louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04934007: Bilateral Lateral OFC rTMS in Obsessive Compulsive Disorder
Official title: A Randomized Control Trial of Bilateral Lateral OFC rTMS in Obsessive Compulsive Disorder
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Obsessive-Compulsive Disorder
Keywords: rTMS
D-B80 A/P
Lead sponsor: Centre Hospitalier Henri Laborit
Sponsor class: OTHER
First posted: 2021-06-22
Enrollment: 136
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: According to the literature the lateral part of the Orbito Frontal Cortex (lOFC) is a relevant bilateral target for repetitive Trans-cranial Magnetic Stimulation (rTMS) in Obsessive Compulsive Disorder (OCD). Both hemispheres are concerned in terms of target.


Eligibility criteria: Inclusion Criteria:

* Age: Participants will be both males and females, 18-65 years of age included.
* diagnosis of OCD
* all the patients must have failed to respond to at least two different pharmacological treatment used for at least 6 weeks
* Affiliation to a social security system (recipient or assignee),
* Signed written inform consent form

Exclusion Criteria:

* The exclusion criteria are a diagnosis of another psychiatric disorder (except for anxious disorders), a diagnosis of a significant active medical illness, pregnancy or other neurological illness
* In accordance with the safety criteria for rTMS, patients with a history of seizure or bearing pacemakers, mobile metal implants, implanted medical pumps, or metal clips placed inside the skull will also be excluded
* The patients won't be allowed to change their medication during the trial. The treatment must be stable at least 3 week before day 0.
* Female subject who is pregnant, or of child-bearing age, sexually active and not using reliable contraception or who is nursing,
* Patient under curators
* Patient hospitalized under duress
* Patient unable to give his or hers informed consent

Primary outcomes:
measure: Yale Brown Obsessive Compulsive Scale score
timeFrame: baseline and 25 days
Secondary outcomes:
measure: Yale Brown Obsessive Compulsive Scale
timeFrame: baseline and 70 days
measure: general assessement functioning (GAF)
timeFrame: baseline and 25 days
measure: general assessement functioning (GAF)
timeFrame: baseline and 70 days
measure: Clinical Global Impression (CGI)
timeFrame: baseline and 25 days
measure: Clinical Global Impression (CGI)
timeFrame: baseline and 70 days
measure: Adverse events linked to the rTMS treatment
timeFrame: 70 days
Other outcomes:
Locations:
city: Paris
country: France
facility: Sorbonne University, Pitié-Salpêtrière Hospital
city: Poitiers
country: France
facility: Centre Hospitalier Henri Laborit
Study officials:
affiliation: Centre Hospitalier Henri Laborit
name: Ghina Harika-Germaneau
role: STUDY_DIRECTOR
References:
Clinical trial NCT05252507: Art for Hearts/Black Women's Hearts Paint Night
Official title: Art for Hearts/Black Women's Hearts Paint Night
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress
Blood Pressure
Lead sponsor: Virginia Commonwealth University
Sponsor class: OTHER
Collaborators: name: Association of Black Cardiologists (ABC)
First posted: 2022-02-23
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The purpose of this research study is to learn about different techniques that can be used to increase self-reflection, reduce stress, manage high blood pressure in Black women.

Detailed description: The researchers want to know how Black women process stress and cope with it during the pandemic, and if managing stress related through a tailored stress reduction activity/art program affect psychological and blood pressure outcomes over the course of 2 months. It is possible that this information may help people reduce their stress and get treatment for high blood pressure sooner, which can help prevent other heart problems over time.

Eligibility criteria: Inclusion Criteria:

* self-identify as African American or black
* have a measured blood pressure (BP) of \<140/90 mmHg

Exclusion Criteria:

* Are experiencing cognitive impairment
* Report an untreated psychotic disorder, bipolar disorder, any organic brain syndromes, or substance abuse disorder that the study team believes may result in being a threat to themselves or others
* Report hospitalization for any psychiatric disorder within the past 12 months

Primary outcomes:
measure: Change in blood pressure
timeFrame: Baseline to 8 weeks
measure: Change in psychological state
timeFrame: Baseline to 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
Study officials:
affiliation: Virginia Commonwealth University
name: Anika L Hines, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01850407: Preparing Caregivers for the Child Sexual Abuse Examination: Are Informational Leaflets Helpful?
Official title: Preparing Caregivers for the Child Sexual Abuse Examination: Are Informational Leaflets Helpful?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Child Sexual Abuse, Suspected
Keywords: Lack of Preparation for Abused Children during Medical Examination
Lead sponsor: Hackensack Meridian Health
Sponsor class: OTHER
First posted: 2013-05-09
Enrollment: 37
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: Children are typically inadequately prepared for the sexual abuse medical examination. Caregivers report lack of examination knowledge as a barrier to preparing their children. The purpose of this study was to determine if informational leaflets provided prior to the examination are helpful to caregivers in preparing their children.


Eligibility criteria: Inclusion Criteria:

* consecutive caregivers accompanying children for scheduled sexual abuse medical examination

Exclusion Criteria:

* Lack of consent
* Failure to complete study

Primary outcomes:
measure: To determine the helpfulness of informational leaflets in preparing caregivers for the child sex abuse examination
timeFrame: one month
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Hackensack Meridian Health
name: Nina Agrawal, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05338307: Preliminary Investigation of β-hydroxybutyrate Supplementation in Colorectal Cancer Prevention
Official title: Preliminary Investigation of β-hydroxybutyrate Supplementation in Colorectal Cancer
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Colorectal Cancer
Lead sponsor: Abramson Cancer Center at Penn Medicine
Sponsor class: OTHER
First posted: 2022-04-21
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The aim of this study is to assess the feasibility of beta-hydroxybutyrate (BHB) supplementation in individuals who are undergoing a standard-of-care colonoscopy or flexible sigmoidoscopy.

Detailed description: The aim of this study is to assess the feasibility of β-hydroxybutyrate (BHB) supplementation in individuals who are undergoing a standard-of-care colonoscopy or flexible sigmoidoscopy in order to determine whether BHB supplementation is safe and tolerable. Additionally, this study will determine whether BHB supplementations increases serum BHB levels, and leads to transcription and protein expression changes in the colonic mucosa. BHB supplementation will be performed through oral administration of HVMN Ketone-IQ, a commercially available BHB supplement, with an active ingredient of R-1,3-Butanediol, which gets converted to BHB.

Eligibility criteria: Inclusion Criteria:

* Age of 18 years or older
* Scheduled for a colonoscopy or flexible sigmoidoscopy as part of the patient's standard care
* Can provide informed consent

Exclusion Criteria:

* Subject is pregnant, a prisoner, or is under 18 years of age
* Patient is not able to undergo colonoscopy or flexible sigmoidoscopy
* Prior total proctocolectomy
* History of inflammatory bowel disease
* History of diabetes mellitus and are currently on medical diabetes therapy
* History of chronic kidney disease with an eGFR \< 60 mL/min/1.73m2
* Cancer diagnosis where the subject is receiving active therapy
* Use of either a ketogenic diet or intermittent fasting (defined as a fasting period of 16 hours or more per day that is not associated with a medical procedure) during the 4 weeks prior to enrollment

Primary outcomes:
measure: Determine whether oral BHB supplementation is safe and tolerable
timeFrame: Through study completion, which will be approximately 2 years
Secondary outcomes:
measure: Determine whether oral BHB supplementations increases serum BHB levels
timeFrame: Through study completion, which will be approximately 2 years
measure: Investigate whether oral BHB supplementation leads to transcription and protein expression changes in the colonic mucosa
timeFrame: Through study completion, which will be approximately 2 years
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Abramson Cancer Center of the University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Bryson W Katona, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06830707: Effect of Lower Limb Constraint Induced Movement Therapy Using a Torque-Assisted Exoskeletal Wearable Device
Official title: Effect of Lower Limb Constraint Induced Movement Therapy Using a Torque-Assisted Exoskeletal Wearable Device on Ambulatory Function in Late Subacute and Chronic Stroke Patients, Single-Center, Single-blinded Cross-over Prospective Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Stroke
Subacute Stroke
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2025-02-17
Enrollment: 16
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

Brief summary: The aim of this study was to investigate the effects of lower limb constraint induced motor therapy using the robotic rehabilitation device on ambulatory function in chronic stroke patients.


Eligibility criteria: Inclusion Criteria:

* Adults aged 19 years or older
* Patients with hemiparesis due to ischemic or hemorrhagic stroke
* Patients in the late subacute or chronic phase, at least 3 months after the onset of stroke
* Individuals who can independently walk with a Functional Ambulatory Category score of 3 or higher
* Patients who are able to use Torque-Assisted Exoskeletal Wearable Device Height: 140 cm to 190 cm Weight: 80 kg or less Shoe size: 230 mm to 290 mm
* Patients who were independent walkers and had no difficulties performing activities of daily living (mRS ≤ 1)

Exclusion Criteria:

* Patients with severe cognitive impairment (MMSE \<10) or significant communication difficulties such as speech disorders
* Patients with spasticity in one-sided lower limbs, rated 2 or higher on the Modified Ashworth Scale (MAS)
* Patients with severe musculoskeletal disorders of the lower limbs
* Patients with contractures that limit the range of motion in the lower limbs
* Patients with an apparent leg length discrepancy of 2 cm or more
* Patients with fractures, open trauma, or non-healing ulcers in the lower limbs
* Patients with serious internal diseases such as cardiovascular disease or pulmonary disease that make it difficult to use Exoskeletal Wearable Device for walking therapy
* Patients with a history of osteoporotic fractures
* Patients with other neurological disorders affecting walking (e.g., Parkinson's disease, multiple sclerosis, etc.)
* Any other cases where the investigator determines that participation in this study is inappropriate

Primary outcomes:
measure: Comparison of the change in walking speed
timeFrame: 3 weeks follow up
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
References:
Clinical trial NCT00545207: A Study of Bonviva (Ibandronate) Once Monthly in Post-Menopausal Women With Osteopenia.
Official title: A Randomized, Double-blind Study of the Effect of Oral Monthly Bonviva on in Vivo Bone Micro-architecture Parameters in Post-menopausal Women With Osteopenia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Post-Menopausal Osteopenia
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2007-10-17
Enrollment: 150
Sex: FEMALE
Minimum age (years): 55
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This 2 arm study will compare the effect of oral Bonviva (150mg, monthly) and placebo on parameters of bone micro-architecture, assessed by CT scan, bone turnover and bone mineral density. Patients will be randomized to receive either Bonviva 150mg po or placebo monthly, and measurements will be taken at baseline, and at intervals over 2 years. The anticipated time on study treatment is 2+ years, and the target sample size is 100-500 individuals.


Eligibility criteria: Inclusion Criteria:

* post-menopausal women, aged 55-75 years;
* diagnosed osteopenia.

Exclusion Criteria:

* history of osteoporotic vertebral fracture;
* contraindication to ibandronate.

Primary outcomes:
measure: Trabecular BV/TV at distal radius of non-dominant arm
timeFrame: 12 arms
Secondary outcomes:
measure: Trabecular BV/TV at distal radius of non-dominant arm
timeFrame: 6 months and 2 years
measure: Bone density, trabecular BV/TV at distal tibia
timeFrame: 6 months, 1 and 2 years
measure: Serum CTX
timeFrame: Intervals throughout study
measure: Lumbar hip and wrist BMD
timeFrame: 1 and 2 years
measure: AEs and laboratory parameters
timeFrame: Throughout study
Other outcomes:
Locations:
city: Lyon
country: France
city: Paris
country: France
city: Saint-priest En Jarez
country: France
city: Toulouse
country: France
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT03530007: Anti-shivering Effect of Ondansetron
Official title: Comparison Between Two Different Doses of Ondansetron on the Incidence of Spinal Shivering During Cesarean Section
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Shivering
Ondansetron
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2018-05-21
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Shivering is one of the most frequent complications occurring during or after spinal anesthesia with many side effects. The aim of the present study was to compare between two different doses of ondansetron for anti-shivering effect

Detailed description: Shivering is one of the most frequent complications occurring during or after spinal anesthesia, it affects about 40%-60 % of patients under spinal anesthesia. Intra and Post spinal shivering is distressing for the patients and anesthetist. Shivering may aggravate medical conditions in patients with limited cardiac or respiratory functions. It increases tissue oxygen demand many folds which in turn leads to increase the load on respiratory and cardiac systems to cope with increased aerobic metabolism. Shivering interferes with good patient monitoring by causing artifacts of electrocardiography, invasive and non-invasive blood pressure, pulse oximetry, etc... . Postoperatively shivering may cause discomfort to the patient, increases wound pain by stretching incision, increase the incidence of bleeding and infection.

We aim to compare the prophylactic use of two different doses of ondansetron on the incidence of shivering after spinal anesthesia in patients scheduled for lower limb surgery.

The primary outcome was percentage of patients suffering from shivering after spinal anesthesia, secondary outcomes include any side effects related to both doses.

Eligibility criteria: Inclusion Criteria:

* Age between 18-65 years
* Both sexes
* American Society of Anesthesiologists
* physical status I and II
* scheduled for lower limb surgery under spinal anesthesia

Exclusion Criteria:

* Uncooperative patients
* psychologically unstable patients
* obese patients with BMI \>30 preoperative use of ondansetron, or opioids Fever Patients with some clinical conditions like hypo- or hyperthyroidism, Parkinson's disease.

Primary outcomes:
measure: incidence of shivering
timeFrame: for 24 hours after spinal anesthesia
Secondary outcomes:
measure: Axillary temperature
timeFrame: for 24 hours after spinal anesthesia
measure: core temperature
timeFrame: for 24 hours after spinal anesthesia
measure: incidence of hypotension
timeFrame: for 24 hours after spinal anesthesia
measure: incidence of nausea and vomiting
timeFrame: for 24 hours after spinal anesthesia
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06318507: The Intestinal Microbiome in Triple Negative Breast Cancer Treated with Immunotherapy
Official title: The Intestinal Microbiome in Triple Negative Breast Cancer Treated with Immunotherapy
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Breast Neoplasms
Lead sponsor: Pennington Biomedical Research Center
Sponsor class: OTHER
First posted: 2024-03-19
Enrollment: 25
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population will consist of survivors of early triple-negative breast cancer.

Brief summary: This study will determine how the intestinal microbiome differs between patients with obesity and early triple-negative breast cancer who achieve a pathologic complete response from preoperative anti-PD-1 immunotherapy (pembrolizumab) versus patients who do not.


Eligibility criteria: Inclusion Criteria:

* Age ≥18 years
* Female biological sex
* Newly diagnosed, previously untreated, histologically confirmed early triple-negative breast cancer
* Plan to initiate preoperative anti-PD-1 immunotherapy using pembrolizumab
* Overweight or obesity, defined as a body mass index \>=25 kg/m2
* Ability to provide written informed consent
* Allow the collection and storage of biospecimens and data for future use

Exclusion Criteria:

* Active autoimmune disease
* Concomitant conditions that require the use of antibiotics (e.g., chronic sinusitis)
* Digestive disease disorders (e.g., irritable bowel syndrome, Crohn's disease)
* Currently pregnant, breastfeeding, or planning to become pregnant within the next 24 weeks
* Recent (within 90 days) use of glucocorticoids for more than 10 consecutive days
* Any other cardiovascular, pulmonary, orthopedic, neurologic, psychiatric, or other condition that, in the investigator's opinion, would preclude participation or successful compliance with the protocol
* Any other situation that, in the opinion of the investigator, would negatively impact subject safety or successful compliance with the protocol

Primary outcomes:
measure: Pathologic Complete Response (pCR)
timeFrame: Week 24
Secondary outcomes:
Other outcomes:
Locations:
city: Baton Rouge
country: United States
facility: Pennington Biomedical Research Center
state: Louisiana
Study officials:
References:
Clinical trial NCT03507907: The Effects of Mulligan Mobilization Technique in Older Adults With Neck Pain
Official title: The Effects of Mulligan Mobilization Technique in Older Adults With Neck Pain: A Randomized Controlled, Double-Blind Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neck Pain
Keywords: neck pain
older adults
mobilization
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2018-04-25
Enrollment: 40
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: When the literature is examined, there is study investigating the effect of mulligan mobilization technique on older adults with neck pain. This study aims to investigate the effect of mulligan mobilization technique on pain, range of motion, functional level, kinesiophobia, fear of movement, depression and quality of life in older adults with neck pain.

Detailed description: Neck pain is common in older adults. There are a lot of approaches for treatment of neck pain such as soft tıssue mobilizations, electirical stimulations etc. Mulligan proposes mobilization with movement (MWM) technique for various musculoskeletal disorders. But there is no study related MWM for older adults with neck pain. The purpose of this study is to examine the effect of mulligan mobilization technique on pain, range of motion (ROM), functional level, kinesiophobia, depression and quality of life (QoL) in older adults with neck pain. The hypothesis of our study is MWM can be effective on ROM, kinesiophobia, depression and QoL in older adults with neck pain.

Eligibility criteria: Inclusion Criteria:

* Ongoing neck pain for at least 3 months,
* Having no neurological, rheumatological or musculoskeletal problems
* Having not taken any analgesic medication for neck pain for the last 3 months.

Exclusion Criteria:

* Neck pain originating from various pathologies
* Presence of cord compression,
* Vertebrobasilar artery insufficiency,
* Severe radiculopathy,
* Osteoporosis or osteopenia (t score\>-1),
* Long-term use of anticoagulant or corticosteroid drugs,
* Patients who had received any treatment for their neck pain.

Primary outcomes:
measure: Visual Analogue Scale
timeFrame: 5 months
Secondary outcomes:
measure: Neck Disability Index
timeFrame: 5 months
measure: Tampa Scale of Kinesiophobia
timeFrame: 5 months
measure: Universal goniometer
timeFrame: 5 months
measure: Beck Depression Inventory
timeFrame: 5 months
measure: Short Form-36
timeFrame: 5 months
Other outcomes:
Locations:
city: Kırşehir
country: Turkey
facility: Ahi Evran University
Study officials:
References:
citation: Buyukturan O, Buyukturan B, Sas S, Kararti C, Ceylan I. The Effect of Mulligan Mobilization Technique in Older Adults with Neck Pain: A Randomized Controlled, Double-Blind Study. Pain Res Manag. 2018 May 15;2018:2856375. doi: 10.1155/2018/2856375. eCollection 2018.