louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03838965: The Effects of Labor Stages and Interventions on Hemodynamic Measures During & After Childbirth With Noninvasive Sensors
Official title: The Effects of Labor Stages and Interventions on Hemodynamic Measures During and After Childbirth (Epidural, Rupture of Membranes, Cesarean Sections and Preeclampsia) With Noninvasive Sensors.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rupture of Membranes; Premature
Cesarean Section; Infection
Preeclampsia
Lead sponsor: Hillel Yaffe Medical Center
Sponsor class: OTHER_GOV
First posted: 2019-02-12
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The Effects of Labor Stages and Interventions on Hemodynamic Measures During and After Childbirth ( Epidural, Rupture Membranses Cesarean Sections and Preeclampsia) With Noninvasive Sensors.


Eligibility criteria: Inclusion Criteria:

* Pregnant woman between 18-45 years old
* with non cardiovascular disease

Exclusion Criteria:

* woman with a cardiovascular disease
* woman who don't agree to participate in the trial

Primary outcomes:
measure: biobeat sensor is a noninvasive sensor of the the hymodynamic measures during the childbirth
timeFrame: 24 hours
Secondary outcomes:
measure: biobeat sensor is a noninvasive sensor of the the hymodynamic measures after 24 hours of the childbirth
timeFrame: 24 hours
Other outcomes:
Locations:
city: Hadera
country: Israel
facility: Hillel Yaffe Medical Center
Study officials:
affiliation: Hillel Yaffe Medical Center
name: Yuval Atsmon, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04946565: The Impact of Sinopharm COVID-19 Vaccination on Male Fertility
Official title: The Impact of Sinopharm COVID-19 Vaccination on Male Fertility of the Egyptian Population
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Male Infertility
Hypogonadism, Male
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2021-07-01
Enrollment: 100
Sex: MALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Men of reproductive age scheduled for COVID-19 Sinopharm Vaccine

Brief summary: The investigators shall study the effect of Sinopharm vaccination on semen parameters and serum testosterone

Detailed description: The investigators shall compare semen parameter (sperm density, sperm motility, and percentage of abnormal sperm form) as well as morning serum testosterone before vaccination, and 3 months after the second dose of the vaccine.

Eligibility criteria: Inclusion Criteria:

Receiving Sinopharm COVID-19 vaccines Male age 18-50 years old

Exclusion Criteria:

* Adults unable to consent
* Men who have been receiving Testosterone replacement therapy or anabolic steroids within the last year
* Men with a history of male infertility
* Men with a genetic or other medical condition known to be associated with decreased semen parameters Positive COVID-19 PCR test within the 3 months

Primary outcomes:
measure: Sperm density count/ml
timeFrame: up to 6 months
measure: Total sperm count per ejaculate
timeFrame: up to 6 months
measure: Percentage of motile sperm
timeFrame: up to 6 months
measure: Percentage of abnormal sperm forms
timeFrame: up to 6 months
Secondary outcomes:
measure: Morning serum testosterone
timeFrame: up to 6 months
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of Medicine, Cairo University
Study officials:
affiliation: Cairo University
name: Mohamed Tarek H Anis, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02376465: A Pilot Evaluation of an Experimental BLI4600 Formulation for Bowel Preparation in Adult Patients Undergoing Colonoscopy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Bowel Preparation for Colonoscopy
Lead sponsor: Braintree Laboratories
Sponsor class: INDUSTRY
First posted: 2015-03-03
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: To evaluate the safety, tolerance and efficacy of BLI4600 in multiple dosing regimens as a bowel preparation prior to colonoscopy in adult patients.


Eligibility criteria: Inclusion Criteria:

Male or female outpatients who are undergoing colonoscopy for a routinely accepted indication

At least 18 years of age

If female, and of child-bearing potential, is using an acceptable form of birth control (hormonal birth control, IUD, double-barrier method, depot contraceptive, abstinent, or vasectomized spouse).

Negative urine pregnancy test at screening, if applicable

In the Investigator's judgment, subject is mentally competent to provide informed consent to participate in the study

Exclusion Criteria:

Subjects with known or suspected ileus, severe ulcerative colitis, gastrointestinal obstruction, gastric retention, bowel perforation, toxic colitis or megacolon.

Subjects who had previous significant gastrointestinal surgeries (e.g. colostomy, colectomy, gastric bypass, stomach stapling).

Subjects with uncontrolled pre-existing electrolyte abnormalities, such as hypernatremia, hyponatremia, hyperphosphatemia, hypokalemia, hypocalcemia, dehydration, or those secondary to the use of diuretics or angiotensin converting enzyme (ACE) inhibitors.

Subjects with a prior history of renal, liver or cardiac insufficiency.

Subjects with impaired consciousness that predisposes them to pulmonary aspiration.

Subjects undergoing colonoscopy for foreign body removal and/or decompression.

Subjects who are pregnant or lactating, or intending to become pregnant during the study.

Subjects of childbearing potential who refuse a pregnancy test.

Subjects allergic to any preparation components.

Subjects who, in the opinion of the Investigator, should not be included in the study for any reason, including inability to follow study procedures.

Subjects who have participated in an investigational surgical, drug, or device study within the past 30 days.

Subjects who withdraw consent before completion of Visit 1 procedures.

Primary outcomes:
measure: % of subjects with successful preparation on a 4 point scale (1 = poor, 2 = fair, 3 = good, 4 = excellent)
timeFrame: 1 Day
Secondary outcomes:
measure: Ottawa Bowel Preparation Scale Score
timeFrame: 1 Day
Other outcomes:
Locations:
city: Mobile
country: United States
facility: University of South Alabama
state: Alabama
Study officials:
affiliation: Braintree Laboratories, Inc.
name: John McGowan, MPH
role: STUDY_DIRECTOR
References:
Clinical trial NCT03108365: Evaluating the Effectiveness of Axiostat Hemostatic Dressing Material Versus Conventional Method of Hemostasis and Healing of Extraction Wounds in Patients on Oral Anti-Platelet Drugs - A Comparative Study
Official title: Evaluating the Effectiveness of Axiostat Hemostatic Dressing Material Versus Conventional Method of Hemostasis and Healing of Extraction Wounds in Patients on Oral Anti-Platelet Drugs - A Comparative Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tooth Extraction
Lead sponsor: Axio Biosolutions Pvt. Ltd.
Sponsor class: OTHER
First posted: 2017-04-11
Enrollment: 40
Sex: ALL
Minimum age (years): 35
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The rationale of this study was to evaluate the efficacy of Axiostat hemostatic dental dressing in achieving hemostasis post-extraction and determining its effect on pain and healing of the extraction wound, compared to control, i.e. conventional method of extraction in patients on oral anti-platelet therapy.


Eligibility criteria: Inclusion criteria

* Patients undergoing multiple tooth extractions aged b/w 35- 70 years and with INR values ≤ 3.5 (1-3.5)
* If present, sugar level should be under control

Exclusion criteria

* Patients undergoing a single tooth or multiple extractions in same quadrant; and those with an allergy to seafood.

Primary outcomes:
measure: Time to achieve haemostasis
timeFrame: 1 Day
Secondary outcomes:
measure: Pain & Healing Scale
timeFrame: Upto 1 Day
Other outcomes:
Locations:
Study officials:
affiliation: KLE Dental College, Belgaun
name: Dr. Tejraj Kale
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02056665: Study to Evaluate the Efficacy and Safety of Minocycline in Angelman Syndrome
Official title: Randomized Clinical Trial, Placebo Compared to Evaluate the Efficacy and Safety of Minocycline in Angelman Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Angelman Syndrome
Keywords: Angelman Syndrome
EFFICACY
SAFETY
MINOCYCLINE
Pediatrics population
Rare diseases
Lead sponsor: Puerta de Hierro University Hospital
Sponsor class: OTHER
First posted: 2014-02-06
Enrollment: 32
Sex: ALL
Minimum age (years): 6
Maximum age (years): 30
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: RANDOMIZED CLINICAL TRIAL, PLACEBO COMPARED TO EVALUATE THE EFFICACY AND SAFETY OF MINOCYCLINE IN ANGELMAN SYNDROME (A-MANECE STUDY)

Detailed description: STUDY TO EVALUATE THE EFFICACY AND SAFETY OF MINOCYCLINE IN ANGELMAN SYNDROME

Eligibility criteria: Inclusion Criteria:

* Male or female between 6 and 30 years old.
* Clinical diagnosis of Angelman Syndrome and molecular confirmation of diagnosis.
* The participant has an acceptable guardian can give consent on behalf of the participant.

Exclusion Criteria:

* Patients with hypersensitivity to tetracyclines.
* Patients with impaired hepatic or renal function and in those with mainly drug allergy history.
* Any other condition that in the opinion of the investigator is considered clinically relevant and that administration of minocycline contraindicated

Primary outcomes:
measure: Increased on the equivalent age of development
timeFrame: 8, 16 and 24 weeks
Secondary outcomes:
measure: Improved specific cognitive, language and communication, motor development, social-emotional and adaptive behavior
timeFrame: 8, 16 and 24 weeks
measure: Improvement of EEG.
timeFrame: 8, 16 and 24 weeks
measure: Safety and tolerability
timeFrame: 8, 16 and 24 weeks
measure: Clinical Global impression (CGI)
timeFrame: 8, 16 and 24 weeks
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Puerta de Hierro University Hospital
Study officials:
affiliation: Clinical Pharmacology. Puerta de Hierro University Hospital
name: Belen Ruiz-Antorán
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ruiz-Antoran B, Sancho-Lopez A, Cazorla-Calleja R, Lopez-Pajaro LF, Leiva A, Iglesias-Escalera G, Marin-Serrano ME, Rincon-Ortega M, Lara-Herguedas J, Rossignoli-Palomeque T, Valiente-Rodriguez S, Gonzalez-Marques J, Roman-Riechmann E, Avendano-Sola C. A randomized placebo controlled clinical trial to evaluate the efficacy and safety of minocycline in patients with Angelman syndrome (A-MANECE study). Orphanet J Rare Dis. 2018 Aug 20;13(1):144. doi: 10.1186/s13023-018-0891-6.
Clinical trial NCT01758965: Surgicel® Fibrillar for Delayed Bleeding After ESD
Official title: Surgicel® (Fibrillar) for Preventing Delayed Bleeding After ESD in Stomach: A Prospective Randomized Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Benign Neoplasm of Stomach
Malignant Neoplasm of Stomach
Lead sponsor: Soonchunhyang University Hospital
Sponsor class: OTHER
First posted: 2013-01-01
Enrollment: 146
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The aim of this study is to assess the effect of Surgicel® Fibrillar as adjuvant treatment to H2RA on preventing ulcer bleeding after ESD for gastric epithelial tumors

Detailed description: 1. Patient (1) Inclusion: Diagnosed as gastric dysplasia or early gastric cancer

   * Scheduled for ESD (2) Exclusion: Coagulopathy- liver cirrhosis, thrombocytopenia
   * Anti-platelet agents
2. Method

(1) Study group: combination with Surgicel® Fibrillar and H2RA (2) Control group: monotherapy with PPI 3. Sample size : 157 4. Result

1. Primary endpoint: rate of delayed bleeding after ESD
2. Secondary endpoint: follow-up hemoglobin after ESD

Eligibility criteria: Inclusion Criteria:

* ESD for gastric dysplasia or early gastric cancer

Exclusion Criteria:

* Coagulopathy: liver cirrhosis, thrombocytopenia
* Anti-platelet agents

Primary outcomes:
measure: Delayed bleeding rate after ESD
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Bucheon
country: Korea, Republic of
facility: Digestive Disease Center, Department of Internal Medicine, Soonchunhyang University College of Medicine
state: Gyeonggi-do
Study officials:
References:
Clinical trial NCT04347265: Ultrasound-guided Neuromodulation Percutaneous in Lower Back Pain
Official title: Ultrasound-guided Neuromodulation Percutaneous in Lower Back Pain: a Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lower Back Pain
Lead sponsor: University of Seville
Sponsor class: OTHER
First posted: 2020-04-15
Enrollment: 30
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: In our daily clinical practice, one of the most frequent reasons for consultation physiotherapists is low back pain (LBP). Regardless of the origin of the problem, the approach from physiotherapy contemplates the reduction of pain through different procedures, including neuromodulation.

In the field of Physiotherapy, ultrasound-guided Percutaneous Neuromodulation (PNM) is defined as the application through a needle with ultrasound guidance of an electrical current at low or medium frequency, seeking a sensitive and / or motor response of a peripheral nerve in some point of its trajectory, or of a muscle in a motor point, with a therapeutic objective. The objective of this study is to analyze that the effect of PNM on the sciatic nerve produces statistically significant changes in pain, joint range and functionality in patients with chronic LBP. Thirty subjects will be recruited, which will be divided into 3 groups: group 1 to which PNM will be applied to the sciatic nerve in the gluteus region; group 2 to which PNM will be applied to the sciatic nerve in the middle of the thigh; and group 3 to which PNM will be applied to the sciatic nerve before popliteus region. The PNM intervention with NMP will consist in the single application of an asymmetric rectangular biphasic current (250 microseconds, 3 Hz) during 90 seconds


Eligibility criteria: Inclusion Criteria:

* Diagnosis of Lower Back Pain
* Having no other therapy

Exclusion Criteria:

* Other pathology (discal hernia, injured limbs, neurological pathology)
* Belenophobia

Primary outcomes:
measure: Level of pain
timeFrame: From baseline measurement up to 1 week
measure: Range of motion
timeFrame: From baseline measurement up to 1 week
measure: Y Balance Test
timeFrame: From baseline measurement up to 1 week
measure: Owestry questionnaire
timeFrame: From baseline measurement up to 1 week
Secondary outcomes:
Other outcomes:
Locations:
city: Seville
country: Spain
facility: Blanca de la Cruz Torres
Study officials:
affiliation: University of Seville
name: Blanca De la Cruz Torres, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT03302065: Comparison of the Pharmacokinetics of Tiotropium Delivered From Test Inhaler Products With Reference
Official title: Phase I Randomised, Four-period Balanced Incomplete Block Design Cross-over Study in Healthy Male and Female Volunteers to Compare the Pharmacokinetics of Tiotropium Delivered From Four Test pMDI Products With One Reference Product
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: inhalation
anticholinergic
Lead sponsor: Solventum US LLC
Sponsor class: INDUSTRY
Collaborators: name: 3M
First posted: 2017-10-04
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to compare the absorption of four different inhalation products with the reference product in healthy volunteers.

Detailed description: Healthy subjects will be enrolled and will receive single doses of 4 test inhalation products and two reference inhalation products according to a five-period cross-over design. Plasma tiotropium levels will be measured pre-dose and over 48 hours post-dose.

Eligibility criteria: Inclusion Criteria:

* Healthy Volunteer
* Willing and able to give informed consent
* Willing to withhold all alcoholic beverages for 48 hours and all xanthine- containing foods and beverages for 24 hours prior to reporting to clinic
* Subjects must agree to use an adequate method of contraception from admission through 12 weeks after last administration

Exclusion Criteria:

* Evidence or history of clinically significant abnormalities or disease or chronic respiratory disorders
* Any presence or history of a clinically significant allergy including any adverse reaction to study drug
* History of drug or alcohol abuse within the past 2 years
* Smoked tobacco within the past 6 months or have a history of more than 10- pack years (number of packs smoked per day x number of years smoked)
* Donation or loss of greater than 400 mL of blood within the previous 3 months
* Have received any prescription medication within 4 weeks or investigational medication within 12 weeks of study (exception: contraceptives are permitted)
* Have received any non-prescription medication within 14 days prior to dosing (exception: paracetamol use within 2 days)
* Upper respiratory tract infection (excluding otitis media) within 14 days of the first study day, or lower respiratory tract infection within the last 3 months
* If female, nursing, lactating or pregnant
* Regular alcohol consumption in males \>21 units per week and females \>14 units per week (1 unit = ½ pint beer, 25 mL of 40% spirit or a 125 mL glass of wine)

Primary outcomes:
measure: Cmax
timeFrame: 48 hours
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: 3M
name: Victoria Sessions, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT00542165: Multicenter Prospective Study on the Changes of Sexual Function Following Treatment With Alfuzosin (Xatral XL®) in Patients With Benign Prostate Hypertrophy
Official title: Multicenter Prospective Study on the Changes of Sexual Function Following Treatment With Alfuzosin (Xatral XL) in Patients With Benign Prostatic Hypertrophy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: BPH/LUTS/Sexual Functions
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2007-10-10
Enrollment: 166
Sex: MALE
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To collect under daily practice conditions, clinical data on the changes of sexual function when a new formulation of alfuzosin(Xatral XL® )is administered once daily in patients with lower urinary tract symptoms(LUTS) suggestive of prostatic hypertrophy


Eligibility criteria: Inclusion Criteria:

* male patients suffering from LUTS lasting 6months and over
* male patients aged 50 years old and over who has a continuous active partner

Exclusion Criteria:

* Primary hypogonadism and neuropathy patients
* History of prostate surgery
* Patients with prostate cancer
* History of organ surgery or organ damage in pelvis
* History of myocardiac infarction, stroke, and life threatening arrythmia within last 6 months
* Patients with haematuria caused by other reasons except BPH
* Patients with uncontrolled hypertension in spite of treatment with antihypertensive agents
* History of a malignant tumor within last 5 years
* Patients who are currently controlled with other medication for erectile dysfunction
* Patients who have been administered with androgen or antiandrogen
* Patients who is treated for psychiatric disorder or depression
* Combination with other alpha1-blockers
* Patients previously not improved by an alpha1-blocker treatment
* Known hypersensitivity to the alfuzosin
* History of postural hypotension or syncope
* Hepatic insufficiency
* Unstable angina pectoris

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Primary outcomes:
measure: IIEF and GEQ (Global Efficacy Question)
timeFrame: at intermediate visit (M1) and at end-point visit(M3)
Secondary outcomes:
measure: blood pressure and heart rate measure in sitting position
timeFrame: at each visit
measure: IPSS and Quality of Life Score
timeFrame: at intermediate visit (M1) and at end-point visit(M3)
measure: Maximum flow rate and post voiding residual urine
timeFrame: at end-point visit(M3)
measure: Spontaneous reported adverse events
timeFrame: During all the study period
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Sanofi-Aventis
Study officials:
affiliation: Sanofi
name: Tae-Young Ahn
role: STUDY_DIRECTOR
References: