cyrilzakka/clinical-trials huggingface dataset:
Medicinal vs. Orthotic Comparison for Migraine Prevention: A Double-Blind Study

To understand the impacts of using a fixed orthotic facial exercise appliance (BLAfit®) for migraine reduction, as compared to medication (fremanezumab-vfrm) and control.

The investigators will be studying the impacts of using an orthotic facial exercise device (BLAfit®) in the prevention of migraines for those who suffer from roughly 10-15 migraines per month. In order to test the efficacy of this device and its exercise routine, investigators will have one arm of our study receive the BLAfit® device and perform the exercises for one minute daily for three months. In Arm #2, there will be another treatment: Ajovy® (fremanezumab-vfrm) injections- which is a known and commonly practiced clinical prevention treatment for migraine patients. Patients in this arm will receive three injections of Ajovy, which is will be meant to last 3 months. In addition, investigators will have a placebo group that will receive three saline injections, which are meant to mimic the three Ajovy® injections. Arms #2 and #3 of this study will be conducted in a double-blind fashion, as both the clinician providing the injections and the patients receiving the injections will not know if the injecting substance is Ajovy or saline, so as to minimize bias. All patients in all three months will log their number and pain level of their migraines each day for three months. Upon conclusion, they will meet with our in-house neurologist (Principal Investigator \& Sponsor) for a final in-person evaluation and questionnaire. Results from the three groups will then be analyzed.

Eligibility Criteria:
Inclusion Criteria:

* Those eligible to participate must be between the ages of 18 to 55 years.
* The individual must experience at least 2 migraines per week.
* They must be capable of visiting the medical facility in Manhattan Beach, California where the in-person screening and final evaluation will be conducted (following COVID-19 public health guidelines).
* They must be able to communicate with the study team via any teleconferencing service such as Zoom, Google Hangouts, or FaceTime.

Exclusion Criteria:

* Patients must not have any intracranial pathology, neurological or psychological conditions, epilepsy, cancer, any history of chemotherapy, hospitalized for depression, psychiatric conditions, seizures, or tumors.
* Patients cannot have taken Botox® for migraine treatments.
* Patients cannot have had a history of head or neck surgery.
* Patients cannot be taking: propranolol, amitriptyline, flunarizine, topiramate, combination, galcanezumab-gnlm, fremanezumab-vfrm, or erenumab-aooe.
* Patients must not be deemed a vulnerable subject (including but not limited to: children, prisoners, pregnant women, mentally disabled persons).
Early Treatment for Acute ACL Tear

This research study is the first of its kind and will allow health care professionals and researchers to answer many questions about the reasons why anterior cruciate ligament (ACL) injury leads to knee pain and disability and osteoarthritis. We also hope that this study will be the beginning of new, more powerful and safer drugs to help patients with ACL injuries heal sooner and return to sports or daily activities pain free. Study participants will be recruited from the University of Kentucky and Vanderbilt University.

The purpose of this research is to gather information on how safe and effective Kenalog® is in alleviating knee pain following ACL rupture.

Injury to the knee during sports participation often involves partial of full detachment of the ACL. ACL tears cause pain, swelling and inflammation. While the swelling and inflammation usually goes away in time, individuals with ACL injuries may experience pain and notice knee instability (knee slipping, etc.). Often surgery can repair or replace the ACL within the joint, allowing individuals the ability to walk or run again pain free or participate in sports. Unfortunately, osteoarthritis of the knee, which also causes pain and swelling, can occur in that same knee 10-20 years later for reasons which are not well understood.

In this research study, we hope to prevent and reduce the initial post-operative pain. The reduction of pain will allow for earlier movement of the knee joint and preparation for surgery. It may also reduce the risk to develop osteoarthritis in individuals with ACL injuries by treating them within 1-2 days after their injury.

