louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03524391: Effect of Yoga Counselling on Quality of Life and Psychological Outcomes of Prostate Cancer Patients
Official title: Effect of Yoga Counselling on Quality of Life and Psychological Outcomes of Prostate Cancer Patients: Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prostate Cancer
Lead sponsor: NMP Medical Research Institute
Sponsor class: OTHER
Collaborators: name: Warwick Research Services
First posted: 2018-05-14
Enrollment: 92
Sex: MALE
Minimum age (years): 40
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Cancer is second leading cause of death worldwide. The psychological issues are related to all stages of the disease affecting outcome of treatment and overall quality of life. The study evaluated the effectiveness of yoga counselling among prostate cancer patients on their quality of life and psychological outcomes.


Eligibility criteria: Inclusion Criteria:

* Primary diagnosis of Prostate Cancer
* Sign a consent form allowing related information to be included in this research.

Exclusion Criteria:

* Have pre-existing diagnosed psychiatric conditions
* Currently taking psychotropic medications
* Have been diagnosed with cancer other than prostate cancer
* Evidence of active substance abuse.

Primary outcomes:
measure: Anxiety and Depression
timeFrame: Change from baseline to 12 weeks
Secondary outcomes:
measure: Quality of Life
timeFrame: Change from baseline to 12 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Warwick Research Services
name: Neha Sharma, PhD
role: STUDY_DIRECTOR
affiliation: NMP Medical Research Institute, India
name: Dhruv Singh
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01326091: Patient Positioning in Lumbar Fusion Surgery and Its Impact on Spinal Sagittal Balance and Surgeon Satisfaction
Official title: Operative Patient Positioning in Lumbar Fusion Surgery and Its Impact on Spinal Sagittal Balance and Surgeon Satisfaction
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Intervertebral Disk Degeneration
Keywords: Lumbar fusion surgery
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2011-03-30
Enrollment: 7
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: This is a parallel, randomized controlled trial comparing two types of patient positioning and their effect on radiologic measures (pre-surgery visit, in the operating room prior to surgery, at the conclusion of surgery, and at 3 weeks after surgery at patients' postoperative visits) as well as surgeon satisfaction (prior to the end of the surgery) and patient outcomes using patient self reported scales (pre-surgery, post surgery at 3 weeks follow-up).

Detailed description: The investigators are evaluating how patient positioning affects radiologic metrics as well as surgeon satisfaction (surgeon being blinded to positioning). Patients will be allocated to either a hyperlordotic or a standard positioning group by computer generated randomization. Surgeons will perform all of their standard techniques to promote lordosis with instrumentation. Adult patients, ages 18-65, undergoing lumbar surgical fusion will be asked to participate.

Eligibility criteria: Inclusion Criteria:

* Adults patients, aged between 18 and 65 years of age
* Patients undergoing lumbar fusion for degenerative conditions

Exclusion Criteria:

* Patients \< 18 years of age or \> 65 years of age
* Patients who have a history of metastatic disease
* Patients who currently have a pending workman's compensation claim
* Patients who have had a previous spinal surgery
* Patients who have or have had a spinal infection
* Patients who have a spinal deformity, such as scoliosis
* Women who are pregnant
* Inpatients

Primary outcomes:
measure: To assess if the specific intra-operative positioning affects post-operative sagittal alignment
timeFrame: Will be assessed during immediate post-operative period (day 1) as well as 3 weeks post-operatively
Secondary outcomes:
measure: Surgeon satisfaction with operative patient positioning
timeFrame: During surgery (day 1)
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
affiliation: Duke University
name: Oren N Gottfried, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01076491: High Dose Inhaled Mannitol Study
Official title: A Pilot Study to Investigate the Feasibility and Tolerability of Inhaling a High Dose of Dry Powder Mannitol (IDPM) Per Breath Administered Via a Dry Powder Inhaler Loaded With a Single Capsule in Subjects With Bronchiectasis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Bronchiectasis
Lead sponsor: Syntara
Sponsor class: INDUSTRY
First posted: 2010-02-26
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP

Brief summary: This study is to investigate the safety and tolerability of high doses of inhaled mannitol in subjects with bronchiectasis to further direct development of an improved drug delivery system.


Eligibility criteria: Inclusion Criteria:

* adult subjects with non-CF bronchiectasis
* FEV1 \> 50 % predicted and \> 1.0L

Exclusion Criteria:

* bronchiectasis due to CF or endobronchial lesion
* respiratory infection requiring IV antibiotics in last 4 weeks
* pregnancy
* significant haemoptysis in last 6 months
* active TB
* end stage ILD
* contraindications as determined by investigator

Primary outcomes:
measure: emitted dose
timeFrame: single measure
Secondary outcomes:
Other outcomes:
Locations:
city: Sydney
country: Australia
facility: Royal Prince Alfred Hospital
state: New South Wales
Study officials:
References:
Clinical trial NCT05128591: A Study to Compare Pharmacokinetic Parameters and Safety Profiles Between AD-109 and AD-1091
Official title: An Open-label, Randomized, Single-dose, 2-sequence, 2-period, Crossover, Phase 1 Study Under Fed State to Evaluate the Safety and Pharmacokinetics of AD-109 in Healthy Male Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Embolism and Thrombosis
Lead sponsor: Addpharma Inc.
Sponsor class: INDUSTRY
First posted: 2021-11-22
Enrollment: 38
Sex: MALE
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Primary endpoint of this study is to evaluate the pharmacokinetic characteristics of AD-109 in healthy male subjects.

Detailed description: The purpose of this study is to evaluate the pharmacokinetic characteristics and safety profiles of AD-109 compared with AD-1091 in healthy male subjects.

Eligibility criteria: Inclusion Criteria:

* Body weight equal to or greater than 50kg and Body mass index (BMI) between 18.0 kg/m2 and 30.0 kg/m2 at the time of screening visit
* The Age equal to or greater than 19 in healthy male volunteers at the time of screening visit

Exclusion Criteria:

* Patients with Medical history increasing the risk of bleeding

Primary outcomes:
measure: Peak Plasma Concentration (Cmax)
timeFrame: pre-dose to 34 hours
measure: Area Under the Curve in time plot (AUCt)
timeFrame: pre-dose to 34 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: H+ Yangji Hospital
Study officials:
References:
Clinical trial NCT05216991: Sugammadex and Quantitative Monitoring in "Fast-Track Anesthesia" During Liver Transplantation
Official title: The Role of Sugammadex and Quantitative Monitoring in "Fast-Track Anesthesia" During Liver Transplantation
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Liver Transplant Surgery
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2022-02-01
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing liver transplant surgery at Mayo Clinic in Florida. All study participants will receive their routine standard of care intraoperatively which consists of receiving sugmmadex as part of anesthesia, as well as, monitored with a quantitative monitor device on their dominant or nondominant hand, per standard of care.

Brief summary: The purpose of this research is to estimate the frequency of postoperative lasting muscle weakness in patients receiving Sugammadex after undergoing liver transplant surgery by using electromyographic device (EMG), such as TetraGraph.


Eligibility criteria: Inclusion Criteria:

* Patients willing to participate and provide an informed consent.
* Patients undergoing primary liver transplantation.

Exclusion Criteria:

* Patients with unilateral disorders, such as stroke, carpal tunnel syndrome, broken wrist with nerve damage, Dupuytren contracture, or any similar wrist injury.
* Patients with systemic neuromuscular diseases such as myasthenia gravis.
* Patients with a known history of cerebrovascular accident (CVA).
* Patients undergoing repeat liver transplantation or concomitant pancreas/kidney transplantation at the time of liver transplantation.
* Patients admitted to the intensive care unit prior to liver transplantation.

Primary outcomes:
measure: Incidence of postoperative residual weakness in the recovery room
timeFrame: Approximately 10 minutes of surgery recovery period
Secondary outcomes:
measure: ICU Admission
timeFrame: 30 days
measure: Hospital length of stay
timeFrame: 30 days
measure: Postoperative pulmonary complications
timeFrame: 30 days
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: Mayo Clinic Florida
state: Florida
Study officials:
affiliation: Mayo Clinic
name: J. Ross Renew, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00475891: Determination of Genetic Relatedness of Linezolid-resistant Vancomycin-resistant Enterococci (VRE) Surveillance Cultures
Official title: Determination of Genetic Relatedness of Linezolid-resistant Vancomycin-resistant Enterococci (VRE) Surveillance Cultures
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Isolate
Linezolid
Keywords: isolate
infection
linezolid
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
First posted: 2007-05-21
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: isolates for rectal surveillance

Brief summary: The study will help in identifying the best empiric antibiotic option for Linezolid resistant Vancomycin-resistant Enterococci (VRE) infections. This research is important because it allows the determination of resistance rates to antibiotics that may not be frequently tested to by the clinical microbiology laboratory at UPMC-Presbyterian. It also will provide antibiotic minimum inhibitory concentrations (MICs) for these pathogens which may help in identifying the best empiric antibiotic option for Linezolid-resistant VRE infections.

Detailed description: After 20 linezolid-resistant VRE isolates are identified, genetic relatedness will be determined using a method known as Pulse-field gel electrophoresis (PFGE). No patient related data will accompany these isolates, nor will any related identifiers. These isolates will be tested using standardized susceptibility methods. We will then grow each isolate and test via approved laboratory standards (E-test, AB Biodisk, Stockholm, Sweden) to the drug linezolid. Those determined to be resistant using this approved methodology will be saved until 20 isolates are identified. For resistant isolates found, analytical and molecular techniques will be performed to determine the mechanisms of resistance and whether resistant isolates are coming from a single source/being transmitted from person to person.

Eligibility criteria: Inclusion Criteria:

* Dr. Harrison's laboratory collected the rectal surveillance isolates for infection control purposes. The isolates will be from January 1, 2006 to December 31, 2006.

Primary outcomes:
measure: dead or alive
timeFrame: end of study
Secondary outcomes:
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh Medical Center
name: Brian Potoski, Pharm D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00690391: Analysis of Palliative Surgery in View of Quality of Life and Prognosis
Official title: Analysis of Palliative Surgery in View of Quality of Life and Prognosis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cancer
Quality of Life
Keywords: surgery
prognostic
palliation
Lead sponsor: Johann Wolfgang Goethe University Hospital
Sponsor class: OTHER
First posted: 2008-06-04
Enrollment: 250
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with plannes surgery and cancer in he University hospital Frankfurt

Brief summary: The purpose of this study is to define if palliative surgery in patients with cancer improves quality of life and prognosis.

Detailed description: The purpose of this study is to find out if palliative surgery in patients with cancer improves quality of life and prognosis. There will be a scheduled assessment of quality of life and assessment of postoperative complications. prognostic scoring will be performed before surgical intervention.

Eligibility criteria: Inclusion Criteria:

* clinical diagnosis of inoperable cancer
* planned surgery
* able to give interview
* written informed consent

Exclusion Criteria:

* unconsciousness
* psychiatric disorder
* not able to communicate in German

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Frankfurt
country: Germany
facility: University hospital Frankfurt
Study officials:
affiliation: Goethe University
name: Christoph Wullstein, PD DR.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03645291: Comparison of Skin Prick Testing and Intradermal Skin Test Result of Local and Imported Insect Allergen Extracts
Official title: Comparison of Skin Prick Testing and Intradermal Skin Test Result of Local and Imported Insect Allergen Extracts in Patients With Severe Insect Sting Allergy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Allergy to Arthropod Sting
Keywords: insect sting allergy
Hymenoptera allergy
local insect allergen extracts
Lead sponsor: Mahidol University
Sponsor class: OTHER
First posted: 2018-08-24
Enrollment: 27
Sex: ALL
Minimum age (years): 5
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Comparison of skin prick testing and Intradermal skin test result of local and imported insect allergen extracts in patients with severe insect sting allergy
Primary purpose: DIAGNOSTIC

Brief summary: Comparison the results of skin prick testing and Intradermal skin test result of local and imported insect allergen extracts in patients with serious insect sting allergy reactions

Detailed description: The patients with serious insect sting allergy reactions were evaluated and skin prick test and intradermal test with local and imported insect allergen extracts were performed. Specific IgE for insects was also performed. The results of skin prick testing and Intradermal skin test of local and imported insect allergen extracts were compared. The results also compared with specific IgE to insects

Eligibility criteria: Inclusion Criteria:

* Patients with severe insect allergy reaction
* Allow being done skin test and blood foe specific IgE

Exclusion Criteria:

* Serious systemic diseases
* severe asthma
* pregnant or nursing
* severe and extended skin lesion

Primary outcomes:
measure: Comparison of positive skin test results of local and commercial insect allergen extracts
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Siriraj hospital
Study officials:
affiliation: Siriraj Hospital, Mahidol University, Bangkok, Thailand.
name: Nualanong Visitsunthorn, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00224991: Osteoporosis School
Official title: Effect of Training in Prevention of Falls, Compliance to Treatment and Quality of Life: A Randomized, Prospective Investigation.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoporosis
Keywords: osteoporosis
fall frequency
medical treatment
compliance
quality of life
systematic education
Lead sponsor: Northern Orthopaedic Division, Denmark
Sponsor class: OTHER
First posted: 2005-09-23
Enrollment: 350
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP

Brief summary: The purpose of this study is to investigate the efficacy of systematic education (osteoporosis school) on fall frequency, compliance and quality of life of a group of patients more than fifty years of age.

Hypothetically, systematic information can increase compliance to the medical treatment, decrease the frequency of falls and increase the quality of life.

Detailed description: In most randomized trials compliance to medical treatment in osteoporosis is very high, but compliance tends to be considerably inferior in routine treatment compared to scientific trials. This fact is caused by a narrow selection of motivated patients in the randomized trials. Perhaps, the information given to the patients in scientific trials is more thorough than information given in a routine setting.

There are no trials available that document that compliance to medical treatment of patients with osteoporosis can be increased by intensive systematic information.

Change of lifestyle is an important part in the treatment of these patients. The patients are encouraged to eat more healthy food combined with an intake of calcium and vitamins, reduction of alcohol and tobacco consumption if needed and prevention of fall incidence through changes in the house.

The quality of life is often reduced, partly due to chronic pain, altered social status, physical handicap and partly due to the heavy knowledge of having a chronic decease.

Adaption to the last-mentioned factors can possibly lead to a considerably better quality of life in spite of the unchanged physical handicap.

Randomized trials on efficacy of systematic patient education has in general been positive in other contexts. Young patients with diabetes offered coping skills training have therefore a better metabolic control and quality of life.

No similar randomized trials are available on the efficacy of a systematic education program in osteoporosis.

Eligibility criteria: Inclusion criteria:

* fracture caused by osteoporosis
* fifty years or more of age
* informed consent

Exclusion criteria:

- Physically or mental state that does not participation

Primary outcomes:
measure: Fall frequency
Secondary outcomes:
measure: Compliance
measure: Quality of life
Other outcomes:
Locations:
city: Hjoerring
country: Denmark
facility: Northern Orthopaedic Division, Klinik Hjoerring
state: Northern Jutland
Study officials:
affiliation: Northern Orthopaedic Division
name: Annette Jaquet
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01540591: Intralipid for Repeated Implantation Failure
Official title: Does Intralipid Infusion Improve the Implantation Rate in Repeated Implantation Failure: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Infertility
Keywords: repeated implantation failure
intralipid
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2012-02-29
Enrollment: 200
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Intralipid infusion can improve outcome in women with recurrent Intracytoplasmic sperm injection ( ICSI) failure due to elevated TH1 cytokine response.

Detailed description: Infertile patients undergoing Intracytoplasmic Sperm Injection (ICSI) cycle with history of repeated implantation failure, intralipid will be given to the intervention group.

The primary outcome measure is the clinical pregnancy rate, secondary outcome measures implantation rate, ongoing pregnancy rate, abortion rate.

Eligibility criteria: Inclusion Criteria:

* Infertile patients undergoing ICSI cycle with history of repeated implantation failure

Exclusion Criteria:

1. Disturbances of normal fat metabolism such as pathologic hyperlipemia
2. Allergic to it; or to eggs, soybean oil, or safflower oil.
3. Severe liver disease, kidney disease, lung disease, anemia, blood clotting disorder.
4. Uterine fibroid, endometrial polyp, endometriosis and hydrosalpinx.

Primary outcomes:
measure: clinical pregnancy rate
timeFrame: 10 month
Secondary outcomes:
measure: implantation rate
timeFrame: 10 month
measure: ongoing pregnancy rate
timeFrame: 14 month
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Kasr Al-ainy hospital
Study officials:
affiliation: Faculty of medicine, Cairo University, Cairo, Egypt
name: Waleed El-khayat, M.D.
role: PRINCIPAL_INVESTIGATOR
References: