linjc16/ctgov huggingface dataset:
Longitudinal Evaluation of Microbial and Host Signatures During Immunotherapy for Lung Cancer

Study Overview
=================
Brief Summary
-----------------
This study will prospectively collect airway, stool, and blood samples on 80 subjects with lung cancer undergoing immunotherapy. Investigators will evaluate airway/stool microbial signatures associated with local (lower airway) and systemic (blood) immune tone.They will then study whether microbiota and/or host signatures predict subjects' response by longitudinal assessment of the progression free survival. They will also repeat sampling after 8 weeks of immunotherapy to expand our mechanistic understanding of the response to treatment.

Official Title
-----------------
Longitudinal Evaluation of Microbial and Host Signatures During Immunotherapy for Lung Cancer

Conditions
-----------------
Lung Cancer

Intervention / Treatment
-----------------
* Other: Bronchoscopy
* Other: Research Procedures


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients with a diagnosis of advanced stage unresectable Non-Small Cell Lung Cancer and indication for PD-1 blockade treatment (either as monotherapy or combined with chemotherapy) Exclusion Criteria: Antibiotic, steroid, or chemotherapy received within the prior month since these are possible confounders that may impact the microbiome and the host immunity. Brain metastasis (as evaluated by MRI obtained as part of standard of care staging evaluation) FEV1<50% predicted Cardiovascular disease (defined as abnormal EKG, known or suspected coronary artery disease or congestive heart failure) Renal disease Coagulopathy Liver disease

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 100 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 |
| --- | --- |
| Advanced stage unresectable Non-Small Cell Lung Cancer<br>Adult patients with a diagnosis of advanced stage unresectable Non-Small Cell Lung Cancer and indication for PD-1 blockade treatment (either as monotherapy or combined with chemotherapy) | Other: Bronchoscopy<br>* The patient will then return within a week for a research bronchoscopy to sample the upper and lower airways<br>Other: Research Procedures<br>* electrocardiogram, blood work (CBC, chemistry, coagulation profile and liver function tests, pregnancy test if applicable), X-ray and pulmonary function (spirometry) testing, and provide the patient with a stool collection kit.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free survival (PFS) | over ≥ 1-year follow-up | 3 Years | 
| Microbiota signatures in lower and upper airways |  | 3 Years | 
| Microbiota signatures in stool |  | 3 Years |
Active Screening of Latent TB Infection, Treatment and Long Term Follow-up in Prison

Study Overview
=================
Brief Summary
-----------------
LTBI Treatment is effective in prison

Detailed Description
-----------------
LTBI treatment will be conducted in a prison with either isoniazid or rifampin

Official Title
-----------------
Active Screening of Latent TB Infection, Treatment and Long Term Follow-up in Prison

Conditions
-----------------
Tuberculosis

Intervention / Treatment
-----------------
* Drug: isoniazid , randomized, open label
* Drug: rifampin, randomized, open label


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: all people who is LTBI, and have ability to sign the informed concent Exclusion Criteria: previously adverse effect from anti-TB medication complete treatment of TB in the pass; active TB AST, ALT > 3 times of normal limit platelet < 150 k/mm3 T-bil > 2 times of normal limit
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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: 2<br>For patients who diagnosed with LTBI, they choose to receive LTBI treatment depends on their willingness; if they choose not, then they are in no intervention arm. | |
| Experimental: 1<br>Provided INH 6m or RMP 4 m; whether enter treatment arm is determined by patient's willingness | Drug: isoniazid , randomized, open label<br>* isoniazid 300mg/tab 1 tab qd, 6 months (the other treatment arm is rifampin)<br>Drug: rifampin, randomized, open label<br>* rifampin 300mg/capsule 2 caps qd, 4 months (the other treatment arm is isoniazid)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| COMPLETE RATE OF LTBI TREATMENT |  | 1.5 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy |  | 3 year |
Comparison of Self-Fixating vs Non-Fixating Hernia Mesh

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine if self-fixating polyester mesh will have lower incidence of chronic postoperative pain and recurrence than non-fixating polyester mesh when used for laparoscopic inguinal hernia repair.

Detailed Description
-----------------
This is a randomized, blinded comparison of self-gripping mesh and standard polyester mesh for laparoscopic, primary inguinal hernia repair performed in a Totally ExtraPeritoneal (TEP) fashion.

Official Title
-----------------
A Randomized Controlled Study of Self Fixating Mesh Versus Non Fixating Polyester Mesh for Laparoscopic Inguinal Hernia Repair

Conditions
-----------------
Inguinal Hernia

Intervention / Treatment
-----------------
* Procedure: Use of self-fixating mesh for inguinal hernia repair
* Procedure: Use of non-fixating mesh for inguinal hernia repair
* Procedure: Absorbable tacks may be used in hernias >2cm


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: > 18 years ASA Classification I, II, III scheduled for elective TEP inguinal hernia repair Exclusion Criteria: ASA Classification IV or greater needing emergency surgery known history of narcotic dependence undergoing bilateral inguinal or combined umbilical hernia repair undergoing other procedures during same anesthetic undergoing recurrent inguinal hernia repair

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Self-Fixating Hernia Mesh<br>Self-fixating polyester mesh will be used for laparoscopic inguinal hernia repair. | Procedure: Use of self-fixating mesh for inguinal hernia repair<br>* Parietex ProGrip will be used to repair inguinal hernia<br>* Other names: Parietex ProGrip;Procedure: Absorbable tacks may be used in hernias >2cm<br>* Patients randomized to the Parietex ProGrip study group will be further randomized to either receive absorbable tacks or no tacks if the hernia measures >2cm<br>|
| Placebo Comparator: Non-Fixating Hernia Mesh<br>Non-fixating polyester mesh will be used for laparoscopic hernia repair. | Procedure: Use of non-fixating mesh for inguinal hernia repair<br>* Parietex Anatomic mesh will be used to repair inguinal hernias.<br>* Other names: Parietex Anatomic;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Chronic postoperative pain |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of hernia recurrence |  | 1 year |
The Influence of Lidocaine Volume on Discomfort During Administration of Local Anesthetic

Study Overview
=================
Brief Summary
-----------------
The aim of the study is to find a simple method for pain reduction that can be used in clinical practice when administering digital nerve block with a single subcutaneous injection. It will be investigated whether a smaller volume of lidocaine can decrease pain during injection.

Detailed Description
-----------------
Healthy volunteers will receive a single subcutaneous injection digital nerve block at the base of each ring finger. 2ml 1% lidocaine in one of the fingers, and 1 ml 2% lidocaine in the other. After each injection, the subject will be asked to evaluate the pain on a visual analog scale (0-100 mm). Additionally the sensibility will be tested with a Semmes-Weinstein monofilament, to evaluate if the different methods achieve desired anesthetic effect.

Official Title
-----------------
The Influence of Lidocaine Volume on Discomfort During Administration of Local Anesthetic

Conditions
-----------------
Needlestick Injuries

Intervention / Treatment
-----------------
* Procedure: 2 ml 1% Lidocaine
* Procedure: 1 ml 2% Lidocaine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age 18 - 65 Exclusion Criteria: regular use of analgesics known hypersensitivity of local anaesthetic renal-, heart- or liver disease known peripheral neuropathy or diabetes mellitus local infection on injection site circulation disorders in upper extremities (e.g. Raynaud´s phenomenon)

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 2 milliliter lidocaine<br>2 ml 1% Lidocaine in one ring finger, 1 ml 2% Lidocaine in the other ring finger | Procedure: 2 ml 1% Lidocaine<br> <br> |
| Experimental: 1 milliliter lidocaine<br>1 ml 1% Lidocaine in one ring finger, 2 ml 2% Lidocaine in the other ring finger | Procedure: 1 ml 2% Lidocaine<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pain | visual analog scale 0-100mm questionnaire | 60 seconds | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Injections, Lidocaine, Pain, Healthy volunteers
Special Drug Use Investigation for VALTREX (Valaciclovir) (Suppression Prophylaxis)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to collect and assess information on proper use of valaciclovir regarding safety and efficacy of long-term use in suppressive therapy for subjects with recurrent genital herpes.

Official Title
-----------------
Special Drug Use Investigation for VALTREX (Valaciclovir) (Suppression Prophylaxis)

Conditions
-----------------
Genital Herpes

Intervention / Treatment
-----------------
* Drug: Valaciclovir Hydrochloride.


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects who started suppressive therapy for recurrent genital herpes for the first time Exclusion Criteria: Subjects with a history of hypersensitivity to the ingredients of VALTREX or aciclovir
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Subjects with recurrent genital herpes<br> | Drug: Valaciclovir Hydrochloride.<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The number of adverse events in Japanese subjects with recurrent genital herpes treated with valaciclovir |  | 1 year |
WOODCAST Hand Resting Splint - Study of User Experience

Study Overview
=================
Brief Summary
-----------------
The aim of the study is to collect comments form users of new type of hand resting splint.

Detailed Description
-----------------
An ecologically friendly and biodegradable wood-plastic composite cast (WOODCAST) is used as a hand resting splint in this study.

Official Title
-----------------
User Experience From WOODCAST 2mm Hand Resting Splint

Conditions
-----------------
Patient Satisfaction

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patient treatment involves hand resting splint; age of patient 18 - 90 years; skills with language Finnish language (written and spoken) Exclusion Criteria: decreased co-operation of the patient; patient with multiple illnesses; malignancy; an illness affecting the general health.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 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 |
| --- | --- |
| hand resting splint<br>Patients with hand resting splint treatment | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| User satisfaction | After using hand resting splint for two weeks, patient will fill a questionaire. In the questionaire patient is asked to assess the used splint (e.g. functional performance, visual appearance), by giving points (from 1 to 10 points). Patient will use two splints from different materials during the treatment (both of the splint will be assessed by the patient). | 2-4 weeks |
First Trimester of Pregnancy: Impact of a History of Miscarriage on Women's Stress

Study Overview
=================
Brief Summary
-----------------
Miscarriage is the spontaneous termination of pregnancy before 22 weeks of amenorrhea. The most frequent complication of pregnancy, it represents 10 to 25% of pregnancies and affects one in four women. Miscarriage is considered by medical personnel to be common and trivial. however, for women, it is very often a traumatic event, a source of worry for futures pregnancies.

Detailed Description
-----------------
The aim of the study is to evaluate association between history of spontaneous termination of pregnancy and women's stress during the first trimester of pregnancy.

Official Title
-----------------
First Trimester of Pregnancy: Impact of a History of Miscarriage on Women's Stress

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

Intervention / Treatment
-----------------
* Other: Data collection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: female pregnant (positive plasma HCG) in the first trimester of pregnancy aged 18 years old and more agreeing to participate in the study Exclusion Criteria: - less than 18 years old

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| with history of spontaneous termination of pregnancy group<br>pregnant women in the first trimester of pregnancy with history of spontaneous termination of pregnancy | Other: Data collection<br>* evaluation of women's stress<br>|
| without history of spontaneous termination of pregnancy group<br>pregnant women in the first trimester of pregnancy without history of spontaneous termination of pregnancy | Other: Data collection<br>* evaluation of women's stress<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Women's stress | Women's stress evaluated using Antenatal Perceived Stress Inventory (APSI). APSI includes 12 items on medico-obstetric risks and baby's health (4 items), psychosocial changes related to pregnancy (3 items) and childbirth projections (5 items). Each item is coded from 1 to 5 points: not at all stressed, a little stressed, moderately stressed, very stressed and enormously stressed. The overall score ranges from 12 to 60 points. | Day 0 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
pregnancy, women's stress, history of spontaneous termination of pregnancy
Study of Bile Acids in Patients With Peroxisomal Disorders

Study Overview
=================
Brief Summary
-----------------
OBJECTIVES: I. Determine the effectiveness of oral bile acid therapy with cholic acid, chenodeoxycholic acid, and ursodeoxycholic acid in patients with peroxisomal disorders involving impaired primary bile acid synthesis. II. Determine whether suppression of synthesis of atypical bile acids and enrichment of bile acid pool with this regimen is effective in treating this patient population and improving quality of life.

Detailed Description
-----------------
PROTOCOL OUTLINE: Patients receive oral cholic acid and oral chenodeoxycholic acid on day 1. On day 4, patients receive oral cholic and ursodeoxycholic acids. Patients are assessed at 3 and 6 months for liver function response, neurologic status, and nutritional status. Patients receive treatment until disease progression or unacceptable toxic effects are observed. Completion date provided represents the completion date of the grant per OOPD records

Conditions
-----------------
Infantile Refsum's Disease, Zellweger Syndrome, Bifunctional Enzyme Deficiency, Adrenoleukodystrophy

Intervention / Treatment
-----------------
* Drug: chenodeoxycholic acid
* Drug: cholic acid
* Drug: ursodiol


Participation Criteria
=================
Eligibility Criteria
-----------------
Biochemically proven peroxisomal disorder, including: Zellweger syndrome Pseudo-Zellweger syndrome Neonatal adrenoleukodystrophy Bifunctional enzyme deficiency Infantile Refsum's disease

Ages Eligible for Study
-----------------
Maximum Age: 5 Years

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

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

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

Design Details

Primary Purpose: Treatment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: chenodeoxycholic acid|nan|
|Drug: cholic acid|nan|
|Drug: ursodiol|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
-----------------
Zellweger syndrome, adrenoleukodystrophy, bifunctional enzyme deficiency, inborn errors of metabolism, infantile Refsum's disease, peroxisomal disorders, pseudo-Zellweger syndrome, rare disease, sphingolipidoses
Aggressiveness of Care at the End of Life in Cancer Patients

Study Overview
=================
Brief Summary
-----------------
Cancer is the commonest cause of death in Singapore, and many cancer deaths occur in hospital. Management of cancer patients is getting more complex with constant development of new drugs, interventional procedures and supportive measures. Despite this, the majority of advanced cancer patients will die from their disease or related complications. There is a lack of data on the utilisation of health resources in advanced cancer patients in this country. In this study the investigators ask themselves how aggressive care was in the last 3 months of the patient's life. The investigators will be collecting data on specific cancer treatments, interventional procedures, and supportive measures.

Official Title
-----------------
Aggressiveness of Care at the End of Life in Cancer Patients

Conditions
-----------------
Advanced Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Advanced cancer patients who passed away as an inpatient in NUH, under the department of Haematology Oncology. Exclusion Criteria: Patients with haematologic malignancies.
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 |
| --- | --- | --- |
| To describe the trends in the aggressiveness of care for advanced cancer patients near the end of life. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Advanced cancer patients dying in hospital receive aggressive cancer-specific therapy and supportive measures.