cyrilzakka/clinical-trials huggingface dataset:
Fertility in Young Adults Who Did (Not) Store Testicular Tissue Before a Treatment Leading to Fertility Problems

The goal of this prospective comparative interventional cohort study is to assess the fertility status of young adult men (≥18 years) who received gonadotoxic treatment during childhood for the treatment of cancer or hematological disorders. These treatment protocols are highly gonadotoxic (i.e. they may cause later fertility problems) and therefore these patients have been proposed to store some testicular tissue during childhood as an option to preserve their fertility.

The main questions this study aims to answer are (1) the impact of the received gonadotoxic treatment on the later fertility status and (2) the additional impact of a testicular biopsy procedure (performed at a young age to harvest testicular tissue for storage) on the future fertility.

Participants will be asked to undergo a physical examination by a fertility specialist, to undergo a scrotal ultrasound, to give a blood sample, and to provide a semen sample.

Researchers will compare the patients fertility status between the different received gonadotoxic treatment protocols, between patients who underwent a testicular biopsy procedure at a young age and those who did not, and compare the patients fertility status with the reproductive health of spontaneously conceived young adults.

See the subsequent protocol sections.

Eligibility Criteria:
Inclusion criteria

* young adult men (≥18 years)
* diagnosis of cancer or hematological disorder during childhood (\<18 years)
* high-risk gonadotoxic treatment received during childhood
* at least one year after the last received genotoxic treatment
* did/did not undergo a testicular biopsy procedure at a young age for fertility preservation

Exclusion criteria

- prepubertal patients and adolescents (\<18 years)
Safety and Efficacy of the Surpass Evolve Flow Diverter in Treating Intracranial Aneurysms

Safety and Efficacy of the Surpass Evolve Flow Diverter in Treating Intracranial Aneurysms

This study aims to retrospectively evaluate the efficacy and safety of the Surpass Evolve Flow Diverter in treating complex intracranial aneurysms. It seeks to assess long-term outcomes and complication rates while analyzing the impact of patient characteristics and aneurysm types on treatment effectiveness. By collecting data from multiple centers, the study ensures broad representativeness, ultimately providing valuable insights for clinical management on a global scale.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 years with a confirmed diagnosis of intracranial aneurysm.
2. Imaging studies confirming suitability for Surpass Evolve Flow Diverter treatment.
3. Aneurysms meeting flow diverter treatment indications (e.g., aneurysms larger than 4 mm).
4. At least six months of follow-up data available post-treatment.

Exclusion Criteria:

1. Patients with acutely ruptured aneurysms or significant bleeding.
2. Patients with incomplete data or insufficient follow-up records.
A Double-blind Randomized Clinical Trial on the Efficacy of Magnetic Sacral Roots Stimulation for the Treatment of NE

The purpose of this study is to assess the efficacy of daily sacral root magnetic stimulation for 10 sessions in patients with nocturnal enuresis.Eligible patients were randomized to receive either real or sham repetitive sacral root magnetic stimulation (rSMS; 15 Hz with a total of 1500 pulses/session) for 10 sessions. Evaluation was performed before starting treatment, immediately after the 5th and 10th treatment session, and 1 month later, using frequency of enuresis/week, visual analogue scale (VAS) and Quality of life. Cortical excitability of upper and lower limbs were done before and after the end of sessions.

The purpose of this study is to assess the efficacy of daily sacral root magnetic stimulation for 10 sessions in patients with nocturnal enuresis. Eligible patients were randomized to receive either real or sham repetitive sacral root magnetic stimulation (rSMS; 15 Hz with a total of 1500 pulses/session) for 10 sessions. Evaluation was performed before starting treatment, immediately after the 5th and 10th treatment session, and 1 month later, using frequency of enuresis/week, visual analogue scale (VAS) and Quality of life. Cortical excitability of upper and lower limbs were done before and after the end of sessions.

Eligibility Criteria:
Inclusion Criteria:

* All subjects diagnosed as patients with primary monosymptomatic nocturnal enuresis according to the Diagnostic and statistical manual of mental disorders, 4th revised edn (DSM-IV)

Exclusion Criteria:

* We exclude any patient with pacemakers or any metallic devices
* Patients with evidence of urinary tract infection.
A Single Center Study on the Effectiveness and Safety of Polyp Classification With Artificial Intelligence

This is an artificial intelligence-based optical endoscopic polyp diagnosis system that can assist endoscopic doctors in diagnosing polyps and improve the quality of training in clinical Settings.

Large sessile and laterally spreading colorectal lesions(LSLs) are increasingly encountered during colonoscopy. LSLs have an increased risk of harbouring invasive cancer and can be challenging to excise endoscopically. Wide-field endoscopic mucosal resection (WF-EMR) is widely used in treating LSLs. In the East, meanwhile endoscopic submucosal dissection (ESD) is the dominant technique due to its ability to achieve en bloc resection in over 80% of cases. Many papers have demonstrated that selective-esd has the highest economic benefit. The key is to find a reliable way to select.

Eligibility Criteria:
Inclusion Criteria:

1. male or female aged 18 or above;
2. colonoscopy and related examinations should be performed to further clarify the characteristics of digestive tract diseases;
3. be able to read, understand and sign the informed consent;
4. the researcher believes that the subject can understand the process of the clinical study, is willing and able to complete all the study procedures and follow-up visits, and cooperate with the study procedures;
5. patients with \> 1cm lesion detected by colonoscopy, requiring magnification staining or surgical resection.

Exclusion Criteria:

1. have participated in other clinical trials, signed the informed consent and have been in the follow-up period of other clinical trials;
2. drug or alcohol abuse or psychological disorder in the last 5 years;
3. pregnant or nursing women;
4. subjects with previous history of intestinal surgery;
5. the researcher considers that the subject is not suitable for colonoscopy and related examination;
6. high-risk diseases or other special conditions that the investigator considers inappropriate for the subject to participate in the clinical trial.
Diet Effect on Cancer Treatment Outcome

The study will look at the end result of 2 types of diets effect on treatment outcome of cancer patients using N-111.

The study will be evaluated during a double blind, placebo-controlled evaluation of the effect diet has on the response of patients taking N-111 who are on a vegetarian diet vs a non-vegetarian diet or a placebo. This will involve assessing the patients progress or lack thereof over a 3-month period of time as outlined in Outcome Measures section below.

Eligibility Criteria:
Inclusion Criteria:

* A positive diagnosis of breast cancer as determined by Fine Needle Biopsy or open biopsy with associated Cancer Antigen blood markers.
* Prostate cancer as determined by a Transrectal Biopsy with associated Prostate- specific antigen blood work.

Exclusion Criteria:

* •Patients without the positive diagnosis of breast or prostate cancer.
Goal-directed Mobilization of Medical Inpatients

Immobilization in general internal medicine inpatients is a major contributor to morbidity and mortality. Goal-directed mobilization (GDM) may improve mobility. The aim of this study is to assess, if GDM increases physical activity (DEMMI score) during hospitalization and improves quality of care until 3 months after hospitalization.


Eligibility Criteria:
Inclusion Criteria:

* All consenting patients aged ≥ 18 years admitted to the Department of General Internal Medicine, Inselspital, Bern University Hospital, Bern, Switzerland, who have an indication for physiotherapy (prescription by the resident in charge or the care coordinator).
* Participants must be randomized at latest on the second day after hospital admission.
* Written informed consent.

Exclusion Criteria:

* Inability to follow study procedures, i.e., due to language problems (unable to read, speak or understand German), psychological disorders, severe dementia (defined as to levels 5 - 7 in the Global Deterioration Scale), blindness, Patients unable to provide informed consent themselves
* Expected hospital stay for \< 5 days
* Medically indicated bedrest for more than 24 h, e.g. after surgery
* Injuries or neurologic deficits of one or both lower extremities directly impairing walking capacity (e.g. fractures, hemiplegia, previous use of a wheelchair or bedriddenness)
* Terminal illness
* Pregnancy or breast feeding
* Previous enrolment in this study
* Enrolment of the investigator, his/her family members, employees and other dependent persons
BASKA Laryngeal Mask Airway in Either Volume or Pressure Controlled Ventilation in Laparoscopic Cholecystectomy

this study will be undertaken to compare the efficacy of BASKA mask in volume controlled and pressure controlled ventilation in laparoscopic cholecystectomy.

Laparoscopic cholecystectomy is one of the most commonly performed surgical procedures and the laryngeal mask airway (LMA) is the most common supraglottic airway device used by the anesthesiologists to manage airway during general anesthesia. Use of LMA has some advantages when compared to endotracheal intubation, such as quick and ease of placement, a lesser requirement for neuromuscular blockade and a lower incidence of postoperative morbidity. However, the use of the LMA in laparoscopy is controversial, based on a concern about increased risk of regurgitation and pulmonary aspiration. The ability of these devices to provide optimal ventilation during laparoscopic procedures has been also questioned. The most important parameter to secure an adequate ventilation and oxygenation for the LMA under pneumoperitoneum condition is its seal pressure of airway The BASKA mask is a novel supraglottic airway device. It has many of the features of other supraglottic airways, These include; A non-inflatable cuff, that it is continuous with the central channel of the device. As the pressure increases with positive pressure ventilation, the cuff itself is 'inflated', this may improve the seal, reduce leak, and make ventilation more efficient

Eligibility Criteria:
Inclusion Criteria:

* patients scheduled for elective cholecystectomy laparoscopic surgery.
* Age: 18-60 years.
* ASA physical status: I-II.

Exclusion Criteria:

* Patient refusal.
* History of cardiac disease, psychological disorders, respiratory diseases including asthma, renal or hepatic failure.
* Patients who have high risk of regurgitation or aspiration based on history of gastro esophageal reflux, hiatus hernia, diabetes and gross obesity.
* Neck pathology.
* Patients who predicted difficult airway (based on a history of difficult airway, mouth opening was less than 2.5 cm, inter-incisor distance \< 20 mm, cervical spine pathology, modified Mallampati class III/IV, or thyromental distance \< 65 mm).
* Preoperative sore throat.
Efficacy and Safety of Novel Treatment Options for Adults With COVID-19 Pneumonia

CCAP is an investigator-initiated multicentre, randomized, double blinded, placebo-controlled trial, which aims to assess the safety and efficacy of treatment with convalescent plasma for patients with moderate-severe COVID-19.

Participants will be randomized 2:1 to two parallel treatment arms: Convalescent plasma, and intravenous placebo.

Primary outcome is a composite endpoint of all-cause mortality or need of invasive mechanical ventilation up to 28 days.

The study is a randomized, double blinded, placebo-controlled, multicenter study with two parallel treatment arms consisting of either convalescent plasma or intravenous placebo. We plan to enroll a total of 1100 patients yielding a statistical power of 80 % to show a 30% relative reduction in risk of mechanical ventilation or death at day 28. Patients with confirmed COVID-19 infection and signs compatible with pneumonia will be enrolled in the study. The participants will be randomized 2:1 to the parallel treatment arms, and receive either single dose infusion treatment.

The primary outcome is a composite endpoint of all-cause mortality or need of invasive mechanical ventilation up to 28 days. Interim analysis will be performed frequently.

As new knowledge of treatment options for COVID-19 have emerged, the treatment arms including sarilumab, baricitininb, hydroxychloroquine and oral placebo have been terminated.

Eligibility Criteria:
Inclusion Criteria:

* ≥18 years of age
* Confirmed COVID-19 infection by presence of SARS-CoV-2 nucleic acid by polymerase chain reaction (PCR)
* Evidence of pneumonia given by at least one of the following: SpO2 ≤93% on ambient air or PaO2/FiO2 \<300 mmHg/40 kPa OR Radiographic findings compatible with COVID-19 pneumonia
* For women of childbearing potential: Negative pregnancy test and willingness to use contraceptive (consistent with local regulations) during study period
* Signed Informed Consent Form by any patient capable of giving consent, or, when the patient is not capable of giving consent, by his or her legal/authorized representatives

Exclusion Criteria:

* In the opinion of the investigator, progression to death is imminent and inevitable within the next 24 hours, irrespective of the provision of treatment
* Participating in other drug clinical trials (participation in COVID-19 antiviral trials may be permitted if approved by sponsor)\*
* Pregnant or breastfeeding, positive pregnancy test in a pre-dose examination
* Any serious medical condition or abnormality of clinical laboratory tests that, in the investigator's judgment, precludes the patient's safe participation in and completion of the study
The Role of the Omentum in the Treatment of Morbid Obesity

The purpose of this research is to determine some of the reasons that blood sugar and insulin levels improve after bariatric surgery but before weight loss begins, as well as why people respond differently to weight loss surgery. It will also examine whether removing the fat around the stomach and large intestine (the omentum) will improve weight loss. Finally, it will see why there are differences between Whites and African Americans who have weight loss surgery.

The purpose of this research is to tease out the mechanisms related to changes in insulin sensitivity, metabolism, hormones, and body composition following bariatric surgery. Because preliminary data indicate differing responses to this surgery, both Caucasian and African American adults, scheduled for RYGB, are being recruited to participate. It is believed that the omentum contributes to hepatic insulin resistance, both because of the increased delivery of NEFAs via the portal vein, and the increased production of cytokines. Because of this, it is postulated that removing the omentum as part of bariatric surgery will speed up the reversal of insulin resistance and diminish racial differences in response to the surgery.

Data are derived from tissue and blood samples obtained operatively (from individuals having bariatric surgery and other abdominal operations), as well as during hyperinsulinemic-euglycemic clamps, from indirect calorimetry, DEXA, Health-related Quality of Life surveys, and 24-hour urine samples. There were 66 participants randomized to omentectomy/no omentectomy. A post hoc data power analysis determined that this number of subjects is sufficient for data analysis.

Eligibility Criteria:
Inclusion Criteria:

* BMI \> 40
* BMI \> 35 with co-morbidities
* normal creatinine/liver labs
* insurance approval for RYGB or resources to self-pay
* proximity to Nashville, TN

Exclusion Criteria:

* use of anticoagulants, steroids, therapeutic niacin
* previous bariatric surgery
Study of MRA in Patients With Rheumatoid Arthritis (RA)

This is an open-label, extension, Phase II study to evaluate the long-term safety and efficacy of MRA in Patients with RA who were participated in Study MRA009JP.


Eligibility Criteria:
Inclusion Criteria:

* Patients administered MRA more than 2 times in preceding study, MRA009JP, and evaluated the efficacy and the safety.
* Patients confirmed to have shown the safety in the preceding study.

Exclusion Criteria:

* Patients with Class IV Steinbrocker functional activity at evaluation within 4 weeks before treatment with the study drug
* Patients who received any of the following treatments between the start of preceding study and the registration of this study.

  1. Plasma exchange therapy
  2. Surgical treatment (e.g., operation)
Leucovorin and Fluorouracil Compared With Observation in Treating Patients With Colorectal Cancer That Has Been Surgically Removed

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. It is not yet known whether chemotherapy is more effective than observation in patients who have had surgery to remove colorectal cancer.

PURPOSE: This randomized phase III trial is studying leucovorin and fluorouracil to see how well they work compared to observation in treating patients with colorectal cancer that has been surgically removed.

OBJECTIVES:

* Compare all-cause mortality in patients with resected colorectal cancer treated with adjuvant chemotherapy with L-leucovorin and fluorouracil vs observation.
* Compare the recurrence rates in patients treated with this regimen vs observation.
* Compare the effectiveness of a monthly 5-day schedule vs a once weekly schedule of L-leucovorin and fluorouracil in this patient population.

OUTLINE: This is a randomized, open-label, multicenter study. Patients are randomized to receive adjuvant chemotherapy (arm I) or undergo observation only (arm II).

* Arm I: Within 12 weeks of surgery, patients receive L-leucovorin IV followed by fluorouracil IV on days 1-5 every 4 weeks for 6 courses. Alternatively, patients may receive L-leucovorin IV followed by fluorouracil IV on day 1 weekly for 30 weeks.
* Arm II: Patients undergo observation. Patients are followed annually.

PROJECTED ACCRUAL: A total of 2,500 patients (1,250 per arm) will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Completely resected stage II or III colorectal cancer
* No distant metastases
* No positive resection margins
* No positive peritoneal washings

PATIENT CHARACTERISTICS:

Age:

* 18 and over

Performance status:

* Not specified

Life expectancy:

* Not specified

Hematopoietic:

* Not specified

Hepatic:

* Not specified

Renal:

* Not specified

Other:

* No clear definite indication for, or contraindication against, systemic chemotherapy with L-leucovorin and fluorouracil

PRIOR CONCURRENT THERAPY:

Biologic therapy:

* Not specified

Chemotherapy:

* No concurrent chemotherapy in observation only arm

Endocrine therapy:

* Not specified

Radiotherapy:

* Concurrent radiotherapy allowed in adjuvant chemotherapy arm provided chemotherapy administered on the once weekly schedule

Surgery:

* See Disease Characteristics
A Study of Tocilizumab in Combination With DMARDs in Patients With Moderate to Severe Rheumatoid Arthritis

This 2-arm study assessed the safety and efficacy of tocilizumab versus placebo, both in combination with disease modifying antirheumatic drugs (DMARDs), in regard to reduction in signs and symptoms, in patients with moderate to severe active rheumatoid arthritis with an inadequate response to DMARDs. Patients were randomized in a ratio of 2:1 to receive either tocilizumab 8 mg/kg intravenously (IV) or placebo IV every 4 weeks. All patients also received stable antirheumatic therapy, including permitted DMARDs. The anticipated time on study treatment was 3-12 months and the target sample size was 500+ individuals.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients, ≥18 years of age
* Active rheumatoid arthritis of \>6 months duration
* Received permitted DMARDs each at a stable dose for at least 7 weeks prior to baseline

Exclusion Criteria:

* Rheumatic autoimmune disease or inflammatory joint disease other than rheumatoid arthritis
* Major surgery within 8 weeks prior to screening or planned within 6 months following randomization
* Unsuccessful treatment with a biologic agent, including an anti-TNF agent
* Previous treatment with tocilizumab
Safety, Pharmacokinetic Study of RVX000222 in Healthy Subjects and Subjects With Low HDL Cholesterol

The purpose of this study is to investigate an oral formulation of RVX000222 for safety, pharmacokinetic and efficacy in healthy subjects.

One-third of the US population, almost 80 million adults, have cardiovascular disease and mortality associated with heart disease which still remains a leading cause of death around the world. The major risk factors for cardiovascular disease associated with atherosclerosis is dyslipidemia, characterized by high levels of low density lipoprotein (LDL) and/or low levels of high density lipoprotein (HDL).

HDL has a well established role in atherosclerosis and cardiovascular disease protection. HDL mediates the removal of cholesterol from the atherosclerotic plaques for elimination from the body. The major component of HDL consists of apolipoprotein A-I (ApoA I). Recent intervention studies with synthetic HDL particles and recombinant ApoA-I have shown that HDL has the capacity to reverse coronary atherosclerosis.

RVX000222 is a member of a novel class of small molecules that are candidates for the treatment of dyslipidemia by increasing plasma levels of ApoA-I and HDL.

Eligibility Criteria:
Inclusion Criteria:

* Subjects who meet the following criteria may be enrolled:

  1. Be men or women between 18 and 65 years old, inclusive
  2. Weigh between 60 kg and 110 kg, inclusive, and have a BMI ≥25 kg/m2.
  3. Healthy volunteers with normal or low HDL
  4. If female, non-pregnant (as determined by a negative serum pregnancy test at Screening), non-lactating, and not of childbearing-potential or willing to practice an acceptable form of birth control. If male, be willing to practice an acceptable form of birth control.

Exclusion Criteria:

* Subjects who meet any of the following criteria will not be enrolled:

  1. Have presently, or have a history of, clinically significant disease, including cardiovascular, gastrointestinal, renal, hepatic, pulmonary, endocrine, hematologic, vascular, immunologic, metabolic, neurological, or collagen disease, as judged by the Investigator.
  2. Have active cholecystitis or gallbladder symptoms within 60 days prior to Check-in (subjects who have had a cholecystectomy are not excluded from this study).
  3. Have had a clinically significant illness, in the opinion of the Investigator, within 30 days prior to Check-in.
  4. Have hypertension that is currently being treated, or uncontrolled hypertension
  5. Have a serum creatinine \>1.5 mg/dL, hemoglobin \<11.2 g/dL, or white blood cell count \<4000/μL.
  6. Have positive test results for HIV, hepatitis A, B, or C.
  7. Have a positive result on drug screen testing.