cyrilzakka/clinical-trials huggingface dataset:
The Effect of Cupping on Spasticity and Function of the Lower Extremity During Rehabilitation After Stroke

Physical therapists use dry static cupping for the treatment of many conditions, including spasticity for patients post-stroke. While research better describes the effects of dry static cupping for patients with orthopedic conditions, information is lacking on central conditions, such as stroke and resulting spasticity.

Cupping is an ancient alternative medicine. A common form of cupping, called dry static cupping, involves creating negative pressure inside a therapeutic cup. The cup is then placed on the skin, creating a light suction effect. In Eastern Medicine, cupping has been used to treat a variety of diseases. More recently, in Western society, cupping has been used after injury, and among other effects, has been found to improve blood volume and tissue oxygenation to an area. These effects have originally been thought to be peripheral in nature, occurring at the cupping site, hence, why cupping has been used for treatment for conditions like carpal tunnel syndrome, spinal pain, knee osteoarthritis, and other musculoskeletal conditions.

However, a recent systematic review found cupping to be beneficial for rehabilitation after stroke. These conclusions raise the question of a possible mechanism for cupping to improve impairments related to the central nervous system, such as spasticity after stroke. However, many of the studies to date have serious methodological flaws that limit the direct causation of cupping to the reduction of spasticity. As well, the majority of studies only involve the upper extremity. No study has yet looked at the therapeutic effects of dry static cupping on lower extremity spasticity reduction after stroke.

Eligibility Criteria:
Inclusion Criteria:

* Age 30-80
* Acute stroke (within 6 months of stroke), with spasticity \& hemiparesis of LE
* Referred by doctor for rehabilitation for a stroke-related condition
* Attending Ascension Rehabilitation of Joliet for rehabilitation
* Able to read or verbally understand English or Spanish

Exclusion Criteria:

* Absent sensation of the areas to be cupped
* Significant cognitive impairment
* Pregnancy
* Prescription anticoagulant medications
* Blood clotting disorder
* Uncontrolled hypertension
* Uncontrolled diabetes
* Open wounds within the cupping area
* Current DVT
* Hematoma over the cupping area
* Fracture over the cupping area
* Active cancer within the cupping area
* Current use of Baclofen
* Current use of Botox
* Current use of an anti-spasticity medication
PMCF Study for Partial Vision Restoration Using the Subretinal Implant RETINA IMPLANT Alpha AMS

This study is a post-market clinical follow-up (PMCF) study to monitor the safety, lifetime and efficacy of patients using the CE-certified RETINA IMPLANT Alpha AMS.

This study is a post-market clinical follow-up (PMCF) study to monitor the safety, lifetime and efficacy of patients using the CE-certified RETINA IMPLANT Alpha AMS. For Germany, it is under the exceptions mentioned in §23b MPG (Medizinproduktegesetz, German Medical Device Law). Its purpose is to collect data that is created during the regular therapy with the implant. No additional examinations are performed, except a patient questionnaire.

Eligibility Criteria:
Inclusion Criteria:

* Patients who received a RETINA IMPLANT Alpha AMS.
* Patients willing and able to give written informed consent.

Exclusion Criteria:

* none
An Observational Study of Adjuvant Treatment With Capecitabine (Xeloda) in Combination With Oxaliplatin in Participants With Stage III Colon Cancer

This observational study evaluates the efficacy and safety of capecitabine in combination with oxaliplatin in the adjuvant setting in participants with Stage III colon cancer. Data were collected from each participant for up to 36 months or until disease recurrence.


Eligibility Criteria:
Inclusion Criteria:

* Adult participants, \>/= 18 years of age
* Treatment in line with the currently approved indication in the Summary of Product Characteristics

Exclusion Criteria:

* Contraindications according to the current Summary of Product Characteristics
Frequency of SOD1 and C9orf72 Gene Mutations in French ALS

The purpose of the study is to determine the frequency of mutations in the C9orf72 and SOD1 genes in the incident population of ALS patients followed in the FILSLAN centres

After obtaining free and informed consent for genetic characteristic tests, a blood sample will be taken during hospitalisation for diagnostic confirmation or during the quarterly multidisciplinary consultations planned for these patients in the classic follow-up set up within the ALS centres of the FILSLAN network if the genetic status is not already known. This sample will be integrated into the standard management of ALS patients, which includes a neurological examination and paraclinical explorations, including a biological assessment.

The patient will then be reviewed during the standard multidisciplinary follow-up consultations. Information to the patient on his or her C9orf72 or SOD1 genetic status will be included in the quarterly multidisciplinary consultations for the classic follow-up of ALS patients.

It should also be noted that the data (ALSFRS-r score, weight, FEV) collected during the 6 and 12 month consultations will be processed for the purposes of this research.

For patients included in the quarterly multidisciplinary consultations planned in the classic follow-up, if the genetic blood sample was taken during the initial hospitalisation for diagnosis, then it will not be repeated in the framework of the research. In this case, the genetic status of C9orf72 or SOD1 will be available at the inclusion visit and the patient will receive specific information about his or her genetic status.

Consent for the research will nevertheless be obtained in order to have the patient's agreement to the processing of their health data for the purposes of the research at inclusion, 6 months and 12 months.

Eligibility Criteria:
Inclusion Criteria:

* Adult aged ≥ 18 years old
* ALS defined, probable or likely based on neurophysiological data according to Airlie House criteria (Brooks, 2000)
* Sporadic ALS or familial ALS defined by the existence of a case of ALS or FTD among first or second degree relatives of the patient included (Byrne et al, 2011).
* Participant affiliated to a social security scheme
* Free, informed and signed consent for the examination of the genetic characteristics of the participant

Exclusion Criteria:

* All conditions mimicking ALS including motor neuropathies with multiple conduction blocks and all cases of ALS that do not meet the criteria of the Airlie House classification.
* Patients who are cognitively incapable of signing the consent to participate in this study.
GRIB Forsoeget-2004

The difficulties in loosing weight may not stem from lack og knowledge about nutrition, as implied by the standard treatment but from difficulties in following the advice. The hypothesis is, that revealing and addressing these difficulties psychotherapeutically may be more efficient in obtaining weight reduction. The effect of psychological group treatment of severely overweight children and their parents is compared with traditional nutritional information. In other words: Which is better: back-up or enlightenment?

At on-set the children get a medical examination, blood-tests, measurement of height, weight, skin-fold, waist and hip. Children and parents fill out questionnaires on social and educational background as well as motivation and expectations to the treatment. All Children are thereafter randomised into two groups:multi-disciplinary group intervention versus traditional information. The randomisation is stratified according to gender and degree of overweight (135%-145% and \>145%) supposing that the degree of overweight may mirror the difficulties in loosing weight. The experimental intervention consists of one lecture of general nutrition, weekly psychological group sessions for the children followed by physical exercise, and separate bi-monthly group sessions for the parents. After six months children and parents go to separate group sessions once a month for six months. The control group is offered nutritional advice once with a brief follow-up after one month. The height and weight of the children is measured every month, and the fat % is measured with DEXA-scanning at on-set, after six months, and after twelve months

Eligibility Criteria:
Inclusion Criteria:

* Weight compared to hight over 135% of the Danish norms (www.peadiatri.dk)

Exclusion Criteria:

* None of the parents wants to participate
* Diagnosed somatic course of overweight
* Parents or children do not speak danish
* Sever physical handicap
* Psychiatric illness or mental retardation in children or parents
* Severe child abuse
* Siblings participation in the trail.
Risk Factors for Anxiety and Depression Among Pregnant Women During the COVID-19 Pandemic

The article presents a protocol of a cross-sectional study of mental health of pregnant women in relation to the COVID 19 pandemic. The primary aim is to compare differences in anxiety and depression scores of pregnant women between countries affected by the COVID-19 pandemic. The secondary aim is to assess demographic, economic, and social aspects affecting maternal anxiety and depression scores among pregnant women worldwide in the time of the COVID-19 pandemic. Finally, investigators will be able to compare differences in perception of the different aspects of the COVID-19 pandemic (social distancing, restrictions related to delivery) between countries and according to the epidemic status (number of infected patients, number of reported deaths). The comparisons will also be done according to COVID-19 status of the participants.


Eligibility Criteria:
Inclusion Criteria:

* declaration of being pregnant
* being able to complete the survey in the available languages
* answer the screening questions
* provide informed consent for participation

Exclusion Criteria:

* not providing online informed consent for participation
* if the participant does not click on the submit button at the end of the survey
* not answer all the GAD-7 and PHQ-9 scale questions
Lactobacillus Rhamnosus GG: Interaction With Human Microbiota and Immunity

Hypothesis: Probiotics have been used as novel adjunct therapeutic approach in atopic dermatitis. In addition to balancing the gut microecology and promoting host immune defences, specific probiotics might further aid in controlling the microbial colonization of the skin, thereby reducing proneness to secondary infections which typically cause sustained symptoms.

Thirty-nine infants with atopic dermatitis,randomized for a three-month-period in a double-blind design to receive extensively hydrolysed casein formula (NutramigenR, Mead-Johnson, USA) supplemented with (n=19) or without (n=20) Lactobacillus rhamnosus GG (ATCC 53103) 5.0 x 107 cfu/g to achieve a daily intake of 3.4 x 109 cfu.

Sampling (blood and faecal samples, cotton swab from the skin) and clinical examination of the infant, including SCORAD assessment to determine the severity of atopic dermatitis, at each study visit (at entry and one month and three months thereafter).


Eligibility Criteria:
Inclusion Criteria:

* clinical diagnosis of atopic dermatitis
* age 4 we - 18 mo

Exclusion Criteria:

* skin infection or severe infection at the time of enrollment
Electroconvulsive Therapy and Neuroradiology

The study will apply state of the art radiology through advanced magnetic resonance imaging (MRI) techniques to investigate structural and functional brain effects of ECT.

As a multi-disciplinary collaboration, imaging findings will be correlated to psychiatric response parameters, neuropsychological functioning as well as neurochemical and genetic biomarkers that can elucidate the underlying mechanisms. The aim is to document both treatment effects and potential harmful effects of ECT.

Sample: n = 40 patients in a major depressive episode (bipolar and major depressive disorder). Two control groups with n = 15 in each group: age and gender matched healthy volunteers not receiving ECT and patients undergoing electrical cardioversion (ECV) for atrial fibrillation (AF). Observation time: six months.

Eligibility Criteria:
Inclusion Criteria:

* Patients (age \> 18) referred to the ECT-unit and accepted for treatment because of moderate and severe depression,
* fulfilling the criteria for the following ICD-10 diagnoses: F31.3 and F31.4; F32.1 and F32.2 and F32.3; F33.1 and F33.2 and F33.3.
* symptom intensity must be verified by a score ≥ 25 on the Montgomery and Åsberg Depression Rating Scale (MADRS).

Exclusion Criteria:

* ECT treatment within the last 12 months.
* Pregnancy.
* Patients unable to give written informed consent (according to the responsible clinician or ECT responsible).
* Patients who cannot participate in the MRI scanning because of contraindications to MRI.
Clinical Evaluation of a Point-of-Care (POC), SARS-CoV-2 (COVID-19) IgG Antibody Test in Fingerstick Whole Blood

Prospective, multi-center, observational, blinded clinical trial to compare a new point of care (POC) SARS-CoV-2 IgG antibody test to a reference SARS-CoV-2 PCR test using fingerstick whole blood.

Patients with PCR testing in outpatient setting will be screened and asked to participate in the study.

Subjects with a positive diagnosis of COVID-19 confirmed by a positive, EUA SARS-CoV-2 PCR test will be stratified by the number of days since first symptom onset (i.e. 0-7, 8-14, or \>15 days) in the positive cohort Subjects with a negative diagnosis of COVID-19 confirmed by a negative, EUA SARS-CoV-2 PCR test within 0-7 days of PCR sample collection will be included in the negative cohort.

Treating clinicians, clinical research coordinators and study subjects will be blinded to the POC test results.

Quality assurance will be assured with site monitoring to check accuracy and completeness of data entered.

Eligibility Criteria:
Positive Cohort

Inclusion Criteria:

* Patients with high-sensitive EUA PCR results (positive result)
* Previous diagnostic of SARS-Cov-2
* Signed informed consent

Exclusion Criteria:

* Missing PCR results
* Results from a non-high-sensitive PCR test

Negative Cohort

Inclusion Criteria:

* Patients with high-sensitive EUA PCR results (negative result)
* Signed informed consent

Exclusion Criteria:

* Missing PCR results
* Results from a non-high-sensitive PCR test
* Previous diagnostic of SARS-Cov-2
* History of a positive SARS-CoV-2 antibody test (IgG, IgM or Total Antibody)
* Negative SARS-Cov-2 PCR result that occurred \> 7 days from study visit
Atazanavir or Lopinavir in HIV Post-exposure Prophylaxis

The study compares the adherence of 240 HIV-negative subjects randomly assigned to 2 different antiretroviral therapies for 28 days after accidental exposure to HIV.


Eligibility Criteria:
Inclusion Criteria:

* Age \> 18
* HIV exposure requiring prophylaxis under current guidelines

Exclusion Criteria:

* Pregnancy
* Suspected drug resistance in source case
* Contraindications to the study drugs
Left Ventricular Pacing Vectors Effectiveness to Narrow Phrenic Nerve Stimulation

Evaluation of three left ventricular pacing polarities effectiveness to narrow phrenic nerve stimulation.

The primary endpoint of the study aims at demonstrating that the three left ventricular polarities in the Cardiac Resynchronisation Therapy-Defibrillator could bypass phrenic nerve stimulation at least in 90% of implants.

Success was defined as an absence of phrenic nerve stimulation (threshold \> 7V) or in case of phrenic nerve stimulation occurrence (threshold \< 7V), as the resolution of the phrenic nerve stimulation by reprogramming one of the 3 left ventricular pacing polarities available in the device : left ventricular tip- left ventricular ring (bipolar), left ventricular tip- right ventricular ring (pseudo-bipolar) and left ventricular ring-right ventricular coil.

Any occurrence of phrenic nerve stimulation without resolution by reprogramming was considered as a failure.

Eligibility Criteria:
Inclusion Criteria:

* Eligible for an implantation of a Cardiac Resynchronization Therapy-Defibrillator according to relevant regulations (will be only tolerated primo-implantation and upgrade)
* Patient scheduled for implantation of a Cardiac Resynchronization Therapy-Defibrillator
* Patient has given his informed consent

Exclusion Criteria:

* Any contraindication for Implantable Cardioverter Defibrillator therapy
* Heart transplantation or waiting for heart transplantation
* Implanted with a ventricular assist device (VAD)
* Inability to understand the purpose of the study or to cooperate
* Not available for routine follow-up visits
* Life expectancy less than 12 months
* Age of less than 18 years and et pregnancy
* Under guardianship
Effect of Intensive Cognitive Rehabilitation in Subacute Stroke Patient

Early stroke rehabilitation is known to be an effective and essential therapy in gaining functional independence and preventing complications. However, there was no consensus of proper amount of cognitive rehabilitation in stroke patients. In this study, the investigators assess the effects of the intensive cognitive rehabilitation during subacute phase to improve cognitive function at 6 months after onset in patients with first-ever strokes.

Intensive cognitive rehabilitation group

* cognitive therapy for 1 hours on every working day for 4 weeks

Conventional cognitive rehabilitation group

* cognitive therapy for 30 minutes on every working day for 4 weeks

Eligibility Criteria:
Inclusion Criteria:

* Acute first-ever stroke
* Korean Mini-Mental State Examination: 11\~24 at 7 days after stroke onset

Exclusion Criteria:

* Transient ischemic stroke
Role of CTC´s Spread During Pancreaticoduodenectomy in Patients With Pancreatic and Periampullary Tumors

This multicentre, prospective and randomized study aims(1:1) to compare the rate of recurrence, metastasis and survival according to the levels of intraoperative circulating tumor cells (CTCs) during cephalic duodenopancreatectomy in patients with pancreatic and periampullary tumors.

Cephalic duodenopancreatectomy is the technique indicated for patients with pancreatic head carcinoma and periampullar tumors.

There are different technical variants, it is not standardized what is the best option in relation to local recurrence, metastasis and survival.

In the study, patients will be randomized into two study groups with pancreatic and periampullary tumors undergoing cephalic pancreatectomy (NT) vs initial approach by superior mesenteric artery (SMA).

The measurement of circulating tumor cells (CTCs) allows to assess the degree of cellular dissemination due to surgical manipulation.CTCs will be evaluated during surgery (nº CTCs / mL blood). To do this, a maximum of 4 blood samples from the portal vein will be performed, in each study group according to the following scheme:

* NT group: basal (at the beginning of surgery), portal vein pancreatic detachment, postresection (NT2) and before closure (NT3).
* SMA group: basal (at the beginning of surgery), after Kocher maneuver and SMA dissection, postresection, before closure.

Subsequently, the quantified levels of CTCs will be correlated with the occurrence of local tumor recurrence, metastasis development and patient patient survival.

Eligibility Criteria:
Inclusion Criteria:

1. Patients older than 18 years, with adenocarcinomas of the pancreas and potentially resectable periampullary tumors by cephalic duodenopancreatectomy or total duodenopancreatectomy indicated intraoperatively for technical reasons, who voluntarily agree to participate in the study and sign informed consent

Exclusion Criteria:

1. Patients in whom liver metastases or peritoneal carcinomatosis are detected during surgery.
2. Patients with neuroendocrine pancreatic tumors or cystic tumors.
3. Patients in whom tumor resection is not finally achieved because it shows intraoperatively that the tumor is locally advanced and unresectable.
4. Patients with macroscopic residual tumor (R2).
5. High-risk patients with severe pathology (ASA IV) according to the American Association of Anesthesiologists.
6. Patients receiving neoadjuvant therapy
7. Patients in whom the intraoperative pathological anatomy indicates borders of pancreatic resection affected
To Compare Therapeutic Effect of Intravitreal Bevacizumab and Triamcinolone in Resistant Uveitic Cystoid Macular Edema

Cystoid macular edema (CME) is one of the common causes of vision loss in patients with UveitiS .Triamcinolone has been effectively used in reducing CME and improving the vision. Also there are some documents which recommend Bevacizumab(avastin) could reduce macular edema. This study compare intravitreous injection of triamcinolone and avastin in patients with resistant uveitic cystoid macular edema.

This study compare intravitreous injection of triamcinolone and avastin in patients with resistant uveitic cystoid macular edema.

Eligibility Criteria:
Inclusion Criteria:

* Uveitic CME
* Uveitic CME refractory to routine treatment
* Vision better than 5/200 and worse than 20/50

Exclusion Criteria:

* Mono- Ocular patients
* History of vitrectomy
* Glaucoma or ocular hypertension
* History of other retinal disease that can cause macular edema
* Pregnancy
* Significant media opacity
* Vision better than 20/50
Assessment of Delayed-type Hypersensitivity Reactions to SARS-CoV-2 Peptide Antigens

This dose finding, multi-cohort study is designed to evaluate the safety and efficacy of intradermally-injectedTNX-2100, synthesized SARS-CoV-2 peptide antigens and assess the presence and magnitude of DTH reactions.

Three IPs (TNX-2110, TNX- 2120, TNX-2130) will be administered by intradermal injection (0.1 mL) in two concentration strengths (Stage 1: "1:10 dilution" and Stage 2: "undiluted"). Subjects will also receive one intradermal injection (0.1 mL) of a positive control (CANDIN®), and one intradermal injection (0.1 mL) of a negative control "diluent".

Eligibility Criteria:
Inclusion Criteria:

Male or female subjects aged 18 - 65 years of age, inclusive, in good general health as determined by medical evaluation Subject receives a negativeSARS-CoV-2 PCR test result at their screening or baseline visit

Exclusion Criteria:

Subjects will be excluded if they have clinically significant underlying conditions associated with high risk for severe COVID-19 infections as identified by the Centers for Disease Control and Prevention (CDC) (Appendix 2). These conditions include, but are not limited to: chronic obstructive pulmonary disease, diabetes mellitus (Type 1 and 2), obesity, hypertension, heart disease, and cerebrovascular disease.