linjc16/ctgov huggingface dataset:
Clonal Mast Cell Disorders in Exercise-Induced Anaphylaxis

Study Overview
=================
Brief Summary
-----------------
Anaphylaxis is a serious allergic reaction that develops rapidly and can cause death. Some patients experience anaphylaxis is association with exercise, a disorder called exercise-induced anaphylaxis. A subset of patients with unexplained anaphylaxis, especially those with hypotension during the anaphylactic episodes, have been shown to have abnormal, clonal populations of a certain cell type, mast cells, in the bone marrow. This has been described in at least one patient with exercise-induced anaphylaxis. The investigators would like review the findings in a group of patients with exercise-induced anaphylaxis who have undergone evaluation for the presence of abnormal, clonal mast cells.

Official Title
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Detection of Clonal Mast Cell Disorders Among Patients With Exercise-induced Anaphylaxis

Conditions
-----------------
Anaphylaxis

Participation Criteria
=================
Eligibility Criteria
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Inclusion Criteria: Anaphylaxis in association with exercise on at least two occasions During anaphylactic reaction, the subject must have experienced one or more of the following: flushing, hypotension, lack of urticaria Exclusion Criteria: Pregnancy

Ages Eligible for Study
-----------------
Minimum Age: 21 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 |
| --- | --- | --- |
| Number of participants with presence of clonal abnormalities in the bone marrow specimen | Presence of clonal mast cells in bone marrow as assessed by D816V c-kit mutation or CD25 will be recorded for each participant. | Baseline | 
| Number of participants with presence of clonal abnormalities in the bone marrow specimen | Presence of clonal mast cells in bone marrow as assessed by D816V c-kit mutation or CD25 will be recorded for each participant. The data will be reported as the number of participant with exercise induced anaphylaxis carrying these clonal mast cells in this observational study. Presence of mast cells will be correlated with clinical parameters such as symptoms experienced during anapylaxis. | Baseline | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
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clonal mast cell disorder, exercise-induced anaphylaxis, hypotension
Soft Tissue Tenderness and Fibromyalgia Among Schizophrenia Patients.

Study Overview
=================
Brief Summary
-----------------
Numerous studies reported on comorbidity of fibromyalgia and psychiatric disorders. Approximately 30% of patients with fibromyalgia have major depression at the time of diagnosis; the lifetime prevalence of depression is 74% and that of an anxiety disorder is 60%. In some fibromyalgia patients, mood and cognitive problems are much more prominent than tenderness. From the psychiatric point of view, 49% of PTSD patients and 5% of major depression patients fulfill criteria for diagnosing fibromyalgia. The association between schizophrenia and fibromyalgia is still unknown. Study hypothesis Schizophrenia patients, who have an aberrant sensation of pain, have lower prevalence of FM compared to the general population. Primary objectives Demonstrate that schizophrenia patients have lower prevalence of FM, compared to the general population. To compare the self-reported extent and intensity of pain with selected tender points examination.

Official Title
-----------------
Soft Tissue Tenderness and Fibromyalgia Among Schizophrenia Patients.

Conditions
-----------------
Fibromyalgia, Schizophrenia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women above 18 years of age. Patients must meet DSM-5 criteria for a diagnosis of schizophrenia. A stabled mental state. If hospitalized, patients are scheduled for discharge on the basis of clinical assessment of psychiatric symptoms. Exclusion Criteria: Mental co-morbidity. Diagnosis of myofascial pain syndrome or chronic fatigue syndrome. Alcohol or drug use. Usage of any pain reliever medications during the week before recruitment.

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 |
| --- | --- | --- |
| To compare the self-reported extent by questionnarie and intensity of pain with selected tender points examination. | To compare the self-reported extent and intensity of pain with selected tender points examination. | 1 day | 
| To compare between the degrees in pain recognition in schizophrenia patients who suffer from fibromyalgia to pain recognition in schizophrenia patients who do not suffer from fibromyalgia. | To compare between the degrees in pain recognition in schizophrenia patients who suffer from fibromyalgia to pain recognition in schizophrenia patients who do not suffer from fibromyalgia. | 1 day |
An Exploratory Study of NBI-34060 Capsules and Next Day Functioning

Study Overview
=================
Brief Summary
-----------------
NBI-34060 is an investigational (research) medication being studied in people with insomnia. The current study is designed to evaluate how people, who experience a nighttime awakening with difficulty returning to sleep, feel during the next day after dosing with NBI-34060. The study will also examine the pattern and extent of nighttime awakenings as reported by the patients, as well as and the patient's sleep experience during treatment.

Official Title
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An Exploratory Phase IIIb, Single-Blind, Outpatient Study to Assess Next-Day Functioning in Adult Primary Insomnia Patients Following the Administration of NBI-34060 Capsules During the Night

Conditions
-----------------
Insomnia

Intervention / Treatment
-----------------
* Drug: NBI-34060


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: insomnia (DSM-IV diagnosed; at least one month) Nocturnal awakenings Usual bedtimes between 9:00PM and Midnight. Bedtimes that do not vary by more than 2 hours on 5 or more nights per week. A usual time in bed of 7 to 9 hours. Exclusion Criteria: no serious concomitant illness no other condition that could interfere with sleep

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 64 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: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: NBI-34060|10 mg capsules; dosed as needed for falling back asleep after a bothersome awakening provided there are at least 4 hours remaining in bed; no more than one dose per night.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessments of Next-Day Function |  | daily/six weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Life |  | biweekly/six weeks |
The Influence of Karate on Bleeding in Hemophilic Patients.

Study Overview
=================
Brief Summary
-----------------
Hemophilia patients tend to lower their physical activity level due to the fear of increasing bleeding episodes. Although recent literature has shown that with routine muscle strengthening and physical activity, the frequency and duration of bleeds was reduced. Our study has built a routine of strength training exercises and karate training. The study is built in two stages, each stage being three months. The participants fill out a bleeding diary that includes information from the previous six months. It includes place of bleed, duration, pain level, spontaneous or traumatic bleed, factor replacement and joint limitation. Before the exercise, the participants are tested for muscle strength and endurance. The bleeding diary will be filled out following the first three months and the second phase as will the muscle strength and endurance. We are hoping to see a drastic reduction of bleeding episodes occurring especially from spontaneous bleeds.

Detailed Description
-----------------
none - Hemophilia patients tend to lower their physical activity level due to the fear of increasing bleeding episodes. Although recent literature has shown that with routine muscle strengthening and physical activity, the frequency and duration of bleeds was reduced. Our study has built a routine of strength training exercises and karate training. The study is built in two stages, each stage being three months. The participants fill out a bleeding diary that includes information from the previous six months. It includes place of bleed, duration, pain level, spontaneous or traumatic bleed, factor replacement and joint limitation. Before the exercise, the participants are tested for muscle strength and endurance. The bleeding diary will be filled out following the first three months and the second phase as will the muscle strength and endurance. We are hoping to see a drastic reduction of bleeding episodes occurring especially from spontaneous bleeds.

Official Title
-----------------
The Influence of Karate on Bleeding in Hemophilic Patients.

Conditions
-----------------
Hemophilia A

Intervention / Treatment
-----------------
* Behavioral: Karate exercises and strengthening exercises


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Severe Hemophilia. Exclusion Criteria: No Inhibitors.

Ages Eligible for Study
-----------------
Minimum Age: 11 Years
Maximum Age: 19 Years

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Karate exercises and strengthening exercises|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Evaluation of Molecular Forms of PSA and Human Kallikrein 2 in a Cohort of Patients With Locally Resected Prostate Cancer But Biochemical Recurrence

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate if a new blood test looking at PSA and a group of PSA related proteins in a patient's blood can indicate which men after surgery with a rising PSA could benefit from treatment, and/or indicate which men are at higher risk for recurrence before initial treatment is given.

Official Title
-----------------
Evaluation of Molecular Forms of PSA and Human Kallikrein 2 in a Cohort of Patients With Locally Resected Prostate Cancer But Biochemical Recurrence

Conditions
-----------------
Prostate Cancer

Intervention / Treatment
-----------------
* Other: blood draw


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients treated with radical prostatectomy that develop a rising serum PSA ≥ 0.05ng/ml and have not received any kind of additional therapy. Patients who have had additional therapy post radical prostatectomy are eligible for this study if ≥1 year has passed since treatment and the patient develops a rising serum PSA ≥0.05ng/ml. Exclusion Criteria: Previous additional therapy for prostate cancer, less than 1 year ago No evidence of rising PSA Patients unwilling to undergo venesection

Ages Eligible for Study
-----------------
Minimum Age: 30 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Pts with prostate cancer<br>This study is planned to determine the kallikrein panel of 200 patients presenting with biochemical recurrence (PSA ≥ 0.05ng/ml) after radical prostatectomy prior to any additional therapy or minimum post 1 year additional therapy. | Other: blood draw<br>* Venous blood will be collected in an EDTA Vacutainer tubeup to 10 mL and will be immediately put on ice. This sample may be drawn as a stand-alone blood draw. Samples will be centrifuged at 1900g (3000-3200 RPM) for 15 Minutes and the serum aliquoted into freezer vials and stored at -80°C until analysis. In addition patients who have not received treatment for biochemical recurrence after their first draw are eligible for subsequent draws to determine the reproducibility of the test over time.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| profile of a panel of kallikrein related serine proteases in the blood | of patients that present with biochemical recurrence after radical prostatectomy. | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
PSA, Human Kallikrein 2, locally resected prostate cancer, biochemical recurrence, 14-041
Cultures a.m.Kamme-Lindbergh in Suspicion of Infected TKA

Study Overview
=================
Brief Summary
-----------------
Cultures from total knee arthroplasties, obtained a.m. Kamme-Lindberg in revision cases.

Official Title
-----------------
Cultures From Total Knee Arthroplasties, Obtained a.m. Kamme-Lindberg in Revision Cases.

Conditions
-----------------
Total Knee Arthritis, Viral; Infection, Slow Virus

Intervention / Treatment
-----------------
* Procedure: culture a.m. Kamme-Lindberg


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Exclusion Criteria:

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 |
| --- |
|Procedure: culture a.m. Kamme-Lindberg|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Role of Senescence in the Development of Endometrial Cancer

Study Overview
=================
Brief Summary
-----------------
Several molecular studies showed chromosomal alterations in patients with endometrial cancer, with gains in 1q, 19p, 19q, 8q, 10q and 10p and loss of 4q, 16q and 18q. Several genes of interest have been identified (P53, PTEN, PIK3CA, ß-catenin, K-ras ...). A study has already been carried out at the Reims University Hospital with inclusion of patients with endometrial cancer and patients with endometrial hyperplasia. It identified specific alterations of nosologic continuum of pathology and characterize areas of interest on the genome.

Detailed Description
-----------------
make a pangenomic investigation of genetic abnormalities in atypical endometrial hyperplasia and endometrial cancers.

Official Title
-----------------
Role of Senescence in the Development of Endometrial Cancer

Conditions
-----------------
Endometrial Hyperplasia and Endometrial Cancers

Intervention / Treatment
-----------------
* Genetic: Genetic analysis


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patient with endometrial hyperplasia or endometrial cancer patient consenting to participate to the study patient enrolled in the national healthcare insurance program patient older than 18 years Exclusion Criteria: - patient with neoadjuvant chemotherapy or radiotherapy prior to surgery

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group cases patients<br>patients with endometrial hyperplasia or endometrial cancers | Genetic: Genetic analysis<br>* Genetic analysis of the samples taken during the surgery (hysterectomy or curettage resection) using CGH array technique.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Genetic imbalances | Genetic aberrations detected by comparative genomic hybridization (CGH arry) | Day 0 |
Extension Study of AGT-181-102 to Evaluate Long Term Safety and Activity of AGT-181

Study Overview
=================
Brief Summary
-----------------
AGT-181 is a fusion protein containing alpha-L-Iduronidase that is intended to deliver the enzyme peripherally and to the brain, when administered intravenously. This study is an extension of a safety and dose ranging study to obtain long term safety and exposure data, as well as information on the biological activity of the investigational drug

Official Title
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An Extension Study of AGT-181-102 Evaluating Safety and Glycosaminoglycans (GAGs) in Adult Patients With Hurler-Scheie or Scheie Syndrome Who Have Completed 8-Weeks of Dosing With AGT-181 in Study AGT-181-102

Conditions
-----------------
Mucopolysaccharidosis I

Intervention / Treatment
-----------------
* Drug: AGT-181


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Must have completed clinical trial AGT-181-102 Voluntary written consent by patient or legally responsible representative All women of childbearing potential and sexually mature males must be advised to use a medically accepted method of contraception throughout the study. Negative pregnancy test (females) Exclusion Criteria: Refusal to complete screening evaluations. Any medical condition or other circumstances that may significantly interfere with study compliance Patient is pregnant or lactating Clinically significant spinal cord compression, evidence of cervical instability. Subject developed clinically relevant hypersensitivity to AGT-181

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AGT-181<br>AGT-181 (fusion protein of anti-human insulin receptor monoclonal antibody and alpha-L-iduronidase) administered once weekly x 26 weeks at same dose level as subject received in core study | Drug: AGT-181<br>* intravenous infusion over 3-4 hours<br>* Other names: fusion protein of monoclonal antibody to human insulin receptor fused to alpha-L-iduronidase;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with adverse events as a measure of safety and tolerability |  | 104 weeks (2 years) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| changes in urinary or plasma glycosaminoglycans (GAGs) |  | 104 weeks (2 years) | 
| change in liver size |  | 104 weeks (2 years) | 
| change in spleen size |  | 104 weeks (2 years) | 
| change in levels of heparan sulfate and dermatan sulfate in the cerebrospinal fluid |  | 104 weeks (2 years) |
Vulvar Paget Disease

Study Overview
=================
Brief Summary
-----------------
In this study only women with vulvar paget disease will be included and will be analysed retrospectively. Vulvar paget disease patients are frequently treated with surgical resection of the affected tissue. During a surgical treatment surgical margins are frequently positive. Recidives are seen frequently after surgical treatment or the development of other pathologies such as vulvar carcinoma. In this study the outcome of the vulvar paget disease will be analysed and compared between the participants. It's primary goal is to create a better view on the outcome and the prognosis to prevent e.g. complications in the future.

Detailed Description
-----------------
In this study only women with vulvar paget disease will be included and will be analysed retrospectively. Vulvar paget disease patients are frequently treated with surgical resection of the affected tissue. During a surgical treatment surgical margins are frequently positive. Recidives are seen frequently after surgical treatment or the development of other pathologies such as vulvar carcinoma. In this study the outcome of the vulvar paget disease will be analysed and compared between the participants. It's primary goal is to create a better view on the outcome and the prognosis to prevent e.g. complications in the future. All the information of the patients will be gathered retrospectively from their medical file , after they gave their consent.

Official Title
-----------------
Analyses of the Outcome of a Treatment of Vulvar Paget Disease

Conditions
-----------------
Vulvar Paget's Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Vulvar Paget disease Exclusion Criteria: No exclusion criteria

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 99 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 |
| --- | --- |
| Vulvar Paget Disease<br>Women with vulvar paget disease | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of complications after the treatment of vulvar Paget disease | Number of complications after treatment | Max. 10 years after treatment | 
| Type of complications after the treatment of vulvar Paget disease | Type of complications after treatment | Max. 10 years after treatment |