cyrilzakka/clinical-trials huggingface dataset:
MNGIE Allogeneic Hematopoietic Stem Cell Transplant Safety Study

The purpose of this study is to find out if a stem cell transplant is safe for patients with a very rare disease. The stem cell transplant is called AHSCT (for "allogeneic hematopoetic stem cell transplantation"). The rare disease is called MNGIE (for "Mitochondrial NeuroGastroIntestinal Encephalomyopathy"). Patients with MNGIE will be transplanted with stem cells from an individual who is human leukocyte antigen (HLA) 10/10 matched. The purpose of the transplant is the production of thymidine phosphorylase.

Patients who have been identified as having MNGIE by genetic testing and/or reduced thymidine phosphorylase levels will be considered for this study. The study team physician will evaluate the condition of the patient and determine if they are eligible. An HLA matched donor is necessary for transplantation. If a suitable donor is found the transplant process can proceed. The patient receives immunosuppressive therapy ( 1 week in the hospital) with subsequent IV transfer of stem cells from the donor. The patient remains in the hospital for approximately 1 month to monitor the transplant. The patient is required to attend research visits at days 0, 100, 6m, 18m and 24 m.

Eligibility Criteria:
Inclusion Criteria:

* Homozygous or compound heterozygous mutations in the TYMP gene
* Plasma thymidine level \>3micromole/L
* Plasma deoxyuridine \>7.5 micromole/L
* 5 to 55 years of age
* Appropriate stem cell donor (HLA 10/10 matched)
* Karnofsky performance of at least 55

Exclusion Criteria:

* Severe cognitive impairment
* Severe psychiatric illness
* Moderate to severe lung disease
* Prior episode of peritonitis due to perforated diverticula
* Prior episode of intestinal pseudo-obstruction
* Moderate to severe hepatopathy
* Moderate to severe diabetes Mellitus
* Moderate to severe cardiomyopathy
* Moderate to severe nephropathy
* Pregnancy or planning to become pregnant during study
* Hypersensitivity to E.coli derived products
* HIV disease
* Positive to anti-donor HLA DP
Study to Investigate the Long Term Survivorship of Coflex

Examine the long-term survivorship via CT Scan of the coflex in patients who presented with spinous process fracture(s) at 24 months in the Paradigm Spine coflex IDE Study.

This is a prospective, multi-center, single-arm, radiographic evaluation of all coflex IDE patients who presented with a spinous process fracture at 24 months as identified by independent radiographic review (using X-ray or CT). All patients were enrolled and followed through 60 months under the IDE and extended follow-up protocol.

The specific objective of this CT Study is to perform a sub-analysis of the patients with 24 month spinous process fracture(s) via a CT scan at post-60 months. A CT Scan will be performed and analyzed by an independent radiographic review lab for evidence of fracture or healing at the long term timepoint.

Eligibility Criteria:
Inclusion Criteria:

* Participant in coflex IDE Study
* Willing and able to give informed consent
* Spinous process fracture identified by site and/or radiographic lab at 24 months

Exclusion Criteria:

* Subjects who died, were withdrawn or withdrew consent to participate in the study
* Subjects who are pregnant, or planning to become pregnant, during the course of this study
* Subjects who have cancer, whether active or in remission
Comparison of Efficacy and Safety of Two Different Types of Botulinum Toxin Type A in Moderate to Severe Cervical Dystonia

The purpose of this study is to compare two types of botulinum toxin type A to treat the involuntary muscle contractions in the neck


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with cervical dystonia/spasmodic torticollis for at least 18 months
* Successfully treated previously with botulinum toxin type A

Exclusion Criteria:

* Breast feeding, pregnant or could become pregnant
* Surgery or spinal cord stimulation for cervical dystonia
* Previous injections of phenol, alcohol for cervical dystonia
Efficacy of Long Pulsed 1064nm Laser for Facial Skin Tightening

We study the efficacy of 1 pass of stacking pulses of long pulse 1064nm laser on the face for skin tightening immediately post laser and 3 months follow up.

To study the efficacy on facial skin tightening and wrinkle reduction after a single pass of double stacking pulses of long pulse 1064nm laser on the face in skin types III-V immediately post procedure and at 3 months. The study is a split-face placebo-controlled single-blind study.

