louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04747171: Intrathecal Additives for Spinal Anaesthesia in Elective Caesarean Sections
Official title: A Comparative Study of Postoperative Analgesia of Different Intrathecal Additives for Spinal Anaesthesia in Elective Caesarean Sections
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pain, Postoperative
Lead sponsor: Benha University
Sponsor class: OTHER
First posted: 2021-02-10
Enrollment: 105
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: we designed this randomized, single -blind, prospective clinical study to test postoperative analgesia of three intrathecal additives in elective caesarean sections which are magnesium, dexamethasone and dexmedetomidine.


Eligibility criteria: Inclusion Criteria:

* American Society of Anesthesiologists classII-III adult female patient (age :18 -40 years old )
* Elective cesarean section under spinal anaesthesia
* Gestational age \> 37 weeks
* BMI less than 30 kg/m2

Exclusion Criteria:

* Patient refusal
* unable to give consent
* age \< 18 or \> 40
* BMI more than 30 kg/m2
* known allergy to the study medication
* coagulopathies or on anticoagulant medications
* diabetic neuropathy
* patients with psychiatric disorders

Primary outcomes:
measure: analgesic effect
timeFrame: Up to 24 hours after surgery
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03950193: Prematurity and Parental Involvement in Child Development Care
Official title: Association Between Presence and Parental Participation in Perinatal Care and Child Psychiatric Profile at 24 Months After Preterm Birth
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Premature Birth
Keywords: Parental presence
parental involvement
parental stress
development care
psychic development
Lead sponsor: CHU de Reims
Sponsor class: OTHER
First posted: 2019-05-15
Enrollment: 1
Sex: ALL
Minimum age (years): 22
Maximum age (years): 26
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Premature children

Brief summary: The aims of the study is to evaluate the association between presence and parental participation in perinatal care and psychic development of the child at 24 months

Detailed description: In France, as in developed countries, the premature birth rate has been rising over the past few years. Premature labor is a particularly stressful birth. It is recognized that the level of parental stress is greater at a premature birth compared to a term birth. The neuro-developmental consequences of premature birth are important. A possible association between prematurity and the onset of mental disorders such as hyperactivity, inattention, emotional problems, conduct disorders, autistic disorders and social difficulties has been shown. It has been shown that parental presence, holding and skin to skin during hospitalization would be beneficial for the child's motor development and psychological well-being by reducing the stress of the child.

Eligibility criteria: inclusion criteria : child born very prematurely between 27 and 31 weeks gestational age + 6 days child taken in charge at the intensive care unit of Reims University Hospital for at least 3 weeks child aged 24 months (+/- 2 months) the holders of parental authority are more 18 years old the holders of parental authority know how to speak, read and write French the holders of parental authority agree to participate in the study

exclusion criteria :

- child has a serious pathology (abnormal brain MRI)

Primary outcomes:
measure: Child Behavior Check List
timeFrame: Day 0
Secondary outcomes:
Other outcomes:
Locations:
city: Reims
country: France
facility: Damien JOLLY
Study officials:
References:
Clinical trial NCT02487693: Radiofrquency Ablation Combined With Cytokine-induced Killer Cells for the Patients With Ovarian Carcinoma
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Ovarian Carcinoma
Lead sponsor: The First People's Hospital of Changzhou
Sponsor class: OTHER
First posted: 2015-07-01
Enrollment: 50
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether combining of radiofrequency ablation (RFA) and cytokine-induced killer cells (CIK) transfusion can prolong survival of patients with ovarian carcinoma.

Detailed description: The primary objective is to evaluate whether RFA followed by CIK transfusion can prolong survival of patients with ovarian carcinoma.

Eligibility criteria: Inclusion Criteria:

1. patients diagnosed with FIGO stage II ovarian carcinoma;
2. cytoreductive surgery performed and 6 courses of platinum-based chemotherapy completed;
3. medical records maintain comprehensive data on treatment and follow-up;
4. no history of previous malignancies.

Exclusion Criteria:

1. neoadjuvant chemotherapy applied;
2. less than 6 courses of chemotherapy or more than 6 courses of chemotherapy completed;
3. medical records maintain incomplete data on treatment or follow-up;
4. history of previous malignancy.

Primary outcomes:
measure: Recurrence-free survival
timeFrame: 1 year
Secondary outcomes:
measure: Adverse events
timeFrame: 4 weeks
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04600193: a Randomized Controlled Trial of the Intake of Organic and Inorganic Phosphate in Peritoneal Dialysis Patients
Official title: a Randomized Controlled Trial of the Intake of Organic and Inorganic Phosphate in Peritoneal Dialysis Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Kidney Disease Requiring Chronic Dialysis
Lead sponsor: University of Copenhagen
Sponsor class: OTHER
Collaborators: name: Stine Kristensen
name: Gita Krüger Mørch
name: Rizwan Butt
name: Ditte Hansen
First posted: 2020-10-23
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: Hyperphosphatemia is a common problem among patientens suffering from chronic kidney disease. Hyperphosphatemia is associated with increased risk of cardiovascular diseases. One of the treatments are through the diet, where patients are instructed ind reducing their daily intake of phosphate. But since phosphate exists in both organic and inorganic forms in the diet, this leads to several problems. Informations of the bioavability and furthermore the effect of plasma koncentrations of phosphate are lacking for both forms of phosphate.


Eligibility criteria: Inclusion Criteria:

* Patients \> 18 years
* Competent
* The patient should be able to take a sample of p-fluid and urine by himself
* Chronic peritoneal dialysis
* Reads and understand danish
* Has been informed written and oraly about the study and signed informed consent
* P-phosphate koncentrations 0,7-2,0 .mol/l
* P - ioniset calcium 1,1-1,4 mmol/l

Exclusion Criteria:

* Pregnant or breast-feeding
* Terminal patients
* If the experience acute infections or other acute situations they will be excluded from the study

Primary outcomes:
measure: Plasma levels of phosphate
timeFrame: six days
Secondary outcomes:
measure: Changes in p-phosphate
timeFrame: six days
measure: changes in p-calcium
timeFrame: six days
measure: Changes in p-sodium
timeFrame: six days
measure: Changes in p-potassium
timeFrame: six days
measure: changes in p-PTH
timeFrame: six days
measure: Changes in p-FGF23
timeFrame: six days
measure: Changes in p-magnesium
timeFrame: six days
measure: Koncentration of phosphate in peritoneal dialysis fluid
timeFrame: six days
measure: Koncentration of phosphate in urine
timeFrame: six days
Other outcomes:
Locations:
city: Herlev
country: Denmark
facility: Herlev Hospital
Study officials:
affiliation: University of Copenhagen
name: Jens Rikardt Andersen, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06725771: A Non-randomized Controlled Trial Was Conducted to Observe the Improvement in the Level of HAMA in Patients With Generalized Anxiety Disorder During the 6-week Period of Oral Treatment With Chaihu Jia Longgu Muli Tang (Bupleurum Plus Dragon Bone and Oyster Shell Decoction) Combined With Sertraline.
Official title: Clinical Study on the Treatment of Generalized Anxiety Disorder With Chaihu Jia Longgu Muli Tang (Bupleurum Plus Dragon Bone and Oyster Shell Decoction)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Generalised Anxiety Disorder
Keywords: Generalized Anxiety Disorder
Chaihu Jia Longgu Muli Tang
Sertraline
Heat-Depressed on Shao-Yang
Lead sponsor: Jiangsu Province Hospital of Traditional Chinese Medicine
Sponsor class: OTHER
Collaborators: name: Jiangsu Province Hospital of Traditional Chinese Medicine
First posted: 2024-12-10
Enrollment: 205
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to clinically observe the efficacy of Bupleurum Plus Dragon Bone and Oyster Shell Decoction in the treatment of Generalized Anxiety Disorder to improve the scores of HAMA

Detailed description: Generalized Anxiety Disorder, not only results in a disturbed psychological condition, but even daily life with coworkers and family will also be disrupted. Chaihu Jia Longgu Muli Tang (Bupleurum Plus Dragon Bone and Oyster Shell Decoction), a compound Chinese herbal medicine found in "Treatise on Cold Damage", has been used for treating mental disorders with symptoms such as chest distress, irritability, being frightened, etc since the China Han dynasty. In this study, we will observe the efficacy of this formula, in order to provide an evidence-based basis for clinical observation and evaluation of Generalized Anxiety Disorder.

Eligibility criteria: Inclusion Criteria:

* Meets the western medical diagnostic criteria for generalized anxiety disorder;
* The TCM diagnosis is Heat-Depressed on Shao-Yang (rè yù shǎo yáng) type;
* Hamilton Anxiety Scale (HAMA) score ≥ 7;
* Age 18-80 years old.

Exclusion Criteria:

* Allergy to Chinese Medicine formulas;
* Pregnant or breastfeeding;
* Suicidal ideation and suicide attempt;
* Substance use disorders;
* Severe cardiovascular diseases liver diseases and kidney diseases.

Primary outcomes:
measure: Hamilton Anxiety Scale (HAMA)
timeFrame: 0, 2, 4, 6 weeks
Secondary outcomes:
measure: Heat-Depressed on Shaoyang scale
timeFrame: 0, 2, 4, 6 weeks
Other outcomes:
measure: Pittsburgh Sleep Quality Index (PSQI)
timeFrame: 0, 2, 4, 6 weeks
measure: Hamilton Depression Scale (HAMD-24)
timeFrame: 0, 2, 4, 6 weeks
Locations:
city: Nanjing
country: China
facility: Jiangsu Province Hospital of TCM Affiliated Hospital of Nanjing University of Chinese Medicine
state: Jiangsu
Study officials:
References:
Clinical trial NCT01617993: Eeva™ Continued Access Study: Assessing the Usability of Eeva in a Clinical Setting
Official title: Eeva Continued Access Study.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Infertility
Keywords: in vitro fertilization
assisted reproduction
noninvasive imaging of embryos
time lapse imaging of embryos
traditional morphological grading of embryos
prediction of blastocysts
infertility
Genital Diseases, Male
Genital Diseases, Female
Lead sponsor: Progyny, Inc.
Sponsor class: INDUSTRY
First posted: 2012-06-13
Enrollment: 31
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women in the United States who undergo IVF treatment and imaging of their embryos with Eeva.

Brief summary: User questionnaire of Eeva System usability and reports of device malfunctions.

Detailed description: This study is designed to evaluate the use of Eeva by IVF laboratory staff during routine procedures. The fertilized eggs will be placed in an Eeva dish and the development of the embryos will be monitored by the Eeva system in a standard incubator. On day 3 of embryo culture, Eeva blastocyst prediction data will be printed from the system to be used to assist the embryologist in selecting the best embryo(s). The performance of the system will be summarized and the user feedback from the embryologists will be collected.

Eligibility criteria: Inclusion Criteria:

* Women undergoing fresh in vitro fertilization treatment using their own eggs or donor eggs
* Subject is ≥ 18 and ≤ 40 years of age.
* Subject has basal antral follicle count (AFC) ≥ 8 prior to stimulation cycle.
* Fertilization using only ejaculated sperm (fresh or frozen) - no surgically retrieved sperm.
* Subject has ≥ 5 normally fertilized eggs (2 PN)
* Willing to have all 2PN embryos monitored by Eeva
* Willing to comply with study protocol and procedures and able to speak English.
* Willing to provide written informed consent.

Exclusion Criteria:

* Reinseminated eggs.
* History of cancer.
* Gestational carriers.
* Planned preimplantation genetic diagnosis or preimplantation genetic screening.
* Previously enrolled in this study
* Concurrent participation in another clinical study.

Primary outcomes:
measure: User questionnaire of Eeva System usability and reports of device malfunctions.
timeFrame: Participants will be followed through ongoing pregnancy, at approximately 10-12 weeks gestational age.
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: Pacific Fertility Center
state: California
city: San Jose
country: United States
facility: Fertility Physicians of Northern California
state: California
city: San Ramon
country: United States
facility: Reproductive Science Center
state: California
Study officials:
affiliation: Progyny, Inc.
name: Shehua Shen, ELD, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02501993: Nasopharyngeal Carcinoma Screening in Zhongshan City
Official title: Serology Screening Test for the Detection of Nasopharyngeal Carcinoma in Zhongshan City
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Nasopharyngeal Carcinoma
Lead sponsor: Zhongshan People's Hospital, Guangdong, China
Sponsor class: OTHER
First posted: 2015-07-17
Enrollment: 25000
Sex: ALL
Minimum age (years): 30
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Residents of Zhongshan City

Brief summary: The primary objective is to determine the early diagnosis rate and mortality rate of the Nasopharyngeal Carcinoma (NPC) in the study population.

The secondary objective is to determine the incidence of NPC in the study population.

Detailed description: The research is to evaluate the effect of NPC screening, also as an extended study of Screening for Nasopharyngeal Carcinoma in High Risk Populations (NCT00941538).

The program was conducted in Xiaolan and Minzhong towns of Zhongshan city in 2012.

All participants will be tested for anti-EBV antibody by using serum samples. Participants are stratified into those having high, moderate and low antibody levels, those having moderate antibody levels are invited to retest annually in the following 3 years and those found to have high antibody levels on these occasions are referred to centers for diagnostic workup for NPC.

Eligibility criteria: Inclusion Criteria:

* Subject residents in Zhongshan city
* Subject is 30 to 59 years of age inclusive
* Subject has no medical record of nasopharyngeal carcinoma
* ECOG 0-2
* Subject has psychical condition and well consciousness
* Subject is able to comprehend, sign, and date the written informed consent document to participate in the study.

Exclusion Criteria:

* Subject has heavy cardiovascular, liver or kidney disease
* Subject has medical record of nasopharyngeal carcinoma
* Subject who is not residing in Zhongshan City

Primary outcomes:
measure: The early detection rate (stage I and II) of Nasopharyngeal Carcinoma
timeFrame: 10 years
measure: The mortality rate of Nasopharyngeal Carcinoma
timeFrame: 10 years
Secondary outcomes:
measure: The incidence of Nasopharyngeal Carcinoma
timeFrame: 10 years
Other outcomes:
Locations:
city: Zhongshan
country: China
facility: Zhongshan People's Hospital
state: Guangdong
Study officials:
affiliation: Zhongshan People's Hospital, Guangdong, China
name: Mingfang Ji, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02579993: ABCB5 as a Prognostic Marker in Survival of Cultivated Limbal Stem Cell Transplantation
Official title: ABCB5 as a Prognostic Marker in Survival of Cultivated Limbal Stem Cell Transplantation Expanded in Vitro on Amniotic Membrane in Patients With Limbal Stem Cell Deficiency.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Limbal Stem Cell Deficiency
Keywords: Cornea
Limbal stem cell
Lead sponsor: Instituto de Oftalmología Fundación Conde de Valenciana
Sponsor class: OTHER
Collaborators: name: National Council of Science and Technology, Mexico
First posted: 2015-10-20
Enrollment: 10
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: In this study the prognostic value of ABCB5 in survival of the limbal stem cell transplantation expanded in vitro on amniotic membrane for corneal surface reconstruction in patients with limbal stem cell deficiency will be analyzed.

Detailed description: There are several diseases that cause the cornea to lose its clarity and directly affects the vision of the individual, therefore, the use of limbal stem cells has been having increasing acceptance in the field of medical therapy. An open clinical study is running with patients with limbal stem cell deficiency, performing a limbal stem cell transplantation expanded in vitro on amniotic membrane and the value of ABCB5 as a prognostic factor in the survival of transplant will be determined. The corneal surface status will be the primary endpoint.

Eligibility criteria: Inclusion Criteria:

1. Bilateral limbal stem cell deficiency of any etiology.
2. Corneal impression cytology positive for goblet cells.
3. Ocular ultrasound results within normal parameters.
4. Agree to participate in the study and sign the informed consent.

Exclusion Criteria:

1. Active immunological diseases.

Primary outcomes:
measure: Objective clinical evaluation
timeFrame: 6 months
measure: Objective clinical evaluation
timeFrame: 12 months
Secondary outcomes:
measure: Corneal cells morphology
timeFrame: 6 months
measure: Corneal cells morphology
timeFrame: 12 months
measure: Quality of life questionnaire
timeFrame: 6 months
measure: Quality of life questionnaire
timeFrame: 12 months
measure: Visual acuity
timeFrame: 6 months
measure: Visual acuity
timeFrame: 12 months
Other outcomes:
Locations:
city: Mexico City
country: Mexico
facility: Instituto de Oftalmologia Conde de Valenciana
Study officials:
affiliation: Instituto de Oftalmologia Conde de Valenciana
name: Yonathan Garfias, MD, PhD
role: STUDY_DIRECTOR
References:
citation: Serna-Ojeda JC, Garcia-Mejia M, Graue-Hernandez EO, Navas A, Garfias Y. Short-Term Results Analysis in the Allogenic Transplantation of Limbal Stem Cells Expanded on Amniotic Membrane in Patients with Bilateral Limbal Stem Cell Deficiency. J Ocul Pharmacol Ther. 2020 May;36(4):238-246. doi: 10.1089/jop.2019.0147. Epub 2020 Feb 20.
Clinical trial NCT02751593: Thrombocytopenia in Gestational Period
Official title: Thrombocytopenia in Gestational Period
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Immune Thrombocytopenia
Pregnancy
Keywords: pregnancy
Immune Thrombocytopenia
dexamethasone
Lead sponsor: Peking University People's Hospital
Sponsor class: OTHER
First posted: 2016-04-26
Enrollment: 70
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The project was undertaking by Peking University People's Hospital and other well-known hospitals in China. Aims at evaluating efficacy and safety of dexamethasone in management of ITP in pregnancy.

Detailed description: The investigators are undertaking a multicenter, open-labeled, pilot study of 50 ITP patients in pregnancy from Peking University People's Hospital and other well-known hospitals in China. ITP patients in pregnancy who failed to respond to prednisone, IVIG and developed refractoriness to platelet transfusion will be given dexamethasone intravenously at a dose of 40mg every day for four days. Platelet count, bleeding and other symptoms will be evaluated before and after treatment. Adverse events will be recorded throughout the study.

Eligibility criteria: Inclusion Criteria:

* Subject is between 20-50 years old.
* After 12 weeks gestation.
* Diagnosed with ITP meeting the diagnostic criteria for immune thrombocytopenia.
* Patients who have no response or relapsed after Corticosteroid or IVIG.
* Patients developed refractoriness to platelet transfusion.
* To show a platelet count \< 30×10\^9/L, and with bleeding manifestations.
* Willing and able to sign written informed consent.

Exclusion Criteria:

* Received chemotherapy or anticoagulants or other drugs affecting the platelet counts within 3 months before the screening visit.
* Received second-line ITP-specific treatments (eg, cyclophosphamide, 6-mercaptopurine, vincristine, vinblastine, etc) within 3 months before the screening visit.
* Current HIV infection or hepatitis B virus or hepatitis C virus infections.
* Severe medical condition (lung, hepatic or renal disorder) other than chronic ITP.
* Unstable or uncontrolled disease or condition related to or impacting cardiac function (e.g., unstable angina, congestive heart failure, uncontrolled hypertension or cardiac arrhythmia).
* Have a known diagnosis of other autoimmune diseases, established in the medical history and laboratory findings with positive results for the determination of antinuclear antibodies, anti-cardiolipin antibodies, lupus anticoagulant or direct Coombs test.
* Patients who are deemed unsuitable for the study by the investigator.

Primary outcomes:
measure: Response rate (CR+R)
timeFrame: 3 months
Secondary outcomes:
measure: Platelet count
timeFrame: 2 years
measure: Adverse events
timeFrame: 2 years
measure: live birth rate
timeFrame: 2 years
Other outcomes:
Locations:
Study officials:
affiliation: Peking University People's Hospital
name: Xiao-hui Zhang, Dr
role: STUDY_CHAIR
References: