cyrilzakka/clinical-trials huggingface dataset:
Cortical Priming to Optimize Gait Rehabilitation Post Stroke

Over four million stroke survivors currently living in the United States are unable to walk independently in the community. To increase the effectiveness of gait rehabilitation, it is critical to develop therapies that are based on an understanding of brain adaptations that occur after stroke. This project will be the first step towards the development of a novel therapeutic approach using brain stimulation to increase walking capacity in stroke survivors and understand the neural mechanisms that are associated with impairment and functional recovery.


Eligibility Criteria:
Inclusion Criteria:

* Age 50 - 80 years
* First ever monohemispheric stroke \> 6 months since onset
* Residual hemiparetic gait deficits
* Able to walk without an ankle orthotic for 5 minutes at self-paced speed. Handheld assistive device is acceptable.

Exclusion Criteria:

* Severe osteoporosis
* Contracture-limiting range of motion of lower limb
* Uncontrolled anti-spasticity medications during the study period
* Cardiorespiratory or metabolic diseases (e.g. cardiac arrhythmia, uncontrolled hypertension or diabetes, chronic emphysema)
* Unhealed decubiti, persistent infection
* Significant cognitive or communication impairment (MMSE \<21), which could impede the understanding of the purpose of procedures of the study or prevent the patient from performing the tracking task.
* Lesions pertaining to the brainstem and cerebellum
Concurrent Low Intensity Shockwave Therapy on Collagenase Clostridium Histolyticum for Peyronie's Disease

The purpose of this research is to determine whether or not low-intensity shockwave therapy (LiSWT) with Xiaflex treatment will result in greater improvements to the curvature of the penis.


Eligibility Criteria:
Inclusion Criteria

• Diagnosed with PD

* Palpable penile plaque
* Dorsal, lateral, or dorsolateral penile curvature
* Penile curvature \> 30 degrees and \< 90 degrees as measured using goniometer during objective curvature assessment
* Non-calcified plaque or grade 1 calcification ("stippling", no shadowing) as determined by penile duplex Doppler ultrasound (PDDU)
* "Stable PD symptoms' defined as PD symptom duration \> 6-months or stable symptoms \> 3-months

Exclusion Criteria:

* Prior intralesional injections or surgery for PD.
* Severe baseline penile pain.
* Moderate or severe baseline ED based on IIEF-EF domain.
* History of low intensity shockwave therapy for sexual dysfunction (ED or PD).
* Ventral (downward) or ventrolateral penile curvature.
* Moderate or severe (grade 2/3) plaque calcification as determined by PDDU.
* Inability to achieve satisfactory erection rigidity at time of baseline curvature assessment.
Pure Single Incision Laparoscopic Distal Gastrectomy (SIDG) Versus Totally Laparoscopic Distal Gastrectomy (TLDG)

1. Compare the immune response and postoperative complications between pure SIDG (single-incision laparoscopic distal gastrectomy) and TLDG (totally laparoscopic distal gastrectomy) for early gastric cancer (EGC)
2. Validate the safety, usefulness, minimal invasiveness and feasibility of SIDG (EGC)

There are some trends of reducing the numbers and lengths of wounds in the fields of laparoscopic surgery.

Recently, Beyond laparoscopy-assisted distal gastrectomy (LADG), which has the mini-laparotomy, TLDG, which has no mini-laparotomy in epigastrium but in umbilicus, has been popular procedure in the treatment of gastric cancer. Furthermore, the report on early experience of SIDG, which has no incision except umbilicus port, is going to be published.

However, there've been no objective reports and data on real minimal invasiveness and benefits between 2 procedures. In this study, I would like to find out the benefits of the reducing port and wound size by comparing the above 2 procedures' immune response and postoperative complications.

This study is planned as a phase II study.

There are no references on this subject, so the investigators set the numbers of each groups into 30, which is minimal requirement for the parametric comparisons.

Eligibility Criteria:
Inclusion Criteria:

* clinically early gastric cancer, potentially possible to perform distal gastrectomy (cancer in the distal 2/3rds)
* 20\< Age \< 80

Exclusion Criteria

* history of other malignancy
* received preoperative chemotherapy
Aims to Explore the Safety, Tolerability, and Preliminary Efficacy of SCTB41 in Adult Patients with Advanced Malignant Solid Tumours.

This study aims to explore the safety, tolerability, PK characteristics, immunogenicity, and preliminary anti-tumor efficacy of SCTB41 as a monotherapy in adult patients with advanced malignant solid tumours. This study is an open label, multicentre, dose-escalation and dose-expansion Phase I/II clinical trial.


Eligibility Criteria:
Inclusion Criteria:

1. Voluntarily sign the informed consent form (ICF);
2. Male or female, ≥18 years old;
3. Survival duration more than 3 months;
4. ECOG score ≤ 1 point;
5. Participants in Phase Ia (dose-escalation phase) are required to meet the following criteria: histologically or cytologically confirmed diagnosis of advanced malignant solid tumour;
6. Participants in Phase Ib (dose-expansion phase) and Phase II are required to meet the following criteria: Histologically or cytologically confirmed specific type advanced malignant solid tumours;
7. Adequate organ and bone marrow function.

Exclusion Criteria:

1. Participants with brainstem, meningeal, spinal metastases, orcompression; active central nervous system metastases;
2. Other malignancies diagnosed;
3. History of hypertensive crisis or hypertensive encephalopathy; presence of uncontrolled hypertension. History of arterial thrombosis or deep veinthrombosis within 6 months prior to enrollment;
4. Presence of any active autoimmune disease or a history of autoimmunedisease with an expected recurrence;
5. Received chemotherapy, immunotherapy, biologic therapy, or other antitumor treatments within 4 weeks before enrollment;
6. Need for immunosuppressive drugs within 2 weeks prior to enrollment oranticipated during the study;
7. Significant coagulopathy or other evident risk of bleeding;
8. uncontrolled effusions in the serous cavities within 4 weeks before enrollment；
9. Major surgery or significant trauma within 4 weeks prior to enrollment;presence of unhealed skin wounds, surgical sites, trauma sites, severe- Page 3 of 4 \[DRAFT\] -mucosal ulcers, or fractures, or if the Investigator deems the participantunsuitable for the study;
10. History of permanent discontinuation of immunotherapy due to immunerelated toxicity or occurrence of ≥ Grade 3 irAEs;
11. Known severe allergy to similar antibody drugs;
12. Presence of active infection；
13. History of organ transplantation or stem cell transplantation;
14. Pregnant or breastfeeding female; women of childbearing potential withpositive pregnancy test within 7 days before the enrollment; participants(including males of childbearing potential and their female partners, and females of childbearing potential and their male partners) unwilling to use medically recognized effective contraception during the study and for 6 months after treatment ends.
Previous Cesarean Sections

This is a retrospective chart review. The purpose is to look at the outcomes for women and newborns who decided to attempt a trial of labor after 3 or more previous cesarean sections.

In 2006, the vaginal birth after cesarean (VBAC) rate was 8.5%, compared to a rate of 28.3% in 1996. This was also associated with a rise in the rate of cesarean section from approximately 20% to 31.1% over that same period of time. In that 10 year period, some hospitals stopped offering a trial of labor after cesarean (TOLAC) altogether.

Currently, the American College of Obstetricians and Gynecologists states in Practice Bulletin 115 (2010), Vaginal Birth After Previous Cesarean Delivery, "it is reasonable to consider women with 2 previous low transverse cesarean deliveries to be candidates for TOLAC...Data regarding the risk for women undergoing TOLAC with more than two previous cesarean deliveries is limited."

In 1994, a study reviewing10 years of data regarding trial of labor after cesarean. Of their population with 3 or more previous cesarean deliveries, 30% of patients underwent a trial of labor, with a 79% success rate. In this group, the uterine rupture rate was 1.2% with zero perinatal deaths related to rupture, which is compared to a rupture rate of 1.8% and 1 perinatal death in the group of 2 previous cesarean deliveries.

In 2002, another study described the outcomes of women who underwent a trial of labor after 2 or more previous cesarean deliveries at two large university hospitals in the Netherlands, but it included just 59 patients total and only 4 of these had 3 previous cesarean deliveries. No patients with more than 3 previous cesarean deliveries had a trial of labor.

A study in 2010, described a large cohort of women from the northeastern United States with 3 or more previous cesarean deliveries, including those attempting VBAC. This cohort included 89 women, of whom 79.8% had a successful VBAC. However, of the women who had a TOLAC, 40.4% delivered in a university hospital and only 18.0% in a hospital with an OB/GYN residency, compared to 56.9% and 25.4% of women who had an elective repeat cesarean section. In the group that had a TOLAC, there were no cases of uterine rupture.

There still remains a lack of data about the outcomes of the delivery of women who desire a trial of labor after 3 or more previous cesarean deliveries at a single institution.

The investigators will analyze and compare the management and outcomes of women and neonates for patients who attempted a trial of labor after 3 or more previous cesareans. We will also compare them to women and neonates of patients who underwent a repeat cesarean section without a trial of labor.

Eligibility Criteria:
Inclusion Criteria:

* Women with a history of 3 or more cesarean sections
* pregnant
* singleton

Exclusion Criteria:

* Less than 3 cesarean sections
The Effectiveness of Alternating Stimulation in Preventing Tolerance in Essential Tremor Patients

The purpose of this study is to investigate the hypothesis that alternating DBS parameters on a weekly basis will prevent tolerance to stimulation and thus waning of benefit, compared with non-alternating stimulation. The primary endpoint will be preserved tremor control with the alternating group compared with standard treatment using the Tremor Research Group Essential Tremor Rating Assessment Scale (TETRAS). Key secondary endpoints will be preserved activities of daily living measures as well as preserved tremor control as quantified by motion sensor data.

This study has one primary aim: To determine if alternating DBS stimulation parameters on a weekly basis will be superior at preserving tremor control compared with usual stimulation (non-alternating stimulation) in ET patients with VIM DBS.


Eligibility Criteria:
Inclusion Criteria:

1. Patients with clinically diagnosed ET who have had placement of VIM DBS and are willing to undergo a baseline programming visit and 12-week follow-up assessment
2. At least initial benefit from VIM DBS as judged by patient report and clinician exam
3. VIM DBS placement no less than three months from entry into study
4. Patients must demonstrate ability to use patient programmer to switch between group settings on a weekly basis
5. Ability to wear wrist monitor for 2 week intervals, twice during the study 6. Patients with the following IPG types: Activa PC, SC or RC

Exclusion Criteria:

1. Atypical tremor disorder including but not limited to tremor due to multiple sclerosis, medication-induced tremor, Parkinson's disease or parkinsonian syndrome
2. DBS placement complicated by infection, hemorrhage or stroke
3. Previous thalamotomy (either stereotactic, gamma knife or focused ultrasound) or previous DBS surgery resulting in explantation and reimplantation
4. Known incorrect or poor lead placement
5. Inability to change group settings on a weekly basis at least 75% of the time
6. Inability to tolerate 12-week period without additional programming changes, including voltage stimulation adjustment
7. Inability to tolerate 12-week period without adjustment of anti-tremor medications, including primidone, beta-blockers, gabapentin, topiramate and/or benzodiazepines
8. Battery voltage \< or equal to 2.70V
9. Patient with the following IPG types: Soletra, Kinetra or Itrel
10. Inability to tolerate two group settings due to side effects or lack of efficacy
Pituitary Gland Enlargement Was First Diagnosed by Optical Coherence Tomography (OCT)

OCT is now an established way to measure the thickness of the Retinal Nerve Fiber Layer (RNFL) in the retina of the eye. The thickness of the RNFL is always a reflection of the number of the RNFs in any particular area of the retina. Each single RNF runs a long course starting from the cell body which is the retinal ganglion cell in the retina and ends in the thalamus of the brain where it relays visual information to other nerve cell in the thalamus. Along this long course RNFs are in close anatomical relationship with the pituitary gland crossing just above this gland about midway along their course. Hence enlargement of this gland can interfere with the RNFs.

The inferior chiasmal syndrome is known to be caused by pituitary gland enlightenment because the pituitary gland lies just below the optic chiasma. The visual RNFs are organized in a very specific way along their long course from the retina to the Lateral Geniculate Body (LGB) in the thalamus. Pituitary enlargement would compromise particular RNFs. It is well known and established that pituitary enlargement, if not properly treated in time, would possibly cause bitemporal hemianopia due to interference with the crossing RNFs of the nasal half of each retina. In this study pituitary enlargement was suspected by OCT findings while the patient still had perfect peripheral visual field in each eye.

Eligibility Criteria:
Inclusion Criteria:

* healthy patients with frequent or persistent headache of unknown reasons.

Exclusion Criteria:

* patients who were previously diagnosed with or treated from pituitary enlargement
Validity of Activity Monitors to Study Walking

Wearable activity monitors represent a real opportunity to assess people' daily walking activity, however their level of validity remains poorly understood in the assessment of intermittent walking activity, i.e. as it occurs in everyday life conditions. Indeed, the available validation studies mainly focused on steps count accuracy of wearable activity monitors, but their validity to detect and quantify bouts of intermittent walking in daily life conditions remains insufficiently studied. It is important not only to determine which indicators would be the most accurate but also which methods would be the most suitable for detecting intermittent walking bouts, and then estimating energy expenditure. The main objective of the VAMOS project is to study the criterion and convergent validity of consumer-level and research-grade wearable activity monitors in assessing daily life intermittent walking in healthy subjects.


Eligibility Criteria:
Inclusion Criteria:

* Be at least 20 years old and under 80 years old.
* Have understood the objectives of the study and its constraints.
* Have read and signed a free and informed consent.
* Be affiliated to the French social security system

Exclusion Criteria:

* Known contraindications or limitations to walking, and reported by the participant.
* Case of hypertension, heart failure, angina pectoris, diabetes, chronic obstructive pulmonary disease, proven by the presence of medication in relation to these diseases and the medical history reported by the participant.
* Case of factors, medical treatments, or diseases likely to lead to a functional limitation to walking and/or a significant modification of the physiological responses to exercise, e.g. active smoking (ongoing or weaned for less than six months), cancer (ongoing), Parkinson's disease, kidney failure (ongoing), proven by the presence of medication in relation to these diseases and the medical history reported by the participant.
* History of cardiovascular disease (heart failure, stroke, heart attack myocardium...) reported by the participant.
* Woman with known ongoing pregnancy (self-declared) or breastfeeding woman.
* Adults subject to legal protection (safeguard of justice, curatorship, guardianship), persons deprived of liberty.
* Simultaneous participation in another research involving the human person.
* Consent withdrawal during the study.
* Any health concern that would appear during the study and that no longer would allow the person to continue to participate.
Imaging of Type 1 Diabetes Progression

Type 1 diabetes results from the autoimmune destruction of the insulin-producing beta cells of the islets of Langerhans of the pancreas. Initially, diabetes is usually clinically silent with immune cells invading the pancreatic islets, a process termed insulitis, which eventually leads to loss of beta cells in the islets. If enough beta cells are destroyed, the body can not make enough insulin to maintain blood sugars in the normal range and clinical diabetes develops. The purpose of this study is to assess the ability of magnetic resonance imaging with ferumoxytol to detect changes in the pancreas associated with the insulitis of type 1 diabetes.

This study is designed to monitor changes associated with the development of autoimmune diabetes. A magnetic resonance imaging (MRI) based technique will be used to noninvasively measure changes within the pancreas associated with the development of autoimmune diabetes. The iron-containing drug ferumoxytol will be used as an intravenous MRI contrast agent for this study.

Individuals will be asked to participate one time, for 1-year, or over a 2-year period. During the development phase of the study, each imaging series will consist of 3 or more MRI scans. At the initial imaging visit a pre-ferumoxytol scan will be done, followed by ferumoxytol injection, and then an immediate post-injection scan. The subsequent scans will be concluded within 96 hours of ferumoxytol injection (typically at 48 hours). Those who participate for 1-year will have repeat imaging at approximate times 0, 6 months, and 12 months. Those who participate for 2-years will have repeat imaging at approximate times 0, 3, 6, 12, 18, and 24 months after enrollment.

Measurements of autoimmunity and metabolic parameters (collected as part of collaborating diabetes clinical studies) will be used in the data analysis for the longitudinal portion of the study. Stimulated C-peptide will be measured as a marker of endogenous insulin production capacity and beta-cell mass.

Eligibility Criteria:
Inclusion Criteria:

* Participation in a collaborating diabetes clinical trial
* Able to understand written consent document and HIPAA authorization prior to initiation of study related procedures and are willing to participate

Exclusion Criteria:

* Known allergy to ferumoxytol or iron
* Individuals who are pregnant or lactating
* Iron saturation above the upper limit of normal
* Individuals with a counter-indication to MRI, such as the presence of metallic prostheses or implanted metal device (e.g., infusion pump, defibrillator)
* Individuals with known clinical conditions that may lead to iron overload including hemochromatosis, cirrhosis, or sickle cell disease
Use of 68Ga-DOTATOC PET/CT-enterography for Detection of the Primary Lesion in Neuroendocrine Tumors of the Small Bowel

The neuroendocrine neoplasms of the small intestine (Si-NENs) is a relatively rare malignancy. Surgical resection is the only curative treatment for the early-stage. It remains controversial its application for advanced metastatic gastroenteropancreatic neuroendocrine tumours (GEP-NETs).

The identification of metastatic disease and tumor grade are the most important prognostic factors in advanced GEPNETs. Therefore, precise staging and evaluation of disease burden with a reliable imaging method is crucial for determining the correct stage of the disease and consequently the correct treatment.

A unique feature of NeuroEndocrinal Tumors (NETs) is the expression of somatostatin receptors (SSTR) which can be targeted with radiolabeled peptides for imaging.

The Positron Emission Tomography-Computed Tomography (PET/CT) technique using somatostatin analogs labeled with the positron emitting isotope, 68Ga (68Ga-DOTA peptides), has been shown to offer advantages over conventional imaging modalities as well as additional important quantitative and qualitative diagnostic information.

The aim of this study is to calculate the sensitivity (SE), the specificity (SP), the positive and negative predictive values (PPV and NPV) and the overall accuracy of 68Ga-DOTATOC PET/CT-enterography in detecting in primary lesion and multifocality of siNETs.


Eligibility Criteria:
Inclusion Criteria:

* patients with small bowel neuroendocrine tumours
* tumors with any grade (from 1 to 3) and any Ki 67 percentage
* patients eligible for surgical resection

Exclusion Criteria:

* patients with synchronous other oncological disease
* patients with Inflammatory bowel disease
* patients Not eligible for surgery
Study of Anaesthesia Costs and Recovery Profiles

The purpose of this study is to compare the perioperative hemodynamic parameters, recovery profiles and cost containment of sevoflurane and propofol based general anesthesia for otorhinolaryngeal surgery.

Sevoflurane and propofol are two basic drugs in the maintenance of anaesthesia. In this study we compared the perioperative hemodynamic parameters, recovery profiles and cost containment of sevoflurane and propofol based general anaesthesia for otorhinolaryngeal surgery. Patients were equally divided into four anaesthetic subgroups. In groups A and C anaesthesia was based on sevoflurane or propofol, respectively, without bispectral index (BIS) and train-of-for monitor (TOF) monitoring. In groups B and D anaesthesia was based on sevoflurane or propofol, respectively, with BIS and TOF monitoring. Drug consumption, recovery profiles and anaesthesia costs were analysed.

ECG, main arterial pressure (MAP), heart rate, oxygen saturation of peripheral haemoglobin (SpO2), pressure of end-tidal carbon dioxide was monitored continuously and registered at 5 min intervals during anaesthesia. Each group received propofol for anaesthesia induction. In group A and B anaesthesia was maintained with sevoflurane, in groups C and D with propofol. In groups B and D the depth of anaesthesia (BIS® Quatro Brain Monitoring Sensor, Covidien) and the neuromuscular blocking status (Infinity®, Trident® NMT SmartPod®, Dräger Medical) were monitored too. BIS and TOF values were recorded at 5 min intervals.

Eligibility Criteria:
Inclusion Criteria:

* ASA physical status grade I or II who were scheduled for elective otorhinolaryngological surgery.

Exclusion Criteria:

* Individuals with a history of bronchial asthma, chronic obstructive pulmonary disease, epilepsy, psychiatric illness, cerebrovascular or congenital neuromuscular disease.