louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03776708: Effect of Spinal Manipulation on Experimental Pain in Asymptomatic Subjects.
Official title: What is the Regional and Remote Effect of Spinal Manipulation on Pressure Pain Threshold in Asymptomatic Subjects Over Time: A Randomized Placebo-controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spinal Manipulation
Keywords: pressure pain threshold
asymptomatic subjects
duration
Lead sponsor: Institut Franco Europeen de Chiropratique
Sponsor class: OTHER
First posted: 2018-12-17
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Spinal manipulation is often used for its effect on pain, but more information is needed concerning its mechanisms of action.

Detailed description: The effect of spinal manipulation on the pressure pain threshold in asymptomatic subjects should be challenged by a validated sham procedure, regionally and remotely over time. Further information is needed concerning its duration and its size.

Research questions:

1. What is the regional effect of spinal manipulation on the pressure pain threshold in asymptomatic subjects, when compared to a valid sham procedure?
2. What is the remote effect of spinal manipulation on the pressure pain threshold in asymptomatic subjects, when compared to a valid sham procedure?
3. What is the duration of the effect of spinal manipulation on the pressure pain threshold in asymptomatic subjects?
4. What is the size of the effect of spinal manipulation on the pressure pain threshold in asymptomatic subjects over time?

Eligibility criteria: Inclusion Criteria:

* The subjects must be young (18-30 years old)
* asymptomatic (no pain in the tested area, but the study accepts pain elsewhere, as long as it is less than 1/10 on the BOX-scale).
* Chiropractic students.

Exclusion Criteria:

* The subjects must not be reporting any spinal pain lasting more than a month
* and/or having taken painkillers 24h prior to the study.
* Contra-indications to the spinal manipulation (instability, fracture, malformation, bone or ligament fragility, and inflammations).

Primary outcomes:
measure: Change of the Pressure Pain threshold
timeFrame: The change of the Pressure Pain Threshold is assessed from baseline to immediately after spinal manipulation, and then every fifteen minutes for about an hour.
Secondary outcomes:
Other outcomes:
Locations:
city: Ivry-sur-Seine
country: France
facility: Institut Franco Européen de chiropraxie (iFEC)
state: Val De Marne
Study officials:
affiliation: Institut Franco Européen de Chiropraxie
name: Charlotte Leboeuf-Yde, DC, MPH, PhD, Professor
role: STUDY_DIRECTOR
References:
Clinical trial NCT01350908: Study of Circulating Tumoral DNA in Ovarian Cancer
Official title: Development and Validation of a Circulating Tumor DNA Detection Technique in Patients With Ovarian Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ovarian Cancer
Lead sponsor: Institut Curie
Sponsor class: OTHER
First posted: 2011-05-10
Enrollment: 25
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: Circulating tumor DNA detection and quantification in patients with ovarian cancer.

Detailed description: Technique development:

In a first step, the different available techniques will be evaluated for specificity and sensibility using serial dilutions of cell lines with or without TP53 mutation.

Validation:

The tumor DNA detection rate will be estimated from patient's blood with ovarian cancer.

The investigators will study 25 patients to obtain at least 15 patients bearing a TP53 mutation that could be characterized in the primitive tumor or metastasis. With those 15 patients, the investigators will determine the most sensitive technique and the best cost/efficiency ratio.

Eligibility criteria: Inclusion Criteria:

* Age \> or = 18 years.
* Patient with invasive ovarian cancer stage II to IV from FIGO classification.
* Patient treated by surgery.
* Patient with tumor or metastasis available for TP53 status characterization
* Patient able to stand a blood collection.
* Signed written informed consent approved by AFSSAPS and CPP.

Exclusion Criteria:

* Patient without social protection / insurance.
* Borderline ovarian tumor.
* Non carcinoma ovarian tumor
* Patient with invasive ovarian cancer 5 years before diagnosis
* Current pregnancy and lactation.
* All social, medical, psychological, situations making the study impossible.
* Person deprived of liberty.

Primary outcomes:
measure: Assessment and development of circulating tumor DNA detection techniques
timeFrame: 2 years
Secondary outcomes:
measure: Comparison of the detection techniques (PAP (pyrophosphorolysis activated polymerisation), BEAMing, NGS(Next sequencing generation) with regards to feasibility, robustness, sensitivity and cost.
timeFrame: 2 years
Other outcomes:
Locations:
city: Paris
country: France
facility: Institut Curie
Study officials:
affiliation: Institut Curie
name: LANTZ Olivier, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02089308: Nicotine Patch - Bioequivalence Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Smokers
Keywords: Smoking cessation
Nicotine
Tobacco Use Disorder
Central Nervous System Agents
Lead sponsor: Pierre Fabre Medicament
Sponsor class: INDUSTRY
First posted: 2014-03-17
Enrollment: 74
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: The purpose of this study is to evaluate the bioequivalence of a new transdermal nicotine patch to that of a reference formulation following repeated applications


Eligibility criteria: Inclusion Criteria:

* Healthy male subject aged 18 to 45 years (inclusive)
* Current Smoker of \>or = 5 and \< or = to 15 cigarettes/day
* Fagerström score \< or =5 at selection
* Absence of any clinically significant abnormal findings at physical examination, vital sign, Electrocardiogram ECG, biological examinations in the investigator's opinion.

Exclusion Criteria:

* Presence of any significant medical findings or significant history (in particular any cardio-vascular disease, severe renal or hepatic insufficiency, current gastric or duodenal ulcer) that may impact the safety, the interpretation of the results and/or the participation of the subject in the study according to the opinion of the investigator
* Any visible skin disorder, abnormal skin pigmentation or dermatologic disease liable to interfere with use or safety assessment of a transdermal patch

Primary outcomes:
measure: Maximum Plasma Concentration (Cmax)
timeFrame: During the third application of each period,12 time points up to 24h after the application
measure: Time to Maximum Concentration (Tmax)
timeFrame: During the third application of each period,12 time points up to 24h after the application
measure: Area under the plasma concentration-time curve (AUC)
timeFrame: During the third application of each period, 12 time points up to 24h after the application
Secondary outcomes:
Other outcomes:
Locations:
city: Gieres
country: France
Study officials:
References:
Clinical trial NCT01295008: Androgenetic Alopecia in Fabry Disease
Official title: Androgenetic Alopecia in Fabry Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Fabry Disease
Keywords: Fabry disease
Male pattern baldness
Alopecia
GLA gene mutation
Alpha-galactosidase A
Lead sponsor: Baylor Research Institute
Sponsor class: OTHER
First posted: 2011-02-14
Enrollment: 107
Sex: MALE
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Selected from specialy clinic

Brief summary: The purpose of this study is to assess whether patients with the classic form of Fabry disease have significantly less androgenic alopecia (male pattern baldness).

Detailed description: Objectives: To test the hypothesis that adult males with classic form of Fabry disease have a significantly lower incidence of androgenic alopecia than matched controls.

Study Population: 120 patients aged 20-64 with Fabry disease that have GLA mutations or alpha-galactosidase A activity associated with no residual enzyme activity and non-Fabry male controls of the same age range and the same number of non-Fabry controls.

Design: This is a cross-sectional study comparing the prevalence of androgenic alopecia in two groups of subjects.

Outcome Measures: The levels of the outcome will be no androgenic alopecia and frontal only androgenetic alopecia opposed to vertex only and frontal and vertex androgenetic alopecia.

Eligibility criteria: Inclusion Criteria:

* Male patients with Fabry disease age 20-64 years old.
* Healthy male controls age 20-64 years old
* GLA gene mutations associated with the classic form of Fabry disease or having alpha-galactosidase A activity that is essentially zero
* Patients who freely agree to participate in this study and understand the nature, risks and benefits of this study and give their written informed consent.

Primary outcomes:
measure: No and frontal only androgenetic alopecia
timeFrame: 1 Year
Secondary outcomes:
measure: Vertex only and frontal and vertex androgenetic alopecia.
timeFrame: 1 Year
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Baylor University Medical Center
state: Texas
Study officials:
affiliation: Baylor Research Institute
name: Raphael Schiffmann, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00732108: Is Topiramate Effective in Treating Dizziness in Patient's With Migraine-Associated Dizziness
Official title: Efficacy of Topiramate in Patients Wih Migraine-Associated Dizziness
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Migraine
Headache
Dizziness
Keywords: migraine
headache
dizziness
vertigo
topiramate
Topamax
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: American Academy of Otolaryngology-Head and Neck Surgery Foundation
First posted: 2008-08-11
Enrollment: 0
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: The purpose of this study is to determine whether topiramate effective in treating dizziness symptoms that are associated with migraine headaches.

Detailed description: Migraine is a common disorder, often associated with dizziness symptoms. In many cases, dizziness is one of the only manifestations of migraine headaches. Various classes of drugs have been advocated as treatment for migraine-associated dizziness, though none has been shown to be superior over the others.

Topiramate is a drug approved for migraine prophylaxis. This study is designed to assess if there are significant changes in dizziness frequency and severity in patients diagnosed with migraine-associated dizziness treated with topiramate. Demonstrating benefit of topiramate with a placebo-controlled study to alleviate symptoms of dizziness would serve to clarify effective treatment options for patients with migraine-associated dizziness.

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of migraine-associated dizziness.

Exclusion Criteria:

* Previous or current use of topiramate prior to study enrollment.
* Need for continued use of the following medications for any medical reason during the study: ergots, anti-epileptics, beta-blockers, calcium channel blockers, monoamine oxidase inhibitors, high-dose magnesium, high-dose riboflavin, corticosteroids, local anesthetics, botulinum toxin, or herbal preparations.
* History of nephrolithiasis.
* Women whom are pregnant or breastfeeding.
* Patients with known sensitivity to topiramate.
* Patients with a history of glaucoma.
* Patients with severe medical condition(s) that in the view of the investigator prohibits participation in the study.

Primary outcomes:
measure: Change in mean 28-day monthly vertigo frequency from baseline.
timeFrame: 4 weeks, 8 weeks
measure: Change in Dizziness Handicap Inventory scores from baseline.
timeFrame: 4 weeks, 8 weeks
Secondary outcomes:
measure: Change in an individual's perception of vertigo symptoms based on a 1 to 10 scale.
timeFrame: 4 weeks, 8 weeks
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
Study officials:
affiliation: University of California, San Francisco
name: Lawrence R Lustig, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00196508: A Study Comparing Topical Skin Adhesive or Sutures for Closure Due to Episiotomy or Perineal Tears Following Childbirth
Official title: A Randomized, Multi Center Study to Evaluate the Clinical Performance of Topical Skin Adhesive in Comparison to Sutures for Perineal Skin Closure Following Childbirth
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Episiotomy
Perineal Tear
Keywords: Childbirth
Lead sponsor: Ethicon, Inc.
Sponsor class: INDUSTRY
First posted: 2005-09-20
Enrollment: 118
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: This is a randomized controlled trial and multi-centered study with a 2-arm design. The treatment group will receive topical skin adhesive for skin closure of their wound and the control will receive sutures. Subjects will be assessed at follow-up visits. Patients are required to maintain a diary postpartum.


Eligibility criteria: Inclusion Criteria:

* Patient is at least 18 years of age.
* Patient has an episiotomy incision or perineal tear resulting from a vaginal delivery.
* Patient agrees to participate in the follow-up schedule of assessments and completion of a daily diary.
* Patient has signed the informed consent form.

Exclusion Criteria:

* Patient has peripheral vascular disease.
* Patient has insulin dependent diabetes mellitus.
* Patient has a blood clotting disorder that requires therapy.
* Patient has a personal or family history of keloid formation or hypertrophy.
* Patient has a known allergy to cyanoacrylates or formaldehyde.
* Patient has impaired wound healing by history. Patient is a chronic steroid user.

Primary outcomes:
measure: Topical skin adhesive is non-inferior to sutures when used for skin closure following an episiotomy incision or perineal tear resulting from childbirth
measure: The incidence of perineal skin opening requiring re-closure post-partum
Secondary outcomes:
measure: Presence and extent of clinically relevant skin openings
measure: Presence and extent of acute inflammatory reaction, pain, itch and discomfort associated with the perineal skin area
measure: Perineal skin closure cosmesis
measure: Patient satisfaction
Other outcomes:
Locations:
city: Bessemer
country: United States
state: Alabama
city: Moorestown
country: United States
facility: Phoenix OB-GYN Associates
state: New Jersey
city: Memphis
country: United States
facility: McDonald Murrmann Women's Clinic
state: Tennessee
city: Norfolk
country: United States
facility: Tidewater Physicians for Women
state: Virginia
city: Virginia Beach
country: United States
facility: Virginia Beach Obstetrics & Gynecology
state: Virginia
Study officials:
References:
Clinical trial NCT01189708: Prevention of Incisional Hernia After Elective Open Abdominal Aortic Aneurysm (AAA) Repair
Official title: Prevention of Incisional Hernia After Elective Open Abdominal Aortic Aneurysm Repair
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Abdominal Aortic Aneurysm
Keywords: Abdominal aortic aneurysm
Abdominal hernia
Lead sponsor: Cantonal Hospital of St. Gallen
Sponsor class: OTHER
First posted: 2010-08-27
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The aim of this study is to investigate the effect of the implantation of an Ultrapro® Mesh as prevention of incisional hernia after elective open abdominal aortic aneurysm repair. According to the literature these patients have an increased risk for an incisional hernia. By the implantation of an artificial mesh into the abdominal wall during the first abdominal aortic aneurysm repair, the risk can be reduced dramatically. In small feasibility studies incisional hernia rates as low as 0% have been achieved.

Patients scheduled for elective open abdominal aortic aneurysm repair will be randomized into two groups, one receiving an onlay mesh, the other conventional wound closure with sutures.

Detailed description: Prospective randomized controlled study with two study arms.

Arm 1: Abdominal wall will be closed with a prophylactic mesh implantation in onlay technique after elective open abdominal aortic aneurysm repair.

Arm 2: Abdominal wall will be closed with standard sutures (without mesh implantation)

After the patients gave their informed consent to participate in the study, they will be randomized to one of the two treatment arms. Allocation is carried out based on a prepared randomization list.

Primary endpoint is the rate of incisional hernias within the follow-up period of 2 years. Secondary endpoints are postoperative complications and adverse events during the follow-up period.

Study enrollment was prematurely terminated on 30. Apr 2009. Already enrolled patients will be followed for 24 months according to protocol.

Eligibility criteria: Inclusion Criteria:

* Patient scheduled for elective or early elective open repair of aortic aneurysm

Exclusion Criteria:

* Emergency surgery
* EVAR (endovascular procedure)
* Patients with previous midline laparotomy
* Patients with in situ abdominal mesh after previous hernia repair
* Patients with large diastasis of abdominal wall
* Allergy to penicillin
* Women before menopause (mesh can interfere with potential future pregnancies)

Primary outcomes:
measure: Incidence of incisional hernia
timeFrame: 24 months
Secondary outcomes:
measure: Rate of postoperative complications
timeFrame: 7 days
measure: operation time
timeFrame: 4 hours
measure: Rate of adverse events
timeFrame: 24 months
Other outcomes:
Locations:
city: St. Gallen
country: Switzerland
facility: Kantonsspital St. Gallen, Department of Surgery
state: Saint Gallen
Study officials:
affiliation: KSSG
name: Wolfgang Nagel, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03476408: Plantar Sensation, Balance, Risk of Falling and Gait in Patients With Schizophrenia
Official title: Investigation of the Relationship Between Plantar Sensation, Balance, Risk of Falling and Gait in Patients With Schizophrenia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Plantar Sensation
Balance; Distorted
Fall
Gait Disorders, Neurologic
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2018-03-26
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Cerebellar vermis anomalies are present in schizophrenic individuals. This condition leads to postural balance problems. Foot and ankle complex have a special role for maintaining balance. However, there is no study about this topic in schizophrenic individuals.


Eligibility criteria: Inclusion Criteria:

* diagnose of schizophrenia according to DSM-5
* being an individual in remission against the risk of having an attack
* individuals who use the same psychotropic drugs for at least 4 weeks

Exclusion Criteria:

* Individuals with physical and neurological comorbidities

Primary outcomes:
measure: Semmes-Weinstein Monofilament test
timeFrame: 1 year
measure: Berg Balance Scale
timeFrame: 1 year
measure: Tinetti Fall Risk Scale
timeFrame: 1 year
measure: Spinal Mouse
timeFrame: 1 year
measure: Walk a Line Battery
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Kırşehir
country: Turkey
facility: Ahi Evran University
state: Kirşehi̇r
city: Kırşehir
country: Turkey
facility: Ahi Evran University
Study officials:
References:
Clinical trial NCT01131208: Biomarkers in Patients With Diffuse Large B-Cell Lymphoma Treated With Combination Chemotherapy With or Without Rituximab
Official title: Gene Expression Profiling Using Paraffin-embedded Tissues and the Nuclease Protection Assay in Diffuse Large B-cell Lymphoma (DLBCL) Treated With CHOP or R-CHOP: An ECOG and SWOG Correlative Study of E4494
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lymphoma
Keywords: contiguous stage II adult diffuse large cell lymphoma
noncontiguous stage II adult diffuse large cell lymphoma
recurrent adult diffuse large cell lymphoma
stage I adult diffuse large cell lymphoma
stage III adult diffuse large cell lymphoma
stage IV adult diffuse large cell lymphoma
Lead sponsor: Eastern Cooperative Oncology Group
Sponsor class: NETWORK
Collaborators: name: National Cancer Institute (NCI)
First posted: 2010-05-26
Enrollment: 200
Sex: ALL
Minimum age (years): 60
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Samples from patients enrolled on E4402 from whom samples were submitted for research

Brief summary: RATIONALE: Studying samples of tissue from patients with cancer in the laboratory may help doctors identify and learn more about biomarkers related to cancer. It may also help doctors predict how well patients will respond to treatment.

PURPOSE: This research study is studying biomarkers in patients with diffuse large B-cell lymphoma treated with combination chemotherapy with or without rituximab.

Detailed description: OBJECTIVES:

* To identify genes predictive of clinical outcome (failure-free survival and overall survival) among patients with diffuse large B-cell lymphoma treated with CHOP or R-CHOP induction on ECOG-E4494 using the nuclease protection assay for measuring gene expression in paraffin-embedded tissue.
* To identify genes that change their prognostic profile with the addition of rituximab to CHOP chemotherapy.

OUTLINE: This is a multicenter study.

Unstained formalin-fixed, paraffin-embedded samples are analyzed for gene expression via nuclease protection assay.

Eligibility criteria: DISEASE CHARACTERISTICS:

* Diagnosis of diffuse large B-cell lymphoma
* Treated with CHOP or R-CHOP on ECOG-E4494

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics

Primary outcomes:
measure: Identification of genes predictive of clinical outcome
timeFrame: 1 month
measure: Identification of genes that change their prognostic profile with the addition of rituximab to CHOP chemotherapy
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Robert H. Lurie Cancer Center
name: Jane N. Winter, MD
role: PRINCIPAL_INVESTIGATOR
References: