linjc16/ctgov huggingface dataset:
Effect of Acupuncture on Postoperative Nausea and Vomiting

Study Overview
=================
Brief Summary
-----------------
The aim of the study is to investigate if P6 acupuncture made after induction of general anaesthesia might be effective for the prevention of PONV as ondansetron and if the acupuncture-ondansetron combination could enhance single therapy efficacy in patients undergoing laparoscopic cholecystectomy.

Conditions
-----------------
Cholelithiasis

Intervention / Treatment
-----------------
* Other: Acupuncture
* Drug: Ondansetron
* Drug: Physiological saline solution
* Other: Sham acupuncture
* Drug: Ondansetron
* Other: Acupuncture at P6 point
* Drug: Physiological saline solution
* Other: Sham acupuncture


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients ASA I-II scheduled for elective laparoscopic cholecystectomy. Exclusion Criteria: Patient's refusal Patients with history of carpal tunnel syndrome or eczema at P6 point Pregnant patients Female patients in a phase of the menstrual cycle other than premenstrual, nausea and vomiting within 24 hours before anaesthesia Known allergy to anti-inflammatory drugs, opioids and ondansetron. Patients with a pre-existing chronic pain disorder or with a gastrointestinal disease.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br>Patients receiving acupuncture at P6 point plus physiological saline solution | Other: Acupuncture<br> <br> Drug: Physiological saline solution<br> <br> |
| Active Comparator: B<br>Patients receiving ondansetron plus sham acupuncture | Drug: Ondansetron<br> <br> Other: Sham acupuncture<br> <br> |
| Other: C<br>Patients receiving ondansetron plus acupuncture at P6 point | Drug: Ondansetron<br> <br> Other: Acupuncture at P6 point<br> <br> |
| Placebo Comparator: D<br>Patients receiving physiological saline solution plus sham acupuncture | Drug: Physiological saline solution<br> <br> Other: Sham acupuncture<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| postoperative nausea and vomiting |  | 24 postoperative hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Patients undergoing laparoscopic cholecystectomy for cholelithiasis
Effect of Protein Composition on Gastric Emptying

Study Overview
=================
Brief Summary
-----------------
The protein composition of nutrition may affect the rate of gastric emptying and gastric fysiology. This is espesially important in children with neurologic impariment, who commonly rely on tube feedings, have feeding problems, nausea, vomiting, gastroesophageal reflux and delayed gastric emptying. We aim to find out whether 4 different protein sources affect the rate of gastric emptying and electrofysiology in this group of children.

Detailed Description
-----------------
Several factors in nutrition are known to affect gastric emptying rate, such as energy content, temperature, viscosity etc. In infants the protein composition affects gastric emptying. Children with cerebral pasly commonly have foregut dysmotility - with nausea, vomiting, feeding intolerance and gastroesophageal reflux. Tube feedings, usually based on cows milk are commonly used. Our hypothesis is that the source and thus protein composition of feeding affects gastric emptying rate and electrofysiology. Using four different tube feedings, standardized for content of fat, glucose and calories, we will measure gastric emptying rate using C13 octanoic acid as well as electrogastrography will be recorded. The protein modules are derived from casein, whey/casein mixture, hydrolyzed whey and aminoacids. Children with cerebral paresis and gastrostomy will be included. Each serves as his / her own control. The primary endpoint is gastric emptying rate, the secondary endpoint electrogastrography.

Official Title
-----------------
Effect of the Protein Composition on the Gastric Emptying Rate in Children With Cerebral Paresis

Conditions
-----------------
Cerebral Palsy, Gastric Dysmotility, Enteral Feeding

Intervention / Treatment
-----------------
* Procedure: Nutrition composition


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Cerebral paresis, user of tube feedings through gastrostomy - Exclusion Criteria: Use of valproic acid (interferes with breath test). Age >16 y. -

Ages Eligible for Study
-----------------
Minimum Age: 1 Year
Maximum Age: 16 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: Crossover Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Nutrition composition|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gastric emptying, measured by octanoic acid breath test. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Electrogastrography |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cerebral palsy, protein composition, gastric emptying rate, tube feeding
Prevalence of Malnutrition in Oncologic Patients

Study Overview
=================
Brief Summary
-----------------
Malnutrition is a common phenomenon in cancer patients. Deteriorated nutritional status is associated with poor clinical outcome. The purpose of this study is to determine the prevalence of hospital malnutrition and its impact on functionality, quality of life and mortality in cancer patients and to test the reference percentiles of phase angle values (Bosy Westphal et al JPEN 2006) as indicator of cancer cachexia and predictor of mortality. Hypothesis: The fifth reference percentile of the phase angle norm values is a prognostically relevant cut off value indicating cancer cachexia in terms of malnutrition, fatigue and impaired functional status, as well as predictive of 6-month mortality

Official Title
-----------------
Prevalence and Impact of Malnutrition in Hospitalised Patients

Conditions
-----------------
Cancer, Malnutrition

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients suffering from cancer. Patients who have signed a written Informed Consent. Exclusion Criteria: Patients with implanted pacemaker or defibrillator Patients with neuromuscular disease or hemiplegia.

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 |
| --- | --- | --- |
| Prevalence of malnutrition | Phase angle (bioelectrical impedance analysis) Nutritional status(SGA), muscle function (grip strength) | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life | Quality of life is determined with the questionnaire QLQ C-30 of the European Organisation for Research and Treatment of Cancer (EORTC) | 1 day | 
| Mortality | Patients are going to be contacted via telephone six months after the first assessment. Deceased patients will be determined by the local death register | 6 months | 
| Depression | Risk for depression is assessed using the Center for Epidemiological Studies Depression Scale (CES-D) | 1 day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
mortality, functional status
Artelon Metatarsophalangeal (MTP) Spacer

Study Overview
=================
Brief Summary
-----------------
The aim of this prospective, case series is to evaluate the surgical treatment of painful and disabling osteoarthrosis in the MTP-I joint by insertion of an Artelon MTP Spacer.

Official Title
-----------------
Artelon MTP Spacer - Surgical Treatment of Mild to Moderate Hallux Rigidus

Conditions
-----------------
Osteoarthritis, Hallux Rigidus

Intervention / Treatment
-----------------
* Device: Artelon MTP Spacer


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The patient experiences pain and limitations of the great toe dorsiflexion at the MTP-I joint. The patient has a clinically and radiographically verified arthritis in the MTP-I joint indicating the need for surgical treatment. The patient reads, understands and is able to complete the study questionnaires in Swedish. The patient has received written and oral information regarding the study and has signed the informed consent form. Exclusion criteria: The patient has a pronounced hallux rigidus without mobility in the MTP-I joint (ROM = 0°). The patient has previously received surgical treatment affecting the anatomy of the MTP-I joint. The patient has a systemic rheumatic disease, ongoing infection, hallux valgus or is seriously ill.
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: Artelon MTP Spacer<br>Metatarsophalageal hemi-implant | Device: Artelon MTP Spacer<br>* Metatarsophalangeal hemi-implant<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain, function and alignment of the treated toe evaluated by the investigator using the American Orthopeadic Foot & Ankle Society (AOFAS) clinical rating system. |  | pre-treatment and 12 months post-op |
Retrospective Case Study to Validate Existing Chemoresponse Marker Test in Ovarian, Peritoneal or Fallopian Cancer Cases

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to improve upon and validate the prognostic and/or predictive accuracy of a drug response marker by the development of improved alternative algorithms based on the actual clinical outcome of retrospective cases.

Detailed Description
-----------------
This is a multicenter, retrospective chart review study of de-identified drug response marker results and a limited data set of clinical outcome data. Data from approximately 512 cases will be collected from approximately 30 sites and correlated to the secondary endpoints identified in order to produce a training set that will incorporate additional improvements to the existing ChemoFx scoring system. The outcome of progression free survival will be defined as the period of time between the first dose of chemotherapy following the report of the marker result until clinical progression or death. Objective response will be measured from the first dose of chemotherapy following the report of the marker result until progression or change in therapy.

Official Title
-----------------
Retrospective Study to Develop a Training Set for a Cross Validated Chemoresponse Marker Algorithm in Cases With Ovarian, Peritoneal or Fallopian Tube Cancer

Conditions
-----------------
Ovarian Cancer, Peritoneal Cancer, Fallopian Tube Cancer

Intervention / Treatment
-----------------
* Other: ChemoFx


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Case has an original pathology report showing, epithelial ovarian, peritoneal, or fallopian tube carcinoma. Cases must meet one of the following classifications: Recurrent: Complete Response following primary therapy and a period of absence of no measurable disease; Persistent: Partial Response following 6 cycles of a platinum based therapy with measurable disease remaining or Refractory: Stable Disease or Progressive Disease during primary platinum therapy. Case must have a commercial ChemoFx drug response marker final report Exclusion Criteria: Cases with evidence of synchronous primary endometrial cancer or a past history of primary endometrial cancer are excluded unless all of the following conditions are met: Stage not greater than I-B; Less than 3 mm invasion without vascular or lymphatic invasion; No poorly differentiated subtype, including papillary serous, clear cell, or other FIGO Grade 3 lesion.

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Ovarian, Peritoneal, Fallopian Cancer<br>Recurrent, Peristent or Refractory | Other: ChemoFx<br>* Chemoresponse Marker Assay<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Single-Operator Versus Dual-Operator Double-balloon Endoscopy in Patients With Small-Bowel Disorders

Study Overview
=================
Brief Summary
-----------------
Double-balloon endoscopy (DBE) is a new device that allows diagnosis and treatment throughout the entire small intestine. Although the originally described method requires two operators, the investigators have recently developed a method to perform DBE by a single operator. The investigators here assessed the clinical usefulness of this one-person method in comparison to the conventional two-person DBE.

Official Title
-----------------
Prospective Trial Comparing Single-Operator and Dual-Operator Double-balloon Endoscopy in Patients With Small-Bowel Disorders

Conditions
-----------------
Small-Bowel Disorders

Intervention / Treatment
-----------------
* Procedure: Single-operator double-balloon endoscopy
* Procedure: dual-operator double-balloon endoscopy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: suspected or known small-bowel disease age: 16-70 Exclusion Criteria: pregnancy coagulation disorders prior surgery of the small bowel and colon

Ages Eligible for Study
-----------------
Minimum Age: 16 Years
Maximum Age: 70 Years

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

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

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

Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Single-operator DBE<br>Single-operator double-balloon endoscopy | Procedure: Single-operator double-balloon endoscopy<br>* Single-operator double-balloon endoscopy<br>|
| Active Comparator: Dual-operator DBE<br>Dual-operator double-balloon endoscopy | Procedure: dual-operator double-balloon endoscopy<br>* dual-operator double-balloon endoscopy<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| completion whether the complete enteroscopy is achieved? | The completion rate for examination of the entire small intestine | 2 hours | 
| lesion-discovery | lesion-discovery rate | 2 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| observation time |  | 2 hours | 
| Number of Participants with Adverse Events |  | 2 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
double-balloon endoscopy, diagnostic yield
Swallowing Disorders in Minimally Consciousness Patients (MCS)

Study Overview
=================
Brief Summary
-----------------
This study aimed to characterize swallowing disorders in minimally consciousness patients after brain traumatic injury.

Detailed Description
-----------------
After inclusion, the patients will underwent a videofluoroscopy and the Wessex Head Injury Matrix.

Official Title
-----------------
Swallowing Disorders and Consciousness Alteration in Severe Traumatic Brain Injury Patients

Conditions
-----------------
Swallowing Disorder, Traumatic Brain Injury

Intervention / Treatment
-----------------
* Other: videofluoroscopy
* Other: Wessex Head Injury Matrix scale


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Legal representant signed Aged between 18 and 70 years Having a severe TBI (Glasgow < 8) Without counterindication to underwent a VideoFluoroScopy Could hold a setting position Exclusion Criteria: Pregnancy ongoing Having a pathologic al examination of IX, X, XII cranial nerve examination Massif faciale fracture Psychiatric illness Medical history of swallowing disorders

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 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
Interventional Model Description: Description of swallowing
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Minimally consciousness Patient<br>Wessex Head Injury Matrix scale and Videofluoroscopy for characterization of swallowing disorders in Minimally consciousness Patient | Other: videofluoroscopy<br>* Swallowing description in Minimally consciousness Patient<br>Other: Wessex Head Injury Matrix scale<br>* Wessex Head Injury Matrix scale in Minimally consciousness Patient<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stages of swallowing disorders | swallowing disorder stage is done using videofluoroscopy | Day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation between Wessex Head Injury Matrix (WHIM) and stage of swallowing disorder | Correlation between Wessex Head Injury Matrix (WHIM) and swallowing disorder (Videofluoroscopy) | Day 1 |
Mannose Binding Lectin Gene Polymorphism Versus Microbial Virulence in the Pathogenesis of Vulvovaginal Candidiasis

Study Overview
=================
Brief Summary
-----------------
The vaginal mucosa is inhabited by both fungal and bacterial microorganisms which normally co-exist with the host in a tightly regulated and commensal manner.

Detailed Description
-----------------
Nevertheless, under certain circumstances, this co-existence can turn into a pathologic state followed by symptomatic disease

Official Title
-----------------
Mannose Binding Lectin Gene Polymorphism Versus Microbial Virulence in the Pathogenesis of Vulvovaginal Candidiasis in Egypt

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

Intervention / Treatment
-----------------
* Diagnostic Test: blood sample


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 1. Married females in the reproductive age period. 2. Females complaining of vaginal discharge (whitish and scanty), itching, dyspareunia, pruritis, and signs of vulvovaginitis ie. erythema. Exclusion Criteria: females who attended the same clinic in the same period, matched the cases regarding the age group, without having Candida infection as confirmed by culture of vaginal swabs.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 42 Years

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: blood sample|Whole blood was collected on EDTA (1mg/ml) to prevent clotting and DNA degradation.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the number of women who have mutation in MBL2 gene polymorphism | women who have mutation in MBL2 gene polymorphism | a month |
Combination Therapy With Fludarabine, Mitoxantrone and Rituximab in Mantle Cell Lymphoma

Study Overview
=================
Brief Summary
-----------------
This study is being done in order to determine the effectiveness of the combination of fludarabine, mitoxantrone, and rituximab in patients with mantle cell lymphoma. All three drugs,fludarabine, mitoxantrone, and rituximab have been approved by the U.S. Food and Drug Administration (FDA)for the treatment of certain types of lymphoma. Rituximab is a drug (called a monoclonal antibody) which has anti-tumor activity on certain types of lymphoma. The combination of chemotherapy (fludarabine and mitoxantrone) with rituximab has not yet been investigated in patients with mantle cell lymphoma and therefore the combination in investigational.

Official Title
-----------------
A Pilot Phase II Trial of Combination Therapy With Fludarabine, Mitoxantrone and Rituximab in Mantle Cell Lymphoma

Conditions
-----------------
Mantle Cell Lymphoma

Intervention / Treatment
-----------------
* Drug: Fludarabine, Mitoxantrone and Rituximab


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pathologic diagnosis of Non-Hodgkin's Lymphoma of the mantle cell sub-type lymphoma only, as determined by morphologic assessment and consistent immunophemotypic markers Newly diagnosed and patients who have received prior treatment are eligible Measurable or evaluable disease Karnofsky performance status greater or equal to 50% Men and women, age greater or equal to 18 years old AGC greater or equal to 1.0; platelets greater or equal to 75,000; Hemoglobin greater or equal to 8.0 (unless because of lymphomatous infiltration of the marrow) Creatinine less than 2.0; bilirubin less than 2.0; SGOT less than 3 times upper limit of normal (unless elevations are due to lymphomatous involvement) Women of child bearing potential must have negative pregnancy test within 14 days of study entry. Signed informed consent Exclusion Criteria: History of congestive heart failure or significant cardiac disease Prior exposure to either fludarabine or mitoxantrone. Prior exposure to rituximab allowed Active infection HIV seropositive Pregnant or lactating females Second active malignancy, other than squamous cell skin cancer,in-situ cervical cancer, or history of other cancer diagnosed within the preceding 5 years Presence of psychological or emotional disorders which would make valid informed consent impossible

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

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Fludarabine, Mitoxantrone and Rituximab|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |