cyrilzakka/clinical-trials huggingface dataset:
Treatment of Dysmenorrhoea With the OVA TENS Apparatus

Dysmenorrhoea (menstrual pain) is a common complaint among women, leading to use of analgesics, reduced quality of life, and interference with daily activities such as going to work or school.

Transcutaneous electrical nerve stimulation (TENS) is a well established method for treatment of pain. Several clinical studies have shown TENS treatment to be effective against dysmenorrhoea. A TENS apparatus specifically developed for the treatment of dysmenorrhoea has now become commercially available (OVA), but is has not been tested in clinical studies.

This study will be done to evaluate the clinical utility of treatment with OVA in women with primary dysmenorrhoea.

Study aims: To compare perception of dysmenorrhoea with and without use of OVA.

Design: Prospective, clinical study lasting four months. The women will use the OVA apparatus during every other menstruation.

Inclusion: 20 female volunteers with primary dysmenorrhoea.

Exclusion: Pregnancy, either ongoing or planned during the study period. Secondary dysmenorrhoea.

Consent: The participants will receive verbal and written information and will sign a consent form.

Randomisation: The participants are randomised to start with either active treatment or observation by drawing a closed, opaque envelope containing the forms for registration of perception of pain.

Registering pain: The participants will mark their perceived degree of dysmenorrhoea daily on 10 cm visual analogue scale (VAS) during each menstruation.

Filling in forms: During each of the four menstruations throughout the study period the participants will respond daily to the questions on the form and note degree of pain on the VAS. At the end of each menstruation they will mail the current form in a stamped and addressed envelope to the study coordinator.

Statistics: We assume that a difference of 2 VAS-points is required for an effect to be of clinical interest. One-sided t-test for paired data will be used in the analysis.

Power calculation using the statistics program SSD v7.0 has shown that 16 participants is required to demonstrate a difference of 2 points at level of significance p=0.01, 90% power and assumed standard deviation of 2.

Eligibility Criteria:
Inclusion Criteria:

* Primary dysmenorrhoea

Exclusion Criteria:

* Pregnancy
Study of SIB-IMRT in Combination With 5-FU and Mitomycin-C Among Patients With Locally Advanced Anal Canal Cancer: Efficacy, Safety and Quality of Life

Anal canal carcinoma (ACC) represents 1.2% of digestive cancers. Its incidence is increasing. As epidermoid ACC (95% of ACC) are particularly sensitive to radio and chemotherapy, concomitant radio-chemotherapy is the standard treatment of locally advanced ACC, with proven efficacy on locoregional control, anal sphincter preservation, progression-free survival and complete response rate higher than 80%.

Nevertheless, conventional radiotherapy frequently induces significant non-haematological toxicities requiring treatment interruptions. Thus, treatment usually includes a chemotherapy (5-Fluorouracil and Mitomycine-C) and 25 fractions of 1.8 Gy followed by a planned 1-week (or more) interruption and a boost, for a total 54-60 Gy radiation dose over 9 weeks.

Considering the numerous anatomic pelvic structures, ACC has become a localisation of interest for Intensity-Modulated Radiation Therapy (IMRT) associated with less toxicity.

However, IMRT induces grade≥3 cutaneous toxicities requiring irradiation breaks. Dose escalade did not show its interest: 60 Grays remains the standard.

Assuming the deleterious effect of increased overall treatment time on local control and survival in head-and-neck and cervical cancers and the epidermoid histology of ACC, the benefit of no irradiation break on ACC tumour control is of interest.

IMRT offers the possibility to deliver different doses to different target volumes simultaneously by altered fractionation schedule like SIB-IMRT (simultaneously integrated boost-IMRT). Several SIB-IMRT schedules have been retrospectively evaluated. Similar results were observed with moderate doses and schedules delivering higher doses with short interruptions. Nevertheless, standard SIB-IMRT schedule in ACC still not exist.


Eligibility Criteria:
Inclusion Criteria:

* WHO performance status ≤ 2
* Age \> 18 years
* Epidermoid anal canal carcinoma histologically proven, locally advanced with an indication of radiation of pelvic and inguinal nodes concomitantly to chemotherapy
* The T corresponds to the larger dimension of tumor at the rectal examination and the N is assessed by imaging pelvic MRI-imaging, CT-scan, optionally PET-CT). Eligible tumors are: T2 more than 4 cm N0-N3, T2-T4 N1-N3 or usN1, T3-T4 N0, M0 according to the 6th edition of the American Joint Committee on cancer staging manual.
* Laboratory data obtained ≤ 14 days prior to registration on study, with adequate bone marrow, hepatic and renal function defined as follows: hemoglobinemia, neutrophil, platelet counts, bilirubin and creatinin level
* Informed consent form

Exclusion Criteria:

* Previous invasive cancer within 5 years except basocellular cancer and in situ cervical cancer
* Tumors with predominant skin involvement
* Presence of metastases
* History of pelvic irradiation
* Contraindication to radiotherapy or chemotherapy
* Known HIV positive patients
Evaluation of the Impact of an Individual Peer Support Intervention for Stroke Patients When Returning Home: a Mixed Methods Pilot Study

Going back home following a stroke is a key step for the patient and his or her relatives. Due to the brutality of stroke and increasingly shorter in-hospital lengths of stay, patients and their families must adapt quickly to the patient's new health functioning and the new caregiving and support role for family members.

Peer support could be an innovative and inexpensive approach to addressing these issues. Peer-helpers are patient-partners who put their experiential knowledge from life with the disease at the disposal of other patients to offer them social and emotional support in the management of the disease in connection with care, social and community structures. Group peer support programs face organizational challenges and fail to address the full range of patient needs for stroke home visits. Individualized and more flexible support could better meet the needs of patients. Our hypothesis is that individual peer support improves quality of life and patient empowerment during the discharge period compared to usual practice.


Eligibility Criteria:
Inclusion Criteria:

* Adult patient,
* Having had a first confirmed, ischemic or hemorrhagic stroke
* Managed in the participating rehabilitation center
* Whose discharge to home directly from the rehabilitation center is planned
* Presenting a modified Rankin score of 1 to 3 when deciding to leave the stroke center
* Having given its written consent
* Whose main residence is located in the Rhône department
* Aphasic patients may be included if a caregiver can follow up with the case manager

Exclusion Criteria:

* Patient living in an institution prior to stroke
* included in a gerontological network before stroke
* Patient unable to understand quality of life questionnaires
* Patient with unstable medical or psychological conditions who, in the opinion of the investigator, could lead the subject to be non-compliant or uncooperative during the study or could compromise patient safety or participation in the study
* Patient under guardianship or curatorship
* Patient not affiliated to a social health insurance
Effects of Manual Therapy and Respiratory Muscle Training on the Maximal Inspiratory Pressure in Patients With Asthma

The aim of this study is to assess if an intervention of manual therapy and motor control exercises combined with an inspiratory muscle training program is more effective than an inspiratory muscle training program alone in increasing the maximum inspiratory pressure in patients with asthma. In addition, the study pretends to evaluate the changes caused by the intervention regarding possible postural changes and thoracic diameter.


Eligibility Criteria:
Inclusion Criteria:

* Asthmatics subjects aged between 18 and 65 years

Exclusion Criteria:

* Were excluded participants who presented neurologic, psychiatric or cognitive pathologies which difficult the cooperation, inflammatory disease of the cervical spine and/or severe orthopedic problems that difficult the daily activities, history of thoracic surgery, vertebral fracture, abnormal thorax radiography, spinal and thoracic structured musculoskeletal disorders and to present any contraindication of treatment techniques (e.g. ostheophorosis). In case of exacerbation of asthma, missing more than one treatment session and/or to appear any contraindication to continue the treatment routine during the six weeks of the study the patient also were excluded.
Effect of Omacor on Triglycerides in HIV Infected Subjects

Omacor is likely to decrease lipid parameters in HIV infected subjects. In these subjects the lipid are decrease due to HAART treatment


Eligibility Criteria:
Inclusion Criteria:

* Triglycerides between 200 and 800
* diagnosed HIV infection
* following HAART therapy

Exclusion Criteria:

* other malignant disease
* not compliant
* allergy against fish oil
* soy or olive oil
Concurrent Treatment for Patients With Cervical Radiculopathy

This study evaluates the effectiveness of two treatment interventions in patients with cervical radiculopathy. One group will receive a concurrent approach using traction and neuromobilizations. The other group will receive the sequential approach of traction and neuromobilizations

Physical therapists routinely use cervical traction and manual therapy in patients with cervical radiculopathy. The standard of care is a sequential approach in which the patients receive interventions successively. This study will provide the standard of care approach for one group while the other group receives the concurrent approach in which the patient will have neuromobilizations while they are receiving mechanical traction. Both groups will also receive exercise and manual therapy to the cervical and thoracic spine.

Eligibility Criteria:
Inclusion criteria:

* Participants that test positive on at least 3 out of 4 special tests.
* Participants will score at least 10 on the Neck Disability Index
* Participants will score at least 2 on the numeric pain rating scale

Exclusion Criteria:

* Do not test positive on at least 3 of 4 special tests.
* Signs of cervical trauma
* Cervical myelopathy
* Active pregnancy
* Medical red flags (fracture, tumor, long term steroid use, rheumatoid arthritis, and osteoporosis)
* Evidence of vascular compromise
* Cervical spine surgery
* Recent injections in the past six weeks
Contingency Management for Smoking Cessation in Homeless Smokers

The purpose of this study is to examine the effectiveness of an internet-based contingency management program for smoking cessation in persons who are homeless. Thirty homeless smokers will be enrolled in the study. Participants will receive payment based on their own low carbon monoxide readings, which indicate being quit from smoking. Participants will be prescribed nicotine replacement (patches and either gum or lozenge)and bupropion. All participants will receive a four sessions of smoking cessation counseling, and will be trained to perform carbon monoxide monitoring with a device provided by the study. They will also be provided with a mobile phone equipped with a video camera, and will use this equipment at home to monitor their carbon monoxide . Participants will record videos of themselves taking a carbon monoxide reading and displaying the results, and will upload the videos to a secured website that is only accessible by the research team members and the participant. Payment will be based on providing carbon monoxide readings that indicate abstinence.

The study is designed to address the following aims:

Specific Aim 1: To evaluate whether it is feasible to use internet-based contingency management for helping smokers who are homeless stop smoking.

Specific Aim 2: To evaluate how effective internet-based contingency managementis on decreasing smoking in smokers who are homeless.


Eligibility Criteria:
Inclusion Criteria:

* must be a Veteran who is eligible for care within the VA system;
* must be currently homeless or have been homeless more than twice in the past year period;
* must have current smoking status of at least 10 cigarettes per day for at least 1 year (verified with breath carbon monoxidemeasurement);
* must be aged 18 to 70;
* must be English speaker

Exclusion Criteria:

* Pregnancy;
* Any substance use disorder in any of the following drug categories: opioids, cocaine, alcohol, sedatives, stimulants, hallucinogens, or drugs categorized as "other" per the Structured Clinical Interview for Diagnostic and Statistical Manual-IV.
* Urine drug screen results positive for cocaine, amphetamines, stimulants, opioids, or hallucinogens;
* Not stable on medications for the study period;
* Use of any other forms of nicotine such as cigars, pipes, or chewing tobacco;
* Participants may be excluded if they have a seizure disorder, uncontrolled diabetes or an eating disorder;
* Prior history of hepatitis or cirrhosis; current hepatitis or cirrhosis
* Score less than 80 on Kaufman Brief Intelligence Test
Rehabilitation Intervention to Prevent Adverse Events Related to Androgen-deprivation Therapy (ADT) in Patients With Metastatic Prostate Cancer (PCa): a Single Arm Feasibility Study (ReCaP Study)

This is a drug-free, single arm, single center, superiority, interventional study aimed at treatment feasibility.

The main aim of the current study is to assess feasibility of a tailored exercise program as measured by adherence to exercise program in metastatic PCa patients undergoing ADT.

Secondary aims are: to deepen the knowledge on other feasibility aspects (recruitment/retention), to monitor safety, to assess the effects in reducing the AEs of ADT (on loss of strength, loss of physical performance and fatigue, number of accidental falls and fractures), to monitor pain and the change in physical activity habits.

The rehabilitation intervention will be led by a Physiotherapist and will include: a 12 weeks standardized multicomponent exercise (aerobic, resistance, balance and flexibility, and impact exercise if indicated), supervised by the physiotherapist, on an outpatient basis or in telerehabilitation. This program will be adapted to single patient needs. Every exercise session will last almost 60 minutes and patients will be supervised twice a week. One more exercise session per week will be self-managed by patients.

At baseline a physiatrist will visit patients with bone metastasis and collect data on sites of bone metastasis, associated level of pain, and risk of pathological fractures. For all participants, the physiotherapist will assess muscle strength (Hand Grip Strength-HGS), physical performance (Short Physical Performance Battery-SPPB), level of fatigue (FACIT-F), and data collection on physical activity habits (International Physical Activity Questionnaire-IPAQ).

The enrollment will be closed after 1 year from the activation of the study or when the target of patients will be reached, whichever occurs firstly.

For each patient, data will be collected for 12 months. The duration of the study is expected to be around 2 years.

Follow-ups are scheduled at 12 weeks, 24 weeks and 12 months.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of prostatic adenocarcinoma;
* Metastatic disease candidate to ADT treatment and ADT free;
* ECOG PS 0-1.

Exclusion Criteria:

* Physical conditions that may limit adherence to the study (heart failure NYHA 3-4, pathologic fractures, previous disability limiting exercise, etc);
* Psychological/psychiatric conditions that may limit adherence to the study (moderate-severe cognitive impairment, psychiatric disorders, etc.)
* Other concomitant active malignancies
Safety and Effectiveness of Juvéderm® VOLUMA XC Injectable Gel for Cheek Augmentation

Multicenter, single-blind, randomized, "no-treatment" control study to demonstrate the safety and effectiveness of VOLUMA XC for deep injection for cheek augmentation to correct age-related volume deficit in the mid-face.


Eligibility Criteria:
Inclusion Criteria:

* Male or female, 35-65 years of age
* Zygomaticomalar region, anteromedial cheek, submalar region, and/or overall mid-facial volume deficit assessed by the Treating Investigator as grade 3, 4, or 5 on the photometric Mid-Face Volume Deficit Scale (MFVDS)
* Desire cheek augmentation to correct age-related volume deficit in the mid-face
* Accept the obligation not to receive any other facial procedures or treatments affecting facial volume deficit at any time during the study

Exclusion Criteria:

* Received (or is planning to receive) anti-coagulation, anti-platelet, or thrombolytic medications (e.g., warfarin), anti-inflammatory drugs \[oral/injectable corticosteroids or Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)\], or other substances known to increase coagulation time from 10 days pre- to 3 days post injection \[Study device injections may be delayed as necessary to accommodate this 10-day wash-out period.\]
* Have undergone facial plastic surgery (with the exception of rhinoplasty more than 2 years prior to enrollment), tissue grafting, or tissue augmentation with silicone, fat, or other permanent, or semi-permanent dermal fillers or be planning to undergo any of these procedures at any time during the study
* Have undergone temporary facial dermal filler injections with hyaluronic acid-based fillers within 12 months, porcine-based collagen fillers within 24 months, or neuromodulator injections, mesotherapy, or resurfacing within 6 months prior to entry in the study or be planning to undergo any of these procedures at any time during the study
* Have begun use of any new over-the-counter or prescription, oral or topical, anti-wrinkle products in the treatment area within 90 days prior to enrollment or be planning to begin use of such products at any time during the study.
* Have very thin skin in the mid-facial region, tendency to accumulate fluid in the lower eyelids, or large infraorbital fat pads
* Have mid-face volume deficit due to congenital defect, trauma, abnormalities in adipose tissue related to immune-mediated diseases such as generalized lipodystrophy, partial lipodystrophy, inherited disease, or HIV-related disease
* Have a history of anaphylaxis, multiple severe allergies, atopy, or allergy to lidocaine (or any amide-based anesthetic), hyaluronic acid products, or Streptococcal protein, or have plans to undergo desensitization therapy during the term of the study
* Have noticeable acne scarring, an active inflammation, infection, cancerous or pre-cancerous lesion, or unhealed wound or have undergone radiation treatment in the area to be treated
Clinical And Radiographic Evaluation Of Premixed Bio-ceramic MTA In Indirect Pulp Capping Of Young Permanent Molars

The present study aims to evaluate the clinical and radiographic success of premixed bio-ceramic MTA versus calcium hydroxide in indirect pulp capping of young permanent molars.

Researchers are still in search of an ideal material for pulp capping, and they evaluated numerous dental materials. For many decades, calcium hydroxide has been the 'gold standard' material for maintaining pulp vitality. Both clinically and histologically, it has been found to produce satisfactory results in indirect and direct pulp capping because it can stimulate the formation of tertiary dentine by the pulp and it has antimicrobial properties.

Due to the drawbacks of calcium hydroxide, several materials have been developed, such as NeoPUTTY which is premixed bio-ceramic Mineral Trioxide Aggregate (MTA) that triggers hydroxyapatite. Its firm, non-tacky consistency, wash-out resistance, and bioactivity make it a pediatric dentists' preferred material for every pulp need. It also delivers ready-to-use material for immediate placement with zero waste, saving cost and chair time.

Eligibility Criteria:
Inclusion Criteria:

* Patients who have young permanent molars with deep carious lesions.
* Restorable young permanent molars with no clinical symptoms of irreversible pulpitis.
* Permanent molars with no clinical or radiographic signs of pulp necrosis including swelling, fistula, pain on percussion,pathologic tooth mobility, thickening of the periodontal ligament space, radiolucency at the periapical area.

Exclusion Criteria:

* Medically compromised patients who have systemic disease.
* Uncooperative patients who refuse treatment
* Permanent molars that were previously restored
* Children whose parents or caregivers refuse to participate in the study.
Study Evaluating IMA-026 in Healthy Japanese Males

To assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of ascending, single subcutaneous or intravenous doses of IMA-026 in healthy Japanese male subjects


Eligibility Criteria:
Inclusion Criteria:

* Men ages 20 to 40 years, inclusive, at screening
* Body mass index (BMI) in the range of 17.6 to 26.4 kg/m2 and body weight \> 45 kg
* Healthy as determined by the investigator on the basis of medical history, physical examination, clinical laboratory test results, vitals signs, and 12 lead ECG.