linjc16/ctgov huggingface dataset:
Long-Term Follow-Up Safety Monitoring of Patients Dosed in the First-in-Man Phase I/II Study of TT-034.

Study Overview
=================
Brief Summary
-----------------
This is a long-term safety follow-up protocol for subjects who received TT-034 under the B2801001 protocol and consists of monitoring for at least 4.5 years.

Detailed Description
-----------------
The main purpose of this follow-up study is to detect events suggestive of delayed adverse effects of the study drug by review of clinical histories and discussion with subjects to identify/elicit significant medical events, including but not limited to hematologic, malignant, autoimmune, neurologic, and hepatic events.

Official Title
-----------------
Follow-up to Study Protocol B2801001, A Phase I/II, Open-Label Dose Escalation Study to Evaluate the Safety and Efficacy of Single Doses of TT-034 in Patients With Chronic Hepatitis C [CHC] Infection

Conditions
-----------------
Hepatitis C

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Prior enrollment in Study B2801001 and dosing with TT-034 An informed consent form for this study signed and dated by the subject or a legally acceptable representative Exclusion Criteria: There are no specific exclusion criteria for this follow-up study

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 |
| --- | --- |
| Dosed subjects<br>There is no intervention. This is a observational study monitoring subjects that were dosed with TT-034 in the Tacere B2801001 study, | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Long Term Safety as measured through an assessment of adverse events | The primary objective is to assess the long-term safety of TT-034 administered in subjects with CHC through an assessment of adverse events with a focus on hematologic, malignant, autoimmune, neurologic and hepatic events. | 4.5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Long Term Viral Load | The secondary objective is to monitor long-term HCV viral load, as available, of subjects who have received TT-034. | 4.5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Adeno-associated viral vectors, Adeno-associated virus, AAV, AAV8, ddRNAi, shRNA, RNAi, Hepatitis, Chronic Hepatitis C, HCV, CHC, Genotype 1
Web-based International Multi-Center Clinical Study for Parkinson's Disease

Study Overview
=================
Brief Summary
-----------------
The objectives of this study are (1) to compare the clinical outcome in correlation with the electrode positions estimated by web-based image fusion of the preoperative MRI and the postoperative brain CT taken at a stable period after surgery using mutual information technique in the patients with advanced Parkinson's disease (PD) after bilateral STN DBS and (2) to examine whether the documentation of the electrode position by using mutual information technique at a stable period after unilateral or bilateral STN stimulation provides useful information for the postoperative programming.

Official Title
-----------------
Web-based International Multi-Center Clinical Study for Parkinson's Disease; the Evaluation of Clinical Outcome Based on the Electrode Position Estimated From the Fused Images of Preoperative MRI and Postoperative CT After Bilateral STN DBS

Conditions
-----------------
Parkinson Disease

Intervention / Treatment
-----------------
* Procedure: electrode position


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Advanced Parkinson Disease patients Exclusion Criteria: The patients who have experienced any perioperative or postoperative complications The patients with severe cognitive impairment, ongoing psychiatric problems, an unsatisfactory general condition for evaluation, or an inability

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 70 Years

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

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

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

Design Details

Primary Purpose: Screening
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: electrode position, STN DBS, Parkinson' disease<br>To determine the electrode positions with the relationship of the STN from the fused images of the preoperative MRI and the postoperative CT via web-site. | Procedure: electrode position<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine the electrode positions with the relationship of the STN from the fused images of the preoperative MRI and the postoperative CT |  | at 1 month after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| UPDRS, H&Y, ADL scores, LEDD |  | at 6 and 12 months after surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
electrodeposition, Subthalamic Nucleus, Deep Brain Stimulation, Parkinson Disease
Effects of Pilates Training on Physical Performance of Cricketers

Study Overview
=================
Brief Summary
-----------------
This study is designed to evaluate the effectiveness of Pilates training improves physical fitness of cricket players.

Detailed Description
-----------------
During the modern times, researchers have notably increased their knowledge, grounded on literature, with regards to the relationship between core stability and athletic performance. Number of research studies have also been completed that underline the benefits of core stability training on injury prevention or performance, but in combination with other training modalities such as speed, power, strength and agility. Although several studies have investigated core stability benefits in athletes but there are very limited studies have presented the role of Pilate training in increasing the core strength and stability of cricket players in order to maximize their performance in the game. This study will contribute in describing the effects of Pilate training in cricket players.

Official Title
-----------------
Effects of Pilates Training on Physical Performance of Cricketers

Conditions
-----------------
Core Strengthening

Intervention / Treatment
-----------------
* Other: Pilate training


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Participants falling in this category would be recruited into the study. Active Male cricketers. Had practiced for at least 2 years Age group of 19-30 Players with normal BMI (ranging in between 18.5 to 24.9) Exclusion Criteria: Participant failing to fall in this category would be excluded of the study. History of metabolic diseases. History of recent fractures. Players taking substance inhibited (in and out of the competition) by WADA Had extreme discomfort on contracting the abdominal muscles. Were spin bowlers.

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 30 Years

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

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

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

Design Details

Primary Purpose: Other
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pilate training<br>The participants of this group perform pilate training along with conventional cricket training. | Other: Pilate training<br>* Pilates is an exercise training program used to build core strength and flexibility.<br>|
| No Intervention: Conventional training<br>The participants perform only conventional cricket training. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the effectiveness of Pilates training improves physical fitness of cricket players. |  | 4 weeks |
OS NMB Depth Measured by Central and Peripheral Monitor.

Study Overview
=================
Brief Summary
-----------------
Comparing during anesthesia in the same patient 2 neuromuscular monitors on the same arm.

Detailed Description
-----------------
NMT (neuromuscular transmission) depth can be measured at the same arm with two different methods during clinical practice. the first (TOF Watch) measures the musculus adductor pollicis acceleration while the second method (TOF Cuff Monitor) uses a blood pressure cuff to measure the pressure changes induced by the upper arm muscles. During general anesthesia when NMB (neuromuscular block) is required both methods are used. Every 5 minutes, if clinical required, the NMB is monitored by TOF-PTC. If the measurement of TOF is zero the monitor continues by measuring PTC ( the system will measure TOF followed by PTC if TOF is zero) TOF-PTC is recorded and later compared for identity or systematic difference in one or the other direction. The measured answer can be TOF 4 (4 answers) with a ratio between answer 1 and 4 expressed and a percentage, TOF 3 (3 answers), TOF 2, TOF 1, TOF 0 + PTC 20, TOF 0 + PTC 19, up to TOF 0 + PTC 0

Official Title
-----------------
Observational Study Measuring Neuromuscular Block Depth by a TOF or PTC Monitor on the Thumb and on the Upper Arm of the Same Side.

Conditions
-----------------
Neuromuscular Blockade

Intervention / Treatment
-----------------
* Diagnostic Test: measuring neuromuscular block


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: all patients scheduled for an elective surgery requiring neuromuscular block during anesthesia laparoscopic surgery of upper abdomen including all types of bariatric surgery. Exclusion Criteria: not possible to measure NMT (neuromuscular transmission) by cuff or thumb monitor upper arm obesity excluding the use of an upper arm blood pressure cuff allergy to NMB (neuromuscular blockers) contra indication for a deep NMB

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

| Intervention/Treatment |
| --- |
|Diagnostic Test: measuring neuromuscular block|During anesthesia patients are monitored with two instead of one NMT monitor. the difference in measured TOF-PTC is compared|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| TOF-PTC value | Difference in TOF-PTC measured by two different devices during anesthesia. | From induction of anesthesia (intubation with ETT) till end of anesthesia (extubation of ETT) most frequent between 1 and 2 hours, max 6 hours in duration |
Evaluation of Cognitive Impairment in the Elderly Admitted to Nursing Homes

Study Overview
=================
Brief Summary
-----------------
This research aims at analysing the profile of the elderly with cognitive impairment (IC) and inquiring about the mental illnesses that cause cognitive impairment of a population (elderly admitted to nursing homes with a high incidence).

Detailed Description
-----------------
The objectives of these studies are to determine the presence of IC and the profile of users who suffer from it in 8 nursing homes in the province of Pontevedra of new admission in 2017, as well as the identification of the frequency of underdiagnosis in the filiation of the mental pathology that causes IC and if that underdiagnosis is related to the presence of doctors or nurses specialists in geriatrics. Sociodemographic, clinical (with special relevance in cognitive assessment and the presence of mental disorders) and functional variables will be analyzed. In addition to providing information that can improve the DC early detection as well as the scarcity of studies in this field, the importance of this research is justified by developing treatment guidelines for people with IC in the future

Official Title
-----------------
Evaluation of Cognitive Impairment in the Elderly Admitted to Nursing Homes

Conditions
-----------------
Neurocognitive Disorder, Etiology of Neurocognitive Disorder

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Vounteer Elderly Admitted to Nursing homes From 60 years old Exclusion Criteria: Elderly without cognitive assessment at admission Existence of doubts about the presence of IC

Ages Eligible for Study
-----------------
Minimum Age: 60 Years

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Ederly<br>Elderly Admitted to Nursing homes | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Study of Evaluation of Cognitive Impairment. MEC o MMSE <24 points or diagnosis of Neurocognitive disorder |  | Two years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Statistical correlation of CI with educational level. |  | Two years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cognitive impairment, nursing home, neurocognitive disorder
Safety and Effectiveness of the Akreos Toric Intraocular Lens.

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the safety and effectiveness of the Akreos Toric IOL following cataract surgery.

Official Title
-----------------
Monocular Study to Evaluate the Safety and Effectiveness of the Akreos™ Toric IOL When Used to Correct Primary Aphakia With the Reduction of Astigmatism

Conditions
-----------------
Cataract, Astigmatism

Intervention / Treatment
-----------------
* Device: Akreos Toric IOL
* Device: Akreos Advanced Optics Aspheric Intraocular Lens (Akreos AO)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects must be willing and able to provide written consent on the EC approved Informed Consent form. Subjects must require a lens power from 15 to 30 diopters. Exclusion Criteria: Subjects with any anterior segment pathology for which extracapsular phacoemulsification cataract surgery would be contraindicated. Subjects with corneal pathology potentially affecting topography.

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: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Akreos Toric<br>Akreos Toric Intraocular Lens | Device: Akreos Toric IOL<br>* Lens implant following cataract surgery<br>|
| Active Comparator: Akreos Advanced<br>Akreos Advanced Optics Aspheric Intraocular Lens (Akreos AO) | Device: Akreos Advanced Optics Aspheric Intraocular Lens (Akreos AO)<br>* Lens implant following cataract surgery<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction of cylinder, Lens axis misalignment as determined by a photographic method. |  | 32 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lens misalignment as determined by postoperative manifest refraction and vector analysis. |  | 32 months |
Pregnancy Rate by HCG Administration Versus Urinary LH Surge Method in Patients Undergoing IUI

Study Overview
=================
Brief Summary
-----------------
To compare pregnancy rate by Human Chorionic Gonadotropin (HCG) administration and urinary Luteinizing Hormone (LH) surge method for insemination in patients undergoing Intrauterine Insemination (IUI) at Montaserieh infertility center. The present study comprised 309 infertile women candidate for IUI, randomly divided into LH surge and HCG groups (assign the number for each patient, odds number for LH and even number for HCG group). All patients were subjected to baseline ultrasound and received clomiphene citrate before undergoing serial transvaginal sonography. LH was measured using LH kit when 2-5 follicles (18-20 mm) appeared in LH surge group, and if positive, IUI was performed after 24 hours. In HCG group, the patients received HCG 1000 units and underwent IUI after 36 hours. The pregnancy rate was then compared in LH and HCG groups.

Conditions
-----------------
Pregnancy

Intervention / Treatment
-----------------
* Drug: LH
* Drug: HCG
* Drug: Clomiphene


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: infertile women candidate for IUI Exclusion Criteria: women with negative urinary LH surge which required HCG administration, those with more than 5 follicles who had to use LH kit and not receive HCG to avoid ovarian hyperstimulation.

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: HCG group<br>HCG group | Drug: HCG<br> <br> Drug: Clomiphene<br> <br> |
| Experimental: LH group<br>LH group | Drug: LH<br> <br> Drug: Clomiphene<br> <br> |
| Experimental: clomiphene citrate<br>clomiphene citrate | Drug: LH<br> <br> Drug: HCG<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pregnancy rate |  | Two weeks after IUI |
Epidemiology of IgA Selective Deficiency - Clinical Manifestations and Risk of Transmission

Study Overview
=================
Brief Summary
-----------------
The management of patients with a selective IgA deficiency currently consists of symptomatic treatment with treatment of infections by occasional or prolonged antibiotic therapy, immunosuppressive treatments for autoimmune pathologies, symptomatic treatment of allergic manifestations. IVIG supplements are sometimes proposed in the event of recurrent infections and the demonstration of deficiencies in IgG subclasses (IgG1, 2, 3) often not sought for diagnosis The factors associated with the severity of clinical manifestations are not well identified and patients with IgA deficiency must be monitored over the long term because of the risk of the appearance of autoimmune manifestations and neoplasia. The identification of such factors could lead to the proposal of close monitoring for these patients. IgA deficiency, which is frequent, has not been identified as a risk factor for severe COVID-19 infection, probably due to a lack of studies with sufficient recruitment. The therapeutic attitude concerning patients with an IgA deficiency in the event of COVID-19 infection is therefore not consensual. There is currently no action to be taken regarding the risk of transmission of IgA deficiency.

Official Title
-----------------
Epidemiology of IgA Selective Deficiency - Clinical Manifestations and Risk of Transmission: A Retrospective Cohort Study in Strasbourg University Hospital

Conditions
-----------------
COVID-19

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Major subject (≥18 years old) Subject treated at the HUS, with a primary selective IgA deficiency, considered as definitive (IgA concentration < 0.07g/L or total absence of IgA on immunofixation) or as probable (IgA concentration lower than two standard leads to standard for age) with no other humoral immunodeficiency and no other cause of decreased gammaglobulins 01/01/2005 to 01/31/2022. Subject having not expressed, after being informed, their opposition to the reuse of their data for the purposes of this research. Exclusion criteria: . Subject who expressed their opposition to participating in the study

Ages Eligible for Study
-----------------
Minimum 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 |
| --- | --- | --- |
| Positive test result for covid-19 |  | 1 hour after hospitalization | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
COVID-19, IgA deficiency, Antibiotic therapy, Immunosuppressive treatments, Autoimmune manifestations, Neoplasia
Assessment of the Tolerability of Dry Airflow in the Nasal Cavity During Sleep

Study Overview
=================
Brief Summary
-----------------
Preliminary data show that high flow nasal air has been shown to reduce promote heat exchange due to evaporation of nasal mucus by the air flow resulting in heat loss. It is unclear whether unidirectional nasal airflow is well tolerated in healthy individuals. The central hypothesis of this proposal is that dry high flow nasal air will be sufficiently tolerated in healthy adults.

Official Title
-----------------
Assessment of the Tolerability of Dry Airflow in the Nasal Cavity During Sleep

Conditions
-----------------
Healthy Adults

Intervention / Treatment
-----------------
* Device: Nasal High Flow


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy men and women Able to consent Age ≥ 18 BMI<30kg/m2 Exclusion Criteria: Previous diagnosis of obstructive sleep apnea or sleep disorder History of Constant Positive Airway Pressure treatment for Obstructive Sleep Apnea History of recurrent epistasis Pregnancy (self-report) Deviated nasal septum Unstable cardiovascular disease (decompensated Congestive Heart Failure, myocardial infarction or revascularization procedures, unstable arrhythmias) Uncontrolled hypertension with BP > 190/110 Daytime hypoxemia with oxygen saturation<90% (measured at history and physical examination) Supplemental oxygen use Work in transportation industry as a driver or pilot.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 100 Years

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

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

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

Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Nasal High Flow<br>All subjects are in this group | Device: Nasal High Flow<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subjective Tolerability using Questionnaire | Participant response to nasal high flow using 7 point Likert scale | Baseline |