cyrilzakka/clinical-trials huggingface dataset:
Safety and Accuracy of the Saranas EBBMS for the Detection of Endovascular Procedure Related Bleeding Events

To evaluate the safety and accuracy of the Saranas EBBMS for the detection of access site related internal bleeding events during large-bore endovascular procedures.


Eligibility Criteria:
Inclusion Criteria:

* ≥18 years of age
* Willing and capable to sign an Informed Consent form
* Planned endovascular procedure such as trans-femoral transcatheter aortic valve replacement (TAVR), balloon aortic valvuloplasty, percutaneous coronary intervention, complex or high-risk percutaneous coronary intervention requiring hemodynamic support device (Impella 2.5, Impella CP, and ECMO), endovascular aortic repair (EVAR), any other endovascular procedures requiring arterial or venous access or surgical insertion of hemodynamic support

Exclusion Criteria:

* Subject is participating, or planning to participate in a clinical trial or study of an investigational product that may influence the data collected for this investigation
* Inability to access artery or vein for the endovascular procedure
* Current active bleeding
* Pre-procedural conditions precluding the realization of a post-procedural CT scan
* Pregnancy
* Mental disability or any other lack of fitness, in the Investigator's opinion, to preclude subject's participation in or ability to complete the study as planned
Dasatinib in Imatinib Resistant/Intolerant Chinese CML (Chronic and Advanced Phase) Subjects

The primary objective of this study is to estimate the major cytogenetic response (MCyR) rate to Dasatinib in subjects with CP CML, complete and overall hematologic response (CHR and OHR) rate in subjects with AD CML or Ph+ ALL who have primary or acquired resistance to imatinib, or are intolerant of imatinib, when administered at 100 mg QD (Chronic CML) or 70mg BID (AP CML and Ph+ALL).


Eligibility Criteria:
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

* Signed Written Informed Consent
* Men and women, ages 18 years of age or older
* Subjects with Chronic Phase (CP) or Advanced Disease (AD) chronic myeloid leukemia (CML)/Ph+ Acute Lymphoblastic Leukemia (Ph+ ALL)
* Subjects resistant/intolerant to imatinib
* Subjects presenting:

  1. Eastern Cooperative Oncology Group (ECOG) performance status (PS) score 0-2
  2. Adequate hepatic function
  3. Adequate renal function
  4. Sodium, Potassium, Magnesium, Phosphorus, Calcium higher or equal than the lower limit of normal range

Exclusion Criteria:

* Women of child bearing potential who are not using adequate birth control
* Women who are pregnant or breastfeeding
* Subjects eligible for stem cell transplantation
* Serious uncontrolled medical disorder or active infection
* Uncontrolled or significant cardiovascular disease
* Concurrent incurable malignancy other than CML
* Subjects who received imatinib, interferon, cytarabine within 7 days or other antineoplastic agents other than hydroxyurea within 14 days before dasatinib, Dasatinib in the past
* History of significant bleeding unrelated to CML
Local Continuous Wound Infusion of Anesthetics in the Management of Post-operative Pain After Total Hip Arthroplasty.

The combination of subarachnoid anaesthesia (SAB) and continuous local wound infiltration (LCWI) with a consistent amount of local anaesthetics could prevent central sensitization through an additive or synergistic effect because it can maintain continuous inhibition of nociceptive afferents

Wound infiltration with local anesthetics is an analgesic technique that has been adopted for post-operative analgesia following a range of surgical orthopaedic procedures. Pain management by infusion of local aesthetic into wounds was found to improve pain, reduced opioid use and side effects, increase patient satisfaction, and shorten the hospital stay when compared to placebo or no treatment, but actually it was not definitively proven that wound infiltration provides additional analgesic or outcome benefit in the setting of a comprehensive multimodal analgesic approach. The hypothesis of this study is that a consistent amount of Levobupivacaine 0.5% for LCWI and LIA could provide a more extended postoperative analgesia for post-operative incident and rest pain with a better post-operative recovery and rehabilitation following THA, in the first 72 hours after surgery.

Eligibility Criteria:
Inclusion Criteria:

* 18-90 years of age
* American Society of Anaesthesiologists (ASA) physical status I-III
* total hip arthroplasty.

Exclusion Criteria:

* pregnancy
* body mass index (BMI) \>35
* allergy to local anaesthetics
* skeletal and/or muscle abnormalities of the spine
* primary and/or secondary neurological diseases
* psychiatric diseases
* history of chronic pain and/or neuropathic disorders
* history of drug abuse
* state of sepsis
* infection and/or tumours within the skin on the back
* primary or secondary coagulopathies
* primary or secondary heart, liver and renal failure.
PET Scan to Study Brain Control of Human Movement

Positron Emission Tomography (PET) is a technique used to investigate activity in areas of the brain. The PET technique allows researchers to study the normal processes in the brain (central nervous system) of normal individuals and patients with neurologic illnesses without physical / structural damage to the brain.

When a region of the brain is active, it uses more fuel in the form of oxygen and sugar (glucose). As the brain uses more fuel it produces more waste products, carbon dioxide and water. Blood carries fuel to the brain and waste products away from the brain. As brain activity increases, blood flow to and from the area of activity also increases. This is known as regional cerebral blood flow (rCBF). Knowing these facts, researchers can use radioactive water (H215O) and PET scans to observe what areas of the brain are receiving more blood flow.

In this study researchers plan to investigate the changes in regional cerebral blood flow (rCBF) as patients participate in different activities. The activities are designed to stimulate the areas of the brain responsible for voluntary motor activity and sensation. By comparing the results of PET scans performed in different conditions, researchers can locate regions of the brain responsible for specific tasks.

This study should provide new information about voluntary movements in humans and the preparation involved in controlling them.

The main purpose of the studies presented in this protocol is to investigate the physiology of motor control in health as well as the pathophysiological modifications taking place during disease. To this end, we will investigate changes in regional cerebral blood flow (rCBF) as an index of regional neuronal activity, associated with various motor and sensory tasks using Positron Emission Tomography (PET). The rCBF will be obtained by measuring the distribution of the cerebral radioactivity during emission scans following the intravenous bolus injection of 15O-labeled water. The very short half-life of 15O (2 minutes) allows us to measure rCBF repeatedly under different task conditions (see methodology and experimental procedures). With the comparison between PET scans performed in different conditions, we can detect the specific task-related activated regions. PET images will be coregistered to high resolution Magnetic Resonance Images (MRI) to get more accurate anatomical information regarding the activated areas. The results will be correlated with that from other physiological approaches including Electroencephalography (EEG), Transcranial Magnetic Stimulation (TMS), functional Magnetic Resonance Imaging (fMRI), and Magnetic Resonance Spectroscopy (MRS). These studies should provide new information not only about the executive component of the voluntary movements in humans but also the different organizational aspects of the preparatory processes that control them.

Eligibility Criteria:
Patients with movement disorder and normal volunteers.
IGEV Followed by Autologous Transplantation for Refractory or Relapsed Hodgkin Lymphoma

The aim of study is to prove IGEV regimen followed by autologous stem cell transplantation as salvage treatment in patients with refractory or relapsed Hodgkin lymphoma is effective.

The standard treatment in patients with refractory or relapsed Hodgkin lymphoma is salvage chemotherapy followed by autologous transplantation for responsive patients. However, the standard of salvage chemotherapy remains uncertain. This study is to evaluate the efficacy and safety of IGEV regimen in a single-center basis.

Eligibility Criteria:
Inclusion Criteria:

* Age range: 18-65 years old
* Histological confirmed refractory or relapsed Hodgkin lymphoma
* With at least one site of measurable disease according to IWC criteria
* ECOG performance status 0-1
* Life expectancy of more than 3 months
* Bone marrow function: ANC≧1.5×109/L, PLT≧100×109/L, Hb≧80g/L
* Liver function: total bilirubin, ALT and AST \<1.5×UNL
* Renal function: Cr\<1.5×UNL, CCR≧45ml/min
* No contraindication for transplantation

Exclusion Criteria:

* No prior chemotherapy
* With more than 2 lines of prior chemotherapy exposure
* Evidence of CNS and bone marrow involvement
* History of other malignancies except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix
* Pregnant or lactating women
* Significant active infection
Out Patient Talc Slurry Via Indwelling Pleural Catheter for Malignant Pleural Effusion Vs Usual Inpatient Management

This is a multicentre randomised controlled trial evaluating global health related quality of life outcomes in patients with malignant pleural effusions. Patients will be randomised to receive either chest drain and talc pleurodesis or indwelling pleural catheter and talc pleurodesis. Patients will be followed up for 3 months post intervention


Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis of malignant pleural effusion
2. WHO performance status 2 or less unless performance status is impaired by presence of effusion and likely to significantly improve with drainage
3. Expected survival greater than 3 months

Exclusion Criteria:

1. Age less than 18 years old
2. Pregnant or lactating
3. Known allergy to Talc or Lignocaine
4. Lack of symptomatic relief from effusion drainage
5. At least twice weekly drainage cannot be undertaken
6. Lymphoma or small cell carcinoma except\*:

   1. Failure of chemotherapy
   2. Deemed for palliative management
7. Non malignant effusions
8. Loculated pleural effusion
9. Unable to provide written informed consent to trial participation
Targeting Interventions at Venues Where Risk of HIV Transmission is High

The aim of this study is to investigate whether distribution of condoms and condom demonstrations by youth peer educators in venues where people meet new sexual partners in Livingstone, Zambia, leads to increased condom use among guests socializing in these venues.

In countries where the HIV prevalence is high, focusing on high risk places such as venues where people meet new sexual partners is probably more effective in reducing the transmission rate of HIV than targeting interventions just at perceived high risk groups. A survey conducted in 2005 in places where people met new sexual partners in Livingstone found that guests socializing there were engaging in high risk sex, but condoms were not always available in the venues. In this intervention study, youth peer educators will distribute condoms and demonstrate condom use in venues where people meet new sexual partners. After the intervention has run for a year, condom use among guests socializing in such venues in the intervention township will be compared with condom use among people socializing in similar venues in a comparison township.

Eligibility Criteria:
Inclusion Criteria:

* Socializing in a venue where people are said to be meeting new sexual partners
* Age 18 years and above

Exclusion Criteria:

* Too drunk to give sensible answers
Functional Links Between the Temporomandibular Joint and the Pelvis in Gynecology

1 Recruitment. 2. Collection of written consents for the study. 3. Random assignment to groups with and without intervention. 4. Completion of questionnaires by study participants, postural pattern assessment, temporomandibular joint assessment, and platform assessment.

5. Performance of visceral therapy in the group with intervention, in the group without intervention placebo. Duration 5 weeks, treatment 1x per week at the same time of day and given day e.g. Mondays only.

6. Reassessment as in step 4. 7. Data collection, statistical analyses. 8. Interpretation of results for female participants. 9. Preparation of results for scientific publications.

Methods

After taking a detailed history, patients will be asked to:

1. Completing: the SF-36 quality of life assessment questionnaire and Female Sexual Function Index assessment, and marking on a numerical scale their pain sensations for the temporomandibular joint and for the pelvis, World Health Organization Quality of Life BREF (WHOQOL-BREF).

   The SF-36 questionnaire, FSFI scale, World Health Organization Quality of Life BREF (WHOQOL-BREF) and numerical scale (assessing pain sensations for the temporomandibular joint and pelvic joint), will also be subjected to completion/checking after the completion of manual visceral treatments in groups with physiotherapy intervention for both conditions.
2. Type of postural pattern according to Hall-Wernham-Littlejohn: type I - normal, type II - anterior pelvic tilt, type III - posterior pelvic tilt.

3 Pelvic type assessment: normal, high, low; pelvic type will be assessed in each patient and in groups with physiotherapeutic intervention for both conditions before and after manual visceral treatments.

4. Assessment of mobility in the temporomandibular joints in the sagittal plane CromWell digital caliper, and diagnosis using standardized protocols.

5. Postural assessment on the Posturomed Technomex platform and Podoscope Sensor Medica.

6. 6.Manual visceral treatments The treatments will be performed after the patient is qualified by the obstetrician-gynecologist specialist.

7. After performing techniques and placebo in both groups, filling out questionnaires again, measuring on the platform, pattern posture..

8. Statistical analysis: upon completion of the study, the collected quantitative and qualitative data will be subjected to statistical analysis. The choice of statistical tools will depend on the obtained probability distribution.

Eligibility Criteria:
Inclusion Criteria:

1. Written consent to participate in the study.
2. Female patients after surgical treatment with prolapse of reproductive organs and diagnosed endometriosis.

Exclusion Criteria:

1. No written consent to participate in the study.
2. Cancer.
3. Injury to the temporomandibular joint and pelvis.
4. Fibromyalgia.
5. Rheumatic diseases.
6. At each stage of the experiment if the patient decides that she does not want to participate she is excluded.
Preoperative Chemoradiotherapy for Locally Advanced Resectable Gastric Adenocarcinoma

Gastric cancer is a high incidence in Asia, and one of the leading cause of death in Korea. A cure rate is improving due to early diagnosis. However, the 5-year survival rate of gastric cancer excluding early gastric cancer is about 40 \~ 67%. Therefore, several methods for lowering the recurrence rate have been attempted and concurrent chemoradiotherapy can be considered as a method to lower the recurrence rate of gastric cancer. The purpose of this study is to evaluate the pathologic response rate and safety of patients who underwent surgery after chemoradiotherapy.

Gastric cancer is a high incidence in Asia, and one of the leading cause of death in Korea. A cure rate is improving due to early diagnosis. However, the 5-year survival rate of gastric cancer excluding early gastric cancer is about 40 \~ 67%. Therefore, several methods for lowering the recurrence rate have been attempted and concurrent chemoradiotherapy can be considered as a method to lower the recurrence rate of gastric cancer. The purpose of this study is to evaluate the pathologic response rate and safety of patients who underwent surgery after chemoradiotherapy.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 20 years old
2. Histologically confirmed gastric adenocarcinoma
3. clinical stage : resectable gastric cancer

   * advanced confirmed (EGD)
   * extramural infiltration\> 1 mm (CT)
   * positive serosa invasion (EUS)
4. Eastern Cooperative Oncology Group performance status 0 or 1
5. no prior chemotherapy and radiotherapy
6. measurable lesion or evaluable lesion according to Response Evaluation Criteria in Solid Tumors version 1.1 criteria
7. Patients with adequate organ function
8. Signed informed consent

Exclusion Criteria:

1. Metastasis esophageal invasion \> 3cm
2. inoperable peritoneal seeding disease determined by exploratory laparotomy
3. T4b invading the surrounding organs
4. lymph node metastasis outside the celiac trunk Lymph node and splenic lymph node
5. uncontrolled viral infections (HIV, HBV, HCV)
6. Pregnant or lactating women, women of childbearing potential not employing adequate contraception
7. severe hypersensitivity reactions to S-1, cisplatin
8. Subjects with uncontrolled clinically significant cardiovascular medical history, uncontrolled infection or complication
9. Other co-existing malignancies or malignancies diagnosed within the last 5 years except for curatively treated non-melanoma skin cancer or in situ carcinoma of the cervix
The Effect of Hot Pack Application on Postoperative Ileus Undergoing Surgery for Gynecologic Malignancies

Postoperative ileus (POI), is an extensively known complication characterized by an impairment of normal gastrointestinal motor activity after abdominal surgery and may also occur after surgery at other sites due to non-mechanical causes. \[1\]. This clinical asset has been linked to prominent perioperative morbidity with the following financial burden owing to extended hospitalization \[1\]. Furthermore, POI can postpone adjuvant treatments, such as chemotherapy in patients who went through surgery for cancers.

Abdominal tenderness and distension, nausea and vomiting, delay in the passage of flatus and stool, and intolerance to solid food are the prime symptoms of POI \[1-3\]. It is generally transient, but if prolonged, can cause surgical incision dehiscence, intestinal anastomotic fistula, abdominal cavity infection, intestinal ischemia, aspiration pneumonia, and other serious complications \[4-6\]. Hence, many clinicians have focused on averting POI. Many studies have analyzed preventive methods, such as preoperative mobilization of the patient, adequate pain control, gum chewing, epidural anesthesia, coffee consumption, and motility agents such as metoclopramide and alvimopan \[7-15\]. For all the manifold remedy approaches, POI maintains a difficult clinical challenge that compromises the rapid improvement of patients who underwent abdominal surgery.

Recently, thermal attempts have been employs for several situations such as inflammatory bowel disease, chronic pelvic pain, and abdominal pain \[16\]. It may be used in two different ways; whole body or local. Local thermal therapy can be carried out by hot pack or paraffin \[17\]. It has been demonstrated that local thermotherapy abate myotonia, enhances circulation, and eases pain by expediting the removal of the pain-producing substance. Local thermal therapy is widely used for a number of conditions such as pain, nausea, vomiting, and some bowel diseases in traditional Chinese medicine \[18\].


Eligibility Criteria:
Inclusion Criteria:

* patiens aith aged ≥18 years olds
* patients undergoing elective exhaustive staging surgery (total hysterectomy (Type A-C2), systematic pelvic para-aortic lymphadenectomy ± bilateral salpingo-oophorectomy and ± omentectomy by abdominal approach containing either open or laparoscopic surgery.

Exclusion Criteria:

* ASA score \>3,
* chronic constipation (defined as ≤2 bowel movements per week),
* inflammatory bowel disease,
* irritable bowel syndrome,
* compromised liver function,
* clinically significant cardiac arrhythmia,
* Thyroid disorder,
* History of abdominal bowel surgery,
* previous abdominal irradiation,
* previous neoadjuvant chemotherapy or hyperthermic intraperitoneal chemotherapy,
* Performed upper abdominal surgery
* The covid-19 positive test result,
* bowel anastomosis.
The LD Lync Study - Natural History Study of Lipodystrophy Syndromes

Genetic lipodystrophy syndromes are extremely rare, orphan diseases with overall estimated prevalence of less than 2,000 in the United States. These rare disorders characterized by selective loss of adipose tissue and predisposition to insulin resistance and its metabolic complications diabetes, dyslipidemia and hepatic steatosis. Due to these metabolic problems, atherosclerotic vascular disease, recurrent episodes of acute pancreatitis, cirrhosis and other morbidities complicate the lives of these patients.

In the last few years, several genes for CGL (AGPAT2, BSCL2, CAV1 and PTRF); FPL (LMNA, PPARG, AKT2, CIDEC, LIPE, PLIN1, PCYT1A and ADRA2A); MAD (LMNA and ZMPSTE24); APS (LMNA); autoinflammatory (PSMB8); NPS (FBN1, CAV1); SHORT syndrome (PIK3R1); and MDP syndrome (POLD1) have been identified. However, there is paucity of information about the natural history of these rare syndromes, especially genotype-specific causes of morbidity and mortality.

To overcome the problems outlined above, this multicenter, collaborative, prospective, observational natural history cohort study will be conducted on approximately 500 patients with genetic or acquired lipodystrophy syndromes. Patients will be assessed on a yearly basis for approximately 5 to 7 years to collect robust clinical, metabolic, morbidity and mortality data. Medical history and patient questionnaires will be completed on a yearly basis by patients registered in the study. Clinical data such as vitals, laboratory results and anthropometric measurements will also be collected from patients' medical records if available.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of genetic lipodystrophy Supportive data: 1) Presence of biallelic known disease-causing variants in the genes for autosomal recessive lipodystrophy syndromes; 2) Presence of a known (or de novo loss of function) disease-causing variant in the genes for autosomal dominant lipodystrophy syndromes.

Exclusion Criteria:

* HIV-infected patients with lipodystrophy
* Drug-induced lipodystrophy
Vietnamese Women's Health Project III

The purpose of this protocol is to understand the extent of symptom perception and preventive care-seeking among Vietnamese American women and their impact on cervical cancer screening from the perspectives and experiences of key informants including primary health care providers and Vietnamese American women (VAW, foreign-born and United States-born). With this information, the investigators can better understand how to promote cervical cancer screening in the Vietnamese community.

No further extensive description.

Eligibility Criteria:
Inclusion Criteria:

* Primary health care providers are eligible to participate in the study if they meet the following criteria:

  * self-identify as currently practicing as a primary licensed independent practitioner including as a medical physician or nurse practitioner,
  * whose service populations include Vietnamese American women,
  * and are able to understand and speak English or Vietnamese.
* Vietnamese American women are eligible to participate in the study if they meet the following criteria:

  * self-identify as a Vietnamese American woman (foreign-born women who have immigrated to the United States from other countries or are United States-born),
  * between ages 21 to 65 years old,
  * have not had a hysterectomy,
  * and are able to understand and speak English or Vietnamese.

Exclusion Criteria:

* Not a Vietnamese American woman
* Not between the ages of 21 to 65 years old
* Had a hysterectomy