intramuscular injection and within 1 minute after the procedure is completed.
Other outcomes:
Locations:
city: Konya
country: Turkey
facility: Necmettin Erbakan University
state: Meram
Study officials:
affiliation: Necmettin Erbakan University
name: Serpil SU
role: STUDY_CHAIR
References:
Clinical trial NCT06982547: Clinical Study on the Treatment of Refractory Rheumatoid Arthritis With UTAA91 Injection
Official title: Clinical Study on the Treatment of Refractory Moderate - to - Severe Active Rheumatoid Arthritis With UTAA91 Injection
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: EARLY_PHASE1
Conditions: Rheumatoid Arthritis (RA)
Lead sponsor: PersonGen BioTherapeutics (Suzhou) Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2025-05-21
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: UTAA91 injection
Primary purpose: TREATMENT

Brief summary: This clinical trial is designed as a single - arm, open - label, single - center, investigator - initiated early - phase clinical study. The primary objective is to evaluate the safety of UTAA91 injection in treating subjects with refractory moderate - to - severe active rheumatoid arthritis.


Eligibility criteria: Inclusion Criteria:

* Aged ≥18 years (inclusive of the boundary value), with no restriction on gender.
* Expected survival time of at least 3 months.
* Subjects with refractory moderate - to - severe active rheumatoid arthritis who have failed standard treatment or lack effective therapeutic options.
* Meet the requirements for liver and kidney function, as well as cardiopulmonary function.
* Free from severe psychiatric disorders.
* Able to understand the trial and have signed the informed consent form.

Exclusion Criteria:

* A history of malignant tumors other than relapsed/refractory autoimmune diseases (R/R AID) within 5 years prior to screening.
* Subjects with positive results in virus/syphilis tests.
* Severe cardiac diseases or unstable systemic diseases.
* Active or uncontrollable infections requiring systemic treatment within 7 days before administration; evidence of central nervous system invasion at screening.
* Pregnant or breastfeeding women, female subjects planning to become pregnant within 2 years after cell infusion, or male subjects whose partners plan to become pregnant within 2 years after their cell infusion.
* Subjects who have received CAR - T therapy or other gene - modified cell therapies before screening.
* Subjects who participated in other clinical studies within 1 month before screening.
* Other conditions deemed unsuitable for enrollment by the investigator.

Primary outcomes:
measure: Adverse events
timeFrame: About 1 year
Secondary outcomes:
measure: Cmax
timeFrame: About 1 year
measure: Tmax
timeFrame: About 1 year
measure: Disease remission rate
timeFrame: About 3 months
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
state: Hubei
Study officials:
References:
Clinical trial NCT00882947: Post-Marketing Surveillance of Ventavis® in Chinese Patients With Primary Pulmonary Hypertension (PPH)
Official title: Post-Marketing Surveillance of Ventavis® in Chinese Patients With Primary Pulmonary Hypertension (PPH)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Primary Hypertension
Keywords: Primary Pulmonary Hypertension (PPH)
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2009-04-17
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult Chinese patients (age 18-65 male and female) with Primary Pulmonary Hypertension

Brief summary: The purpose of this study is to demonstrate the safety and efficacy of inhaled Iloprost (Ventavis®) among adult Chinese patients with primary pulmonary hypertension, which is in compliance with Chinese SFDA regulation.


Eligibility criteria: Inclusion Criteria:

* Both male and female age 18-65 years old
* The treating physician has chosen Ventavis as a suitable long-term treatment for the patient
* Patient with Primary Pulmonary Hypertension (i.e. IPAH or FPAH) and classified as NYHA functional class III
* Written informed/data protection consent
* No prior treatment with Ventavis or other active treatments for PPH within 6 weeks of date of study.

Exclusion Criteria:

* Known or newly identified contraindication for administration of Ventavis as stated in the Ventavis product package insert.

Primary outcomes:
measure: Frequency of Adverse Events
timeFrame: At week 4,12 and 24
Secondary outcomes:
measure: 6 minute walking test (6-MWT)
timeFrame: At week 4,12 and 24
measure: NYHA functional class
timeFrame: At week 4,12 and 24
Other outcomes:
Locations:
city: Many Locations
country: China
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT06939647: An Expanded Access Study to Assess Treprostinil Palmitil Inhalation Powder (TPIP) for Participants With Pulmonary Arterial Hypertension (PAH) and Pulmonary Hypertension Associated With Interstitial Lung Disease (PH-ILD)
Official title: Treprostinil Palmitil Inhalation Powder (TPIP) in Patients With Pulmonary Arterial Hypertension or Pulmonary Hypertension Associated With Interstitial Lung Disease
Study type: EXPANDED_ACCESS
Overall status: AVAILABLE
Conditions: Pulmonary Arterial Hypertension
Interstitial Lung Disease
Lead sponsor: Insmed Incorporated
Sponsor class: INDUSTRY
First posted: 2025-04-23
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT

Brief summary: The purpose of this study is to provide continued access to TPIP for participants who have successfully completed the open-label extension (OLE) studies of INS1009-203 for PAH or INS1009-212 for PH-ILD.

Detailed description: Participants will receive TPIP 80 micrograms (μg), 160 μg, or 320 μg, inhalation single-dose capsules, orally, once daily (QD).

Eligibility criteria: Inclusion Criteria

* The participant is ineligible for or cannot be treated satisfactorily with alternative commercially available therapy for PAH or PH-ILD.
* Participant provides their informed consent to participate as per local requirements.
* Participant must have successfully completed the OLE INS1009-203 or INS1009-212 studies.
* Based on the treating physician's judgement on participant's medical history and an evaluation of the overall risk-benefit profile, the participant will be determined to be suitable for continued TPIP treatment within this program.
* Requests for the post-OLE INS1009-203 and INS1009-212 TPIP studies must originate from the investigators of INS1009-203 and INS1009-212 TPIP studies, respectively.
* Female participants must be postmenopausal (defined as no menses for 12 months without an alternative medical cause), surgically sterile, or using highly effective contraception (failure rate \<1% per year when used consistently and correctly) from Day 1 to at least 90 days after the last dose.
* Male participants with female partners must adhere to contraception requirements to avoid potential exposure to the embryo/fetus based on the partner's reproductive status. For partners of childbearing potential, effective contraception must be used from Day 1 to at least 90 days after the last dose.

Exclusion Criteria:

* No specific exclusion criteria.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02935647: Burst Suppression Anesthesia for Treatment of Severe Depression
Official title: Burst Suppression Anesthesia for Treatment of Severe Depression
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Major Depressive Disorder
Lead sponsor: University of Utah
Sponsor class: OTHER
First posted: 2016-10-17
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study is designed to determine if the antidepressant effects of deep anesthesia via propofol are related to EEG burst suppression.

Detailed description: Ten individuals with treatment resistant major depressive disorder will undergo 10 treatments of deep anesthesia via propofol over a 3-week period. Depression will be evaluated before and after treatment.

Eligibility criteria: Inclusion Criteria:

* • Diagnosis of Major Depressive Disorder (MDD) or bipolar Disorder (I or II, most recent episode must be depression

  * Failed at least 2 anti-depressant treatments and no ECT in past 6 months
  * Age between 18-55 years
  * BMI \< 35
  * Hamilton Rating Scale for Depression (HSRD) score \> 18
  * Quick Inventory of Depression Scale (QIDS) score \> 10.

Exclusion Criteria:

* • Diagnosis of primary psychotic disorder, dysthymia, or personality disorder

  * Significant pre-morbid cognitive impairment
  * Hypertension and current use of ACE inhibitor or AR blocker medications
  * Symptomatic coronary artery disease or congestive heart failure
  * History of transient ischemic or neurologic signs during the past year
  * History of or susceptibility to malignant hyperthermia
  * Contraindication to isoflurane or propofol anesthesia (as determined by anesthesiologist)
  * Diabetes requiring insulin
  * Poor kidney function
  * Chronic use of benzodiazepines or opioids
  * Individuals incompetent to provide consent (e.g. catatonic, psychotic).

Primary outcomes:
measure: Hamilton Rating Scale for Depression
timeFrame: 3 weeks
Secondary outcomes:
measure: Quick Inventory of Depressive Symptoms
timeFrame: 3 weeks
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: University Neuropsychiatric Institute
state: Utah
Study officials:
References:
citation: Mickey BJ, White AT, Arp AM, Leonardi K, Torres MM, Larson AL, Odell DH, Whittingham SA, Beck MM, Jessop JE, Sakata DJ, Bushnell LA, Pierson MD, Solzbacher D, Kendrick EJ, Weeks HR 3rd, Light AR, Light KC, Tadler SC. Propofol for Treatment-Resistant Depression: A Pilot Study. Int J Neuropsychopharmacol. 2018 Dec 1;21(12):1079-1089. doi: 10.1093/ijnp/pyy085.
Clinical trial NCT02333747: Can Transcutaneous Electrical Acupoint Stimulation Improve the Quality of Recovery After Thyroidectomy?
Official title: The Effects of Transcutaneous Electrical Acupoint Stimulation on the Quality of Recovery After Thyroidectomy Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Complications
Lead sponsor: Fujian Provincial Hospital
Sponsor class: OTHER
First posted: 2015-01-07
Enrollment: 84
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The effect of transcutaneous electric acupoint stimulation (TEAS) on the quality of recovery in patients undergoing thyroidectomy surgery remains unclear. Therefore, the investigators conducted this prospective, randomized, double-blind study to verify the hypothesis that pre-operative TEAS could improve the quality of recovery (QoR) after thyroidectomy surgery.

Detailed description: Transcutaneous electric acupoint stimulation (TEAS) is a form of non-invasive electrical stimulation that produces a perceptible sensation via electrodes attached to the skin. It has no risk of infections and can potentially be applied by medical personnel with minimal training. Clinical trials have demonstrated that TEAS reduces the consumption of intra-operative anesthetics and general anesthesia related side-effects.

Eligibility criteria: Inclusion Criteria:

* Consecutive female patients aged 18 to 60 with American Society of Anesthesiologists physical status (ASA) physical status I or II, who underwent general anesthesia for elective thyroidectomy surgery

Exclusion Criteria:

* potentially difficult airway,
* a history of chronic pain,
* drug or alcohol abuse,
* mental disorder,
* intake of any analgesic drug within 48 h before surgery, and
* previous experience with acupuncture treatment

Primary outcomes:
measure: the quality of recovery, as measured by a 40-item questionnaire
timeFrame: 24 hours after surgery
Secondary outcomes:
measure: the incidence of postoperative nausea and vomiting
timeFrame: 24 hours after surgery
measure: postoperative pain intensity, as assessed using Visual Analogue Scale (VAS)
timeFrame: 24 hours after surgery
measure: patient's satisfaction, as evaluated with a 10-point numerical rating scale: 10= excellent, 1= bad.
timeFrame: at 24 hours after surgery
Other outcomes:
Locations:
city: Fuzhou
country: China
facility: Fujian Provincial Hospital
state: Fujian
Study officials:
affiliation: Fujian Provincial Hospital, China
name: Yanqing Chen, MD
role: STUDY_DIRECTOR
References:
citation: Chen Y, Yang Y, Yao Y, Dai D, Qian B, Liu P. Does transcutaneous electric acupoint stimulation improve the quality of recovery after thyroidectomy? A prospective randomized controlled trial. Int J Clin Exp Med. 2015 Aug 15;8(8):13622-7. eCollection 2015.
Clinical trial NCT04093947: Characteristics of Subjects With Overweight or Obesity at the Onset of Hypertension
Official title: Characteristics of Subjects With Overweight or Obesity at the Onset of Hypertension
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hypertension
Obesity
Lead sponsor: Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis
Sponsor class: OTHER
First posted: 2019-09-18
Enrollment: 100
Sex: ALL
Minimum age (years): 35
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients who came to the Outpatient Clinic of Nutrition at the National Institute of Gastroenterology "S. de Bellis," Research Hospital, Castellana Grotte, Italy.

Brief summary: The study aims to investigate the characteristics of subjects with hypertension at onset among a cohort of apparently healthy subjects, with overweight or obesity (BMI ≥ 25 Kg / m2), and free of any drug treatment at the baseline. The evaluation includes anthropometric (weight, height, BMI, waist circumference), haematochemical (hormones, metabolic and routine) parameters and the screening for hypertension with ABPM. The diagnosis of hypertension is made in accordance with the 2017 guidelines of the American College of Cardiology / American Heart Association ACC / AHA.


Eligibility criteria: Inclusion Criteria:

* Overweight or obesity (BMI\> 25 Kg/m2)

Exclusion Criteria:

* Any kind of drug
* Hypertension
* Endocrine diseases (diabetes mellitus, hypo or hyperthyroidism, hypopituitarism, etc.),
* Chronic inflammatory diseases
* Renal failure
* Liver failure
* Angina pectoris
* Myocardial infarction and heart failure
* Genetic heart diseases
* Thrombocytopenias

