linjc16/ctgov huggingface dataset:
Nystatin Pastilles for the Prevention of Oral Candidiasis in Patients With AIDS or ARC

Study Overview
=================
Brief Summary
-----------------
To determine a safe, effective, and convenient dosing schedule for nystatin pastilles in the prevention of oral candidiasis in patients with AIDS or AIDS related complex (ARC) (group III or IV, CDC classification).

Official Title
-----------------
Nystatin Pastilles for the Prevention of Oral Candidiasis in Patients With AIDS or ARC

Conditions
-----------------
Candidiasis, Oral, HIV Infections

Intervention / Treatment
-----------------
* Drug: Nystatin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria Concurrent Medication: Allowed: Systemic or oral antibiotics. Experimental drugs (IND drugs) which are targeted specifically against the AIDS (group IV CDC classification) virus or stimulate the immune system. Patients with the following conditions are included: AIDS or AIDS related complex (ARC) (HIV infection Group 3 or 4, CDC classification) who have had culture-proven oral candidiasis clinically cured within 7 days of study entry and are likely to be compliant for the 20 weeks of nystatin pastille prophylaxis. Able to follow instructions regarding the use of a pastille. Patients entering part II of this study (randomized double-blind) must have been clinically cured of oral candidiasis within 1 - 7 days of entry into this randomized study. Oral lesions such as Kaposi's sarcoma, herpes zoster, and herpes simplex can be enrolled. Exclusion Criteria Co-existing Condition: Patients with the following are excluded: Systemic candidiasis. Hypersensitivity to nystatin. Suspected or proven candidal esophagitis. Patients with the following are excluded: Systemic candidiasis. Projected survival of less than 6 months. Unable to maintain a pastille in the buccal cavity for approximately 20 minutes twice a day. Hypersensitivity to nystatin. Suspected or proven candidal esophagitis.

Ages Eligible for Study
-----------------
Minimum Age: 12 Years

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

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

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

Design Details

Primary Purpose: Treatment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Nystatin|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
-----------------
Nystatin, AIDS-Related Opportunistic Infections, Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Candidiasis, Oral
Psychosocial Interventions in the Treatment of Youth With Type 1 Diabetes Mellitus

Study Overview
=================
Brief Summary
-----------------
Primary Objective is to evaluate the influence of psychosocial interventions in the treatment of children and adolescents with type 1 diabetes mellitus by measuring the connection between these interventions to quality of life and to metabolic control. Secondary Objective is to provide an opportunity, through quality of life (QOL) questionnaires, for enhanced communication between the patient, family and diabetes care team and also an opportunity to resolve negative issues.

Official Title
-----------------
Intensive Individual and Familial Psychosocial Interventions in the Treatment of Children and Adolescents With Type 1 Diabetes Mellitus

Conditions
-----------------
Diabetes Mellitus

Intervention / Treatment
-----------------
* Behavioral: psychosocial intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All children and adolescents with type 1 diabetes mellitus attending Assaf Harofeh Pediatric Diabetes Clinic will be eligible for inclusion in the study.

Ages Eligible for Study
-----------------
Maximum 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 |
| --- | --- |
| Diabetes mellitus<br>All children and adolescents with type 1 diabetes mellitus attending Assaf Harofeh Pediatric Diabetes Clinic | Behavioral: psychosocial intervention<br>* The interventions will include an art therapist, a social worker and volunteer work under the supervision of a diabetes nurse. These therapies will be given to selected patients based on individual needs. We will use existing questionnaires in order to identify problematic areas and quantify quality of life<br>|

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
-----------------
diabetes mellitus, psychosocial, metabolic control, quality of life questionnaires, children, adolescents
Comparison of Staples Versus Subcuticular Suture in Class III Obese Women Undergoing Cesarean Delivery

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the optimal skin closure technique (staples versus subcuticular suture) at the time of cesarean delivery in Class III obese women with body mass index (BMI) of >/= 40kg/m2.

Official Title
-----------------
Comparison of Staples Versus Subcuticular Suture in Class III Obese Women Undergoing Cesarean Delivery

Conditions
-----------------
Obesity, Severe, Cesarean Section

Intervention / Treatment
-----------------
* Device: Absorbable subcuticular suture
* Device: Stainless steel staples


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women > 18 years old undergoing cesarean delivery BMI of >/= 40 kg/m2 as determined by height and weight reported during their admission Live gestation 23 weeks or greater Women who are able to follow-up 7-14 days after hospital discharge for a visual wound check.. Exclusion Criteria: Active lupus flare HIV/AIDS Current treatment for cancer or h/o radiation to the abdomen/pelvis Hypersensitivity to steri-strips

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Stainless steel staples<br>Patients in this arm will receive stainless steel staples for skin closure at time of cesarean section. | Device: Stainless steel staples<br>* Patients will receive stainless steel staples for skin closure at time of cesarean section.<br>* Other names: Staples;|
| Active Comparator: Absorbable subcuticular Suture<br>Patients will receive absorbable subcuticular suture for skin closure at time of cesarean section. | Device: Absorbable subcuticular suture<br>* Patients will receive absorbable subcuticular suture for skin closure at time of cesarean section.<br>* Other names: 3-0 monocryl;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composite Wound complication | Rate of wound complications defined as composite wound complication, which includes infection requiring antibiotics, hematoma, seroma, separation or disruption, and/or readmission to the hospital for wound concerns. | Within 6 weeks postpartum | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient satisfaction with wound healing | Patients' satisfaction with the healing of their wound within 7-14 days after hospital discharge. | Within 2 weeks postpartum | 
| Patient pain score | Patients' pain associated with their wound within 7-14 days after hospital discharge. | Within 2 weeks postpartum |
Machine Learning Predict Acute Kidney Injury in Patients Following Cardiac Surgery

Study Overview
=================
Brief Summary
-----------------
Cardiac surgery-associated acute kidney injury (CSA-AKI) is a major complication which may result in adverse impact on short- and long-term mortality. The investigatorshere developed several prediction models based on machine learning technique to allow early identification of patients who at the high risk of unfavorable kidney outcomes. The retrospective study comprised 2108 consecutive patients who underwent cardiac surgery from January 2017 to December 2020.

Official Title
-----------------
Using Machine Learning to Predict Acute Kidney Injury in Patients Following Cardiac Surgery

Conditions
-----------------
Machine Learning, Acute Kidney Injury

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age over 18 years who underwent cardiac surgery Exclusion Criteria: data miss greater than 10%

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

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| acute kidney injury | postoperative AKI was defined according to KDIGO criteria during the first 7 days after operation. Postoperative AKI was defined as either at an increase of at least 50% within 7 days or 0.3 mg/dL elevation within 48 h compared with the reference serum creatinine level. | 7 days |
Vaginal Tactile Imaging in Assessment of Pelvic Floor Conditions

Study Overview
=================
Brief Summary
-----------------
The clinical study includes investigation of the outcomes of surgery for biomechanical restoration of pelvic floor conditions, monitoring pelvic floor conditions under conservative treatment/management, identification and investigation changes of pelvic floor muscle contractions and their significance in characterization of pelvic floor conditions, assessment of tactile imaging reproducibility, including pelvic floor muscle contraction.

Official Title
-----------------
Vaginal Tactile Imaging in Assessment of Pelvic Floor Conditions

Conditions
-----------------
Pelvic Organ Prolapse

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: No prior pelvic floor surgery, and Normal pelvic floor conditions, or POP Stage I affecting one or more vaginal compartment, or POP Stage II affecting one or more vaginal compartment, or POP Stage III affecting one or more vaginal compartment, or POP Stage IV affecting one or more vaginal compartment. Exclusion Criteria: Active skin infection or ulceration within the vagina Presence of a vaginal septum; Active cancer of the colon, rectum wall, cervix, vaginal, uterus or bladder; Ongoing radiation therapy for pelvic cancer; Impacted stool; Significant pre-existing pelvic pain including levator ani syndrome, severe vaginismus or vulvadynia; Severe hemorrhoids; Significant circulatory or cardiac conditions that could cause excessive risk from the examination as determined by attending physician; Current pregnancy.

Ages Eligible for Study
-----------------
Minimum Age: 21 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Pre/post surgery pelvic floor assessment<br> | |
| Conservative treatmen monitoring<br> | |
| Pelvic floor muscle contrictions<br> | |
| Imaging reproducibility<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tissue elasticity measured as a gradient in tactile image. Unit of Measure: kPa/mm |  | From 1 day to 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pelvic Floor Biomechanics, Tissue Elasticity, Tactile Imaging
Effects of Neo40(TM) With Caffeine on Cycling Time Trial Performance

Study Overview
=================
Brief Summary
-----------------
Acute supplementation of Neo40(TM), a nitrate lozenge, will improve cycling performance

Official Title
-----------------
Effects of Neo40(TM) With Caffeine on Cycling Time Trial Performance

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

Intervention / Treatment
-----------------
* Dietary Supplement: Placebo
* Dietary Supplement: Nitrate supplement with caffeine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Regular commuter cyclist or spin class participant Male (VO2max < 50) or Female (VO2max < 45) Healthy Blood pressure below 140/90 Non-smoker Exclusion Criteria: Does not cycle 2-3 times/week Regular consumption of performance-enhancing substances Type I or Type II diabetes Renal, hepatic or cardiac disease Current infectious disease

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 49 Years

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

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

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

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Nitrate supplement with caffeine<br> | Dietary Supplement: Nitrate supplement with caffeine<br>* Lozenge consisting of beetroot and 75 mg caffeine<br>|
| Placebo Comparator: Placebo<br> | Dietary Supplement: Placebo<br>* Same form factor and flavor as test lozenge but contains no active ingredients<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improved Time Trial Performance | Participants will cycle 20 min at increasing intensity: 8 min at 55% VO2max, 6 min at 65% VO2max, 6 min at 75% VO2max. The 20 km time trial consists of rolling hills. | After 20 min steady-state cycling | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improved work efficiency | Expired gases will be collected and compared to expected VO2. Blood will be collected prior to treatment, prior to exercise and during each cycling intensity to analyze lactate accumulation. | During 20 min steady-state cycling | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
nitric oxide, cycling performance, lactate, VO2
Impact of Fish Oil Supplementation in 3rd Trimester of Pregnancy on Maternal and Offspring Health

Study Overview
=================
Brief Summary
-----------------
The aim of the trial is to investigate the effect of daily supplementation with 2.7 grams of long chain n-3 fatty acids during the third trimester of pregnancy. In 1990, 533 pregnant women, while they were in gestational week 30, were randomized to fish oil supplements providing the mentioned amount of long chain n-3 fatty acids, olive oil supplements, or no supplements; they were asked to take the supplements until delivery. Health outcomes were assessed during pregnancy and delivery. Further, offspring health and development has been examined during the ensuring two decades by making linkages to the rich Danish health and administrative registries, by asking the offspring to complete web-based questionnaires, and by examining the offspring physically.

Official Title
-----------------
Impact of Fish Oil Supplementation in 3rd Trimester of Pregnancy on Maternal and Offspring Health

Conditions
-----------------
Preterm Delivery, Atopy, Metabolic Syndrome

Intervention / Treatment
-----------------
* Dietary Supplement: Fish oil
* Dietary Supplement: Olive oil


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy pregnant women in gestation week 30 Exclusion Criteria: Bleeding episodes during pregnancy

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 50 Years

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

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

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

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Fish oil supplementation<br>These women received 4 1-g capsules of fish oil per day providing 2,7 grams long chain n-3 fatty acids per day, from gestation week 30 until delivery | Dietary Supplement: Fish oil<br>* 4 1-g gelatine capsules per day providing 2,7 grams long chain n-3 fatty acids<br>* Other names: Pikasol;|
| Placebo Comparator: Olive oil<br>These women received 4 1-g capsules with olive oil per day from gestational week 30 until delivery | Dietary Supplement: Olive oil<br>* 4 1-g gelatine capsules with virgin olive oil<br>|
| No Intervention: No oil supplement<br>These women received no capsules with oil | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gestation length | We assesed impact of fish oil supplementation in pregnancy on timing of spontaneous delivery | 1989-1990 (1 year) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
RCT, Fish oil, Pregnancy, Birth weight, Gestational age, Asthma and allergies, Metabolic syndrome, Obesity
A Study to Evaluate the Risk of Developing a Heart Condition Called Valvular Regurgitation in Patients With Acromegaly Treated With Either Lanreotide or Octreotide

Study Overview
=================
Brief Summary
-----------------
The aim of the study is to compare the risk of acromegaly patients developing valvular regurgitation when receiving lanreotide or octreotide

Official Title
-----------------
A Multicentre Prospective Controlled Observer Blinded Cohort Study in Patients With Acromegaly to Evaluate the Risk of Cardiac Valvular Regurgitation in Patients Treated With Lanreotide Relative to Patients Treated With Octreotide

Conditions
-----------------
Acromegaly

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient has a diagnosis of Acromegaly Patient is being treated with lanreotide or octreotide in any dose form at the selection visit or is a de novo patient who is due to commence treatment within 2 weeks of baseline Patient started treatment with either lanreotide or octreotide when both products were available on the market in their country Patient must not change treatment form lanreotide to octreotide or vice versa for the duration of the study Exclusion Criteria: Patients with known significant valve abnormalities prior to treatment with either lanreotide or octreotide Patients who have received treatment with a somatostatin analogue other than lanreotide or octreotide for more than 3 months Patients who have received treatment with a GH antagonist for more than 3 months Patients who have had heart valve replacement therapy

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 |
| --- | --- | --- |
| Assessment of the risk of new or worsening valvular regurgitation in any valve by echocardiography at baseline & 12 months |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of the risk of new or worsening valvular regurgitation in any valve by echocardiography at baseline & 6 months |  |  | 
| Risk in each of the 4 valves at 6 & 12 months |  |  | 
| Risk of significant regurgitation in each valve at 6 & 12 months |  |  | 
| Prevalence of valvular regurgitation at baseline |  |  | 
| Assessment of GH and IGF-1 levels at baseline, 6 months & 12 months |  |  |
Pain After Deep Electrical Stimulation in the Groin in Pain Free Subjects

Study Overview
=================
Brief Summary
-----------------
Sensory disturbances in persistent postherniotomy pain, include hyperalgesia from deeper structures as well as the skin. Whether this is one combined pain syndrome, where for instance deep pain leads to cutaneous hyperalgesia, or two isolated synchronous pain conditions, is unknown. By Giving pain free subjects an intense non-harmful electrical stimulation in deeper tissues in the groin and recording the skin sensory function, this hypothesis will be tested

Official Title
-----------------
Hyperalgesia After Deep Electrical Stimulation in Pain Free Subjects

Conditions
-----------------
Persistent Postherniotomy Pain

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: male, age >18 yr, pain-free, caucasian Exclusion Criteria: previous groin surgery, groin hernia, sensory disturbaces, use of painmedication, drug or alcohol abuse.

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br>1. Healthy, un-operated, groin-hernia free, pain-free and medicinal free males | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in skin pain detection threshold before and during deep electrical pain stimulation. | Heat pain detection threshold by use of a Thermotester (Somedic AS Sweden) is assessed before and during deep electrical pain stimulation (6 of 10 point on a NRS scale. Deep pain stimulation is performed by two needle electrodes, placed under ultrasound guidance, 5 mm apart in various tissue and locations in the groin: Musculus rectus abdominis dxt. ( 10 cm craniel to the external inguinal ring) - Subcutaneous, and muscular stimulation. Spina iliaca anterior superior dxt. ( 2 cm lateral to the ilica spine) - subcutaneous, m obliquus externus and nervns ilioinguinalis stimulation. External inguinal ring - subcutaneous and funicle stimulation. | 14 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Test-retest of primary outcome | The primay and additional assesments are re-measured 14 days after the primary assemssment to allow evaluation of test-retest reliability. | 14 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hyperalgesia, Persistent pain, deep pain, electrical stimulation, groin hernia