cyrilzakka/clinical-trials huggingface dataset:
Strengthening in Sub-acute Stroke Survivors: A Randomized Controlled Trial

The goal of this study is to compare between Eccentric training and conventional therapy in sub-acute stroke survivors. The primary objective of this study is to evaluate improvements in gait speed after four months of ET in comparison to conventional therapy for patients with sub-acute stroke. Secondary objectives involve assessing: i) modifications in neuromuscular parameters of PF, ii) changes in muscle stiffness within PF during passive mobilization and active force generation, and iii) modifications in architectural parameters of PF.

This study will be a single-blinded, controlled, randomized design, wherein participants will be randomly assigned to one of two groups: the Conventional Therapy Group (CTG) or the Eccentric Training Group (ETG). Both groups will undergo a comprehensive series of assessments at three key time points: Ji (initial assessment), Jint (intermediate assessment), and Jf (final assessment). The study will commence with a recruitment phase, followed by a screening phase. Subsequently, there will be a 4-week period allocated for experimental testing before the intervention, and an additional 4 weeks for experimental testing after the intervention. These assessments will encompass a wide range of evaluations, including clinical health assessments, biomechanical assessments, neuromuscular evaluations, and functional assessments

Eligibility Criteria:
Inclusion Criteria:

* Subacute hemiparesis (\> 3 months)
* BMI between 18.5 and 25
* Written consent to participate in the study.

Exclusion Criteria:

* Ankle impairment
* Botulinum toxin injections in PF within the last 4 months before study inclusion
* Medical contraindication for maximal effort
* Neurodegenerative disorders
* Cardiovascular disorders
* History of epilepsy.
Drinking Water PFAS, Pregnancy Outcome and Maternal Morbidity

The aim of the project is to assess the association between exposure to per- and polyfluoroalkyl substances (PFAS) via drinking water in pregnancy and birth outcomes (i.e. growth retardation, premature birth, and congenital developmental defects) and maternal morbidity (gestational hypertension, diabetes and preeclampsia) in a prospective population-wide register study.


Eligibility Criteria:
Inclusion Criteria:

* Pregnant women residing in Swedish localities with a population exceeding 10,000 inhabitants and giving birth during 2012-2018

Exclusion Criteria:

* Lack of data of PFAS levels in municipal drinking water (entire localities excluded)
* Mothers not living in the study area consistently between first trimester and four years prior to birth
Comparison of NN1250 Versus Insulin Detemir, Both Combined With Insulin Aspart in Subjects With Type 1 Diabetes

This trial is conducted in Japan. The aim of this clinical trial is to investigate the safety (with emphasis on hypoglycaemia) after switching from long-acting insulin analogue or intermediate-acting insulin to insulin degludec (NN1250, SIBA) on a basal-bolus regimen in subjects with type 1 diabetes mellitus.


Eligibility Criteria:
Inclusion Criteria:

* Subjects with type 1 diabetes mellitus more than one year
* Current treatment: basal (once daily at bedtime) - bolus (three times a day just before main meals) regimen only for at least 12 weeks using a long-acting insulin analogue excluding insulin detemir or intermediate-acting insulin as a basal insulin and NovoRapid® as bolus insulin (a brand of basal insulin preparation has not been changed in the preceding 12 weeks)
* HbA1c below 10.0%
* Body Mass Index (BMI) below 30.0 kg/m\^2

Exclusion Criteria:

* Known hypoglycaemia unawareness or recurrent major hypoglycaemia
* Current treatment with total insulin dose of more than 100 U or IU/day
* Current treatment or expected to start treatment with systemic corticosteroid
Respiratory Muscle Endurance Training in Obese Patients

Obese patients are known to have increased work of breathing inducing dyspnea, exercise intolerance and impaired quality of life. Respiratory muscle training is known to increase respiratory muscle capacity, reduce dyspnoea and improve exercise performance in healthy subjects and respiratory patients. The investigators hypothesized that Respiratory muscle training would reduce dyspnoea, increase exercise tolerance and quality of life in obese patients.


Eligibility Criteria:
Inclusion Criteria:

* Obese patients (BMI \> 30 kg/m2), without respiratory pathology (VEMS \> 80% predicted, VEMS/CV \> 80%)
* men or women
* age between 18 and 60 years old

Exclusion Criteria:

* Respiratory, cardiovascular, musculoskeletal diseases
* Alcoholism
Stem Cell Study for Long COVID-19 Neurological Symptoms

The purpose of this research study is to test the safety and benefit of a human cord blood derived stem cell infusion as a treatment for individuals with post COVID-19 neurological problems. Participants in the study will have 6 clinic visits over a 12 to 14 mo. period with each visit lasting 2 to 6 hours. Participants will receive 1 stem cell infusion at study visit #3. Participants will have a brain PET and MRI scan at the baseline and 6mo. post-infusion visits. Follow-up safety assessments will be conducted at 6mo. and 1yr. after the stem cell infusion.

This is a non-randomized, Phase 1/2a dose escalation study using allogenic cord tissue MSC's in adults with chronic neurological symptoms following an acute COVID-19 infection.

Eligibility Criteria:
Inclusion Criteria:

1. Adults between 18 and 55 years of age.
2. Documented history of COVID-19 infection with resulting neurological sequela.
3. Post-Covid-19 Functional Status score of grades 3 or 4.
4. Chronic neurological symptoms defined as anxiety/depression, pain syndromes, sleep disorders, and /or memory disorders ("brain fog") persisting 6 months after an acute COVID-19 infection.
5. Ability to obtain consent from the subject.
6. Ability to communicate in English or Spanish (required for validated neurocognitive outcome testing).

Exclusion Criteria:

1. Known history of:

   1. intellectual deficiency or psychiatric conditions likely to invalidate our ability to assess changes in cognition or behavior,
   2. recently treated infection,
   3. renal disease or altered renal function (screening serum creatinine \> 1.5 mg/dL),
   4. hepatic disease or altered liver function (screening SGPT \> 150 U/L and/or T. Bilirubin \>1.3 mg/dL),
   5. cancer,
   6. immunosuppression (screening WBC \< 3, 000 cells/ml),
   7. HIV+,
   8. chemical or ETOH dependency that in the opinion of the investigator would preclude participation in the study,
   9. acute or chronic lung disease requiring significant medication/oxygen supplementation,
   10. bleeding disorders including immune-mediated heparin-induced thrombocytopenia,
   11. hypercoagulable disorders (Protein C, S, ATIII deficiencies), Factor V Leiden,
   12. known sensitivity to heparin, Lovenox, and pork products,
   13. individuals with mechanical prosthetic heart valves.
2. Pulse oximetry oxygen saturation \<93% on room air.
3. Other acute or chronic medical conditions that, in the opinion of the investigator, may increase the risks associated with study participation.
4. For women of childbearing potential, a positive pregnancy test at the screening visit or, for both women and men, unwillingness to comply with acceptable methods of birth control during the study.
5. Previous or concurrent participation in an interventional drug or biological study.
6. Inability to undergo the diagnostic tests (PET/DT-MRI) or unwilling/unable to cooperate with the diagnostic tests and outcome assessments.
7. Unwilling or unable to return for follow-up study visits.
8. Prisoner/Incarcerated.
Efficacy and Safety of Moisturising Cream with or Without Vitamin E and Urea Cream in Palmar-plantar Erythrodysesthesia

This is a single-centre, phase II, three-arm, randomised controlled trial to evaluate the efficacy and safety of a cosmetic moisturising cream containing palm-oil-derived vitamin E concentrate or a similar moisturising cream without the vitamin E concentrate in addition to urea-based cream, or urea-based cream alone (1:1:1) in patients who are receiving capecitabine-based cancer therapy and develop capecitabine-associated PPE of NCI-CTCAE grade 1.

In this study, 90 cancer patients from Sarawak General Hospital who are receiving capecitabine-based therapy (2000-2500mg daily dose) and develop PPE of NCI-CTCAE grade 1 will be recruited and randomised 1:1:1 to three study arms. The participants who are randomised to treatment arms will receive moisturising creams with or without palm-oil-derived vitamin E concentrate, in addition to urea-based cream for external application on palms and soles. Participants who are randomised to the control arm will be required to use urea-based cream only.

Both patients and investigators will be blinded to the investigational cream assignment i.e., double-blind. However, blinding will not be applicable to the use of urea cream i.e., open-label. The patients will need to use the cream(s) at least two times a day for nine to eighteen weeks or equivalent to three to six treatment cycles of capecitabine. At week-9, the patients who are planned to continue capecitabine therapy and do not develop PPE of grade 2/3 will continue to receive the study treatments for additional nine weeks or equivalent to three treatment cycles of capecitabine (extended period).

The patients will be assessed for their PPE grading, symptoms, dermatological quality of life, pain score, and adverse events at the end of each capecitabine treatment cycle at the clinic.

Eligibility Criteria:
Inclusion Criteria:

1. 18 years old and above
2. Able to give written consent freely
3. Receiving capecitabine at 2000-2500mg/m2/day or 1000-1250/m2/dose twice a day, at least 1 dose, as monotherapy or in combination therapy
4. Receiving urea-based cream
5. Developed PPE of NCI-CTCAE grade 1
6. Have at least three cycles of chemotherapy to complete
7. Life expectancy ≥ 6 months
8. ECOG≤2

Exclusion Criteria:

1. Unable to understand the information sheet and informed consent form
2. Allergy history towards vitamin E and its isoforms or any components of the investigational products
3. Unable to tolerate urea-based products
4. Other pre-existing dermatological diseases or conditions that may interfere the evaluation of PPE
5. PPE complicated with infection
6. Receiving other agent(s) that are known to cause PPE or hand- foot syndrome and hand-foot skin reactions
7. Receiving long-term topical or systemic steroid treatment (except as part of pre-or post-medications of chemotherapy regime)
8. Pregnant or lactating mother
9. Participating in another interventional trial
10. Refuses to interrupt his/her usual care
11. Anticipated inability to follow-up
The Effect of Intranasal Oxytocin on Emphatic Abilities in Patients With Post Traumatic Stress Disorder (PTSD)

Oxytocin (OT) - a neurohormone and neuromodulator which is mainly synthesized in the hypothalamus - is a key mediator of complex social and affective behaviors, including emotional empathy. Recently, several theoretical studies suggested that PTSD patients have abnormal functioning of the OT system. According to these theories, dysfunction in the oxytocin system may modulate the interpersonal impairment that characterizes PTSD, and therefore intranasal OT may potentially relieve these symptoms. The main goal of this study is to examine the effects of administration of nasal OT on empathic abilities among PTSD patients. Another goal of this study is to examine the relationship between empathic abilities and the ability to retrieve autobiographical memories among PTSD patients.


Eligibility Criteria:
Inclusion Criteria:

* PTSD patients (DSM-IV criteria)
* Ability to provide written informed consent

Exclusion Criteria:

* Suicidality
* Psychosis
* Arrhythmia
* Cardiac disease (arrythmia, heart failure)
* Hyponatremia
* Severe renal insufficiency
* Liver cirrhosis
* Pregnancy
Ziv-aflibercept Efficacy in Better Regulating AMD

This is a randomized, open-label, interventional, controlled study to determine the effects of Zaltrap on Neovascularized Wet Macular Degeneration as compared to the control anti-vascular endothelial growth factor ("anti-VEGF") injections (bevacizumab, ranibizumab, or aflibercept).


Eligibility Criteria:
Inclusion Criteria:

* Are age 50-99
* Have neovascular Age-related Macular Degeneration ("AMD") with an eye undergoing maintenance treatment with one or more of the following anti-VEGF drugs: bevacizumab, ranibizumab, or aflibercept.
* Have an eye undergoing treatment that is of low visual potential (20/200 Snellen equivalent or worse) and the contralateral eye must have better visual potential.
* Are willing and able to provide signed informed consent and willing to undertake all scheduled study-related assessments, visits, and treatments.
* Have received an intravitreal injection of one of the drugs listed above within 120 days of Day 1 of the trial.
* Both males and females will be enrolled.

Exclusion Criteria:

* Active intraocular inflammation or infection
* History of vitreous hemorrhage within three months prior to Day 1 of the study
* Uncontrolled ocular hypertension or glaucoma in the study eye (defined as Intraocular Pressure ("IOP") \>25 mm Hg or a Cup to Disc ratio \> 0.8 despite treatment with anti-glaucoma medication) or any such condition which the investigator feels may warrant a glaucoma filtering surgery during the study
* History of stroke within the last three months prior to Day 1 of the study
* History of myocardial infarction within the last three months prior to Day 1 of the study
* Undergone intraocular surgery or laser treatments within the last three months,
* Significant Epiretinal Membrane ("ERM") or Vitreomacular Traction ("VMT") causing distortion of macular anatomy
* No use of ocular corticosteroids within the last six months and no use of systemic corticosteroids at a dose of \>10 mg/day
* Not have active malignancies within the last 12 months except appropriately treated carcinoma in situ of the cervix, melanoma, and prostate cancers treated with a curative intent
* Inability to comply with study or follow-up procedures
* Women who may become pregnant or lactating or intend to become pregnant during the study
* Women who are of childbearing potential, including women who have had tubal ligation, must have a blood test within 21 days prior to Day 1 of the study. A woman is considered to not be of childbearing potential if she is postmenopausal or has undergone hysterectomy and/or bilateral oophorectomy. Postmenopausal is defined as 12 consecutive months with no menses without an alternative medical cause.
Different Metabolic Characteristics in the Presence of Brown Adipose Tissue in Humans

Functional brown adipose tissue (BAT) exists in adult humans and can be detected by PET and especially during acute cold exposure. It is conceivable that BAT activity might reduce the risk of developing obesity since fat stores are used for thermogenesis, and a directed enhancement of adipocyte metabolism might have value in weight reduction. So it is important to know the different metabolic characteristics in human adults who have detected BAT. Therefore, the purpose of the investigators study is to compare different metabolic characteristics in the presence of brown adipose tissue in humans.


Eligibility Criteria:
Inclusion Criteria:

* Patients who underwent 18FDG-PET/CT scan year between 2008-2010

Exclusion Criteria:

* History of cardiovascular disease (myocardial infarction, unstable angina, stroke, or cardiovascular revascularization)
* Diabetes
* Stage 2 hypertension
* Severe renal or hepatic disease
A Study of Recombinant Human Erythropoietin Beta (NeoRecormon) in Anemic Cancer Participants Treated With Chemotherapy

This study will evaluate the efficacy and tolerability of subcutaneous (SC) or intramuscular (IM) recombinant human erythropoietin beta (r-HuEPO) in participants with anemia and histologically or cytologically confirmed cancer.


Eligibility Criteria:
Inclusion Criteria:

* Histological or cytological confirmed cancer
* Participants who are treated with at least first line chemotherapy
* Hemoglobin less than (\<) 11 grams per deciliter (g/dL)
* Participants able to receive iron supplement, if necessary

Exclusion Criteria:

* History of hypersensitivity to active or inactive excipients of r-HuEPO
* Insufficient controllable hypertension
* Thalassemic syndromes
* Anemia caused by hematic loss
* Women who are pregnant or lactating
A Study to Assess Hemoglobin Level Depending on the Comorbidity Index in Chronic Kidney Disease (CKD) Participants Not in Dialysis Treated With Methoxy Polyethylene Glycol-Epoetin Beta (COMETE)

This prospective, multicenter, observational study will evaluate the impact of comorbidity factors on the hemoglobin level in participants with chronic kidney disease who are not on dialysis and initiated on treatment with methoxy polyethylene glycol-epoetin beta (Mircera). Data will be collected for 9 months after initiation of methoxy polyethylene glycol-epoetin beta treatment.


Eligibility Criteria:
Inclusion Criteria:

* Participants with chronic kidney disease not on dialysis
* Treatment-naïve for erythropoiesis-stimulating agents (ESAs), not having received ESAs in the 6 months prior to inclusion in this study
* Hemoglobin level less then (\<)10 grams per deciliter (g/dL) at inclusion
* Participants for whom the treating physician has decided to initiate treatment with methoxy polyethylene glycol-epoetin beta for medical reasons prior to study start

Exclusion Criteria:

* Functional renal transplant
* Current participation in a clinical trial in anemia due to chronic kidney disease
Tear Production by Nasal Neurostimulation Compared to Active Control

This crossover design study evaluates the effectiveness of the Oculeve Intranasal Neurostimulator comparing the effect of intranasal (active) versus extranasal (control) stimulation on tear production as measured by the Jones Schirmer test in participants with dry eye disease.

In this randomized, controlled study, participants will receive two applications of approximately a three-minute duration, one intranasal (active) and one extranasal (control), in randomized sequence at Visit 2 (Day 1). At Visits 3 (Day 15) and 4 (Day 29), participants will undergo two applications of approximately an eight-minute duration, one intranasal (active) and one extranasal (control), in randomized sequence. The Schirmer test is a clinically relevant and accepted measure to assess tear production over a specified time interval, generally five minutes. Tear meniscus height (TMH) and, to a lesser extent, tear meniscus area (TMA) have been reported as measures of tear quantity and/or production and have been used to diagnose dry eye disease (DED). One reliable means of measuring TMH and TMA is via use of optical coherence tomography (OCT), an established medical imaging technique that uses light to capture micrometer-resolution images from within optical scattering media such as biological tissue. Due to the non-invasive nature of the technique, this study was designed to explore the utility of TMH and TMA captured by OCT as a means of evaluating stimulated tear production following use of the study device.

Eligibility Criteria:
Inclusion Criteria:

* Mild to severe dry eye disease
* Have not worn contact lenses for at least seven days prior to the Screening Visit and willing to forego the use of contact lenses for the duration of the study
* Literate, able to speak English or Spanish, and able to complete questionnaires independently

Exclusion Criteria:

* Previously used the Intranasal Neurostimulator at any time
* Used commercial lid hygiene product within 14 days of the Screening Visit or plan to use at any time during the study
* Chronic or recurrent epistaxis, coagulation disorders or other conditions that, in the opinion of the investigator, may lead to the risk of clinically significant increased bleeding
* Nasal or sinus surgery (including history of application of nasal cautery) or significant trauma to these areas
* Severe nasal airway obstruction (e.g. severe septal deviation or inferior turbinate hypertrophy) or vascularized polyp as confirmed by nasal endoscopic examination at the Screening Visit
* Have an implanted metallic or other electronic device in the head, a cardiac demand pacemaker, or an implanted defibrillator
* Participation in any clinical trial with a new active substance or a new device within 30 days of the Screening Visit
Early Intervention for Adolescents With Patellofemoral Pain Syndrome

Self-reported, unspecific knee pain is highly prevalent among adolescents. A large proportion of the unspecific knee pain can be attributed to Patellofemoral Pain Syndrome (PFPS). There are a number of treatment options for PFPS. Physical therapy has been advocated as one of the cornerstones in rehabilitation of patients with PFPS. Twenty-five years ago, McConnell proposed a multimodal approach that combined several treatment options. The regimen included retraining of the vastus medialis oblique muscle through functional weight bearing activities. This exercise is combined with patellar taping, patellar mobilization, and stretching to improve patellar tracking, reduce pain, and enhance vastus medialis oblique muscle activation. Short term results (\<12 months) indicates that multimodal physiotherapy is more effective than placebo treatment.

While treatment for PFPS may be successful for the short-term, long-term results are less promising. A recent review covering the long term prognosis for patients diagnosed with PFPS, reported that only 1/3 of those diagnosed with PFPS and treated conservatively were pain free 12 months after diagnosis. Further ¼ stopped participating in sports because of knee pain.

Predictors of long term outcome (\>52weeks) indicate that a long symptom duration, higher age and greater severity at baseline are associated to poorer outcome after treatment. These prognostic factors suggest that an early initiation of treatment might lead to a better long-term prognosis. The purpose of this study is to examine the short and long-term effectiveness of multi-modal physiotherapy compared to standard wait-and-see treatment applied at a very early state of disease among adolescents. The investigators hypothesized a significantly larger proportion of completely recovered patients at three-month follow-up in the interventions group compared to the control group.


Eligibility Criteria:
Inclusion Criteria:

* Age 15-19 years
* Insidious onset of anterior knee or retropatellar pain of greater than six weeks' duration
* Provoked by at least two of prolonged sitting or kneeling, squatting, running, hopping, or stair walking
* Tenderness on palpation of the patella, or pain with step down or double leg squat
* Worst pain over the previous week of at least 30 mm on a 100 mm visual analogue scale.

Exclusion criteria:

* Concomitant injury or pain from the hip, lumbar spine, or other knee structures
* Previous knee surgery
* Patellofemoral instability
* Knee joint effusion
* Use of physiotherapy for treating knee pain within the previous year
* Use of weekly use anti-inflammatory drugs.