Kornimate/medical-research-clean huggingface dataset:
clinical assessment of dental implant

Conditions: Tooth Loss

Summary: primary endpoints : the implant survival and success rate of v3 and c1 implants will be compared. implant success rate will be evaluated by measuring the peri-implant bone remodeling from baseline to 1 year post insertion. the hypothesis is those implant survival rates of the test (v3) and control group (c1) are similar and that test v3 implant allows less peri-implant bone loss. secondary endpoints : the thickness of hard tissue in the buccal aspect of the v3 and c1 implants will be compared. the bone thickness will be measured in cone beam computerized tomography (cbct) on the day of implantation, 4 and at one year after the final restoration. the hypothesis is that v3 implant allows thicker bone dimension in the cervical area.


Eligibility criteria:
inclusion criteria: * subject must have voluntarily signed the informed consent form before any study related action * age: 18 with one or more missing teeth in the maxillary area, seeking for implant therapy. * men/women * in good systemic health (asa i/ ii) * present with no contra indication against oral surgical interventions * patients required replacement of a single missing tooth. the tooth at the implant site(s) must have been extracted or lost at least 12 weeks before the date of implantation. * at least 10 mm of bone in the vertical dimension * at least 6 mm of bone in the bucco-lingual dimension. * no need for bone augmentation procedure in any of the dimensions * full mouth plaque score (fmpi) lower or equal than 25% exclusion criteria: * autoimmune disease require medical treatment * medical conditions requiring prolonged use of steroids * use of bisphosphonate intravenously or more then * infection (local or systemic) - patient with gingivitis or active local infection will undergo a medical treatment prior to his entrance to the study, each individual will be evaluated prior to study procedure for suitability, in case of systemic infection the evaluation will be based on medical anamneses, and if necessary will be referred to relevant medical tests. * current pregnancy or breastfeeding women * alcoholism or chronically drug abuse * immunocompromised patients * uncontrolled diabetes * smokers * prisoners

Keywords: single missing tooth implants peri-implant bone remodeling bone thickness thickness of soft tissue
efficacy and safety of relaxin for the treatment of acute heart failure

Conditions: Heart Failure, Congestive

Summary: different doses of relaxin will be compared to placebo to determine efficacy and safety for the treatment of patients hospitalized with acute heart failure

this is an international, randomized, double-blind, placebo-controlled, phase ii/iii trial of intravenous recombinant relaxin for the treatment of signs and symptoms in patients hospitalized for acute decompensated heart failure. the phase ii pilot study has completed; the phase iii main portion of the trial is ongoing.

Eligibility criteria:
inclusion criteria: * hospitalized for acute heart failure * dyspnea at rest or with minimal exertion * pulmonary congestion * able to provide informed consent * systolic blood pressure \> 125 mmhg * impaired renal function defined as an egfr of 30-75 ml/min/1.73m2 exclusion criteria: * use of other iv therapies for acute heart failure * fever or sepsis * recent major neurologic event * recent major surgery * recent acute coronary syndrome * other recent investigational drug use

Keywords: heart failure renal dysfunction relaxin vasodilator
benefit of paramedical care in accompanying caregivers of patients that had surgery for an head and neck invasive cancer

Conditions: Head and Neck Cancer

Summary: head and neck invasive cancer usually requires surgery that is associated with modifications of the body structure of patient regarding breathing, eating and communication. these modifications are correlated with an important loss of autonomy in patients. during the study, while the patient is hospitalised after the surgery, the paramedical team will train the caregiver of the patient from experimental group a new dimension of autonomy in order to assure a safe return home. the level of learning depends on each caregiver and patient; therefore, an adapted training is provided. this study evaluates the impact of paramedical care in accompanying caregivers of patients that had surgery for an ent invasive cancer, by comparing the experimental group (paramedical care) to the standard group (standard care). the hypothesis of the study is that a benefit will be seen in the experimental group, by reducing the caregiver burden, improving the quality of life of patients and lowering the rate of hospitalisations and prolonged hospitalisations in these patients.


Eligibility criteria:
inclusion criteria patients : * age between 18 and 85 years old * ecog ≤ 2 * patient diagnosed with an head and neck squamous-cell carcinoma, stage t2-t4/n+, non-metastatic, localised at larynx, pharynx, oropharynx, oral cavity or maxillary, needing curative surgery, with indication of radiotherapy after surgery, in accordance to decision of the regular multidisciplinary meetings in cancerology * no ongoing measure of corrective justice for the patient * informed consent form signed * patient covered by health system exclusion criteria: * patient scheduled for surgery after radiotherapy or for surgery on site already irradiated * patient or caregiver that do not agree to participate in the study (the pair patient-caregiver is needed) * history of psychological or sensorial disorder or anomaly that can prevent the patient from understanding the conditions for study participation
group a streptococcus saliva study

Conditions: Group A Streptococcal Infections

Summary: this study is being done to evaluate whether saliva can be used to diagnose gas infection and also to compare different testing methods in the microbiology lab. the saliva sample testing will be compared to the throat swab testing to see if saliva testing works as well. the lab will also try different testing methods to see if a faster type of testing (e.g. molecular testing) works as well as the regular method, which takes 48 hours to get results. this is important because throat swabs can be challenging to collect in some children, and saliva is often much easier and more acceptable by children to collect. this could improve our ability to accurately diagnose and treat gas infections.


Eligibility criteria:
inclusion criteria: * \< 19 years of age * have provided a sample for gas testing (bacterial throat swab or poct rapid antigen test) at the discretion of the clinical team * able to provide a saliva sample exclusion criteria: * parent/guardian and/or patient unable to consent or assent * unable to provide a saliva sample
m7824 versus pembrolizumab as a first-line (1l) treatment in participants with programmed death-ligand 1 (pd-l1) expressing advanced non-small cell lung cancer (nsclc)

Conditions: Non-small Cell Lung Cancer

Summary: the purpose of the study is to evaluate the efficacy and safety of bintrafusp alfa (m7824) compared with pembrolizumab in participants with advanced nsclc with high pd-l1-tumor expression, with no epidermal growth factor receptor (egfr) mutation or anaplastic lymphoma kinase (alk) translocation. the phase iii adaptive design allows for the option to recruit up to 584 patients based on pre-specified rules.


Eligibility criteria:
inclusion criteria: * histologically confirmed diagnosis of advanced nsclc * have not received prior systemic therapy treatment for their advanced/stage four nsclc. completion of treatment with cytotoxic chemotherapy, biological therapy, and/or radiation as part of neoadjuvant/adjuvant therapy is allowed as long as therapy was completed at least 6 months prior to the diagnosis of metastatic disease. confirmation of resolution of toxic effects of previous neoadjuvant/adjuvant chemotherapy therapy to grade less than or equal to 1. for radiation toxicity or prior major surgeries, participants should have recovered from side effects and/or complications * have measurable disease based on recist 1.1 * have a life expectancy of at least 3 months * availability of tumor tissue (less than 6 months old) before the first dose is mandatory to determine pd-l1 expression level prior to enrollment * pd-l1 high status as determined by central testing * other protocol defined inclusion criteria could apply exclusion criteria: * participants with nonsquamous nsclc histologies whose tumor harbors any of the following molecular alterations and targeted therapy is locally approved: epidermal growth factor receptor (egfr) sensitizing (activating) mutation, anaplastic lymphoma kinase (alk) translocation, ros1 rearrangement, or braf v600e mutation * has received major surgery within 4 weeks prior to the first dose of study intervention; received thoracic radiation therapy of greater than 30 units of gray (gy) within 6 months prior to the first dose of study * known severe hypersensitivity to investigational products (m7824 or pembrolizumab), or any components in their formulations * previous malignant disease (other than the target malignancy to be investigated in this study) within the last 3 years * other protocol defined exclusion criteria could apply

Keywords: m7824 pembrolizumab pd-l1-tumor expression intr@pid lung 037 bintrafusp alfa
study to assess the safety, tolerability, and pharmacokinetics/pharmacodynamics of gw003 in patients with breast cancer

Conditions: Chemotherapy-induced Neutropenia

Summary: the purpose of the present trial is to evaluate the safety, tolerability and pharmacokinetics(pk)/pharmacodynamics(pd) of single subcutaneous injection of gw003 in breast cancer patients. moreover, the efficacy will be assessed preliminary.

this is an single-center, open-label, randomized, active-controlled phase i study evaluating tolerability and pharmacokinetics/pharmacodynamics of single subcutaneous injections of gw003 in the breast cancer patients.gw003 is recombinant human serum albumin/human granulocyte-colony stimulating factor(i)fusion protein .it is a long-acting g-csf(granulocyte-colony stimulating factor). in this study, participants will be administered a single dose of gw003. every subject will only accept one dose. in addition to tolerability and safety, pharmacokinetics/pharmacodynamics, preliminary efficacy and immunogenicity of gw003 will be evaluated as well.

Eligibility criteria:
inclusion criteria: * aged 18 years to 70 years, female * patients with histologically-confirmed breast cancer and plan to accept adjuvant chemotherapy(epirubicin plus cyclophosphamide) * have an eastern cooperative oncology group(ecog) performance status≤2 * have no clinically significant impairment in cardiac, liver and kidney * adequate hematologic, hepatic and renal function which should meet the following requirements: 1. absolute neutrophil count(anc)≥1.5 x 10\^9/l 2. blood platelet(plt)≥100 x 10\^9/l 3. serum creatinine(scr)≤1.5 times the upper limit of normal(uln) 4. total bilirubin(tbil)≤1.5×uln 5. aspartate aminotransferase(ast) /serum glutamic-oxaloacetic transaminase(sgot) and/or alanine aminotransferase(alt)/serum glutamic pyruvic transaminase(sgpt) ≤ 2.5 x uln 6. hemoglobin(hb)\>9 g/dl 7. alkaline phosphatase(alp)≤1.5×uln * expected to comply with protocol * with urine human chorionic gonadotropin (hcg) negative * signed informed consent exclusion criteria: * with acute infection * with history of bone marrow transplant and/or stem cell transplant * with primary hematological diseases, such as myelodysplastic syndromes, aplastic anemia, sickle cell anemia * received surgery within 3 weeks before chemotherapy * received g-csf within 4 weeks before involved in this study * females who are pregnant or lactating * participated in other clinical trials at the same time or within 4 weeks before screening * known allergy to chemotherapy drugs,recombinant human granulocyte-colony stimulating factor rh(rhg-csf) or any other biological products * with cacoethic addiction such as drug abuse or alcoholism * with other cases which is not suitable for this study judged by investigator

Keywords: neutropenia breast cancer gw003
dextroamphetamine as adjunct in cocaine/opiate dependent patients - 3

Conditions: Cocaine-Related Disorders; Opioid-Related Disorders

Summary: the purpose of this study is to evaluate dextroamphetamine sulfate (sustained release) as an adjunct in concurrent cocaine and opiate dependent patients.

this 27-week double-blind, placebo controlled treatment is designed to evaluate dextroamphetamine sulfate (sustained release) as an adjunct in concurrent cocaine and opiate dependent patients. all subjects will receive methadone. for the treatment of cocaine dependence, subjects will receive one of 2 doses of dextroamphetamine (15 or 30mg) or placebo. after 4 weeks of treatment the dose level of dextroamphetamine is doubled (30 or 60mg). this dose is maintained for 20 weeks; during which subjects attend twice weekly visits to the clinic and receive weekly cognitive behavioral therapy. follow up evaluations will be conducted out to 3 months post treatment. subjects will be assisted in transferring to houston area methadone clinics to maintain treatment for opiate dependence following treatment completion.

Eligibility criteria:
inclusion criteria- subject must: * exhibit cocaine and opiate dependence through a dsm-iv diagnosis as determined by scid. * be between 18 and 45 years old * women must agree to use contraception * have an ekg that has been confirmed by a cardiologist * give a cocaine positive urine during screening - present with evidence of opiate withdrawal exclusion criteria- subject must not: • have a serious medical illness including, but not limited to the following: hypertension significant heart disease clinically significant cardiovascular abnormality angina hepatic, renal, or gastrointestinal disorders that could result in an altered metabolism or excretion of study agent * have any axis i disorder that is not related to drug use * have current dependence on any psychoactive disorder other than nicotine * be on probation or parole for reasons other than those related to drug charges (asi) * be pregnant or lactating * have been in any outside treatment in 3 months

Keywords: cocaine dependence
safety and efficacy of sqin™ on xerosis in adults with mobility problems and paralysis

Conditions: Xerosis

Summary: in the general population, xerosis is often caused by external factors such as seasonal changes. in that case, the best way to relieve dry skin is to use a standard moisturizer. however, for those suffering of mobility problems due to age or paralysis (e.g., spinal cord injury, multiple sclerosis, parkinson's, etc), xerosis is often severe and chronic because of the multiple causes (endogenous rather than exogenous ones) underlying such mobility impairment-related skin problems. this study is a double-blind, randomized study with positive control (active comparator) to assess the safety and efficacy of sqin with cansats (co-activation of natural synergistically acting target-receptors) technology on dry skin in patients suffering of paralysis.

xerosis is a medical term for dry skin. when it results in skin that is scaly and itchy, the condition is called pruritus. this occurs when natural moisture is drawn out of the skin. the skin needs moisture to protect itself. the best way to relieve dry skin normally, for those suffering of seasonal dry skin problems, is to use standard moisturizers. however, for those suffering of mobility problems due to age or paralysis (spinal cord injury, multiple sclerosis, parkinson's, alzheimer's, muscular dystrophy, amputation, cerebral palsy, or other comparable disorders), xerosis becomes severe and chronic because of the multiple causes (endogenous metabolic problems and dysfunctions rather than exogenous ones). sqin with cansats technology is designed to act upon multiple mechanisms for enhanced protecting, moisturizing, and repairing effects. based upon preliminary evidence, sqin with cansats technology can thus elicit significantly superior effects compared with standard, commercially available moisturizers.

Eligibility criteria:
inclusion criteria: * paralyzed due to a spinal cord injury (traumatic or non-traumatic origin) * chronically injured (at least 3 months post-injury) * paraplegic or tetraplegic * 18-75 years of age * men and women * french-speaking exclusion criteria: * acute or subacute stage (within 1 day and 3 months post-injury) * had tumor(s) (malignant or non-malignant) of the skin in the last five (5) years * allergic or hypersensitive to any ingredient, investigational or control product * with psychiatric or mental disorder(s) * children (younger than 18 year-old) or elderly (older than 75 year-old) * not french-speaking
itil-168 in advanced melanoma

Conditions: Advanced Cutaneous Melanoma

Summary: delta-1 is a phase 2 clinical trial to evaluate the efficacy and safety of itil-168 in adult subjects with advanced melanoma who have previously been treated with a pd-1 inhibitor. itil-168 is a cell therapy derived from a patient's own tumor-infiltrating immune cells (lymphocytes; tils).


Eligibility criteria:
key inclusion criteria: * histologically confirmed advanced (unresectable or metastatic) cutaneous melanoma. * cohort 1: disease that is relapsed after or refractory to at least 1 prior line of systemic therapy that must include a pd-1 inhibitor and, if positive for proto- oncogene braf v600 activating mutation, targeted therapy. * cohort 2: disease that is persistent after discontinuing pd-1 due to toxicity. patients with a proto-oncogene braf v600 activating mutation must have progressed after targeted therapy. * cohort 3: disease that is stable (sd) after at least 4 doses of a pd-1 inhibitor. patients with a proto-oncogene braf v600 activating mutation must have progressed after targeted therapy. * medically suitable for surgical resection of tumor tissue * following tumor resection for til harvest, will have, at minimum, 1 remaining measurable lesion as identified by ct or mri per response evaluation criteria in solid tumors (recist) v1.1 * eastern cooperative oncology group (ecog) performance status 0 or 1 * adequate bone marrow and organ function key exclusion criteria: * history of another primary malignancy within the previous 3 years * melanoma of uveal, acral, or mucosal origin * previously received an allogeneic stem cell transplant or organ allograft * previously received til or engineered cell therapy ( eg, car t-cell) * significant cardiac disease * stroke or transient ischemic attack within 12 months of enrollment * history of significant central nervous system (cns) disorder * symptomatic and/or untreated cns metastases * history of significant autoimmune disease within 2 years prior to enrollment * known history of severe, immediate hypersensitivity reaction attributed to cyclophosphamide, fludarabine, or il-2.

Keywords: itil-168 cell therapy melanoma autologous cell therapy cellular immunotherapy til autologous adoptive cell transfer immuno-oncology il-2 autologous adoptive cell therapy tumor infiltrating lymphocytes t-cell therapy
parp-inhibitor on advanced metastatic breast cancer in germline palb2 mutations carriers

Conditions: Metastatic Breast Cancer in Germline-PALB2 Mutations Carriers

Summary: the study aims at exploring the potential benefit of a parp-inhibitor, niraparib, in metastatic breast cancer developing in germline-palb2 mutations carriers. this study is designed as a multicentre one-arm two-stage phase 2 clinical trial


Eligibility criteria:
inclusion criteria: * adult patients over 18 years * palb2 germline heterozygous mutation carrier, wild type brca1\&2 (breast cancer 1\&2) affected with metastatic breast cancer in first metastatic treatment line or beyond * histologically or cytologically confirmed breast cancer with evidence of metastatic disease. * triple negative breast cancer; patients affected with triple negative cancers should have received anthracyclines and taxanes in neo/adjuvant therapy. * or patients with hormonal receptor positive (hr+)/ human epidermal growth factor receptor 2 negative (her2-) breast cancer, with treatment failure after a second line of therapy; estrogen receptor/progesteronereceptor breast cancer positive patients must have received and progressed on currently recommended therapies in this indication (endocrine therapy, cdk4/6 inhibitors (adjuvant or metastatic)), or have a disease form that the treating physician believes to be inappropriate for recommended therapies in this indication. * prior therapy with an anthracycline and a taxane in an adjuvant setting. * prior platinum allowed as long as no breast cancer progression occurred on treatment or if given in adjuvant/neoadjuvant setting, at least 12 months elapsed from last dose to study entry. * eastern cooperative oncology group (ecog) performance status 0-2. * adequate bone marrow, kidney and liver function. * patients without visceral crisis exclusion criteria: * patients with her2 positive disease. * untreated and/or uncontrolled brain metastases. * patients in visceral crisis requiring chemotherapy * cytopenia, defined with the following thresholds: (i) neutrophil count \< 1500/mm3; platelet count\< 100 000/mm3; hemoglobin \<9g/dl * prior malignancy unless curatively treated and disease-free for \> 5 years prior to study entry. prior adequately treated non-melanoma skin cancer, in situ cancer of the cervix, ductal carcinoma in situ (dcis) or stage i grade 1 endometrial cancer allowed. * known hiv (human immunodeficiency virus) infection. * pregnant or breast-feeding women. * lack of affiliation to a social security benefit plan (as a beneficiary or assignee)
international registry of congenital portosystemic shunt (ircpss)

Conditions: Congenital Portosystemic Shunt; CPSS (Congenital Portosystemic Shunt)

Summary: congenital portosystemic shunt (cpss) is a rare condition important by the multiplicity and severity of associated complications. cpss is venous anomaly in which blood coming from the intestines only partially passes through the liver. this leads to the accumulation of potentially toxic factors that cause systemic effects. complications vary among the individuals, and currently, it is challenging to predict which individuals will develop severe complications. the ircpss registry is established with the aim of centralizing detailed clinical follow-up and biological information from participants around the world who suffer from congenital portosystemic shunt (cpss). a multidisciplinary consortium of experts is collaborating to enhance our understanding of the prevalence, natural history, individual risks, and physiopathology of the disease through the ircpss registry.


Eligibility criteria:
inclusion criteria: individual with cpss exclusion criteria: secondary shunt without evidence of congenital shunt

Keywords: shunt portosystemic portasystemic porto-systemic porta-systemic registry liver rare disease abernethy malformation vascular malformation hypertension, pulmonary hepatopulmonary syndrome liver neoplasms hyperinsulinemic hypoglycemia hyperinsulinism insulin resistance hyperandrogenism hepatic encephalopathy hyperammonemia