linjc16/ctgov huggingface dataset:
Impairment of Sleep and Pattern of Breathing Before and After Opioid Withdrawal in Comparison to Patients Without Opioid Withdrawal

Study Overview
=================
Brief Summary
-----------------
Main of the study is to assess the influence of high-dose opioids on the sleep architecture and patterns of breathing using non-invasive polysomnographic measurements before and after opioid withdrawal in patient who undergo opioid withdrawal independently from the present study. These data will be compared to polysomnographic data of patients under opioid treatment who do not undergo opioid withdrawal as well as to patients without opioid treatment.

Conditions
-----------------
Sleep Architecture Under Opioid Medication

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: older than 18 year, indication for opioid withdrawal (cohort 1), opioid intake (cohort 1 and 2) Exclusion Criteria: plaster allergic reactions, opioid withdrawal (cohort 2), opioid intake (cohort 3)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| withdrawal<br>patients who undergo an opioid withdrawal | |
| opioids<br>patients on opioid medication without withdrawal | |
| opioid-free<br>patients with chronic pain without opioid medication | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| frequency of an abnormal apnoea-hypnoea index |  | 3 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| changes of the sleep duration and architecture |  | 3 weeks |
Individual Patient Investigational New Drug (IND) Expanded Access Program of JNJ-68284528, a Chimeric Antigen Receptor T Cell (CAR-T) Therapy for Participant With Multiple Myeloma

Study Overview
=================
Brief Summary
-----------------
The purpose of this individual-patient investigational new drug (IND) single patient request (SPR) is to provide participants treatment with JNJ-68284528, an investigational product prior to its marketing authorization. Such access may be considered for participants with serious/life-threatening diseases or conditions, where there exists no alternative treatments or where alternative treatments have been exhausted.

Official Title
-----------------
Individual Patient IND Expanded Access Program JNJ-68284528, a Chimeric Antigen Receptor T Cell (CAR-T) Therapy for Patient J.M. With Multiple Myeloma

Conditions
-----------------
Multiple Myeloma

Intervention / Treatment
-----------------
* Drug: JNJ-68284528


Participation Criteria
=================

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: JNJ-68284528|JNJ-68284528 will be administered as a single intravenous (IV). The target dose will be the recommended Phase 2 dose (RP2D) of 0.75*10^6 chimeric antigen receptor (CAR)-positive viable T cells per kilogram (cells/kg) (range: 0.5 to 1.0*10^6 CAR-positive viable T cells/kg).|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Abdominal Versus Vaginal Hysteropexy

Study Overview
=================
Brief Summary
-----------------
This study will compare the vaginal versus the abdominal approach for the management of uterine prolapse

Detailed Description
-----------------
this study compares The unilateral sacrospinous hysteropexy with prolene sutures versus the abdominal sacral hysteropexy using Mersilene suture for the management of uterine prolapse

Official Title
-----------------
Trans Vaginal Sacrospinous Hysteropexy Versus Abdominal Sacral Hysteropexy for the Management of Uterine Prolapse

Conditions
-----------------
Uterine Prolapse

Intervention / Treatment
-----------------
* Procedure: Sacral Hysteropexy
* Procedure: sacrospinous Hysteropexy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Uterine Prolapse Exclusion Criteria: Previous prolapse surgery Hereditary Connective tissue disorders

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 40 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sacral Hysteropexy<br>Abdominal approach for uterine suspension | Procedure: Sacral Hysteropexy<br>* Abdominal approach for uterine suspension<br>|
| Experimental: sacrospinous Hysteropexy<br>Transvaginal approach for uterine suspension | Procedure: sacrospinous Hysteropexy<br>* Transvaginal approach for uterine suspension<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pelvic organ prolapse quantification system | compare Pelvic organ prolapse quantification system between groups | 3 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Perioperative data | operative time | 1 day | 
| operative details | blood loss | 1 day |
An Improved Method for the Measurement of Oxygen and Anaesthetic Agent Uptake in Patients Using the Foldes-Biro Equation

Study Overview
=================
Brief Summary
-----------------
The primary aim is to confirm the efficacy of a new non-invasive method for measuring the oxygen uptake during general anesthesia of patients undergoing surgery under cardiopulmonary bypass. The method has already been successfully tested in the laboratory under controlled conditions. In the patient group chosen, oxygen uptake is simultaneously calculated, for comparison purposes, from monitoring measurements made routinely as part of normal patient care in these cases, using a pulmonary artery catheter - an invasive technique from which severe complications occasionally arise, including death. A secondary aim is to elucidate the time course of uptake of the anaesthetic vapor, isoflurane, during this kind of surgery.

Detailed Description
-----------------
In a series of 30 patients undergoing cardiopulmonary bypass, the change in nitrogen concentration between fresh gas entering the anesthetic breathing system and the exhaust gas leaving it in an otherwise closed system is used to determine total gas uptake by the principle of insoluble gas dilution. Oxygen and anaesthetic agent uptakes are then automatically determined by a computer directly linked to a rapid gas analyzer, every 15 seconds. As a control, oxygen is calculated using the reverse Fick method. Measured arterial and mixed venous oxygen saturations were used to do this, and the cardiac output which was determined by thermodilution.

Official Title
-----------------
The Modified Foldes-Biro Equation Used in Patients Under General Anaesthesia for the Measurement of Oxygen and Anaesthetic Agent Uptake

Conditions
-----------------
E03.155.197, E03.155.253

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients undergoing non-emergency procedures using cardiopulmonary bypass in whom pulmonary artery catheterization was to be performed for routine monitoring purposes, including mixed venous oxygen determinations and thermodilution cardiac output determinations. Exclusion Criteria: High risk patients (ASA 4+) Acute lung injury, sepsis Tricuspid regurgitation Patients under 18 years of age Patients unable to give informed consent

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| oxygen uptake |  | During surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Oxygen uptake, Anesthetic gas uptake
Development of Automated Real-time Algorithms for Detection of Dislocation of the Carpus

Study Overview
=================
Brief Summary
-----------------
Perilunate dislocation of the carpus is a serious lesion of the wrist which is defined by a total loss of contact of the articular surfaces capito-lunar, scapholunate and lunate-triquetral. Rare by its frequency, it represents 5 to 10% of traumatic injuries of the wrist. Perilunate wrist dislocation is a rare injury that goes unnoticed in 25% of cases. Even with surgical treatment, 50-100% of patients will develop radiocarpal and/or midcarpal osteoarthritis.

Official Title
-----------------
Study CARPUS :  Development of Automated Real-time Algorithms for Detection of Dislocation of the Carpus 

Conditions
-----------------
Perilunate Dislocation

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria : Major subjects (≥18 years old) Treated at the University Hospitals of Strasbourg for a carpal dislocation Presence of carpal radiographs that may indicate the presence of a lesion Subjects who have not expressed their opposition, after information, to the re-use of their data for the purposes of this research Exclusion criteria : Subject having expressed his opposition to participate in the study Subject under legal protection, guardianship or curatorship

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Retrospective analysis of carpal X-rays for the development of an algorithm to automatically identify the presence of pathology in the carpal anatomical area |  | Files analysed retrospectively from January 01, 2012 to December 31, 2022 will be examined] | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Perilunate dislocation, Carpus dislocation, Radiocarpal osteoarthritis, mid-carpal osteoarthritis
Child and Infant Learning Project

Study Overview
=================
Brief Summary
-----------------
To learn more about the cognitive and motor development of infants and young children born with a craniofacial defect called craniosynostosis.

Detailed Description
-----------------
In the first phase of this multi-site, 10-year longitudinal study, infants with one of four types of single-suture craniosynostosis were recruited: sagittal, metopic, right unilateral coronal, and left unilateral coronal. A case-matched control group of healthy, normal infants was also followed. This study, which is now in its second phase, is following this same cohort of children at the age of 7 years.

Official Title
-----------------
Neurobehavioral Correlates of Craniosynostosis

Conditions
-----------------
Craniosynostosis

Intervention / Treatment
-----------------
* Behavioral: neurobehavioral development


Participation Criteria
=================
Eligibility Criteria
-----------------
Enrollment criteria at Phase 1: Confirmed diagnosis of single-suture, nonsyndromic craniosynostosis (sagittal, metopic, unilateral coronal, or lambdoid) Corrective (cranioplastic) surgery not yet performed Child born at 34 weeks gestation or later Absence of neurological conditions/significant health problems 33 months or younger at time of enrollment (male or female). Enrollment criteria at Phase 2: All participants enrolled in phase 1 are invited to participate in phase 2.

Ages Eligible for Study
-----------------
Minimum Age: 2 Months
Maximum Age: 7 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: neurobehavioral development|observational study of infant and child development|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neurodevelopment as assessed by the Bayley Scales of Infant Development II |  | 1st assessment - post diagnosis, pre surgery. 2nd assessment - Target age 18 months. 3rd assessment - Target age 36 months. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neurodevelopment as assessed by the Wechsler Intelligence Scale for Children Version IV |  | Target age 7 years |
Effectiveness of Circulating DNA for Predicting the Relapse and Overall Survival in NHL Patients

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the effectiveness of circulating DNA from peripheral blood for predicting the prognosis and relapse in DLBCL and PTCL patients.

Detailed Description
-----------------
The investigators plan to prospectively involve 300 Non-hodgkin Lymphoma patients, including both diffuse large B cell lymphomas and peripheral T cell lymphomas without previous treatment from Peking Union Medical College Hospital. The following parameters were collected: age, sex, subtype, Eastern Cooperative Oncology Group (ECOG) performance status (PS), Ann Arbor stage (I-IV), presence of B symptoms, number and type of involved sites, prognostic index including International Prognostic Index (IPI) for DLBCLand PIT for PTCL based on medical record review. All patients would have regular treatment and follow up in PUMCH. During the follow up, treatment response was evaluated by contrast enhanced computed tomography or PET-CT. The peripheral blood would be collected and circulating DNA would be tested at the time of diagnosis, interim of treatment, end of treatment, 1 year follow-up, 1.5 year of follow-up, 2 year of follow up, 3 year of follow-up and disease progression or relapse. TCR/BCR domain would be sequenced by high-throughput sequencing.

Official Title
-----------------
Effectiveness of Circulating DNA for Predicting the Relapse and Overall Survival in Non-hodgkin Lymphoma Patients

Conditions
-----------------
Diffuse Large B Cell Lymphoma, Peripheral T Cell Lymphoma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: pathologically confirmed diffuse large B cell lymphoma (DLBCL nos, PCNSL, ALK+ DLBCL, DLBCL/BL) or peripheral T cell lymphoma (AITL, ALCL, PTCL nos, NK/T nasal type, EATL, HSTL) no treatment before hCG(-) 18 years old to 80 years old Exclusion Criteria: other tumors severe infections

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Non-hodgkin Lymphoma<br>300 Non-hodgkin Lymphoma patients (age >=18y) without previous treatment would be administered, including DLBCLs and PTCLs. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall survival |  | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| relapse of the disease |  | within 3 years | 
| progression free survival |  | 3 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Circulating DNA, Diffuse Large B Cell Lymphoma, Peripheral T-Cell Lymphoma, prognosis
Physician's Evaluation of Cyclosporine Ophthalmic Emulsion 0.05%

Study Overview
=================
Brief Summary
-----------------
The objective of this retrospective chart review is to evaluate the patient characteristics, treatment variations and efficacy of a second trial of Cyclosporine Ophthalmic Emulsion 0.05% therapy in chronic dry eye patients who were initially treated with Cyclosporine Ophthalmic Emulsion 0.05% but discontinued use after less than 12 weeks of treatment.

Conditions
-----------------
Dry Eye Disease

Intervention / Treatment
-----------------
* Drug: Cyclosporine Ophthalmic Emulsion 0.05%


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults >16 years of age Dry eye patients Subject with history of less than 12 weeks of initial RESTASIS® treatment Subject started second trial of RESTASIS® treatment prior to June 1, 2008 First day of second trial of RESTASIS® started ≥ 4 weeks after the last day of previous RESTASIS® treatment Exclusion Criteria: Patients with Contact Lens Intolerance Patients with Ocular Rosacea

Ages Eligible for Study
-----------------
Minimum Age: 16 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients who received Restasis®<br>Patients who received Restasis® (cyclosporine ophthalmic emulsion 0.05%) | Drug: Cyclosporine Ophthalmic Emulsion 0.05%<br>* One drop two times a day approximately 12 hours apart<br>* Other names: RESTASIS®;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Patients With Complete Clearing of Corneal Staining at Month 12 | Percentage of patients with complete clearing of corneal staining at month 12. Corneal staining is evaluated following administration of fluorescein dye into the eye. Complete clearing is defined as the absence of corneal staining. | Month 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Schirmer's Test at Month 12 | Schirmer's test at month 12. The Schirmer's tear test is performed on the eye with or without anesthesia (numbing eye drop). The amount of tears produced by the eye in 5 minutes is measured in millimeters by means of a graduated paper scale. Data not reported due to limited number of patients with Schirmer's test data recorded. | Month 12 |
Combining Registry Data in Haemophilia: TARGET H

Study Overview
=================
Brief Summary
-----------------
This is an investigator-initiated, multinational, retrospective, non-interventional pilot study conducted in five haemophilia treatment centres from different geographical regions that maintain a local (Algeria, Malaysia) or national (India, Iran, South Africa) haemophilia registry. Data from a randomly selected sample of patients from national or local registries are anonymously collated and analysed.The aims are to determine the feasibility of combining data from national and local registries in countries with developing healthcare systems and to assess how existing registries implemented current recommendations for data collection in terms of available fields and their completion.

Detailed Description
-----------------
The study is conducted in five haemophilia treatment centres (HTCs) from different geographical regions (Algeria, India, Iran, Malaysia and South Africa) that maintain a local or national haemophilia registry. Data will be collected from 20 randomly selected, active patient records from each participating registry/country. In countries with national registries, data from local registries will not be permitted for inclusion to allow adequate assessment of the possibility of registry harmonisation across various regions. Participating centres will report data as available in the data source without seeking additional information to fill source data gaps at the time of data collection. In addition, each investigator will complete a basic questionnaire on feasibility parameters to confirm the source and accuracy of the data, as well as challenges experienced during data collection. Analysed parameters will be grouped into three categories: sociodemographic, disease, and treatment and disease outcome parameters. Feasibility assessment will be performed for all study variables and the percentage availability of each study variable recorded in the participating registries wii be determined, as well as the proportion of missing data for existing variables.

Official Title
-----------------
An Observational Pilot sTudy to Assess the Feasibility of Combining Data From Patient Registries in Countries With Developing Health Care Systems to EvaluaTe Haemophilia Management

Conditions
-----------------
Haemophilia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: male diagnosis of haemophilia A or B with or without inhibitors no other inherited bleeding disorder active patient record willing and able to provide written consent Exclusion Criteria: - unwilling or unable to provide written consent
Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Haemophilia registry data | sosiodemographic parameters, disease parameters and treatment and disease outcome parameters | May to September 2015 |
Assessing AlloSure Dd-cfDNA Monitoring Insights of Renal Allografts With Longitudinal Surveillance

Study Overview
=================
Brief Summary
-----------------
Prospective Observational Multicenter Cohort. External validation of donor derived cell free DNA in Renal Transplantation. Assessing performance of dd-cfDNA as a surveillance tool and its association with clinical outcomes. Outcomes include formation of de-novo DSA, eGFR decline, performance of AlloSure dd-cfDNA in Allograft rejection.

Official Title
-----------------
Assessing AlloSure Dd-cfDNA Monitoring Insights of Renal Allografts With Longitudinal Surveillance

Conditions
-----------------
Kidney Transplant Rejection

Intervention / Treatment
-----------------
* Device: AlloSure


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Renal transplant patients

Ages Eligible for Study
-----------------
Minimum Age: 12 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Prospective observational cohort<br> | Device: AlloSure<br>* Patients will receive donor-derived cell-free DNA testing for surveillance and for-cause.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Validation of AlloSure in Allograft rejection |  | October 2020 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Performance of AS with De-Novo DSAs, Performance in subclinical and protocol biopsies vs clinically indicated for cause biopsies, Survival analysis considering AS surveillance |  | October 2020 |