linjc16/ctgov huggingface dataset:
Collection of Placenta for Mitochondria Isolation

Study Overview
=================
Brief Summary
-----------------
Placenta will be collected and from these, mitochondrial will be harvested. Mitochondria will be used in mitochondrial augmentation therapy.

Official Title
-----------------
Collection of Placenta for Mitochondria Isolation for Use in Mitochondrial Augmentation

Conditions
-----------------
Pregnancy Related

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy females, singleton pregnancy Planned elective C-section uncomplicated pregnancy Exclusion Criteria: Donor positive for viruses tested Donor excessive smoker or drinker Donor known to carry mitochondrial disease

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

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

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 |
| --- | --- | --- |
| Placenta donated | The purpose of this study is to collect placenta for the production of mitochondria. Therefore, only general measurements are taken such as placenta weight and health of mother during pregnancy. No further intervention or interaction with the mother will occur, and she does not receive any drug product or treatment prior to or after placenta donation. | immediate |
Resistance Training as Treatment of Achilles Tendinopathy

Study Overview
=================
Brief Summary
-----------------
The use of eccentric resistance training as management of Achilles tendinopathy is widespread. The investigators have recently demonstrated that heavy slow resistance training was superior in the management of patellar tendinopathy. Hypothesis: heavy slow resistance training is more effective than eccentric resistance training in the clinical management of Achilles tendinopathy.

Official Title
-----------------
Heavy Slow Resistance Versus Eccentric Training in the Treatment of Achilles Tendinopathy. A Randomized Controlled Trial.

Conditions
-----------------
Achilles Tendinopathy

Intervention / Treatment
-----------------
* Other: Heavy slow resistance training
* Other: Eccentric resistance training


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Unilateral Achilles tendon pain, Symptoms for at least three months, Ultrasonographical tendon abnormalities, AND Able to comply with both intervention arms. Exclusion Criteria: Bilateral symptoms, Previous surgery below knee, Corticosteroid injections below the knee during past year, Hypercholesterol, Diabetes, OR Arthritis.

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

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Heavy slow resistance training<br>12 wks of heavy slow resistance training. training three times per week. each session: 3 heel-raise exercises. 12-6RM. Slow contractions. | Other: Heavy slow resistance training<br>* Heel-raises. 12-6RM. each contraction performed slowly. three times weekly for 12 weeks<br>|
| Active Comparator: Eccentric resistance training<br>12 wks of eccentric resistance training. 3 x 15 Eccentric heel-raises performed twice daily. | Other: Eccentric resistance training<br>* Eccentric heel-raises. 3 x 15 reps performed twice daily for 12 wks.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| VISA-A score |  | 0,12 wks + 1yr follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tendon thickness |  | 0,12 wks + 1yr follow-up | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Tendinopathy, Achilles, Eccentric training, Heavy slow resistance training
Wait and See Antibiotic Prescription for Acute Otitis Media: A Randomized Controlled Trial

Study Overview
=================
Brief Summary
-----------------
To determine if a wait and see prescription for ear infections in childhood reduces use of antibiotics compared to an immediate prescription

Detailed Description
-----------------
We conducted a randomized, controlled trial evaluating a consecutive series of children diagnosed with AOM during a one year period in an urban pediatric emergency department, utilizing diagnostic recommendations from contemporary evidence-based guidelines. The objectives of the study were to determine whether treatment of AOM using a Wait and See Prescription (WASP) significantly reduces use of antimicrobials compared with a Standard Prescription (SP) and to evaluate the effects of this intervention on clinical symptoms and adverse outcomes related to antibiotic use.

Official Title
-----------------
Wait and See Antibiotic Prescription for Acute Otitis Media: A Randomized Controlled Trial

Conditions
-----------------
Otitis Media

Intervention / Treatment
-----------------
* Behavioral: Prescription Fill Status


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Children between the ages of 6 months - 12 years who were diagnosed with Acute Otitis Media Exclusion Criteria: clinician suspicion or diagnosis of a concurrent bacterial infection patient appeared toxic as determined by the PEM clinician patient was hospitalized history of compromised immunity patient was treated with antimicrobials in the preceding seven days either tympanic membrane was perforated myringotomy tubes were present uncertain access to medical care primary language of the parent or guardian was neither English nor Spanish prior enrollment in the study

Ages Eligible for Study
-----------------
Minimum Age: 6 Months
Maximum Age: 12 Years

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

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

| Intervention/Treatment |
| --- |
|Behavioral: Prescription Fill Status|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of each group that filled the antibiotic prescription |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical course of the illness; side effects of medications; days of school/work missed; unscheduled medical visits |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Otitis, Antibiotic, Prescription
Work-Related Fibromyalgia

Study Overview
=================
Brief Summary
-----------------
The research is about fibromyalgia prevalency in working population and searching work-related fibromyalgia.

Detailed Description
-----------------
4 different job population will be included in the study. Totally 200 people wil be included and evaluated. All participants will be women. The investigators will diagnose fibromyalgia with 2016 updated diagnostic criteria and evaluate work related musculoskeletal pain with nordic musculoskeletal questionnaire.

Official Title
-----------------
Work-Related Fibromyalgia

Conditions
-----------------
Fibromyalgia, Secondary

Intervention / Treatment
-----------------
* Other: working hours


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: working at least 3 months in same working place Exclusion Criteria: Diagnosed with the other musculoskeletal diseases

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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 |
| --- | --- |
| Factory workers<br> | Other: working hours<br>* weekly working hours<br>|
| Nurses<br> | Other: working hours<br>* weekly working hours<br>|
| Janitors<br> | Other: working hours<br>* weekly working hours<br>|
| Data automation employees<br> | Other: working hours<br>* weekly working hours<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| work related fibromyalgia | fibromyalgia in working population | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Fibromyalgia, Musculoskeletal Diseases, Work
Daptomycin Pharmacokinetics in Critically Ill Patients Undergoing Continuous Veno-venous Hemodiafiltration, a Dose Finding Study

Study Overview
=================
Brief Summary
-----------------
Daptomycin kinetics in CRRT Trial with medicinal product

Conditions
-----------------
Gram-Positive Bacterial Infections

Intervention / Treatment
-----------------
* Drug: Daptomycin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: male or female of 18 years or older females: negative pregnancy test Hospitalisation in the medical ICU High suspicion or evidence of Gram-positive infections requiring antibiotic therapy Subjects receiving standard antibiotic treatment for Gram-positive infection Evidence of renal failure Clinical necessity for continuous renal replacement therapy Written informed consent signed by the patient or a next of kin and an independent physician in case the patient is not able to sign. Exclusion criteria: Skeletal muscle disorders or CPK levels of > 2 x ULN History of hypersensitivity to the drug Participation in another study Subjects with a history of muscle disease Patients with severe liver function impairment (Child Life expectancy of less than 5 days

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 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: Daptomycin|Daptomycin kinetics in CRRT|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics |  | 2011 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Gram positive infection and CRRT
Time To Efficacy and Onset Of Action Of Linezolid

Study Overview
=================
Brief Summary
-----------------
To assess the onset of action of linezolid

Official Title
-----------------
Time To Efficacy and Onset Of Action Of Linezolid In Skin and Soft Tissue Infections

Conditions
-----------------
Gram-Positive Bacterial Infections, Skin and Connective Tissue Diseases

Intervention / Treatment
-----------------
* Drug: linezolid


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: suspected grampositive infection fever > 38 C Exclusion Criteria: Infections to be treated successfully by surgical procedures

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

| Intervention/Treatment |
| --- |
|Drug: linezolid|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to defervescence |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction of CRP levels Reduction of leucocyte count |  |  |
Cyberknife Radiosurgery and Quality of Life

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to look at pain control and QOL improvement after treatment with CK Radiosurgery for spinal metastases.

Official Title
-----------------
Cyberknife Radiosurgery and Quality of Life

Conditions
-----------------
Bone Cancer, Central Nervous System Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with a spinal metastasis who will be treated with Cyberknife radiosurgery. There are no age or gender restrictions. There are no life expectancy restrictions. Karnofsky Performance Status greater than 40. Negative pregnancy test or clinically assessed as not pregnant. Ability to understand and the willingness to sign a written informed consent document. Exclusion Criteria: Patients with benign tumors will not be included (neurofibromas, schwannomas, etc.) Other investigational medications or treatments will be noted, but will not preclude inclusion. Pregnant or nursing patients will be not be included in the study due to radiation exposure.

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 |
| --- | --- | --- |
Comparative Assessment of the Clinical Utility of Ovarian Stimulation With Menotropin Versus Menotropin Plus GnRH Antagonist

Study Overview
=================
Brief Summary
-----------------
To assess the effectiveness of protocols of ovarian hyperstimulation combining urinary gonadotrophins + GnRH antagonist vs urinary gonadotrophins, to achieve clinical pregnancy in females undergoing intrauterine insemination. Study hypothesis: protocols combining urinary gonadotrophins + GnRH antagonist should be more effective than monotherapy.

Official Title
-----------------
Comparative Assessment of the Clinical Utility of Ovarian Stimulation With Menotropin Versus Menotropin Plus GnRH Antagonist Following Two Protocols of Ovulation Induction for Intrauterine Insemination

Conditions
-----------------
Sterility

Intervention / Treatment
-----------------
* Drug: hMG-HP
* Drug: hMG + GnRH antagonist


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women aged 18-36 years Body mass index (BMI) between 18 and 26 Prolactin within the laboratory normal range Couples affected by sterility able to treat by IUI (intrauterine insemination) Patients undergoing Menopur® treatment Normal thyroid function Regular menses (21-35 days) Couples willing to participate in the study that have signed the informed consent form Seminal sample REM>3 million Exclusion Criteria: Two previous ART (assisted reproductive technology) cycles without ongoing pregnancy Policystic ovarian syndrome Evidence of significant bacterial infection in the seminogram of the couple in the preceding 6 months

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 36 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 |
| --- | --- |
| hMG-HP<br>Patients with a condition | Drug: hMG-HP<br> <br> |
| hMG-HP + GnRH antagonist<br>Patients with a condition | Drug: hMG + GnRH antagonist<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical pregnancy rate |  | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Live birth rate |  | 40 weeks |
Centralized Pan-South African Survey on the Undertreatment of Hypercholesterolaemia

Study Overview
=================
Brief Summary
-----------------
This is a multi-centre survey of patients who are currently on lipid lowering pharmacological treatment in South Africa.

Official Title
-----------------
Centralized Pan-South African Survey on the Undertreatment of Hypercholesterolaemia.

Conditions
-----------------
Undertreatment of Hypercholesterolaemia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject must be 18 years of age or older of either gender or race. Subject must provide informed consent and comply with the survey procedures. Subject is on lipid lowering drug treatment for at least 3 months, with no dose change for a minimum of 6 weeks. Exclusion Criteria: Subjects who are unwilling or unable to provide informed consent.

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Hyperchlesterolaemia<br>Participants undertreated with hypercholesterolaemia | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients on lipid-lowering pharmacological treatment reaching LDL-C goals according to NCEP ATP III/Updated 2004 NCEP ATP III |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients on lipid-lowering pharmacological treatment reaching LDL-C goals according to NCEP ATP III/Updated 2004 NCEP ATP III |  |  | 
| Proportion of patients on lipid-lowering pharmacological treatment reaching LDL-C goals according to the Fourth Joint European Task Force Guidelines/South African Guidelines in primary/secondary prevention patients, patients with metabolic syndrome |  |  | 
| Proportion of patients on lipid-lowering pharmacological treatment reaching the non HDL-C goals according to NCEP ATP III/Updated 2004 NCEP ATP III Guidelines |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pan South African Survey on the Undertreatment of Hypercholesterolaemia
Prognostic Score To Predict Major Complications After Pancreaticoduodenectomy

Study Overview
=================
Brief Summary
-----------------
Pancreaticoduodenectomy (PD) still carries a high rate of severe postoperative complications. No score is currently available to help identify the patient's surgical risk. The purpose of this study was to develop and validate a prognostic score to predict major postoperative complications after PD.

Detailed Description
-----------------
The investigators prospectively collected in an electronic database preoperative, intraoperative and outcome data of 700 patients undergoing PD in our Institution from 2002 to 2010. The investigators used a multivariate logistic regression analysis to create a new score to predict severe complications defined as Clavien-Dindo classification III, IV and V. The score was developed using a random two-thirds of the population (469 patients), and was then validated and calibrated in the remaining third of the patients (231).

Official Title
-----------------
A PROGNOSTIC SCORE TO PREDICT MAJOR COMPLICATIONS AFTER PANCREATICODUODENECTOMY.

Conditions
-----------------
Pancreatic Neoplasm

Intervention / Treatment
-----------------
* Procedure: Pancreaticoduodenectomy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Patients undergoing pancreaticoduodenectomy in our Institution Exclusion Criteria: Metastatic disease Patient not suitable for surgery

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 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 |
| --- | --- |
| Pancreaticoduodenectomy (PD)<br>Patients undergoing PD from 2002 to 2010 | Procedure: Pancreaticoduodenectomy<br>* Resection of pancreatic lesion<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major Complication rate | Clavien-Dindo grade III to V complications considered as major | Postoperative. Until 30 days after discharge | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
pancreas, pancreaticoduodenectomy, major complications
A Pilot Study to Explore the Role of Gut Flora in Acne

Study Overview
=================
Brief Summary
-----------------
This study seeks to correlate microbiome sequencing data with information provided by patients and their medical records.

Detailed Description
-----------------
The goal of this Research Study is to better understand how the genetic information in subject's microbiome correlates to acne.

Official Title
-----------------
A Non-Interventional Pilot Study to Explore the Role of Gut Flora in Acne

Conditions
-----------------
Acne, Acne Vulgaris, Acne Keloidalis, Acne Keloid, Acne Conglobata, Acne Rosacea, Acne Inversa, Acne Cystic, Acne Pomade, Acne Indurata, Acne Papular, Acne Tropica, Acne Urticata, Acne Fulminans, Acne Follicular, Acne Tropicalis, Acne Detergicans, Acne Iodide, Acne Varioliformis

Intervention / Treatment
-----------------
* Other: No intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Signed informed consent, demonstrating that the patient understands the procedures required for the study and the purpose of the study a. May be signed by parent or legal guardian in the case of minor or adult unable to provide consent Male or female of all ages. Diagnosis of acne by a physician Exclusion Criteria: Refusal to sign informed consent form History of bariatric surgery, total colectomy with ileorectal anastomosis or proctocolectomy. Postoperative stoma, ostomy, or ileoanal pouch Participation in any experimental drug protocol within the past 12 weeks Treatment with total parenteral nutrition
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Diagnosis of Acne<br>Patients who have been diagnosed with acne, subdivided into the various types. | Other: No intervention<br>* There is no intervention for this study.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation of Microbiome to Disease via Relative Abundance Found in Microbiome Sequencing | Relative abundance of bacterial classes within taxonomic phyla and, more broadly, within their domain will be analyzed by sequencing the gut microbiome. These data will then be categorized with acne. | Three years |