cyrilzakka/clinical-trials huggingface dataset:
A Study of Enfortumab Vedotin in Japanese Subjects With Locally Advanced or Metastatic Urothelial Carcinoma

The objective of this study is to assess the safety, tolerability and pharmacokinetics of enfortumab vedotin (ASG-22CE) when administered intravenously to Japanese subjects with locally advanced or metastatic urothelial carcinoma. This study will also assess the immunogenicity as defined by the incidence of anti-drug antibody (ADA) and anti-tumor activity of enfortumab vedotin (ASG-22CE) when administered intravenously to Japanese subjects with locally advanced or metastatic urothelial carcinoma.

All subjects will receive a single 30 minute intravenous (IV) infusion of enfortumab vedotin (ASG-22CE) once weekly for 3 weeks of every 4 weeks (i.e., on Days 1, 8, and 15). A cycle is 28 days.

Eligibility Criteria:
Inclusion Criteria:

* Subject must have histologically confirmed, locally advanced (TNM classification T3b and any N; or T and N2-3) or metastatic Transitional Cell Carcinoma of the Urothelium (TCCU) (i.e., cancer of the bladder, renal pelvis, ureter, or urethra). Subjects with Urothelial Carcinoma with squamous differentiation or mixed cell types are eligible.
* Subject must be able to submit a tumor tissue samples for Nectin-4 expression analysis at central laboratory.
* Subject must have failed at least one prior chemotherapy regimen for advanced disease. Urothelial and bladder cancer subjects are not required to have failed prior chemotherapy regimen if considered unfit for cisplatin-based chemotherapy.
* Subject must have measurable disease according to Response Evaluation Criteria in Solid Tumor (RECIST) (version 1.1).
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

Exclusion Criteria:

* Preexisting sensory neuropathy Grade ≥ 2.
* Preexisting motor neuropathy Grade ≥ 2.
* Uncontrolled central nervous system metastasis that requires active treatment.
* Any anticancer therapy within 14 days prior to the first dose of study drug.
* Subjects with pre-existing immunotherapy-related adverse events requiring high doses of systemic steroids are not eligible.
Cerebral Bleeding in COVID-19 ARDS Patients on Veno-venous ECMO

Critically ill patients with severe acute respiratory distress syndrome (ARDS) sometimes require treatment with veno-venous extracorporeal membrane oxygenation (ECMO) to support gas exchange. To prevent clotting of the ECMO circuit, these patients need to be anticoagulated. This protective anticoagulation also leeds to an increased bleeding risk.

Most critically ill COVID-19 patients suffer from an ARDS and some require ECMO support. However, the optimal strategy and targets for the anticoagulation of these patients remain uncertain. Studies have shown that COVID-19 is associated with endotheliopathy probably leading to procoagulatory effects. On the other hand, the incidence of bleeding complications associated with this endotheliopathy is not clear and remains to be elucidated.

Anticoagulation of COVID-19 patients on ECMO thus poses a challenge for clinicians.

The hypothesis of the current project is that COVID-19 patients with ARDS on ECMO exhibit a higher number of bleeding complications compared to historical control patients with non-COVID-19 ARDS requiring ECMO support.

The primary aim of the project is to retrospectively analyze the incidence of bleeding complications (especially cerebral bleedings) in critically ill COVID-19 patients with ARDS requiring ECMO support. The incidences of bleeding will be compared with a historical control cohort of non-COVID-19 patients on ECMO support.

The data analysis will be set up within a multicentric, retrospective study involving the University Hospital Zurich (Switzerland), the Medical School Hannover (Germany) and the University Hospital Bonn (Germany). The aim of the multicentric approach is to increase the case load and to improve the validity of the data, which could possibly have therapeutic implications in the future.

Aside from demographic and baseline date, mortality and causes of death, comorbidities, the anticoagulation strategy (substance, targets of anticoagulation) and laboratory parameters of the anticoagulation during the bleeding events will be collected.

Furthermore, the intensity of the ECMO treatment (blood flow, sweep gas flow, oxygen requirement) during the bleeding events and the catecholamine use during ECMO implantation will be analyzed.

To enhance comparability, intensive care specific treatments (proning, sedation and analgesia, COVID-19 targeted therapy) will be collected and analyzed.

Eligibility Criteria:
Inclusion Criteria:

* Critically ill patients with ARDS requiring ECMO support from all three study sites
* age \> 18 years

Exclusion Criteria:

- Presence of an objective, declared denial to participate
Efficacy of Bilateral Superficial Cervical Plexus Block vs. Local Infiltration of Lidocaine 2% in Tracheostomy Procedure

The aim of this study was to compare the efficacy between superficial cervical plexus block and local infiltration of lidocaine 2% in patients undergoing tracheostomy procedure.

Ethical approval was obtained from Ethics Committee of Faculty of Medicine, Universitas Indonesia - Dr. Cipto Mangunkusumo Hospital.

Eligible subjects for this study will be recruited with consecutive sampling method within certain period until minimum number of subjects required for this study is filled.

Informed consents will be given to each subject before participating in the study. Patients will be randomly divided into two groups using closed envelops.

Subjects who will receive bilateral superficial cervical plexus block is the interventional group whereas subjects who will receive local infiltration of lidocaine 2% is the control group.

Before, during, and after the procedure, all subjects are monitored (blood pressure, heart rate, respiratory rate, and electrocardiography). Monitoring data, including pain, will be recorded. Pain is measured by using visual analog scale or verbal numeric rating scale.

Arterial blood sample (approximately 3 cc) from each subject will be withdrawn twice and put into tubes containing anticoagulant for substance-P examination. Initial withdrawal is done before the anesthetics are given while the last one is done after the tracheostomy procedure.

Before the procedure, location for incision and block will be marked. Interventional group will be given 10 mL of Bupivacaine 0.5% on each side of the neck (as marked) by using 20 mL spuit with 25 G 1.5 inch needle whereas control group will be given 4 mL of Lidocaine 2% on incisional region (as marked) by using 5 mL spuit with 25 G 1.5 inch needle. 1 mg of Midazolam can be given intravenously before the block if there is no contraindication. Tracheostomy will be performed 15 minutes after the block is administered or local infiltration has worked. After tracheostomy, patients will be continually monitored in post-anesthesia care unit while their blood samples will be delivered to laboratory for ELISA test.

Eligibility Criteria:
Inclusion Criteria:

* Physical Status ASA 1-3

Exclusion Criteria:

* Pregnant
* Blood clotting disorder
* Allergic to anesthetics (Lidocaine, Bupivacaine) used in this study
* Local infection on procedure area
* Deformity on procedure area
Efficacy and Safety of Romosozumab Treatment in Postmenopausal Women With Osteoporosis

The purpose of this study is to determine if treatment with romosozumab is effective in preventing fractures in women with postmenopausal osteoporosis


Eligibility Criteria:
Inclusion Criteria:

- Postmenopausal women with osteoporosis, defined as low bone mineral density (BMD T-score at the total hip or femoral neck of ≤ -2.50)

Exclusion Criteria:

* BMD T-score of ≤ -3.50 at the total hip or femoral neck
* History of hip fracture
* Any severe or more than 2 moderate vertebral fractures, as assessed by the central imaging based on lateral spine x-rays
* Use of agents affecting bone metabolism
* History of metabolic or bone disease (except osteoporosis)
* Vitamin D insufficiency (vitamin D repletion and rescreening is permitted)
* Current hyper- or hypocalcemia
* Current, uncontrolled hyper- or hypothyroidism
* Current, uncontrolled hyper- or hypoparathyroidism
Influence of Human Albumin Supplementation on Kidney Dysfunction After Liver Transplantation

To verify whether albumin administration to achieve serum concentration above 30g/L (treated group) and its maintenance within plasmatic physiologic range (above 30 g/L) for five days diminishes rate of AKI at Day 7 after liver transplantation as compared to restrained albumin administration (when serum concentration is at 20 g/L or below (control)).


Eligibility Criteria:
Inclusion Criteria:

* Male and female subjects equal or above 18 yrs old.
* Recipients of primary liver allografts from a deceased donor (including after cardiac death) and as a single organ (liver only).
* Capability of understanding the purpose and risks of the study.
* Written informed consent

Exclusion Criteria:

* Fulminant hepatitis
* Kidney injury at baseline (Estimated Glomerular Filtration Rate \< 50 ml/min in Modification of diet in renal disease-6) including hepatorenal syndrome
* Use of an induction agent Basiliximab at liver transplantation
* Protected person (adults legally protected, under judicial protection, guardianship, or supervision), person deprived of their liberty
* At the time of randomisation, participation to another interventional study
Targeting Monoaminergic Neuronal Networks in the Parkinsonian Patients After Carbon Monoxide Intoxication

The study purpose is to determine the clinical values of 18F-FP-(+)-DTBZ in the diagnosis of Parkinsonism in patients with carbon monoxide intoxication, regional distribution and its correlation with clinical parameters. This study is expected to be completed in a period of 3 years.

With the urbanization of Taiwanese society, there are increasing numbers of people committing suicide by charcoal burning, making carbon monoxide (CO) encephalopathy a new pandemic phenomenon. In CO related parkinsonism, the clinical features included gait disturbances, mask face, rigidities and small steps. From literature searches, the CO related parkinsonism is related to white matter damages or decline in dopamine innervations. From our previous research results, the CO related neuronal damages would started from reversible or progressive white matter demyelination. For some patients, axonopathy or gray matter atrophy developed and became irreversible. The neuronal networks in determining development of Parkinsonism required to be established.

In terms of neurotransmitter, most of the clinical data for Parkinsonism came from studies of idiopathic Parkinson's disease while the data of CO related Parkinsonism were limited to case reports. From neuropathology studies in idiopathic Parkinson's disease, dopamine deficits and decreased in monoamine transporters were observed well before the development of clinical features. Although there is linkage between CO related Parkinsonism and dopamine deficits, patients with CO intoxication had poor response to levodopa. The observation suggested the critical networks and neurotransmitters were still not well understood.

18F-FP-(+)-DTBZ is a newly developed nuclear medicine tracer for monoamine transporter. The study purpose is to determine the clinical values of 18F-FP-(+)-DTBZ in the diagnosis of Parkinsonism in patients with carbon monoxide intoxication, regional distribution and its correlation with clinical parameters. This is a three-year prospective research. For each patient, the PET will be arranged twice, with an interval of 18 months. The regional distribuation of 18F-FP-(+)-DTBZ in relation to Parkinsonism severity and regional reduction patterns longitudially will be assessed in order to understand the regional neurotoxicity and the functional progression.

Eligibility Criteria:
Inclusion criteria

1. Male or female age 20 years to 65 years.
2. Patients group should fulfilled diagnostic criteria of carbon monoxide intoxication
3. Patients who provide a written informed consent prior to study entry. If the patient is incapable of informed consent, the caregiver may consent on behalf of the patient (the patient must still confirm consent)

Exclusion criteria

1. History of developmental disorders, agitated mood or a confused state that prevented either a neuropsychiatric interview or neuroimaging.
2. Unable to stay still in the PET scanner for 30 minutes.
3. History or presence of QTc prolongation. (\>500msec)
4. Pregnancy and breast feeding.
A Study to Evaluate ONM-100, an Intraoperative Fluorescence Imaging Agent for the Detection of Cancer

This study is to evaluate diagnostic performance, safety and timing of post-dose imaging of ONM-100, an intraoperative fluorescence imaging agent for the detection of cancer in patients with solid tumors undergoing routine surgery.


Eligibility Criteria:
Inclusion Criteria:

* Biopsy-confirmed diagnosis of primary or recurrent respective tumor type and scheduled to undergo surgical resection
* Part 1: Biopsy-confirmed diagnosis of head and neck squamous cell carcinoma (HNSCC) or breast cancer
* Part 2: Biopsy-confirmed diagnosis of HNSCC, breast cancer, colorectal cancer, prostate cancer, ovarian cancer, urothelial carcinoma and non-small cell lung cancer.
* Part 3: Stage 2 to 4 HNSCC Including T0 or Tx unknown Primary cancers

Exclusion Criteria:

* Histologically diagnosed by an excisional biopsy procedure
* Tumors at sites of which the surgeon would assess that in vivo intraoperative imaging would not be feasible
* Life expectancy \<12 weeks
* Hepatic impairment (Child-Pugh score \>5) or significant liver disease including active hepatitis or cirrhosis
The Public Private Partnership Addressing Literacy-Numeracy to Improve Diabetes Care

The primary hypotheses are that the intervention will improve A1C, blood pressure, lipids, weight, self-efficacy, self-management behaviors, and use of clinical services at 12 and 24 months follow-up.


Eligibility Criteria:
Inclusion Criteria:

* Patient has a clinical diagnosis of Type 2 Diabetes
* Age 18-85 years
* English or Spanish speaking
* Most recent A1C ≥ 7.5%
* Patient agrees to participate in the study for the full two years duration.

Exclusion Criteria:

* Poor visual acuity (vision worse than 20/50 using Rosenbaum Pocket Screener) -- Significant dementia or psychosis (by health provider report or chart review)
* Terminal illness with anticipated life expectancy \< 2 years (per health provider or patient report).
tDCS in Treatment of Craving in Sexual Addiction

In patients with addiction to a substance, an increase in activity in the prefrontal cortex induced by transcranial Direct Current Stimulation -tDCS (non-invasive technique, modulating cortical activity by applying low-intensity electrical currents between two electrodes),may help reduce craving in people addicted to alcohol and tobacco. By analogy with addictive behavior with a substance, the craving observed in certain behavioral addictions would involve the same neural circuits.

The main hypothesis is to reduce the sexual craving associated with the viewing of erotic images during active brain stimulation compared to placebo stimulation. Functional MRI will allow to better understand the neural circuits involved in sexual addiction and in the expected inhibition of sexual arousal by tDCS in sexual addictions during visualization erotic images.

The concept of sexual addiction appeared in American literature about 20 years ago. The term sexual addiction describes an excessive, increasing, and especially uncontrolled frequency of sexual behavior, as a conventional rule, associated with a compelling and irrepressible sexual desire (craving), which persists in spite of the possible negative consequences and personal suffering of the subject. The prevalence of this condition is estimated to be approximately 3-6% in the general population in the United States, it is independent of the socio-cultural environment. The pathophysiology of sexual addictions remains very poorly understood.

Numerous studies have focused on substance addictions and their pathophysiology. The mesolimbic dopaminergic system plays a major role in addictive behavior. The prefrontal cortex and the basolateral region of the amygdala play an important role in the craving and may cause relapse in subjects. In subjects with sexual addiction, only one controlled study has been conducted on the role of antidepressant treatment in the reduction of craving. The objective of the study is not only to evaluate the efficacy of tDCS neurostimulation in this disorder but also to identify the brain structures involved in this addictive disorder.

Eligibility Criteria:
Inclusion Criteria:

* 18-60 year old male
* Heterosexual
* Right-handed (Manual laterality test)
* With a sexual addiction (PEACCE Tool\> 3 and Carnes ≥ 13/25) except for controls
* Having signed a written and informed consent
* Subject benefiting from social security

Exclusion Criteria:

* Subject presenting a medical pathology requiring drug treatment,
* Severe psychiatric pathology (bipolar disorder, hyperactivity or schizophrenia) or another addiction (alcohol, illicit substances or behavioral addiction)
* Subject consuming psychotropic drugs in progress or during the last month
* Subject not understanding French
* Subject under tutorship or curatorship
* Subjects with neurological disease including epilepsy or a history of head trauma
* Subjects hospitalized in enforced hospitalization
* Subject presenting a contraindication to tDCS: subject with an electrical or metal brain implant
* Subject with a contraindication to MRI
Evaluation of Safety and Efficacy of the Apyx™ Device for the Repair of Pelvic Organ Prolapse (POP)

The aim of this study is to further evaluate this minimally invasive SSLF technique with respect to safety, clinical effectiveness, and patient satisfaction. The procedure will be performed in women electing to undergo surgical repair of their prolapse who wish to preserve their uterus, and will be evaluated using standardized measures and questionnaires.

This study will evaluate sacrospinous ligament fixation using an incision-free technique - a technique that was developed with the goal of offering a technically simple, safe, and effective alternative to surgical prolapse repair procedures. When compared to previously reported SSLF methods, this technique has undergone novel modifications with the intent of maximizing efficacy and minimizing invasiveness. First, each sacrospinous ligament is approached trans-vaginally using a small diameter, low profile needle as the delivery platform for the anchoring unit. Secondly, the suspension is bilateral, thus maintaining vaginal length and width without deviation or narrowing of the vagina as might occur with a traditional (unilateral) sacrospinous repair. And third, using bio-degradable sutures and a securing element that stabilizes the fixation as opposed to performing an incision in the vaginal wall for suturing enables an incision-free procedure leaving the vagina free of any device after a period of several weeks.

Eligibility Criteria:
Inclusion Criteria:

Women with prolapse electing to undergo reconstructive vaginal surgery for primary uterovaginal prolapse, who wish to enroll in this trial of an incision-free prolapse repair technique, after being familiarized with the suspected benefits and risks of the procedure.

* Ages 18-90 years old
* POP-Q Stage 2 or greater with an apical support defect, also defined as uterovaginal prolapse
* Desire of uterine preservation
* Patient is willing to return for follow-up evaluation and questionnaire completion at 3 months, 6 months, and 12 months, in addition to routine postoperative standard of care.
* English fluency

Exclusion Criteria:

* Previous vaginal, abdominal, or laparoscopic repair for pelvic organ prolapse
* Prior hysterectomy
* Known allergy to Nitinol / Stainless Steel / Polydioxanone.
* Suspected uterine pathology, including malignancy.
* History of chronic pelvic pain, interstitial cystitis or fibromyalgia.
* Women diagnosed with symptomatic uterine fibroids, cervical elongation or hypertrophy, abnormal uterine or vaginal bleeding.
* History of Pelvic Inflammatory Disease (PID)
* Prior pelvic radiation therapy or malignancy.
* Diagnosis of reproductive tract anomalies.
* Pregnant or lactating women.
* Participation in another trial
* Inability to provide informed consent for study enrollment
* PI's subjective assessment that study procedure will not plausibly correct patient pelvic organ prolapse symptoms due to anatomic considerations
Exercise and Disease Progression in Amyotrophic Lateral Sclerosis Patients

This study evaluated the influence of a tailored aerobic exercise protocol on the functional outcome in ALS patients. In addition, the investigators compare some CPET variables collected during exercise testing in both groups.

This work aimed to evaluate the effects of a moderate aerobic exercise with controlled intensity determined by Cardiopulmonary Exercise Testing (CPET) and its role on the functional status in ALS patients versus standard care. Additionally, the investigators explored the performance of CPET variables - oxygen uptake (VO2) expressed in L/min, in percentage of predicted or in metabolic equivalents (METs) at peak effort, at anaerobic threshold (AT), the respiratory compensation point (RCP) when achieved, Dioxide Carbon output in L/min (VCO2) and the minute ventilation in L/min (VE) throughout the study.

Assessments:(diagnostic visit - T0), at study entry (T1) and 6 months after (T2) using:

Functional status by Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised (ALSFRS-R), Respiratory function tests (RFT): Forced Vital Capacity predicted (%FVC) and Oxygen saturation provided by pulse oximetry.

CPET was performed in both groups at study entry and 6 months later (T1 and T2), using a treadmill (WOODWAY®) coupled with a gas exchange analyzer (METALYZER® 3B) with ergo-spirometry system using a breath-by-breath technology developed by CORTEX® systems.

Intervention:

G1(Interventional group) performed moderate exercise protocol two times/week in a treadmill in the lower range of the training zone determined by CPET + standard care (range of motion exercise, gait and balance training under continuous pulse oximetry observation).

G2 (control group) performed a standard care exercise program at home or at other rehabilitation units without pulse oximetry observation.

Eligibility Criteria:
Inclusion Criteria:

* Consecutive patients diagnosed with definite, probable, or probable laboratory supported ALS
* Disease duration from first symptoms between 6-24 months to exclude slow and fast progression
* ALSFRS-R ≥ 30
* FVC (%predicted) ≥ 70%

Exclusion Criteria:

* Other medical conditions, like cardiac insufficiency and lung disorders or others conditions limiting exercise training;
* Heavy smoking habits with laboratorial evidence of significant bronchial constriction;
* Signs of associated dementia or psychiatric disorders.

Note: None of the patients were on tube feeding, invasive or non-invasive mechanical ventilation at admission of study protocol (T1).