linjc16/ctgov huggingface dataset:
Diagnosis of Cutaneous Leishmaniasis Using the CL-detect Rapid Test in Travelers and Migrants in Belgium

Study Overview
=================
Brief Summary
-----------------
Cutaneous Leishmaniasis (CL) is a neglected tropical disease which is increasingly seen in travelers and migrants evaluated in travel clinics of non-endemic countries. Various CL species are present in different parts of the world, and these different species vary in severity, prognosis and therapeutic approaches. At ITM, diagnosis of CL in suspected patients is done using a skin biopsy, analyzed by diagnostic PCR, and species typing PCR. This method is invasive, and diagnosis is often delayed for days to weeks. The new antigen-based CL Detect Rapid Test uses dental broach sampling and has results within 30 minutes. Dental broach samples left over from the Cl Detect Rapid test may still be used for PCR including species typing. How well the CL Detect Rapid Test performs in the varied population of a travel clinic and whether it is possible to use dental broach sampling for further PCR tests in this population needs to be evaluated The aim of this study is to study the performance of the CL Detect Rapid Test and whether dental broach sampling can replace skin biopsy for CL at ITM.

Official Title
-----------------
Diagnosis of Cutaneous Leishmaniasis Using the CL-detect Rapid Test in Travelers and Migrants in Belgium

Conditions
-----------------
Cutaneous Leishmaniases

Intervention / Treatment
-----------------
* Diagnostic Test: Dental Broach


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Skin biopsy for leishmania test requested by treating ITM clinician OR externally requested skin biopsy for Leishmania tested at ITM with an ITM consultation <7 days of the biopsy sample willing and able to provide consent/assent not on CL treatment
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| CL suspicion<br>Patients with skin lesions suspected to be cutaneous leishmaniasis | Diagnostic Test: Dental Broach<br>* Dental broach, RDT and PCR<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic accuracy of CL detect RDT | Against combined reference of microscopy and PCR using skin punch biopsy | 2019-2010 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of PCR positives on dental broach sample | Compared to PCR positives on skin punch biopsy | 2019-2020 | 
| Proportion of successful species typing on dental broach sample | Compared to successful species typing on skin punch biopsy sample | 2019-2020 |
A Double-Blind, Placebo-Controlled Study With Open-Label Follow-Up To Determine the Safety and Efficacy of Subcutaneous Doses of r-HuEPO in AIDS Patients With Anemia Induced by Their Disease and AZT Therapy

Study Overview
=================
Brief Summary
-----------------
To determine the safety and efficacy of erythropoietin administered subcutaneously to AIDS patients with anemia secondary to their disease and/or concomitant zidovudine (AZT) therapy. Efficacy will be assessed by correction of anemia and decrease in transfusion requirements.

Official Title
-----------------
A Double-Blind, Placebo-Controlled Study With Open-Label Follow-Up To Determine the Safety and Efficacy of Subcutaneous Doses of r-HuEPO in AIDS Patients With Anemia Induced by Their Disease and AZT Therapy

Conditions
-----------------
HIV Infections, Cytopenias

Intervention / Treatment
-----------------
* Drug: Epoetin alfa


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria Concurrent Medication: Allowed: Maintenance dose of zidovudine (AZT) of at least 400 mg daily. Exclusion Criteria Co-existing Condition: Patients with the following are excluded: History of any primary hematologic disease. Clinically significant disease / dysfunction of the pulmonary, cardiovascular, endocrine, neurologic, gastrointestinal, or genitourinary systems not attributable to underlying AIDS. AIDS-related dementia. Uncontrolled hypertension (diastolic blood pressure > 100 mmHg). Presence of concomitant iron deficiency. Anemia attributable to factors other than AIDS or zidovudine (AZT) therapy. Acute opportunistic infection. History of seizures. Patients with clinically significant disease / dysfunction of the pulmonary, cardiovascular, endocrine, neurologic, gastrointestinal, or genitourinary systems not attributable to underlying AIDS are excluded. Must not have previously participated in any other r-HuEPO clinical studies. Prior Medication: Excluded within 30 days of study entry: Experimental drug or experimental device. Cytotoxic chemotherapy. Excluded within 2 months of study entry: Androgen therapy. Clinical diagnosis of AIDS and related anemia. Clinical diagnosis of AIDS. Clinically stable for 1 month preceding study entry. Maintenance dose of zidovudine (AZT) of at least 400 mg daily. Substance abuse.

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
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Epoetin alfa|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
-----------------
Recombinant Proteins, Injections, Subcutaneous, Erythropoietin, Acquired Immunodeficiency Syndrome, Anemia, Zidovudine
Study Evaluating the Safety and Tolerability of SCA-136 in Healthy Japanese Male Subjects

Study Overview
=================
Brief Summary
-----------------
This study is being conducted to assess the safety and tolerability of ascending multiple oral doses of SCA-136 administered to healthy Japanese male subjects.

Official Title
-----------------
An Ascending Multiple Dose Study of the Safety, Pharmacokinetics, and Pharmacodynamics of SCA-136 Administered Orally to Healthy Japanese Male Subjects

Conditions
-----------------
Schizophrenia

Intervention / Treatment
-----------------
* Drug: SCA-136


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Healty Japanese men willing to use a medically acceptable form of contraception. Exclusion criteria: Any significant disease Positive urine drug screen Increased liver function tests Use of prescription drugs.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 45 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: SCA-136|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events, safety laboratory results, vital signs, and ECGs will be used to monitor subject safety. |  |  |
Endometrial Scratching Prior to Controlled Ovarian Stimulation (COH) in Women Undergoing In-vitro Fertilization With Previous IVF Failure

Study Overview
=================
Brief Summary
-----------------
Scratching the linning of the womb before IVF cycle could increase the chances of having a baby after an IVF cycle.

Detailed Description
-----------------
All women with history of RIF (as defined by ESHRE) and who wish to undertake another assisted conception treatment cycle are invited to participate in the trial. Women will be randomised to two arms; one undergoing endometrial sampling and control. Women in the experimental arm will be subjected to endometrial scrapping with Pipelle biopsy catheter two times; on days 21 and 26 of the cycle prior to the IVF index cycle and after initiation of the GnRHa in the long agonist protocol. Women in the control group will undergo a placebo procedure using the uterine sound on the same days of the cycle like women in the intervention group.

Official Title
-----------------
Endometrial Injury Prior to Controlled Ovarian Stimulation (COH) in Women Undergoing In-vitro Fertilization in Women With Previous IVF Failure.

Conditions
-----------------
Infertility

Intervention / Treatment
-----------------
* Procedure: scratching
* Procedure: A PLACEBO PROCEDURE


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: WOMEN WITH PREVIOUS IVF FAILURE UNDERGOING IVF TREATMENT - Exclusion Criteria: WOMEN>40 YEARS OLD WOMEN UNDERGOING THEIR FIRST IVF TREATMENT CYCLE

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

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: scratching<br>endometrial scratching prior ivf cycle | Procedure: scratching<br>* endometrial scratching before COH in IVF<br>Procedure: A PLACEBO PROCEDURE<br>* A PLACEBO PROCEDURE<br>|
| Placebo Comparator: PLACEBO<br>PLACEBO PROCEDURE | Procedure: A PLACEBO PROCEDURE<br>* A PLACEBO PROCEDURE<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| live birth rate per woman |  | 9 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ongoing pregnancy rate |  | 12 weeks |
A Phase I Study of ZD1839 and Palliative Thoracic Radiotherapy in Patients With Non-small-cell Lung Cancer

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to characterize the safety profile of ZD1839 in combination with Palliative thoracic Radiotherapy in patients with non-small cell lung cancer

