linjc16/ctgov huggingface dataset:
Misoprostol Prior to Intrauterine Device Insertion

Study Overview
=================
Brief Summary
-----------------
The intrauterine device (IUD) is a reliable, safe, long acting, and effective contraceptive method . In spite of that, the pain associated with IUD insertion can be a cause against its insertion. Many researches have been conducted aiming to decrease the degree of pain during IUD insertion; these studies included medical and also technical methods. The physicians usually prefer to insert the IUD during women's menses because the women are very unlikely to be pregnant and the insertion is easier and the pain is lower The easiness of IUD insertion is a very important issue that can increase women's satisfaction and decrease insertion pain.

Official Title
-----------------
Misoprostol Prior to Intrauterine Device Insertion in Non-menstruating Women

Conditions
-----------------
IUD

Intervention / Treatment
-----------------
* Drug: Misoprostol
* Device: IUD


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women aged 18-45 years Non-pregnant women Women who will come when there are non-menstruating. Exclusion Criteria: Women received any analgesics or misoprostol in the 24 hours prior to insertion Women with any contraindications for IUD insertion Nulliparous women Women refuse to participate. Women have any contraindication of misoprostol.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Misoprostol group<br>400 µg misoprostol vaginally ; these tablets will be introduced by the principal investigator, digitally without using speculum, 3 hours before IUD insertion into the posterior vaginal fornix of the woman while lying in the lithotomy position | Drug: Misoprostol<br>* will be used 3 h before IUD insertion<br>Device: IUD<br>* a copper T380A IUD<br>|
| Other: No misoprostol group<br>will not receive any pre-insertion medications. | Device: IUD<br>* a copper T380A IUD<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The degree of pain perception during IUD insertion assessed by visual analogue scale | The visual analogue scale scored from 0 to 10 degree, 0 degree means no pain while 10 degree means maximum pain | 5 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The ease of IUD insertion: will be measured by visual analogue like scale [from 0 to 10] | 0 means very easy insertion and 10 means so difficult insertion | 5 minutes |
Comparison of Stent Suturing Versus OTSC Stentfix

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate whether OTSC stentfix is a feasible, safe, and efficient device that can be used for esophageal stent fixation (to prevent stent migration) in patients with benign, non-stricture esophageal lesions, including leaks, perforation, and fistulae. Currently, self-expandable metal stents (SEMS) have a risk of migration which can lead to adverse events such as bleeding and perforation. There has been clinical experience demonstrating that stent suturing can prevent stent migration. However, stent suturing can significantly increase endoscopic procedural time. The use of OTSC stentfix for stent fixation is promising as it is likely less time-consuming and less technically difficult, with likely a similar rate of fixation and migration. This non-inferiority study aims to investigate how OTSC stentfix functions as compared to stent suturing. If OTSC stentfix is at least comparable to stent suturing, it can reduce endoscopy procedural times, minimize peri-endoscopic risks, and minimize adverse events related to stent migration.

Official Title
-----------------
Comparison of Stent Suturing Versus OTSC Stentfix in Preventing Esophageal Stent Migration in Non-Stricture Esophageal Lesions

Conditions
-----------------
Esophageal Stent Fixation

Intervention / Treatment
-----------------
* Device: OTSC Stentfix


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All adults (18+ years) Have benign, non-stricture esophageal lesions (i.e. fistulae, perforation, leaks) warranting esophageal stent placement as an inpatient or outpatient Ability to consent to stent fixation. Exclusion Criteria: < 18 years old

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 |
| --- | --- |
| Experimental: OTSC Stentfix<br> | Device: OTSC Stentfix<br>* The OTSC stentfix will be placed during upper endoscopy after a self-expanding metal stent has been deployed.<br>|
| No Intervention: Stent Suturing<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Average rate of stent migration |  | 48 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Procedural time needed for stent fixation |  | 120 minutes | 
| Duration of time until stent migration for stents that fail fixation |  | 48 weeks |
Survey: COVID-19 Patients Managed in the Operating Theatre of Belgian Hospitals

Study Overview
=================
Brief Summary
-----------------
COVID-19 pandemic has an important impact on the health care provided by the anesthesiologists. Different societies of anesthesiology have provided guidelines and recommendations on how to manage patients who have been tested positive for COVID-19 or suspected to be infected. It is therefore important to know whether these guidelines have been implemented or were possible to be implemented. Otherwise patients who are presenting COVID-19 often show pulmonary complications. The airway management and the ventilation management of these patients can be therefore challenging and can possibly influence their outcome. It is thus important to obtain a large database with information about the characteristics of these patients, how these patients have been managed and their in-hospital outcome. Information regarding the correct implementation of guidelines is as well necessary for future guidance of health care providers.

Official Title
-----------------
Survey on Patients With Suspected or Confirmed COVID-19 Requiring Anesthesia Care for Their Intervention

Conditions
-----------------
COVID-19

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients (pediatric/adults/parturients) who are tested positive for COVID-19 or who are suspected to be infected Exclusion Criteria: No oral consent -

Ages Eligible for Study
-----------------
Minimum Age: 1 Hour
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 |
| --- | --- |
| COVID-19<br>Any pediatric or adult patient with COVID-19 or suspected of COVID-19 scheduled for any intervention | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Global evaluation of the implication of the Belgian anesthesiologists during COVID-19 pandemic | To evaluate whether Belgian anesthesiologists have followed or could follow the recommendations regarding the management of COVID-19 patients and what were the characteristics of these patients and how they have been managed and what were their outcomes | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| If any compare our results with other countries | To compare the descriptives and the outcome data of our patients with other countries | 4 weeks |
Malignant Genito-urinary Tumors in Children: South Egypt Cancer Institute Experience

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to identify demographic & disease characteristics in pediatric oncology patients diagnosed with one of genitourinary tumors & treatment outcomes in these patients.

Detailed Description
-----------------
Background: Tumors of the kidney, bladder, prostate, testis, and adrenal represent a large part of the adult urologic practice, but are relatively infrequent in children. Genitourinary tumors contribute to pediatric solid tumors. Wilms tumor, rhabdomyosarcoma, and germ cell tumors are the most common malignant genitourinary tumors in children. The natural history and management of these tumors in the pediatric age is different from that of the adults. As result of the successful work of several clinical trial groups in recent decades, there has been a significant improvement in their cure rates. Patients & Methods: From January 2001 till December 2015, retrieval & analysis of the medical records of pediatric patients with genitourinary tumors will be made at the pediatric oncology department, South Egypt Cancer Institute which represents the largest referral center in Upper Egypt. These data will be categorized according to demographic characteristics, clinico-pathologic features, treatment modalities received, and outcomes of treatments in these patients.

Official Title
-----------------
Malignant Genito-urinary Tumors in Children: South Egypt Cancer Institute Experience

Conditions
-----------------
Genitourinary Neoplasms, Neoplasms, Genitourinary

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients whose age less than or equal to 18 years. Patients diagnosed with any of neoplasms affecting the genitourinary system. Exclusion Criteria: Patients whose age more than 18 years.

Ages Eligible for Study
-----------------
Maximum 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 |
| --- | --- | --- |
| Overall survival (OS) | Time from the date of initiation of treatment until death from any cause | Participants will be retrospectively followed forward in time from the date of initiation of treatment till the primary completion date of the study, an expected average of 5 years | 
| Event Free Survival (EFS) | Time from the date of initiation of treatment until disease progression, or death for any reason. | Participants will be retrospectively followed forward in time from the date of initiation of treatment till the primary completion date of the study, an expected average of 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Childhood Cancer, Genitourinary tumors, urogenital tumors, Pediatric Oncology
Effects of Melatonin in PCOS Women

Study Overview
=================
Brief Summary
-----------------
The aim of our study is to investigate the effects of a treatment with melatonin on clinical, endocrine and metabolic features in women affected by PCOS. The study group included 40 patients treatend with 2 mg of melatonin daily for six months. Menstrual pattern, anthropometric parameters, hirsutism score, ultrasound ovarian volume and antral follicular count, an oral glucose tollerance test and hormonal assays are evaluated before and after therapy.

Official Title
-----------------
Effects of 6 Months of Melatonin Treatment on Clinical, Endocrine ed Metabolic Features in Women Affected by PCOS

Conditions
-----------------
Polycystic Ovary Syndrome

Intervention / Treatment
-----------------
* Drug: Melatonin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: women with PCOS in accordance with Rotterdam criteria Exclusion Criteria: pregnancy past history of cardiovascular diseases diabetes mellitus (or impaired glucose tolerance as determined by a standard 75 gr oral glucose tolerance test) hypertension significant liver or renal impairment other hormonal dysfunction (hypothalamic, pituitary, thiroidal or adrenal) neoplasms

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

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

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: open<br>therapy with melatonin 2 mg daily for six months | Drug: Melatonin<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of cycles in six months of therapy |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| hirsutism score | Ferriman Gallwey score | 6 months | 
| testosterone levels |  | 6 months | 
| insulin levels |  | 6 months | 
| total cholesterol |  | 6 months | 
| HDL cholesterol |  | 6 months | 
| LDL cholesterol |  | 6 months | 
| tryglycerides |  | 6 months | 
| androstenedione levels |  | 6 months | 
| free androgen index |  | 6 months | 
| AMH levels |  | 6 months |
Use of Avanta Metacarpophalangeal (MCP) Joint Implant Finger Prosthesis, Humanitarian Use Device

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to allow patients to undergo surgery with the SR™ MCP (Metacarpophalangeal) Implants for finger arthritis. This is NOT a research study, but rather, a requirement by the FDA for humanitarian use of device.

Detailed Description
-----------------
The purpose of this IRB approved study is to allow patients to undergo surgery with the SR™ MCP (Metacarpophalangeal) Implants. This is NOT a research study, but rather, a requirement by the FDA for humanitarian use of device. Use of the SR™ MCP is approved for humanitarian use by the FDA when either the patient is in need of a revision of failed MCP prothesis(es) or the patient expects to place his/her hand under loading situation which preclude the use of an alternative implant in the painful osteo-arthritic and post traumatic arthritic MCP joint.

Official Title
-----------------
Use of Avanta Metacarpophalangeal (MCP) Joint Implant Finger Prosthesis, Humanitarian Use Device

Conditions
-----------------
Arthroplasty of the MCP Joint

Intervention / Treatment
-----------------
* Device: SR™MCP


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patient is in need of a revision of failed MCP prosthesis(es) patient expects to place his/her hands under loading situations which preclude the use of an alternative implant in the painful osteo-arthritic and post traumatic arthritic MCP joint Exclusion Criteria: patient is not in need of a revision of a failed MCP prothesis(es) patient is eligible to use an alternative implant

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: SR™MCP|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
-----------------
osteo-arthritis, post traumatic arthritis
Registry for Primary Ciliary Dyskinesia

Study Overview
=================
Brief Summary
-----------------
Primary Ciliary Dyskinesia (PCD) is a rare disease, which means that any single PCD center has experience with a limited number of patients. PCD Registry is the collection of data about PCD from many centers and countries who treat children with PCD. Collecting data about PCD increase the knowledge on PCD, better describe the course of the disease, and help to better understand the progression of the disease and be used to develop new treatments. In the PCD registry of Alberta, important information about PCD such as time of diagnosis, symptoms, and tests which led to the diagnosis, state of health at diagnosis, the progression of lung function, the occurrence of severe infections, tests and treatments data will be collected from the patients' medical records.

Detailed Description
-----------------
In order to better characterize the clinical course, and improve the diagnosis and treatment of PCD, the investigators propose to establish a provincial PCD registry in Alberta. This registry will be securely linked to the currently existing International Registry for PCD and will allow more researchers to use the information to do research on PCD. The investigators will collect demographic data: current age, sex, age, diagnostic findings and symptoms at diagnosis; in addition, clinical data about PCD which are recorded during the past and future clinical visits and encounters (e.g. lung function, weight, height, infections, treatments, and complications) will also be collected.

Official Title
-----------------
Registry for Primary Ciliary Dyskinesia: : Systematic Data Collection on Incidence, Clinical Presentation, Treatment and Course of the Disease

Conditions
-----------------
Primary Ciliary Dyskinesia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical diagnosis of PCD Abnormal findings in at least two of the following tests: High-frequency video microscopic finding, transmission electron microscopy finding, immunofluorescence finding, low nasal NO concentration/production, demonstration of biallelic disease-causing mutations by genotyping. Exclusion Criteria: • Failure or unwillingness to give written informed consent.
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 |
| --- | --- | --- |
| Age of diagnosis | Years | 2017-2030 | 
| Lung Function | % predicted for age | 2017-2030 |
Validation of the NTX Wireless Patient Monitoring System

Study Overview
=================
Brief Summary
-----------------
Reduction in time to detection of Clinically Significant events Reduction of time to Intervention during Clinically Significant events Reduction in the number of admissions to Intensive Care

Detailed Description
-----------------
1200 patients will have wireless monitors attached to their arm. They will be randomized to have their vital signs filtered through software that generates alerts, or software that does not generate alerts. Low and high limit alarms will be set according to published guidelines and adjusted at will by the response team. If appropriate the Vanderbilt University Medical Center Rapid Response team will be initiated per Institutional Policy

Official Title
-----------------
A Validation of the NTX Wireless Patient Monitoring System in Combination With Novel Computer Interface to Generate Proactive Medical Responses to Patient Specific Events

Conditions
-----------------
Desaturation, Bradycardia, Tachycardia, Hypertension, Hypotension

Intervention / Treatment
-----------------
* Other: Rapid Response Team (NTX wireless monitoring system)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Ability to give written informed consent Patients that are hospitalized for longer than 24 hours and are located on the 4th, 5th, or 6th floor of the Vanderbilt University Medical Center Round Wing Patients must be ≥18 years of age Exclusion Criteria: ICU patients Female subjects who are pregnant Patients < 18 years of age Patients that have a contradiction for continuous Blood Pressure monitoring

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br>monitored | Other: Rapid Response Team (NTX wireless monitoring system)<br>* If the subject is experiencing a life threatening change in their vital signs, the Rapid Response Team will be initiated per VUMC protocol.<br>* Other names: - attending nurse action per VUMC protocol;|
| 2<br>control | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine if the NTX wireless monitoring system in combination with a novel computer interface will provide early detection of potentially life threatening changes in patient's vital signs |  | an interim analysis will be performed after 400 patients have been placed on the study, again after 800 have been places on the study | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
NTX, Nihon Kohden, mobile monitoring
Treatment After Palbociclib-containing Regimens

Study Overview
=================
Brief Summary
-----------------
To evaluate the prescription patterns and treatment outcomes of subsequent therapies after progression on palbociclib in the real world.

Official Title
-----------------
A Multi-center Study of the Treatment Patterns and Clinical Outcomes of Subsequent Therapies After Progression on Palbociclib in HR+/HER2- Metastatic Breast Cancer

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: woman, age > 18 years old Diagnosed with HR+/HER2- Metastatic Breast Cancer Patients received at least one-cycle next-line treatment after progression on combined palbociclib and endocrine therapy Complete medical history was available Exclusion Criteria: 1. Medical history was incomplete

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

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 |
| --- | --- | --- |
| PFS | Progression free survival | 6 weeks | 
| Adverse events | Number of participants with treatment-related adverse events as assessed by Common Terminology Criteria for Adverse Events version 4.0 (CTCAE v4.0) | 6 weeks |