cyrilzakka/clinical-trials huggingface dataset:
Tailored Interventions to Improve Hypertension Management After Stroke or Transient Ischemic Attack (TIA)

The purpose of this study is to determine the effectiveness of interventions to improve adherence to medication and healthier lifestyle choices on blood pressure over a 6 month period in a group of people at high risk for recurrent stroke events. The participants have already had a stroke or TIA, and have uncontrolled blood pressure, as well as problems with memory and problem-solving, or miss taking medications, or who do not believe in the effectiveness of their medications. Interventions focus on motivational interviewing, adherence counseling with memory cuing, and self-monitoring of blood pressure.

* randomized, controlled trial at 4 sites
* measurement of blood pressure, missed pills, self-efficacy rating at baseline and 6 months
* contacting family pharmacists to evaluate prescription renewal patterns at baseline and 6 months

Eligibility Criteria:
Inclusion Criteria:

* diagnosis of stroke or TIA
* hypertension
* Montreal Cognitive Assessment score less than 26
* self report of missed pills
* self-efficacy rating less than 100%

Exclusion Criteria:

* inability to give informed consent
* 18 years of age or younger
Effects of Continuous Nerve Block vs Single Injection Block With PCA vs PCA on Pain and Function After Knee Replacement

The purpose of this study is to compare the effectiveness of three analgesia techniques on pain relief and functional recovery after knee replacement: continuous femoral nerve block vs single-injection femoral nerve block with intravenous patient controlled analgesia vs intravenous patient controlled analgesia.

Primary Outcome Measures:

* Incidence of patients with significant pain on movement on day 1 post surgery
* Range of knee flexion

Secondary Outcome Measures:

* Pain intensity (rest/movement)
* Functional recovery
* Knee Injury and Osteoarthritis Score
* Side effects/ Adverse outcomes
* SF12 Quality of Life Questionnaire
* Length of stay

Eligibility Criteria:
Inclusion Criteria:

* 40 years and above
* Osteoarthritis
* Primary unilateral total knee replacement
* No other lower extremity joint disease
* ASA I-III
* Body mass index \< 35
* No severe cardiac or pulmonary diseases
* No chronic narcotic therapy or illicit drug use
* Mentally competent to understand study procedures and use of pain scales
* Able to provide informed consent

Exclusion Criteria:

* Any cause for knee replacement other than osteoarthritis
* Total knee revision
* Any contraindication for femoral block
* Abnormal coagulation studies
* Thrombocytopenia less than 100,000/cc
* Known hepatic or renal insufficiency
* Neurological disease involving lower extremities
* Major surgery during the last 2 weeks pre-operatively
* History of allergy to study medications
* History of post-operative bleeding over 2000 cc/24 hours
* History of opioid or alcohol abuse
* Currently taking or has taken opioid \> 30 consecutive days of daily use at a daily dose \> 15mg morphine, within the past 2 weeks prior to surgery
* Previously has not responded to opioid analgesics for treatment of pain
* Pregnancy or breastfeeding
HIP Fracture REhabilitation Programme for Elderly With Hip Fractures

Objectives: To evaluate the feasibility of a HIP fracture REhabilitation Programme (HIP-REP).This study will investigate adherence, satisfaction, technical and practical circumstances regarding implementation and taking this into account when evaluating the feasibility of the HIP-REP program.

Hypothesis: By testing the feasibility of a HIP-REP for the participants and the usefulness of the selected measurement tools, the investigators will be able to evaluate and adjust the HIP-REP before evaluating this in a larger Randomized controlled trial (RCT).

Little is known about the feasibility and effect of an intersectoral rehabilitation intervention aiming at reducing the decrease in Activities of Daily Living (ADL) ability for elderly with hip fractures. Despite positive surgical outcomes, one-quarter dies within a year after surgery, around eight percent are readmitted to hospital, and just one-third regain their pre-fracture level of physical functioning and ADL ability. After hip fracture, the loss of independence, and further decrease in ADL ability often persists beyond three months after surgery. This increases the risk of social isolation, depression and thus a decrease in Quality of Life (QoL). Therefore, the investigators want to evaluate whether an activity-based rehabilitation intervention across sectors is feasible and influences this fragile group of patients. The investigators hope to increase the ability to safely and independently perform ADL in elderly with hip fractures, and thereby enhance their health-related QoL.

Eligibility Criteria:
Inclusion Criteria:

* Aged 65 years or older
* Recent proximal hip fracture (S 72.0 Medial femur fracture, S 72.1, Pertrochanteric femur fracture, S 72.2 Subtrochanteric femur fracture)
* Living at home prior to hip fracture in Herlev, Gentofte or Lyngby-Taarbæk municipalities
* Ability to give informed consent
* Discharged from hospital and receiving or having received rehabilitation in one municipalities within the last 3 months from onset

Exclusion Criteria:

* Not expected to be discharged to home or rehabilitation centers in the municipality
* Not able to speak and/or understand Danish
* Have prior severe physical and /or mental disabilities
A Multicenter Prospective Registry for the Management of Degenerative Spine Disorders

Details regarding the degenerative spine disorders will be collected with a specific focus on the use of osteobiologics in treating degenerative conditions and their impact on fusion, as well as patient-reported outcomes for these conditions.

The registry is designed to be open-ended. However, a statistical evaluation of the content und structure of database and CRFs in order to investigate the feasibility and quality of data collection is planned to take place prior to the registry expansion.

Variables applicable to patients with a degenerative spine disorder which will be collected in the registry include:

* Patient details
* Symptoms
* Diagnosis
* Imaging assessment
* Treatment details

Feasibility phase:

The statistical evaluation of the feasibility and quality of data collection will be performed after the first 5 sites have each enrolled 12 patients with a degenerative pathology and documented one follow-up visit. During this evaluation, enrolment of further patients can be continued.

Based on the findings of this feasibility phase, adjustments to the existing database can be performed before the registry is rolled out on larger scale.

Registry expansion:

Following the evaluation process of the feasibility phase, the registry will be expanded to allow data entry in more sites globally. Multi-site participation of this registry will be rolled-out in stages, and will be offered to sites with appropriate expertise which are selected based on their potential (interest, resources and expected patient volume).

Eligibility Criteria:
Inclusion Criteria:

* Patient aged 18 years or older
* Patient diagnosed with a degenerative spine disorder who receives treatment for the degenerative spine disorder
* Patient capable of understanding the content of the patient information / Informed Consent Form
* Patient willing and able to participate in the registry
* Patient who has agreed to participate in the registry by providing consent according to the applicable local law and the declaration of Helsinki

Exclusion Criteria:

* None
HBOT in the Treatment and Prevention of aGVHD

Allogeneic hematopoietic stem cell transplantation (allo-HSCT) is a potentially curative therapeutic strategy for patients with hematopoietic malignancies. However, the therapeutic benefits and wider application of allo-HSCT are limited by acute graft-versus-host disease (aGVHD), the latter remains a major obstacle against long-term survival for this population. New aGVHD prophylactic and therapeutic strategies that are superior in efficacy, safety, cost-effectiveness, and less technically demanding are still in desperate need. Hyperbaric oxygen therapy (HBOT) has been confirmed as an effective and economical therapeutic modality for hemorrhagic cystitis (HC) whether induced by infection or acute graft-versus-host disease (aGVHD) for transplant recipients. However, little is known about its involvement in aGVHD. In this study, the investigators designed a randomized, controlled, and open clinical trial to confirm the safety and efficacy of HBOT on aGVHD in patient underwent allo-HSCT.

Allogeneic hematopoietic stem cell transplantation (allo-HSCT) is a potentially curative therapeutic strategy for patients with hematopoietic malignancies. However, the therapeutic benefits and wider application of allo-HSCT are limited by acute graft-versus-host disease (aGVHD), the latter remains a major obstacle against long-term survival for this population. New aGVHD prophylactic and therapeutic strategies that are superior in efficacy, safety, cost-effectiveness, and less technically demanding are still in desperate need.

Although a variety of immune and non-immune cells are involved in the development of aGVHD, reactive oxygen species (ROS) has been proved as the primary triggers of the inflammatory response and play a key role in the pathogenesis of aGVHD. Therefore, strategies targeting ROS production are crucial for effectively managing aGVHD. Hyperbaric oxygen therapy (HBOT) is a well-established treatment method, which is used to improve non-healing ulcers secondary to aGVHD and hemorrhagic cystitis (HC) after allo-HSCT whether induced by infection or aGVHD. Even the exact mechanism is not fully understood, HBOT was demonstrated to reduce a series of pro-inflammatory cytokines release and can improve the action of antibiotics.

