linjc16/ctgov huggingface dataset:
Platelet-Rich Protein and the Endometrium

Study Overview
=================
Brief Summary
-----------------
Platelet-rich plasma (PRP) may promote the endometrial growth and improve pregnancy outcome of patients with thin endometrium undergoing ART treatments.

Official Title
-----------------
Can Platelet-rich Plasma (PRP) Promote Endometrial Growth and Improve Pregnancy Outcome of Patients With Thin Endometrium Undergoing Assisted Reproductive Technology (ART) Treatments?

Conditions
-----------------
Infertility

Intervention / Treatment
-----------------
* Other: PRP injection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women undergoing a frozen thawed embryo transfer cycle with poor endometrial response to estrogen (< 7 mm) after at least two standard preparation protocols, of which one was canceled due to thin endometrium Exclusion Criteria: none

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 54 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PRP injection<br> | Other: PRP injection<br>* autologous intrauterine infusion of PRP<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| endometrial thickness >7mm |  | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Positive serum pregnancy test |  | 14 days post embryo transfer |
Fragmentation of Elastin as a Biological Marker of Frailty and Impact in Tumor Progression in Elderly Patients With Cancer

Study Overview
=================
Brief Summary
-----------------
The aim of the study is to evaluate frailty in patients aged ≥ 65 years with cancer. The elderly population is very heterogeneous, it is necessary to evaluate these elderly patients before treatment to assess the risk-benefit balance. To date, this assessment relies on subjective clinical methods often not optimal, and slow to implement. An innovative method of evaluation could be the determination of elastin peptides. Indeed, the rate of these peptides, which are linked to serious conditions associated with age, rising inexorably with age and dose could help determine more objectively the type of treatment to offer older patients. Expected results : This study will allow better identification of the group of frail elderly through more relevant biological marker that clinical assessment, often subjective and not available within a period compatible with the treatment of newly diagnosed cancer. This biological assessment will also enable optimal management of elderly patients in particular by allowing the geriatrician better efficiency.

Official Title
-----------------
Fragmentation of Elastin as a Biological Marker of Frailty and Impact in Tumor Progression in Elderly Patients With Cancer

Conditions
-----------------
Cancer

Intervention / Treatment
-----------------
* Biological: blood withdrawn
* Biological: urine collection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 65 years or older diagnosis of cancer affiliation to a social security scheme Signed informed consent for the study and for the collection of biological samples Exclusion Criteria: Patient protected by law (guardianship, trusteeship)

Ages Eligible for Study
-----------------
Minimum Age: 65 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: patients<br> | Biological: blood withdrawn<br> <br> Biological: urine collection<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| elastin peptides quantification |  | up to 36 months |
Clinical Evaluation of the Nucleus 5 Cochlear Implant (CI) System

Study Overview
=================
Brief Summary
-----------------
To evaluate the performance of the Nucleus 5 Cochlear Implant System.

Detailed Description
-----------------
Performance outcomes of newly implanted adult recipients using the Nucleus 5 Cochlear Implant System.

Official Title
-----------------
Clinical Evaluation of the Nucleus 5 Cochlear Implant System

Conditions
-----------------
Hearing Loss

Intervention / Treatment
-----------------
* Device: Nucleus 5 Cochlear implant
* Device: Cochlear implantation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Eighteen years of age or older at the time of the study. Postlinguistic onset of bilateral severe-to-profound sensorineural hearing loss Bilateral severe-to-profound hearing loss that meets current cochlear implant criteria (<50% open-set sentence recognition in quiet scores in the ear to be implanted and <60% in the best-aided condition) English spoken as the primary language. Willingness to participate in and to comply with all requirements of the study Subject may receive bilateral simultaneous cochlear implants. Exclusion Criteria: Previous cochlear implant experience Congenital hearing loss (for the purpose of this study, onset prior to 2 years-of-age). Ossification, absence of cochlear development or any other cochlear anomaly that might prevent complete insertion of the electrode array. Normal hearing in one or both ears. Hearing loss of neural or central origin (e.g., deafness due to lesions on the acoustic nerve or central auditory pathway). Active middle-ear infection. Unwillingness and/or inability of the candidate to comply with all investigational requirements including, but not limited to, study protocol and surgical procedure.

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?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Single Arm<br>Single arm design | Device: Nucleus 5 Cochlear implant<br>* Cochlear implant surgery<br>Device: Cochlear implantation<br>* Implantation<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CNC Monosyllabic Word Performance - Treated Ear | CNC Word Test is a validated test of open-set word recognition. The test consists of 10 lists with 50 monosyllabic words in each list. Subject responses are scored for both words and phonemes correct in the correct sequence. Subjects will be tested using a configuration of speech at 0º azimuth in quiet. | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Speech perception ability in the CI alone condition
Analyses of Human Samples Collected in Clinical Trials

Study Overview
=================
Brief Summary
-----------------
Cancer patients in clinical trials donate various human samples (e.g., serum, plasma, blood, urine, feces, bile, saliva) for research purposes. The purpose of this study is to conduct further analyses on these existing samples from clinical trials that are being performed outside of, but in collaboration with, the National Cancer Institute.

Detailed Description
-----------------
Various human samples (e.g., serum, plasma, whole blood, erythrocytes, urine, feces, bile, and/or saliva) will be collected from cancer patients enrolled on approved clinical trials, in accordance with the local protocol. These trials are being conducted at outside institutions, in collaboration with the National Cancer Institute (NCI) and the samples will be sent to the NCI for pharmacological analysis, involving determination of parent drug and/or metabolite concentrations and subsequent pharmacokinetics and statistical data analysis. This study aims to further characterize the clinical pharmacokinetic behavior of select cancer therapeutics. Future collaborators will be added via the protocol amendment procedure.

Official Title
-----------------
Pharmacological Analysis of Human Samples Collected in Clinical Trials Performed Outside of the Intramural National Cancer Institute

Conditions
-----------------
Leukemia, Myeloid, Neoplasm Metastasis, Leukemia, Lymphoid, Prostate Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
INCLUSION CRITERIA: Any patients entered on approved trials of cancer therapeutics or agents that are commonly administered to patients with cancer at institutions outside of the intramural NCI are eligible for inclusion, provided that they have consented to pharmacological analysis in the original consent form. EXCLUSION CRITERIA: None anticipated at this time.

Ages Eligible for Study
-----------------
Maximum Age: 100 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 |
| --- | --- |
| 1/ patients<br>Patients on approved clinical trials | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Drug and/or metabolite concentration | To quantitate drug and/or metabolite concentrations in human blood samples | Ongoing | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacological behavior of agents | To characterize the clinical pharmacological behavior of agents | Ongoing | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pharmacokinetics, Quantify, HPLC, LC/MS, Pharmacodynamics
Mucosal-Associated Invariant T Cells in Cases of Miscarriage

Study Overview
=================
Brief Summary
-----------------
Miscarriage is the most frequently encountered complication of pregnancy ranging from 10% to 30%. The etiology of recurrent spontaneous miscarriage (RSM) in 40%-50% of cases cannot be identified. Immunological disturbances have been suggested to play an important role. Previous studies have focused that women with miscarriage have elevated NK cell numbers and activity both in the periphery and in the endometrium. Also, NK cells in women with RSM displayed an imbalance of Killer cell Ig-like receptors (KIRs) in favor of activating KIR leading to an unbalanced activation of dNK cytotoxicity and higher risk of miscarriage.

Official Title
-----------------
Analysis of Mucosal-Associated Invariant T (MAIT) Cells in Cases of Spontaneous and Recurrent Miscarriage

Conditions
-----------------
Miscarriage

Intervention / Treatment
-----------------
* Diagnostic Test: MAIT cells


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Regular marital life with the same partner. Regularly menstruating before current pregnancy. Spontaneous conception. Exclusion Criteria: Women with Polycystic ovarian syndrome or any endocrinal abnormalities like DM, thyroid disorders. History of abnormal uterine cavity proved by sonohysterography or hysteroscopy before pregnancy. Women with positive consanguinity.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 35 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| study group<br>women with spontaneous miscarriage | Diagnostic Test: MAIT cells<br>* 1- Decidual tissues will be washed in phosphate buffer saline (PBS), and then preserved in Rosewell Park Memorial Institute (RPMI) 1640 medium supplemented with 100 U/mL penicillin, 100 mg/mL streptomycin and 5% fetal bovine serum (GIBCO BRL, Thermo Fisher Scientific, USA) until transfer to the laboratory. At the flow cytometry laboratory, the tissue samples will be minced finely and enzymatically digested by adding 3 ml collagenase enzyme type Ia and 2 ml PBS for 40 minutes at 37°C in shaking water path at 100 r.p.m. Cell suspensions obtained will be filtered, then the pellet after centrifugation will be treated with red blood cells lysing solution and washed with PBS.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The percentages of MAIT cells and MAIT cells expressing CD56 and CD16 in comparison with NK cells and NKT cells in both blood and decidua | All markers will be measured by flow cytometry | 24 hours |
Autonomic Dysreflexia in Spinal Cord Injury

Study Overview
=================
Brief Summary
-----------------
Autonomic dysreflexia in high spinal cord-injured can be initiated by a full bladder or bowel, or when trying to empty either. This randomised study aims at evaluating whether irrigation procedure or digital stimulation or evacuation of the rectum is less provocative of autonomic dysreflexia. Participants have their bowels emptied on different days, in the morning fasting. Bladder filling with sterile saline water is evaluated on a third day as a control.

Official Title
-----------------
Autonom Dysrefleksi Ved Rygmarvsskade

Conditions
-----------------
Autonomic Dysfunction, Spinal Cord Injured

Intervention / Treatment
-----------------
* Procedure: bowel emptying


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: People with a spinal cord injury above th6 and with symptoms of autonomic dysreflexia. At least one year post injury. 18 years or older. Informed consent. Exclusion Criteria: Usage of prophylactic anti-autonomic dysreflexia medication. Pregnant or breastfeeding. People who is not able to follow the sudy protocol. No former major surgery in the abdomen or pelvic region. No former radiotherapy in the pelvic region.

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: Prevention
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Autonomic dysrefleksia<br>Autonomic dysreflexia in SCI when emptying bowels or filling bladder | Procedure: bowel emptying<br>* Bowel is emptied using Peristeen® irrigation system one day, by digital stimulation another trial day or filling the bladder with saline water on a third trial day. BP is measured by Finometer Pro®, respiration frequency by BIOPACK and skin conductivity measured by Biopack and nor-epinephrine and epinephrine are measured in plasma three times during each examination.<br>* Other names: Finometer Pro;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intervention induces 25 % raise in BP compared to baseline measurements. |  | Outcome are monitored all through bowel or bladder-procedure at each of three study-days, and compaire to measurements at baseline. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Autonomic dysfunction, Spinal cord injured, Neurogenic bowel, Neurogenic bladder
Cerebral Toxoplasmosis and AIDS

Study Overview
=================
Brief Summary
-----------------
With a HIV incidence much higher in the DFA than in European French territory, this disease is a major public health problem in these areas, especially in French Guiana. Cerebral toxoplasmosis is a priority among the opportunistic infections in AIDS patients from the DFA because of its frequency (French West Indies) and of its lethality (French Guiana). The diagnosis of cerebral toxoplasmosis may be difficult because based only on presumptive clinical and radiological features. The response to specific antitoxoplasmic therapy confirms a posteriori the diagnosis. In reference to the data collected by the Biological Resource Centre Toxoplasma, in particular in French Guiana, we think that T. gondii strains reactivating in AIDS patients from DFA are genetically different from those reactivating in AIDS patients from Europe, with an increased capacity for dissemination via peripheral blood in the first ones. This more frequent or more prolonged parasitemia could facilitate the diagnosis of cerebral toxoplasmosis by PCR test from peripheral blood samples in AIDS patients from the French departments of America.

Official Title
-----------------
Cerebral Toxoplasmosis and AIDS in the French Departments of America (DFA). Diagnostic Contribution of a PCR Assay and Genetic Diversity of Toxoplasma Gondii.

Conditions
-----------------
Cerebral Toxoplasmosis, AIDS

Intervention / Treatment
-----------------
* Other: Toxoplasma PCR assay


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patient (> 18 years) Patient being informed and accepting to participate in the study with signature of informed consent HIV positive serology Clinical and radiological suspicion of cerebral toxoplasmosis justifying the start of specific antitoxoplasmic therapy Exclusion Criteria: Protected patient Patient uncovered by social insurance Specific antitoxoplasmic therapy already initiated since 72h or more

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 |
| --- |
|Other: Toxoplasma PCR assay|Toxoplasma PCR assay|

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

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Isolation, genetic typing and storage of T. gondii strains collected among AIDS patients with cerebral toxoplasmosis from the DFA. |  | 3 years |
Predictors of Hospital-Based Care in Asthma

Study Overview
=================
Brief Summary
-----------------
To identify clinical predictors of episodes of hospital-based care in people with asthma.

Detailed Description
-----------------
BACKGROUND: This study was of great practical importance because asthma is a common condition (3-5 percent of the population) which has had a recent, unexplained rise in morbidity and mortality. Many previous epidemiological studies focused on predictors of hospitalization for people with asthma seen in the emergency room. These studies were of limited value for the practicing physician who sees the vast majority of patients with asthma. Results from this study should, for the first time, enable a profile to be constructed of the high risk patient with asthma which includes identification of modifiable risk factors. These results can be used for physician and patient education programs as well as to target medical intervention. DESIGN NARRATIVE: The study developed a key piece of information needed for outpatient care of patients with asthma; a profile of patients at risk for severe, potentially life-threatening exacerbations of asthma. The experimental design was a prospective study of 800 patients with asthma drawn from a large, pre-paid health care plan. The key advantage of this population was that all the care occurred within the health plan. Characteristics identified included demographic factors, socioeconomic status; patient characteristics such as tobacco use, atopy, pattern of medication use, self-reporting of compliance/adherence, attitudes about asthma; historical assessment of indoor air quality; characteristics of asthma such as duration of asthma, lung function, and variation in asthma symptoms; and speciality of physician. The outcome measures were obtained over a three year period and included all episodes of hospital-based care including hospitalizations, emergency room visits, and urgency care clinic visits. Based on these data, models were developed which assigned relative risk to each of the independent variables. These models were validated in a subset of the population. The study completion date listed in this record was obtained from the End Date entered in the Protocol Registration and Results System (PRS) record.

Conditions
-----------------
Asthma, Lung Diseases

Participation Criteria
=================
Eligibility Criteria
-----------------
No eligibility criteria

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

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 |
| --- | --- | --- |