cyrilzakka/clinical-trials huggingface dataset:
A Placebo-controlled Study to Investigate Safety and Efficacy of BIA 2-093

The purpose of this study is to determine the efficacy of BIA 2 093 in the treatment of epileptic patients with refractory simple or complex partial seizures with or without secondary generalization.

This clinical trial was performed as a multicentre, add-on, double-blind, randomised, placebo-controlled, phase II study. During the double-blind treatment phase (12 weeks) patients were assigned to three treatment groups receiving BIA 2 093 once daily (ODG - once-daily group), BIA 2 093 twice daily (TDG - twice-daily group) or placebo (PLG - placebo group), respectively. Daily doses of BIA 2 093 were increased at four-weekly periods (400 mg, 800 mg and 1200 mg).

On completion of the 12-week double-blind treatment period, a 1-week tapering period was scheduled.

Eligibility Criteria:
Inclusion Criteria:

* Male and female patients aged 18-65 years
* Patients with simple or complex partial seizures with or without secondary generalization since at least one year prior to randomisation visit
* At least 4 seizures per month within the last 2 months prior to randomisation
* Stable dose regimen of a maximum of two of the following AEDs: phenytoin, valproate, primidone, phenobarbital, lamotrigine, gabapentin, topiramate, clonazepam, during 2 months prior to randomisation
* Electroencephalogram (EEG) findings not contradicting the epilepsy diagnosis (e.g., primarily generalized epilepsy)
* Written informed consent.

Exclusion Criteria:

* Patient with nervus vagus stimulation
* Patient with primarily generalized seizures
* Known progressive neurological disturbance
* A history of status epilepticus within the past 3 months
* Seizure of non-epileptic origin
* Restricted legal competence and incapability to follow trial instructions
* Major psychiatric disorders
* Concurrent drug therapy with monoamine oxidase inhibitors or calcium channel blockers
* Need of excluded concomitant medication (see section 9.4.6.2)
* Use of oxcarbazepine or carbamazepine during the last 6 months before the randomisation visit
* Known hypersensitivity to oxcarbazepine or carbamazepine, or its metabolites
* Abuse of alcohol, drugs or medications
* History of relevant cardiac, renal, hepatic, endocrine, gastrointestinal, metabolic, hematologic or oncology disorders
* Second- or third-degree atrioventricular block not corrected with a pacemaker
* Relevant laboratory abnormalities (e.g., Na+\< 130 mmol/L, alanine (ALT) or aspartate (AST) transaminase \>2.0 times the upper limit of normal, white blood cell (WBC) count \<3000 cells/mm3)
* Pregnancy, nursing or inadequate contraception in women of childbearing age (oral contraception should be combined with a barrier method)
* Participation in other clinical trials within the last 2 months
* History of non-compliance.
3-Week Study of Asenapine, Olanzapine and Placebo for Treatment of Bipolar Mania (P07008)

Bipolar disorder is characterized by mood swings that range from high (manic) to low (depressed) states. Sometimes, symptoms of both depression and mania are present (mixed episodes). Asenapine is an investigational medication for the treatment of manic or mixed episodes of bipolar disorder. This is a 3-week study that will test the safety and efficacy of this medication. Patients will receive either asenapine, olanzapine (a medication that is already approved for the treatment of bipolar mania), or placebo (no active medication). Patients will be required to stay in the hospital for at least the first seven days of treatment. Patients that complete the 3 week study may be eligible to continue in extension studies for an additional 9 (study A7501006) to 49 (study A7501007) weeks.


Eligibility Criteria:
Inclusion Criteria:

* Have a DSMIV diagnosis of bipolar I disorder, current episode manic or mixed.

Exclusion Criteria:

* Patients with unstable medical conditions or clinically significant laboratory abnormalities or patients who are rapid cyclers (ie. have had 4 or more (including current) mood episodes in the past 12 months); have any other psychiatric disorder other than bipolar I disorder as a primary diagnosis.
Massage for Low Back Pain in Nursing Staff

Objectives: Semi experimental Clinical Trial aimed at verifying the effectiveness of massage for lower back pain occupational as well as to assess the influence of technique in performing work activities and life in the team nursing.

Method: 18 officials received 7-8 massage sessions, twice per week, with the same protocol points. Data were collected on baseline, after one and two months and they responded 2 questionnaires (Functional Assessment of Oswestry and Risk Assessment in Movement and Transfer Scale) and the Numeric Pain Scale.

Eligibility Criteria:
Inclusion Criteria:

1. Voluntary participation in the study of employees with availability of time for submission to the sessions
2. Not be pregnant
3. Hold shift of at least 6 hours daily
4. Do not go on vacation or leave care during the study period
5. Reporting back pain self-reported or confirmed by medical diagnosis
6. Not having passed off due to back pain in past 6 months
7. Do not submit spondylolisthesis, disc herniation and sciatic pain self-reported or confirmed by medical diagnosis
8. Do not use anti-inflammatory drugs
9. Individuals that showed greater than 0 (zero) in the Numerical Pain Scale (10) Score higher than 15 on the Functional Assessment Questionnaire Oswestry

Exclusion Criteria:

* Employees who left the study or that lost more than one session
Study of Temozolomide in Previously Untreated Acute Myeloid Leukemia (AML) and Myelodysplastic Syndrome (MDS) Participants With Low O6-Methylguanine Methyltransferase (MGMT) Expression (P05052)

The primary objective of this study is to evaluate the safety, tolerability, and efficacy of temozolomide in acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS) participants who are not candidates for standard induction therapy and exhibit low MGMT expression.


Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of acute myeloid leukemia (AML), any subtype except acute promyelocytic leukemia (APL), by the World Health Organization (WHO) criteria, or high risk MDS with blasts between 10 and 20% in the bone marrow.
* No prior AML chemotherapy except hydroxyurea.
* Leukemic blast count \<30x10\^9/L at the start of therapy. Prior cytoreduction with hydroxyurea (maximum 14 days) is permitted.
* Participant is not a candidate for aggressive induction based on at least one of the following: adverse-risk cytogenetics (complete or partial deletion of 5 or 7, complex \[\>3\] cytogenetic abnormalities, inv3, 11q23 abnormalities); secondary AML (antecedent hematologic disorder or therapy-related AML); comorbid medical illnesses precluding standard induction therapy; participant's refusal of standard induction therapy.
* Confirmed low MGMT expression (MGMT: beta-actin ≤0.2), as evaluated by Western blot, or weak MGMT expression defined as \> 0.2 and ≤2.5 if promoter is methylated, upon Sponsor approval.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.
* Use of medically approved contraception in fertile males and females.
* Negative urine or serum pregnancy test for women of childbearing potential (72 hours prior to Baseline).

Exclusion Criteria:

* Serum bilirubin \>2 times the upper limit of normal (ULN), or serum aspartate aminotransferase/ alanine aminotransferase \>5 times ULN.
* Serum creatinine \>200 umol/L.
* History of other malignancies within 1 year prior to study entry, with the exception of localized nonmelanomatous skin cancer or cervical cancer in situ.
* Presence of active uncontrolled infection.
* Known human immunodeficiency virus (HIV) infection.
* Any medical condition that may interfere with protocol evaluation or oral medication intake.
* Prior chemotherapy other than hydroxyurea.
Selective Laryngeal Reinnervation for Bilateral Vocal Fold Paralysis

This is a prospective observational study examining the treatment outcomes of selective laryngeal reinnervation procedures for patients with bilateral vocal fold paralysis.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18-70
* Patients with bilateral vocal fold paralysis without any improvement for 6 months

Exclusion Criteria:

* Patients with neck or chest radiation
* Patients with severe respiratory compromise
* Patients with cricoarytenoid ankylosis
* Patients with pacemakers
* Patients who are pregnant
* Patients with cochlear implant, or any nerve stimulator implants
The Effect of UVB Phototherapy With Microneedling and Circled Needing in Vitiligo Patients

Vitiligo is a relatively common acquired disorder of pigmentation characterized by the development of well-defined white macules on the skin. Biopsies of lesional skin reveal a loss of epidermal melanocytes. Lesions may occur in a localized or generalized distribution and may coalesce into large, depigmented areas. Given the contrast between the white areas and normal skin, the disease is most disfiguring in darker skin types and has a profound impact on the quality of life of both children and adults . Patients with vitiligo often experience stigmatization, social isolation, and low self-esteem. The therapys include topical steroids, topical immunosuppresant, systemic steroids, phototherapy, and surgery.

The aim of this study is to investigate the effect of phototherpy and accupuncture combined therapy for vitiligo patients.


Eligibility Criteria:
Inclusion Criteria:

Clinical diagnosis of Vitiligo

Exclusion Criteria:

* pregnancy
* immune disorder
* infection
* other dermatosis in treating areas
Thermal Cures in the Treatment of Multiple Sclerosis

Multiple Sclerosis (MS) is a chronic, progressive disease with a high prevalence in France, with significant public health consequences. The benefit of spa treatments on the quality of life in this population has not been evaluated. The methods of study in clinical pharmacology can be a scientific methodological model for the evaluation of thermal practices and it is in this perspective that investigators want to lead this project.

Multiple sclerosis (MS) is a chronic, progressive disease with a high prevalence in France, and its consequences in terms of public health are important. In this disease, the alteration of the quality of life (QoL) is constant and multifactorial : pain, fatigue, decrease in functional capacities, sleep disorders, cognitive disorders, vesico-sphincterian disorders, anomolytic disorders. -rectal and genito-sexual. The benefit of thermal cures on the quality of life in this population has not been evaluated, even if there is some literature in the literature suggesting a benefit of hydrotherapy on equilibrium or on pain.

Eligibility Criteria:
Inclusion Criteria:

* Patient with primary or progressive secondary-phase MS
* Showing EDSS \<7 severity criteria
* Patient with MS for whom an indication of spa treatment has been made,
* Patient agreeing to participate in this study and therefore accepting the constraints related to the design "immediate cure-deferred cure",
* Patient receiving the general social security scheme,
* Patient having given written consent to participate in the study

Exclusion Criteria:

* Patient does not meet the inclusion criteria,
* Patient with relapsing remitting MS
* Patient unfit according to the investigator to complete the rating scales
* Patient with heat intolerance called "Uhthoff effect"
* Patient with a contraindication to the spa treatment: urinary or faecal leakage, wound, thrombophlebitis less than three months old, unstabilized cardio respiratory disease.
* Patient with serious life-threatening condition (ie, cancer)
* Patient under tutorship or curatorship
* Patient participating in another interventional clinical research project
Low Dose Rapamycin in ME/CFS, Long-COVID, and Other Infection Associated Chronic Conditions

The goal of this observational study is to assess the clinical response and the effect of autophagy function in patients before, during and throughout oral low dose sirolimus (rapamycin) therapy. The main questions this study aims to answer are:

* Does rapamycin reduce the overall symptom burden in this patient population and does it improve the quality of life?
* Does rapamycin change mTOR driven autophagy deficits observed in a subset of patients?

Participants will be asked to complete a series of questionnaires and quality of life instruments before starting rapamycin therapy prescribed by their physician and throughout their course of treatment. Study blood samples will be collected before starting therapy and throughout the course of treatment to assess serological markers of autophagy function.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of ME/CFS that meets the Institute of Medicine (IOM) criteria
* Diagnosis of Long-COVID (PASC clinical criteria)

Exclusion Criteria:

* No diagnosis of ME/CFS or Long-COVID
Semi-permanent Acupuncture Effect on Cervical Ripening

Cervical ripening is a medical treatment that can cause physical or emotional discomfort in pregnant women and is not without risks. This is a pilot study to assess feasibility and calculate the number of participants necessary for a complete clinical trial. The aim is to evaluate whether acupuncture can reduce the need for treatment (cervical ripening) in pregnant women at low or intermediate risk. Participants will be divided into two groups: one group will receive acupuncture, and the other will receive a simulated treatment of acupuncture.


Eligibility Criteria:
Inclusion Criteria:

* Anticipated delivery at the study center.
* Ability to collaborate in necessary evaluations.
* Legal capacity to provide informed consent.
* Signature of the informed consent for inclusion in the study, by oneself.

Exclusion Criteria:

* Pregnancy with high or very high risk as described by the Pregnancy and Childbirth Monitoring Protocols of the Department of Health of Catalonia
* History of cesarean delivery.
* Language barrier preventing collaboration in study procedures.
* Cognitive or affective pathology limiting the ability to collaborate with study procedures.
* Participation in another clinical trial involving an experimental intervention during the period of this trial and/or establishing a visit frequency incompatible with this trial.
Neurofeedback Rehabilitation Based on Motor Imaging in Patients in the Immobilization Phase

As the prevalence of motor impairment increases with age, the proportion of the population affected by physical limitations is likely to increase in the coming years, considering that one in three people will be over 60 in 2050 (compared to one in five in 2005, INSEE projections). The possibility of reducing recovery time and / or improving the improvement of motor deficits is today a public health issue. The possibility of developing new therapeutic tools using innovative motor imaging rehabilitation technologies is an opportunity to offer rehabilitation adapted to specific disorders, personalized in relation to the patient's performance, and in continuity with the therapist. In this research project, we will use the principle of neurofeedback rehabilitation (EEG) based on motor imaging with a brain-computer interface. Feedback will consist of therapeutic video games.Here, we will test the feasibility of such approach in 10 healthy subjects, 10 patients with amyotrophic lateral sclerosis and 10 patients with uppel shoulder surgery.


Eligibility Criteria:
Inclusion Criteria:

Common to the 3 populations concerned:

* patients or subjects of both sexes;
* age: 18-70 years;
* ability to give consent in writing;
* Health Insurance.

  a) SLA:
* patients with amyotrophic lateral sclerosis (defined according to the El Escorial criteria: possible, probable or definite), at the time of diagnosis;
* Percentage of forced vital capacity (FVC) ≥ 65% of the predicted value for age, gender and size.

  b) Patients after a shoulder trauma: patients with scheduled shoulder surgery. c) Healthy subjects.

Exclusion Criteria:

* Dementia (MMSE score \<24/30)
* Pregnancy or patient not having effective contraception.
* Other neurological, psychiatric or orthopedic disease leading to a motor handicap or an inability to correctly realize the experimental paradigm: interfering with the evaluation of the movements of the upper limb, incapacity to realize the mental imagery of the movement.
* Visual impairment resulting in an inability to properly view the computer screen.
* History of epilepsy or active epilepsy.
* Contraindication to MRI: cardiac or neuronal simulator, ferromagnetic surgical clips, implants and metal objects, intraocular foreign bodies, claustrophobia
* Persons under guardianship, trusteeship or any other administrative or judicial measure of deprivation of rights and liberty
* Subject in the exclusion period of another interventional research or participating in any other interventional research or therapeutic trial
* Presence of another severe progressive pathology
Loncastixumab Tesirine (ADCT-402) Expanded Access Program (EAP) for Patients With Relapsed/Refractory Diffuse Large B-Cell Lymphoma

The EAP is for patients with relapsed/refractory diffuse large b-cell lymphoma (R/R DLBCL) that cannot be treated by currently available drugs, cell therapy, or clinical trials. ADC Therapeutics will evaluate patients for approval into the program.


Eligibility Criteria:
Inclusion Criteria:

* Male or female patient aged 18 years or older
* Pathologic diagnosis of DLBCL
* Relapsed/Refractory Diffuse Large B-Cell Lymphoma (R/R DLBCL) that cannot be treated by currently available drugs, cell therapy, or clinical trials
* Women of childbearing potential must agree to use a highly effective method of contraception from the time of giving informed consent until at least six months after the last dose of loncastuximab tesirine. Men with female partners who are of childbearing potential must agree that they will use a highly effective method of contraception from the time of giving informed consent until at least six months after the patient receives his last dose of loncastuximab tesirine

Exclusion Criteria:

* Known history of hypersensitivity to or positive serum human Anti-Drug Antibodies to loncastuximab tesirine
* Total bilirubin \>1.5 x upper limit of normal (ULN)
* Active second primary malignancy other than non-melanoma skin cancers, nonmetastatic prostate cancer, in situ cervical cancer, ductal or lobular carcinoma in situ of the breast, or other malignancy that ADCT Head of Medical Affairs and/or designee, and treating physician agree and document should not be exclusionary
* Autologous Stem Cell Transplantation (SCT) within 30 days prior to start of loncastuximab tesirine
* Allogeneic SCT within 60 days prior to start of loncastuximab tesirine
* Clinically significant third space fluid accumulation (i.e., ascites requiring drainage or pleural effusion that is either requiring drainage or associated with shortness of breath)
* Lymphoma with active central nervous system involvement at the time of screening, including leptomeningeal disease
* Breastfeeding or pregnant
* Major surgery, radiotherapy, chemotherapy or other anti-neoplastic therapy within 14 days prior to starting loncastuximab tesirine, except shorter if approved by ADCT
* Use of any other experimental medication within 14 days prior to starting loncastuximab tesirine
* Any other significant medical illness, abnormality, or condition that would, in the treating physician's judgment, make the patient inappropriate to receive loncastuximab tesirine or put the patient at risk
Comparison of a Conventional and a Realistic Self-modified Model

According to the recently published german guidelines for the prehospital airway management regular training for cricothyroidotomy is recommended.

Even though participants prefer animal or cadaver trainingmodels, it is not possible to perform this comprehensive for a large number of participants due to organizational requirements like food hygiene, limited shelf-life and preparation time and expense.

Therefore the investigators modified an available for purchase cricothyroidotomy trainer (the AirSim Combo X) with everyday suitable and cost-effective utensils.

As a control group the investigators used a conventional simple plastic model.

Obesity is an important risk factor for a cannot intubate cannot ventilate situation. Obese patients are more likely to require a cricothyroidotomy, due to failure rates of routine airway management. Relevant landmarks can be difficult to palpate. And the greater depth of the soft tissues overlying the larynx. Due to this reasons the investigators modified the adult intubation manikin AirSim Combo X with a drunk baby diaper to simulate the neck of an obese patient.

As a further modification the investigators prepared freezer bags filled with faked blood to simulate a possible bleeding.

35 medial doctors of the department of anesthesiology and 35 paramedics are going to perform two cricothyroidotomies in each model.

For the one time participants use the ScalpelCric Set and for the other time participants use the ScalpelCric Set plus a speculum.

Primary endpoint is the evaluation of reality of the two different manikins.

Eligibility Criteria:
Inclusion Criteria:

* written informed consent
* german language in speaking and writing
* capability of giving consent

Exclusion Criteria:

* participants unwilling or unable to give informed consent
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Atrosimab (ATM001) in Healthy Volunteers

This is a double-blind, parallel group and placebo-controlled clinical study to assess safety tolerability, pharmacokinetics and pharmacodynamics of Atrosimab in healthy volunteers


Eligibility Criteria:
Inclusion Criteria:

* healthy male subjects
* body mass index 18-32 kg/m2
* normal physical examination, clinical laboratory values and ECG
* additional inclusion criteria apply

Exclusion Criteria:

* febrile or infectious illness at least 7 days prior to the first administration
* any active physical disease, acute or chronic
* history of alcohol or drug abuse
* history of chronic or recurrent metabolic, renal, hepatic, pulmonary, gastrointestinal, neurological, endocrinological, immunological, psychiatric, or cardio-vascular disease, myopathies and bleeding tendency
* additional exclusion criteria apply
Stepwise Shock Wave Lithotripsy in Pediatric Urolithiasis

To evaluate and compare the results of conventional and stepwise shock wave lithotripsy treatment modalities in pediatric urinary lithiasis.

Between March 2008 and February 2012, 81 patients were randomized and included in this study. Shock wave lithotripsy was performed by using a Dornier Compact Delta instrument. Localizations of radiopaque and non-opaque stones were estimated by using flouroscopy and ultrasonography, respectively. Treatment energy was set on 13 kV in the conventional group. In the stepwise group, treatment energy was initially set on 10 kV and gradually increased up to 13 kV per 250 shocks. The maximum numbers of shocks in both groups were limited to 3000. Patients were followed up with 15 days interval. In each visit, patients were respectively questioned for pain, hematuria and history of stone passage. In case of treatment failure, shock wave lithotripsy was repeated.

Eligibility Criteria:
Inclusion Criteria:

The patients with pediatric urinary lithiasis.

Exclusion Criteria:

Resistant urinary tract infections Coagulopathies Anatomically obstructed urinary system