cyrilzakka/clinical-trials huggingface dataset:
Autologous Mesenchymal Stem Cell Transplant for Parkinson's Disease

This study is intended to look at the safety and efficacy of the use of autologous bone marrow derived stem cell transplant in patients with advanced Parkinson's disease.

Parkinson's disease, a neurodegenerative disorder, still at its best can only be controlled by medical or surgical treatment. For more than two decades various groups have tried using modified cell transplants for curing this disease. Earlier results with use of fetal mesencephalic cell transplant were encouraging, but this had to be discontinued due to severe side effects.

Current interest, in the use of Mesenchymal stem cells as a pluripotent cell for developing neural cells has been the background for this study. Reliance Life sciences had found encouraging results with the use of human MSCs in Rat model of PD. Based on this and other data, Jaslok Hospital and Research Centre has initiated a pilot study to investigate the efficacy of Autologous MSCs in treating advanced PD. This cells will be harvested from bone marrow, processed at RLS laboratory and transplanted by stereotactic techniques into the striatum of the patient.

Eligibility Criteria:
Inclusion Criteria

* Male or female between 35-70 years of age.
* Patient with current diagnosis of PD with motor complications (as confirmed by neurologist) as per the standard criteria and guidelines.
* Patients with at least 5 years since the disease.
* Responsiveness to Levodopa or dopa agonist. This is defined as improvement between Off and On UPDRS by at least 33% of the Motor UPDRS.
* PD of Stage 2.5, 3 \& 4 of HOEHN \& YAHR staging.
* Stable Parkinsonian medications for the 60 days prior to the surgical therapy.
* MRI not showing gross atrophy or any other pathology of brain.
* Patients with score less than 19 for the Montgomery-Asberg Rating Scale (MADRS) for Depression.
* NO Significant cognitive impairment.MMSE \> 24.
* The participant is able to comply with and understand the required visit schedule and all required tests and procedures.
* The participant (and/or LAR) must sign an informed consent.

Exclusion Criteria:

* History of intracranial surgeries or implantation of a device for Parkinson's disease two years prior to treatment.
* History of psychiatric disorders like schizophrenia or psychotic disorders.
* History of other malignancy, with the exception of treated cutaneous squamous cell or basal cell carcinoma, within 5 years.
* Contraindication for MRI
* General medical contraindications for surgery like coagulopathy
* Subjects with abnormal hematology and chemistry values, unless the out of range values are clinically significant with respect to general surgery.
* Severe skin infection or osteomyelitis at the site of bone marrow aspiration potentially limiting the procedure.
* Positive test results for HIV.
* History of drug or alcohol abuse
* Pregnant or nursing women
Safety and Immunogenicity of Personalized Genomic Vaccine and Tumor Treating Fields (TTFields) to Treat Glioblastoma

The purpose of this study is to use precision medicine in the form of a vaccine, a mutation-derived tumor antigen vaccine (MTA-based vaccine) in combination with standard care treatment of glioblastoma (GBM) and Tumor Treating Fields (TTFields).

The study is designed to determine whether this treatment combination is well tolerated and safe.

This is a single-arm, single institution phase 1a / 1b study to test the safety, tolerability, and immunogenicity of MTA-based personalized vaccine in patients with newly diagnosed GBM along with the use of continual TTFields. MTA-based personalized vaccine is prepared in the laboratory with several peptides based on each patient's own tumor sequence.

The vaccine is given after the radiation and chemotherapy portion of the treatment, in the maintenance phase of temozolomide in conjunction with the TTFields.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18
* Confirmation of GBM (WHO grade IV).
* Maximal debulking surgery and undergo radiotherapy concomitant with Temozolomide (45-70Gy)
* Stable disease after treatment of radiation with chemotherapy
* Life expectancy \> 16 weeks.
* Performance status of 0-2 (Eastern Cooperative Oncology Group).
* First vaccine treatment start date at least 4 weeks out but not more than 8 weeks from the last dose of concomitant Temozolomide or radiotherapy.
* Must have tumor tissue sufficient sequencing.
* Have adequate bone marrow function
* Require Dexamethasone ≤ 4mg daily on a stable dose
* Acceptable hematologic, hepatic, and renal function and these tests must be performed within 14 days prior to study
* The participant must be deemed competent to give informed consent.
* The participant must agree to use two effective forms of contraception beginning at least four (4) weeks prior to study entry.

Exclusion Criteria:

* Progression of disease at time of screening.
* Implanted pacemaker, programmable shunts, defibrillator, deep brain stimulator, other implanted electronic devices in the brain, or documented clinically significant arrhythmias.
* Infra-tentorial tumor or multifocal disease.
* History of hypersensitivity reaction to Temozolomide.
* Receiving any other investigational agents.
* Prior history of unrelated neoplastic disease, and having received systemic therapy for the secondary malignancy within the twelve (12) month period preceding the screening evaluation.
* (HIV/AIDS), Chronic hepatitis B or hepatitis C.
* History of, or is reasonably suspected to meet criteria for the diagnosis of a known congenital or acquired disorder causing systemic immunosuppression.
* History of, or is reasonably suspected to meet criteria for the diagnosis of a systemic auto-immune/inflammatory disease or other autoimmune disorder with the exception of: Vitiligo
* Positive pregnancy test \[45 CFR 46.203(b)\]. (CFR = Code of Federal Regulations)
OBDIPHY (OBesity DIgital-PHYsical Care Study)

This is a prospective randomized controlled multicentre non-inferiority trial. The aim of this study to evaluate digi-physical care compared to regular physical/in person care and investigate if digi-physical care can be an equal or even better treatment alternative among families with children or adolescents living with obesity in Sweden. The study participants will either get treatment as usual or treatment as usual combined with digi-physical solution. The digi-physical solution includes thar half of the session is digital and they get an app where they can self-monitoring health data, have an overview over they treatment plan and easy communicate with theirs caregivers.

This study is multi centre in three different county council in southwest of Sweden which include children and adolescents in the age of 10-16 year. The study participants will either get treatment as usual, which includes four in person session with healthcare professionals as doctor, nurse or dietitian (the control group) or treatment as usual combined with digi-physical solution (intervention group). The intervention group will beyond treatment as usual get a digital communication platform (including an app) where the patient has a good overview of their treatment plan, can report self-monitored health data as daily steps and weight once a week and monitor the daily work with their selected health goal. Everything in the app is individually tailored together with the patient. The patient with digi-physical care will also have assess to a chat for communication with their caregivers. The app has a high degree of authentication and classified as a journal system. Half of yearly treatment as usual sessions will be digital for the intervention group.

The digi-physical method of treatment is developed and based on the desire from the patient association HOBS (hälsa oberoende av storlek). In parts of Sweden people have long distance to the clinic which makes it difficult to be present at the treatment in-clinic sessions and the families loses many hours away from school and work. The null hypothesis is that digi-physical care will have a positive effect on BMI SDS, however inferior to treatment as usual.

In addition to evaluate that this new treatment alternative is safe will also ISO-BMI, weight development and metabolic risk factors be evaluated. The study does not include any extra blood samples or visits to the clinic thus everything is collected according to regular care programs. To evaluate the food intake and possible changes there will be three 24-h recalls, combined with riksmaten flex, performed. There will also be questions about their physical activity and a survey (PEDS-QL) for mental health. For a few volunteered patient families, approximate 15-20, will participate in semi-structured deep interviews.

Eligibility Criteria:
Inclusion Criteria:

* ISO-BMI 30 or above.

Exclusion Criteria:

* Lack of Swedish skills
* Patients potential for obesity surgery
* Patient with obesity syndrome
Topical or Oral Minoxidil for the Treatment of Endocrine Therapy-Induced Alopecia in Patients With Stage I-IV Breast Cancer

This early phase I trial studies the possible benefits and/or side effects of topical or oral minoxidil in treating endocrine therapy-induced hair loss (alopecia) in patients with stage I-IV breast cancer. Endocrine therapy-induced alopecia (EIA) is a distressing side effect that leads to reduced quality of life and early cessation of therapy in women undergoing treatment for breast cancer. Patients on endocrine therapy commonly report hair loss or thinning. Minoxidil is a drug that may promote hair growth and reduce hair loss. Oral minoxidil may increase hair density in women with EIA, and work the same as topical minoxidil in treating EIA in patients with breast cancer.

PRIMARY OBJECTIVES:

I. To evaluate the safety and tolerability of low-dose oral minoxidil in patients with breast cancer and EIA.

II. To obtain preliminary data to support whether low-dose oral minoxidil is a reasonable alternative to topical minoxidil in patients with EIA.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Patients apply minoxidil foam topically to affected areas of the scalp once daily (QD) for up to 12 months in the absence of disease progression or unacceptable toxicity.

ARM II: Patients receive minoxidil orally (PO) QD for up to 12 months in the absence of disease progression or unacceptable toxicity.

Eligibility Criteria:
Inclusion Criteria:

* Women \>= 18 years of age
* Established diagnosis of breast cancer stages I-IV
* On endocrine therapy including tamoxifen or aromatase inhibitors with or without concurrent use of ovarian function suppression
* Self-reporting hair loss since starting endocrine therapy

Exclusion Criteria:

* Pregnant or nursing women
* Current chemotherapy use or prior chemotherapy use within the last 2 years
* History of scarring/cicatricial alopecia or alopecia areata
* Prior use of oral or topical minoxidil
* Prior or ongoing use of spironolactone
* Known sensitivity to minoxidil
* Untreated hypothyroidism or iron deficiency as determined by thyroid stimulating hormone (TSH) with reflex free T4 and ferritin level \> 40 to be checked at the time of enrolling if not completed in the 12 months prior
Oral Dydrogesterone vs. Micronized Vaginal Progesterone for Luteal Phase Support in Frozen-thawed Embryo Transfer Cycles

The aim of this randomized controlled trial is to compare the efficacy of oral dydrogesterone vs. micronized vaginal progesterone for luteal phase support in frozen-thawed embryo transfer cycles.


Eligibility Criteria:
Inclusion Criteria:

* Ages between 20 and 40
* Modified natural frozen- thawed embryo transfer cycles

Exclusion Criteria:

* Recurrent implantation failure
* Recurrent pregnancy loss
* Presence of uterine pathology
A Study to Investigate the Influence of Hepatic Impairment on MK-8189 Treatment (MK-8189-012)

The purpose of this study is to compare the pharmacokinetics (PK) of MK-8189 in participants with moderate hepatic impairment (based on the Child-Pugh classification) to healthy participants. This is Part 1 of the study; following review of the safety and PK data from Part 1, a decision will be made as to whether Part 2 of the study will be initiated. If done, Part 2 of the study will compare the PK of MK-8189 in participants with mild hepatic impairment to healthy participants.


Eligibility Criteria:
Inclusion Criteria:

* Is a continuous non-smoker or moderate smoker (of fewer than 20 cigarettes/day or equivalent)
* Female participant is not pregnant or breastfeeding and is not woman of childbearing potential (WOCBP) or is a WOCBP using contraception or abstinent from heterosexual intercourse during the intervention period and for at least 14 days after the last dose of study intervention
* (For hepatically impaired participants) Has a diagnosis of chronic (\>6 months), stable (no acute episodes within the previous 2 months due to deterioration in hepatic function) hepatic impairment

Exclusion Criteria:

* Has a history of clinically significant endocrine, gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary or major neurological abnormalities or diseases
* Has a history of cancer; exceptions include (1) adequately treated non-melanomatous skin carcinoma or carcinoma in situ of the cervix, (2) other successfully treated malignancies
* Has a history of significant multiple and/or severe allergies or has had significant intolerability to prescription or non-prescription drugs or food
* Is positive for hepatitis B, hepatitis C or human immunodeficiency virus (HIV)
* Has had major surgery or lost 1 unit of blood within 4 weeks prior to prestudy visit
* Consumes greater than 3 glasses of alcoholic beverages per day
* Consumes greater than 6 servings (1 serving is \~120 mg of caffeine) caffeinated beverages per day
* (For hepatically impaired participants) Is taking medications to treat chronic medical conditions and has not been on a stable regimen for at least 1 month and/or is unable to withhold the use of the medications during study
Bacterial Epidemiology and Empirical Antibiotherapy in Patients With Prosthetic Joint Infection

The purpose of this study is to establish a bacterial epidemiology in patients who present a prosthetic joint infection and for which a surgery is necessary. At the time of the first surgery, as the bacteria responsible for the infection are not known, a probabilistic antibiotherapy is initiated at once after the surgical treatment. The antibiotherapy is then adapted to the bacteria from samples collected during the surgery when they are identified (the delay is 14-21 days).

The study will focus on bacteria identified on samples collected during the surgery; the delay between the implantation of the prosthesis and the presentation of symptoms will be considered : more than one year vs. less than one year.

Investigators assume that there is not the same type of bacteria involved in those two cases of delays and that the probabilistic antibiotherapy may be not optimal when the symptoms are presented more than one year after implantation of the prosthesis. A probabilistic antibiotherapy not adapted lead to develop resistance for the bacteria and decrease the chance to cure the patient (increasing of relapse).

The result of this study will allow medical doctors to have an optimal probabilistic antibiotherapy, depending on the delay between implantation of the prosthesis and the presentation of the symptoms.


