louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03180125: Hyaluronic Acid Hydro-dissection Use in Idiopathic Carpal Tunnel Syndrome Guided by Ultrasonic Study
Official title: Use of Hyaluronic Acid Injection in Treatment of Idiopathic Carpal Tunnel Syndrome Versus Corticosteroid Injection Sonographically Guided
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Carpal Tunnel Syndrome
Keywords: hydrodissection
sodium hyaluorinate
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2017-06-08
Enrollment: 80
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: carpal tunnel syndrome (CTS) is the most common compression syndrome in the upper extremities, CTS is characterized by typical anatomic changes, the most probable swelling of the median nerve in the proximal part of the CT.

Local infiltration of corticosteroids easily leads to atrophy of the median nerve, subcutaneous fat, and systematic complications, surgical treatment decision is always taken by the patient who sometimes wants to delay or avoid the surgery because of psychological or medical concerns, It would be interesting if low molecular weight sodium hyaluorinate injection is used as an alternative conservative treatment of CTS. This study aims to investigate if, and to what extent, hydro-dissection using 1% lidocain followed by injection of Sodium hyaluronate versus 1% lidocain followed by injection of 40 mg of triamcinolone acetonide, under ultrasound guidance.

Detailed description: 60 CT patients, blindly divided into two groups. Both will underwent median nerve hydro-dissection using 1% lidocain followed by group I injection of Sodium hyaluronate and group II injection of 40 mg of triamcinolone acetonide, under ultrasound guidance. Baseline VAS pain and nerve conduction study, patient satisfaction, and therapeutic duration, will be determined in 2nd week, 3rd and 6th month after the procedure. US measurements of the median nerve cross-sectional area (CSA) in the CT inlet will be compared pre and post procedure in 6th month and use NCS results as the gold standard diagnostic test.

Eligibility criteria: Inclusion Criteria:

* patients with mild or moderate carpal tunnel diagnosed by nerve conduction study

Exclusion Criteria:

* secondary carpal tunnel to any other disease and peripheral neuropathy patients

Primary outcomes:
measure: neuropathic pain VAS
timeFrame: 2 weeks
Secondary outcomes:
measure: nerve conduction study
timeFrame: 1 month
Other outcomes:
measure: Patient satisfaction
timeFrame: 1month
Locations:
city: Assiut
country: Egypt
facility: Assiut governorate
Study officials:
References:
Clinical trial NCT02766725: Thermosensitive Gels for the Vaginal Delivery of Sildenafil Citrate
Official title: Development and Clinical Evaluation of Thermosensitive Gels for the Vaginal Delivery of Sildenafil Citrate on the Endometrium of Women Use Clomiphene Citrate for Induction of Ovulation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Infertility
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2016-05-10
Enrollment: 90
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study was to develop and characterize in situ thermosensitive gels for the vaginal administration of sildenafil as a potential treatment of the endometrial thinning that occurs as a result of the use of clomiphene citrate in induction of ovulation in women with World Health Organization type II EU gonadotrophic anovulation.


Eligibility criteria: Inclusion Criteria:

* women with polycystic ovaries

Exclusion Criteria:

* women with other causes of infertility

Primary outcomes:
measure: The change of Doppler resistance index after the treatment
timeFrame: 10 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Soliman GM, Fetih G, Abbas AM. Thermosensitive bioadhesive gels for the vaginal delivery of sildenafil citrate: in vitro characterization and clinical evaluation in women using clomiphene citrate for induction of ovulation. Drug Dev Ind Pharm. 2017 Mar;43(3):399-408. doi: 10.1080/03639045.2016.1254239. Epub 2016 Nov 14.
Clinical trial NCT04447625: Intrauterine Antibiotic Infusion in Treating Chronic Endometritis and Restoring Reproductive Dynamics
Official title: Introducing Intrauterine Antibiotic Infusion as a Novel Approach in Effectively Treating Chronic Endometritis and Restoring Reproductive Dynamics: A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Chronic Endometritis
Keywords: CE treatment
infertility
oral antibiotic administration
intrauterine antibiotic infusion
Lead sponsor: Genesis Athens Clinic
Sponsor class: OTHER
First posted: 2020-06-25
Enrollment: 80
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Chronic Endometritis (CE) is related to infertility and entails a challenging management. This study investigates the treatment of off-label intrauterine antibiotic infusion (IAI) combined with oral antibiotic administration (OAA), and it assesses respective performance against the gold standard treatment of OAA. Data sourced herein reports on treatment efficiency and fertility restoration for both patients aiming to conceive naturally or via In Vitro fertilization (IVF).


Eligibility criteria: Inclusion Criteria:

* Positive diagnosis of CE
* Recurrent Pregnancy Loss (RPL) or Recurrent Implantation Failure (RIF)
* No previous live birth
* FSH and LH levels -evaluated on day 2 of the menstrual cycle- \<12 IU/ml
* AMH levels \>1.1ng/ml
* Progesterone levels -evaluated on day 21 of the menstrual cycle- \> 2 and \<25 ng/ml
* 18.5\<BMI\<29.9
* 18\<Patients' age\<40

Exclusion Criteria:

* Diagnosed endometriosis or other related Pelvic Inflammatory Disorder (PID)
* Current or previous cancer diagnosis
* Auto-immune, genetic or reproductive disorders
* Reproductive history of pregnancy loss due to genetic abnormalities
* Male factor infertility diagnosis

Primary outcomes:
measure: Treatment efficiency rate
timeFrame: Treatment efficiency rate was assessed immediately after treatment completion
measure: Side-effects rate
timeFrame: Side-effects were monitored from treatment initiation until completion of treatment. Treatment duration: 14 days for Arm 1 and 30 days for Arm 2
Secondary outcomes:
measure: Clinical pregnancy rate
timeFrame: Clinical pregnancy rate was assessed 6-7 weeks following last menstrual period for patients that achieved a pregnancy. A time frame of 6 months was allowed for patients to achieve a pregnancy post treatment.
measure: Live birth rate
timeFrame: A time frame of 40-41 weeks was allowed to assess live birth rate following patients' last menstrual period.
Other outcomes:
Locations:
city: Athens
country: Greece
facility: Human Reproduction LTD
state: Holargos
Study officials:
References:
Clinical trial NCT00927225: Local Infiltration Analgesia in Bilateral Knee Arthroplasty - Efficacy of Subcutaneous Wound Infiltration With Local Anesthetic
Official title: Local Infiltration Analgesia in Bilateral Knee Arthroplasty - Efficacy of Subcutaneous Wound Infiltration With Local Anesthetic.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pain, Postoperative
Lead sponsor: Hvidovre University Hospital
Sponsor class: OTHER
Collaborators: name: Lundbeck Foundation
First posted: 2009-06-24
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Local infiltration analgesia is effective in total knee arthroplasty for postoperative pain management, but the efficacy of subcutaneous wound infiltration has not been evaluated. This study aims at evaluating the efficacy of subcutaneous wound infiltration in total knee arthroplasty in 16 patients undergoing bilateral knee arthroplasty.


Eligibility criteria: Inclusion Criteria:

* total bilateral knee arthroplasty

Exclusion Criteria:

* immunological diseases
* treatment with opioids or steroids
* allergy to any drugs administered

Primary outcomes:
measure: Postoperative pain
timeFrame: 1-6 hours postoperative
Secondary outcomes:
Other outcomes:
Locations:
city: Hvidovre
country: Denmark
facility: Hvidovre University Hospital
Study officials:
References:
citation: Andersen LO, Husted H, Kristensen BB, Otte KS, Gaarn-Larsen L, Kehlet H. Analgesic efficacy of subcutaneous local anaesthetic wound infiltration in bilateral knee arthroplasty: a randomised, placebo-controlled, double-blind trial. Acta Anaesthesiol Scand. 2010 May;54(5):543-8. doi: 10.1111/j.1399-6576.2009.02196.x. Epub 2010 Jan 6.
Clinical trial NCT02833025: Point-of-care Assessment of Thrombin Generation and Platelet Function in Children Requiring Cardiopulmonary Bypass
Official title: Point-of-care Assessment of Thrombin Generation and Platelet Function in Children Undergoing Cardiac Surgery With Cardiopulmonary Bypass
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Platelet Function Tests
Thrombin Generation Tests
Perioperative Coagulopathy
Lead sponsor: The Hospital for Sick Children
Sponsor class: OTHER
Collaborators: name: Synapse B.V. Research Institute, University of Maastricht
First posted: 2016-07-14
Enrollment: 130
Sex: ALL
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children aged ≤5 years undergoing cardiac surgery with cardiopulmonary bypass

Brief summary: Coagulopathy after cardiopulmonary bypass (CPB) is associated with increased morbidity and mortality. Clot formation and clot stability are important factors in coagulation and hemostasis. As such platelet dysfunction and impaired thrombin generation play a central role in bleeding after cardiac surgery. The primary objective of this study is to evaluate the relationship between point-of-care determined platelet function and thrombin generation and postoperative bleeding in infants and young children undergoing cardiac surgery with cardiopulmonary bypass adjusting for clinically important confounding factors.


Eligibility criteria: Inclusion Criteria:

1. Age ≤5 years
2. Undergoing cardiac surgery with cardiopulmonary bypass

Exclusion Criteria:

1. Non-english speaking parents/care-givers
2. Refusal to consent
3. Extracorporeal membrane oxygenation (ECMO) or ventricular assist device prior to surgery
4. Therapeutic heparin use (unfractionated or low molecular weight) in the immediate preoperative period (\<12 hr)
5. Weight \<3 kg

Primary outcomes:
measure: Postoperative chest tube blood loss
timeFrame: 24hr
Secondary outcomes:
measure: Postoperative chest tube blood loss
timeFrame: 6hr
measure: Postoperative chest tube blood loss
timeFrame: 12hr
measure: Transfusion of blood products
timeFrame: 24hr
measure: All-cause mortality
timeFrame: within 30 days
measure: Length of hospital stay
timeFrame: through study completion, an average of less than one month
measure: Length of ICU stay
timeFrame: within 30 days
measure: Duration of mechanical ventilation
timeFrame: within 30 days
measure: Inotropes
timeFrame: within 30 days
measure: Kidney injury
timeFrame: within 30 days
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: The Hospital for Sick Children
state: Ontario
Study officials:
affiliation: The Hospital for Sick Children
name: James D O'Leary, MBBCh, MM, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01782625: Hypercapnia: Cognitive Effects and Monitoring
Official title: Hypercapnia: Cognitive Effects and Monitoring
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypercapnia
Exercise
Nitrogen Narcosis
Diving
Immersion
Keywords: diving
cognitive impairment
nitrogen narcosis
narcosis
end tidal carbon dioxide
arterial carbon dioxide
immersion
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2013-02-04
Enrollment: 58
Sex: MALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The investigators will simulate the conditions of a working, helmeted diver by using exercising, "head out" immersed subjects to test the following hypotheses:

1. An algorithm can be developed which predicts cognitive performance in immersed exercising divers, based on the exhaled carbon dioxide (PETCO2) and the diver's inspired partial pressures of oxygen and nitrogen (PIO2 and PIN2).
2. PETCO2 using mass spectrometry is an accurate estimate of arterial carbon dioxide (PaCO2) at rest and during immersed exercise and can be used as a PaCO2 surrogate at levels exceeding 50 mmHg and depths up to 158 fsw (gas density 6.4 g/l, similar to 165 fsw density of 6.8 g/l).


Eligibility criteria: Inclusion Criteria:

* healthy,
* male,
* age greater than 18,
* age less than 50

Exclusion Criteria:

* smoker,
* asthma,
* cardiac disease,
* inability to pedal a bicycle ergometer,
* inability to perform vigorous exercise

Primary outcomes:
measure: Is cognitive ability different while resting versus compared to cognitive ability while diving, breathing different gas mixtures and while exercising?
timeFrame: pre-dive to dive to post-dive (approximately 2 hours)
Secondary outcomes:
measure: How does exhaled (end tidal) carbon dioxide compare with arterial carbon dioxide?
timeFrame: pre-dive to dive to post dive (approximately 2 hours)
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke Center for Hyperbaric Medicine and Environmental Physiology
state: North Carolina
Study officials:
affiliation: Duke University
name: John J Freiberger, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06320925: SportsPro: Post-Market Clinical Follow Up Study
Official title: A Retrospective, Multi-Center, Post-Market Clinical Follow-Up Study of Stryker Class IIb Implants
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Shoulder Injuries
Knee Injuries
Hip Injuries
Lead sponsor: Stryker Endoscopy
Sponsor class: INDUSTRY
First posted: 2024-03-20
Enrollment: 1500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who have undergone a surgical procedure (per indications for use) using the Stryker implants who meet all of the inclusion/exclusion criteria will be screened and enrolled by participating Investigators.

Brief summary: Retrospective, multi-center, chart review (only to include data that is part of the surgeons' standard practice)

Detailed description: The purpose of this study is to leverage standard of care data to provide further characterization of clinical outcomes following shoulder, hip and knee joint surgeries.

* Primary Objective: To describe clinical outcomes of the Stryker Device in the shoulder, hip, and knee joints 6 months after surgical intervention.
* Secondary Objective: To describe clinical outcomes of the Stryker Device in the shoulder, hip, and knee joints 3 months after surgical intervention.
* Safety Objective: To describe safety of the Stryker implants in the shoulder, hip, and knee joints 6 months after intervention.

Eligibility criteria: Inclusion Criteria:

1. Subject was ≥ 18 years of age at the time of the surgery
2. Subject has undergone joint space repair using one of the study devices

Exclusion Criteria:

1. Subjects who are less than 6 months post-intervention
2. Concurrent participation in an investigational clinical study during the study period

Primary outcomes:
measure: ASES
timeFrame: 6 months
measure: iHOT-12
timeFrame: 6 months
measure: mHHS
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Musculoskeletal-Orthopedic Research and Education Foundation
state: Arizona
city: Englewood
country: United States
facility: Steadman Hawkins Clinic Denver
state: Colorado
city: San Antonio
country: United States
facility: TSAOG Orthopaedics & Spine
state: Texas
Study officials:
References:
Clinical trial NCT06028425: A Study to Evaluate the Effect of Food on LOXO-783 in Healthy Participants
Official title: A Phase 1 Study to Evaluate the Effect of Food on the Pharmacokinetics of LOXO-783 in Healthy Adult Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
Collaborators: name: Loxo Oncology, Inc.
First posted: 2023-09-08
Enrollment: 42
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 main purpose of this study is to measure how much of LOXO-783 is in the bloodstream and how the body handles and eliminates LOXO-783 when administered in fasting and fed states in healthy participants. The study will also evaluate the safety and tolerability of LOXO-783. Participation could last up to 63 days including screening period.


Eligibility criteria: Inclusion Criteria:

* Healthy status as defined by the absence of evidence of any clinically significant active or chronic disease
* Body mass index (BMI): 18.0 to 32.0 kilograms per square meter (kg/m²), inclusive

Exclusion Criteria:

* Females who are lactating or of childbearing potential
* Clinically significant history of any drug sensitivity, drug allergy, or food allergy

Primary outcomes:
measure: Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of LOXO-783
timeFrame: Predose on Day 1 up to 96 hours postdose
measure: PK: Area Under the Concentration-Time Curve (AUC) from Time 0 to Infinity (AUC [0-∞]) of LOXO-783
timeFrame: Predose on Day 1 up to 96 hours postdose
Secondary outcomes:
Other outcomes:
Locations:
city: Daytona Beach
country: United States
facility: Fortrea Clinical Research Unit
state: Florida
Study officials:
affiliation: Loxo Oncology, Inc.
name: Yingying Guo-Avrutin, MD, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00880425: Do Patients With Chronic Daily Headache Have Continuous Headache or Moments of Headache Relief?
Official title: Do Patients With Chronic Daily Headache Have Continuous Headache or Moments of Headache Relief?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Daily Headache
Lead sponsor: Thomas Jefferson University
Sponsor class: OTHER
First posted: 2009-04-13
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Headache clinic patients with diagnosis of Chronic Migraine, New Daily Persistent Headache, Chronic Tension type headache, or chronic post traumatic headache, over age 18.

Brief summary: The objective of this study is to determine if patients with chronic daily headache have continuous headache or moments of headache relief. The secondary objective of this study is to determine the period of time patients who have chronic daily headache that is not continuous are headache free.

Detailed description: This study is a retrospective chart review of all patients over the age of 18 who are seen by the co-investigator during one initial, or routine follow up visit, with the diagnosis of chronic migraine, chronic tension type headache, new daily persistent headache, or chronic post traumatic headache(per International Headache Classification II guidelines6). Patients with the above diagnosis during their routine care are asked five standard questions about their headaches by the co-investigator, and the responses are recorded in the patient's medical record (see question sheet attached). These questions pertain to the patients' health care, and are asked of most patients at the Jefferson Headache center with chronic headache routinely during office visits.

Eligibility criteria: Inclusion Criteria:

* Patients with Chronic Migraine, New Daily Persistent Headache, Chronic Tension type headache, or chronic post traumatic headache seen at the Jefferson Headache Center.

Exclusion Criteria:

* Subjects under age 18.

Primary outcomes:
measure: Number of Subjects With Daily Headache Who Have Continuous Headache
timeFrame: Records were reviewed from April 2009 through June 2009
Secondary outcomes:
measure: Number of Patient With Daily Headache Who Have Non-continuous Headache
timeFrame: Records were reviewed from April 2009 through June 2009
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Jessica Ailani
state: Pennsylvania
Study officials:
affiliation: Thomas Jefferson University
name: Stephen D Silberstein, MD
role: PRINCIPAL_INVESTIGATOR
References: