linjc16/ctgov huggingface dataset:
Prospective Evaluation of a Commercially Available Hydrogel Spacer

Study Overview
=================
Brief Summary
-----------------
Dosimetry efficacy evaluation of the hydrogel spacer

Detailed Description
-----------------
Single arm study for evaluation of dosimetry following use of a commercially available hydrogel spacer implanted in 20 males undergoing radiotherapy to treat prostate cancer. Study will utilize pre and post gel insertion CT images to determine the endpoints.

Official Title
-----------------
Clinical Protocol for the Prospective Evaluation of a Commercially Available Hydrogel Spacer

Conditions
-----------------
Prostate Cancer

Intervention / Treatment
-----------------
* Other: Observation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Males At lease 18 years of age Undergoing external beam or brachy radiation therapy with a hydrogel spacer Exclusion Criteria: Invasive adenocarcinoma that is extracapsular and demonstrates posterior extension

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Radiation with Hydrogel Spacer<br>Males at least 18 years of age, who will be undergoing radiation therapy with a hydrogel spacer in place. | Other: Observation<br>* Assessment of rectal dosimetry change from pre-insertion to post-insertion in subjects with prostate cancer who have undergone radiotherapy with a hydrogel spacer.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dosimetry changes | Assessment of rectal radiation exposure as compared between rectal dose volume histograms calculated for pre and post Hydrogel Injection | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prostate to rectum spacing | Prostate to rectum spacing measurement for evaluation of the perirectal distance post-hydrogel insertion | 1 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Prostate, Prostate Cancer, Spacer, Perirectal spacer
Sertaconazole 2% Cream to Improve Symptoms Associated With Atopic Dermatitis

Study Overview
=================
Brief Summary
-----------------
Investigation aimed to explore the efficacy of a topical Sertaconazole cream 2% in patients with skin alterations associated with atopic dermatitis

Official Title
-----------------
Randomisierte, Doppelblinde, Plazebo-kontrollierte Prüfung Zum Nachweis Der Wirksamkeit Und Der Lokalen Verträglichkeit Einer 2%Igen Sertaconazol-Crème Bei Patienten Mit Atopischer Dermatitis (Abridged)

Conditions
-----------------
Skin Alterations Associated With Atopic Dermatitis

Intervention / Treatment
-----------------
* Drug: Sertaconazole 2% cream
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Informed consent Atopic Dermatitis Patients with SCORing Atopic Dermatitis (SCORAD) ≤ 40 Atopic lesion localisation: arms; additional legs, neck Exclusion Criteria: SCORAD > 40 Unstable, uncontrolled medical status (e.g. active systemic or topical infection) Active immunosuppression or cancer Narcotics- or Alcohol abuse Participation in another clinical trial until one month prior inclusion Known allergies against an ingredient of the investigational medicinal product Different periods of grace for certain pre-treatments, e.g. topical corticosteroids, immune modulating drugs Pregnancy or lactation

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Sertaconazole 2% cream<br>2x daily treatment with Sertaconazole 2% cream for 4 weeks, 2 weeks follow-up | Drug: Sertaconazole 2% cream<br> <br> |
| Placebo Comparator: Placebo Arm<br>2x daily treatment with Placebo cream for 4 weeks, 2 weeks follow-up | Drug: Placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Patient Global Assessment (PGA) |  | day 1, day 28 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Eczema Area and Severity Index (EASI) |  | day 1, day 28 | 
| Change in Dermatology Life Quality Index (DLQI) |  | d1, d28 | 
| Change in Patient Benefit Index (PBI) |  | day 1, day 28 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Skin alterations, Atopic Dermatitis
Effect of a Soluble Fibre Blend and Medium Chain Triglycerides on Body Composition and Cardiometabolic Risk Factors

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate whether the addition of capsules containing soluble fibre complex emulsified with medium chain triglycerides and taken before with meals will lead to a significant amount of weight loss, reduced glycemic volatility and diminished cardio metabolic risk factors in overweight and obese individuals when compared to a placebo control. We believe that those participants taking 3-6 capsules per day of the treatment capsules over a 14 week period will loose a significant amount of weight compared to the placebo group.

Official Title
-----------------
The Effect and Dose-response of Soluble Fibre Blend and Medium Chain Triglycerides (MCT) on Body Composition and Cardiometabolic Risk Factors in Overweight and Obese Adults: a Double-blind, Placebo-controlled Study.

Conditions
-----------------
People Who Are Overweight or Obesity

Intervention / Treatment
-----------------
* Dietary Supplement: soluble fibre complex and medium chain triglycerides
* Dietary Supplement: cellulose and soybean oil


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: BMI 27 - 35 kg/m2 Exclusion Criteria: -

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 45 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>cellulose and soybean oil | Dietary Supplement: cellulose and soybean oil<br> <br> |
| Experimental: Intervention<br>soluble fibre complex and medium chain triglycerides | Dietary Supplement: soluble fibre complex and medium chain triglycerides<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| weight loss |  | baseline, biweekly and final visit | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| glycemic volatility and cardio metabolic risk factors |  | baseline and final visit |
Correlation Between Clinical Deterioration in Schizophrenic Patients and Hair Cortisol Levels

Study Overview
=================
Brief Summary
-----------------
The importance of stress as a possible deteriorating factor for schizophrenic patients is well documented. However, this notion is based on subjective experience and retrospective psychological analysis. A novel method of measuring cortisol using hair has a proven correlation to subjective stress in non-clinical as well as psychiatric clinical populations. This pilot study will attempt to assess the use of cortisol hair level, as a marker of stress, to predict clinical deterioration in schizophrenic patients.

Conditions
-----------------
Schizophrenia, Schizo-Affective Disorder

Intervention / Treatment
-----------------
* Biological: Hair Sample


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 18-50 Diagnosis of schizophrenia or schizoaffective disorder, made by a senior psychiatrist. Signing an informed consent. Exclusion Criteria: Additional psychiatric diagnosis Boldness or hair shorter than 1cm Physiological disturbance in the HPA or the use of steroidal medication Neurological disease (past or present) or neurosurgery. Pregnancy Substantial chronic physical diseases/

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 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 |
| --- | --- |
| Schizophrenia patients<br> | Biological: Hair Sample<br>* Analysis of hair cortisol levels<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline in Positive And Negative Symptoms Score | correlation between hair cortisol level change from baseline and PANSS score change from baseline. | 3 month | 
| Change from Baseline in Positive And Negative Symptoms Score | correlation between hair cortisol level change from baseline and PANSS score change from baseline. | 6 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline in SANS, CGI, CDS, GAF and QOL Scores | correlation between hair cortisol level change from baseline and SANS, CDS, GAF, CGI, and QOL scores change from baseline. | 3 month | 
| Change from Baseline in SANS, CGI, CDS, GAF and QOL Scores | correlation between hair cortisol level change from baseline and SANS, CDS, GAF, CGI, and QOL scores change from baseline. | 6 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Schizophrenia, Schizo-Affective Disorder, Stress, Cortisol, PANSS
Atosiban Improves Implantation and Pregnancy Rates in Patients With Repeated Implantation Failure

Study Overview
=================
Brief Summary
-----------------
Atosiban, administered at embryo transfer, can improve the implantation rate and the clinical pregnancy rate in patients with repeated implantation failure undergoing IVF-ET (in-vitro fertilization and embryo transfer).

Detailed Description
-----------------
Atosiban is a mixed oxytocin and vasopressin V1A receptor antagonist.Combined antagonism at oxytocin and vasopressin V1A receptors reduces uterine contractions with a corresponding decrease in intrauterine production of prostaglandin F2alpha and improved uterine blood supply. These effects are of potential benefit for implantation support during IVF-ET cycles.

Official Title
-----------------
Atosiban Improves Implantation and Pregnancy Rates in Patients With Repeated Implantation Failure

Conditions
-----------------
Repeated Implantation Failure

Intervention / Treatment
-----------------
* Drug: atosiban


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: had repeated implantation failure have at least 1 good quality embryo for transfer Exclusion Criteria: uterine abnormalities that could compromise the implantation process (e.g. fibroids, endometrial polyp, bicornuate uterus, adhesion of uterine cavity)
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 |
| --- | --- |
| Other: Atosiban<br> | Drug: atosiban<br>* Atosiban was administered as a 6.75mg IV bolus dose 30 minutes prior to embryo transfer followed by a 1-hour IV infusion at dose of 18 mg/h then a 2-hour IV infusion at 6 mg/h.<br>* Other names: Tractocile;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical pregnancy |  | 5 weeks after intervention | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
atosiban, implantation rate, clinical pregnancy, uterine contractility, IVF-ET
Hormonal Contraception and Risk of Chlamydia and Gonorrhea

Study Overview
=================
Brief Summary
-----------------
There are biological reasons to suspect that hormones may affect the risk of a woman becoming infected with a sexually transmitted disease. The evidence on this issue to date is mixed and previous studies have methodologic flaws making it difficult to draw conclusions about the results. This study compares the risk of developing either Chlamydial or Gonorrheal infection among three groups of women: those using combined oral contraceptives (birth control pills); those using the injectable hormone (brand name Depo Provera); and those women using non-hormonal contraceptive methods.

Detailed Description
-----------------
The study was designed to examine the relationship between hormonal contraceptive use and possible increased risk of Chlamydial and Gonococcal sexually transmitted infections, and to determine if any increased risk appeared to be mediated by the extent of cervical ectopy. Eight hundred and nineteen women, ages 15 to 45 years, were recruited from an inner city clinic and from a nearby suburban clinic. The women were classified into three groups based on type of contraceptive used. One group used oral contraceptives; the second used injectable depo-medroxyprogesterone acetate (DMPA); and the third group used non-hormonal contraceptive methods. Women from each group were followed at 3, 6, and 12 months after enrollment to determine if a new infection with Chlamydia or Gonorrhea had occurred and to evaluate the extent of cervical ectopy present.

Official Title
-----------------
Hormonal Contraception, Cervical Ectopy, and STDs

Conditions
-----------------
Chlamydia Infection, Neisseriaceae Infection

Intervention / Treatment
-----------------
* Drug: Depo Medroxyprogesterone acetate
* Drug: Combined oral contraceptives


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Female age 15 to 45 years no hormone use at enrollment not pregnant or planning pregnancy Exclusion Criteria: Cervical cancer presently or in history hysterectomy, cone biopsy, or cervical cryotherapy

Ages Eligible for Study
-----------------
Minimum Age: 15 Years
Maximum Age: 45 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Depo Medroxyprogesterone acetate|nan|
|Drug: Combined oral contraceptives|nan|

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
-----------------
epidemiology, relative risk, cervical ectopy, hormonal contraceptives, sexually transmitted infections
Breathing Disorders in Patients With Congestive Heart Failure

Study Overview
=================
Brief Summary
-----------------
The investigators prospectively evaluated 89 consecutive outpatients (29 female) with stable congestive heart failure. The presence of sleep disordered breathing (SDB) and Cheyne-Stokes respiration (CSR) while awake were investigated by overnight polysomnography. Males and females were similar in age, body mass index, and LVEF. Prevalence of SDB was higher in males than females. During follow up of 25±10 months, 27% of the population died. Nonsurvivors had lower LVEF (p=0.01), worse NYHA class (p=0.03) a higher proportion of CSR-awake (p<0.001) than survivors.

Detailed Description
-----------------
Bakground: There is little information in sleep disordered breathing (SDB) in women with congestive heart failure (CHF). We studied consecutive CHF patients in order to compare SDB characteristics according to gender, and to determine overall mortality impact of SDB and Cheyne-Stokes respiration (CSR) while awake. Methods: Eighty nine consecutive outpatients (29 female) with stable CHF (LVEF<45%) were prospectively evaluated. The presence of SDB, as characterized by obstructive sleep apnea (OSA) and CSR during sleep, as well as CSR while awake before sleep onset, were investigated by overnight polysomnography.

Official Title
-----------------
Breathing Disorders in Patients With Congestive Heart Failure: Gender and Mortality Impact

Conditions
-----------------
Congestive Heart Failure

Intervention / Treatment
-----------------
* Other: Polysomnography


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with resting left ventricular ejection fraction (LVEF) of less than 45% as determined by echocardiography; Stable clinical condition as defined by no changes in drug therapy for at least one month before evaluation. Exclusion Criteria: Patients with neurological, pulmonary, renal, musculoskeletal disease, unstable angina, primary valvular heart disease or previous diagnosis of sleep disordered breathing.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 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 |
| --- | --- |
| CHF Patients<br>Congestive Heart Failure Patients | Other: Polysomnography<br>* examination for sleep disorders<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
-----------------
Sleep apnea, Cheyne-Stokes Respiration, Congestive Heart Failure
Efficacy of Laflavon in Lowering Triglycerides and Raising High-Density Lipoprotein (HDL)

Study Overview
=================
Brief Summary
-----------------
A trial of LaFlavon in Patients with Metabolic Syndrome to Evaluate its Effectiveness in Lowering Triglycerides and Raising High-Density Lipoprotein (HDL).

Official Title
-----------------
Trial of Laflavon in Patients With Metabolic Syndrome to Evaluate Its Effectiveness in Lowering Triglycerides and Raising High-Density Lipoprotein (HDL)

Conditions
-----------------
Metabolic Disease

Intervention / Treatment
-----------------
* Dietary Supplement: LaFlavon


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Men and Women with Metabolic Syndrome Elevated Triglycerides (> 150) Low High-Density Lipoprotein (HDL) (< 35) Willingness to take study nutritional supplement once a day for 3 months Exclusion Criteria: Women who are pregnant, nursing, or who intend pregnancy during the period of treatment Known milk, soy or whey allergy

Ages Eligible for Study
-----------------
Minimum Age: 45 Years
Maximum Age: 75 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LaFlavon<br> | Dietary Supplement: LaFlavon<br>* two tablets of LaFlavon (two x 3.5mg lycopene/25 mg soy isoflavone) daily for three months<br>* Other names: Lycopene/Isoflavon;|
| No Intervention: Placebo<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Increase in High-Density Lipoprotein (HDL) |  | Change from Baseline in High-Density Lipoprotein (HDL) at 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| changes of liver enzymes |  | Baseline and 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Metabolic
Effects of Buprenorphine on Ulnar Nerve Motor Block

Study Overview
=================
Brief Summary
-----------------
Recent reports showed that the opioid buprenorphine is a very potent sodium channel blocker. Buprenorphine not only exerts a strong antinociception, but also a long lasting antihyperalgesic effect. This antihyperalgesic effect is not observed for other clinically employed opioids but is common for local anaesthetics. The principal aim of the study is to compare the speed of onset and the time of recovery of motor blockage achieved by lidocaine and buprenorphine, respectively. The investigators hypothesize that the blocking capacity of buprenorphine is equal to the one of lidocaine.

Official Title
-----------------
Effects of Buprenorphine on Ulnar Nerve Motor Block

Conditions
-----------------
Healthy Volunteers

Intervention / Treatment
-----------------
* Drug: buprenorphine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male Age: 18 - 65 years Weight: 50-100kg Height: 155-195cm Signed and dated informed consent Sufficient command of German language Exclusion Criteria: Contraindications to the class of drugs under study Vulnerable subjects (intellectually or mental impaired) Known hypersensitivity to class of drugs or the investigational product Drug abuse Known peripheral neuropathies Diabetes mellitus Chronic alcohol consumption Congestive heart disease Participants of other studies during study period

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

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

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

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

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: buprenorphine|intradermal injection|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The principal aim of the study is to measure the speed of onset and the time of recovery of motor blockage achieved by lidocaine and buprenorphine |  | 6 hours |