cyrilzakka/clinical-trials huggingface dataset:
The Acute Effect Comparisons of Manual Therapy Or Ankle Motion in Individuals Who Had Achilles Tendon Repair

Achilles tendon rupture is common among physically active individuals. Limitations, decreases in the level of standing on heel rise, and due to these limitations, failures in functional activities such as returning to sports, walking, running, jumping and performance tests are observed. Manual therapy methods included in rehabilitation programs are an effective option in solving these problems. The aim of the study is to investigate the effects of Compressive Myofascial Release and Ankle joint mobilization on ankle joint movement, functional tests, elasticity and stiffness of the muscle-tendon complex and muscle tone parameters in individuals who underwent Achilles tendon repair.

Achilles tendon rupture is common among physically active individuals. It has been reported that 73% of all Achilles tendon ruptures are sports-related and injuries frequently occur between the ages of 30-49. Conservative or surgical treatments can be applied after Achilles tendon ruptures. After Achilles tendon injuries and repair, decreases in Soleus muscle strength and endurance, changes in lower extremity muscle activation levels, decreases in Gastro-Soleus muscle circumference, increase in Achilles tendon thickness and stiffness, decreases in elasticity, elongations in the Achilles tendon, ankle dorsiflexion range of motion. Limitations, decreases in the level of standing on heel rise, and due to these limitations, failures in functional activities such as returning to sports, walking, running, jumping and performance tests are observed. Manual therapy methods included in rehabilitation programs are an effective option in solving these problems. The aim of the study is to investigate the effects of Compressive Myofascial Release and Ankle joint mobilization on ankle joint movement, functional tests, elasticity and stiffness of the muscle-tendon complex and muscle tone parameters in individuals who underwent Achilles tendon repair. Compressive myofascial release will be applied to a group that has undergone Achilles tendon repair surgery, and ankle mobilization will be applied to another group. Muscle-tendon passive mechanical properties will be evaluated with Myoton-3 before and after the applications. Toe elevation level, ankle joint range of motion and Achilles tendon rest angle will be evaluated before and after the application.

Eligibility Criteria:
Inclusion Criteria:

* • Being male between the ages of 18-55,

  * Having unilateral Achilles tendon repair performed for at least 6 months,
  * No open wound,
  * No history of fracture accompanying Achilles injury.

Exclusion Criteria:

* • Presence of a history of repeated Achilles tendon rupture,

  * Having a rupture or tendon injury on the contralateral side,
  * Having a neurological deficit,
  * Having a history of injury in any of the lower extremity joints for the last 1 year,
  * Having a history of surgery other than Achilles tendon repair in any of the lower extremities,
  * Having a history of corticosteroids applied to the Achilles tendon,
A Long-Term Follow-Up Study of Participants With Cystinosis Who Previously Received CTNS-RD-04

This is a multinational, long-term follow-up study to assess the long-term safety and durability of CTNS-RD-04 treatment in participants who received a single dose administration of lentiviral gene therapy. No investigational product will be administered in this study. Participants will continue periodic safety and efficacy assessments in this long-term follow-up study up to 15 years from the initial date of CTNS-RD-04 infusion.

Participants enrolled in a study where the individual received CTNS-RD-04 will be offered participation in the CTNS-RD-04-LTF01 study. The Baseline visit for the CTNS-RD-04-LTF01 study will likely coincide with the final visit in the parent study. Participants confirmed eligible for the CTNS-RD-04-LTF01 study will be asked to return for study visits at approximately 6-month intervals for the first 4 years and annually thereafter for up to 11 years until a total of 15 years have elapsed during which time continued safety, engraftment, and efficacy of CTNS-RD-04 treatment will be assessed.

Eligibility Criteria:
Inclusion Criteria:

• Participant must have received CTNS-RD-04 in a preceding study

Exclusion Criteria:

• Participant is currently enrolled in an CTNS-RD-04 treatment study. Participants who have either completed, withdrawn, or prematurely discontinued participation for any reason at any time after receiving CTNS-RD-04 are eligible for CTNS RD 04 LTF01 study participation.
Study of Vardenafil in Patients Suffering From Erectile Dysfunction and Metabolic Syndrome

This is a controlled, randomized, multi-center prospective study of vardenafil to determine efficacy on Erectile Dysfunction (ED), tolerability and safety in men with ED and Metabolic Syndrome. This study will explore the rate of patients who do need to switch to the highest dosage based upon the expectation that most men can stay on vardenafil 10 mg PRN (pro re nata)


Eligibility Criteria:
Inclusion Criteria:

* Stable heterosexual relationship
* History of erectile dysfunction for at least 6 months
* IIEF- EF Domain entry score (at Visit 2): \>21 points
* Documented metabolic syndrome according to the IDF (International Diabetes Foundation)
* Subjects motivated for erectile dysfunction treatment
* Documented, dated, written informed consent

Exclusion Criteria:

* Any underlying cardiovascular condition
* History of myocardial infarction
* Uncontrolled atrial fibrillation
* Resting hypotension
* Postural hypotension within 6 months of Visit 1
* History of congenital QT prolongation
* Bleeding disorder
* History of prostatectomy because of prostate cancer
* Hereditary degenerative retinal disorders
* History of loss of vision because of NAION (non-arteritic anterior ischemic optic neuropathy)
* 29 Additional Exclusion Criteria
Aerobic Exercise and Blood Biochemical Factors in Spinal Cord Injury

Background:

Patients with spinal cord injury (SCI) have a higher prevalence of cardiovascular diseases compared to the healthy population. Aerobic exercise training is one of the recommended treatments. However, literature regarding the effect of aerobic training on patients with SCI is scarce. This study evaluated changes in parameters of exercise physiology and serum myokines immediately after exercise and after a training program among patients with SCI.

Method:

Male patients with SCI and age- and sex-matched healthy individuals were recruited. Cardio-pulmonary exercise testing (CPET) was used to determine oxygen uptake at peak exercise and anaerobic threshold in both groups. The patients with SCI attended aerobic exercise training for 36 sessions within 12-16 weeks. Basic data, hemodynamic and exercise physiology parameters, and serum myokine (myostatin, insulin like growth factor, and follistatin) concentrations were measured pre- and post-exercise in both groups, and were repeated in patients with SCI post-training.

The patients with SCI were invited to undergo a 12- to 16-week exercise training by arm ergometry. The exercise physiology and measurements of hemodynamic parameters and cytokines were repeated after completion of the training.

Eligibility Criteria:
Inclusion Criteria:

* age \>20 years, male sex, and onset of injury more than one year

Exclusion Criteria:

* known heart disease, atrial fibrillation/flutter, ventricular bigeminy, active inflammatory disease, malignancy, and cardiac pacemakers
Effect of GOS Supplementation on Amoxicillin-treated Gut Microbiota From Healthy Adults

Prebiotics are thought to be a potential means to prevent antibiotic-associated diarrhoea because of their ability to stimulate beneficial bacteria. In-vitro results showed a promising recovery of Bifidobacteria combined with an increase of Short Chain Fatty Acids (SCFA) upon Galacto-oligosaccharides (GOS) supplementation to amoxicillin-treated microbiota. As the microbiota is nowadays considered as a key factor in human health, a further understanding of the gut microbiota functioning in-vivo is essential. This understanding of the use of specific prebiotics may possibly be beneficial in the prevention or recovery of antibiotic-disturbed microbiota. As the effects of GOS supplementation on the microbiota composition and activity from healthy adults receiving amoxicillin have never been tested in-vivo, the investigators propose the current study as a proof of principle.

Objective:

To explore whether the promising effects of GOS supplementation on the composition and activity of gut microbiota from healthy adults as found by in-vitro, can also be observed in-vivo.

Study population:

10 healthy men and women volunteers, 18 - 40 yr old


Eligibility Criteria:
Inclusion Criteria:

* Age: 18-40 \*
* BMI: 18.5-25 kg/m2
* Stable weight over the last 6 months
* Western diet
* Availability of information about birth by caesarean section and breast-feeding
* Regular defecation (\~1day)
* Healthy as judge by the participant himself
* Having signed the informed consent form

Exclusion Criteria:

* Smoking or drug use
* Pregnant (include planning to be or gave birth in the last 6 months) or lactating woman
* Using contraceptive pill
* Gastro-intestinal diseases (e.g. irritable bowel syndrome, inflammatory bowel disease)
* Traveling to an Asian, African or south American country \< 6 months before the study
* Hypersensitivity or food allergy for products used in this study (e.g. Lactose, Penicillin)
* Having hepatic disease and renal failure
* Using medication other than paracetamol, acetylsalicylic acid (aspirin), hay fever, asthma
* Not willing to have the family doctor be informed about participation to the study.
* Antibiotic use \< 3 months before the study
* More than 3 antibiotic treatments in the last 2 years.
* Probiotic or prebiotic use \< 1 month before the study\*
Evaluating the Use of Two Different Needles in Subjects With Diabetes

This trial is conducted in Europe. The aim of this trial is to compare two needle types when used with a disposable insulin injection pen in the everyday life setting of an insulin treated patient with diabetes.


Eligibility Criteria:
Inclusion Criteria:

* Signed and dated informed consent obtained before any trial-related activities
* Diagnosed type 1 or type 2 diabetes
* Treated with insulin

Exclusion Criteria:

* Previous participation in this trial
* Mental incapacity, unwillingness or language barriers precluding adequate understanding or co-operation
* Any disease or condition which the investigator feels would interfere with the trial
Treatment Outcomes For Functional Dyspepsia Based On Current International Guidelines In Multi-Ethnic Asian Patients

Functional dyspepsia (FD) is among the most established and common functional gastrointestinal disorders (FGIDs). FD is subdivided into two subtypes based on symptoms: epigastric pain syndrome (EPS) and postprandial distress syndrome (PDS).

Based on international guidelines (Asian Consensus and Rome Consensus), a prokinetic, medication which promotes gut movement (such as Itopride) should be the 1st line treatment for the PDS sub-type and a proton pump inhibitor, medication which reduces stomach acid production (such as Esomeprazole) should be the 1st line treatment for the EPS sub-type.

However, in the routine practice in Malaysia, proton pump inhibitor is still commonly used as 1st line treatment for FD, regardless of subtypes. This may be one of the reasons why FD continues to be inadequately treated locally and causes poor health-related quality of life (QOL) in FD patients.

The purpose of this study is to compare the clinical symptoms and quality of life improvement in patients with functional dyspepsia (FD) after treatment according to international guidelines versus treatment according to routine practice. Adverse effects when managed according to guidelines versus routine practice will also be evaluated.


Eligibility Criteria:
Inclusion Criteria:

1. Patients diagnosed with Functional Dyspepsia using Rome IV diagnostic criteria: patients on prior dyspepsia treatment can be recruited after washout period of 2 weeks
2. Subject who has ability to provide written informed consent and willingness to comply with the requirement of the protocol
3. Able to communicate in English, Malay or Mandarin languages

Exclusion Criteria:

1. Patients with known hypersensitivity to Itopride and/or proton pump inhibitors or to any of the excipients of the study medication
2. Patients with a contraindication to any of the study drugs
3. Pregnant / breast feeding women
4. Presence of family history of GI malignancy or alarm features suggested malignancy - e.g. Unintentional weight loss (≥ 10% of body weight in recent 6 months), GI bleeding
5. Patients consuming regular Aspirin or NSAIDs (except low-dose Aspirin at a dose of 325 mg/day or less for cardiovascular prophylaxis)
6. History of erosive esophagitis, peptic ulcer disease within 1 year prior to the screening
7. History of gastrointestinal (GI) malignancy, primary esophageal motility disorder, documented upper GI surgery
8. Patients with any hepatobiliary or pancreatic diseases
9. Patients with severe depression, anxiety, or other psychological disorder
10. Patients with any terminal disease
11. Presence of irritable bowel syndrome (Rome IV criteria) or inflammatory bowel disease (IBD)
12. Other conditions determined by the investigator to be inappropriate for this clinical study
Serological Response to mRNA and Inactivated COVID-19 Vaccine in Health Care Workers in Hong Kong

Since the first local case of COVID-19 confirmed on 4 Feb 2020, Hong Kong has already experienced 4 waves of COVID-19 surge, with more than 9000 cases reported. A number of vaccines have been shown to be efficacious against symptomatic and severe infection by inducing neutralizing antibody (NAB) against spike protein of the SARS-CoV-2 virus. However, the duration of protection and longevity of antibody response is unknown.

Health care workers (HCWs) who are planning to receive COVID-19 vaccine will be recruited. The level of antibody against spike protein by different quantitative assays will also be serially measured .


Eligibility Criteria:
Inclusion Criteria:

1. Any staff, visiting doctor, nursing student of HKSH who are aged 18 or above
2. No contraindication for COVID-19 vaccination and plan to receive the intended dosages at the appropriate interval.
3. A baseline serology taken within 1 week before vaccination shows no evidence of recent infection.
4. No history of documented COVID-19 infection

Exclusion Criteria:

-
Transvaginal Ultrasound Cervical Length Screening in Singleton Pregnancy Without Prior Spontaneous Preterm Birth

Preterm birth (PTB) is a major cause of perinatal morbidity and mortality. Worldwide, about 15 million babies are born too soon every year, causing 1.1 million deaths, as well as short- and long-term disability in countless survivors. Few prognostic tests are available to predict PTB. A short transvaginal ultrasound cervical length (TVU CL) has been shown to be a good predictor of PTB.Different strategies have been adopted for prevention of PTB. The evidence supports the use of vaginal progesterone in singleton pregnancies with short cervix, while cervical cerclage seems to be beneficial only in the subgroup of singleton gestations with both prior spontaneous PTB and TVU CL ≤25mm, and not in singletons without prior PTB, nor in multiple gestations.

However, so far there are no level-1 data on the efficacy of TVU CL screening neither in low risk nor in high risk pregnancy Thus, we aim to assess the efficacy of a policy of TVU CL screening in singleton pregnancy without prior spontaneous PTB


Eligibility Criteria:
Inclusion Criteria:

* 18-50 years of age
* Singleton pregnancy (limits the participants to female gender)
* No prior spontaneous preterm delivery, defined as spontaneous preterm delivery 16 0/7 - 36 6/7 weeks

Exclusion Criteria:

* Multiple gestation
* Prior spontaneous preterm birth 16-36 6/7 weeks
* Ruptured membranes at time of randomization
* Lethal fetal structural anomaly at time of randomization
* Fetal chromosomal abnormality at time of randomization
* Placenta previa and/or accreta at time of randomization
* Women who already underwent TVU CL measurement during the index pregnancy
Efficacy and Safety Study to Evaluate MT-6548 in Hemodialysis Subjects Not Receiving ESAs With Anemia Associated With Chronic Kidney Disease in Japan

For hemodialysis subjects not receiving ESAs with anemia associated with chronic kidney disease, evaluate Hb correction and maintenance effect and safety of MT-6548.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of CKD
* Receiving hemodialysis or hemodiafiltration 3 times a week for more than 12 weeks prior to the screening period, excluding receiving home dialysis or combination of peritoneal dialysis.
* Not being treated with ESAs or if being treated with ESAs, leave defined interval between last ESAs administration and the first day of the screening period
* Mean of the two screening Hb levels closest in time to the baseline visit is ≥8.0 g/dL and \<10.0 g/dL
* Fluctuation between the two Hb levels closest in time to the baseline visit during the screening period less than 1.5 g/dL
* Serum ferritin ≥ 100 ng/mL, or TSAT ≥20% during the screening period
* Folate and vitamin B12 ≥ lower limit of normal during the screening period

Exclusion Criteria:

* Anemia due to a main cause other than CKD: sickle cell disease, myelodysplastic syndrome, bone marrow fibrosis, hematologic malignancy, hemolytic anemia, thalassemia, or pure red cell aplasia
* Active bleeding or recent blood loss within 8 weeks prior to the screening period
* RBC transfusion within 8 weeks prior to the screening period
* Received testosterone enanthate or mepitiostane within 8 weeks prior to the screening period
* AST, ALT, or total bilirubin \>2.5 x upper limit of normal during the screening period
* Uncontrolled hypertension (diastolic blood pressure \>110 mm Hg or systolic blood pressure \>180 mm Hg) at the first day of the screening period and Day 1
* Ophthalmic examinations during the screening period correspond to either of the following criteria;

  * No available fundal findings
  * Findings indicating the presence of active fundal disease
* Severe heart failure (New York Heart Association Class IV)
* Cerebrovascular disorder or acute coronary syndrome (hospitalization due to unstable angina or myocardial infarction), requiring hospitalization due to urgent percutaneous intervention for coronary or heart failure within 12 weeks prior to the screening period
* Current or history of malignancy. History of malignancy with no recurrence for the recent 5 years is not an exclusion criterion
* New onset or recurrent event of deep vein thrombosis or pulmonary embolism within 12 weeks prior to the screening period
* Current or history of hemosiderosis or hemochromatosis
* History of prior organ transplantation or scheduled organ transplant, or prior transplantation of hematopoietic stem cell or bone marrow
* Males and females of childbearing potential who are unwilling to use an acceptable method of contraception during the designated period (Males: during the study and 90 days after the last dose, females: during study and 30 days after the last dose)
* Females who are pregnant or breast feeding, or are predicted to be pregnant
Dose Escalation of Interleukin-1 (IL-7) Added on Antiviral Treatment and Vaccination in HBeAg-negative Chronic Hepatitis B Virus (HBV) Infected Patients

This study is designed to evaluate the safety of biological active dose of a new experimental drug, IL-7, in combination with anti viral therapy and vaccine in patients with Hepatitis B chronic infection.

This is a Phase I/IIa inter-patient dose-escalation study assessing weekly doses of Interleukin-7 (CYT107) in HBeAg-negative chronic hepatitis B infected adult patients. The dose escalation is aimed at establishing the safety of a biologically active doses of CYT107 added to the current antiviral therapy with entecavir or tenofovir and vaccination or not. At each dose level, study patients will receive one subcutaneous administration of CYT107 per week for a total of 4.

Groups of 8 patients will be entered at each dose level of CYT107. Three dose levels are planned.

At each dose level, patients are randomized between 2 arms of treatment: tritherapy (CYT107, vaccine and antiviral treatment) or bitherapy (CYT107 and vaccine). Each treatment group is composed of 4 patients, 3 receiving experimental treatments, 1 just the current antiviral treatment (control patient).

According to the treatment arm, eligible patients initially receive a vaccine if in treatment group of tritherapy, thereafter, CYT107 is added for a cycle of four weekly injections (if not a control patient) at a defined dose level. If in treatment group of tritherapy, patients will receive 2 additional doses of vaccine.

The treatment phase for the tritherapy group is from first vaccine D0 to last vaccine W12 and includes CYT107 administration from W4 to W7.

The treatment phase for the bitehrapy group is from W4 to W7 corresponding to CYT104 injections.

The patients are then followed on a regular basis until reaching 52 weeks after the D0.

Participants will have 1 overnight hospitalization and 12 clinic visit on a period of 55 weeks.

During the visits the following may be done:

* medical history, physical examination, blood tests
* electrocardiograms (ECG)
* chest X-Ray
* liver/spleen imaging
* urine tests

Eligibility Criteria:
Inclusion Criteria:

* Chronic HBV-infected patients
* HBeAg-negative patients
* Age \> 18 years
* Patients with active chronic hepatitis at the start of the antiviral treatment
* Patient with a HBV DNA undetectable (\<70 copies/ml) stable for at least 3 months under entecavir or tenofovir treatment.
* Ongoing treatment by entecavir or tenofovir at screening Note: previous treatment with pegylated IFN monotherapy, before the start of entecavir or tenofovir, is acceptable

Exclusion Criteria:

* Infection by HCV
* Infection by HIV-1 and /or HIV-2
* Apart from HBV infection, presence of active infection requiring a specific treatment or a hospitalization
* Previous treatment by lamivudine and/or nucleosides analogues
* Inactive carrier
* Cirrhosis
* Other liver disease (notably from alcoholic, metabolic or immunological origin)
* History of clinical autoimmune disease or active auto-immune disease
* Type I diabetes mellitus
* Severe asthma, presently on chronic medications
PRILIGY Usage Patterns in Selected Populations

This study will use electronic health services databases to describe the usage patterns of dapoxetine hydrochloride (PRILIGY) in Germany and Italy with a focus on describing the extent and proportion of patients with characteristics suggestive of the use of PRILIGY within, versus outside of the intended use population.

This study will use anonymized (nameless) patient data from electronic health services databases in Germany and Italy to describe the proportion of PRILIGY (dapoxetine hydrochloride) usage among those patients with characteristics suggestive of the use of PRILIGY within versus outside (eg, those with contraindications) of the intended use (IU) population. This is an observational study; no investigational drug will be administered.

Eligibility Criteria:
Inclusion Criteria:

* Received a prescription for PRILIGY
* Treated by physicians who contributed data to the IMS Disease Analyzer database for Germany and Thales database for Italy

Exclusion Criteria:

* Age not specified
* Sex not specified as "male
* " Fewer than 6 months (183 days) of history in the electronic health services databases before receiving the first prescription for PRILIGY (At least 6 months of history in the database is not required for the patients of the German urologists).