linjc16/ctgov huggingface dataset:
Effect of Ascorbic Acid Final Flush on Post-operative Pain in Mandibular Molars.

Study Overview
=================
Brief Summary
-----------------
The study is conducted to evaluate the effect of Ascorbic acid as a final flush on post operative pain after single visit root canal treatment in cases with symptomatic irreversible pulpits.

Official Title
-----------------
Effect of Ascorbic Acid as a Final Flush on Post-operative Pain After Single Visit Root Canal Treatment for Patients With Symptomatic Irreversible Pulpits Related to Mandibular Molars: Randomized Controlled Trial.

Conditions
-----------------
Post Operative Pain

Intervention / Treatment
-----------------
* Drug: Ascorbic acid
* Other: saline


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients above 18 years old and to 60. Male or female. Patients seeking root canal treatment. mandibular molar teeth with symptomatic irreversible pulpits with preoperative acute or moderate pain with hot and cold stimulation with normal periapical radiographic appearance . healthy patient (ASA I,II). Patient who can understand NRS and sign informed consent. Exclusion Criteria: Medically compromised patients having significant systemic disorders. (ASA III or IV). History of intolerance to NSAIDS. External root resorption. Internal root resorption. Vertical root fracture. Periapical lesion. Pregnancy. Use of ibuprofen in the last 12 hour. Bleeding disorder. Long term corticosteroid use. Mobility Grade II or III. Pocket depth more than 5mm. Previous root canal therapy. Non-restorability. TMJ problems, bruxism, clenching or traumatic occlusion. Inability to perceive the given instructions.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ascorbic acid<br>Ascorbic acid IV ampoules 20% as a final flush irrigation 3ml after cleaning and shaping. | Drug: Ascorbic acid<br>* Ascorbic acid IV ampoules (20%).<br>* Other names: Vitamin C;|
| Placebo Comparator: Saline<br>A mixture of sodium chloride and water (0.9%) as a final flush irrigation 3 ml after cleaning and shaping. | Other: saline<br>* saline (0.9%)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain intensity measured by numerical rating scale where 0= no pain, 1-3= mild pain, 4-6= moderate pain and 7-10= severe pain. |  | up to 48 hours after root canal treatment. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| If there are analgesics taken by the patient after root canal treatment and that will be measured by a questionnaire. |  | up to 48 hours. |
Placebo Controlled Dose-Response Study Of PD-217,014 In The Treatment Of Postherpetic Neuralgia

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the effectiveness of PD-217,014 in the treatment of chronic pain following a shingles infection.

Official Title
-----------------
A Multi-Center, Randomized, Double Blind, Dose-Response, Placebo And Gabapentin Controlled Study Of PD-217,014 In The Treatment Of Postherpetic Neuralgia

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

Intervention / Treatment
-----------------
* Drug: PD-217,014


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients must have pain present for more than 3 months after the healing of shingles skin rash. Patients at screening must have a score >=40 mm on the pain visual analogue scale. Exclusion Criteria: Patients with poor renal function. Patients with other severe pain, that may impair the self-assessment of the pain due to shingles. Patients with abnormal electrocardiogram.

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: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: PD-217,014|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To characterise the effectiveness of PD-217,014 in the treatment of chronic pain. A numerical pain intensity rating scale is used to assess pain and a mean endpoint (week 4) pain score change from baseline is calculated. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| - Assess the effect of PD-217,014 on responder rate based on the primary endpoint, mean endpoint sleep interference score and the SF-McGill questionnaire (change from baseline to week 4) |  |  |
Sleep Enhancement Training Study for Experienced Shiftworkers

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine if a modified version of the Sleep Enhancement Fatigue Reduction Training (SEFRT) system can improve sleep and health-related symptoms and quality of life in experienced shift-working nurses.

Official Title
-----------------
Sleep Enhancement Training Study for Experienced Shiftworkers

Conditions
-----------------
Shift-Work Sleep Disorder

Intervention / Treatment
-----------------
* Behavioral: NIOSH shiftwork booklet
* Behavioral: Sleep Enhancement Training System


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: English-speaking nurses scheduled to work at least 2 consecutive night shifts per week during the next 3 months ≥40 years of age experiencing disturbed sleep related to night-shift Exclusion Criteria: current diagnosis of sleep disorder or affective illness

Ages Eligible for Study
-----------------
Minimum Age: 40 Years

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

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

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

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br> | Behavioral: NIOSH shiftwork booklet<br>* weekly readings about coping with shiftwork<br>Behavioral: Sleep Enhancement Training System<br>* 4 week program of readings and relaxation programs<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| actigraphy measures of sleep |  | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| subjective measures of sleep and well-being |  | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
shift-work, sleep, nurse, relaxation
A 1-Year Safety Study of OTO-104 in Subjects With Unilateral Meniere's Disease Located in United Kingdom

Study Overview
=================
Brief Summary
-----------------
This is a 2-part study of OTO-104 in subjects with unilateral Meniere's disease in the United Kingdom. The first part is a randomized, placebo-controlled study comparing the safety profile of 2 injections of OTO-104 or placebo spaced 3 months apart. The second part is an open-label extension where all subjects will receive an additional 2 intratympanic injections of OTO-104 spaced 3 months apart. Each subject will participate on the study for a total of 1 year.

Official Title
-----------------
A 6-Month, Prospective, Randomized, Multicenter, Placebo-Controlled Safety Study of OTO-104 Given at 3-Month Intervals by Intratympanic Injection in Subjects With Unilateral Meniere's Disease Followed by a 6-Month Open-Label Extension

Conditions
-----------------
Meniere's Disease

Intervention / Treatment
-----------------
* Drug: OTO-104
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria includes, but is not limited to: Subject has a diagnosis of definite unilateral Meniere's disease. Subject agrees to maintain their current standard of care treatments for Meniere's disease while on-study. Exclusion Criteria includes, but is not limited to: Subject is pregnant or lactating. Subject has a history of immunodeficiency disease. Subject has a history of previous endolymphatic sac surgery. Subject has a history of previous use of intratympanic gentamicin in the affected ear. Subject has a history of drop attacks. Subject has experienced an adverse reaction to intratympanic injection of steroids.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 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 |
| --- | --- |
| Active Comparator: OTO-104<br>12 mg OTO-104 (dexamethasone) | Drug: OTO-104<br> <br> |
| Placebo Comparator: Placebo<br>OTO-104 vehicle | Drug: Placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety | Otoscopy, audiometry, tympanometry, adverse events | Up to 1 Year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Meniere's Symptom Questionnaire |  | Up to 1 Year |
Budesonide for Prevention of Acute Gastrointestinal GVHD Following Allogenic Stem Cell Transplantation

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether orale budesonide is effective in the prevention of acute gastrointestinal graft-versus-host disease (GVHD) following allogenic stem cell transplantation.

Detailed Description
-----------------
The purpose of this study is to determine whether orale budesonide is effective in the prevention of acute gastrointestinal graft-versus-host disease (GVHD) following allogenic stem cell transplantation.

Official Title
-----------------
Efficacy and Safety of Orale Budesonide in the Prevention of Acute Gastrointestinal Graft-versus-host Disease Following Allogenic Stem Cell Transplantation

Conditions
-----------------
Leukemia, Graft-Versus-Host Disease

Intervention / Treatment
-----------------
* Drug: Budesonide


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: planned allogenic stem cell or bone marrow transplantation HLA identity (max. 1 mismatch) standard GVHD prophylaxis with cyclosporin A or tacrolimus combined with MTX, +/- ATG or Campath1H written informed consent Exclusion Criteria: history of allogenic transplantation in vitro T-cell depleted transplant pretreatment with budesonide within the previous 4 weeks known intolerance to budesonide gastrointestinal infections portal hypertension concomitant infectious diseases liver cirrhosis, impaired liver function severe mental disorder lack of compliance drug or alcohol abuse pregnancy, lactation childbearing potential without effective contraception

Ages Eligible for Study
-----------------
Minimum Age: 12 Years
Maximum Age: 65 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: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Budesonide|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| incidence of acute gastrointestinal (GI) GVHD in the active group versus placebo group |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| safety |  |  | 
| grade of acute GI GVHD |  |  | 
| incidence of chronic GI GVHD |  |  | 
| incidence of infectious complications |  |  | 
| overall and disease-free survival 1 yr after transplant |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
graft-versus-host disease, budesonide, stem cell transplantation
18348-Human Phototoxicity Test

Study Overview
=================
Brief Summary
-----------------
To determine the phototoxic potential of a topically applied article in human subjects

Official Title
-----------------
Human Phototoxicity Test

Conditions
-----------------
Sunscreening Agents

Intervention / Treatment
-----------------
* Other: Sunscreen Lotion (BAY987521)
* Other: Untreated Skin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: be male or female between the ages of 18 and 60 inclusive; be lightly pigmented (Fitzpatrick Skin Type I, II, III); have read and signed the written Informed Consent Form and have completed a HIPAA Authorization Form in conformance with 45CFR Parts 160 and 164; be in general good health as determined by the subject's medical history and in the discretion of the investigator; Exclusion Criteria: have a visible sunburn; have a history of sun hypersensitivity/photosensitivity or photosensitive dermatosis; must not have a known sensitivity or allergy against any of the active and non-active ingredients of the test product. have a history of allergies or sensitivities to cosmetics, toiletries or any dermatological products

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1<br>All subjects are patched. | Other: Sunscreen Lotion (BAY987521)<br>* 50 μl/cm*2 of each test product is applied to duplicate skin sites (approximately 2 x 2 cm each) on the lower or mid-back.Formulation A: Y49-103, Formulation B: Y71-150.<br>Other: Untreated Skin<br>* This site is patched without treatment as irradiated control<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intensity of skin reactions will be evaluated using the 5 point |  | Up to 48 hours |
Study to Evaluate the Effects of Food Ingestion on the Pharmacokinetics of CHF 5074 in Healthy Young Male Subjects

Study Overview
=================
Brief Summary
-----------------
To evaluate the effects of a high-calorie high-fat meal on the extent and rate of absorption of CHF 5074 after single oral administration in young healthy male volunteers.

Official Title
-----------------
Randomized, Balanced, Single Dose, Cross-Over Study to Evaluate the Effects of Food Ingestion on the Pharmacokinetics of CHF 5074 in Healthy Young Male Subjects

Conditions
-----------------
Alzheimer's Disease

Intervention / Treatment
-----------------
* Drug: CHF 5074
* Drug: CHF 5974


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject is judged to be in good health on the basis of medical history, complete physical examination including vital signs, 12-lead electrocardiogram (ECG) and standard laboratory tests. Subject has a body mass index between 18 and 30 kg/m^2, inclusive. Exclusion Criteria: Medical history (within the last 10 years) of major cardiovascular, hepatic or renal disease. Abnormal result of liver function tests, renal function tests or thyroid tests performed at screening. Significant allergic conditions that require medical treatment Use of any psychoactive, recreational or prescription drug within the 4 weeks prior to study drug administration. Use of ibuprofen, sulindac sulfide, indomethacin, flurbiprofen within 2 weeks prior to study drug administration.

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CHF 5074 (fed group)<br>oral tablet, single dose | Drug: CHF 5974<br>* Drug is administered to subject after consumption of a high fat, high calorie meal<br>|
| Experimental: CHF 5074 (fasting group)<br>oral tablet, single dose | Drug: CHF 5074<br>* Drug is administered to subject in a fasting state<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| area under the curve of plasma CHF 5074 levels from 0 to 96 hours (AUC 0-96) |  | from Day 1 to Day 5 | 
| peak CHF 5074 plasma concentration (Cmax) |  | from Day 1 to Day 5 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the time of occurrence of Cmax (Tmax) |  | from Day 1 to Day 5 |
Endometrial Assessment of Women With Uterine Infection

Study Overview
=================
Brief Summary
-----------------
Unexplained infertility is clinically diagnosed when there are no apparent or clear factors causing infertility on regular infertility assessment tools . Failure of implantation is a possible factor causing unexplained infertility .

Detailed Description
-----------------
Implantation is the main rate limiting step in IVF outcome. Implantation is described at the cellular and the molecular levels by adhesion or fixation of a good quality embryo to receptive endometrium within a critical period of time, which is called the window of implantation

Official Title
-----------------
Endometrial Assessment Women With Infertility Who Will do IUI and ICSI

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

Intervention / Treatment
-----------------
* Procedure: manipulation of endometrium


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women with infertility age from 20-40 years Exclusion Criteria: Any factor of infertility

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 40 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: A randomized controlled trial
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Hysteroscopic evaluation<br>Hysteroscopic evaluation Active group : infection Manipulation of endometrium with saline | Procedure: manipulation of endometrium<br>* Manipulation of endometrium with saline<br>* Other names: Saline infusion;|
| Other: control group<br>Hysteroscopic evaluation Control group : No infection | Procedure: manipulation of endometrium<br>* Manipulation of endometrium with saline<br>* Other names: Saline infusion;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the number of women who will get pregnant after IUI | How many women will get pregnant after IUI | within 4 weeks |
Identification of Serum and/or Plasma Biomarkers for the Diagnosis Prognosis and/or Prediction of Invasive Mycosis in Neutropenic Patients

Study Overview
=================
Brief Summary
-----------------
The aim of the present work is to study the protein expressions profiles of neutropenic patients (with a high risk of invasive mycosis) who developed - versus who did not develop invasive mycosis (principally aspergillosis and candidosis) in order to identify biomarkers for the diagnosis, prognosis and /or prediction of invasive mycosis.

Conditions
-----------------
Neutropenic Patients

Intervention / Treatment
-----------------
* Other: Samples taken at the clinical hematology unit


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Patients with malignant haemopathy who received chemotherapy likely to lead to severe neutropenia (PN<500/mm3) for a foreseeable period of 10 days. Patients aged 14 years or older (no upper age limit) Patients with malignant haemopathy who received an autologous marrow graft. Patients with severe idiopathic medullar aplasia (PN<500/mm3) who need to be hospitalised for at least 10 days consecutively (with or without immunosuppressant treatment). Patients who have provided written informed consent to participate in this study. Exclusion Criteria: Patients who received an allograft of marrow or hematopoietic stem cell transplant (given that these patients carry a risk of aspergillosis, which in most cases appears after medullar recovery, they will not be included in the study). Patients who received an autologous hematopoietic stem cell transplant (given that the duration of the neutropenia is often less than 10 days). Patients who do not meet the inclusion criteria Persons not covered by the national Health Insurance Agency

Ages Eligible for Study
-----------------
Minimum Age: 14 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 |
| --- | --- |
| Other: neutropenic patients<br> | Other: Samples taken at the clinical hematology unit<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the variability of protein profiles |  | baseline |