In this study, the investigators plan to initiate a randomized, controlled, and open clinical cohort study confirm the safety and efficacy of HBOT on aGVHD in patient underwent allo-HSCT.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing allogeneic stem cell transplantation
* Patients develop aGVHD
* The count of neutrophilia cells over 0.5 \* 109/L, hemoglobin over 60 g/L, platelet over 30 \*109/L
* Signed informed consent

Exclusion Criteria:

* Unsuitable to the study due to severe complication such as uncontrolled severe infection
* Claustrophobia
* Ear diseases such as otitis media
* Eye diseases such as glaucoma
* Epilepsy history
* Important organ dysfunction
* Coagulopathy
Seroquel in Bipolar Depression Versus Lithium

This study is being carried out to see if quetiapine fumarate (Seroquel) is effective in treating bipolar depression during an 8-week acute phase compared with placebo and lithium, followed by continuation treatment for 26 up to 52 with quetiapine fumarate (Seroquel) compared to placebo.


Eligibility Criteria:
Inclusion Criteria:

* Patients with a diagnosis of bipolar I disorder or bipolar II disorder, currently depressed, aged 18 to 65 years old and outpatient status at enrolment and randomization.

Exclusion Criteria:

* Patients with a current DSM-IV Axis I disorder other than bipolar disorder that is symptomatic or requiring treatment within 6 months of enrolment,
* History of non-response to an adequate treatment
* Patients who, in the investigator's judgment pose a current serious suicidal or homicidal risk
* Pregnancy or lactation
* Clinically relevant disease or clinical finding
TEMPUS ARIES: A Biobank Registry Platform Study in Oncology

This study is a non-interventional, multicenter, multicohort evaluation of participants with cancer who will undergo longitudinal plasma ctDNA biomarker profiling at specific time points in addition to standard of care therapy.


Eligibility Criteria:
Inclusion Criteria:

1. ≥18 years of age
2. Willing to participate in the research
3. Able to provide informed consent
4. Must be diagnosed with cancer

Exclusion Criteria:

1. Not willing or able to have additional blood samples collected
A PhaseⅡ Study: SOX vs SP in Adjuvant Chemotherapy After D2 Surgery

To investigate the efficiency and safety of SOX or SP adjuvant chemotherapy to phase II and III gastric cancer patients after D2 surgery. If SOX is equal to SP in efficiency and less toxicity.


Eligibility Criteria:
Inclusion Criteria:

* histologically confirmed Phase III adenocarcinoma of gastric and esophageal-gastric junction ( AJCC 7th)
* without previous treatment, including radiotherapy, chemotherapy and immunotherapy
* Hb≥90g/L,WBC 4×109/L-10×109/L,ANC≥2×109/L,Platelet≥100×109/L
* creatinine≤1 UNL
* total bilirubin≤1.5 UNL,AST(SGOT),ALT(SGPT) and ALP≤2.5 UNL
* ECOG score 0 - 2
* take chemotherapy for 8 weeks after surgery
* older than 18 years
* can be followed up, good compliance
* can take medicine orally
* having signed informed consent

Exclusion Criteria:

* combined disease lead to Life Expectancy less than 3 years
* any evidence to show metastasis,including cancer cells in peritoneal fluid
* inability to take oral medication for difficult to swallow, intestinal obstruction，active intestinal blooding or perforation
* previous treatment,including cytotoxic chemotherapy, radio chemotherapy or immunotherapy ( except corticosteroid hormone）
* operation within 4 weeks, or not recovered from last major operation
* allergy with fluorouracil
* allergy with Platinum or any composition in research drugs
* uncontrollable seizure disorder，central nervous system disease or mental disorders, and has clinical significance by judgement of researchers, or can influnce understanding of informed consent or compliance to take orally drugs
* in the past 12 months, has clinical significant heart disease(active),such as symptomatic coronary heart disease, \> =Stage II congestive cardiac failure;congestive heart failure as NYHA standard, or serious arrhythmias need take medicine( as Appendix 10th),or myocardical infarction.
* pregnancy， lactation， women in child-bearing period and her spouses reject to take effictive method to conraception
* other previous malignancy within 5 years, except healed skin basal cell carcinoma and carcinoma in cervix
* peripheral neuropathy\> grade 1 of CTCAEv3, except the neural abnormality patients who only lose deep tendon reflex（DTRs）.
* serious complicated infection or other complicated diseases and hard to controll.
* As one of belowing:
* ANC \< 2×109/L
* Platelet\<100×109/L
* total bilirubin\>1.5 UNL
* ALAT、ASAT \> 2.5 x ULN
* ALP\> 2.5 x ULN
* Any investigational agent within the past 28 days. That is the patient had jioned another trial.
Effects of High Intensity Stepping Training on Gait in Patients With Ataxia

The purpose of this study is to examine the effects of high intensity stepping training on gait recovery, including walking speed and endurance, in patients with cerebellar ataxia. The hypothesis is that there will be a significant improvement in gait outcome measures (6 Minute Walk Test and 10 Meter Walk Test) in patients who receive high-intensity stepping training during physical therapy.


Eligibility Criteria:
Inclusion Criteria:

* diagnosis of ataxia
* admitted to The Institute for Rehabilitation and Research (TIRR) Texas Medical Center (TMC) Inpatient or TIRR Kirby Glenn Outpatient
* pathology that primarily affects the brain/cerebellum, including degenerative diseases, stroke, traumatic brain injury (TBI), posterior fossa tumor, and multiple sclerosis (MS)
* ambulatory at initial evaluation or will have functional ambulation goals at initial evaluation (as noted by 10 meter walk test and 6 minute walk test measures documented as 0)
* chronicity of injury will be of at least 1 month or greater

Exclusion Criteria:

* diagnoses that may have cerebellar involvement but without cerebellar ataxia as a principal impairment such as autism, down syndrome, schizophrenia, etc
* non ambulatory or who are not able to participate in high intensity stepping training due to cardiac involvement (such as cardiac rehabilitation parameters) or due to orthopedic limitations (such as weight bearing parameters)
Capecitabine and Mitomycin C in Treatment of Patients With Metastatic Breast Cancer

This is an open-label, non-comparative efficacy and safety study of Capecitabine and Mitomycin C as first-line treatment in patients with previously untreated metastatic breast cancer.


Eligibility Criteria:
Inclusion Criteria:

* Histologically/cytologically confirmed breast cancer
* Metastatic breast cancer, having at least one target lesion according to the RECIST criteria. Bone metastases, leptomeningeal disease, ascites, pleural or pericardial effusions, inflammatory breast disease, lymphangitic spread or cystic lesions are not acceptable as target lesions. Target lesions must be ≥ 10 mm longest diameter measured in one dimension using spiral CT, or ≥ 20 mm longest diameter measured in one dimension using conventional techniques. In addition to the definitions pertaining to the target lesion(s) from the RECIST criteria above, the target lesion(s) must not have been previously irradiated (newly arising lesions in previously irradiated areas are acceptable).
* Age \> 18 years
* Signed informed consent obtained prior to initiation of any study-specific procedures or treatment

Exclusion Criteria:

* Prior cytotoxic chemotherapy or active/passive immunotherapy for metastatic breast disease
* Prior usage of capecitabine or mitomycin as adjuvant or neoadjuvant treatment
* Life expectancy \< 3 months
* Not-ambulatory or with an ECOG performance status \> 1
* Insufficient hematological, renal and hepatic functions:
* hemoglobin \< 8.0 g/dL
* absolute neutrophils count (ANC) \< 1.5 x 109/L
* platelet count \< 100 x 109/L
* serum creatinine \> 1.25 x N\*
* total bilirubin \> 2.0 x N\*
* ASAT and/or ALAT \> 2.5 x N\* (in case of liver metastases \> 5 x N\*)
* alkaline phosphatase \> 2.5 x N\* (in case of liver metastases \> 5 x N\*, in case of bone metastases \> 10 x N\*) \*N = upper limit of standard range
* Severe renal impairment \[creatinine clearance \< 30 mL/min (calculated according to cockcroft and Gault)\]
Corneal Thickness Changes During Corneal Collagen Cross-linking With Ultraviolet-A Irradiation and Riboflavin

The purpose of this study is to evaluate the corneal pachymetric variations during and after corneal collagen cross-linking (CXL) treatment with ultraviolet-A irradiation (UVA) and hypo-osmolar riboflavin solution in thin corneas.

To evaluate the corneal pachymetric variations during and after corneal collagen cross-linking (CXL) treatment with ultraviolet-A irradiation (UVA) and hypo-osmolar riboflavin solution in thin corneas.

Eighteen eyes of 18 patients, 11 men and 7 women, with progressive keratoconus and thinnest corneal thickness (TCT) less than 400µm were included in this study.

After the epithelium removal, iso-osmolar riboflavin was applied to the cornea every 3 minutes (30 min). Hipo-osmolar riboflavin was then applied every 20 seconds until the TCT reached 400µm. UVA irradiation was performed for 30 min. Pachymetry was recorded at the thinnest point of the cornea preoperatively, after epithelial removal, after iso-osmolar riboflavin, after hypo-osmolar riboflavin, after UVA irradiation, and at 1, 6 and 12 months.

Eligibility Criteria:
Inclusion Criteria:

* Progressive Keratoconus
* thin corneas

Exclusion Criteria:

* Contact lens use for less than 3 weeks
* Non progressive keratoconus
* Thinest corneal thickness above 400 micra
A Clinical Studyf of SHR-1701 or Placebo in Combination With BP102 and XELOX in the First-line Treatment of mCRC

This is a two-arm, randomized, double-blinded, multicenter phase II/III clinical study to evaluate the safety and clinical efficacy of SHR-1701 or placebo in combination with BP102 (biosimilar to bevacizumab) and XELOX in first-line treatment of patients with mCRC.


Eligibility Criteria:
Inclusion Criteria:

1. Patients with unresectable recurrent or metastatic adenocarcinoma of the colon or rectum confirmed histologically
2. For subjects who have not previously received any systemic antitumor therapy and who have previously received neoadjuvant or adjuvant therapy, the first detection of recurrence or metastasis should be ≥12 months after the last administration of neoadjuvant or adjuvant therapy
3. At least 1 measurable lesion according to RECIST V1.1
4. The vital organs are functioning well
5. ECOG score is 0 \~ 1
6. Contraception was initiated from the signing of the informed consent until at least 6 months after the last dosing of the study drug

Exclusion Criteria:

1. Recurrent or metastatic lesions can be treated with radical surgery
2. Presence of central nervous system or meningeal metastases;
3. Moderate and severe ascites of clinical symptoms;Uncontrolled or moderate or greater pleural effusion or pericardial effusion
4. Poorly controlled hypertension (systolic blood pressure ≥140 mmHg and/or diastolic blood pressure ≥90 mmHg in the case of regular antihypertensive therapy) and prior hypertensive crisis or hypertensive encephalopathy
5. Severe cardiovascular and cerebrovascular diseases;Have clinical heart symptoms or diseases that are not well controlledSubjects with a history of myocardial infarction or unstable angina pectoris
6. Subject with current interstitial pneumonia or interstitial lung disease, or with a previous history of interstitial pneumonia or interstitial lung disease requiring hormone therapy
7. Previous treatment with targeted T cell costimulatory molecules and immune checkpoint inhibitors;Previous treatment with antiepidermal growth factor receptor or any antiangiogenic drug
Study in Healthy Males to Assess Bioavailability of Single Fostamatinib With iv Micro Tracer Dose

Study in healthy males to assess bioavailability of single fostamatinib with iv micro tracer dose.

A Study to Assess the Absolute Bioavailability of a Single Oral Dose of Fostamatinib with Respect to an Intravenous Micro Tracer Dose of \[14C\] R406 in Healthy Male Volunteers.

Eligibility Criteria:
Inclusion Criteria:

* Healthy male volunteers aged 18 to 55 years (inclusive), with a weight of at least 50 kg and a body mass index (BMI) between 18 and 30 kg/m2 (inclusive)
* Male volunteers willing to use barrier contraception ie, condoms with spermicide, from the first day of the investigational product administration until 3 months after the last administration of the investigational product

Exclusion Criteria:

* History of any clinically significant disease or disorder
* History or presence of GI, hepatic, or renal disease or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs
* Any clinically significant illness, medical/surgical procedure or trauma within 4 weeks of the first administration of drug
* Volunteers who smoke more than 5 cigarettes or the equivalent in tobacco per day
* Any clinically significant abnormalities in clinical chemistry, hematology or urinalysis results as judged by the Investigator