cyrilzakka/clinical-trials huggingface dataset:
The Effects of the Novel Unloading Device "HEPHAISTOS" on Bone, Muscles and Vessels

11 healthy men used the HEPHAISTOS unloading orthosis in an ambulatory 8 week intervention study.

It greatly reduces calf muscle forces without reducing ground reaction forces.

The 56day unloading intervention with HEPHAISTOS had the following key objectives:

1. Primary objective: Assessment and evaluation of bone adaptation.
2. Secondary objective: Assessment and evaluation of functional and structural muscular adaptations.
3. Third objective: Assessment and evaluation of functional and structural vascular adaptations.
4. Fourth objective: Assessment and evaluation if the present findings deviate from findings observed in established unloading models.

Eligibility Criteria:
Inclusion Criteria:

* male
* age: 20-45
* BMI: 20-30

Exclusion Criteria:

* smoking
* professional sports men
* diabetes
* rheumatism
* muscle and joint disease
* bone fractures within 12 months prior to the study
* cruciate ligament rupture within 10 years prior to the study
* metal implants
* participation in any other clinical study within 2 months prior to the study haemophilia
* any blood vessel disease
* epilepsy
* claustrophobia
* herniated disk
* cardiac pulse generator
* drug or alcohol abuse
* hyperlipidaemia
* kidney disease
* hyperhomocysteaemia
* hyper/hypouricemia
* hyper/hypocalcaemia
* anaemia
* vitamin d deficit
* chronical back pain
* deficient certificate of good conduct
* achilles tendon injury
A Study for Participants With Pancreatic Cancer

The purpose of the Phase 1 portion of this study was to determine the dose of LY2603618 that can be safely administered 24 hours after gemcitabine treatment. This dose was then used for the Phase 2 portion of the study. The Phase 2 portion of the study evaluated whether LY2603618, when administered 24 hours after gemcitabine therapy, was an effective treatment for participants with pancreatic cancer.

Phase 1 included a dose escalation of LY2603618 doses from 70 milligrams/meter squared (mg/m\^2) to 250 mg/m\^2 divided into 5 cohorts. Each participant was assigned to a single cohort with no intra-participant dose escalation. Phase 1 also included an expansion cohort where participants received a flat dose of 200 or 230 mg LY2603618. Participants received gemcitabine on Days 1, 8, and 15, followed by LY2603618 on Days 2, 9, and 16 of each 28-day cycle. The purpose of the Phase 1 portion was to determine the maximum tolerated LY2603618 dose to be carried into the Phase 2 portion of the study.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with cancer that is metastatic and/or advanced during Phase 1
* Diagnosed with pancreatic cancer that is metastatic and not amenable to surgery
* Must be at least 18 years of age
* Adequate hematological, liver, and renal functions
* Eastern Cooperative Oncology Group (ECOG) status of 0 to 2

Exclusion Criteria:

* Known hypersensitivity to gemcitabine
* Pregnant or lactating females or refusal to use medically approved contraceptive precautions
* Had prior treatment with radiotherapy involving more than 25% of marrow producing area
* Have received treatment in the last 30 days with a drug which has not received regulatory approval for any indication at the time of study entry
Comparison of Microwave and Radiofrequency Ablation for Liver

According to randomized controlled trial requirement, the therapeutic effectiveness of cooled-probe microwave ablation and radiofrequency ablation on early-stage hepatocellular carcinoma is compared to find a better approach for minimally invasive thermal ablation.

According to following enrollment standard, about \>400 cases of biopsy-proved hepatocellular carcinoma(HCC) patients will be involved in the study. They will be treated with percutaneously microwave ablation (MWA) and radiofrequency ablation(RFA). The indications of patients enrolled in the study were as follows: tumor size ≤5cm in diameter, tumor number ≤3, Child-Pugh class A or B classification, no evidence of extrahepatic metastasis, vein or bile duct tumor embolus, and no any other anti-cancer treatment was accepted. MWA or RFA is selected for the patient according to the sequence of their visit to the hospital based on randomization number arrangement produced by SPSS 16.0 statistical software. The therapeutic effectiveness will be compared between two modalities.

Eligibility Criteria:
Inclusion Criteria:

* tumor size ≤5cm in diameter,
* tumor number ≤3,
* Child-Pugh class A or B classification,
* no evidence of extrahepatic metastasis,
* vein or bile duct tumor embolus, and
* no any other anti-cancer treatment

Exclusion Criteria:

* not meeting the inclusion criteria
Rituximab Combining Bortezomib Versus Rituximab in Management of ITP

The project was undertaking by Qilu Hospital of Shandong University and other 2 well-known hospitals in China. In order to report the efficacy and safety of rituximab combining with bortezomib for the treatment of adults with immune thrombocytopenia (ITP), compared to rituximab alone .

The investigators anticipate to undertaking a parallel group, multicentre, randomised controlled trial of 100 ITP adult patients from 3 medical centers in China. One part of the participants are randomly selected to receive rituximab (given with a fixed dose of 500 mg administered as an intravenous infusion every two weeks, for 2 times totally) combining with bortezomib (given subcutaneous injection at a fixed dose of 2.0 mg weekly, for 4 times totally), the others are selected to receive rituximab alone (given with a fixed dose of 500 mg administered as an intravenous infusion every two weeks, for 2 times totally). Platelet count, bleeding and other symptoms were evaluated before and after treatment, adverse events are also recorded throughout the study in order to report the efficacy and safety of the combination therapy compared to rituximab alone therapy for the treatment of adults with ITP.

Eligibility Criteria:
Inclusion Criteria:

1. Meet the diagnostic criteria for immune thrombocytopenia.
2. Not previously used rituximab and bortezomid,untreated patients, may be male or female, between the ages of 18 \~ 80 years.
3. To show a platelet count \< 30×10\^9/L, and with bleeding manifestations.
4. Eastern Cooperative Oncology Group（ECOG）performance status ≤ 2.

Exclusion Criteria:

1. Received chemotherapy or anticoagulants or other drugs affecting the platelet counts within 3 months before the screening visit.
2. Current HIV infection or hepatitis B virus or hepatitis C virus infections.
3. Severe medical condition (lung, hepatic or renal disorder) other than ITP. Unstable or uncontrolled disease or condition related to or impacting cardiac function (e.g., unstable angina, congestive heart failure, uncontrolled hypertension or cardiac arrhythmia)
4. Female patients who are nursing or pregnant, who may be pregnant, or who contemplate pregnancy during the study period.
5. Have a known diagnosis of other autoimmune diseases, established in the medical history and laboratory findings with positive results for the determination of antinuclear antibodies, anti-cardiolipin antibodies, lupus anticoagulant or direct Coombs test.
6. Patients who are deemed unsuitable for the study by the investigator
[18F]FLT PET/CT in Rb+ Metastatic Breast Cancer

In this study positron emission tomography (PET/CT) imaging will be used to evaluate proliferative activity in sites of metastatic disease using the investigational radiotracer \[18F\]fluorothymidine (FLT).

This protocol is designed to develop relationships between parameters determined from imaging biomarker studies and ones used for determination of therapeutic response to combined CDK4 Inhibitor and chemotherapy regimens. Imaging will occur prior to starting therapy on the separate therapeutic protocol UPCC 06115. Patients may undergo a second FLT PET/CT scan following a 3-day run of ribociclib (LEE011) (day -6 to -4) and a third FLT PET/CT scan on cycle 1 day 12 following two treatments of weekly Paclitaxel to compare changes in FLT uptake measures.

Eligibility Criteria:
Inclusion Criteria:

1. At least 18 years of age
2. History of histologically or cytologically confirmed breast cancer, any ER, PR or HER2 status is allowed as long as it expresses the Rb protein.
3. At least one site of metastatic breast cancer that is outside of the liver and bone that is identified by standard imaging (e.g. CT, MRI, FDG PET/CT, ultrasound, x-ray)
4. Participants must be informed of the investigational nature of this study and provide written informed consent in accordance with institutional and federal guidelines prior to study-specific procedures.
5. Patients must be candidates to receive treatment on the therapeutic trial UPCC06115, a Phase I study of ribociclib (LEE011) and weekly paclitaxel.

Exclusion Criteria:

1. Females who are pregnant at the time of screening will not be eligible for this study, urine pregnancy test will be performed at screening in women of child-bearing potential.
2. Inability to tolerate imaging procedures in the opinion of an investigator or treating physician
3. Serious or unstable medical or psychological conditions that, in the opinion of the investigator, would compromise the subject's safety or successful participation in the study.
4. Ineligible for the therapeutic trial UPCC 06115
Preoperative Percutaneous Radiofrequency Ablation of Primary and Secondary Lung Tumors

The purpose of the study is to evaluate the effectiveness of radiofrequency ablation by pathological correlation and to characterize the tissue response after treatment of primary and secondary pulmonary tumors.

Thermal ablation therapy is an increasingly performed technique in the local tumor treatment. Among these techniques, image-guided radiofrequency (RF) ablation attained widespread consideration in the therapy of liver tumors and osteoid osteoma. Promising results of hepatic RF ablation raised expectations to utilize the advantages of image-guided ablation therapy for the treatment of pulmonary malignancies. The purpose of the study is to evaluate the effectiveness of radiofrequency ablation by pathological correlation and to characterize the tissue response after treatment of primary and secondary pulmonary tumors. Computed tomography-guided RF ablation is performed in local or general anesthesia, followed by surgical resection three days later. An analysis of complete RF ablation and a characterization of tissue response is performed by hematoxylin and eosin staining, immunostaining, and electron microscopy. Adverse effects and complications are recorded.

Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent for radiofrequency ablation and surgery
* Maximum of 3 lung tumors
* Maximum tumor size 5 cm
* Must be able to receive standard surgery

Exclusion Criteria:

* Pathological coagulation tests
* Pregnant or breast feeding
* Maximum tumor size more than 5 cm
* Bilateral secondary lung cancer with more than 3 tumors
* Inoperable patient
Single Dose Study to Assess Efficacy, Safety and Tolerability of LAS100977 in Asthmatic Patients.

The purpose of this study is to evaluate the pharmacodynamics of single doses of inhaled LAS100977 QD in patients with persistent asthma.


Eligibility Criteria:
Inclusion Criteria:

1. Adult male and female patients aged 18-70 years (both included).
2. Clinical diagnosis of persistent asthma (according to GINA guidelines 2009 update) for at least 6 months prior to screening.
3. Screening FEV1 value of 60% \< FEV1 ≤ 85% of the predicted normal value.
4. FEV1 reversibility ≥ 12% and an absolute increase of at least 200 ml over baseline value after inhalation of 400µg (four inhalations) of salbutamol.
5. Pre-dose FEV1 value of first treatment period within the range of ± 20% of the FEV1 measured at screening prior to salbutamol inhalation.
6. Patients on a stable dose and regimen

Exclusion Criteria:

1. Current smokers, former smokers within the last 6 months, or ex-smokers with a history of more than 10 pack-years.
2. Patients diagnosed with COPD.
3. Recent Respiratory tract infections within 6 weeks before Screening Visit.
4. Intubation (ever) or hospitalization for longer than 24 hours for the management of an asthma exacerbation within the preceding 6 weeks of the screening visit.
5. Clinically significant respiratory conditions.
6. Clinically significant cardiovascular conditions.
7. Patients unable to properly use a dry powder or pMDI inhaler device or unable to perform acceptable spirometry.
8. Clinically relevant abnormalities laboratory, ECG parameters or physical examination results at the screening evaluation that in the investigator's opinion, preclude study participation.
9. Patients who intend to use any concomitant medication not permitted by this protocol or who have not undergone the required washout period for a particular prohibited medication.
Robot-assisted Gait Training for Patients With Stroke

Investigation of the clinical feasibility and efficacy of a newly developed robot-assisted gait training system for stroke survivors. It is anticipated that robot-assisted gait rehabilitation in combination with standard hospital based rehabilitation will achieve significantly better gait outcomes than standard hospital based rehabilitation alone.

Stroke is the leading cause of permanent disability in most developed countries world wide with one-third of the surviving patients from stroke fail to regain independent walking ability. Robot-assisted gait rehabilitation that is able to deliver high intensity and consistent repeatability in a safe and controlled environment are gaining traction and advocators for its inclusion as part of the routine post-stroke rehabilitation program. However, despite the recent technological advances in the development and design of better robotics, the exact benefit of the robot-assisted therapy over traditional rehabilitation remain sparse and unclear. It is therefore the aim of the proposed project to fulfil this important gap in our clinical knowledge by comparatively investigate the clinical feasibility and efficacy of a recently developed HIWIN Robotic Gait Training System (MRG-P100) against the traditional rehabilitation program with an emphasis on the determination of functional recovery and the appropriate gait adaptation of such robotic system for stroke survivors.

Eligibility Criteria:
Inclusion Criteria:

1. Between the age of 20-65 years;
2. Diagnosis of first, single unilateral cortical-subcortical stroke verified by brain imaging;
3. Paresis of a lower limb;
4. Inability to walk without aid or device.

Exclusion Criteria:

1. Deemed by a physician to be medically unstable;
2. Other prior musculoskeletal conditions that affected gait capacity;
3. Co-existence of other neurological diseases;
4. Cognitive impairments that would impact on the safe participation in the study (MMSE\<23) -
Safety and Efficacy Trial of ACZONE (Dapsone) Gel, 7.5% in 9 to 11 Year-Old Patients With Acne Vulgaris

This study will evaluate the safety, tolerability, pharmacokinetics (PK) and efficacy of ACZONE Gel, 7.5% administered topically once-daily for 12 weeks in 9 to 11 year-olds with acne vulgaris.


Eligibility Criteria:
Inclusion Criteria:

-Has acne vulgaris on the face, including the nose, with 20 to 100 total lesions (noninflammatory and/or inflammatory).

Exclusion Criteria:

* Has uncontrolled systemic disease(s)
* Has severe cystic acne, acne conglobata, acne fulminans, or secondary acne (chloracne, drug-induced acne)
* Has used topical dapsone within 1 month prior to the screening
* Has used oral dapsone within 2 months prior to screening.
Cultivating Well-being in Subclinical Paranoia

The intervention is called Feliz-Mente, with third generation therapy components that aims to improve wellbeing and self-enhancement. Without intervening directly on the symptoms, it is expected to increase positive experiences, the use of personal strengths and positive relationships, and aims to build a more meaningful self-narrative in persons with subclinical paranoia. Feliz-Mente is a group intervention of 12 sessions in which participants are expected to perform exercises during and between sessions by the use of a mobile application to improve treatment adherence and daily practice. The design for the present study is a randomized controlled trial, which compares the post-intervention measures of the experimental group (group receiving the intervention and the daily use of a mobile application of the program) with the post-intervention measures of the control group (treatment as usual + waiting list).


Eligibility Criteria:
Inclusion Criteria:

* Participants between 18 and 35 years old
* At least two standard deviations above mean on the scales of distress, suspicion and /or interpersonal sensitivity in the SCL-90 questionnaire.

Exclusion Criteria:

* Participants with borderline personality disorder
* Participants with substance use disorders and /or
* Participants with severe cognitive impairment.
Adaptation and Validation of the Arabic Version of EuroQol 5D-5L

The aim of the work is to provide a validated Arabic version of EuroQol 5D-5L ,so that it would be used as a quality of life assessment tool for Egyptian patients

Specific objectives:

1. Cross cultural adaptation of the translated Arabic version of EuroQol 5D-5L.
2. Assessment of the reliability of the translated Arabic version of EuroQol 5D-5L.
3. Testing the validity of the translated version of EuroQol 5D-5L.

Chronic back pain is one of the most important disabling illnesses. It has a high incidence, high prevalence and high cost to society. One of the most common causes of back pain are degenerative spine diseases which aﬀect all aspects of quality of life (QoL) of the patients. They could aﬀect job opportunities, social activities and hinder the patients from performing common daily activities.It was found that many factors could affect quality of life of spine degenerative diseases patients such as sex, age, body mass index (BMI), employment status , living with other family members, smoking, orthopedic disorder in another part of the body (other than spinal disease), history of spinal surgery, and bladder function. Comprehensive assessment of these patients should include health related quality of life (HRQoL) measures in addition to the objective clinical measures of the diseases. Europeans Quality of life questionnaire 5 dimensions ,5 levels (EQ-5D-5L) is a standardized measure of health status developed by the EuroQol Group which provides a simple, generic measure of health for clinical and economic appraisal (2).Despite being translated and validated in many languages, there is no validated Arabic version of EQ-5D-5L to measure the quality of life. The objective of this study is to evaluate the reliability and validity of the Arabic version of the questionnaire for Egyptian patients diagnosed to have Spine degenerative diseases.

Eligibility Criteria:
Inclusion Criteria:

* patients operated upon for spine degenerative disease coming for follow up in the outpatient clinics.

Exclusion Criteria:

* preoperative patients and immediate postoperative patients.
Efficacy and Safety of Etanercept in Active RA Despite Methotrexate Therapy in Japan

Multi-center, parallel-group, randomized, open control study. All patients will be selected to two treatment groups.

1. Etanercept alone treatment group (25mg, twice/week, s.c.)
2. Etanercept combined with MTX group (25mg, twice/week, s.c.+MTX 6-8mg/week)


Eligibility Criteria:
Inclusion Criteria:

* Patients had to be at least 18 years of age
* fulfilled the 1987 revised classification criteria for RA by in American College of Rheumatology (ACR)
* met the guidelines for the proper use of ETN in Japan (having at least 6 tender joints and 6 swollen joints
* either serum C-reactive protein more than 2 mg/dl or ESR no less than 28 mm at 1 hour, with adequate safety profiles)
* be ACR functional class I-III
* have been receiving MTX 6 mg/week for a minimum of 3 months at a stable dose for at least 4 weeks at the time of study enrollment

Exclusion Criteria:

* Patients who required concurrent use of prednisone (PSL) \>10 mg/day, or its equivalent, were excluded from study entry
* the start of dose increment of PSL equivalents within 3 months of the study enrollment
* experience of antirheumatic therapy except for MTX and PSL equivalents
* previous treatment with ETN or any other biological treatment
Safety of Two Trivalent Influenza Vaccines Evaluated in Children and Adolescents 4 to 17 Years of Age

Evaluate safety and tolerability of TIVa or TIVb vaccine in healthy children and adolescents 4 to 17 years of age.


Eligibility Criteria:
Inclusion Criteria:

- Healthy subjects 4-17 years of age

Exclusion Criteria:

* Subjects who are not healthy,
* Subjects who are pregnant or breast feeding,
* Subjects with a history of severe allergic reaction or allergic to any of the vaccine components.
A Comparison of Safety and Treatment in Subjects With Osteoarthritis Taking Low Dose Aspirin

The purpose of this study is to compare the gastroduodenal ulceration rate, gastrointestinal complication rate and non-steroidal anti-inflammatory drug-associated dyspepsia between lansoprazole, naproxen and celecoxib, taken once daily (QD) or twice daily (BID), in participants with osteoarthritis taking low dose aspirin.

This study was designed to compare the effectiveness of reducing the incidence of gastroduodenal ulcers between lansoprazole 30mg QD + naproxen 500mg BID vs celecoxib 200mg QD in subjects with osteoarthritis taking low dose aspirin. Approximately 100 sites across the U.S. will enroll subjects with normal endoscopic findings and negative H.pylori. The duration of the study will be a maximum of 14 weeks including a screening period of up to 2 weeks and a 12 week treatment period. Gelusil will be provided for dyspepsia symptom rescue.

Eligibility Criteria:
Inclusion Criteria:

* Must require the chronic use of a non-steroidal anti-inflammatory drug for the treatment of osteoarthritis.
* Must be taking daily aspirin for cardiovascular prophylaxis.
* Clinical Laboratory values within normal limits for this population

Exclusion Criteria:

* History of gastric, duodenal or esophageal surgery except simple oversew of an ulcer.
* Evidence of uncontrolled, clinically significant disease.
* History of cancer within the past 5 years.
* Presence of gastroduodenal ulcers, esophageal ulcer or \>= 10 gastroduodenal erosions during the screening endoscopy. Known history of gastroduodenal ulcer or bleeding within the past year. Esophageal stricture requiring dilatation.
* Presence of Barrett's esophagus with dysplastic changes.
* Systemic disease affecting the esophagus or a history of caustic or physiochemical trauma or irradiation to the esophagus.
* Sero-tests positive for H. pylori.
* Evidence of Zollinger-Ellison syndrome, esophageal varices, cholecystitis, or pancreaticobiliary tract disease.
* Requires treatment with an excluded medication such as proton pump inhibitors, histamine H2 receptor antagonists, antacids, corticosteroids, lithium, fluconazole, misoprostol, probenecid, methotrexate, anticoagulants, St. John's wart, dong quai, feverfew, garlic, ginger, horse chestnut, red clover or white willow supplements or bisphosphonates.