cyrilzakka/clinical-trials huggingface dataset:
Study of Oral Atogepant Tablets to Assess Safety and Efficacy in Adult Participants With Migraine

A migraine attack is a moderate or severe headache that usually occurs on one side of the head and is often accompanied by throbbing, sensitivity to light, sensitivity to sound, nausea, or other symptoms. The main goal of the study is to see if atogepant is effective, safe, and well-tolerated in treating migraine attacks quickly.

Atogepant is a medicine currently approved for the preventive treatment of migraine in adults and has been shown to be effective and well tolerated when taken daily to prevent migraine attacks. This study includes double-blind phase means that neither the participants nor the study doctors know who is given which study treatment (atogepant or placebo) followed by an open-label phase meaning that both participants and study doctors know which study treatment is given. All participants will receive atogepant during the open-label part of the study. This study will include 1300 participants aged 18-75 years with a history of migraine at approximately 160 sites across the world.

All participants will receive both atogepant and placebo to treat qualifying migraines. At the start of the study, participants will be randomized to 1 of 4 dosing sequences to determine when they will receive atogepant and when they will receive placebo during the study. After treating 4 qualifying migraine attacks, participants will receive open-label atogepant for any additional migraine attacks they have until the end of the study (Week 24).

There may be a bigger responsibility for participants in this study than there would be in participants receiving standard of care treatment. participants will attend regular visits during the study at a hospital or clinic, as well as telephone visits, and the effects of treatment will be checked by completion of questionnaires in an electronic diary, medical assessments, blood tests, and checking for side effects.


Eligibility Criteria:
Inclusion Criteria:

* History of migraine (with or without aura) according to the International Classification of Headache Disorders 3rd Edition (ICHD-3) for \>= 12 months prior to Visit 1/Screening.
* History of 2 to 8 migraine attacks of moderate to severe headache pain in each of the 3 months prior to Visit 1/Screening per investigator judgment.
* Migraine onset before the age of 50.
* History of migraines lasting between 4 and 72 hours when untreated or treated unsuccessfully and migraine episodes separated by at least 48 hours of headache pain freedom.

Exclusion Criteria:

* History of an average of 15 or more headache days per month in the 6 months prior to Visit 1/Screening per the investigator's judgment, or a current diagnosis of chronic migraine as defined by ICHD-3.
* Require hospital/emergency room treatment for migraine attacks on 3 or more occasions within 6 months prior to Visit 1/Screening.
Fecal Microbiota Transplantation in Patients With Multiple Drug Resistant Klebsiella Pneumoniae Pneumonia

Multidrug-resistant Klebsiella pneumoniae (MDR-KP) infections account for 10% of all nosocomial infections, and even with effective antibiotics, the mortality rate is as high as 50%. Intestinal bacteria transplantation can not only treat intestinal diseases, but also inhibit the colonization and proliferation of drug-resistant bacteria. This study explored the therapeutic value of fecal microbiota transplantation in patients with MDR-KP pneumonia.

Intervention study (controlled clinical study) : patients with multidrug-resistant Klebsiella pneumoniae pneumonia were randomly assigned to the experimental group (conventional antibiotic treatment + fecal microbiota transplantation) and the control group (conventional antibiotic treatment); The clinical symptoms, inflammatory indexes, immune indexes, intestinal microecology, respiratory microecology and antibiotic resistance gene changes were compared between the two groups.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-75;
* Meet the diagnostic criteria for community-acquired pneumonia or hospital-acquired pneumonia;
* The etiological results of sputum or alveolar lavage fluid suggested MDR-KP infection;
* The patient or his family members voluntarily participated, collected alveolar lavage fluid and stool samples, agreed to perform FMT treatment, and signed the informed consent.

Exclusion Criteria:

* Subjects with persistent bronchial asthma, severe pulmonary dysfunction, or inability to tolerate bronchoscopy;
* Patients with severe damage of intestinal barrier such as sepsis and digestive tract perforation due to various reasons;
* Those currently diagnosed with explosive colitis or toxic megacolon have gastroesophageal reflux disease or peptic ulcer; Subjects taking probiotics within 6 months;
* Enteral nutrition patients who could not tolerate 50% of heat calorie requirements due to severe diarrhea, significant fibrous intestinal stenosis, severe gastrointestinal bleeding, high-flow intestinal fistula and other reasons.
* Patients with obvious bleeding tendency, severe pulmonary hypertension, superior vena cava obstruction, and aortic aneurysm rupture risk;
* Patients with malignant hypertension, recent myocardial infarction (≤6 months), severe arrhythmia, and cardiac insufficiency;
* suffering from malignant tumor diseases, congenital or acquired immune deficiency diseases, other systemic inflammatory response diseases;
* Those who have recently been treated with high-risk immunosuppressive/cytotoxic drugs, such as rituximab, doxorubicin, or steroid hormones (20mg/d ponisone or higher) for more than 4 weeks;
* Severe immunosuppression: adult neutrophils \<1 500/mm3, child neutrophils \<1 000/mm3;
* Pregnancy or lactation;
* There is a mental disability or active mental illness that prevents informed consent;
* Conditions deemed unsuitable for study inclusion by other clinicians.
Deep Brain Stimulation Recovery in Treatment-Resistant Schizophrenia

The purpose of this project is to improve the clinical response and personal recovery of patients with treatment-resistant schizophrenia (TRS).

The Project aims to improve the efficacy of the first worldwide study of Deep Brain Stimulation (DBS) carried out in our hospital -PI12 / 00042: Deep Brain Stimulation in the treatment of refractory schizophrenia- through the implementation of a white matter tractography approach, which have demonstrated to improve efficacy in other DBS studies .

Moreover, and in line with the National Strategy of Mental Health of the National Health System, this project aims to promote integrated and comprehensive care for patients with mental illness by multidisciplinary teams which includes family care, as we consider it is important to add to the DBS treatment program, a psychological intervention module based on the recovery model. Therefore, the main objectives of the present project are:

i) to optimizethe efficacy and tolerability of DBS in TRS;

ii) investigate whether the REFOCUS intervention improves the recovery of patients who are being treated with DBS. To this end, a double-blind, randomized, crossover clinical trial of DBS will be performed for 6 patients with TRS. Patients will be randomized to receive tractography-based target guidance DBS in the anterior cingulate cortex (ACC) or the nucleus accumbens (Nac). The 21 patient previously intervened with DBS (Affective disorders and TRS) and the ones included in this project, will enter into a psychological intervention phase, based on the REFOCUS model

Eligibility Criteria:
Inclusion Criteria:

* Individuals aged 18-50 years
* Meet DSM-5 criteria for schizophrenia, with a duration of illness \< than 15 years.
* Meet updated TRS criteria.
* Non-sustained response to electroconvulsive therapy.

Exclusion Criteria:

* Contraindications to neurosurgery or DBS
* Epilepsy or seizures clozapine-induced
* Suicidal or self-harming behaviour in the last 6 months
* Other psychiatric disorders (including personality disorders)
* Significant cognitive impairment (Vocabulary test WAIS IV-TR, IQ \<70, and SCIP\<55)
* Severe medical non-controlled diseases
* Pregnancy or breastfeeding
* Substance use disorders (except nicotine)
Promoting Adherence to Treatment in Schizophrenia

The project evaluates a culturally adapted, family-based intervention designed to promote treatment adherence among Mexican-Americans with schizophrenia using a randomized, controlled design in a public mental health setting. Mexican-American patients with schizophrenia and their families were randomly assigned to either: 1) one year of multi- family groups that emphasize the importance of attitudes towards adherence, subjective norms, and self-perceived and actual adherence skills in maintaining adherence, added to ongoing customary outpatient care; 2) standard multi-family groups without an emphasis on medication adherence, added to customary outpatient care; or 3) customary outpatient care only (monthly pharmacotherapy sessions and additional services as clinically needed). The study hypotheses are that subjects assigned to the adapted multi-family group would have better medication adherence, less psychiatric symptoms and fewer psychiatric hospitalizations throughout the course of the study (one year of treatment and one year of follow up) compared to the comparison conditions.

As above

Eligibility Criteria:
Inclusion Criteria:

* DSM-IV diagnosis of schizophrenia or schizoaffective disorder;
* Between 18 and 50 years of age;
* Of Mexican origin and speaks Spanish fluently;
* Was without antipsychotic medication without medical authorization for one continuous week in the month prior to hospitalization;
* Was living with his/her family of origin immediately preceding the inpatient stay and would return to live with his/her family after discharge; and
* The patient and at least one family member were willing to participate.

Exclusion Criteria:

* Patient on conservatorship or legal guardian status
Effects of Global Postural Re-education Versus Laser-guided Exercise in Non-specific Chronic Low Back Pain

Effects of Global Postural Re-education Versus Laser-guided Supervised Exercise in Individuals With Non-specific Chronic Low Back Pain

The objective of this study will be to investigate the effectiveness of GPR or LGE, in addition to PNE and home exercise program. The primary outcomes will be pain intensity, disability, and fingertip to floor test. The secondary outcomes will be pain catastrophizing, kinesiophobia and depression.

Eligibility Criteria:
Inclusion Criteria:

* Aged between 18 and 45 years.
* Diagnosed with NSLBP.
* Experiencing NSCLBP for ≥ 3 months and score at least 3/10 on the Numerical Pain Rating Scale (NPRS).

Exclusion Criteria:

* Diagnosed with a condition that hinders their ability to engage in physical exercise (e.g., uncontrolled diabetes, cardiovascular disease, orthopedic impairments; balancing problems).
* Diagnosed with severe spine conditions (such as fractures, tumors, ankylosing spondylitis, or inflammatory disorders).
* Diagnosed with neurological problems (such as spine nerve problems or cauda equina syndrome)
* Diagnosed with mental illness or severe cognitive impairment that made it impossible to follow the PNE program.
* With a physical condition that made it impossible to complete the PNE program (the timed "up and go" test had to be completed in 10 seconds at a minimum).
* Receiving alternate therapy for related pathologies (myopathies and neurological diseases) that prevented them from completing the PNE program.
ALL Ultrasound Predicts the Success of ACL Repair?

This case series evaluates whether patients with an anterior cruciate ligament (ACL) repair have better outcome if the anterolateral ligament (ALL) was repaired or not considering the ultrasound (US) pre-surgical recommendation.

In this case series, the surgeon will decide which patient will have ACL only or ACL and ALL surgery on the basis on multiple parameters. All patient will undergo detailed pre-clinical evaluation, including an ultrasonographic evaluation of the integrity of the ALL.

Two subgroups will be compared for the primary outcome (International Knee Documentation Committee score at 8 months of follow-up). In subgroup 1, the surgeon will follow the ultrasonographic evaluation of the ALL considering the ALL repair (i.e. : ALL intact on the ultrasound, ACL repair only; ALL broken on ultrasound; ACL and ALL repair). In subgroup 2, the surgeon will not follow the ultrasonographic evaluation of the ALL considering the ALL repair.

Secondary outcomes of interest will be evaluated with multivariate regression analysis.

Sample size calculation:

The chosen parameter of interest for the primary outcome evaluation is a continuous response variable (IKDC score) from two independent subgroups (ultrasonographic evaluation of the ALL followed or not for the surgical repair), considering a ratio of 1:3 between the two subgroups. In a previous study (AJSM Sonnery-Cottet 2017) the response within each subject group was normally distributed with standard deviation 13.1. If the true difference between the group means is the published minimal clinically important difference of 9 (AJSM Nwachukwu 2017), we will need to study 30 experimental subjects and 90 control subjects to be able to reject the null hypothesis that the population means of the experimental and control groups are equal with probability (power) 0.9. The Type I error probability associated with this test of this null hypothesis is 0.05.

Eligibility Criteria:
Inclusion Criteria:

* Patients with an ACL rupture and pre-surgical ultrasound evaluation

Exclusion Criteria:

* Sedentary patient without sports activities
* Prior ACL rupture of the same knee
* Posterior cruciate ligament rupture
Napoleon Measurement of Gastrojejunal Anastomosis

This is a clinical trial assessing the feasibility of the Napoleon device for measuring the gastrojejunal anastomosis (GJA). The study population is Roux-en-Y gastric bypass (RYGB) patients with weight regain undergoing an endoscopy at Bellevue Hospital Center or Brigham and Women's Hospital. investigators aim for a sample size of up to 100 cases. For each case, endoscopists will first visually estimate the diameter of the GJA by comparing its size to the upper endoscope. Then, they will measure the GJA with Napoleon. Investigators will compare the GJA measurements performed using visual estimation and Napoleon. A survey will be given to all endoscopists to assess the level of ease using Napoleon.


Eligibility Criteria:
Inclusion Criteria:

In order to be eligible to participate in this study, an individual must meet all of the following criteria:

1. RYGB patient with weight regain age 18-90
2. Scheduled for an endoscopy
3. Willingness and ability to provide informed consent

Exclusion Criteria:

An individual who meets any of the following criteria will be excluded from participation in this study:

1. History of prior endoscopies with complications
Coagulation Test Changes Associated With Acute Normovolemic Hemodilution in Cardiac Surgery

The researchers are trying to reduce the need for blood transfusions in subjects having surgery that will involve the use of cardiopulmonary bypass. A unit of whole blood will be removed as part of their standard of care prior to going on cardiopulmonary bypass (CPB). This unit is given back to the subject post CPB. This has been shown to reduce the need for blood transfusion in patients.

Subjects will be asked to allow the researchers to take the blood left over from normal standard of care blood draws and do coagulation testing. If clinically indicated, the blood, about 2 units, will be withdrawn from the subject. The researchers will also collect 8 ml (less than two teaspoons) of blood through the catheter that was placed as part of standard of care.

Eligibility Criteria:
Inclusion Criteria:

* Undergoing a cardiac surgical procedure utilizing cardiopulmonary bypass
* Permission to use medical records in research

Exclusion Criteria:

* Unable to grant informed consent or comply with study procedure
* Patient refusal of ANH withdrawal.
* Undergoing emergency open heart-surgery
* CPB time is expected to be \< 30 minutes
* Less than 18 years of age
* Pregnant
Electrophysiological Characteristics and Anatomical Differentiation of Epileptic and Non-epileptic Myoclonus.

This study was conducted on a series of patients with myoclonus to identify the electrophysiological characteristics and the anatomical classification of myoclonus of different causes.

The current study included 50 patients with different types of myoclonus in comparison to 30 control subjects. Electrophysiological study was done for all patients by Somatosensory Evoked Potential (SSEP) and Electroencephalography (EEG) while the control group underwent SSEP. SSEP was studied in the patients and control group by stimulation of right and left median nerves.

Eligibility Criteria:
Inclusion Criteria:

* Myoclonus classified into primary and secondary myoclonus.

Exclusion Criteria:

* Psychiatric comorbidity to exclude psychological myoclonus.
Liposomal-Cisplatin Analogue (L-NDDP) in Treating Patients With Malignant Pleural Mesothelioma

RATIONALE: Patient abstract not available

PURPOSE: Patient abstract not available

OBJECTIVES: I. Determine the antitumor efficacy of a liposomal-cisplatin analogue (L-NDDP) administered into the pleural space in patients with malignant pleural mesothelioma. II. Determine the time to progression and overall survival in this patient population. III. Evaluate the quantitative and qualitative toxicity of intrapleural L-NDDP.

OUTLINE: All patients undergo a thoracoscopy under general anesthesia. The thoracoscope is removed and any collected fluid is drained from the chest cavity. The first treatment with liposomal-cisplatin analogue (L-NDDP) is administered at this time into the intrapleural space over a 10 minute period. Subsequent 10 minute intrapleural infusions of L-NDDP through a percutaneous catheter are administered every 3 weeks. Treatment continues unless unacceptable toxic effects or disease progression occurs. Antitumor activity is assessed 2 months after the second course of therapy, and every 2 months thereafter.

PROJECTED ACCRUAL: A total of 14-30 patients will be accrued for this study within 2.5 years.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Pathologically confirmed malignant pleural mesothelioma Free flowing pleural effusion

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Zubrod 0-2 Life expectancy: At least 12 weeks Hematopoietic: WBC greater than 4,000/mm3 Granulocyte count greater than 1,500/mm3 Platelet count greater than 100,000/mm3 Hepatic: Bilirubin no greater than 1.5 mg/dL SGPT no greater than 1.5 times upper limit of normal Renal: Creatinine no greater than 1.5 mg/dL Cardiovascular: No unstable angina No clinical evidence of congestive heart failure Pulmonary: No postobstructive pneumonia Other: Fertile patients must use effective contraception Not pregnant or nursing No serious concurrent infection No prior malignancies except basal cell or squamous cell skin carcinomas, stage I colon, cervical, breast, prostate, head and neck, or lung cancer, as long as there has been no evidence of tumor occurrence within the past 5 years

PRIOR CONCURRENT THERAPY: Biologic therapy: At least 3 weeks since prior biologic therapy No concurrent immunotherapy Chemotherapy: No prior chemotherapy No concurrent chemotherapy Endocrine therapy: At least 3 weeks since prior hormonal therapy No concurrent hormonal therapy Radiotherapy: No prior chest radiotherapy At least 3 weeks since other prior radiotherapy No concurrent radiotherapy Surgery: Prior pleurodesis or chest surgery on the same side of the effusion is allowed as long as there is a free flowing pleural effusion without loculation At least 2 weeks since major surgery other than biopsy Other: At least 3 weeks since use of any other investigational medication No concurrent use of any other investigational medications
Effectiveness of Mobile Intervention for Breast Feeding Counseling (MIBFc) in Primiparous Mothers

The purpose of this study is to evaluate the effectiveness of mobile intervention for breastfeeding counseling (MIBFc) to improve exclusive breastfeeding duration among primiparous women in Finland.

The investigators hypothesize that the use of mobile intervention for breastfeeding counseling to primiparous women improve the exclusive breastfeeding rates, breastfeeding attitudes, breastfeeding confidence and the satisfaction of breastfeeding counselling. These outcomes are assumed to be higher in the intervention group than in the control group.

Eligibility Criteria:
Inclusion Criteria:

* primiparous women
* 18 years or older
* finnish language
* singleton foetus
* have an intention to breastfeed
* have a smartphone

Exclusion Criteria:

* multiple pregnancy
* risk pregnancy, or other disease to be monitored
Oral Citrulline Supplementation in COPD Patients With Malnutrition

Chronic obstructive pulmonary disease (COPD) is complicated by malnutrition in 20-70% of cases. In COPD, low fat-free mass is associated with a higher risk of morbidity and mortality. L-citrulline is a non-protein amino acid that has a direct effect on muscle protein synthesis. Oral supplementation with L-citrulline (10 g/day) in malnourished patients has shown to increase fat-free mass. The effects of L-citrulline supplementation in malnourished COPD patients are unknown.

The main objective of this prospective, single-centre, randomised, double-blind, placebo-controlled study will be to determine the impact of 45 days of nutritional supplementation with L-citrulline (10 g/day) on lean body mass (fat-free mass index (in kg.m-2) measured by bioelectrical impedance analysis) in malnourished patients (BMI \< 20 kg/m2 if \< 70 years old or \< 22 kg/m2 if ≥ 70 years old) with COPD at stages 3-4 of the GOLD classification.


Eligibility Criteria:
Inclusion Criteria:

* Men and women aged 50 and over
* COPD stage 3 or 4 according to GOLD criteria
* BMI \< 20 kg/m2 if \< 70 years old or \< 22 kg/m2 if ≥ 70 years old
* Suspicion of sarcopenia marked by a score of 4 or more on the SARC-F questionnaire
* Absence of severe COPD exacerbation for at least 3 months

Exclusion Criteria:

* Main respiratory disease other than COPD
* Daily long-term use of systemic corticosteroids (\>6 months per year, whatever the dose)
* Severe and end-stage renal insufficiency (creatinine clearance \<30ml/min)
* Patient with severe hypotension, uncontrolled hypertension (at investigator's discretion)
* Contraindication to L-citrulline intake: VKA and/or cancer chemotherapy
* Osmotic diarrhoea
* Severe and/or uncontrolled progressive pathology likely to be life-threatening
* Psychiatric pathology (schizophrenia, dementia, severe bipolar/psychotic disorders, severe depressive syndrome)
* Pacemaker or other implanted electronic device
An RCT of Trauma Focused-Cognitive Behavioral Therapy With Sexually Exploited, War-affected Girls in the DRC

To date, no RCT has examined the efficacy of Trauma-Focused Cognitive Behavioral Therapy with Sexually Exploited, War Affected Adolescent Girls in the Democratic Republic of Congo. This study seeks to fill this gap by designing, implementing and testing such an intervention using both an intervention and waiting list control group.


Eligibility Criteria:
Inclusion Criteria:

-Suicidal ideation (irrespective of score on any other measure)

Exclusion Criteria:

* psychosis
* mental retardation
* inability to understand Swahili
* one standard deviation below the mean on every measure