Eligibility Criteria:
Inclusion Criteria:

* currently participating in sporting activities
* Normal contralateral knee status
* Anterior Cruciate Ligament (ACL) injury occurred while playing a sporting activity

Exclusion Criteria:

* underlying inflammatory disease (i.e. Rheumatoid Arthritis, Psoriatic Arthritis, etc.)
* have been diagnosed with hepatitis B or tuberculosis
* currently have an infection, including infection of the skin
* have a disease that weakens your immune system such as diabetes, cancer, HIV or AIDs
* other major medical condition requiring treatment with immunosuppressant or modulating drugs.
* A history of chronic use of non-steroidal anti-inflammatory drugs
* previous exposure or allergic reaction to Kenalog
* prior knee surgery (Ipsilateral or contralateral)
* have received any investigational drug with 4 weeks of study Visit 1
Study of Tamsulosin, Solifenacin and Mirabegron in Alleviating Ureteral Stent-related Symptoms

A comparative study on the efficacy of Tamsulosin, Solifenacin and Mirabegron in alleviating ureteral stent-related symptoms: a randomized controlled trial.

Ureteral stent related symptoms can be a major issue in patient undergoing stent placement after any procedure such as- complains of pain, urinary symptoms, sex related and work related and other symptoms. These symptoms can be alleviated with use of drugs such as Tamsulosin, Solifenacin and Mirabegron. Patient recruited in each arm of the study will have their stent related symptoms scoring done using a validated outcome assessment tool to measure the ureteral stent-related symptoms, Ureteral Stent Symptom Questionnaire (USSQ) on day 1, day 7 and day 14 after the stent placement.

Eligibility Criteria:
Inclusion Criteria:

• Eligible participants were adult patients (aged 19-80 years) who underwent unilateral retrograde rigid ureteroscopy (URS) or retrograde intrarenal surgery (RIRS) with planned ureteric stent insertion for urinary tract stones

Exclusion Criteria:

* Concomitant use of a-blockers, anticholinergics, corticosteroids, calcium channel blockers, and analgesics
* Undergoing percutaneous nephrolithotomy, open ureteric surgery or laparoscopic ureteric surgery, including ureterolithotomy
* Neurogenic bladder, Over Active Bladder (OAB) syndrome, and neurological and psychiatric diseases
* Preoperative febrile Urinary Tract Infection (UTI)
* Pregnancy or breastfeeding;
* A single kidney
* Moderate or severe cardiovascular or cerebrovascular disease
* Hepatic dysfunction
* History of pelvic surgery or irradiation
* History of bladder or prostate surgery
* Other acute medical conditions (including acute pancreatitis, acute gastroenteritis, musculoskeletal disorders) that might influence the Ureteral Stent Symptom Questionnaire(USSQ) pain score
* Allergy to any medication
Calcium From Fish Bone in Volunteers With Osteopenia

The aims of this study are to explore efficacy and safety of calcium from fish bone in volunteers with osteopenia. The volunteers are divided into 2 groups which are calcium from fish bone treatment group and calcium carbonate treatment group. Both groups received the calciums everyday for 6 months. Bone mineral density, blood examination, physical examination, adverse events, and satisfaction are evaluated before and after treatment.

The aims of this study are to explore efficacy and safety of calcium from fish bone in volunteers with osteopenia. The volunteers are divided into 2 groups which are calcium from fish bone treatment group and calcium carbonate treatment group. Both groups received the calciums everyday for 6 months. Bone mineral density is analyzed before and after treatment. Osteocalcin, total procollagen type-1 N-terminal propeptide (P1NP), beta-crosslaps, parathyroid hormone (PTH), calcium, phosphate level, vitamin D level (Serum 25(OH)D), albumin, aspartate transaminase (AST), alanine transaminase (ALT), alkaline phosphatase (ALP), creatinine (Cr), blood urea nitrogen (BUN), and complete blood count (CBC) are assessed before and after taking for 3 and 6 months. Physical performance and food diary are also tested and records. Moreover, adverse effects including skin allergy, gastrointestinal abnormality, respiratory abnormality are evaluated. Satisfaction is asked after treatment.

Eligibility Criteria:
Inclusion Criteria:

* Male age more than 70 years or female age more than 65 years or all age volunteers that have at least 1 risk factors which are menopause before 45 years, menopause with the height reduction (more than 4 cm), body mass index less than 20 kg/mm2, bone fracture history, taking some medicine that has an effect on bone density reduction, have disease that has an effect on bone density reduction, Father and mother have bone fracture history, fracture risk assessment tool (FRAX) in intermediate risk, osteoporosis self-assessment tool for asian (OSTA) score, khon kaen osteoporosis study (KKOS) score in intermediate risk or higher intermediate risk
* Bone mineral density between -1 to -2.5
* No osteosclerosis
* Can read and write
* Willing to be volunteer

Exclusion Criteria:

* Allergic to calcium, magnesium, phosphorus, zinc, collagen, and osteocalcin
* Taking calcium or vitamin D with in 14 days before the study start
* Taking osteosclerosis' medicine
* Have uncontrolled diseases
* Pregnancy and lactation
* Participating in other study
Open Non-Comparative Study To Evaluate Administration Of a New Nutraceutical

The Research Hypothesis for the present pilot study in a special care setting is that in a population suffering of mild and recent sleep disorders the pre-sleep arousal measured by the Pre-Sleep Arousal Scale (PSAS) after 30 days of oral administration with a nutraceutical composed of hawthorn, lavender and hop (Sonidor®) shall significantly improve in comparison with the baseline condition.

Sonidor® was developed as a nutraceutical composed of hawthorn, lavender and hop inducing sleep and relaxation in subjects with mild sleep disturbances. In addition, the Sonidor® innovative three-layer-tablet formulation should allow the active components to be released with different speeds into the gastrointestinal tract exerting a synergistic action to induce sleep-promoting effects.

Primary objective is to have a preliminary evaluation of the efficacy of Sonidor® in subjects affected by persistent mild sleep disorders (difficulty in initiating sleep for at least 1 month and reduced quality of sleeping) to whom in special care setting have been suggested sleep hygiene guidelines and administered the tested nutraceutical for one month.

Eligibility Criteria:
Inclusion Criteria:

1. Men and women, aged 18 to 70 years with persistent, recent (at least 1 month) and mild sleep disorders related to pre-sleep arousal and reduced quality of sleeping;
2. PSAS at baseline between 16 and 24;
3. ISI at baseline ≥ 12;
4. Able to communicate adequately with the Investigator and to comply with the requirements for the entire study;
5. Capable of and freely willing to provide written informed consent prior to participating in the study;

Exclusion Criteria:

l. Subjects with Morningness-Eveningness Questionnaire Self-Assessment (MEQSA) values between 16 and 41; 2. Pregnancy and/or breast-feeding; 3. Subjects assuming beta blockers, hypnotic or sedative drugs or other nutraceuticals; 4. Psychosis, schizophrenia, mania, depressive disorders, history of suicide attempt, or suicidal ideation, or any other psychiatric illness (with the exception of intermittent anxiety); 5. Known intolerance to the tested product or at one of the ingredients (hawthorn, lavender or hop); 6. Drug or alcohol abuse within 12 months of Day 0; 7. All clinical conditions that, at the evaluation of the Investigator, can be referred to as secondary insomnia; 8. Participation in an interventional clinical study or administration of any investigational agents in the previous 30 days; 9. Presence of any clinically significant medical condition judged by the investigator to preclude the subject's inclusion in the study;
Weight-bearing of Patients After Pelvic Ring Fracture

Pelvic ring fractures are fractures associated with high morbidity and mortality. When the fracture is displaced, surgical management to achieve reduction and fixation of the anterior and posterior annulus is the current reference. The optimal technique that gives the best results is controversial. Open reductions and internal fixations (ORIFs) are associated with more blood loss and a higher rate of infection, while closed reductions and percutaneous fixations (CRPF) are associated with more screw misplacements and thus vascular or nerve damage. The results appear to be similar in the literature between the two approaches

Surgery for pelvic ring fractures has become increasingly common over the past three decades Recovery is often delayed for weeks post-surgery, depending on the center. Modern management emphasizes early rehabilitation, including early mobility and weight-bearing, when possible. Increasing the number of screws, their diameter and length, and systematically fixing both anterior and posterior lesions add safety for early reloading

The aim of the study is The main objective of the study is to evaluate the clinical outcome associated with early weight-bearing in patients operated on for a pelvic ring fracture in a large cohort of patients at Grenoble University Hospital, compared to patients operated on for the same type of pelvic ring fracture with delayed weight-bearing.

The investigator hypothesize that early weight-bearing of pelvic ring fractures with biomechanically stable fixation does not result in significant differences in clinical outcomes at a minimum of one year compared to patients with delayed weight-bearing


Eligibility Criteria:
Inclusion Criteria:

* Adult patient at the time of injury
* Pelvic ring fracture
* Pre-operative X-rays
* Pre-operative CT scan
* Post-operative X-rays
* Postoperative CT scan
* Willingness and ability to participate in the study.

Exclusion Criteria:

* Ipsi-lateral fracture of the femoral and/or associated acetabulum (Floating Hip C or B)
* Pregnant and breastfeeding women
* People under guardianship, protected adults
Efficacy and Tolerability of Full Dose Enteric-coated Mycophenolate Sodium, in Addition to Cyclosporine for Microemulsion Reduced Dose, in Maintenance Renal Transplant Recipients

The study will evaluate kidney graft function in maintenance renal transplant patients.


Eligibility Criteria:
Inclusion criteria:

* Male or female recipients of single or double renal transplant performed since at least one year and no more that 5 years
* Age \> 18 yrs
* Adequate and stable renal function
* Informed consent.

Exclusion criteria:

* Kidney transplant combined with other organs;
* Significant proteinuria
* Severe ongoing infections;
* Present or historical malignant neoplasia, of any type, with the exception of excised non metastatic non-melanoma skin cancer and previous malignant neoplasia cured since at least 5 years;
* Relapse of the end-stage renal disease on the transplanted kidney;
* Leucopenia, thrombocytopenia or severe anemia;

Other protocol-defined inclusion/exclusion criteria may apply
Study of the Determinants of Emergency Dialysis in Reunion Island

Among patients followed by nephrologists, the frequency of emergency dialysis starts' and their social and clinical determinants are not well known, especially in Reunion Island. In this context, we aim to study and understand the determinants of emergency dialysis initiation. For Reunion Island, the data remain very fragmented.


Eligibility Criteria:
Inclusion Criteria:

* Adult patient ≥18 years
* Starting dialysis in a dialysis centre in Réunion Island
* Having expressed their non-opposition or Emergency inclusion (non-opposition collected afterwards)

Exclusion Criteria:

* Under legal protection (safeguard of justice, guardianship)
* Unable to answer questionnaires
Premixed, Sequential and Manually Mixed Administration of Intrathecal Fentanyl and Bupivacaine in Cesarean Section

This study aims to distinguish between premixed, sequential, and manually mixed administration of intrathecal fentanyl and bupivacaine in cesarean section.

Cesarean section (CS) is a lifesaving procedure when there is both maternal and fetal problems. The rate of CS increases dramatically from time to time. Regional anesthesia techniques are highly preferred for CS compared to general anesthesia.

Coadministration of intrathecal opioids and local anesthetics (LAs) have been found to produce a potent intra and postoperative analgesic synergism without further depression of efferent sympathetic activity, hence results in less adverse hemodynamic effects, even with sub-therapeutic doses of LAs.

Fentanyl has been considered the intrathecal LAs adjuvant of choice owing to its potency, fast onset and short duration of action, and lower incidence of respiratory depression.

Eligibility Criteria:
Inclusion Criteria:

* Age from 18 to 40 years.
* Height between 150 to175 cm.
* Body mass index (BMI) between 18.5 and 30 kg/m2.
* American Society of Anesthesiology (ASA) physical status II.
* Scheduled for cesarean section under spinal anesthesia.

Exclusion Criteria:

* Pre-operation hypotension and bradycardia.
* Preeclampsia.
* Multiple pregnancy and macrosomia.
* Complete or partial failed spinal.
* Patients with skin infections at the site of injection.
* Patients with coagulation disorders.
* Patients with spinal deformities.
* Patients having regional nerve block other than spinal anesthesia.
The Role of Calcipotriol as Radioprotector of Skin

Examining the hypothesis that protecting keratinocytes by calcipotriol can prevent in-vivo cutaneous side effect in patients receiving radiotherapy to the breast.

To check the connection between the skin effect of radiotherapy and different parameters including diseases such as diabetes and lupus, use of medications, allergies, weight, habits, size of the irradiated breast, previous chemotherapy treatment and exposure to sunlight.

STUDY PROTOCOL

Fifty women diagnosed with breast cancer planned to receive adjuvant radiotherapy, will participate in the study. About 15 minutes after receiving the daily radiation dose fraction, a cream containing an active vitamin D analogue will be applied to half of the breast with inspection of a nurse. The other half of the breast will have a standard cream applied . During the days that radiotherapy is not administered the standard cream will be applied to both halves of the breast in a case of strong reaction to radiotherapy (e.g. strong erythema, painful tenderness etc.)The adverse skin effects will be assessed according to the following criteria:

1. . an assessment by a physician and a nurse according to the RTOG score (6).

   As follows:

   Grade 0 - no reaction. Grade 1 - light erythema dry peeling, decrease in sweat production. Grade 3 - extensive moist peeling, pitting edema. Grade 4 - ulcers, bleeding and necrosis.
2. . A questionnaire to each patient regarding the efficacy and safety of the cream.
3. . Number of interruption of radiotherapy treatment. The assessment will be done each week during radiotherapy treatment and weekly for three weeks following the completion of radiotherapy treatment.

Safety report will be sent to the local independent ethics committee after the examination of the first ten patients.

The protective effect of the cream containing calcipotriol will be compared to the standard treatment and analyzed statistically using the parameters mention above. The relation between the background disease, medications, allergies, weight, habits, size of the irradiated breast, sun exposure, previous chemotherapy treatment and exposure to sunlight and the skin reaction will be evaluated.

INCLUSION CRITERIA

1. . Age ranging from 18 to 75.
2. . Confirmed histological diagnosis of Breast cancer.
3. . Radiotherapy treatment to the breast following lumpectomy.

EXCLUSION CRITERIA

1. . Scleroderma.
2. . An extremely large breast. Interfiled above 25 cm.
3. . Prior radiotherapy to the same breast, radiotherapy to the contra lateral breast is not a contraindication.
4. . Mastectomy.

Eligibility Criteria:
Inclusion Criteria:

1. Age ranging from 18 to 75.
2. Confirmed histological diagnosis of Breast cancer.
3. Radiotherapy treatment to the breast following lumpectomy.

Exclusion Criteria:

1. Scleroderma.
2. An extremely large breast. Interfiled above 25 cm.
3. Prior radiotherapy to the same breast, radiotherapy to the contra lateral breast is not a contraindication.
4. Mastectomy.
Evaluation of the Efficacy and Tolerability of Treatment With Interleukin-2 in Severe and Resistant Alopecia Areata

Alopecia areata is an autoimmune disease associated with infiltration of cluster of differentiation 4(CD4 +) and cluster of differentiation 8 (CD8) + cells around the hair follicles. One of the therapeutic approaches of inflammatory diseases such as alopecia areata is the induction of tolerance. This tolerance induction can be obtained by stimulating regulatory T cells (Treg). The low-dose interleukin-2 plays a central role in the development, expansion, regulation and survival of regulatory T cells CD4 + cluster of differentiation 25 (CD25) + forkhead box protein 3 (FoxP3). Recently, recombinant interleukin 2 (IL2-R) with low dose showed very promising results in two inflammatory disease (GVHD vasculitis and cryoglobulinemia secondary to hepatitis C): clinical efficacy, increased population Treg in the blood and an excellent safety profile. We hypothesized that administration of IL2-R in patients with severe alopecia areata might allow regrowth via activation of Treg and thus induce regrowth of the air.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years, 60 ≤ years.
* Male or female
* Clinical diagnosis of alopecia areata,
* Severe alopecia areata (\> 50% of the surface of the scalp reached)
* Alopecia areata resistant to at least one systemic therapy: phototherapy (UVB or PUVA), methotrexate or corticosteroids
* Signature of the informed consent and authorization of the right image
* Effective contraception will be maintained for the duration of the study.
* Affiliation to the Social Security

Exclusion Criteria:

* Pregnancy or refusal of contraception in women of childbearing age,
* Refusal of contraception for men
* Local treatment (corticosteroids, minoxidil) or systemic (oral corticosteroids, methotrexate or other immunosuppressive agents) for less than 2 months,
* Cancer or autoimmune disease or in remission evolutionary
* Excessive alcohol intake (more than 3 glasses of wine a day or a drink per day)
* HIV, hepatitis C virus, hepatitis B virus
* Patient with renal and / or hepatic impairment,
* Patient with shingles, chickenpox, herpes, tuberculosis, an infectious disease scalable, respiratory failure ...
* Vulnerable person (anyone younger, adults under guardianship, deprived of liberty)
* Indication against treatment with IL2-R
* Presenting an indication against the Proleukin