cyrilzakka/clinical-trials huggingface dataset:
Human Mesenchymal Stem Cells For Acute Respiratory Distress Syndrome

This is a Phase 1, open label, dose escalation, multi-center clinical trial of Allogeneic Bone Marrow-Derived Human Mesenchymal Stem Cells (hMSCs) for the treatment of Acute Respiratory Distress Syndrome (ARDS). The purpose of this study is to assess the safety of hMSCs in patients with ARDS.

The primary objective of this study is to assess the safety of intravenous infusion of Allogeneic Bone Marrow-Derived Human Mesenchymal Stem Cells (hMSCs) in patients with ARDS.

Eligibility Criteria:
Inclusion Criteria:

Patients will be eligible for inclusion if they meet all of the below criteria. Criteria 1-3 must all be present within a 24-hour time period and at the time of enrollment:

Acute onset (defined below) of:

1. A need for positive pressure ventilation by an endotracheal or tracheal tube with a PaO2/FiO2 ratio \< 200 with at least 8 cm H2O positive end-expiratory airway pressure (PEEP)
2. Bilateral infiltrates consistent with pulmonary edema on frontal chest radiograph
3. No clinical evidence of left atrial hypertension for bilateral pulmonary infiltrates.

In addition to meeting inclusion criteria, enrollment must occur within 96-hours of first meeting ARDS criteria per the Berlin definition of ARDS.

Exclusion Criteria:

1. Age less than 18 years
2. Greater than 96 hours since first meeting ARDS criteria per the Berlin definition of ARDS
3. Pregnant or breast-feeding
4. Prisoner
5. Presence of any active malignancy (other than non-melanoma skin cancer) that required treatment within the last 2 years
6. Any other irreversible disease or condition for which 6-month mortality is estimated to be greater than 50%
7. Moderate to severe liver failure (Childs-Pugh Score \> 12)
8. Severe chronic respiratory disease with a PaCO2 \> 50 mm Hg or the use of home oxygen
9. Patient, surrogate, or physician not committed to full support (exception: a patient will not be excluded if he/she would receive all supportive care except for attempts at resuscitation from cardiac arrest).
10. Major trauma in the prior 5 days
11. Lung transplant patient
12. No consent/inability to obtain consent
13. Moribund patient not expected to survive 24 hours
14. WHO Class III or IV pulmonary hypertension
15. Documented deep venous thrombosis or pulmonary embolism within past 3 months
16. No arterial line/no intent to place an arterial line
17. No intent/unwillingness to follow lung protective ventilation strategy or fluid management protocol
18. Currently receiving extracorporeal life support (ECLS) or high-frequency oscillatory ventilation (HFOV)
Evaluation of a Human Acellular Dermal Matrix in Post Mastectomy Reconstruction

Use of a HADM and implant in post-mastectomy breast reconstruction.

This is a prospective, single-site pilot study in which outcomes associated with the use of Flex HD® Pliable™ Perforated, Human Acellular Dermal Matrix and an implant which are used in post-mastectomy breast reconstruction will be obtained. The data collected will include reconstructive outcomes, aesthetic outcomes and patient-reported outcomes in order to ascertain advantages and disadvantages of using this particular HADM in post-mastectomy breast reconstruction.

Eligibility Criteria:
Inclusion Criteria:

* Scheduled to undergo a single or two-stage, tissue-assisted, implant breast reconstruction
* Mastectomy may be unilateral or bilateral, prophylactic or therapeutic
* Skin incision may be skin sparing, or nipple-areolar sparing
* Have signed written, informed consent
* Be at least 18 years of age

Exclusion Criteria:

* Patients undergoing autologous breast reconstruction
* Patients undergoing breast reconstruction following complications of breast augmentation, mastopexy, breast reduction, or breast conservation surgery (lumpectomy)
* Patients undergoing reconstruction after previously failed attempts at reconstruction
* Patients undergoing autologous breast reconstruction in conjunction with a tissue expander (such as a latissimus dorsi flap, DIEP flap)
* There will be no exclusions based on race or ethnicity
* BMI \> 40
* Previous Radiation Treatment. Note: Post-operative radiation treatment does not exclude subjects from study continuation once enrolled.
Placebo-Controlled Crossover Study to Evaluate Donepezil and MK-3134 for Reversal of Cognitive Impairment Associated With Scopolamine Administration (3134-005)(COMPLETED)

The drug, scopolamine, can result in short-term impairments of cognitive function, attention, and memory that resemble those seen in aging and Alzheimer's disease. This study tested the capability of both individual and combined doses of MK-3134 and the current standard treatment: donepezil (Aricept), to reverse such impairments, following a single dose of scopolamine. Participants were evaluated after each of 5 different treatment periods (in a cross-over, double-dummy design): A: placebo to match both donepezil (oral \[PO\]) and MK-3134 (PO) followed by placebo scopolamine (subcutaneous \[SQ\]); B: placebo to match both donepezil (PO) and MK-3134 (PO), followed by scopolamine SQ; C: MK-3134 (PO) followed by scopolamine SQ; D: donepezil (PO) followed by scopolamine SQ; E: MK-3134 (PO) and donepezil (PO) followed by scopolamine SQ. The doses of MK3134, donepezil, and scopolamine were the same over all treatment arms in which the specified drug was administered. There were 8 total visits for each treatment period, including 5 Treatment Visits requiring 14-day intervals between visits for study-drug washout. Participants were assessed for cognitive function before and after each treatment period during the Treatment Visits.


Eligibility Criteria:
Participants were eligible for inclusion in the study who were:

* Male between 18 and 40 years of age.
* Non-smokers, in good health (as defined in protocol), and were willing to follow study-related procedures.

Participants were not eligible for inclusion in the study if they:

* Had a history of illness that, in the opinion of the study investigator or as specified in protocol, might confound the results of the study or posed an potential, additional risk to the participant if they were to participate in the study.
* Were taking any medication (prescription, nonprescription, vitamin supplements or herbal, illicit or legitimate) except for acetaminophen.
* Had a history of any significant head injury/trauma.
A Study on Induced Weight Gain During Atypical Antipsychotic Treatment and Its Management With Psychoeducational Programme

Olanzapine is an atypical antipsychotic agent indicated for the treatment of schizophrenia and moderate to severe manic episode.

Olanzapine is among the many antipsychotic agents associated with weight gain . The mechanism for antipsychotic drug-related weight gain is not known, although antagonism of serotonin receptors, especially the 5HT2C , and histamine receptors has been hypothesized.

The purpose of this study is to observe the efficacy of a psychoeducational programme in managing the increased weight as a side effect of the olanzapine treatment.

Interventions to prevent weight gain associated with olanzapine should at least include periodic monitoring and recommendations for changes in diet and physical activity.

This is a phase IV, randomised, parallel study of subjects previously treated with olanzapine as antipsychotic monotherapy, which have shown an increase of B.M.I. \>7% from the beginning of antipsychotic treatment (assessed during the routine visits). For the first 12 weeks of the trial approximately 60 outpatients, enrolled in one site during a period of one year, will be randomised in a 1:1 ratio into 2 treatment groups: olanzapine + psychoeducational programme or olanzapine alone. In the following 12 weeks of the study all patients undergo the psychoeducational programme. The efficacy of this programme will be assessed monitoring the mean difference from baseline to endpoint in total body weight and BMI.


Eligibility Criteria:
Inclusion Criteria:

* All patients, previously treated with olanzapine as antipsychotic monotherapy, which have shown a weight gain with an increase of BMI \>7% (assessed during the routine visits from the beginning of antipsychotic treatment).
* Male or female subjects at least 18 and no more than 65 years of age.
* Subjects must be considered reliable.
* Each subject must have a level of understanding sufficient to perform all tests and examinations required by the protocol.
* Each patient, (and a patient's legal representative if mandated by local law), must understand the nature of the study and must sign an informed consent document.

Exclusion criteria:

* Serious, unstable illnesses such that death is anticipated within 1 year or intensive care unit hospitalization for the disease is anticipated within 6 months. This includes hepatic (specifically any degree of jaundice), renal, gastroenterologic, respiratory, cardiovascular (including ischemic heart disease), endocrinologic, neurologic, immunologic, or hematologic diseases (specifically current agranulocytosis with an absolute neutrophil count \<500 mm3).
* Prior treatment with any antipsychotic drugs associated to olanzapine.
* Judged clinically to be at significant suicidal or homicidal risk and/or agitated enough to necessitate use of restraints.
REmote Data Acquisition After SURgery

In this clinical study, the investigators will compare vital parameters measurements obtained using continuous data from reference monitors and continuous wireless MultiSense® monitoring patch in 60 patients immediately after in-ward surgery and over 7 days.

The MultiSense® strip is a unique, band aid-sized, clinical signal quality, connected strip for real-time monitoring of cardio-respiratory parameters. The MultiSense® strip measures in real-time, remotely and continuously 11 clinical key-indicators by being attached to the patient thorax: Electrocardiogram (ECG) trace, heart rate, oxygen saturation, respiratory rate and relative respiration depth, pulse transit time, plethysmographic trace, perfusion index, skin temperature, physical activity and body position. Designed to be worn continuously for at least seven days, the patient can keep the patch during his sleep or in the shower.

The aim of this study is to determine the quality of measurements of clinical signs provided by MultiSense® strip in comparison to measurements made with conventional medical devices in the hospital setting, in terms of accuracy, connectivity, generation of artefactual data and stability of data transmission. The study population includes 60 patients undergoing visceral or digestive surgery. Once in the post-operative monitoring room, the MultiSense® strip will be attached on patient's thorax. The monitoring will last 7 days through post-operative monitoring room (continuous comparison with reference monitor), general ward (comparison with spot-check monitoring) and patient's home.

Eligibility Criteria:
Inclusion Criteria:

* Man or woman over 18 years old
* Patient programmed for an elective in-ward surgery
* Patient located in Strasbourg area
* Patient with Wi-Fi and/or Cellular connectivity at home
* Patient able to receive and understand information related to the study and give written informed consent.
* Patient affiliated to the French social security system

Exclusion Criteria:

* Patient with a skin disease that would not allow the use of an adhesive
* Patient with an implantable device such as a pacemaker
* Pregnant or lactating patient
* Patient in exclusion period (determined by a previous or a current study)
* Patient under guardianship or trusteeship
* Patient under the protection of justice
Efficacy and Safety Study of QLG1080 in Patients With Hormone-sensitive Advanced Prostate Cancer

The purpose of this study was to evaluate the efficacy and safety of QLG1080 in patients with hormone-sensitive advanced prostate cancer.


Eligibility Criteria:
Inclusion Criteria:

* 1. Histological or cytological diagnosis of prostate cancer;；
* Advanced prostate cancer patients eligible for endocrine therapy, able to receive continuous androgen deprivation therapy for at least 6 months.
* Serum testosterone ≥150 ng/dL (5.2nmol/L) at screening visit;
* The Eastern Cooperative Oncology Group (ECOG) score is 0 to 1.

Exclusion Criteria:

* Diagnosed or suspected of hormone-resistant prostate cancer;
* For prostate cancer patients who have had or are undergoing endocrine therapy
* Patients who have previously undergone pituitectomy or adrenalectomy or have pituitary disease or adrenal dysfunction;
* Those who have had any prostate surgery within 4 weeks prior to initial dosing or prostate surgery or other major surgical treatment during the planned trial period (except urinary tract obstruction relief);
* The imaging results of screening visits clearly showed the presence of brain metastases;
Pharmacological Modulations of Allergen-Specific Immunotherapy

There is mounting evidence that successful allergen immunotherapy (SIT) functions through the induction of different subset of Treg including Foxp3 positive cells, therefore additional strategies to enhance this property are highly attractive. Based on previous findings we assumed that combine allergen immunotherapy with non-specific treatments such as glucocorticosteroids and vitamin D3 as well as montelukast sodium treatment might enhanced allergen tolerance induction and improved clinical effectiveness of allergen-specific immunotherapy

There is mounting evidence that successful allergen immunotherapy (SIT) functions through the induction of different subset of Treg including Foxp3 positive cells, therefore additional strategies to enhance this property are highly attractive. Since corticosteroids directly induce the development of an IL-10-synthesizing regulatory T-cell population (Tr1) and this effect can be greatly increased with vitamin D3 treatment we , we assumed that combine allergen immunotherapy with non-specific treatments such as glucocorticosteroids and vitamin D3 as well as montelukast sodium treatment might enhanced allergen tolerance induction and improved clinical effectiveness of allergen-specific immunotherapy, therefore we conducted the stud comparing the effect of glucocorticosteroid, glucocorticosteroid with vitamin D3 or montelukast sodium on early immunological and clinical effect of allergen-specific immunotherapy in asthmatic children.

Eligibility Criteria:
Inclusion Criteria:

* allergic asthma with regular symptoms requiring long-term treatment with inhaled corticosteroids
* disease duration of at least 2 years
* sensitisation only to house dust mites
* resting FEV1 of more or equal 70%

Exclusion Criteria:

* sensitization to allergens other than house dust mites
* discontinuation of SIT from any reasons
* need of a daily dose below 200 or above 800 mcg of budesonide or equivalent
* other chronic disease including vitamin D3 deficiency and/or resistance which could influence the results of the study or the patient's ability to participate in the study as judged by the investigator
* medications that resulted in patient exclusion included: inhaled long acting β2-agonist, leukotriene modifiers, β-blockers (eye drops included) or oral corticosteroids within 6 month before the pre-study visit.
RF Ablation of Treatment of Metastatic Lesions in Patients Undergoing Antiangiogenic Therapy for Stage IV Renal Cell Carcinoma

The purpose of this study is to look at the effects of a procedure called radiofrequency ablation on kidney tumors from patients who are undergoing antiangiogenic treatment. Antiangiogenic treatment is a type of treatment that inhibits formation of new blood vessels that are required for tumor growth. Radiofrequency ablation (RF ablation) involves inserting a needle into tumor tissue and administering heat to the tumor tissue that is sufficient to kill the tumor cells.

* Participants will undergo a RF ablation procedure of one or more of their tumors that have not gone away while they have been undergoing antiangiogenic treatment. The RF ablation procedure will be performed in the operating room at one of the Dana-Farber/Harvard Cancer Center hospitals and will be performed under general anesthesia.
* Blood will also be drawn 2-4 weeks before the procedure, at the time of teh procedure and 2-4 weeks after the procedure.
* The RF ablation procedure will be performed at specified times in relation to the participants antiangiogenic treatment (sorafenib or sunitinib): a) If the participant is taking sorafenib, they will be asked to stop taking it 2-5 days prior to the RF ablation procedure; b) if the participant is taking sunitinib, they will be asked to stop taking it 4-7 days prior to the RF ablation procedure.
* Participants will have an MRI or a CT scan of their tumor(s) within 2-4 weeks of the procedure and 2-4 weeks after the procedure. The MRI or CT will scan the tumor(s) to determine how much blood flow is going to them.
* At the time of RF ablation, participants will have a biopsy of their tumor(s) and will receive a CT scan in the area the ablation was performed after the procedure to assess for any bleeding. They will also be monitored for 4 hours after the RF ablation procedure.

Eligibility Criteria:
Inclusion Criteria:

* Patients who are on antiangiogenic therapy for a minimum of 4 weeks and have isolated metastatic lesions showing either persistence or resistance to therapy that might benefit from local therapy such as RF ablation.
* Male or female patients 18 years of age or older
* Clinical, radiographic, or pathologic diagnosis of clear cell RCC
* Ongoing treatment with sorafenib or sunitinib, off clinical trials
* Acceptable risk for general anesthesia in the judgement of the study investigator and by the department of anesthesiology upon preoperative testing.
* At least one lesion that has not completely resolved while on antiangiogenic therapy
* Candidate lesions of 1cm or greater in diameter
* Safe access to the tumor for a needle placed under ultrasound guidance
* ECOG Performance Status of 0 or 1
* Adequate bone marrow, and renal as assessed by the laboratory requirements outlined in the protocol

Exclusion Criteria:

* History of bleeding diathesis or unexpected surgical bleeding
* Patients currently on anticoagulation
* Medical contraindication to MR imaging (pacemaker, metal debris in eye, etc.)
* Prior RF to the index tumor
* Pregnant or lactating
Multicenter Study of 9-Aminocamptothecin (9-AC) in Patients With Refractory Leukemia

The purpose of this study is to evaluate the side effects of 9-Aminocamptothecin (9-AC) and to determine the best dose which should be used to treat leukemia.

* The treatment patients will receive involves a continuous infusion of 9-AC intravenously for a 72 hour period. Since we are unsure of the safest and most effective dose, successive groups of 4-7 patients will receive larger doses of this drug until the largest dose given safely is established.
* Prior to the start of therapy a bone marrow aspirate and biopsy will be taken for diagnostic and research purposes. A bone marrow exam will be repeated at 48 hours in order to determine the effects of 9-AC on leukemic cells in the bone marrow. A bone marrow scan will also be performed 14 days after the start of therapy to assess response.
* Frequent blood testing will be done throughout treatment, including blood samples to determine the levels of the 9-AC in the blood.
* Treatment could be stopped prematurely if any of the following occur: 1) drug causes severe side effects, 2) the drug does not control the leukemia, or 3) the doctors or the patient feel that it is no longer in the patients best interest to receive this therapy.
* Approximately 7 days after the conclusion of the 9-AC infusion, it is likely that the patient's blood counts will be low and will require support with antibiotics, red cell transfusions and platelet transfusions.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* AML or ALL in first or subsequent relapse, secondary AML, or CML in blastic phase
* Central venous access
* ECOG performance status of less than or equal to 2
* Bilirubin \< 1.3
* SGOT \< 2 x ULN
* Alkaline phosphatase \< 2 x ULN
* Creatinine \< 1.5

Exclusion Criteria:

* Undergone bone marrow transplantation
* Uncontrolled infection
* Other active malignancy
* HIV positivity
* Serious medical or psychiatric illness
* Pregnancy
Randomized Trial With Trastuzumab Versus Observation in Breast Cancer Patients

Epithelial tumor cells can be detected in the bone marrow and/or the peripheral blood \[disseminated and circulating tumor cells, (DTCs) and (CTCs) respectively\] of otherwise metastases-free patients with early breast cancer. Several studies have shown that the presence of these cells is an independent factor associated with an increased incidence of early disease relapse and disease-related death. In almost 50% of the patients, adjuvant chemotherapy cannot eliminate these occult tumor cells and this is also associated with a higher probability of early relapse and death. In 60-70% of the patients, DTCs and/or CTCs express the HER2/c-neu molecule and one or two administrations of their monoclonal antibody trastuzumab (HERCEPTIN) could eliminate these cells for a period ranging from 3-12 months.

This pilot trial will compare the efficacy of the anti-HER2/erb-B2 monoclonal antibody trastuzumab (HERCEPTIN) given after the completion of the standard adjuvant chemotherapy and radiotherapy versus observation in patients with stage I-III operable breast cancer who have detectable cytokeratin-19 (CK-19) mRNA-positive tumor cells in the bone marrow or the peripheral blood before and/or after the adjuvant treatment.

Eligibility Criteria:
Inclusion Criteria:

* Age \>= 18 years.
* Performance status (World Health Organization \[WHO\]) \< 3
* Adequate bone marrow function (absolute neutrophil count \> 1000/mm\^3, platelet count \> 100000/mm\^3, hemoglobin \> 9 gr/mm\^3)
* Adequate liver (bilirubin \< 1.5 times upper limit of normal and SGOT/SGPT \< 2 times upper limit of normal) and renal function ( creatinine \< 2 mg/dl)
* Adequate cardiac function (left ventricular ejection fraction \[LVEF\] \> 50%).
* Informed consent
* Histologically or cytologically confirmed breast adenocarcinoma
* Prior surgical excision of the primary breast tumor
* Prior completion of standard adjuvant chemotherapy and/or radiotherapy
* Locally advanced disease after the completion of neo-adjuvant chemotherapy, surgical excision and radiotherapy provided that there was no evidence of local or metastatic disease
* Absence of any clinical or laboratory evidence of metastatic disease
* Detection of CTCs and/or DTCs (when it could be feasible) before the initiation and/or after the completion of adjuvant chemotherapy and/or radiotherapy
* Expression of HER2/c-neu on the primary tumor is not mandatory

Exclusion Criteria:

* Other invasive malignancy within the past 5 years except nonmelanoma skin cancer
* Other concurrent uncontrolled illness
* Psychiatric illness or social situation that would preclude study compliance
* Pregnant or nursing
* Positive pregnancy test
* History of allergic reaction attributed to trastuzumab (HERCEPTIN)