linjc16/ctgov huggingface dataset:
A 48 Week Study Comparing Treatment With Saquinavir + Lopinavir/Ritonavir in Combination With Enfuvirtide HAART Versus Saquinavir + Lopinavir/Ritonavir + Other Nucleoside Combinations to See the Efficacy of These Treatments in Patients Infected With HIV-1

Study Overview
=================
Brief Summary
-----------------
The main objective of this study is to compare the safety and efficacy of an enfuvirtide containing regimen to a nucleoside combination regimen. Resistance information will also be collected.

Conditions
-----------------
HIV Infection

Intervention / Treatment
-----------------
* Drug: FUZEON [enfuvirtide]


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: CD4 cell count greater than 50 cells/mm^3 HIV-1 RNA viral load greater than or equal to 5000 copies/mL Patients must be HIV treatment experienced Patients diagnosed with HIV-1 infection Exclusion Criteria: Female patients must not be able to have children or must be under effective contraceptives Female patients who are pregnant Have taken enfuvirtide and/or T-1249 before Have serious kidney problems Alcohol and/or drug abuse Have had an organ transplant

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: FUZEON [enfuvirtide]|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Study Evaluating the Gastrointestinal Safety of PLA-695 Compared to Placebo and Naproxen

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to provide an initial assessment of the gastrointestinal safety of a 7-day regimen of PLA-695 compared to placebo or naproxen.

Official Title
-----------------
A Randomized, Double-Blind, Parallel Group Study To Compare The 7-Day Gastrointestinal Safety of 2 Doses of PLA-695 To That Of Placebo And Naproxen

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Drug: PLA-695
* Drug: Naproxen
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy men or women of nonchildbearing potential, aged 18 to 60 years. Exclusion Criteria: Abnormal baseline endoscopy. Positive Helicobacter pylori serology.

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: PLA-695|nan|
|Drug: Naproxen|nan|
|Drug: Placebo|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The rate of erosions and ulcers present after 7 days of treatment for PLA-65 will be compared to placebo and naproxen. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Health
SEDPARK2: Post Marketing Surveillance to Observe Safety and Efficacy of Piribedil in Parkinson's Disease (PIR-002/K)

Study Overview
=================
Brief Summary
-----------------
The objective of the Post Marketing Surveillance Study is to investigate the use of the non-ergot dopamine agonist piribedil (trade name: CLARIUM) in mono- and combination therapy in patients with Morbus Parkinson. Neurologists in private practices in Germany should document the safety and course of the disease/change of parkinsonian symptoms during stabilisation on, or change over from other dopamine agonist treatment under routine conditions. Piribedil should be prescribed according to its marketing authorisation.

Official Title
-----------------
Stabilization on, or Change-Over to the Non-Ergot Dopamine Agonist Piribedil in Patients With Morbus Parkinson - a Post Marketing Surveillance Study in Private Practices.

Conditions
-----------------
Parkinson's Disease

Intervention / Treatment
-----------------
* Drug: Piribedil


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male and female patients 18 years and older. Indication: Morbus Parkinson. Treatment with piribedil for the first time. Monotherapy with piribedil. Combination therapy with L-Dopa (from the beginning or secondary in combination with other antiparkinsonian drugs). 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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Parkinsonian patients<br> | Drug: Piribedil<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| to monitor use in daily routine practice including adverse events |  | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| to monitor use in daily routine practice including efficacy aspects |  | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Piribedil (trade name: Clarium), non-ergot dopamine agonist, Morbus Parkinson, Tolerability, Efficacy, Post Marketing Surveillance
Intragastric Injections of Botox for the Treatment of Obesity

Study Overview
=================
Brief Summary
-----------------
One possible angle for treating obesity could be slowing down the gastric emptying time. By prolonging the gastric emptying time, the person would ideally experience increased sensation of satiety, and in the long run reduce food intake. If such a treatment provides a clinically significant weight loss, this could be an alternative for surgical procedures, avoiding the risk for perioperative complications as well as complications in the long run. There are now several pilot studies documenting that intragastric treatment with botulinum toxin A (BTA) can be effective, although the treatment perspective is short and do not include repeated injections. However, they demonstrate that BTA-injections are safe for the patient. The treatment is administered by endoscopy.

Official Title
-----------------
Treatment of Morbid Obesity by Intragastric Injections of Botulinum Toxin A. A Randomized, Double-blind, Placebo Controlled, Phase II-trial

Conditions
-----------------
Obesity, Morbid

Intervention / Treatment
-----------------
* Drug: Botulinum Toxin Type A
* Drug: Saline solution


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: BMI > 35 Exclusion Criteria: Known hypersensitivity to medication Neuro muscular disease Dysphagia Tendency for aspiration Ulcus Use of aminoglycoside antibiotics and/or spectinomycin lately Previous side effects of botox injections Previous bariatric surgery Previous cancer in GI-tract Other obesity treatment last 12 months Severe eating disorder Hypothyroidism Pregnancy/brest feeding Reduced competence to consent

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Botulinum toxin A<br>Botulinum toxin type A injection in muscles of stomach wall | Drug: Botulinum Toxin Type A<br> <br> * Other names: Botox;|
| Placebo Comparator: Saline solution<br>Placebo (saline solution) injection first 6 months, then active treatment | Drug: Botulinum Toxin Type A<br> <br> * Other names: Botox;Drug: Saline solution<br> <br> * Other names: NaCl;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body weight |  | Change from baseline to 6 months; 1 year; 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
botulinum toxin, Endoscopy, Satiation, Diet, Weight Loss
The Use of Ultrasound in Nasogastric Tube Placement in Children Admitted to the Pediatric ICU

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine if ultrasound (US), when used by the clinician, can determine the presence of nasogastric tube (NGT) in the stomach of patients admitted to the pediatric intensive care unit (PICU).

Detailed Description
-----------------
Currently, the standard of care is to routinely obtain an X-ray (XR) after every nasogastric tube (NGT) placement in the pediatric intensive care unit (PICU). After obtaining informed consent and the child's assent, a short (less than 10 minutes) ultrasound (US) scan of the abdomen within 2 hours of the routine XR.

Official Title
-----------------
The Use of Ultrasound to Determine Correct Nasogastric Tube Placement in Children Admitted to the Pediatric ICU: a Pilot Study

Conditions
-----------------
Nasogastric Tube

Intervention / Treatment
-----------------
* Diagnostic Test: Ultrasound following X-ray


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: PICU patient undergoing routine NGT insertion by nursing staff Exclusion Criteria: Any contraindication for US probe placement such as skin infection and abdominal wounds. Hemodynamically unstable patients. Patients for whom NGT placement will not be verified by XR, such as Ataxia Telangiectasia patients.

Ages Eligible for Study
-----------------
Minimum Age: 0 Years
Maximum Age: 18 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: Ultrasound following X-ray<br>An ultrasound scan of the abdomen within 2 hours of the routine X-ray will be performed by a physician blinded to the X-ray results. | Diagnostic Test: Ultrasound following X-ray<br>* A short (less than 10 minutes) ultrasound (US) scan of the abdomen within 2 hours of the routine X-ray (XR). The performer will be a physician who received a focused training on relevant US views, blinded to the XR image and report.<br>* Other names: Ultrasound;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correct placement of NG tube | The operational definition will be the number of correct identification of NG tube position using ultrasound, as compared to the official X-ray read. | Up to 10 minutes | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
nasogastric tube, ultrasound
Perception Prognosis, Goals of Treatment, and Communication

Study Overview
=================
Brief Summary
-----------------
The purpose of this research study is to assess what the participant understands about their illness, prognosis, the goals of the cancer treatment and their communication with their oncology providers. This study will help us to figure out how the investigators can improve how other patients understand their illness and goals of treatment and help us improve communication with their doctors. This research is being done because there is not a lot of information on how much patients understand about their illness and prognosis.

Detailed Description
-----------------
Participants will be asked to answer a few basic questions regarding race, ethnicity, religion, relationship status, education, income, and living situation. They will then be asked to complete a questionnaire which contains questions about their mood, spirituality, quality of life and their understanding of their treatment and prognosis and their communication with their oncologist. They will complete these questionnaires in the clinic or infusion room on one of their regularly scheduled visit.

Official Title
-----------------
Pilot Study to Investigate Advanced Cancer Patient's Perspective of Their Prognosis, Goals of Treatment, and Quality of Communication With Their Oncologists

Conditions
-----------------
Gastric Cancer, Esophageal Cancer, Pancreatic Cancer, Liver Cancer, Biliary Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Confirmed new diagnosis of advanced gastric, esophageal, pancreatic, and hepatobiliary cancer, not being treated with curative intent. Planning to receive chemotherapy at Massachusetts General Hospital Ability to read and respond to questions in English. Exclusion Criteria: Prior chemotherapy for current stage of disease.

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 |
| --- | --- | --- |
| Completion of surveys |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patients perceptions of prognosis, goals of care, and communication with providers |  | 1 year | 
| Quality of end of life care |  | 1 year | 
| Survival |  | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
advanced cancer
Single Balloon Enterosocpy Obscure Gastrointestinal Bleeding Bleed

Study Overview
=================
Brief Summary
-----------------
The goal of the present study is to investigate the clinical outcomes of patients with gastrointestinal bleeding originating from the small intestine following diagnostic investigation with single balloon enteroscopy. We hypothesize that single balloon enteroscopy can arrive at a diagnosis and provide therapeutics in a majority of patients with gastrointestinal bleeding originating in the small intestine.

Detailed Description
-----------------
The small intestine has been, until recent years, a black box to gastroenterologists because it is difficult to see and reach. Radiological imaging provides little details of small intestinal mucosa. Capsule endoscopy, introduced in 2001, enables gastroenterologists to visualize the entire small intestine from within for the first time, but it is only a diagnostic tool. Single-balloon enteroscopy (SBE) is a new enteroscopy methods that use an overtube with one balloon or a spiral to help pleat bowel onto the endoscope and allow examination of the distal small bowel. This methods allow for biopsy, hemostasis, and other therapeutic interventions to be performed in the small bowel. Early reports have been promising; with 50-70% diagnostic yield for small bowel pathology reported in the literature. However, despite these promising results the impact SBE findings on patient outcomes is not clear.

Official Title
-----------------
LONG-TERM OUTCOMES AFTER SINGLE-BALLOON ENTEROSCOPY IN PATIENTS WITH OBSCURE GASTROINTESTINAL BLEEDING

Conditions
-----------------
Obscure Gastrointestinal Bleeding

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with Obscure Gastrointestinal Bleeding undergoing SBE at Barnes Jewish Hospital Exclusion Criteria: Less than 3 months of follow up after SBE The endoscope could not be advanced into the duodenum will be excluded.

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 |
| --- | --- |
| Consecutive patients undergoing SBE for OGIB<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrence of obscure gastrointestinal bleeding following single balloon enteroscopy | The primary outcome is recurrence of gastrointestinal bleeding, defined as recurrent overt or occult gastrointestinal bleeding, hospitalization for gastrointestinal bleeding or acute blood loss anemia. | 4 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Single-Balloon-Enteroscopy, Push-and-Pull Enteroscopy
Scintigraphic Evaluation of IPAA Function in Patients With Ulcerative Colitis

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to evaluate scintigraphic methods as objective factors for functional outcome in patients treated with ileal-pouch-anal anastomosis (IPAA). The gastrointestinal transit-time and the degree of evacuation are evaluated in relation to the functional outcome.

Official Title
-----------------
Scintigraphic Evaluation of IPAA Function in CU Patients

Conditions
-----------------
Ulcerative Colitis

Intervention / Treatment
-----------------
* Other: Transittime. Defecography


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Ulcerative colitis patients

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 100 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Ulcerative colitis patients with ileal-pouch-anal anastomosis<br> | Other: Transittime. Defecography<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gastrointestinal transit-time | The small bowel transittime until food is in the IPAA | 12 weeks |
Compassionate Use of REGN-COV2 for the Treatment of COVID-19

Study Overview
=================
Brief Summary
-----------------
Compassionate Use requests will be considered for individuals who test positive for SARS-CoV-2 and where there is reasonable basis to believe that the patient is infected with a susceptible variant.

Detailed Description
-----------------
Compassionate Use requests are only being considered in response to Individual Patient Investigational New Drug (IND) applications.

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

Intervention / Treatment
-----------------
* Drug: REGN10933+REGN10987 combination therapy


Participation Criteria
=================

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: REGN10933+REGN10987 combination therapy|Administered intravenously (IV) single dose|

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
-----------------
Post-exposure
Omnifit Hydroxylapatite (HA) Hip Outcomes Study

Study Overview
=================
Brief Summary
-----------------
The purpose of this study was to obtain up to 25 year post-operative data on the Omnifit Hydroxylapatite (HA) Hip System in support of the hypothesis that it is a satisfactory system for reducing implant loosening, permitting tissue bonding onto the hydroxylapatite surfaces of the implant and providing a safe, efficient, and well-functioning hip in a wide spectrum of clinical circumstances.

Official Title
-----------------
Omnifit Hydroxylapatite (HA) Hip Outcomes Study

Conditions
-----------------
Arthroplasty, Replacement, Hip

Intervention / Treatment
-----------------
* Device: Omnifit HA Hip Stem


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: For use as a universal hip replacement: Acute femoral neck fracture. Non-union of femoral head and neck fractures. Aseptic necrosis of the femoral head. Osteoarthritis, rheumatoid arthritis, or post-traumatic arthritis of the hip with minimal acetabular involvement or distortion. Salvage of failed total hip arthroplasty. For use as a total hip replacement: Severely disabled joints resulting from painful osteoarthritis, rheumatoid arthritis, or post-traumatic arthritis. Revision of previous unsuccessful femoral head replacement, cup arthroplasty, or other procedure. Exclusion Criteria: Active infection in or near the hip joint. Pathological bone conditions which would significantly compromise the ability to carry physiologic stress levels and for which bone grafting would be inappropriate (i.e. severe osteoporosis, Paget's Disease, renal osteodystrophy, etc.). Neuro-muscular disorders in which the potentially adverse effects on prosthesis function are not outweighed by the benefits to be gained by the patient from usage of the implant. Mental disorders which would compromise essential patient post-operative care. Skeletal immaturity. Extreme obesity. Significant probability that patient could not return for required follow-up evaluations.

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 |
| --- | --- |
| Other: Omnifit HA Hip Stem<br>Participants underwent total hip replacement surgery using the Omnifit HA Hip Stem. | Device: Omnifit HA Hip Stem<br>* Total Hip Replacement with Omnifit HA Hip Stem<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patients Will be Evaluated for Pain, Functional Level, and Clinical Complications Utilizing the Harris Hip Score. |  | 25 Years Post-Operatively |