louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02828475: CALYPSO Pilot Study: Machine Learning Based Predictions of Surgical Complications
Official title: Pilot Study for a Clinical Analytical Platform for Surgical Outcomes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Complication of Surgical Procedure
Postoperative Infection
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2016-07-11
Enrollment: 200
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 high risk general and oncologic abdominal surgery.

Brief summary: This is a pilot study of surgical patients whose postoperative care will be augmented with a personalized risk prediction platform (CALYPSO app).

Detailed description: CALYPSO is a software platform that uses machine learning techniques to create personalized risk predictions for postoperative complications. Individual risk factors are then linked to best-practice interventions tailored to the individual patient. The investigator aims to test the hypothesis that using CALYPSO-augmented postoperative care will reduce complication rates in patients undergoing elective general surgery. Subjects undergoing surgery will be assigned to the CALYPSO intervention in the postoperative period.

Eligibility criteria: Inclusion Criteria:

* \>18 years of age
* Undergoing elective surgery
* Undergoing high risk colon, rectal, pancreas, gastric surgery with predicted length of stay greater or equal to 3 days

Exclusion Criteria:

* Surgeries with less than 3 days of anticipated length of stay (e.g. stoma takedown)

Primary outcomes:
measure: Thirty Day Overall Complications
timeFrame: 30 days after surgery
Secondary outcomes:
measure: Thirty Day Mortality
timeFrame: 30 days after surgery
measure: Wound Complications
timeFrame: 30 days after surgery
measure: Cardiac Complications
timeFrame: 30 days after surgery
measure: Respiratory Complications
timeFrame: 30 days after surgery
measure: Thrombotic complications
timeFrame: 30 days after surgery
measure: Renal Complications
timeFrame: 30 days after surgery
measure: urinary tract infections
timeFrame: 30 days after surgery
measure: Neurologic complications
timeFrame: 30 days after surgery
measure: Septic complications
timeFrame: 30 days after surgery
measure: Unplanned reoperation
timeFrame: 30 days after surgery
measure: unplanned readmission
timeFrame: 30 days after surgery
measure: bleeding complications
timeFrame: up to 72 hours after surgery
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
affiliation: Duke University Department of Surgery
name: Zhifei Sun, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT04077775: Lumbopelvic Biomechanical Variables and TMJ Kinematics Changes in Pregnant Women: A Case-Control Study
Official title: Lumbopelvic Biomechanical Variables and TMJ Kinematics Changes in Pregnant Women: A Case-Control Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pelvic Pain
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2019-09-04
Enrollment: 60
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Observational model: CASE_CONTROL
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 30 women will participate in this study, thirty women diagnosed as having cyclic pelvic pain and thirty women diagnosed as having non cyclic pelvic pain thirty women normal women will not having pelvic pain. They will be selected from outpatient clinic of obstetrics and Gynaecology department in El-Hosary family health Centre.

All participants will be given a full explanation of the protocol of the study and informed consent form will be signed from each subject before participating in the study

Brief summary: The relationship between the pelvis and stomatognathic system:

Various rationales for the relationship between the spine or pelvis and TMJ have been found. These theories include fascial, myological interrelationships, referred pain patterns and facilitating tonic neck reflexes involving inter segmental spinal pathways. A contributing mechanism could be the relationship between how TMJ occlusion, head position and body posture relate to the body's natural neurological visual/vestibular righting mechanism (Blum, 2004).

There is a Correlation between the facial axis together with the lordotic angle and the pelvic inclination, the inner gonial angle and the mandibular plane with the lordotic angle and the pelvic inclination, as well as the facial depth with the pelvic inclination showed a significant correlation (Carsten et al., 2007).


Eligibility criteria: Inclusion Criteria:

* The age of the participants will be ranged from 20 to 40 years. Their body mass index will be ranged from 20 to 25 kg/m2. They will have regular menstrual cycle. They will not receive any hormonal therapy or taking any regular drugs.

Exclusion Criteria:

* Bone disease. Discogenic state with radiculopathy or not. Systemic disease of musculoskeletal system. Any sensory problems. Previous vertebral fractures. Major spinal structural abnormality. Major jaw abnormality. Any jaw orthotics or prosthesis. Missing teeth.

Primary outcomes:
measure: body mass index
timeFrame: 3 months
measure: Satisfaction assessed by the VAS
timeFrame: 3 months
measure: pelvic tilt in degrees:
timeFrame: 3 months
measure: jaw movement
timeFrame: 3 months
measure: Spinal curves Measurement
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Rovan Elbesh
Study officials:
References:
Clinical trial NCT05099575: Protocols for Prevention of PPH During CS in High Risk Group
Official title: Different Protocols for Prevention of Atonic Postpartum Hemorrhage During Cesarean Delivery in High Risk Group
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Atonic PPH
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2021-10-29
Enrollment: 448
Sex: FEMALE
Minimum age (years): 19
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CROSSOVER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Prevention of atonic PPH during CD in high risk group

Brief summary: PPH is one of the most leading causes of maternal mortality,. It means loss of 500 ml blood after vaginal delivery and 1000 ml blood after cesarean delivery. Although it's preventable it represents about 27%of maternal deaths. Atony is the main cause of PPH. 70%of PPH corresponds to uterine atony. Uterotonics like oxytocin, misoprostol, ergometrine, carbetocin and combinations of these drugs can be used but until now there is no agreement on medication that can be the most effective.


Eligibility criteria: Inclusion Criteria:

* 1. Pregnant full term\>37 w 2. Maternal age 19- 40 3.physical state 1\&2 4.patient willing to enter the study

Exclusion Criteria:

* 1.who refuse to participate in study 2.immunocomprmized and patients who had contraindicated from any of drugs used 3.patients with hypersensitivity to any drug

Primary outcomes:
measure: Amount of blood loss
timeFrame: 1 year
Secondary outcomes:
measure: Finding the drug most effective with least adverse effects
timeFrame: 1 year
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01840475: Arm Spasticity - Non-Interventional Study Early BIRD (BoNT Treatment: Initial and Repeated Documentation)
Official title: International, Multicenter, Non-interventional, Prospective, Longitudinal Study to Investigate the Effectiveness of Botulinum Toxin A (Dysport®) Injections in Patients Suffering From Post-stroke Arm Spasticity With Respect to Early, Medium or Late Start of Treatment.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Post-stroke Arm Spasticity
Lead sponsor: Ipsen
Sponsor class: INDUSTRY
First posted: 2013-04-25
Enrollment: 302
Sex: ALL
Minimum age (years): 25
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients suffering from post-stroke arm spasticity registered with Neurological clinics, Rehab centers with BoNT out-patient clinics and neurological practices.

Brief summary: Botulinum toxin A (BoNT-A) is effective and safe in alleviating post-stroke spasticity and reducing the burden of associated symptoms.

The hypothesis for this non-interventional study in arm spasticity (AS-NIS early BIRD) is no significant difference between naïve and pre-treated patients. The patients will be divided in sub-groups according to the time interval between occurrence of stroke and start of treatment (early, medium and late start of treatment according to the first and third quartiles time distribution). It is hypothesized that the "early" start of treatment group will have a reduced modified Ashworth scale (MAS) on the elbow and wrist flexors when compared to the "late" start of treatment group.


Eligibility criteria: Inclusion Criteria:

* Written informed consent prior to data collection
* Hemiparesis and clinically relevant upper limb post-stroke spasticity
* Treated with Dysport® or with the intention to be treated with Dysport® according to local SmPC
* BoNT naïve or pre-treated with any BoNT product

Exclusion Criteria:

* Recurrent stroke
* Sensitivity to Dysport® or to its excipients or any other contraindications as given in the local SmPC for Dysport®

Primary outcomes:
measure: Comparison of modified Ashworth scale (MAS) between patients with early start of treatment and patients with late start of treatment in the overall population (naive and pre-treated).
timeFrame: Final study visit: approximately 20 months after first visit
Secondary outcomes:
measure: Comparison of modified Ashworth scale (MAS) between patients with early start of treatment and patients with late start of treatment in the overall population (naive and pre-treated).
timeFrame: Approximately every 4 months starting from baseline up to 2 years
Other outcomes:
Locations:
city: Hermagor
country: Austria
city: Bidart
country: France
city: Berlin
country: Germany
city: Zwolle
country: Netherlands
city: Bern
country: Switzerland
Study officials:
affiliation: Ipsen
name: Ipsen Medical Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT02580175: Surgical Evacuation of Abortion Under Ultrasonographic Guide
Official title: Surgical Evacuation of First Trimester Missed Miscarriage With or Without Use of Transabdominal Ultrasound
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Abortion
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2015-10-20
Enrollment: 200
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Abortion is considered the most common cause of fetal demise all over the world. The majority of cases occur in the first trimester. The termination of abortion may be by medical or surgical methods, however; the surgical methods represent the greater part of termination. Therefore, the safety of this procedure is a worldwide public health concern. Many clinical studies have reported the safety of surgical evacuation in the first trimester.

The suction-aspiration or vacuum aspiration is the most common surgical method of induced abortion. This consists of removing the fetus, embryo, placenta, and membranes by suction using a manual syringe or electric pump. However; these techniques always need cervical dilation before aspiration. The menstrual extraction does not require cervical dilation and can be used in very early pregnancy.


Eligibility criteria: Inclusion Criteria:

* women with non-viable first trimester intrauterine pregnancy
* no contraindication to surgical evacuation under general anesthesia

Exclusion Criteria:

* gestational age more than 13 weeks
* hemodynamically unstable
* suspicion of an ectopic pregnancy

Primary outcomes:
measure: Measurement of endometrial thickness by ultrasound (mm)
timeFrame: 1 month
Secondary outcomes:
measure: Measurement of blood loss (mL)
timeFrame: 1 month
measure: measurement of operative time (minutes)
timeFrame: 1 month
measure: measurement of Hemoglobin level(g/ml)
timeFrame: 1 month
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Women Health Hospital - Assiut university
Study officials:
References:
Clinical trial NCT00727675: Chronic Pain and Opioid Dependence Assessment and Treatment
Official title: Chronic Pain and Opioid Dependence Assessment and Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Pain
Opioid Dependency
Keywords: chronic pain
opioid dependence
Cognitive Behavioral Therapy (CBT)
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2008-08-04
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study involves the development of an integrated psychotherapy that addresses both chronic pain and opioid dependence(POD).

Detailed description: To conduct a pre-pilot study with 20 POD patients to a) evaluate the acceptability and potential efficacy of specific sessions (i.e., reduced illicit opioid use as assessed by urine toxicology and self-report findings, and decreased pain as evidenced by attenuated pain intensity and pain interference on self-report measures from baseline throughout treatment) for inclusion in integrated Cognitive Behavioral Therapy (CBT) for POD and the sequence of sessions, b) assess patients' satisfaction with integrated CBT as evidenced by qualitative feedback from individual exit interviews, and c) develop and modify initial therapist training and process rating measures. Products will include a) a manual for integrated CBT for POD to be used in opioid treatment programs and primary care settings with POD patients, b) therapist training materials, and c) process rating instruments.

Eligibility criteria: Inclusion Criteria:

* at least 18 years of age
* currently in Methadone Maintenance Treatment (MMT) at the APT Foundation in New Haven, CT
* opioid dependence
* experience moderate to severe chronic pain

Exclusion Criteria:

* current suicide or homicide risk
* are unable to complete the informed consent or surveys because of psychiatric impairment
* have cognitive impairment
* are unable to read or understand English

Primary outcomes:
measure: Reduced illicit opioid use and pain
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale University School of Medicine
state: Connecticut
Study officials:
affiliation: Yale University
name: Declan T. Barry, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Barry DT, Cutter CJ, Beitel M, Kerns RD, Liong C, Schottenfeld RS. Psychiatric Disorders Among Patients Seeking Treatment for Co-Occurring Chronic Pain and Opioid Use Disorder. J Clin Psychiatry. 2016 Oct;77(10):1413-1419. doi: 10.4088/JCP.15m09963.
Clinical trial NCT04805775: Desflurane and Postoperative Sleep Quality in Patients Undergoing Elective Breast Surgery
Official title: Effect of Desflurane on Postoperative Sleep Quality in Patients Undergoing Elective Breast Surgery: A Non-inferiority Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Desflurane
Propofol
Postoperative Sleep
PSQI
Breast Tumor
Lead sponsor: Zhongnan Hospital
Sponsor class: OTHER
First posted: 2021-03-18
Enrollment: 118
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study intends to investigate the effects of desflurane on postoperative sleep quality to guide perioperative patient management.


Eligibility criteria: Inclusion Criteria:

1. Undergoing elective breast surgery
2. Age 18-75 years old
3. ASA-PS grade I or II
4. Those who voluntarily participate in the research and sign the informed consent

Exclusion Criteria:

1. Cognitive impairment (MMSE \<27) before the operation
2. The patients received adjuvant chemotherapy before the operation
3. At present, they are taking psychoactive, opioid, anti-anxiety, and hypnotic drugs
4. Known or treated patients with obstructive sleep apnea
5. Patients with other cancers

Primary outcomes:
measure: Pittsburgh sleep quality index
timeFrame: Postoperative 3rd day
Secondary outcomes:
measure: Pittsburgh sleep quality index
timeFrame: Postoperative 7th, and 30th days
measure: Total sleep time (TST), Rapid eye movement time (REM), Wakefulness after sleep onset (WASO)
timeFrame: Postoperative 1st, 2nd, and 3rd days
measure: Self-Rating Anxiety Scale Scores
timeFrame: Postoperative 3rd, 7th, and 30th days
measure: Self-Rating Depression Scale Scores
timeFrame: Postoperative 3rd, 7th and 30th days
measure: Visual analogue scale scores
timeFrame: Postoperative 3rd, 7th and 30th days
measure: Flurbiprofen dose
timeFrame: Postoperative 1st, 2nd, and 3rd days
measure: Recovery time and quality (steward scores)
timeFrame: Up to 2 hours after operation
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Zhongnan Hospital of Wuhan University
state: Hubei
Study officials:
References:
Clinical trial NCT04303975: The Association of hsCRP and Radiotherapy-Induced Toxicity in Patients With Nasopharyngeal Carcinoma
Official title: An Explorative Study on the Association of High Sensitivity C-Reactive Protein (hsCRP) and Radiotherapy-Induced Toxicity in Patients With Nasopharyngeal Carcinoma
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Nasopharyngeal Carcinoma
Head and Neck Cancer
Toxicity Due to Radiotherapy
Lead sponsor: Jiangmen Central Hospital
Sponsor class: OTHER
First posted: 2020-03-11
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients diagnosed with nasopharyngeal carcinoma during the conducting of this trail at Jiangmen Central Hospital.

Brief summary: The primary purpose of this study is to explore the association of high sensitivity C-reactive protein (hsCRP) and radiotherapy(RT)-induced toxicity in patients with nasopharyngeal carcinoma. In each patient, hsCRP levels in the pre- and post-RT plasma samples will be measured according to the schedule we set.


Eligibility criteria: Inclusion Criteria:

* Patients were pathologically newly diagnosed with nasopharyngeal carcinoma and had no previous history of other tumors
* According to the treatment strategies of doctors, patients need to receive radiotherapy with or without chemotherapy (for example, neoadjuvant chemotherapy, concurrent chemotherapy, adjuvant chemotherapy) or targeted therapy
* Willingness to sign the informed consent and return to enrolling institution for follow-up and data collection

Exclusion Criteria:

* Patients do not conform to the inclusion criteria
* Pregnant or Nursing women
* Men or women of childbearing potential who are unwilling to employ adequate contraception
* Vital organs dysfunction(for example, kidneys, heart, liver, lungs, brain)
* Other contraindications or unsuitable conditions for radiotherapy

Primary outcomes:
measure: hsCRP levels
timeFrame: Through treatments completion，12 weeks
measure: Incidence of adverse events
timeFrame: Through treatments completion，12 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Affiliated Jiangmen Hospital of Sun Yat-Sen University
name: Jiarong Chen, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01191515: Prospective Evaluation of Near and Intermediate Visual Outcomes With Monofocal Intraocular Lenses: The Mast Study
Official title: Prospective Evaluation of Near and Intermediate Visual Outcomes With Monofocal Intraocular Lenses: The Mast Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Patients Implanted With Monofocal Intraocular Lens
Keywords: Previous Cataract patients
Monofocal IOL implant
Evaluation
Lead sponsor: Innovative Medical
Sponsor class: INDUSTRY
Collaborators: name: Staar Surgical Company
First posted: 2010-08-30
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Prospective evaluation of 200 patients male or female at least 18 years of age who have previously undergone phacoemulsification (the break-up and removal of a cataract) between one and 36 months earlier

Brief summary: The purpose of this study is to evaluate the near and intermediate visual outcomes of patients who have undergone routine cataract surgery (removal of cloudy crystalline lens) with phacoemulsification (the break-up and removal of cloudy lens) and monofocal IOL ( a plastic lens implanted to replace eye's natural lens) placement in the capsular bag in at least one eye.


Eligibility criteria: Inclusion Criteria:

* Male or female patients at least 18 years of age
* Patients who underwent routine cataract surgery with phacoemulsification and monofocal iol placement in the capsular bag in at least one eye within the last 36 months
* At least 1 month postop before follow-up evaluation
* All Patients must have a DCVA of 20/25 or better

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Williamsburg
country: United States
facility: Advanced Vision Institute
state: Virginia
Study officials:
affiliation: Advanced Vision Institute
name: Glenn Campbell, MD
role: PRINCIPAL_INVESTIGATOR
References: