Kornimate/medical-research-clean huggingface dataset:
fixed-dose safety and efficacy study of asenapine for the treatment of acute manic or mixed episode in bipolar 1 disorder (p05691)

Conditions: Bipolar 1 Disorder

Summary: this trial will study the efficacy and safety of a fixed dose of asenapine in participants diagnosed with bipolar 1 disorder. participants who qualify for the study will be randomly assigned to receive a fixed dose of asenapine (either 5 mg or 10 mg twice daily \[bid\]) or placebo (bid) for 3 weeks. throughout the trial, observations will be made on each participant at various times to assess the safety and effectiveness of the study treatment. the primary hypothesis is that there is at least one dose of asenapine that is superior to placebo in the change from baseline in manic symptoms (as measured by young mania rating scale \[ymrs\]) at day 21 of the trial.


Eligibility criteria:
inclusion criteria: * each participant must be at least 18 years of age * male, or a female who is not of child-bearing potential or who is non-pregnant, non-lactating, and is using a medically accepted method of contraception * each participant must have a current diagnosis of bipolar i disorder, current episode manic or mixed * each participant must be confirmed to be experiencing an acute manic or mixed bipolar 1 episode * each participant must have discontinued the use of all prohibited psychotropic medications exclusion criteria: * a participant must not have a primary axis i disorder other than bipolar 1 disorder (i.e., an axis 1 disorder other than bipolar 1 disorder that is primarily responsible for current symptoms and functional impairment) * a participant must not currently (within the past 6 months) meet the diagnostic and statistical manual of mental disorders fourth edition, text revision (dsm-iv-tr™) criteria for substance abuse or dependence (excluding nicotine) * a participant must not be at imminent risk of self-harm or harm to others, in the investigator's opinion based on clinical interview and responses provided on the columbia suicide severity rating scale (cssrs).
placebo-controlled evaluation of cocculine® efficacy in the management of nausea after chemotherapy in breast cancer.

Conditions: Breast Cancer

Summary: the purpose of the study is to determine whether a homeopathic remedy (cocculine®) is effective in the prevention of chemotherapy-induced nausea in non metastatic breast cancer. eligible patients will be randomly assigned to one of 2-arms: cocculine® or placebo. the number of patients required to demonstrate a 0.5-point reduction in nausea on a visual analogue scale, assuming an alpha risk of 5% in a two-sided test and 85% power, is 396 (198 per arm). it has been estimated that the enrollment period should be 18 months.

the proportion of women with breast cancer treated by chemotherapy (ct) is increasing. ct-induced nausea and vomiting negatively impact patient quality of life. the primary objective of the trial is to evaluate against a placebo the efficacy of cocculine® administered as an adjunct to conventional treatments (corticosteroids and 5-ht3 receptor antagonists) for the management of nausea induced by a 1st course of adjuvant ct with fac50, fec100 or tac in patients with non-metastatic breast cancer. secondary objectives are to test: * the persistence of cocculine® efficacy over the 2nd and 3rd ct courses * the contribution of cocculine® to the global management of nausea and vomiting during adjuvant ct * patient compliance with cocculine® dose. eligible patients will be randomly assigned to one of 2 arms: cocculine® or placebo.

Eligibility criteria:
inclusion criteria: * women with histologically proven non metastatic breast cancer * no previous chemotherapy * treatment planning including 6 adjuvant ct courses with the first 3 being necessarily of the fac50, fec100 or tac type * age\>= 18 years * ecog performance status (ps) \<= 2 (who scale) * patient able to read and understand french * written, voluntary, informed consent exclusion criteria: * previous treatment with chemotherapy (including neo-adjuvant chemotherapy for breast cancer) * previous malignancies (except basal cell skin cancer or cervical cancer in situ or any other curatively treated malignancy in complete remission for more than 5 years) * contraindication to corticosteroids or 5-ht3 receptor antagonists * treatment with cocculine® or any other anti-emetic drug in the 15 days before inclusion * pregnant or lactating women * follow-up impossible for social, geographical, familial or psychological reasons * patients who cannot be contacted by phone

Keywords: non metastatic breast cancer adjuvant chemotherapy nausea vomiting quality of life homeopathy
pharmacokinetics study of epratuzumab in systemic lupus erythematosus (sle)

Conditions: Lupus Erythematosus, Systemic

Summary: the goal of this study is to evaluate how epratuzumab is processed by the body (pharmacokinetics) and whether 2 dose levels of epratuzumab are safe and effective in patients with sle.

this study is planned to provide information on how the body processes epratuzumab and how epratuzumab affects the body when epratuzumab is given once weekly for 4 weeks in a row at one of 2 different dose levels. additional information will be obtained related to the natural variability of disease activity in sle patients.

Eligibility criteria:
inclusion criteria: * has sle by american college of rheumatology revised criteria (meets \>/= 4 criteria) * has had sle for at least 6 months prior to study entry * has at least one elevated autoantibody level at study entry * has moderately active sle disease at study entry in any body/organ system (full criteria not present here due to length of considerations. the protocols should be consulted regarding the complete list of entry criteria.) exclusion criteria: * active severe lupus as defined by bilag index level a in any body system or organ * allergy to human antibodies or murine * prior therapy with other anti-b cell antibodies

Keywords: study of epratuzumab in systemic lupus erythematosus systemic lupus erythematosus sle
a phase 1 study of sb1518 for the treatment of advanced lymphoid malignancies

Conditions: Lymphoma, Malignant; Hodgkin's Lymphoma; B Cell Lymphoma

Summary: this is a phase 1 dose escalation study to determine the maximum tolerated dose and the dose limiting toxicities of sb1518 when given alone once daily by mouth to subjects with advanced lymphoid malignancies.


Eligibility criteria:
inclusion criteria: * subjects with histologically documented diagnosis of a lymphoid malignancy as defined in the world health organization (who) classification scheme except for those listed in exclusion criteria * subject must have received at least 2 prior regimens for their lymphoid malignancy, one of which was an anthracycline-containing combination regimen and have shown disease relapse or did not respond to the prior regimen * subjects with classic hl or diffuse large b cell lymphoma must have failed, refused or are ineligible to receive stem cell transplant * subjects must have measurable lesions (at least one target lesion measuring 2cm in diameter) by computerized tomography (ct) scan * eastern cooperative oncology group (ecog) performance status 0-2 * all men of reproductive potential and women of child-bearing potential must agree to practice effective contraception during the entire study period and for one month after the last study treatment unless documentation of infertility exists. additionally, women of child-bearing potential must have a negative pregnancy test within 14 days prior to the first dose of study drug * able to understand and willing to sign the informed consent form exclusion criteria: * post-transplant lymphoproliferative disease (ptld), burkitt's lymphoma, burkitt-like lymphoma, lymphoblastic lymphoma/leukemia, multiple myeloma, or hiv-associated lymphoma * history of or active central nervous system (cns) malignancy * have undergone allogeneic stem cell transplant and were treated with immunosuppressing agent within the past 6 months * active graft-versus-host disease (gvhd) * uncontrolled inter-current illness including, but not limited to, ongoing active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements as judged by treating physician. subjects receiving antibiotics for infections that are under control may be included in the study * concurrent malignancy, except those subjects with early stage squamous cell carcinoma of the skin, basal cell carcinoma of the skin, or cervical intraepithelial neoplasia are eligible for the study * known hiv-positive (such subjects are at increased risk of lethal infections when treated with potentially marrow-suppressive therapy) * known active hepatitis a, b or c * women who are pregnant or lactating

Keywords: lymphoid malignancies hodgkin's lymphoma diffuse large b cell lymphoma
using rheological methods to characterize cystic fibrosis (cf) sputum and the effects of mucoactive agents

Conditions: Cystic Fibrosis

Summary: the purpose of this study is to characterize the rheological properties of cystic fibrosis (cf) and healthy sputum and to examine the effects of mucoactive agents on the rheology of cf and healthy sputum. by collaborating with genentech, the investigators (scientists at ucsf) plan to incorporate the latest scientific findings into our work to discover and develop new treatments for cf.

there are two major mechanisms for mucus clearance in the airway, both of which are dependent upon optimal mucus viscosity and elasticity. these mechanisms are severely impaired in cystic fibrosis. the physical properties of sputum can be measured using rheological methods, enabling comparison between mucus in health and in disease. therapies which enhance mucus clearance from the airway and decrease the volume of airway secretions are collectively called "mucoactive agents." therapies which specifically disrupt innate mucus architecture by breaking intermolecular entanglements and bonds are called mucolytic agents. mucolytic drugs can be considered in three general categories: classic mucolytics (n-acetylcysteine), peptide mucolytics (pulmozyme®), and non-destructive mucolytics (hypertonic saline). using state-of-the-art rheological methods, we can characterize the physical properties of cf mucus and measure the rheologic effects of mucoactive drugs more accurately and reproducibly than what has been previously done in the literature. in this way, we will determine which of the current mucoactive agents are most effective in normalizing sputum rheology in cf, and we will gain important insights about the limitations of current mucoactive drugs.

Eligibility criteria:
inclusion criteria: * healthy control subjects: * age 18-65 * no history of lung disease or cardiac disease * cystic fibrosis subjects: * age 18-65 * diagnosis of cf - sweat chloride values \> 60 mm on pilocarpine iontophoresis sweat tests and/or 2 allelic cf-producing mutations by genetic analysis exclusion criteria: * use of recreational drugs within 1 year prior to enrollment * use of tobacco within 1 year prior to enrollment, or \> 10 pack-year tobacco history * upper respiratory tract infection in the 4 weeks prior to enrollment in the study * current use of antihistamines to treat allergies
evaluation of a long versus short clomid protocol for controlled ovarian stimulation

Conditions: Infertility, Female

Summary: the goal of this clinical trial is to evaluate a long clomid protocol as compared to a 5-day clomid protocol for ovarian stimulation in patients with diminished ovarian reserve undergoing ovarian stimulation for in-vitro fertilization or egg freezing. the aim of the long clomid protocol is to intensify stimulation of the ovaries and reduce both cost and injection burden for patients. participants will be randomized to receive the long clomid protocol vs. the typical protocol involving clomid only for 5 days followed by growth hormone-releasing hormone (gnrh) antagonist. the primary outcome the investigators will evaluate will be the number of eggs retrieved.

clomiphene citrate (clomid) is often used for assisted reproductive technologies and may be used to augment ovarian stimulation with exogenous gonadotropins by stimulating pituitary follicle-stimulating hormone (fsh) release in addition. the mechanism of action of clomid is antagonism at the estrogen receptor, and this stimulates fsh release from the pituitary. the typical clomid-based protocol has involved clomid only given for the first five days of stimulation to allow for endometrial development later in the cycle for a fresh embryo transfer following the oocyte retrieval. this protocol involves the addition of a gnrh antagonist medication later in the cycle to prevent premature ovulation. recent national trends in ivf, however, have moved towards frozen embryo transfers and use of preimplantation genetic testing, which obviates any concerns regarding the endometrium. recent experience in our clinic has suggested that clomid may also prevent premature ovulation by antagonizing the positive feedback that is responsible for the luteinizing hormone (lh) surge and ovulation. given in this manner, clomid can be given throughout the duration of an ovarian stimulation cycle, achieve higher fsh levels and degree of ovarian stimulation in patients with diminished ovarian reserve, and obviate the need for gnrh antagonist medication (another expensive subcutaneous injection). the objective of this study is to compare a "long clomid protocol" (i.e. using clomid throughout the entire duration of the ivf cycle) as compared to the typical 5-day clomid protocol. the investigators hypothesize that the long clomid protocol will be non-inferior to the typical five-day course and obviate the need for gnrh antagonist by preventing premature ovulation. patients with diminished ovarian reserve and anticipated poor response to ovarian stimulation will be randomized to the long clomid protocol vs. a 5-day clomid with gnrh antagonist protocol. the primary outcome will be oocyte yield. secondary outcome will be premature ovulation, embryo development, and pregnancy outcomes.

Eligibility criteria:
inclusion criteria: * diminished ovarian reserve * prior poor response to ovarian stimulation exclusion criteria: * normal ovarian reserve or good response * allergy or adverse reaction to clomid * minimal stimulation protocols * history of prior premature ovulation
national observatory of mycoplasma infections in children under 18 ages in france

Conditions: Mycoplasma Infections; Hospitalized Children

Summary: this study was set up because of an unusual increase in the number of cases of mycoplasma infections in france between june and november 2023. clinical data from children with mycoplasma infections will be collected to characterise this infection and facilitate hospital management.

in this study, the number of cases will be collected. in addition, we will determine the clinical, biological and microbiological characteristics of these cases. these following data will be collected: signs or symptoms associated with this infection, clinical complications, biological and microbiological tests done during hospitalisation, treatment used during hospitalization, results of thoracic x-ray and lung ultrasound.

Eligibility criteria:
inclusion criteria: * age \<18 years (only hospitalized children) * documented mycoplasma infection (positive multiplex pcr and/or positive serology) exclusion criteria: * refusal by one of the parents or by child in understanding age
treatment of knee osteoarthritis: neuromuscular electrical stimulation and low-level laser.

Conditions: Knee Osteoarthritis

Summary: * the purpose of this study is to determine the effects of low-level laser therapy in combination with neuromuscular electrical stimulation on neuromuscular (muscular strength and morphology) and functional parameters (pain and functional tests) in elderly with knee osteoarthritis. * the hypothesis is that the association of low-level laser therapy with neuromuscular electrical stimulation could reduce joint pain associated with the inflammation and consequently potentiates the effects of electrical stimulation on the muscular system.

* participants was randomized into one of three intervention groups (intervention period = 8 weeks after a 4 weeks control period in all groups). * electrical stimulation group (18-32 min of pulsed current, stimulation frequency of 80hz (hertz), pulse duration of 200μs and stimulation intensity fixed near to maximal tolerated), * laser group (low-level laser therapy dose of 4-6j (joules) per point, six points at the knee joint) * combined group (electrical stimulation and low-level laser therapy).

Eligibility criteria:
inclusion criteria: * elderly. * symptomatic knee osteoarthritis. * radiographic diagnostic of grade 2 or 3 knee osteoarthritis. exclusion criteria: * a body mass index higher than 40 kg/m2. * a diagnosis of hip, ankle, or toe osteoarthritis. * the use of crutches for locomotion. * participation in a strength-training programme or physiotherapy treatment for knee osteoarthritis in the past six months. * neurological or cognitive disorders. * rheumatoid arthritis. * electronic implants. * previous or upcoming surgery (within three months). * any cardiorespiratory, neuromuscular, or metabolic disease that could represent an absolute contraindication or a contraindication to the performance of maximum strength tests.

Keywords: neuromuscular electrical stimulation low-level laser therapy knee osteoarthritis muscle architecture functionality neuromuscular parameters
video-assisted telephone cpr with the emergencyeye-software - a pilot study

Conditions: Cardiac Arrest

Summary: technical advance as broad-bandwidth wireless internet coverage and the ubiquity utilization of smartphones has opened up new possibilities which surpass the normal audio-only telephony. high quality and real-time video-telephony is now feasible. however until now this technology hasn't been deployed in the emergency respond service. in the hope of helping the detection of the cardiac arrest, offer the possibility to evaluate and correct via a video-instructed cpr (v-cpr) and to facilitate a fast localization of the emergency site, a new software (emergencyeye®/ramses®) was developed which enables the dispatcher a video-telephony with the callers mobile terminal (smartphone) if suitable. this technology hasn't been tested in a randomized controlled trail yet and no data exists that shows if v-cpr in comparison to t-cpr and non-instructed cpr leads to a better bystander cpr-performance.

technical advance as broad-bandwidth wireless internet coverage and the ubiquity utilization of smartphones has opened up new possibilities which surpass the normal audio-only telephony. high quality and real-time video-telephony is now feasible. however until now this technology hasn't been deployed in the emergency respond service. in the hope of helping the detection of the cardiac arrest, offer the possibility to evaluate and correct via a video-instructed cpr (v-cpr) and to facilitate a fast localization of the emergency site, a new software (emergencyeye®/ramses®) was developed which enables the dispatcher a video-telephony with the callers mobile terminal (smartphone) if suitable. this technology hasn't been tested in a randomized controlled trail yet and no data exists that shows if v-cpr in comparison to t-cpr and non-instructed cpr leads to a better bystander cpr-performance.

Eligibility criteria:
inclusion criteria: * healthy volunteer exclusion criteria: * healthcare providers (medical practitioners, nurses, paramedics etc.) * pregnant women * people with cardio-pulmonary and musculoskeletal diseases or any other impairment that would risk harm for the volunteer while performing cpr for 8 minutes
population pharmacokinetics of tacrolimus in nephrotic syndrome

Conditions: Nephrotic Syndrome; Tacrolimus; Pharmacokinetics

Summary: this study will use a multi-center, prospective design, with a "real world study" model, to include 200 patients with nephrotic syndrome. based on the population pharmacokinetics (ppk) model, it will study genotype and clinical factors in patients with nephrotic syndrome, to explore the pharmacokinetics/ pharmacodynamics (pk/pd) relationship of tacrolimus in patients with nephrotic syndrome, and develop an optimal medication regimen.


Eligibility criteria:
inclusion criteria: * （1）patients with nephrotic syndrome： 1. proteinuria greater than 3.5 g/24 hour 2. serum albumin \<30 g/l 3. clinical evidence of peripheral oedema 4. hyperlipidemia 1) and 2) are necessary for diagnosis. * （2）18-75years old（include 75），gender is not limited； * （3）voluntary signing informed consent。 exclusion criteria: * （1）secondary nephrotic syndrome； * （2）allergic to tacrolimus or other unsuitable use of tacrolimus； * （3）with other immunosuppressive agents such as cyclosporin a, cyclophosphamide, mycophenolate mofetil, leflunomide, tripterygium wilfordii (hormone is not restricted)； * （4）severe liver dysfunction (transaminase \> 3 uln, or bilirubin \> 3 uln)； * （5）severe renal insufficiency（egfr\<30 ml/min/1.73m2） * （6）joined other clinical trials within 1 month； * （7）missing clinical data； * （8）pregnancy, lactation or planning for pregnancy within 12 months； * （9）researchers believe that patients who are not suitable for this clinical trial。

Keywords: nephrotic syndrome tacrolimus population pharmacokinetics