cyrilzakka/clinical-trials huggingface dataset:
Vardenafil in Tinnitus

There is incidental evidence (casuistic findings) that the treatment with vardenafil of male patients suffering from erectile dysfunction and comorbid tinnitus experienced an improvement of their tinnitus.

Randomized, parallel-group, double-blind, placebo-controlled trial over 16 weeks (12 weeks of treatment + 4 weeks follow-up) with 10 mg vardenafil BID p.o. in men and women with chronic tinnitus.


Eligibility Criteria:
Inclusion Criteria:

* Chronic subjective cochlear tinnitus
* No treatment of tinnitus within 4 weeks prior to study entry
* Duration of tinnitus \> 3 months

Exclusion Criteria:

* Acute tinnitus
* Intermittent tinnitus
* History of M. Menieré
* History of conductive deafness
* History of psychogenic deafness
* History of tumors of the middle ear, inner ear or cerebella-pontine angle (malignant and non malignant)
* Patients diagnosed of multiple sclerosis
* History of myocardial infarction, stroke, or life-threatening arrhythmia within the prior 6 months
* Nitrates or nitric oxide donors
* Any other concurrent treatment of tinnitus during study
* pregnant and breast-feeding women
* women with child-bearing potential not using adequate birth control method (Note: as adequate method of birth control oral contraception, spiral or sexual abstinence is recommended)
* Other exclusion criteria apply according to the Summary of Product Characteristics
Phase I Study of Intrathecal Topotecan

The purpose of this study is to determine the qualitative and quantitative toxicity of intrathecal topotecan, a topoisomerase I inhibitor, in patients with meningeal malignancies refractory to conventional therapy (radiation therapy and chemotherapy).

The purpose of this study is to determine the qualitative and quantitative toxicity of intrathecal topotecan, a topoisomerase I inhibitor, in patients with meningeal malignancies refractory to conventional therapy (radiation therapy and chemotherapy). A safe dose of topotecan that can be recommended for intrathecal administration in subsequent phase II studies will be established in a limited dosage escalation schedule. The CSF pharmacokinetics of intrathecal topotecan will also be studied. Topotecan will be administered intrathecally on a bi-weekly basis for four to six weeks, followed by weekly administration for 1 month, twice monthly administration for four months and then monthly IT administration.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

Leukemia, lymphoma, or solid tumor with overt meningeal involvement considered refractory to conventional therapy.

CSF leukemic cell count at least 5 per cubic millimeter with evidence of blast cells on cytospin or cytology required for leukemia and lymphoma patients.

Tumor cells on cytospin or cytology or measurable meningeal disease on CT or MRI required for patients with solid tumors.

No clinical evidence of obstructive hydrocephalus or compartmentalization of the CSF flow as documented by indium-111- or technetium-99-DPTA flow study.

PRIOR/CONCURRENT THERAPY:

At least 1 week since CNS therapy.

Biologic Therapy: Recovery from toxic effects of prior immunotherapy required.

Chemotherapy:

Recovery from toxic effects of prior chemotherapy required.

No concomitant therapy to treat meningeal malignancy (intrathecal or systemic).

Concomitant chemotherapy to control systemic disease or bulk CNS disease allowed except: Investigational agents. Agents that penetrate the CNS (e.g., high-dose methotrexate, thiotepa, high-dose cytarabine, fluorouracil, intravenous mercaptopurine).

Agents known to have serious unpredictable CNS side effects.

Endocrine Therapy: Not specified.

Radiotherapy: Recovery from toxic effects of prior radiotherapy required. Patient eligible if flow restored following focal radiotherapy to the blockage site.

Surgery: Not specified.

PATIENT CHARACTERISTICS:

Age: 3 and over (older patients giving consent will be enrolled before the very young, if possible).

Performance status: ECOG 0-2.

Life expectancy: At least 8 weeks.

Hematopoietic: See Disease Characteristics.

Hepatic: Bilirubin less than 2.0 mg/dL, SGPT less than 3 times normal.

Renal: Creatinine less than 1.5 mg/dL.

Metabolic: Serum electrolytes (including calcium and phosphate) normal.

Other: No significant systemic illness (e.g., infection). Not pregnant or lactating.
Low Dose Radiation Therapy for Severe-Acute-Respiratory-Syndrome-Coronavirus-2 (SARS-CoV-2), COVID-19

This study is to analyse the efficacy of LD-RT for treatment of Severe-Acute-Respiratory-Syndrome-Coronavirus-2 (SARS-CoV-2).

Management of patients with SARS-CoV-2 presents a great challenge in the ongoing pandemic. The inflammatory reaction, evident in the later stages of the disease, is linked with high mortality rates. Pharmaceutical interventions at this stage often do not achieve the desired effects. Low Dose Radiation Therapy (LD-RT) has been utilized for treatment of inflammatory conditions because of its immunomodulatory effects. Thus, LD-RT may be an option in SARS-CoV-2 based on pre-clinical models and early clinical data. This study is to analyse the efficacy of LD-RT for treatment of Severe-Acute-Respiratory-Syndrome-Coronavirus-2 (SARS-CoV-2).

Eligibility Criteria:
Inclusion Criteria:

* Age of male patients \>40 years
* Age of female patients \>50 years
* Patients with SARS-CoV-2 requiring mechanical ventilation
* Informed consent obtained by the legal representative of the patient

Exclusion Criteria:

* Pregnancy
Effects of the Breath Stacking Technique After Upper Abdominal Surgery

This study evaluates the effects of the breath stacking technique in patients after upper abdominal surgery. Half of the patients receive routine physical therapy associated with the Breath Stacking technique, while the other half will receive only routine physical therapy.

This randomized controlled study aims to evaluate the effects of the Breath Stacking technique in patients undergoing upper abdominal surgery on clinical, physiological and cardiopulmonary variables. These individuals were randomized to compose the control group (CG) and the intervention group (GBS). The routine physical therapy was performed in both groups and in the GBS two daily sessions of up to 20 minutes of Breath Stacking technique were applied. To verify the effect of this intervention, before and after the protocol, patients underwent the following evaluations: algometry, cirtometry in the axillary line , umbilical line and the xiphoid process, ventilometry, spirometry and manovacuometry.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing a surgical procedure that involves in an incision in the upper quadrants of the abdominal region.

Exclusion Criteria:

* Intolerance to the use of BS mask.
* Chronic obstructive pulmonary disease (COPD), Asthma, Chron's disease.
* Liver trauma severe with hemodynamic repercussions.
* Patients undergoing esophagectomy.
* Sepsis with complications postoperative hemodynamics.
* Need for surgical reintervention.
* Forwarded to Intensive Care Unit or need for mechanical ventilation after discharge from the anesthetic recovery.
* Cognitive dysfunction that makes it impossible to understand and execute evaluations and intervention.
Observational Study to Evaluate PAD Treatment Clinical and Economic Outcomes

The purpose of this study is to evaluate acute and long term clinical and economic outcomes of endovascular procedures to treat Peripheral Arterial Disease (PAD).

This is a prospective, observational, multi-center, clinical study examining predictors of clinical outcomes for patients undergoing endovascular treatment of lesions within or extending into the target area (10 cm above the medial epicondyle to the digital arteries). This includes disease in a vessel located within or extending into the distal superficial femoral artery (SFA), popliteal (POP), tibial peroneal trunk (TPT), anterior tibial (AT), posterior tibial (PT), and peroneal tibial (PR) arteries.

Eligibility Criteria:
Inclusion Criteria:

1. Subject's age ≥ 18 years.
2. Subject presents with a Rutherford classification of 2 to 6.
3. Subject presents with clinical evidence of PAD requiring endovascular intervention on one or both limbs that includes a target lesion in a native vessel located within or extending into 10 cm above the medial epicondyle to the digital arteries.

   * If subject presents with bilateral disease, the first limb treated with a lesion in the target area will be considered the target limb.
   * For subjects with one or more wounds on the target limb, the target lesion(s) should be considered the lesion(s) in the vessel(s) that provide(s) blood flow to the wound(s).
4. Subject has at least one lesion in a native vessel located within or extending into the target area that is crossed and treated with an endovascular device.

Exclusion Criteria:

1. Subject is unwilling or unable to sign the IRB-approved informed consent form (ICF).
2. Subject is unable to understand or comply with the study protocol requirements.
3. Subject is currently participating in an investigational drug or other device study that can clinically interfere with the endpoints of this study.
4. Subject requires a conversion from endovascular intervention to a surgical bypass graft for any lesion(s) in the target area, as determined by the Investigator.
5. Subject has an in-stent restenosis in the target area, and this lesion is the only one requiring treatment.
6. Subject is pregnant or planning to become pregnant within the study period.
7. Subject has an anticipated life span of less than one (1) year.
BN80927 in Patients With Advanced Malignant Solid Tumors

The purpose of this study was to determine the maximum tolerated dose and the recommended dose of BN80927 in patients with advanced malignant solid tumors.


Eligibility Criteria:
Inclusion Criteria:

All included patients:

* Gave their written (personally signed and dated) informed consent
* had histologically or cytologically documented malignant solid tumour
* had received no more than three prior chemotherapy regimens
* had failed the standard therapy or had no option of an active standard therapy
* had an estimated survival time of greater than 3 months (according to the investigator's assessment)
* had a World Health Organisation (WHO) performance status score ≤1
* were free from other serious concurrent disease
* had adequate bone marrow function
* had adequate liver function
* had adequate renal function
* who were female and of child-bearing potential must have had a negative result in a pre-study pregnancy test β-human-chorionic-gonadotrophin (β-HCG).

Exclusion Criteria:

No patient included:

* was pregnant or lactating
* was unable and/or unwilling to comply fully with the protocol and the study instructions;
* presented with any concomitant condition, which could compromise the objectives of the study
* had received an investigational drug within 30 days prior to study entry or was scheduled to require concurrent treatment with an experimental drug or treatment during the study
* had received chemotherapy or hormonotherapy within 4 weeks of study entry, or had received chemotherapy with nitrosoureas or mitomycin-C within 6 weeks of study entry
* had received any extensive palliative or curative radiotherapy (no more than 35% of their active bone marrow) within 2 weeks of study entry, or had not fully recovered from such treatment
* had previously received a bone marrow transplant (BMT) or peripheral blood progenitor cells (PBPC)
* had clinical evidence of major organ failure or brain metastases.
Effect of Physical Exercise Program on Outcomes and Level of Depression

Due to physical and physiological changes that occur in pregnant women, depression is very common during this period. Recent research findings indicate that antenatal maternal mood state impacts on babies health. Nowadays, many researchers are focussed on examining the effects of physical exercise on foetal and maternal outcomes.

The main aim of this study was to assess the effectiveness of a supervised exercise program consisted of 25-30 minutes of cardiovascular exercise,10 minutes of specific exercises (strength and balance exercises), and 10 minutes of pelvis floor muscles training, on the prevention and treatment of depression in pregnant women. Additionally, the other purpose of the study was to analyze the effects of depression and physical exercise on outcomes.

Hypothesis: Pregnant women who do regular exercise during their pregnancies would have a better mood state than pregnant women who are sedentary, without having any negative effect on outcomes.

BACKROUND: Recent studies have estimated the prevalence of depression during pregnancy at between 10% and 30%. This state can produce negative effects on the fetus as:

* Affect cerebral development
* Increase the risk of preterm birth and low birth weight
* Increase the risk of childhood overweight problems
* Adverse impact on the cognitive, emotional, social, and behavioural development of infants

Due to the possible side effect of antidepressants on mother and fetus, its necessary to examine alternative solutions to this state.

Eligibility Criteria:
Inclusion Criteria:

* Being healthy and able to exercise following American College of Obstetricians and Gynecologists (ACOG) guidelines
* Being able to communicate in spanish
* Giving birth at Hospital Universitario de Fuenlabrada

Exclusion Criteria:

* Multiparity
* Obstetrician complications
* Being interested in the study after 18 weeks
* Not being regular in physical exercise program
* Younger than 18 years old
Study of Oral Fluid Testing Approach

The purpose of this study is to identify and evaluate oral fluid testing as a biologic measure of cannabis use days that can be assessed remotely. The researchers will conduct this fully virtual study among a community sample of 200 individuals aged 18-30 years who have used cannabis at least 1 time per week on average in the past 30 days. Participants will complete oral fluid (saliva) tests, urine tests, and Timeline Follow-back interviews (self-report) that indicate their recent cannabis use (delta-9-THC). Participants will present for 3 virtual study visits and be asked to complete activities in between: Study Visit 1 (Day 0; informed consent, baseline survey, TLFB interview), Study Visit 2 (\~Day 3; TLFB interview, urine testing), 6 days of at-home videorecorded oral fluid testing, Study Visit 3 (\~Day 12; TLFB interview, urine test, oral fluid test, survey, interview).


Eligibility Criteria:
Inclusion Criteria:

* Age 18 to 30 years
* Cannabis use on \>=1x/week in the past 30 days
* Ownership of a portable device that is capable of videoconference and videorecording (i.e., smartphone, tablet computer, or laptop computer)
* Ability to read and speak English
* Availability for duration of the study (2-3 weeks).
* To proceed to oral fluid testing, positive result for urinary TCH-COOH

Exclusion Criteria:

• Inability/unwillingness to provide contact information
Feasibility of An Active Video Gaming Intervention

Replacing sedentary behaviors during leisure time with active video gaming (AVG) has been shown to be an enjoyable option for increasing the amount of physical activity acquired each week. This project will examine the feasibility of an AVG intervention using the GAIMplank.

Replacing sedentary behaviors during leisure time with active video gaming (AVG) has been shown to be an enjoyable option for increasing the amount of physical activity acquired each week. A growing body of literature indicates that increases in energy expenditure can be achieved during AVG play in people with physical disabilities, including those with mobility impairments such as cerebral palsy (CP), spinal cord injury, stroke, and other neurological conditions. AVGs are particularly important for people with disabilities given the higher rate of inaccessible features in the built environment and the difficulty in finding activities they enjoy. Since AVG devices are relatively affordable, they also hold promise as a scalable product for promoting higher levels of physical activity and fitness among people with disabilities.

There continues to be a pressing need to make gaming controllers accessible to people who are unable to stand for long periods, cannot stand on a small platform due to poor balance or extreme obesity, or who are unable to stand and are full-time wheelchair users. The GAIMplank controller, was developed and tested for usability among people with mobility impairments. During usability testing, a sample of 21 adults were able to successfully access and play a series of standard PC video games using trunk/body movements to produce game play action. Using validated survey tools, participant usability scores and qualitative feedback indicated above average usability for the GAIMplank system. In addition, participants enjoyed the activity and reported game play as light to moderate intensity activity.

This project will examine the feasibility of an AVG intervention using the GAIMplank.

Eligibility Criteria:
Inclusion Criteria:

* 18+ years of age
* Self-reported physical disability that limits their mobility
* Communicate in English

Exclusion Criteria:

* Significant impairment in visual acuity that prevents seeing a 52" TV screen to follow exercise
* Body weight \>400 lbs
* Cognitive or linguistic problems with understanding instructions or filling in self-administered outcome measures in English as determined by a score of \<17 on the telephone-version of the Mini-Mental State Exam
* Any other conditions that would limit ability to play video games
* Cardiovascular disease event within the past 6 months
* Severe pulmonary disease or renal failure
* Currently pregnant
* Ongoing exacerbation of a health condition
Compare Immunogenicity & Safety of 2 Formulations of GSK Biologicals' DTPa-HBV-IPV/Hib Vaccine Given in Healthy Infants

In this study, infants will be randomly allocated into three groups:

* one group of subjects will receive DTPa-HBV-IPV/Hib vaccine (new formulation)
* the second group of subjects will receive DTPa-HBV-IPV/Hib vaccine (current formulation)
* the third group of subjects will receive DTPa-HBV-IPV vaccine The study will be double-blind for the two groups receiving the DTPa-HBV-IPV/Hib vaccine (new or current formulation). The study will be single-blind for the group receiving DTPa-HBV-IPV vaccine.

A study to compare the immunogenicity \& safety of 2 formulations of GlaxoSmithKline (GSK) Biologicals' DTPa-HBV-IPV/Hib vaccine given in healthy infants at 3,4 \& 5 months age. The immunogenicity \& safety of DTPa-HBV-IPV vaccine will also be evaluated in a 3rd group of subjects Subjects in the group that will receive DTPa-HBV-IPV/Hib vaccine (current formulation) will be the control group for the group that will receive DTPa-HBV-IPV/Hib vaccine (new formulation)

Eligibility Criteria:
"Inclusion criteria:

* A healthy male or female infant between, and including, 11 and 17 weeks of age at the time of the first vaccination.
* Infant born to known hepatitis B surface antigen (HBsAg) seronegative mother (documented laboratory result of HBsAg assay from the maternal blood sample is available).
* Born after a normal gestation period (between 36 and 42 weeks).
* Written informed consent obtained from the parent or guardian of the subject.

Exclusion criteria:

* Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
* Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.
* Any chronic drug therapy to be continued during the study period.
* Planned administration/ administration of a vaccine not foreseen by the study protocol during the period starting from 30 days before each dose of study vaccine and ending 30 days after the last vaccine dose.
* Previous vaccination against diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B and/or Haemophilus influenzae diseases.
* Known history of or exposure to diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B and/or Haemophilus influenzae diseases since birth.
* History of allergic disease or reactions likely to be exacerbated by any component of the vaccines.

"
Effects of High-intensity Exercise Training on Physical Fitness, Cognition, Language in Post-stroke Aphasia

The goal of this clinical trial is to establish the feasibility and fidelity of a high-intensity exercise program for individuals with post-stroke aphasia. The main questions it aims to answer are:

* Is it feasible for stroke survivors with aphasia to participate in a long in-person physical exercise program?
* Does participation in a physical exercise program lead to physical fitness, cognitive, language and/or psychological changes?

Participants can take part in two different physical exercise interventions:

* Low intensity intervention (control intervention);
* High-intensity physical exercise intervention (target intervention).


Eligibility Criteria:
Inclusion Criteria:

* aphasia following single or multiple ischemic or hemorrhagic stroke;
* at least 6 months from the last stroke;
* proficient in English before the stroke;
* at least 8 years of education;
* between the ages of 18 and 80;
* independent with ambulation without a device (single-point cane accepted);
* medically stable with no contraindications to participate in regular physical exercise as determined by the patient's own primary care provider or other treating provider.

Exclusion Criteria:

* prior history of dementia, neurologic illness (other than stroke), or substance abuse;
* significant visual or hearing disabilities (e.g., neglect, uncorrected visual or hearing loss) that interfere with testing;
* per self-report uncontrolled cardiorespiratory and/or metabolic disorders incompatible with exercise.
Dose-finding Study of LIK066 Compared With Placebo or Sitagliptin to Evaluate Change in HbA1c in Patients With Diabetes

The purpose of the study is to evaluate the efficacy, tolerability and short-term safety of LIK066 to support dose selection for phase 3.


Eligibility Criteria:
Inclusion Criteria:

1. Confirmed diagnosis of T2DM by standard criteria
2. Drug-naïve patients, defined as patients not having received any anti-diabetic medication previously,
3. Currently untreated patients , who, after the diagnosis of T2DM, have received anti-diabetic medication for not more than 12 consecutive weeks, and have not received any anti-diabetic treatment within 12 weeks prior to Visit 1
4. Patients being treated with mono-therapy for at least 8 consecutive weeks prior to Visit 1 with the following OADs: metformin, dipeptidyl peptidase-4 inhibitors (DPP-4i), SU, glinide, alpha-glucosidase inhibitor (AGI)
5. HbA1c ≥ 7 to ≤ 10.5% at Visit 1 for drug-naïve/currently untreated patients
6. HbA1c ≥ 7 to ≤ 9.5% at Visit 1 for patients treated with OAD monotherapy
7. HbA1c ≥ 7 to ≤ 10.5% at Visit 199 for ALL patients
8. Age: ≥18 and ≤ 75 years old at Visit 1
9. BMI ≥22 to ≤45 kg/m2 at Visit 1

Exclusion Criteria:

1. FPG ≥270 mg/dl (15 mmol/L) for drug-naïve/currently untreated patients or ≥240 mg/dl (13.3 mmol/L) for patients on OAD monotherapy at Visit 1
2. Insulin treatment \>4 consecutive weeks in the last 6 months, corticosteroid use \>7 days in the last 8 weeks, use of growth hormones in the last 6 months, or use of weight control products \> 4 weeks in the last 6 months
3. History of acute metabolic complications, CV disease, type 1 diabetes mellitus, hepatic disorders, pancreatitis, chronic diarrhea
4. Significant lab abnormalities such as TSH outside of normal range, UACR\>300 mg/g creatinine, eGFR \<60 ml/min/1.73m2, hemoglobin \<12 g/L in men and \<11 g/L in women, hematuria
5. ECG abnormalities including AV block, long QT syndrome or QTc\>450 msec for men and \>470 msec for women
6. History of malignancy
7. Women of child-bearing potential not using effective methods of contraception Other protocol-defined inclusion/exclusion criteria may apply