louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05699876: Melatonin vs Gabapentin for Post Trauma Surgery
Official title: A Comparative Study of Melatonin and Gabapentin as Premedication for Patients Undergoing Surgery Following Trauma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Anxiety, Preoperarative
Keywords: melatonin
gabapentin
preoperative anxiety
Lead sponsor: All India Institute of Medical Sciences
Sponsor class: OTHER
First posted: 2023-01-26
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This project aims to compare the effect of preoperative administration of melatonin and gabapentin in reducing preoperative anxiety, stress markers and postoperative pain levels in trauma patients undergoing surgery. Gabapentin has analgesic as well as sedative properties. Melatonin, a hormone has been extensively used in intensive care units and has found to improve the sleep cycle and reduce pain. It is now being explored as a preoperative medication.


Eligibility criteria: Inclusion criteria: Patients will be recruited if they satisfy the following inclusion criteria:

* Age 18-65 years,
* ASA score I-II,
* Scheduled either for non-emergency surgery after trauma and
* Presumptive duration of operation not exceeding 3 hours.

Exclusion criteria: The following patients will be excluded from the study:

* Patients for emergency surgeries
* Surgeries taking place after 1pm (to account for diurnal variation in cortisol levels)
* Patients having altered mental state, history of psychiatric disorder, history of drug abuse or those on chronic pain medication
* Patients who have come for a repeat surgery and have already been included once in the study

Primary outcomes:
measure: preoperative anxiety
timeFrame: 30 minutes after drug administration
Secondary outcomes:
measure: inflammatory markers
timeFrame: before and 30 minutes after drug administrartion
measure: Sedation score
timeFrame: before and 30 minutes after drug administrartion
measure: post operative analgesia
timeFrame: 24 hours postoperative
Other outcomes:
Locations:
city: New Delhi
country: India
facility: Aiims
state: Delhi
Study officials:
References:
Clinical trial NCT02474576: Percutaneous Aponeurotomy in the Treatment of Dupuytren's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dupuytren Disease
Lead sponsor: Groupe Hospitalier Diaconesses Croix Saint-Simon
Sponsor class: OTHER
First posted: 2015-06-17
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The efficiency of percutaneous aponeurotomy in the treatment of Dupuytrens disease is well known. However, the duration of the clinical improvement after aponeurotomy is not well known.

This study aims primarily at measuring the incidence rate of local relapse of Dupuytrens-induced finger flessum, within two years following treatment by percutaneous aponeurotomy in Dupuytrens.


Eligibility criteria: Inclusion Criteria:

* Patient suffers from Dupuytren disease
* Patient has at least one finger with at least 20° flessum on the metacarpophalangeal joint and/or on the proximal interphalangeal joint
* Patient has chosen to benefit from local treatment

Exclusion Criteria:

* Pregnancy
* Breastfeeding
* No social insurance

Primary outcomes:
measure: Frequency of local relapse at 24 months
timeFrame: 24 months after treatment by aponeurotomy
Secondary outcomes:
measure: Primary success rate of aponeurotomy
timeFrame: 3 months after treatment
measure: Frequency of local relapse at 12 months
timeFrame: 12 months after treatment by aponeurotomy
measure: Frequency of local relapse at 36 months
timeFrame: 36 months after treatment by aponeurotomy
measure: Frequency of local relapse at 48 months
timeFrame: 48 months after treatment by aponeurotomy
measure: Frequency of local relapse at 60 months
timeFrame: 60 months after treatment by aponeurotomy
Other outcomes:
Locations:
city: Paris
country: France
facility: Diaconesses Croix Saint-Simon Hospital Group
Study officials:
References:
Clinical trial NCT03803176: Tissue Plasminogen Activator & Plasminogen Activator Inhibitor Type-1 In Gingival Tissues Of Chronic Periodontitis
Official title: Effect Of Periodontal Surgery On Tissue Plasminogen Activator And Plasminogen Activator Inhibitor Type-1 Gene Expression In Gingival Tissues Of Chronic Periodontitis Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Periodontitis
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2019-01-14
Enrollment: 30
Sex: ALL
Minimum age (years): 30
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Study population includes 30 subjects recruited from the outpatient clinic of Oral Medicine \& Periodontology department, Faculty of Dentistry, Cairo University. Ages range from 30-50 years old.

Brief summary: Tissue Plasminogen Activator and Plasminogen Activator Inhibitor Type-1 Gene Expression will be evaluated clinically and histopathologically through Hematoxylin and eosin as well as by quantitative reverse transcription polymerase chain reaction in the gingival tissues of chronic periodontitis in an attempt to investigate whether the expression of these proteins could be involved in the disease pathogenesis or not, and to assess as well if their expression will be affected by the applied surgical periodontal treatment.

Detailed description: 30 subjects were enrolled in this study and divided into: Group I (Control Group): 10 periodontally healthy volunteers, Group II (Chronic Periodontitis Group): 20 patients suffering severe CP and Group III (Treated Group): 20 patients who were scheduled for OFD. Gingival samples were collected from all subjects at baseline and at 3 months after OFD from the CP patients. Then, Hematoxylin and eosin (H\&E) stained slides were examined and gene expression levels of t-PA and PAI-1 were measured in the gingiva through quantitative reverse transcription polymerase chain reaction (RT-PCR).

Eligibility criteria: Inclusion Criteria:

* Patients with severe chronic periodontitis
* Pocket depth (PD) of ≥5 mm
* Clinical attachment level (CAL) ≥5 mm

Exclusion Criteria:

* Pregnant women
* Subjects taking any type of medication and/or antibiotic therapy during the 3 months before the study
* Subjects who received periodontal treatment within the past 6 months
* Smokers

Primary outcomes:
measure: Clinical attachment level
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cairo University
Study officials:
affiliation: Cairo University
name: Gihane G Madkour, Ass Prof
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01412476: Coenzyme Q10 and Vitamin A, C, E in Relation to the Oxidative Stress, Antioxidant Enzyme Activity and Inflammation in Subjects With Metabolic Syndrome
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Metabolic Syndrome
Lead sponsor: Chung Shan Medical University
Sponsor class: OTHER
Collaborators: name: National Science and Technology Council, Taiwan
First posted: 2011-08-09
Enrollment: 72
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: The investigators recruited MS patients (case group, n = 100). The inclusion criteria of MS are according to the Bureau of Health Promotion, Department of Health in Taiwan (2007). The health subject were recrited from previous study (n = 105).

Brief summary: Metabolic syndrome (MS) is a significant risk factor of cardiovascular disease. However, the relationships between coenzyme Q10, antioxidant vitamins (Vitamin A, C, E) and the prevention of the risk of MS are still inconsistent. The purposes of this study are going to investigate the relation of coenzyme Q10, antioxidant vitamins concentration with the blood lipid levels, the markers of lipid peroxidation (TBARS), antioxidant enzymes activities (catalase, glutathione peroxidase and superoxide dismutase), and the inflammatory markers (hs-CRP,IL-6 and adiponectin). The investigators will recruit MS patients (case group, n = 100) and age-gender matched healthy subjects from previous study(n = 105) as a control group . The inclusion criteria of MS are according to the Bureau of Health Promotion, Department of Health in Taiwan (2007).Hopefully, the results of this study could provide the information to what has been know in MS subjects. The investigators expect coenzyme Q10 or antioxidant vitamins could be a preventive supplement to reduce the risk of MS.


Eligibility criteria: Inclusion Criteria:

* Metabolic syndrome
* Healthy individuals with normal blood biochemical values.

Exclusion Criteria:

* Age \< 18y
* Antioxidant vitamins supplements use
* Pregnant women

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Taichung
country: Taiwan
facility: Ping-Ting Lin
Study officials:
affiliation: Chung Shan Medical University
name: Ping-Ting Lin, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01694576: NPC Staged N2-3M0:Adjuvant Chemotherapy or Just Observation After Concurrent Chemoradiation
Official title: Adjuvant Chemotherapy or Not for NPC Patients Staged N2-3M0 After Concurrent Chemotherapy :a Phase Ⅱ Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Nasopharyngeal Carcinoma
Keywords: Nasopharyngeal carcinoma staged N2-3M0
Adjuvant chemotherapy
Lead sponsor: Jiangsu Cancer Institute & Hospital
Sponsor class: OTHER
First posted: 2012-09-27
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: By this clinical trial, the investigators are trying to give an answer to such a question. Whether NPC patients staged N2-3M0 need adjuvant chemotherapy consisting of paclitaxel and platinum after concurrent chemoradiation?

Detailed description: Recent research (Lancet Oncology 2012)shows that no survival benefits were achieved by adding adjuvant chemotherapy after concurrent chemoradiation in patients with locoregionally advanced NPC. But in patients with even high risk of distant metastasis(staged N2-3M0),is adjuvant chemotherapy necessary?

Eligibility criteria: Inclusion Criteria:

1. pathologically confirmed untreated NPC patients staged N2-3M0
2. age: 18y - 65y
3. with MRI examinations
4. ECOG≤2
5. with written consent

Exclusion Criteria:

1. without a second cancer
2. pregnancy
3. with other severe diseases(blood,liver ,kidney or heart diseases)
4. could not staged properly
5. without written consent

Primary outcomes:
measure: treatment toxicity based on a CTCAE3.0 grading system
timeFrame: 6 months
Secondary outcomes:
measure: progress free survival
timeFrame: 24 months
Other outcomes:
measure: distant metastasis free survival
timeFrame: 24 months
Locations:
city: Nanjing
country: China
facility: Jiangsu Cancer Hospital
state: Jiangsu
Study officials:
affiliation: Department of Radiotherapy,Jiangsu Cancer Hospital
name: Xia He, M.D. and PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06982976: Efficacy and Safety of Photodynamic Therapy for Cervical and Vaginal Intraepithelial Neoplasia
Official title: Efficacy and Safety of Photodynamic Therapy for Cervical and Vaginal Intraepithelial Neoplasia:A Multicenter Prospective Cohort Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Precancerous Cervical Lesion
Keywords: ALA-PDT
HPV
CIN
VAIN
Lead sponsor: Peking University Third Hospital
Sponsor class: OTHER
First posted: 2025-05-21
Enrollment: 250
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To investigate the efficacy and safety of photodynamic therapy (20% 5-amino-ketovalerate 630nm red light) in the treatment of cervical and vaginal intraepithelial neoplasia in women in the real world.


Eligibility criteria: Inclusion Criteria:

* cervical/vaginal high-grade squamous intraepithelial lesions (HSILs) confirmed by colposcopy and pathological biopsy (CIN2 /CIN3 and/or VaIN2/ VaIN3) or persistent CIN1/VaIN1 lasting for more than one year with a strong willingness to treat;
* colposcopy was adequate, and analysable colposcopy images were retained;
* endocervical curettage (ECC) did not suggest higher-grade lesions.

Exclusion Criteria:

* coexistence or suspicion of cancer;
* porphyria or suspected allergies to red and blue light;
* severe medical comorbidities；

Primary outcomes:
measure: Efficacy of the treatment
timeFrame: 1 month after the treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Unniversity Third Hospital
state: Beijing
Study officials:
References:
Clinical trial NCT03296176: Metabolomic Study in Huntington's Disease (METABO-HD)
Official title: Metabolomic Study in Huntington's Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Huntington Disease
Lead sponsor: University Hospital, Angers
Sponsor class: OTHER_GOV
First posted: 2017-09-28
Enrollment: 150
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The purpose of this project is to study Huntington's disease by metabolomic approach.


Eligibility criteria: Inclusion Criteria:

For all groups:

* age between 20 and 70 years
* signature of the informed consent
* covered by social security

For presymptomatic group:

* positive genetic test with CAG repeat length ≥ 37 in HTT gene
* Unified Huntington Disease Rating Scale ≤ 5

For symptomatic group:

* positive genetic test with CAG repeat length ≥ 37 in HTT gene
* The Unified Huntington's Disease Rating Scale motor score ≥ 6
* The Total Functional Capacity score ≥ 11

Exclusion Criteria for all groups:

* participation in another therapeutic trial (3 months exclusion period)
* pregnancy and breastfeeding
* persons deprived of their liberty by judicial or administrative decision

Primary outcomes:
measure: metabolite mass
timeFrame: at baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Angers
country: France
facility: CHU Angers
Study officials:
affiliation: University Hospital, Angers
name: Christophe Verny, PU-PH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06807476: Turkish of the Acupuncture Readiness Attitude Scale
Official title: Turkish Validity and Reliability of the Acupuncture Readiness Attitude Scale
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acupuncture
Reliability and Validity
Keywords: Turkish
Lead sponsor: Trakya University
Sponsor class: OTHER
Collaborators: name: Bartın Unıversity
First posted: 2025-02-04
Enrollment: 510
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Women over 18 age, living in Turkiye, using social media (Facebook, Instagram), and agreeing to participate in the study

Brief summary: Objectives: Acupuncture is often used to promote health and well-being, relieve pain, and treat a variety of medical conditions. Acupuncture is believed to work by stimulating the body's natural healing processes, and it is important that individuals are prepared to receive acupuncture. The study aims to examine the Turkish validity and reliability of the Acupuncture Readiness Attitude Scale, which will be used to evaluate the well-being levels of haptonomy and haptotherapy practices in women.

Design: The study was methodological type. Methods: The study conducted between Aug 9 and December 30, 2024, with 510 women who volunteered to participate by sharing forum pages on social media (Facebook, Instagram) via the web. Data were collected using a personal information form, including sociodemographic and obstetric characteristics and the Acupuncture Readiness Attitude Scale.


Eligibility criteria: Inclusion Criteria:

* Individuals who are over the age of 18,
* Live in Turkey,
* Use social media, and agree to participate in the study will be included in the study.

Exclusion Criteria:

* Women who do not know how to read or write Turkish,
* Have hearing or vision problems or mental disabilities,
* Do not have social media,
* Do not volunteer to participate in the study will not be included in the study.

Primary outcomes:
measure: The Acupuncture Readiness Attitude Scale
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Bartın
country: Turkey
facility: Bartın University
Study officials:
References:
Clinical trial NCT00134576: Automated Assessment of Mental Health in the Workplace
Official title: Automated Assessment of Mental Health in the Workplace
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mental Disorders
Lead sponsor: Boston Medical Center
Sponsor class: OTHER
Collaborators: name: Centers for Disease Control and Prevention
First posted: 2005-08-25
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL

Brief summary: The purpose of this study is to design, refine, and test for the effectiveness of a computer-based telephone system (Telephone-Linked Communications for Detection of Mental Health Disorders in the Workplace; TLC-Detect) that will screen workers for mental health distress; educate them about seeking treatment; and follow up with them over a 6 month period.


Eligibility criteria: Inclusion Criteria:

* Employment with benefits at Boston Medical Center, Boston University, or Florida Power and Light Company
* Ability to speak and understand conversational English
* \> 18 years of age
* Access to a touch-tone telephone
* Screen positive for the World Health Organization (WHO)-5 Well-Being Index

Exclusion Criteria:

* Being under treatment (medication or therapy) for a mental health disorder
* Taking medication for a serious/major medical disorder that interferes with normal life
* Taking medication prescribed for mental health treatment on a daily basis
* Diagnosed with schizophrenia
* Planning to go on leave for over 6 months

Primary outcomes:
measure: Absenteeism and presentism (functionality at work), measured every three months for 6 months
timeFrame: 6 months
Secondary outcomes:
measure: Treatment status, timing of measurement depends upon symptom severity
timeFrame: 6 months
measure: Health status measured every three months for 6 months
timeFrame: 6 months
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston Medical Center
state: Massachusetts
Study officials:
affiliation: Boston University
name: Ramesh Farzanfar, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02323776: Defining the Radiotherapy Dose and Volume Parameters Affecting Postoperative Complications in Esophageal Cancer Patients
Official title: Correlation of Radiotherapy-related Features With Postoperative Complications in Patients With Esophageal Cancer Treated With Trimodality Therapy
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Esophageal Cancer
Lead sponsor: Maastricht Radiation Oncology
Sponsor class: OTHER
First posted: 2014-12-23
Enrollment: 150
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Oesophageal cancer patients who were initially treated with a preoperative dose of radiation in combination with chemotherapy and who subsequently underwent surgical resection at the Atrium Hospital in Heerlen. All patients were included in a prospectively maintained database.

Brief summary: The purpose of this study is to identify features of the cumulative dose-volume histogram (DVH) for patients treated with trimodality therapy in oesophageal cancer and correlate these with postoperative complications.

Detailed description: Intention to treat analysis in patients initially assigned to be treated with the trimodality protocol: neoadjuvant chemoradiotherapy followed by surgery.

The investigators will retrospectively evaluate several parameters of the treatment planning of patients treated with a preoperative regimen (CROSS regimen 41,4 Gy in 23 fractions or 50, 4 Gy in 28 fractions ):

* PTV volume1
* MLD, V30, V20, V15, V10, VS5 (Volume lung less dan 5 Gy)2 (lung toxicity)
* MHD, V20, V30, V403 (heart toxicity)
* Mean stomach dose, V50 stomach
* Mitochondrial DNA if available per patient Pre-existing cardiac,pulmonary comorbidity, smoking behavior, BMI, type of surgery and chemotherapy (especially taxanes) will be scored and take into account in a multivariate analysis. The investigators will collect these data and correlate the data with the presence of postoperative complications, time of onset of complications and duration of hospitalization. These latter data are already scored in a prospective manner at the Atrium Medical Center in Heerlen.

Eligibility criteria: Inclusion Criteria:

* Oesophageal cancer patients
* initially treated with a preoperative dose of radiation in combination with chemotherapy and subsequently undergone surgical resection

Exclusion Criteria:

* Patients who were treated with definitive chemoradiation or palliative radiotherapy

Primary outcomes:
measure: Postoperative complications
timeFrame: within 30 and 90 Days after operation
Secondary outcomes:
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: MAASTRO clinic
Study officials:
affiliation: Maastro Clinic, The Netherlands
name: Philippe Lambin, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: