louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04912362: The Effectiveness of YAG Iridotomy in Preventing Peripheral Anterior Synechia After CLASS in Primary Open Angle Glaucoma
Official title: Effectiveness of YAG Laser Iridotomy in Preventing Peripheral Anterior Synechia After CO2 Laser-Assisted Sclerectomy Surgery in Primary Open Angle Glaucoma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Glaucoma, Open-angle
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
First posted: 2021-06-03
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: To investigate the effectiveness of YAG laser iridotomy in preventing peripheral anterior synechia after CO2 Laser-Assisted Sclerectomy Surgery and the long-term effect of reducing intraocular pressure

Detailed description: Group A: YAG laser iridotomy was performed one week before operation, followed by CO2 Laser-Assisted Sclerectomy Surgery; Group B: only CO2 Laser-Assisted Sclerectomy Surgery; The patients were followed up for 1 year to observe and compare the difference of the incidence of peripheral anterior synechia and the effect of long-term intraocular pressure control between the two groups.

Eligibility criteria: Inclusion Criteria:

* Primary open angle glaucoma patients in Ophthalmic Center;
* Topical use of hypotensive drugs in the treatment of poor or intolerable intraocular pressure control;
* The patients were 18 to 50 years old, regardless of gender;
* Class operation was performed;
* Patients are able and willing to comply with the research guidance and may complete all visits required by the research;
* Informed consent has been signed.

Exclusion Criteria:

* Allergic to any perioperative medication in this study;
* History of ocular trauma;
* Any previous intraocular surgery;
* Gonioscopy showed a narrow angle (Schaffer III or below);
* Secondary glaucoma was diagnosed;
* Optic atrophy caused by other reasons;
* Severe complications such as rupture of posterior capsule and choroidal hemorrhage occurred during operation;
* Patients with severe ocular complications after operation
* The patient's history indicated that he had severe dysfunction of heart, lung, liver and kidney;
* Women in pregnancy, lactation or planned pregnancy;
* The researchers believe that the patient's condition may put the patient at significant risk, may confuse the results of the study, or may significantly interfere with the patient's participation in the study.

Primary outcomes:
measure: Intraocular pressure
timeFrame: 1 year
measure: Peripheral anterior synechia
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Eye center, 2nd Affiliated Hospital, School of Medicine, Zhejiang University
state: Zhejiang
Study officials:
affiliation: 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
name: Kaijun Wang, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01519362: A Woman Suffered From Leukocytopenia and Widespread Migration After Polyacrylamide Hydrogel (PAAG) Injection in Epicranial Aponeurosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Complication
Keywords: Polyacrylamide hydrogel
leukocytopenia
migration
complication
epicranial aponeurosis
PAAG injection
Lead sponsor: The First Hospital of Jilin University
Sponsor class: OTHER
First posted: 2012-01-26
Enrollment: 1
Sex: FEMALE
Minimum age (years): 50
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: A 50-year-old lady had PAAG injected into her bilateral temporal epicranial aponeurosis for augmentation

Brief summary: Polyacrylamide hydrogel (PAAG) has been used as an injectable filler for soft tissue augmentation in different parts of the body , such as face, breast , or even penis for more than a decade . However, there are never reports about the application of a large amount of PAAG in epicranial aponeurosis to change the contour of the upper cranium accompanied with leukocytopenia. This fancy application turned out to be a disaster for the women who suffered from leukocytopenia , widespread migration of PAAG, recurrent swelling of the affected tissues and temporal pain changing with the temperature and the facial expression .


Eligibility criteria: Inclusion Criteria:

* PAAG injected into bilateral temporal epicranial aponeurosis

Exclusion Criteria:

* PAAG injected into other parts of the body

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02896062: Development and Evaluation of a Sleep-coaching Program
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Insomnia
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
First posted: 2016-09-12
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: In the present study, a 4-week sleep coaching program is developed and evaluated in members of the German armed Forces. The aim of the program is to provide an efficient tool to prevent sleep disorders, and to improve mild sleep disorders, with a special focus on insomnia.

Detailed description: In the present study, a sleep-coaching program for small groups of a maximum of eight participants is developed. The program is comprised of four different sessions and is provided to member of the German armed forces. One session lasts approximately 1.5 hours and sessions are applied on a weekly basis. Each session deals with a different topic, addressing all major categories of sleep disorders (insomnia, hypersomnia, circadian rhythm disorders, sleep-related breathing disorders) and teaching ways of self-help and information on when to seek medical treatment. The program is evaluated by a cross-over study design with treatment and waiting control groups. After the treatment group has finished the course, the waiting group attends the sleep coaching session. All subjects fill in sleep logs and several questionnaires prior to (t0) and after the treatment group has finished the sleep coaching (t1), after the waiting group has finished the course (t2), and in a 3-month follow-up session (t3). Furthermore, sleep is recorded according to the AASM-standard criteria for two consecutive nights each at the time-points t0, t1, and t2. Subjective and objective sleep quality will be compared across the time-points, and between groups. In total, at least 48 participants are included in study.

Eligibility criteria: Inclusion Criteria:

* subjectively impaired sleep quality
* member of the German armed forces

Exclusion Criteria:

* subjects with a clinically relevant psychiatric decease
* not able to give informed consent

Primary outcomes:
measure: subjective sleep quality assessed by PSQI
timeFrame: 5 months
Secondary outcomes:
measure: objective sleep quality assessed by PSG
timeFrame: 2 months
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Charité - University Medicine Berlin
Study officials:
References:
citation: Sauter C, Kowalski JT, Stein M, Rottger S, Danker-Hopfe H. Effects of a Workplace-Based Sleep Health Program on Sleep in Members of the German Armed Forces. J Clin Sleep Med. 2019 Mar 15;15(3):417-429. doi: 10.5664/jcsm.7666.
Clinical trial NCT04240262: Microwave Ablation for Leiomyoma
Official title: Prospective Observational Trial of Microwave Ablation for Leiomyoma (MYOMIC2)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Uterine Fibroid
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
First posted: 2020-01-27
Enrollment: 200
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: Women with symptoms from uterine fibroids

Brief summary: This prospective observational study aims to evaluate the effectiveness and acceptability of percutaneous or vaginal ultrasound guided microwave ablation for the treatment of symptoms related to uterine fibroids. We will include 200 women.


Eligibility criteria: Inclusion Criteria:

* premenopausal
* no future child wish
* acceptable risks for general anestesia or sedation
* willing to comply with protocol

Exclusion Criteria:

* current or future child wish
* bleeding disorder with increased risk of bleeding

Primary outcomes:
measure: Symptom severity of uterine fibroids
timeFrame: 6 months post treatment
Secondary outcomes:
measure: Quality of Life score
timeFrame: 6 months post treatment
measure: menstrual bleeding
timeFrame: 6 months post treatment
measure: acceptability
timeFrame: 2 hours post treatment and 6 months post treatment (+/- 2 weeks)
Other outcomes:
Locations:
city: Taby
country: Sweden
facility: Helena Kopp Kallner
Study officials:
References:
Clinical trial NCT00575562: Phase I Study of KRN330 Monoclonal Antibody in Patients With Colorectal Cancer
Official title: Phase I Study of KRN330 Monoclonal Antibody in Patients With Colorectal Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Colorectal Cancer
Lead sponsor: Kyowa Kirin Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2007-12-18
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The primary objective of this study is to assess the safety and tolerability of KRN330 in patients with relapsed or refractory advanced or metastatic colorectal cancer.


Eligibility criteria: Inclusion Criteria:

1. Have histologically confirmed colorectal cancer that is advanced or metastatic with measurable or assessable disease.
2. Are not candidates for a surgically curative procedure.
3. Have progressed despite, are intolerant of, or are not appropriate for current therapies.

Exclusion Criteria:

1. Have an active, uncontrolled infection.
2. Have known or suspected cerebral metastasis.
3. Have had a myocardial infarction (MI) or cerebrovascular accident (CVA) within the last 6 months; or meet the criteria for AHA class III or IV congestive heart failure (CHF).
4. Have any significant concurrent disease or illness that would interfere with the interpretation of study results.
5. Pregnant or breastfeeding women and male or female patients who do not agree to use effective contraceptive method(s) during the study.

   -

Primary outcomes:
measure: The primary objective of this study is to assess the safety and tolerability of KRN330 in patients with relapsed or refractory advanced or metastatic colorectal cancer.
timeFrame: For up to12 weeks
Secondary outcomes:
measure: The secondary objectives are to determine the degree of immunogenicity, gain information on the pharmacokinetic profile, assess the anti-tumor effects of KRN330 and determine the maximum tolerated dose (MTD).
timeFrame: For up to12 weeks
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Sarah Cannon Research Institute
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt-Ingram Cancer Center
state: Tennessee
Study officials:
affiliation: Ingram Professor of Cancer Research, Vanderbilt University
name: Jordan Berlin, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: SCRI Development Innovations, LLC
name: Howard A Burris, III, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05509062: Establishing Guidelines for Manual Lymphatic Drainage
Official title: Establishing Guidelines for Manual Lymphatic Drainage
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lymphedema of Leg
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
First posted: 2022-08-19
Enrollment: 64
Sex: ALL
Minimum age (years): 30
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Treatment Group 1 Treatment Group 2 Treatment Group 3
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to establish optimal guidelines for Manual Lymphatic Drainage in participants with lower extremity lymphedema.

Detailed description: To determine if there is a difference in L-Dex Score and Segmental Limb Volume in participants with lower extremity lymphedema as measured in liters by the SOZO machine between participants who receive Manual Lymphatic Drainage (MLD) techniques utilizing light tactile pressure with 5-10 mmHg without skin stretch versus medium tactile pressure of 11-20 mmHg and medium skin stretch with therapist in a stationary position, versus firm tactile pressure (\> 21 mmHg) and maximal skin stretch with therapist weight shift.

Eligibility criteria: Inclusion Criteria:

* All adults between the age of 30 - 75 years
* Lower extremity lymphedema

Exclusion Criteria:

* Pregnant women
* Participants who are unable to stand independently for up to 2 mins
* Participants who cannot make their own decisions
* Participants undergoing cancer treatment
* Participants with an Infection (active cellulitis)
* Participants with a known Iodine Allergy
* Participants who weigh more than 375 lbs
* Participants with cardiac arrhythmias or implanted electronic equipment
* Participants who have undergone joint replacement in involved extremity
* Participants with cardiac insufficiency

Primary outcomes:
measure: Change in The L-dex (Lymphedema Index).
timeFrame: 18 months
Secondary outcomes:
measure: Change in Total body weight in liters
timeFrame: 18 Months
measure: Change in Extracellular Fluid in liters
timeFrame: 18 months
measure: Change in Intracellular Fluid in liters
timeFrame: 18 Months
measure: Change in Skeletal Muscle Mass in lbs
timeFrame: 18 Months
measure: Change in Fat Mass in lbs
timeFrame: 18 Months
measure: Change in Free Fat Mass in lbs
timeFrame: 18 Months
measure: Change in Basal Metabolic Rate (BMR) in lbs
timeFrame: 18 Months
measure: Change in Basal Metabolic Rate in kg/m^2
timeFrame: 18 months
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado Anschutz Medical Campus
state: Colorado
Study officials:
affiliation: University of Colorado Denver | Anschutz
name: Marco Del Chiaro
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00722462: The Effect of Acupuncture on Pregnancy Rates in Women Undergoing Embryo Transfer
Official title: The Effect of Acupuncture on Pregnancy Rates in Women Undergoing Embryo Transfer After in Vitro Fertilization: A Prospective Randomized Sham-controlled Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Pregnancy
Keywords: Infertility
IVF
Acupuncture
Lead sponsor: Ottawa Fertility Centre
Sponsor class: OTHER
First posted: 2008-07-25
Enrollment: 30
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The present study is designed to test the hypothesis that acupuncture, before and after embryo transfer, significantly improves pregnancy rates, compared to embryo transfer with sham acupuncture and no acupuncture at all.


Eligibility criteria: Inclusion Criteria:

* patient is undergoing embryo transfer after IVF or ICSI
* patient has given informed consent to participate

Exclusion Criteria:

* frozen embryo transfer
* previous enrollment in study

Primary outcomes:
measure: Clinical Pregnancy
timeFrame: 4-5 weeks after treatment
Secondary outcomes:
measure: Live birth
timeFrame: 9 months after treatment
measure: Implantation rate
timeFrame: 4-5 weeks after treatment
measure: Side effects with acupuncture treatment
timeFrame: 2 weeks after treatment
Other outcomes:
Locations:
city: Ottawa
country: Canada
facility: Ottawa Fertility Centre
state: Ontario
Study officials:
affiliation: Ottawa Fertility Centre
name: Arthur Leader, MD
role: STUDY_CHAIR
affiliation: Ottawa Fertility Centre
name: Doron Shmorgun, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04067362: Chicory Fiber Effect on Satiety and GI Tolerance
Official title: The Effects of 2 Inulin Sources on Satiety and Gastrointestinal Tolerance
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Diet, Healthy
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2019-08-26
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: The investigators are comparing 2 fiber treatments to a fiber free treatment for acute satiety and GI response.

Detailed description: The investigators are measuring satiety and GI response after subjects consume 3 acute breakfast meals: 1. fiber-free control; 2. chicory root flour containing inulin; 3. inulin fiber supplement. After breakfast, subjects will complete subjective satiety instruments and describe any GI symptoms.

Eligibility criteria: Inclusion Criteria:

no food allergies; healthy; willing to consume breakfast in laboratory setting; usual low fiber diet;

Exclusion Criteria:

smokers, taking dietary supplements containing fiber

-

Primary outcomes:
measure: satiety
timeFrame: 2 hours
Secondary outcomes:
measure: Gastrointestinal response
timeFrame: 24 hours
Other outcomes:
Locations:
city: Saint Paul
country: United States
facility: University of Minnesota
state: Minnesota
Study officials:
References:
Clinical trial NCT00948662: Study Evaluating The Safety And Tolerability Of Administration Of Single Oral Doses Of SAM-760 To Healthy Subjects
Official title: Ascending Single Dose Study Of The Safety, Tolerability And Pharmacokinetics Of SAM-760 Administered Orally To Healthy Young And Healthy Elderly Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Safety
tolerability
ascending single doses
healthy subjects
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2009-07-29
Enrollment: 124
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: This study will assess the safety and tolerability of ascending single oral doses of SAM-760 in healthy young adult and healthy elderly subjects. The secondary objectives are to provide the concentrations of SAM-760 in the blood and to evaluate the effect of a high-fat meal on the concentrations in the blood of SAM-760 administered to healthy young adult subjects, and to evaluate the effects of concomitant administration of ketoconazole on the safety and the concentrations of SAM-760 in the blood of a single dose of SAM-760 in healthy young adult subjects.


Eligibility criteria: Inclusion Criteria:

* Men or women of non-childbearing potential aged 18 to 50 years inclusive (healthy young subjects) and \> 65 years (healthy elderly subjects) at screening.
* Body mass index (BMI) in the range of 18 to 32 kg/m2 and body weight \>= 50 kg.

Exclusion Criteria:

* Presence or history of any disorder that may prevent the successful completion of the study.
* Any surgical or medical condition that may interfere with the absorption, distribution, metabolism, or excretion of the investigational drug or placebo.

Primary outcomes:
measure: Number of participants with adverse events as a measure of safety and tolerability.
timeFrame: 5 days
Secondary outcomes:
measure: Maximum concentration (Cmax) for PF-05212377 over time.
timeFrame: 5 days
measure: Measurement of Area Under the curve (AUC) for PF-05212377.
timeFrame: 5 days
measure: Time of maximum (Tmax) concentration of PF-05212377 in plasma.
timeFrame: 5 days
measure: Elimination half life (t1/2) of PF-05212377.
timeFrame: 5 days
Other outcomes:
Locations:
city: Rueil Malmaison
country: France
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT05004662: Partnering With Food Bank to Provide Tobacco Treatment to Underserved Smokers
Official title: Partnering With a State Food Bank to Provide Tobacco Treatment to Underserved Smokers (Project NOURISH)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Smoking Cessation
Lead sponsor: H. Lee Moffitt Cancer Center and Research Institute
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2021-08-13
Enrollment: 520
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study will evaluate the efficacy and economic impact of a theoretically-based, fully automated, interactive smartphone-based smoking cessation intervention.


Eligibility criteria: Inclusion Criteria:

* \>100 lifetime cigarettes
* English or Spanish speaking
* Currently smoke \> 5 cigarettes/day
* Process a smartphone compatible with the project app
* Have a valid email address

Exclusion Criteria:

* Currently pregnant or breastfeeding
* Current use of smoking cessation medications
* Enrolled in a smoking cessation study
* Household member enrolled in the study
* Failure to electronically confirm participation with 14 days of randomization via electronic link sent to participant's smartphone

Primary outcomes:
measure: Self Reported 7 Day Abstinence Smoking Status
timeFrame: 12 Month Follow-Up
Secondary outcomes:
measure: Smoking Status by Saliva Cotinine Kit
timeFrame: 12 Month Follow-Up
measure: Self Reported 24 Hours Smoking Abstinence
timeFrame: 12 Month Follow-Up
measure: 30 Day Smoking Abstinence
timeFrame: 12 Month Follow-Up
measure: Continuous Smoking Abstinence
timeFrame: 12 Month Follow-Up
Other outcomes:
Locations:
city: Tampa
country: United States
facility: Moffitt Cancer Center
state: Florida
Study officials:
affiliation: Moffitt Cancer Center
name: Damon J Vidrine, Dr.PH
role: PRINCIPAL_INVESTIGATOR
affiliation: Moffitt Cancer Center
name: Jennifer I Vidrine, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Vidrine JI, Shih YT, Businelle MS, Sutton SK, Hoover DS, Cottrell-Daniels C, Fennell BS, Bowles KE, Vidrine DJ. Comparison of an automated smartphone-based smoking cessation intervention versus standard quitline-delivered treatment among underserved smokers: protocol for a randomized controlled trial. BMC Public Health. 2022 Mar 22;22(1):563. doi: 10.1186/s12889-022-12840-7.