cyrilzakka/clinical-trials huggingface dataset:
Functional Electrical Stimulation Use in Trans-tibial Amputations

The purpose of this study is to demonstrate the efficacy of functional electrical stimulation (FES) for trans-tibial amputees. The investigators aim to demonstrate that providing three months of FES intervention will increase knee extension strength, increase volume of the residual limb and decrease chronic and phantom pain.

SUMMARY STUDY GOALS: The purpose of this study is to demonstrate the efficacy of FES for trans-tibial amputees. The investigators aim to demonstrate that providing three months of FES intervention will increase knee extension strength, increase volume of the residual limb and decrease chronic and phantom pain.

EXPERIMENTAL DESIGN: Randomized control trial METHODS: Twenty participants will be recruited and randomly divided into two groups, one group will receive the FES intervention while the other group will continue with activities of daily living. Both groups will keep a daily log of number of hours the prosthesis is worn, number of hours the FES is worn (if used) and any changes in skin conditions or medications. Both groups will return for assessment visits at 4, 8, and 12 weeks and a follow up visit 3 months post-intervention for investigators to inspect the residual limb and check the fit of the prosthetic socket, record residual limb knee extension strength on the Biodex machine, take measurements (circumferences and lengths) of the residual limb with a tape measure and ruler, scan the limb with the hand held three-dimensional motion-tracking laser scanner system and the participant will be asked to complete a pain questionnaire. The Prosthetic Evaluation Questionnaire (PEQ) will be completed at the 12 week and the 3 month follow-up visits. Although outcomes data were captured during each assessment visit (0, 4, 8 and 12 weeks and 3 months), changes in the primary outcomes (strength, volume and pain) at timepoints 0 weeks (pre-intervention) and 12 weeks (post- intervention) were of primary interest.

Eligibility Criteria:
Inclusion Criteria:

* Men and women over 18 years of age.
* Participants have a unilateral trans-tibial amputation with a minimum of a 4" residual limb. This length of amputation was chosen to provide for adequate surface area for the electrodes.
* Participants must be a minimum of two years postoperative to insure proper healing of the limb has occurred.
* Participants have chronic limb pain.
* No prior experience in using TENS or FES.

Exclusion Criteria:

* No cardiac conditions, such as hypertension, congestive heart failure, or a pacemaker.
* People with severe diabetes who have insensate skin and or neuropathy.
Misoprostol for Treatment of Postpartum Hemorrhage at Community-level Births in Egypt

This randomized controlled community-based trial will assess the effectiveness of administration of 800 mcg sublingual misoprostol with standard of care vs. placebo with standard of care for postpartum hemorrhage treatment at the community level, primarily home births attended by primary health care unit (PHU) staff in Etay El Barood and Kafr El Dawar districts (El Beheira governorate), Egypt. Standard of care per national guidelines in this setting is referral to a higher level health facility.

Hospital-based clinical trials have demonstrated misoprostol to be a safe and effective treatment option for postpartum hemorrhage (PPH). Additional research is needed to demonstrate how these findings translate into program effectiveness at lower levels of the health care system, including community home births, where access to skilled providers and treatment options are limited and misoprostol could potentially have the greatest impact on maternal health outcomes. This randomized controlled community treatment trial will assess the effectiveness of misoprostol with standard of care (i.e., referral to higher level care) vs. placebo with standard of care for PPH treatment at the community level, primarily home births attended by primary health care unit staff in Etay El Barood and Kafr El Dawar districts (El Beheira governorate), Egypt. This research will help guide decisions on how to introduce misoprostol into PPH care programs in different contexts such as primary care settings, including community-based home births.

Eligibility Criteria:
Inclusion Criteria:

* women delivering with provider from participating primary health unit (PHU)
* willing and able to give informed consent
* vaginal delivery

Exclusion Criteria:

* women too advanced into active labor to provide informed consent
* known allergy to misoprostol and/or other prostaglandin
* women presenting with pregnancy complications, such as hypertension, suspected multiple pregnancy, previous caesarean section, suspected still birth, antepartum hemorrhage, previous complication in the third trimester (should be referred to higher level care for delivery)
Long Term Effects of Multifocal Orthokeratology on Corneal and Choroidal Structures in Healthy Subjects With Myopia- A Pilot Study

Orthokeratology has the benefit for slowing down myopia progression and enabling unaided vision during the day. To investigate proposed possible changes of conventional and multifocal orthokeratology in the cornea and choroid this study will image both structures with high resolution optical coherence tomographs over a six month period. Findings will help to plan larger trials over a longer period of time in adults and teenagers.


Eligibility Criteria:
Inclusion Criteria:

* Men and women aged over 18 years
* Myopia defined as between -1D and -6 D with an increase of 0.5D within the last 18months prior to inclusion
* Prospect orthokeratology contact lens wearers
* Normal findings in the slit lamp examination, no corneal pathologies

Exclusion Criteria:

* Participation in a clinical trial in the previous 3 weeks
* Presence of any abnormalities (such as refractive surgery) preventing reliable measurements as judged by the investigator
* Current contact lens wearers
* Pregnancy, planned pregnancy or lactating
Single-center Study on Laparoscopic Distal Subtotal Gastrectomy for Advanced Gastric Cancer

Laparoscopic distal subtotal gastrectomy with lymph node dissection for treatment of gastric cancer is popular in East Asian countries. However, the long-term follow-up outcome based on randomized clinical trial (RCT) is still rare. Some studies indicated that laparoscopic distal subtotal gastrectomy with D2 lymphadenectomy is a technically feasible and safe procedure by experienced surgeons in high-volume specialized hospitals. However, the application of it is still limited because of lack of solid evidence on the oncologic efficacy. Nowadays, the proportion of patients with locally advanced gastric cancer is estimated up to 80 percent of all gastric cancer cases in China. Before the clinical application of laparoscopic procedure for the treatment with curative intent to advanced gastric cancer located at the middle- or lower-third of the stomach, the oncologic efficacy must be verified.Accordingly, the comparison of long-term outcome between laparoscopic and open distal subtotal gastrectomy with D2 lymphadenectomy for locally advanced gastric cancer based on a well designed RCT is needed.


Eligibility Criteria:
Inclusion Criteria:

* Age from over 18 to under 75 years Primary gastric adenocarcinoma (papillary, tubular, mucinous, signet ring cell, or poorly differentiated) confirmed pathologically by endoscopic biopsy cT2-4a, N0-3, M0 at preoperative evaluation according to the AJCC Cancer Staging Manual Seventh Edition Expected curative resection through distal subtotal gastrectomy with D2 lymphadenectomy Performance status of 0 or 1 on ECOG (Eastern Cooperative Oncology Group) scale ASA (American Society of Anesthesiology) score class I, II, or III Written informed consent

Exclusion Criteria:

* Women during pregnancy or breast-feeding Severe mental disorder History of previous upper abdominal surgery (except laparoscopic cholecystectomy) History of previous gastrectomy, endoscopic mucosal resection or endoscopic submucosal dissection Enlarged or bulky regional lymph node diameter over 3cm by preoperative imaging History of other malignant disease within past five years History of previous neoadjuvant chemotherapy or radiotherapy History of unstable angina or myocardial infarction within past six months History of cerebrovascular accident within past six months History of continuous systematic administration of corticosteroids within one month Requirement of simultaneous surgery for other disease Emergency surgery due to complication (bleeding, obstruction or perforation) caused by gastric cancer FEV1\<50% of predicted values
Immune Checkpoint Inhibitors and Anti-vascular Endothelial Growth Factor Antibody/tyrosine Kinase Inhibitors with or Without TACE for Advanced HCC with Vascular Invasions

Immune checkpoint inhibitors and anti-vascular endothelial growth factor antibody/tyrosine kinase inhibitors with or without transarterial chemoembolization as first-line treatment for advanced hepatocellular carcinoma with vascular invasions

The vascular invasions is a common complication in 16% to 30% of patients with hepatocellular carcinoma (HCC), contributing to poor prognosis and increasing the risk of cancer recurrence, with a median survival of approximately 2.7 to 4 months without intervention. Both the European Association for the Study of the Liver and the American Association for the Study of Liver Diseases guidelines recommend that HCC patients with vascular invasions be classified as Barcelona Clinic Liver Cancer Stage C and receive systemic treatments. Nevertheless, there is limited data on patients with highly complicated HCC and no optimal treatment strategy for this patient population. Tyrosine kinase inhibitors (TKIs) and immune checkpoint inhibitors (ICIs) are commonly utilized in the systemic therapy of HCC, while the combination of transcatheter arterial chemoembolization (TACE) with systemic therapy has significantly improved treatment outcomes in advanced-stage patients. Therefore, we hypothesized that a triplet regimen comprising TACE, TKI, and ICIs may yield better prognoses for HCC patients with vascular invasions. This study aims to compare the safety and efficacy of the triplet regimen of TKIs, ICIs, and TACE versus Lenvatinib combined with ICIs in advanced-stage HCC with vascular invasions

Eligibility Criteria:
1. Has a diagnosis of HCC confirmed by radiology, histology, or cytology;
2. Barcelona Clinic Liver Cancer (BCLC) stage C with the presence of macrovascular invasion;
3. Has not received any previous systemic therapy for HCC (including chemotherapy, molecularly targeted therapy, immunotherapy);
4. Both PD-1/PD-L1 inhibitors and anti-angiogenesis drugs patients received only include marketed drugs but are not limited to HCC approval;
5. TACE was performed after the first PD-1/PD-L1 inhibitor/anti-angiogenic drug treatment or before treatment (within 3 months);
6. Received at least 1 cycle of PD-1/PD-L1 inhibitor/anti-angiogenic drug combination therapy after TACE treatment;
7. Has repeated measurable intrahepatic lesions;

Exclusion Criteria:

1. Cholangiocarcinoma, fibrolamellar, sarcomatoid hepatocellular carcinoma, and mixed hepatocellular/cholangiocarcinoma subtypes(confirmed by histology, or pathology) are not eligible;
2. Unable to meet criteria of combination timeframe described above;
3. Child-Pugh C or PS\>2 or Severe hepatic encephalopathy
Combined Peripheral (BreEStim) and Central Electrical Stimulation (tDCS) for Neuropathic Pain Management - Spinal Cord Injury

This study looks at the effect of combined breathing-controlled electrical stimulation (BreEStim) and transcranial direct current stimulation (tDCS) on neuropathic pain after spinal cord injury, amputation, or brain injury. The hypothesis is that a single session of combined BreEStim and tDCS will produce an additive analgesic effect. This record covers the study in a population of spinal cord injury patients. Note that this study will also enroll healthy volunteers, brain injury patients, and amputation patients and that this study as applied to these other populations will be covered in separate ClinicalTrials.gov records.


Eligibility Criteria:
Inclusion Criteria:

* between 18 and 75 years
* male and female subjects
* has neuropathic pain after traumatic spinal cord injury
* has chronic pain, \>3 months
* is stable on oral pain medications at least two weeks. (patients are allowed to continue their pain medications, i.e., no change in pain medications.)

Exclusion Criteria:

* currently adjusting oral pain medications for their neuropathic pain
* have pain, but not neuropathic (e.g., from inflammation at the incision wound of the residual limb or neuroma)
* have a pacemaker, or other metal and/or implanted devices
* have amputation in their arm(s)
* have spinal cord injury (SCI) involving impairment of arms
* have cognitive impairment from brain injury or are not able to follow commands, or to give consent
* have asthma or other pulmonary disease
* are not medically stable
* have preexisting psychiatric disorders
* alcohol or drug abuse
* have a history of seizures/Epilepsy, or taking benzodiazepines, anticonvulsants, and antidepressants.
* Mini-mental state examination (MMSE), a brief 30-point questionnaire test that is commonly used in the literature, will be used to screen for cognitive impairment. A brain injury patient with a score of 24 or lower on MMSE will be excluded.
Assessment of Hyperkalemia's Illness and Treatment Burden in Chronic Kidney Disease and Heart Failure Patients: HK Registry Pilot Study

Overall study aim of this study is to analyse descriptive statistics of Patient-Reported Outcome（PROs） which will be used in the Hyperkalemia（HK） registry study in hyperkalemia patients with Chronic Kidney Disease（CKD） or Heart Failure（HF） to describe the practice patterns of hyperkalemia treatment in in clinical practice. Based on these assessments, this study will provide the information for the applicability of PRO measurements which will be used in the Hyperkalemia registry study to the study population, i.e. CKD and/or HF patients with hyperkalemia


Eligibility Criteria:
Inclusion Criteria:

* Outpatients aged ≥20 years
* Hyperkalemia patients defined as meeting either of the following criteria:

  1. Having a history of S-K ≥5.1 mmol/L ≥2 times within 6 months before enrolment
  2. Having a history of S-K ≥5.5 mmol/L once within 6 months before enrolment
  3. Currently treated by potassium binders for the treatment of hyperkalemia at enrolment
* Having been diagnosed as CKD (≥stage 3b) or HFrEF by investigators as defined below:

CKD is diagnosed based on the guidelines of CKD issued by the Japanese Society of Nephrology (JSN, 2018) as being either or both of condition 1 and 2 for ≥3 months

1. Clear sign of kidney impairment based on urinalysis, imaging, blood test, or biopsy. Especially, existence of ≥0.15 g/gCr of proteinuria (≥30 mg/gCr of albuminuria) is important.
2. GFR \<45 mL/min/1.73m2 Within the routine clinical practice, GFR is estimated by serum creatinine, gender, and age using following the formulation.

eGFR creat (mL/min/1.73m2) = 194 x serum creatinine (mg/dL)-1.094 x age (years)-0.287 (for female patients, x 0.739)

≥Stage 3b CKD is diagnosed based on the following eGFR categories:

* Stage 3b: 30 mL/min/1.73m2 ≤ eGFR \<45 mL/min/1.73m2
* Stage 4: 15 mL/min/1.73m2 ≤ eGFR \<30 mL/min/1.73m2
* Stage 5: eGFR \<15 mL/min/1.73m2

Patients with HFrEF is enrolled if patients meet following criteria within 6 months:

1. EF ≤40%
2. NYHA class II-IV

   * Provision of signed, written, and detailed informed consent
   * Signed written informed consent by themselves

Exclusion Criteria:

* Currently on any chronic RRT (including hemodialysis or peritoneal dialysis \>30 days, or kidney transplant) within 6 months before enrolment
* Patients with acute kidney injury at enrolment •Patients who took blood transfusion or potassium supplements within 6 months before enrolment
* Active malignancy or life expectancy of less than 6 months.
* Patients who have GI disturbance/chronic diarrhoea/stoma, and investigators determine those affect significantly serum K level
* Patients who have autoimmune disorders, and investigators determine those affect significantly serum K level
* Patients whose lab data have suspicion for pseudohyperkalemia
* Patients who are pregnant, lactating, or planning to become pregnant
* Current participation in interventional studies and/or clinical trials
* Patients who, in the opinion of the investigators, would be unlikely to comply with self-assessments
CP-690,550 and Midazolam Drug-Drug Interaction Study

CP-690,550 and midazolam are metabolized by similar enzymes in the liver. This study is designed to assess whether co-administration of CP-690,500 and midazolam will effect the metabolism of midazolam in healthy volunteers.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male and/or female (non-child bearing potential) subjects

Exclusion Criteria:

* Clinically significant infections within the past 3 months
* History of previously untreated infection with Mycobacterium tuberculosis
* Positive screening test for hepatitis B surface antigen, anti-hepatitis C antibody, or human immunodeficiency virus
Pegylated Arginine Deiminase in Treating Patients With Metastatic Melanoma That Cannot Be Removed by Surgery

RATIONALE: Pegylated arginine deiminase may stop the growth of tumor cells by taking away an amino acid needed for cell growth.

PURPOSE: This phase II trial is studying how well pegylated arginine deiminase works in treating patients with metastatic melanoma that cannot be removed by surgery.

OBJECTIVES:

Primary:

* Determine the clinical response (complete and partial response) in patients with unresectable metastatic melanoma treated with pegylated arginine deiminase.

Secondary:

* Determine the toxicity profile of this drug in these patients.
* Determine the pharmacokinetics and pharmacodynamics of this drug in these patients.
* Determine the progression-free survival and overall survival of patients treated with this drug.

OUTLINE: Patients receive pegylated arginine deiminase intramuscularly once or twice a week in weeks 1-4. Courses repeat every 4 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.

Blood samples are acquired at baseline and every 2 weeks thereafter for pharmacokinetic and pharmacodynamic studies.

After completion of study treatment, patients are followed every 3 months for 1 year, every 6 months for 5 years, and annually thereafter.

PROJECTED ACCRUAL: A total of 43 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically confirmed metastatic melanoma, meeting any of the following criteria:

  * Progressive disease after chemotherapy, radiotherapy, surgery, or immunotherapy
  * No longer responding to standard therapy OR have refused standard therapy
* Unresectable disease
* Measurable or evaluable disease
* No clinical ascites
* No symptomatic pleural effusion

PATIENT CHARACTERISTICS:

* Life expectancy ≥ 12 weeks
* Karnofsky performance status 70-100%
* Bilirubin ≤ 3.0 mg/dL
* Albumin ≥ 3.0 g/dL
* Alkaline phosphatase \< 5 times upper limit of normal (ULN)
* Serum glucose \> 60 mg/dL
* Amylase \< 1.5 times ULN
* Absolute neutrophil count \> 1,500/mm³
* Platelet count \> 100,000/mm³
* No New York Heart Association class III-IV heart failure
* No serious infection requiring treatment with antibiotics
* No known allergy to E. coli drug products (e.g., sargramostim \[GM-CSF\])
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use 2 forms of effective contraception

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
* At least 4 weeks since prior anticancer therapy
* At least 4 weeks since prior surgery and recovered
* No concurrent participation in another investigational drug study
Alcohol Detoxification in Primary Care Treatment (ADEPT)

Once someone becomes dependent on alcohol (alcoholic), the risks of complications from alcohol withdrawal when they stop drinking grow. These can include a life-threatening fit or delirium tremens (see things, become frightened). To prevent such complications, people take medication such as benzodiazepines (e.g., valium or librium) in reducing doses for about a week; this is called detoxification or 'detox.' In the UK effective alcohol treatment exists but little is known about what is the best detox medication. Alternative drugs to benzodiazepines appear to protect the brain from the toxicity of alcohol withdrawal and to reduce the likelihood of drinking again. This study will examine the feasibility of comparing medication regimens for alcohol detox for the first time in primary care. It will include a standard detox regimen (librium over 8 days) alone and together with a drug, acamprosate, that has been shown to reduce toxicity of alcohol withdrawal in preclinical models and is used after detox to help people remain sober. It will focus on the practicalities of doing such a study as well as assessing how people feel (withdrawal symptoms) and do (drinking during first month).

Aims and objectives:

To provide a framework for investigating the hypothesis that for those patients undergoing alcohol detox in primary care adding acamprosate to a reducing regimen of a benzodiazepine (chlordiazepoxide) provides better symptom control during detox compared with benzodiazepine alone. In addition we will assess improvement in sleep, drinking outcomes, completion rates and cognitive performance.

Specific primary aim:

This feasibility study aims to inform a full application for an RCT to compare the effectiveness and cost-effectiveness of acamprosate as an adjunctive treatment for benzodiazepines for alcohol detox in primary care.

Key objectives are to:

1. determine the optimal method of recruiting patients in primary care and estimate likely recruitment rate
2. investigate feasibility of completion of and variation in our proposed primary outcome measure in the community - Clinical Institute of Withdrawal Scale-Alcohol (symptoms during detox), and secondary outcome measures - drinking during first month (via diary to derive % days abstinent), completion of detox, sleep and cognitive performance.
3. investigate patient and GP acceptability of this randomised trial using qualitative measures.

Eligibility Criteria:
Inclusion Criteria:

* Anyone (18-65 years old) consulting their GP for whom a community based alcohol detox requiring medication is appropriate.
* Due to acamprosate's license for maintaining abstinence, nobody under the age of 18 and over 65 will be recruited.

Exclusion Criteria:

* Unsuitable for home/community detox, e.g., with current or significant history of:

  * delirium tremens or seizures
  * current or history of high dose polydrug use
  * significant medical or psychiatric ill health
  * pregnant or breast feeding
  * Wernicke's encephalopathy