linjc16/ctgov huggingface dataset:
Interest of Karate Kata Practice on the Self-esteem of Patients Living With HIV

Study Overview
=================
Brief Summary
-----------------
Since ancient times, physical and sports activity has been recognized as bringing many health benefits. Descriptive and interventional studies on physical activity are developing, demonstrating physical and psychological benefits for patients with various diseases. Physical activity is effective in improving self-esteem in the general population. Good self-esteem allows for better autonomy to manage a chronic illness. The benefit of physical activity in patients living with HIV has been the subject of several studies, notably outside France, and seems to improve the quality of life. We hypothesize that sport, especially karate kata, could improve self-esteem in patients living with HIV, and represent another non-drug aid, in patients living with HIV.

Official Title
-----------------
Interest of Karate Kata Practice on the Self-esteem of Patients Living With HIV

Conditions
-----------------
Patients Living With HIV

Intervention / Treatment
-----------------
* Other: karate kata


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patient living with HIV Patient seen in the infectious diseases department of Le Mans hospital, during a consultation or day hospitalization for HIV follow-up Aged 18 years and older Patients able to understand and to give informed consent to participate in the study valid social security coverage written and signed informed consent by the patient and investigator Exclusion Criteria: refusal to participate to the study pregnant or brest-feeding women person subject to a legal protection measure patient with psychiatric disease patient under legal protection medical contraindication to play karate kata

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: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: patient living with HIV<br> | Other: karate kata<br>* sessions of karate kata every week during 4 months<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect of karate kata training on self-esteem among patients living with HIV followed at the Le Mans hospital center | Change from Baseline at 4 months as assessed by Rosenberg's questionnaire | 4 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
HIV, KARATE KATA, SELF ESTEEM
Pre-therapeutic Analysis of the Individual Radiosensitivity of Cancer Patients in Luxembourg (APRI-Lux): Prospective National Interventional Study With Minimal Risk

Study Overview
=================
Brief Summary
-----------------
Pre-therapeutic analysis of the individual radiosensitivity of cancer patients in Luxembourg

Official Title
-----------------
Pre-therapeutic Analysis of the Individual Radiosensitivity of Cancer Patients in Luxembourg (APRI-Lux): Prospective National Interventional Study With Minimal Risk

Conditions
-----------------
Radiosensitivity, Cancer, Radiation Toxicity

Intervention / Treatment
-----------------
* Biological: Blood sample collection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient over 18 years old Patient with an indication for curative radiotherapy Patient having given his signed written informed consent before any specific procedure of the protocol. Exclusion Criteria: Patient with a contraindication to radiotherapy Patient with an indication for palliative radiotherapy Patient with a history of radiotherapy in the area where the cancer is located Patient unable to submit to the medical follow-up of the trial for geographical, social or psychological reasons.

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: Health Services Research
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Radiosensitivity<br>Patient who agree to participate in this research study will have blood sample collected in order to perform the RadioDtect test. | Biological: Blood sample collection<br>* Blood sample collection : 2 X 6 mL<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Validation of RadioDtect test on early radiation-induced toxicity | prospectively validate the predictive capacities of the RadioDtect individual radiosensitivity blood test on early radiation-induced toxicity. The validation will be based on ATM protein assay and rate of acute toxicities of grade ≥ 2 to 3 months according to NCI-CTCAE v4.03 criteria | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Validation of RadioDtect test on delayed radiation-induced toxicity | to prospectively validate the predictive capacities of the RadioDtect individual. radiosensitivity blood test on delayed radiation-induced toxicity at 12 months. The validation will be based on ATM protein assay and rate of acute toxicities of grade ≥ 2 to 3 months according to NCI-CTCAE v4.03 criteria | 12 months |
A Relative Bioavailability Study of Metformin HCL Tablets, 1000 mg Under Fasting Conditions

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to demonstrate the relative bioequivalence of Metformin HCL Tablets, 1000 mg under fasting conditions.

Official Title
-----------------
A Relative Bioavailability Study of Metformin HCL 1000 mg Tablets Under Fasting Conditions

Conditions
-----------------
Type 2 Diabetes

Intervention / Treatment
-----------------
* Drug: Metformin HCL Tablets, 1000 mg Sandoz
* Drug: Glucophage 1000 mg


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: No clinically significant abnormal finding on physical exam, medical history, or clinical laboratory results on screening. Exclusion Criteria: Positive test results for HIV or hepatitis B or C. Treatment for drug or alcohol dependence.

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
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Metformin HCL Tablets, 1000 mg | Drug: Metformin HCL Tablets, 1000 mg Sandoz<br> <br> |
| Active Comparator: 2<br>Glucophage 1000 mg Tablets | Drug: Glucophage 1000 mg<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bioequivalence according to US FDA guidelines |  | 9 days |
Hysteroscopic Surgery; Retrospective Cross-sectional Study of Reproductive Outcome

Study Overview
=================
Brief Summary
-----------------
study of the effect of hysteroscopic sptoplast and hysteroscopic myomectomy on reproductive performance of patients with infertility and /or miscarriages

Detailed Description
-----------------
Retrospective study and analysis of the reproductive outcome in patients who underwent hysteroscopic surgery for infertility at Jordan university hospital and Al-Noor fertility centre in Amman, Jordan in the period September 2016-october 2021. Patients were followed up for a minimum of 6 months after surgery. Resection of uterine septum or submucosal fibroids were included. Data was obtained from the electronic and paper-based clinical files for patients who were operated upon at these hospitals. Patients who missed follow up after the operation will be contacted by phone or invite them for a clinic review to know of their fertility status and pregnancy outcome.

Official Title
-----------------
Fertility-enhancing Hysteroscopic Surgery; Multi-center Retrospective Cross-sectional Study of Reproductive Outcome

Conditions
-----------------
Hysteroscopic Metroplasty and Myomectomy

Intervention / Treatment
-----------------
* Procedure: Naser Al-Husban


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: those with primary or secondary infertility of more than 1 year with normal seminal fluid analysis, normal female hormonal profile, patent fallopian tubes bilaterally (as confirmed by hysterosalpingography HSG), normal thyroid function, no previous uterine surgery and no medical diseases. Cases with recurrent miscarriages were those with 2 or more first or second trimester miscarriages of an apparently normal singleton fetus with no hormonal, endocrine or maternal or paternal karyotype abnormalities and with no previous history of term pregnancy(s). Exclusion Criteria: All patients who were operated upon outside the context of infertility (heavy bleeding…etc), patients with combined (maternal and paternal) infertility factors, Patients with history of any number of term pregnancy, Previous uterine surgery, Patients with medical diseases, Those with abnormal female hormonal profile, Those with other potential factors for infertility including endometriosis Patients with incomplete or missing data and could not be contacted. Patients who had myomectomy or septal resection done using bipolar hysteroscopy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 49 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Naser Al-Husban|uterine surgery|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pregnancy rate | spontaneous | 6 months |
Pharmacokinetics of Decursin/Decursinol Angelate (CognIQTM)

Study Overview
=================
Brief Summary
-----------------
This study is to investigate how human bodies absorb and metabolize two herbal drugs. The information is critical for drug development and could not be obtained from any other studies using animals. The two herbal drugs are decursin and decursinol angelate (DA) which naturally exist in a traditional herb Angelica gigas Nakai (AGN). Preclinical and clinical studies indicated that AGN and decursin/DA were quite safe to animals and human.

Official Title
-----------------
Single Oral Dose Pharmacokinetics of Decursin/Decursinol Angelate in Healthy Adult Men and Women

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Dietary Supplement: 800mg dietary supplement CognIQTM (4 capsules) by oral at hour 0


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Health subjects weighing between 50 to 91 kilograms (110 to 200 pounds) Subjects 18 to 65 years of age Subjects having normal hepatic, renal and bone marrow function as assessed by history, physical and clinical chemistry analysis Exclusion Criteria: Subjects positive for HIV, HBV and HCV Subjects with diabetes-due to length of fasting Subjects regularly taking any kind of prescription medications Subjects taking oral contraception, hormone-containing IUDs, contraception implants, or Depo medroxyprogesterone injections Subjects taking any food or herbal supplements containing AGN (e.g. CognIQTM, D-Cursinol, Decursinol-50™, Ache Action™, Fast-Acting Joint Formula, EstroG-100™) within 30 days of the study. Female subjects that are pregnant, <6 months postpartum, or breastfeeding women.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: study herb<br> | Dietary Supplement: 800mg dietary supplement CognIQTM (4 capsules) by oral at hour 0<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the plasma concentration versus time curve (AUC) of decursin, decursinol angelate (DA) and decursinol |  | 0, 0.5, 1, 2, 3, 4, 6, 8, 12 , 24, 48 hours post-dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| vital signs, plasma biochemistry and blood cell counts of subjects after consumption the study herb |  | 0 and 24 hours post-dose | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
decursinol angelate, bio-availability, decursin, decursinol, subjects
Pain Detection and Interception in Neonates

Study Overview
=================
Brief Summary
-----------------
Hypothesis: May the introduction of NIDCAP during blood sample reduced pain in neonates during blood sample Compare the effect of venous and capillary blood sample method

Detailed Description
-----------------
introducing the: Newborn Individualized Developmental Care and Assessment Program

Official Title
-----------------
Pain Detection and Interception in Neonates During Blood Sampling

Conditions
-----------------
Pain Detection, Pain Intervention

Intervention / Treatment
-----------------
* Procedure: Introduction of better conditions during blood sampling


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Born gestation age 31-36 Exclusion Criteria: Infection, respiratory distress

Ages Eligible for Study
-----------------
Minimum Age: 31 Weeks
Maximum Age: 36 Weeks

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

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: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Introduction of better conditions during blood sampling|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| value of Premature Infant Pain Profile |  |  | 
| Heart rate |  |  | 
| Saturation |  |  | 
| Skin conductance changes |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pain, Neonates, NIDCAP, Venous, Capillary
Early Diagnosis, Pathogenesis and Progression of Open Angle Glaucoma

Study Overview
=================
Brief Summary
-----------------
The Erlangen Glaucoma Registry is a clinical registry for cross sectional and longitudinal observation of patients with open angle glaucoma (OAG) or glaucoma suspect, founded in 1991. The primary aim is the evaluation of diagnostic and prognostic validity of morphometrical, sensory and hemodynamical diagnostic procedures. No therapeutic studies are performed.

Detailed Description
-----------------
Purpose: Detection of onset and progression of structural and functional damage due to glaucoma. Determination of rate and amount of progressive change due to glaucoma. Characterisation of the relationship between structural and functional change over time. Evaluation of predictive factors for the development and progression of glaucoma.

Official Title
-----------------
Glaucoma Including Pseudoexfoliation Syndrome (SFB 539)

Conditions
-----------------
Primary Open Angle Glaucoma, Secondary Open Angle Glaucoma, Ocular Hypertension

Participation Criteria
=================
Eligibility Criteria
-----------------
Participants: Patients: Primary open angle glaucoma, secondary open angle glaucoma due to PEX or MDS, glaucoma suspects including ocular hypertension Healthy volunteers (for cross sectional analysis only) Inclusion Criteria: Open anterior chamber angle Best corrected visual acuity 0.7 or better Age between 18 and 65 years Exclusion Criteria: Any eye disease other than glaucoma Systemic diseases with potentially ocular involvement (e.g., diabetes mellitus) Myopic or hyperopic refractive error exceeding 8.0 diopters

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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 |
| --- | --- | --- |
| Time to Disease Progression |  | up to 20 years |
Neurologic Complications in Peripheral Regional Anesthesia - An Evaluation Based on a Standardized Protocol

Study Overview
=================
Brief Summary
-----------------
To evaluate the incidence of neurologic complications as a consequence of peripheral regional anesthesia, all patients receiving peripheral nerve blocks will be evaluated according to a standardized protocol screening pain, motoric and sensory function recovering to defined periods, and according to a study protocol defining the items.

Detailed Description
-----------------
Neurologic complications as an adverse effect occur in all types of regional anesthesia. Reviewing the literature, the incidence spreads from 0.02 up to 3 percent. The incidence remains unclear because of different types of definitions, too. In this study, we evaluate all patients receiving peripheral regional anesthesia 24 hours after block performance according to a standardized study protocol. In case of any conspicuousness concerning motoric or sensory function or pain, the patient will be evaluated again after 48 hours. Further on, in case of neurologic dysfunction, periods of investigation will be after 3 days, 1 week, 2 weeks, 1 month, 3 months, 6 months and 1 year. This study includes the definition for nerve damage concerning motoric and sensory neural function and pain. The patients will be recruited among all patients from our hospital receiving continuous peripheral regional anesthesia.

Official Title
-----------------
Neurologic Complications in Peripheral Regional Anesthesia - A Clinical Follow Up Study to Evaluate the Incidence of Neurologic Complications Defined According to a Standardized Protocol Considering Motoric and Sensory Function and Pain

Conditions
-----------------
Anesthesia, Conduction, Nerve Block, Adverse Effects

Intervention / Treatment
-----------------
* Procedure: peripheral regional anesthesia


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients receiving peripheral regional anesthesia Exclusion Criteria: Missing agreement

Ages Eligible for Study
-----------------
Minimum Age: 10 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: peripheral regional anesthesia|evaluation and description of adverse effects|

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
-----------------
peripheral regional anesthesia, nerve damage, adverse effects, neurologic complication, neuropathy
Pain in Oncolgy: Evaluation of a Non Invasive Monitoring Device (ANI). A Monocentric Prospective Study

Study Overview
=================
Brief Summary
-----------------
l'ANI (Analgesia Nociception Index The main objective of the research is to estimate the Analgesia Nociception Index (ANI) as a parameter giving the possibility of measuring the pain in painful metastatic cancer. The parameter ANI is compared with visual analogical scale (VAS) score.

Official Title
-----------------
Pain in Oncolgy: Evaluation of a Non Invasive Monitoring Device (ANI). A Monocentric Prospective Study

Conditions
-----------------
Pain, Cancer

Intervention / Treatment
-----------------
* Device: Non Invasive Monitoring Device (ANI)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: more than 18 years, -no legal protection, - life expectancy is considered over 3-months not receiving of béta-blocking, Having a rhythm sinusal without extrasystole benefiting from a coverage by a social security system Exclusion Criteria: Pace-Maker Diabetes mellitus

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Metastatic cancer<br> | Device: Non Invasive Monitoring Device (ANI)<br>* Pain measure by ANI monitor and with visual analogical scale<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of the ANI parameter with the VAS |  | 4 hours |