louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05517928: A Study to Evaluate the Impact of Lactobacillus Rhamnosus GG on Proton Pump Inhibitor-Induced Gut Dysbiosis
Official title: Exploratory Study of the Impact of Lactobacillus Rhamnosus GG on Proton Pump Inhibitor-Induced Gut Dysbiosis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Healthy
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2022-08-26
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The purpose of this study is to investigate the impact of the probiotic Lactobacillus rhamnosus (LGG) on proton pump inhibitor (PPI)-induced changes to the microbes that live in the gastrointestinal tract and are passed out in the stool. PPI medicines reduce stomach acid and are commonly used to treat acid reflux disease.


Eligibility criteria: Inclusion Criteria:

* Individuals on an unrestricted regular diet with no dietary restrictions (vegan, low FODMAP, gluten free, dairy-free etc) or other fad diets (e.g., keto, intermittent fasting, etc.).
* Healthy subjects will be screened for current or chronic GI symptoms using a 16-item questionnaire.
* Only those with an absence of symptoms will eligible to participate.

Exclusion Criteria:

* For healthy volunteers, will include prior surgery altering the esophagus, stomach, and intestine (except appendectomy).
* Chronic daily use of medications affecting GI secretion or motor function.
* The presence of any GI-motility affecting systemic diseases or untreated psychiatric disease.
* Pregnancy.

Primary outcomes:
measure: Change in Observed Operational Taxonomic Unit (OTU) diversity.
timeFrame: Baseline, Day 56
Secondary outcomes:
measure: Adverse Events
timeFrame: 60 days
measure: Changes in Shannon diversity index.
timeFrame: Baseline, Day 56
measure: Changes in enrichment according to Kyoto Encyclopedia of Genes and Genomes (KEGG) pathways.
timeFrame: Baseline, Day 56
measure: Changes in taxa units.
timeFrame: Baseline, Day 56
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Mayo Clinic Arizona
state: Arizona
Study officials:
affiliation: Mayo Clinic
name: John DiBaise, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02815228: Sun Protection Factor Assay (SPF Assay 19009)
Official title: Sun Protection Factor (SPF) Assay: UVA Protection Factor Assay Minimal Persistent Pigment-Darkening Dose
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sunscreening Agents
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2016-06-28
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To evaluate the Sun Protection Factor efficacy on human skin.


Eligibility criteria: Inclusion Criteria:

* Fitzpatrick Skin Type l, ll and/or lll for UVB testing. Fitzpatrick Skin Type ll, lll and/or lV for UVA testing.
* Male and female.
* Aged between 18-70 years old.
* Good health as determined from the HRL SHF (Subject History Form).
* Signed and dated Informed Consent Form.
* Signed and dated HIPAA (Health Insurance Portability and Accountability Act) form.
* An unambiguous MED (Minimal Erythema Dose) or MPPD (Minimal Persistent Pigment Darkening Dose)

Exclusion Criteria:

* Subjects on test at any other research laboratory or clinic.
* Known allergy or sensitivity to sunscreens, cosmetics and toiletries, topical drugs and/or ultraviolet light.
* Pre-existing dermatologic conditions which have been diagnoses by a medical professional (e.g. psoriasis, eczema, etc.) which would interfere with this study.
* Pre-existing other medical conditions (e.g. adult asthma, diabetes).
* Treatment with antihistamines or corticosteroids within one week prior to initiation of the test.
* Treatment with antibiotics within two weeks prior to initiation of the test.
* Chronic medication which could affect the results of the study.
* Known pregnant or nursing women.

Primary outcomes:
measure: Minimal Erythema Dose (MED)
timeFrame: Up to 15 minutes
measure: Minimal Persistent Pigment Darkening Dose (MPPD)
timeFrame: Up to 15 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Union
country: United States
state: New Jersey
Study officials:
References:
Clinical trial NCT03363828: The Temporo-spatial Dynamics of Genital Tract Microbiota
Official title: The Temporo-spatial Dynamics of Genital Tract Microbiota - an Observational Study in IVF-Freeze All Patients Treated With Estradiol
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Infertility, Female
Lead sponsor: Regionshospitalet Viborg, Skive
Sponsor class: OTHER
Collaborators: name: Statens Serum Institut
First posted: 2017-12-06
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Infertile couples attending IVF treatment and referred to a segmentation protocol.

Brief summary: The investigators aim to examine the endometrium with state of the art sequencing techniques to investigate the endometrial microbiota. The endometrial microbiota has been perceived to be sterile, however, this seems incorrect from recent studies. Thus, the primary outcome is to compare the rate of ascending infection from the semen to the vagina to the endometrium and to investigate which bacteria are capable of inhabiting these environments. Furthermore, cervical mucus will be obtained in order to test for immunological, microbiological and mechanical properties that may be involved in ascending infection. Finally, the study aim to characterize the temporal changes in the vaginal microbiota during estrogenic treatment with Estrofem® or Vivelle Dot (R) for preparation of the endometrium prior to embryo transfer.


Eligibility criteria: Inclusion Criteria:

* Patients in IVF Freeze-all/segmentation treatment protocol.
* Written informed consent.

Exclusion Criteria:

* Uterine malformations
* HIV, Hepatitis B or C positivity. HPV CIN 2 or higher. Chlamydia trachomatis positivity.
* Any uncontrolled concomitant disease (e.g. uncontrolled diabetes, uncontrolled hypertension etc.)

Primary outcomes:
measure: Rate of ascending infection/sharing of bacteria in the genital tract
timeFrame: This outcome data is measured at the day of oocyte retrieval.
Secondary outcomes:
measure: Next generation sequencing techniques will be used to assess the vaginal microbiota.I.e. measure of relative abundances
timeFrame: Examined longitudinally throughout the segmentation cycle. The estimated time to event is 40 days from oocyte retrieval until frozen embryo transfer following a strict protocol.
measure: qPCR to assess the vaginal microbiota. I.e. a quantitative measure Copies/mL.
timeFrame: Examined longitudinally throughout the segmentation cycle. The estimated time to event is 40 days from oocyte retrieval until frozen embryo transfer following a strict protocol.
measure: Number of participants with a Clinical pregnancy
timeFrame: 7-9 weeks after inclusion.
measure: Number of participants with a Live birth
timeFrame: 36-42 weeks after inclusion
Other outcomes:
Locations:
city: Skive
country: Denmark
facility: The Fertility Clinic Skive
city: Skive
country: Denmark
facility: The Fertility Clinic, Regional Hospital of Skive
Study officials:
References:
Clinical trial NCT03293628: Comparing Two Techniques of Haemostasis After Cervical Conization
Official title: Randomized Clinical Trial Comparing Two Techniques of Haemostasis After Cervical Conization With High Frequency Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Cervical Intraepithelial Neoplasia
Cervix Neoplasm
Keywords: cervical intraepithelial neoplasia
haemostasis
vaginal pack
Loop electrical excision procedure
randomized clinical trials
uterine cervical neoplasm
Lead sponsor: Barretos Cancer Hospital
Sponsor class: OTHER
First posted: 2017-09-26
Enrollment: 100
Sex: FEMALE
Minimum age (years): 19
Maximum age (years): 68
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients were allocated in two arms (50 patients each): without vaginal pack (group 1 - GP1) and with vaginal pack (group 2 - GP2).Randomization was generated through a computer program creating a random entry list in the study, separating in group 1 (local application of Monsel's solution without intra-vaginal gauze buffer) and group 2 (application of Monsel's solution with intra-vaginal gauze). In this way, all patients had an equal chance of being included in both groups.
Primary purpose: TREATMENT

Brief summary: The LEEP conization is commonly used for cervical pathologies treatment. The techniques for hemostasis usually used are: cautery, Monsel's solution and vaginal pack. Actually, there is no consensus about the best technique and there is not much information that validates the use of some of that. To compare the use or not of vaginal pack as methods of hemostasis after LEEP conization for management of cervical lesions.

Detailed description: A randomized clinical trial was conducted at Gynecology Oncology Department/Barretos Cancer Hospital for patients with indication of LEEP conization. After local IRB approval, patients were allocated in two arms (50 patients each): without vaginal pack (group 1 - GP1) and with vaginal pack (group 2 - GP2). The Monsel's solution was used in all patients. Intraoperative and postoperative outcomes will be evaluated: operative time, intraoperative and postoperative bleeding, hormonal status, age, parity and cone specimens' characteristics as well as short-term outcome were recorded and compared using Chi-square test, Fisher exact test and t-test where appropriate.

Eligibility criteria: Inclusion Criteria:

* Indication of cervical conization.

Exclusion Criteria:

* We excluded patients who were not treated by our department physicians or if the patient did not return for follow-up.

Primary outcomes:
measure: Vaginal bleeding until 30 days after surgery
timeFrame: Until 30 days after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Barretos
country: Brazil
facility: Hospital do Câncer de Barretos
state: SP
Study officials:
affiliation: Hospital do Câncer de Barretos
name: Ricardo D Reis, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02335528: SimCoach Evaluation: A Virtual Human Intervention to Encourage Servicemember Help-seeking for PTSD and Depression
Official title: SimCoach Evaluation: A Virtual Human Intervention to Encourage Servicemember Help-seeking for PTSD and Depression
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post-traumatic Stress Disorder
Depression
Lead sponsor: RAND
Sponsor class: OTHER
First posted: 2015-01-09
Enrollment: 333
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: SimCoach, a computer program featuring a virtual human that speaks and gestures in a videogame-like interface, is designed to encourage servicemembers, especially those with signs or symptoms of post-traumatic stress disorder (PTSD) or depression, to seek help to improve their psychological health. The assessment included a formative component assessing SimCoach's design, development, and implementation approaches, as well as a summative component assessing outcomes among participants in a user experience survey and a randomized controlled trial (RCT).


Eligibility criteria: Inclusion Criteria:

* 18 years of age and
* active duty or Reserve servicemember or National Guard servicemember and
* being off duty

Exclusion Criteria:

* under the age of 18 years
* retired servicemember or not a servicemember
* currently on duty
* currently incarcerated, on parole, or on probation

Primary outcomes:
measure: Help-seeking intentions
timeFrame: within 30 days
measure: Perceived barriers to care
timeFrame: within 30 days
Secondary outcomes:
measure: User experience
timeFrame: Immediately following their interaction with SimCoach or online form (up to 5 min)
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03691428: Stress Reduction Study for Partners of Early Stage Dementia
Official title: A Daily Self-Regulation Intervention for Persons With Early Stage Alzheimer's Disease and Related Dementias and Their Spouses
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dementia Caregiving
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2018-10-01
Enrollment: 90
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: This is a study designed to pilot a WOOP (Wish Outcome Obstacle Plan) intervention for spouses of persons with early stage dementia for the purposes of future research. The investigators will be using two cohorts. One who will get the intervention and the other who will be wait listed and receive the intervention at a later date. Spouses of persons with dementia will use WOOP, a brief goal attainment sequence, every day for 16 days. Participants will complete surveys before the intervention, at Day 16, and at a 3-month follow-up. The outcome measures are goal attainment, emotion regulation skills, psychological health, and support quality. As of 9/2020 this entire study is being conducted remotely.


Eligibility criteria: Inclusion/Exclusion Criteria:

* The couple is married or in a cohabiting, committed relationship.
* One partner has early Adult Dementia (AD) or a related dementia using criteria: symptoms consistent with early-stage dementia or memory impairment (e.g., AD, vascular dementia) and scores on the Neuropsychiatric Inventory (NPI) ≥3; Mini-Mental State Examination (MMSE) ≥18 and ≤27; and Barthel Index (BI) ≥5 and ≤1923. Or\>20 on Telephone Interview for Cognitive Status. (TICS)
* The spouse will have to score 27 or higher on the MMSE. Or\>25 on TICS.
* Both participants must agree to participate and complete baseline interviews.
* Both partners are at least 60 years old.

Primary outcomes:
measure: Change in Perceived Stress
timeFrame: baseline, 3 months
measure: Change in Positive Affect
timeFrame: baseline, 3 months
measure: Change in Depressive Symptoms
timeFrame: baseline, 3 months
measure: Change in Quality of Life
timeFrame: baseline, 3 months
measure: Change in Negative Emotions
timeFrame: baseline, 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Joan Monin
state: Connecticut
Study officials:
References:
citation: Monin JK, Oettingen G, Laws H, David D, DeMatteo L, Marottoli R. A Controlled Pilot Study of the Wish Outcome Obstacle Plan Strategy for Spouses of Persons With Early-Stage Dementia. J Gerontol B Psychol Sci Soc Sci. 2022 Mar 3;77(3):513-524. doi: 10.1093/geronb/gbab115.
Clinical trial NCT03288428: Analgesia Comparison of Nalbuphine and Morphine for Laparoscopic Myomectomy
Official title: Analgesia Comparison of Nalbuphine and Morphine for Laparoscopic Myomectomy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Postoperative Pain
Lead sponsor: Peking University First Hospital
Sponsor class: OTHER
First posted: 2017-09-20
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: to compare the analgesia and side effect of nalbuphine and morphine for elective Laparoscopic myomectomy.

Detailed description: To compare the analgesia and side effect of nalbuphine and morphine for elective Laparoscopic myomectomy, by using patient controlled analgesia postoperatively, a randomized, double blind clinical trial. Patients undergoing elective Laparoscopic myomectomy are randomly divided into two groups: nalbuphine and morphine groups. All patients are under general anesthesia with routine methods. The nalbuphine group receive postoperative patient controlled analgesia using nalbuphine 30mg/120ml, while the morphine group receive postoperative patient controlled analgesia using morphine 60mg/120ml. Perioperative parameters are to be collected to compare the two groups.

Eligibility criteria: Inclusion Criteria:

* elective Laparoscopic myomectomy patients 24hr post-operative patient controlled analgesia analgesia no mild or severe liver or renal disfunction

Exclusion Criteria:

* can't understand patient controlled analgesia device refuse trial

Primary outcomes:
measure: numerical rating scale
timeFrame: 24 hr post-operatively
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: First hospital Peking University
state: Beijing
Study officials:
References:
Clinical trial NCT02156128: Subjective Memory Complaints, Objective Memory Performance and Cognitive Training
Official title: Study of Subjective Memory Complaints, Objective Memory Performance and Cognitive Training in Patients With Complex Symptom Disorders
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fatigue Syndrome, Chronic
Chronic Pain
Anxiety Disorders
Depressive Disorder
Sleep Disorders
Keywords: Cognitive therapy
Lead sponsor: Norwegian University of Science and Technology
Sponsor class: OTHER
First posted: 2014-06-05
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to examine if repetitive computerized cognitive training improves working memory in patients who are on sick leave due to complex symptom disorders (chronic pain, chronic fatigue, anxiety, depression and or sleep disorders), and whether effects of cognitive control training transfer to other tasks.


Eligibility criteria: Inclusion Criteria:

* on sick leave due to complex symptom disorders: chronic pain, chronic fatigue, anxiety, depression and/or sleep disorders
* on sick leave for at least eight weeks.

Exclusion Criteria:

* severe mental disorder
* acute psychosis
* ongoing manic episode
* suicidal ideation
* ongoing abuse of alcohol or any other substance.
* not able to communicate in Norwegian

Primary outcomes:
measure: Working memory capacity
timeFrame: 7 weeks
Secondary outcomes:
measure: Subjective memory complaints (SMC)
timeFrame: 7 weeks
measure: Transfer to inhibition
timeFrame: 7 weeks
Other outcomes:
Locations:
city: Trondheim
country: Norway
facility: NKSS Nasjonal kompetansetjeneste for sammensatte symptomlidelser
Study officials:
affiliation: Norwegian University of Science and Technology
name: Nils I Landrø, Prof
role: STUDY_DIRECTOR
References:
citation: Aasvik JK, Woodhouse A, Stiles TC, Jacobsen HB, Landmark T, Glette M, Borchgrevink PC, Landro NI. Effectiveness of Working Memory Training among Subjects Currently on Sick Leave Due to Complex Symptoms. Front Psychol. 2017 Jan 6;7:2003. doi: 10.3389/fpsyg.2016.02003. eCollection 2016.
Clinical trial NCT04276428: A Study of LY3209590 in Japanese Participants With Type 2 Diabetes Mellitus
Official title: A Multiple-Dose Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LY3209590 in Japanese Patients With Type 2 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2020-02-19
Enrollment: 28
Sex: ALL
Minimum age (years): 20
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The main purpose of this study is to evaluate the safety of a study drug known as LY3209590 in Japanese participants with type 2 diabetes. Side effects and tolerability will be documented. Blood samples will be taken to compare how the body handles the drug and how it affects blood sugar levels. The study will last almost five months for each participant.


Eligibility criteria: Inclusion Criteria:

* Have type 2 diabetes mellitus (T2DM) for at least 1 year
* Have received a stable daily dose of basal insulin at screening
* Have hemoglobin A1c (HbA1c) greater than or equal to (≥)6.5 percent (%) and less than or equal to (≤)10.0% at screening
* Have a body mass index greater than (\>)18.5 and ≤40.0 kilograms per square meter (kg/m²) at screening

Exclusion Criteria:

* Have received a total daily dose of insulin \>1.2 units per kilogram (U/kg) of body weight at screening
* Have received insulins except for basal insulins
* Have received sulfonylurea at more than half of the maximum approved dose level
* Have a history of multiple and/or severe allergies to drugs or foods or a history of severe anaphylactic reaction or history of significant atopy
* Have had more than 1 episode of severe hypoglycemia within 6 months before entry

Primary outcomes:
measure: Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
timeFrame: Baseline through Day 85
Secondary outcomes:
measure: Pharmacokinetics (PK): Area Under the Drug-Plasma-Concentration-Versus-Time Curve from Time Zero to 168 Hours Postdose (AUC[0-168]) of LY3209590
timeFrame: Predose on Day 1 through Day 85
measure: Pharmacodynamics (PD): Change from Baseline in Fasting Plasma Glucose
timeFrame: Day 1 through Day 85
Other outcomes:
Locations:
city: Shinjuku-ku
country: Japan
facility: Clinical Research Hospital Tokyo
state: Jp-13
city: Hachioji
country: Japan
facility: P-one clinic
state: Tokyo
city: Yokohama
country: Japan
facility: Yokohama Minoru Clinic
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: STUDY_DIRECTOR
References: