cyrilzakka/clinical-trials huggingface dataset:
Study to Evaluate Music Therapy on Irritability and Impulsivity in Patients With Huntington's Disease (MUSIC-HD)

The study is an open-label clinical trial evaluating whether music therapy combined with conventional management reduces irritability and impulsivity in 15 patients with early-stage Huntington's disease. This pilot study aims to show the interest of alternative non-pharmacological measures such as a digital music therapy tool, adapted to an audience of Huntington's patients, to help manage the psychobehavioral symptoms frequently observed in this affection, and to avoid breakdowns due to caregiver exhaustion.

The participants will be recruited at the Clinical Investigation Center (CIC) of the University Hospital of Poitiers and will receive music therapy for 3 months.

After the start of the musical intervention, 3 visits (at 1 month, 3 months and 6 months) will be performed by practitioners, nurses and neuropsychologist at the CIC. Participants will answer questionnaires : irritability (BITe and PBA-s sub-score), impulsivity (UPPS-P and Delay discounting task), anxiety (STAI-Y and HAM-A), and quality of life: H-QoL-I. Caregivers will be asked to rate the patient's irritability and anxiety using a Lickert scale from 0 to 10, and the patient's impulsivity with the ISDC.

Eligibility Criteria:
Inclusion Criteria:

* Age \>= 18 years
* Huntington disease genetically confirmed by the presence of at least 35 repeats of the CAG triplet in exon 1 of the HTT gene
* UHDRS (Unified Huntington's disease Rating Scale) score \<= 5 with a diagnostic confidence score =4
* Absence of significant cognitive impairment MoCA \>=24
* Stable drug therapy in the 28 days prior inclusion and during the study
* Without legal tutors or subordination
* Affiliated to a health insurance system as required by the French law on biomedical research
* Written informed consent for participation in the study

Exclusion Criteria:

* Inability to give free and informed consent for study participation
* Significant hearing impairment
* Participating to another study the day of enrollement
* Persons benefiting from enhanced protection, i.e.persons deprived of their liberty by a judicial or administrative decision, adults under legal and finally patients in a vital emergency situation.
Instrumental Sealing of Arterial Puncture Site Closure Device Versus Manual Compression Trial

Are novel vascular closure devices noninferior to manual compression regarding access site complications after coronary angiography?

Vascular closure devices have been shown to be safe and effective in reducing the time to hemostasis and immobilization when compared to manual compression following coronary angiography. This effect is beneficial in patients presenting with chronic back pain, prostate enlargement, mental impairment or other disorders that preclude prolonged bed rest.

However, adequately powered large scale randomized trials with vascular closure devices remain a gap in the scientific literature.

This trial compares, in a randomised design two novel vascular closure devices (FemoSeal \& ExoSeal) versus manual compression after coronary angiography. This study is aimed to investigate if novel vascular closure devices are noninferior to manual compression regarding access site complications.

Eligibility Criteria:
Inclusion Criteria:

* Patient between 18 and 85 years of age
* Patients undergoing femoral access coronary angiography
* Access only with 6 F sheath
* Patient must be competent for providing informed written consent

Exclusion Criteria:

* Peripheral arterial occlusive disease
* Prior peripheral artery surgery
* Percutaneous coronary intervention
* Femoral access device closure in last 30 days
* Scheduled Coronary Angiography/Intervention within 90 days
* Critical limb ischemic
* Uncontrolled hypertension \>220/110 mmHg
* Coagulopathy (bleeding disorder)
* Local infection
* Common femoral artery lumen diameter \< 5 mm
* Allergy to absorbable suture
* Autoimmune Disease
* Pregnancy
Do Peanut Shaped Birthing Balls Reduce the Length of Labor in Patients With Epidural Analgesia?

Labor patients who meet inclusion and exclusion criteria will be consented to be participate in this study to determine if the use of a peanut shaped birthing ball reduces the length of labor and reduces the incidence of cesarean section. Subjects will be randomized at the time of consent to either use the birthing ball or not use the birthing ball from the time of labor analgesia until complete cervical dilation.


Eligibility Criteria:
Inclusion Criteria:

* nulliparous
* \>/= 18 years of age
* not allergic to medications used for labor analgesia
* no contraindications to labor analgesia
* ASA I-II
* EGA \>/= 37 weeks

Exclusion Criteria:

* under age 18
* Spanish speaking only
* multiparous
* EGA \<37 weeks
Diagnosis and Management of Myofascial Pain Syndrome in Women With Mastectomies

Myofascial pain considerably affects women undergoing treatment for breast cancer, is characterized by the presence of myofascial taut bands and trigger points. This study aims to evaluate the effects of ischemic compression, high-voltage electrical stimulation and rehabilitation of kinesio in women with myofascial pain following treatment of breast cancer. This is a randomized blind controlled study. For this, we invited 60 volunteers undergoing treatment for breast cancer, randomized and allocated into three groups: G1 (cinesioterapia), G2 (ischemic compression cinesioterapia +) and G3 (high voltage electrical stimulation cinesioterapia +). The stance, the plantar pressure distribution and the balance will be assessed by means of photogrammetry and baropodometry respectively. Myofascial trigger points will be assessed with the use of infrared thermography, algometry and numerical rating scale of pain (END). Moreover, the quality of life of the volunteers will be assessed by the Functional Assessment of Cancer Therapy-Breast (FACT-B +4). The volunteers will undergo 10 sessions of treatment, and reassessed at the end of treatment and after thirty days. Normality test is used to verify data distribution and consistent statistical test for proper intra and comparisons between groups, being thus considered two factors in the comparisons, time and group. A significance level of 5% is assumed.


Eligibility Criteria:
Inclusion Criteria:

* mastectomy
* aged between 35 and 70 years
* myofascial trigger point in the upper trapezius muscle

Exclusion Criteria:

* metastasis or recurrence of breast cancer
* bilateral mastectomy
* in physiotherapy treatment
* degenerative diseases of the spine
* use of muscle relaxants or anti-inflammatory analgesics in the last week
* report of fibromyalgia
Laparoscopic Extraperitoneal ( Modified) Burch Colposuspension

Urinary incontinence is a very common problem in women and can be seen at any age. Laparoscopic burch operation has been shown to be an effective, convenient and safe method in women with stress incontinence. Laparoscopic Burch operation is less invasive because it is advantageous in terms of hospitalization time, blood loss, pain and recovery time, but the disadvantage is the procedure time. Modified extraperitoneal technique may be a good method for lowering the procedure time.

In the research; The pre- and postoperative urodynamics of patients who underwent laparoscopic extraperitoneal (modified) burch operation in the Gynecology and Obstetrics Clinic of Istanbul Health Sciences University Gaziosmanpasa Training and Research Hospital will be compared. Surgical outcomes together with complications will also be assessed.

In addition, the QUALITY OF LIFE (SF36), which determines the quality of life of the patients related to the urinary system functions, and the UROGENITAL DISTRESS INVENTORY (UDI - 6), INCONTINENCE IMPACT QUESTIONNAIRE (IIQ-7) questionnaires that determine the effects of urinary incontinence, will be assessed preoperatively and postoperative 6 months of the patients.

Eligibility Criteria:
Inclusion Criteria:

* having stress urinary incontinence

Exclusion Criteria:

* having any kind of urogynecological surgery history
* having pelvic mass
* having endometrial or myometrial pathology
* having uterine prolapsus grater than grade 2
* benign obese
Eccentric Resistance Training With Blood Flow Restriction on Muscle Function

The study will determine the effects of adding blood flow restriction to eccentric training to assess whether this increases the improvements of muscle strength and size.

Subjects will be randomly assigned to two groups: an eccentric only resistance training group or an eccentric training plus blood flow restriction group. Subjects will train at a moderately low intensity on a multiple-joint eccentric device. Those in the blood flow restriction will wear blood flow restriction cuffs on their upper thighs to reduce blood flow during the brief protocol. The training session will occur twice per week and will last \~5 minutes, including a one minute warm up, a one minute cool down and a three minute workout phase. The training program will last 7 weeks. Testing will be conducted at baseline (following a one session familiarization), 4 weeks and after the end of the 7 week training period. Assessments will focus on muscle strength, function, and morphology (size).

Eligibility Criteria:
Inclusion Criteria:

* 18-30 years of age
* currently engaged in some form of resistance training between 1-3 times per week
* must have been training aerobically, but no more than 3 hours a week for the past six months

Exclusion Criteria:

* Must not have had any surgery of the lower limbs within the past 1 year period
* Must not have any neuromuscular disorder (e.g., Muscular dystrophy etc.)
* \< 76 inches tall (in order to fit on the training machine)
* Maximal strength of \< 725 lbs for the eccentric training device
* If any of the subjects are pregnant or plan to be pregnant in the duration of the protocol.

For those randomized to the BFR group, if any of the subject's thighs are too large for the BFR cuffs (greater than 68 cm).
Kagocel® for the Prevention of ARVI and Influenza in Young People

This study evaluates the use of Kagocel for the prevention of acute respiratory viral infections (ARVI) and influenza during the epidemic rise in the incidence of diseases in Russia in 2018 (epidemiology: the number of cases during the period of Kagocel administration and follow-up, bacterial exacerbations, the number of repeated episodes (reinfection), demographics of patients, safety, adherence to treatment) in students at risk due to stress, lack of sleep and fatigue.

This non-interventional prospective study included 75 health students over the age of 18 who had no symptoms of acute respiratory viral infections (ARVI) and influenza at the time of inclusion and had not taken any antiviral medications to prevent ARVI and influenza for 30 days before.

The total duration of the study was 2 months: the first month participants took either Kagocel (the main group), or did not take anything at all (the control group), during the next 1 month all participants were monitored.

The diagnosis of influenza and ARVI has been confirmed in accordance with the world health organization (WHO) guidelines for the pharmacological treatment of pandemic influenza A (H1N1) 2009 and other influenza viruses. All patient examinations are conducted in accordance with local routine clinical practice and local and international standards of care.

By the study were analysed and compared those data between groups:

* demography
* anamnesis data (the incidence of ARVI and flu for previous year, the date of the lastest episode of the disease, the presence of concomitant diseases, including ENT-organs, the date of the lastest influenza vaccination).
* timelines: start of Kagocel's prevention - only for the group receiving Kagocel's prevention; start of the disease; duration of ARVI and influenza symptoms (fever, headache, runny nose, sore throat, cough); start of treatment
* symptomatic therapy (Yes/no, drug name)
* bacterial exacerbations (Yes/no)
* treatment of bacterial exacerbations (Yes/no)
* adverse events

Eligibility Criteria:
Inclusion Criteria:

* signed informed consent to participate in the study.
* age from 18 to 30 years.
* the subject of the study does not have symptoms of ARVI and influenza at the time of inclusion in the study.
* there are no contraindications to the use of Kagocel: pregnancy and lactation, hypersensitivity to the components of the drug, lactase deficiency, lactose intolerance, glucose-galactose malabsorption (only for the group receiving kagocel prevention).
* the subject of the study should not to take other medications to prevent colds and flu while participating in the study.
* no history of participation in a clinical trial of any drug less than 30 days prior to inclusion in this study.
* no history of treatment by interferon or interferon inducers less than 30 days prior to inclusion in this study.

Exclusion Criteria:

* no exclusion criteria except participating in a current clinical trial because of non-interventional study design
"Outcomes of Surgical Removal of Foreign Body Granulomas"

Illicit subcutaneous injection of high-viscosity fluids for restoration and improvement of body contour is a growing trend all around the world. Many local and systemic complications have been described. Local complications include deformity at the site of injection, granulomas and several skin changes like erythema, induration, and plaques (well-circumscribed, elevated, superficial, solid lesion).

The investigator designed a single-center, cross-sectional, retrospective, consecutive case series study and evaluated 49 surgeries performed in 35 patients with the history of foreign substances injection for cosmetic purposes and developed local complications. Investigators divided 4 groups accordingly to localization of foreign substances (FS). Group 1) FS disseminated to both lower extremities and buttocks; group 2) FS isolated to buttocks with moderate to severe skin changes, Group 3) FS isolated to lower legs with mild skin changes and superficial ulcerations and 4) FS isolated to lower legs with moderate to severe skin changes and/or ulceration. The investigators treated all patients surgically, which consisted of isolate ultrasonic liposuction for extraction of the material from the affected region (group 1) In-bloc excision and primary closure (group 2), Resection plus Vacuum assisted closure (VAC) and split thickness skin graft (STSG) (group 3) and In-bloc excision and microsurgical reconstruction (group 4). Statistical analysis was performed to find relations between type of surgery with complications, reactivation of symptoms, time for reactivation and a disease-free survival test (kaplan meier) was done.


Eligibility Criteria:
Inclusion Criteria:

* History of injection of foreign substances for cosmetic purposes
* Develop symptoms of Autoimmune syndrome induced by adjuvants
* Mild to severe skin changes

Exclusion Criteria:

* Refuse to participate in the analysis
The Effect of Some Parturients' Characteristics on Sensory Block Level After Spinal Anesthesia

Although the exact mechanism remains unknown, the association of pregnancy and decreased local anesthetic requirement is clear. demonstrated that more local anesthetic is required for cesarean section under combined spinal-epidural anesthesia in preterm compared with term patients.

However, in pregnant patients, venous engorgement is prominent in the supine but not the lateral position, which suggests direct compression of the inferior vena cava by the gravid uterus. Second, an increase in intraabdominal pressure may affect the retroperitoneal area and may cause inward movement of soft tissue in the intervertebral foramina. Recent magnetic resonance imaging studies in pregnant patients, although without intraabdominal pressure measurements, suggested the latter because they showed limited contact of engorged veins along the dural sac which may therefore not be responsible for compression of the dura.

If elevated intraabdominal pressure contributes to high anesthetic spread during pregnancy, one would expect a relationship between intraabdominal pressure and maximum sensory block level.

Eligibility Criteria:
Inclusion Criteria:

* adult female partner
* aged 18 to 40 years.
* scheduled for elective cesarean section.

Exclusion Criteria:

* Patients with coagulopathy or under anti-coagulation therapy.
* Gastrointestinal disease,
* motion sickness.
* diabetes mellitus.
* Patients with preeclampsia,
(SGB) in Men Treated for Prostate Cancer Improve Hot Flashes

Androgen Deprivation Therapy (ADT) is a critical component of advanced prostate cancer treatment but causes numerous adverse effects including decreased bone mass, decreased muscle mass, gynecomastia, erectile dysfunction, loss of sexual desire, depression, disordered sleep, urinary symptoms, and hot flashes (HF). HF are unpleasant paroxysmal episodes of flushing, sweating with vasodilation of the face, neck, and chest. These episodes can last for seconds to minutes and are often associated with night sweats, anxiety, and insomnia and have negative effects on quality of life.

Stellate ganglion blockade (SGB) with local anesthetic may be an effective treatment of HF in men on ADT, but has not been studied in any published clinical trials.

The stellate ganglion is a neural structure in the anterior cervical spine region and is part of the sympathetic nervous system. It has been injected safely in the practice of pain management for more than 50 years in cases of post herpetic neuralgia (shingles), complex regional pain syndrome (CRPS) and other painful neuropathies as well as some types of cardiac dysrhythmias.

Given the frequency and severity and interference of HF in men on ADT for prostate cancer, in addition to the negative effects HF impose on this patient population and a paucity of effective treatments, finding alternative treatments for HF in this population is needed.


Eligibility Criteria:
Inclusion Criteria:

1. Men with prostate cancer (with or without metastatic disease) on ADT for at least 2 months
2. Age less than 65 years
3. Body Mass Index (BMI) less than 32
4. Willingness to undergo image guided intervention
5. Greater than 28 hot flashes per week.

Exclusion Criteria:

1. Conditions that preclude SGB or sham intervention (e.g., anatomic abnormalities of the anterior neck or cervical spine; metastatic disease in or near the cervical spine; goiter;cardiac/pulmonary compromise; sleep apnea; acute illness/infection; coagulopathy or bleeding disorder; allergic reactions/contraindications to a local anesthetic or contrast dye)
2. Current treatment of prostate cancer with radium or chemotherapy
3. Use of treatments in the past two months that can affect HF (e.g., testosterone or androgen supplementation) Note: SSRIs, serotonin norepinephrine uptake inhibitors, and membrane stabilizers will be allowed but must be on stable unchanged dose for at least 8 weeks)
4. Inability to write, speak, or read in English
Gene Transfer Therapy for Severe Combined Immunodeficieny Disease (SCID) Due to Adenosine Deaminase (ADA) Deficiency: A Natural History Study

This study will monitor the long-term effects of gene therapy in patients with severe combined immunodeficiency disease (SCID) due to a deficiency in an enzyme called adenosine deaminase (ADA). It will also follow the course of disease in children who are not receiving gene therapy, but may have received enzyme replacement therapy with the drug PEG-ADA.

ADA is essential for the growth and proper functioning of infection-fighting white blood cells called T and B lymphocytes. Patients who lack this enzyme are, therefore, immune deficient and vulnerable to frequent infections. Injections of PEG-ADA may increase the number of immune cells and reduce infections, but this enzyme replacement therapy is not a definitive cure. In addition, patients may become resistant or allergic to the drug. Gene therapy, in which a normal ADA gene is inserted into the patient's cells, attempts to correcting the underlying cause of disease.

Patients with SCID due to ADA deficiency may be eligible for this study. Patients may or may not have received enzyme replacement therapy or gene transfer therapy, or both. Participants will have follow-up visits at the National Institutes of Health in Bethesda, Maryland, at least once a year for a physical examination, blood tests, and possibly the following additional procedures to evaluate immune function:

1. Bone marrow sampling - A small amount of marrow from the hip bone is drawn (aspirated) through a needle. The procedure can be done under local anesthesia or light sedation.
2. Injection of small amounts of fluids into the arm to study if the patient's lymphocytes respond normally.
3. Administration of vaccination shots.
4. Collection of white blood cells through apheresis - Whole blood is collected through a needle placed in an arm vein. The blood circulates through a machine that separates it into its components. The white cells are then removed, and the red cells, platelets and plasma are returned to the body, either through the same needle used to draw the blood or through a second needle placed in the other arm.
5. Blood drawings to obtain and study the patient's lymphocytes.

The primary purpose of this study is to continue to provide clinical follow-up for ADA-deficient patients treated with gene therapy under the original protocol 90-HG-0195 (IND 3624) and its amendments (IND 4647 and IND 5056). The objectives are the long-term monitoring of the beneficial effects of gene therapy and continued surveillance of potential adverse effects associated with the gene transfer procedures.

No new subjects will be enrolled in this protocol.

Eligibility Criteria:
New patients will not be treated under protocol 90-HG-0195 as new and improved vectors and technologies have become available in the recent years.

New patients with ADA deficiency, however, may be enrolled in protocol 90-HG-0195 for clinical evaluation of their immune system and pre-treatment testing of transduction procedures.
Short-term Effects of Perindopril-amlodipine Versus Perindopril-indapamide in Type 2 Diabetes

This was a double-blinded randomized controlled trial of 24-hour blood pressure control in sub Saharan type 2 diabetes patients, newly diagnosed for hypertension. They were allocated to receive either a fixed combination of perindopril + amlodipine or perindopril + indapamide for 42 days.

This was a double-blinded randomized controlled trial conducted at the National Obesity Center and the cardiology unit of the Yaoundé Central Hospital in Cameroon from October 2016 to May 2017. Eligible patients were type 2 diabetes patients, newly diagnosed for hypertension (grade I or II) with confirmation on ambulatory BP monitoring (ABPM). Patients were either on lifestyle modification alone or on a stable anti-diabetic treatment for the past three months, aged 25-65 years naïve to any anti-hypertensive treatment, who provided their written informed consent. Participants were assigned to receive as anti-hypertensive treatment perindopril-amlodipine once daily or perindopril-indapamide at the same frequency. The two groups were followed up and monitored for sixth weeks and patients did not take any additional treatment with BP modifying properties.

The primary outcome was the relative change in circadian blood pressure profile between the two groups after six weeks of treatment

Eligibility Criteria:
Inclusion Criteria:

* adult diabetes patients aged between 25-65 years,
* with grade I or grade II (WHO classification) hypertension on the clinical measure, confirmed by ABPM
* naïve to any anti-hypertensive treatment
* written informed consent.

Exclusion Criteria:

* Patients with grade III hypertension (WHO classification) were classified as hypertensive emergency,
* estimated creatinine clearance ˂30ml/min/1.73m2 (using Modified Diet in Renal Diseases formula)
* alanine transaminase (ALT)≥ 3 normal
* any contraindication to study drugs (hypersensitivity)
* pregnant or breastfeeding women