cyrilzakka/clinical-trials huggingface dataset:
Ovarian Stimulation Using Recombinant Follicle-stimulating Hormone (FSH) and Gonadotrophin Releasing Hormone (GnRH) Agonist in Alternate Days

The present prospective study was designed to compare the effects of administering a daily dose of gonadotrophin releasing hormone (GnRH) antagonist vs. an alternate-day dosage of GnRH agonist on ovarian response and in vitro fertilization (IVF) outcome in patients stimulated with recombinant follicle-stimulating hormone (FSH) and human chorionic gonadotrophin (hCG) microdose.

Inclusion criteria were as follows: women of good physical and mental health, under 37 years old, with regular menstrual cycles of 25-35 days, normal basal FSH and luteinizing hormone (LH) levels, body mass index (BMI) less than 30 kg/m2, presence of both ovaries and intact uterus, absence of polycystic ovaries, endometriosis, or gynaecological / medical disorders and a negative result in a screening for sexually transmitted diseases.

No patient had received any hormone therapy for at least 60 days preceding the study. Eligible patients who agreed to participate were randomized in two treatment groups. Patients were allocated to a GnRH analogue treatment group according to a computer-generated randomization table.

Eligibility Criteria:
Inclusion Criteria:

* women of good physical and mental health
* under 37 years old, with regular menstrual cycles of 25-35 days
* normal basal FSH and LH levels
* BMI less than 30 kg/m2
* presence of both ovaries and intact uterus
* absence of polycystic ovaries
* endometriosis, or gynaecological / medical disorders and a negative result in a screening for sexually transmitted diseases
* all patients signed a written informed consent form
* no patient had received any hormone therapy for at least 60 days preceding the study.
Systemic Absorption of Dexamethasone Oral Rinse in Patients With Oral Lichen Planus

The objective of this study is to see the amount of systemic absorption of a standard dose of dexamethasone oral rinse for patients with symptomatic oral lichen planus (OLP) or oral lichenoid reactions (OLR) and healthy subjects (those who do not have OLP or OLR aka the control group).


Eligibility Criteria:
Inclusion Criteria:

1. Over 18 years old
2. Non-pregnant
3. Newly diagnosed subjects with OLP/OLR. Definition of 'newly" in this case : new patient with complaint regarding oral erosions and ulceration, and diagnose clinically with OLP or OLR for the first time
4. Those not exposed to topical or systemic corticosteroids for the previous 1 month. Meaning, those willing to not take this OLP/OLR treatment for 1 month before their visit
5. Experimental group is clinically diagnosed with OLP/OLR
6. Controls must have no history of OLP/OLR

Exclusion Criteria:

1 . Under 18 years old 2. Pregnant women 3. Recent history (\< than one month) of exposure to topical or systemic corticosteroids.

4. History of advanced kidney, liver disease, or systemic fungal infection. 5. Corticosteroids hypersensitivity. 6. Active oral candidiasis 7. Patients on blood thinners medication ,anemic or suffer from bleeding disorders
The Evaluation of Balance Control by Quantification of Temporospatial Measures While Forward and Side Reaching

Balance control is the sum action of the sense and reaction systems. In order to perform different activities in different postures one must have the ability to control and to adjust his balance in different conditions.A deficit in brain action following injury, disease or aging can undermine the ability to control balance and increase the risk to fall.The limitation in gait and mobility can increase morbidity. There is a limited number of tools evaluating and recording balance control ability. Most of this tools are observational and can be used in the clinical field. The aim of this work is to estimate the feasibility of an objective tool that can evaluate balance by tracking objective quantitative measures during the standard physical therapy session without using an expensive equipment. By using this tool the therapist can monitor the patient and collect quantitive data while performing tasks while keeping balance. This tool will allow the therapist to detect changes in balance and evaluate the effect of different conditions on the patients balance. This tool is based on the well known functional reach test. The addition of this tool to the test is the use of a simple camera and a computer softwear that will collect the data and analyze it while performing the test. This tool will give the therapist information on the responsiveness and the spatiotemporal measures of the performance. The aim of this work is to check what is the contribution of spatiotemporal measures of the functional reach test among patients suffering from acquired brain injury to the understanding of the motor function and balance control of people suffering from brain injury. .


Eligibility Criteria:
Inclusion Criteria:

* Acquired Brain Injury patients Can stand without assistance for at list 10 sec. Can walk 10m with or without walking aid Has no limitation in RPOM of the upper or lower limb need no guardian

Exclusion Criteria:

* Apraxia of all kind Aphasia Neglect
Deep Brain Stimulation Follow-up After 10 Years

The purpose of this study is to examine the long-term effect of Deep Brain Stimulation (DBS) for patients with Parkinson's Disease. We have data for patients operated with DBS since 1998. We wish to examine the effect of stimulation on motor symptoms as well as make a follow-up on complications and side-effects related to treatment. We also wish to follow-up on the quality of life-studies made in the years 2003-2008.

Parkinson's Disease (PD) is caused by a progressive loss of dopamine-producing cells in substantia nigra in mesencephalon.

PD is characterized by the symptoms resting tremor, rigidity and bradykinesia. Later in the course of the disease, patients develop gait- and balance symptoms. In the first years of the disease, the patients' symptoms are treated well with levodopa. As the disease develops and the loss of dopamine-producing cells grows, the physiological buffer-capacity for levodopa is lost and patients develop motor fluctuations in the shape of on-off symptoms and dyskinesias. Patients with these symptoms may benefit from implantation of electrodes in the subthalamic nucleus, which is stimulated by an pulse generator on the chest.

A number of studies have found a long-term effect of DBS, but most of these studies have a follow-up time of no more than five years. Overall, these studies show a beneficial effect of DBS after five years: The patients need less medication, the number of off-periods is decreased and they score lower on the Unified Parkinson Disease Rating Scale, part three. However, the axial symptoms and the bradykinesia progress.

As of yet, few studies examine the effect of Deep Brain Stimulation after 10 years. In our study we wish to examine the effect of DBS for all patients operated at Aarhus University Hospital in the years 1998-2002, which gives us a follow-up time of 10-14 years.

Eligibility Criteria:
Inclusion Criteria:

* Patients with Parkinson's Disease treated with DBS at Aarhus University Hospital in the years 1998-2002.

Exclusion Criteria:

* Dementia, i.e. MMSE\<24
* DBS removed
* Deceased
Psychosocial Treatment for Improving Chances of Survival in Women With Breast Cancer

This study will investigate the influence of psychosocial treatment on psychological outcomes and survival among women with metastatic or recurrent breast cancer.

The objective of this study is to investigate the influence of psychosocial treatment on psychological outcomes and survival among women with metastatic/recurrent breast cancer.

Eligibility Criteria:
Inclusion Criteria:

Women were eligible for the study if they had documented metastatic or recurrent breast cancer, were proficient enough in English to be able to complete questionnaires and participate in a support group, were living in the Greater San Francisco Bay Area, and had a Karnofsky score of at least 70%.19 Exclusion Criteria:

Women were excluded if they had any of the following risk factors: positive supraclavicular lymph nodes as the only metastatic lesion at the time of initial diagnosis; active non-breast cancers within the past 10 years; or other concurrent medical conditions likely to influence short-term survival. Basal cell or squamous cell carcinomas of the skin, in situ cancer of the cervix, or melanoma with a Breslow depth less than 0.76 mm were allowed.
Rituximab Trial for Pediatric Nephrotic Syndrome

Anti-CD20 agent has been proposed as a rescue therapy for refractory nephrotic syndrome(NS) on the basis of favorable clinical observations. Yet the long-term effect on maintaining remission or the likelihood of becoming rituximab-dependent is unclear and the information on the safety profile of rituximab is limited. This trial was designed to investigate the safety and efficacy of Rituximab in children with refractory NS.


Eligibility Criteria:
Inclusion Criteria:

(A)steroid/calcineurin inhibitor resistant nephrotic syndrome

1. steroid resistance: no remission after 4 weeks of daily oral corticosteroid (60mg/m2/day)
2. calcineurin inhibitor resistance: no remission after 3 months of therapeutic dose administration of cyclosporine and/or tacrolimus
3. no remission defined by persistent proteinuria of nephrotic range for the last 3 months
4. post-transplant patients were included in the study

(B)steroid-dependent nephrotic syndrome

1. Steroid-dependent patients who had been on various known medications (such as corticosteroids, cyclophosphamide, chlorambucil, calcineurin inhibitors, levamisole ..) continuously for more than 2 years
2. definition of dependency: more than two consecutive relapse events in 2 weeks after discontinuation of steroid or calcineurin inhibitor

   * no improvement in relapsing frequency with calcineurin inhibitor use
   * unable to continue with calcineurin inhibitor due to side effects
   * unable to continue with calcineurin inhibitor due to prolonged use (over 2 years)
   * other conditions in which the clinician considers difficult to control disease with steroids or calcineurin inhibitors only.

Exclusion Criteria:

* previous rituximab use
* secondary nephrotic syndrome
* estimated GFR \<60mL/min/1.73m2 or under 50% of age-matched standard GFR
* chronic or acute active infection (e.g. hepatitis B,C, herpes, varicella zoster)
* prior live vaccine inoculation within 1 month (from the study enrollment)
* cardiovascular diseases, pulmonary or pleural diseases
* uncontrolled hypertension
* leukocytopenia (absolute neutrophil count \<1500/mm3) or thrombocytopenia (\<75000/mm3)
* pregnancy
Perioperative Epidural Anesthesia and Analgesia on Gut Microbiota

As the only curative treatment for end-stage liver diseases, liver transplantation has been widely carried out around the world. The shortage of organs from deceased donors facilitate the adoption of living donor liver transplantation. Living donor hepatectomy is the most massive operation a healthy person could undergo, so donor safety is of utmost importance. However, previous studies focused on the outcomes of liver transplant recipients. There are still many uncertainties about the recovery in living liver donors.

The body microorganisms that reside in the human intestinal tract, referred to as the gut microbiota, are essential to human metabolism and immunity. The physiological functions of microbiota include defense against pathogens, providing nutrients such as vitamin B12 folate and vitamin K, and modulating gut integrity and permeability. Despite relatively stable microbiota during life, different illnesses, surgeries, medications dietary factors, and lifestyle changes could contribute to the imbalance of ecosystems resulting many gastrointestinal and extra-gastrointestinal disorders. Many researches have established a relationship between the gut microbiome and patients with liver disease such as liver cirrhosis, alcoholic liver disease and obesity related liver diseases etc. These liver disorders are associated with bacterial overgrowth, dysbiosis, and increased intestinal permeability. However, the relationship between hepatectomy and microbiota has not been fully investigated, especially in healthy liver donors.

Many routine perioperative management can impact the state of the microbiome and therefore can impact clinical outcomes, like bowel preparation and antibiotics. Potential factors affecting the gut microbiota also include perioperative manipulation, stress released hormones, and opioids. Maintenance of proper anesthetic depth is beneficial to attenuate surgical stress. However, general anesthesia including volatile anesthetics and opioids, is associated with altered gut microbiota. Therefore, regional anesthesia and analgesia which effectively attenuating surgical stress while efficiently reducing general anesthetics consumption, seem to provide promising advantages. Epidural analgesia has been proved to improve gastrointestinal function in major abdominal and thoracic surgery. However, the effect of perioperative epidural anesthesia and analgesia on microbiota is not clear.


Eligibility Criteria:
Inclusion Criteria:

1. Expected to receive living liver hepatectomy in National Taiwan University Hospital, age between 20 and 55 years old.

Exclusion Criteria:

1. Previous use of antibiotics within four weeks.
2. Previous gastrointestinal surgery.
Open Label Extension Study of Licarbazepine in the Treatment of Manic Episodes of Bipolar I Disorder

This extension study is designed to assess the long-tem tolerability and safety of licarbazepine in patients who completed the 6-week double-blind study CLIC477D2303.


Eligibility Criteria:
Inclusion Criteria:

* written informed consent provided prior to participation in the extension study
* successful completion of study CLIC477D2303
* cooperation and willingness to comply with all study requirements

Exclusion Criteria:

* premature discontinuation from study CLIC477D2303
* failure to comply with study CLIC477D2303
H-29 DELTA Multihole TT Study.

This study is aimed to provide a clinical and radiographic evaluation of 50 suitable subjects who underwent a complex primary or a revision Total Hip Arthroplasties with DELTA Multihole TT acetabular cup in 2019 onwards.


Eligibility Criteria:
Inclusion Criteria:

* Male or female subjects who underwent a Total Hip Arthroplasty with Delta Multihole TT acetabular cup, as per indications for use, in 2019 onwards
* Age ≥ 18 years old
* Subjects who have signed the written informed consent approved by the reference Ethics Committee (EC)
* Subjects able to comply with the protocol and to perform all scheduled follow-up visits

Exclusion Criteria:

* Male or female subjects who underwent a Total Hip Arthroplasty with Delta Multihole TT acetabular cup, but showed any of the contraindications reported in the Instruction for Use
* Age \< 18 years old
* Any clinically significant pathology based on clinical history that the Investigator feels may affect the study evaluation including, but not limited to:

  1. significant neurological or musculoskeletal disorders or disease that may adversely affect gait and compromise functional recovery.
  2. neuromuscular or neurosensory deficit which would limit the ability to assess the performance of the device.
  3. known metabolic disorders leading to progressive bone deterioration.
* Hip replacement on the contralateral side performed within less than one year.
* Female subjects who are pregnant, nursing or planning a pregnancy.
Effects of Homemade Oral Nutrition Supplements for Patients on Hemodialysis With Protein-energy Wasting

The goal of this clinical trial is to learn if homemade oral nutrition supplements works to treat protein energy wasting in patients on hemodialysis. It will also learn about the cost-effectiveness of homemade oral nutrition supplements. The main questions it aims to answer are:

* Does homemade oral nutrition supplements improve the nutritional status of patients on hemodialysis with protein energy wasting?
* What is the cost-effectiveness of homemade oral nutrition supplements?

Researchers will compare homemade oral nutrition supplements to commercial oral nutrition supplements to see if homemade oral nutrition supplements works to treat protein energy wasting in patients on hemodialysis.

Participants will:

* Take homemade or commercial oral nutrition supplements every day for 6 months
* Have assessment of nutritional status performed by researchers every three monthly


Eligibility Criteria:
Inclusion Criteria:

* on maintenance HD dialysis treatment (thrice weekly and 4-hour per session) for at least three months
* age 18 - 70 year old
* diagnosed with protein energy wasting using the malnutrition inflammation score (≥ 5)

Exclusion Criteria:

* a history of poor adherence to HD treatment (frequently miss the HD treatment for more than one session every month)
* a history of frequent hospitalization (more than once in the past one month)
* on regular oral nutrition supplements
* diagnosed with malignancy
* pregnant or lactating women
* allergic to study products such as soy milk or milk
Optimization of ITBS for Depression

Repetitive TMS (rTMS) is a well-established method for modulating brain activity. Through successive stimulations in the form of magnetic fields, it is possible to modify the sensitivity of neurons in the brain, also known as cortical excitability. Cortical excitability is important for the induction of brain plasticity, the ability of the brain to reorganize itself and form new connections in response to stimuli. A particular class of rTMS, intermittent theta burst TMS (iTBS), is commonly used to modulate cortical excitability and induce plasticity for therapeutic purposes, notably for treatment-resistant depression.

Different iTBS stimulation parameters can be used to induce plasticity. This study will focus on two parameters, namely, the form and duration of the electromagnetic stimulation. The shape of the electromagnetic pulse refers to how the electromagnetic wave is configured over time, while the duration is simply the period during which this electromagnetic pulse remains active. These parameters are expected to influence the effectiveness of iTBS in modulating cortical activity but remain little studied.

The main aim of this study will be to compare the effectiveness of different stimulation parameters in the induction of plasticity, which will then make it possible to improve the rTMS protocols used for treatment-resistant depression.


Eligibility Criteria:
Inclusion Criteria:

* Be between 18 and 35 years old
* Be of right manual dominance
* In good health

Exclusion Criteria:

* Have an implant or pacemaker,
* Having tinnitus,
* Have a history of fainting,
* Have already had an epileptic seizure or have a family history of epilepsy,
* Have a known neurological disease,
* Be under psychotropic medication,
* Have suffered from substance abuse or dependence in the last 6 months,
* Have a neurostimulator,
* Have a splinter or metallic implant in the head or the rest of the body,
* Have a cochlear implant,
* Have an automated injection system implanted (insulin pump),
* Have a transdermal patch,
* Have tattoos in the area to be studied,
* Be pregnant or breastfeeding,
The Effect of Reiki in Patients With Type-II Diabetes

Aim: To evaluate the effects of Reiki on subjective well-being, happiness, and some metabolic variables in patients with Type-II diabetes.

This study, designed as a randomized controlled trial with a pretest-posttest design, was conducted between September 2022 and August 2023 at the Internal Medicine clinic of Kanuni Sultan Süleyman Training and Research Hospital, Istanbul Provincial Health Directorate. The participants were voluntary individuals who had been diagnosed with Type-II Diabetes Mellitus at least 6 months prior, had a BMI ≥ 25kg/m² (overweight or obese), HbA1c ≥ 6.5%, were following a diabetes-specific diet or using oral antidiabetics, and were neither Reiki practitioners nor instructors. Randomization was used to assign participants to either the Reiki group or the control group. During the pretest, participants were asked to complete the Personal Information Form, the Subjective Well-Being Scale (SWS), and the OXFORD Happiness Scale (OHS). Pre-intervention fasting and postprandial blood glucose levels, HbA1c percentage, body mass index, LDL-HDL/total cholesterol, triglyceride levels, and blood pressure measurements were obtained from the patients' records and documented.The Reiki group received 20 minutes of remote Reiki once a day for 4 consecutive days, while no intervention was applied to the control group. The Subjective Well-Being Scale and OXFORD Happiness Scale were reapplied to both groups at the first and second months following the intervention, and the metabolic values, along with these scales, were measured again in the third month.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with Type-II Diabetes Mellitus at least 6 months prior
* Had a BMI ≥ 25kg/m² (overweight or obese)
* HbA1c ≥ 6.5%

Exclusion Criteria:

* Being diagnosed with another disease and needing treatment during the data collection process
* Being a Reiki practitioner or instructor
* Using insulin for treatment
Study for the Treatment of the Bone Marrow Edema:Core Decompression VS Bone Marrow Concentrate (BMC) VS Bone Substitute

Randomized, controlled, three-arm, double-blind study : control group, treated with core decompression technique VS subchondral plasty by injecting i-FactorTM VS injections of autologous BMC.

The clinical trial is a randomized, controlled, three-arm, double-blind study, involving up to 120 patients. Eligible subjects will be randomly allocated to one of the three treatment groups: control group, treated with core decompression technique, study group 1, treated with subchondral plasty by injecting i-FactorTM, and study group 2, treated by injections of autologous BMC.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female patients between 18 and 75 years;
2. Symptomatic subchondral bone marrow lesions of femoral condyles (grade ≥ 1 according to the WORMS MRI score);
3. Failure after at least two months of a conservative treatment;
4. Single BME areas involving a single compartment of the knee;
5. Availability of the patients to participate actively in the rehabilitation protocol and follow-up clinic and radiology;
6. Signature of informed consent.

Exclusion Criteria:

1. Patients incapable of discernment;
2. History of allergy to calcium phosphates;
3. Patients with malignancies;
4. Patients with rheumatic diseases;
5. Patients with diabetes;
6. Patients suffering of metabolic disorders of the thyroid;
7. Patients with history of abuse of alcohol, drugs or medication;
8. Patients with advanced osteoarthritis (Kellgren-Lawrence grade\> 3);
9. Body Mass Index\> 35;
10. BME that involve more than one compartment;
11. Patients with trauma in the 6 months prior to the intervention. -
Imaging Young Myeloma (IMAgerie JEune Myélome)

Multicenter open-label prospective comparative study of PET-scan and MRI at the time of diagnosis, after 3 cycles of induction therapy (RVD) and at the completion of therapy.


Eligibility Criteria:
Inclusion Criteria:

* symptomatic de novo multiple myeloma
* less than 65 years of age
* enrolled in the IFM/DFCI clinical trial

Exclusion Criteria:

* 66 years of age or more
* not eligible for high-dose therapy
* Cons-indications to MRI or PET-Scan