louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02114463: Comparison of Two Kinds of Postoperative Analgesia After Amputation
Official title: Comparison of Two Kinds of Postoperative Analgesia After Amputation:a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Pain
Complications
Keywords: Local analgesia system
Ropivacaine
Analgesic efficacy after operation
Postoperative
Lead sponsor: Guangzhou General Hospital of Guangzhou Military Command
Sponsor class: OTHER
First posted: 2014-04-15
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Pain after amputation is a significant problem among amputees. Phantom limb pain may appear in up to 85% of patients and is usually resistant to a wide variety of treatments.It is believed that regional anesthesia, by preventing the establishment of central sensitization, may play a role in reducing the incidence of acute and chronic pain. Therefore the investigators will compare two methods of postoperative analgesic after after amputation by their efficiency and complication.

Detailed description: Peripheral nerve transection results in an afferent nociceptive barrage that initiates spinal cord hyperexcitability with expansion of the receptive fields of dorsal horn neurons that respond to the nearest intact afferents. These neuroplastic changes are believed to be responsible for the development of postsurgical chronic pain syndromes, including phantom limb and stump pain.At present, there are no randomized studies with sample sizes that ensure power, or blinded for end-point assessment,to support the evidence on pharmacological and non-pharmacological treatments of Pain after amputation. Consequently, our study was designed to arrive at clear conclusions about treatment efficacy and to give stronger recommendations for clinical practice.

Eligibility criteria: Inclusion Criteria:

1. Patients of American Association of anesthetists（ASA）Grade 1 or 2
2. Aged between 18 and 65 years
3. Undergoing elective total knee replacement

Exclusion Criteria:

1. Mental illness can not match
2. Nerve block, epidural anesthesia contraindicated
3. People who have Slow-type arrhythmias
4. History of chronic headaches and long-term use of analgesic drugs
5. People who were postoperative consciousness, language or hearing impaired

Primary outcomes:
measure: pain
timeFrame: 72 hours postoperation
Secondary outcomes:
measure: Phantom pain
timeFrame: three months postoperation
measure: complication
timeFrame: 72 hours postoperation
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Guangzhou Military Region General Hospital, Department of Anesthesiology
state: Guangdong
Study officials:
References:
Clinical trial NCT06539663: The Role of OmniLenz® in the Treatment of Small Corneal Perforations Secondary to Exposure Keratitis in ICU Patients
Official title: The Role of OmniLenz® in the Treatment of Small Corneal Perforations Secondary to Exposure Keratitis in ICU Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Corneal Perforation
Exposure Keratitis
Infectious Keratitis
Lead sponsor: Farwaniya Hospital
Sponsor class: OTHER_GOV
First posted: 2024-08-06
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Case series of 5 ICU patients in Farwaniya Hospital who developed exposure keratitis and a subsequent small corneal perforation between April 2022 and April 2024.

The investigators highlight the non-surgical role of OmniLenz® in the treatment of small corneal perforations secondary to exposure keratitis. The inclusion criteria were corneal perforation less than 1mm in size, positive culture \& sensitivity results and showing initial improvement on topical antibiotic eye drops.

Detailed description: The primary outcome measures were healing of the corneal perforation, a negative Seidel test and reformation of the anterior chamber.

Secondary outcome measures were improvement of all three of ciliary injection, state of epithelial defect, and corneal infiltration.

Eligibility criteria: Inclusion/Exclusion Criteria:

* Patients with small corneal perforations measuring \< 1 mm in diameter. Those with larger perforations (\>1mm) were excluded.
* Patients with conclusive results of keratitis (confirmed via culture and sensitivity scraping) AND showing improved keratitis following antibiotic treatment. Those with no confirmed keratitis through C\&S or with inconclusive scraping results were excluded.
* No age or gender restrictions were applied.

Primary outcomes:
measure: Size of corneal perforation
timeFrame: one week
Secondary outcomes:
measure: size of epithelial defect
timeFrame: one week
Other outcomes:
Locations:
city: Kuwait
country: Kuwait
facility: Farwaniya Hospital
Study officials:
References:
Clinical trial NCT04762563: Effect of Treatment on Connective Tissue in Low Back Pain
Official title: The Effect of Instrument Assisted Soft Tissue Mobilization and Kinesiology Taping on Connective Tissue Thickness in Patients With Chronic Low Back Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Low Back Pain
Connective Tissue Defect (Diagnosis)
Lead sponsor: Okan University
Sponsor class: OTHER
Collaborators: name: Medical Park Hospital Istanbul
First posted: 2021-02-21
Enrollment: 60
Sex: ALL
Minimum age (years): 30
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to investigate the effects of instrument assisted soft tissue mobilization (IASTM) and kinesiology taping (KT) that are additional treatment to the conservative treatment for the lumbar region and hamstrings and connective tissue thickness in patients with chronic non-specific low back pain (CNSLBP).


Eligibility criteria: Inclusion Criteria:

* between the ages of 30 and 50
* who had low back pain for at least 12 weeks,
* received no physical therapy in the last 6 months,
* received no IASTM or chemotherapy,
* had normal movement of the hip joint
* Visual Analog Scale value above 3

Exclusion Criteria:

* the presence of allergy and skin diseases,
* pregnancy,
* major structural spinal deformity (scoliosis, kyphosis, stenosis),
* inflammatory disease,
* presence of extruded and sequestered herniation, -signs of neurological disease, -
* presence of orthopedic diseases such as fracture
* a history of spinal surgery.

Primary outcomes:
measure: straight leg test
timeFrame: 4 weeks
measure: sit and reach test
timeFrame: 4 weeks
measure: Modified Schober test
timeFrame: 4 weeks
measure: finger-ground distance measurement
timeFrame: 4 weeks
measure: Ultrasonography
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Emine Atıcı
state: None Selected
Study officials:
References:
Clinical trial NCT06376435: A Multicentre Real-world Study of Heptapopal Ethanolamine Tablets in Concurrent/Sequential Radioimmunoinduced Thrombocytopenia
Official title: A Multicentre Real-world Study of Heptapopal Ethanolamine Tablets in Concurrent/Sequential Radioimmunoinduced Thrombocytopenia
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Cancer, Therapy-Related
Lead sponsor: Hebei Medical University Fourth Hospital
Sponsor class: OTHER
First posted: 2024-04-19
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with solid malignancies undergoing radiotherapy/chemotherapy/immunosuppressant induced thrombocytopenia

Brief summary: The objective of this study was to observe and evaluate the efficacy and safety of hexapopal ethanolamine tablets in the treatment of synchronous/sequential radioimmunoinduced thrombocytopenia in the real world.

The subjects of this study were patients with solid malignant tumors who had received radioimmunoinduced thrombocytopenia.

This study will retrospectively and prospectively collect real-world data related to investigational drugs, and will observe 500 patients to observe the diagnosis and treatment pattern of radiochemo-induced thrombocytopenia. The study included a screening period (no more than one week) and a treatment period (at least two cycles).Participants meeting protocol inclusion criteria were defined as having platelet values \< 100×109/L during radioimmunotherapy.


Eligibility criteria: Inclusion Criteria:

* Understand the research procedure and voluntarily sign the informed consent to participate in the study
* Subjects ≥18 years of age receiving synchronous/sequential chemotherapeutic therapy
* Patients with platelet count ≤100×109/L or platelet count decrease ≥ 50×109/L or platelet count \> 100×109/L but need to be prophylaxis with hexapopethanolamine tablets
* Researchers believe that subjects need to be treated with hexapopal.

Exclusion Criteria:

* The subjects are conducting clinical intervention studies
* Patients with known or expected allergy or intolerance to the active ingredient or excipient of hexapopar
* Pregnant or lactating women
* Other conditions deemed unsuitable for inclusion in the study by the researcher.

Primary outcomes:
measure: The proportion of patients recovered to 100×109/L
timeFrame: 14 days after starting treatment with the study drug
Secondary outcomes:
measure: The proportion of patients recovered to 75×109/L
timeFrame: up to 2 months
measure: Time for platelet recovery to 100×109/L
timeFrame: up to 2 months
measure: Proportion of patients with treatment delay or dose reduction
timeFrame: up to 2 months
measure: TRAE
timeFrame: up to 2 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04306835: The Impact of CBT-i on CPAP Therapy Use and Drop Outs in OSAS Patients With Insomnia.
Official title: The Impact of Cognitive Behavioral Therapy for Insomnia on CPAP Therapy Use and Drop Outs in Obstructive Sleep Apnea Syndrome Patients With Insomnia.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Insomnia
Obstructive Sleep Apnea
Cognitive Behavioral Therapy
Continuous Positive Airway Pressure
Lead sponsor: Universitair Ziekenhuis Brussel
Sponsor class: OTHER
First posted: 2020-03-13
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Patients follow the fully standard sleep test according to the normal procedure. This means that they undergo a polysomnography and fill in a questionnaire. If according to the questionnaire, there is insomnia, the patient also receives an intake interview to check whether this is indeed the case. If the patient has both disorders and meets the inclusion and exclusion criteria, they will be asked to sign the informed consent. If the patient agrees, the CPAP-therapy will be started as usual, simultaneously with CGT-i. The latter will last 7 weeks and will cover the following points: psycho-education, sleep restriction and sleep hygiene, cognition, relaxation and relapse prevention. Because of the design of this study (starting CGT-I as soon as possible after the diagnosis of OSAS) and the groups already planned for CBT-I, it is not possible for all participants to participate in group cognitive behavioral therapy, therefore individual sessions were provided for these participants. The patient comes for monitoring at set times.


Eligibility criteria: Inclusion Criteria:

* All patients, male and female, with an OSAS diagnosed by full polysomnography and insomnia diagnosed by questionnaires.
* Age between 18 and 75 years
* Dutch as native language

Exclusion Criteria:

* Patients younger than 18 years and older than 75 years
* Patients with a burn-out
* Patients with restless legs
* Pregnant woman
* Patients who work as shift workers
* Patients with severe psychiatric disorder
* Patients who take sleep medication, unless it can be reduced and stopped during cognitive behavior therapy
* Patients with daily alcohol abuse (men \> 3 drinks on any day or 14 per week, women \> 2 drinks on any day or 7 per week)

Primary outcomes:
measure: The number of drop-outs in patients participating in the study.
timeFrame: 12 weeks
measure: CPAP habituation in patients participating in the study.
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Jette
country: Belgium
facility: UZ Brussel
state: Brussels
Study officials:
References:
Clinical trial NCT01979835: GyneFix-Viz*: A Study of Serosal-Anchor (SA) Distance
Official title: GYNEFIX-VIZ*: A STUDY OF SEROSAL-ANCHOR (SA) DISTANCE IN WOMEN IMMEDIATELY AND 6-8 WEEKS FOLLOWING INSERTION
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Contraception
Keywords: intrauterine device, contraception
Lead sponsor: Wiebe, Ellen, M.D.
Sponsor class: OTHER
First posted: 2013-11-08
Enrollment: 1030
Sex: FEMALE
Minimum age (years): 16
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The GyneFix-Viz is a frameless copper intrauterine device (IUD) used for contraception. The GyneFix IUD has been marketed in Europe and Asia for about 10 years. The new anchor in the GyneFix IUD was designed to be more visible on ultrasound and this could improve safety by reducing failed insertions and perforations. We now need to know how easy it is for doctors to see and measure the distance of the anchor to the outside of the uterus. The purpose of this open, prospective, observational study is to assess the feasibility of measuring the distance from the serosa of the uterus to the anchor following insertion of the GyneFix-Viz and at follow-up 6-8 weeks later. Secondary objectives are to assess the ease and pain of insertion, the acceptability of the device to Canadian women and any complications. We will also compare expulsion rates in post-abortion and other women.


Eligibility criteria: Inclusion Criteria:

1. healthy women requesting intrauterine contraception
2. willing to have a GyneFix IUD for pregnancy prevention
3. able to return for a follow-up ultrasound
4. able to read and understand consent form

Exclusion Criteria:

1. Any contraindications precluding insertion of an IUD (e.g., infection, cancer of the uterus, malformation etc.)
2. Immediately after a pregnancy interruption \> 10 weeks gestation

Primary outcomes:
measure: Serosal-anchor Measurement
timeFrame: 6-8 weeks
Secondary outcomes:
measure: Complications
timeFrame: 5 years
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: Willow Women's Clinic
state: British Columbia
Study officials:
affiliation: University of BC
name: Ellen R WIEBE, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00532935: MK0431A vs. Pioglitazone in Patients With Type 2 Diabetes Mellitus (0431A-066)
Official title: A Phase III Randomized, Active-Comparator (Pioglitazone) Controlled Clinical Trial to Study the Efficacy and Safety of the MK0431A (A Fixed-Dose Combination Tablet of Sitagliptin and Metformin) in Patients With Type 2 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Type 2 Diabetes Mellitus
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2007-09-21
Enrollment: 517
Sex: ALL
Minimum age (years): 18
Maximum age (years): 78
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A study to evaluate the efficacy and safety of MK0431A in comparison to a commonly used medication in patients with type 2 diabetes


Eligibility criteria: General Inclusion Criteria:

* Patient has type 2 diabetes mellitus
* Patient is inadequately controlled and not on treatment with insulin or oral antihyperglycemic therapy

General Exclusion Criteria:

* Patient has a history of type 1 diabetes mellitus or history of ketoacidosis
* Patient was on antihyperglycemic agent therapy (oral or insulin) within the prior 12 weeks
* Patient was on \>4 weeks (cumulatively) of antihyperglycemic therapy (oral or insulin) over the prior 3 years

Primary outcomes:
measure: Change From Baseline in A1C at Week 32
timeFrame: Baseline and Week 32
Secondary outcomes:
measure: Change From Baseline in Fasting Plasma Glucose (FPG) at Week 1
timeFrame: Baseline and Week 1
measure: Change From Baseline in 2-hour Post-Meal Glucose (PMG) at Week 32
timeFrame: Baseline and Week 32
measure: Change From Baseline in FPG at Week 32
timeFrame: Baseline and Week 32
measure: Percent of Participants With A1C <7.0% at Week 32
timeFrame: Week 32
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Wainstein J, Katz L, Engel SS, Xu L, Golm GT, Hussain S, O'Neill EA, Kaufman KD, Goldstein BJ. Initial therapy with the fixed-dose combination of sitagliptin and metformin results in greater improvement in glycaemic control compared with pioglitazone monotherapy in patients with type 2 diabetes. Diabetes Obes Metab. 2012 May;14(5):409-18. doi: 10.1111/j.1463-1326.2011.01530.x. Epub 2011 Dec 22.
Clinical trial NCT00002135: An Open-Label Safety Study of Oral Ganciclovir Maintenance Treatment of CMV Retinitis in People With Limited Venous Access
Official title: An Open-Label Safety Study of Oral Ganciclovir Maintenance Treatment of CMV Retinitis in People With Limited Venous Access
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cytomegalovirus Retinitis
HIV Infections
Keywords: Retinitis
Ganciclovir
Administration, Oral
Acquired Immunodeficiency Syndrome
Lead sponsor: NIH AIDS Clinical Trials Information Service
Sponsor class: INDUSTRY
First posted: 2001-08-31
Sex: ALL
Minimum age (years): 13
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: To provide oral ganciclovir to patients who require maintenance for control of cytomegalovirus (CMV) retinitis, but who lack patent permanent central venous access for long-term administration of intravenous drugs.

Detailed description: Patients receive oral ganciclovir as maintenance. Patients enrolled at time of closure of enrollment will receive 2 months of study drug and undergo follow-up.

Eligibility criteria: Inclusion Criteria

Patients must have:

* AIDS.
* Stable CMV retinitis.
* Treatment with IV ganciclovir or IV foscarnet for at least 18 of the past 21 days.
* No permanent central IV catheter at present.
* Had a permanent central IV catheter removed two or more times within the past 6 months due to catheter infection or thrombosis.
* Consent of guardian if less than legal age of consent.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

* Require continuation of concomitant medications precluded by this protocol.

Concurrent Medication:

Excluded:

* Intravitreal anti-CMV treatment.
* Any other concomitant medications precluded by the protocol.

Patients with the following prior condition are excluded:

History of hypersensitivity to acyclovir or ganciclovir.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Roche Global Development - Palo Alto
state: California
Study officials:
References:
citation: Intravenous versus oral ganciclovir: European/Australian comparative study of efficacy and safety in the prevention of cytomegalovirus retinitis recurrence in patients with AIDS. The Oral Ganciclovir European and Australian Cooperative Study Group. AIDS. 1995 May;9(5):471-7.
citation: Drew WL, Ives D, Lalezari JP, Crumpacker C, Follansbee SE, Spector SA, Benson CA, Friedberg DN, Hubbard L, Stempien MJ, et al. Oral ganciclovir as maintenance treatment for cytomegalovirus retinitis in patients with AIDS. Syntex Cooperative Oral Ganciclovir Study Group. N Engl J Med. 1995 Sep 7;333(10):615-20. doi: 10.1056/NEJM199509073331002.
Clinical trial NCT00786786: Perceived Barriers to Exercise in Individuals Living With Spinal Cord Injury
Official title: Perceived Barriers to Exercise in Individuals Living With Spinal Cord Injury.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Spinal Cord Injury
Keywords: Any person with a spinal cord injury
at least 18 years of age
Lead sponsor: University of California, Irvine
Sponsor class: OTHER
First posted: 2008-11-06
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Any person with a spinal cord injury who is at least 18 years of age, lives in the United States of America, and can read English.

Brief summary: Purpose: This project is designed to identify what the key barriers to participating in exercise are for the general population of people living with spinal cord injury (SCI) in the United States (US).

Detailed description: Purpose: This project is designed to identify what the key barriers to participating in exercise are for the general population of people living with spinal cord injury (SCI) in the United States (US).

Background: A previous study of 681 people living with SCI demonstrated that the majority of participants thought that exercise was important (97%), but that only 57% actually had access to exercise (K.D. Anderson. 2004. Targeting recovery: Priorities of the spinal cord injured population. J. Neurotrauma. 21:1371-1383). The next step in continuing that research is to determine in more detail what the perceived barriers to exercise are so that they can be addressed in multiple settings (research design of exercise protocols, community access and awareness, clinical effectiveness, etc.).

Methods: Internet-based survey of people with spinal cord injuries (SCI). Expected Results: It is expected that the perceived barriers will fall under 3 main categories (internal, resources, and structural). However, there may be other barriers we are unaware of, for example, societal or cultural factors or other factors completely unforeseen.

Relevance to Rehabilitation: The findings of this project will provide valuable information needed to design strategies aimed at improving participation in exercise by people living with SCI. SCI results in several secondary health conditions over time, which can likely be positively impacted by exercise.

Eligibility criteria: Inclusion Criteria:

* Any person with a spinal cord injury who is at least 18 years of age, lives in the United States of America, and can read English.

Exclusion Criteria:

* People who cannot read English will not be included because the website will be hosted in English and the survey software (phpQuestionnaire 2.2 by Chumpsoft, Inc.) default language is English.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Irvine
country: United States
facility: University of California, Irvine
state: California
Study officials:
affiliation: University of California, Irvine
name: Kimberly Anderson, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: