louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01398241: A Study of RO5267683 in Healthy Subjects
Official title: Assessment of Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of RO5267683 in an Adaptive, Randomized, Investigator-blind and Subject-blind, Multiple-ascending Dose, Placebo-controlled, Study Following Oral Administrations in Healthy Subjects for 28 Days
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteer
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2011-07-20
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: This investigator-blind, subject-blind, randomized, placebo-controlled study will evaluate the safety, pharmacokinetics and pharmacodynamics of multiple ascending doses of RO5267683 in healthy volunteers. Subjects will be randomized to receive either RO5267683 or placebo orally daily for 28 days. Follow-up will be 10 weeks after the last dose.


Eligibility criteria: Inclusion Criteria:

* Healthy male and female subjects, 18 to 45 years of age,
* Body mass index (BMI) 18 to 30 kg/m2 inclusive, and a minimum weight of 50 kg at screening
* Female subjects must be surgically sterile or post-menopausal
* Male subjects must use a barrier method of contraception for the duration of the study and for 90 days after the last dose

Exclusion Criteria:

* History or evidence of any clinically significant disease or disorder
* Administration of an investigational drug or device within 3 months prior to dosing on Day 1
* Positive for hepatitis B, hepatitis C or HIV at screening
* Subjects on hormone replacement therapy who have not been receiving a stable dose for at least 2 months prior to start of dosing

Primary outcomes:
measure: Safety: Incidence of adverse events
timeFrame: 14 weeks
Secondary outcomes:
measure: Pharmacokinetics: Plasma concentrations
timeFrame: 14 weeks
measure: Pharmacokinetics: Urine concentrations
timeFrame: 4 weeks
measure: Lipid levels in the blood
timeFrame: 14 weeks
Other outcomes:
Locations:
city: Strasbourg
country: France
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT01920841: A Blinded Comparison Trial of Two Topical Creams to Reduce Thigh Girth and to Smooth Thigh Skin in Women
Official title: A Blinded Comparison Trial of Two Topical Creams to Reduce Thigh Girth and to Smooth Thigh Skin in Women.
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Weight Loss
Keywords: lipolytic
herbal extracts
thigh girth
thigh smoothness
Lead sponsor: Pennington Biomedical Research Center
Sponsor class: OTHER
Collaborators: name: Nerium Biotechnology Inc
First posted: 2013-08-12
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 52
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate efficacy of two lipolytic creams differing in their bases and demonstrate that their herbal ingredients can reduce the size of the thigh and smooth the appearance of the thigh skin. It is hypothesized that creams with two different cream bases containing herbal products that stimulate the lipolytic process through stimulation of the beta-adrenergic receptor, with one cream base applied to each thigh daily 5 days a week for 4 weeks will reduce thigh girth and smooth the thigh skin compared to baseline.

Detailed description: Participants will apply one cream (A) to one thigh and the second cream (B) to the other thigh under the supervision of a female clinic staff. The thigh to which each cream will be applied will be selected randomly, but half of the subjects will have cream A on the right thigh and cream B on the opposite thigh while the other half of the subjects will have the sides reversed. To evaluate the primary endpoint, both thighs will be measured at baseline and at the end of each treatment week, and the secondary endpoint will be assessed with standardized pictures of each thigh at baseline and on the last day of the fourth week which will end the study.

Eligibility criteria: Inclusion Criteria:

* Women who feel that their thighs are too large and the skin is insufficiently smooth.

Exclusion Criteria:

* Pregnant or nursing

Primary outcomes:
measure: Difference in girth of the two thighs from baseline over the course of the treatment period
timeFrame: Four weeks
Secondary outcomes:
measure: Smoothness of the skin on the thighs treated with the two lipolytic creams differing in their bases compared to baseline using standardized photographs at baseline and at the end of the treatment.
timeFrame: Four weeks
measure: Adverse events
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Baton Rouge
country: United States
facility: Pennington Biomedical Research Center
state: Louisiana
Study officials:
affiliation: Pennington Biomedical Research Center
name: Frank L Greenway, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03314441: Effects of Regular Practice of Yoga on Subjective and Objective Sleep Quality in Primary Insomnia
Official title: Effects of Regular Practice of Yoga on Subjective and Objective Sleep Quality in Primary Insomnia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Primary Insomnia
Keywords: yoga
sleep quality
sleep quantity
sleep efficiency
insomnia
Lead sponsor: Centre Hospitalier Universitaire Saint Pierre
Sponsor class: OTHER
First posted: 2017-10-19
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 4 yoga lessons with and instructors on a 3 months period. Patients are asked to exercise yoga daily for 5 to 30 minutes.
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to assess the effects of regular Viniyoga in patients suffering from primary insomnia.

Detailed description: Insomnia is very prevalent in Europe (14-27%). Cognitive behavioral therapy is the treatment of choice in patients suffering from primary insomnia, allowing to obtain a long term (2 years) sleep quality improvements in 62% of patients. Yoga is another behavioral therapy that have shown benefits in patients suffering from anxiety disorders. Few studies have been focused on yoga benefits in sleep disorders. The purpose of the study is to assess the effects of regular Viniyoga on sleep quality (subjective and objective) in patients suffering from primary insomnia.

Eligibility criteria: Inclusion Criteria:

-primary insomnia

Exclusion Criteria:

* shift work,
* associated sleep disorder (sleep apnea, narcolepsy,..)

Primary outcomes:
measure: total sleep time
timeFrame: 3 months
Secondary outcomes:
measure: sleep latency
timeFrame: 3 months
measure: sleep efficiency
timeFrame: 3 months
measure: wake after sleep onset
timeFrame: 3 months
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: CHu Saint Pierre
Study officials:
affiliation: CHU St Pierre
name: Marie Bruyneel, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Turmel D, Carlier S, Bruyneel AV, Bruyneel M. Tailored individual Yoga practice improves sleep quality, fatigue, anxiety, and depression in chronic insomnia disorder. BMC Psychiatry. 2022 Apr 14;22(1):267. doi: 10.1186/s12888-022-03936-w.
Clinical trial NCT06910241: Lidocaine Versus Diphenhydramine to Achieve Local Anesthesia for Laceration Repairs
Official title: Lidocaine Versus Diphenhydramine to Achieve Local Anesthesia for Laceration Repairs
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE3
Conditions: Laceration of Skin
Lead sponsor: Florida Atlantic University
Sponsor class: OTHER
Collaborators: name: Baptist Health South Florida
First posted: 2025-04-04
Enrollment: 100
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: Diphenhydramine, when injected locally, has been shown to achieve a certain level of local anesthesia. It has been documented for use in simple bedside procedures, however there is a gap in knowledge in its comparison to lidocaine. The purpose of the study is to determine if local infiltration of diphenhydramine is noninferior to the use of lidocaine 1% when trying to achieve local anesthesia for simple laceration repair. Patients who present to the emergency department with a simple laceration will be enrolled in the study. Patients will be evaluated for the pain of the injection as well as the pain of the laceration repair procedure post injection.


Eligibility criteria: Inclusion Criteria:

* Lacerations requiring one layer of sutures
* Lacerations appropriate for repair by emergency physicians

Exclusion Criteria:

* Active bleeding from laceration
* Complex lacerations requiring multiple layers
* Lacerations to be repaired by a specialist service
* Patients with allergies to either diphenhydramine or lidocaine
* Laceration repairs would benefit from the use of epinephrine as an additive to the local anesthetic

Primary outcomes:
measure: Sensation reduction
timeFrame: Measurements will be recorded before drug injection and immediately after laceration repair.
Secondary outcomes:
measure: Anesthesia satisfaction by patient
timeFrame: Immediately after laceration repair
measure: Anesthesia satisfaction by physician
timeFrame: Immediately after laceration repair
Other outcomes:
Locations:
city: Boynton Beach
country: United States
facility: Bethesda Hospital East
state: Florida
Study officials:
References:
Clinical trial NCT03092141: Physical Training in Patients With Relapsing Polychondritis
Official title: Physical Training in Patients With Relapsing Polychondritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Physical Activity
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2017-03-27
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: Patients will submitted to physical training (12-weeks, twice/week)
Primary purpose: TREATMENT

Brief summary: Physical training may improve physical capacity and health parameters in various systemic autoimmune diseases. Therefore, the present study will assess the role of an exercise training program in patients with relapsing polychondritis.

Detailed description: Impact of physical training in patients with relapsing polychondritis.

Eligibility criteria: Inclusion Criteria:

* Fullfill the classification criteria of McADAM et al. (1976)
* Using prednisone ≤ 0.5 mg/kg/day in the last three months
* Sedentary

Exclusion Criteria:

* Disease relapsing
* Overlapping disease
* Chronic and/or current infections (viral, bacterial or fungal)
* Patients undergoing major surgery within six months before the study
* With commitment to ambulation (joint affection in limbs)
* Smoking
* Diabetes mellitus

Primary outcomes:
measure: Cardiopulmonary test
timeFrame: 12 weeks
Secondary outcomes:
measure: Strength muscle tests
timeFrame: 12 weeks
measure: Healthy Assessment Questionnaire (HAQ)
timeFrame: 12 weeks
measure: Functional muscle tests
timeFrame: 12 weeks
measure: Muscle biopsy
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Samuel Katsuyuki Shinjo
Study officials:
affiliation: University of Sao Paulo
name: Samuel K Shinjo, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03396341: Responses to Genetic Risk Modifier Testing Among Women With BRCA1/2 Mutations
Official title: Responses to Genetic Risk Modifier Testing Among Women With BRCA1/2 Mutations
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Genetic Testing
BRCA1/2
Keywords: BRCA1/2 Mutations
17-489
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
Collaborators: name: Phenogen Sciences
First posted: 2018-01-10
Enrollment: 400
Sex: FEMALE
Minimum age (years): 25
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Potential participants (i.e., patients receiving a positive BRCA1/2 mutation result) will be identified and approached by their primary genetic counselor.

Brief summary: The purpose of this study is to describe how women with BRCA1/2 mutations react to genetic risk modifier testing, and to examine how they make decisions about their healthcare.


Eligibility criteria: Inclusion Criteria:

* Female patient, age 25 years or older (given that women under this age are not generally recommended to receive BRCA1/2 genetic testing)
* Completed full sequence or targeted genetic testing with a clinically confirmed BRCA1 or BRCA2 deleterious mutation identified
* No personal history of breast cancer
* English-fluent; the surveys were designed and validated in English and are not currently available in other languages. Translation of questionnaires into other languages would require reestablishing the reliability and validity of these measures. Therefore, participants must be able to communicate in English to complete the surveys.

Exclusion Criteria:

* Previous receipt of any prophylactic mastectomy.
* Major psychiatric illness or cognitive impairment that in the judgment of the study investigators or study staff would preclude study participation.
* Any patients who are unable to comply with the study procedures as determined by the study investigators or study staff.

Primary outcomes:
measure: number of patients that opt for preventive mastectomy or to pursue surveillance
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Dana Farber Cancer Institute (Data Collection Only)
state: Massachusetts
city: Basking Ridge
country: United States
facility: Memorial Sloan-Kettering at Basking Ridge
state: New Jersey
city: Commack
country: United States
facility: Memorial Sloan Kettering Commack
state: New York
city: Harrison
country: United States
facility: Memorial Sloan Kettering Westchester
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
city: Uniondale
country: United States
facility: Memorial Sloan Kettering Nassau
state: New York
city: Philadelphia
country: United States
facility: Abramson Cancer Center at University of Pennsylvania Medical Center (Data Collection Only)
state: Pennsylvania
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Jada Hamilton, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01812941: Evaluation of Mitochondrial Dysfunction in Severe Burn and Trauma Patients
Official title: Evaluation of Mitochondrial Dysfunction in Severe Burn and Trauma Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Burns
Trauma
Keywords: burns
trauma
Lead sponsor: University of South Alabama
Sponsor class: OTHER
First posted: 2013-03-18
Enrollment: 50
Sex: ALL
Minimum age (years): 19
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this project is to evaluate the level of mitochondrial dysfunction several patient populations: Burn, trauma, and control group of healthy volunteers.

Study hypothesis: Increased plasma concentrations of a newly discovered inflammatory mediated, called mtDNA DAMPS associated with the occurrence of multi-organ dysfunction syndrome in severly injured patients.

As the severity of a burn injury or trauma injury increase, so will systemic mitochondrial dysfunction.

Detailed description: Increased plasma concentrations of a newly discovered inflammatory mediated, called mtDNA DAMPS associated with the occurrence of multi-organ dysfunction syndrome in severly injured patients.

A normal healthy sub-population will be used as a control.

Eligibility criteria: Inclusion Criteria:

* Burn injury must be less than 24 hours old at time of initial sampling
* Burn must be 2nd or 3rd degree and at least 10% TBSA
* ISS (injury severity score) \> 15

Exclusion Criteria:

* Burn injury/trauma injury \> than 24hours old at time of initial sampling
* Burn \< 10% total body surface area.
* Evidence of active infection on admission in the burn subjects.
* \< 19 years of age and \> 70 years

Primary outcomes:
measure: Plasma mtDNA DAMPs concentration
timeFrame: approximately 1 year to assess outcome measure
Secondary outcomes:
Other outcomes:
Locations:
city: Mobile
country: United States
facility: University of South Alabama Medical Center
state: Alabama
Study officials:
affiliation: University of South Alabama, Department of Surgery
name: Jon Simmons, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Simmons JD, Lee YL, Mulekar S, Kuck JL, Brevard SB, Gonzalez RP, Gillespie MN, Richards WO. Elevated levels of plasma mitochondrial DNA DAMPs are linked to clinical outcome in severely injured human subjects. Ann Surg. 2013 Oct;258(4):591-6; discussion 596-8. doi: 10.1097/SLA.0b013e3182a4ea46.
Clinical trial NCT00941941: Non-Mesh Versus Mesh Method for Inguinal Hernia Repair
Official title: Comparison of Non-mesh (Desarda) and Mesh (Lichtenstein) Methods for Inguinal Hernia Repair at Mulago Hospital: a Double-blind Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hernia, Inguinal
Keywords: Inguinal
Hernia
Hernia-repair
Non-mesh
Mesh
Desarda
Lichtenstein
Lead sponsor: Makerere University
Sponsor class: OTHER
Collaborators: name: Mulago Hospital, Uganda
First posted: 2009-07-20
Enrollment: 98
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study aims at establishing the effectiveness of the non-mesh (Desarda) technique for the treatment of primary inguinal hernias at Mulago Hospital in Uganda. First developed and used in India, the Desarda method is reported to offer superior outcomes such as minimal postoperative groin pain and near zero recurrence rates. In comparison to the mesh-based repairs, it is a simple and affordable technique suitable for the resource-constrained communities. It is devoid of complications associated with foreign body implants. Early clinical outcomes which include acute groin pain, time to resumption of normal gait, operative time and complications will be assessed. Participants will be followed at 2 hours, 3 days, 7 days and 14 days postoperatively.

The investigators hypothesize that the mean postoperative acute groin pain score, or the mean postoperative day of return to normal gait is different in adult patients who undergo the non-mesh (Desarda) repair from what it is in those who undergo the mesh (Lichtenstein) technique of hernia repair.


Eligibility criteria: Inclusion Criteria:

* Aged 18 and above;
* with a primary, reducible inguinal or inguino-scrotal hernia;
* who consent to participate in the study;
* who have a telephone contact.

Exclusion Criteria:

* Giant inguino-scrotal hernias;
* Obstructive uropathy or chronic obstructive pulmonary disease;
* Impaired mental state and are unable to give an accurate assessment of the key outcomes of the operation.

Primary outcomes:
measure: Acute groin pain after surgery (measured on pain visual analogue scale of 0-10)
timeFrame: 2 Weeks
measure: Time (in days) taken to return to normal gait
timeFrame: 2 Weeks
Secondary outcomes:
measure: Operative time (in Minutes)
timeFrame: 2 hours
measure: Complications during and after surgery
timeFrame: 2 Weeks
Other outcomes:
Locations:
city: Kampala
country: Uganda
facility: Mulago National Referral Hospital
state: Central
Study officials:
affiliation: Makerere University
name: William Manyilirah
role: PRINCIPAL_INVESTIGATOR
affiliation: Makerere University
name: Alex Upoki
role: STUDY_CHAIR
References:
Clinical trial NCT02555241: Emergence of Generative Language
Official title: Instructional Programming to Promote the Emergence of Generative Language in Children With Autism Spectrum Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Autism Spectrum Disorder
Keywords: ASD, Children
Lead sponsor: Emory University
Sponsor class: OTHER
First posted: 2015-09-21
Enrollment: 9
Sex: ALL
Minimum age (years): 4
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to investigate the effects of several applied behavior teaching procedures on the use of multi-word utterances by children with autism.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of Autism Spectrum Disorder (ASD)
* Provide a diagnostic report confirming a diagnosis of ASD and/or obtain a total raw score of 15 or greater on the Social Questionnaire Lifetime Form (SCQ)
* Speaks primarily in one word utterances
* English as their primary language
* Follows simple 1-step instructions
* Transportation/availability to attend 3, 1-hour sessions each week for 12 weeks

Exclusion Criteria:

* Children with significant problem behavior that interferes with structured intervention

Primary outcomes:
measure: Change in Mean Length of Utterances (MLU) during manding
timeFrame: Baseline (Up to 24 Weeks), End of Standard Treatment (Up to 36 weeks)
measure: Acquisition of noun-verb and color-shape combinations during tacting
timeFrame: Baseline (Up to 24 Weeks), End of Standard Treatment (Up to 36 weeks)
measure: Emergence of intraverbal responses
timeFrame: Baseline (Up to 24 Weeks), End of Standard Treatment (Up to 36 weeks)
Secondary outcomes:
measure: Change in Macarthur Bates-Communicative Development Inventory (CDI) Score
timeFrame: Baseline (Up to 24 Weeks), End of Standard Treatment (Up to 36 weeks)
measure: Observe overall improvements in pragmatic language within social/play interactions with parents/caregivers, as measured on the Direct Observation of Spoken Language (DOSL).
timeFrame: Baseline (Up to 24 Weeks), End of Standard Treatment (Up to 36 weeks)
Other outcomes:
Locations:
Study officials:
affiliation: Emory University Assistant Professor
name: Alice Shillingsburg
role: PRINCIPAL_INVESTIGATOR
References: