louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05641779: Pigtail Catheter for Drainage of (Pneumothorax/Simple Effusion) is a Effective Procedure
Official title: Pigtail Catheter for Drainage of (Pneumothorax/Simple Effusion) is a Effective Procedure
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pleural Effusion
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2022-12-08
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: all patient full filing my inclusion criteria participate in my study

Brief summary: Assessment and evaluation of Pigtail application in drainage of pneumothorax and haemothorax.

Detailed description: Chest injuries are common following blunt and penetrating trauma. Fewer than 10 per cent of blunt injuries and 15-30 per cent of penetrating injuries require surgical management1. Most can be managed with tube thoracostomy to expand the lung (pneumothorax) or to drain blood (haemothorax)2. Although tube thoracostomy is fairly effective, it can be associated with complications such as mispositioning, malfunction, or injury by insertion through the diaphragm or liver3-5. The standard tube size.

Has usuallybeen32-40Fr.Insertion of such a large -calibre tube requires a cut-down technique, can be traumatic, and is often associated with signiﬁcant pain and discomfort. Pigtail catheters, originally used by cardiologists to drain chronic pericardial effusion6, were later modiﬁed and adapted for pleural drainage7. Because of their small size and reduced trauma during placement, patients may experience signiﬁcantly decreased pain and discomfort. Pigtail catheters are frequently used in the paediatric population8-10, as well as in adult, non-traumatic situations11-17 Pigtail catheters inserted at the bedside have similar efﬁcacy to traditional chest tube.

Eligibility criteria: Inclusion Criteria:

* iatrogenic pneumothorax

Exclusion Criteria:

* Age less than 18 years.
* refused to participate.
* Unconscious.
* spontaneous pneumothorax.

Primary outcomes:
measure: Effective drainage of pleural effusion and pneumothorax
timeFrame: baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut University Hospital
Study officials:
affiliation: Assiut University
name: ali a wahab, profesor
role: STUDY_DIRECTOR
affiliation: Assiut University
name: mahmoud h elnaby, lecturer
role: STUDY_DIRECTOR
References:
citation: Chang SH, Kang YN, Chiu HY, Chiu YH. A Systematic Review and Meta-Analysis Comparing Pigtail Catheter and Chest Tube as the Initial Treatment for Pneumothorax. Chest. 2018 May;153(5):1201-1212. doi: 10.1016/j.chest.2018.01.048. Epub 2018 Feb 13.
Clinical trial NCT05856279: Immediate Effect of Two Selected Mulligan Techniques in Nonspecific Low Back Pain
Official title: Immediate Effect of Two Selected Mulligan Techniques on Lumbar Sagittal Mobility in Nonspecific Low Back Pain
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Back Pain
Keywords: mulligan
lumbar
sagittal
mobility
Back
pain
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2023-05-12
Enrollment: 40
Sex: ALL
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: mulligan SNAG and mulligan lion position
Primary purpose: TREATMENT

Brief summary: To compare between immediate effect of SNAG and mulligan lion position in range of motion (ROM) , pain, functional ability and kinesiophobia on patients with nonspecific low back pain.

Detailed description: Low back pain (LBP) is a global health problem.Orthopedic Manual therapy (OMT) is most commonly recommended form of treatment of LBP and it is also frequently used in clinical practice in various countries. Mulligan introduced a new technique in manual therapy. Mulligan has a great role in the treatment of LBP.General techniques of mulligan are MWM, SNAGs and natural apophyseal glides (NAGs).

Lumber SNAG have immediate and short term on pain and function in treatment of patients with NSLBP.Mulligan has special techniques, one of them is modified lumbar SNAG (lion position) .It has short term effect in reducing pain and activity limitation. Up to investigated knowledge, No previous studies comparing immediate effect of two techniques in range of motion (ROM), pain, functional ability and kinesiophobia

Eligibility criteria: Inclusion Criteria:

1. 3 to 7 on VAS.
2. Back Pain duration of 6 week or more .
3. 20-40 years old .
4. Patients of both sexes will be concluded .
5. body mass index (18.5-29.9 KG/M2).

Exclusion Criteria:

1. fracture, osteoporosis, myelopathy, multiple adjacent radiculopathies, cauda equina syndrome, vertebral bone disease and bony joint instability .
2. Infective conditions of spine, autoimmune disorders, Pacemakers, malignancy .
3. History of surgery or injection at lumbar spine 1 year ago .

Primary outcomes:
measure: ROM
timeFrame: up to 2 hours after technique
Secondary outcomes:
measure: degree of Pain
timeFrame: one week
Other outcomes:
measure: Functional disability
timeFrame: one week
measure: Kinesiophobia
timeFrame: one week
Locations:
city: Beheira
country: Egypt
facility: Samaa Atef Abd El Azeez Mohammed
Study officials:
affiliation: physical therapist at Badr central hospital
name: samaa Mohammed
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01675479: Safety and Effectiveness of Wavefront-Guided LASIK Correction of Hyperopic Refractive Errors
Official title: A Prospective Study to Evaluate the Safety and Effectiveness of Wavefront-Guided Lasik Correction of Hyperopic Refractive Errors With the iDesign Advanced Wavescan Studio™ System and Star S4 IR™ Excimer Laser System
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hyperopia
Keywords: refractive
errors
Lead sponsor: Abbott Medical Optics
Sponsor class: INDUSTRY
First posted: 2012-08-30
Enrollment: 167
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Demonstrate that wavefront-guided LASIK using measurements from the iDesign System is safe and effective for the treatment of Hyperopia.


Eligibility criteria: Inclusion Criteria:

* At least 18 years of age at the time of pre-operative exam
* Best Spectacle Corrected Visual Acuity (BSCVA) of 20/20 or better
* Demonstration of refractive stability
* Anticipated post-operative stromal bed thickness of at least 250 microns
* Willing and capable of returning for follow-up examinations for the duration of the study

Exclusion Criteria:

* Women who are pregnant, breast-feeding, or intend to become pregnant over the course of the study
* Concurrent use of topical or systemic medications that may impair healing
* History of any medical conditions that could affect wound healing
* History of prior intraocular or corneal surgery, active ophthalmic disease, or other ocular abnormality
* Evidence of keratoconus, corneal irregularity, or abnormal topography in the operative eye(s)
* Known sensitivity or inappropriate responsiveness to any of the medications used in the post-operative course

Primary outcomes:
measure: Number of Eyes With a Loss of >2 Lines for Best Spectacle Corrected Visual Acuity (BSCVA)
timeFrame: 12 Months
Secondary outcomes:
measure: Number of Eyes With Uncorrected Visual Acuity (VA) of 20/40 or Better
timeFrame: 12 Months
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Maloney Vision Institute
state: California
city: Miami
country: United States
facility: University of Miami Bascom Palmer Eye Institute
state: Florida
city: Chicago
country: United States
facility: Kraff Eye Institute
state: Illinois
city: Chesterfield
country: United States
facility: Pepose Vision Institute
state: Missouri
city: Kansas City
country: United States
facility: Durrie Vision
state: Missouri
city: Albuquerque
country: United States
facility: Coleman Vision
state: New Mexico
city: Nacogdoches
country: United States
facility: Lehmann Eye Center
state: Texas
city: Fairfax
country: United States
facility: The Eye Center
state: Virginia
city: Renton
country: United States
facility: King LASIK
state: Washington
Study officials:
affiliation: Johnson & Johnson Surgical Vision
name: Johnson & Johnson Surgical Vision Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT02179684: Surgery or Clincial Follow up, in Patients With Bell' s Palsy
Official title: Surgery or Clinical Follow-up in Patients With Bell's Palsy. A Prospective, Parallell, Single Center, Randomized , Open Surgery Clinical Study.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Bell Palsy
Keywords: Cranial Nerve fascial paresis
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
First posted: 2014-07-02
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to investigate if an early surgical intervention on patienst with Bell´s Palsy has a better impact on their facial muscular function and their quality of life as compared to conventional therapy.


Eligibility criteria: Inclusion Criteria:

1. Patients with Bell´s Palsy
2. Men and women aged 18-55 y
3. Score \< 70 according to Sunny Brook scale (SB)
4. Signed informed consent

Exclusion Criteria:

1. High bloodpressure
2. Diabetes
3. Pregnancy
4. Currently on immunodepressive treatment
5. Smoker
6. Psychiatric disorder
7. Cor incomp, according to NYHA grade: IV, kidney or liver disorder, that greatly influence patienst ability to receive surgery

Primary outcomes:
measure: Sunny Brook (SB) score > 70
timeFrame: 1 year
Secondary outcomes:
measure: Facial Disability Index
timeFrame: 15 month
measure: FaCe
timeFrame: 15 month
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Karolinska University Hospital
state: Solna
city: Uppsala
country: Sweden
facility: Uppsala Akademiska Hospital, EENT department
Study officials:
affiliation: Karolinska Institutet
name: Malou Hultcrantz, M.D prof.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01073384: A Dose Ranging Study of Delayed Release Beclomethasone for Prevention of Acute Enteritis in Patients With Rectal Cancer
Official title: A Phase 1/2 Study to Evaluate Escalating Doses of SGX201 [Delayed Release Oral Beclomethasone Dipropionate (BDP)] for Prevention of Signs and Symptoms of Acute Enteritis in Patients With Rectal Cancer Treated With Combined Chemotherapy and Radiation Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Enteritis
Lead sponsor: Soligenix
Sponsor class: INDUSTRY
Collaborators: name: National Cancer Institute (NCI)
First posted: 2010-02-23
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to evaluate the safety and preliminary efficacy of four doses of SGX201 in subjects with rectal cancer treated with concurrent radiation and chemotherapy.


Eligibility criteria: Inclusion Criteria:

* Primary rectal cancer
* Planned course of conventional neoadjuvant radiation therapy before surgery
* Scheduled to receive chemotherapy
* \>/= 18 years of age
* Negative pregnancy test

Exclusion Criteria:

* History of acute or chronic regional enteritis or inflammatory bowel disease
* Stool incontinence
* Uncontrollable diarrhea
* Abdominal-perineal resection or other surgery leaving patient without a functioning rectum
* Patients using colostomy or ileostomy
* Liver function tests \> 3x upper limit of normal, or bilirubin test result \> 1.5 the upper limit of normal
* Calculated creatinine clearance \<60 mL/minute
* Planned hyperfractionated or split course radiation
* Planned brachytherapy prior to completion of all external beam radiation therapy
* Prior pelvic RT
* An on-going infection
* ECOG score \>/= 3
* Leukopenia \<2,000 WBC/mm3 or Hg \<10.5 g/dL
* Participation in an investigational drug trial within the previous 30 days
* Patients with a medical condition that would interfere with study compliance
* Known hypersensitivity to 5-FU or capecitabine
* Anticipated inability to tolerate oral administration of SGX201
* Pregnant or breastfeeding

Primary outcomes:
measure: Preliminary Efficacy
timeFrame: One day prior to and 7 days after radiation therapy
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern University Medical Center
state: Illinois
city: Boston
country: United States
facility: Boston University
state: Massachusetts
Study officials:
affiliation: Soligenix
name: Kevin Horgan, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00916084: Comparative Results of Maxillary Deficiency Treatment by Fixed Tongue Appliance and Fixed Facemask in Growing Patients
Official title: This Study is to Apply the Tongue Force to Correct the Dentofacial Deformities
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Maxillary Deficiency
Lead sponsor: Shahid Beheshti University
Sponsor class: OTHER
First posted: 2009-06-09
Enrollment: 20
Sex: ALL
Minimum age (years): 7
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A new fixed appliance will be used to transfer the tongue force during its physiological activity to advance the nasomaxillary complex; this method will be compared with the traditional method which uses a facemask with a fixed appliance in the mouth.

Detailed description: The above method will be compared with traditional one which uses the facemask in combination with an intra-oral fixed appliance.

Eligibility criteria: Inclusion Criteria:

* Growing patients
* Class III with maxillary deficiency

Exclusion Criteria:

* Previous orthodontic treatment
* Uncooperative patients

Primary outcomes:
measure: Cephalometric angles and clinical features
timeFrame: At least 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Shahid Beheshti Medical University
Study officials:
affiliation: Shaheed Beheshti dental school
name: Rahman Showkatbakhsh, Professor
role: STUDY_CHAIR
affiliation: Shahid Beheshti Dental school
name: Mohammad Behnaz
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01952184: Oocyte Survival After Vitrification in an Open or Closed Device With Closed Storage.
Official title: Oocyte Survival After Vitrification in an Open or Closed Commercial Device: Study on Sibling Donor Oocytes.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Survival
Embryo Quality
Keywords: vitrification
oocyte
donor
open
closed
Lead sponsor: Universitair Ziekenhuis Brussel
Sponsor class: OTHER
First posted: 2013-09-27
Enrollment: 48
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 36
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The survival rate (and embryo quality) of donor oocytes with two commercially available devices.

Detailed description: Donor sibling oocytes will be vitrified with two commercially available devices. The first device is closed vitrification with closed storage and the second device is open vitrification with closed storage. Oocyte acceptors receive oocytes from both devices. With the increase in cooling rate generated by the open vitrification (second device), we expect to get an increase in survival rate of 10%. Besides this, embryo quality will be assessed with oocytes obtained from both devices.

Eligibility criteria: Inclusion Criteria:

* Donor: ≤36 years old on day of oocyte retrieval
* Donor: ≥ 6 mature oocytes

Exclusion Criteria:

* Donor: \< 6 mature oocytes

Primary outcomes:
measure: Survival rate
timeFrame: up to 6 days after every warming cycle
Secondary outcomes:
measure: Embryo development
timeFrame: up to 6 days after every warming cycle
Other outcomes:
Locations:
city: Jette
country: Belgium
facility: Universitair Ziekenhuis Brussel
state: Brussels
Study officials:
affiliation: Centrum voor Reproductieve Geneeskunde, UZBrussel
name: Neelke De Munck, MSc.
role: PRINCIPAL_INVESTIGATOR
References:
citation: De Munck N, Santos-Ribeiro S, Stoop D, Van de Velde H, Verheyen G. Open versus closed oocyte vitrification in an oocyte donation programme: a prospective randomized sibling oocyte study. Hum Reprod. 2016 Feb;31(2):377-84. doi: 10.1093/humrep/dev321. Epub 2016 Jan 2.
Clinical trial NCT01634984: The Diagnostic Technology Applied Research of CDK5RAP2 in Breast Cancer
Official title: The Diagnostic Technology Applied Research of CDK5RAP2 in Breast Cancer
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Breast Cancer
Keywords: expression of CDK5RAP2
Lead sponsor: Tianjin Medical University Cancer Institute and Hospital
Sponsor class: OTHER
First posted: 2012-07-06
Enrollment: 500
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 500 patients with breast cancer

Brief summary: Selected 400 cases of women with primary breast cancer who were treated with operation randomly, then detect the expression of CDK5RAP2 of cancer tissue. At the same time randomly selected 100 women with primary breast cancer who were under neoadjuvant chemotherapy. Detect the expression of CDK5RAP2 before and after neoadjuvant chemotherapy.

Detailed description: The investigators selected 400 cases of women with primary breast cancer who were treated with operation randomly,then detect the expression of CDK5RAP2 of cancer tissue. At the same time randomly selected 100 women with primary breast cancer who were under neoadjuvant chemotherapy. Detect the expression of CDK5RAP2 before and after neoadjuvant chemotherapy.

Eligibility criteria: Inclusion Criteria:

1. Provision of informed consent
2. Pathological confirmation of breast cancer
3. Tumor stage(TNM):T2-4bN0-3M0
4. ER(+) and/or PR(+).
5. Premenopausal woman.
6. Age≥40 years
7. Measurable disease as per RECIST criteria
8. Karnofsky≥70
9. Laboratory criteria:

   * PLT≥100\*109/L
   * WBC≥4000/mm3
   * HGB≥10g/dl
   * ALT and AST\<2\*ULN

Exclusion Criteria:

1. Presence of metastatic disease.
2. Inflammatory breast cancer.
3. Bilateral breast cancer.
4. previous chemotherapy or hormonal therapy for current breast neoplasm.
5. other malignant tumor (concurrent or previous).
6. Pregnant woman.
7. Hypersensitive to any drug in CEF regimen or any ingredient of Zoladex.
8. Any severe systemic disease contraindicating chemotherapy.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Tianjin
country: China
facility: Jin Zhang
Study officials:
affiliation: Tianjin Cancer Hospital
name: Jin Zhang, Pro.
role: STUDY_CHAIR
References:
Clinical trial NCT02962284: One-year, Open Extension to Evaluate the Treatment of Patients With Castration-Resistant Prostate Cancer With YONSA™
Official title: An Open-Label, Single-Arm, Multiple Center Extension Study to Evaluate One Year of Treatment of Patients With Metastatic Castration-Resistant Prostate Cancer With YONSA™ 500 mg (4 x 125 mg qd) With Methylprednisolone (4 mg Bid)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Metastatic Prostate Cancer
Lead sponsor: Sun Pharmaceutical Industries Limited
Sponsor class: INDUSTRY
First posted: 2016-11-11
Enrollment: 20
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is an open-label, single-arm, multi-center extension study to evaluate safety in patients with mCRPC of YONSA 500 mg (4 x 125 mg qd) with methylprednisolone (4 mg bid). Patients will have successfully completed an 84-day treatment with abiraterone acetate in a previous trial. Results from the final visit of the previous study will be used to determine patient's eligibility for this study. Patients in this study will be eligible to receive open-label YONSA with methylprednisolone for up to 12 months. Pharmacodynamic parameters of serum testosterone and PSA levels will be monitored. Disease progression will be assessed by PCWG2 criteria.


Eligibility criteria: Inclusion Criteria:

* Successful completion of 84 days of treatment with YONSA in Churchill Pharmaceuticals clinical trial, CHL-AA-201
* Last dose of YONSA or Zytiga within 45 days prior to treatment in this study
* Written informed consent obtained prior to any study-related procedure being performed
* Has in the investigator's opinion, the potential to gain clinical benefit with YONSA treatment
* Ongoing therapy with a GnRH agonist or antagonist AND serum testosterone level \<50 ng/dL at screening
* Life expectancy of at least 9 months at screening
* Subject is willing and able to comply with all protocol requirements assessments
* Agrees to protocol-defined use of effective contraception.

Exclusion Criteria:

* Serious concurrent illness, including psychiatric illness, that would interfere with study participation
* Inability to swallow tablets whole
* Known hypersensitivity to YONSA, methylprednisolone, or any excipients in study medications
* Moderate to severe hepatic impairment (Child-Pugh Classes B and C)

Primary outcomes:
measure: Number of Subjects With Adverse Events
timeFrame: one year
Secondary outcomes:
measure: Proportion of Subjects With Disease Progression
timeFrame: one year
measure: Testosterone Levels
timeFrame: Baseline and 360 days
measure: Prostate Specific Antigen Levels
timeFrame: One year
measure: Testosterone Complete Suppression
timeFrame: 360 days
measure: Percentage of Subjects With Prostate Specific Antigen - 50 Response
timeFrame: 360 days
Other outcomes:
Locations:
Study officials:
affiliation: Churchill Pharmaceuticals LLC
name: Paul Nemeth, Ph.D.
role: STUDY_DIRECTOR
References: