linjc16/ctgov huggingface dataset:
Endometrial Scratching in Couples With Unexplained Subfertility

Study Overview
=================
Brief Summary
-----------------
Endometrial scratching in luteal phase of a spontaneous menstrual cycle may increase pregnancy rate in women with unexplained infertility.

Official Title
-----------------
Endometrial Scratching in Couples With Unexplained Subfertility

Conditions
-----------------
Subfertility

Intervention / Treatment
-----------------
* Procedure: scratching


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: women aged between 20 and 39 years with at least one year of infertility regular menstruation with the length of the cycle between 22-34 days and ovulation confirmed by appropriately timed mid-luteal progesterone fertile semen variables bilateral tubal patency (demonstrated by laparoscopy or hysterosalpingography).

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 39 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Scrathcing<br>scratching of endometrium on day 21-26 of a spontaneous menstrual cycle | Procedure: scratching<br>* scratching endometrium on day 21-26 of a spontaneous menstrual cycle<br>|
| Placebo Comparator: Control<br>Uterine sounding on day 21-26 of a spontaneous menstrual cycle | Procedure: scratching<br>* scratching endometrium on day 21-26 of a spontaneous menstrual cycle<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical pregnancy rate |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| miscarriage rate |  | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Unexplained infertility-endometrial scratching, effect of endometrial biopsy (scratching) on clinical pregnancy rates in women with unexplained infertility
Dermacyd PH_DETINLYN (Lactic Acid) Tangerine Mix - Compatibility

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to demonstrate the absence of irritation potential (primary dermic irritability and cumulated dermic irritability) and allergy (sensibilization) of the product Dermacyd PHDETINLYN Tangerine Mix.None.

Official Title
-----------------
Study for Dermatological Evaluation of Topic Compatibility (Primary and Accumulated Dermical Irritability, Dermical Sensitivity) of Dermacyd PH_DETINLYN (Lactic Acid) Tangerine Mix

Conditions
-----------------
Hygiene

Intervention / Treatment
-----------------
* Drug: Dermacyd PH_DETINLYN (Lactic Acid)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Phototype Skin I,II, III e IV Integral skin test in the region; Willingness in following the study procedures and to be present in the clinic at the days and scheduled time for medical evaluations and for application of occlusion; Exclusion inclusion: Lactation or gestation Use of Antiinflammatory and/or immunossupression drugs Personnel history of atopy; History of sensitivity or irritation for topic products; Active cutaneous disease; Use of new drugs or cosmetics during the study The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Dermacyd PH_DETINLYN (Lactic Acid) | Drug: Dermacyd PH_DETINLYN (Lactic Acid)<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The absence of primary and accumulated dermical irritability and dermical sensitivity will be evaluated using International Contact Dermatitis Research Group (ICDRG) scale. |  | Throughout the study |
Neuroendocrine Neoplasms Methylation Based Classifier - The NEMESIs-study

Study Overview
=================
Brief Summary
-----------------
Neuroendocrine neoplasms (NEN) are rare tumors that mainly occur in the gastrointestinal tract and the lungs. The currently available diagnostic and prognostic markers do not adequately represent the diversity of these tumors. Methylation analyzes of the tumor DNA represent a new, promising approach. The aim of this project is therefore to improve the diagnostic and prognostic evaluation of neuroendocrine neoplasms by means of methylation analysis of the tumor DNA. On the one hand, existing tumor samples from the biobank of Basel University Hospital are evaluated, on the other hand, patients who are undergoing an operation will be prospectively inquired

Official Title
-----------------
Neuroendocrine Neoplasms Methylation Based Classifier - The NEMESIs-study

Conditions
-----------------
Neuroendocrine Tumors

Intervention / Treatment
-----------------
* Diagnostic Test: Methylation analysis


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: neuroendocrine tumor Exclusion Criteria: insufficient amount or quality of neuroendocrine tumor sample

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 |
| --- | --- |
| Retrospective analysis<br>Methylome of existing neuroendocrine tumor samples from the biobank of Basel University Hospital will be evaluated | Diagnostic Test: Methylation analysis<br>* Methylation analysis<br>|
| Prospective analysis<br>Methylome analysis of tumor samples of neuroendocrine tumor patients undergoing an operation or biopsy will be prospectively evaluated | Diagnostic Test: Methylation analysis<br>* Methylation analysis<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Methylation-based classification of NEN samples | NEN samples will be classified according to methylation analysis | 3 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Methyloma
Ondexxya for Intravenous Injection 200mg Drug Use Result Investigation (All Case Investigation)

Study Overview
=================
Brief Summary
-----------------
This survey will be conducted to investigate the status of occurrence of the safety specifications set for Safety specification in patients who received Ondexxya Intravenous Injection 200 mg. In addition, this survey will be implemented to understand the followings by collecting safety and effectiveness information under actual use conditions.

Detailed Description
-----------------
This survey will be conducted to investigate the status of occurrence of the safety specifications set for Safety specification in patients who received Ondexxya Intravenous Injection 200 mg. In addition, this survey will be implemented to understand the followings by collecting safety and effectiveness information under actual use conditions. Detection of unknown adverse drug reactions Incidence of adverse drug reactions under actual use conditions of the drug Factors that may affect the safety or effectiveness Safety specification Thrombotic events, Infusion reaction, re-bleeding

Official Title
-----------------
Ondexxya for Intravenous Injection 200mg Drug Use Result Investigation (All Case Investigation)

Conditions
-----------------
Life Threatening Bleeding, Factor Xa Inhibitor

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients treated with this drug to neutralize the anticoagulant effect of a FXa inhibitor (apixaban, rivaroxaban, or edoxaban) at onset of a life-threatening bleeding episode or a unarrestable bleeding episode. Exclusion Criteria: N/A
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 |
| --- | --- | --- |
| Incidence of adverse drug reactions, Incidence of safety specifications, Incidence of adverse drug reactions by patient background factor | Incidence of adverse drug reactions, Incidence of safety specifications, Incidence of adverse drug reactions by patient background factor | 30days |
The Study of Association Between Intradialysis Sodium Balance and Clinical Outcomes in Chronic Hemodialysis Patients

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether the change of serum and dialysate sodium level during hemodialysis can influence on blood pressure and intradialytic weight gain in chronic hemodialysis patients.

Conditions
-----------------
End-stage Renal Disease

Intervention / Treatment
-----------------
* Device: hemodialysis


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age 20 years or more hemodialysis vintage over 3 months dialyzed for 4 hours three times per week hemodialysis adequacy (Kt/V) over 1.2 Exclusion Criteria: diagnosed with chronic hepatitis or infection

Ages Eligible for Study
-----------------
Minimum Age: 20 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 |
| --- | --- |
| chronic hemodialysis patients<br> | Device: hemodialysis<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| intradialytic sodium gradient | change of serum sodium level between initiation and termination of hemodialysis | baseline and 4 hours |
Paperless Partograph for Management of Low Risk Labor

Study Overview
=================
Brief Summary
-----------------
Paperless partograph is a technique used for monitoring the progress of labor before delivery, and arriving at the accurate time to intervene for ensuring a safe delivery. The study will be carried out to find out the effectiveness of paperless partograph in management of labor and its effect on maternal and neonatal outcomes

Official Title
-----------------
A Randomized Clinical Trial of Paperless Versus Modified World Health Organization Partograph in Management of First Stage of Labour

Conditions
-----------------
Normal Labor

Intervention / Treatment
-----------------
* Procedure: modified partograph
* Procedure: paperless partograph


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Age: 18 to 40 years Gestational age 38-42 weeks Singleton pregnancy Vertex presentation Women who will accept to participate in the study Exclusion criteria: Malpresentation Induced labour Multiple pregnancy Medical diseases with pregnancy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 Years

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

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

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

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: modified partograph<br>routine modified partograph | Procedure: modified partograph<br> <br> |
| Active Comparator: paperless partograph<br>paperless partograph with no graph paper | Procedure: paperless partograph<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of active phase of labor | calculated in hours between cervical dilatation more than 3 cm till fully dilated | 12 hours |
Prevention of Hypertension: A Randomized Trial

Study Overview
=================
Brief Summary
-----------------
To determine whether improved nutrition to correct overweight and high sodium intake, and regular frequent moderate rhythmic exercise to improve cardio-pulmonary fitness and to slow heart rate could lower blood pressure and prevent development of hypertension in hypertension-prone individuals.

Detailed Description
-----------------
BACKGROUND: Diet modification is one of the strategies in the primary prevention of hypertension. Studies of the association between various factors and blood pressure in different populations have shown the occurrence of specific dietary factors associated with elevated blood pressures. The factors include overweight, alcohol consumption and high sodium intake. Heart rate is also an independent predictor of risk of hypertension. Diet and exercise are amenable to intervention to influence blood pressure with the aim of reducing the risk of developing hypertension. DESIGN NARRATIVE: In the first phase of the trial participants were randomized to a Monitored (Control) Group or to an Intervention Group receiving individualized intervention to achieve changes in diet and physical activity. The goals of the Intervention Group were: a reduction of at least 10 pounds or 5 percent of body weight for those above desirable weight; a reduction in daily sodium intake to 1800 mg; a modification of alcohol intake to no more than two drinks per day; and an increase in regular, moderate physical activity. The primary endpoint in the first phase of the trial was the comparison of mean blood pressure in the Intervention Group versus the Monitored Group. In the second phase of the trial, all randomized participants were followed for a minimum of five years. The primary endpoints in the second phase were the incidence of high blood pressure and/or hypertension.

Conditions
-----------------
Cardiovascular Diseases, Heart Diseases, Hypertension, Vascular Diseases

Intervention / Treatment
-----------------
* Behavioral: diet, reducing
* Behavioral: diet, sodium-restricted
* Behavioral: alcohol restriction
* Behavioral: exercise


Participation Criteria
=================
Eligibility Criteria
-----------------
Men and women, ages 30 to 44. Normal high blood pressure of 80-89 mm Hg.

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 44 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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: diet, reducing|nan|
|Behavioral: diet, sodium-restricted|nan|
|Behavioral: alcohol restriction|nan|
|Behavioral: exercise|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Quantitative Determination of Brain Water Content in Patients During and After Hepatic Encepalopathy

Study Overview
=================
Brief Summary
-----------------
There is increasing evidence that the pathophysiology of hepatic encephalopathy (HE) is tightly associated with low-grade cerebral edema. Uptake of ammonia in astrocytes leads to osmotic swelling caused by glutamine formation. Previous studies were performed in covert HE patients or used indirect methods. Methods: The investigators wish to describes quantitative measurement of localized water content using MRI water mapping in a cohort of patients with cirrhosis during an episode of overt HE type C and again after recovery. Furthermore patients with cirrhosis and no history of HE and healthy subjects will be investigated as controls.

Official Title
-----------------
Quantitative Determination of Brain Water Content in Patients During and After Hepatic Encepalopathy Measured by MR

Conditions
-----------------
Hepatic Encephalopathy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with type C HE during and after HE, Patients with stable cirrhosis and Healthy subjects Exclusion Criteria: Patients with pace-maker Metal implants

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Absolute brain water content measured by water mapping |  | Patients are recruited during an episode of acute HE, the patients are rescanned within a time frame of 6 weeks. Patients with stable cirrhosis and healthy subjects are scanned only once. |
Perioperative Nutrition in Upper Gastrointestinal (GI) Cancer Surgery

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to demonstrate the influence of peri-operative nutrition on the post-operative complications, preservation of lean body mass and length of stay after gastrectomy or oesophagectomy.

Official Title
-----------------
Perioperative Nutrition in Upper GI Cancer Surgery (Oesophagectomy or Gastrectomy)

Conditions
-----------------
Stomach Neoplasms, Esophageal Neoplasms

Intervention / Treatment
-----------------
* Dietary Supplement: Impact
* Dietary Supplement: Glucose load


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Surgery for Upper GI cancer Age over 18 Informed consent Exclusion Criteria: Major swallowing disorders Dementia or other psychological state precluding compliance and understanding of research protocol Pre-existing enteral or parenteral nutrition

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nutrition<br>Pre-operative immunonutritrion, pre-operative glucose load, post-operative early immunonutrition | Dietary Supplement: Impact<br>* Preoperative 5 day oral Impact and early post-operative enteral Impact<br>Dietary Supplement: Glucose load<br>* Pre-operative glucose load: 800 ml of PreOp (Nutricia) 12 h before surgery; 400 ml of PreOp (Nutricia) 2 hours before surgery<br>* Other names: PreOp Nutricia;|
| No Intervention: Control<br>No immunonutrition, no glucose load, no early enteral immunonutrition | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of post-operative complications |  | 30 days | 
| Length of stay |  | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life |  | 1 year | 
| Body composition |  | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Gastric cancer, Esophageal cancer, Surgical complications, Immunonutrition
Protocol for Postmenopausal Women at Increased Risk of Developing Breast Cancer

Study Overview
=================
Brief Summary
-----------------
A study to examine the potential associations between common single nucleotide polymorphisms and pre-cancerous conditions in breast tissue specimens from postmenopausal women.

Detailed Description
-----------------
A study to examine the correlation between single nucleotide polymorphisms (SNPs) affecting steroid and carcinogen metabolism and benign breast tissue cytomorphology collected via random periareolar fine needle aspiration in postmenopausal women at increased risk for breast cancer and taking hormone replacement therapy.

Official Title
-----------------
Correlation of SNP Patterns With Fine Needle Aspiration Cytomorphology in High Risk Postmenopausal Women

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

Intervention / Treatment
-----------------
* Procedure: Fine needle aspiration


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: postmenopausal women on or off hormone replacement therapy at high risk of developing breast cancer determined by family or personal history postmenopausal women not on hormone replacement therapy for at minimum six months prior to corresponding aspiration willing to participate in companion protocol (KUMC HSC#4601) for random periareolar fine needle aspiration (RPFNA) for correlational studies Exclusion Criteria: women who have been on raloxifene, tamoxifen, letrozole, anastrozole or exemestane within the six months prior to RPFNA.

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 |
| --- | --- |
| 1<br>Post-menopausal women who are at increased risk for development of breast cancer on the basis of family or personal history. | Procedure: Fine needle aspiration<br>* Fine needle aspiration<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation of SNP patterns with cytlomorphology of breast fine needle aspirates. | develoment of algorithm for prediction of risk of developing breast cancer. | ongoing | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
SNPs, single nucleotide polymorphism, breast atypia, breast epithelial hyperplasia, high risk for breast cancer