louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05679505: Vagus Nerve Stimulation for Post-COVID Syndrome
Official title: Effects of Vagus Nerve Stimulation in Post-COVID-19 Syndrome: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Long COVID
Vagus Nerve Stimulations
Heart Rates
Autonomic Nervous System Disorders
Lead sponsor: Bahçeşehir University
Sponsor class: OTHER
First posted: 2023-01-11
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The aim of this study is to increase parasympathetic activity and decrease the severity of symptoms by providing vagal stimulation with the t-VNS method in order to suppress the increased sympathetic activity in patients with prolonged Covid symptoms.The main question\[s\] it aims to answer are:

Question 1:Is left ear transcutaneous vagus nerve stimulation effective in suppressing the symptoms of patients in Post Covid syndrome?

Question 2:Is bilateral auricular transcutaneous vagus nerve stimulation effective in suppressing the symptoms of patients in Post Covid syndrome?

A 5-minute heart rate variability measurement will be performed to measure the effectiveness of vagus nerve stimulation in participants.HRV is a non-invasive method used to evaluate ANS activity and is a measure of heart rate change over a period of time


Eligibility criteria: Inclusion Criteria:

* Being 18 years or older
* Experiencing at least one of the post-covid symptoms for 12 weeks or longer

Exclusion Criteria:

* Considering that the female reproductive hormones level in the body and menstrual cycle may affect the ANS in female patients, female participants in perimenopausal, post-menopausal and pregnancy conditions were excluded from the study.
* Participants who used medication for the treatment of ANS dysfunction in the last six months were also excluded from the study.

Primary outcomes:
measure: Heart Rate Variability
timeFrame: After the evaluation of the patients on the first day of participation in the study, the final evaluation was completed at the end of the 10th session (10 days later).
Secondary outcomes:
measure: Fatigue Severity Scale
timeFrame: After the evaluation of the patients on the first day of participation in the study, the final evaluation was completed at the end of the 10th session (10 days later).
Other outcomes:
Locations:
city: Iğdır
country: Turkey
facility: Iğdır State Hospital
Study officials:
affiliation: Igdir University
name: Ramazan Erenler, Prof. Dr.
role: STUDY_CHAIR
References:
Clinical trial NCT03414905: Management of Malignant Pleural Effusions Using an Indwelling Tunneled Pleural Catheter and Non-Vacuum Collection System
Official title: Management of Malignant Pleural Effusions Using an Indwelling Tunneled Pleural Catheter and Non-Vacuum Collection System
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Malignant Pleural Effusion
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: Merit Medical Systems, Inc.
First posted: 2018-01-30
Enrollment: 40
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: The participants will be seen at Washington University School of Medicine.

Brief summary: In this study, the investigators will collect data on patients who are using the Aspira system as part of their clinical care for the management of recurrent pleural effusion. Data will be collected on patient demographics, placement of the pleural catheter, palliation of dyspnea, complication rates, and rates of spontaneous pleurodesis.


Eligibility criteria: Inclusion Criteria:

* Male or female, at least 18 years of age, inclusive
* Subject has a symptomatic malignant pleural effusion requiring intervention. For an effusion to be defined as malignant, at least one of the following must be true

  * There is cytological confirmation of pleural malignancy
  * The effusion is an exudate (per Light's criteria Pleural fluid protein/Serum protein \>0.5, Pleural fluid LDH/Serum LDH \>0.6, or Pleural fluid LDH \>2/3 the upper limit of normal) in the context of histocytologically proven malignancy elsewhere, with no other clear cause for fluid identified
* Subject is able to provide informed consent
* Subject has sufficient pleural fluid to allow safe insertion of an indwelling tunneled pleural catheter as determined by the PI
* Subject is able to perform home drainage of the pleural effusion or has sufficient resources (family member, caregiver, home health).

Exclusion Criteria:

* Subject is pregnant
* Subject has evidence, in the opinion of the PI, of either ongoing systemic or pleural infection
* Subjects with uncorrected coagulopathy

Primary outcomes:
measure: Relief of dyspnea as measured using the Visual Analog Scale for Dyspnea (VAS-Dyspnea)
timeFrame: Through 2 weeks following catheter insertion
Secondary outcomes:
measure: Rate of infection
timeFrame: 1 year
measure: Rate of spontaneous pleurodesis
timeFrame: 1 year
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Alexander Chen, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04699305: Safety and Efficacy of ActiGraft Treatment in Wound Care in Medical Centers
Official title: An Observational Clinical Registry to Collect Safety and Efficacy Data on Wound Care in Medical Centers
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cutaneous Wounds
Keywords: DFU, PU, Surgical, Vascular, Trauma
Lead sponsor: RedDress Ltd.
Sponsor class: INDUSTRY
First posted: 2021-01-07
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with all types of exuding cutaneous wound

Brief summary: Multicenter observational study to explore the efficacy of ActiGraft in the treatment of exuding cutaneous wounds in real-life usage.


Eligibility criteria: Inclusion Criteria:

* Subject is ≥18 years of age
* Subject has an exuding cutaneous wound
* Subject agrees to the use of his health data, including photos of his wound in analysis and publications
* Subject/LAR must be able to read and understand English and/or Spanish

Exclusion Criteria:

* Subject/LAR is unable to read and understand English or Spanish.

Primary outcomes:
measure: Percentage area reduction (PAR) at 4 weeks
timeFrame: 4 weeks
measure: Nature, frequency, and severity of adverse events in the intent to treat population
timeFrame: 1 year
Secondary outcomes:
measure: Percentage area reduction at 8 and 12 weeks
timeFrame: 12 weeks
Other outcomes:
measure: Reduction in pain at 4 weeks
timeFrame: 4 weeks
Locations:
city: Las Vegas
country: United States
facility: Wound Care Experts
state: Nevada
Study officials:
affiliation: RedDress Ltd.
name: Sharon Sirota
role: STUDY_DIRECTOR
References:
citation: Williams M, Davidson D, Wahab N, Hawkins J, Wachuku CD, Snyder R. Innovative treatment utilizing an autologous blood clot for diabetic foot ulcers. Wounds. 2022 Jul;34(7):195-200. doi: 10.25270/wnds/21089.
Clinical trial NCT02300805: Accuracy of Endometrial Volume Measured by VOCAL Versus Office Hysteroscopy for Diagnosis of Endometrial Polyps
Official title: Accuracy of Endometrial Volume Measured by Virtual Organ Computer-aided AnaLysis (VOCAL)Versus Office Hysteroscopy for Diagnosis of Endometrial Polyps
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Premenopausal; Metrorrhagia
Keywords: Endometrial volume , VOCAL , Endometrial , Metrorrhagia
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2014-11-25
Enrollment: 117
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Premenopausal women complaining of irregular vaginal bleeding

Brief summary: Endometrial volume will be assessed by 3DUS and VOCAL and compared to the results of office hysterscopy to measure the abilty of this technique to diagnose endometrial polyps in women complaining of abnormal uterine bleeding.

The safety of both procedures will be compared .


Eligibility criteria: Inclusion Criteria:

* Age more than 20 years
* Patients with irregular vaginal bleeding

Exclusion Criteria:

* Age less than 20 years
* Postmenopausal women
* presence of uterine fibroids
* Causes of vaginal bleeding due to systemic pathology , anticoagulant use , patients on hormonal contraception or using Intra Uterine Contraceptive Device ( IUCD ) .

Primary outcomes:
measure: To measure the Safety and Tolerability" and "Efficacy of 3DUS versus office Hysteroscopy for diagnosis of endometrial polyps in premenopausal women
timeFrame: one year
Secondary outcomes:
measure: To measure the best cut off value for endometrial volume (CC ) using Three Dimensional Sonography ( 3DUS and (VOCAL ) to diagnose endometrial polyps in women with premenopausal bleeding
timeFrame: One year
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams Maternity Hospital
Study officials:
References:
Clinical trial NCT01831505: Feasibility of Assessing Lymphoma Response to Precise Local Injection of Candidate Chemotherapy Agents
Official title: Feasibility of Assessing Lymphoma Response to Precise Local Injection of Candidate Chemotherapy Agents Using the CIVO(tm) Microdosing System
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Lymphoma
Keywords: personalized medicine
in vivo drug sensitivity
chemotherapy
lymphoma
microinjection
Lead sponsor: Presage Biosciences
Sponsor class: INDUSTRY
Collaborators: name: National Institutes of Health (NIH)
name: National Cancer Institute (NCI)
name: Fred Hutchinson Cancer Center
First posted: 2013-04-15
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: Many cancer patients are prescribed drugs to which their cancer is already resistant - and thus suffer toxicity with no potential for benefit. Previous attempts to assess chemoresistance or sensitivity in vitro have failed. This is a feasibility study in human patients with newly diagnosed or recurrent lymphoma to determine how human cancerous lymph nodes in situ respond to standard of care therapeutics precisely microinjected with the CIVO(tm) microdosing system.


Eligibility criteria: Inclusion Criteria:

* 18 years of age or over
* Has enlarged lymph node(s) highly suspicious of lymphoma; or has been diagnosed with lymphoma but is untreated; or has persistent recurrent, or progressive lymphoma
* At least one enlarged lymph node that is considered accessible for percutaneous injection by the investigator and that is at least 2 cm in longest dimension.
* ECOG performance status of 0-2 (or a Karnofsky performance status of \>50%).
* Labs required for enrollment: Absolute neutrophil count \> 1000/mm3, platelet count \> 50,000/mm3, hematocrit \> 25%, creatinine \<3.0 mg/dl, total bilirubin \<4.0 mg/dl, SGOT and SGPT less than five times the institutional upper limits of normal.

Exclusion Criteria:

* Lymphoma patients in which the delay of surgery until the lymph node resection date or other factors associated with the study are not feasible.
* Patients with central nervous system disease.
* Any therapy that is potentially immunosuppressive or has anticancer activity in the 4 weeks prior to device microinjection.
* Patients with active fungal, viral, or bacterial infections
* Pregnant women.
* Inability to give informed consent.

Primary outcomes:
measure: Evaluation of the response to locally injected drugs
timeFrame: 1-3 days post injection after injection
Secondary outcomes:
measure: Evaluate the safety profile of multiple simultaneous microinjections using custom syringe
timeFrame: up to 28 days
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Seattle Cancer Care Alliance
state: Washington
Study officials:
affiliation: Fred Hutchinson Cancer Center
name: Oliver W Press, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01825005: Predicting Outcome in Cervix Carcinoma: a Prospective Study
Official title: Predicting Outcome in Cervix Carcinoma: a Prospective Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cervical Cancer
Keywords: cervical cancer
Lead sponsor: Maastricht Radiation Oncology
Sponsor class: OTHER
First posted: 2013-04-05
Enrollment: 423
Sex: FEMALE
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 patients with cervical cancer can be included in the study.

Brief summary: The main aim is to validate and improve the predictive model for survival and toxicity in patients with cervical cancer through multicentric prospective data collection. The data contain information on patient, tumor and treatment characteristics. For this study, additional health related QOL scores will be assessed using the EORTC Quality of Life Questionair-CX24 and C30. The long term aim, beyond this specific study, is to build a Decision Support System based on the predictive model validated in this study.


Eligibility criteria: Inclusion Criteria:

* histological or cytological proven cervical cancer
* informed consent according to national rules

Exclusion Criteria:

* no histological or cytological proven cervical cancer
* no informed consent according to national rules

Primary outcomes:
measure: five-year overall survival rate
timeFrame: 5 years after treatment
Secondary outcomes:
measure: three-year distant disease free survival
timeFrame: 3 years
measure: three-year local disease free survival
timeFrame: 3 years
measure: five-year distant disease free survival
timeFrame: 5 years
measure: five-year local disease free survival
timeFrame: 5 years
measure: number of participants with early adverse events as a measure of safety and tolerability
timeFrame: 2 months
measure: number of participants with late adverse events as a measure of safety and tolerability
timeFrame: 5 years
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: Maastricht University Hospital
city: Bloemfontein
country: South Africa
facility: Bloemfontein medicross
state: Free State
Study officials:
affiliation: Maastricht University hospital, dep of radiotherapy (Maastro clinic)
name: P Lambin, Prof
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06211205: Effectiveness of a Customized 3D Printed Nostril Retainer Combined With Taping Vs.Taping Only on Enhancing the Nasolabial Esthetics and Maxillary Arch Dimensions in Infants With Unilateral Complete Cleft Lip and Palate.
Official title: Effectiveness of a Customized 3D Printed Nostril Retainer Combined With Taping Vs. Taping Only on Enhancing the Nasolabial Esthetics and Maxillary Arch Dimensions in Infants With Unilateral Complete Cleft Lip and Palate: A Randomized Clinical Trial.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Cleft Lip and Palate
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2024-01-18
Enrollment: 30
Sex: ALL
Maximum age (years): 30
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Lip taping was proven as simple, handy technique of PSIO for alveolar molding yielding enhanced maxillary arch dimensions in UCCLP infants.

The approach behind this study is to combine this simple step with a digitally designed 3D printed customized nasal molding device to enhance the naslolabial esthetics and maxillary arch dimensions in infants with unilateral complete cleft lip and palate, employing full digital workflow.


Eligibility criteria: Inclusion Criteria:

1. Infants with age range from 1-30 days.
2. Unilateral complete cleft lip and palate
3. Medically free subjects.
4. Both males and females.

Exclusion Criteria:

1. Patients older than 30 days.
2. Syndromic patients with other defects in addition to cleft lip and palate.
3. Patients with bilateral cleft lip and palate.
4. Incomplete cleft lip.
5. Patient with previous surgical lip repair or adhesion.
6. Patients with previous presurgical infant orthopedic treatment.
7. Medically compromised patients.

Primary outcomes:
measure: Nasolabial esthetics
timeFrame: 3 months
Secondary outcomes:
measure: Maxillary arch changes
timeFrame: 3 months
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Department of Orthodontics, Faculty of Dentistry, Cairo university
Study officials:
References:
Clinical trial NCT01580605: French National Registry of Adults With Growth Hormone Deficiency Treated With Somatropin
Official title: Prospective, Longitudinal and National Follow-up Program of Adult Patients With Somatotropic Hormone Deficiency for Whom Substituting Treatment by Norditropin SimpleXx Was Started
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Growth Hormone Disorder
Adult Growth Hormone Deficiency
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2012-04-19
Enrollment: 331
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All adult patients with growth hormone deficiency and treated with Norditropin® SimpleXx (somatropin) for whom Norditropin® SimpleXx® has been initiated either before or during the registry inclusion period

Brief summary: This study is conducted in Europe. The aim of this study is to extract data from the French National Registry holding information about patients having initiated growth hormone therapy with the objective to describe patients receiving growth hormone therapy, assess efficacy and safety of somatropin (Norditropin® SimpleXx®) and evaluate treatment compliance.


Eligibility criteria: Inclusion Criteria:

* Adult with growth hormone deficiency
* Treated with Norditropin® SimpleXx (somatropin)

Primary outcomes:
measure: Weight
timeFrame: Once a year for 5 years
measure: Body composition
timeFrame: Once a year for 5 years
measure: Waist:Hip Ratio
timeFrame: Once a year for 5 years
measure: Body mass index (BMI)
timeFrame: Once a year for 5 years
Secondary outcomes:
measure: IGF-1 (Insulin-like growth factor 1) concentration
timeFrame: Once a year for 5 years
measure: Lipids: Total cholesterol, high-density lipoprotein (HDL), low-density lipoprotein (LDL) and triglycerides
timeFrame: Once a year for 5 years
measure: Dose prescribed
timeFrame: Once a year for 5 years
Other outcomes:
Locations:
city: Lyon
country: France
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
citation: Borson-Chazot F, Chabre O, Salenave S, Klein M, Brac de la Perriere A, Reznik Y, Kerlan V, Hacques E, Villette B. Adherence to growth hormone therapy guidelines in a real-world French cohort of adult patients with growth hormone deficiency. Ann Endocrinol (Paris). 2021 Feb;82(1):59-68. doi: 10.1016/j.ando.2020.11.007. Epub 2020 Dec 5.
Clinical trial NCT04525105: SMAD2, SMAD3 AND TGF-β GENE EXPRESSION IN URGE URINARY INCONTINENCE
Official title: ARE SMAD2, SMAD3 AND TGF-β GENE EXPRESSION VALUABLE IN THE MANAGEMENT OF THE URGE URINARY INCONTINENCE?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: SMAD2
SMAD3
TGF-β
Pelvic Organ Prolapse
Urge Urinary Incontinence
Lead sponsor: Muğla Sıtkı Koçman University
Sponsor class: OTHER
First posted: 2020-08-25
Enrollment: 24
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients who had been diagnosed with POP and UUI and asymptomatic women without complaints of POP and UUI

Brief summary: Urge urinary incontinence (UUI) is a common health problem. Changes in collagen metabolism in pelvic support organs, such as uterosacral ligaments (USLs), might be responsible for the complex pathophysiology of UUI. The TGF-β pathway is involved in collagen synthesis and degradation. The Transforming Growth Family- β (TGF-β) superfamily has essential intracellular signaling components, such as newly identified SMAD family members. We evaluated the changes in the levels of TGF-β and SMAD gene and protein expression in the USL of patients with concomitant pelvic organ prolapse (POP) and UUI.

Detailed description: This study included 10 patients who had been diagnosed with POP and UUI in the study group and 14 asymptomatic women without complaints of POP and UUI in the control group. Biopsy samples were collected from bilateral USL tissues during vaginal or abdominal hysterectomy. Total RNA was extracted from USL tissue and analyzed by qPCR. The protein expression levels were also analyzed with ELISA.

Eligibility criteria: Inclusion Criteria:

* patients who had been diagnosed with POP and UUI
* asymptomatic women without complaints of POP and UUI

Exclusion Criteria:

* Women who have SUI,
* a history of gynecologic malignancy,
* endometriosis,
* connective tissue disorders,
* asthma,
* previous pelvic inflammatory disease,
* pelvic radiation anamnesis,
* smoking,
* previous surgery for POP or UI,
* those on steroid therapy and hormone replacement therapy

Primary outcomes:
measure: SMAD2
timeFrame: intraoperative
measure: SMAD3
timeFrame: intraoperative
measure: TGF-ß1 mRNA Expression Levels
timeFrame: intraoperative
Secondary outcomes:
Other outcomes:
Locations:
city: Mugla
country: Turkey
facility: Mugla Sıtkı Kocman University Faculty of Medicine
Study officials:
References:
citation: Akin MN, Sivaslioglu AA, Edgunlu T, Kasap B, Celik SK. SMAD2, SMAD3 and TGF-beta GENE expressions in women suffering from urge urinary incontinence and pelvic organ prolapse. Mol Biol Rep. 2021 Feb;48(2):1401-1407. doi: 10.1007/s11033-021-06220-4. Epub 2021 Feb 18.