Official Title
-----------------
A Phase I Study of ZD1839 (Iressa) and Palliative Thoracic Radiotherapy in Patients With Non-small Cell Lung Cancer

Conditions
-----------------
Non-small-cell Lung Cancer

Intervention / Treatment
-----------------
* Drug: Gefitinib
* Procedure: palliative thoracic radiotherapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Provision of written informed consent Patients requiring low dose palliative thoracic irradiation to a field size of less than or equal to 150cm2 Histologically or cytologically conformed non-small cell lung cancer Aged 18 or over Exclusion Criteria: Previous thoracic radiotherapy Any condition that may pre-dispose the patient to suffer an individual drug-relaged DLT (dose limiting toxicity) event Known hypersensitivity to any component of study medication

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: Gefitinib|nan|
|Procedure: palliative thoracic radiotherapy|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To characterize the safety profile of ZD 1839 in these patients |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To measure the quality of life compared to baseline |  |  | 
| To measure the change in disease related symptoms compared to baseline |  |  |
Monitoring of Needle-placement With Multiple Frequency Bioimpedance Monitoring

Study Overview
=================
Brief Summary
-----------------
A novel algorithm for bioimpedance measurements to detect nerve tissue, and discriminate it from other tissue types has been developed in a porcine model, by analysing a complex impedance dataset based on multiple measurement frequencies. It must now be confirm that the previous results are applicable in humans. Measurements from 24 predefined needle positions will be obtained in 16 of the 32 volunteers that are included in the study (part A). A new algorithm to detect nerve tissue will be developed based on these measurement results. Further impedance algorithms will be developed for other tissue type. The efficacy of the algorithms (sensitivity and specificity) will be evaluated in the 16 following volunteers (part B).

Official Title
-----------------
Monitoring of Needle-placement With Multiple Frequency Bioimpedance Monitoring

Conditions
-----------------
Electric Impedance, Human, Hypodermic Needles, Tissues, Nerve

Intervention / Treatment
-----------------
* Other: Needle placement in different tissue types


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age ≥ 18 years American society of anaesthesiologists score (ASA) 1 or 2 Volunteers that have given informed written consent Exclusion Criteria: Volunteers that cannot cooperate for the examination Volunteers with neurologic disease, nerve- or vascular impairment ASA > 2

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 |
| --- | --- |
| Needle placement in different tissue types<br>Needle placement and impedance measurements in different tissue types | Other: Needle placement in different tissue types<br>* Bioimpedance will be measured for needle positions in different tissue types<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Success in the identification of nerve tissue by the use of an algorithm based on a multiple frequency impedance measurement (MFIM) algorithm. The outcome is binary (success vs failure). |  | From day 1 up to 12 months |
Gammaglobulins Level is Predictive Factor of Evolution in Sarcoidosis

Study Overview
=================
Brief Summary
-----------------
Evaluation of the rate of achievement of serum protein electrophoresis (PPE) in diagnosis in a retrospective cohort of patients at Rennes University Hospital

Detailed Description
-----------------
In 50% of cases, sarcoidosis is associated with polyclonal hypergammaglobulinemia. The other forms have a normal gamma globulin level. The level of gamma globulinemia has not yet been studied as an evolutionary predictive factor. Furthermore, there are disseminated granulomatoses sharing common characteristics with sarcoidosis, associated with Common Variable Immunodeficiency deficit (DICV) type Primary Immunodeficiency syndrome (DIP), thus occurring in hypogammaglobulinemic patients.

Official Title
-----------------
Gammaglobulins Level is Predictive Factor of Evolution in Sarcoidosis

Conditions
-----------------
Sarcoidosis

Intervention / Treatment
-----------------
* Biological: Analysis of gamma globulin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Patients newly diagnosed with sarcoidosis Exclusion Criteria: Comorbidity responsible for a change in the level of gamma globulin Other etiology of granulomatosis
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: Analysis of gamma globulin|Electrophoresis of proteins|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Study of gamma globulin level present in the blood at the time of diagnosis of sarcoidosis on disease activity | Electrophoresis rates of serum proteins | Day 1 | 
| Study of gamma globulin level present in the blood at the time of diagnosis of sarcoidosis on the course of the disease | Electrophoresis rates of serum proteins | Day 1 |
A Double-Blind, Placebo-Controlled Study With Open-Label Follow-Up To Determine the Safety and Efficacy of r-HuEPO in AIDS and Advanced ARC Patients With Anemia

Study Overview
=================
Brief Summary
-----------------
To determine the safety and efficacy of r-HuEPO administration to patients with AIDS or advanced AIDS related complex (ARC) and anemia secondary to their disease.

Official Title
-----------------
A Double-Blind, Placebo-Controlled Study With Open-Label Follow-Up To Determine the Safety and Efficacy of r-HuEPO in AIDS and Advanced ARC Patients With Anemia

Conditions
-----------------
HIV Infections, Cytopenias

Intervention / Treatment
-----------------
* Drug: Epoetin alfa


Participation Criteria
=================
Eligibility Criteria
-----------------
Exclusion Criteria Co-existing Condition: Patients with the following are excluded: History of any primary hematologic disease. HIV disease related dementia. Uncontrolled hypertension (diastolic blood pressure > 100 mmHg). Presence of concomitant iron deficiency. Anemia attributable to factors other than HIV disease or zidovudine (AZT) therapy. Acute opportunistic infection. History of seizures. Clinically significant disease / dysfunction of the pulmonary, cardiovascular, endocrine, neurologic, gastrointestinal, or genitourinary systems not attributable to underlying HIV disease. Concurrent Medication: Excluded: Zidovudine (AZT) therapy during the double-blind phase of study. Patients with the following are excluded: History of any primary hematologic disease. Clinically significant disease / dysfunction of the pulmonary, cardiovascular, endocrine, neurologic, gastrointestinal, or genitourinary systems not attributable to underlying HIV disease. HIV disease related dementia. Uncontrolled hypertension (diastolic blood pressure > 100 mmHg). Presence of concomitant iron deficiency. Prior Medication: Excluded within 30 days of study entry: Experimental drug or experimental device. Cytotoxic chemotherapy. Excluded within 2 months of study entry: Androgen therapy. Zidovudine (AZT) therapy and during the double-blind phase. Clinical diagnosis with AIDS or AIDS related complex (ARC) and related anemia. Clinical diagnosis of AIDS or ARC. Clinically stable for 1 month preceding study entry. Patients should preferably be transfusion dependent. Substance abuse.

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
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Epoetin alfa|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
-----------------
Recombinant Proteins, Erythropoietin, Acquired Immunodeficiency Syndrome, Anemia, AIDS-Related Complex, Zidovudine
Dutch National Prospective EMR Cohort

Study Overview
=================
Brief Summary
-----------------
A Prospective Study: Longterm Follow Up until S2 (2nd surveillance) at 18 months after EMR for Large Flat/Sessile Colonic Polyps.

Official Title
-----------------
Dutch National Prospective EMR Cohort. Longterm Follow Up After EMR for Large Flat/Sessile Colonic Polyps, a Prospective Study.

Conditions
-----------------
Large Bowel Polyp

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Flat or sessile polyp morphology (Paris classification 0-IIa/b/c, Is) Polyp size >20 mm Therapy: EMR Age > 18 years old Written informed consent Exclusion Criteria: Participation in a competing study, such as the CLIPPER trial (registration number: NL62949.091.17).

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 |
| --- | --- | --- |
| Complications | Delayed bleeding, perforation and postpolypectomy syndrome | 30 days post EMR | 
| Recurrence | Pathological and endoscopical re-appearance of adenoma | 6 months (S1) and 18 months (S2) after EMR |