louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04651920: A Study on Association Between HR Genes and the HRD Status in Chinese Epithelial Ovarian Cancer
Official title: A Study on Association Between Homologous Recombination Genes and the Homologous Recombination Deficiency Status in Chinese Population With Epithelial Ovarian Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Epithelial Ovarian Cancer
Chinese
Homologous Recombination Deficiency
BRCA1 Mutation
BRCA2 Mutation
Prognosis
Homologous Recombination Genes
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2020-12-03
Enrollment: 240
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Chinese population with confirmed diagnosis of epithelial ovarian cancer with known targeted gene mutations via a multi-panel testing of 27 genes and known resistance to platinum-based chemotherapy

Brief summary: The association between homologous recombination (HR) gene mutations and homologous recombination deficiency (HRD) status in Chinese epithelial ovarian cancer (EOC) patients is little known. This study would recruit 400 Chinese EOC patients with known targeted gene mutations via a multi-panel testing of 27 genes, including BRCA1/BRCA2. All patients accept evaluation of HRD model, which is based on the loss of heterozygosity (LOH), telomere allele imbalance (TAI) and large-scale state transitions (LST). The mutated genes, HRD score model and their relationship with the prognosis, would provide a full description of for the Chinese EOC patients, and a potential explanation of platinum-resistance in such population.


Eligibility criteria: Inclusion Criteria:

* Aged 18 years or older
* Pathological confirmation of epithelial ovarian cancer
* With available tumor tissues
* Given consents to participate the study

Exclusion Criteria:

* Not meeting all of the inclusion criteria

Primary outcomes:
measure: Homologous recombination deficiency (HRD) score
timeFrame: Two years
Secondary outcomes:
measure: Progression-free survival
timeFrame: Five years
measure: Overall survival
timeFrame: Five years
Other outcomes:
Locations:
city: Beijing
country: China
facility: Lei Li
state: Beijing
Study officials:
affiliation: Peking Union Medical College Hospital
name: Lei Li, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06271720: Impact of Visceral Manipulation Versus Integrated Neuromuscular Inhibition Technique in Shoulder Impingement Syndrome
Official title: Impact of Visceral Manipulation Versus Integrated Neuromuscular Inhibition Technique in Shoulder Impingement Syndrome
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Shoulder Impingement
Lead sponsor: Egyptian Chinese University
Sponsor class: OTHER
First posted: 2024-02-22
Enrollment: 75
Sex: ALL
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will be conducted To evaluate the effect of Visceral Manipulation versus Integrated Neuromuscular Inhibition Technique on the upper fiber of trapezius on pain intensity, pain threshold, shoulder range of motion, and function in shoulder impingement syndrome

Detailed description: HYPOTHESES

It will be hypothesized that:

1. There will be no statistically significant effect of Visceral Manipulation on the upper fiber of the trapezius on pain intensity, pain threshold, shoulder range of motion, or function in shoulder impingement syndrome
2. There will be no statistically significant effect of the Integrated Neuromuscular Inhibition Technique on the upper fiber of the trapezius on pain intensity, pain threshold, shoulder range of motion, or function in shoulder impingement syndrome.
3. There will be no statistically significant difference in the effect of visceral manipulation versus the integrated neuromuscular inhibition technique on the upper fiber of the trapezius on pain intensity, pain threshold, shoulder range of motion, and function in shoulder impingement syndrome.

This study will be conducted to answer the following questions:

Is there an effect of Visceral Manipulation versus Integrated Neuromuscular Inhibition Technique on the upper fiber of the trapezius on pain intensity, pain threshold, shoulder range of motion, and function in shoulder impingement syndrome?

Eligibility criteria: Inclusion Criteria:

* -active myofascial trigger points in the upper trapezius muscle, and chronic Pain lasting more than 12 weeks
* BMI between 25 and 30 Kg/m².

Exclusion Criteria:

* a previous fracture in the cervical spine or shoulder surgery
* acute inflammatory condition.
* Malignant tumor.
* Multiple osteophytes.
* Cervical posture abnormalities.
* Osteoporosis.

Primary outcomes:
measure: pain intensity
timeFrame: pre treatment and after 4 weeks
measure: pain pressure threshold
timeFrame: pre treatment and after 4 weeks
measure: shoulder range of motion
timeFrame: pre treatment and after 4 weeks
measure: shoulder functional level
timeFrame: pre treatment and after 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05282420: Ranibizumab Versus Aflibercept for CRVO in Young Patients.
Official title: Ranibizumab Versus Aflibercept for Macular Edema Secondary to Non-ischemic Central Retinal Vein Occlusion in Young Adult Patients.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Non-Ischemic Central Retinal Vein Occlusion With Macular Edema
Keywords: non ischemic CRVO
Macular edema
Ranibizumab
Aflibercept
Lead sponsor: South Valley University
Sponsor class: OTHER
First posted: 2022-03-16
Enrollment: 40
Sex: ALL
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients were randomized into two groups, twenty patients (20 eyes) each. The first group received 0.5 mg\\0.1 ml ranibizumab intravitreal injections and the second group received 2.0 mg\\0.1 ml aflibercept intravitreal injections. all patients were followed up for at least 12 months.

Patients were given the planned treatment throughout the study and no switching was done between anti-VEGF drugs
Primary purpose: TREATMENT

Brief summary: this study will compare the efficacy and safety of use either Ranibizumab and Aflibercept in treatment of macular edema resulting from non ischemic central retinal vein occlusion in patients younger than 5o years old

Detailed description: This is a prospective randomized interventional study, Forty eyes of forty patients younger than 50 years with macular edema due to non-ischemic CRVO were enrolled in the study.

Patients will be randomized into 2 groups. First group will receive intravitreal injection of Ranibizumab 0.5 mg\\0.1ml. the second group will receive intravitreal injection of 2.0 mg\\0.1 ml Aflibercept. All patients will be followed up for 12 months.

Eligibility criteria: Inclusion Criteria:

* patients younger than 50 years with macular edema due to non-ischemic CRVO

Exclusion Criteria: Other conditions that might affect the macula as

1. diabetic retinopathy, intraocular inflammation, age related macular degeneration, patients with solar or radiation retinopathy,
2. patients with ischemic type CRVO and patients who had recent intraocular surgery.
3. patients who had previous intravitreal injections, ophthalmic laser surgeries.
4. patients with dense cataracts whom fundus was difficult to scan.
5. Patients who were lost to follow up visits were also excluded

Primary outcomes:
measure: Best corrected visual acuity BCVA
timeFrame: at 12 months post-injection
Secondary outcomes:
measure: reduction of macular edema
timeFrame: at 12 months post-injection
Other outcomes:
Locations:
city: Qinā
country: Egypt
facility: Ahmed Ali Ahmed Amer
state: Qena
Study officials:
References:
Clinical trial NCT03201120: Reducing UV Exposure to Prevent Skin Cancer: Message Development & Testing
Official title: Reducing UV Exposure to Prevent Skin Cancer: Message Development & Testing
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Behavior, Health
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
Collaborators: name: Centers for Disease Control and Prevention
First posted: 2017-06-28
Enrollment: 3595
Sex: ALL
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Phase 3b of the research will be a laboratory experiment that uses an experimental and analytic design that is parallel to that used in Phase 3a, the online experiment. The primary objective of Phase 3b is to assess physiological response (i.e., eye tracking) to different message appeals of the audio-visual messages used in Phase 3a on respondents' behavioral intentions and UV-related behavioral choices post-exposure. Including time for preparation, viewing, and removal of the monitoring equipment, the message viewing session will take about 45 minutes per session.


Eligibility criteria: Inclusion Criteria:

* 18-49 year old non-Hispanic white (NHW) adults
* OR 18-25 year old NHW females who have tanned indoors in the past 12 months

Exclusion Criteria:

-

Primary outcomes:
measure: Laboratory Survey
timeFrame: Baseline
measure: Follow-up Survey
timeFrame: Two weeks post baseline Laboratory Survey
Secondary outcomes:
measure: Measure of Behavioral Intent
timeFrame: Baseline
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: CIRNA Lab
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Karen Glanz, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02244320: Observational Study in Patients With Functional Benign Prostatic Hyperplasia Symptoms Who Switched From Phytotherapy to ALNA® (Tamsulosin)
Official title: Observational Study in Patients With Functional BPH (Benign Prostatic Hyperplasia) Symptoms Who Switched From Phytotherapy to ALNA® (Tamsulosin)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Prostatic Hyperplasia
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2014-09-19
Enrollment: 4150
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with functional BPH symptoms recruited at urologist offices

Brief summary: The objective of the observational study were to investigate the switch from phytotherapy to ALNA® after at least 4 weeks of phytotherapy and still presented with a symptom sum score of ≥ 8 points (International Prostate Symptom Score (IPSS))


Eligibility criteria: Inclusion Criteria:

* Patients suffering from BPH symptoms
* Preceding treatment with a phytotherapeutic for at least 4 weeks
* IPSS sum score ≥ 8 points prior to treatment start with ALNA®
* Indication for a switch to treatment with ALNA® for a minimum period of 2 months

Exclusion Criteria:

* Patients fulfilling one of the general or specific contraindications listed in the ALNA® Summary of Product Characteristic, particularly patients with known hypersensitivities against tamsulosin hydrochloride or any other ingredient of the product, orthostatic dysregulation or severe liver insufficiency
* Patients receiving ALNA® within the 4 weeks prior to the start of the present observational study

Primary outcomes:
measure: Change in IPSS sum score
timeFrame: Day 1, 2 months
measure: Change in Quality-of-Life Index (QoL) rated on a 7-point scale
timeFrame: Day 1, 2 months
Secondary outcomes:
measure: Change in sexual satisfaction rated on a 4-point scale
timeFrame: Day 1, 2 months
measure: Change in maximum urinary flow rate (ml/sec)
timeFrame: Day 1, 2 months
measure: Change in residual urine volume (ml)
timeFrame: Day 1, 2 months
measure: Patient's global assessment of the preceding phytotherapy on a 3-point scale
timeFrame: Day 1
measure: Patient's global assessment of the therapy with ALNA® on a 3-point scale
timeFrame: after 2 months
measure: Efficacy assessment of the preceding phytotherapy by physician rated on 4-point scale
timeFrame: Day 1
measure: Efficacy assessment of the therapy with ALNA® by physician rated on 4-point scale
timeFrame: after 2 months
measure: Tolerability assessment of the preceding phytotherapy by physician rated on 4-point scale
timeFrame: Day 1
measure: Tolerability assessment of the therapy with ALNA® by physician rated on 4-point scale
timeFrame: after 2 months
measure: Number of patients with adverse drug reactions (ADR)
timeFrame: up to 2 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02752620: Osteopathic Manipulative Treatment Versus Therapeutic Exercises in Subjects With Chronic Non-specific Low Back Pain
Official title: Osteopathic Manipulative Treatment Versus Therapeutic Exercises in Subjects With Chronic Non-specific Low Back Pain: a Randomized Controlled and Double-blind Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Low Back Pain
Keywords: osteopathic manipulative treatment
Chronic nonspecific low back pain
low back pain
Lead sponsor: Rio de Janeiro State University
Sponsor class: OTHER
Collaborators: name: Estácio S.A.
First posted: 2016-04-27
Enrollment: 38
Sex: ALL
Minimum age (years): 30
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study evaluates the effectiveness of treatment osteopathic manipulation in the treatment of subjects with chronic nonspecific low back pain.


Eligibility criteria: Inclusion Criteria:

* Subjects with constant or intermittent low back pain with intensity greater than 30 mm visual analog scale (VAS) for at least three months duration, with a diagnosis of chronic low back pain

Exclusion Criteria:

* Subjects who have spine fractures,
* Dislocations
* Ligament ruptures
* Muscle ruptures
* Skin lacerations
* Sacroiliitis
* Vertebral osteomyelitis
* Infection
* Disc herniations with radicular symptoms
* Rheumatic disorders
* Cauda equina syndrome
* Tumors
* Referred pain visceral
* Red flags
* Lower limb discrepancy greater than 2 cm
* Several conditions requiring participants to be absent for more than two weeks of activities in the experiment
* Positioning itself as not volunteer the same.

Primary outcomes:
measure: Pain
timeFrame: 5 weeks
Secondary outcomes:
measure: Disability
timeFrame: 5 weeks
measure: kinesiophobia
timeFrame: 5 weeks
measure: Depression
timeFrame: 5 weeks
Other outcomes:
Locations:
city: Rio de Janeiro
country: Brazil
facility: Estácio de Sá University
Study officials:
affiliation: UERJ
name: Frederico Meirelles, Master /PT
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00681720: Positron Emission Tomography (PET) Study With (11C)Flumazenil to Determine Central GABAA Receptor Occupancy of AZD7325
Official title: An Open Label Positron Emission Tomography (PET) Study With (11C)Flumazenil to Determine Central GABAA Receptor Occupancy of AZD7325 After Oral Administration to Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Anxiety
Keywords: Anxiety
GABA receptors
Positron Emission Tomography
PET
phase I
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2008-05-21
Enrollment: 4
Sex: MALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The study is carried out in order to determine the relationship between the dose of AZD7325 and the blood concentration of AZD7325, and to investigate to which extent AZD7325 binds to the GABAA receptors.


Eligibility criteria: Inclusion Criteria:

* Body Mass Index (BMI) of 18-30 kg/m2 and weight of 60-100 kg
* Clinically normal physical findings, medical history and laboratory values.

Exclusion Criteria:

* Clinically significant illness or clinical relevant trauma within 2 weeks before the study start.
* Intake of another investigational drug or participation in a clinical study the past 12 weeks.
* Previous participation in a PET study within the past 12 months. Suffer from claustrophobia and would be unable to undergo MRI (magnetic resonance imaging) or PET scanning.

Primary outcomes:
measure: Positron emission tomography using the radioligand (11C)flumazenil
timeFrame: 4 times per subject
Secondary outcomes:
measure: To assess safety of AZD7325 by assessment of adverse events, vital signs, ECGs, physical examination, psychometric tests and laboratory variables.
timeFrame: 6 visits with tests for the 2 subjects in the first group (Panel 1). 7 visits with tests for the 2 subjects in the second group (Panel 2). Some tests will be done several times per visit. All tests will not be done at every visit
measure: Investigate the pharmacokinetics of AZD7325 following single doses of AZD7325 by assessment of drug concentration in plasma
timeFrame: 3 times per subject. Up to 48 hours each time.
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Research Site
Study officials:
affiliation: AstraZeneca Clinical Pharmacology Unit, Stockholm, Sweden
name: Bo Fransson
role: PRINCIPAL_INVESTIGATOR
affiliation: AstraZeneca R&D, Study Delivery, Clinical Development, Södertälje, Sweden
name: Eva Taavo
role: STUDY_DIRECTOR
References:
citation: Jucaite A, Cselenyi Z, Lappalainen J, McCarthy DJ, Lee CM, Nyberg S, Varnas K, Stenkrona P, Halldin C, Cross A, Farde L. GABAA receptor occupancy by subtype selective GABAAalpha2,3 modulators: PET studies in humans. Psychopharmacology (Berl). 2017 Feb;234(4):707-716. doi: 10.1007/s00213-016-4506-4. Epub 2016 Dec 24.
Clinical trial NCT00576082: Borrelia Species in Cutaneous Lyme Borreliosis
Official title: DIVERSITY OF BORRELIA SPECIES INVOLVED IN CUTANEOUS MANIFESTATIONS OF LYME BORRELIOSIS IN FRANCE
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Lyme Borreliosis
Keywords: Lyme borreliosis
Erythema migrans
Borrelial lymphocytoma
Acrodermatitis chronica atrophicans
Borrelia burgdorferi
Borrelia afzelii
Borrelia garinii
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
Collaborators: name: Société de Dermatologie Française
First posted: 2007-12-18
Enrollment: 900
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Every adult patient presenting with either erythema migrans, borrelial lymphocytoma or acrodermatitis chronica atrophicans

Brief summary: The aim of this study is to identify the species of Borrelia involved in the dermatologic manifestations of Lyme borreliosis in France. Indeed, in Europe, as opposed to North America, many bacterial species are involved in Lyme borreliosis. Yet, very few is known about the prevalence and distribution of different bacteriological species that account for the disease in France. Thus, this a nation-wide study in which all French dermatologists are invited to participate. Every adult patient presenting with one of the cutaneous manifestation of Lyme borreliosis: erythema migrans, lymphocytoma or acrodermatitis chronica atrophicans can be included in the study. If the patient agrees participating, after information and written consent, a cutaneous biopsy will be performed in order to isolate Borrelia by means of culture and PCR. An estimated 400 biopsies should be performed within 2 years.


Eligibility criteria: Inclusion criteria:

* Informed adult patient who signed written consent with one the following conditions:
* erythema migrans
* borrelial lymphocytoma
* acrodermatitis chronica atrophicans

Exclusion criteria:

* pregnancy or lactation
* allergy to local anesthesia
* patient who refuses biopsy

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Service de Dermatologie, Hôpital Civil
city: Strasbourg
country: France
facility: Service des Maladies infectieuses et tropicales, Nouvel Hôpital Civil, Hôpitaux Universitaires de Strasbourg
Study officials:
affiliation: Hôpitaux Universitaires de Strasbourg
name: Dan LISPKER, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01708382: Feasibility Study: Lifting and Tightening of the Elbows
Official title: Feasibility Study: Evaluation of the Ulthera® System for Lifting and Tightening of the Elbow Tissue - A Feasibility Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Skin Laxity
Keywords: Ulthera® System
Ultherapy™ Treatment
Ulthera, Inc.
Ultrasound treatment for skin tightening
Lead sponsor: Merz North America, Inc.
Sponsor class: INDUSTRY
First posted: 2012-10-17
Enrollment: 21
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Up to 20 subjects will be treated. Treated subjects will receive one Ulthera® treatment on the elbows. Follow-up visits will occur at 90 and 180 days post-treatment. Study images will be obtained pre-treatment, immediately post-treatment, and at each follow-up visit.

Detailed description: This is a prospective, single-center, pilot clinical trial to evaluate the efficacy of the Ulthera® System to improve skin laxity above the elbows. Masked assessment of pre- and post-treatment photos will be performed. Global Aesthetic Improvement Scale scores and patient satisfaction questionnaires will also be obtained.

Eligibility criteria: Inclusion Criteria:

* Male or female, age 21 to 65 years.
* Subject in good health.
* Mild to moderate skin laxity on the elbows.
* Understands and accepts the obligation not to undergo any other procedures in the areas to be treated through the follow-up period.
* Willingness and ability to comply with protocol requirements, including returning for follow-up visits and abstaining from exclusionary procedures for the duration of the study.
* Subjects of childbearing potential must have a negative urine pregnancy test result and must not be lactating at Visit 1 and be willing and able to use an acceptable method of birth control

Exclusion Criteria:

* Presence of an active systemic or local skin disease that may affect wound healing.
* Excessive subcutaneous fat around the elbows.
* Excessive skin laxity around the elbows.
* Significant scarring in areas to be treated.
* Significant open wounds or lesions in the area to be treated

Primary outcomes:
measure: Overall improvement of skin laxity in the areas treated
timeFrame: 90 days post-treatment
Secondary outcomes:
measure: Aesthetic improvement
timeFrame: 90 and 180 days post-treatment
Other outcomes:
Locations:
city: New York
country: United States
facility: New York Cosmetic, Skin and Laser Surgery Center
state: New York
Study officials:
affiliation: New York Cosmetic, Skin, and Laser Surgery Center
name: Cameron K Rokhsar, MD
role: PRINCIPAL_INVESTIGATOR
References: