cyrilzakka/clinical-trials huggingface dataset:
Impact of Amyloidosis on TAVI Patients

To analyze the prevalence and impact on the prognosis of amyloidosis due to transthyretin in patients with severe aortic stenosis who undergo percutaneous aortic valve implantation.

Type and design of the study: Multicentric, prospective cohort, observational.

Number and characteristics of the patients: 321 patients to whom TAVI has been implanted due to severe degenerative AS.

Duration of the study

* Recruitment period: All consecutive patients undergoing a non-invasive diagnostic study of amyloidosis (scintigraphy with technetium pyrophosphate99 and blood protein electrophoresis) will be recruited before discharge, in centers with proven experience, will accept non-invasive diagnosis with resonance) and have an implanted percutaneous aortic prosthesis for severe aortic stenosis.
* Follow-up period: clinical and echocardiographic follow-up will be carried out before discharge, in consultation at three, six, twelve and twenty-four months.

Inclusion: 1 year

Follow up: 2 years

Data analysis: 6 months

Total: 3 years and 6 months

Events

* Main event: cardiovascular events (cardiovascular death, stroke, infarction)
* Secondary events: death from any cause, readmission due to heart failure, pacemaker implantation, functional class evaluation

Countries and participating centers: Various Spanish and international centers will be invited to participate.

Eligibility Criteria:
Inclusion Criteria:

* Aortic valve replacement with a percutaneous prosthesis due to severe aortic stenosis after evaluation by the Heart Team.
* Ability to understand and sign informed consent.
* They do not meet any of the exclusion criteria.

Exclusion Criteria:

* Death as a complication of the procedure during hospitalization.
* Associated mitral valve disease requiring intervention
* TAVI valve-in-valve implant.
* Does not sign informed consent.
Compassion-Focused Therapy for Distressing Mood Swings: A Case Series

The goal of this case series is to investigate whether a brief compassion-focused intervention is a safe, acceptable and feasible therapy for clients with bipolar affective disorder. The secondary questions are whether a brief compassion focused intervention for BPD clients is associated with changes in bipolar mood symptoms and/ or with changes in psychological processes linked to mood symptoms in bipolar, including: Self-compassion, perfectionism, social comparison and social safeness. Four visual analogue scales will also be completed daily by each participant throughout the project. These scales will measure domains relevant to BPAD symptomology and self-compassion.

Participants will complete a 4 session Compassion-Focused Therapy Intervention. The first session will involve completion of the psychoeducation and formulation work which was started during the initial assessment session. Each intervention session will also involve the introduction and practice of CFT techniques or exercises. The trial therapist will introduce the exercise and practice it together with the participant during the session. Participants will then be asked to continue practicing the exercises for homework. Their experience of the practice and any difficulties can then be discussed at the start of the next session.


Eligibility Criteria:
Inclusion Criteria:

* Adults (18 years and older)
* Diagnosis of Bipolar Affective Disorder

Exclusion Criteria:

* Client considered to be actively at acute risk - judgement made by responsible clinical team and also by risk assessment at our first assessment session. High risk clients are excluded as due to time constraints it will be difficult to address risk issues and complete the intervention in the short time frame we have outlined.
* Client already receiving some form of CFT intervention, as this be a potential confounder.
* Level of English not strong enough to complete assessment and intervention sessions without use of interpreter. Again, due to time constraints it would be difficult to complete the intervention with clients in the timeframe outline whilst using an interpreter or navigating the language barrier.
Drug-Coated Chocolate PTA Balloon in Patients With Peripheral Arterial Disease - The ENDURE Trial

This first-in-man study is to evaluate the Drug-Coated Chocolate (DCC) Balloon for percutaneous arterial angioplasty in patients with symptomatic peripheral arterial disease. The study focuses on acute device performance and peri-procedural safety and also seeks to further characterize the performance of the device.

This is a prospective, multi-center, single-arm study. Symptomatic lower extremity Peripheral Arterial Disease (PAD) patients presenting for endovascular revascularization will be enrolled in the study if they meet all entry criteria. The study will include patients from New Zealand and the European Union. The endpoints were designed to establish safety of the DCC and to identify long-term clinical benefits of this technology.

The patients treated in this study will be designated into the above the knee (ATK) follow-up schedule if they are treated with the DCC in the SFA or Popliteal vessels. This schedule calls for clinical visits with duplex ultrasounds at 1,6 and 12 months. Patients will be designated into the below the knee (BTK) follow-up schedule if they are treated with the DCC in the Peroneal, Anterior Tibial, Posterior Tibial or Pedal vessels. These patients will have clinical visits at 1, 3 and 6 months with duplex ultrasound at the 1 and 6 months visits only.

Eligibility Criteria:
Key Inclusion Criteria:

* Intermittent claudication or critical limb ischemia
* Atherosclerotic target lesion \>70% stenosis
* Reference vessel diameter (RVD) between 2.0 and 6.0mm
* Angiographic evidence of distal run-off
* Target lesion length \<150mm that consists of no more than two adjacent lesions( \< 25mm apart) and is able to be completely covered with inflation of no more than two DCC devices

Key Exclusion Criteria:

* Acute limb ischemia or thrombolytic therapy
* Known and relevant allergies/hypersensitivities
* Known impaired renal function
* Known bleeding disorder
* Severe calcification at the target lesion
* Previous bypass or stent at, or proximal to, target vessel
* Aneurysm in target limb
* Prior major limb amputation
* Use of a any of the following: re-entry device, atherectomy, laser or other ablation procedure, or cutting/scoring balloon at the target lesion; use of drug eluting stent, or non-study drug coated balloon in the target limb.
A Phase III Study Evaluating The Efficacy and Safety of HSK3486 for Sedation or Anesthesia

This is a Phase III, randomized, double-blind, propofol-controlled, parallel-design, multi-center study to evaluate the efficacy and safety of HSK3486 for sedation or anesthesia in patients undergoing colonoscopy and gastroscopy.

The study will enroll approximately 280 adults. The maximum study duration is anticipated to be up to nine months.


Eligibility Criteria:
Inclusion Criteria:

1. Scheduled to undergo a diagnostic or therapeutic colonoscopy or gastroscopy;
2. Male or female patients, ASA grade I\~II, aged ≥ 18 and \< 65;
3. Body mass index (BMI) ≥ 18 and ≤ 30 kg/m2;
4. During screening and baseline, the respiratory rate ≥10 and ≤24, SpO2 when inhaling ≥95%, SBP≥90mmHg, DBP≥60mmHg, HR≥60 and ≤100;
5. Patient can understand the procedure of this study and is willing to comply with study requirements. The patient can sign the ICF voluntarily.

Exclusion Criteria:

1. Patients were contraindicated in general anesthesia.
2. Patients with a known sensitivity to propofol, opioids, naloxone, eggs, soy products or a medical condition such that these agents were contraindicated.
3. The patient has some history or evidence of increased risk of sedation or anesthesia, such as cardiovascular disease, respiratory disease, cerebrovascular disease, gastrodintestinal disease and other system disease prior to the screening and/or baseline period.
4. Patients with a history of drug or ethanol abuse with the past 3 months.
5. Patients with respiratory management difficulties (Modified Mallampati grade IV).
6. Patients in receipt of any investigational drug within 30 days before screening.
7. Patients in receipt of propofol, opioid , other sedative or anesthetic or analgesics within 72 hours prior to baseline.
8. Abnormal laboratory results consisting of any of the following:

1) neutrophil count≤ 1.5×109/L； 2）platelet≤ 80×109/L； 3）hemoglobin≤ 90 g/L; 4）aspartate aminotransferase≥ 1.5×ULN； 5）total bilirubin≥ 1.5×ULN； 6） serum creatinine≥ 1.2×ULN. 9. Pregnant women or female patients with a positive serum or urine human chorionic gonadotropin pregnancy test at screening or baseline or lactating female patients.

10. Patients with an inability to communicate well with the investigator, or deemed unsuitable according to the investigator (in each case providing a reason).
Bowel Preparation in Minimally Invasive Gynecologic Surgery

This is a prospective randomized study of patients who are scheduled to undergo minimally invasive robotic gynecologic surgery. Patients will be randomized to require either pre-surgical bowel preparation vs. no bowel preparation. The effect of bowel preparation on intraoperative visualization, bowel handling, intestinal load and ease of surgery will be assessed. Patient comfort and satisfaction will be assessed.

Bowel preparation prior to gynecologic surgery is a common practice based more on assumptions than evidence. Expert opinion rules over evidence regarding its utility and necessity. The objective of this study is to determine if there is an association between the use of bowel preparation in minimally invasive gynecologic surgery and the ease of the surgery. This is a randomized controlled trial of adult patients of Dr. Muhammad Aslam who are scheduled to undergo minimally invasive robotic gynecologic surgery at Henry Ford St. John Hospital and Henry Ford Macomb-Oakland Hospital-Warren Campus. Patients will be randomly assigned to receive or not receive instructions to perform bowel preparation one day prior to surgery using an over-the-counter Fleet® saline enema. Data to be collected include demographics, body mass index (BMI), parity, and surgical history. Data collection from patients will be performed on postoperative day one prior to discharge from the hospital. Data collection will include patient satisfaction with having to use or not using bowel preparation for surgery and pain control. Dr. Aslam will complete a survey following each surgery about intraoperative visualization, bowel handling, intestinal load, and the overall ease of surgery. According to the power analysis, at least 75 subjects will be needed in each group, for a total of 150. To account for attrition, the sample size will be inflated by 10% plus an additional one subject, to maintain an even number of subjects (166 subjects). Three hundred patients may need to be initially screened to obtain 166. Univariable analysis of factors associated with the bowel preparation group will be assessed using Student's t-test and chi-squared analysis. Multivariable analysis of acceptable bowel preparation will be done using logistic regression.

Eligibility Criteria:
Inclusion Criteria:

* Scheduled to undergo minimally invasive robotic gynecologic surgery;
* Age 18 years and above
* Willing to perform an enema if randomized to the enema group
* Able to read and understand English
* Willing to sign an informed consent form

Exclusion Criteria:

* Scheduled for open surgery
* Younger than 18 years of age
* Unwilling to perform an enema if randomized to the enema group
* Unable to read and understand English
* Unwilling to sign an informed consent form
Aromatase Plus GnRH Analogue Versus GnRH Analog Alone in Adenomyosis

With this study the investigators want to test which is the best medical treatment for symptomatic adenomyosis affecting women undergoing IVF and with previous implantation failure, between Aromatase inhibitor plus GnRH analog versus GnRH alone, in term pregnancy rate and uterine volume reduction.

Recently it has been shown that adenomyosis negatively affects the pregnancy rate in IVF cycles. The investigators used in the past for the treatment of other benign gynecological diseases such as endometriosis and uterine myomas a combined therapy with Aromatase inhibitor plus GnRH analog. With this study the investigators want evaluate which is the best way to treat adenomyosis in order to obtain a higher pregnancy rate in women with symptomatic adenomyosis undergoing IVF who failed a previous IVF attempt. For these reasons the investigators set this controlled trial between GnRH analog plus Aromatase Inhibitor (3.75 mg monthly of Leuprolide plus 1.0mg day of Anastrazole for 3 months) versus an active comparator as GnRH analog alone (3.75 mg monthly of Leuprolide for 3 months) after the treatment patients will undergo embryo transfer of a cryopreserved blastocyst in a previous IVF cycle, and will be followed up for uterine dimension reduction and pain symptom reduction.

Eligibility Criteria:
Inclusion Criteria:

* women with healty conditions
* Adenomyosis
* increased uterine dimensions
* recurrent implantation failure

Exclusion Criteria:

* presence of systemic diseases
Simplified Insulin Regimen for the Elderly

Basal-bolus insulin therapy, which includes one injection of long acting insulin and three injections of short acting insulin is the most commonly used insulin treatment. However, many older patients find the basal-bolus insulin regimen hard to manage because it involves 4 injections and 4 blood glucose tests each day. It is possible that a simplified treatment that involves one injection of long acting insulin daily and two blood glucose tests daily might be equally effective. This simplified regimen, if effective, would be easier to use and might result in less errors. Therefore, the investigators want to conduct this study to compare using a single daily injection of basal insulin with the usual basal-bolus insulin regimen in elderly patients (age \>65 years) with type 2 diabetes.


Eligibility Criteria:
Inclusion Criteria:

-Age \>65 years

Exclusion Criteria:

* Unable to provide informed consent
* Enrollment in another research study
* History of hypoglycemia unawareness
* Pregnant women
* Prisoners
Neoadjuvant Temozolomide Combined With Simultaneous IMRT for Treatment of Glioblastoma

This study is a prospective, multi-center, randomized controlled clinical study. Indications: Glioblastoma diagnosed after surgery (WHO grade IV). The patient received conventional postoperative concurrent radiotherapy and chemotherapy, or neoadjuvant temozolomide combined with concurrent increased intensity-modulated radiotherapy. According to data from previous clinical trials, conventional doses of concurrent radiotherapy and chemotherapy PFS 6.9 months neoadjuvant temozolomide combined with concurrently increased intensity-modulated radiotherapy PFS 13.7 months, an estimated 20% leakage rate, and a total sample size of 80 patients.


Eligibility Criteria:
Inclusion Criteria:

* Age: 18 to 70 years old
* A patient with high-grade (WHO grade IV) glioma diagnosed pathologically
* ECOG score ≤ 3 points
* The expected survival time is greater than 3 months
* Patients undergoing surgery for the first time
* Patients who have not received radiotherapy at the treatment site in the past
* The following hematological indicators need to be met Neutrophil count ≥1.5×109/L Hemoglobin ≥9g/dL Platelet count ≥70×109/L
* The following biochemical indicators need to be met Total bilirubin≤1.5×upper limit of normal (ULN) AST and ALT\<1.5×ULN Creatinine clearance rate ≥60ml/min
* Patients of childbearing age need to take appropriate protective measures (contraception or other methods of birth control) before enrollment and during the trial
* The signed informed consent form
* Ability to follow research protocols and follow-up procedures

Exclusion Criteria:

* Patients with recurrent glioma who have previously undergone surgery or radiotherapy and chemotherapy
* Glioma of the spinal cord
* ECOG score\> 3 points
* Severe mental symptoms; uncontrollable status epilepticus
* Patients with malignant tumors in other parts
* The patient has an active bacterial, viral or fungal infection (≥ Grade 2 NCI-CTC, 4th edition)
* The patient has severe liver and kidney dysfunction, HIV infection, HCV infection, uncontrollable coronary artery disease or asthma, uncontrollable cerebrovascular disease or other diseases that the researcher thinks cannot be included in the group
* Pregnant and lactating women. Women of childbearing age must have a negative pregnancy test within 7 days before joining the group
* Drug abuse, clinical, psychological or social factors affect informed consent or research implementation
* Any uncertain factors that affect the safety or compliance of patients
A Multicenter Randomized Trial Comparing IM Nails and Plate Fixation in Distal Femur Fractures

This study looks at two (2) types of surgical treatments and hopes to answer the question, "which is the best way to surgically treat a distal femur fracture?" Both procedures being studied are standard of care (used routinely) and use FDA approved devices. All medical and surgical treatment will be the same for participants as non-participants.

The study is a randomized controlled multicenter trial in which individuals sustaining a fracture of the supracondylar (metaphyseal) region of the distal femur will be operatively managed by one of two strategies. The first strategy involves fixation of the fracture with a reamed, interlocking intramedullary nail (Nail Group). The second treatment strategy involves open reduction and internal fixation of the fracture with a locking periarticular plate (Plate Group). The null hypothesis of the study is that there will be no difference in the two groups with respect to the primary and secondary outcome measures. To the degree possible, patients in the two groups will receive post-operative care according to the same standards and protocols.

Eligibility Criteria:
Inclusion Criteria:

* Skeletally mature
* Fracture of the metaphyseal distal femur with or without intra-articular extension and with or without a TKA
* Fracture requiring operative treatment amenable to either IM nail or plate
* Informed consent obtained
* Patient is English speaking

Exclusion Criteria:

* Fracture of the metaphyseal distal femur with intra-articular communition,
* Fracture with vascular injury (Gustillo Type IIIC injury) requiring repair,
* Pathological fracture,
* Known metabolic bone disease,
* Contralateral distal femur fractures (bilateral injury) or ipsilateral lower extremity injury that would compromise function of the knee
* Retained hardware or existing deformity in the affected limb that would complicate IM nailing or plating
* Symptomatic knee arthritis
* Soft tissue injuries compromising either treatment method with nail or plate
* Surgical delay greater than 3 weeks for closed fractures or 24 hours for open fractures
* Immunocompromised
* Unable to comply with postoperative rehabilitation protocols or instructions (i.e. head injured or mentally impaired)
* Current or impending incarceration
* Unlikely to follow-up in surgeon's estimation
Mechanized Instrumentation for Endodontic Treatment of Primary Teeth

Mechanized instrumentation systems stand out amongst various devices used in modern Endodontics. Its use in Pediatric Dentistry, its action in primary teeth, has been in the center of many discussions and laboratory studies. Nevertheless, up to now, a lack of clinical studies on this issue can be found. Our objective is to conduct a double blinded, 2 years follow up clinical trial to compare the success of endodontic treatment in primary teeth using mechanized reciprocating instrumentation to the use of manual instrumentation.

With the approval of the Ethics Committee of University of São Paulo, after clinical and radiographic examination, patients in search for endodontic treatment in primary teeth will be invited to take part in the study. The participants of the study will be randomized to one of two groups (manual or reciprocating instrumentation). Endodontic treatment will be held by a specialist according to the randomized group. A blinded examiner will proceed one week, 3 months, 6 months, 12 months and 24 months follow ups. Clinical and radiographic conditions of endodontic treatments will be analyzed to classify them as Success or Failure. The unit of analysis will be the teeth; hence, each participant may have more than one tooth included in the study. The randomization will be performed considering the tooth. Data analysis will consider the cluster nature of the sample.

The primary outcome of the study will be the success rates according to the groups. The longevity of treatments will be evaluated by estimating survival rates by Kaplan-Meier and Cox regression. The differences between survival rates of both groups will be through Cox regression adjusted for the cluster nature of the sample (more than one tooth per participant), considering a level of significance of 5%.

Eligibility Criteria:
Inclusion Criteria:

* Primary molar teeth with necessity of endodontic treatment.
* Patients whose parents or guardians consent to their participation in the study

Exclusion Criteria:

Teeth presenting one of the following:

* Resorption of more than 2/3 of the root
* Destruction of the crypt of the permanent successor
* Pulp chamber floor drilling.
* Presence of internal resorption
Study of Platinum Plus Etoposide With or Without Tislelizumab in Participants With Untreated Extensive-Stage Small Cell Lung Cancer

This Phase 3 study was a randomized, double-blind, placebo-controlled, multicenter trial designed to evaluate the efficacy of tislelizumab in combination with either cisplatin or carboplatin and etoposide (Arm A), compared to placebo combined with either cisplatin or carboplatin and etoposide (Arm B), as a first-line treatment for participants with previously untreated extensive-stage small cell lung cancer (ES-SCLC).


Eligibility Criteria:
Key Inclusion Criteria:

1. Age≥18 years old, male or female, signed Informed Consent Form (ICF).
2. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
3. Histologically or cytologically confirmed ES-SCLC
4. No prior systemic treatment for ES-SCLC
5. Adequate hematologic and end organ function

Key Exclusion Criteria:

1. Active leptomeningeal disease or uncontrolled, untreated brain metastasis;
2. Prior therapy with an antibody or drug against immune checkpoint pathways, including but not limited to, anti program death receptor-1 (anti-PD-1), anti-PD-L1, or anti cytotoxic T lymphocyte associated antigen 4 (anti CTLA-4) antibody;
3. Was administered a live vaccine ≤ 4 weeks before randomization;
4. Active autoimmune diseases or history of autoimmune diseases that may relapse
5. Any condition that required systemic treatment with either corticosteroids or other immunosuppressive medication ≤ 14 days before randomization;
6. With a history of interstitial lung disease, non-infectious pneumonitis, or uncontrolled systemic diseases;
7. Severe chronic or active infections requiring systemic antibacterial, antifungal or antiviral therapy within 2 weeks prior to randomization, including but not limited to tuberculosis infection;
8. Participant with untreated hepatitis B virus (HBV)/hepatitis C virus (HCV), or a known history of HIV infection;
9. Participants with toxicities (as a result of prior anticancer therapy) which have not recovered to baseline or stabilized at the time of randomization;
10. Clinically significant pericardial effusion, or Clinically uncontrolled pleural effusion

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.