cyrilzakka/clinical-trials huggingface dataset:
A Study of HGS1029 (AEG40826-2HCl) in Subjects With Advanced Solid Tumors

The purpose of this study is to evaluate the safety and tolerability of HGS1029 in subjects with advanced solid tumors and to determine a phase 2 dose.


Eligibility Criteria:
Inclusion Criteria:

* Confirmed advanced solid malignancy
* Life expectancy of at least 3 months
* Age 18 years or older
* Acceptable liver function
* Acceptable renal function
* Acceptable hematologic status

Exclusion Criteria:

* Received investigational (not yet approved by a regulatory authority)agent within 4 weeks before enrollment.
* Received non-investigational agent within 3 weeks before enrollment.
* Progressive CNS involvement including the need of corticosteroids
* Pregnant or breast-feeding women
* Active, uncontrolled bacterial, viral, or fungal infections within 2 weeks of Cycle 1 Day 1
* Known HIV infection
Forces and Translation Distance During an Inferior Glide of the Shoulder

This study evaluates the force and translation distance in the GH joint during a manual inferior glide of the humerus.

There has been limited research on how the variance of force affects MT outcomes and what the best practices of MT should be. No specific force threshold necessary to achieve a predetermined translational distance within the joint has been quantified within the literature. The purpose of this study was to quantify the amount of force necessary to perform an inferior glide to the glenohumeral joint and reach to end-range. A secondary aim was to determine the impact of co-variables, such as gender, height, weight, and age, on the amount of force required to translate the humeral head within the glenohumeral joint. Musculoskeletal Ultrasound imaging using the GE LogiQe was used to measure the translation of the humeral head. The manipulation force was measured using the Novel Pliance Glove device and software.

Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers
* Able to read the English language fluently

Exclusion Criteria:

* a history of injury of the right shoulder
* right shoulder surgery
* presence of shoulder pain
* comorbidities affecting natural ROM within the dominant shoulder
Non Exudative AMD Imaged With SS-OCT- Extension

The investigators wish to better understand the role of the choriocapillaris (CC) in the formation and progression of non-exudative in age related macular degeneration (armd) by imaging the retinal pigment epithelium (rpe) and the choroidal microvasculature and by studying their inter-dependence to determine if the loss of the CC could prove useful as an anatomic clinical trial endpoint in future drug trials.

The investigators wish to better understand the role of the choriocapillaris (CC) in the formation and progression of non-exudative in age related macular degeneration (armd) by imaging the retinal pigment epithelium (rpe) and the choroidal microvasculature and by studying their inter-dependence to determine if the loss of the CC could prove useful as an anatomic clinical trial endpoint in future drug trials. This is an extension of a currently ongoing longitudinal observational study (BIRC-01) (NCT03688243).

Eligibility Criteria:
Inclusion Criteria:

* Enrollment in and completion of the BIRC-01 study
* Clinic diagnosis of non-exudative iAMD in at least one eye with a drusen volume in the central 3 mm circle centered on the fovea of at least 0.02 mm3 in the absence of GA or nGA as diagnosed with OCT en face imaging OR Clinical diagnosis of early or early/intermediate stage AMD in one eye in the absence of nGA or GA and exudative AMD in the other eye OR clinical diagnosis of GA or nGA secondary to AMD that is at least the size of a large druse (125 microns in diameter; 0.05 mm2) and no greater than 7 disc areas (17 mm2) in at least one eye which has never been treated with anti-VEGF agents
* Willing and able to comply with clinic visits and study-related procedures
* Provide signed informed consent

Exclusion Criteria:

* Subjects with exudative AMD in both eyes
* Eyes with evidence of non-proliferative and proliferative diabetic retinopathy.
* Presence of confounding ocular diagnosis such as myopia \>6D, or other ocular conditions that may cause retinal pigment epithelium atrophy or exudative MNV
* Subjects currently or previously enrolled in other interventional clinical trials in which treatment was administered to the study eye.
* Previous vitrectomy or intravitreal injections in the study eye.
* Axial length measurement ≥ 26 mm.
* Subjects unable to give informed consent.
* Subjects who are unable to comply with imaging guidelines
RE-SEARCH Study: A Study to Learn How and in Which Amount Regorafenib is Given in Usual Practice to Patients in Spain: a Study Looking Back at Cases That Have Already Happened When the Study Begins.

Researchers are collecting more information to improve treatment of metastatic colorectal cancer (mCRC) with regorafenib.

Metastatic colorectal cancer (mCRC) is a cancer that starts in the large bowel and involves the rectum (the lowest part of the gut) and has spread to other parts of the body. Regorafenib is available to treat patients with mCRC that have previously been treated with, or are not considered candidates for, available therapies. It is an anti-cancer drug that blocks several proteins called enzymes which are involved in the growth of cancer. It is known that doctors may change the amount (the dose) of regorafenib they give, so that the patients better tolerate the treatment. Little information is however available on the doses of regorafenib given in Spain in usual practice.

In this study researchers want to learn how and in which amount regorafenib is usually given to patients with mCRC in Spain. They aim to identify the starting dose of regorafenib and to describe dosing patterns during the first two four-week treatment periods (cycles) according to usual clinical practice.

To answer these questions, the researchers will look back at cases that have already happened when the study begins. Medical history data from the day of diagnosis of the mCRC until the day prior to the inclusion in the study is collected from the medical records of adult patients with mCRC. All patients must have started their treatment with regorafenib since January 2017 and have taken regorafenib for at least 3 months.

The researchers will collect the information between around June 2021 until around November 2021. The final report is planned to be available in July 2022.

No investigational products will be administered in this study. Moreover, no additional visits or laboratory tests will be performed apart from the usual tests/treatments done in usual practice.


Eligibility Criteria:
Inclusion Criteria:

* Patient ≥ 18 years
* Patients with histological confirmation of mCRC
* Patient who started treatment with regorafenib for mCRC according to usual clinical practice during or after January 2017 and at least 3 months prior to the inclusion in the study

Exclusion Criteria:

* Patient who have been treated with regorafenib during their participation in a clinical trial
Treatment of Gastrocnemius Tightness and Subsequent Chronic Plantar Fasciitis with Botulinum Toxin a

This prospective clinical cohort study will follow 40 patients who recieve botulinum toxin A treatment for proximal medial gastrocnemius tightness with subsequent Chronic Plantar Fasciitis for two years. Three injections of botulinum toxin (75IU) will be administered with intervals of three months. Participants will be followed at baseline, 3 months, 6 months, 1 year and 2 years with Patient Related Outcome Measures (PROMS) and physical test (Ergotest and ankle dorsiflexion).

The connection between gastrocnemius tightness and plantar fasciitis has been demonstrated in several clinical studies. Patients with chronic pathology, and unsatisfactory results from physical therapy, may benefit from gastrocnemius lengthening. This is usually obtained with proximal medial gastrocnemius recession surgery (PMGR), but recent studies and recent experience from our hospital suggest that similar effect may be obtained with ultrasound guided- injections of Botulinum Toxin A injections in the proximal medial gastrocnemius muscle.

This study will follow patients with gastrcnemius tightness (demonstrated by the Silferskiolds test) and subsequent chronic (MRI-verified) plantar fasciitits who has not recieved satisfactiory results from at least three months of guided physcial therapy.

Participants will recieve three ultrasound guided injections of 75IU of Botulinum Toxin A with three month intervals.

They will be followed with clinical controls for two years after the first injection.

THe main outcome is the Manchester Oxford Foot Questionnaire (MOxFQ).

Eligibility Criteria:
Inclusion criteria:

1. Age 18-75 years.
2. An isolated gastrocnemius contracture must be verified with the Silfverskiölds test before inclusion.
3. Diagnosis plantar fasciitis verified clinically by an orthopaedic surgeon.
4. Diagnosis verified by MRI. MRI criteria: Thickening of the plantar fascia, oedema in the calcaneus, pathological signal changes in the plantar fascia (35)
5. Duration of symptoms must be at least 12 months prior to first BTA injection.
6. Conventional Physical Therapy must have been tried at least three months without a significant reduction of symptoms in the affected foot.

Exclusion criteria:

1. Previously undergone surgery for plantar fasciitis.
2. Patients with severe talocrural pathology or serious malalignment of foot and ankle
3. Severely reduced peripheral circulation
4. History of alcoholism, drug abuse, psychological or other emotional problems likely to jeopardize informed consent.
5. Patients with a contraindication/non-compliance for MRI examination.
6. History of allergic reaction/anaphylactic reaction or other contraindication to botulinum toxin.
7. Not able to read and/or speak a Scandinavian language or English adequately.
Use of a Dual-agent Local Analgesic (Bupivacaine-meloxicam) for Abdominal Incisions in Patients Undergoing Retropubic Mid-urethral Sling Surgery

This study will compare the use of a dual-agent local analgesic (bupivacaine-meloxicam) for abdominal incisions in patients undergoing retropubic mid-urethral sling surgery to see if narcotic usage and pain are impacted.


Eligibility Criteria:
Inclusion Criteria:

* undergoing retropubic mid-urethral sling surgery (with concomitant anterior repair or urethrocele repair)
* English as first language

Exclusion Criteria:

* patients undergoing concomitant posterior repair, vaginal vault suspension, or any other intra-peritoneal surgeries including hysterectomy
* NSAID use within 7 days of surgery
* steroid use within 10 days
* daily opioid use in the last 3 months
* long acting opioids within 3 days
* any opioids within 24h
* patients unable to consent for themselves
* patients allergic to meloxicam or bupivacaine
* pregnant or lactating patients
Trauma Exposure, Emotion Regulation and Eating Pathology in Obese Patients

The purpose of this study is to investigate the associations between lifetime exposure to traumatic events, emotion regulation strategies, and eating pathology of patients with obesity.


Eligibility Criteria:
Inclusion Criteria:

* Adults
* Obese (BMI \>= 30)
* Recruited from the nutrition service of Hôpital Européen Georges-Pompidou
* Informed consent provided

Exclusion Criteria:

* PTSD symptoms (score \> 33 ; PTSD Checklist-5)
* Bariatric surgery patients
* Difficulties to understand French language
* Patients under social protection
A Trial of HRS-8427 in the Treatment of Adults With Bacterial Pneumonia

The purpose of this study is to evaluate the efficacy and safety of HRS -8427 in patients with HABP/VABP.


Eligibility Criteria:
Inclusion Criteria:

1. Be able and willing to provide a written informed consent before the study, fully understand the study and be able to complete the study according to the protocol.
2. Male and female, ≥18 years.
3. Judged by the investigator, clinical diagnosis with HABP/VABP, expectation that the patients will require hospitalization and initial treatment with intravenous antibiotics.
4. All subjects must have a chest radiograph during screening or within 48h before randomization, showing the presence of new or progressive infiltrate(s) suggestive of bacterial pneumonia.
5. Women of childbearing potential must have a negative serum pregnancy test before the first dose and must be non-lactating. Fertile female subjects or male subjects whose partner is a fertile female agree to use highly effective form of contraception, with no plan of birth and sperm/ovum donation from the time of signing the informed consent form (ICF) till 14 days after the end of treatment.

Exclusion Criteria:

1. Subjects who have known or suspected community-acquired bacterial pneumonia (CABP), atypical pneumonia, or chemical pneumonia.
2. Subjects who have known or suspected pneumonia caused by mycoplasma, chlamydia, legionella, viruses, fungi or parasites.
3. HABP or VABP caused by obstruction.
4. Subjects who have received potentially effective antibiotic therapy for a continuous duration of more than 24 hours during the previous 72 hours prior to randomization.
5. Impairment of renal function with estimated glomerular filtration rate \< 15 mL/min, or receiving peritoneal dialysis/hemodialysis.
6. Subjects with significant laboratory abnormalities.
7. Other pulmonary diseases that may confound the assessment of efficacy or safety.
8. Known history of immune deficiency disease or receive immunocompromising treatment.
9. Severe cardiovascular and cerebrovascular diseases with clinical significance and unstable or uncontrolled condition.
10. Known or suspected central nervous system infections.
11. Patients received cancer treatment within 4 weeks before randomization or planned treatment during the study period.
12. Drug abuse within 1 year prior to randomization.
13. Judged by the Investigator, other reasons unsuitable for this study.
Prediction of the Efficacy of Activated Recombinant Human Factor VII in Adult Congenital Haemophilia A or B Patients With Inhibitors by Use of Thromboelastography

This trial is conducted in Europe and the United States of America (USA). The aim of this trial is to evaluate the basal and spiked TEG® (Thromboelastography) or ROTEM® (Thromboelastometry) profiles of frequently bleeding haemophilia subjects with inhibitors in a non-bleeding state.

The TEG parameters are: R time (Reaction Time), K time (K Time (arbitrary measurement)), a (a angle), MA (Maximum Amplitude) and LY30 (Lysis 30 min after MA) while the ROTEM parameters are: CT (Clotting Time), CFT (Clot Formation Time), a (a angle), MCF (Maximum Clot Firmness) and LI60 (Lysis index 60 min after CT)

Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of congenital haemophilia A or B with a FVIII:C clot activity or FIX:C clot activity, respectively, less than 5%
* Presently use of activated recombinant human factor VII (NovoSeven®) as haemostatic agent for preventive treatment or treatment of bleeding episodes
* A documented historical or present record for the presence of inhibitors to factor VIII or IX, respectively
* A documented history of 2 or more joint bleeding episodes during the preceding 12 months
* Subjects must be in a non-bleeding state (i.e. no clinical manifestations of active bleeds)

Exclusion Criteria:

* Subjects who have received any haemostatic treatment for a bleeding episode within the last 7 days prior to this trial
* Immune tolerance therapy within the last 30 days prior to this trial
* Clinically relevant coagulation disorders other than congenital haemophilia A or B
* Thrombocytopenia (platelet count below 60,000 platelets/mcl)
* Prophylactic haemostatic treatment within 3 days prior to this trial
TD01 Master Study (Safety and Efficacy Study)

This clinical investigation is designed to confirm the safety and efficacy of the TD01 ICD lead.


Eligibility Criteria:
Inclusion Criteria:

* Meet standard indication for ICD/CRT-D therapy
* First ICD/CRT-D implantation or upgrade from pacemaker
* Duly signed informed consent form
* Willing to participate for the whole study duration
* Patient accepts Home Monitoring concept and is able to activate and use the CardioMessenger
* Patient has a legal capacity and ability to consent

Exclusion Criteria:

* Meet a standard contraindication for an ICD/CRT-D therapy
* Age \< 18 years
* Pregnant or breast-feeding
* Cardiac surgery planned within the next six months
* Enrollment in another cardiac clinical investigation with active treatment arm
* Mechanical tricuspid valve prosthesis or severe tricuspid valve disease
* Known dexamethasone acetate intolerance
Upgrade Program Implementation at Colorrectal Surgery and Complications: Early Diagnosis

The anastomotic leak (AL) is a very serious complication in colorectal surgery not only because of its severity but its frequency. Other facet for study, besides the risk factor and prevention, is the AL early diagnostic, due to minimize the clinical consequences and severity; and avoid the failure-to-recue. Several studies analyze the Creactive protein (CRP) and Procalcitonine (PCT) usefulness in AL predictor before the clinical signs appear.

At a prospective observational study carry on our center, it concluded that CRP at 3rd day after surgery over 15mg/dl was a very important AL predictor, even before the clinical changes appear. The aim of this study is minimize the severity complications and the mortality due to AL appears. The aim of this study is minimize the severity complications and the mortality due to AL by means of introduces an upgrade program in which a CT scan will be conduct in all the patients with high CRP levels at 3rd, 4th or 5th postoperative day, with the goal to know the AL early and make all the therapeutic step to minimize the consequences.


Eligibility Criteria:
Inclusion Criteria:

* Patients over 18 years of age.
* Patients undergoing elective colorectal surgery due to neoplastic or non-neoplastic etiology.
* Patients with an anastomosis performed in the surgical act.
* Signed informed consent.

Exclusion Criteria:

* Patients who require transfer to another center.
* Patients with fatal evolution: those who require urgent reoperation for an inarverted perforation, early leakage of anastomosis or death before the third postoperative day.
Phenotype, Genotype and Biomarkers 2

The purpose of this study is to learn more about amyotrophic lateral sclerosis (ALS) and other related neurodegenerative diseases, including frontotemporal dementia (FTD), primary lateral sclerosis (PLS), hereditary spastic paraplegia (HSP), progressive muscular atrophy (PMA) and multisystem proteinopathy (MSP). More precisely, the investigator wants to identify the links that exist between the disease phenotype (phenotype refers to observable signs and symptoms) and the disease genotype (genotype refers to your genetic information). The investigator also wants to identify biomarkers of ALS and related diseases.


Eligibility Criteria:
Inclusion Criteria for affected individuals (primary participants) include:

* Clinical diagnosis or suspicion of ALS or a related disorder, including, but not limited to, ALS-FTD, PLS, HSP, FTD, Multisystem Proteinopathy (MSP) and PMA.
* Subject is able and willing to comply with study procedures

Exclusion Criteria for affected individuals (primary participants) include:

* Subjects with a condition or who are in a situation which, in the PI's opinion, could confound the study finding or may interfere significantly with the individual's participation and compliance with the study protocol -- including but not limited to neurological, psychological and/or medical conditions

Inclusion criteria for biological family members (secondary participants) include:

* Family member of an enrolled affected primary participant

Exclusion Criteria for biological family members (secondary participants) include:

* Subjects with a condition or who are in a situation which, in the PI's opinion, could confound the study finding or may interfere significantly with the individual's participation and compliance with the study protocol -- including but not limited to neurological, psychological and/or medical conditions
The Efficacy and Safety of TBCB vs TBFB in Diagnosis of GGO

The aim of this study is to investigate the difference of efficacy and safety between transbronchial cryobiopsy (TBCB) and transbronchial forceps biopsy (TBFB) in the diagnosis of lung ground-glass opacity.

The conventional biopsy method for lung ground-glass opacity (GGO) diagnosis is to use disposable guided sheath (including biopsy forceps and cell brushes) which have some limitations, such as big physical damage, small biopsy tissue, etc. Cryobiospy is a new technique for biopsy developed in recent years which has many advantages over conventional biopsy, such as larger tissue, higher diagnosis yield, less complication, etc. The investigators will explore the efficacy and safety of cryobiospy vs. biopsy forceps in GGO diagnosis. The study is designed as a prospective, randomized controlled trial, 184 patients will be expected to enroll in the study and receive EBUS examination before biopsy to check whether the GGO lesions exist or not. This is a parallel-control study that patients with GGO lesions will be randomized to either TBCB group or TBFB group for biopsy. The primary aim is to compare the diagnostic yields of the two biopsy techniques. The secondary endpoint is to assess the tissue size, sampling time, number of sampling and the quality of specimen.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female aged between 18 and 80.
2. CT or other imaging examination suggest a tendency towards malignant GGO (size ≥ 8 mm). The ground glass composition is more than 50%.
3. Thin-slice CT scan with bronchial access or adjacent lesions.
4. Multidisciplinary assessment suggest that bronchopulmonary biopsy is needed to identify the pathological features of GGO.
5. It is suitable for pathological biopsy by transbronchial cryobiopsy or forceps biopsy.
6. Ability to read, understand and sign ICF.

Exclusion Criteria:

1. Disseminated GGO, suspected of benign or infectious lesions.
2. Preoperative imaging examination showed that the biopsy lesion was adjacent to the middle or large vessels.
3. There are contraindications for bronchoscopy, such as irreparable coagulation dysfunction, severe cardiopulmonary insufficiency.
4. Intolerance or difficulty in cooperating with bronchoscopy, etc.
5. Routine bronchoscopic abnormalities, such as endoscopic lesions, external pressure, mucosal lesions, stenosis, hemorrhage, etc.
6. Vulnerable groups, such as pregnant women, etc.
7. Some other special situations investigator consider subjects are not suitable to participant in this study.