cyrilzakka/clinical-trials huggingface dataset:
The Influence of Acute Static Stretching on the Ankle Joint-position Sense of Soccer Players

The aim of this study isto investigate the influence of acute static stretching on the ankle joint position sense of soccer players.

This crossover randomized controlled trial will include semi-professional soccer players. All participants will perform 3 conditions: two experimental conditions, of static stretching of the gastrocnemius and tibialis anterior muscles, for 30 seconds or 90 seconds; and a control condition (rest). Ankle joint position sense of the dominant limb will be assessed before and immediately after the conditions for the range of 20º of plantar flexion by active repositioning, and using a video camera. Absolute, relative and variable angular errors will be calculated.

Eligibility Criteria:
Inclusion Criteria:

* male soccer players from the senior level
* aged between 18 and 30 years old
* with normal plantar flexion range of motion
* without history of lower limb injuries in the last 6 months

Exclusion Criteria:

* those with cardiorespiratory, vestibular or neurological diseases
* with bone or joint deformities in the lower limb
* cerebral concussion in the last 3 months
* history of lower limb surgery
* those with positive ankle integrity tests (anterior drawer test, talus tilt test and external rotation stress test)
A POC and Dose-Ranging Study of HTD1801 in PSC Patients

The study was a dose-ranging, 18-week study comparing two doses of HTD1801 (500 mg BID and 1000 mg BID) to placebo in adult subjects with PSC.


Eligibility Criteria:
Inclusion Criteria:

* Male or female between 18 and 75 years of age;
* Have a clinical diagnosis of PSC as evident by chronic cholestasis of more than six months duration with either a consistent magnetic resonance cholangiopancreatography (MRCP)/endoscopic retrograde cholangiopancreatography (ERCP) showing sclerosing cholangitis;
* If subjects have Inflammatory Bowel Disease (IBD) they will be eligible to participate. If a subject has IBD, documented evidence of IBD must have been evident by prior endoscopy or in previous medical records for ≥6 months. In addition, subjects may only enter the study with a Partial Mayo Score of 0-4, inclusively. Subjects who are on treatment are allowed, provided they are stable for 3 months if taking:

  1. 5-amino salicylic acid drugs,
  2. azathioprine,
  3. 6-mercaptopurine, or methotrexate
  4. biologics;
* Have a serum ALP ≥1.5 × upper limit of normal (ULN);
* Be able to understand and sign a written informed consent form (ICF);
* Subjects receiving allowed concomitant medications need to be on stable therapy for 28 days prior to the Baseline visit, with the exception of ursodeoxycholic acid (UDCA), which should be stable for at least 6 weeks prior to the Baseline visit.

Exclusion Criteria:

* Presence of documented secondary sclerosing cholangitis (such as ischemic cholangitis, recurrent pancreatitis, intraductal stone disease, severe bacterial cholangitis, surgical or blunt abdominal trauma, recurrent pyogenic cholangitis, choledocholithiasis, toxic sclerosing cholangitis due to chemical agents, or any other cause of secondary sclerosing cholangitis) on prior clinical investigations;
* Small duct PSC;
* Presence of percutaneous drain or bile duct stent;
* History of cholangiocarcinoma or clinical suspicion of new dominant stricture within 1 year by MRCP/ERCP. Presence of dominant stricture without ERCP evidence of cholangiocarcinoma is acceptable if stable for ≥ 1 year;
* Ascending cholangitis within 60 days prior to Screening;
* History of alcohol or substance abuse or dependence;
* Prior or planned liver transplantation;
* Presence of alternative causes of chronic liver disease, including alcoholic liver disease, nonalcoholic steatohepatitis, primary biliary cirrhosis, autoimmune hepatitis;
* Platelet count below 125,000/mm3, albumin below 3.0 g/dL, International Normalized Ratio (INR) \> 1.2, or a history of ascites, or encephalopathy, or history of esophageal variceal bleeding;
* Severe active IBD or flare in colitis activity within the last 90 days requiring intensification of therapy beyond baseline treatment;
Study on the Protective Effect of a Flexible Sleeve Penis Protection Device on Penis After Circumcision

Circumcision is a common clinical procedure for both circumcision and phimosis, which are common disorders of the male reproductive system. For post-circumcision patients, a flexible sleeve penile protection device was invented as a modification of the traditional gauze bandage. This study investigated the protective effect of the device by recruiting post-circumcision patients to use the device and collecting indicators related to post-operative recovery and patients' experience of using the device.

Circumcision is a common clinical procedure for both circumcision and phimosis, which are common disorders of the male reproductive system. Post-circumcision patients remain at risk of gauze detachment, wound pain and post-operative bleeding, leading to serious post-operative adverse effects, including complications such as dehiscence and infection. The investigators have invented a flexible sleeve penile protection device, which consists of two components, a flexible sleeve and a hood, the main function of the flexible sleeve is to stop bleeding with compression and immobilisation, and the main function of the hood is to provide protection to the head of the penis and prevent the wound from rubbing against clothing leading to pain.

The aim of this study was to investigate the protective effect of a flexible sleeve penile protection device on post-circumcision patients in terms of gauze loosening and dislodging, post-operative pain and post-operative bleeding. This study was a prospective randomized controlled trial of patients who underwent circumcision at Peking University Third Hospital from February 2023 to May 2023. Patients in the experimental group were wrapped with this device postoperatively, while patients in the control group were wrapped with traditional gauze postoperatively. Patients were followed up regularly after surgery, and indicators such as complications, pain and recovery time were collected to investigate the protective effect of this device.

Eligibility Criteria:
Inclusion Criteria:

1. Diagnosed redundant prepuce and circumcised at Peking University Third Hospital.
2. Male patients aged between 12 and 60 years (inclusive).
3. The person or guardian fully understands and signs the informed consent form.

Exclusion Criteria:

1. Acute urinary and genital infections, such as acute urethritis, acute prostatitis, acute epididymitis, etc., or trauma.
2. Abnormal blood clotting function.
3. Those who are allergic to the materials used in the manufacture of the product.
4. Patients who are mentally incapable or unable to understand the requirements for participation in the study and have difficulty in cooperating.
5. Subjects who, in the opinion of the investigator, are unable to comply with follow-up, compromising the scientific validity and integrity of the study.
High Dose Somatostatin Analogues in Neuroendocrine Tumors

Octreotide (OCT) is a somatostatin analogue (SSA) available in a long-acting formulation, conventionally administered every 28 days at the maximum dose of 30 mg. Together with lanreotide, it is considered the therapy of choice in the control of endocrine syndromes associated with neuroendocrine tumors (NET)s. A complete or partial clinical response to SSA therapy is generally achieved in at least 50% of the patients with neuroendocrine syndrome. Many studies reported a clinical response in 70-90% of functioning NETs. In about 36-50% of the patients with progressive advanced well differentiated NET (WDNET), a stabilization of disease occurs after treatment with subcutaneous OCT. By developing long-acting slow-release SSA formulation, long-acting OCT (LAR), lanreotide-SR, lanreotide-Autogel, the patient's compliance to SSA therapy was improved and escape from treatment, which was common with the subcutaneous formulation, was avoided. However, rate of objective response was not significantly improved as compared to short-acting SSA. On the other hand, it has to be remarked that long-acting SSA are being used in NET patients at doses correspondent to the low doses of short-acting formulation. The higher commercially available doses of LAR is 30 mg, which is assumed to be comparable to 300 µg of short-acting OCT in the therapy of acromegaly.

Only one study was designed to investigate the use of high-dose LAR (160 mg every 28 days). In this study, objective and hormonal responses in patients with progressive metastatic ileal NET non-responder to standard doses, was significantly elevated. However, this compound has never been commercialized and, of consequence, this first preliminary observation has not been confirmed by further studies.

No systematic studies were performed with the commercially available long-acting SSA used in high-dose treatments. In patients with progressive locally advanced or metastatic NET, increase of the dose or reduction of the interval between injections is a relatively common "empirical" clinical practice, but no studies have been performed to evaluate safety and efficacy of this treatment schedule.

The patient population will include the patients with a histologically documented diagnosis of WDNET, defined according to the last WHO Classification criteria for NET of gastro-entero-pancreatic, bronchial, thymic or other origin; and showing tumor progression under a standard dose treatment with LAR (30 mg every 28 days) for at least 6 months. Progressive disease will be defined as increased tumor size according to RECIST definitions.

Eligibility Criteria:
Inclusion Criteria:

* Well differentiated neuroendocrine tumors in disease progression

Exclusion Criteria:

* Well differentiated neuroendocrine tumors without disease progression
* Patients with intolerance to somatostatin analogues
Screening for Abdominal Aortic Aneurysms in the General Practice by Ultraportable Ultrasound

Abdominal aortic aneurysm (AAA) is a localized dilatation of a segment of the aorta artery in its abdominal portion. It affects 1.7% of men aged 65 years and older. In the high-risk population (male smokers aged 65-75 years), its prevalence is estimated to be between 2.8 and 9%. Mortality of ruptured AAAs is high (80% of deaths before hospitalization or perioperatively), whereas mortality of scheduled procedures for unruptured AAAs is less than 5%. AAA screening has been shown to significantly reduce the specific mortality rate in the medium and long term. The French National Authority for Health (HAS) recommends targeted screening for AAA by ultrasound at the radiologist. The target population is male smokers or former smokers aged 65 to 75 years, as well as all persons aged 50 to 75 years with a family history of AAA. Despite recommendations, the rate of access to targeted screening appears low. Ultrasound screening for AAA is a rapid, noninvasive, and reproducible test. It relies primarily on the measurement of the maximum diameter of the abdominal aorta in cross-section. It has been demonstrated that the learning of the ultrasound screening procedure for AAA is very fast and that the performance of non-radiologists trained in this procedure alone is similar to that of radiologists.

In addition, new ultra-portable ultrasound devices, inexpensive and with validated performances have appeared on the market in the last few years, making it possible to equip general practitioners (GPs). We propose a simplified care pathway for AAA screening, by equipping GPs with an ultra-portable ultrasound scanner and by training them to perform the screening procedure, which will be performed in the office or at the patient's home, during a usual consultation of general medicine. Our hypothesis is that this new organization will allow better access to screening for the target population, at a lower cost, compared to the current screening method recommended by the HAS (referral of the patient to the radiologist).


Eligibility Criteria:
Inclusion Criteria:

* Male
* In the absence of a family history of AAA: Patient aged 65 to 75 years, chronic current or past smoker, active smoker (defined as having smoked at least one cigarette per day) or former smoker (defined as having quit smoking less than 20 years ago, regardless of the number of cigarettes smoked).
* If there is a family history of AAA: Patient between 50 and 75 years of age
* Express consent to participate in the study
* Affiliated or beneficiary of a social security plan

Exclusion Criteria:

* Patient with a legal protection measure
* Patient with previous AAA screening less than 5 years old
* Patient unable to understand the study / give informed consent (cognitive impairment, communication impairment)
Effect of Plavix on NO (Nitrogen Monoxide) Production of the Endothelial Function

To determine whether in the laser Doppler flowmetric parameters characteristic of endothelial dysfunction at patients with clinically manifest atherosclerosis any change can be detected at plavix (clopidogrel) treatment. Laser Doppler /LD/ measurement combined with iontophoresis evaluates the effect of acetylcholine /ACh/ /endothelium dependent/ and sodium nitroprusside /NSP/ /endothelium independent/ on the microcirculation of the skin


Eligibility Criteria:
Inclusion Criteria:

* Proven, peripheral arterial disease, Fontain II-III stage, patient submitted to secondary prophylactic thrombocyte aggregation inhibiting treatment
* Doppler index \< 0,8

Exclusion Criteria:

* Hypersensitivity to the active ingredient or one of the components of the drug
* Active pathological bleeding, e.g. gastric ulcer, intracranial bleeding
* Pregnancy, breast-feeding
* Severe, known hepatic insufficiency
* Severe, known renal insufficiency

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Evaluation of Xpert MTB/RIF Assay for the Rapid Identification of TB and TB Rifampin Resistance in Pulmonary Tuberculosis Suspects

This observational Mycobacterium tuberculosis (MTB) diagnostics evaluation study is a longitudinal study of pulmonary TB suspects who are undergoing sputum evaluation for pulmonary TB. The sensitivity and specificity of the Xpert MTB/RIF (Mycobacterium tuberculosis/rifampin) assay performed on the first sputum collected for Xpert testing will be compared to gold standard conventional culture methods on two sputum specimens, in HIV-infected and HIV-uninfected participants.


Eligibility Criteria:
Inclusion Criteria:

* Suspected pulmonary TB (more information on the criterion can be found in the protocol)
* Men and women age equal to or greater than 18 years
* Ability and willingness of candidate or legal guardian/representative to provide informed consent
* Collection of two sputum samples for AFB smear and culture collected within 7 days prior to entry.
* Availability of two samples for Xpert MTB/RIF testing collected within 7 days prior to entry.
* Determination and/or documentation of HIV status
* For HIV-positive candidates, a CD4+ cell count obtained within 45 days prior to study entry or drawn at the time of entry at any laboratory that has a CLIA certification or its equivalent.

Exclusion Criteria:

* Either receipt of ≥48 cumulative hours OR three or more doses of anti-TB treatment within 180 days prior to completion of second sputum collection for Xpert testing
* Receipt of more than 7 cumulative days of antibiotics intended for bacterial treatment that may have anti-tuberculosis activity, within the 14 days prior to first sputum collection
* Active drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements
Changes in Acid Base Status During High Salt Intake

The study aimed to examine the effects of an alkalinisation of a NaCl (sodium chloride, salt)-rich diet on acid base status, bone metabolism, protein turnover and other influenced physiological systems. Due to increased urinary calcium excretion and bone resorption a high NaCl-intake is considered as a risk factor for osteoporosis. On the contrary an alkaline diet is known to have a beneficial influence on bone metabolism. Therefore the investigators hypothesized that an alkaline diet can reduce NaCl-induced bone resorption.

8 healthy male volunteers took part in a stationary study carried out in the metabolic ward of the German Aerospace Center. The study consisted of 2 campaigns, each lasting 16 days. Both campaigns were divided into 5 days of adaptation, 10 days of intervention and 1.5 days of stationary recovery. During the intervention period the volunteers diet was NaCl-rich (7.7 mmol Na/kg body weight/day) and supplemented in one campaign by 90 mmol potassium bicarbonate (KHCO3) in a randomized cross-over design. The other campaign served as control.

Bone metabolism was studied by bone formation markers in the fasting morning blood and 24h-urinary bone resorption markers. Acid base status was assessed by blood gas analyses in the fasted and the postprandial state as well as urinary markers. Protein turnover was studied with stable isotopes. Further physiological systems like energy metabolism and the cardiovascular system are also under investigation.


Eligibility Criteria:
Inclusion Criteria:

* healthy males
* 19 - 35 years
* 65 - 85kg
* 170 - 190 cm
* successfully completed psychological and medical screening

Exclusion Criteria:

* athletes
* smoking
* drug- or alcohol abuse
* hyperlipidemia
* renal diseases
* obesity
* anemia
* bone diseases
* diabetes
* rheumatism
* blood donation within three month prior to study start
* participation in another clinical investigation three month prior to study start
Random Evaluation of Patients Who Have Had Laparoscopic Partial Nephrectomy

The purpose of this study is to evaluate the necessity of using hemostatic agents as a tool when performing robotic partial nephrectomy in the treatment of kidney cancer. This project asks whether patients who undergo robotic partial nephrectomy without the surgeon using hemostatic agents during the procedure will have the same, fewer, or more complications than when patients undergo this same surgery with the surgeon using hemostatic agents during the procedure.


Eligibility Criteria:
Inclusion Criteria:

1. Male and female patients aged 18 years and older.
2. Patients must have a solid or cystic renal mass suspicious for malignancy by imaging with ultrasound, computed tomography (CT) scan, or magnetic resonance imaging (MRI).
3. Patients must be initially scheduled RALPN as opposed to radical nephrectomy or other techniques for partial nephrectomy such as open surgery or pure laparoscopy without robot assistance.
4. Patients with bilateral kidneys or a solitary kidney, so long as these are native kidneys as opposed to a transplanted kidney.
5. Patients can have the common single renal artery and single renal vein, or they can have common variants such as two renal arteries and/or two renal veins.

Exclusion Criteria:

1. Patients on hemodialysis.
2. Patients who have had a renal transplantation.
3. Patients on therapeutic anticoagulation prior to surgery (example anticoagulants include: aspirin 325 mg daily, clopidogrel, warfarin, fondaparinux, dabigatran, and rivaroxaban). However, patients who take aspirin 81 mg daily as their daily regimen will be included.
4. Patients with bleeding disorders (example: hemophilia) and other documented coagulopathy (example: chronic liver disease) with INR greater than 1.0 at baseline.
5. Patients who have had a prior surgical procedure, aside from percutaneous renal biopsy, on the kidney in the current operation.
6. Patients with over 100 mL of estimated blood loss (calculated by anesthesia team using the suction canisters) prior to clamping of the renal hilum will be excluded.
Counteracting Learned Non-use Through Augmented Visuomotor Feedback in Virtual Reality (RGS)

The purpose of this study is to determine if Reinforcement-Induced Movement Therapy (RIMT), a novel rehabilitation method that augments visuomotor feedback of movements of the patient in virtual reality, is effective in treating hemiparesis resp. learned non-use.


Eligibility Criteria:
Inclusion Criteria:

* Mild-to-moderate upper-limbs hemiparesis (Proximal Medical Research Council Scale \> 2) due to ischemic or hemorrhagic stroke
* Spasticity in the affected limb (Modified Ashworth Scale \<3)
* First-ever ischemic or hemorrhagic stroke (\>4 weeks post-stroke)
* Sufficient cognitive capacity for following the instruction of the intervention (Mini-Mental State Evaluation \>24)

Exclusion Criteria:

* Cognitive impairment that impede the correct execution or understanding of the intervention
* Severe impairments in vision or visual perception abilities (such as vision loss or spatial neglect), in spasticity, in communication abilities (such as aphasia or apraxia), severe pain as well as other neuromuscular or orthopedic changes that impede the correct execution of the intervention training
* Mental dysfunctioning during the acute or subacute phase after the stroke.
Effect of Community-based Reablement

This study aims o investigate the effect of a diversified community-based reablement on motor function, cognitive function, performance in activities of daily living (ADL), and physical performance of older people living in remote areas. Older adults who are mobile but unstable were recruited from 6 public elderly day care centers in remote areas of the New Taipei City. Experimental group received a 10-wk diversified community-based reablement service including group exercise, cognitive training, health education for 1.5 hours, and individualized reablement for 1.0 hour, while control group received 1.5-hr group intervention and 1.0-hr placebo intervention. The de Morton Mobility Index (DEMMI), Saint Louis Mental Status Examination (SLUMS), Barthel Index (BI), Canadian Occupational Performance Measure (COPM), and the Short Physical Performance Battery (SPPB) including balance, gait speed, chair stand tests were evaluated twice before and after interventions. The results of the current study are expected to provide evidence in supporting a novel and diversified community-based reablement in remote areas.


Eligibility Criteria:
Inclusion Criteria:

* living in community and participating in public elderly day care centers in remote areas of the New Taipei City
* speaking with Chinese or Taiwanese
* DEMMI score of 39-67

Exclusion Criteria:

* diagnosed with moderate or severe cognitive impairment (CDR score of 2 or above)
* unable to understand or follow one step instruction
An Investigational Immuno-therapy Study of Nivolumab Combined With Ipilimumab Compared to Nivolumab by Itself After Complete Surgical Removal of Stage IIIb/c/d or Stage IV Melanoma

The purpose of this study is to determine whether an investigational immunotherapy Nivolumab, when combined with Ipilimumab, is more effective than Nivolumab by itself, in delaying the return of cancer in patients who have had a complete surgical removal of stage IIIb/c/d or stage IV Melanoma


Eligibility Criteria:
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

* Completely surgically resected stage IIIb/c/d or stage IV melanoma within 12 weeks of participation in study.
* Must have full activity or, if limited, must be able to walk and carry out activities such as light house work or office work
* No prior anti-cancer treatment for melanoma (except surgery for the melanoma lesion(s) and/or except for adjuvant radiation therapy (RT) after neurosurgical resection for central nervous system (CNS) lesions)

Exclusion Criteria:

* History of uveal melanoma
* Patients with active, known or suspected autoimmune disease
* Prior treatment with interferon (if complete \< 6 months prior to participation in study), anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways

Other protocol defined inclusion/exclusion criteria could apply