linjc16/ctgov huggingface dataset:
Efficacy and Safety of Probiotics in Neonatal Hyperbilirubinemia

Study Overview
=================
Brief Summary
-----------------
Neonatal Jaundice occurs in 60% of term infants and 80% of premature infants. Although it is transient, it is associated with high rate of readmission of patients in the first week of infancy. Neonatal jaundice can cause neurological complications and kernicterus. Considering the fact that there have been a lot of studies on probiotic role in management of necrotizing enterocolitis (NEC) and few studies on their role in neonatal jaundice, we carried out this study to determine the efficacy and safety of probiotics in neonatal hyperbilirubinemia in infants hospitalized in children hospital in Bandar Abbas.

Official Title
-----------------
Efficacy and Safety of Probiotics in Neonatal Hyperbilirubinemia

Conditions
-----------------
Hyperbilirubinemia, Neonatal

Intervention / Treatment
-----------------
* Drug: Probiotic


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Between 2 and 28 days old Having jaundice Gestational age between 35-42 weeks Exclusion Criteria: Less than 2 days or more than 28 days old Gestational age out of the range of 35-42 weeks Infants whose parents refused to cooperate Patients with sepsis and other comorbid conditions

Ages Eligible for Study
-----------------
Minimum Age: 2 Days
Maximum Age: 28 Days

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Probiotic<br>Routine phototherapy plus probiotic oral drops at the dose of 10 drops daily | Drug: Probiotic<br>* Probiotics drop<br>* Other names: PediLact;|
| No Intervention: No probiotic<br>Routine phototherapy | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of phototherapy | Duration of phototherapy | 6 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Discharge rate | percentage of infants discharged from the hospital at 2nd, 3rd, 4th, and 5th days of admission | 6 days |
The Relationship Between Psychological Factors and Bell's Palsy

Study Overview
=================
Brief Summary
-----------------
The aim of this study was to explore the risk factors for Bell's palsy (BP) and to examine whether psychological factors are the potential risk factors for the occurrence of BP.

Detailed Description
-----------------
We conducted a case-control, multi-center clinical investigation. A total of 695 subjects were assigned to the case group (n=355) and the control group (n=340). All the BP patients were enrolled from 11 State Hospitals in China, and all the controls were selected from the same district to match for the patients. The study was coordinated by a tertiary referral centre, Tongji Hospital. The House-Brackmann grading system and Facial Disability Index (FDI) was adopted to assess the BP patients. Kessler 10-Item Psychological Distress Scale（K10）was usde to explore the psychological distress, and the Cattell 16 Personality Factor (16PF) scale was employed to evaluate the personality profiles of all subjects.

Official Title
-----------------
Study of Psychological Factors on the Occurence of Bell's Palsy

Conditions
-----------------
Bell's Palsy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Patients who were diagnosed to have unilateral facial-nerve weakness without any identifiable causes within 168 hours after onset of symptoms; aged 18 to 65 years. Exclusion criteria： illiterate; the facial paralysis is caused by herpes zoster; recurrent facial paralysis; noticeable asymmetry of the face before the illness which may affect the evaluation; history of peptic ulcer disease, severe hypertension, uncontrolled diabetes, liver and kidney dysfunction, pregnancy, mental illness, or serious systemic diseases which may affect the treatment.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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 |
| --- | --- | --- |
| House-Brackmann scale (HBS) |  | within 168 hours after onset of symptoms | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Bell's palsy, psychological stress, personality factors, psychological factors
Efficacy and Safety Study of OSI-211 (Liposomal Lurtotecan) to Treat Recurrent Small Cell Lung Cancer

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether OSI-211 (Liposomal Lurtotecan) is an effective and safe treatment for patients with recurrent small cell lung cancer.

Official Title
-----------------
Phase II Study to Determine the Efficacy of OSI-211 (Liposomal Lurtotecan) Given on Days 1, 2 & 3 Every 3 Weeks in Patients With Recurrent Small Cell Lung Cancer

Conditions
-----------------
SCLC, Carcinoma, Small Cell

Intervention / Treatment
-----------------
* Drug: OSI-211 (Liposomal Lurtotecan)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Confirmed recurrent small cell lung cancer. One prior treatment of chemotherapy. At least three weeks since last chemotherapy treatment and recovery from any related side effects. At least three weeks since last chest radiotherapy and at least 10 days since head irradiation and recovery from acute side effects. At least one target tumor less than or equal to 20 mm (or less than or equal to 10 mm on spiral CT-scan). If a patient has had previous documented Central Nervous System (CNS) involvement, only controlled disease is acceptable. Exclusion Criteria: Superior vena cava syndrome.

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: OSI-211 (Liposomal Lurtotecan)|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
-----------------
Small Cell Lung Cancer
Safety and Feasibility of Autologous Endothelial Progenitor Cells Transplantation in Patients With Idiopathic Pulmonary Arterial Hypertension

Study Overview
=================
Brief Summary
-----------------
Recent researches indicate that impairment of vascular and endothelial homeostasis plays a major role in the initiation and development of IPAH.We have recently reported the safety and feasibility data for autologous endothelial progenitor cells (EPCs) injection in patients with IPAH. Yet many questions remain unanswered: what is the ideal quantity of EPCs for therapy, the duration of the therapeutic effect, and moreover, the potential toxicity of such therapy. To help answer these questions, we designed the one year follow-up to investigate the safety and efficacy of autologous EPCs injection in patients with IPAH.

Official Title
-----------------
One-Year Follow-Up of Autologous Endothelial Progenitor Cells Transplantation in Patients With Idiopathic Pulmonary Arterial Hypertension

Conditions
-----------------
Idiopathic Pulmonary Arterial Hypertension

Intervention / Treatment
-----------------
* Procedure: Transplantation of autologous endothelial progenitor cells


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The inclusion criteria included a base-line six minute walking distance between 100 and 450 m A resting mean pulmonary-artery pressure greater than 30 mm Hg A pulmonarycapillary wedge pressure of less than 15 mm Hg Pulmonary vascular resistance greater than 240 dyn•sec•cm-5 18-60 years old Exclusion Criteria: The exclusion criteria included secondary pulmonary hypertension as a result of heart disease Pulmonary disease Sleep-associated disorders Chronic thromboembolic disease Autoimmune or collagen vascular disease HIV infection Liver disease New York Heart Association functional class IV Major bleeding requiring blood transfusion Diabetes Renal dysfunction Evidence for malignant diseases were excluded

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

| Intervention/Treatment |
| --- |
|Procedure: Transplantation of autologous endothelial progenitor cells|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Management of Post-delivery Pain and Its Impact on Resumption of Sexuality

Study Overview
=================
Brief Summary
-----------------
Study of management of pain and information given to women post-delivery and their impact of the resumption of sexuality. Survey to be completed by women at 8 and 15 days and 1 or 3 months after delivery.

Official Title
-----------------
Management of Post-delivery Pain and Its Impact on Resumption of Sexuality

Conditions
-----------------
Sexuality, Delivery

Intervention / Treatment
-----------------
* Other: Survey


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Primiparous woman Age between 18 and 45 years old Delivery after 37 weeks of amenorrhea Speaking French Pregnancy, delivery and new-born examination without morphologic or biometric abnormalities, respiratory distress and no pathology discovered at neonatal screening on day 3 Heterosexual woman with partner Signed consent Affiliate of national health insurance scheme Exclusion Criteria: Multiple pregnancy, BMI > 30 Conjugopathie Known psychiatric history Medical history with gynecologic impact Surgery history with gynecologic impacts Hysterectomy post-delivery Protected by French law

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 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 |
| --- | --- |
| Women post-delivery<br> | Other: Survey<br>* Survey completed at 1 day, 8 days 1 or 3 months post delivery<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post-delivery sexuality resumption | Time to sexuality resumption | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Discussion with healthcare professional on post-delivery sexuality | Number of women receiving advice from a health professional | 1 month | 
| Pain post-delivery | Number of women needed pain treatment or with problem for sexuality resumption | 3 months | 
| Sexual health | Frequency of sex | 3 months |
A Randomised Study Comparing Tissue Conservation in Conventional Versus Mohs' Surgery of Basal Cell Carcinoma

Study Overview
=================
Brief Summary
-----------------
We have compared to types of surgery to assess which one leaves the smaller surgical defect.

Detailed Description
-----------------
Patients with a clinical diagnosis of a nodular basal cell carcinoma of less than 1 centimetre and 1 centimetre away from eyes, nose and ears were either randomized to undergo Mohs Micrographic Surgery or standard surgical excision. After the tumour had been removed the defect was measured.

Official Title
-----------------
A Randomised Study Comparing Tissue Conservation in Conventional Versus Mohs' Surgery of Basal Cell Carcinoma

Conditions
-----------------
Carcinoma, Basal Cell

Intervention / Treatment
-----------------
* Procedure: standard surgery
* Procedure: Mohs micrographic surgery


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects with a clinical diagnosis of a nodular basal cell carcinoma of less than 1 cm, 1 cm away from eye, nose or ears Exclusion Criteria: Subjects of less than 18 years of age Subjects unable to comply with instructions, Immunosuppressed subjects

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: standard surgery<br>basal cell carcinomas were excised with 4 mm margins | Procedure: standard surgery<br>* excision with 4 mm margins<br>|
| Active Comparator: Mohs<br>Basal cell carcinoma were removed via Mohs Micrographic surgery | Procedure: Mohs micrographic surgery<br>* excision of basal cell carcinoma with 2 mm margins and immediate examination of margins for residual tumour. residual tumour was excised until complete tumour removal was achieved.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| defect size after surgery |  | immediately after surgery |
A Trial for Patients With Gestational Trophoblastic Disease

Study Overview
=================
Brief Summary
-----------------
This phase II study is evaluating the activity of Pemetrexed in patients diagnosed with low risk Gestational Trophoblastic Tumor (GTT) that have failed prior treatment.

Official Title
-----------------
A Phase II Trial of Pemetrexed (Alimta) in the Treatment of Recurrent or Persistent Low Risk Gestational Trophoblastic Tumor

Conditions
-----------------
Trophoblastic Neoplasms, Uterine Neoplasms, Hydatidiform Mole, Choriocarcinoma

Intervention / Treatment
-----------------
* Drug: Pemetrexed


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Persistent or recurrent low risk Gestational Trophoblastic Tumor (GTT) WHO score 2-6 (re-evaluated at the time of relapse Histologically confirmed complete or partial moles on initial evacuation Patients with mild to moderate renal insufficiency should avoid taking NSAIDs with short elimination half-lives for a period of 2 days before, the day of, and 2 days following administration of pemetrexed. All patients taking NSAIDs with longer half-lives, should interrupt dosing for at least 5 days before, the day of, and 2 days following pemetrexed administration. Folic Acid (350-1000 micrograms) must be given daily beginning approximately 5-7 days prior to first dose of pemetrexed and continuing daily until 3 weeks after the last dose of study therapy. Vitamin B12 (1000 micrograms) will be administered as an intramuscular injection approximately 1 to 2 weeks prior to first dose of pemetrexed and repeated approximately every 9 weeks until 3 weeks after the last dose of study therapy. Exclusion Criteria: Previous treatment that included chemotherapy other than actinomycin -D or methotrexate (+/- folinic acid). Patients with more than 8 metastatic lesions identified Patients with metastases to liver, spleen, brain, kidney or GI tract
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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine the activity of Pemetrexed in failed low risk Gestational Trophoblastic Tumor (GTT) patients |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine the toxicity of Pemetrexed in failed low risk Gestational Trophoblastic Tumor (GTT) patients |  |  |
Device Study to Evaluate the Detection and Characterization of Middle Ear Fluid in Children

Study Overview
=================
Brief Summary
-----------------
The study has three objectives: To determine if the device can detect if middle ear fluid is present in children who are scheduled for tube placement (myringotomy) If fluid is present to characterize the fluid as thick or thin Evaluate the safety of the device

Official Title
-----------------
A Prospective, Multi Center, Non-randomized Clinical Trial to Evaluate the Ear Effusion Detection and Characterization System (EEDCS) to Detect and Characterize Middle Ear Fluid in Children

Conditions
-----------------
Otitis Media With Effusion, Middle Ear Effusion

Intervention / Treatment
-----------------
* Procedure: Myringotomy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 6 months to 17 years scheduled to undergo myringotomy procedure Exclusion Criteria: mastoiditis tympanostomy tubes chronic middle ear disease otitis externa perforations of the middle ear use of antibiotic ear drops within 2 days of surgery systemic antibiotic use

Ages Eligible for Study
-----------------
Minimum Age: 6 Months
Maximum Age: 17 Years

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

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

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

Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Myringotomy<br>On arm | Procedure: Myringotomy<br>* tube placement for children with multiple ear infections<br>* Other names: ear tubes;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| detection of middle ear fluid | device will be used during myringotomy procedure to detect middle ear fluid | day one | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| fluid viscosity | fluid obtained during myringotomy will be tested for viscosity | day one | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Otitis Media with Effusion, Middle Ear Effusion
Massive Burns: Retrospective Analysis of Changes in Outcomes Across 18 Years

Study Overview
=================
Brief Summary
-----------------
Burns treatment and management has evolved since the 90s, particularly for massive burns (≥ 50% of total body surface area (TBSA)). This study aims at analyzing the impact of the management changes on the length of intensive care unit (ICU) stay, the take of skin grafts and the mortality.

Detailed Description
-----------------
Review of all massively burned patients treated at Lausanne University Hospital burn intensive care unit (ca. 40-60 patients). Analysis of changes in length of intensive care unit stay (LICU), skin graft take rate or mortality between 2000 and 2018. Hypothesis : the optimization of resuscitation procedures and of nutrition therapy combined with the use of novel surgical techniques has brought a significant improvement in outcomes. Association between outcomes and year of admission will be assessed through correlation analysis and logistic regression analysis. Potential cofounders will be assessed through stepwise linear regression analysis

Official Title
-----------------
Massive Burns: Retrospective Analysis of Change in Outcomes Across 18 Years

Conditions
-----------------
Burns

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All adult patients (>18 years old) with burns ≥50% TBSA admitted in the burn intensive care unit (ICU) of the Lausanne University Hospital Exclusion Criteria: Patients admitted in the burn center ICU with another primary diagnosis than burn (e.g. necrotizing fasciitis, gangrene, toxic epidermal necrolysis) Patients referred from and/or to another ICU Patients in which active withdrawal of care was decided within 48h of admission Patients with first degree burns only

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- | --- |
| LICU/Percent TBSA | Ratio between the length of stay in the ICU and the total body surface area burned | 18 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent TBSA grafted/ Percent TBSA deep burns | Ratio between the TBSA grafted and the deep burns TBSA | 18 years | 
| Daily nutritional intakes | Daily energy, proteins, lipids and carbohydrates intakes per kilogram of body weight | 18 years | 
| Mortality | Percentage of patients who received maximal care and died nonetheless | 18 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Burn surgery, Massive burns, Intensive care unit, Burn infections, Skin grafts, Critical illness, Cultured epithelial autografts, Nutrition, Glucose