linjc16/ctgov huggingface dataset:
A Study of KRN23 in Subjects With X-linked Hypophosphatemic Rickets/Osteomalacia

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to assess the safety and tolerability of KRN23 after a single subcutaneous (SC) administration in subjects with X-linked hypophosphatemic rickets/osteomalacia (XLH) in Japan or Korea.

Official Title
-----------------
A Phase 1, Multicenter, Open-label, Sequential Dose-escalation, Single-dose Study to Assess the Safety and Tolerability of KRN23 in Subjects With X-linked Hypophosphatemic Rickets/Osteomalacia.

Conditions
-----------------
X-linked Hypophosphatemic Rickets/Osteomalacia

Intervention / Treatment
-----------------
* Drug: KRN23


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years or older Patients with XLH Exclusion Criteria: Have an active infection or chronic inflammatory disease Have uncontrolled hypertension Have uncontrolled diabetes mellitus History of known immunodeficiency Use of a pharmacologic vitamin D metabolite or its analogs within 21 days prior to screening and after screening Use of phosphate, calcium preparation, calcimimetics, aluminum hydroxide antacids, thiazide diuretic, acetazolamide, or phosphate, calcium, and/or vitamin D-containing supplements within 10 days prior to screening and after screening Pregnant or lactating females, women who are possibly pregnant or patients who have no intention of utilizing adequate contraception

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 |
| --- | --- |
| Experimental: KRN23<br>Single SC administration on day 1 | Drug: KRN23<br>* Single SC administration on day 1: 0.3, 0.6 and 1.0 mg/kg<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number and types of adverse events | The safety of KRN23 assessed by number and types of adverse events, laboratory tests | Up to 7 weeks after dosing | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Profiles of pharmacokinetics |  | Pre-dose, 24, 48, 96, 168, 336, 504, 672, 840, 1176 hours post-dose | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
XLH
Effects of High Voltage Electrical Stimulation, Shortwave Diathermy and Kinesiotherapy on Arterial Blood Flow in the Lower Limbs of Diabetic Women

Study Overview
=================
Brief Summary
-----------------
Peripheral arterial disease (PAD) is a pathological condition limiting, resulting from a narrowing or occlusion of the artery diameter due to aneurysms, inflammation, atherosclerosis and thromboembolic events. One of the main risk factors for the development of DAP is diabetes mellitus due to its relation to the process of atherogenesis. Thus, the objective of this study is to evaluate the effects of three treatment modalities for PAD on the blood flow velocity. It is a crossover study. Fifteen women with diabetes receive three types of treatment, the order defined according draw: high voltage electrical stimulation, shortwave diathermy and kinesiotherapy. The blood flow of the lower limb will be assessed by Doppler ultrasound. The hypothesis of this study is that physical therapy resources increase the circulation of the lower limb.

Conditions
-----------------
Diabetes, Peripheral Arterial Disease

Intervention / Treatment
-----------------
* Other: high-voltage electrical stimulation
* Other: Kinesiotherapy
* Other: shortwave diathermy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women Diagnosis of diabetes Diagnosis of peripheral arterial disease Exclusion Criteria: Regular physical activity Smokers Thrombosis active Severe peripheral arterial disease

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 90 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Kinesiotherapy<br>Will be made active and resisted exercises of the lower limbs. | Other: Kinesiotherapy<br> <br> |
| Experimental: shortwave diathermy<br>Will be applied for 20 minutes on the lower limbs. | Other: shortwave diathermy<br> <br> |
| Experimental: high-voltage electrical stimulation<br>The therapeutic current will be applied for 20 minutes on lower limbs. | Other: high-voltage electrical stimulation<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Doppler ultrasound | Will evaluate the blood flow in the following arteries of the lower limbs: femoral, popliteal, posterior tibial and dorsalis pedis. | 1 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Physical Therapy Modalities, Electric Stimulation Therapy, Hyperthermia, Induced, Diabetes Mellitus
Recurrent Failures in assIsted Reproductive Techniques (The FIRST Registry)

Study Overview
=================
Brief Summary
-----------------
Assisted Reproductive Technologies (ARTs) are widely used in couples with fertility problems. However, despite ART treatment options have evolved over time, the implantation rate remains rather low. A possible role for inherited and acquired thrombophilias has been invoked, especially in women with previous implantation failures. However, several factors could play a role in these conditions. A potential benefit of low-molecular-weight heparin (LMWH) in improving ART outcomes, independently of the presence of thrombophilia, has been recently suggested. This register is designed in order to better define all possible variables influencing ART outcome and improve clinical management of women with previous implantation failures. During this study the investigators will collect and evaluate clinical data regarding the first cycle in women with previous ART failures.

Official Title
-----------------
A Registry on Outcomes in Women Undergoing Assisted Reproductive Techniques After Recurrent Failures

Conditions
-----------------
Infertility

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 2 or more implantation failures/losses of clinical pregnancies after ART ART cycle at enrolment Informed consent Exclusion Criteria: Ovarian hypofunction Uterine pathology Hydrosalpinges Previous inclusion in the study

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

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of live births |  | 10 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of clinical pregnancies after ART |  | 10 months |
Kanglaite Injection Phase I Study

Study Overview
=================
Brief Summary
-----------------
The Kanglaite Injection (KLT)is a novel broad spectrum anti-cancer injection produced from traditional Chinese medicinal herbs (the Coix Seed). It was approved in China in 1995 and has become the most popular anti-cancer drug in China. In June of 2001, the Phase I study of KLT commenced at the Huntsman Cancer Institute in Salt Lake City, Utah, with the objectives of 1) To determine the maximum tolerated dose (MTD) and the safety profile of KLT in patients with refractory solid tumors; 2) To determine the pharmacokinetics of KLT in patients with refractory solid tumors; and 3) To gather preliminary efficacy data. The method of testing is open-label, sequential cohort, dose-escalation study.

Official Title
-----------------
Phase I Study of KLT in Patients With Solid Tumors Refractory to Standard Therapy

Conditions
-----------------
Solid Tumors Refractory To Standard Therapy, Neoplasms

Intervention / Treatment
-----------------
* Drug: Kanglaite Injection (KLT)


Participation Criteria
=================
Eligibility Criteria
-----------------
Patients with histological evidence of malignancy that has become refractory to standard therapy, or for whom effective standard therapy does not exist. Patients with an estimated life-expectancy of at least 3 months Patients with a Karnofsky Performance Score of at least 60% Patients with no history of congestive heart failure (CHF), and normal ejection fraction by echocardiography Patients with adequate renal and hepatic function Patients with adequate bone marrow status

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: Kanglaite Injection (KLT)|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
-----------------
MTD, Safety, Pharmacokinetics, Efficacy
The Effect of a Multispecies Probiotic on Hypersensitivity in Irritable Bowel Syndrome (IBS) Patients

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether a specifically designed multispecies probiotic decreases visceral hypersensitivity in IBS-patient (defined by an increased pain tolerance threshold). Moreover, the effect on general symptom scores and inflammatory and microbiological parameters will be studied.

Official Title
-----------------
The Effect of a Multispecies Probiotic on Hypersensitivity in IBS Patients

Conditions
-----------------
Irritable Bowel Syndrome, Hypersensitivity

Intervention / Treatment
-----------------
* Dietary Supplement: multispecies probiotic (Ecologic 801)
* Dietary Supplement: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical diagnosis of IBS according to the Rome III criteria Increased visceral perception according to barostat measurements, defined as a pain tolerance threshold at smaller than or equal to 23 mmHg Age between 18 and 65 years BMI between 18.5 and 30 kg/m2 Exclusion Criteria: Known gastro-intestinal diseases Major abdominal surgery Previous radiotherapy, chemotherapy Clinical significant systemic diseases Critically ill patients or patients suffering from severe acute pancreatitis Patients with organs failure Patients receiving enteral feeding Excessive alcohol intake (greater than 15 consumptions per week) (planned) pregnancy or lactation Use of pre-, probiotics in the month before and during the study Use of antibiotics in the two months before and during the study Use of anti-diarrhoea medication, anti-laxatives or anti-acid medication in the two weeks before and during the study Use of anti depressives (especially SSRI's) in the month before and during the study Use of other medication if less then one month on stable dosage

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Dietary Supplement: multispecies probiotic (Ecologic 801)<br>* once daily, 5 gram [10e9 cfu/gram]<br>* Other names: Ecologic 801;|
| Placebo Comparator: 2<br> | Dietary Supplement: Placebo<br>* once daily, 5 gram [10e9 cfu/gram]<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain tolerance threshold |  | t=0 and t=6 weeks | 
| VAS score for pain at pressure step 29 mmHg |  | t=0 and t=6 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Irritable Bowel Syndrome, Hypersensitivity, Probiotics, Multispecies
A Study to Investigate the Pharmacokinetics, Safety and Tolerability of Voriconazole in Children

Study Overview
=================
Brief Summary
-----------------
This is a study to investigate the pharmacokinetics, safety and tolerability of several doses of voriconazole, intravenous and oral suspension formulations, in children

Official Title
-----------------
An Open-label, Intravenous to Oral Switch, Multiple Dose Multi-Centre Study to Investigate the Pharmacokinetics, Safety and Tolerability of Voriconazole in Hospitalized Children Aged 2 to 12 Years Who Require Treatment for the Prevention of Systemic Fungal Infections.

Conditions
-----------------
Neutropenia

Intervention / Treatment
-----------------
* Drug: Voriconazole


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Children who require a systemic antifungal agent for the prevention of systemic fungal infection Exclusion Criteria: Children who are receiving medications which cannot be taken concomitantly with voriconazole.

Ages Eligible for Study
-----------------
Minimum Age: 2 Years
Maximum Age: 12 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: Voriconazole|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary objective was to investigate the pharmacokinetics of voriconazole following intravenous (iv) to oral administration in immunocompromised children aged 2 to <12years. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The secondary objective was to evaluate the safety and tolerability of multiple dose administration of voriconazole in immunocompromised children requiring treatment for the prevention of systemic fungal infection. |  |  |
Prediction of Postoperative Acute Kidney Injury in Patients With Acute Type A Aortic Dissection Using Cystatin C

Study Overview
=================
Brief Summary
-----------------
The research aimed to predict postoperative acute kidney injury in patients with acute type A aortic dissection preliminarily by exploring the correlation of preoperative cystatin C level and incidence of postoperative acute kidney injury and combining with relevant risk factors.

Official Title
-----------------
Prediction of Postoperative Acute Kidney Injury in Patients With Acute Type A Aortic Dissection Using Cystatin C

Conditions
-----------------
Aortic Dissection, Acute Kidney Injury

Intervention / Treatment
-----------------
* Other: postoperative acute kidney injury
* Other: none postoperative acute kidney injury


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18-80 years old Acute type A aortic dissection diagnosed by CT angiography Exclusion Criteria: History of chronic kidney disease History of cardiovascular operation Pregnancy status

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 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 |
| --- | --- |
| AKI<br>patients suffered postoperative acute kidney injury | Other: postoperative acute kidney injury<br>* patients suffered postoperative acute kidney injury<br>|
| Non-AKI<br>patients did not suffer postoperative acute kidney injury | Other: none postoperative acute kidney injury<br>* patients did not suffered postoperative acute kidney injury<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| postoperative acute kidney injury | YES; NO | From date of operation until the date of acute kidney injury or date of death from any cause, whichever came first, assessed up to 30 days. |
INvestigational Study Into Transplantation of the Uterus

Study Overview
=================
Brief Summary
-----------------
Observational study on cohort of 10 women undergoing uterine transplantation using deceased donors

Official Title
-----------------
INvestigational Study Into Transplantation of the Uterus

Conditions
-----------------
Mayer-Rokitansky-Kuster Syndrome, Asherson's Syndrome, Postpartum Hemorrhage, Cervical Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Female Age - 24-38 (or 40 if eggs frozen <38) AUFI Normal length vagina No renal pathology BMI <30kg/m2 ASA grade I Meet psychological criteria Meet HFEA criteria for IVF Eligible for NHS treatment Speak fluent English Exclusion Criteria: Unsuccessful oocyte retrieval (<10 good quality embryos) Previous multiple/significant surgeries Severe endometriosis Cancer patients <5 years in remission Previous living childbirth, adopted child or child born through surrogacy HIV or Hepatitis B / C positive Skin or intestinal neovagina

Ages Eligible for Study
-----------------
Minimum Age: 24 Years
Maximum Age: 38 Years

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Live birth rate |  | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pregnancy rate |  | 5 years | 
| Transplant success rate |  | 3 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Gynaecology, Immunosuppression, In-vitro Fertilisation, Infertility, MRKH, Pregnancy, Transplantation, Uterus
Prebiotics as a Means to Modulate Gut Fermentation, Metabolism, Appetite and Cognition

Study Overview
=================
Brief Summary
-----------------
This study aims at investigating the impact of colonic fermentation of intrinsic indigestible carbohydrates in cereal whole kernels after three days consumption, on metabolic variables and cognition. The study is performed in healthy, normal to slightly over-weight test subjects.

Official Title
-----------------
Prebiotics as Means to Modulate Colonic Events, With the Purpose to Increase Beneficial Effects on Metabolism, Satiety and Cognition.

Conditions
-----------------
Metabolic Syndrome

Intervention / Treatment
-----------------
* Other: test meal
* Other: reference meal


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: BMI 19-28 kg/m2 Exclusion Criteria: gastrointestinal diseases metabolic disorders tobacco/snuff user antibiotic/probiotic treatment

Ages Eligible for Study
-----------------
Minimum Age: 50 Years
Maximum Age: 70 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: indigestible carbohydrates<br>test meal: indigestible carbohydrates | Other: test meal<br> <br> |
| Experimental: reference<br>reference meal: no indigestible carbohydrates | Other: reference meal<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the plasma concentration versus time curve (AUC) of the test meal | The differences in AUC between different risk markers, assessed in plasma or serum,after intake of the test meal in comparison to the reference meal is measured. Example of variables measured are glucose, insulin, appetite hormones, inflammatory markers, markers of colonic fermentation. | Post-prandially after breakfast, 0-150 min | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cognitive performance | The cognitive performance of the test subjects is measured to investigate work memory and specific attention. | Post-prandially after breakfast, 0-210 min | 
| Subjective satiety | The subjective sensation of satiety, hunger and desire to eat is measured using a questionnaire. | post-prandially after breakfast, 0-150 min |