louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00918710: Human Papillomavirus and Oropharynx Carcinoma
Official title: Impact of the Human Papillomavirus (HPV) Status in Carcinologic Prognosis of Oropharynx Squamous Cell Carcinoma.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Oropharyngeal Neoplasms
Keywords: Squamous cell carcinoma of Oropharynx
Human papillomavirus.
Biological prognostic markers.
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2009-06-11
Enrollment: 362
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: Patients with squamous cell carcinoma of oropharynx followed by the participating centers

Brief summary: High risk papillomavirus (HR-HPV) have an oncogenic role in Oropharyngeal squamous cell carcinomas (OP-SCC) in at least 25% of the cases and the prevalence is increasing. HPV+ might be more chemo and radio sensible with a better prognosis (disease-free survival (DFS) and overall survival (OS) as compared to HPV negative OP-SCC ; hypothesis : 2y DFS \> 20% improvement). The principal objective is to determine the impact of the status of HR-HPV in the prognosis of the OP-SCC. The principal criteria is the 2-years DFS.

Secondary objective : virologic characteristics of HPV+ tumors.

Detailed description: The study has no impact on the treatment of the observed population. The clinical study include TNM status, previous story of HPV infection, smoking and alcoholic habits, treatment and outcome during 5 years. The virologic study include : HPV type, E6-E7 viral charge of HPV16, viral DNA integration in the tumoral genome, HPV16 variants, expression of HPV 16, 18, 31, 45 coding oncoproteins E6-E7 mRNA. Moreover a serologic study will be done.

Eligibility criteria: Inclusion Criteria:

* Squamous cell carcinoma of Oropharynx proven histologically
* All stages TNM
* informed consent
* No previous or simultaneous Head Neck cancer
* Age \>18

Exclusion Criteria:

* Squamous cell carcinoma other than oropharynx
* 2nd synchronous SCC localization
* No consent
* age \< 18

Primary outcomes:
measure: DFS at 2 years in HPV + and - tumors
timeFrame: at 2 years
Secondary outcomes:
measure: Overall survival
timeFrame: At 2 years
measure: HPV status
timeFrame: At the inclusion
measure: Overall survival
timeFrame: At 5 years
Other outcomes:
Locations:
city: Paris
country: France
facility: Tenon Hospital, APHP
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Jean LACAU, PhD, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Pretet JL, Dalstein V, Touze A, Beby-Defaux A, Soussan P, Jacquin E, Birembaut P, Clavel C, Mougin C, Rousseau A, Lacau Saint Guily J; Papillophar Study Group. High levels of HPV16-L1 antibody but not HPV16 DNA load or integration predict oropharyngeal patient outcome: The Papillophar study. Clin Exp Med. 2023 Feb;23(1):87-96. doi: 10.1007/s10238-022-00796-2. Epub 2022 Feb 23.
Clinical trial NCT02675010: Value of Additional Corpus Biopsy for Diagnosis of H Pylori in Atrophic Gastritis. Prospective Non-randomized Study
Official title: Value of Additional Corpus Biopsy for Diagnosis of H Pylori in Atrophic Gastritis. Prospective Non-randomized Multicenter Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Helicobacter Pylori
Gastric Antrum
CORPUS BIOPSIES
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2016-02-05
Enrollment: 400
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: There are controversies about the best sites -biopsy based -tests for H pylori associated gastritis. The study is designed to evaluate the optimal site of gastric mucosal biopsy for identification of Helicobacter pylori, especially in case of gastric atrophy and/or intestinal metaplasia.

Detailed description: . The study is designed to evaluate the optimal site of gastric mucosal biopsy for identification of Helicobacter pylori, especially in case of gastric atrophy and/or intestinal metaplasia. 400 patients with dyspepsia are planned to be enrolled in this study. in addition to the routine antral biospy, corpus biospies are taken to evaluate the optimal site of gastric mucosal biopsy for identification of Helicobacter pylori, especially in case of gastric atrophy and/or intestinal metaplasia.

