cyrilzakka/clinical-trials huggingface dataset:
Efficacy of Pergoveris in Aged IVF Patients

To compare the efficacy between LH supplementation (Pergoveris) and non-LH supplementation (Follitropin alpha) in patients aged ≥ 35 years undergoing IVF treatment.

Study hypothesis: Pergoveris (LH supplementation) is better than follitropin alpha (non-LH supplementation) for ovarian stimulation in aged IVF patients.

A randomized controlled single center study.

Based on the difference of 19.1% in the clinical pregnancy rate between the two treatment groups, with and without LH supplementation, in a previous study, with 90% power and a 2-sided P-value of 0.05, the number of subjects required was 109 per group (total 218). The recruitment target was 120 subjects per group (total 240) to allow for dropouts.

Eligible subjects were randomized in blocks of 4 via a computer generated random number list to either the Pergoveris arm or the follitropin alpha arm.

Ovarian stimulation was performed by using GnRH antagonist protocol.

Follitropin alfa (recombinant FSH) was administered on day 2 or day 3 of the menstrual cycle. The first FSH dose was determined according to each individual patient, based on the process as follows:

* AFC ≤ 6: 300 IU/day
* AFC 7-15: 225 IU/day
* AFC ≥ 16: 150 IU/day

GnRH antagonist (Cetrotide, Merck-Serono) was administered on day 5 of FSH administration.

* Recombinant LH (in the form of Pergoveris) was supplemented from day 6 of FSH administration. Patients in the Pergoveris group would be administered a reduced dose of recombinant FSH (reduced by 150 IU/day) which was replaced with Pergoveris (150IU FSH + 75IU LH)/day.
* The Follitropin alpha group retained recombinant FSH. In both groups, if the number of developing follicles was inappropriate, the dose could be titrated depending on the physician's judgment.

Monitoring the follicular development was performed by vaginal ultrasound probe, quantifying LH, estradiol and progesterone, starting from day 5 of FSH, based on the current processes of the hospital.

OPU and embryo transfer: OPU was performed 36 hours after hCG administration. Embryos were transferred on day 2.

Luteal phase support: daily vaginal progesterone

Pregnancy testing and ultrasound: a pregnancy test was done 14 days after embryo transfer. Beta hCG \> 5mIU/ml was considered positive. Fetal ultrasound was performed 3 weeks after a positive pregnancy test to verify clinical pregnancy.

Eligibility Criteria:
Inclusion Criteria:

* age ≥ 35 years
* body mass index \<28 kg/m2
* had ≤ 3 previous IVF attempts
* receiving a GnRH-antagonist protocol
* agreement to participate in the study, and to disclose any medical events to the investigator. The subject must be willing and able to comply with the protocol requirements for the duration of the study.
* have given written informed consent with the understanding that the subject may withdraw consent at any time

Exclusion Criteria:

* participating in another interventional clinical trial
* PCOS or WHO group 1
* have uterine abnormalities
* have endocrine disorders such as hyperprolactinemia, thyroid disorders
Saphenous Nerve Block Versus Platelet Rich Plasma for Chronic Knee Osteoarthritis

Knee osteoarthritis, as a progressive disease is one of the most common causes of pain, motor disorder and disability in the elderly. By increasing age, the cartilage is eroded and endures degenerative changes due to physiological and biomechanical changes as well as metabolic effects and trauma . Non-surgical interventions for pain control of knee osteoarthritis include weight loss, exercise, changes in daily activities, physiotherapy, nonsteroidal anti-inflammatory drugs (NSAIDs) and analgesics .However ,the intra-articular injection is recently recommended by many studies such as corticosteroids, hyaluronic acid, Growth hormone, dextrose ,and platelet rich plasma.

Intra-articular injection of platelets are activated and undergo degranulation, releasing a range of growth factors, including transforming growth factor beta (TGF-β), platelet-derived growth factor (PDGF), insulin-like growth factor, vascular endothelial growth factors, epidermal growth factors and basic fibroblast growth factor 2. These growth factors are thought to activate a variety of signaling pathways, which promote healing of bone and soft tissue.Also,some minimally invasive therapeutic options have been effective in pain relieve in KA, such as ultrasound-guided saphenous nerve block .

The aim of this study is to compare the efficacy of ultrasound guided saphenous nerve block versus platelet rich plasma injection in the management of chronic pain in patients with knee OA. This study will be conducted to evaluate which modality is more effective.

Eligibility Criteria:
Inclusion Criteria:

* Patients who are not competent to understand the study protocol
* Radiographic evidence of OA of knee of 2nd degree.
* Chronic pain for at least 6 months prior to study entry (day 0).
* Pain relief not achieved with conservative therapies during the last 6 months

Exclusion Criteria:

* Patient refusal.
* Bleeding disorders.
* Coagulation disorders.
* Local skin infection
* Current other problem in the affected extremity .
* Psychiatric disorders affecting co-operation of the patient .
* Previous chronic opioid use.
* Intra articular knee injection within previous three months.
* History of traumatic arthropathy.
* History of neuropathic arthropathy.
* Allergy or hypersensitivity to any of the study medication.
* Any condition that could interfere with the interpretation of the outcome assessments.
* Pregnancy
* Lactating women.
* low back pain due to central cause.
Zambia Chlorhexidine Application Trial

This will be a cluster-randomized controlled trial to assess whether washing the umbilical cord with a disinfectant (4% chlorhexidine) helps to reduce neonatal deaths in Zambia when compared to the current standard of care, dry cord care.

The primary goals of the Zambia Chlorhexidine Application Trial (ZamCAT) are to assess whether daily 4% chlorhexidine cord cleansing is more effective than dry cord care for the prevention of neonatal deaths and omphalitis (umbilical cord infection) in Southern Province, Zambia. Secondary goals are to 1) compare where pregnant women plan to deliver and where they actually deliver, and 2) to describe the health services network available to pregnant and postpartum women in case of serious illness among the women and their newborn infants.

Clusters consisting of individual health centers and their respective catchment areas will be assigned to one of two arms. In the intervention clusters, mothers will apply 4% chlorhexidine to their infants daily until 3 days after the cord completely separates. Mothers in the control clusters will use dry cord care as per normal routine standard of care and in accordance with Zambia Ministry of Health policy.

In order to achieve the 4th Millennium Development Goal of reducing child mortality by two-thirds, simple, inexpensive, and scalable interventions are required. If the use of a 4% chlorhexidine umbilical cord wash effectively reduces neonatal mortality, this will be a low-cost intervention that can be easily translated from a research project into a program for countrywide implementation in Zambia. These results will also add to the limited evidence base about the effectiveness of interventions for reduction of neonatal mortality in sub-Saharan Africa.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant women in the 2nd or 3rd trimester
* Age 15 years and above
* Pregnant women who plan to stay in the study area (catchment area of the health facility) for delivery and one month post partum
* Willingness to provide cord care as per the protocol of their cluster
* Willingness to provide informed consent

Exclusion Criteria:

* Pregnant women who are not willing to provide cord care as per the protocol of their cluster
* Pregnant women who are not willing to provide informed consent
* Pregnant women in the 1st trimester
* Pregnant women under age 15 years
A Phase II Trial Neoadjuvant Paclitaxel and Cisplatin in Patients With Locally Advanced Head and Neck Cancer

The purpose of this clinical research study is to learn if a paclitaxel-cisplatin combination regimen given in the neoadjuvant setting is active in locally advanced head and neck cancer. the safety of this treatment will also be studied.


Eligibility Criteria:
Inclusion Criteria:

* Locally advanced, Stage II-IV (except M1), hand and neck cancer
* \> = 1 measurable lesion
* not been previously treated for head and neck cancer

Exclusion Criteria:

* history of another malignancy
* organ allografts
* pre-exiting neuropathy \> = CTC grade 2
Daily Target Guided Radiation Therapy Using the Calypso 4D Localization System in Patients Who Have Had a Prostatectomy for Prostate Cancer

This study will evaluate the daily use of a unique daily organ tracking system on target localization in patients treated with radiation therapy after radical prostatectomy for prostate cancer.

Improved coverage of the target volume with radiotherapy could result in improved cancer control rates and decreased coverage of surrounding structures potentially decreasing treatment toxicity.

This prospective study evaluates the clinical utility of a novel real-time localization system of the prostate bed during adjuvant or salvage radiotherapy after radical prostatectomy. This study will also determine positioning errors using daily cone-beam computed tomography in patients set up with the Calypso 4D Localization System. Subjects will have Beacon® Transponders implanted into the prostate bed. The Calypso 4D Localization System will localize the position of the prostate bed. Cone beam CT will be used daily to measure inter-transponder distance. The Calypso system will also track the prostate bed position in real time during the entire radiation treatment. The treatments will be adjusted as required to ensure accurate treatment of the clinical target volume. The time of, the number, and extent of adjustments will be recorded for analysis.

Daily cone-beam computed tomography images will also be retrospectively analyzed to assess for adequate target coverage. The analysis will be performed retrospectively through manual 3-D registration of the cone-beam CT dataset with the treatment planning CT scan. This information will determine the margins necessary for the PTV using the Calypso 4D Localization System and potentially may allow a reduction in the PTV volumes on future studies.

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed adenocarcinoma of the prostate initially managed with prostatectomy with a detectable PSA, positive surgical margins, or extra-prostatic extension.
* Ability to comply with study schedule
* Age 40 or older
* Zubrod PS 0 or 1 (appendix 1)
* Signed informed consent

Exclusion Criteria:

* Node positive or metastatic prostate cancer
* History of prior pelvic radiotherapy
* History of abdominoperineal resection
* History of inflammatory bowel disease or connective tissue disease
* History of bleeding disorder or any active anticoagulant or anti-platelet medication which cannot be discontinued safely for transponder placement.
* PT or INR outside normal range for institution
* Active implanted devices such as cardiac pacemakers and automatic defibrillators.
* Prosthetic implants in the pelvic region that contain metal or conductive materials (eg., an artificial hip).
* Patients with maximum anterior-posterior separation through the torso minus the height of the center of the prostate greater than 17 cm (technical reason for Calypso System, see appendix 5).
* History of HIV infection
Resistance Training in Lung Cancer Patients on Chemotherapy

The purpose of this study is to examine the effectiveness of a resistance training program on reducing systemic inflammation and improving chemotherapy completion in lung cancer patients being treated with curative intent chemotherapy.


Eligibility Criteria:
Inclusion Criteria:

* Histologically diagnosed with lung cancer
* Stage I, II, or III
* Eligible for chemotherapy with curative intent
* 21 years of age or older
* Approval to participate in study by treating oncologist or family physician

Exclusion Criteria:

* Unstable cardiac disease
* Untreated bone or brain metastases
Radiofrequency Ablation in Relieving Pain in Patients With Bones Metastases

RATIONALE: Radiofrequency ablation uses high-frequency electric current to kill tumor cells and may help to relieve pain caused by bone metastases.

PURPOSE: Phase II trial to study the effectiveness of radiofrequency ablation in relieving pain in patients who have bone metastases.

OBJECTIVES:

* Determine the efficacy of radiofrequency ablation, in terms of pain relief at 4 weeks, in patients with painful bone metastases.
* Determine the safety of this regimen in these patients.
* Compare the change in pain interference with daily life and analgesic use at 4 weeks vs baseline in patients treated with this regimen.
* Determine the time to recurrence of worst pain in patients treated with this regimen.

OUTLINE: This is a multicenter study.

Patients receive radiofrequency ablation (RFA) to targeted tumor(s) on day 0 (multiple tumors may receive ablation in multiple sessions). Patients who achieve a reduction in worst pain of at least 2 points within 4-8 weeks but experience recurring pain at the RFA site or are diagnosed with a new painful lesion within 4-24 weeks receive 1 additional treatment to the recurring or new site.

Pain (using the Brief Pain Inventory scale of 0-10), analgesic use, and quality of life are assessed at baseline, on day 1, weekly for 4 weeks, and then every 2 weeks for 20 weeks.

Patients are followed for 6 months beyond the last RFA treatment.

PROJECTED ACCRUAL: A maximum of 50 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically or cytologically confirmed bone metastases
* Pain refractory to non-opioid analgesic medication and radiotherapy OR
* Patient is considered a poor candidate for opioid analgesics or radiotherapy
* Initial worst pain score within the past 24 hours at least 4 on a scale of 0-10
* Tumors deemed accessible for radiofrequency ablation
* No evidence of impending fracture in weight-bearing bones (more than 50% loss of cortical bone)
* Tumors must be more than 1 cm from critical structures including:

  * Spinal cord, brain, or other critical nerve structures
  * Large abdominal vessel (e.g., aorta or inferior vena cava)
  * Bowel or bladder

PATIENT CHARACTERISTICS:

Age:

* 18 and over

Performance status:

* Not specified

Life expectancy:

* More than 2 months

Hematopoietic:

* Platelet count at least 75,000/mm3

Hepatic:

* INR less than 1.5

Renal:

* Not specified

Other:

* Not pregnant or nursing
* Negative pregnancy test

PRIOR CONCURRENT THERAPY:

Biologic therapy:

* Not specified

Chemotherapy:

* At least 3 weeks since prior chemotherapy

Endocrine therapy:

* Not specified

Radiotherapy:

* At least 3 weeks since prior radiotherapy

Surgery:

* Not specified

Other:

* At least 3 days since prior aspirin, ibuprofen, or other nonsteroidal anti-inflammatory drugs
* No concurrent anticoagulants
Impact on Quality of Life, Fatigue and Cognitive Function in Anti-angiogenesis in Patients With Metastatic Kidney Cancer

Longitudinal study nonrandomized, multicenter observational descriptive monitoring patients treated with anti-angiogenic for metastatic kidney cancer


Eligibility Criteria:
Inclusion Criteria:

* Patient (e) Age (e) over 18 years
* Kidney cancer metastatic or locally advanced
* Anti-angiogenic or targeted therapy (bevacizumab, sorafenib, sunitinib, temsirolimus, another molecule or developing or having obtained authorization in this indication) may be associated with interferon or combined together
* Proposed treatment in first line or second line
* Brain imaging not finding brain metastases
* Having signed the informed consent of study participation
* The patient may have received prior anti-angiogenic

Exclusion Criteria:

* Cancer of the kidney other than primitive
* Previous history of cancer other than kidney cancer in complete remission for less than 5 years
* Patients under 18 years
* Patients whose treatment is associated with chemotherapy
* disorders of cognitive functions to existing treatment delivery
* Pathology psychiatric evolutionary
* Refusal of participation
* Patient unable to respond to cognitive tests
* Drug use
* Heavy drinking (WHO criteria)
* History of stroke
* History of head trauma
* Brain metastases known
* MMS below normal compared to existing standards for age and socio-cultural
Reducing Patient Memory Recall in the Burning Mouth Patient Population

The goal of this study is to learn about burning mouth syndrome symptoms in real time in patients with burning mouth syndrome. The main questions it aims to answer are:

(1) To test the ability of a smartphone app to collect repeated observations of individual data to assess fluctuations in BMS symptoms (pain) at multiple points in the day as they happen; (2) To evaluate a panel of salivary biomarkers in patients with burning mouth syndrome (BMS) and to study their relationship with clinical variables. With a collaboration between Penn Dental Medicine and Wharton School of Business, our proposal aims to vastly improve the characterization of burning mouth syndrome through the use of a smartphone app and/or text-based notification.

Participants will attend 2 study visits where they will complete questionnaires and provide saliva samples and will respond to notifications/text message prompts on their smart phone 3 times a day for 12 weeks.

This is a prospective study with the aims: (1) To test the ability of a smartphone app to collect repeated observations of individual data to assess fluctuations in BMS symptoms (pain) at multiple points in the day as they happen; (2) To evaluate a panel of salivary biomarkers in patients with burning mouth syndrome (BMS) and to study their relationship with clinical variables.

Participants will attend 2 study visits. Visit 1 of the study will consist of screening during the baseline visit. It will include administration of questionnaires, informed consent, collection of salivary samples, helping to download the app and/or helping to set up the smartphone to receive text notifications, and assisting with the demonstration of taking surveys on smartphones.

Track Your Happiness app, a smartphone and/or text-based notification system to take surveys, will collect data on people's experiences across a random sample of the moments of their lives. Participants will receives notifications 3 times per day at random times, and will be prompted to answer questions related to the burning mouth, to exercise, and a random selection of non-clinical Track Your Happiness questions, e.g., "Are you interacting with anyone right now?" "How do you feel right now?" Participants will receive these notifications for 12 weeks.

The final study visit (visit 2) will take place 12 weeks after Visit 1. Visit 2 will consist of questionnaires and collection of salivary samples.

Eligibility Criteria:
Inclusion Criteria:

1. Individuals aged 18 years and older
2. Willing and able to provide informed consent
3. Have been diagnosed with BMS for at least three months by an Oral Medicine or other specialist
4. Willing to submit a saliva sample
5. Have continuous access to a smartphone

Exclusion criteria:

1. In the opinion of the investigator, is unable or unlikely to comply fully with the study requirements or procedures for any reason (e.g. cognitive or physical impairment)
2. Prior head and neck radiation and/or chemotherapy
3. Medications that modulate or suppress the inflammatory system
The Depth of Endotracheal Tube Insertion

Virtual experiment : comparing the new method with conventional method of determining the depth of endotracheal intubation.

Effective airway management is the primary concern of the anesthesiologist. The conventional method of determining the insertion length of the endotracheal tube, 21 cm for women and 23 cm for men, shows a high incidence of endobronchial intubations in the analyzed population.The aim of this study is form a new and safe practice habit by passing the endotracheal tube with the balloon just 2 cm below the vocal cords during intubation.

Eligibility Criteria:
Inclusion Criteria:

* Patients who are scheduled for elective surgery under general anesthesia

Exclusion Criteria:

* Patients with anatomical defects of the face, neck, or upper airway
* Patients at risk for pulmonary aspiration of gastric content
To Evaluate the Efficacy and the Safety of Monthly Versus Weekly Oral Risedronate With Vitamin D in Compliance, Improvement of Vitamin D and BMD in Korean Postmenopausal Osteoporotic Women

The purpose of this study is to evaluate the Efficacy and the Safety of Monthly(RisenexM group) versus Weekly Oral risedronate(Risenexsplus group) in Korean postmenopausal osteoporotic women(Phase IV)

The purpose of this study is to evaluate the Efficacy and the Safety of Monthly(RisenexM group) versus Weekly Oral risedronate(Risenexsplus group) with Vitamin D in compliance, improvement of vitaminD and BMD in Korean postmenopausal osteoporotic women(Phase IV)

Eligibility Criteria:
Inclusion Criteria:

1. Female osteoporosis patients over 19years of age(with menopause).

   Definition of osteporosis
   * They had a BMD T-score -2.5 or less at mean Lumbar spine(L1\~L4), Femoral neck or total. Or evidence of at least one vertebral fracture.

   Definition of menopause(can be one of three condition)
   * For 12months spontaneous amenorrhea
   * For 6months spontaneous amenorrhea with serum FSH(Follicle stimulating hormone) is 40 mlIU/mL and over
   * 6weeks after bilateral ovariectomy whether hysterectomy of not
2. Patients who can be treated with oral bisphosphonate drugs
3. Patients who have adequate to be measured DXA(Dual energy x-ray absorptiometry)
4. Patients who made a voluntary agreement after explanation of this study
5. Patients who participated in clinical trial(HL_RSNP_401) must have taken the Risenexplus and finish the study for 12 months.

Exclusion Criteria:

1. Patients with esophagus disorder.
2. Patients administered with osteoprosis therapy(except calcium,Vit.D medication) within previous 3 months
3. Patients with serum calcium concentrations 8.0mg/dL under.
4. Patients with severe nephropathy(serum creatinine\> doulble of normal level
5. Patients with unable to sit upright or stand 30minutes.
Art'Health: Effects of Artistic and Participative Workshops at the MAMAC of Nice on the Health of Seniors

Study with two arms, one of which receives an intervention in the form of participative artistic workshops at the MAMAC and the other was assigned as the control group. Well-being, Quality of life, Health, Apathy and Olfactory identification scales are proposed before the intervention, during the intervention at the end of each month (M1, M2, M3), 6 months after the end of the intervention (M9) and 12 months after the end of the intervention (M15).


Eligibility Criteria:
Inclusion Criteria:

1. Be 65 years of age at the time of signing the consent,
2. Having internet access and an electronic tool (smartphone and/or tablet) at home as repeated assessments will be proposed on a dedicated and secure internet platform,
3. To master the French language,
4. To be available during participatory workshop sessions at MAMAC.
5. Be affiliated to Social Security

Exclusion Criteria:

1. Do not master the French language,
2. Severe sensory and/or cognitive impairment identified by the IP and their representatives during the inclusion interview,
3. Person under guardianship, curatorship or safeguarding of justice,
4. Person unable to give or sign consent.