linjc16/ctgov huggingface dataset:
Growth and Tolerance of Cow Milk-Based Infant Formulas

Study Overview
=================
Brief Summary
-----------------
This clinical trial will assess growth, tolerance and adverse events of cow milk-based infant formulas in healthy, term infants.

Official Title
-----------------
Growth and Tolerance of Cow Milk-Based Infant Formulas

Conditions
-----------------
Body Weight

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Singleton, 12-16 days of age at randomization Term infant with birth weight of minimum of 2500 g Solely formula fed Signed Informed Consent and Protected Health Information Exclusion Criteria: History of underlying metabolic or chronic disease or immunocompromised Acute infection Feeding difficulties or formula intolerance

Ages Eligible for Study
-----------------
Minimum Age: 12 Days
Maximum Age: 16 Days

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 |
| --- | --- |
| Control<br> | |
| Experimental 1<br> | |
| Experimental 2<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body weight measured on calibrated infant scale at each study visit |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Twenty-four hour recall of infant formula intake at each study visit |  |  | 
| Medically-confirmed adverse events collected throughout the study period |  |  | 
| Twenty-four hour recall of stool characteristics (number and consistency) and tolerance at each study visit |  |  | 
| Parental Product Assessment Questionnaire completed at Study Visit 2 | Assessment of physical properties of product and infant's reaction during consumption. |  | 
| Body Length and Head Circumference measured at each study visit |  |  |
Evaluating the Safety and Efficacy of LIPO-202 for the Reduction of Central Abdominal Bulging Due to Subcutaneous Fat

Study Overview
=================
Brief Summary
-----------------
This is a multi-center, randomized, double-blinded, placebo-controlled study evaluating the safety and efficacy of LIPO-202 for the reduction of central abdominal bulging due to subcutaneous fat in non-obese subjects.

Official Title
-----------------
A Multi-Center, Randomized, Double-Blinded, Placebo-Controlled Study Evaluating the Safety and Efficacy of LIPO-202 for the Reduction of Central Abdominal Bulging Due to Subcutaneous Fat in Non-Obese Subjects

Conditions
-----------------
Central Abdominal Bulging

Intervention / Treatment
-----------------
* Drug: LIPO-202
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy male or non-pregnant female subjects Capable of providing written consent. BMI < 30 kg/m2 Stable diet and exercise routine Central abdominal bulging that is evaluated by the clinician at least slight bulge, not flat Exclusion Criteria: Have had any treatment of the fat around your abdomen, including surgical procedures (tummy tuck, liposuction), injections for fat loss or treatments with devices to reduce fat in your abdomen. Plan on starting a weight loss or exercise program during the study. Known hypersensitivity to study drugs

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: LIPO-202<br>Experimental arm | Drug: LIPO-202<br> <br> * Other names: Salmeterol;|
| Placebo Comparator: Placebo<br>Placebo comparator | Drug: Placebo<br> <br> * Other names: Placebo for LIPO-202;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety as measured by Physical examination, adverse events, vital signs, and laboratory tests. | Physical examination, adverse events, vital signs, and laboratory tests. | 8 weeks | 
| Change in the clinician reported photonumeric score |  | 8 weeks post the start of treatment | 
| Change in the patient reported global abdominal perception score |  | 8 weeks post the start of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in waist circumference |  | 8 weeks post the start of treatment |
Elsamitrucin (SPI 28090) for Relapsed or Refractory Non-Hodgkin's Lymphoma

Study Overview
=================
Brief Summary
-----------------
To determine the safety and efficacy of elsamitrucin in patients with relapsed or refractory non-Hodgkin's lymphoma (NHL). To determine if elsamitrucin is efficacious in a particular pathologic NHL subtype(s).

Official Title
-----------------
A Multi-Center, Open-Label, Non-Randomized Phase II Study of Elsamitrucin (SPI 28090) In Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma

Conditions
-----------------
Mantle Cell Lymphoma, Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

Intervention / Treatment
-----------------
* Drug: Elsamitrucin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Relapsed or Refractory mantle cell lymphoma and/or CLL/SLL except Burkitt's, Burkitt's like or HIV-associated lymphoma at least one prior cytotoxic chemotherapy regimens measurable disease adequate bone marrow, liver and kidney function ECOG PS 0-2 Exclusion Criteria: prior treatment with elsamitrucin prior chemo, antibody or radiotherapy for NHL within 28 days prior to start to treatment HIV positive or known AIDS syndrome uncontrolled medical disease or psychiatric condition/s

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: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Photon/Proton Radiation Therapy for Oropharyngeal Cancers

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to collect information from the questionnaire and medical records to see what effects proton radiation has on cancer and collect and analyze morbidity outcomes: incidence of xerostomia (dry mouth) and tumor control.

Detailed Description
-----------------
This is an outcomes study and is designed to collect information from the questionnaire and medical records to see what effects proton radiation has on cancer and collect and analyze morbidity outcomes: incidence of xerostomia (dry mouth) and tumor control.

Official Title
-----------------
A Clinical Outcomes Protocol of Photon/Proton Beam Radiation Therapy for Oropharyngeal Cancers

Conditions
-----------------
Oropharyngeal Cancers

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Biopsy-proven squamous cell carcinoma of oropharynx (tonsillar pillars, tonsillar fossa, soft palate, base of tongue). Stage-grouping: Stage I (T1N0) Stage II (T2N0) Favorable Stage III (T1N1/T2N1) and selected stage IV (T1-T2 early N2b)2 or less lymph node and 2 or less cm diameter lymph node Unfavorable stage III and selected stage IV (any T, N2c/N3) Surgery of the primary tumor/lymph nodes is limited to incisional/excisional biopsies. Will receive treatment with proton radiation. Exclusion Criteria: Evidence of distant metastasis. Previous irradiation for head and neck cancer.

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Photon/Proton Radiation Therapy<br>Data collection will be obtained from the patient's medical records including initial evaluation, pathology report, dosimetry information, radiotherapy completion records and follow-up. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Collect and analyze morbidity outcomes: incidence of xerostomia |  | From date of registration until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Collect and analyze tumor control outcomes. |  | From date of registration until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Oropharyngeal, cancer, proton, radiation, outcomes
China PEACE 5r-HF Study

Study Overview
=================
Brief Summary
-----------------
This study will use a two-stage random sampling design to create a nationally representative sample of patients with heart failure (HF) in China. The investigators sought to describe the clinical profiles, to assess treatment patterns and in-hospital outcomes for HF, and to identify targets for care quality improvement.

Detailed Description
-----------------
This study will use a two-stage random sampling design to create a nationally representative sample in China, and randomly sample patients with HF as a primary diagnosis, and were admitted to hospital from January 1st, 2015 to December 31st, 2015. The sample size is estimated to be 10,000. The investigators will collect photocopies of the sampled medical records and centrally abstract detailed information, which included demographic characteristics, medical history, clinical features, diagnostic tests, in-hospital procedures, lab tests, treatments, and in-hospital outcomes. Data abstraction quality was monitored by random auditing of 5% of the medical records, with overall variable accuracy exceeding 98%. Analyses will examine patient characteristics, diagnostic testing patterns, in-hospital treatments, in-hospital outcomes, and variation in results across regions and hospitals. Practical guidelines, quality evaluative system, and risk model will be established based on the findings, to improve patient outcomes for HF in the future.

Official Title
-----------------
China Patient-centered Evaluative Assessment of Cardiac Events (PEACE): Retrospective Study of Patients With Heart Failure (HF)

Conditions
-----------------
Heart Failure

Intervention / Treatment
-----------------
* Other: Observational study


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with heart failure as the primary reason for hospitalization, including both new-onset HF or decompensation of chronic HF。 Hospitalized during January 1st, 2015 to December 31st, 2015 Aged 18 years or above Exclusion Criteria: None

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 |
| --- |
|Other: Observational study|This is a non-interventional study, patients receive their usual treatment as determined by the physician.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Death |  | Duration of hospitalization, an average of 10 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
heart failure, retrospective
Effect of Bifidobacterium on Irritable Bowel Syndrome

Study Overview
=================
Brief Summary
-----------------
There has been no data on effect of Bifidobacterium breve on symptoms of patients with irritable bowel syndrome (IBS). We hypothesized that Bifidobacterium breve is effective on symptoms of IBS patients.

Detailed Description
-----------------
There has been no data on effect of Bifidobacterium breve on symptoms of patients with irritable bowel syndrome (IBS). We hypothesized that Bifidobacterium breve is effective on symptoms of IBS patients. IBS patients will be enrolled via advertisement. Any IBS subtypes will not be rejected. They will take either 1.0 g of Bifidobacterium breve 3 times a day or same amount of placebo for 8 weeks. IBS symptoms and allied markers will be checked before, during, and after the administration.

Official Title
-----------------
Effect of Bifidobacterium on Irritable Bowel Syndrome

Conditions
-----------------
Irritable Bowel Syndrome

Intervention / Treatment
-----------------
* Drug: Bifidobacterium breve
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of IBS with Rome II definition Exclusion Criteria: Diagnosis of serious diseases (both physically and mentally)

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: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br>Bifidobacterium breve | Drug: Bifidobacterium breve<br>* 1.0 g of Bifidobacterium breve, taking orally, 3 times a day for 8 weeks.<br>|
| Placebo Comparator: B<br>Placebo | Drug: Placebo<br>* 1.0 g of placebo, taking orally, 3 times a day for 8 weeks.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adequate relief and SIBSQ |  | 2, 0, 2, 4, 8 weeks during treatment and 4 weeks after treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Psychometric test, bowel gas, blood, and feces. |  | 2, 0, 2, 4, 8 weeks during treatment and 4 weeks after treatment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
stress, brain-gut interactions, visceral perception, gastrointestinal motility, emotion
Inhaled Sedation Using the Anesthetic-conserving Device ( ANACONDA) in Prehospital Emergency Medecine.

Study Overview
=================
Brief Summary
-----------------
Achieving the optimal sedation level for patient management is not always possible using our standard intravenous medications in Pre-hospital Emergency medicine. Inhaled sedation is possible with the Anesthetic-conserving device with a standard respirator. The pharmacodynamics and pharmacokinetics of halogenated agents allow deep sedation quickly after absorption. The feasibility of inhaled sedation has never been studied in hospital.

Detailed Description
-----------------
Retrospecive clinical monocentric study with sedated ventilated patients with isoflurane with the AnaConda® system out of hospital.

Official Title
-----------------
Feasibility of Isoflurane Sedation Using an Anesthetic-conserving Device in Prehospital Emergency Medicine: A Retrospective Study

Conditions
-----------------
Endotracheal Intubation, Deep Sedation

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient sedated by isoflurane with Anesthetic-conserving device in pre-hospital Major patient not opposed to participating Exclusion Criteria: Adults Under legal protection patient refusal to participate in study

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| depth of sedation | depth of sedation (measured by the Ramsay Score) 10 minutes from start of the sedation and at stop of pre hospital sedation. The Ramsay score ranges level of sedation from 1(patient anxious ,agitated,restless) to 6 (patient exhibits no response). | up to 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| hemodynamic tolerance of patients during isoflurane sedation | comparison of heart rate (heart beats per minute) before isoflurane start and 10 minutes from start of the sedation and at stop of pre hospital sedation | up to 1 day | 
| hemodynamic tolerance of patients during isoflurane sedation | comparison of medium blood pressure (mmHg) before isoflurane start and 10 minutes from start of the sedation and at stop of pre hospital sedation | up to 1day |
A Multi-Omics Study of Vasospastic Angina

Study Overview
=================
Brief Summary
-----------------
This is a observational study to identify the key factor associated with vasospastic angina and to explore the prognosis of the participants. The study will recruit 400 patients with vasospastic angina, 400 healthy controls and 400 patients with acute myocardial infarction. Next generation sequencing, metabolome and proteomics will be performed in these participants.

Official Title
-----------------
Identification of the Key Factors Increasing the Risk of Vasospastic Angina Based on Multi-omics.

Conditions
-----------------
Vasospastic Angina

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years of age or older diagnosed as vasospastic angina Exclusion Criteria: participate in any drug clinical trials within 3 months patients with life-threatening complications, or the researchers determined that the survival time of patients with no more than 1 years serious neurological disease (Alzheimer's disease, Parkinson syndrome, progressive lower limbs or deaf patients) previous history of cancer or tumor, or pathological examination confirmed precancerous lesions (such as breast ductal carcinoma in situ, or atypical hyperplasia of the cervix)

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with acute myocardial infarction<br>Patients with acute myocardial infarction | |
| Healthy controls<br>Healthy controls | |
| Patients with vasospastic angina<br>Patients with vasospastic angina | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiovascular Death | Death from cardiovascular causes and any unknown death unless there was another certain cause | up to 48 months | 
| Stroke | A rapid onset of a new focal loss of neurologic function caused by an ischemic central nervous system event with residual symptoms lasting at least 24 hours from their onset or leading to death | up to 48 months | 
| Myocardial Infarction | The definition of myocardial infarction was consistent with the Third Universal Definition of Myocardial Infarction. | up to 48 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrent angina | Recurrent angina | up to 48 months | 
| Rehospitalization due to cardiovascular causes | Rehospitalization due to cardiovascular causes | up to 48 months |
Pharmacokinetics of Insulin Detemir in Healthy Volunteers From Taiwan

Study Overview
=================
Brief Summary
-----------------
This trial is conducted in Asia. The aim of this trial is to investigate pharmacokinetics of insulin detemir in healthy Taiwanese subjects.

Official Title
-----------------
A Single Centre, Open-labelled Trial to Investigate the Pharmacokinetics of Insulin Detemir in Healthy Taiwanese Subjects

Conditions
-----------------
Diabetes, Healthy

Intervention / Treatment
-----------------
* Drug: insulin detemir


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Considered generally healthy upon completion of medical history and physical examination as judged by the investigator Body mass index (BMI) between 18 and 27 kg/m^2, inclusive Fasting plasma glucose maximum 6.1 mmol/l Non-smoker or smoking maximum 5 cigarettes per day or the equivalent Exclusion Criteria: Participation in any other clinical trial involving other investigational products within the last 3 months Subject with a history of alcohol or drug dependence Subject with a first-degree relative with diabetes mellitus

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 Years

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

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: Insulin detemir<br> | Drug: insulin detemir<br>* Single dose, 0.5 U/kg, administered s.c. (under the skin)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the insulin detemir concentration curve |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum insulin detemir concentration |  |  | 
| Time to maximum insulin detemir concentration |  |  | 
| The mean residence time of insulin detemir |  |  | 
| Insulin detemir half-life |  |  |