Eligibility criteria: Inclusion Criteria:

* Patients included in this study are those with peptic ulcer disease, previous upper gastrointestinal surgery, a known or a suspected past history of H.pylori eradication therapy, a personal or first-degree family history of gastric cancer

Exclusion Criteria:

* those having received antibiotic or proton pump inhibitor treatment one month beforehand

Primary outcomes:
measure: H PYLORI POSITIVITY
timeFrame: 2 YEARS
Secondary outcomes:
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Mansoura University Hospital
Study officials:
affiliation: MANSOURA FACULTY OF MEDICINE
name: MOHAMED ABDELLATIF, ASS PROF
role: STUDY_CHAIR
References:
Clinical trial NCT05458310: The Development of Incisional Hernia in Relation to Specimen Extraction Site After Laparoscopic Colorectal Surgeries
Official title: The Development of Incisional Hernia in Relation to Specimen Extraction Site After Laparoscopic Colorectal Surgeries: A Retrospective Single Centered Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hernia
Lead sponsor: Prince Sultan Military College of Health Sciences
Sponsor class: OTHER
First posted: 2022-07-14
Enrollment: 120
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study included all colorectal cancer patients over 2 years who were followed up or admitted to PSMMC under the service of colorectal surgery unit and who underwent laparoscopic low anterior resection, left colectomy or right colectomy with an age of 16 years or older.

Brief summary: This is a retrospec/ve cohort study of colon cancer patients who underwent laparoscopic colorectal surgeries at Prince Sultan Military Medical City (PSMMC) in Riyadh, Saudi Arabia. The aim of this study is to determine the best site for specimen extrac/on with lowest risk of developing incisional hernia a0er laparoscopic colorectal surgeries.


Eligibility criteria: Inclusion Criteria:

* The study included all colorectal cancer patients over 2 years who were followed up or admitted to PSMMC under the service of colorectal surgery unit and who underwent laparoscopic low anterior resection, left colectomy or right colectomy with an age of 16 years or older.

Exclusion Criteria:

* Duplicated data, subjects younger than 16, patients with previous abdominal surgery, and surgically complicated cases which were converted to open surgery were excluded.

Primary outcomes:
measure: Type of incision
timeFrame: Over 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Riyadh
country: Saudi Arabia
facility: Prince Sultan Military Medical City
Study officials:
References:
Clinical trial NCT02584010: Efficacy Study of Two Silicon-based Products to Treat Scars
Official title: Comparative, Open, Randomized Trial Between Two Silicon-based Products to Treat Postoperative Scars
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Scars
Keywords: Postoperative scars
Cicatrix
Cicatrization
Lead sponsor: Ache Laboratorios Farmaceuticos S.A.
Sponsor class: INDUSTRY
First posted: 2015-10-22
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aims to determine if a silicon-based gel and a silicon-based aerosol are effective in the treatment of postoperative scars.

Detailed description: Improve the final aspect of scars, have been a challenge for medicine. Silicon based products have been used in various ways to prevent hypertrophic scars and keloids since 1980. A great percentage of studies shows that silicon-based products improves the aspect of scars in different pathologies. The main objective of this trial is to evaluate the efficacy, using the Vancouver scale, of two silicon-based products (Kelofin gel and Kelofin aerosol) after 180 days.

300 participants that meet all the inclusion criteria and are not classified in any of the exclusion criteria will be randomly allocated to one of thre treatment groups( Kelofin Gel, Kelofin Aerosol and no treatment) of the study.

Eligibility criteria: Inclusion Criteria:

* Fitzpatrick skin phototype I, II, III or IV
* Participant that has a recent surgical scar on remodeling phase (14 ± 7 days after surgery) from the following: breast plastic with inframammary incision (fold beneath the breast) or abdominoplasty, cesarean section, hysterectomy (removal of the uterus), oophorectomy (removal of ovaries), oophoroplasty (removal of nodules, cysts, etc. of the ovaries), salpingectomy (removal of the fallopian tubes), tubal ligation, exploratory laparotomy and ectopic pregnancy (pregnancy outside the uterus) (Pfannenstiel access road - transverse incision , below the navel and approximately one finger above the symphysis pubis).

Exclusion Criteria:

* Skin Pathology in the product application area;
* Diabetes;
* Immune impairment;
* Use of systemic corticosteroids or immunosuppressants;
* Skin diseases: vitiligo, psoriasis, lupus, atopic dermatitis;
* Background reaction to silicon-based products;
* Other illnesses or medications that may interfere directly in the study or endanger the health of the participant.

Primary outcomes:
measure: Evaluation of scars clinical improvement
timeFrame: 180 days
Secondary outcomes:
measure: Evaluation of scars color improvement
timeFrame: 180 days
measure: Evaluation of scars measurement improvement
timeFrame: 180 days
measure: Participants satisfaction regarding the treatment
timeFrame: 180 days
measure: Adverse events occurrence
timeFrame: 180 days
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01752010: Comparing Acupuncture, BioModulator, and Transcutaneous Electrical Nerve Stimulation for Symptomatic Treatment of Chronic Pain.
Official title: A Randomized Study Comparing the Tennant BioModulator to Transcutaneous Electrical Nerve Stimulation (TENS) and Traditional Chinese Acupuncture for the Symptomatic Treatment of Chronic Pain Among Injured Service Members.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Pain
Depression
PTSD Symptoms
Sleep
Lead sponsor: Samueli Institute for Information Biology
Sponsor class: OTHER
First posted: 2012-12-18
Enrollment: 98
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary objective of this preliminary study is to compare the Tennant BioModulator with Transcutaneous Electrical Nerve Stimulation (TENS) and Traditional Chinese Acupuncture for the management of chronic pain among injured service members. The secondary objective is to investigate any associative effects or benefits on sleep, Post-Traumatic Stress Disorder (PTSD) symptoms, or depression.


Eligibility criteria: Inclusion Criteria:

* Subjects must be Injured service members between the ages of 18 and 60, inclusive;
* The pain must have been present for 3 months or greater prior to entry into the study;
* Subjects must agree to follow the medication regime as directed by the pain clinic provider for the duration of the study;
* Subjects must be able to speak and read English and understand study procedures

Exclusion Criteria:

* Epilepsy
* Pregnancy, or considering pregnancy within the study time-frame
* Pacemaker
* History of cardiac arrhythmias
* Implantable devices (AICD, pump, etc.)
* Surgical intervention during the past month for the treatment of low back pain or its underlying etiology
* Documented history of prescription medication abuse
* Abuse of illicit drugs within the last 6 months
* Participation in a clinical trial for an investigational drug and/or agent within 30 days prior to screening

Primary outcomes:
measure: Chronic pain
timeFrame: Baseline; post-intervention; one-month follow up.
Secondary outcomes:
measure: Depression, PTSD symptoms, Sleep.
timeFrame: Baseline; post-intervention; one-month follow up.
Other outcomes:
Locations:
city: Fort Sam Houston
country: United States
facility: Brooke Army Medical Center
state: Texas
Study officials:
affiliation: Brooke Army Medical Center
name: Michael Schlicher, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Peacock KS, Stoerkel E, Libretto S, Zhang W, Inman A, Schlicher M, Cowsar JD Jr, Eddie D, Walter J. A randomized trial comparing the Tennant Biomodulator to transcutaneous electrical nerve stimulation and traditional Chinese acupuncture for the treatment of chronic pain in military service members. Mil Med Res. 2019 Dec 2;6(1):37. doi: 10.1186/s40779-019-0227-4.
Clinical trial NCT01934010: AM-101 in the Treatment of Post-Acute Tinnitus 1
Official title: AM-101 in the Post-Acute Treatment of Peripheral Tinnitus 1 (AMPACT1) - an Open-Label Extension to the TACTT2 Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Tinnitus
Lead sponsor: Auris Medical, Inc.
Sponsor class: INDUSTRY
First posted: 2013-09-04
Enrollment: 260
Sex: ALL
Minimum age (years): 18
Maximum age (years): 76
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this research study is to test the safety and local tolerance of repeated treatment cycles of AM-101.

Detailed description: This open-label extension study is assessing the safety and local tolerance of repeated treatment cycles of AM-101 in subjects previously treated in the scope of the TACTT2 study (NCT01803646).

Eligibility criteria: Inclusion Criteria:

* Completion of TACTT2 study;
* Negative pregnancy test (woman of childbearing potential);
* Willing and able to attend the study visits during at least one treatment cycle.

Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* Adverse event leading to treatment discontinuation in TACTT2;
* Meniere's Disease, endolymphatic hydrops, acoustic neuroma, severe or fluctuating hearing loss, otitis media, otitis externa, abnormality of tympanic membrane;
* Ongoing drug-based therapy for otitis media or otitis externa;
* Drug-based therapy known as potentially tinnitus-inducing;
* Other treatment of tinnitus;
* Drug abuse or alcoholism;
* Subjects with psychiatric diseases requiring drug treatment;
* Use of antidepressant or anti-anxiety medication;
* Any clinically relevant disorder or abnormality in physical examination;
* Women who are breast-feeding, pregnant or who are planning to become pregnant during the study;
* Women of childbearing potential who are unwilling or unable to practice contraception.

Other protocol-defined exclusion criteria may apply.

Primary outcomes:
measure: Frequency of Subjects With a Deterioration of Hearing Threshold at Day 35 (Air Conduction)
timeFrame: Day 1 (TV1) to Day 35 (FUV2) of cycle 1
measure: Frequency of Subjects With a Deterioration of Hearing Threshold at Day 119 (Air Conduction)
timeFrame: Day 84 (TV4) to Day 119 (FUV5) of cycle 2
measure: Frequency of Subjects With a Deterioration of Hearing Threshold at Day 203 (Air Conduction)
timeFrame: Day 168 (TV7) up to Day 203 (FUV8) of cycle 3
Secondary outcomes:
measure: Frequency of Subjects With a Deterioration of Hearing Threshold at Day 84 (Air Conduction)
timeFrame: Day 1 (TV1) to Day 84 (FUV3) of cycle 1
measure: Frequency of Subjects With a Deterioration of Hearing Threshold at Day 168 (Air Conduction)
timeFrame: Day 84 (TV4) to Day 168 (FUV6) of cycle 2
measure: Frequency of Subjects With a Deterioration of Hearing Threshold at Day 252 (Air Conduction)
timeFrame: Day 168 (TV7) to Day 252 (FUV9) of cycle 3
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: Medpace
state: Ohio
Study officials:
References:
Clinical trial NCT00175110: The Effect of Hibiscus Sabdariffa L. Tea on Blood Pressure
Official title: The Effect of Hibiscus Sabdariffa L. Tisane on Blood Pressure in Prehypertensive and Mildly Hypertensive Men and Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Hypertension
Keywords: pre-hypertension
mild hypertension
Lead sponsor: Tufts University
Sponsor class: OTHER
Collaborators: name: Celestial Seasonings
name: Tufts Medical Center
First posted: 2005-09-15
Enrollment: 66
Sex: ALL
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this study is to find out whether the plant compounds present in Hibiscus sabdariffa, a plant commonly used in herbal tea blends and other beverages, will have a beneficial effect on blood pressure in people with mildly elevated blood pressure.


Eligibility criteria: Inclusion Criteria:

* Systolic blood pressure 120-150 mm Hg
* Diastolic blood pressure 95 mm Hg or less
* Body mass index (BMI) 18.5-34.9 kg/m2

Exclusion Criteria:

* Smoking
* Use of medications that influence blood pressure
* Cardiovascular disease
* Chronic kidney disease
* Diabetes
* Regular use of vitamin C supplements (min 500 mg/day) within prior 30 days
* Regular strenuous aerobic activity greater than 30 min/day
* Excessive intake of caffeine or alcohol
* Pregnancy within last 6 months or during study period
* Abnormal complete blood count (CBC), urinalysis or electrocardiogram (EKG)

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Jean Mayer USDA Human Nutrition Research Center on Aging at Tufts University
state: Massachusetts
Study officials:
affiliation: Tufts Medical Center
name: Jeffrey B Blumberg, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: McKay DL, Chen CY, Saltzman E, Blumberg JB. Hibiscus sabdariffa L. tea (tisane) lowers blood pressure in prehypertensive and mildly hypertensive adults. J Nutr. 2010 Feb;140(2):298-303. doi: 10.3945/jn.109.115097. Epub 2009 Dec 16.
Clinical trial NCT05602012: Mindfulness Based Cognitive Counseling on Social Anxiety
Official title: The Effect of Mindfulness Based Cognitive Counseling Group for Social Anxiety, Assertiveness and Self-Confidence in Nursing Students
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Social Anxiety
Assertiveness
Self Confidence
Lead sponsor: Gazi University
Sponsor class: OTHER
First posted: 2022-11-01
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of the study is to determine the effect of group mindfulness based cognitive counseling on social anxiety, assertiveness and self-confidence in nursing students and the relationship of these variables to change over time.

Detailed description: This is a randomized controlled and single-center study. The universe of the research consisted of nursing students who applied for counseling within the scope of the announcement made on the department web page. The research will be carried out in a state university, Faculty of Health Sciences, Department of Nursing between February 22, 2022 - December 23, 2022. In the study, the assignment of students to the intervention and control groups was made by simple randomization. Participant Information Form, Liebowitz Social Anxiety Scale, Self-Confidence Scale and Assertiveness Inventory will be used to collect the data of the study. Data collection tools will be applied three times simultaneously with the control group as a pre-test at the beginning of the study, as a post-test at the last session of the intervention group ( 2 month), and as a follow-up test 6 months after the last session of the intervention group.

Eligibility criteria: Inclusion Criteria:

* Liebowitz social anxiety scale score \>50
* 18 years of age or older
* Volunteering to participate in the study

Exclusion Criteria:

* Diagnosed with a mental disorders
* History of participating in a counseling program
* Currently receiving individual or group counseling
* Unable to attend more than two sessions
* Diagnosed with a physical or mental disorder during group sessions

Primary outcomes:
measure: Liebowitz Social Anxiety Scale
timeFrame: Change from baseline to week 8 (2-month) and 6-month follow up
Secondary outcomes:
measure: Assertiveness Inventory
timeFrame: Change from baseline to week 8 (2-month) and 6-month follow-up
measure: Self Confidence Scale
timeFrame: Change from baseline to week 8 (2-month) and 6-month follow-up
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Feride Ercan
Study officials:
References:
citation: Demir S, Ercan F. The effectiveness of cognitive behavioral therapy-based group counseling on depressive symptomatology, anxiety levels, automatic thoughts, and coping ways Turkish nursing students: A randomized controlled trial. Perspect Psychiatr Care. 2022 Oct;58(4):2394-2406. doi: 10.1111/ppc.13073. Epub 2022 Mar 24.
Clinical trial NCT02602912: Identification of Spine Structures by Using BIP-Needles
Official title: INJ-SPINE-01 Identification of Spine Structures by Using BIP-Needles
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spinal Puncture
Lead sponsor: Injeq Ltd
Sponsor class: INDUSTRY
First posted: 2015-11-11
Enrollment: 69
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The main purpose of the study is to assess the feasibility and clinical performance of impedance based tissue identification in various spine structures.


Eligibility criteria: Inclusion Criteria:

* Voluntary adult patients going through medical operation involving spinal puncture, spinal fluid sampling or intrathecal drug injection.

Exclusion Criteria:

* Participation to other clinical study
* Exclusion criteria are the same as generally for spinal anaesthesia and lumbar punctures. Exclusion criteria includes infection on skin area, systemic anticoagulation, sepsis, anatomical unsuitability and refusal
* In addition for not giving (or not capable to give) the consent personally for any reason is an absolute exclusion criterion. In practice this means that study is for adult patients only.

Primary outcomes:
measure: True positive and false positive detection of cerebrospinal fluid marked in case report form
timeFrame: During spinal puncture
Secondary outcomes:
Other outcomes:
Locations:
city: Tampere
country: Finland
facility: Tampere University Hospital
Study officials:
References: