linjc16/ctgov huggingface dataset:
Prospective Study of Head and Neck Cancer Radiation Treatment With or Without Amifostine

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare the incidence of stomatitis when treating with amifostine before radiation treatment.

Official Title
-----------------
Prospective, Open-label, Randomized, Control Study of Head and Neck Cancer Radiation Treatment With or Without Amifostine

Conditions
-----------------
Oral Mucositis, Stomatitis

Intervention / Treatment
-----------------
* Drug: Amifostine
* Radiation: Amifostine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18-70 years old, male or female Primary treatment of phase I-IVA head and neck cancer patients, identified by histological and pathological diagnosis Postoperative patients should receive radiation treatment in 12 weeks ECOG <2 Expected lifetime ≥6months No severe complications (hypertension, CHD, diabetes and psychiatric history, etc.) Not involved in other clinical trials Sign ICF Exclusion Criteria: ECOG >2 Suffered other cancers in the past 5 years Received amifostine treatment in the past 4 weeks Unable to complete treatment or sign ICF because of medical or physical reasons

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cytofos group A<br>Amifostine 500 mg sc, qod, 3 times per week Radiation treatment 30 min after amifostine treatment, 1.8-2.0 Gy/day × 30-35 times | Drug: Amifostine<br>* 500 mg sc, qod, 3 times per week<br>Radiation: Amifostine<br>* 500mg rinsing wash, qod, 3 times per week<br>|
| Experimental: Cytofos group B<br>Amifostine 500mg rinsing wash, qod, 3 times per week Radiation treatment 5 min after amifostine treatment, 1.8-2.0 Gy/day × 30-35 times | Drug: Amifostine<br>* 500 mg sc, qod, 3 times per week<br>Radiation: Amifostine<br>* 500mg rinsing wash, qod, 3 times per week<br>|
| Active Comparator: Control group<br>Radiation treatment 1.8-2.0 Gy/day × 30-35 times | Drug: Amifostine<br>* 500 mg sc, qod, 3 times per week<br>Radiation: Amifostine<br>* 500mg rinsing wash, qod, 3 times per week<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence and duration of oral mucositis |  | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Identify whether Cytofos can reduce the incidence and duration of HNC patients' oral mucositis caused by radiotherapy.
Effect of Resistance Training on Jump Landing Mechanics in Young Female Athletes

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine if jump landing mechanics in young female athletes can be improved with a resistance training intervention.

Detailed Description
-----------------
After initial baseline testing, athletes were randomly selected to receive upper body (control group) or lower body (intervention group) resistance training. Athletes attended supervised training sessions twice per week for 12 weeks, after which they were re-tested.

Official Title
-----------------
Effect of a Resistance Training Program on the Jump Landing Biomechanics of Young Female Athletes

Conditions
-----------------
Anterior Cruciate Ligament Injury

Intervention / Treatment
-----------------
* Other: Leg training
* Other: Arm training


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: at least one year experience playing organized sports Exclusion Criteria: previous experience with resistance training any injury with a pain level of more than 3/10 on VAS any health condition that would preclude them from completing the training or testing previous experience using a Biodex dynamometer

Ages Eligible for Study
-----------------
Minimum Age: 10 Years
Maximum Age: 14 Years

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

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

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: Leg training<br>Lower body resistance training only | Other: Leg training<br>* Lower body resistance training twice per week for one hour each time.<br>|
| Active Comparator: Arm training<br>Upper body resistance training only | Other: Arm training<br>* Upper body resistance training twice per week for one hour each time.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Landing Error Scoring System score from Baseline to 12 weeks. |  | Baseline and 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neuromuscular power of the hip abductors measured by a Biodex isokinetic dynamometer |  | 12 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
resistance training
A Comparison Between Titanium Femoral Stem and Cobalt-Chromium Femoral Stem in Cemented Hip Arthroplasty

Study Overview
=================
Brief Summary
-----------------
In this randomised study, the migration of a specific cemented titanium femoral stem will be compared with a similar cemented cobalt-chromium stem using Roentgen stereogrammetric analysis (RSA). In addition, the periprosthetic bone mineral density (BMD) will be evaluated to point out any interference from the modulus of the stem investigated.

Official Title
-----------------
A Comparison Between Titanium Femoral Stem and Cobalt-Chromium Femoral Stem in Cemented Hip Arthroplasty. A Randomized Prospective Roentgen Stereogrammetric Analysis.

Conditions
-----------------
Osteoarthritis

Intervention / Treatment
-----------------
* Device: Bi-Metric femoral implant (titanium versus cobalt-chromium)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Primary osteoarthritis of the hip Spinal anesthesia Informed written consent Exclusion Criteria: Neuromuscular disease in the affected leg Vascular disease in the affected leg Fracture sequelae in the affected hip Weight over 100 kg Regular non-steroid anti-inflammatory drug (NSAID) intake in the postoperative period

Ages Eligible for Study
-----------------
Minimum Age: 60 Years
Maximum Age: 75 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 |
| --- |
|Device: Bi-Metric femoral implant (titanium versus cobalt-chromium)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Migration of femoral components evaluated by RSA |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Periprosthetic BMD changes evaluated by DEXA |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
RSA, Osteoarthritis, Hip arthroplasty, DEXA, Titanium, Cobalt chromium, Bone cement
Clinical Research of Adoptive BCMA CAR-NK Cells on Relapse/Refractory MM

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to infuse BCMA CAR-NK 92 cells to the patients with relapsed and refractory multiple myeloma (MM), to assess the safety and feasibility of this strategy. The CAR enables the NK-92 cells to recognize and kill the MM cells by targeting of BCMA, a protein expressed of the surface of the malignant plasma cells in MM patients.

Official Title
-----------------
Clinical Research of Adoptive BCMA CAR-NK Cells on Relapse/Refractory MM

Conditions
-----------------
Multiple Myeloma

Intervention / Treatment
-----------------
* Biological: BCMA CAR-NK 92 cells


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years to 80 years, expected survival > 3 months Confirmed diagnosis of active MM as defined by IMWG. BCMA expression of the malignant cells must be detected by immunohistochemistry or by flow cytometry BCMA-expressing B cell malignancy must be assured and must be relapsed or refractory disease ECOG performance status of 0 - 1 Cardiac function: 1 - 2 levels; Liver: TBIL ≤ 3ULN，AST ≤ 2.5 ULN，ALT ≤ 2.5ULN; kidney: Cr ≤ 1.25ULN No serious allergic constitution No other serous diseases that conflicts with the clinical program No other cancer history Female participants of reproductive potential must have a negative serum pregnancy test Subjects must have signed written, informed consent Exclusion Criteria: Pregnant or lactating women Uncontrolled active infection, HIV infection, syphilis serology reaction positive Active hepatitis B or hepatitis C infection Recent or current use of glucocorticoid or other immunosuppressor Serious mental disorder With severe cardiac, liver, renal insufficiency, diabetes and other diseases Participate in other clinical research in the past three months Previously treatment with any gene therapy products

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?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: anti-tumor response of BCMA CAR-NK-92<br>Patients with relapsed and refractory MM of BCMA expression will be treated with BCMA CAR-NK 92 cells. | Biological: BCMA CAR-NK 92 cells<br>* The subject will be observed for any side effects during this time and all the adverse events will be recorded.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of treatment related adverse events as assessed by CTCAE v4.03 | Defined as >= Grade 3 signs/symptoms, laboratory toxicities, and clinical events) that are possibly, likely, or definitely related to study treatment. | 1 year |
The Comparison of Three Different Immunosuppressant Regimens in Kidney Transplant Recipients.

Study Overview
=================
Brief Summary
-----------------
The study is being done to compare the safety and effects (good and bad) of three different combinations of immunosuppression drugs used by kidney transplant recipients while also looking at their kidney function.

Detailed Description
-----------------
This is an open-label, randomized, comparative, multinational study. The study will be looking at the kidney function of kidney transplant recipients, while also comparing the safety and the effects (good and bad) of three different combinations of immunosuppression drugs in combination with prednisone, following treatment with Daclizumab (Zenapax). The three combinations are; (1) sirolimus and tacrolimus followed by the withdrawal of tacrolimus after three months; (2) sirolimus and mycophenolate mofetil (MMF); and (3) tacrolimus and MMF. The participants will be required to return to throughout the next 24 months following their transplant for physical exams, chest x-ray, blood, and urine tests. Participants will be put into one of three groups, and receive the study drugs starting on the day of transplant. Due to some drugs affecting the drug levels of sirolimus, participants need to agree not to take any new drugs during the study unless approved by the study doctor.

Official Title
-----------------
A Randomized Open-label Study to Compare the Safety and Efficacy of Two Different Sirolimus Regimens With a Tacrolimus + Mycophenolate Mofetil Regimen in De Novo Renal Allograft Recipients.

Conditions
-----------------
Kidney Transplant

Intervention / Treatment
-----------------
* Drug: Sirolimus


Participation Criteria
=================
Eligibility Criteria
-----------------
Participants must be at least between the ages of 18 and 75, and will be receiving their first or second kidney transplant.

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- |
|Drug: Sirolimus|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Calculated creatinine clearance at 12 months after transplantation. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Calculated creatinine clearance at 26, 78, and 104 weeks post transplantation. |  |  | 
| Serum creatinine at 26, 52, 78, and 104 weeks post transplantation. |  |  | 
| Subject and graft survival at 26, 52, 78, and 104 weeks post transplantation. |  |  | 
| Incidence and severity of biopsy-confirmed acute rejection at 26, 52, 78, and 108 weeks post transplantation. |  |  | 
| Severity of rejection, including histological grade of the first acute rejection episode. |  |  |
MODULA-Study: Modul 10: Benefit of CRT-Therapy in CRT-Patients With QRS-Complex of 120 - 150 Ms

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare the benefit of cardiac resynchronization therapy (CRT)-therapy in patients with a QRS-complex of 120-150 ms to patients with a QRS-complex of > 150 ms.

Detailed Description
-----------------
The objective of this study is to compare the benefit of CRT-therapy in patients with a QRS-complex of 120-150 ms to patients with a QRS-complex of > 150 ms within 12 months. A benefit is defined as change in quality of life and change in physical ability.

Official Title
-----------------
MODULA-Study: Modul 10: Benefit of CRT-therapy in CRT-Patients With QRS-complex of 120 - 150 ms

Conditions
-----------------
Heart Failure

Intervention / Treatment
-----------------
* Behavioral: CRT-P and CRT-D devices


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with cardiac resynchronization therapy with a defibrillator (CRT-D) or cardiac resynchronization therapy pacemakers (CRT-P) system New York Heart Association (NYHA) III Ejection fraction (EF) below 35% Optimised medical therapy QRS-complex above 120 ms Exclusion Criteria: Patients with CRT-P and atrial fibrillation

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 |
| --- | --- |
| QRS 120-150 ms<br>Subjects with a QRS width between 120-150 ms | Behavioral: CRT-P and CRT-D devices<br> <br> |
| QRS >150 ms<br>Subjects with a QRS width >150 ms | Behavioral: CRT-P and CRT-D devices<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Observational: Benefit of CRT |  | 12 month |
Validation of Korean Version of ICIQ-SF

Study Overview
=================
Brief Summary
-----------------
Validation of the Korean version of the ICIQ-UI SF for pregnant and postpartum women Evaluation the effect of urinary incontinence in pregnant and postpartum women.

Conditions
-----------------
Urinary Incontinence

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Being pregnant or postpartum ≤ 3 weeks Able to read and understand Korean At least 18 years of age Exclusion Criteria: Refuse to participate in the study Pelvic inflammatory disease Psychiatric disease Needed to be treated in the 7 days

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- | --- |
| Urinary incontinence |  | 1-2 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Postpartum period, Urinary incontinence, Validation study, Pregnant women
A Study of the Association of Sleep Dysfunction and Burning Mouth Syndrome

Study Overview
=================
Brief Summary
-----------------
This is a case control study of the association between burning mouth syndrome and sleep dysfunction. Cases will comprise of patients diagnosed with burning mouth syndrome at the UCSF oral medicine clinic. Controls will include patients with leukoplakia, pigmented lesions, traumatic lesions, benign tumors, mucoceles, and pemphigoid matched on age (5 years) and gender to the cases. New patients as well as those presenting for follow-up visits will be eligible. Each case and control subject will be administered the following 4 questionnaires by interview: (1) enrollment questionnaire (2) Sleep scale from the medical outcomes study (MOS), (3) current sleep status scale and (4) a numerical rating scale for measurement of oral symptoms. Cases (BMS patients) will be followed in the clinic or by telephone contact once per month for the following 6 months and questionnaires 1 (question 6 only), 2, 3 and 4 will be administered by interview.

Official Title
-----------------
A Study of the Association of Sleep Dysfunction and Burning Mouth Syndrome

Conditions
-----------------
Burning Mouth Syndrome

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Cases will comprise of patients diagnosed with burning mouth syndrome at the UCSF oral medicine clinic. Controls will include patients with leukoplakia, pigmented lesions, traumatic lesions, aphthous ulcers, reticular oral lichen planus, benign tumors, mucoceles, and pemphigoid matched on age (5 years) and gender to the cases. New patients as well as those presenting for follow-up visits will be eligible. Exclusion Criteria: Age below 18 years Pregnancy Systemic corticosteroid therapy within the previous 2 weeks.

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 |
| --- | --- |
| 1<br>Burning Mouth Syndrome Group | |
| 2<br>Control Group | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sleep quality and quantity |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Burning Mouth Syndrome, Sleep, Neuropathic pain, Glossodynia, Chronic pain, Orofacial pain
Brow Enhancement Study

Study Overview
=================
Brief Summary
-----------------
Investigation into brow aesthetics using Botox in Conjunction with Juvederm XC as evaluated by patient satisfaction

Official Title
-----------------
Investigation Into Brow Aesthetics Using Botox in Conjunction With Juvederm Ultra XC as Evaluated by Patient Satisfaction

Conditions
-----------------
Brow Ptosis

Intervention / Treatment
-----------------
* Device: Juvederm XC
* Drug: Botox


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Men and women Exclusion Criteria: Persons who have not had Botox for months. Women who are pregnant, breastfeeding, or trying to get pregnant.

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Juvederm XC<br>Juvederm XC | Device: Juvederm XC<br>* Filler<br>|
| Active Comparator: Botox<br>Medication used to block neuromuscular transmission | Drug: Botox<br>* 26 units dosed one time<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Participant satisfaction with combined injection with Botox and Juvederm XC |  | 5 months |