Eligibility Criteria:
Inclusion Criteria:

* ages 35-60 years

Exclusion Criteria:

1. History of skin malignancy
2. Patients on immunosuppression
3. Patients with other known internal malignancy
4. Patients with malnutrition, vitamin or mineral insufficiency
5. Patients on colchicine, penicillamine
6. Patients with weight loss 7.5% of usual body weight within 3 months
7. history of botulinum toxin injection within 6 months
8. history of facial filler injection within 1year
Endoscopic Mucosal Injection Versus Ultrasound-Guided Injection of Triamcinolone to Treat Subglottic Stenosis

This study employs a multicenter, randomized controlled trial method, where patients meeting the inclusion criteria for subglottic stenosis are randomly divided into two groups. These groups are respectively undergoing translaryngeal endoscopic mucosal injection and ultrasound-guided injection of triamcinolone treatment. The comparison will focus on various indicators such as therapeutic effect, incidence of adverse reactions, treatment costs, and hospital resource utilization between the two groups. The safety and effectiveness will be compared to determine the relative merits of the two treatment methods.


Eligibility Criteria:
Inclusion Criteria:

* 1: "Diagnosed with subglottic stenosis through laryngoscopic examination or imaging studies such as CT."
* 2: "Experiencing symptoms related to subglottic stenosis, such as breathing difficulties, hoarseness, etc."

Exclusion Criteria:

* 1: "Severe cardiopulmonary dysfunction, patients extremely debilitated and unable to tolerate the procedure."
* 2: "Patients allergic to lidocaine, midazolam, triamcinolone, or any of their components."
* 3: "Pregnant or lactating women."
* 4: "Unstable angina, congestive heart failure, severe bronchial asthma."
* 5: "Severe hypertension and arrhythmias, hemodynamically unstable, and severe respiratory failure (PaO2 \<60mmHg after oxygen therapy or mechanical ventilation)."
* 6: "Known coagulation dysfunction, inability to stop anticoagulants, antiplatelet agents, aspirin, or nonsteroidal anti-inflammatory drugs before treatment."
* 7: "Patients do not agree to participate in this study."
* 8: "Participation in other studies within the last three months and not withdrawn or concluded, or having received triamcinolone treatment less than 1 month ago."
* 9: "Researchers believe there are any circumstances making the patient unsuitable for inclusion."
Bioavailability Pilot Study of Versus W0035 Versus Stromectol

Ivermectin is prescribed for the treatment of helminthic infections sensitive to ivermectin. However, it is currently only available as a tablet formulation. W0035 is a powder for oral suspension of ivermectin developed by PIERRE FABRE DERMATOLOGIE intended to be administered to children for the treatment of helminthic infections sensitive to ivermectin and mentioned in the Summary of Product Characteristics (SmPC) of Stromectol.

PIERRE FABRE DERMATOLOGIE intends to carry out this pilot bioavailability study in order to define the most appropriate formulation to be used in the bioequivalence study.


Eligibility Criteria:
Inclusion Criteria:

* 18.5 ≤ BMI ≤ 30.0 kg/m².
* Non-smoker subject with a breath carbon monoxide reading of ≤10 ppm at screening.
* Agree to use effective contraception method

Exclusion Criteria: most specific out of 30.

* History of or current symptomatic orthostatic hypotension
* Hyper-eosinophilia or subject at risk of microfilaremic disease or clinical suspicion of intestinal helminth infection
* History of or current macroscopic or microscopic hematuria
* Positive serology for Hepatitis Bs antigen (HBs), Hepatitis C Virus (HCV) and HIV 1 and 2 antibodies.
* Organic disorder likely to modify, absorption, distribution or elimination of the medication.
Functional Assessment of Activities of Daily Living (ADL) in Patients Who Underwent Mini-monovision Correction

Patients who underwent mini-monovision (with bilateral myopic defocus, MM-BMD) surgery for presbyopia correction with monofocal intraocular lenses implantation are supposed to have sufficient uncorrected vision capacity for activities of daily living (ADLs) that require: a) distant vision(DV), (ie. driving), b) intermediate vision (IV), (ie. computer word processing), c) near vision (NV), (ie. book reading). Primary objectives of the study are: 1) the development of a series of tasks in a research setting that will simulate common ADLs that require DV, IV, and NV. 2) the identification of potential correlations of the tasks in the research setting with demographic, clinical and other parameters of the study participants.

