cyrilzakka/clinical-trials huggingface dataset:
A Feasibility Study on the Value of Pelvic Floor Training After Pelvic Organ Prolapse Surgery

The main objective is to assess the feasibility of a randomized controlled trial that investigates the effects of pelvic floor training on recurrence in pelvic organ prolapse surgeries. This will be achieved by measuring POP-Q stage and by a validated questionnaire before surgery and one year after. Women having POP surgery at Landspitali will be offered to participate if they meet the criteria of the research. Participants will be randomized into two groups, interventions and control group that gets standard care at the hospital. The intervention group will meet a physiotherapist 6 weeks post-op for targeted physiotherapy with pelvic floor training, conventional advice and support. Over 16 weeks period participants in intervention group will get physiotherapy four times and get two follow up phone calls. Pelvic floor activity will be measured with EMG and symptoms collected with questionnaire before surgery and year post-op.

Recurrent surgeries are common problem shortly after the first one. POP symtoms can be bothersome for women and reduce their quality of life. More knowledge is needed to figure out if targeted physiotherapy with pelvic floor training can help reduce recurrency and bothersome symptoms.

A feasibility study to assess the practicality of physiotherapy treatment after pelvic organ prolapse (POP) surgery and the effect on recurrent POP symptoms, pelvic floor activity and general physical fitness.

Pelvic organ prolapse is a common problem among women and many do need surgery. Little is known about recurrence of POP surgeries. Pelvic floor muscle training (PFMT) has positive effects on POP symptoms and quality of life. Research shows PFMT can reduce stage of the prolapse.

Before surgery POP-Q stage will be measured by urogynocologist. Pelvic floor muscle activity will be measured with EMG vaginal probes. General physical fitness will be tested with 30s chair-stand and core strenght with prone bride test. An Icelandic version of The Australian Female PelvicFloor questionnaire will be used to assess symptoms and affect on quality of life.

Participants will be randomized into two groups, intervention and control group. The control group gets standard care at the hospital. The interventional group gets physiotherapy with PFMT, conventional advise and support. During 16 weeks intervention participants get four sessions with specialized physiotherapist and two follow up phone calls. Follow up measures will be made at 12 months.

Eligibility Criteria:
Inclusion Criteria:

* Women having their first POP surgery at LSH
* \<80 years old
* Icelandic speaking

Exclusion Criteria:

* Women that previously have had incontinence surgery, hysterectomy or previous POP surgery.
* Dementia, physical disabilities that could affect the research, previous radiotherapy and neurological diseases.
* Women participating in the research that need to have recurrent POP surgery or incontinence surgery within the year of the surgery.
Tolerance Assesment of the Usage of an Analgesic Dose of Esketamine for Treatment of Moderate to Intense Pain in an Emergency Departement

KETAMINE has been used for several years in emergency departments for analgesic purposes. Its ease of use and its analgesic effect have been demonstrated in several studies.

Nevertheless, this molecule is not devoid of side effects, in particular the very frequent occurrence of nausea, vomiting, anxiety, an overall feeling of discomfort and more rarely hallucinations, feelings of unreality, or tachycardia.

Recently, ESKETAMINE, used as an anesthetic but also in the USA as an antidepressant, has obtained its Marketing Authorization in the management of moderate to severe pain. ESKETAMINE corresponds to the S-(-)-KETAMINE enantiomer. Like KETAMINE, it acts as a non-competitive antagonist of the N-methyl-D-aspartate (NMDA) receptor but unlike KETAMINE does not interact, with the sigma receptors responsible for hallucinations and delusional symptoms. ESKETAMINE aimed at anesthetic is about twice as potent as KETAMINE and would also be eliminated more quickly.

Studies suggest that at equivalent doses, ESKETAMINE would be better tolerated than the KETAMINE usually used in emergency departments.

In this study, the tolerance of ESKETAMINE used at analgesic doses for treatment of moderate to severe pain will be assessed in an emergency departement

A wider usage of ESKETAMINE for analgesia purpose in emergency departments is expected, with a better tolerance for the patients compared to KETAMINE


Eligibility Criteria:
Inclusion Criteria:

* Age is 18 years old or more
* Moderate to severe pain as assessed by the patient with a verbal numerical rating scale (NRS) of 6/10 or more ; NRS goes from 0 (no pain) to 10 (the worst pain imaginable)
* Physician has decided to use ESKETAMINE
* Patient is not opposed to enroll in the study after having been informed, as attested by the physician in the patient's file

Exclusion Criteria:

* Adult under juridic protection, under guardianship, under curatorship
* Patient unable to express his consent
* Patient deprived of liberty by a judicial or administrative decision
* Pregnant, parturient or nursing mother
* Patients physically or mentally unable to answer the questionnaire
* Typical kidney colic pain
Peri-operative Analgesia for Single-incision Laparoscopic Appendectomy

Laparoscopic appendectomy is a very common intervention in pediatric surgery. To improve outcomes, some teams have developed the use of single-site laparoscopic appendectomy (SILAP). Nevertheless, there is no consensus yet and no published data on the better perioperative analgesia, and different modalities including general intravenous analgesia, locoregional pre-operative analgesia and local analgesia can be used.

The aim of this retrospective study is to describe the different types of perioperative analgesia routinely used and to compare them to determine the more efficient one for early postoperative pain relief.

Eligibility Criteria:
Inclusion Criteria:

* All patients operated on for appendectomy by SILAP, aged 15 years and under in our pediatric surgical center.

Exclusion Criteria:

* Patients aged 16 years or more.
* Patients with concomitant pathologies potentially inducing hyper- or hypoesthesia (e.g. cancers, spinal cord injury, etc...)
* Patients with contraindications for the use of IV analgesics.
* patients operated on for appendectomy through 3-ports laparoscopy or open surgery.
* Opposition of the patients and their representative to the study.
Efficacy of Ametop Cream in Reducing Pain of Local Anesthetic Infiltration

Ametop is a numbing cream used to ease the pain of having blood drawn or an IV inserted. It is safe and virtually none enters the blood stream. It's effectiveness at reducing the pain of the freezing injection prior to epidural/ spinal anesthesia in pregnant women has not been studied.

We propose to randomize 70 women to have either the numbing cream or a similar looking moisturizing cream placed on their lower back before their anesthetic. They will rate the discomfort of the freezing injection allowing us to compare the two groups and determine if the numbing cream is effective.

Eligibility Criteria:
Inclusion Criteria:

* Any pregnant subject undergoing an elective procedure under neuraxial anesthesia.

Exclusion Criteria:

* Any contraindication to neuraxial anesthesia
* Subjects in labour
NGS-based Thyroscan Genomic Classifier in the Diagnosis of Thyroid Nodules

The purpose of this study is to evaluate the accuracy of Thyroscan in the differential diagnosis of benign and malignant thyroid nodules with suspecious ultrasound features

The prevalence of thyroid nodules by high-resolution ultrasound can be as high as 20%, though most of them are benign lesions, only about 5%\~15% are malignant lesions. Based on 1.4 billion population in China, there are approximately 280 million thyroid nodule carriers, of which approximately 14\~42 million are potential patients with thyroid cancer. Now thyroid cancer is the fastest growing cancer and the 4th most common cancer in women in China. Therefore, the key point in the evaluation of thyroid nodules is the differential diagnosis of benign and malignant nodules. At present, the commonly used imaging and cytological diagnostic techniques for thyroid nodules include ultrasound and ultrasound-guided fine needle aspiration biopsy (FNAB), as well as emerging molecular diagnostic techniques.

The purpose of this study is to evaluate the accuracy of Thyroscan in the diagnosis of benign and malignant thyroid nodules with suspecious ultrasound features. For patients who have signed an informed consent, the subjects undergo fine needle aspiration of thyroid nodules classified as C-TIRADS catagories 3 or 4a under the guidance of ultrasound or palpation before receiving surgical treatment. One needle is used to prepare cytological smear, and one needle is preserved and sent to Thyroscan detection. The histopathological is obtained as the "gold standerd" after surgical treatment.

Eligibility Criteria:
Inclusion Criteria:

1. Patients sign the informed consent form for participating in the reasearch study.
2. Patient's age is 18 years or older.
3. Ultrasound showed at least one thyroid nodule, and it was classified as C-TIRADS Category 3/4a.
4. The surgeon has evaluated the indications for surgery, and the subject is willing to receive surgical intervention in the medical institution.
5. Surgical indications include but are not limited to one of the following conditions: 1) Thyroid nodules are compressed or affect aesthetics; 2) The patient's subjective wishes require surgical removal of the nodules; 3) FNA samples with indeterminate cytology are classified as Bethesda III and IV, requiring diagnostic surgery; 4) After the investigator's assessment, there are other surgical indications.
6. Preoperative FNAB to obtain sufficient cells to meet FNA samples with indeterminate cytology are classified as Bethesda III and IV.
7. The final pathological diagnosis is obtained after surgury.

Exclusion Criteria:

1. The subject has a history of thyroid tumor.
2. The subject has swollen lymph nodes in the central area or/and lateral neck area.
3. The subject is not suitable for fine-needle aspiration biopsy and surgical treatment due to other conditions such as comorbid diseases.
4. FNAB interprets the thyroid nodule as Bethesda V and VI categories.
5. Subjects who intend to receive the radiofrequency ablation therapy.
6. Other conditions determined by the researcher that do not meet the criteria of enrollment.
A Study to Determine the Efficacy and Safety of Lenalidomide in Patients With Mantle Cell NHL Who Have Relapsed or Progressed After Treatment With Bortezomib or Are Refractory to Bortezomib. The "EMERGE" Trial

To evaluate the safety and efficacy of Lenalidomide (Revlimid (R)) in subjects with mantle cell lymphoma who have relapsed, progressed or are refractory to bortezomib.

Follow up phase will continue until either 100% of the patients have died, are lost to follow up or have withdrawn consent or a maximum of 4 years from the last patient enrolled, whichever comes first. All other efficacy and safety endpoints will be updated at this time. In the unlikely event that the study will be closed and patients are still responding to treatment at this time, Celgene will discuss with the treating physicians options to provide further treatment to the patient after study closure in line with local regulation.

Follow up for second primary malignancies and OS will continue until 100% of the patients have died, are lost to follow up, have withdrawn consent, or a maximum of 5 years from the last patient enrolled, whichever comes first.

10 October 2017: In regard to the last subject last visit date/study completion date, the prolongation of timelines is due to the bridging of a treatment gap for a patient responding to study medication until non-study medication is available.

Eligibility Criteria:
Inclusion Criteria:

* Biopsy proven mantle cell lymphoma
* Patients must have documents relapsed, refractory or PD after treatment with bortezomib
* Must have measureable disease on cross sectional imaging by CT
* Eastern Cooperative Oncology Group (ECOG) performance score 0,1 or 2
* Willing to follow pregnancy precautions

Exclusion Criteria:

* Any of the following laboratory abnormalities

  * Absolute neutrophil count (ANC) \< 1,500 cells/mm3 (1.5 x 109/L)
  * Platelet count \< 60,000/mm3 (60 x 109/L)
  * Serum aspartate transaminase/Serum glutamic oxaloacetic transaminase(AST/SGOT) or alanine transaminase/Serum glutamic pyruvic transaminase (ALT/SGPT) \> 3.0 x upper limit of normal (ULN), except in patients with documented liver involvement by lymphoma.
  * Serum total bilirubin \> 1.5 x ULN, except in cases of Gilbert's Syndrome and documented liver involvement by lymphoma.
  * Calculated creatinine clearance (Cockcroft-Gault formula) of \< 30 mL /min
  * Patients who are candidates for high dose chemotherapy/allogeneic stem cell transplant are not eligible
  * History of active central nervous system (CNS) lymphoma within the previous 3 months
  * Subjects not willing or unable to take deep vein thrombosis (DVT) prophylaxis
  * Prior history of malignancies, other than MCL, unless the patient has been free of the disease for ≥ 3 years
  * Positive Human immunodeficiency virus (HIV) or active Hepatitis B or C
Pleural Bleomycin vs Mechanical Abrasion in Malignant Pleural Effusion

Comparision between pleurodesis by pleural abrasion using medical thoracoscopy and bleomycin instillation via indwelling pleural catheter. Evaluating the effectiveness of pleural abrasion using medical thoracoscopy in patients with malignant pleural effusion and evaluating the role of ROSE in diagnosis and management of malignant pleural effusion

Malignant pleural effusion cause significant morbidity so drainage effusion can provide great palliation and improve quality of life of these patients. There are several diagnostic tools for diagnosing malignant pleural effusion as pleural fluid cytology, closed pleural biopsy or thoracosopic pleural biopsy. Medical thoracoscopy has significant role in diagnosis and management of malignant pleural effusion. Also, pleurodesis may be performed through it by mechanical methods as pleural abrasion or chemical methods by talc poudrage, bleomycin or cisplatin instillation . and surgically through pleurectomy. Recently, using of ROSE (Rapis On-Site Examination) technique during medical thoracoscopy showed high accuracy for distinguishing between benign and malignant lesions, and this help in decision making. In our study, we will use mechanical pleurodesis by pleural abrasion using medical thoracoscpy and chemical pleurodesis by instillation of bleomycin via indwelling pleural catheter.

Eligibility Criteria:
Inclusion Criteria:

* Patients who are 18 years old or more.
* patients with rapidly accumulating moderate \& massive malignant pleural. effusion that need frequent aspiration to relieve dyspnea and affect quality of life of the patient.

Exclusion Criteria:

* patients not fit for thoracoscoy.
* patients with life expectency less than 1 month .
* trapped lung (endobronchial lesion).
* excessive pleural adhesios.
* mild effusion not need frequent aspiration and not affect
* quality of life .
* patients with chest infection : pneumonia , empyema .
* patients with performance status that doesn't expected to increase by 1
Single-rescuer Pediatric Resuscitation

The objective of this pilot study was to compare the manual chest compressions (CC) versus CC feedback device TrueCPR vs mechanical CC device LifeLine ARM during simulated pediatric cardiopulmonary resuscitation


Eligibility Criteria:
Inclusion Criteria:

* give voluntary consent to participate in the study
* maximum 1 year of work experience in medicine
* minimum 10 clinical resuscitations
* paramedics, nurses, physicians

Exclusion Criteria:

* not meet the above criteria
* wrist or low back diseases
* pregnancy
Sintilimab Combined With Lenvatinib in Local Advanced Hepatocellular Carcinoma

This ia a single-arm, single-center, not-randomized, open-label phase II study. The purpose of this study is to evaluate the efficacy and safety of Sintilimab (PD-1 antibody) combined with Lenvatinib(TKI) for the treatment of local advanced hepatocellular carcinoma.


Eligibility Criteria:
Inclusion Criteria:

* Has a diagnosis of hepatocellular carcinoma confirmed by radiology, histology, or cytology
* Barcelona Clinic Liver Cancer (BCLC) Stage C disease without any distant or lymphatic metastasis , or BCLC Stage B disease not amenable to curative surgery
* No previous systemic anticancer treatment or TACE treatment
* Age ≥18 years
* ECOG performance status: 0-1
* Child Pugh score≤7
* Has at least one measurable hepatocellular carcinoma (HCC) lesion based on RECIST 1.1
* Life expectancy ≥12 weeks.
* Patients must be able to understand and willing to sign a written informed consent document

Exclusion Criteria:

* Fibrous lamina hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma, cholangiocarcinoma
* History of hepatic encephalopathy or liver transplantation
* Pleural effusion, ascites and pericardial effusion with clinical symptoms or needing drainage.
* Untreated hepatitis infection: HBV DNA\>2000IU/mlor10000 copy/ml, HCV RNA\> 1000copy/ml, both HbsAg and anti-HCV body are positive.
* Patients with clinically significant gastrointestinal bleeding within 30 days prior to study entry.
* History of symptomatic interstitial lung disease or other conditions that may cause confusion when discovering or managing suspicious drug-related lung toxicity
* With serious systemic diseases such as heart disease and cerebrovascular disease, and the condition is unstable or uncontrollable.
* Evidence of active pulmonary tuberculosis (TB).
* Positive test of immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)
* History of allergic reactions to related drugs
* Pregnant women, nursing mothers
TOM: Testosterone in Older Men With Sarcopenia

The purpose of this study is to determine whether testosterone replacement in older men with low testosterone levels will increase muscle strength, improve physical performance and overall sense of well being, and reduce fatigue.

The primary objective of this study is to determine whether testosterone replacement in older men, who have low testosterone levels and mild to moderate physical impairment, will increase their maximal voluntary muscle strength of major upper and lower extremity muscle groups. The second objective is to determine whether testosterone replacement will improve the power of knee extension, physical performance tests, the level of physical activity (measured by 3D accelerometer), self-reported disability, exercise tolerance and mobility. The third objective is to determine whether testosterone supplementation improves fatigue, affect, and overall sense of well being in older men with low testosterone levels. A fourth objective is to define the Minimum Clinically Important Differences in physical measures perceived by the participants (MCID).

Participant involvement will require 15-17 clinic visits over 28 weeks. Five to 7 of these visits are for physical testing, including body composition, muscle performance, and physical function. Throughout the study, hormone measurements will be obtained.

Eligibility Criteria:
Inclusion Criteria:

* Community dwelling, ages 65 and older
* Self-reported difficulty in climbing 10 steps without resting, or difficulty in walking 2 or 3 blocks outside on level ground
* A score of 4 to 9 on the Short Physical Performance Battery (mild to moderate physical impairment)
* Total serum testosterone level (TT) \< 350 ng/dL and \> 100 ng/dL
* Without dementia (Mini-Mental State Examination \[MMSE\] score \> 24)

Exclusion Criteria:

* Use of testosterone, anabolic steroids, dehydroepiandrosterone (DHEA), androstenedione or recombinant growth hormone (rGH) in the past year
* Alcohol or drug abuse
* Use of anti-convulsants or glucocorticoids (equivalent to prednisone \> 20 mg/day)
* Prostate cancer, breast cancer or other cancers with life expectancy \< 5 years
* Limiting neuromuscular, joint or bone disease, or history of stroke with residual neurological problems
* Any neurological condition that would impact cognitive functioning including:

  * epilepsy
  * multiple sclerosis
  * HIV
  * Parkinson's disease
  * stroke
  * other focal lesion
* Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) Axis I psychiatric disorder in past year or use of psychotropic medications in 6 months
* Abnormal prostate examination; PSA \> 4 ng/mL; or BPH symptom score \> 21
* Unstable angina, New York (NY) class III or IV congestive heart failure or myocardial infarction within 3 months of entry
* Abnormal laboratory values (at discretion of principal investigator)
* Untreated thyroid disease; systolic blood pressure \> 160 or diastolic \> 100 mm Hg
* Body mass index \> 40 kg/m2
* Untreated severe obstructive sleep apnea
Preterm Lung Patient Registry

The goal of the Preterm Lung Patient Registry is to collect data on individuals with neonatal lung disease to better understand the illness and ultimately improve their care and survival. The Patient Registry was established in 2008 as a means to monitor important trends in the BPD population and to improve understanding, treatment, and survival.

The Preterm Lung Patient Registry is an observational study designed to identify epidemiologic and genetic factors associated with chronic lung disease in former preterm infants or those with lung disease in the neonatal period. The Patient Registry is used by both clinicians and researchers to better understand BPD and to improve care of individuals with BPD. It is used to assess phenotype and genotype information from former preterm infants with lung disease. Data in the Patient Registry will be analyzed and an regular report of BPD health trends will be created. Using this information, BPD clinicians can address quality improvement initiatives, and examine changing health care issues, including nutritional status, infection control, pulmonary treatment, metabolic and associated genetic variants. The Patient Registry will also play an important role in directing clinical care and in the design of clinical research studies. Researchers use the registry to help in investigating various aspects of neonatal lung diseases like BPD, including medications, diagnostic procedures, and eligibility for clinical trials.

Eligibility Criteria:
Inclusion Criteria:

* Former preterm infant
Endogenous Lithium Clearance in Acute Kidney Injury

Critically ill patients are at high risk of developing acute kidney injury (AKI). Lithium is freely filtrated at the glomerulus and almost completely reabsorbed in the proximal tubule, which provides a quantitative estimation of proximal tubule reabsorption. The investigators hypothesized that endogenous lithium reabsorption is impaired in the early stages of critical illness.

Investigators would like to study 10 ICU patients with AKI diagnosed, 10 patients without AKI, and 10 healthy controls.

Blood and urine samples will be obtained at 08:00, 14:00 and 20:00 during one day. Renal clearance of creatinine (CCr) and lithium will be calculated.

Eligibility Criteria:
Inclusion Criteria:

* ICU patients diagnosed with AKI, without AKI and healthy controls

Exclusion Criteria:

-