louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01109446: Treatment of Lateral Epicondylitis: Platelet Rich Plasma Versus Steroid Versus Saline Solution
Official title: Treatment of Lateral Epicondylitis. Platelet Rich Plasma vs. Steroid vs. Saline Solution
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lateral Epicondylitis
Keywords: Lateral Epicondylitis
Tennis Elbow
Epicondylitis Lateralis
Lead sponsor: University of Aarhus
Sponsor class: OTHER
First posted: 2010-04-23
Enrollment: 60
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: We wish to address the efficacy and safety of Platelet Rich Plasma (blood platelets), a new treatment for lateral epicondylitis (tennis elbow) and compare this new treatment to either injection with steroid or saline solution.

All injections are guided by ultrasonography.

Detailed description: Plate Rich Plasma (PRP) is a new treatment for tendinopathy. A high concentration of blood platelets is made from the patients own blod, and then injected into the tendon. The idea is that the complex mixture of growth factors within the platelets can stimulate the healing process of the tendon. We want to address the efficacy and safety of this new treatment and compare it to either the best documented treatment, Steroid injection, or to a saline solution. We want to make a randomized controlled trial with 60 participants, 20 in each of the 3 groups, and a 12 months follow up. All injections are guided by ultrasonography.

Eligibility criteria: Inclusion Criteria:

* Duration of tennis elbow \> 6 months
* Doppler activity on ultrasonography
* Lateral elbow pain that is maximal over the lateral epicondyle, and increases with pressure on the lateral epicondyle, and resisted dorsiflexion and/or middle finger.

Exclusion Criteria:

* Inflammatory disease.
* Fibromyalgia.
* Pain in hand or shoulder/neck in the same arm as being treated.
* Anticoagulation treatment.
* Wounds around the elbow.
* Treatment with steroids within the last 3 months.

Primary outcomes:
measure: Changes in pain as a continuous outcome measure. Using The Patient-Rated Tennis Elbow Evaluation (PRTEE) questionaire.
timeFrame: first day, 1 months, 3 months, 6 months, 12 months.
Secondary outcomes:
measure: Functional Disability
timeFrame: First day, 1 month, 3 months, 6 months, 12 months
measure: Ultrasonographic changes
timeFrame: first day, 1 months, 3 months, 6 months, 12 months
measure: Adverse events
timeFrame: through out the entire 12 months
measure: Pain induced by the treatment
timeFrame: 1 months after treatment
Other outcomes:
Locations:
city: Silkeborg
country: Denmark
facility: Silkeborg Regional Hospital Department of Reumatology
Study officials:
References:
Clinical trial NCT00209846: A Study of Gaboxadol in Primary Insomnia
Official title: A Prospective Randomised Double-Blind Parallel-Group Placebo-Controlled Study of Gaboxadol in Primary Insomnia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Primary Insomnia
Keywords: Primary insomnia
Lead sponsor: H. Lundbeck A/S
Sponsor class: INDUSTRY
First posted: 2005-09-21
Enrollment: 320
Sex: ALL
Minimum age (years): 66
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To evaluate the safety and tolerability of gaboxadol in primary insomnia.

Detailed description: To obtain long-term safety data in elderly patients with gaboxadol.

Eligibility criteria: Inclusion Criteria:

* patients with a diagnosis of primary insomnia

Primary outcomes:
measure: Safety
measure: Tolerability
Secondary outcomes:
Other outcomes:
Locations:
city: Göteborg
country: Sweden
facility: Non-US study, principal location:
Study officials:
affiliation: H. Lundbeck A/S
name: Please contact: Annelies van der Hammen Legters
role: STUDY_DIRECTOR
References:
Clinical trial NCT02144246: Contraceptive Hormones and Women With Cystic Fibrosis
Official title: Contraceptive Hormones and Women With Cystic Fibrosis: Satisfaction and Effects on Disease
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Cystic Fibrosis Exacerbations While on and Off Hormonal Contraception
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
Collaborators: name: Society of Family Planning
First posted: 2014-05-21
Enrollment: 5
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP

Brief summary: Primary Objective Our primary objective in this study is to evaluate satisfaction of hormonal contraception in this sample of women and to evaluate the impact that this hormonal contraceptive has on cystic fibrosis (CF) disease in women with regular menstrual cycles accompanied by cyclic exacerbations.

We hypothesize:

1a) women with CF who perceive an overall benefit of hormonal contraception will be more satisfied than women with CF who do not perceive a benefit,

1b) women with CF who have cyclic exacerbations will have decreased Pseudomonas aeruginosa mucoidy conversion while using hormonal contraception,

1c) women with CF who have cyclic exacerbations will have improved patient-reported quality of life indices while on hormonal contraception, and

1d) women with CF who have cyclic exacerbations will have improvement in pulmonary function tests while on hormonal contraception.

Secondary Objective We plan to secondarily evaluate the cervical mucus of women with CF at the time of ovulation and compare it to that of healthy controls.

We hypothesize that women with CF have ovulatory cervical mucus similar to healthy peers.


Eligibility criteria: Inclusion Criteria:

* female, reproductive age (18-40), cyclic CF exacerbations, regular menstrual cycles

Exclusion Criteria:

* pregnant, desires pregnancy, contra-indication to hormonal contraception, currently using hormonal contraception

Primary outcomes:
measure: Satisfaction with contraception
timeFrame: 18 months
measure: Exacerbation rate
timeFrame: 18 months
measure: Satisfaction with contraception
timeFrame: 18 months
Secondary outcomes:
measure: Cervical Mucus
timeFrame: 3 months
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Hospital of the University of Pennsylvania
state: Pennsylvania
Study officials:
References:
Clinical trial NCT05886946: Abg in Blunt Chest Trauma
Official title: Arterial Blood Gas as an Early Screening Tool for Predicting Lung Injury in Blunt Chest Trauma
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Blunt Injury of Thorax
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2023-06-02
Enrollment: 150
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: blunt chest trauma

Brief summary: This study aims to determine the value of ABG measurments in patients with blunt chest trauma and its role in prognosis of different outcomes and the results would aid the emergency physicians to speed up the management and reduce the cost of diagnosis


Eligibility criteria: Inclusion Criteria:

- all patient with polytrauma or blunt trauma to chest and thoraco-abdominal area from both genders are included in the study

Exclusion Criteria:

* shocked patients whom were intubated ,patients that had pulmonary disease or heart diseases ,penetrating chest injury ,pregnant female ,patients who do not want to participate in the study

Primary outcomes:
measure: Arterial blood gas as an early screening tool for predicting lung injury in blunt chest trauma
timeFrame: 5 minutes after arrival to emergency
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03684746: Innovation Adoption in Medical Robotic Surgery: Case of Royal Bournemouth Hospital
Official title: Innovation Adoption in Medical Robotic Surgery: Case of Royal Bournemouth Hospital
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Staff Attitude
Lead sponsor: Bournemouth University
Sponsor class: OTHER
Collaborators: name: Royal Bournemouth Hospital
First posted: 2018-09-26
Enrollment: 35
Sex: ALL
Maximum age (years): 90
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Medical experts and hospital staff involved directly on indirectly in Robotic Surgery at the NHS site - these individuals will have the necessary knowledge to contribute to this study.

Brief summary: This research sets to address two key areas. The first is identified by the researcher in academic literature that there is a lack of a comprehensive innovation adoption model in UK National Health System (NHS), specifically for Medical Robotic Surgery. Existing frameworks are mainly developed in the US or in other fields. The second problem was identified by surgeons involved in Robotic Surgery in Royal Bournemouth Hospital (RBH). The project started by offering RBH a deeper understanding of the innovation adoption process, issues and development of an adapted innovation model, however after our initial meeting with the Surgical Director and his team, it was clear that one the main areas RBH was keen for us to investigate, was the communication pathway of all stakeholders involved in robotic surgery adoption. They were concerned that key staff dealing with patients undergoing medical robotic surgery were uninformed about the technology and process which can impact patients' experience and staff communication.

The research will develop a comprehensive innovation adoption model for robotic surgery (and similar medical innovation) in NHS. Currently there are no models adapted to NHS UK structure and requirements. This model will assist the NHS to understand and evaluate any innovation adoption process within the NHS and to avoid future innovation adoption failure.

The case example will Identify the communication pathway and key stakeholders in RBH for the process of Gastrointestinal Robotic Surgery, evaluation of stakeholders' knowledge and needs and further proposing ways to improve adoption and increase knowledge. NHS can use the proposed communication pathway to identify stakeholders that need to be informed, trained and communicated to, in any innovation adoption process within NHS.


Eligibility criteria: Inclusion Criteria:

Being involved with conducting Robotic Surgery or caring for patients undergoing Robotic Surgery

Exclusion Criteria:

-

As this study is recruiting staff, and there is no medical intervention, the eligibility criteria is basic.

Primary outcomes:
measure: Surgical Innovation Framework
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Bournemouth
country: United Kingdom
facility: Royal Bournemouth Hospital
Study officials:
References:
Clinical trial NCT04490746: Identifcation of Biomarkers for Active Pulmonary Tuberculosis
Official title: Identifcation of Biomarkers for Active Pulmonary Tuberculosis Using a Metabolomics Approach: a Prospective Multicenter Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Tuberculosis
Diagnosis
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
First posted: 2020-07-29
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with active tuberculosis and latent tuberculosis infection

Brief summary: This experiment is designed to analyze the metabolites in body fluids from patients with active tuberculosis and latent tuberculosis infection also with health volunteer, then combine the metabolic product features with clinical characteristics, to develop a kind of metabolites targets to evaluate the progress in tuberculosis, thus provide a basis for further utilization of humoral metabolites in the diagnosis of tuberculosis.


Eligibility criteria: Inclusion Criteria:

* patients with active tuberculosis and latent tuberculosis infection

Exclusion Criteria:

* have other serious health problems

Primary outcomes:
measure: metabolic product
timeFrame: 24 hours after sampling
Secondary outcomes:
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Department of Ultrasound, Second Affiliated Hospital, School of Medicine, Zhejiang University
state: Zhejiang
Study officials:
affiliation: Second Affiliated Hospital, School of Medicine, Zhejiang University
name: Pintong Huang
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01241110: To Compare Ofloxacin With Azitromycin for Pelvic Inflammatory Disease (PID) Treatment
Official title: Phase 4 Study of Azitromicin in the Treatment of PID
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pelvic Inflammatory Disease
Keywords: PID, Ofloxacin, Azitromicine, Metronidazole
Lead sponsor: Guilan University of Medical Sciences
Sponsor class: OTHER
First posted: 2010-11-16
Enrollment: 100
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Objective: To compare two oral treatments: Ofloxacin + Metronidazole, and Azitromycin +Metronidazole in outpatients with Pelvic Inflammatory Disease.

Materials and Methods: Two hundred patients divided to two groups( A , B). Group A (treated by Ofloxacin 400 mg. + Metronidazole 500mg) and Group B (a single dose of oral Azitromicine 1gr + Metronidazole 500mg) for 10 days, were compared in terms of side effects and efficacy

Detailed description: Two hundred patients divided to two groups( A , B). Group A (treated by Ofloxacin 400 mg. + Metronidazole 500mg) and Group B (a single dose of oral Azitromicine 1gr + Metronidazole 500mg) for 10 days, were compared in terms of side effects and efficacy

Eligibility criteria: Inclusion Criteria:Eligibility criteria were having three out of five following symptoms: a-lower abdominal pain, b-vaginal discharges, c- adnexal tenderness, d-cervical motion tenderness (CMT), e-cervisitis.

-

Exclusion Criteria:Excluding criteria were as follows: a-unmarried women, b-pregnant women, c-women with infection during menstruation, d- history of abortion or miscarriage during the last month, e-underlying diseases such as diabetes, f-used antibiotics in the last month, or allergy to the antibiotics used in the study, g-history of Pelvic Inflammatory Disease within the last year, and h- suspicion of being multi partner.

-

Primary outcomes:
measure: to compare two oral antibiotic protocols in terms of side effects and efficacy.
timeFrame: Jan 2010- Aug 2010
Secondary outcomes:
measure: single oral dose of Azitromicine could be the drug of choice in the outpatient treatment of Pelvic Inflammatory Disease
timeFrame: Jan 2010- Aug 2010
Other outcomes:
Locations:
city: Rasht
country: Iran, Islamic Republic of
facility: Alzahra Maternity Hospital
state: Guilan
Study officials:
affiliation: Guilan University of Medical Sciences
name: Fariba Mirblook, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00674310: A Single-Dose, 2-Period, 2-Treatment, 2-Way Crossover Bioequivalency Study of Ropinirole 0.25 mg Tablets Under Fed Conditions
Official title: A Single-Dose, 2-Period, 2-Treatment, 2-Way Crossover Bioequivalency Study of Ropinirole 0.25 mg Tablets Under Fed Conditions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson's Disease
Restless Leg Syndrome
Lead sponsor: West-Ward Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2008-05-07
Enrollment: 29
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The objective of this study was to assess the single dose bioequivalence of Roxane's Ropinirole tablets,0.25 mg, to ReQuip Tablets, 0.25 mg (GlaxoSmithKline) under fed conditions using a single dose, randomized, 2-treatment, 2-period, 2-sequence cross-over design.

Detailed description: The objective of this study was to assess the single dose bioequivalence of Roxane's Ropinirole tablets,0.25 mg, to ReQuip Tablets, 0.25 mg (GlaxoSmithKline) under fed conditions using a single dose, randomized, 2-treatment, 2-period, 2-sequence cross-over design.

Eligibility criteria: Inclusion Criteria:

* No clinically significant abnormal finding on the physical examination, medical history, or clinical laboratory results during screening

Exclusion Criteria:

* Positive test for HIV, Hepatitis B, or Hepatitis C.
* Treatment with known enzyme altering drugs.
* History of allergic or adverse response to ropinirole or any other comparable product.

Primary outcomes:
measure: Bioequivalence
timeFrame: Baseline, Two period, seven day washout
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: SFBC Anapharm
name: Richard Larouche, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06365710: Physiotherapy vs Telerehabilitation After Volar Plating of Distal Radius Fracture
Official title: A Randomized Controlled Trial Comparing Traditional Physiotherapy vs Telerehabilitation After Volar Plating of Distal Radius Fracture: a Study Protocol
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Orthopedic Procedures
Physical Therapy Modalities
Postoperative Care
Rehabilitation
Wrist Fractures
Lead sponsor: Töölö Hospital
Sponsor class: OTHER
First posted: 2024-04-15
Enrollment: 84
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: Trial purpose is to research the outcome comparing traditional physiotherapy vs telerehabilitation after volar plating of distal radius fracture.

Patients with distal radius fracture that meet the operative criteria set by the Finnish Current Care guidelines are randomized (1:1 computer generated sequence with random block size) to two parallel groups and will undergo operative treatment and traditional physiotherapy vs telerehabilitation.

Baseline data is collected preoperatively and patients are followed at 1, 3 and 12 months after enrollment. The primary end-point is 3 months and the primary outcome is the Patient-Rated Wrist Evaluation (PRWE).


Eligibility criteria: Inclusion Criteria:

* Distal radius fracture, which applies the surgical requirements
* age between 18 to 65 years
* Non concomitant injuries including ligament injuries and distal ulna fractures, however ulnar styloid avulsion is accepted
* No significant comorbidities
* No previous problems with the examined hand
* Ability to understand Finnish fluently

Exclusion Criteria:

* High energy or multiple injuries
* Open fractures
* Injury of both upper extremities
* Other operative injury on the same side
* Rheumatoid arthritis of other inflammatory joint disease
* Heavy smoker (over 20 cigarettes per day)
* Disease of medication slowing ossification
* Alcohol or drug abuse
* Psychiatric disorder with poor treatment balance
* Neurological disorder which affects the function of the injured extremity
* Fixation material other than a volar locking plate
* Fracture fixation is not stable enough to start rehabilitation after 14 days

Primary outcomes:
measure: Patient-Rated Wrist Evaluation (PRWE)
timeFrame: 12 months
Secondary outcomes:
measure: Grip strength
timeFrame: 12 months
measure: Quick Disabilities of the arm, shoulder, and hand
timeFrame: 12 months
measure: Pain (Visual Analogue Scale)
timeFrame: 12 months
measure: Wrist range of motion (ROM)
timeFrame: 12 months
measure: Adverse events
timeFrame: 12 months
measure: Global improvement
timeFrame: 12 months
measure: Patient-rated Quality of Life (EQ-5D)
timeFrame: 12 months
measure: Cost-utility analysis
timeFrame: 12 months
Other outcomes:
Locations:
city: Helsinki
country: Finland
facility: Division of Musculosceletal and Plastic Surgery, Hand Surgery Unit, Helsinki University Hospital
state: Uusimaa
Study officials:
References:
Clinical trial NCT00907010: Sarcopenia and Aging
Official title: Sarcopenia and Aging
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sarcopenia
Keywords: Ageing
Sarcopenia
Muscular contraction
Lead sponsor: Universidade de Franca
Sponsor class: OTHER
First posted: 2009-05-21
Enrollment: 48
Sex: ALL
Minimum age (years): 11
Maximum age (years): 82
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 48 individuals participated in this study, being divided into four groups according to the age: (G1) 11to 18 years old, (G2) 20 to 26 years old, (G3) 45 to 60 years old and (G4) 66 - 82 years old.

Brief summary: Objective: Evaluate the muscular strength in the ageing process and identify the changes between the abdominal muscles, upper and louver edges.

Method: 48 individuals participated in this study, being divided into four groups according to the age: (G1) 11to 18 years old, (G2) 20 to 26 years old, (G3) 45 to 60 years old and (G4) 66 - 82 years old. The excluding criterion included people who work out more than three times a week, severe arthrosin, stroke, significant cognitive deficit , obesity, use of ortheses for louver members or any break, with or without metallic implant. The evaluation instruments used were: (1) Esfigmomanômetro (EM), (2) Trunk flexor in the supine position,, (3) Jamar Dinamômetro and (4) Preston Pinch Gauge Dinamômetro.

Detailed description: Forty-eight subjects participated voluntarily in this work and is divided into four groups of 12 participants with 6 men and 6 women: (G1) 11 to 18 years (G2) 20 to 26 years (G3) from 45 to 60 and (G4) 66 to 82 years, selected in dependency of Unifran and residences of the city of Franca, Sao Paulo - Brazil. To evaluate muscle strength, a BD sphygmomanometer was used to analyze the strength of flexors and extensors of the knee. The Jamar Dynamometer was used to assess the functional integrity of the upper and Preston Pinch Gauge Dynamometer for evaluation of gripper hands.

Eligibility criteria: Inclusion Criteria:

* absence of the basic pathology that interferes directly in the muscle

Exclusion Criteria:

* people who work out more than three times a week
* severe arthrosin
* stroke
* significant cognitive deficit
* obesity
* use of ortheses for louver members or any break
* with or without metallic implant

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Universidade de Franca
name: Lislei Patrizzi
role: STUDY_DIRECTOR
References: