cyrilzakka/clinical-trials huggingface dataset:
A Study of Guselkumab Therapy in Participants With Moderately to Severely Active Ulcerative Colitis

The purpose of this study is to evaluate the efficacy, including clinical remission of guselkumab subcutaneous (SC) induction compared to placebo in participants with moderately to severely active ulcerative colitis (UC).


Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent form
* 18 years of age or older
* Documented diagnosis of ulcerative colitis (UC) at least 12 weeks prior to screening
* Moderately to severely active UC as per the modified Mayo score
* Demonstrated inadequate response to or intolerance of conventional therapy and/or advanced therapy as defined in the protocol

Exclusion Criteria:

* Diagnosis of indeterminate colitis, microscopic colitis, ischemic colitis, or Crohn's disease
* Surgery within 8 weeks before screening or planned surgery during the study that may confound the evaluation of benefit from study intervention
* Receiving prohibited medications and treatments
* UC limited to the rectum only
* Active severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) corona virus disease (COVID-19) infection
A Comparison of Medication Augmentation and PST in the Treatment of Depression in Older Adults

The purpose of this study is to compare the effectiveness of two different augmentation strategies of antidepressant treatment for depressed older adults who have not responded to an adequate trial of antidepressant medication. The first augmentation strategy is Problem Solving Therapy (PST), a 12-week psychotherapy treatment that has been shown to be effective in depressed older adults. The second augmentation strategy is medication augmentation, which will begin with six weeks of aripiprazole, an atypical antipsychotic medication that has also been shown to be effective in depressed older adults who have failed a trial of antidepressant medication.

Depression is common in older adults, and antidepressant medication is only effective in about 60% of patients seeking treatment. The purpose of this study is to compare the effectiveness of two different augmentation strategies of antidepressant treatment for depressed older adults who have not responded to an adequate trial of antidepressant medication. The first augmentation strategy is Problem Solving Therapy (PST), a 12-week psychotherapy treatment that has been shown to be effective in depressed older adults. The second augmentation strategy is medication augmentation, which will begin with six weeks of aripiprazole, an atypical antipsychotic medication that has also been shown to be effective in depressed older adults who have failed a trial of antidepressant medication. If patients have not remitted at the end of the 6 week aripiprazole trial, the aripiprazole will be stopped and they will be started on bupropion for the remaining 6 weeks of the study. Both aripiprazole augmentation and bupropion augmentation in depressed older adults have been approved by the FDA. No study has compared the effectiveness of PST and medication augmentation strategies for depressed older adults who are non-responders to an adequate trial of antidepressant medication in the current episode of their depression.

Eligibility Criteria:
Inclusion Criteria:

* Ages 50-90, inclusive
* Current diagnosis of major depressive disorder or dysthymia
* Treatment with either citalopram 30/mg or duloxetine 60 mg/day (6 weeks total, with at least three weeks of treatment at that dose)
* Hamilton Rating Scale for Depression (HRSD) \>= 14
* Willing and able to complete NP testing
* Willing and able to complete medical exam, EKG, blood tests, and urine screen
* Willing and able to give consent

Exclusion Criteria:

* Meets criteria for psychotic depression
* MMSE score \<24
* Bipolar disorder, psychotic disorder, or OCD
* History of alcohol or drug dependence (excluding nicotine) within past six months
* Suicide attempt within past six months or HRSD item 2 score \> 2
* Diagnosis of probable Alzheimer's disease
* Diagnosis of probable vascular dementia
* Acute, severe, or unstable medical illness
* Patients in psychotherapy
* Diagnosis of Parkinson's Disease
* Blood glucose \>200 and/or total cholesterol \>250
Study to Evaluate SC Route of Administration of Ofatumumab in RA Patients

This study will examine the safety and tolerability, PK and PD of subcutaneously administered GSK1841157 in patients with RA on stable dose Methotrexate. The study comprises a single dose escalation/de-escalation phase to investigate the minimal efficacious dose based on PD markers with an acceptable safety profile.


Eligibility Criteria:
Key Inclusion Criteria:

* Male or female aged ≥ 18 years
* A diagnosis of rheumatoid arthritis according to the American College of Rheumatology (ACR1987 classification) of at least six months prior to screening
* Subjects must be treated with MTX, 7.5-25 mg/week, for at least 12 weeks prior to Visit 2, with the last 4 weeks prior to Day 2 at a stable dosage
* Patient must be willing to receive folic acid ≥5mg/wk 4 weeks prior to baseline administered according to locally accepted practice
* Body mass index (BMI) \< 35kg/m2 (inclusive)
* Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form

Key Exclusion Criteria:

* Subjects with a history of a rheumatic autoimmune disease other than RA (except secondary Sjögren's syndrome), or with significant systemic involvement secondary to RA (vasculitis, pulmonary fibrosis or Felty's syndrome)
* Previous exposure to biologic cell depleting anti-rheumatic therapies, including investigational compounds (e.g. anti-CD11a, anti-CD19, anti-CD20, anti-CD22, anti-BLyS/BAFF, anti-CD3, anti-CD4, anti-CD5, anti-CD52)
* Exposure to etanercept \< 4 weeks, infliximab or adalimumab \< 8 weeks, or abatacept or anakinra \< 12 weeks prior to visit 2
* Received any of the following treatments within 4 weeks prior to Visit 2:
* Anti-cancer therapy (e.g. alkylating agents, anti-metabolites, purine analogues, monoclonal antibodies)
* Glucocorticoid unless given in doses equivalent to ≤ 10 mg of prednisolone /day
* Intra-articular, i.m. or IV corticosteroids
* Live/attenuated vaccinations
* Cyclosporine
* Azathioprine
* Penicillamine
* Sulfasalazine
* Bucillamine
* Hydroxychloroquine
* Chloroquine
* Exposure to leflunomide within 12 weeks prior to visit 2 unless the subject has completed peroral cholestyramine treatment
* Exposure to gold therapy ≤ 12 weeks prior to Visit 2
* Exposure to IV immunogammaglobulins ≤ 24 weeks prior to Visit 2
* Past or current malignant melanoma
* Chronic or ongoing active infectious disease requiring systemic treatment such as, but not limited to, renal infection, chest infection with bronchiectasis, tuberculosis and active hepatitis B and C
* History of significant cerebrovascular disease
* Positive plasma / white cell JC Virus (JCV) PCR (either compartment)
Efficacy of a Full-Thickness Placental Allograft in Lumbar Microdiscectomy

To evaluate the efficacy of full thickness placental allograft use in Microdiscectomy application. To evaluate post-microdiscectomy reherniation rate in patients treated with full-thickness placental allografts.

The primary objective is to evaluate the efficacy of full thickness placental allograft use in improving back and leg pain, when applied to patients undergoing lumbar microdiscectomy.

Eligibility Criteria:
Inclusion Criteria:

* Ambulatory with radiating low back and leg pain for greater than 6 months prior to surgery with clinical diagnosis of lumbar protruding disc.
* Consent and compliance with all aspects of the study protocol, methods, providing data during follow-up contact.

Exclusion Criteria:

* Severe hypertension systolic blood pressure (greater than or equal to 200 mm -Hg or diastolic blood pressure greater than or equal to 182 mm Hg)
* BMI greater than 45 kg/m2
* Subject has had major surgery at the index level
* Is an active smoker or stopped smoking in the last 6 months
* Any pain that could interfere with the assessment of index level pain (e.g. pain in any other part of the spine)
* Active rheumatoid arthritis
* Active, local or systemic malignancy such as lung cancer or leukemia
* History of vascular disease or sickle cell anemia
* Use of the following medications:

No significant anticoagulant therapy (e.g. Heparin or Lovenox) during the study (treatment such as Aspirin and Plavix are allowed)

* No systemic treatments that may interfere with safety or efficacy assessments during the study
* No immunosuppressants
* No use of corticosteroids

  * Subject is pregnant or plans to become pregnant within 24 months of treatment
  * Subject does not provide full consent
  * Personal injury, workman's compensation or other legally-related treatment patients.
Evaluation of Safety of Contraloid Acetate in Patients With Mild Cognitive Impairment Due to Alzheimer's Disease

Patients with mild cognitive impairment due to Alzheimer's disease (MCI due to AD) are at high risk to develop Alzheimer´s dementia. The therapeutic agent Contraloid has the potential to influence the chronic neurodegenerative process of AD. As Contraloid was so far only administered to healthy subjects, the rational of the proposed study is first to collect safety data in patients diagnosed with MCI due to AD, as the absorption, distribution, metabolism and excretion processes may be altered by disease, aging, comorbidities and concomitant drug therapies. Additionally, the design of a subsequent phase II study will be based on the data of this study. The results of the exploratory analyses will enable power calculations and the identification of the most useful and reliable biomarkers for the subsequent proof of concept phase II study.


Eligibility Criteria:
Inclusion Criteria:

1. Patients diagnosed with MCI due to AD according to DSM-V
2. Age between 50 and 80 years (male and female)
3. MMSE score 22-30
4. Written informed consent (according AMG §40 (1) 3b)
5. Level of Aβ-oligomers: mind. 1fM
6. CSF according to diagnosis (p-tau \> 62 pg/ml, total CSF Aβ 1-42/1-40 ratio ≤ 0.055)
7. 3 months prior to screening stable medication
8. Females without childbearing potential

Exclusion Criteria:

1. History of seizures
2. History of stroke or TIA
3. Unstable medical, neurological or psychiatric condition
4. Current treatment with one of the following substances:

   * Typical antipsychotic or neuroleptic medication within 6 months of screening
   * Anti-coagulation medications within 3 months of screening
   * Chronic use of opiates or opioids (including long-acting opioid medication) within 3 months of screening
   * Stimulant medications (amphetamine, methylphenidate preparations, or modafinil) within 1 month of screening and throughout the study
   * Chronic use of benzodiazepines, barbiturates, or hypnotics from 3 months before screening
5. Persons who are legally detained in an official institution
6. Persons who may be dependent on the sponsor, the investigator or the trial site
7. Persons without caregiver
8. Participation in other clinical trials according to AMG (1 month before the time of this trial)
9. Persons showing EEG abnormalities
Weight Distribution Asymmetry in Relation to Speed During Gait in Children With Spastic Cerebral Palsy.

Background: Improving walking ability is one of the major concerns in therapeutic interventions for children with cerebral palsy.

Aim: determine the relation between the weight distributed on both lower limb and speed during walking.

sixty children with spastic diplegia (group A) and forty-five with hemiparesis ( group B) with age ranged from ten to twelve, they had spasticity grade 1 and 1+ according to modified ashworth scale and they were able to walk with assistance (level II on Gross Motor Classification System).Evaluation was held by the Biodex gait trainer for measuring weight distribution on both lower limbs and speed during gait to determine if there was a relation between weight distribution asymmetry and the speed of gait of those children

Eligibility Criteria:
Inclusion Criteria:

The selection criteria to the diplegic group were as follows:

1. children diagnosed as spastic diplegia or hemiplegia;
2. the ability to stand independently without support for not less than 30 seconds;
3. the ability to walk independently; a classification of level II in the Gross Motor Function Classification System (GMFCS);
4. and capability to understand simple verbal commands.

Exclusion criteria:

1. Participants were excluded if they were treated for lower limbs orthopedic surgical or with botulinum toxin injection within the last 6 months
2. or if they had fixed lower limb deformity.
Neoadjuvant Radiosurgery for Resectable Brain Metastases: Phase I/II Study

This Phase I/II trial studies the ability to stop brain metastases from coming back after treatment with radiosurgery followed by surgical resection. It will also evaluate the side effects of these combined treatments and help determine the best radiosurgery dose. Radiosurgery focuses the x-rays directly to the tumor and cause less damage to the normal tissue in the brain.

PRIMARY OBJECTIVES:

I. To determine the safety (risk of acute and long-term toxicities) of neoadjuvant radiosurgery at escalating doses followed by surgical resection of brain metastases. (Phase I)

II. To determine the local control of brain metastases treated with neoadjuvant radiosurgery followed by surgical resection. (Phase II)

SECONDARY OBJECTIVES:

I. To determine the rate of distant brain failure when brain metastases are managed with neoadjuvant radiosurgery followed by surgical resection.

II. To estimate the rate of salvage surgery, whole brain radiation therapy (WBRT), or stereotactic radiosurgery (SRS) for participants treated with neoadjuvant radiosurgery followed by surgical resection.

III. To determine the rate of radiation necrosis/steroid dependency. IV. To determine the radiobiologic impact of neoadjuvant radiosurgery for resected brain metastases.

OUTLINE: This is a phase I, dose-escalation study of radiosurgery followed by a phase II study.

The following outcomes were removed from the protocol in an amendment:

* Changes in neurocognitive function as measured by the Hopkins Verbal Learning Test (HVLT), Controlled Oral Word Association (COWA) \& Trailmaking Test B, and Trailmaking Test A
* QOL measured by FACT-BR and EORTC-QLQ30

Eligibility Criteria:
Inclusion Criteria:

* Have a prior histologic diagnosis of cancer other than small cell lung cancer, lymphoma, and germ cell histologies
* Magnetic resonance imaging (MRI) evidence of 1-4 brain metastases, with at least one lesion \> 20 mm and ≤ 50 mm in maximal diameter and determined to be appropriate for SRS and gross total resection; all other brain metastases are appropriate for SRS
* Patient can have prior SRS to lesions other than the one planned for neoadjuvant SRS and resection
* Patient must have a Karnofsky performance score of ≥ 70

Exclusion Criteria:

* Patient deemed medically unfit to undergo surgical resection of brain metastasis
* Prior whole brain radiotherapy
* Patient with contraindication for imaging with MRI
* Inability to participate in study activities due to physical or mental limitations
* Inability or unwillingness to return for all the required follow-up visits
* At the time of planning, unable to deliver 10 Gray (Gy) or less to optic nerve/chiasm
* Tumor located in the brainstem
* Imaging or cytologic evidence of leptomeningeal disease
Remediation of Emotional Deficits in Multiple Sclerosis and Traumatic Brain Injury

This study will examine the efficacy of a clinical intervention for improving emotional processing in individuals with MS and TBI.(1)The main outcome measure will be changes in emotional processing measures from pre to post treatment.

(2)This study will also assess the impact of the emotional processing intervention on changes in pre and post treatment depression and anxiety, as well as fatigue.(3) This study will additionally measure the impact of the emotional processing intervention on cognitive functioning, specifically processing speed, attention and executive abilities. This will be accomplished through the completion of a neuropsychological battery prior to and following the completion of treatment.(4)Finally, the investigators will measure the impact of the intervention on quality of life and social functioning, utilizing a pre and post treatment assessment consisting of measures of self-efficacy, quality of life, functional abilities, and awareness.


Eligibility Criteria:
Inclusion Criteria:

* diagnosis of Multiple Sclerosis or Traumatic Brain Injury
* Fluent in English
* processing speed impairment (based on evaluation)

Exclusion Criteria:

* currently taking steroids and/or benzodiazepines
* prior stroke or neurological diease
* history of significant pyschiatric illness (for example, bipolar disorder, schizophrenia, or psychosis) or a current diagnosis of Major Depressive Disorder, Schizophrenia, Epilepsy, Bipolar Disorder
* significant alcohol or drug abuse history
A Study on the Treatment of Recurrent Clubfoot With the Tendon Release of Musculi Tibialis Posterior

The musculi tibialis posterior can adduct the foot, so releasing the tedon of the muscle can help to correct the deformity of the forefoot adduction.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of recurrent idiopathic clubfoot
* The initial treatment was treated with the ponseti method
* Dynamic supination
* The max-dorsiflexion of angle \<5°
* The fore foot is adduct
* The sole is cavus

Exclusion Criteria:

* Symptomatic recurrent clubfoot
* Tarsal fusion
* Rigid recurrent clubfoot
EEG Objectification in Neuropsychiatry

The main objective of the study is to evaluate the use of EEG in the management and follow-up of neuropsychiatric disorders. Secondary objectives are therefore better understanding of the pathological activations in neural network during neuropsychiatric disorders, their clinical evolution and response to therapies.

Patients are having EEG recordings as a routine part of their clinical evaluation and diagnosis. EEG recording is harmless, has no side effects, any radiation or any mechanical or electrical influence. It is of short duration and may be done in the EEG institute or the patient's room.

Eligibility Criteria:
Inclusion Criteria:

* diagnosis of the investigated neuropsychiatric disease

Exclusion Criteria:

* Other co-existing neuropsychiatric conditions
* Refusal to participate in the study
Metagenome Analysis of Gut Microbiota in CC Patients

Constipation is a heterogeneous and multifactorial disease, influenced by a number of different genetic and environmental factors. By applying the standard two-stage GWAS strategy to design and carry out a metagenome-wide association study (MGWAS) to find the relationship between gut microbiota and constipation, to identify disease-associated metagenomic markers.

This study is a two-stage case-control metagenome-wide association study (MGWAS) based on deep next-generation shotgun sequencing of DNA extracted from the stool samples from a total of 50 Chinese constipation patients and healthy controls.

Eligibility Criteria:
Inclusion Criteria:

1. Chronic constipation according to Rome III criteria;
2. Age ≥ 18 years;
3. BMI: 18.5-25kg/m2;

Exclusion Criteria:

1. Bowel constipation due to innate factor (e.g. megacolon) or secondary interventions (e.g. drugs, endocrine, metabolic, neurologic or psychologic disorders);
2. History or evidence of gastrointestinal diseases (e.g. cancer, inflammatory bowel diseases);
3. Previous abdominal surgery, except cholecystectomy, appendicectomy, tubal ligation and cesarean section;
4. Previous proctological or perianal surgery;
5. Rectal prolapse and/or grade 3-4 internal hemorrhoids according to AGA classification;
6. A constipation condition meeting the Rome III criteria for IBS or functional abdominal pain syndrome;
7. Pregnant or breast-feeding women;
8. Infection with enteric pathogen;
9. Usage of probiotics, prebiotics, antibiotics or PPIs within the last month;
10. Smoking or alcohol addiction within the last 3 months;
11. Uncontrolled hepatic, renal, cardiovascular, respiratory or psychiatric disease;
12. Disease or therapy with drugs (e.g. antidepressants, opioid narcotic analgesics, anticholinergics, calcium antagonists, nitrates, antimuscarinics) that, in the opinion of the investigator, could affect intestinal transit and microbiota.
GASC1 Inhibitor Caffeic Acid for Squamous Esophageal Cell Cancer (ESCC)

Caffeic acid can target inhibit GASC1 (gene amplified in squamous cell carcinoma 1, also known as KDM4C and JMJD2C) expression and GASC1 is confirmed to be a new oncogene in several cancers including esophageal cancer. This study aims to investigate the efficiency and safety of coffeic acid in chinese advanced esophageal squamous cell cancer (ESCC).

Background: More than half of global esophageal cancer cases came from China.80 percentage patients were diagnosed with advanced disease and suffered from the poor outcome.With the development of target therapy among cancers,the overall survival and life quality of patients has been continuous improved recently.However,there had little reports focusing on target therapy in esophageal cancer . Caffeic acid as an ordinary drug is used for thrombocytopenia when patient received chemotherapy. Newly studies shown caffeic acid can target inhibit GASC1 expression, and GASC1 is confirmed to be a new oncogene in esophageal cancer.

Aim: to investigate the efficiency and safety of caffeic acid in chinese advanced esophageal squamous cell cancer.

Methods: 80 advanced ESCC patients who failed to the chemotherapy or chemoradiotherapy (1 or 2 line) will be randomized to two arms: arm A and arm B. In arm A, 40 patients will receive coffeic acid treatment: 100-200mg, tid, po, 2 weeks treated then 1 week black interval(weight \>50kg, 200mg per time, weight \< or =50kg, 100mg per time; in arm B, 40 patients will receive the placebo tablets. 1 years follow-up for all patients in this trial. Patients in both arms can receive any other ways of anti cancer therapy in the same time.

Primary endpoints: OS; Second endpoints: PFS

Eligibility Criteria:
Inclusion Criteria:

1. Chinese
2. esophageal squamous cell cancer
3. stage IV or recurrence disease
4. chemotherapy, or radiotherapy, or palliative care is going on

Exclusion Criteria:

1. PS (performance status): ≥ 3
2. severe hepatic and renal dysfunction
3. hypercoagulability
4. thrombocytosis