Patients who underwent mini-monovision (with bilateral myopic defocus, MM-BMD) surgery for presbyopia correction with monofocal intraocular lenses implantation are supposed to have sufficient uncorrected vision capacity for activities of daily living (ADLs) that require: a) distant vision(DV), (ie. driving), b) intermediate vision (IV), (ie. computer word processing), c) near vision (NV), (ie. book reading). Primary objectives of the study are: 1) the development of a series of tasks in a research setting that will simulate common ADLs that require DV, IV, and NV. 2) the identification of potential correlations of the tasks in the research setting with demographic, clinical and other parameters of the study participants

Eligibility Criteria:
Inclusion Criteria:

* Presbyopic patients that underwent mini-monovision correction with bilateral myopic defocus with monofocal intraocular lenses implantation

Exclusion Criteria:

* Glaucoma
* Corneal pathology
* Fundus pathology
* Severe neurological/mental diseases that interfere with visual acuity
Detection of Peripheral Blood Biomarkers in Intermediate Phase Spinal Cord Injury: Correlation With Neurological and Functional Outcomes, and Comparison to Other Central and Peripheral Neurological Conditions.

This research looks for markers in the blood of people with spinal cord injury that may be a sign of injury severity, or serve as a clue to the degree of recovery. Investigators would also like to compare the marker profile of these patient with that of other neurological conditions such as stroke and Guillain-Barre syndrome.

Patients participating in this trial will be those accepted to neuro-rehabilitation in Sheba medical center, Israel. They will join the trial at their arrival to the ward, no less than 2 week after the beginning of their condition, but no later than 3 months.

Patients will be examined by the research staff three times:

1. At arrival, the patients will be neurologically examined and their functional abilities will be assessed. Blood will be drawn and sent to the lab.
2. At 6 months after the beginning of the neurological condition the same will be repeated: the patients will be neurologically examined and their functional abilities will be assessed, and blood will be drawn and sent to the lab.
3. The final examination will take place 1 year after the beginning of the neurological condition. This time only the neurological and functional abilities will be assessed without blood tests.

The blood samples will be tested in the research lab. Then investigators shall compare the clinical findings with the laboratory findings, and see if any of the markers found reflect the injury severity or predict the recovery.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of traumatic or non-traumatic Spinal cord injury, Guillain-barre syndrome or Stroke
* No more than 3 months after injury or disease onset
* Condition severe enough to necessitate hospital/day care unit
* Signed the informed consent form

Exclusion Criteria:

* Psychiatric or cognitive situations that may interfere with the trial
Effectiveness of Nurse Tele-consultation on the Quality of Elective Colonoscopy, Procedure-related Anxiety, and Financial Toxicity

This is a multicenter, non-pharmacological, experimental, prospective, randomized study, with two arms (1:1) in a single-blind design. The study aims to evaluate the effectiveness of a tele-consultation procedure in patients undergoing elective colonoscopy in terms of quality of the exam, anxiety procedure-related and financial toxicity.

The aim of this study is to evaluate the effectiveness, in daily clinical practice, of a tele-consultation procedure (defined as a telephone consultation with the patient conducted by nursing staff with an appropriate level of experience in digestive endoscopy) with the goal of:

1. improving adherence to methods and timing for the correct intake of the intestinal preparation by patients undergoing elective colonoscopy;
2. assessing whether the tele-consultation can reduce anxiety and procedure-related stress, promoting a better emotional state in patients undergoing colonoscopy.

Eligibility Criteria:
Inclusion Criteria:

Subjects eligible for outpatient pancolonoscopy:

* for diagnostic purposes;
* for screening purposes;
* for post-polypectomy follow-up;
* of both genders;
* of all ethnicities;

Exclusion Criteria:

* Patients under 18 years of age or over 80 years of age;
* Patients on waiting lists with SHORT priority: the procedure to be provided within a short time (no more than 10 days);
* Patients included in GOM pathways who undergo colonoscopy within 10 days;
* Pregnancy;
* Presence of known contraindications to bowel preparation;
* Presence of known contraindications to performing pancolonoscopy;
* Patients who have undergone colonic resection and/or have a colostomy/ileostomy;
* Patients with cognitive impairments;
* Patients declared legally incompetent or unable to understand and make decisions;
* Patients unable to provide informed consent.
Guilt Focused Psychological Intervention

Participants in the intervention study will be 120 caregivers with guilt feelings linked with care and high levels of emotional distress (anxiety and/or depression), randomly allocated to the intervention conditions: intervention group and cognitive-behavioral comparison group. The intervention will be provided in a group setting and will consist in 8 sessions plus 3 booster sessions. The effect of the intervention on guilt feelings, depressive and anxious symptomatology, and biomarkers of cardiovascular risk will be assessed after the intervention and at follow-ups at 6 months.

1. Contact with collaborator centers. Centers with previous collaboration with the research team will provide contact data of potential participants. In addition, information of the project will be made available through posters, news, and internet (e.g., social networks).
2. Previous to the assessment each participant will be randomly allocated to the intervention conditions (guilt focused intervention (GFI) and cognitive behavioral therapy (CBT)) following the CONSORT recommendations. Randomization will be made through random numbers using computerized procedures.
3. Once contacted, caregivers will be requested to sign an informed consent and, if the inclusion criteria are met, the interview will take place. Interviews will be conducted by trained psychologists blinded to the project aims and hypothesis.
4. The interviews will consist in questions and questionnaires specifically selected for the project.
5. The intervention conditions have been developed following previous studies by the team or recognized researchers, or following previous research studies in the topic of caregiving stress or related topics (e.g. psychotherapeutic strategies for reducing distress).
6. The interventions will take place in group format (maximum 8 participants per group). Each intervention will consist in 8 weekly sessions plus 3 booster sessions in a 5 month period.
7. Participants will be assessed again after the intervention (2 months) and at the follow-up (6 months).

Eligibility Criteria:
Inclusion Criteria:

* Identifying themselves as the main caregiver of the relative with dementia
* Dedicating at least one daily hour to caregiving tasks
* Having cared for at least three consecutive months
* Not having participated in a psychotherapeutic intervention in the last year
* Showing scores equal or higher than 16 on the Center for Epidemiological Studies-Depression Scale (CES-D; Radloff, 1977) and/or 13 on the Tension-Anxiety subscale from the Profile of Mood States scale (POMS; McNair et al., 1971)
* Showing a score of at least 16 in the Caregiver Guilt Questionnaire (Losada et al., 2010).

Exclusion Criteria:

* Those different to the inclusion criteria
Helical Tomotherapy in Multiple Myeloma

To explore the safety and efficacy of systemic radiotherapy (TBI) combined with melphalan (Mel) for pretreatment of autologous hematopoietic stem cells in multiple myeloma.

This study is a single-center, prospective clinical study targeting myeloma patients requiring transplantation, and investigating the efficacy and safety of TBI combined with Mel regimen for transplant pretreatment. Subjects who meet the enrollment criteria were screened to enter the study and receive the corresponding regimen treatment.

Eligibility Criteria:
Inclusion Criteria:

1. Multiple myeloma patients receiving induction therapy and stem cell mobilization preparation for autologous transplantation;
2. Should agree to comply with all contraceptive requirements; 3, ECOG≤2;

4. Total bilirubin, ALT and AST \<2×UNL (upper limit of normal), BUN \< 30 mg/dL; 5. At least 2 x 10\^6 CD34+ cells /kg were collected; 6.absolute neutrophil count \>1000/uL and a platelet count of \>100,000/uL; 7. The expected survival time is more than 3 months; 8. Written informed consent was obtained from the patients or their immediate family members.

Exclusion Criteria:

Any of the following was an exclusion criterion:

1. According to the investigator's judgment, patients who cannot tolerate melphalan and radiotherapy;
2. Patients with known active hepatitis B virus (HBV) or hepatitis C virus (HCV), or seropositive for human immunodeficiency virus (HIV);
3. patients with uncontrolled or severe cardiovascular disease
4. According to the protocol or the investigator's judgment, the patient has a serious physical or mental illness
Effect of Pneumatic Tourniquet on Arm Swelling After Lymph Node Removal

The purpose of the proposed study is to evaluate the acute impact of swelling caused by low-pressure tourniquet use in the setting of ipsilateral prior axillary lymph node dissection and the change in swelling reduction following tourniquet use in three limb postures versus healthy volunteers.

PRIMARY OBJECTIVES:

I. To evaluate reduction in swelling and safety of tourniquet use in patients with prior axillary lymph node dissection

OUTLINE:

Participants raise their arm for 15 minutes, then wear a tourniquet inflated for 25 minutes. Hand volume is measured by aqueous volumeter at baseline, after use of the tourniquet and every 5 minutes for 30 minutes, while the arm is placed at a raised on head position, shoulder-level brace position, or at waist in a sling position.

PROCEDURE:

Participants raise their arm for 15 minutes, then wear a tourniquet 8000 inflated for 25 minutes. Hand volume is measured by aqueous volumeter at baseline, after use of the tourniquet and every 5 minutes for 30 minutes, while the arm is placed at a raised on head position, shoulder-level brace position, or at waist in a sling position.

Eligibility Criteria:
Inclusion Criteria:

* Have previously undergone axillary lymph node dissection
* Or healthy volunteers

Exclusion Criteria:

* Have new-onset lymphedema of the involved limb.
* Infection including cellulitis
* Trauma or planned axillary surgery within 6 months of participation
* Any prior axillary radiation
The Effectiveness and Safety of Dong-A Opalmon® Tablet in Patients with Acquired Lumbar Spinal Stenosis

This study is to evaluate the Effectiveness and Safety of Dong-A Opalmon® Tablet in Patients With Acquired Lumbar Spinal Stenosis


Eligibility Criteria:
Inclusion Criteria:

* Men or women aged ≥ 19 years
* Subjects with acquired Lumbar Spinal Stenosis who show normal results in the Straight Leg Raising (SLR) test and exhibit intermittent claudication, requiring treatment with Dong-A Opalmon® tab
* Subjects who voluntarily consent to participate in this observational study

Exclusion Criteria:

* Subject for whom the medicinal products administration is contraindicated according to the approved domestic drug information: Pregnant women or those who may be pregnant, Subject with genetic disorders such as galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption
* Subjects considered as unsuitable for participation in this observational study by the principal investigator or sub-investigator
To Demonstrate Superiority of Decitabine Over Azacitidine in Subjects With Intermediate- or High-risk MDS.

The purpose of this study is to compare the response of patients with Intermediate or High Risk myelodysplastic syndromes (MDS) following treatment with decitabine or azacitidine.


Eligibility Criteria:
Inclusion Criteria

Subjects who meet all of the following criteria may be included in the study:

1. Must have a diagnosis of primary myelodysplastic syndromes (MDS) of Intermediate-1 transfusion dependent, Intermediate-2, or High-risk \[defined by International Prognostic Scoring System (IPSS) score of ≥0.5\] and recognized French-American-British (FAB) classifications
2. Male or female, 18 years of age or older with signed informed consent
3. Adequate renal function
4. Demonstrated normal liver function
5. Female subjects of childbearing age must have negative pregnancy test within 1 week of study entry and agree to use adequate contraception for the duration of the trial and for a minimum of six months after last dose of decitabine or azacitidine received.
6. Male subjects must agree to use adequate contraception for the duration of the trial and for a minimum of six months after last dose of decitabine or azacitidine received.

Exclusion Criteria

Subjects who meet any of the following criteria will be excluded from participation in the study:

1. Current use of radiotherapy for extramedullary disease for 2 weeks prior to entering study (permitted if \> 2 weeks from study entry and if recovered from toxic effects of therapy)
2. Systemic fungal, bacterial, or viral infection which is not controlled (i.e., ongoing signs or symptoms of infection and without improvement despite appropriate treatment)
3. Pregnancy or current lactation
4. Significant concurrent disease, illness, or psychiatric disorder
5. Treatment with an investigational agent 30 days prior to the first dose of decitabine or azacitidine
Medication Adherence in Patients With Sarcoidosis

The goal of the study is to look at the relationship between how individuals with Sarcoidosis take the sarcoidosis medicines and how it affects the disease, to evaluate any factors that may make individuals not want to take the medicines, and to develop and refine ways to help support individuals with Sarcoidosis especially when it comes to the medicines. The overall hypothesis is higher medication adherence will be associated with better clinical outcomes in sarcoidosis. The investigators will enroll 150 patients with biopsy proven pulmonary sarcoidosis for at least one year who are on any oral treatment regimen for at least six months into a 12-month longitudinal study.


Eligibility Criteria:
Inclusion Criteria:

* At least 18 years of age.
* Physician diagnosis of Sarcoidosis.
* Biopsy proven pulmonary involvement of Sarcoidosis.
* On oral Sarcoidosis medications for at least 6 months.
* Permanently reside in Maryland or D.C.
* Fully vaccinated against COVID-19.

Exclusion Criteria:

* Non-english speaking.
* Unable to provide consent.
* Unable to participate in orally administered questionnaires.