linjc16/ctgov huggingface dataset:
Arkansas Expanded Access COVID-19 Convalescent Plasma Treatment Program

Study Overview
=================
Brief Summary
-----------------
This is an expanded access treatment protocol to treat up to 100 patients with severe or life-threatening, laboratory confirmed COVID-19 with COVID-19 convalescent plasma.

Detailed Description
-----------------
This is an expanded access treatment protocol to treat up to 100 subjects with severe or life-threatening, laboratory confirmed COVID-19 with COVID-19 convalescent plasma. Subjects will receive 1-2 units (200-400 mL per unit, not to exceed 550 mL total) of ABO compatible, low isohemagglutinin titer, COVID-19 convalescent plasma. Plasma will be administered one unit per day for up to two days. The duration of infusion will usually take 1 to 2 hours (rate of 100 to 250 mL/hr). The infusion should not exceed 4 hours. Plasma infusions will be administered following standard institutional procedures, including the use of premedications (e.g. acetaminophen, diphenhydramine, etc.) as necessary.

Official Title
-----------------
Arkansas Expanded Access COVID-19 Convalescent Plasma Treatment Program

Conditions
-----------------
COVID-19

Intervention / Treatment
-----------------
* Biological: Convalescent Plasma


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or Female 18 years of age or older Laboratory confirmed COVID-19 via SARS-CoV-2 RT-PCR testing Patients currently hospitalized with severe or life-threatening COVID-19 or patients the treating physician deems to be at high-risk for progressing to severe or life-threatening COVID-19. Severe disease, defined as one or more of the following: dyspnea, respiratory frequency ≥ 30/min, blood oxygen saturation ≤ 93%, partial pressure of arterial oxygen to fraction of inspired oxygen ratio < 300, and/or lung infiltrates > 50% within 24 to 48 hours Life-threatening disease, defined as one or more of the following: respiratory failure, septic shock, and/or multiple organ dysfunction or failure Patients or their legally authorized representative must provide informed consent. Exclusion Criteria: Female patients with positive pregnancy test, breastfeeding, or planning to become pregnant/breastfeed during the study period. Patients who have received pooled immunoglobulin in past 30 days Contraindication to transfusions or history of prior reactions to transfusion blood products

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: Convalescent Plasma|1-2 units (200-400 mL per unit, not to exceed 550 mL total) of ABO compatible, low isohemagglutinin titer, COVID-19 convalescent plasma|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
TACE for HCC by TANDEM and Idarubicin

Study Overview
=================
Brief Summary
-----------------
DcBeads and lipiodol-transarterial chemoembolization (TACE) of hepatocellular carcinoma (HCC) using doxorubicin result in about 50% objective response rate at 6 months (Precision V study, Lammer et al. CVIR 2010) We previously demonstrated that idarubicin was the most effective drug on 3 HCC cell lines (Boulin et al., Anticancer drugs 2009). We tested idarubicin-loaded beads in a phase I trial (Boulin et al., Aliment Pharmacol Therapy 2012) and more recently in a prospective multicentric phase II trial (IDASPHERE II, Magna Cum Laude CIRSE 2017, B Guiu et al.). This trial was stopped at interim analysis because the endpoint was reached. Tandem beads are precisely calibrated, of small size, allowing the maximization of ischemic effects together with an optimal efficacy of the drug. We previously published that idarubicin was able to load fastly in Tandem, with minimal modification of bead diameter and a very interesting releasing profile of the drug (Guiu et al., JVIR 2015). We used TANDEM combined with idarubicin in our practice for the treatment of HCC by TACE (in-label use of beads and the drug). No clinical study (even retrospective) has been published so far with TANDEM-IDA (except our first paper published in JVIR in 2015, only 4 patients). Here we propose to collect the retrospective data of patients treated by TANDEM-IDA, to help to design a future multicentric randomized phase II trial

Official Title
-----------------
Retrospective Study on TACE for HCC by TANDEM and Idarubicin

Conditions
-----------------
Hepatocellular Carcinoma (HCC)

Intervention / Treatment
-----------------
* Drug: Transarterial chemoembolization using TANDEM and idarubicin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: HCC according to histological examination or Barcelona criteria Measurable targets according to mRECIST v1.1 Child A or B7 cirrhosis (without decompensation in the past 6 months) HCC not candidate to surgery or ablation Age ≥ 18 years Performance status 0 or 1 Thrombocytes ≥ 50 000/mm3, neutrophil count≥ 1 000/mm3, creatininemia ≤ 150 µmol/L No cardiac failure Exclusion Criteria: Follow-up < 1month Lobar/main portal venous thrombus Prior treatment by systemic chemotherapy or radioembolization

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Transarterial chemoembolization using TANDEM and idarubicin|Transarterial chemoembolization using TANDEM and idarubicin|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| tumeur response | tumeur response | 1 day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
TACE
Fosamax Bone Loss Study: Alendronate to Prevent Bone Loss

Study Overview
=================
Brief Summary
-----------------
This is a study to determine if Fosamax (alendronate), a medication approved by the Food and Drug Administration (FDA) for the prevention and treatment of osteoporosis in postmenopausal women, is effective in decreasing the rate of bone loss which often begins to increase in the three to five years preceding the menopause (perimenopausal transition). During the three to five years prior to the menopause, the rate of bone loss increases. One way that physicians treat this is with oral contraceptive medication. However, the incidence of complications from oral contraceptives after the age of 40 increases. Therefore, a non-hormonal means of preventing bone loss should be useful. Fosamax (alendronate) is in a class of compounds called bisphosphonates. This study is being done to determine whether Fosamax can be used to prevent the increased rate of bone loss during the perimenopausal transition.

Official Title
-----------------
Alendronate to Prevent Perimenopausal Transition Bone Loss

Conditions
-----------------
Perimenopausal Bone Loss

Intervention / Treatment
-----------------
* Drug: Fosamax


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women ages 40-54 with symptomology of perimenopause including hot flashes, irregular periods and vaginal dryness. Exclusion Criteria: Women should not be on hormone replacements, oral contraceptives, or bone mineral enhancing medications (bisphosphonates, selective estrogen receptor modulators [SERM's], parathyroid hormone [PTH], calcitriol, fluorides) They should not have any abnormalities of the esophagus which delay esophageal emptying They should not have hypocalcemia or severe kidney disease Their bone mineral density (T-score) should not be greater than 2 standard deviations.

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 54 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: Fosamax|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
-----------------
Perimenopausal bone loss
Diabetes Control and Complications Trial (DCCT)

Study Overview
=================
Brief Summary
-----------------
Background. Long-term microvascular and neurologic complications cause major morbidity and mortality in patients with insulin-dependent diabetes mellitus (IDDM). We examined whether intensive treatment with the goal of maintaining blood glucose concentrations close to the normal range could decrease the frequency and severity of these complications. Methods. A total of 1441 patients with IDDM -- 726 with no retinopathy at base line (the primary-prevention cohort) and 715 with mild retinopathy (the secondary-intervention cohort) were randomly assigned to intensive therapy administered either with an external insulin pump or by three or more daily insulin injections and guided by frequent blood glucose monitoring or to conventional therapy with one or two daily insulin injections. The patients were followed for a mean of 6.5 years, and the appearance and progression of retinopathy and other complications were assessed regularly.

Official Title
-----------------
Diabetes Control and Complications Trial (DCCT)

Conditions
-----------------
Type 1 Diabetes Mellitus

Intervention / Treatment
-----------------
* Behavioral: Insulin


Participation Criteria
=================
Eligibility Criteria
-----------------
Eligibility Criteria: The major criteria for eligibility included insulin dependence, as evidenced by deficient C-peptide secretion; an age of 13 to 39 years; and the absence of hypertension, hypercholesterolemia, and severe diabetic complications or medical conditions. To be eligible for the primary-prevention cohort, patients were required to have had insulin dependent diabetes mellitus (IDDM) for one to five years, to have no retinopathy as detected by seven-field stereoscopic fundus photography, and to have urinary albumin excretion of less than 40 mg per 24 hours. To be eligible for the secondary-intervention cohort, the patients were required to have IDDM for 1 to 15 years, to have very-mild to moderate nonproliferative retinopathy, and to have urinary albumin excretion of less than 200 mg per 24 hours.

Ages Eligible for Study
-----------------
Minimum Age: 13 Years
Maximum Age: 39 Years

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

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

| Intervention/Treatment |
| --- |
|Behavioral: Insulin|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
BF2.649 in Patients With OSA, Still Complaining of EDS and Refusing to be Treated by CPAP.

Study Overview
=================
Brief Summary
-----------------
Multicenter randomized double blind study versus placebo during 12 weeks with at first, an escalating dose period followed by stable dose period at the selected dose. This double-blind period can be followed by a 9 months open-label period if the patient wishes to continue with the study product.

Detailed Description
-----------------
The first period (12 weeks double blind period) will aim at demonstrating the efficacy and safety of BF2.649 by verifying whether the results of BF2.649 are superior to those of placebo. The aim of the second period (open label extension phase) will be to assess the long-term tolerance, as well as the maintenance of the BF2.649 efficacy.

Official Title
-----------------
Efficacy and Safety of BF2.649 in Treatment of Excessive Daytime Sleepiness in Patients With Obstructive Sleep Apnea (OSA) Refusing the Nasal Continuous Positive Airway Pressure (nCPAP) Therapy

Conditions
-----------------
Obstructive Sleep Apnea, Excessive Daytime Sleepiness

Intervention / Treatment
-----------------
* Drug: BF2.649
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with OSA still complaining EDS,refusing nCPAP ESS score ≥ 12 Exclusion Criteria: Patients suffering from insomnia without OSA Co-existing narcolepsy Patient with sleep debt not due to OSA Acute or chronic severe disease

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BF2.649<br>BF2.649 capsules dosed at 5 mg, 10 mg, 20 mg | Drug: BF2.649<br>* 1 capsule per day in the morning before the breakfast<br>* Other names: Pitolisant;|
| Placebo Comparator: Placebo<br>Capsules of placebo containing lactose with low, medium and high dosage | Drug: Placebo<br>* 1 capsule per day in the morning before the breakfast<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ESS (Epworth Sleepiness Scale) change from baseline |  | From baseline to week 12 and week 51 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Multicenter, Randomized, Double-blind, Efficacy and safety study, BF2.649 versus placebo, Patients suffering from Obstructive Sleep Apnea, Complaining from Excessive Daytime Sleepiness, Refusing nasal Continuous Positive Airway Pressure
Comparison of TAP (Transversus Abdominis Plane) and Ilioinguinal/Iliohypogastric Nerve Block for Analgesia of Open Inguinal Herniorrhaphy

Study Overview
=================
Brief Summary
-----------------
TAP was recommended by PROSPECT for further investigation as an appropriate analgesic method after open herniorrhaphy. Ilioinguinal/iliohypogastric nerve block is one of the oldest methods of analgesia. The researchers wish to investigate whether the TAP block is as effective as the ilioinguinal/iliohypogastric nerve block?

Official Title
-----------------
Comparison Between Two Ultrasound-guided Blocks (Transversus Abdominis Plane and Ilioinguinal/Iliohypogastric Nerve Blocks) for Pain Relief After Open Inguinal Herniorrhaphy

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

Intervention / Treatment
-----------------
* Procedure: Preoperative Ultrasound Guided Ilioinguinal/Iliohypogastric Block
* Procedure: Preoperative Ultrasound Guided Posterior TAP Block
* Drug: Patient controlled analgesia


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients undergoing elective primary unilateral open tension-free mesh inguinal hernia repair Exclusion Criteria: Inability to consent to the study BMI more than 40 Skin infection near injection site Chronic hepatic or renal failure Peripheral neuropathy Proven opioid dependency Coagulopathy Thrombocytopenia Dementia Lack of orientation Impossibility to understand VAS Patients suffering from chronic pain

Ages Eligible for Study
-----------------
Minimum Age: 18 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: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: TAP Block<br> | Procedure: Preoperative Ultrasound Guided Posterior TAP Block<br> <br> |
| Active Comparator: II/IH Block<br> | Procedure: Preoperative Ultrasound Guided Ilioinguinal/Iliohypogastric Block<br> <br> |
| Active Comparator: Control Group<br> | Drug: Patient controlled analgesia<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| postoperative pain | Intensity of pain in rest and during movement at the operation day and 2 days postoperaive. | 2 days postoperatively | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Analgesia, postoperative
A Study of HR19024 in Subjects With Advanced Solid Tumor

Study Overview
=================
Brief Summary
-----------------
To evaluate the safety，tolerability，pharmacokinetic characteristics and preliminary efficacy of HR19024 injection in the treatment of advanced solid tumor

Official Title
-----------------
An Open-label Phase 1a Study of the Safety and Tolerability of HR19024 Injection in Subjects With Advanced Solid Tumor

Conditions
-----------------
Advanced Solid Tumor

Intervention / Treatment
-----------------
* Drug: HR19024


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ECOG performance status 0 or 1 Histologically confirmed advanced solid tumor Life expectancy of greater than or equal to (>=) 12 weeks At least one measurable lesion is present according to the efficacy evaluation criteria for solid tumors (RECIST 1.1) Able and willing to provide a written informed consent Exclusion Criteria: Subjects with unresolved toxicity （> CTCAE G1）of prior therapy at the time of enrolment Subjects who had received anti-tumor treatments such as surgery, chemotherapy, radiotherapy recently

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
Intervention Model: Single Group Assignment
Interventional Model Description: HR19024 for all enrolled subjects
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HR19024<br>Part 1: Dose escalation of HR19024 montherapy for advanced solid tumor Part 2：PK expansion of HR19024 montherapy for advanced solid tumor Part 3: Efficacy expansion of HR19024 montherapy for advanced solid tumor | Drug: HR19024<br>* Intravenous infusion<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum tolerated dose (MTD) of HR19024 |  | 21-day cycle (tri-weekly) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response rate (RR) |  | up to 6 months following the date the last patient was randomized | 
| Disease Control Rate |  | up to 6 months following the date the last patient was randomized | 
| Duration of Response |  | up to 6 months following the date the last patient was randomized | 
| Progression free survival (PFS) |  | up to 6 months following the date the last patient was randomized |
Effects of Multimodal Pain Therapy in Patients With Mixed Chronic Pain Syndromes

Study Overview
=================
Brief Summary
-----------------
Complex and chronified pain syndromes requires a specialized therapeutic concept. From patients with chronic low back pain the investigators know, that an interdisciplinary multi-modal approach may improve the therapeutic success. In this observational study the investigators investigated if the multi-modal pain therapy is also effective in patients with mixed chronic pain syndromes.

Detailed Description
-----------------
The multi-modal pain therapy includes: specific drug therapy pain education psychological therapy physical therapy behavioral therapy work hardening bio-feedback ergotherapy

Official Title
-----------------
Influence of a Multimodal Day-unit Pain Therapy on Pain Experience, Pain-related Disability and Depression in Patients With Chronic Pain Syndromes

Conditions
-----------------
Chronic Pain

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age >= 18 years and <= 65 years verified chronic pain for more than 6 month Exclusion Criteria: application for a pension non-accordance with multi-modal pain therapy dominant geriatric symptoms dominant psychiatric symptoms

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?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| chronic pain<br>260 consecutive patients with verified chronic pain syndromes | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| intensity of pain | pain intensity 1 year after multi-modale therapy compared with pain intensity before treatment | Change from Baseline in intensity of pain at 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pain disability index | pain disability index 6 month after multi-modale therapy compared with pain disability index before treatment | Change from Baseline in pain disability index at 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
multi-modal pain therapy, chronic pain