louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04535622: Efficacy of Exercise Program for Facedown Posture-related Pain After Retinal Surgery
Official title: A Randomized Controlled Trial to Evaluate Effect of a Structured Rehabilitation Exercise Program on Facedown Posture-related Pain After Retinal Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Macular Holes
Retinal Detachment
Keywords: face-down posture
musculoskeletal pain
vitrectomy
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2020-09-02
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to evaluate the effects of a structured exercise program on musculoskeletal pain of patients in face-down posture after retinal surgery.

Detailed description: After being informed about the study, patients who are planning to get vitrectomy for macular hole or retinal detachment are going to be randomly assigned into two groups; exercise group and control group. All patients are going be admitted to the hospital prior to the surgery. After the surgery is done, the patients are going to maintain a face-down position in the ward until postoperative day 3. After returning to the ward after surgery and completed the pain scoring forms, exercise training is going to be conducted for patients assigned to the exercise group by a physical therapist. Three times of daily self-exercise sessions are going to be performed according to the training provided to the patients. Pain score will be measured on the first, second and the third postoperative days. Patients will be discharged on the third postoperative days.

Eligibility criteria: Inclusion Criteria:

* Patients who are getting vitrectomy for macular hole or retinal detachment and planning to maintain face-down posture.

Exclusion Criteria:

* Pre-existing musculoskeletal disorder.
* low visiual acuity in the opposite eye (best-corrected visual acuity less than 20/200 by snellen chart) making patients hard to get the exercise training.
* Patients with posture prescriptions other than the prone position

Primary outcomes:
measure: Final pain score at back neck, shoulder, and lower back
timeFrame: postoperative day 3
Secondary outcomes:
measure: pain score at back neck, shoulder, and lower back right on surgery day
timeFrame: surgery day
measure: pain score at back neck, shoulder, and lower back on postoperative day 1
timeFrame: postoperative day 1
measure: pain score at back neck, shoulder, and lower back on postoperative day 2
timeFrame: postoperative day 2
Other outcomes:
measure: Patients satisfaction on the exercise program
timeFrame: postoperative day 3
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
affiliation: Samsung Medical Center
name: Se Woong Kang, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02654522: The Use of a Recombinant DNA-based Hyaluronidase to Dissolve Fixed Amounts of Hyaluronic Acid Dermal Fillers
Official title: The Use of a Recombinant DNA-based Hyaluronidase (RDNAH/ Hylenex Recombinant) to Dissolve Fixed Amounts of a Variety of Popular Hyaluronic Acid (HA) Dermal Fillers in Human Subjects.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Dermal Filler
Lead sponsor: Steve Yoelin M.D. Medical Associates, Inc.
Sponsor class: OTHER
First posted: 2016-01-13
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether or not Recombinant DNA-based hyaluronidase (RDNAH/Hylenex recombinant), is safe and effective for dissolving hyaluronic acid (HA) dermal fillers.


Eligibility criteria: Inclusion Criteria:

* Male or female 18 years of age or older
* Able to speak/write in the English language
* Negative Pregnancy Test on Day 1
* Proposed injection site must be free of any active inflammation

Exclusion Criteria:

* Pregnant or breast feeding
* History of keloid formation
* History of allergic reaction to hyaluronic acid dermal fillers, hyaluronidase, or any ingredients of the aforementioned products
* Active, uncontrolled inflammatory condition of any type
* History of allergic reaction to lidocaine

Primary outcomes:
measure: Cutaneous Augmentation Grading Scale (Vartanian et al, 2005)
timeFrame: 2-6 hours post initial injection
Secondary outcomes:
measure: Photography (Volar Aspect) at Site of Injection
timeFrame: 1-6 hours post initial injection day 1, day 2
measure: 3-dimensional (3-D) ultrasound imaging
timeFrame: 1-6 hours post initial injection day 1, day 2
Other outcomes:
Locations:
Study officials:
affiliation: Steve Yoelin M.D. Medical Associates, Inc.
name: Steven G Yoelin, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02142322: Perioperative mFOLFOX-6 in Locally Advanced Gastric Cancer
Official title: A Phase II Trial of Perioperative Chemotherapy With Oxaliplatin, 5-Fluorouracil, Leucovorin(MODIFIED FOLFOX6) in Patients With Locally Advanced Operable Gastric Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Advanced Gastric Cancer
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2014-05-20
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a Phase II Trial of Perioperative Chemotherapy with Oxaliplatin, 5-Fluorouracil, Leucovorin(MODIFIED FOLFOX6)in Patients with Locally Advanced Operable Gastric Cancer.

Detailed description: The main purpose of this study is to evaluate response rate (clinical response and pathological response) of oxaliplatin, 5-fluorouracil, leucovorin(MODIFIED FOLFOX6)

Eligibility criteria: Inclusion Criteria:

* Previously untreated patients with pathologically proven advanced gastric adenocarcinoma with regional LN metastasis are eligible for this study (clinical stage: cT2-4 and N+). At least one measurable regional lymph node metastasis according to the Response Evaluation Criteria in Solid Tumors (RECIST v. 1.0) \[17\] is required. Other eligibility criteria include age between 18 and 75 years, Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1, no prior chemotherapy or radiotherapy, and adequate bone marrow, hepatic and renal function (absolute neutrophil count \[ANC\] ≥ 1.5ⅹ109/L, platelet count ≥ 100ⅹ109/L, total bilirubin ≤ 1.5ⅹupper limit of normal \[ULN\], serum transaminases ≤ 2.5ⅹULN, alkaline phosphatase ≤ 2.5ⅹULN, serum creatinine ≤ 1.5ⅹULN or actual or calculated creatinine clearance ≥ 50 mL/min).

Exclusion Criteria:

* Exclusion criteria include clinical stage T1 tumors, clinical or radiologic evidence of distant metastasis, intestinal obstruction or impending obstruction, active tumor bleeding, interstitial pneumonitis or symptomatic pulmonary fibrosis, peripheral neuropathy of National Cancer Institute Common Toxicity Criteria (NCI-CTC) grade ≥1, pregnant or breastfeeding patients, and other serious diseases.

Primary outcomes:
measure: response rate
timeFrame: 22 weeks
Secondary outcomes:
measure: Grade 3-4 toxicity
timeFrame: one year
measure: median overall survival
timeFrame: 1 year
measure: median time to treatment failure
timeFrame: 1 year
measure: resection rate
timeFrame: 1 year
Other outcomes:
Locations:
city: Seongnam
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Seock-Ah Im, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01188122: Optimal Endotracheal Cuff Pressure During Hospitalization in Intensive Care Units Using AnapnoGuard 100 System
Official title: Optimal Endotracheal Cuff Pressure During Hospitalization in Intensive Care Units Using AnapnoGuard 100 System
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ventilator Associated Pneumonia
Keywords: VAP
Lead sponsor: Hospitech Respiration
Sponsor class: INDUSTRY
First posted: 2010-08-25
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: Hospitech Respiration Ltd has developed the AnapnoGuard system, an innovative system intended to enhance optimal endotracheal tube (ETT) cuff inflation, by monitoring carbon dioxide (CO2) in upper airways of mechanically ventilated patients. Optimal ETT cuff inflation will lead to a reduction of complication rate related to mechanical ventilation procedure.

This study was design in order to evaluate the feasibility of using the AnapnoGuard system.


Eligibility criteria: Inclusion Criteria:

* Age above 18 (men and woman);
* Patient is admitted to ICU and expected to receive mechanical ventilation for at least 48 hours;
* Normal chest X-ray;
* Connection of the ETT to the AnapnoGuard system less than 6 hours from intubation initiation;
* Signed informed consent by subject's legally acceptable representative.

Exclusion Criteria:

* Patients who had been treated with mechanical ventilation during the last year;
* Fever from known chest/lung origin;
* Patients with facial, oropharyngeal or neck trauma;
* BMI\>35;
* Height \< 1.6 m;
* Any chest X-ray pathology during the first 24 hours post intubation;
* More than 7 days hospitalization prior to the intubation. Chest/lung infection.

Primary outcomes:
measure: Recording the changes in optimal ETT cuff pressure and their effectors during the course of mechanical ventilation and intubation in Intensive Care Unit (ICU).
timeFrame: during intubation (2-14 days)
Secondary outcomes:
measure: Adverse events occurrence
timeFrame: During intubation (2-14 days)
Other outcomes:
Locations:
city: Bukarest
country: Romania
facility: Spitalu Universitar De Urgente Elias Hospital
Study officials:
affiliation: Spitalu Universitar De Urgenta Elias Hospital
name: Marian Popescu, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01644422: Study To Determine Safety & Efficacy Of Autologous Human Platelet Lysate in Androgenetic Alopecia After Hair Transplant
Official title: A Prospective Multicentric Open Label Randomized Bio-Interventional Phase I/II Pilot Study To Evaluate Safety & Efficacy Of Autologous Human Platelet Lysate For Treatment Of Androgenetic Alopecia In Patients Undergoing Hair Transplant
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Androgenetic Alopecia
Lead sponsor: Kasiak Research Pvt. Ltd.
Sponsor class: INDUSTRY
First posted: 2012-07-19
Enrollment: 30
Sex: MALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a multicentre, open label, randomized, pilot study to evaluate safety and efficacy of Human Platelet Lysate (HPL) in subjects with Androgenetic Alopecia undergoing hair transplantation. The study is being conducted at 2 centers in India. The primary endpoints are Increase in Hair Follicle viability after transplant, Improvement in Caliber \& Density of hair and Improvement in Photographic assessment from randomization to end of study. The secondary endpoints are Physicians and Patients self assessment score.


Eligibility criteria: Inclusion Criteria:

* Male subjects, aged between 18 to 50 years (both inclusive) and in general good health
* Subjects willing to refrain from other AGA treatments during the entire study duration
* Subjects who are willing to give informed consent and adhere to the study protocol

Exclusion Criteria:

* Subjects aged \<18 or \> 50 years
* Subjects with dermatological disorder of scalp that might interfere with study evaluation
* Subjects on Anti-coagulant therapy
* Subjects with clinically significant medical or psychiatric disease as determined by the investigator.
* Subjects unwilling to or unable to comply with the study protocol.
* Subjects taking concomitant therapy that might interfere with the study results in investigators opinion or participating in another trial in the past 30 days.

Primary outcomes:
measure: Improvement in Calibre & Density of Hair as assessed by Folliscope
timeFrame: Day 0, Month 2, End of Study - Month 4
Secondary outcomes:
measure: Photographic assessment
timeFrame: Day 0, Month 1, Month 2, Month 3, End of Study - Month 4
Other outcomes:
measure: Physician's assessment score
timeFrame: End of Study - Month 4
measure: Patient's self assessment score
timeFrame: End of Study - Month 4
Locations:
city: Thane
country: India
facility: Kasiak Research Pvt Ltd
state: Maharashtra
Study officials:
affiliation: Dr. Rajesh Rajput Hair Restore
name: Rajendarsingh Rajput, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Hairrevive
name: Sandeep Sattur, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01058122: Collection, Evaluation and Assessment of Adverse Drug Reactions on the Oncology Ward
Official title: Collection, Evaluation and Assessment of Adverse Drug Reactions on the Oncology Ward
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Adverse Drug Reactions
Keywords: Adverse drug reactions in patients on the oncology ward
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2010-01-28
Enrollment: 129
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: All patients hospitalized at the oncology ward G and H of the university hospital zurich during the 5-month observation period

Brief summary: The proposed cohort study collected within a 5-month observation period adverse drug reaction (Adverse Drug Events - ADE) in patients at the Department of Oncology at the University of Zurich. ADE have been recorded using prospective monitoring and assessed using standardized algorithms regarding causality and severity. Data sources included information from the medical records, laboratory values and internal rounds. Additional information has been collected using a standardized patient questionnaire.

The primary endpoints of this study are to determine the frequency of ADE, the comparison of the quality of data sources and collection methods for the detection of ADE in regard to patient characteristics, size, number of medications, the category of ADE, severity, causation, diagnosis, hospitalization, cause of hospitalization and medication cause. Secondary endpoint is the assessment of the ADE causality, severity and predictability.


Eligibility criteria: Inclusion criteria:

* German-speaking patients,
* At least 18 years old.

Exclusion criteria:

* Patients who could not give her consent, or have given, and any minor patient.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: University hospital zurich
state: ZH
Study officials:
affiliation: UniversitaetsSpital Zuerich
name: 01 Studienregister MasterAdmins
role: STUDY_DIRECTOR
References:
Clinical trial NCT01585922: Noninvasive Positive Pressure Ventilation in Moderate Acute Respiratory Distress Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Respiratory Distress Syndrome
Keywords: noninvasive positive pressure ventilation
Lead sponsor: Beijing Hospital
Sponsor class: OTHER_GOV
First posted: 2012-04-26
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In order to identify the effect of noninvasive positive pressure ventilation (NPPV) on decreasing inflammatory response, improving the pathophysiological manifestation and reducing the morbidity and mortality in the moderate acute respiratory distress syndrome (ARDS) patients, the investigators conduct this clinical trial comparing NPPV with invasive mechanical ventilation in more than twenty ICUs in China.


Eligibility criteria: Inclusion Criteria:

1. acute onset
2. a clinical presentation of respiratory distress
3. arterial oxygen tension/inspired oxygen fraction (PaO2/FiO2) between 200 mmHg to 300 mmHg. The arterial oxygen tension will be measured in fifteen minutes after NPPV (CPAP 5 cmH2O) was used to the patients stably
4. presence of bilateral pulmonary infiltrate on chest radiograph
5. no evidence of left heart failure as assessed by echocardiography and/or a pulmonary artery wedge pressure( PAWP) \< 18 mmHg

Exclusion Criteria:

1. age \> 70 years or \< 18 years
2. PaCO2 \> 50mmHg
3. Glasgow Coma Scale (GCS)\< 11
4. Upper airway/facial deformity or injury
5. pneumothorax or pneumomediastinum
6. unable to spontaneously clear secretions from their airway
7. respiratory arrest
8. severe ventricular arrhythmia or active myocardial ischemia
9. severe organ dysfunction (including gastrointestinal hemorrhage, disseminated intravascular coagulation, hepatic and renal dysfunction, SOFA score \> 1)
10. severe chronic lung diseases(COPD, Asthma or ILD, et al)
11. end-stage patients who are expected to survive less than six months
12. severe abdominal distension
13. refuse to receive NPPV
14. unable to cooperate with NPPV

Primary outcomes:
measure: all cause mortality
timeFrame: From the date of randomization to the date of discharge from ICU and hospital, or to the date of death of all cause, an expected average of 28 days
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Institute of Respiratory Medicine, Beijing Hospital
state: Beijing
Study officials:
References:
citation: Sun B, He H, Wang Z, Qu J, Li X, Ban C, Wan J, Cao B, Tong Z, Wang C. Emergent severe acute respiratory distress syndrome caused by adenovirus type 55 in immunocompetent adults in 2013: a prospective observational study. Crit Care. 2014 Aug 12;18(4):456. doi: 10.1186/s13054-014-0456-6.
Clinical trial NCT03441022: Continuous Data Collection and Analysis for Stroke Prevention Using a Wearable Sensor
Official title: Continuous Data Collection and Analysis for Stroke Prevention Using a Wearable Sensor
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Atrial Fibrillation
Keywords: Cardioversion
BodyGuardian
Amiigo Wristband
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: Koronis Biomedical Technologies
name: National Institute on Aging (NIA)
First posted: 2018-02-22
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to determine whether a wristband that detects your pulse can detect your heart rate and rhythm similar to electrocardiograms (ECG).

Detailed description: The purpose of this study is to determine whether a wristband that detects your pulse can detect your heart rate and rhythm similar to electrocardiograms (ECG). These wristbands detect your pulse based on a technique called "photoplethysmography," (PPG). PPG is a common method in which an individual's pulse is detected based on a light signature interpreted by the wristband. Most commercially available heart rate monitors use PPG to determine your heart rate, but the accuracy is variable.

Eligibility criteria: Inclusion Criteria:

1. Male or female 18 years of age or older with a primary diagnosis of atrial fibrillation
2. Willing and able to provide informed consent and follow the study protocol
3. Clinically indicated planned restoration of normal rhythm

Exclusion Criteria:

1. Unable to provide informed consent
2. Unable to follow the study protocol
3. Women who are pregnant
4. Subjects with implantable devices (only if participating in phase 2-BodyGuardian processes/testing)

Primary outcomes:
measure: Watch Accuracy during Cardioversion
timeFrame: Duration of cardioversion procedure
measure: Watch Accuracy compared to BodyGuardian
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Mayo Clinic
name: Suraj Kapa, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03004222: A Study to Determine the Effectiveness of Utilizing Intraperitoneal Bupivacaine
Official title: A Randomized Double Blinded Study to Determine the Effectiveness of Utilizing Intraperitoneal Bupivacaine: Does it Reduce Post-operative Opioid Use Following Laparoscopic Appendectomy?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Laparoscopic Appendectomy
Lead sponsor: Metro Health, Michigan
Sponsor class: OTHER
First posted: 2016-12-28
Enrollment: 137
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: The purpose of this research is to determine if spraying a local anesthetic to the cecum after a laparoscopic appendectomy decreases the amount of narcotics (pain medicine) needed after surgery and reduces the time to discharge from the hospital.

Detailed description: The purpose of this study is to determine the effectiveness of using intraperitoneal anesthetic during appendectomy. Subjects will be randomized to receive either 20 mL 0.5% bupivicaine or 20 mL of normal saline (placebo) instilled in the right lower quadrant at the cecum after appendix has been removed. Narcotic consumption will be tracked postoperatively. Hypothesis is that instilling local anesthetic at the cecum during a laparoscopic appendectomy will decrease the amount of narcotic a patient uses postoperatively. Secondarily, this study will attempt to determine if there is a decrease in length of stay for the subjects randomized to the anesthetic infiltration.

Eligibility criteria: Inclusion Criteria:

* Patients 18 years of age and older
* Laparoscopic appendectomy at Metro Health Hospital

Exclusion Criteria:

* Adults unable to consent Non-English speaking patients
* Suspected or known malignant disease
* Patients with known allergies to the local anesthetic
* Utilizes opioid pain medicine for a chronic condition
* Elective laparoscopic appendectomy
* Known allergy or contraindication to ketorolac

Primary outcomes:
measure: Total narcotic use following surgery until the time of discharge from the hospital.
timeFrame: 1, 2, 4 hours
Secondary outcomes:
measure: Time to Discharge
timeFrame: 12 hours
measure: Pain Level Scores at 1, 2, 4, and 12 hours postoperatively
timeFrame: 12 hours
Other outcomes:
Locations:
city: Wyoming
country: United States
facility: Metro Health Hospital
state: Michigan
Study officials:
affiliation: Metro Health Hospital
name: Karlin Sevensma, DO
role: PRINCIPAL_INVESTIGATOR
References: