louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03241849: Surgical Technique To Control Postpartum Hemorrhage
Official title: New Surgical Technique To Control Postpartum Hemorrhage Due To Placenta Accreta
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post Partum Hemorrhage
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2017-08-08
Enrollment: 110
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: Placenta accreta is an obstetrical complication where the placenta becomes firmly adherent to the uterine wall. Placenta accreta can lead to considerable maternal morbidity and mortality due to hemorrhage, infection, or other surgical complications such as those resulting from hysterectomy. Retained placenta accreta is usually a rare condition, but its prevalence is increasing due to the rise in the rate of deliveries by Cesarean section.

Placenta accreta is a potentially life-threatening obstetric condition that requires a multidisciplinary approach to management. The incidence of placenta accreta has increased and seems to parallel the increasing cesarean delivery rate. Women at greatest risk of placenta accreta are those who have myometrial damage caused by a previous cesarean delivery with either an anterior or posterior placenta previa overlying the uterine scar. Diagnosis of placenta accreta before delivery allows multidisciplinary planning in an attempt to minimize potential maternal or neonatal morbidity and mortality.


Eligibility criteria: Inclusion Criteria:

1. Estimated gestational age between 34 -40 weeks .
2. Presence of total or focal parts of placenta accreta "morbidly adherent placenta" .
3. Cases with mild vaginal bleeding or not having any vaginal bleeding

Exclusion Criteria:

1. Severe attack of bleeding require an immediate intervention.
2. Associated with placental abruption
3. Patients with known bleeding disorders or on anticoagulant therapy.
4. Preoperative decision to do peripartum hysterectomy.

Primary outcomes:
measure: Amount of blood loss (mL)
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Women Health Hospital - Assiut university
Study officials:
References:
Clinical trial NCT00432549: Detoxification and Treatment of Subjects With Medication Overuse Headache
Official title: Evaluation of Almotriptan and Topiramate in the Detoxification and Treatment of Subjects With Medication Overuse Headache
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Analgesic Rebound Headache
Keywords: Medication overuse
Lead sponsor: The New England Center for Headache, P.C.
Sponsor class: OTHER
Collaborators: name: Ortho-McNeil Neurologics, Inc.
First posted: 2007-02-08
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to assess the benefits of almotriptan used as a transitional therapy and topiramate in subjects with medication overuse headaches (MOH.


Eligibility criteria: Inclusion Criteria:

* Medication overuse headaches 18 years of age and older Must have a diagnosis of probable medication overuse headache Must have greater than fifteen headache days per month Must be in generally good health Female subjects must be postmenopausal or practicing an acceptable method of birth control

Exclusion Criteria:

* Not overusing six or more tablets per day of compounds containing barbituates opioids No overuse of triptans Previous failure or side effects with topiramate or almotriptan Cannot be pregnant or lactating

Primary outcomes:
measure: Primary measure for the detoxification period
measure: Number of days with mild or no pain in the first two weeks of treatment
measure: Primary for the prevention of relapse
measure: Pain free days through day ninety
Secondary outcomes:
measure: Primary measure for the detoxification period
measure: Number of days without any headache in the first two weeks of treatment
measure: Primary for the prevention of relapse
measure: Headache frequency through day ninety
Other outcomes:
Locations:
city: Stamford
country: United States
facility: The New England Center for Headache, P.C.
state: Connecticut
Study officials:
affiliation: The New England Center for Headache, P.C.
name: Fred D Sheftell, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04202549: Improving Neuroprotective Strategy for Ischemic Stroke With Sufficient Recanalization After Thrombectomy by Intra-arterial Cocktail Therapy (INSIST-CT)
Official title: Improving Neuroprotective Strategy for Ischemic Stroke With Sufficient Recanalization After Thrombectomy by Intra-arterial Cocktail Therapy (INSIST-CT): a Prospective, Single Arm, Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ischemic Stroke
Lead sponsor: General Hospital of Shenyang Military Region
Sponsor class: OTHER
First posted: 2019-12-17
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Thrombolysis and endovascular thrombectomy are the most efficient treatments for acute ischemic stroke patients in time window. Although sufficient recanalization after thrombectomy is more than 80%, HERMES study indicated that nearly half of the ischemic stroke patients under thrombectomy suffered obvious disability. Artery reocclusion, hemorrhagic transformation, and no-reflow phenomenon are among the most important reasons of poor prognosis of acute ischemic stroke patients. The investigators speculate that a combination of argatroban, edaravone, and glucocorticoid may be helpful in preventing artery reocclusion, hemorrhagic transformation, and no-reflow phenomenon. This study intends to explore the safety, feasibility and efficacy of thrombectomy with sufficient recanalization bridged by intra-arterial cocktail therapy in acute ischemic stroke patients.


Eligibility criteria: Inclusion Criteria:

1. Age ≥18 years.
2. Patients who presented with acute ischemic stroke and a large vessel occlusion in the anterior circulation and met the criteria of mechanical thrombectomy.
3. Sufficient recanalization （TICI 2b-3）within 7 hours of stroke onset.
4. The availability of informed consent.

Exclusion Criteria:

1. insufficient recanalization（TICI \< 2a）after endovascular treatment;
2. Hemorrhagic stroke: cerebral hemorrhage, subarachnoid hemorrhage.

4. Coagulation disorders, systematic hemorrhagic tendency, thrombocytopenia （ \<100000/mm3）.

5. Severe hepatic or renal dysfunction, increase in ALT or AST (more than 2 times of upper limit of normal value), increase in serum creatinine (more than 1.5 times of upper limit of normal value) or requiring dialysis.

6. Severe uncontrolled hypertension (systolic blood pressure over 200mmHg or diastolic blood pressure over 110 mmHg).

7. Patients with contraindication or allergic to any ingredient of drugs in our study.

8. Unsuitable for this clinical studies assessed by researcher.

Primary outcomes:
measure: Proportion of favorable outcome
timeFrame: 90 days
Secondary outcomes:
measure: Proportion of excellent outcome
timeFrame: 90 days
measure: proportion of early neurological improvement
timeFrame: 48 hours
Other outcomes:
measure: incidence of symptomatic intracranial haemorrhage
timeFrame: 48 hours
Locations:
city: ShenYang
country: China
facility: General Hospital of Northern Theater Command
Study officials:
References:
Clinical trial NCT05165849: A Study of GFS101A in Combination With Toripalimab in Patients With Advanced Solid Tumors
Official title: A Multicenter, Open-label, Phase I/Ⅱ Study to Evaluate the Safety/Tolerability, Pharmacokinetics, and Efficacy of GFS101A in Combination With Toripalimab Treating Patients With Advanced Solid Tumors
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
PHASE2
Conditions: Solid Tumor
Lead sponsor: Genfleet Therapeutics (Shanghai) Inc.
Sponsor class: INDUSTRY
First posted: 2021-12-21
Enrollment: 0
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: The purpose of this study is to evaluate the safety/tolerability, pharmacokinetics, and efficacy of GFS101A in combination with Toripalimab in patients with advanced solid tumors.


Eligibility criteria: Inclusion Criteria:

1. Voluntarily participate in this clinical trial, and are willing to sign informed consent forms.
2. Male or female aged from 18-75 years old (inclusive).
3. Diagnosed with histologically or cytologically confirmed advanced solid tumors.
4. Evaluable lesions defined by RECIST v1.1.
5. Eastern Cooperative Oncology Group performance status of 0 to 1.
6. Subjects or their legal representatives are able to communicate well with Investigators and are willing to comply with the protocol and complete the study.

Exclusion Criteria:

1. With clinically significant cardiac diseases
2. With clinically significant digestive disorders.
3. Other severe disease.
4. Pregnant or lactating women.
5. Other unfavorable situations for subjects to participate in the study judged by Investigators.

Primary outcomes:
measure: Phase I：Incidence of dose limiting toxicity (DLT) events
timeFrame: 21days
measure: Phase II: Overall response rate (ORR) per RECIST 1.1
timeFrame: approximately 12 months after first dose
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05866549: The Effect of The Mindfulness-based Childbirth and Parenting Program
Official title: The Effect of The Mindfulness-based Childbirth and Parenting Program on Prenatal Attachment and Depression, Stress, Anxiety Levels of Pregnants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pregnancy Related
Lead sponsor: Ankara University
Sponsor class: OTHER
First posted: 2023-05-19
Enrollment: 36
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The aim of this study is to determine the effect of Mindfulness-based childbirth and parenting program on prenatal attachment and depression, stress and anxiety levels of pregnants.

The study will be carried out in two different groups. After the pregnants are evaluated in terms of eligibility criteria for the research, the pregnants who are eligible will be informed about the research and written informed consent will be obtained from the pregnants who accept. The random distribution of pregnants to the study groups will be carried out random. The following applications will be made to the groups.


Eligibility criteria: Inclusion Criteria:

* Being at 20-30 weeks of gestation
* Being nulliparous

Exclusion Criteria:

* History of psychiatric illness
* Follow-up in the risky pregnancy clinic
* Not completing the study

Primary outcomes:
measure: Prenatal Attachment Inventory
timeFrame: immediately after participants are assigned to groups and eight weeks later
measure: Depression Anxiety Stress Scale- 21 (DASS 21)
timeFrame: immediately after participants are assigned to groups and eight weeks later
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara University Cebeci Hospital
Study officials:
References:
Clinical trial NCT02730949: D-chiro-Inositol in Overweight Type 1 Diabetes Patients
Official title: A Pilot Study of D-Chiro-Inositol Plus Folic Acid in Overweight Patients With Type 1 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Type 1 Diabetes
Keywords: D-Chiro-Inositol, type 1 diabetes
Lead sponsor: Campus Bio-Medico University
Sponsor class: OTHER
First posted: 2016-04-07
Enrollment: 26
Sex: ALL
Minimum age (years): 17
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this pilot study was to evaluate the effect of D-chiro-Inositol (DCI) oral supplementation in addiction to folic acid compared to folic acid alone on glycaemic control as assessed by HbA1c in overweight or obese T1D patients undergoing intensive insulin therapy.

A 24 weeks, prospective, randomized control trial was carried out in T1D patients, aged 17-50 years (13 males, 13 females), with disease duration \> 1 year and BMI \>25, attending as outpatients the Endocrinology and Diabetes Unit of University Campus Bio-Medico in Rome


Eligibility criteria: Inclusion Criteria:

* T1D patients
* aged 17-50 years
* disease duration \> 1 year
* BMI \>25

Exclusion Criteria:

* learning disabilities
* presence of chronic conditions potentially able to influence daily activities (visual or auditory disability, motor impairment for neurological or orthopaedic problems).
* T1D patients affected from diabetic complications
* pregnancy

Primary outcomes:
measure: efficacy of DCI oral supplementation on metabolic control
timeFrame: 6 months
Secondary outcomes:
measure: BMI kg/m2
timeFrame: 6 months
measure: Insulin Requirement (I.R.) IU/kg
timeFrame: 6 months
Other outcomes:
Locations:
city: Rome
country: Italy
facility: University Campus Bio Medico
Study officials:
affiliation: University Campus Bio-medico
name: Paolo Pozzilli, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Maurizi AR, Menduni M, Del Toro R, Kyanvash S, Maggi D, Guglielmi C, Pantano AL, Defeudis G, Fioriti E, Manfrini S, Pozzilli P. A pilot study of D-chiro-inositol plus folic acid in overweight patients with type 1 diabetes. Acta Diabetol. 2017 Apr;54(4):361-365. doi: 10.1007/s00592-016-0954-x. Epub 2016 Dec 30.
Clinical trial NCT04051749: Incidence, Predictors and Validation of Risk Scores to Predict Myocardial Infarction After Noncardiac Vascular Surgery
Official title: Incidence, Predictors and Validation of Risk Scores to Predict Myocardial Infarction After Noncardiac Vascular Surgery, a Cohort Prospective Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Complication of Surgical or Medical Care
Lead sponsor: Centro Hospitalar De São João, E.P.E.
Sponsor class: OTHER
First posted: 2019-08-09
Enrollment: 306
Sex: ALL
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: Consecutive patients submitted to elective arterial VS

Brief summary: Evaluate the incidence and predictors of post-operative mortality after noncardiac Vascular Surgery and compare the performance of existing risk scores.


Eligibility criteria: Inclusion Criteria:

* Elective arterial Vascular Surgery
* Patients \> 18 years

Exclusion Criteria:

* Urgent/Emergent Surgery
* Patients \< 18 years

Primary outcomes:
measure: Major Cardiac Events
timeFrame: 30-day
Secondary outcomes:
measure: Mortality
timeFrame: 30-day
Other outcomes:
Locations:
Study officials:
References:
citation: Reis P, Mourao J, Abelha F. Reply to the commentary on "Incidence, predictors and validation of risk scores to predict postoperative mortality after noncardiac vascular surgery, a prospective cohort study" [Int. J. Surg. 77 (2020) 181-2]. Int J Surg. 2020 Jul;79:47-49. doi: 10.1016/j.ijsu.2020.04.072. Epub 2020 May 11. No abstract available.
Clinical trial NCT03278249: Feasibility Study of Modified Atkins Ketogenic Diet in the Treatment of Newly Diagnosed Malignant Glioma
Official title: Feasibility Study of Modified Atkins Ketogenic Diet in the Treatment of Newly Diagnosed Malignant Glioma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Glioblastoma
Keywords: brain tumor
Lead sponsor: University of Cincinnati
Sponsor class: OTHER
First posted: 2017-09-11
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: TREATMENT

Brief summary: The purpose of this research study is to see if people can produce ketones in their blood with the modified Atkins diet. Modified Atkins diet is a diet that produces ketones in your blood by restricting carbohydrates to \<20 grams per day. Ketones are substances that are produced in the blood when fat is being broken down. Ketones may help radiation work better and may starve your tumor because it is thought that some brain tumors can not use ketones to grow and can only use sugar or glucose to grow.


Eligibility criteria: Inclusion Criteria:

* Histologically confirmed primary malignant glioma, Grade III or IV
* No uncontrolled infection or other active malignancy or chronic systemic immune therapy.
* ECOG performance status \< 3.
* Life expectancy \> three months.
* Adequate labs

Exclusion Criteria:

* Diagnosis of genetic disorder of fat metabolism.
* Type 2 diabetes diagnosed with a hemoglobin A1C \> 6.4
* Allergic to dairy or lactose intolerance

Primary outcomes:
measure: Number of Participants With Ketosis
timeFrame: 6 weeks
Secondary outcomes:
measure: Number of Participants With Progression Free Survival
timeFrame: 6 months
measure: Assessment of Survival
timeFrame: 2 years
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: UC Health
state: Ohio
Study officials:
affiliation: University of Cincinnati
name: Rekha Chaudhary, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01523249: Three-Dimensional Ultrasound (3D US) in Parturients
Official title: Three-Dimensional Ultrasound (3D US) for Epidural Needle Insertion in Parturients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pregnancy
Keywords: 3D ultrasonography
epidural
neuraxial anesthesia
neuraxial analgesia
pregnant woman
parturients
Lead sponsor: University of British Columbia
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
First posted: 2012-02-01
Enrollment: 20
Sex: FEMALE
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Term pregnant women expecting neuraxial anesthesia or analgesia for cesarean delivery or labour pain control at BC Women's Hospital.

Brief summary: The purpose of this study is to compare accuracy of a new three-dimensional ultrasound (3D US) technique with the traditional palpation method for identification of the needle insertion site on patients' skin before epidural needle placement in pregnant women. The investigators hypothesize that the needle puncture site identified by 3D US is located within a 5 mm radius from the puncture site identified by palpation.

Detailed description: Traditionally, the manual palpation of lower back is used to identify the skin insertion point for the epidural needle placement in obstetric patients. Recently, two-dimensional ultrasound (2D US) scanning before the epidural needle insertion proved to improve an accurate determination of inter-vertebral levels and spine midline. 2D US is also useful in determining the depth to the epidural space and needle insertion angle. A three-dimensional ultrasound (3D US) technique is a new advancement in the ultrasound technology. 3D US allows for a real-time, visual guidance of the epidural needle insertion. This study will assess weather 3D US, compared to palpation, can accurately identify the skin needle insertion site for the epidural needle placement.

Eligibility criteria: Inclusion Criteria:

* ASA I or II
* Greater than or equal to 19 years old
* Term pregnancy (greater than or equal to 38 weeks gestation age)
* Ability to read English in order to understand the consent form

Exclusion Criteria:

* BMI greater than or equal to 40
* Scoliosis
* Previous difficult regional anesthesia/analgesia
* Previous lower back surgery
* Active labour
* Allergy to epidural tape, surgical paper tape, or felt pen

Primary outcomes:
measure: Distance between two needle insertion points
timeFrame: 20 minutes of testing prior to delivery
Secondary outcomes:
measure: Distance between needle insertion point and spine midline
timeFrame: 20 minutes of testing prior to delivery
measure: assess quality of 3D US images
timeFrame: one year
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: BC Women's Hospital
state: British Columbia
Study officials:
affiliation: University of British Columbia and BC Women's Hospital
name: Allaudin Kamani, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04905849: Enhancing Cognitive Control Abilities Using Mobile Technology in a Senior Living Community
Official title: Enhancing Cognitive Control Abilities Using Mobile Technology in a Senior Living Community
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aging
Cognitive Change
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2021-05-28
Enrollment: 19
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: The goal of this study is to test the feasibility of launching a personalized digital health assessment and remediation program for the older adults in senior living communities based upon an initial characterization of these abilities. Evidence of feasibility here using these unique methodological approaches would provide empirical evidence supporting the basis for a larger-scale implementation of such digital health technologies into less controlled senior settings.


Eligibility criteria: Inclusion Criteria:

* Must be living at a Senior Living Community
* have own iPad and/or smartphone,
* native-English speaker.

Participation across a spectrum of cognitive abilities is desired for this study, specifically for older adults in a community setting.

Exclusion Criteria:

* Do not have any physical or cognitive limitations that would clearly prevent them from utilizing these applications as intended

Primary outcomes:
measure: Mean Change on Adaptive Cognitive Evaluation (ACE) from Baseline at 6 weeks
timeFrame: At Baseline and post intervention at the 6 week mark
Secondary outcomes:
measure: Mean Change on Everyday Cognition Scale (ECog) from Baseline at 6 weeks
timeFrame: At Baseline and post intervention at the 6 week mark
measure: Mean Change on Cognitive Failures Questionnaire (CFQ) from Baseline at 6 weeks
timeFrame: At Baseline and post intervention at the 6 week mark
measure: Mean Change on General health and well-being (SF-36) from Baseline at 6 weeks
timeFrame: At Baseline and post intervention at the 6 week mark
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: UC San Francisco
state: California
Study officials:
affiliation: UC San Francisco
name: Joaquin Anguera, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: