cyrilzakka/clinical-trials huggingface dataset:
Effectiveness of Telerehabilitation as an Alternative to Outpatient Physiotherapy in the 1 Month After Arthroscopic Rotator Cuff Repair Surgery

The present study aims to verify whether telerehabilitation as an alternative to in-person treatment (both conducted by a physiotherapist) can be a valid option in terms of pain, recovery of the rom, shoulder functionality compared to those provided by therapy alone. face-to-face rehabilitation in patients undergoing arthroscopic rotator cuff repair surgery.


Eligibility Criteria:
Inclusion Criteria:

* Male or female patients aged between 40 and 70 years
* Patients undergoing arthroscopic repair surgery of the rotator cuff tendons
* Start of outpatient treatment within 7 days of discharge from the Orthopedic Department of the Argenta and Delta hospitals
* Continuation of rehabilitation care at the IOR Physical and Rehabilitation Medicine service in Argenta or at the Physical Therapy Rehabilitation Medicine service of the Delta Hospital.
* Patients who have provided informed consent

Exclusion Criteria:

* Previous shoulder surgeries
* difficulty understanding the Italian language/language barrier
* unavailability of IT devices or stable wi-fi connection by the patient
Busulfan, Cyclophosphamide, and Autologous Stem Cell Transplant in Treating Patients With Multiple Myeloma

RATIONALE: Giving high-dose chemotherapy before an autologous stem cell transplant stops the growth of cancer cells by stopping them from dividing or killing them. An autologous stem cell transplant may be able to replace the blood-forming cells that were destroyed by the chemotherapy.

PURPOSE: This phase II trial is studying how well giving busulfan together with cyclophosphamide followed by an autologous stem cell transplant works in treating patients with multiple myeloma.

OBJECTIVES:

Primary

* To compare relapse-free survival and overall survival of patients with multiple myeloma treated with IV busulfan vs historical control patients treated with oral busulfan when administered with cyclophosphamide as a conditioning regimen prior to autologous hematopoietic stem cell transplantation.

Secondary

* To compare pulmonary toxicity rates of IV busulfan vs oral busulfan when administered with cyclophosphamide as a conditioning regimen prior to autologous hematopoietic stem cell transplantation.

OUTLINE: Patients receive high-dose busulfan IV every 6 hours on days -8 to -4 and high-dose cyclophosphamide IV over 4 hours on days -3 and -2. Patients undergo autologous hematopoietic stem cell transplantation on day 0.

After completion of study treatment, patients are followed up periodically.

Eligibility Criteria:
INCLUSION CRITERIA:

* Patients with a diagnosis of plasma cell myeloma
* Patients with cardiac ejection fraction \>= 45% or clearance by Cleveland Clinic Faculty (CCF) cardiologist
* Patients with diffusion capacity of carbon monoxide (DLCO) \>= 45% predicted or clearance by CCF pulmonologist
* Patient with previously harvested peripheral blood progenitor cells with a minimum of 2 x 10\^6 CD 34+ cells/kg harvested

EXCLUSION CRITERIA:

* Patients receiving total body irradiation
* Non-myeloablative/reduced-intensity conditioning
* Pregnant and breast feeding patients
* Human immunodeficiency virus (HIV) positive
* Patients with serum creatinine \> 2.0
* Prior Hematopoietic Stem Cell (HSC) transplant
Socio-Educational Intervention for Rural Suicide Attempters

Compared to a treatment-as-usual group, providing brief mental health education to suicide attempters from rural parts of China at the time of their treatment in the emergency departments of general hospitals or local clinics and 6 home-visits (FOR those subjects WITH PHONES refuse home visits, THE INTERVIEWS WILL BE CONDUCTED OVER THE PHONE) over the twelve months after the attempt demonstrate continuing concern about the attempters ('befriending'), strengthen their social support networks and improve their problem-solving skills will significantly reduce their hopelessness, the severity of depressive symptoms, and level of suicidal ideation.


Eligibility Criteria:
Inclusion Criteria:

* suicide attempters
* must be 18 years or older
* no-zero intent to die

Exclusion Criteria:

* with communication difficulties
* living outside of the research sites
Morphological Abnormalities of the Olfactory Bulb on MRI and Olfactometry in Anosmic Versus Normosmic COVID-19 Patients

Olfactory and gustatory disorders are prevalent symptoms in European COVID-19 patients. This study aimed to detect these disturbances among positive COVID-19 patients (symptom not initially highlighted by the patient and not sought by caregivers) in order to allow early management of olfactory and gustatory dysfunction.

Several medical teams have recently shown that disturbances of smell and taste are common and can be a precursor and even an isolated sign of COVID-19 involvement. Preliminary results suggest the presence of clinical MRI abnormalities, particularly in the olfactory bulbs in anosmic patients with COVID-19.

Anosmia and taste disturbance are early warning signs that could be important in improving the detection and diagnosis of COVID-19, and also in monitoring disease. In addition, disturbances in smell and taste could be an aid in establishing the prognosis of the clinical course of the viral disease. The question of olfactory recovery is also fundamental. To date, we do not know the possibilities of recovery from COVID-19 post viral anosmia. ENT exams, olfactometry and MRI are proposed to study these phenomena.

Eligibility Criteria:
Inclusion Criteria:

* Patient aged 18 or over
* Patient with or without a sense of smell diagnosed with a positive COVID-19 PCR test by nasopharyngeal swab in one of the investigation centers
* Patient who has already undergone cerebral MRI and olfactometry, as part of their routine care, within 3 days of being diagnosed with COVID-19+ or who agrees to undergo cerebral MRI and olfactometry within 3 days of being diagnosed with COVID-19+.
* Patient who signed a consent form
* Patient being affiliated to a Health Insurance plan

Exclusion Criteria:

* History of chronic rhino-sinusitis with or without polyp (s)
* History of major craniofacial trauma that led to loss of smell
* History of chronic sense of smell
* Diagnosis of Parkinson's disease or Alzheimer's disease
* Refusal to perform the 3 MRIs
* Refusal to participate in the study
* Pregnant, parturient or lactating woman
* Patient with contraindications to performing MRI
* Patient not speaking or understanding French
* Patient deprived of liberty or under guardianship
Bovine Milk Oligosaccharide Study

The purpose of this study is to elucidate tolerability and effectiveness in consumption of the complex indigestible sugars from dairy products called bovine milk oligosaccharides (BMO) to enrich intestinal microflora toward beneficial populations.

This is a single-blind crossover study designed to determine if BMO at two different doses selectively enrich beneficial bacteria in the human gut and will be tolerated in healthy participants compared with a placebo control supplement. Each participant will consume two sachets of supplement for eleven days, separated by a two-week washout before starting the second and third arms. To determine the effect of dose, the placebo-control supplement will be administered in the first arm, followed by the low and high dose. Participants will collect stool and first morning urine and study personnel collected blood from each participant at baseline (day 0) and at the end (Day 11) of each study arm for all three arms.

Eligibility Criteria:
Inclusion Criteria:

* Healthy men and women aged 18-40 years old
* BMI 18-25
* Born by vaginal birth (not C-section)
* Breastfed for a minimum of 2 months after birth

Exclusion Criteria:

* Individuals who regularly consume high fiber cereals or fiber supplements
* Individuals who frequently consume yogurt (eligible if willing to refrain consumption during the study period)
* Individuals who are lactose intolerant and/or allergic to dairy or wheat
* Individuals who use tobacco products
* Individuals who are pregnant or lactating
* Individuals with a known presence of gastrointestinal/malabsorption disorders or autoimmune disease
* Individuals taking prescription or over-the-counter medications that include pre/probiotics, corticosteroids, anti-obesity agents, laxatives, and lipid- altering medications
Mercury Versus Automated Blood Pressure Monitoring

Blood pressure (BP) measurement is one of the most commonly performed screening tests in the clinical setting. Its accuracy is vital to the early diagnosis and effective management of hypertension, as emphasized by hypertension management guidelines. For most protocols being conducted in a clinical research setting, obtaining single or serial blood pressure reading(s) is often performed as a safety assessment, especially if the individual is participating in a study that requires a blood draw and/or the administration of a research drug, vaccine or device. It is imperative that the blood pressure data truly reflect the response, if any, the study participant experiences in relation to the research procedures and interventions.

Despite the clear guidelines on manual blood pressure technique, there seems to be large inter-observer variations, both among nursing staff and physicians. These differences are further complicated by variables such as cuff selection and application, incorrect cuff positioning and rapid cuff deflation rate, inadequate rest period, and lack of repeated measurements. The blood pressure measurement obtained by an automated device is not as dependent on observer training and competency as the manual mercury device, yet its use requires careful patient evaluation for caffeine or nicotine use, cuff position, and proper wrist positioning, and instructing the individual not to move or talk if accurate blood pressures are to be obtained. If one performs the automated readings and manual blood pressure measurements under standardized conditions, the mean values will be quite similar; however, this possibility has not yet been fully tested.

Therefore, there is a need to assess systematically if there is in fact a difference in the two blood pressure monitoring approaches under controlled conditions. The goal of this study, then, is to examine our current practice of obtaining manual blood pressure measurement using a mercury sphygmomanometer compared to an automated wrist-mounted blood pressure device.

A possible implication of this study is if the blood pressure measurements using the automated blood pressure device are comparable to the measurements obtained using the mercury sphygmomanometer, than the mercury devices can be replaced by the more environmentally acceptable automated devices in our clinical research setting.

Eligibility Criteria:
Inclusion Criteria:

* Male or Female \>18 and \< 100 years of age
* With or without history of hypertension on or off antihypertensive medications
* Able to understand the information in the informed consent form and can provide written consent
* Upper arm and wrist access

Exclusion Criteria:

* Latex allergy
* Upper arm circumference \> 52mm
* Wrist circumference \< 5 inches and \> 8 3/4 inches
* History of Mastectomy or Upper Extremity Peripheral Vascular Disease
* History of Carpal Tunnel Disease
* History of surgical repair of varicosities in the upper arm or wrist
Feasibility Study of Exercises for Myeloablative Allogeneic Blood and Marrow Transplantation (BMT) Patients

Blood and marrow transplantation (BMT) is commonly used in the treatment of oncologic and hematologic disorders. Patients undergoing Hematopoietic stem cell transplantation (HSCT) are screened for functional status among other criteria to ensure that they are able to endure the rigorous treatment involved during Hematopoietic stem cell transplantation (HSCT). The patient entering the transplant process is possibly already functionally compromised from their disease, prior cancer treatment, and possible other co-morbidities. Additional factors of the transplantation that compromise the independent functional status of the patient include the high dose preparative regimen, pancytopenia, steroid-related side effects, hospitalization, transplantation complications such as infections, pulmonary alterations, acute and chronic Graft-versus-host Disease (GVHD), pain, decreased nutritional input, and other sequelae of transplantation.

Physical Therapy has been utilized in this population primarily as a supportive therapy to prevent and limit the patient's functional decline. Studies have addressed general and aerobic exercise in this population but there is a paucity of research investigating the benefits of a strength-training program, particularly performed in weight-bearing, in attenuating the detrimental effects of the transplantation on functional status.

This is a feasibility study questioning if an exercise program including weight-bearing strengthening exercises and cardiovascular exercise is practical for the patients to carry out as inpatients. The study will also preliminarily determine if this exercise program influences functional outcomes and level of fatigue. Such outcome measures will include 1) FiveTimes Sit-To-Stand Test, 2) Six-Minute Walk Test, 3) stair performance, 4) Functional Assessment of Cancer Therapy-Bone Marrow Transplantation (FACT-BMT) and Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Scales.

The study population will include patients with lymphomas and acute leukemias undergoing matched-related donor allogeneic myeloablative Blood and marrow transplantation (BMT).


Eligibility Criteria:
Inclusion Criteria:

* All diagnoses admitted for a first allogeneic myeloablative Blood and marrow transplantation (BMT)
* Adult subjects greater or equal to 18 year of age. There are no gender or ethnic restrictions
* Karnofsky performance status \>= 70%.
* Admitted to E1 Day-7 (+/- 3 days).
* Patients must be informed of this study and must sign and give written informed consent in accordance with institutional and federal guidelines.

Exclusion Criteria:

* Patients with musculoskeletal, neurological, cardiovascular, and pulmonary impairments will be excluded. Cardiovascular and pulmonary status will be confirmed prior to transplantation by electrocardiogram, echocardiogram, and pulmonary function tests. Musculoskeletal and screening for neurological impairments will be assessed by Karnovsky score \>=70% and by Physical Therapy assessment.
TIPS Microspheres for Perianal Fistula

Phase of Investigation: First-in-human feasibility study

Objectives: Primary objective: Demonstration that TIPS microspheres do not compromise the clinical condition or safety of the patient.

Secondary objective: To demonstrate that TIPS microspheres facilitate natural healing in the context of perianal fistula.

Type of Investigation: First-in-human single site, open label, feasibility study to assess the safety of TIPS microspheres in perianal fistulas and indicative functionality.

Investigation design and methods: First-in-human single delivery of a bioabsorbable device to treat perianal fistula. A standard of care internal flap procedure performed to close the internal fistula opening and up to 300 mg of TIPS microspheres will be inserted into each perianal fistula. Participants will be assessed for healing, inflammation, abscess, sepsis, pain and continence by clinical assessments, blood tests, MRI and questionnaires.

TIPS microspheres are manufactured from GMP grade poly(lactide-co-glycolide) (PLGA) under Good Laboratory Practice (GLP) conditions.

Microspheres will be delivered into the fistula tract using the following procedure:

i) Tract identification with special emphasis on locating the internal and external openings using a fistula probe.

ii) Curettage to remove epithelium lining the tract and cleaning by irrigation with hydrogen peroxide and saline.

iii) Closure of the internal opening by means of a rectoanal advancement flap. iv) Following device kit instructions, prepare a paste of TIPS microspheres with GranuGel.

v) Introduction of TIPS microsphere paste by back-filling. vi) Retention of the microsphere paste using Comfeel adhesive hydrocolloid dressing designed to remain in place for 1 - 14 days.

Each subject will receive a single administration of up to 300 mg of TIPS microspheres implanted into the fistula tract.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 years and above
* Cryptoglandular perianal fistula
* High and low simple trans-sphincteric fistula

Exclusion Criteria:

* Secondary fistula, including Crohn's disease, carcinoma, radiotherapy, tuberculosis
* Evidence of branching fistula anatomy or cavity on MRI
* Inter-sphincteric fistula
* Low trans-phincterictrans-sphincteric fistula amenable to simple fistulotomy
* Immunosuppressed patients
* Participants less than 18 years of age
* Unable to consent
Association Between Euploid Embryo Grade and Maternal Age

Background: Advanced maternal age (AMA) is associated with a reduction in live birth rate (LBR) after ART cycles. The main reason for this reduction is the lower number of oocytes aspirated, the number of developing embryos and the low number of euploid embryos available for transfer. The impact of age on success rates after the transfer of an euploid embryo has been a matter of discussion, with a recent meta-analysis showing a reduction in LBR after the transfer of an euploid blastocyst to women of AMA (1). There could be many reasons for this reduced LBR but they can be categorized into two broad categories - the uterus (including the mother's health) and the embryo (including the oocyte and the sperm).

It is possible that factors associated with reduced embryo quality would manifest in a lower embryo grade.

Objective: To study if there is an association between advanced maternal age and lower embryo grading of euploid embryos.

Hypothesis: Advanced maternal age is associated with a lower embryonic grade in euploid embryos.

Study Design: This is a retrospective cross-sectional study of euploid embryos from patients who have completed IVF with PGT-A testing at a fertility clinic in The Prelude Network (US sites only). A comparison of embryo grade between different age groups (\<35, 40+) will be done after controlling for baseline demographic characteristics.

Eligibility Criteria:
Inclusion Criteria:

* Patients who have completed IVF egg retrieval with PGT-A testing at a fertility clinic in The Prelude Network (US clinics, excluding NYU)
* PGT biopsy was conducted in 2023,
* PGT biopsy was performed on blastocyst stage embryo,
* PGT-A result is euploid.

Exclusion Criteria:

* PGT-A result is mosaic,
* Embryos in which PGT-M was done and were found to be carriers of the mutation,
* Embryos in which PGT-SR was done and were found to be carriers of the structural rearrangement.
Evaluation of Direct Effects of Electric Fields on Brain

Transcranial current stimulation (tCS), a safe, tolerable technique employing weak currents (\~ 1 mA) applied to the scalp, has been shown to be a promising technique in alleviating seizures in focal epilepsy patients. Although studies reveal a decrease in the epileptiform activity due to tCS, this field lacks a quantification of neurophysiological changes during and immediately after stimulation. The investigators hypothesise that tCS can effectively reduce the amplitude and rate of interictal spikes as well as the functional connectivity between regions during and immediately after stimulation. It is thus planned to deliver an extensive quantitative description of the tCS effects on interictal spike activity, functional connectivity and other tissue biomarkers, using the simultaneous recording of intracranial signals during tCS. Moreover, the investigators seek to compare these variations between different tCS paradigms (direct current -tDCS- vs alternate current -tACS- stimulation).


Eligibility Criteria:
Inclusion Criteria:

1. Provision of signed and dated informed consent form
2. Male or female, aged ≥ 18 years old
3. Focal drug-resistant epilepsy
4. Patient undergoing a clinical SEEG investigation
5. Stated willingness to comply with all study procedures and availability for the duration of the study
6. Patient affiliated or beneficiary of a health insurance plan
7. Patient for whom MRI images (3D T1) are exploitable and fit with the minimum MRI requirements needed for biophysical modelling (cf annex in 14.), prior to SEEG electrodes implantation
8. Patient for whom a CT-scan with electrodes (or MRI with electrodes) has been realized after SEEG procedure.

Exclusion Criteria:

1. Difficulty to read or understand the French language, or inability to understand the information regarding the study
2. Person protected by articles L1121-5, L1121-6 and L1121-8 of Public Health Code (pregnant or breastfeeding woman, deprived of liberty by judicial decision, situations of social fragility, adults or unable to express their consent). Pregnancy will be evaluated during screening with a urine pregnancy test.
3. Presence of severe negative outcome of SEEG surgery preventing the acquisition of SEEG data (i.e. hemorragic complications, subcutaneous infection), at the time of inclusion.
4. Patient showing contraindications for electric stimulation at the time of inclusion:

   (A) Patient with unstable or non-controlled neuropsychiatric illness (B) Patients having cardiac or medication implants (C) Patients with implanted pacemakers (D) Patients with serious brain injury (E) Patients showing damage of skin at sites of stimulation
5. Any condition that, according to the investigator, is not compatible with carrying out the study
Impact of Whole-Body Vibration on Anthropometric Measurement and Body Composition in Overweight and Obese University Students

Obesity has become a significant public health concern globally, particularly among university students, where lifestyle changes contribute to increased body weight and fat accumulation. The World Health Organization defines obesity as a condition characterized by excessive fat accumulation that presents a risk to health, with a body mass index (BMI) of 30 or higher being a common threshold for classification. In Saudi Arabia, the prevalence of obesity among young adults is alarming, necessitating effective interventions to combat this issue.


Eligibility Criteria:
Inclusion Criteria:

* Male and female University students with BMI ≥ 25, and their age between 18-25 years.

Exclusion Criteria:

* Musculoskeletal, neurological and cardiovacular conditionds,in addition to pregnancy and insrtion of pacemekers or other metal implants.
Transplantation of Neural Stem Cell-Derived Neurons for Parkinson's Disease

This is a prospective study to demonstrate the safety and efficacy of differentiated neurons-derived from adult CNS progenitors cells transplanted in selected patients with Parkinson's disease.


Eligibility Criteria:
Inclusion Criteria:

1. Able to give informed consent prior to study
2. Male or Female with Diagnostic Criteria of Parkinson's disease
3. Age 35 to 85 years old
4. Parkinson's disease not due to trauma, infection, brain tumor, cerebrovascular disease
5. Hoehn and Yahr Stage III or IV
6. Parkinson's disease observed in the absence of:

   * Oculomotor palsy
   * Cerebellar sign
   * Orthostatic hypotension (drop greater than 20mmHg in mean pressure)
   * Pyramidal sign
   * Amyotrophy
7. Good general health or stable medical condition well controlled, without contraindications to anesthesia

Exclusion Criteria:

1. Patients with severe dementia and brain atrophy on MRI
2. Patients with severe hypertension; renal, liver, cardiac or other major organ disease; coagulopathy; cancer; other significant systemic illnesses; hepatitis, HIV
3. Patients older than 85 or younger than 35
4. Patients who withhold informed consent
5. Patients with a history of alcohol or drug abuse
6. Sexually active women of childbearing potential without adequate form of birth control
7. Evidence of abnormal coagulation or anticoagulant therapy
8. Pregnancy or lactation
9. History of seizure disorders or current use of antiepileptic medication
10. Severe cognitive impairment
11. Clinically significant laboratory abnormality