louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02328950: A 5 Day Course of Fludarabine and Cytarabine Followed by Full Intensity Allogeneic Stem Cell Transplantation (FA5-Bucy) in Treating Patients With High-risk, Recurrent or Refractory Acute Leukemia and Advanced Myelodysplastic Syndrome
Official title: A 5 Day Course of Fludarabine and Cytarabine Followed by Full Intensity Allogeneic Stem Cell Transplantation (FA5-Bucy) in Treating Patients With High-risk, Recurrent or Refractory Acute Leukemia and Advanced Myelodysplastic Syndrome
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Myelodysplastic Syndromes
Leukemia, Myeloid, Acute
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Lead sponsor: Fujian Medical University
Sponsor class: OTHER
First posted: 2014-12-31
Enrollment: 50
Sex: ALL
Minimum age (years): 1
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with high-risk, recurrent or refractory acute leukemia and advanced myelodysplastic syndrome

Brief summary: A 5 day course of fludarabine and cytarabine (FA) will be administered followed by full intensity conditioning regimen (Bucy) in the setting of allogeneic stem cell transplantation (SCT). The purpose of this study is to explore the antileukemic, immunosuppressive effects and safety of FA as the backbone of a conditioning regiment for the treatment of patients with high-risk, recurrent or refractory acute Leukemia and advanced myelodysplastic syndrome.


Eligibility criteria: Inclusion Criteria:

* Signed written informed consent
* Aged between 0-65 years
* Patients suffering from either refractory de novo AML/ALL or relapsed AML/ALL or patients with very high risk AML/ALL in CR1
* Patients with advanced MDS
* Cardiac: Left ventricular ejection fraction ≥ 50%
* Adequate renal and hepatic function
* Performance status: Karnofsky ≥ 70%

Exclusion Criteria:

* Pregnant or lactating females
* Current participation in another clinical trial
* Contra-indication to one of the drug of the regimen
* Any other severe concurrent disease, or have a history of serious organ dysfunction or disease involving the heart, kidney, liver or other organ system that may place the patient at undue risk to undergo the agents included in the conditioning regimen

Primary outcomes:
measure: Relapse rate at one year after allo-SCT
timeFrame: one year
Secondary outcomes:
measure: Even free survival
timeFrame: two year
Other outcomes:
Locations:
city: Fuzhou
country: China
facility: Union Hospital,Fujian Medical University
state: Fujian
Study officials:
References:
Clinical trial NCT05009550: ESP Block on Patient Outcomes in Patients With Liver Tumor Undergoing Radiofrequency Ablation
Official title: Effect of Erector Spina Plain (ESP) Block on Patient Outcomes in Patients With Liver Tumor Undergoing Radiofrequency Ablation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hepatic Carcinoma
Keywords: Erector spinae block
Radiofrequency ablation
Hepatocellular Carcinomas
ultrasound
Lead sponsor: TC Erciyes University
Sponsor class: OTHER
First posted: 2021-08-17
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: To evaluate the ability of Erector spina Plane Block decrease postoperative pain and analgesia requirements in patients undergoing percutaneous Radiofrequency ablation of Hepatocellular Carcinomas.

Detailed description: Erector spina Plane Block is performed with guided ultrasound at T8 transverse process level lead to adequate intraprocedural and postoperative analgesia, in percutaneous Radiofrequency ablation of Hepatocellular Carcinomas.

Eligibility criteria: Inclusion Criteria:

* ASA I-II patients

Exclusion Criteria:

* history of allergy to the study medication
* refused to participate

Primary outcomes:
measure: Numeric Pain Scale assesment
timeFrame: 24 hours after procedure
Secondary outcomes:
measure: Demographic data
timeFrame: 24 hours after procedure
measure: Incidences of adverse effects (like nausea and vomiting)
timeFrame: 24 hours after procedure
Other outcomes:
Locations:
city: Kayseri
country: Turkey
facility: Özlem Öz Gergin
Study officials:
affiliation: TC Erciyes University
name: Ozlem Oz Gergin, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wells SA, Hinshaw JL, Lubner MG, Ziemlewicz TJ, Brace CL, Lee FT Jr. Liver Ablation: Best Practice. Radiol Clin North Am. 2015 Sep;53(5):933-71. doi: 10.1016/j.rcl.2015.05.012.
citation: Joung KW, Choi SS, Jang DM, Kong YG, Lee HM, Shim JH, Won HJ, Shin YM, Kim PN, Song MH. Comparative Effects of Dexmedetomidine and Propofol on US-Guided Radiofrequency Ablation of Hepatic Neoplasm Under Monitored Anesthesia Care: A Randomized Controlled Study. Medicine (Baltimore). 2015 Aug;94(32):e1349. doi: 10.1097/MD.0000000000001349.
Clinical trial NCT03281850: The GLOWING Study: Growing Life, Optimizing Wellness 2
Official title: The GLOWING Study: Growing Life, Optimizing Wellness 2
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy
Lead sponsor: Arkansas Children's Hospital Research Institute
Sponsor class: OTHER
First posted: 2017-09-13
Enrollment: 212
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: A prospective longitudinal cohort of 150 dyads (pregnant women and offspring)

Brief summary: This study will help us learn more about how maternal health can influence child health.

Detailed description: This study follows people who are healthy and less than 36 weeks pregnant to see how the mother's health can impact their child's growth and development. Up to 300 people including the mother and their future child will be a part of this study. The study will follow the child until they are two years of age.

Eligibility criteria: Inclusion Criteria:

* Pre-pregnancy BMI 18.5-45
* Singleton pregnancy
* at least 18 years of age
* conceived without assisted fertility treatments

Exclusion Criteria:

* Preexisting medical conditions (e.g. DM, GDM, CRF, HTN, pre-eclampsia or eclampsia, malignancies, seizure disorder, lupus, serious psychiatric disorders)
* sexually transmitted diseases
* medications during pregnancy known to influence fetal growth
* smoking, alcohol drinking or drug use during pregnancy

Primary outcomes:
measure: Determine energy expenditure in children
timeFrame: 2 years
measure: Determine fat oxidation in children
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Arkansas Children's Nutrition Center
state: Arkansas
Study officials:
affiliation: Arkansas Children's Nutrition Center
name: Aline Andres, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Diaz EC, Williams DK, Cotter M, Sims CR, Wolfe RR, Andres A, Borsheim E. Breastfeeding duration modifies the association between maternal weight status and offspring dietary palmitate oxidation. Am J Clin Nutr. 2022 Aug 4;116(2):404-414. doi: 10.1093/ajcn/nqac097.
Clinical trial NCT00356850: Ocular Pharmacokinetics After a Single Drop Instillation of T1225 0.5, 1, 1.5% in 91 Healthy Volunteers
Official title: Ocular Pharmacokinetics After a Single Drop Instillation, in Each Eye of One of Three Different Concentrations of T1225 (0.5% - 1% - 1.5% Dihydrate) in 91 Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Eye Infections, Bacterial
Lead sponsor: Laboratoires Thea
Sponsor class: INDUSTRY
First posted: 2006-07-26
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To evaluate azithromycin tear concentrations after instillation of one drop of one of the three T1225 concentrations (0.5%, 1% and 1.5%) and to evaluate the ocular safety.

Detailed description: The aim of the present study was to compare azithromycin tear ocular concentrations after a single instillation of three different T1225 concentrations in order to determine early azithromycin tear concentration and to assess the T1225 concentration, which allowed having the higher azithromycin tear concentration, 24 hours after a single instillation.

Eligibility criteria: Inclusion Criteria:

* Male/female aged from 18 to 45 years;
* Written informed consent;
* Healthy volunteers without any subjective ocular symptom;
* Corrected visual acuity \>= 6/10;
* Registered in the national register of healthy volunteers

Exclusion Criteria:

* Ocular trauma, infection or inflammation within the last 3 months;
* Conjunctival hyperaemia (score \>= 2);
* Folliculo-papillary conjunctivitis (score \>= 2);
* Topical ocular treatment within the last month;
* Ocular surgery, including LASIK and PRK, within the last 12 months;
* Other ocular laser within the last 3 months;
* Zithromax® and Azadose® within the last 3 months;
* Medication during the study (except: paracetamol, contraceptives

Primary outcomes:
measure: Area Under the Curve from 0 to 24 hours (AUC0-24h)
measure: Elimination half-life (t1/2)
measure: Maximum Concentration (Cmax)
measure: Concentration 24 hours after instillation (C24h)
Secondary outcomes:
measure: Tolerance
Other outcomes:
Locations:
Study officials:
affiliation: Centre de Pharmacologie Clinique - Clermont-Ferrand (France)
name: Claude DUBRAY, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03769350: Waitlist-Control Trial of Smartphone CBT for Major Depressive Disorder (MDD), Withdrawn
Official title: Smartphone Cognitive Behavioral Therapy for Major Depressive Disorder: A Randomized, Waitlist-control Trial
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Major Depressive Disorder
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: Telefónica S.A.
First posted: 2018-12-07
Enrollment: 0
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 investigators are testing the efficacy of Smartphone-delivered cognitive behavioral therapy (CBT) treatment for major depressive disorder (MDD). The investigators hypothesize that participants receiving app-CBT will have greater improvement in QIDS-C scores than those in the waitlist condition at treatment endpoint (week 8).

Detailed description: The primary aims of this study are to test the efficacy of a Smartphone-based CBT treatment for adults with MDD recruited nationally. Eligible subjects (N=112) will be randomly assigned to 8 weeks of Smartphone-delivered CBT for MDD either immediately, or after a 8-week long waiting period (50-50 chance). The investigators hypothesize that Smartphone-delivered CBT for MDD will be feasible and acceptable to individuals with MDD, and that it will lead to greater reductions in MDD symptom severity compared to the passage of time (waitlist control).

Eligibility criteria: Inclusion Criteria:

* At least 18 years of age
* Current diagnosis of primary DSM-5 MDD, based on MINI
* Currently living in the United States

Exclusion Criteria:

* Psychotropic medication changes within 2 months prior to enrollment (Participants taking psychotropic medication must have been on a stable dose for at least 2 months prior to enrollment and not change medication during study period)
* Past participation in ≥ 4 sessions of CBT for depression
* Current severe substance use disorder
* Lifetime bipolar disorder or psychosis
* Acute, active suicidal ideation as indicated by clinical judgment and/or a score ≥ 2 on the suicidal ideation subscale of the C-SSRS
* Concurrent psychological treatment
* Does not own a supported mobile Smartphone with a data plan
* Lack of technology literacy that would interfere with ability to engage with smartphone treatment

Primary outcomes:
measure: Difference in MDD severity (QIDS-C) at the end of treatment/waitlist period.
timeFrame: Endpoint (week 8)
Secondary outcomes:
measure: Difference in functional impairment at the end of treatment/waitlist period
timeFrame: Endpoint (week 8)
measure: Difference in quality of life at the end of treatment/waitlist period
timeFrame: Endpoint (week 8)
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Sabine Wilhelm, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04603950: IPICK Blocking for TKA With Moderate Flexion Contracture
Official title: IPICK Blocking for Extension Recovery in TKA With Preoperative Moderate Flexion Contracture
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Knee Osteoarthritis
Flexion Contracture of Knees
Anesthesia, Local
Keywords: IPACK
knee osteoarthritis
Flexion Contracture of Knees
Lead sponsor: The First Hospital of Jilin University
Sponsor class: OTHER
First posted: 2020-10-27
Enrollment: 42
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Clinical effect of intermittent multiple IPICK blocking on TKA for knee osteoarthritis with flexion contracture between 5 ° and 10 °

Detailed description: From October 2020 to January 2021, 40 knee osteoarthritis patients with flexion contracture between 5 ° and 10 ° total knee arthroplasty are enrolled in this study. 20 patients are treated with Adductor Canal Block + Infiltration between the Popliteal Artery and Capsule of the Knee, and 20 patients are treated with Adductor Canal Block alone.

Eligibility criteria: Inclusion Criteria:

1. The diagnosis was knee osteoarthritis
2. The flexion contracture was between 5 and 10 degrees
3. ASA grade I-III

Exclusion Criteria:

1. Lower extremity neuropathy.
2. Contraindications of nerve anesthesia or regional anesthesia.
3. unable to cooperate, allergic to the drugs used in this study.
4. Non steroidal anti-inflammatory drugs are not tolerated.
5. chronic opioid consumption (daily or almost daily use)

Primary outcomes:
measure: evaluation of pain
timeFrame: 6 hours after surgery
measure: evaluation of pain
timeFrame: postoperative day 1
measure: evaluation of pain
timeFrame: postoperative day 2
measure: evaluation of pain
timeFrame: postoperative day 3
measure: extension angle
timeFrame: before surgery
measure: extension angle
timeFrame: 0 hour after surgery
measure: extension angle
timeFrame: 6 hour after surgery
measure: extension angle
timeFrame: postoperative day 1
measure: extension angle
timeFrame: postoperative day 2
measure: extension angle
timeFrame: postoperative day 3
Secondary outcomes:
measure: range of motion
timeFrame: 6 hour after surgery
measure: range of motion
timeFrame: postoperative day 1
measure: range of motion
timeFrame: postoperative day 2
measure: range of motion
timeFrame: postoperative day 3
measure: opioid consumption
timeFrame: through hospitalization, an average of 7 days
measure: nerve block related symptoms
timeFrame: through hospitalization, an average of 7 days
measure: postoperative acute pain
timeFrame: through hospitalization, an average of 7 days
Other outcomes:
Locations:
city: Changchun
country: China
facility: The First Hospital of Jilin University
Study officials:
References:
Clinical trial NCT05707650: Reverse Breech Extraction Versus Push Technique for Fetal Delivery When Fetal Head is Deeply Impacted in the Pelvis During CS on A Fully Dilated Cervix
Official title: Reverse Breech Extraction Versus Push Technique for Fetal Delivery When Fetal Head is Deeply Impacted in the Pelvis During CS on A Fully Dilated Cervix
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Obstructed Labor at Second Stage of Labor
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2023-02-01
Enrollment: 70
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Management of impacted fetal head during second stage cesarean requires careful and gentle attention to various surgical steps for delivery of a fetus without adverse maternal and neonatal outcomes, mostly by an experienced surgeon as in such situations, the lower uterine segment may be over-distended and indistinguishable from the vagina. Therefore, the uterine incision may inadvertently be placed too low, or in the vagina.

Also, it may be difficult for the operating surgeon to maneuver his hand below the deeply engaged fetal head, which may be further compounded by the presence of molding and edema on the fetal head (caput succedaneum).

This prospective controlled study was conducted at labor ward of department of obstetrics and gynecology at Ain Shams University Maternity Hospital to compare between the two techniques. A total of 70 pregnant women were enrolled and divided into two equal groups.


Eligibility criteria: Inclusion Criteria:

* • Singleton pregnancies.

  * Cephalic presentation will undergo cesarean section in advanced labor with the fetal head deeply engaged in the pelvis defined as fully dilated cervix and vertex at or below zero station

Exclusion Criteria:

* • Twins Pregnancies.

  * Breech or transverse presentation.
  * Woman has other obstetric indication to cs ex, fetal distress.
  * Woman has risk factor for bleeding ex, bleeding disorders

Primary outcomes:
measure: Uterine incision extension
timeFrame: intra-operative
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of Medecine At Ain Shams University
Study officials:
References:
Clinical trial NCT02037750: Foster Teens' Risk During Transition
Official title: Foster Teens' Risk During Transition: Preventing Drug Use, HIV, & School Problems
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: School Adjustment
Foster Care Disruptions
Keywords: foster care
school adjustment
Lead sponsor: Oregon Social Learning Center
Sponsor class: OTHER
Collaborators: name: San Diego State University
First posted: 2014-01-16
Enrollment: 173
Sex: ALL
Minimum age (years): 9
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to conduct a randomized effectiveness trial to determine whether adding a preventive intervention at the transition from elementary to middle school is effective and cost effective in terms of ameliorating outcomes such as drug and tobacco use, participation in HIV- risking sexual behavior, delinquency, mental health problems, and school failure for young adolescents in foster care. The proposed LINKS intervention marries the goals of child welfare and educational systems. The aims are: a) to determine the effectiveness of the LINKS intervention on key behavioral health and school adjustment outcomes, b) to examine mechanisms of action; specifically the mediating effects of placement failure on outcomes, c) to examine the moderating role of fidelity on outcomes, and d) to examine cost effectiveness and cost avoidance of LINKS.


Eligibility criteria: Inclusion Criteria:

* the focal youth will be transitioning into middle school
* the focal youth is in either a foster or kinship care home
* the focal youth has been in the home for a minimum of 30 days (including those who are newly placed in care and those moving from another type of placement).

Exclusion Criteria:

* youth who are are considered medically fragile (i.e., severely physically or mentally handicapped)

Primary outcomes:
measure: Number of Placement Failures
timeFrame: between Baseline and 18-Months later
Secondary outcomes:
Other outcomes:
Locations:
city: San Diego
country: United States
facility: San Diego State University Foundation
state: California
city: Eugene
country: United States
facility: Oregon Social Learning Center
state: Oregon
Study officials:
affiliation: Oregon Social Learning Center
name: Patricia Chamberlain, Phd
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02976350: Hormone Deficiency in Heart Failure With Preserved Ejection Fraction
Official title: Multiple Hormone Deficiency Syndrome in Heart Failure With Preserved Ejection Fraction
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Failure
Hormone Deficiencies
Keywords: Heart failure
Heart failure with preserved ejection fraction
GH deficiency
Testosterone deficiency
Low- T3 syndrome
Multiple Hormone Deficiencies
Lead sponsor: Federico II University
Sponsor class: OTHER
First posted: 2016-11-29
Enrollment: 35
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Male patients with stable chronic heart failure with preserved ejection fraction

Brief summary: The objective of this study is to describe the prevalence of Multiple Hormone Deficiencies in Heart Failure with preserved Ejection Fraction.

Detailed description: Despite the effectiveness of the neurohormonal model to explain the progression of heart failure and the many insights that it provided for the development of new therapies, there is increasing clinical evidence that suggests that our current models fail to completely explain the disease progression. Thus, neurohormonal models may be necessary but not sufficient to explain all aspects of disease progression in the failing heart. There is evidence suggesting that in heart failure there is a metabolic imbalance characterized by the predominance of the catabolic status over the anabolic drive.

Consistent data coming from several independent groups have documented the reduced activity of most anabolic axes in HF with reduced ejection fraction. To date, no study has addressed the prevalence the presence and the prevalence of the Multiple Hormone Deficiencies in Heart Failure with preserved Ejection Fraction.

Eligibility criteria: Inclusion Criteria:

* Male patients of affected by CHF, secondary to ischemic or idiopathic dilated cardiomyopathy
* left ventricle ejection fraction \> 50% or more

Exclusion Criteria:

* severe liver disease
* serum creatinine levels \>2.5 mg/dl
* history of active cancer with life expectancy below 1 year acute coronary syndrome in the previous 6 months

Primary outcomes:
measure: Prevalence of Hormone deficiency
timeFrame: 1 months
Secondary outcomes:
Other outcomes:
Locations:
city: Napoli
country: Italy
facility: Antonio Cittadini
Study officials:
affiliation: Federico II University
name: Antonio Cittadini, Professor
role: STUDY_CHAIR
References: