louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05208034: Medical Treatment in Ectopic Tubal Pregnancy
Official title: Treatment Success With Two Doses of Methotrexate vs Single Dose of Methotrexate in Ectopic Tubal Pregnancy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ectopic Pregnancy
Lead sponsor: Nishtar Medical University
Sponsor class: OTHER
First posted: 2022-01-26
Enrollment: 100
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trial
Primary purpose: TREATMENT

Brief summary: Ectopic pregnancy (EP) is estimated to be responsible for approximately 20% of all pregnancy-related mortality and 46% early pregnancy mortality.1 Hemodynamically stable women with EP are frequently managed with methotrexate (MTX) while multiple protocols like fixed multiple doses, single-dose as well as two-dose regimens have been in practice for treating EP, but no consensus exists regarding the optimum dosage regimen.

Detailed description: Literature reports multiple dosage regimens of MTX to be associated with increased rates of side effects. Single dose protocol has good compliance and fewer side effects but is linked with lower success rates in comparison to multiple dose protocols.

A new treatment protocol involving "two-doses" of MTX for medical management of EP was introduced in 2007 but most of the research conducted so far has been retrospective in nature and limitations in study designs. No such study in recent years has been done in Pakistan to compare the success and safety of single-dose and two-dose MTX protocols so this study was planned to compare the success rates and safety of two-doses of MTX versus single dose of MTX in tubal EP.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of tubal ectopic pregnancy.
* Pre-treatment beta-human chorionic gonadotrophin (β-hCG) level below 1500 mIU/ml.
* Gestational sac with largest diameter as 4cm.
* Willing to take methotrexate treatment.
* Willing to follow up.

Exclusion Criteria:

* Heterotrophic pregnancy
* Persistent tubal pregnancy
* Embryonic cardiac motion
* Suspected tubal rupture
* Past history of harmful effects of methotrexate treatment on organ functions.

Primary outcomes:
measure: success rate
timeFrame: 4-14 days
Secondary outcomes:
measure: frequency of Side-effects of treatment
timeFrame: 1-14 days
measure: β-hCG Resolution Time
timeFrame: 1-14 days
Other outcomes:
Locations:
city: Multān
country: Pakistan
facility: Nishtar Medical University Hospital
state: Pu
Study officials:
affiliation: Nishtar Medical University
name: Rashida Parveen, FCPS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00908934: AZD9056 Relative Bioavailability Study
Official title: An Open-label, Randomized, 2 Cohort, 2 Period Crossover Study to Assess the Relative Bioavailability of the Phase III to the Phase IIb Formulation of AZD9056 in Healthy Male and Female Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Relative Bioavailability
AZD9056
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2009-05-27
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: The aims of this study are to compare the blood levels achieved with a new formulation of AZD9056 to an existing formulation of AZD9056 used in previous studies.


Eligibility criteria: Inclusion Criteria:

* Provision of informed consent prior to any study-specific procedures
* Healthy Volunteers, Females should not be of childbearing potential
* BMI between 18 and 30 kg/m2

Exclusion Criteria:

* Clinically significant ECG abnormality suggestive of underlying cardiovascular disease
* A history or presence of GI, hepatic or renal disease or other condition known to interfere with the absorption, distribution, metabolism and excretion of drugs
* Known or suspected drug or alcohol abuse or positive DOA test

Primary outcomes:
measure: Relative bioavailability of AZD9056 using PK variables Cmax and AUC
timeFrame: For each study period, intensive sampling occasions on day 1: half hourly after dosing until 4 hours, then 4,6,8 and 12 hours post dose, with once daily sampling on days 2 to 7
Secondary outcomes:
measure: Descriptive PK parameters for AZD9056 using PK variables (tmax, AUC(0-t), t1/2, CL/F and Vz/F)
timeFrame: For each study period, intensive sampling occasions on day 1: half hourly after dosing until 4 hours, then 4,6,8 and 12 hours post dose, with once daily sampling on days 2 to 7
measure: Safety variables (adverse events, safety lab, blood pressure, pulse, ECG)
timeFrame: Frequent sampling occasions throughout the study period
Other outcomes:
Locations:
city: Manchester
country: United Kingdom
facility: Research Site
Study officials:
affiliation: AstraZeneca R&D, Alderley Park, UK
name: Mark Layton
role: STUDY_DIRECTOR
affiliation: ICON Development Solutions, Manchester, UK
name: Simon Constable
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00365534: Use of Magnetic Imaging to Asses the Efficacy of Cap Assisted Colonoscopy in Reducing Looping and Improving Patient Acceptance for the Colonoscopy Procedure
Official title: A Double-Blinded Randomized Study Comparison the Mechanism of Looping Formation and Subject's Acceptance During CAC and Regular Colonoscopy by MEI (MIC Study)
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Colonoscopy
Keywords: First colonoscopy examination
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2006-08-17
Enrollment: 20
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DIAGNOSTIC

Brief summary: The aim of this study is to compare the mechanism of loop formation and acceptance of CAC and regular colonoscopy by MEI.

Detailed description: Colonoscopy is widely used for the investigation of lower gastrointestinal tract disease.However,colonoscopy remains a technically difficult procedure. As the colon is a mobile organ, looping may occur when the colonoscope passes through.Hence,reducing looping during procedure is very improtant to achieve succes as well as patient acceptance.Recently,some studies shown that cap-assisted colonoscopy(CAC)allow better visualisation of the colonic folds, thus increase success rate.However, previous studies shown that magnetic endoscope imaging (MEI)is useful as an adjunct to assist endoscopist in performing the procedure and as a modality to look for the mechanism of looping. Because of such concern,our study is to compare the mechanism of looping formation and acceptance of CAC and regular colonoscopy by MEI.

Eligibility criteria: Inclusion Criteria:

* Patient undergo first colonoscopy examination
* Signed informed consent

Exclusion Criteria:

* Patient had received colonoscopy examination before.
* Patient had prior colorectal surgery done(apart from appendectomy)
* Known to have colonic stricture or obstructing tumour from the result of other investigations such as CT scan or barium enema.
* Presence of acute surgical conditions such as severe colitis, megacolon, ischaemic colitis and active gastrointestinal bleeding.
* Patient could not provide consent.

Primary outcomes:
measure: The MEI score difference between regular colonoscopy and CAC.
Secondary outcomes:
Other outcomes:
Locations:
city: Hong Kong
country: China
facility: Endoscopy Centre,Alice Ho Miu Ling Nethersole Hospital & Tai Po Hospital
Study officials:
affiliation: Chinese University of Hong Kong
name: Yuk Tong Lee, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00037934: Robotic Upper-Limb Neurorehabilitation in Chronic Stroke Patient
Official title: Evaluation of Robotic Upper Extremity Neuro-Rehabilitation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Stroke
Keywords: Robot
Stroke
Upper Extremity
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
Collaborators: name: Massachusetts Institute of Technology
First posted: 2002-05-27
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: We have established the feasibility and effectiveness of robot-aided rehabilitation in stroke patients using a robot for neurological rehabilitation designed and built by MIT. Results of a pilot study of 20 patients were promising and showed that robot therapy is safe, tolerated by patients and produces a significant, measurable benefit. We propose to test that the robotic upper extremity trainer is an acceptable cost effective adjunct to standard occupational therapy for patients with dysfunction of the shoulder and elbow due to hemiparetic stroke in a VA rehabilitation program.


Eligibility criteria: Inclusion Criteria:

* Chronic Stroke
* Manual Muscle Score of Grade 3 or lower in at least one muscle of the affected arm

Exclusion Criteria:

* Acute Stroke
* Contracture or orthopedic problems limiting the movement of the affected arm
* Visual deficit such that the participant cannot see the test pattern on the robot trainer
* Serious complicating medical illness
* Botox treatment to the involved arm within three months of enrollment

Primary outcomes:
measure: Upper limb Motor Status Score, Wolf Motor Function Test, Motor Power Assessment, and Fugl-Meyer Upper Extremity Motor Performance Test
timeFrame: The Primary Outcome measures were performed at baseline, after completion of 18 sessions of intervention and at 3 months follow-up.
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: VA Maryland Health Care System, Baltimore
state: Maryland
Study officials:
affiliation: VA Maryland Health Care System, Baltimore
name: Christopher Bever, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01662934: A Randomized, Sham Device Controlled, Single Blinded Trial of Portable Transcutaneous Electrical Nerve Stimulation and Heat Therapy Machine in Women With Dysmenorrhea
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Dysmenorrhea
Keywords: dysmenorrhea
transcutaneous electrical nerve stimulation
heat therapy
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2012-08-13
Enrollment: 118
Sex: FEMALE
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The hypothesis is that a transcutaneous electrical nerve stimulation and heat therapy machine could reduce dysmenorrhea in women with primary or secondary dysmenorrhea.

Detailed description: Inclusion/Exclusion: Described in Eligibility section. Outcome measures: Change of VAS score before and after use of TENS and heat therapy machine.

Eligibility criteria: Inclusion

* Age\>19
* Premenopausal
* Moderate or severe dysmenorrhea, mainly in low abdomen area

Exclusion

* Pregnant
* Surgery history on lower abdomen
* Recent history of cancer
* TENS device use is contraindicated
* Ibuprofen use is contraindicated

Primary outcomes:
measure: Change of VAS before and after application of machine
timeFrame: Immediately before application of machine and 20minutes after application of machine
Secondary outcomes:
measure: BPI score
timeFrame: 2nd day of menstrual cycle
Other outcomes:
Locations:
city: Seongnam Si
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Gyenggi Do
Study officials:
References:
citation: Lee B, Hong SH, Kim K, Kang WC, No JH, Lee JR, Jee BC, Yang EJ, Cha EJ, Kim YB. Efficacy of the device combining high-frequency transcutaneous electrical nerve stimulation and thermotherapy for relieving primary dysmenorrhea: a randomized, single-blind, placebo-controlled trial. Eur J Obstet Gynecol Reprod Biol. 2015 Nov;194:58-63. doi: 10.1016/j.ejogrb.2015.08.020. Epub 2015 Aug 22.
Clinical trial NCT04775134: Residual SARS-CoV-2 Presence in the Respiratory Tract and Lung Parenchyma (After SARS-CoV-2 Infection or COVID-19)
Official title: Residual SARS-CoV-2 Presence in the Respiratory Tract and Lung Parenchyma
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Covid19
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
First posted: 2021-03-01
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients requiring a medically indicated pulmonary resection.

Brief summary: The aim of this study is to confirm or rule out the residual presence and viability of SARS- CoV-2 in the respiratory tract and lung parenchyma of patients previously infected with SARS-CoV-2.

Presence and viability of SARS-CoV-2 in lung tissue will be assessed with reverse transcriptase-polymerase chain reaction (PCR) and viral culture. The histological location of residual SARS-CoV-2 will be determined with fluorescence immunohistochemistry and single molecule fluorescence in situ hybridization, targeting viral proteins and RNA respectively.

Detailed description: The investigators will collect residuary lung tissue after medically indicated pulmonary resections at the Thoracic Surgery Department of University Hospitals Leuven. More specifically the investigators will collect lung tissue from patients that had earlier PCR proven COVID-19 and/or serum anti-SARS-CoV-2 antibodies.

Furthermore, for negative control of the methodology the investigators will also collect lung tissue from patients that have no signs for earlier SARS-CoV-2 infection.

Eligibility criteria: Inclusion Criteria:

* Patient requires medically indicated pulmonary resection
* Informed consent

Exclusion Criteria:

* Active SARS-CoV-2 infection/COVID-19
* No informed consent

Primary outcomes:
measure: Reverse transcriptase-PCR
timeFrame: Single time point.
measure: Fluorescence immunohistochemistry (IHC)
timeFrame: Single time point.
measure: Single molecule fluorescence in situ hybridization (smFISH)
timeFrame: Single time point.
Secondary outcomes:
measure: Viral culture
timeFrame: Single time point.
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: UZ Leuven
Study officials:
affiliation: UZ Leuven
name: Laurens J Ceulemans, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06487234: Effect of Acute ObeEnd Exposure on Factors Regulating Appetite
Official title: Determining the Physiological Mechanism Behind Acute ObeEnd Device Exposure on Factors Regulating Appetite
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Obesity
Keywords: Acupuncture
Wearable wellness device
Lead sponsor: Concordia University, Montreal
Sponsor class: OTHER
First posted: 2024-07-05
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: n Canada, over 60% of adults are classified as overweight and obese resulting in a public health crisis including increasing health care costs and negatively impacting the well-being of many Canadians. To overcome these barriers, the ObeEnd device, manufactured by WAT Medical Enterprise, is a new and innovative wellness technology that uses electrical pulses to stimulate acupressure point PC6 to help control appetite. PC6 stimulation could potentially modulate appetite and restore gastric dysfunction, which are important factors that contribute to obesity. If PC6 electrostimulation facilitates the normalization of appetite and restoration of gastric dysfunction in those with obesity, then the device could be a potentially helpful aid to weight loss.

To measure the change of appetite hormones and enzymes related to appetite regulation after using the ObeEnd device. The investigators hypothesize that, compared to placebo, acute electrostimulation of PC6 an acupuncture spot on the wrist for a 1 hour period will result in changes in enterogastric hormones in a direction that decreases appetite. This study will provide the first evidence of the acute effects of electrostimulation at PC6 on factors affecting body weight regulation providing insight into the utility of the ObeEnd device for weight control.


Eligibility criteria: Inclusion Criteria:

* People with obesity (BMI\>30kg/m2)
* Generally healthy
* Premenopausal females

Exclusion Criteria:

* Past (\<1 year) or present use of nicotine products
* History of chronic disease or metabolic conditions
* Females who are pregnant, less than 6 months postpartum, or breastfeeding
* Diagnosed hepatic disease, renal impairment, uncontrolled hypothyroidism
* Use of any medications that may affect study outcomes (e.g. hormone replacement therapy)

Primary outcomes:
measure: Appetite assessment
timeFrame: Baseline to 4 hours
measure: Blood Hormones
timeFrame: Baseline to 4 hours
Secondary outcomes:
measure: Blood Pressure
timeFrame: Baseline to after stimulation, on average 1 hour
measure: Heart rate
timeFrame: Baseline to after stimulation, on average 1 hour
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: Concordia University
state: Quebec
Study officials:
affiliation: Concordia University, Montreal
name: Sylvia Santosa, PhD, RD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05613634: Effect of Repetitive Transcranial Magnetic Stimulation in Patients With Peripheral Vestibular Dysfunction
Official title: Effect of Repetitive Transcranial Magnetic Stimulation on Vestibular Function and Self-rated Functional Recovery in Patients With Peripheral Vestibular Dysfunction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Peripheral Vestibular Dysfunction
Keywords: Vestibular dysfunction, repetitive transcranial magnetic stimulation, vestibular physical therapy exercises, vertigo, Activities of daily living.
Lead sponsor: October 6 University
Sponsor class: OTHER
First posted: 2022-11-14
Enrollment: 35
Sex: ALL
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: Background: Vestibular dysfunctions are common disorders in the adult population that can develop at any life decade. Most of the patients with vestibular dysfunction suffer from balance disorders and vertigo that may have a negative impact on daily living activities and social participation.

Objectives: To investigate the effect of repetitive transcranial magnetic stimulation added to vestibular physical therapy exercises on functional recovery in patients with vestibular dysfunction.

Hypothesis: There is no effect of repetitive transcranial magnetic stimulation added to vestibular physical therapy exercises on functional recovery in patients with vestibular dysfunction.


Eligibility criteria: Inclusion Criteria:

* patients diagnosed by an audiologist with a chronic uncompensated unilateral peripheral vestibular weakness
* age ranged from 30 to 60 years, and duration of illness ranged from 4 to 32 months

Exclusion Criteria:

* benign paroxysmal positional vertigo
* bilateral peripheral vestibular weakness
* central vestibular disorders
* acute vestibular weakness
* vertigo of vascular origin (Vertebrobasilar insufficiency) or cervical origin

Primary outcomes:
measure: Video-nystagmography (VNG)
timeFrame: 35 minutes
Secondary outcomes:
measure: Dizziness handicap inventory (DHI)
timeFrame: 20 minutes
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: October 6 University
Study officials:
References:
Clinical trial NCT04060134: A Retrospective Breast Reconstruction Study
Official title: A Retrospective, Multi-Center, Open Label Study Evaluating SimpliDerm™ and Other Human Acellular Dermal Matrices in Breast Reconstruction
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Lead sponsor: Elutia Inc.
Sponsor class: INDUSTRY
First posted: 2019-08-16
Enrollment: 223
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population will consist of up to 300 female patients, who had direct to implant or two-stage immediate breast reconstruction following unilateral or bilateral mastectomy surgery.

Brief summary: To collect data on patients who have previously undergone breast reconstruction utilizing SimpliDerm and other HADMs.

Detailed description: This study is a retrospective, multi-center, open label study evaluating SimpliDerm and other human acellular dermal matrices in breast reconstruction.

A total of up to 300 patients who underwent direct to implant (one stage) or two-stage unilateral or bilateral breast reconstruction with SimpliDerm an other HADMs at the time of implant or TE placement.

Data will be collected for a minimum of one post-surgical visit after direct implant or exchange. If more visits are available, data from those visits will be collected as well.

Eligibility criteria: Inclusion Criteria:

* Female patient who underwent immediate breast reconstruction post-mastectomy; either direct to implant or with a tissue expander followed by exchange for a saline or gel implant.
* HADMs such as: InteguPly, SimpliDerm, AlloDerm, FlexHD, DermACELL, Cortiva, or AlloMax used in the breast reconstruction.

Exclusion Criteria:

* Female patient who underwent cosmetic/aesthetic breast augmentation procedure or revision.
* Female patient who underwent delayed breast reconstruction procedure.
* Female patient who underwent revision of previous breast reconstruction procedure.

Primary outcomes:
measure: Occurrence of Events
timeFrame: From date of surgery through study completion, an average of 9 months
Secondary outcomes:
Other outcomes:
measure: Integration Assessment
timeFrame: From date of surgery through study completion, an average of 9 months
measure: Drain Removal
timeFrame: From date of surgery through study completion, an average of 9 months
measure: Intraoperative fill volume
timeFrame: From date of surgery through study completion, an average of 9 months
Locations:
city: Montgomery
country: United States
facility: Baptist Medical Center South
state: Alabama
city: Muscle Shoals
country: United States
facility: Shoals Plastic Surgery
state: Alabama
city: Nashville
country: United States
facility: Tierney Plastic Surgery
state: Tennessee
city: Austin
country: United States
facility: Ascension/Seton Institute of Reconstructive Plastic Surgery
state: Texas
city: McAllen
country: United States
facility: DHR Health
state: Texas
Study officials:
References: