louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00676611: Acetabular Fractures of Both Columns
Official title: Both Column Acetabular Fractures With Associated Posterior Deformity Patterns: Implications for Surgical Treatment and Prognosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acetabular Fractures
Both Columns
Keywords: Acetabular Fractures
Lead sponsor: Milton S. Hershey Medical Center
Sponsor class: OTHER
First posted: 2008-05-13
Enrollment: 52
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: The study will include 10 patients who have had column fractures with an associated posterior wall fracture or significantly displaced posterior column fracture that required a separate approach for reduction and/or fixation of the hip performed at Hershey Medical Center by two surgeons, Drs. David Goodspeed and J. Spence Reid over a 12 month period (June 2006 - May 2007). There is no control population.

Brief summary: The purpose of this research is to study a specific acetabular (hip socket) fracture pattern and how its treatment affects the functional, clinical, and x-ray outcomes. There are no experimental procedures involved.

Detailed description: This study will identify a small subset of patients that fall outside the Letournel classification system of acetabular fractures. The fracture pattern, its influence on the surgical treatment decision making process, and the radiographic and outcomes will be detailed. In particular, both-column acetabular fractures with significant posterior deformity have been correlated with poor functional outcomes, increased arthritis radiographically, and worse prognosis in general. Despite these findings, there has been no specific study evaluating these injury patterns to date. We present ten patients with both column acetabular fractures and an associated posterior column/wall piece and their clinical outcomes in an effort to help guide surgical treatment and offer prognostic guidance.

Eligibility criteria: Inclusion Criteria:

* All patients that underwent surgical fixation of the hip at Hershey Medical Center between June 2006 and May 2007 by Dr's J. Spence Reid and David Goodspeed.
* They will include patients that are admitted directly from the field or are transferred from outside hospitals.

Exclusion Criteria:

* will be those acetabular fractures of non-traumatic etiology (e.g.: secondary to malignancy or fatigue)
* fractures that have not undergone operative fixation
* pediatric populations under the age of 18
* mentally compromised patients
* those that do not give consent for the clinical evaluation.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Hershey
country: United States
facility: Penn State Milton S. Hershey Medical Center
state: Pennsylvania
Study officials:
affiliation: Penn State Milton S. Hershey
name: David C Goodspeed, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01416311: Drug Use Investigation for REVOLADE (ITP)
Official title: Drug Use Investigation for REVOLADE (Chronic Idiopathic Thrombocytopenic Purpura)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Purpura, Thrombocytopaenic, Idiopathic
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2011-08-15
Enrollment: 5797
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All Japanese subjects with chronic idiopathic thrombocytopenic purpura who recieve REVOLADE

Brief summary: To investigate safety and efficacy in the actual use of REVOLADE collected from all subjects receiving the drug until data from a specified number of subjects are accumulated to identify factors considered to influence its safety and efficacy.

\<Priority investigation item\> Thromboembolism


Eligibility criteria: Inclusion Criteria:

* Subjects with chronic idiopathic thrombocytopenic purpura

Exclusion Criteria:

* Not applicable

Primary outcomes:
measure: The number of subjects with any adverse events treated with REVOLADE
timeFrame: 1 year
Secondary outcomes:
measure: Appearance of thromboembolism
timeFrame: 1 year
Other outcomes:
Locations:
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
Clinical trial NCT03628911: Study to Evaluate Tetanizing Burst Therapy in Patients Undergoing ICD Replacement
Official title: Evaluation of the Ongoing Safety and Preliminary Efficacy of the Tetanizing Burst Therapy (TBT) System in Subjects Undergoing ICD Replacement Due to End-of-battery Life
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cardiac Electrophysiology
Lead sponsor: EP Sciences
Sponsor class: INDUSTRY
First posted: 2018-08-14
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study evaluates whether the addition of tetanizing burst therapy reduces the pain associated with ICD shocks

Detailed description: The implantable cardioverter defibrillator is a device designed to rescue patients from life-threatening arrhythmias by delivering a defibrillation shock to allow restoration of cardiac rhythm. These defibrillation shocks are extremely painful, owing to sudden rapid contraction of thoracic and abdominal skeletal muscle, which, in addition to the heart, are stimulated by the defibrillation shock. Tetanizing Burst Therapy is a novel electrical waveform which tetanizes skeletal muscle with a brief burst of stimulation prior to the ICD shock, thereby reducing muscular contraction due to the shock. This study is designed for those patients who are already undergoing ICD replacement.

Eligibility criteria: Inclusion Criteria:

* Male or Female age 18-80 years, inclusive
* Ability to understand and provide written informed consent
* Normal sinus rhythm
* Standard transvenous left-sided ICD referred for device replacement due to end of battery life

Exclusion Criteria:

* Heart rate \<40 or \>90 bpm
* Atrial fibrillation or pacemaker dependent
* NYHA Class III/IV symptoms of HF
* MI within 90 days of enrollment
* Severe cardiac ischemia manifested by chest pain at rest or with minimal exercise
* History stroke or TIAs
* History of prior ICD pocket infection
* ICD lead resistance that is too high or too low in the opinion of the investigator
* Female who is pregnant or breastfeeding
* Prior heart transplant
* Serum electrolytes out of normal range at participating institution

Primary outcomes:
measure: Less pain after TBT impulse with ICD shock compared to ICD shock alone
timeFrame: 5 minutes
Secondary outcomes:
measure: The efficacy of tetanizing burst therapy in subjects undergoing ICD replacement as assessed by NRS verbal score
timeFrame: 5 minutes
measure: The safety of tetanizing burst therapy in subjects undergoing ICD replacement as assessed by adverse events
timeFrame: 7 days
measure: The device performance of tetanizing burst therapy in subjects undergoing ICD replacement as assessed degree of muscle contraction (Rate of Force Development)
timeFrame: 5 minutes
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Hospital
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Ronald Berger, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00388011: Efficacy and Safety of Intranasal Morphine for Pain After Bunion Surgery
Official title: Randomized, Double-Blind, Placebo and Comparator-Controlled, Dose-Response Trial of the Efficacy and Safety of Intranasal Morphine, Intravenous Morphine and Placebo in Patients With Moderate to Severe Pain Following Orthopedic Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hallux Valgus
Keywords: Post surgical pain
Bunionectomy
Hammer Toe Syndrome
Morphine
Lead sponsor: Javelin Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2006-10-13
Enrollment: 187
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: Study designed to evaluate the efficacy and safety of Intranasal (IN) Morphine Nasal Spray (MNS075) 3.75 mg, 7.5 mg, 15 mg, and 30 mg, intravenous (IV) morphine 7.5 mg, or IN placebo in patients with moderate to severe post-surgical pain following orthopedic surgery. After initial dosing, up to six (6) doses of IN MNS075 7.5 mg or 15 mg for up to twenty-four (24) hours will be evaluated. The rescue dose remained the same for each.

Detailed description: Diagnosis and Main Criteria for Inclusion:

Healthy adult patients (18 to 76 years old), who scored PS-1 to PS-3 according to the American Society of Anesthesiologists Physical Status Classification System, requiring primary, unilateral, first metatarsal bunionectomy surgery alone or with ipsilateral hammertoe repair without additional collateral procedures.

Eligibility criteria: Inclusion Criteria:

* Requires primary unilateral first metatarsal bunionectomy surgery alone or with ipsilateral hammertoe repair under regional anesthesia. The patient requires collateral orthopedic surgical procedures other than ipsilateral hammertoe repair may not be enrolled into the study.
* 18 years of age or older
* Moderate to severe pain within eight (8) hours following completion of the required bunionectomy surgery

Exclusion Criteria:

* Allergy to shellfish
* Signs of nasal congestion, nasal polyps, mucosal lesions of the nostrils, postnasal drip of any etiology or any clinically significant nasal pathology that may affect the absorption of study medication or the assessment of safety.
* Chronic respiratory insufficiency such that treatment with an opioid analgesic is contraindicated

Additional Inclusion/Exclusion Criteria May Apply

Primary outcomes:
measure: VAS Total Pain Relief 0-4 hours (TOTPAR4)
timeFrame: 4 hours
Secondary outcomes:
measure: Other measures of pain relief
timeFrame: Several time points
Other outcomes:
Locations:
Study officials:
affiliation: Jean Brown Research
name: Douglas G Stoker, DPM
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01565811: Prospective Phase II Trial on Prophylactic Perihepatic Lymphadenectomy in Patients With Colorectal Cancer With Liver Metastasis
Official title: Prospective Phase II Trial on Prophylactic Perihepatic Lymphadenectomy in Patients With Colorectal Cancer With Liver Metastasis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colorectal Cancer With Liver Metastasis
Keywords: colon neoplasm, rectal neoplasm, liver metastasis
Lead sponsor: Gachon University Gil Medical Center
Sponsor class: OTHER
First posted: 2012-03-29
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Biopsy confirmed colorectal cancer with liver metastasis

Brief summary: Objective: To evaluate the role of regional lymphadenectomy in patients with colorectal cancer liver metastasis. Background: Lymph node status is 1 of the most important prognostic factors in oncologic surgery; however, the role of lymph node dissection remains unclear for colorectal cancer liver metastasis.

Detailed description: Lymph node status is a definite prognostic factor in oncologic surgery and significantly affects long-term survival, as reported by the tumor staging system of the International Union Against Cancer (IUCC), which is the most widespread classification of malignant tumors worldwide. Regional lymphadenectomy is already the standard procedure that completes hepatic resection in the case of carcinoma arising from the extrahepatic bile duct. However, the indication, extent, and role of lymph node excision are still a matter of discussion, and no clear guidelines exist in patients with colorectal cancer liver metastasis.

Eligibility criteria: Inclusion Criteria:

1. first hepatectomy;
2. age \<75 years;
3. absence of severe cardiovascular,pulmonary, or other associated diseases;
4. absence of other malignant disease;
5. absence of distant metastases secondary to colorectal cancer other than liver metastases (except a solitary peritoneal tumor that could be completely resected during hepatectomy); and
6. complete resection of liver metastases confirmed during surgery.

Exclusion Criteria:

1. HNPCC
2. FAP
3. patient who refuses perihepatic lymphadnectomy
4. medical condition in which surgery cannot be tolerated

Primary outcomes:
measure: complication rate
timeFrame: within 3months
Secondary outcomes:
measure: To evaluate prognostic significance of perihepatic LN involvement with overall survival and disease free survival
timeFrame: 3 years
Other outcomes:
Locations:
city: Incheon
country: Korea, Republic of
facility: Won-Suk Lee
Study officials:
affiliation: Gil Hospital
name: Won-Suk Lee, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02208011: A Comparison of Rapid Immunoassays for the Detection of Ruptured Membranes
Official title: A Comparison of Rapid Immunoassays for the Detection of Ruptured Membranes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Evidence of Ruptured Membranes in Women Greater Than 15 Weekd
Lead sponsor: Louisiana State University, Baton Rouge
Sponsor class: OTHER
Collaborators: name: Woman's Hospital, Louisiana
name: Clinical Innovations, LLC
name: Louisiana State University Health Sciences Center in New Orleans
First posted: 2014-08-04
Enrollment: 140
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pregnant woman presenting to Woman's Hospital, LSU Baton Rouge Clinic with ruptured membranes.

Brief summary: Specific objectives include analysis of performance of ROM Plus® in diagnosing ROM, as compared to Amnisure® and the conventional clinical assessment confirmed by a thorough chart review after delivery.

Inclusion Criteria:

* English speaking
* pregnant woman \>15 weeks gestation undergoing an exam for ruptured membranes

Exclusion Criteria:

* Known placental previa
* Active vaginal bleeding


Eligibility criteria: Inclusion Criteria:

* complaint of ruptured membranes
* IUP \> 15 weeks gestation
* English speaking, over the age of 18yrs old

Exclusion Criteria:

* active bleeding
* placenta previa

Primary outcomes:
measure: evidence of ruptured membranes
timeFrame: up to delivery of infant
Secondary outcomes:
Other outcomes:
Locations:
city: Baton Rouge
country: United States
facility: Woman's Hospital
state: Louisiana
Study officials:
References:
citation: Igbinosa I, Moore FA 3rd, Johnson C, Block JE. Comparison of rapid immunoassays for rupture of fetal membranes. BMC Pregnancy Childbirth. 2017 Apr 26;17(1):128. doi: 10.1186/s12884-017-1311-y.
Clinical trial NCT06715111: Effect of Laser Acupuncture on Postnatal Pelvic Girdle Pain
Official title: Effect of Laser Acupuncture on Postnatal Pelvic Girdle Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Laser Acupuncture
Pelvic Pain
Post Natal
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2024-12-04
Enrollment: 54
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: this study was done to evaluate the effect of laser acupuncture on pelvic girdle pain postnatal females' patients.

Detailed description: Postnatal pelvic girdle pain might be addressed as a gynecologic challenge in the 21 century in women of all ages and it frequently occur simultaneously. Various forms of postnatal pelvic girdle pain were aggravated by moderate daily activities. Laser acupuncture is a therapeutic modality focuses on selected acupoints in a safe maneuver

Eligibility criteria: Inclusion Criteria:

* Fifty-four women suffering from postnatal pelvic girdle pain, clinically diagnosed by a gynecologist.
* Their ages were ranged from 20-45 years old.
* Their body mass index (BMI) was ranged from 25-29.9 kg/m2.
* They shouldn't have any musculoskeletal or neurological disorders.

Exclusion Criteria:

* Current pregnancy.
* Malignant condition
* History of acute infection
* Neurological problem
* Mental problem to prevent evaluation and cooperation.
* Having uncontrolled metabolic diseases like diabetes and thyroid disease.
* Athletic females.

Primary outcomes:
measure: Assessment of change of body mass index
timeFrame: At baseline and after 4 weeks
Secondary outcomes:
measure: Assessment of change of physical activity restrictions
timeFrame: At baseline and after 4 weeks
measure: Assessment of change of postnatal pelvic girdle pain
timeFrame: At baseline and after 4 weeks
measure: Assessment of change of Salivary Cortisol values
timeFrame: At baseline and after 4 weeks
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Out-patient Clinic of Gynecology department of Mansoura International Hospital, Egypt
Study officials:
References:
Clinical trial NCT04249011: WatchPAT Compared to PSG at 8500'
Official title: Assessment of Sleep-related Respiratory Disorders at High Altitude With the WatchPAT200TMU Compared to PSG.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sleep Disorder; Breathing-Related
Lead sponsor: Itamar-Medical, Israel
Sponsor class: INDUSTRY
First posted: 2020-01-30
Enrollment: 22
Sex: ALL
Minimum age (years): 17
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects referred to a sleep lab for full PSG.

Brief summary: Subjects who consent to participate in the research will undergo a simultaneous recording of inlab PSG and WatchPAT200 for comparing the WatchPAT data to PSG at an altitude of 8500'.

Detailed description: The efficacy of the WP200U will be evaluated by comparing it to the PSG manual scoring of sleep disordered breathing (SDB) parameter using the PSG manual scoring as a "gold standard"

Eligibility criteria: Inclusion Criteria:

* Male and females ≥ age 17yrs
* Subject is able to read understand and sign the informed consent form.
* Willing to sleep with the WP200U and PSG simultaneously in the sleep lab.

Exclusion Criteria:

* Use of one of the following medications: alpha blockers, short acting nitrates (less than 3 hours before the study).

  * Any condition that in the opinion of the investigator may adversely affect the safety of the patient or would limit the patient ability to complete the study.

Primary outcomes:
measure: Comparison of AHI and ODI as scored automatically by the WatchPAT compared to manual scoring of full night PSG.
timeFrame: 8 months.
Secondary outcomes:
Other outcomes:
Locations:
city: Woodland Park
country: United States
facility: Mountain Sleep Diagnostics
state: Colorado
Study officials:
affiliation: Itamar-Medical, Israel
name: Koby Sheffy, Phd
role: STUDY_DIRECTOR
References:
Clinical trial NCT02906111: Vaginal Estriol Before and Vaginal Surgery for Prolapse
Official title: Effects on Vaginal Health and Quality of Life in Postmenopausal Women Using Ultra Low Topic Estriol Before Vaginal Surgery for Pelvic Statics Disorders
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Genital Prolapse
Keywords: Estriol
Prolapse
Quality of life
Vaginal health
Vaginal surgery
Lead sponsor: Policlinico Universitario, Catania
Sponsor class: OTHER
First posted: 2016-09-19
Enrollment: 88
Sex: FEMALE
Minimum age (years): 56
Maximum age (years): 63
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether the vaginal estriol before vaginal surgery for pelvic statics disorders is more efficacy of no estriol treatment on vaginal health and quality of life.

Detailed description: The aim of this randomized study was to evaluate the efficacy of low concentration of vaginal estriol gel (0.005%, 50 micrograms/1 g vaginal gel) in women with pelvic statics disorders before vaginal surgical treatment (group A), assessing the vaginal dryness, dysuria, vaginal maturation index (VMI), pH and the Vaginal Health Index (VHI). Secondary, to investigate the changes of sexual function and QoL. Women without pre surgical estriol treatment constituted the control group (group B).

Eligibility criteria: Inclusion Criteria:

* genital dryness,
* irritation/burning/itching of vulvas or vagina
* decreased lubrication with sexual activity
* discomfort or pain with sexual activity
* decreased arousal, orgasm, desire
* dysuria.

Exclusion Criteria:

* previous surgeries for pelvic organ prolapse
* urinary incontinence
* usage of medication
* chronic medical illness
* body mass index (BMI) ≥ 35 kg/m2
* endometrial thickness equal to or greater than 4 mm
* abnormal uterine bleeding
* hormone-dependent malignancies
* history of thromboembolic disease
* liver disease
* usage of HT for less than 3 months
* usage of phytoestrogens within 1 month before the start of the study
* partner affected by sexual disorder
* conflicting with the partner

Primary outcomes:
measure: Vaginal Health Indexes
timeFrame: vaginal gel containing 50 µg of estriol, daily, for a complete cycle of treatment of 12 weeks
Secondary outcomes:
measure: QoL and sexual function were investigated by the Short Form 36 (SF-36)
timeFrame: vaginal gel containing 50 µg of estriol, daily, for a complete cycle of treatment of 12 weeks
measure: Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire short form (PISQ-12), respectively
timeFrame: vaginal gel containing 50 µg of estriol, daily, for a complete cycle of treatment of 12 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Policlinico Catania
name: Antonio Cianci, Prof
role: STUDY_CHAIR
References:
citation: Caruso S, Cianci S, Amore FF, Ventura B, Bambili E, Spadola S, Cianci A. Quality of life and sexual function of naturally postmenopausal women on an ultralow-concentration estriol vaginal gel. Menopause. 2016 Jan;23(1):47-54. doi: 10.1097/GME.0000000000000485.