linjc16/ctgov huggingface dataset:
The Efficacy and Tolerability of Modafinil for Fatigue and Daytime Sleepiness in Cancer Patients: Preliminary Study

Study Overview
=================
Brief Summary
-----------------
Open-pilot study for the efficacy and tolerability of modafinil on the fatigue and somnolence in cancer-patients.

Detailed Description
-----------------
This is an open-pilot study for the efficacy and tolerability of modafinil on the fatigue and somnolence in cancer-patients. Patients with moderate to severe cancer-related fatigue will be treated with modafinil for 4 weeks and psychological tests including self-questionnaire, cognitive test, sleep-wake cycle, quantitative electroencephalogram(QEEG) will be applied pre- and post-treatment.

Official Title
-----------------
The Efficacy and Tolerability of Modafinil for Fatigue and Daytime Sleepiness in Cancer Patients: Preliminary Study

Conditions
-----------------
Fatigue

Intervention / Treatment
-----------------
* Drug: Modafinil


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: solid cancer patient age of 20-65 years old subjects who scored =4 or >4 on the Brief Fatigue Inventory subjects with informed consent Exclusion Criteria: metastatic cancer(stage IV) with psychotic symptoms such as delusion and hallucination or with suicidal risk with delirium or dementia current medication of cognitive enhancer or psychostimulant uncontrolled medical illness current medications that are contraindicated or not recommended for co-administration with modafinil

Ages Eligible for Study
-----------------
Minimum Age: 20 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: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group<br>Subjects who take modafinil for cancer-related fatigue for 4 weeks. | Drug: Modafinil<br>* 200mg of modafinil daily for 4 weeks<br>* Other names: Provigil;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| severity of fatigue (Brief Fatigue Inventory) | Brief Fatigue Inventory | 4 weeks |
Blocking Extracellular Galectin-3 in Patients With Osteoarthritis

Study Overview
=================
Brief Summary
-----------------
The proposed study is a pilot, double-blind, randomized clinical trial comparing galectin-3 inhibition with MCP to placebo for the treatment of knee osteoarthritis.

Official Title
-----------------
Blocking Extracellular Galectin-3 in Patients With Osteoarthritis

Conditions
-----------------
Osteoarthritis

Intervention / Treatment
-----------------
* Dietary Supplement: Modified Citrus Pectin
* Dietary Supplement: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Knee pain in at least one knee for more than half the days in the month prior to screening X-rays showing evidence of knee osteoarthritis by Kellgren and Lawrence Score two or three, with definite osteophytes and possible or definite joint space narrowing, consistent with mild to moderate knee osteoarthritis. If both knees are affected, patients would choose the more severe knee for outcomes assessments. Willingness to maintain stable analgesic regimen throughout the study period Exclusion Criteria: Diagnosis of fibromyalgia Presence of an underlying inflammatory disease in the affected knee, including Rheumatoid Arthritis, Psoriatic Arthritis, Gout, Pseudogout, or other inflammatory disease. Patients who cannot give consent will be excluded, as will patients who cannot speak, read and understand English, as we will not have translated documents, consent forms, and surveys for them. While this supplement is considered very safe and low risk, patients with underlying significant cytopenia (white blood cell count less than 4.0, hemoglobin less than 10, or platelets less than 100), or with impaired renal function (glomerular filtration rate less than 60) or elevated liver enzymes will be excluded as well.

Ages Eligible for Study
-----------------
Minimum Age: 40 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
Interventional Model Description: Randomized, double blind clinical trial
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Intervention<br>Patients will be given Modified Citrus Pectin twice daily for 12 weeks, and have their change in knee pain as measured by survey instruments assessed | Dietary Supplement: Modified Citrus Pectin<br>* MCP versus placebo<br>|
| Placebo Comparator: Control<br>Patients will be given placebo twice daily for 12 weeks, and have their change in knee pain as measured by survey instruments assessed | Dietary Supplement: Placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| WOMAC-Knee |  | 12 weeks |
Efficacy of Umbilical Cord Mesenchymal Stem Cells in Duchenne Muscular Dystrophy

Study Overview
=================
Brief Summary
-----------------
Duchenne muscular dystrophy (DMD) is a genetic disorder caused by an absence of dystrophin and characterized by progressive muscle degeneration. There is no cure for DMD at present but, there are several strategies under-researched for treatment of DMD such as steroid treatment, gene theraphy, exon skipping, stop codon read through and gene repair, cell theraphy and theraphy with drug that help to produce utrophin protein. The aim of this study is investigate the eficacy of human umblical cord mesenchymal stem cells on DMD and understanding if wild type gene can be transfered to the patient.

Official Title
-----------------
Efficacy of Umbilical Cord Mesenchymal Stem Cells in Duchenne Muscular Dystrophy: Phase 1/2 Study

Conditions
-----------------
Duchenne Muscular Dystrophy

Intervention / Treatment
-----------------
* Biological: Umbilical Cord Mesenchymal Stem Cell


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Patients with diagnosis of DMD that is proven clinically and genetically Age between 7-20 Patients need partial respiratory support, during the day Patients have less than or equal to stage I NIH, Liver, renal and cardiac function Patients without cancer Patients without allergic disease Patients without bleeding diathesis, Exclusion Criteria: Patients need complete respiratory support Patients have more than to stage II NIH, Liver, renal and cardiac function Patients have bleeding diathesis and allergic disease

Ages Eligible for Study
-----------------
Minimum Age: 7 Years
Maximum Age: 20 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Umbilical Cord Mesenchymal Stem Cell<br> | Biological: Umbilical Cord Mesenchymal Stem Cell<br> <br> * Other names: umbilical cord mesenchymal stem cells;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duchenne muscular dystrophy gene expression |  | up to 9 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
umbilical cord, mesenchymal stem cell
Efficacy of TCA Effect on Varicella Atrophic Scars

Study Overview
=================
Brief Summary
-----------------
This study aims to determine the efficacy of 70% trichloroacetic acid on atrophic scars of varicella

Detailed Description
-----------------
high concentration trichloroacetic acid peeling has been shown to be effective in treating and flattening the atrophic acne scars. According to the lack of an effective and low cost therapy for removing these relative common and nuisance lesions; We aimed to answer that whether we could achieve the same results from 70% TCA on atrophic varicella scars.

Official Title
-----------------
Evaluation of Tri Chloro Acetic Acid (TCA) Effect on Atrophic Varicella Scars

Conditions
-----------------
Atrophic Varicella Scar

Intervention / Treatment
-----------------
* Drug: 70% trichloroacetic acid


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Atrophic varicella scar on face Exclusion Criteria: Active varicella infection Active Herpetic infection Previous history of keloid formation

Ages Eligible for Study
-----------------
Minimum Age: 15 Years
Maximum Age: 45 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: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: 70% trichloroacetic acid|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective Clearance(before and after photographies were taken) |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subjective Clearance(according to the patients satisfaction) |  |  | 
| Adverse effects(assessed by clinician as erythema, pigmentary changes, scaring) |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
trichloroacetic acid, varicella scar
Total Intravenous Anesthesia: TCI Versus MCI

Study Overview
=================
Brief Summary
-----------------
test the following differences between Schinder's Target Controlled Infusion (TCI ) model and manually controlled infusion (MCI) : remifentanil and propofol total dose given incidence of awareness or inadequate anesthesia number of rescue dose given

Official Title
-----------------
Total Intravenous Anesthesia: TCI Versus MCI, Unresolved Question

Conditions
-----------------
Test the Differences Between Schinder's TCI Model and MCI

Intervention / Treatment
-----------------
* Device: Remifentanil and propofol administration using TCI
* Device: Remifentanil and propofol administration using MCI


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients undergoing breast or thyroid surgery Exclusion Criteria: BMI > 35 Surgery shorter than 30 minutes Patients with history of: alcol or drug abuse, kidney or liver failure, cardiovascular disease

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MCI<br>manually controlled infusion will be used | Device: Remifentanil and propofol administration using MCI<br> <br> |
| Experimental: TCI<br>Target Controlled Infusion will be used | Device: Remifentanil and propofol administration using TCI<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| incidence of awareness or inadequate anesthesia |  | every 3 minutes till the end of surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| remifentanil and propofol total dose given |  | every 30 minutes till the end of surgery |
Impact Of Soft Tissue Manipulation On Dimensional Changes After Posterior Region Extraction.

Study Overview
=================
Brief Summary
-----------------
Alveolar preservation seek to avoid multiple surgical interventions to the patient and decrease costs to the patient. In particular, in a Brazilian population where the need for extraction is great, the development of techniques that safely allow a higher quality of rehabilitation is of paramount importance. Thus, this analysis is of great scientific and therapeutic importance. Within the above, the objective is to use an autogenous connective tissue graft in order to eliminate the need to raise the full-thickness flap and compensate for soft tissue deficiencies, which may reduce dimensional losses after extraction, in addition to reducing the cost of the technique.

Official Title
-----------------
Impact Of Soft Tissue Manipulation On Dimensional Changes After Posterior Region Extraction: A Randomized Controlled Trial

Conditions
-----------------
Alveolar Ridge Preservation, Connective Tissue

Intervention / Treatment
-----------------
* Procedure: Alveolar Ridge Preservation With Gingival Graft


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Systemic health (absence of Hypertension and Diabetes); Indication of dental extraction of at least 2 teeth (with at least 2/3 of bone support, in the region of premolars or molars with indication for extraction; Signature of the consent form; Individuals over 18 years old. Exclusion Criteria: Presence of periodontal disease at the time of surgery; Pregnant and lactating women; Smokers; Be under orthodontic treatment; Use medication that alters the bone healing process, such as those used to treat osteoporosis and the bisphosphonates group; Individuals under 18 years old.

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Atraumatic Extraction Without Gingival Graft<br>Alveolar closure with elevation of total flaps and simple suture (Silk thread 4.0, Ethicon, Johnson & Johnson, SJC). | |
| Experimental: Atraumatic Extraction With Gingival Graft<br>Closure of the alveolus without flap elevation, and placement of a free gingival tissue graft removed from the individual palate. | Procedure: Alveolar Ridge Preservation With Gingival Graft<br>* Closure of the alveolus with the placement of a free gingival tissue graft removed from the individual palate.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Minor Alveolar dimensional loss with gingival graft. | Horizontal and vertical bone loss measures after CBCT base and 3 months. | 3 months |
Pharmacokinetic Properties of Vortioxetine in Healthy Young Chinese Men and Women

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the pharmacokinetic (PK) parameters of vortioxetine after single and multiple oral dosing to healthy Chinese men and women.

Official Title
-----------------
A Randomised, Open-label, Single-centre, Single- and Multiple-dose Interventional Study Investigating the Pharmacokinetic Properties of Vortioxetine in Healthy Young Chinese Men and Women

Conditions
-----------------
Pharmacokinetics

Intervention / Treatment
-----------------
* Drug: Vortioxetine 10 mg single dose
* Drug: Vortioxetine 20 mg single dose
* Drug: Vortioxetine 10 mg multiple dose
* Drug: Vortioxetine 20 mg multiple dose


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy young Chinese men or women Between 18 and 45 years of age (extremes included) BMI between 18.5 and 24 kg/m2 (extremes included) Body weight ≥45 kg. Exclusion Criteria: Pregnant or lactating. Previously been dosed with vortioxetine The subject has taken any investigational medicinal products within 3 months prior to the first dose of IMP (investigational medicinal product) Other protocol defined inclusion and exclusion criteria may apply

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vortioxetine 10 mg single dose<br>8 men and 8 women | Drug: Vortioxetine 10 mg single dose<br>* 10 mg tablet for oral use, single dose<br>* Other names: Lu AA21004;|
| Experimental: Vortioxetine 20 mg single dose<br>8 men and 8 women | Drug: Vortioxetine 20 mg single dose<br>* Two 10 mg tablets for oral use, single dose,<br>* Other names: Lu AA21004;|
| Experimental: Vortioxetine 10 mg multiple dose<br>8 men and 8 women | Drug: Vortioxetine 10 mg multiple dose<br>* 10 mg tablet for oral use once, daily for 14 days.<br>* Other names: Lu AA21004;|
| Experimental: Vortioxetine 20 mg multiple dose<br>8 men and 8 women | Drug: Vortioxetine 20 mg multiple dose<br>* Two 10 mg tablets for oral use, once daily for 14 days.<br>* Other names: Lu AA21004;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics (PK) of vortioxetine and its metabolites: Cmax, AUC, t1/2, oral clearance, apparent volume of distribution, accumulation index, metabolic ratio | Composite pharmacokinetic outcome measures (PK parameters: Cmax, AUC, t1/2, oral clearance, apparent volume of distribution, accumulation index, metabolic ratio) | Day 1 to 312 hours post-dose |
A Safety and Tolerability Study of ABT-089 in Adults With Attention Deficit-Hyperactivity Disorder (ADHD)

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to evaluate the long-term safety and tolerability of ABT-089 in adults with ADHD.

Official Title
-----------------
The Long-Term Safety and Tolerability of ABT-089 in Adults With Attention Deficit-Hyperactivity Disorder (ADHD): An Open-Label Extension Study

Conditions
-----------------
Attention Deficit Hyperactivity Disorder

Intervention / Treatment
-----------------
* Drug: ABT-089


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The subject was randomized into Study M06-855 and completed treatment in Periods 1 and 2 and the 2-week Extension Period If female, subject must be either postmenopausal for at least 1 year, surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy), or practicing at least a method of birth control throughout the study If female, the result of a pregnancy tests are negative The subject is judged to be in generally good health Exclusion Criteria: More than 7 days have elapsed since the last dose of study drug in Study M06-855 The subject has taken any ADHD medication between the last dose of study drug in Study M06-855 and the first dose of study drug in the current study The subject anticipates a move outside the geographic area

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 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: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: ABT-089<br>* Open label study, subjects will take up to 80mg daily for 24 months.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CAARS:INV |  | Day -1, Day 14, Months 1, 2, 3, 6, 9, 12, 15, 18, 21, 24 | 
| CGI-ADHD-S |  | Day -1, Day 14, Months 1, 2, 3, 6, 9, 12, 15, 18, 21, 24 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AAQoL |  | Day -1, Months 3, 6, 9, 12, 15, 18, 21, 24 | 
| WPAI |  | Day -1, Months 3, 6, 9, 12, 15, 18, 21, 24 | 
| RUQ |  | Day -1, Months 3, 6, 9, 12, 15, 18, 21, 24 | 
| FTND |  | Day -1, Months 1, 2, 3, 6, 9, 12, 15, 18, 21, 24 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ADHD
Expanded Access to RBS2418

Study Overview
=================
Brief Summary
-----------------
This is an expanded access treatment protocol designed to provide access of RBS2418 to a single patient with pancreatic cancer.

Detailed Description
-----------------
Given lack of any therapeutic options such as standard of care chemotherapy for this single patient owing to lack of tolerability and opportunity to enroll in any clinical trial due to extent of disease, patient desires to try compassionate use protocol with RBS2418, an oral immunotherapeutic agent that is currently in clinical trials and is well tolerated by patients. Furthermore, patient's tumor has been shown to express ENPP1, the protein targeted by RBS2418

Official Title
-----------------
Expanded Access to RBS2418 for an Individual Patient With Pancreatic Cancer

Conditions
-----------------
Expanded Access in Pancreatic Cancer

Intervention / Treatment
-----------------
* Drug: RBS2418


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The patient is willing and able to provide informed consent. Only the patient for whom this clinical study/experimental treatment was designed will be given the investigational drug under the treatment of the PI. No other patient is authorized to participate in or to receive treatment under this treatment protocol. Exclusion Criteria: Not applicable
Sexes Eligible for Study
-----------------
Female

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: RBS2418|RBS2418 will be administered orally at 200 mg two times per day (BID).|

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

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