linjc16/ctgov huggingface dataset:
Dose Adjustment Trial of SK-1403 in Hemodialysis Patients With Secondary Hyperparathyroidism

Study Overview
=================
Brief Summary
-----------------
This study is conducted to assess the efficacy and safety of SK-1403 in Hemodialysis Patients with Secondary Hyperparathyroidism. In the first treatment period, the efficacy of SK-1403 is assessed after 18 weeks of treatment with SK-1403 individually dose-adjusted . Safety is also assessed during this period. Patients who completed the first treatment period proceed to the second treatment period and receive the treatment with SK-1403 for 34 weeks. Efficacy and safety of SK-1403 are also assessed during this period.

Official Title
-----------------
Dose Adjustment Trial of SK-1403 in Hemodialysis Patients With Secondary Hyperparathyroidism

Conditions
-----------------
Secondary Hyperparathyroidism

Intervention / Treatment
-----------------
* Drug: Dose-adjusted SK-1403


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Average serum PTH>240 pg/mL during 2 weeks at the screening Serum corrected Ca≧8.4 mg/dL at the screening Stable chronic kidney disease patients who undergo hemodialysis or hemodialysis filtration Exclusion Criteria: Primary hyperparathyroidism Severe liver disease Severe Cardiac disease History or family history of Long QT syndrome Malignant tumor Uncontrolled diabetes mellitus Uncontrolled hypertension A history of severe drug allergy

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 79 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: Dose-adjusted SK-1403<br> | Drug: Dose-adjusted SK-1403<br>* SK-1403 is to be administered to patients for the whole treatment periods (52 weeks), with individual dose adjustment<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of patients who achieved serum PTH between 60 pg/mL and 240 pg/mL, inclusive | Assessed by laboratory test value | 18 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of patients who achieved ≥ 30% or 50% reduction in serum PTH from baseline, respectively | Assessed by laboratory test value | 18 weeks | 
| Measured values and Changes from baseline in serum PTH, Ca, P, and serum Ca x P product | Assessed by laboratory test value | 52 weeks |
To Investigate the Safety, Tolerability and Pharmacokinetics of AZD2516 After Multiple Dosing in Healthy Volunteers

Study Overview
=================
Brief Summary
-----------------
AZD2516 is being developed for the oral treatment of chronic neuropathic pain. This study is split in to two parts. Part A will measure the effect of food and a new formulation of the drug in the blood and see how well it is tolerated. Part B will commence after the completion of Part A and will investigate the safety and tolerability of daily dosing with AZD2516.

Official Title
-----------------
A Single Centre Two Part Randomized Phase I Study to Assess the Pharmacokinetics of an ER Formulation of AZD2516 and to Assess the Safety, Tolerability and Pharmacokinetics of AZD2516 After Multiple Ascending Doses in Healthy Volunteers

Conditions
-----------------
Part A Healthy Young Males and Non-fertile Female Volunteers Aged 20 to 45 Years., Part B Healthy Young Males and Non-fertile Female Volunteers Aged 20 to 45 and Elderly Volunteers Aged 60 to 80

Intervention / Treatment
-----------------
* Drug: AZD2516
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Have a body mass index (BMI) between 18 and 30 kg/m2 and weigh at least 50 kg and no more than 100 kg Healthy volunteers able and willing to comply with all study requirements. Exclusion Criteria: An ongoing or history of a medical or psychiatric disease/condition which may put the healthy volunteer at risk or interfere with the study objectives because of participation in the study, as judged by the investigator(s). History of psychotic disorder among first degree relatives.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 80 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>AZD2516 (dose escalating) | Drug: AZD2516<br>* Oral, single, daily, 11 days<br>|
| Placebo Comparator: 2<br>Placebo | Drug: Placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Events, vital signs |  | Day -1 until follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum plasma concentration (Cmax) |  | Day 1 - Day 12 | 
| Time to Cmax (tmax) |  | Day 1 - Day 12 | 
| Terminal rate constant (λz) |  | Day 1 - Day 12 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
AZD2516, Phase 1, Healthy volunteer, pharmacokinetics, safety, tolerability, Multiple ascending doses
Late Pregnancy Sample Collection Study

Study Overview
=================
Brief Summary
-----------------
This study will obtain daily urine samples from pregnant volunteers, from 36 weeks pregnant until birth. All urine samples will be stored and used for research or product validation purposes. The study will also gather information from volunteers regarding a woman's health during her pregnancy.

Detailed Description
-----------------
This study will obtain daily urine samples from pregnant volunteers, from 36 weeks pregnant until birth. It is anticipated 20-40 pregnant women will be recruited to the study. Urine samples will be delivered to SPD either via post, or by hand and form part of the SPD BioBank. All urine samples will be stored and used for research or product validation purposes. The study will also gather information from volunteers regarding a woman's health during her pregnancy, including any bleeding, discharge, discomfort, contractions/ Braxton Hicks via the use of a daily diary. Pregnancy outcome details including labour specifics and birth outcomes such as birth date, weight, and sex of the baby will be obtained 4-6 weeks after the volunteer has given birth via email correspondence between the volunteer and study co-ordinator.

Official Title
-----------------
Late Pregnancy Sample Collection Study

Conditions
-----------------
Pregnancy

Intervention / Treatment
-----------------
* Other: urine sample collection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pregnant female in 3rd trimester of pregnancy Exclusion Criteria: Prescribed bed-rest during third trimester or any other pregnancy complication that would affect the ability to participate in the study more than 38 weeks pregnant Have a planned caesarean section

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: urine sample collection|no drug/devise intervention. sample collection study only|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| late pregnancy urine samples | Number of volunteers providing daily urine samples from 36 weeks pregnant until birth. | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pregnancy complications | Number of participants reporting pregnancy complications from week 36 of pregnancy until birth | 6 weeks | 
| Live birth | number of study participants who's pregnancy resulted in a live birth | 6 weeks | 
| Spontaneous vaginal delivery | number of study participants who's pregnancy resulted in a spontaneous vaginal delivery | 6 weeks | 
| weight of baby | weight of baby in pounds and ounces or kilograms | 6 weeks | 
| multiple births | number of pregnancies resulting in single baby, twins or triplets. | 6 weeks |
Involvement of Nervous System in Muscle Weakness in COPD Patients

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether nervous system alterations and motor drive failure can contribute to muscle weakness in COPD during voluntary movement. If necessary, we will look after the role of nocturnal hypoxia in these alterations.

Detailed Description
-----------------
COPD is a common disease that induces many systemic repercussions. Among these, peripheral muscle dysfunction is particularly deleterious because it leads to the decreases of the level of activity and the quality of life for patients. Movement involves activation of many structures, from the instructor, i.e. the brain, to the effector, i.e. the muscle. Netherless, the studies which have described peripheral muscle dysfunction have been focused on the muscle, so they have proposed a reducing vision of the phenomenon. Other studies have reported cerebral alterations in COPD, like cognitive disturbance, increase of the neuronal conduction time, and decrease of the white matter density, and were associated with chronic hypoxemia. Such alterations are consistent with the existence of a decrease of the central motor drive during voluntary movement in COPD patients. Therefore the study will aim to determine precisely which mechanisms are involved in peripheral muscle dysfunction in copd.

Official Title
-----------------
Phase 1 Impact of Nocturnal Desaturations on Central Motor Drive in COPD Patients: A New Insight on the Systemic Effects of the Disease.

Conditions
-----------------
Chronic Obstructive Pulmonary Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: COPD Patients at stage 2 and 3 Healthy sedentary subjects Exclusion Criteria: Epilepsy, pace-maker, nervous disorders

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 75 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| COPD nocturnal desaturator<br>COPD patients who spend 30% of the nigth with a SaO2 < 90%. | |
| COPD no nocturnal desaturator<br>COPD patients who spend less than 30% of the night with a SaO2 < 90% | |
| control group<br>healthy sedentary subjects | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Level of voluntary activation |  | 2h | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
COPD, nervous system, peripheral muscle dysfunction
Clinical, Biological and Histological Pulmonary and Renal Damage Associated With the SARS-CoV-2 Syndrome in Patients Admitted in ICU

Study Overview
=================
Brief Summary
-----------------
Renal damage in patients hospitalized for ARDS in the ICU can also be related to multiple causes including, but not limited to, the consequences of hemodynamic fluctuations in these patients or the use of nephrotoxic drugs responsible for acute post-ischemic or toxic tubular necrosis. Frequently observed abnormalities of cioagumation may also have a potential impact on renal structures, particularly glomerular capillaries. The researchers wish to characterize and phenotype the renal impairment of patients hospitalized in intensive care with tables of severe Covid19 infections in ARDS: clinical, biological and histological (by performing post-mortem biopsies). Translated with www.DeepL.com/Translator (free version)

Official Title
-----------------
Characterization of the Clinical, Biological and Histological Pulmonary and Renal Damage Associated With the SARS-CoV-2 Syndrome in Patients Admitted in the Intensive Care Unit

Conditions
-----------------
Acute Respiratory Distress Syndrome

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients over 18 years of age Diagnosed Covid-19 by RT PCR Hospitalized in intensive care for management of complications related to Covid-19 from March 1, 2020 to April 20, 2020 Patient not having expressed his or her opposition, after information, to the re-use of his or her data for the purposes of this research. Exclusion Criteria: - Subject who expressed opposition to participating in the study

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Analysis of Clinical, Biological and Histological Pulmonary and Renal Impairment Related to SARS-CoV-2 |  | 1 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ICU, ARDS, Covid-19, SARS-CoV-2, Inflammatory cytokine, Sepsis, Tbular necrosis, Ischemia, Pulmonary damage, Renal damage, Kidney damage
Study to Evaluate Efficacy and Safety of IW-6118 in Patients Undergoing Third Molar Extraction

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the safety of IW-6118 when administered as a single oral dose to patients undergoing third molar extraction. Efficacy will be assessed in an exploratory manner.

Official Title
-----------------
A Phase 2, Single-center, Randomized, Double-blind, Placebo- and Active-controlled, Parallel-group Study of a Single Dose of IW-6118, in Patients Undergoing Third Molar Extraction

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Drug: IW-6118
* Drug: Matching Placebo
* Drug: Naproxen Sodium


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Between 18 and 30 years old at time of screening; BMI > 18.5 and < 30.0; In overall good health with no clinically-significant laboratory, ECG, or physical exam findings; Patient requires two ipsilateral third molar extractions of which one must be a full or partial bony mandibular impaction; Women of childbearing potential must have a negative pregnancy test and must agree to use double-barrier contraception; Other inclusion criteria per protocol. Exclusion Criteria: History of any clinically-significant medical condition; Previous usage of prescription, OTC, or investigational drugs as per protocol requirements; Inadequate levels of pain to be included in the study; Other exclusion criteria per protocol.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 30 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: IW-6118<br> | Drug: IW-6118<br>* Single dose<br>|
| Placebo Comparator: Placebo<br> | Drug: Matching Placebo<br>* Single dose of matching placebo for IW-6118 and/or matching placebo for naproxen sodium<br>|
| Active Comparator: Naproxen Sodium<br> | Drug: Naproxen Sodium<br>* Single dose<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety Assessments | Adverse events, vital signs, laboratory parameters, and ECGs will be assessed. | Duration of the Study | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Healthy subjects
Uterine Flora During Elective and Urgent Cesarean Sections

Study Overview
=================
Brief Summary
-----------------
Hypothesis: The bacterial flora of the uterus during elective Cesarean sections differs from the uterine flora during non-elective Cesarean sections. We want to study whether the uterine flora can predict post-cesarean febrile morbidity and endometritis.

Detailed Description
-----------------
Objective: To evaluate the uterine flora at the time of elective and non-elective cesarean sections and to study the relationship to the development of postpartum fever and/or endometritis. Methods: Eight-hundred women who will be delivered by cesarean section will be enrolled in this study. Cultures will be obtained during the surgery from the open uterine cavity after removal of the placenta. Data regarding postpartum morbidity would be collected.

Official Title
-----------------
Uterine Flora During Elective and Urgent Cesarean Sections and Its Relationship to Postpartum Complications.

Conditions
-----------------
Endometritis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Cesarean delivery Exclusion Criteria: Vaginal delivery

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1.<br>Elective Cesarean sections | |
| 2.<br>Non-elective cesarean section | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To compare bacteriological growth between elective and non-elective cesarean section |  | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To study the various bacteria growth in the uteri, and to compare type of bacteria to post-op morbidity |  | 5 years |
Sun Protection Factor Assay (SPF Assay 201/2016)

Study Overview
=================
Brief Summary
-----------------
To evaluate the Sun Protection Factor efficacy on human skin.

Official Title
-----------------
Sun Protection Factor (SPF) Assay: UVA Protection Factor Assay Minimal Persistent Pigment-Darkening Dose

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

Intervention / Treatment
-----------------
* Drug: BAY987516


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Fitzpatrick Skin Type l, ll and/or lll for UVB testing. Fitzpatrick Skin Type ll, lll and/or lV for UVA testing. Male and female. Aged between 18-70 years old. Good health as determined from the HRL SHF (Subject History Form). Signed and dated Informed Consent Form. Signed and dated HIPAA (Health Insurance Portability and Accountability Act) form. An unambiguous MED (Minimal Erythema Dose) or MPPD (Minimal Persistent Pigment Darkening Dose). Exclusion Criteria: Subjects on test at any other research laboratory or clinic. Known allergy or sensitivity to sunscreens, cosmetics and toiletries, topical drugs and/or ultraviolet light. Pre-existing dermatologic conditions which have been diagnoses by a medical professional (e.g. psoriasis, eczema, etc.) which would interfere with this study. Pre-existing other medical conditions (e.g. adult asthma, diabetes). Treatment with antihistamines or corticosteroids within one week prior to initiation of the test. Treatment with antibiotics within two weeks prior to initiation of the test. Chronic medication which could affect the results of the study. Known pregnant or nursing women.

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BAY987516<br>Each test site area is divided into test sub site areas that are approximately at least 0.5 cm*2. The application of test material is 2 mg/cm*2. Thus, each 50 cm*2 test site area of a subject requires 100 mg of a test material to obtain a standard 2 mg/cm*2 test application. | Drug: BAY987516<br>* Each 50 cm*2 test site area of a subject requires 100 mg of a test material to obtain a standard 2 mg/cm*2 test application. (Formulation Code: Z46-100)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Minimal Erythema Dose (MED) |  | Up to 15 minutes | 
| Minimal Persistent Pigment Darkening Dose (MPPD) |  | Up to 15 minutes |
The Pharmacokinetics Study of Concentrated Herbal Formula and Traditional Herbal Decoctions in Humans

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate the pharmacokinetics in humans of San Huang Xie Jin Tang (SHXJT) and evaluate the bioequivalence between herbal concentrate and traditional decoction.

Official Title
-----------------
Bioequivalence of Bioactive Markers Between Concentrated Herbal Formula and Traditional Herbal Decoctions in Humans

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Drug: San Huang Xie Jin Tang


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The volunteers about 6 8 persons should be aged from 20 to 35 years old with a body weight between 50 80 kg, no marriage and have a healthy body condition.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 35 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: San Huang Xie Jin Tang|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
-----------------
Pharmacokinetics, Bioavailability, Therapeutic Equivalency