cyrilzakka/clinical-trials huggingface dataset:
SSRIs and TDCS Enhance Post-stroke Motor Recovery

Post-stroke motor recovery is compelling but limited. Current rehabilitation has less impacts on the plateau that spontaneous biological recovery could be expected. The advances in non-invasive neuromodulation and neurophysiological characterization of critical motor recovery period enable breaking the proportional recovery limitation. Our pilot studies demonstrated the safety and responsiveness of combing dual transcranial direct current stimulation (tDCS) and motor training in subacute stroke patients. There is also strong evidence that selective serotonin reuptake inhibitors (SSRIs) can substantially increase the effects of tDCS and improve motor function after stroke, even in the absence of depression. This proposal aims to prove the potential of combining of tDCS and the commonly used SSRI citalopram to improve response to a daily motor training intervention in acute stroke patients (Co-STARS trial).

This is a randomized, double-blind, sham-controlled study in 80 patients with first-ever, unilateral, subcortical ischemic stroke 0.5-4 weeks after stroke onset with moderate to severe hemiparesis. Participants were randomized into four groups underwent either real dual tDCS \[ipsilesional primary motor cortex (M1) anodal stimulation and contralesional M1 cathodal stimulation; 2 mA for 20 mins; 10 sessions within 2 weeks\] with citalopram or placebo, or sham stimulation with citalopram or placebo. All will receive concurrent hospitalized intensive rehabilitation of 2 daily sessions of 90-minute physiotherapy. Action reach am test (ARAT), Fugl-Meyer Assessment (FMA), multimodality MRI and EEG will be measured at baseline and after 2 weeks' tDCS modulation. The primary outcome is the ARAT at 3 months after intervention. The combination of tDCS and a SSRI will be expected to improve response to motor training more effectively than either intervention alone. The enhanced responsiveness will be correlated or predicted by biomarkers from multimodality MRI or EEG.

Eligibility Criteria:
Inclusion Criteria:

* aged 20-80;
* first-onset stroke
* brain image confirmed unilateral subcortical infarction
* moderate to severe upper-limb impairment (SAFE score \<8).
* 3 days to 4 weeks after stroke onset
* stable medical condition

Exclusion Criteria:

* metal implants, such as electrodes or pacemaker
* epilepsy history or active spikes from EEG recording
* major depression or taking psychoactive drugs
* alcoholism or drug abuse history
* combined with other severe neurological or psychiatric diagnoses
* pregnancy or breastfeeding;
* other contraindications to brain MRI, such as severe claustrophobia
* intolerance to electrical stimulation
Diaphragmatic Function as a Biomarker

Dyspnea is among the most common symptoms in patients with respiratory diseases such as Asthma, chronic obstructive pulmonary disease (COPD), Fibrosis, and Pulmonary Hypertension. However, the pathophysiology and underlying mechanisms of dyspnea in patients with respiratory diseases are still poorly understood. Diaphragm dysfunction might be highly prevalent in patients with dyspnea and respiratory diseases. The association of diaphragm function and potential prognostic significance in patients with respiratory diseases has not yet been investigated.

The aim of the present project is to comprehensively measure respiratory muscle function and strength in patients with respiratory diseases. The investigators attempt to recruit 800 patients across four disease groups (Asthma, COPD, Fibrosis, and Pulmonary Hypertension) and the investigators intend to measure diaphragm and accessory respiratory muscle function and strength, lung function, and exercise tolerance, as well as the participants' symptom burden during one day at baseline in the investigators' lab. Thereafter, the investigators will follow up on patients by phone 3 months, 6 months, 12 months and 18 months after the investigators have seen them in the investigators' lab. Based on these results, not only the association between dyspnea exercise tolerance and diaphragm function in patients with respiratory diseases can be assessed, but also the prognostic significance of diaphragm dysfunction in these patients can be determined. As such, hospitalization and exacerbation requiring the intake of steroids will be assessed and followed up on by phone, and therefore the prognostic significance of diaphragm dysfunction in predicting hospitalization and the intake of steroids can be determined.

Eligibility Criteria:
Inclusion Criteria:

* patient has one of the following lung diseases: COPD, bronchial asthma, pulmonary fibrosis, pulmonary hypertension
* is 18 years or older
* is mentally and physically able to understand the study and to follow instructions
* are legally competent
* signed declaration of consent

Exclusion Criteria:

* BMI \> 35
* current or treatments or diseases in the past which could influence the evaluation of the study
* Expected lack of willingness to actively participate in study-related measures
* alcohol or drug abuse
* disc herniation/prolapse
* epilepsy
* wheelchair bound
* in custody due to an official or court order
* in a dependent relationship or employment relationship with investigating physician or one of their deputy
* emergency inpatient hospital stay within 4 weeks before study-specific examinations
Keravive by Hydrafacial for Scalp Health and Enhanced Hair Quality

The study aims to assess the efficacy and safety of Keravive by Hydrafacial treatments and Keravive Peptide Spray for scalp health and enhancing hair quality in patients with androgenic alopecia. This study is intended to be a single arm study. Suitable subjects who meet all inclusion criteria and consented will undergo 3 in-office Keravive by Hydrafacial treatments at Day 0 and Weeks 4 and 8 in combination with daily application on Keravive Peptide Spray at home.

Subjects will be assessed at Day 0, and Weeks 4, 8, and 20 by investigators using the Norwood Scale (males), Ludwig Classification (females), and a series of Likert scales for ranking improvement in scalp health and hair quality.

This study is intended to be a single arm study. Suitable subjects who meet all inclusion criteria and consented will undergo 3 in-office Keravive by Hydrafacial treatments at baseline and Weeks 4 and 8 in combination with daily application on Keravive Peptide Spray at home.

Subjects will be assessed at baseline, and Weeks 4, 8, and 20 by investigators using the Norwood Scale (males), Ludwig Classification (females), and a series of Likert scales for ranking improvement in scalp health and hair quality.

Efficacy will be assessed through a series of dynamic and static questionnaires. Investigators will complete static questionnaires at Day 0 and Weeks 4, 8 and 20 rating the subjects' hair appearance, thinning, and temporal line recession using Likert scales. Subjects will complete dynamic questionnaires at Weeks 4, 8 and 20 to compare their current state to their baseline condition for scalp symptoms (itchiness, dryness, and flakiness) and hair quality (overall health, fullness, evenness, pigment, hair growth, and hair loss) using Likert scales. Subjects will also rank their hair appearance at Day 0, Week 4, 8, and 20. Photography will be performed at each study visit. Safety assessments will include investigator- and subject-reported adverse events (AEs) during the study.

Eligibility Criteria:
Inclusion Criteria:

* Norwood Scale score of 2, 3 or 3 Vertex (males) and Ludwig Classification of Type I-1, I-2 or I-3 (females).

Exclusion Criteria:

* Non-study hair loss treatments (e.g., dutasteride, finasteride, minoxidil, nutraceuticals, PRP therapy, laser or LED scalp treatments, etc.)
* Salon treatments such as straightening, perms or coloring.
Early and Late Removal of the Urinary Catheter After Rectum Resection

It was aimed to investigate the need for urinary retention and recatheterization in the postoperative period by removing the urinary catheter in patients undergoing low anterior resection, in the early or late period.

Urinary catheter is placed before abdominal surgery to increase visualization during the operation, prevent bladder injury and provide perioperative urine output monitoring. It is especially useful in patients who will undergo low anterior resection, with a high risk of nerve damage and consequent urinary retention and bladder dysfunction. Urinary catheter removal time differs between operations. Traditionally, the urinary catheter is kept in place for 7 days because urinary retention occurs in some patients whose urinary catheter is displaced in the early period. As the urinary catheter retention time increases, the risk of urinary tract infection also increases.

According to the current ERAS protocol, it is recommended to remove the urinary catheter 48 hours after the surgery in patients who have undergone colorectal surgery and are treated with epidural pain management. However, the ERAS protocol is not specific to patients who have undergone low anterior resection, which is the main point of our study and includes all patients who have undergone colorectal surgery. Most authors still believe that prolonged retention of the urinary catheter will prevent urinary retention and long-term bladder dysfunction. In a randomized controlled study (published in 1999) that we encountered during our own literature search, early removal of the urinary catheter was associated with increased urinary retention \[2\]. In recent studies, some authors have associated the early removal of the urinary catheter with increased urinary retention \[3\], while others claimed the opposite and reported contradictory results \[4\]. Advances in laparoscopic techniques have made it possible to visualize the hypogastric and pelvic nerves (nerves associated with urinary functions) during surgery. In addition to these developments, dissections on embryonic planes and tumor reduction with neoadjuvant chemotherapy protect these nerves during surgery.

Eligibility Criteria:
Inclusion Criteria:

* Patients who will undergo Low Anterior Resection due to rectal cancer in the Department of General Surgery of our university.
* Competent to consent to participate in trial
* Elective surgery
* ASA classification of 1\~3

Exclusion Criteria:

* Patients whose post-treatment status cannot be obtained.

  * Having Bladder surgery before
  * Having a previous prostate surgery.
  * Patient's refusal to participate in the study.
Effectiveness of a French Automated Web-based Smoking Cessation Program

The purpose of this study is to investigate the effectiveness of a French fully automated web-based smoking cessation program known as the "coaching", by comparing it to an online self-help guide.


Eligibility Criteria:
Inclusion Criteria:

* Aged 18 and older
* Smoker
* Willing to quit smoking in the next two weeks
* Having a regular access to Internet
* Having a personal e-mail address
* Not having benefited from the "coaching" the investigators want to assess yet

Exclusion Criteria:

* No personal e-mail address
* Not able to give the informed consent
Clinical Trial to Evaluate Safety and Efficacy of CCX168 in ANCA-Associated Vasculitis

The aim of this trial is to test the safety and efficacy of two dose regimens of the complement C5a receptor CCX168 in patients with anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis (AAV).

Funding Source - FDA OOPD

Complement 5a and its receptor C5aR (CD88) is involved in the pathogenesis of anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis. This is a randomized, double-blind, placebo-controlled Phase 2 study to evaluate the safety and efficacy of the C5aR inhibitor CCX168 in subjects with ANCA-associated vasculitis. The aim of this trial is to test the safety and efficacy of two dose regimens of the complement C5a receptor CCX168 in patients with anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis (AAV).

Study acquired by Amgen and all disclosures were done by previous sponsor ChemoCentryx.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of granulomatosis with polyangiitis (Wegener's), microscopic polyangiitis or renal limited vasculitis
* Male and female subjects, aged at least 18 years, with new or relapsed AAV where treatment with cyclophosphamide or rituximab would be required
* Use of adequate contraception during, and for at least the three months after, any administration of study medication is required
* Positive indirect immunofluorescence (IIF) test for P-ANCA or C-ANCA, or positive ELISA test for anti-proteinase-3 (PR3) or anti-myeloperoxidase (MPO) at screening
* Have at least one "major" item, or at least 3 other items, or at least 2 renal items on the Birmingham Vasculitis Activity Score (BVAS) version 3
* Estimated glomerular filtration rate (eGFR) ≥ 20 mL per minute

Exclusion Criteria:

* Severe disease as determined by rapidly progressive glomerulonephritis, alveolar hemorrhage, hemoptysis, rapid-onset mononeuritis multiplex or central nervous system involvement
* Any other multi-system autoimmune disease
* Medical history of coagulopathy or bleeding disorder
* Received cyclophosphamide within 12 weeks prior to screening; if on azathioprine, mycophenolate mofetil, or methotrexate at the time of screening, these drugs must be withdrawn prior to receiving the cyclophosphamide or rituximab dose on Day 1
* Received intravenous corticosteroids, \>3000 mg methylprednisolone equivalent, within 12 weeks prior to screening
* Received an oral daily dose of a corticosteroid of more than 10 mg prednisone-equivalent for more than 6 weeks continuously prior to the screening visit
* Received rituximab or other B-cell antibody within 52 weeks of screening or 26 weeks provided B cell reconstitution has occurred; received anti-tumor necrosis factor (TNF) treatment, abatacept, alemtuzumab, intravenous immunoglobulin (IVIg), belimumab, tocilizumab, or plasma exchange within 12 weeks prior to screening
A Study of LY2605541 in Healthy Participants

This study looks at the amount of LY2605541 in the body after it is injected under the skin. The study has 3 periods, each lasting 10 days. Each participant will receive one injection in each period. At least 14 days will pass between each injection.


Eligibility Criteria:
Inclusion Criteria:

* Are overtly healthy males or females, as determined by medical history and physical examination
* A body mass index of 18.5 to 30 kilograms per meter square (kg/m\^2)

Exclusion Criteria:

* Have a history or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; of constituting a risk when taking the study medication; or of interfering with the interpretation of data
* Are women with a positive pregnancy test or are women who are lactating
* Intend to use over-the-counter medication within 7 days prior to dosing or prescription medication within 14 days prior to dosing (apart from contraceptive medication, vitamin/mineral supplements, occasional acetaminophen, and/or hormone replacement therapy)
* Have donated blood of more than 500 milliliters (mL) within the last month
* Have an average weekly alcohol intake that exceeds 21 units per week (for males) and 14 units per week (for females)
* Are excessive consumers of xanthines (more than 10 cups of tea, coffee, cola, or hot chocolate per day)
* Have a fasting blood glucose (BG) \>110 milligrams per deciliter (mg/dL) (6.1 millimoles per liter \[mmol/L\])
* Currently smoke more than 10 cigarettes per day, or are unwilling to refrain from smoking for 72 hours prior to each dosing occasion and during confinement
Andecaliximab With mFOLFOX6 as First Line Treatment for Advanced Gastric or Gastroesophageal Junction Adenocarcinoma

The primary objective of this study is to compare the efficacy of andecaliximab (GS-5745) versus placebo in combination with modified fluorouracil (5-FU), leucovorin (LV), and oxaliplatin (OXA) (mFOLFOX6) as measured by overall survival.


Eligibility Criteria:
Key Inclusion Criteria:

* Adults with histologically confirmed adenocarcinoma of the stomach or gastroesophageal junction that is inoperable, locally advanced or metastatic and not amenable to curative therapy
* Adequate hematologic, liver, coagulation and kidney function
* Eastern Cooperative Oncology Group (ECOG) ≤ 1
* Evaluable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v 1.1

Key Exclusion Criteria:

* Previous chemotherapy for locally advanced or metastatic gastric cancer.
* Human Epidermal Growth Factor Receptor 2 (HER2)-positive gastric cancer
* HIV, hepatitis B virus (HBV), or hepatitis C virus (HCV) infection
* Pregnant or breast feeding women
* Individuals with known or suspected central nervous system metastases or individuals requiring chronic daily treatment with oral corticosteroids
* Grade ≥ 2 peripheral neuropathy

Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Effects of Playing Video Games on Energy Balance

The aim of this study is to examine the effects of playing video games on various components of energy balance and substrate metabolism as well as on glucose homeostasis and relevant hormonal systems that might be involved in the underlying mechanisms.


Eligibility Criteria:
Inclusion Criteria:

* Male adolescents between 15 and 19 years of age
* Normal weight (5th percentile to less than the 85th percentile)

Exclusion Criteria:

* Smoking
* Unstable body weight (±4 kg) during the 6 months preceding testing
* Regular physical exercise (\>3 hours/week)
* Excessive intake of alcohol (\>7 drinks/week)
* Substance abuse
* Metabolic disease (e.g. thyroid disease, heart disease, diabetes, etc.)
* Medication that could interfere with the outcome variables
* Eating disorder
* High restraint eating behavior (score ≥8 for cognitive dietary restraint in the Three-Factor Eating Questionnaire)
* Irregular eating schedule (e.g. skipping breakfast)
* Unfamiliar with the use of video games
* Unable to comply with the protocol
Serum Ferritin Concentration in Kenyan Women and Their Preschool Children At Which the Body Begins to Upregulate Iron Absorption from the Diet

Using standardized methods, the investigators will perform stable iron isotope absorption studies in young Kenyan women and their preschool children (2-5y of age) with varying iron status to measure iron absorption from maize meal containing labeled ferrous sulfate. Using these data, this study aim is to define the ferritin in these young women and children at which the body senses iron depletion and begins to upregulate iron absorption from the diet; this approach could provide a functionally defined threshold of iron deficiency in Sub-Saharan African women and children.

In this experimental study in southern Kenya, the investigators will take a baseline venous blood sample to measure iron and inflammation biomarkers in generally healthy young women (n=125) and in their preschool children. The investigators will then administer, after an overnight fast, a standardized test meal porridge made from refined maize and bottled water containing the stable iron isotope 57Fe. Fourteen days later, the investigators will take a second venous blood sample for determination of erythrocyte incorporation of the 57Fe to measure iron absorption from the labeled test meal.

Eligibility Criteria:
Inclusion Criteria:

* \< 75 kg
* BMI between 17 - 27.5 kg/m2
* No acute illness (self-reported)
* No metabolic or gastrointestinal disorders (self-reported)
* No use of medication affecting iron absorption or metabolism during the study
* No intake of mineral/vitamin supplements 2 weeks prior to the first study visit and during study
* Mother of a preschool age child (2-5 years)
* Child has normal Z-scores for WAZ, HAZ and WHZ (-3 - +3)
Study of Lumateperone in the Acute Treatment of Patients With Bipolar Mania

This is a multicenter, randomized, double-blind, placebo-controlled, study in the acute treatment of patients with a diagnosis of bipolar I disorder with manic episodes or manic episodes with mixed features (bipolar mania), with or without psychotic symptoms, according to criteria of the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM 5).

The study will be conducted in 3 phases:

* Screening Period (up to 1 week) during which patient eligibility will be assessed.
* Double-blind Treatment Period (3 weeks) during which all eligible patients will be randomized to receive lumateperone 42 mg or placebo in 1:1 ratio.
* Safety Follow-up Period (1 week) during which all patients will return to the clinic for a safety follow-up visit

Eligibility Criteria:
Inclusion Criteria:

1. Able to provide written informed consent before the initiation of any study specific procedures;
2. Male or female inpatient, between the ages of 18 and 75 years, inclusive;
3. Meets the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM 5) criteria for bipolar I disorder with a current episode of mania or mania with mixed features with or without psychotic symptoms, as confirmed by a trained and Sponsor-approved rater using the modified Structured Clinical Interview for DSM-5, Clinical Trials Version (SCID-5-CT);
4. YMRS total score ≥ 20 and a score of at least 4 on two of the following YMRS items: irritability, speech, content, and disruptive/aggressive behavior at Screening and Baseline;
5. Hospitalized voluntarily before Screening or admitted to inpatient unit at Visit 1 with a primary diagnosis of mania but not \> 14 days before Screening. Hospital admission must be a result of the current manic episode.

Exclusion Criteria:

1. Has a current primary DSM 5 psychiatric diagnosis other than bipolar disorder. These include:

   1. Schizophrenia, schizoaffective disorder, or other psychotic disorders;
   2. Dementia or other cognitive disorders;
   3. Intellectual disability;
   4. Moderate or severe substance use disorder (excluding for nicotine);
2. Experiencing first manic episode;
3. In the opinion of the Investigator, the patient has a significant risk for suicidal behavior during the course of his/her participation in the study or

   1. At Screening, the patient scores "yes" on Items 4 or 5 in the Suicidal Ideation section of the Columbia-Suicide Severity Rating Scale (C-SSRS) within 6 months prior to Screening; or
   2. At Screening, the patient has had 1 or more suicidal attempts within 2 years prior to Screening; or
   3. At Baseline, the patient scores "yes" on Items 4 or 5 in the Suicidal Ideation section of the C-SSRS since the Screening Visit; or
   4. At Screening or Baseline, scores ≥ 4 on Item 10 (suicidal thoughts) on the rater administered Montgomery-Åsberg Depression Rating Scale (MADRS); or
   5. Considered to be an imminent danger to himself/herself or others.
Biomarker Analysis in Post-COVID Patients

Headache is one of the most common neurological manifestations of COVID-19. However, it is unclear whether chronic headache after the initial diagnosis, is associated with ongoing damage of the central nervous system. We investigate cpost-COVID-19 patients with persistent headache lasting longer than 3 weeks, to hospitalized acute COVID-19 patients with neurological symptoms and to other non-COVID-19 disease-controls. Readout are neurologial and glial biomarkers in CSF.

Measurements of neuronal and glial markers in CSF were performed on a SIMOA analyzer (Quanterix) using the Neurology 4-Plex A (Nf-L, Tau, GFAP, UCH-L1) kit.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of COVID, Parkinson's disease, primary headache, Multiples Sclerosis, facial paralysis
* Persistent post-COVID-19 headache after 3 months of infection
* Post COVID-patients without persistent headache
* must be able to perform lumbar puncture

Exclusion criteria

* unknown history of COVID infection
* lumbar puncture not possible