linjc16/ctgov huggingface dataset:
Extended Release Nifedipine Treatment as Maintenance Tocolysis to Prevent Preterm Delivery

Study Overview
=================
Brief Summary
-----------------
To evaluate the treatment efficacy and safety usig extended release nifedipine, as maintenance therapy to pregnant women who were hospitalized and treated for preterm labor until 34 weeks' gestation. After the PTL will stop, we will randomize these women for the treatment group and the control (no treatment) group. The main outcome will be preterm delivery before 34 weeks' gestation. the secondary outcome will be the side effects of the medication and the newborn/mother health variables.

Official Title
-----------------
Extended Release Nifedipine Treatment as Maintenance Tocolysis to Prevent Preterm Delivery:A Prospective Interventional Study

Conditions
-----------------
Preterm Labor

Intervention / Treatment
-----------------
* Drug: Nifedipine extended release


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: pregnancy week 24-33 Singleton pregnancy After successful treatment to stop PTL Exclusion Criteria: Contraindications for Nifedipine extended release treatment.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

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

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

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: A<br>The treated group of pregnant women, after having successful treatment for PTL | Drug: Nifedipine extended release<br>* Nifedipine extended release PO 30 mg X2/d until 34 weeks' gestation<br>* Other names: Osmo-Adalat 30 mg;|
| No Intervention: B<br>The no treatment arm of women treated with tocolysis for PTL. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Nifedipine, Tocolysis, Maintenance, Preterm delivery, extended release nifedipine, PTL
Post-operative Anemia in Lateral Fractures of the Femur.

Study Overview
=================
Brief Summary
-----------------
It was conducted a prospective study with a series of 45 patients with lateral fragility fractures of the femur treated by three different intramedullary nails. Patients were randomized in Group A (15 patients treated by Affixus Zimmer-Biomet), Group B (15 patients treated by EBA2 - Citieffe) and Group C (15 patients treated by Proximal Femoral Nail Antirotation Synthes). One independent observer performed seven biochemical evaluations (hemoglobin serum value) from admission to patient discharge. Surgical time and Blood transfusions number were reported for each partecipant.

Official Title
-----------------
Post-operative Anemia in Lateral Fragility Fractures of the Femur. A Prospective Observational Study in Three Different Intramedullary Nails

Conditions
-----------------
Femur Fracture

Intervention / Treatment
-----------------
* Diagnostic Test: hemoglobin serum value


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: femur fractures type 31-A1, A2, A3 (Muller ME, Nazarian S, Kock P et al.); age more than 65 years; Exclusion Criteria: patients with neurological diseases; finding of anemia before surgery;

Ages Eligible for Study
-----------------
Minimum Age: 65 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 treated with Affixus Zimmer-Biomet<br> | Diagnostic Test: hemoglobin serum value<br>* post-operative anemia evaluated with hemoglobin serum value<br>|
| patients treated with EBA2 Citieffe<br> | Diagnostic Test: hemoglobin serum value<br>* post-operative anemia evaluated with hemoglobin serum value<br>|
| patients treated with Proximal Femoral Nail Antirotation Synthes<br> | Diagnostic Test: hemoglobin serum value<br>* post-operative anemia evaluated with hemoglobin serum value<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in hemoglobin serum value | Post-operative anemia was quantified using the hemoglobin serum value ranging between more than 10 g/dl (no post-operative anemia) and less than 10 g/dl (post-operative anemia). | Preoperative, Day 0, Day 1, Day 2, Day 3, Day 5 (after surgery) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
fragility lateral femoral fractures, intramedullary nail, Post-operative anemia, surgical time, Blood transfusions number
Hyperbaric Oxygen Therapy Can Improve Neurological State Post Meningioma Removal Surgery

Study Overview
=================
Brief Summary
-----------------
The aim of the current study is to evaluate, in a prospective cross-over, randomized study, the effect of hyperbaric oxygen therapy (HBOT) on patients with chronic neurological deficits and cognitive impairment after anterior skull base meningioma tumor removal.

Official Title
-----------------
Hyperbaric Oxygen Therapy Can Improve Neurological State Post Meningioma Removal Surgery -Randomized Prospective Trial

Conditions
-----------------
Intracranial Meningioma, Neurologic Deficits

Intervention / Treatment
-----------------
* Biological: HBOT


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Post intracranial meningioma removal surgery 3-12 months prior to the inclusion in the study. All patients have to have persistent cognitive or neurological complaints regarding without noticeable improvement during the last month prior to their enrolment. Age 18 years or older. Exclusion Criteria: Dynamic neurologic/cognitive improvement or worsening during the past month; Evidence of dynamic cognitive/neurological improvement in the last month. Previous brain radiotherapy and/or radiosurgery. Steroids dependence Seizures 1 month previous to inclusion Had been treated with HBOT for any other reason 1 month prior to inclusion; Have any other indication for HBOT; Chest pathology incompatible with pressure changes; Inner ear disease; Patients suffering from claustrophobia; Inability to sign written informed consent; Smoking patients will not be allowed to smoke during the study and if they would not comply with this demand they will be excluded.

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

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HBOT<br>Group will be treated with HBOT for 60 treatments in 3 months. | Biological: HBOT<br>* HBOT of 2 ATA for 90 minutes, for 60 treatments<br>|
| Other: Control/Crossover<br>Control for 3 months without treatment, and then HBOT for 60 treatments in 3 months. | Biological: HBOT<br>* HBOT of 2 ATA for 90 minutes, for 60 treatments<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neurocognitive functions | Cognitive function will be assessed using the one-hour Mindstreams Computerized Cognitive Test Battery at baseline, 3 months and 6 months to intervention. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Life | Quality of live will be evaluated by the EQ-5D questionnaire at baseline , 3 months and 6 months to intervention. | 6 months |
Pharmacokinetics and Pharmacodynamics of Nasally Applied Esketamine

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is the determination of blood concentration and the effectiveness of esketamine after nasal application.

Official Title
-----------------
Pharmacokinetics and Pharmacodynamics of Nasally Applied Esketamine

Conditions
-----------------
Pain

Intervention / Treatment
-----------------
* Drug: esketamine hydrochloride


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: male age ≥18 years ≤ 45 years healthy non-smoking BMI 18-27 Exclusion Criteria: abuse of drugs known or supposed hypersensitivity and/or contraindication against ketamine or additives participation of another clinical study within the last 30 days chronic obstructed nose breathing or nasal polyps dug allergy blood donation within the last two months

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
-----------------
Male

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Esketamine<br> | Drug: esketamine hydrochloride<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
pharmacokinetics, ketamine, Anesthetics, Dissociative
Decoding Chronic Pain With fMRI

Study Overview
=================
Brief Summary
-----------------
Recent evidence suggests that chronic pain is associated with abnormal connectivity between brain regions associated with the processing of pain. We aim to test the diagnostic power of resting state functional magnetic resonance imaging (MRI) to diagnose patients with chronic back pain. Using new methods of image acquisition and analysis we aim to develop a computational method to correctly classify patients and matched control subjects.

Official Title
-----------------
Observational Study to Determine Abnormalities in Resting State fMRI in Chronic Back Pain.

Conditions
-----------------
Chronic Back Pain

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age 18-60 pain > 6months right-handed non-smoking mechanical back pain Exclusion Criteria: significant neurological or psychiatric disease major systemic illness MRI exclusion criteria

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 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 |
| --- | --- |
| Chronic back pain<br>Adults, >6months duration | |
| Control<br>Age and sex matched controls | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional brain connectivity | Assessed by fMRI | 6 months |
Rapid Assessment of Donor Liver Quality

Study Overview
=================
Brief Summary
-----------------
Aims： Conduct multi-center, prospective and open research on liver quality assessment and establish LSCM liver quality assessment system Classification of liver quality grades by LSCM for different pathological conditions (steatosis, fibrosis, hepatocyte necrosis, etc.) Compare the specificity and sensitivity of LSCM evaluation results with the results of liver donor quality evaluation and intraoperative pathological biopsy results. LSCM classifies the quality of donor liver and compares the recovery of liver function on the first day after liver transplantation. LSCM grades the quality of donor liver and compares the long-term prognosis

Official Title
-----------------
Real-time Noninvasive Assessment of Donor Liver Quality

Conditions
-----------------
Transplant; Failure, Liver

Intervention / Treatment
-----------------
* Diagnostic Test: LSCM examination


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All donor livers to be used for liver transplantations Exclusion Criteria: Exclusion of multiple organ transplantation Exclusion of detached transplantation and partial liver transplantation, etc. Removal of blood type incompatible patients for transplantation Exclusion of poor donor liver quality due to surgical technique (such as hepatic artery embolization) , portal vein thrombosis, etc.) Any form of substance abuse, mental illness or any disease that the investigator believes may interfere with the patient's understanding of the research requirements. Can not complete routine research follow-up, and other circumstances that the investigator believes are not suitable for the experiment.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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 |
| --- | --- |
| LSCM examination<br> | Diagnostic Test: LSCM examination<br>* Cut a piece of donor liver and conduct the LSCM examination after staining fluorescein<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| LSCM examination results | LSCM examination is focus on the detections of the hepatocyte nucleus and the micro structures(such as the micro-circulation、central vein and so on). | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HE section staining pathological examination | All of donor livers must be detected by HE section staining pathological examination and it is mainly focused on the detection of hepatocyte nucleus and the micro structures(such as the micro-circulation、central vein and so on). | 1 week |
The UHSM Cardiovascular Magnetic Resonance Study

Study Overview
=================
Brief Summary
-----------------
This study aims to investigate the diagnostic and prognostic utility of cardiovascular magnetic resonance (CMR) imaging in a large cohort of unselected patients who are undergoing CMR scanning for clinical indications (i.e. suspected/confirmed cardiovascular disease). CMR indices will be related to the presence and severity of cardiovascular disease and other markers of cardiovascular and health status.

Detailed Description
-----------------
Patients will undergo CMR scanning in the usual clinical manner. As part of the study, patients will undergo approximately 5 minutes of extra CMR scanning. Cardiovascular anatomical, structural and functional data will be recorded, including data pertaining to myocardial characteristics (e.g. extracellular volume, oedema, fibrosis, infarction, function, perfusion), pericardial disease; valvular disease; vascular structure and function. Blood sampling will be performed on the same day as CMR scanning for assessment of serum/plasma markers of cardiovascular disease and health status, and DNA analysis. Health questionnaires will be completed on the day of CMR scanning. Follow-up information regarding health status, demographics and concurrent medical conditions and treatments will be obtained over a 10 year period following CMR scanning.

Official Title
-----------------
The University Hospital of South Manchester Cardiovascular Magnetic Resonance Study

Conditions
-----------------
Cardiovascular Diseases

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Any adult patient undergoing clinically indicated CMR scanning at the UHSM CMR Unit. Exclusion Criteria: Age < 18 years, imprisonment, inability to provide informed consent.

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

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All cause mortality |  | 10 years with planned interim analyses | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiovascular death |  | 10 years with planned interim analyses | 
| Hospitalisation for heart failure |  | 10 years with planned interim analyses | 
| Development of cardiovascular disease |  | 10 years with planned interim analyses | 
| Development of complications of cardiovascular disease |  | 10 years with planned interim analyses |
Rheumatoid Arthritis Patients and Porphyromonas Gingivalis

Study Overview
=================
Brief Summary
-----------------
Rheumatoid arthritis (RA) is the most frequent joint inflammatory disease inducing joint destruction strongly correlated with anti-citrullinated protein antibodies citrullinated anti-peptide (ACPA). Precise RA etiology remained unclear with a described association between RA and periodontal disease. The missing link could be a gram-negative anaerobic bacterium called Porphyromonas gingivalis (P. gingivalis), which is heavily involved in periodontal disease and able to induce gingival citrullinated protein via an enzyme called peptidyl arginine deiminase (PAD). DNA of P. gingivalis was detected in synovial tissue and in peripheral blood mononuclear cell. To improve knowledge of P. gingivalis involvement in RA, the investigators will compare its effect on various cell type with comparison with another oral bacteria Provatella intermedia.

Official Title
-----------------
Porphyromonas Gingivalis Contribution in Rheumatoid Arthritis (RA).

Conditions
-----------------
Rheumatoid Arthritis

Intervention / Treatment
-----------------
* Procedure: blood sample
* Procedure: synovial tissue


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age >18 ans RA or osteoarthritis with joint surgery planned Informed consent approved and signed Exclusion Criteria: Pregnancy

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 |
| --- | --- |
| Rheumatoid arthritis<br>blood sample specimen and synoviocytes from synovial tissue | Procedure: blood sample<br> <br> Procedure: synovial tissue<br>* synoviocytes from synovial tissue<br>|
| Osteoarthritis<br>blood sample specimen and synoviocytes from synovial tissue | Procedure: blood sample<br> <br> Procedure: synovial tissue<br>* synoviocytes from synovial tissue<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of genetic signature after induction by P. gingivalis and P. intermedia on synoviocytes |  | day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of specific transcriptome profile induced by P. gingivalis compared to P. intermedia on peripheral blood mononuclear cells (PBMC) and gingival fibroblasts |  | day 1 | 
| Comparison of transcriptome profile between P. gingivalis and P. intermedia on RA synovial cells. |  | day 1 | 
| Comparison of the transcriptomic profile between RA and osteoarthritis synoviocytes |  | day 1 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
rheumatoid arthritis, Porphyromonas gingivalis
The Impact of the Timing of Trigger on IVF Success

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to examine the length of ovarian stimulation with the timing of trigger in an IVF cycle and its potential to impact patient outcomes.

Official Title
-----------------
The Impact of the Timing of Trigger on IVF Success: Randomized Control Trial

Conditions
-----------------
Fertilization in Vitro, Infertility, Embryonic Development

Intervention / Treatment
-----------------
* Other: Timing of trigger


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Planning to move forward with an IVF cycle Have met the requirements of being a patient at CCRM Colorado AMA: 39-44 years old And/or DOR: AMH < 1 & FSH >10 (age independent) Exclusion Criteria: Contraindication for pregnancy Have not fulfilled requirements for IVF cycle Single gene couple or chromosomal rearrangement Severe male factor or testicular surgical sperm removal (need sufficient sperm for ICSI) One ovary Uterine anomalies Stage III or IV endometriosis Explained recurrent miscarriage PCO or PCOS Using donor oocyte or gestational carrier

Ages Eligible for Study
-----------------
Minimum Age: 26 Years
Maximum Age: 44 Years

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

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

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: Testing group<br>Timing of trigger at end of ovarian stimulation in an IVF cycle: trigger when 2 follicles reach 18mm, OR 1 follicle reaches 18mm AND 1 follicle is between 16-18mm. | Other: Timing of trigger<br> <br> |
| No Intervention: Control group<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Euploid Embryos: the percentage of euploid embryos produced as analyzed by comprehensive chromosomal screening, of total embryos tested |  | 4 weeks after egg retrieval | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Egg maturation: the proportion of mature eggs of total number of eggs retrieved |  | 1 week after egg retrieval | 
| Live birth outcomes: the incidence of pregnancy resulting in live birth following embryo transfer of embryos produced by this IVF cycle |  | 9 months after frozen embryo transfer |