cyrilzakka/clinical-trials huggingface dataset:
Clinical Trial on the Use of Cell Therapy in the Treatment of Patients With Amyotrophic Lateral Sclerosis

Our working hypothesis is that the injection of autologous bone marrow mononuclear cells (BMNC) has a positive effect on the natural loss of motor units and on the increase in the size of the motor unit that occurs in patients with ALS during the evolution of the disease

Our working hypothesis is that the injection of autologous bone marrow mononuclear cells (BMNC) has a positive effect on the natural loss of motor units and on the increase in the size of the motor unit that occurs in patients with ALS during the evolution of the disease.

This hypothesis is based on experimental work done in animal models of ALS and the results of our previous phase I clinical trial. In this clinical trial (TCIM / ALS, ClinicalTrials.gov Identifier: NCT02286011) we studied with electrophysiological techniques (in a small number of patients with ALS) the effects of intramuscular injection of a single dose of BMSC in the tibialis anterioris (TA) muscle. . The results indicate that this is a safe procedure and show the presence of a positive and apparently transitory effect on the size and number of motor units of the TA muscle.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of ALS defined or probable according to the criteria established by the World Federation of Neurology
* Age between 18 and 70 years.
* Patient who offers sufficient guarantees of adherence to the protocol.
* Neurophysiological data confirming lower motor neuron involvement at the lumbar and cervical level.
* Assessment of the motor deficit in the dorsal flexion of both feet (between 3 and 5 points on the MRC scale).

Exclusion Criteria:

* Mellitus diabetes.
* Other diseases that may be associated with polyneuropathies.
* Previous history of cerebral stroke.
* Previous pathology of the peripheral nervous system that affected one or both lower or upper limbs, with or without clinically evident neurological sequelae.
* Pregnant or actively breastfeeding patients
* Patients physiologically capable of becoming pregnant, unless they are using a reliable contraceptive method (Annex III)
* Patients with cardiac, renal, hepatic, systemic, immune disease that may influence the survival of the patient during the test.
* Positive serology for hepatitis B, hepatitis C or HIV.
* Clinical and anesthesiological criteria that contraindicate either sedation or the extraction of BM itself (Alteration of the coagulation system or anticoagulated patient with inability to withdraw anticoagulation, hemodynamic instability, skin alteration in the puncture site, etc.)
* Inclusion in other clinical trials in the last 6 months.
* Inability to understand informed consent.
Study to Assess the Efficacy, Safety, and Tolerability of AVP-786 for the Treatment of Agitation in Patients With Dementia of the Alzheimer's Type

This study was conducted to evaluate the efficacy, safety, and tolerability of AVP-786 (deudextromethorphan hydrobromide \[d6-DM\]/quinidine sulfate \[Q\]) compared to placebo for the treatment of agitation in participants with dementia of the Alzheimer's type.

Eligible participants for this study had a diagnosis of probable Alzheimer's disease (AD) and had clinically significant, moderate/severe agitation secondary to AD.

This was multicenter, randomized, double-blind, placebo-controlled study, consisting of 12 weeks of treatment. Screening occurred within 4 weeks prior to randomization. Following screening procedures for assessment of inclusion and exclusion criteria, eligible participants were randomized into the study.

236 participants were randomized into the study.

Study medication was administered orally twice daily from Day 1 through Day 85.

Eligibility Criteria:
Inclusion Criteria:

* Participants with a diagnosis of probable Alzheimer's disease according to the 2011 Neuropsychiatric Inventory Agitation/Aggression (NPI-AA) working groups criteria
* Participants with clinically significant, moderate-to-severe agitation for at least 2 weeks prior to Screening that interferes with daily routine per the Investigator's judgment
* Participants who require pharmacotherapy for the treatment of agitation per the Investigator's judgment after an evaluation of reversible factors and a course of nonpharmacological interventions
* Diagnosis of agitation must meet the International Psychogeriatric Association (IPA) provisional definition of agitation.
* Participants meeting an additional predetermined blinded eligibility criterion, which will remain blinded to the clinical study site Investigators and staff
* Participants with a reliable caregiver who is able and willing to comply with all study procedures, including adherence to administering study drug and not administering any prohibited medications during the course of the study, and who spends a minimum of 2 hours per day for 4 days per week with the participant

Exclusion Criteria:

* Participants with dementia predominantly of the non-Alzheimer's type (e.g., vascular dementia, frontotemporal dementia, Parkinson's disease, substance-induced dementia)
* Participants with symptoms of agitation that are not secondary to Alzheimer's dementia (e.g., secondary to pain, other psychiatric disorder, or delirium)
* Participants with co-existent clinically significant or unstable systemic diseases that could confound the interpretation of the safety results of the study (e.g., malignancy \[except skin basal-cell carcinoma\], poorly controlled diabetes, poorly controlled hypertension, unstable pulmonary, renal or hepatic disease, unstable ischemic cardiac disease, dilated cardiomyopathy, or unstable valvular heart disease)
* Participants with myasthenia gravis
Determination of Factors Involved in the Regulation of Immune Responses After Allogeneic Hematopoietic Stem Cell Transplantation

The study concerns donors and patients receiving allogeneic stem cell haematopoietic transplantation. The aim of the study is to analyse HSC graft content in immune effector T (naive, memory, activated, exhausted) and immunoregulatory cell subtypes (Tregs, iNKT, MDSC) and correlate the results with post-transplant immune reconstitution of those different cell subtypes and clinical events (graft-versus-host-disease, relapse, infections). An ancillary study will focus on the impact of microbiota dysbiosis on post-transplant immune response and regulatory cell subsets.


Eligibility Criteria:
Inclusion Criteria:

* patient of the Nancy CHRU, for whom a CSH allograft is planned. or
* hematopoietic stem cell donors received at Nancy's CHRU for the duration of the research

Exclusion Criteria:

* Positive HIV
* active hepatitis B or C infection
The Accuracy of Direct Digital Intra-oral Scanning Measurements Compared to Measurements on Study Models

The purpose of this study is to compare the accuracy of measurements derived from a commercially available direct intra-oral scanning system with those taken from plaster study models, and to compare cost implications of both systems.

The investigators will test the hypotheses:

* There is no systematic difference between measurements taken from the Trios scanner and study models.
* There is no difference in the cost of producing digital models.

Plaster study models produced from moulds of the teeth are a standard component of orthodontic records. They are fundamental to diagnosis and treatment planning, evaluation of treatment progress and results as well as record keeping. (Santoro et al., 2003) Plaster models must be retained for a minimum of 11 years for a medico legal reasons. This leads to problems of storage in terms of space and cost, in addition to the risk of damage because of the brittle nature of the models. These problems therefore highlight the need for an alternative method for producing and storing study models. This study aims to compare the accuracy of measurements derived from a new commercially available direct intra-oral (inside of the mouth) scanning system (3Shape TRIOS (R)) with those taken from plaster study models, and to compare cost implications of both systems. We will use the results to conclude whether direct intra¬oral scanning can replace traditional plaster models produced from moulds of the teeth.

Eligibility Criteria:
Inclusion Criteria:

* Age range 11 years old to 18 years old.
* Orthodontic patients with a range of malocclusions.
* Dentition without abnormal morphology.
* Adult/permanent dentition from the first molar to first molar in both arches.

Exclusion Criteria:

* Patients under 11 years old and over 18 years old.
* Carious teeth or teeth with significantly altered anatomy.
* Periodontal disease with significant gingival swelling.
Study for Optimizing Anti-inflammatory Prophylaxis

The purpose of this study is to investigate which anti-inflammatory treatment is best at preventing postoperative inflammation following cataract surgery. We want to compare topical prophylaxis with NSAID eye drops to topical prophylaxis with a combination of NSAID and prednisolone. We also want to compare topical prophylaxis with eye drops to drop-less surgery where the anti-inflammatory drug is administered to the subtenonal space at the conclusion of the surgical procedure. In addition, we want to investigate if topical anti-inflammatory prophylaxis should be initiated preoperatively or postoperatively. The primary outcome is change in central macular thickness, measured by optical coherence tomography, 3 months after surgery.


Eligibility Criteria:
Inclusion Criteria:

* Patients with age-related cataracts
* Older than 18 years
* Women must be postmenopausal. Women are asked if they have menstruated within the preceding 12 months.
* Capacity to consent
* Scheduled to undergo cataract surgery at the ophthalmic department at Rigshospitalet-Glostrup, Denmark
* The surgeon must be experienced, defined by a minimum of 1000 cataract extractions completed
* Only 1 eye can be included for each participant, but there are no restrictions as to whether it is the eye that undergoes surgery first or last. If both eyes of a participant are eligible, it will be decided by randomization which eye to be included in the study
* Informed consent to participation

Exclusion Criteria:

* Known allergy to any of the contents of the pharmaceuticals (active and in-active ingredients) used in the study
* Medical history of epiretinal membrane, retinal vein occlusion, retinal detachment, uveitis, glaucoma, diabetes mellitus, exudative age-related macular degeneration (AMD) or AMD with geographical atrophy
* Significant complications to surgery such as posterior capsule rupture/vitreous loss, choroidal hemorrhage, and dislocated lens material
* Pregnancy
* Fertile women, i.e. women who are not menopausal.
* Women who breastfeed
Does Positive Pressure Extubation Reduce Postoperative Desaturation?

Single-center, prospective, controlled, parallel, randomized, single-blind study comparing the conventional extubation technique to two positive pressure extubation techniques on postoperative desaturations

Study realise on university hospital on Lille in France. Patients inclusion is prospective and randomised in three groups. First group : extubation is realised with aspiration in tracheal tube during removal tube Second group : extubation is realised without aspiration but with APL valve set to 20cmH20 Third group : extubation is realised without aspiration but with ventilator parameters were set for PSV mode (inspiratory pressure of 10cmH2O and PEEP identical to that administered in the operating room

Eligibility Criteria:
Inclusion Criteria:

* Visceral or urological surgery
* Scheduled surgery
* Surgical or patient requirement: placement of an arterial catheter
* Supine position
* Post-surgical extubation scheduled in the operating room
* Minimum age of 18 years
* Informed and signed consent

Exclusion Criteria:

* Severe obesity (BMI over 35kg/m2)
* pregnant woman
* Acute or chronic preoperative respiratory pathology.
* Sleep apnea syndrome
* Inability to receive informed information (does not speak, read or understand French)
* Patient under guardianship or curatorship
* Lack of social security coverage
* History of intubation or criteria for difficult intubation or ventilation.
Physical Activity and Cognition Study

The goal of this research study is to examine whether an intervention to increase physical activity using a body-worn sensor affects cognitive (thinking) processes.

The overall duration of participation in this research study is approximately 4 months. During this time, three study visits will be required. The first visit is for informed consent and screening, the second visit is for baseline fitness and cognitive testing, and the third visit is for follow-up fitness and cognitive testing after a 12-week physical activity monitoring program. Participants will be randomized to one of two study arms, a physical activity monitoring arm and a flexibility and balance arm. Both study arms involve wearing a physical activity sensor and monitoring physical activity for a duration of 12 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Non-smoking
* Age between 55-85 years
* Sedentary status (physically inactive; not participating in at least 30 minutes of moderate intensity physical activity on at least three days per week for at least three months)
* Generally healthy men and women
* Living in the greater Boston area
* Available for the 4 month duration of the study
* Native-English speaking or fluent in English (must have attended elementary school and higher in English)

Exclusion Criteria:

* Poor vision that cannot be corrected with glasses or contact lenses
* Presence of an acute infection
* Diagnosis of kidney failure
* Diagnosis of liver disease
* Diagnosis of thyrotoxicosis/hyperthyroidism
* Diagnosis of cancer
* Past or present conditions that affect cognitive functioning:

  1. learning disability
  2. neurological disorders or conditions (movement disorder, history of head trauma or stroke, epilepsy, etc.)
  3. psychiatric disorders or conditions (depression, anxiety disorder, etc.)
* Past or present conditions that are counter indicators for participation in cardio-respiratory fitness assessment and moderate-intensity physical activity:

  1. heart conditions (e.g. heart attack, arrhythmias, etc.)
  2. circulatory conditions (e.g. uncontrolled hypertension, leg claudication, high cholesterol, etc.)
  3. respiratory conditions (e.g., asthma or lung conditions, such as chronic obstructive pulmonary disease, acute bronchitis, acute common cold, lung cancer, pneumonia, etc.)
  4. current musculoskeletal impairments (e.g. fractures, hemiplegia, chronic joint pain, arthritis, osteoporosis, not able to walk comfortably without assistance, etc.)
  5. diagnosis of electrolyte disorder or abnormality
  6. presence of diabetes mellitus
* Obesity
* Prescription medication or other drugs that treat heart, lung, or circulatory conditions (e.g. beta blockers, bronchodilators, etc.)
* Prescription medication or other drugs that affect chemicals in the brain (e.g. antidepressants, anxiolytics, etc.)
* Implanted medical devices, such as a pacemaker or defibrillator
* Unavailable for the approx. 4-month duration of the study
Vitamin D, HbA1c and Vitamin B12 Levels in Patients

Abstract Aim: to compare the serum vitamin D, HbA1c and vitamin B12 levels in patients with gingivitis and four different periodontitis stages diagnosed according to the 2017 Periodontal Disease Classification.

Materials and methods: A total of 606 (378 Female, 228 Male) patients were included in the study. The periodontal status of the patients was diagnosed with gingivitis, stage 1,2,3 and 4 periodontitis groups were formed. HbA1c, vitamin D and vitamin B12 values of the patients were compared and analyzed.

Result:

Conclusion:

bstract Aim: to compare the serum vitamin D, HbA1c and vitamin B12 levels in patients with gingivitis and four different periodontitis stages diagnosed according to the 2017 Periodontal Disease Classification as determined by the American Academy of Periodontology and the European Federation of Periodontology (AAP-EFP) Materials and methods: A total of 606 (378 Female, 228 Male) patients were included in the study. The periodontal status of the patients was diagnosed with gingivitis, stage 1,2,3 and 4 periodontitis groups were formed. HbA1c, vitamin D and vitamin B12 values of the patients were compared and analyzed.

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with gingivitis or periodontitis with complete periodontal diagnostic data (Gingival Index(Löe, 1967), Plaque Index(Löe, 1967), Periodontal pocket depths(PD), Clinical Attachment loss (CAL), Radiological data- Interdental Bone loss (IBL) data
* Non-smoker
* Vit D, HbA1c and B12 vit in blood on the date of application to the clinic and/or in the last 3 months. Patients with data on values were included in the study.

Exclusion Criteria:

* Patients with missing data and not allowing data use
* Smoker
* The data of pregnant and lactating patients were not included in the study.
Clinical Outcome of Female Non-gastric Gastrointestinal Stromal Tumor

To elucidate the prognosis of women with non-gastric primary gastrointestinal stromal tumors.

Gastrointestinal stromal tumor (GIST) are mesenchymal tumors arising from gastrointestinal tract, mesentery, or omentum. They took up about 3% of gastrointestinal malignancies. Although rarely, the clinical presentation of non-gastric GIST might mimick ovarian cancer, and would be managed by gynecologists. Therefore, retrospective review of female non-gastric GIST cases will be performed to investigate the clinical outcome of non-gastric GIST. The result of this study might be used as an important reference for gynecologists.

Eligibility Criteria:
Inclusion Criteria:

* \> 20 years of women.
* non-gastric gastrointestinal stromal tumor

Exclusion Criteria:

* Those without pathological report or surgical record.
Differential Lung Ventilation vs. CPAP

In this study we compared the efficacy of continuous positive airway pressure (CPAP) to differential lung ventilation, in terms of patient's oxygenation, during video assisted thoracoscopic lung resection.

Background: One Lung Ventilation (OLV) is the technique used during lung resection surgery in order to facilitate optimal surgical conditions. OLV may result in hypoxemia due to the shunt created. Several techniques are used to overcome the hypoxemia, one of which is continuous positive airway pressure (CPAP) to the non-dependent lung. Another technique is ventilating the non-dependent lung with a minimal volume, thus creating differential lung ventilation (DLV). In this study we compared the efficacy of CPAP to DLV during video assisted thoracoscopic lung resection.

Patients and Method: This is a prospective study of 30 adult patients undergoing elective video assisted thoracoscopic lung lobectomy. Each patient was ventilated in four modes: two lung ventilation, OLV, OLV+CPAP and OLV+DLV. Fifteen patients were ventilated with CPAP first and DLV next, and the other 15 were ventilated with DLV first and then CPAP. Five minutes separated each mode, during which the non-dependent lung was open to room air. We measured the patient's arterial blood gas during each mode of ventilation. The surgeons, who were blinded to the ventilation technique, were asked to assess the surgical conditions at each stage.

Eligibility Criteria:
Inclusion Criteria:

1. Adult patients diagnised with lung cancer
2. Scheduled to have thoracoscopic lung lobectomy -

Exclusion Criteria:

1. Pregnancy
2. ASA\>=4
3. Difficult intubation -
A Study of Pyrotinib Combined With Capecitabine for Metastatic HER-2 Positive Colorectal Cancer

To evaluate the efficacy and safety of pyrotinib combined with capecitabine in patients with metastatic her-2 positive colorectal cancer after standard treatment.


Eligibility Criteria:
Inclusion Criteria:

1. Patients should be histologically diagnosed with metastatic CRC and after receiving at least two standard treatment regimens；
2. Patients with HER2 positive；
3. Metastatic colorectal cancer (stage Ⅳ, T1-4N0-2M1)；
4. Life expectancy is at least 6 months
5. ECOG score 0-1；
6. The functional level of the major organs must meet the following requirements (no blood transfusion within 2 weeks prior to screening, no use of leukocytes or platelets)：

Exclusion Criteria:

1. The histopathological type is mucinous adenocarcinoma or ovarian implant metastasis；
2. Patients who have previously been treated with anti-Her2-targeted drugs；
3. Patients with surgical opportunity or potential for surgical treatment；
4. Patients with a high risk of bleeding or perforation due to a tumor that has apparently invaded adjacent organs (including large vessels) of the colorectal lesion or who have developed fistulas；
5. Patients with any severe and/or uncontrolled disease;
6. Patients with any or present brain metastases；
7. Women who were pregnant or breast-feeding.
A Study To Determine Bioequivalence Between The Commercial Femulen Tablets And A Reformulation Of Femulen Tablets In Healthy Female Subjects

A pivotal study to determine bioequivalence between a the current marketed formulation of Femulen tablets and reformulated Femulen tablets in healthy female subjects.


Eligibility Criteria:
Inclusion Criteria:

* Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight \>45 kg (99 lbs).
* Healthy female subjects between the ages of 21 and 55 years, inclusive. Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12-lead ECG and clinical laboratory tests.

Exclusion Criteria:

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
* Any condition possibly affecting drug absorption (eg, gastrectomy).
The Effect of Oxytocin on Fear Memory Consolidation Novel Intervention to Prevent Posttraumatic Stress Disorder (PTSD)

The purpose of the study is to learn how differences in learning under mildly-stressful circumstances may be changed by taking oxytocin. Oxytocin is a hormone made naturally in the body. The investigators will also examine the impact of any anxiety, depression, and stress related symptoms on learning processes.


Eligibility Criteria:
Inclusion Criteria:

* Men or women 18 to 65 years of age
* Score in study range on the Neuroticism-Extraversion-Openness-Five Factor Inventory (NEO-FFI)
* No current Axis I Diagnostic and Statistical Manual-IV (DSM) excluded diagnoses as determined by the Structured Clinical Interview DSM (SCID) completed within the past 4 months.
* Must be able and willing to understand study procedures and return to the clinic on two separate consecutive days for the fear-conditioning procedures.
* Subjects must be able to give informed consent and be willing and able to comply with study procedures.

Exclusion Criteria:

* Presence of a current DSM-IV Axis I diagnosis as measured by the SCID.
* A serious medical condition or other condition deemed likely to result in surgery or hospitalization, or which would make participation in the study difficult.
* Patients with a history of trauma resulting in head injury related seizures or with epilepsy (except a prior history of febrile seizures of infancy which are not exclusionary).
* Use of supplemental hormones (birth control, estrogen, testosterone, prednisone, etc) or narcotics.
* Pregnant or lactating women.
* Women of childbearing potential not using medically accepted forms of contraception.
* Current use of the excluded psychiatric medications.
* Known hypersensitivity to oxytocin
* Known hyponatremia.