linjc16/ctgov huggingface dataset:
Open Label Extension Study of [S,S]-Reboxetine in Patients With Fibromyalgia

Study Overview
=================
Brief Summary
-----------------
This is a study to investigate the long-term safety and effectiveness [S,S]-Reboxetine in relieving the symptoms of Fibromyalgia in patients.

Official Title
-----------------
A Multi-center, Long-term, Open-label Extension Study of [S,S]-Reboxetine (PNU-165442G) Administered Once Daily in Patients With Fibromyalgia

Conditions
-----------------
Fibromyalgia

Intervention / Treatment
-----------------
* Drug: [S,S]-Reboxetine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female of any race, at least 18 years of age Patients must meet the ACR criteria for fibromyalgia (ie, widespread pain present for at least 3 months, and pain in at least 11 of 18 specific tender point sites) Completed preceding double-blind randomized, controlled trial Exclusion Criteria: Patients with other severe pain (eg, Diabetic Peripheral Neuropathy and PostHerpetic Neuralgia) that may confound assessment or self evaluation of the pain associated with fibromyalgia Patients with any autoimmune rheumatic disorder, non-focal rheumatic disease (other than fibromyalgia), active infection, or untreated endocrine disorder A current or recent diagnosis (last 6 months) or episode of major depressive disorder, dysthymia and/or uncontrolled depression History of mania, hypomania, other psychotic disorder, or current mood disorder with psychotic features

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: [S,S]-Reboxetine<br>* Once a day, oral treatment, of 4, 6, 8 or 10 mg<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vital Signs |  | 66 weeks | 
| 12-Lead ECG |  | 66 weeks | 
| Hematology & Biochemistry Laboratory Parameters |  | 66 weeks | 
| Adverse Events |  | 66 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Short-Form 36 Health Survey |  | 66 weeks | 
| Sheehan Disability Scale |  | 66 weeks | 
| Pain Visual Analogue Scale |  | 66 weeks | 
| Multidimensional Assessment of Fatigue |  | 66 weeks | 
| Fibromyalgia Impact Questionaire |  | 66 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Phase 3, safety study, [S,S]-Reboxetine, Fibromyalgia
A Study of Loading Doses of Intravenous Bondronat (Ibandronate) in Patients With Breast Cancer and Malignant Bone Disease.

Study Overview
=================
Brief Summary
-----------------
This single arm study will assess the efficacy and safety of loading doses of intravenous Bondronat in patients with breast cancer and malignant bone disease experiencing moderate to severe bone pain. Patients will receive an intravenous infusion of 6mg Bondronat on days 1, 2 and 3. The anticipated time on study treatment is 3 months, and the target sample size is <100 individuals.

Official Title
-----------------
An Open Label Study to Assess the Effect of Intravenous Loading Doses of Bondronat on Bone Pain in Patients With Breast Cancer and Skeletal Metastases

Conditions
-----------------
Pain; Bone Neoplasms; Neoplasm Metastasis

Intervention / Treatment
-----------------
* Drug: ibandronate [Bondronat]


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: female patients, >=18 years of age; breast cancer; bone metastases; moderate to severe pain; adequate renal function. Exclusion Criteria: bisphosphonate treatment within 3 weeks of study enrollment.

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

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

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: ibandronate [Bondronat]<br>* 6mg iv on days 1-3<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain and analgesic consumption |  | Days 1, 7 and 14 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AEs and laboratory parameters |  | Days 1, 4 and 7 | 
| Serum creatinine |  | Days 1, 4 and 7 | 
| Karnofsky index |  | Day 7 |
TEDDY: Spores of Bacillus Clausii in Acute Diarrhoea in Children

Study Overview
=================
Brief Summary
-----------------
Primary objective: To demonstrate the efficacy of a Bacillus clausii probiotic strain compared to placebo in children suffering from acute diarrhoea and treated for 7 days. Secondary objective: To evaluate the clinical safety of the Bacillus clausii probiotic strain versus placebo.

Official Title
-----------------
Comparative Efficacy and Safety of a Bacillus Clausii Probiotic Strain Versus Placebo in the Treatment of Acute Diarrhoea in Children

Conditions
-----------------
Diarrhea

Intervention / Treatment
-----------------
* Drug: Spores of Bacillus Clausii Probiotic Strain


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Infants or Children Non hospitalized infants or children With acute diarrhea evident for less than 48 hours Having had three or more watery stools during the preceding 24 hours Exclusion criteria: Infants or Children With blood stools Having been treated with antibiotics or probiotics within the two weeks before the enrollment Suffering from dehydration defined by a weight loss of at least 5% or by the presence of a skin fold With an history of seizures With immunosuppressive conditions With a current status requiring an antibiotic treatment Suffering from a chronic disease including chronic diarrhea whatever the origin Having received before inclusion one of the following treatments: Probiotics Prebiotics Drugs with adsorbing properties Drugs that modify intestinal secretion like bismuth subsalicylate, acetorphan Drugs that modify intestinal motility (opiates such as loperamide, atropine and other cholinergic agents). Having participated in another clinical trial in the last 3 months prior to the start of the study

Ages Eligible for Study
-----------------
Minimum Age: 6 Months
Maximum Age: 36 Months

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: Spores of Bacillus Clausii Probiotic Strain|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of diarrhoea as counted from the first intake of the investigational product up to the first appearance of a loose stool followed by two-consecutive normal stools |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of infants/children with normal stools at D3, D4, D5, D6 and D7;Mean number of stools per day;Occurrence of vomiting episodes per day after enrolment;Parents'overall global assessment of efficacy at the end of the treatment;other safety criteria |  |  |
Issues and Challenges in Cancer Patients on Active Treatment During the COVID-19 Pandemic

Study Overview
=================
Brief Summary
-----------------
In view of increasing cases of SARS-CoV-2 leading to the COVID-19 Pandemic in India,there has been unprecedented restrictions on travel, work and other aspects of daily life. Our study has been designed to collect data of cancer patients to analyze their issues and challenges during Covid-19 Pandemic.

Detailed Description
-----------------
Protocol No: Onco_Covid-19 Version no:1.0 Objectives: Firstly the patients recently diagnosed with cancer will be selected for enrollment who are on active treatment during lockdown based on the date of their registration in the hospital. This is followed by a telephonic interview with patients or their attendant to carry out a prospective, cross-sectional, observational study in order to address the issues and challenges faced by them during Lockdown. Collection of data will be done through telephonic communication. Participation in this study will be entirely voluntary. Telephonic verbal consent will be taken from the patients or their attendants before collection of their response on the study questionnaire and then will be asked questions accordingly based on the questionnaire which is available in English and Hindi both. Data and general information regarding participants will only be collected in questionnaire. No personal data of the participants will be taken which will also be conveyed to the participant or attendant during telephonic verbal consent.

Official Title
-----------------
An Observational Study to Identify the Issues and Challenges in Cancer Patients on Active Treatment During the COVID-19 Pandemic and the Resulting Lockdown

Conditions
-----------------
Oncology Patients

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Registered with the Max Institute of Cancer Care between Nov 1st 2019 to Jan 31st 2020 Were scheduled to receive one or more modalities of treatment (chemotherapy, surgery, radiation therapy, immunotherapy) during the period Feb 1st 2020 to April 30th 2020 Exclusion Criteria: -

Ages Eligible for Study
-----------------
Minimum Age: 12 Years
Maximum Age: 98 Years

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

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oncology patients | To focus on basic issues encountered by oncology patients such as transportation, medical facility, healthcare support, disease apprehension etc | 4-8 weeks |
Effect of Anesthetic Drugs on Neurocognitive Function in Children With Retinoblastoma Requiring Multiple Anesthetic Exposure - Preliminary Study

Study Overview
=================
Brief Summary
-----------------
This study evaluate the effect of dexmedetomidine on intelligence test in pediatric patients with multiple anesthesia exposure. Children who are diagnosed with retinoblastoma and receive first exam under general anesthesia before age of 2 are included. Intelligence test will performed when patients' age are 4.

Official Title
-----------------
Effect of Anesthetic Drugs on Neurocognitive Function in Children With Retinoblastoma Requiring Multiple Anesthetic Exposure - Preliminary Study

Conditions
-----------------
Retinoblastoma

Intervention / Treatment
-----------------
* Drug: Dexmedetomidine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who are first diagnosed as retinoblastoma and scheduled for EUA and treatment under general anesthesia before age of 2 Exclusion Criteria: -

Ages Eligible for Study
-----------------
Maximum Age: 2 Years

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

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

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

Design Details

Primary Purpose: Other
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control group<br>Children diagnosed with retinoblastoma and received exam under anesthesia (EUA) before the age of 30 months, and is not yet 4 years old Children who are undergoing exams and treatment such as EUA, chemoport insertion, or intra-arterial chemotherapy under general anesthesia Sevoflurane is used only for anesthesia | |
| Experimental: Dexmedetomidine group<br>Children who are diagnosed with retinoblastoma and are scheduled for the first EUA before their age of 30 months. No history of anesthesia | Drug: Dexmedetomidine<br>* Dexmedetomidine (1 mcg/kg loading for 10 min, then 1 mcg/kg/min continuous infusion) is used with sevoflurane in every time of general anesthesia<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| IQ score at age of 4 | Korean-Wechsler Preschool and Primary Scale of Intelligence test (score >131, high; score 116-130, high-normal; socre 85-115, normal; score 70-84; low-normal; score <69; low) | year 4 | 
| Developmental Test | visual-Motor Integration test | year 4 |
Resveratrol as a Preventive Treatment of OHSS

Study Overview
=================
Brief Summary
-----------------
Evaluation of resveratrol treatment oh ovarian hyperstimulation syndrome in egg donors

Detailed Description
-----------------
Randomized clinical trial to evaluate the role of resveratrol in preventing ovarian hyperstimulation syndrome by reducing VGEF expression and estradiol production, imporving hemoconcentration and symptomathology of this condition

Official Title
-----------------
Resveratrol as a Preventive Treatment of Ovarian Hyperstimulation Syndrome

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

Intervention / Treatment
-----------------
* Drug: Resveratrol
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Number of follicles greater than 12 mm after ovarian stimulation Number of retrieved oocytes greater than 21 Exclusion Criteria: >35 years-old PCOS Endometriosis Systemic pathology Positive serologies for HBV, HBC and HIV Abnormal karyotype

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 35 Years

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

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Resveratrol<br>Resveratrol will be administered orally at the dose of 2 g/day for 9 days, starting on the day of ovulation triggering. | Drug: Resveratrol<br>* Resveratrol treatment (2 g/day) will be administered for 9 days, starting from oocyte maturation day.<br>* Other names: Resverasor Plus;Drug: Placebo<br>* Placebo treatment (2 g/day) will be administered for 9 days, starting from oocyte maturation day.<br>|
| Placebo Comparator: Control<br>Placebo treatment will be administered for 9 days, starting on the day of ovulation triggering. | Drug: Resveratrol<br>* Resveratrol treatment (2 g/day) will be administered for 9 days, starting from oocyte maturation day.<br>* Other names: Resverasor Plus;Drug: Placebo<br>* Placebo treatment (2 g/day) will be administered for 9 days, starting from oocyte maturation day.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum VEGF levels | Serum determination of VEGF levels | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hemoconcentration | Volume of red blood cells measured in percentage | 1 day | 
| Serum estradiol levels | Serum determination of estradiol levels asessed in picograms per mililiter | 1 day | 
| Ascitis | Volume of liquid in Douglas pouch asessed in mililiters | 1 day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
OHSS, resveratrol, PCOS
Open-Label Safety Study of AXS-05 in Subjects With Depression

Study Overview
=================
Brief Summary
-----------------
An open-label, long-term, safety study of AXS-05 in patients with major depressive disorder (MDD), including treatment resistant depression.

Detailed Description
-----------------
A multi-center, open-label, long-term study to evaluate the safety and efficacy of AXS-05 in patients with major depressive disorder, including treatment resistant depression, treated for up to one year.

Official Title
-----------------
An Open-Label Study to Assess the Long-term Safety and Efficacy of AXS-05 in Subjects With Major Depressive Disorder

Conditions
-----------------
Major Depressive Disorder, Treatment Resistant Depression, Depression

Intervention / Treatment
-----------------
* Drug: AXS-05 (dextromethorphan and bupropion) oral tablets


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of major depressive disorder, including treatment resistant depression Body mass index (BMI) between 18 and 40 kg/m^2, inclusive Agree to use adequate method of contraception for the duration of the study Additional criteria may apply Exclusion Criteria: Suicide risk Pregnant, breastfeeding, or planning to become pregnant or breastfeed during the study Additional criteria may apply

Ages Eligible for Study
-----------------
Minimum Age: 18 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: AXS-05<br> | Drug: AXS-05 (dextromethorphan and bupropion) oral tablets<br>* Oral tablets, taken twice daily for up to 12 months.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Treatment-emergent AEs (TEAEs) Following Dosing With AXS-05 | Types and rates of adverse events | Up to 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
AXS-05, Antidepressant, Depression, Dextromethorphan, Bupropion, Dopamine Reuptake Inhibitor, NMDA Receptor Antagonist, Nicotinic Acetylcholine Receptor Antagonist, Serotonin Reuptake Inhibitor, Axsome Therapeutics, Norepinephrine Reuptake Inhibitor, Sigma-1 Receptor Agonist, Glutamate Modulator
A Study of Darbepoetin Alfa in Anemic Subjects With Low Risk Myelodysplastic Syndrome

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the effect of 13 weeks of darbepoetin alfa treatment on erythroid response in anemic subjects with low risk Myelodysplastic Syndrome (MDS).

Official Title
-----------------
A Study of Darbepoetin Alfa in Anemic Subjects With Low Risk Myelodysplastic Syndrome

Conditions
-----------------
Myelodysplastic Syndromes

Intervention / Treatment
-----------------
* Drug: Darbepoetin Alfa


Participation Criteria
=================
Eligibility Criteria
-----------------
Eligibility Criteria: General: - Low risk MDS (low or intermediate-1 risk as defined by IPSS) and FAB classification of RA, RARS, or RAEB with blasts less than or equal to 10% determined via a bone marrow biopsy and CBC - Adequate iron stores determined by bone marrow film or section staining for iron via a bone marrow biopsy - ECOG Performance status score of 0, 1, or 2 Laboratory: - Local laboratory screening Hgb less than or equal to 11.0g/dL - Adequate renal function (serum creatinine concentration less than or equal to 2.0 mg/dL) - Adequate liver function (total bilirubin less than or equal to 2 times, ALT less than or equal to 3 times, and AST less than or equal to 3 times the upper limit of the respective normal range) Ethical: - Must be 18 years of age or older - Provide written Institutional Review Board (IRB)-approved informed consent before any screening procedures are performed

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Darbepoetin Alfa|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The proportion of subjects achieving an erythroid response during the 13-week test period |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The proportion of subjects achieving an erythroid response during the 28-week treatment period |  |  | 
| The change in Hb from baseline |  |  | 
| The incidence of red blood cell (RBC) transfusions (greater than or equal to 1 unit) |  |  | 
| The change in FACT-F from baseline |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Myelodysplastic Syndrome