linjc16/ctgov huggingface dataset:
Impacts of Static Magnetic Fields on Dysmenorrhea Pain

Study Overview
=================
Brief Summary
-----------------
Study to determine the effectiveness of a certain type of magnet to reduce period pain

Detailed Description
-----------------
Young women with their period pain levels of 6 or greater on a pain scale of 0-10 will wear a concentric magnet or a sham that is positioned close to the maximum pain site. The pain score after wearing either the magnet or sham will be recorded.

Official Title
-----------------
Impacts of Static Magnetic Fields on Dysmenorrhea Pain

Conditions
-----------------
Period Pain

Intervention / Treatment
-----------------
* Device: Magnet


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Female with period pain score consistently equal to or greater than 6 on a pain scale of 0-10 - Exclusion Criteria: Pain not experienced on almost all menstrual cycles Having secondary dysmenorrhea including endometriosis, fibroids or pelvic inflammatory disease Having a pacemaker or any implanted wires or devices -

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 35 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Magnet group<br>Women wearing magnet a magnet, or sham device indistinguishable from the magnet (determined randomly), will be placed on her abdomen. If the pain is predominately in her abdomen, the device will be placed on the location with the most pain. If the pain is predominantly in the subjects back, the device will be placed on the lower abdomen on the midline between the umbilicus and the pubic bone. | Device: Magnet<br>* Magnet or Sham is worn by subject in close proximity to their described maximum pain site<br>|
| Sham Comparator: Sham group<br>Women wearing sham a magnet, or sham device indistinguishable from the magnet (determined randomly), will be placed on her abdomen. If the pain is predominately in her abdomen, the device will be placed on the location with the most pain. If the pain is predominantly in the subjects back, the device will be placed on the lower abdomen on the midline between the umbilicus and the pubic bone. | Device: Magnet<br>* Magnet or Sham is worn by subject in close proximity to their described maximum pain site<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain score scale of 1-10 / 1 being less pain 10 being more pain | Subject reported pain after wearing device | 40 minutes |
The PRECIOUS Study: Predicting Crohn's & ColitIs Outcomes in the United States

Study Overview
=================
Brief Summary
-----------------
A multi-center observational study based at referral centers and community hospitals within the US. Patients' blood will be collected at enrollment for testing with PredictSURE IBD™, which will occur at a later date. Patients will be prospectively followed up for 12 months with clinicians treating according to local standard of care, with a step-up or accelerated step-up regimen. Clinicians and patients will be blinded to the biomarker results.

Detailed Description
-----------------
This is a multi-center, observational study of newly diagnosed IBD (CD or UC) patients. The Study aims to assess whether a prognostic biomarker can stratify IBD patients in the US.

Official Title
-----------------
The PRECIOUS Study: Predicting Crohn's & ColitIs Outcomes in the United States

Conditions
-----------------
Crohn Disease, Ulcerative Colitis, IBD, Inflammatory Bowel Diseases

Intervention / Treatment
-----------------
* Other: PredictSURE IBD™


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Active UC or CD with typical symptoms in conjunction with at least one objective measure of disease activity: elevated CRP, calprotectin, endoscopic evidence. Not currently receiving systemic therapy* with steroids, immunomodulators or biologics, and at least 7 days since the last steroid dose. Due to be managed using a step-up or accelerated step-up approach (so will not receive biologics as first line therapy). Aged 16-80 years old. Note, the ideal patients for this study are newly diagnosed patients who are treatment-naïve. Exclusion Criteria: The presence of any of the following will preclude patient inclusion: Patients with fistulating peri-anal Crohn's disease or active perianal sepsis. Obstructive symptoms and evidence of a fixed stricture on radiology or colonoscopy. Patients who are scheduled to start on top-down therapy or receive biologics as a first line therapy

Ages Eligible for Study
-----------------
Minimum Age: 16 Years
Maximum Age: 80 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: PredictSURE IBD™|To evaluate a test called PredictSURE IBD™ in the US population|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To stratify patients at diagnosis into high and low- risk cohorts | Stratifying patients into high or low risk of following an aggressive disease course requiring frequent treatment escalations. | 12 month follow up | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
IBD, Inflammatory Bowel Disease, Precious, Crohn's Disease, Ulcerative Colitis
Nephronophthisis : Clinical and Genetic Study

Study Overview
=================
Brief Summary
-----------------
to describe evolution of Nephronophthisis

Detailed Description
-----------------
To specify the long term evolution of Nephronophthisis in terms of renal disease as well as extra-renal damages for patients having a confirmed diagnosis of NPHP1, NPHP2, NPHP3, NPHP4, NPHP5, NPHP6 or NPHP8 gene mutation

Official Title
-----------------
Characterization and Analysis of Long-term Evolution of Renal and Extra-renal Damages in the Course of Nephronophthisis

Conditions
-----------------
Nephronophthisis

Intervention / Treatment
-----------------
* Genetic: genetic diagnosis


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: NPHP1, NPHP2, NPHP3, NPHP4, NPHP5, NPHP6 or NPHP8 gene mutation 7 years old and older Exclusion Criteria: MRI contra-indications

Ages Eligible for Study
-----------------
Minimum Age: 7 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Study group<br>Neurological, ophthalmological, olfactive exams and cerebral MRI | Genetic: genetic diagnosis<br>* to determine the long term evolution of Nephronophthisis in terms of renal disease as well as extra-renal damages for patients having a confirmed diagnosis of NPHP1, NPHP2, NPHP3, NPHP4, NPHP5, NPHP6 or NPHP8 gene mutation<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| to determine the long term evolution of Nephronophthisis in terms of renal disease as well as extra-renal damages for patients having a confirmed diagnosis of NPHP1, NPHP2, NPHP3, NPHP4, NPHP5, NPHP6 or NPHP8 gene mutation |  | start from the first time of clinical diagnosis to now | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| to study siblings to anticipate clinical complications (renal and extra-renal damages) of Nephronophthisis |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
extra renal damages
The Biology of Claudin 3 in Primary Human Mammary Epithelial Cell Culture

Study Overview
=================
Brief Summary
-----------------
The objective of the present study is to determine whether or not primary human mammary epithelial cells are competent for use in molecular studies of transepithelial electrophysiology focusing on the function of the tight junction protein claudin 3. Human breast Tissue will be removed from mastectomy specimens and used as a source to generate epithelial cells for study.

Official Title
-----------------
The Biology of Claudin 3 in Primary Human Mammary Epithelial Cell Culture

Conditions
-----------------
Breast Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects of this pilot study are limited to those female patients who are undergoing therapeutic or prophylactic mastectomy procedures conducted by the department of Surgery at HUMC. Exclusion Criteria: From within this population, no exclusion criteria shall be applied based on age, race, ethnicity, gender, HIV status, or menopause.
Sexes Eligible for Study
-----------------
Female

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 |
| --- | --- | --- |
| Cell line data study |  | one year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
claudin, electrophysiology, breast, screening
A Study to Evaluate Symlin in Adolescent Subjects With Type 1 Diabetes Mellitus

Study Overview
=================
Brief Summary
-----------------
This study will be the first evaluation of Symlin in adolescent subjects with type 1 diabetes mellitus and is designed to evaluate the blood levels (pharmacokinetics), biochemical and physiological effects (pharmacodynamics), and safety and tolerability of Symlin in these subjects.

Official Title
-----------------
A Randomized, Single-Blind, Dose-Rising, Placebo-Controlled, Crossover Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of SYMLIN in Adolescent Subjects With Type 1 Diabetes Mellitus

Conditions
-----------------
Type 1 Diabetes Mellitus

Intervention / Treatment
-----------------
* Drug: pramlintide acetate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosed with type 1 diabetes mellitus for at least 1 year prior to screening Be on a stable regimen requiring multiple daily injections of basal and mealtime insulin or continuous subcutaneous insulin infusion for at least 2 weeks prior to screening HbA1c between 6.0% and 10.0%, inclusive, at screening Body weight >=50 kg at screening Exclusion Criteria: Currently being treated with the following medications: *Any oral antihyperglycemic agent; *Drugs that directly affect gastrointestinal motility Has been previously treated with Symlin/pramlintide (or has participated in a Symlin/pramlintide clinical study) Has received any investigational drug within 1 month of screening

Ages Eligible for Study
-----------------
Minimum Age: 12 Years
Maximum Age: 17 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: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>single doses of pramlintide acetate or placebo, given in three different sequences to three cohorts of subjects | Drug: pramlintide acetate<br>* single subcutaneous doses of 15mcg and 30mcg<br>* Other names: Symlin;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the pharmacokinetics of Symlin in adolescent subjects with type 1 diabetes |  | single doses | 
| To assess the safety and tolerability of Symlin in adolescent subjects with type 1 diabetes |  | single doses | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the effects of Symlin compared to placebo in adolescent subjects with type 1 diabetes on various pharmacodynamic endpoints |  | single doses | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Type 1 Diabetes, pediatric, pramlintide, Symlin, Amylin
Regional and Seasonal Variations in the Incidence and Causative Organisms for Post-traumatic Wound Infections and Osteomyelitis After Open Fractures

Study Overview
=================
Brief Summary
-----------------
To determine if there is a relationship between people with open fractures and the season and location of where the injury occurred and the infections they develop

Official Title
-----------------
Regional and Seasonal Variations in the Incidence and Causative Organisms for Post-traumatic Wound Infections and Osteomyelitis After Open Fractures

Conditions
-----------------
Infection

Intervention / Treatment
-----------------
* Other: Infection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Open Fracture treated surgically between distal radius and distal tibia - Exclusion Criteria: GSW Unable to follow for one year

Ages Eligible for Study
-----------------
Minimum Age: 16 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 |
| --- | --- |
| Open Fractures<br>Patients with Open fractures between the distal radius and the distal tibia | Other: Infection<br>* This is an observational trial<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Infection | Infection of the open fracture | One year after injury |
Identifying New Biomarkers of Parkinson's From Routine Brain Imaging

Study Overview
=================
Brief Summary
-----------------
The study will use routine computer tomography (CT), magnetic resonance spectroscopy (MRI) and nuclear medicine (NM) brain imaging data to produce new diagnostic tests for the onset of Parkinson's disease. This will enable hopefully earlier diagnosis than is currently possible. This will entail the analysis of anonymised CT/MRI/NM brain images collected prior to the point when these subjects were diagnosed with PD.

Detailed Description
-----------------
We intend to use historical CT/MRI/nuclear medicine brain scans to identify novel imaging biomarkers of prodromal Parkinson's disease. The primary data source for the study will be MRI and CT brain scans, whilst nuclear medicine imaging brain imaging (DAT scans) will be used to validate models produced and provide a functional outcome measure of brain dopamine uptake. We shall utilise a an artificial intelligence approach to compare scans of PD cases with matched controls in order to identify these imaging biomarkers. A list of participants with a diagnosis will be compiled. This list, together with relevant clinical data, will be linked with historical CT/MRI/nuclear medicine scans carried out over the preceding years. A control group of matched non-PD scans will also be compiled. The dataset will be anonymised and a bespoke ML pipeline will be used to identify imaging featureswhich may be indicative of prodromal PD. This initial stage will be carried out at University Hospital Plymouth NHS Trust (UHPNT), the Royal Cornwall Hospital NHS Trust (RCHNT) and Cornwall Partnership NHS Trust (CPNT). If successful, findings will be validated in a larger sample of scans compiled from hospitals regionally and nationally.

Official Title
-----------------
Identifying New Biomarkers of Parkinson's From Routine Brain Imaging

Conditions
-----------------
Parkinson Disease

Intervention / Treatment
-----------------
* Diagnostic Test: MRI


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - A clinical diagnosis of Parkinson's Exclusion Criteria: - No clinical diagnosis of Parkinson's

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 |
| --- | --- |
| Parkinson disease<br>Participants with a clinical diagnosis of Parkinson's disease | Diagnostic Test: MRI<br>* Identification of novel biomarkers from MRI<br>|
| Control<br>Controls | Diagnostic Test: MRI<br>* Identification of novel biomarkers from MRI<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The presence of novel putative biomarkers of future PD development as defined by a deep-learning method |  | 3 years |
Dopamine in Orthostatic Tolerance

Study Overview
=================
Brief Summary
-----------------
One goal of this study is to determine whether people with different amounts of dopamine-beta-hydroxylase (DBH) have different responses to events that affect blood pressure and heart rate. We will also study whether increasing dietary salt improves symptoms during upright posture. Finally, we will examine whether the dietary sodium level influences serum DBH activity and whether DBH level influences the response to sodium. DBH levels and the function of the sympathetic or involuntary nervous system will be assessed in normal volunteers and in patients with postural tachycardia syndrome (POTS).

Official Title
-----------------
Dopamine in Orthostatic Tolerance

Conditions
-----------------
Postural Tachycardia Syndrome

Intervention / Treatment
-----------------
* Dietary Supplement: dietary sodium
* Dietary Supplement: dietary sodium
* Dietary Supplement: dietary sodium


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Upright plasma norepinephrine > 600 pg/ml, or An increase in heart rate of > 30 beats per minute upon standing, and Withdrawal of all medications for at least 3 days, and No associated medical illness, and Age 18 - 60 years old. Exclusion Criteria: Older than 60 years of age Routinely taking medications affecting the autonomic nervous system Any chronic illness (cardiac, pulmonary, endocrine, gastrointestinal, rheumatologic) other than POTS Anemia (Hct < 30) Women of childbearing age who are pregnant or nursing Unable to give informed consent

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

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

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

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

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br>10 mEq/day dietary sodium | Dietary Supplement: dietary sodium<br>* 10 mEq/day<br>|
| Experimental: B<br>150 mEq/day dietary sodium | Dietary Supplement: dietary sodium<br>* 150 mEq/day dietary sodium<br>|
| Experimental: C<br>300 mEq/day dietary sodium | Dietary Supplement: dietary sodium<br>* 300 mEq/day<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| plasma dopamine-beta-hydroxylase |  | at enrollment and after tests | 
| plasma dopamine |  | after tests |
ChronoFOLFOX Plus Avastin for Patients With Metastatic Colorectal Cancer

Study Overview
=================
Brief Summary
-----------------
To determine efficacy in the delivery of chronomodulated chemotherapy.

Detailed Description
-----------------
The purpose of this study is to determine if treatment with 5-Fluorouracil, leucovorin, oxaliplatin, and Avastin will cause colorectal tumor cells to shrink or disappear. The study will also determine the safety of these drugs when given together and the quality of life of the patients who are enrolled in the study. It is thought that these drugs will be better tolerated if they are chronomodulated, i.e., if they are given at certain times of day rather than as a continuous infusion.

Official Title
-----------------
ChronoFOLFOX Plus Avastin for Patients With Metastatic Colorectal Cancer

Conditions
-----------------
Colorectal Neoplasms

Intervention / Treatment
-----------------
* Drug: 5-Fluorouracil, leucovorin, oxaliplatin, avastin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histological proof of adenocarcinoma in primary colon or rectum tumor. Evidence of metastatic colorectal cancer or loco-regional recurrence or unresectable disease. Ages 18 to 86 years. Presence of at least one bi-dimensionally measurable disease with at least one diameter > or = 2 cm. WHO/ECOG performance status < 3 (0, 1, or 2) Prior treatment with oxaliplatin, 5-FU, or leucovorin permitted. Signed informed consent Exclusion Criteria: Peripheral sensory neuropathy > or = grade 3. Serum bilirubin (total) > 3 X ULN. Symptomatic or uncontrolled brain metastasis. Metastases limited to bone, pleural effusion, or ascites. Uncontrolled overt cardiac disease. Uncontrolled hypercalcemia. Uncontrolled infections. Uncontrolled hypertension (>180/110) History of GI perforation. History of arterial thromboembolic events. History of congestive heart failure. Patients taking warfarin (Coumadin). Patients who are pregnant.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 86 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: 5-Fluorouracil, leucovorin, oxaliplatin, avastin|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary objective is to determine if the rate of adverse events among patients receiving chronoFOLFOX plus Avastin is acceptable compared to that in previous studies using the FOLFOX4 regimen. |  | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Advanced, metastatic, colorectal, cancer, Avastin