Primary outcomes:
measure: Insulin
timeFrame: At baseline
measure: Potassium
timeFrame: At baseline
measure: Sodium
timeFrame: At baseline
measure: eGFR (estimated glomerular filtration rate)
timeFrame: At baseline
measure: Creatinin
timeFrame: At baseline
measure: Uric acid
timeFrame: At baseline
measure: Total cholesterol
timeFrame: At baseline
measure: Thyroid hormones (FT3, FT4)
timeFrame: At baseline
measure: HDL cholesterol
timeFrame: At baseline
measure: LDL cholesterol
timeFrame: At baseline
measure: Triglycerides
timeFrame: At baseline
measure: TSH
timeFrame: At baseline
Secondary outcomes:
measure: BMI
timeFrame: At baseline
measure: Height
timeFrame: At baseline
measure: Weight
timeFrame: At baseline
Other outcomes:
Locations:
city: Castellana Grotte
country: Italy
facility: National Institute of Gastroenterology IRCCS S. de Bellis
state: Bari
Study officials:
References:
Clinical trial NCT04971447: Extracellular Vesicles and Endothelial Function in Transgender Subjects
Official title: Effects of Plasma Extracellular Vesicles on Endothelial Function in Transgender Subjects
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Transgenderism
Keywords: transgender persons
hormonal therapy
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2021-07-21
Enrollment: 136
Sex: ALL
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Cardiovascular diseases are the leading cause of mortality. In women, the prevalence of cardiovascular diseases is lower and the presentation of coronary events often atypical. The lack of evidence is related in part to the methodology of studies not considering sex as an essential biological variable. Hormonal treatment is prescribed in transgender subjects to promote the development of sexual characteristics of the desired sex. Early cardiovascular effects of hormonal treatment have been reported in transgender men, while long-term mortality is higher in transgender women. The aim of this project is to study the effects of gender affirming hormonal treatment on arterial stiffness in young transgender subjects followed at the University Hospital of Nancy.


Eligibility criteria: Inclusion Criteria:

* Trasgender subject demanding gender affirming hormonal therapy

Exclusion Criteria:

* Previous hormonal therapy
* Pregnancy
* Chronic disease
* Cancer
* Obesity
* Drug abuse
* Alcohol
* Tabac

Primary outcomes:
measure: pulse wave velocity
timeFrame: 24 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01921647: The PK and PD Interaction Between YH4808, Amoxicillin and Clarithromycin in Healthy Subjects
Official title: The Exploration for Pharmacodynamics and Pharmacokinetic Interaction Between YH4808, Amoxicillin and Clarithromycin in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: safety/tolerability and pharmacokinetics/pharmacodynamics
Lead sponsor: Yuhan Corporation
Sponsor class: INDUSTRY
First posted: 2013-08-13
Enrollment: 95
Sex: ALL
Minimum age (years): 20
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief summary: The objective of this study is not only to explore pharmacokinetic interaction after single oral administration but also pharmacodynamics interaction after multiple oral administration of YH4808, amoxicillin and clarithromycin each separately versus coadministration of YH4808, amoxicillin and clarithromycin in healthy volunteers


Eligibility criteria: Inclusion Criteria:

1. healthy male age 20 to 55 over 55kg with Ideal body weight(BMI:18.5\~25)
2. Subject who has no congenital, chronic disease and disease symptoms in medical examination result
3. Subject who is judged to be eligible by principal investigator or sub-investigator according to various reasons including their abnormal test results(clinical laboratory test, 12-lead GCG etc)

Exclusion Criteria:

1. Subject who is hypersensitive to components contained in YH4808 or this drug
2. Subject who has history or presence of clinically significant diseases in liver, kidney, gastrointestinal tract, nervous system, respiratory system, endocrine system, blood tumor, cardiovascular, urinary system, and mental disorder
3. Subject who has history of surgical operation or diseases related to gastrointestinal symptom (e.g. Crohn's disease, ulcer etc except appendectomy or simple for hernia)
4. Other exclusions apply

Primary outcomes:
measure: Cmax, AUClast of YH4808, M3, amoxicillin, clarithromycin, 14-hydroxyclarithromycin
timeFrame: pre dose, 16 times after dosing
Secondary outcomes:
measure: Cmax, AUClast of M8, AUCinf, t1/2, Tmax of YH4808, M3, M8, amoxicillin, clarithromycin, 14-hydroxyclarithromycin
timeFrame: pre dose, 16 times after dosing
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Yonsei University Severance Hospital
Study officials:
affiliation: Severance Hospital
name: Min soo Park, Ph.D, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Park H, Kim CO, Kim M, Lim Y, Lee WY, Yoon S, Park MS. Pharmacodynamic evaluation of YH4808 for Helicobacter pylori eradication in healthy subjects. Transl Clin Pharmacol. 2020 Sep;28(3):136-146. doi: 10.12793/tcp.2020.28.e16. Epub 2020 Sep 23.
citation: Lee WY, Oh E, Cui M, Kim CO, Lim Y, Kim H, Park H, Yoon S, Park MS, Hong T. Evaluation of pharmacokinetic interactions between amoxicillin, clarithromycin, and the potassium-competitive acid blocker YH4808 in healthy subjects. Transl Clin Pharmacol. 2020 Mar;28(1):55-65. doi: 10.12793/tcp.2020.28.e5. Epub 2020 Mar 31.