cyrilzakka/clinical-trials huggingface dataset:
A Study to Evaluate the Safety and Tolerability of Cendakimab in Chinese Healthy Participants

The purpose of this study is to assess the drug levels, safety, and tolerability of cendakimab in healthy male and female Chinese participants.


Eligibility Criteria:
Inclusion Criteria:

* Participants must be Chinese (both biological parents are ethnically Chinese).
* Body mass index (BMI) of 18.0 through 28.0 kilograms/meter squared (kg/m\^2), inclusive. BMI = weight (kg)/\[height (m)\]\^2.
* Body weight ≥ 50.0 kg.

Exclusion Criteria:

* History of clinically significant infection within 4 weeks of dosing on Day 1.
* Significant medical history/condition, laboratory abnormality, or psychiatric illness that would prevent the participant from participating in the study.
* Condition(s) which may confound the ability to interpret data from the study, as determined by the investigator.

Other protocol-defined inclusion/exclusion criteria apply.
Soleus H-Reflex in Different Sitting Postures

The purpose of this study was to examine the effect of prolonged sitting duration and three different sitting postures (erect, slumped, and slouched sitting postures) on spinal nerve root function by measuring the soleus (SOL) H-reflex amplitude. In addition, the pressure under the ischial tuberosities during the three sitting postures were assessed and correlated with the SOL H-reflex amplitude.

Participants were assigned to two groups (prolonged sitting group and controls) based on their daily sitting duration with 15 participants in each group. The outcome measures were recorded during erect, slumped and slouched sitting postures. The differences between the two groups and the three sitting postures in the outcome measures were examined for statistical significance.

Eligibility Criteria:
Inclusion Criteria:

* Able to read, speak, and understand English

Exclusion Criteria:

1. Current complaint of low back pain.
2. Current injury to the ankle and/or foot.
3. Limited ankle movement.
4. Leg length discrepancy.
5. Scoliosis.
6. History of:

   * Back surgery.
   * Calf muscle injury/surgery.
   * Radicular symptoms.
   * Peripheral neuropathy.
   * Upper motor neuron lesion.
   * Systemic and metabolic diseases.
   * Cancer.
7. Pregnant at the time of the study.
8. Use of pain medications at the time of the study.
Treating Amyotrophic Lateral Sclerosis (ALS) With R(+) Pramipexole Dihydrochloride Monohydrate at 60 mg/Day

R(+) pramipexole dihydrochloride monohydrate \[R(+)PPX\], an experimental neuroprotective drug, is provided in this open label extension study to ALS patients who have participated in earlier clinical protocols.


Eligibility Criteria:
Inclusion Criteria:

* Definite diagnosis of ALS

Exclusion Criteria:

* No prior participation in R(+)PPX clinical studies
Pharmacokinetic and Efficacy of SQV/r 1500/100 Plus Tenofovir/Emtricitabine 300/200 mg

Pharmacokinetic and long term efficacy of TDF SQV film coated tablet 1500/100mg once daily plus TDF/FTC300/200mg once daily.

This study will be performed in patients who were previously treated with SQV /r 1000/100mg twice daily or Lopinavir/r plus TDF/FTC once daily as part of the Gemini study. After 48 weeks of the study, the patients will be treated with SQV film coated tablet 1500/100mg once daily plus TDF/FTC300/200mg once daily with good CD4 and VL outcomes. In this study, we would like to evaluate the once-daily dosing of SQV using SQV- SQV film coated tablet 1500/ritonavir 100mg in combination with TDF/FTC300/200mg once daily. We believe that the PK parameters of SQV given at 1500mg daily will be equivalent to the 1000mg twice daily dosing when combined with RTV and TDF/FTC300/200mg OD, and that the once daily regimen will have better safety, tolerability profile than the twice daily regimen while maintaining good CD4 and VL outcome

Eligibility Criteria:
Inclusion Criteria:

1. written informed consent
2. All adults HIV patients previously included in the Gemini study and are currently enrolled in HIV-NAT 006 and treated with SQV /r 1500/100 mg OD plus tenofovir/emtricitabine (TDF/FTC) 300/200 mg once daily

Exclusion Criteria:

1. Inability to understand the nature and extent of the study and the procedures required.
2. ALT/ AST more than 5x upper limit
3. Relevant history or current condition, illness that might interfere with drug absorption, distribution, metabolism or excretion.
4. Use of concomitant medication that may interfere with the pharmacokinetics of saquinavir, ritonavir, tenofovir or emtricitabine
5. History of sensitivity/idiosyncrasy to the drug or chemically related compounds which may be employed in the study.
6. Active drug abuse
Mortality Reduction in Septic Shock by Plasma Adsorption

The study objective is to clarify whether the application of high doses CPFA (Coupled Plasma-Filtration Adsorption) in addition to the current clinical practice is able to reduce hospital mortality in septic shock patients in intensive care unit (ICU).


Eligibility Criteria:
Inclusion Criteria:

* all patients admitted to the ICU in septic shock
* all patients that develop septic shock while in the ICU

Exclusion Criteria:

* Age less than 18 years
* Pregnancy
* Estimated life expectancy (due to comorbidities) less than 90 days
* Presence of relative or absolute contraindications to CPFA
* Absence of informed consen
Treatment of Bulimia Nervosa in a Primary Care Setting

Bulimia Nervosa is a frequent problem for young women. It is widely assumed that this disorder cannot be treated effectively in a primary care setting. This assumption has never been tested empirically, and is probably incorrect.

In the last 15 years, effective treatment interventions for Bulimia Nervosa have been developed and validated in specialized treatment centers. The broad aim of this proposal is to examine whether these treatments, suitably adapted, can be usefully transferred to general health care settings. Specifically, the proposed study will determine the relative and combined effectiveness of the two leading treatments for Bulimia Nervosa in a primary care setting. The two major interventions are treatment with an antidepressant medication, fluoxetine, and with a form of cognitive behavioral therapy, guided self-help, designed for use in primary care.


Eligibility Criteria:
Inclusion Criteria:

* DSM-IV criteria for bulimia nervosa with a modified frequency criterion of at least once a week

Exclusion Criteria:

* Physical disorder requiring hospitalization or ongoing treatment likely to affect eating and/or weight
* Significant suicidal ideation or behavior
* Subjects judged unable to tolerate four-month treatments available in the study because of comorbid psychiatric conditions
* Current drug or alcohol dependence
* Current anorexia nervosa
* Pregnancy or any physical condition or treatments known to influence eating and weight
* Current psychiatric treatment or medication known to affect eating or weight
* Previous course of fluoxetine at a dose of 60 mg. per day for at least four weeks
* Allergy to fluoxetine
* Previous course of cognitive behavioral therapy for Bulimia Nervosa at a qualified center
Low Dose hCG in the Late Follicular Phase

In this study,the investigators compared two protocols for controlled ovarian hyperstimulation in infertility patients requiring IVF. In the control group, the patient undergoes a standard antagonist protocol. In the study group, the administration of gonadotropins is stopped in the late follicular phase and replaced by low dose human chorionic gonadotropins. The primary endpoint of the study is the number of oocytes retrieved in both groups.


Eligibility Criteria:
Inclusion Criteria:

* \< 36 years on day of randomisation
* FSH \< 12 in the early follicular phase
* Normal ultrasound scan
* BMI between 18 and 29 (both inclusive)
* Randomisation at outpatient clinic

Exclusion Criteria:

* Endometriosis ≥ grade 3
* PCO syndrome
* Poor responder
* Endocrine or metabolic abnormalities
Effects of UP-CAT With and Without Visual Feedback in Children With CP

Cerebral palsy (CP) is the most common neurological disorder of movement and/or posture and of motor function, which are due to a non-progressive interference or abnormality of the developing brain. In hemiplegic cerebral palsy (HCP), one side of the body is involved with the upper extremity more affected than the lower. HCP is treated by addressing the underlying cause and by various form of therapy to recover motor function. Motor function in hemi paretic limb particularly fine motor skill may be improved by upper limb children action-observation therapy (UP-CAT).

This will be randomized controlled trial. Non-probability purposive sampling technique will be used for recruiting samples for study. Children will be assessed by House Functional Classification System for hemiplegia to include in the study. Computerized randomization will be used to locate subjects in two groups, and 28 hemiplegic cerebral palsy children will be divided into 2 groups; experimental and control groups. In experimental group hemiplegic cerebral palsy children will perform upper limb exercises with visual feedback for 5 times a week, 15 sets of daily life upper limb activities, each action will be observed for 2 minutes and executed for 2 minutes. In control group hemiplegic cerebral palsy children will perform upper limb activities for 5 times a week, 15 sets of daily life upper limb activities, each action will be observed for 2 minutes and executed for 2 minutes. Both groups will be assessed at the time of recruitment and at the end of 4 weeks. Data will be collected by Melbourne unilateral upper limb (MUUL) and ABILHAND-kids questionnaire. After collection of data, data will be analyzed by SPSS-25.

Eligibility Criteria:
Inclusion Criteria:

* Cerebral palsy children aged 5 years to 10 years at the time of recruitment.
* Both male and female
* According to Modified Ashworth scale of spasticity; score should be +1.
* Mild or moderate UL disability i.e. active use of affected UL from poor active assist use to complete spontaneous use according to House Functional Classification System grade between 4 and 8.

Exclusion Criteria:

* Individuals with the other neurological deficits
* Visual impairment.
* Children with upper limb disabilities other than hemiplegic cerebral palsy.
* Children with uncontrolled epileptic seizures in last 3 years
* Non co-operative patients.
* Previous orthopedic surgery or botulinum toxin A (BoNT-A) injection in the UL within 6 months prior to the enrolment of this study.
Digital Symptom Tracking, Patient Engagement and Quality of Life in GI Oncology Clinic Patients

A pilot study of an ePRO system in cancer patients receiving systemic therapies.

The primary purpose of this pilot study is to determine the feasibility of the Noona Healthcare Mobile PRO Application to describe oncology patient engagement using a web-based symptom self-monitoring instrument. Additionally, the studyy will dentify side effects as well as long term or chronic adverse events during and following cancer therapy based on the United States (US) National Cancer Institute (NCI) Patient Reported Outcomes Common Terminology Criteria for Adverse Events (PRO-CTCAE), and identify patients to participate in future long-term Quality of Life studies following cancer therapy.

The study is not intended to compare outcomes between groups receiving different therapies.

Eligibility Criteria:
Inclusion Criteria:

1. Individuals (men and women) aged 18 years or older
2. History cancer with no limitation on prior lines of therapy in the metastatic setting
3. ECOG performance status of 0-2
4. Estimated life expectancy of at least 12 months
5. Access to smartphone, tablet or computer with capability to utilize symptom-tracking application
6. Willing and able to provide written, signed informed consent after the nature of the study has been explained, and prior to any research-related procedures
7. Willing and able to comply with all study procedures

Exclusion Criteria:

1. Concurrent disease or condition that interferes with participation or safety
2. Non-English speaking, as the application is developed in the English language
3. Children will not be included in the study. The pattern of disease and symptoms are different in children than in an adult population. The web-based tool was designed based on the symptom experience of adults with cancer.
Temozolomide Phase II Clinical Study in Patients With Newly Diagnosed Glioblastoma Multiforme (Study P04661)(COMPLETED)

The purpose of this study is to evaluate the safety of combination therapy of radiotherapy and temozolomide ("concomitant radiotherapy phase"), and then temozolomide monotherapy ("monotherapy phase"), in patients with newly diagnosed glioblastoma multiforme. Progression free survival and response rate will also be calculated.


Eligibility Criteria:
Inclusion Criteria:

* Histopathologically confirmed newly diagnosed glioblastoma multiforme with WHO grade IV.
* Histological diagnosis must be made locally after biopsy or neurosurgical tumor resection.
* Four or more unstained tissue sections or a paraffin block must be provided to the Pathological Judgment Committee as tissue specimens.
* Initial surgery/biopsy at diagnosis performed \<=6 weeks (42 days) prior to treatment with temozolomide.
* Age: \>=18 and \<=70 years.
* ECOG performance status \<=2.
* Stable, non-increasing dose of corticosteroids over the 14 days prior to treatment with temozolomide.
* No prior chemotherapy or radiotherapy.
* Laboratory test values obtained within 14 days before initiation of administration of temozolomide must satisfy the following criteria:

  * absolute neutrophil count \>= 1500/mm\^3;
  * platelet count \>= 100,000/mm\^3;
  * serum creatinine \<=1.5 times the upper limit of laboratory normal;
  * total bilirubin \<=1.5 times the upper limit of laboratory normal;
  * glutamic oxaloacetic transaminase or glutamic pyruvic transaminase \<2.5 times the upper limit of laboratory normal;
  * alkaline phosphatase \< 2.5 times the upper limit of laboratory normal.
* Absence of pathological conditions that interfere with taking oral drugs.
* Contraception during the study period (from informed consent to the day of the last observation/examination of this study) is required in sexually active, potentially fertile patients, regardless of sex, under the supervision of the investigator or sub-investigator.
* The investigator and/or subinvestigator must judge that life expectancy is 12 weeks or more.
* Patients may be included regardless of sex or inpatient/outpatient.

Exclusion Criteria:

* Extensively disseminated glioblastoma multiforme.
* Severe disorders in the heart, liver, kidney, blood, etc.
* Presence of previous or concurrent malignancies at other sites with the exception of surgically cured carcinoma in-situ of the cervix and non melanoma skin cancer.
* Women who are pregnant or lactating.
* Women who may be pregnant or who could become pregnant and do not adopt contraception method(s).
* Participation in another clinical study within 6 weeks prior to the initiation of administration of temozolomide.
* Subjects who the investigator and/or subinvestigator judged inappropriate to participate in the study.
Robotic Assessment of Lower Extremity Motor Learning

The aim of the study is to assess the ability of healthy subjects to generate a motor adaptation in response to a mechanical perturbation generated by a robotic system for treadmill-based gait training (Lokomat by Hocoma AG, a device that received 510K FDA clearance).

The study is divided into two phases.

In phase I of the study, we intend to assess the response of individuals to a variety of different mechanical perturbations generated by a robotic system for treadmill-based gait training (Lokomat by Hocoma AG). Such response is quantified as a displacement from the baseline (i.e. gait cycles with no mechanical perturbation) trajectory of motion of the foot during the swing phase of the gait cycle. This portion of the study is expected to allow us to identify mechanical perturbations that are suitable to study motor adaptation.

In phase II of the study, we plan to carry out experiments using the above-mentioned robotic system to assess the magnitude of the motor adaptation to the mechanical perturbations identified in phase I as suitable for the study. The magnitude of the motor adaptation is quantified as the percentage of the deviation from the baseline trajectory of motion of the foot that subjects compensate for when exposed to the perturbation during multiple consecutive gait cycles.

It is worth noticing that the robotic system utilized to generate the mechanical perturbations (i.e. Lokomat by Hocoma AG) is not programmed by the company to generate the mechanical perturbations evaluated in this project. Our research group wrote the programs to generate such perturbations. It is also worth emphasizing that the 510K FDA clearance does not cover the modifications implemented by our research group.

Eligibility Criteria:
Inclusion Criteria:

* Males and females, healthy adults age 18-55 years, with normal gait.

Exclusion Criteria:

* Lower extremity fractures
* Current or previous history of orthopedic injury that would prevent safe use of the robotic system
* Body/femoral length size beyond the limits of robotic system (femur length between 350-470mm)
* Body weight \> 135kg (\~298 lbs) maximum limit of the body weight support system
* Skin lesions on the lower extremities
* Cardiovascular or pulmonary contraindications
* Motor system or proprioceptive impairments
* Severe cognitive impairments that would prevent the use of the robotic system
A Continuation Trial for Subjects With Lupus That Completed Protocol HGS1006-C1056 or HGS1006-C1057

This is a long-term continuation study to provide continuing treatment to subjects with SLE.

This trial is a long-term continuation study to provide continuing treatment to subjects with System Lupus Erythematosus (SLE).

Eligibility Criteria:
Inclusion Criteria:

* Have completed the HGS 1006-C1056 or HGS 1006-C1057 protocol through the Week 72 or Week 48 visits, respectively.

Exclusion Criteria:

* Have developed any other medical disease or condition that has made the patient unsuitable for this study in the opinion of their physician.
Analgecine for Treatment of Low Back Pain

The study examines the efficacy and safety of Analgecine in the treatment of chronic pain in patients with low back pain for 3 months after surgical treatment. It is a randomized, placebo-controlled, double blind, multi-center phase III clinical trial. Patients with chronic low back pain for 3 months after surgical treatment is recruited (age between 18 and 70; pain visual analysis scale (VAS) between 3 and 8). After randomization, subjects are divided into 3 groups: 1) Treatment with Analgecine (Experiment group); 2) Treatment with Neurotropin (positive control group); 3) Placebo group. Subjects will be undergone 4 measurement time points on day 0, 7, 14, and 21. In each time points, subjects are required to score their pain with pain VAS and to have regular blood, urine, and renal/liver function tests. The changes of the pain VAS at day 21 are compared between groups.


Eligibility Criteria:
Inclusion Criteria:

* Patients with chronic low back pain including patients with spinal degeneration, lumbar herniation, lumbar spinal stenosis, and spondylolisthesis
* Pain sustained for 3 or more months after surgical treatment.
* Diagnosis is done by X-ray examination.
* The Visual analysis Scale for Pain is between 3 and 8.

Exclusion Criteria:

* Acute low back pain patients.
* Allergy to the tested drug.
* Patients with tuberculosis, tumors, Cushing's syndrome, endocrine diseases, neuropathic diseases, psychiatric problems, and serious deficit in heart / liver /renal functions.
* Patients with pain caused by vascular diseases, stress, or tumors.
* Patients with pregnancy, lactation, or planning to have pregnancy within 3 months after recruitment.
* Alcoholic and drug addicted subjects
* Dementia patients who can cooperate with the study activities.
* Patients undergone lumber surgery within 3 months at the date of recruitment.
* Patients who are directly related to the research staff.
* Patients who have been participated in other drug clinical trial in the past 3 months at the date of the recruitment.
* Patients who are not fit for the clinical trial based on the research staff observation.
Receiving Radiation Therapy in the MRgRT Research Facility

The aim of this study is to evaluate the technical performance of magnetic-resonance guided radiotherapy (MRgRT) facility at the Princess Margaret Cancer Centre and the impact on the workflow of the clinical team in this facility.


Eligibility Criteria:
Inclusion Criteria:

* Ability to provide informed consent
* Planned to receive clinical intervention (imaging or treatment) in the MRgRT facility
* At least 18 years of age

Exclusion Criteria:

-
IFN-gamma-releasing Assay Based Approach in Patients With Suspected Tuberculous Peritonitis

The diagnosis of tuberculous peritonitis (TBP) is still challenging, and largely dependent on invasive procedures such as laparoscopy. A recently developed RD-1 gene-based assay for diagnosing TBP shows has given promising results. The investigators thus created a 2-step algorithm using the Blood/Ascites ELISPOT assays and adenosine deaminase (ADA) in ascites for differentiation of TBP from other diagnoses (Blood ELISPOT ≥6 spots or ADA ≥ 21 U/L' as a rule-out test and 'Ascites/Blood ratio ≥3' as a rule-in test). This study is the randomized controlled trial on whether this 2-step algorithm-based approach can reduce the laparoscopic biopsy for the diagnosis of TBP in patients with suspected TBP.


Eligibility Criteria:
Inclusion Criteria:

* all patients with suspected tuberculous peritonitis
* age 16 or more
* formal informed consent

Exclusion Criteria:

* not specified
Metastatic Leiomyosarcoma Biomarker Protocol

Leiomyosarcoma (LMS) is one of the most prevalent soft tissue sarcomas (STS) and can occur in various sites including soft tissue, uterus and retroperitoneal large vessels. Metastatic disease occurs in approximately 50% of patients diagnosed with leiomyosarcoma and prognosis is poor in setting of metastatic disease. A minority of patients benefit from treatment with chemotherapy and early biomarkers of benefit from treatment are lacking. A biomarker of tumor response and patient survival benefit from chemotherapy early in the course of chemotherapy would be of significant impact in treatment planning. Circulating tumor DNA (ctDNA) is present in blood of patients with advanced/metastatic cancer and may serve as biomarker of tumor response to chemotherapy. Blood samples will be collected prior to and during and chemotherapy, and analyzed for ctDNA and for mutations in genes that are associated with increased risk of developing sarcoma. Tumor tissue will be collected and analyzed for changes in genes. Digital images of the sarcoma from CT or MRI scans obtained during treatment will be obtained for advanced radiomic analysis. Study participants will be asked to complete a questionnaire on attitudes and understanding of genetics and genetic testing.


Eligibility Criteria:
Inclusion Criteria:

* Patients with unresectable or metastatic leiomyosarcoma (LMS). There is no age requirement
* Receiving first-line chemotherapy with doxorubicin or gemcitabine/docetaxel
* Target lesions per RECIST 1.1
* Optional archival tumor tissue including 1 H\&E-stained slide and unstained tumor tissue \[either tissue block containing tumor, or minimum of 4 unstained slides (preferably 8 unstained slides)-fresh frozen sample may also be used in lieu of FFPE sample\] available for study research