Eligibility Criteria:
Inclusion Criteria:

* patient with prosthetic joint infection and treated with probabilistic antibiotherapy, between 2010 and 2015, at the Croix-Rousse Hospital

Exclusion Criteria:

* None
Effects of Legume Intake on Cardiovascular Risk Factors Among Adults at Risk for Diabetes

This randomized cross-over study was designed to investigate the effects of legume enriched diet consumption on cardiovascular risk factors among first degree relatives of diabetic patients.


Eligibility Criteria:
Inclusion Criteria:

* subjects aged more than 30 years
* no history of chronic diseases
* no use of blood glucose lowering drugs be wiling to participate to study

Exclusion Criteria:

* do not follow study protocol
* incidence of chronic diseases during the study
* to start use of blood glucose lowering drugs or to change dose and type of current medications
Use of a Vibrotactile Sensory Prosthesis in Patients With Postural Imbalance and Spatial Disorientation

The investigators propose to explore the hypothesis that vibrotactile channels for indicating spatial orientation can be exploited as a sensory prosthesis. The specific research applications will be used for guiding visual orientation, to provide alternative feedback to vision and vestibular signals for controlling balance, and for directional and lateralisation cueing in patients with neglect syndromes. The programme will study whether vibrotactile feedback improves performance and also if it speeds rehabilitation when used as an adjunct to conventional therapy.


Eligibility Criteria:
Inclusion Criteria:

* Sensory impairments
* Unsteadiness

Exclusion Criteria:

* High strokes
Effect of Rifampicin on the Pharmacokinetics of SHR6390 in Healthy Subjects

The primary objective of the study is to evaluate the effect of rifampicin on pharmacokinetics of healthy Chinese adult subjects after oral administration of SHR6390 tablets. The secondary objective of the study is to evaluate the safety of SHR6390 alone and when co-administered with rifampicin.


Eligibility Criteria:
Inclusion Criteria:

1. Sign the informed consent before the trial, and fully understand the trial content, process and possible adverse reactions;
2. Ability to complete the study as required by the protocol;
3. Healthy male or female subjects aged 18 to 45 (including 18 and 45) at the date of signing the informed consent;
4. Male body weight ≥ 50 kg, female body weight ≥ 45 kg, and body mass index (BMI) within the range of 19 \~ 26 kg /m2 (including 19 and 26);
5. Subjects shall ake effective contraceptive measures voluntarily within 3 months from the date of signing the informed consent form to the date of the last medication. Serum HCG test of fertile women before the study must be negative
6. Physical examination (vital signs, physical examination), routine laboratory examination (blood routine, blood biochemistry, urine routine, coagulation function), 12-lead electrocardiogram, orthotopic chest X-ray and abdominal B-ultrasound are normal or abnormal but have no clinical significance

Exclusion Criteria:

1. Allergic constitution;
2. History of drug use, or drug abuse screening positive;
3. Alcoholic or often drinkers;
4. Left ventricular ejection fraction (LVEF) \<50% by echocardiography;
5. A clear medical history of important primary organ diseases such as nervous system, cardiovascular system, urinary system, digestive system, respiratory system, metabolism and musculoskeletal system.
6. Abnormal clinical laboratory tests and clinical significance judged by the investigator or other clinical findings showing the following diseases, including but not limited to gastrointestinal tract, kidney, liver, nerve, blood, endocrine, tumor, lung, immune, mental or cardiovascular and cerebrovascular diseases.
7. Participated in blood donation with blood donation volume ≥400 mL or received blood transfusion within 3 months before screening.
8. Patients who have had any surgery and taken hepatotoxic drugs in the previous 6 months before screening.
9. Patients who use any vitamin product or herb 14 days prior to screening.
10. HCV positive, HIV antibody positive, HBsAg positive, syphilis antibody positive.
11. Subjects who are considered unfit to participate in the study by the investigator
Motivational Interviewing Inadequate Milk and Cortisol

Motivational interviewing is a technique used in many fields. No study has been found in national and international databases investigating the effect of motivational interviewing on the perception of insufficient milk, breastfeeding motivation and cortisol level. The study aimed to evaluate the effect of motivational interviews on the perception of insufficient milk, breastfeeding motivation and cortisol level.

Motivational interviewing; It is an evidence-based and client-centered approach that finds and eliminates the person's complex emotions, motivates, and increases the person's self-efficacy and motivation in the decision-making process. Breast milk is the only physiological baby food that contains the nutrients necessary for babies' absorption in appropriate quantity and quality. It is very important for the mother and baby's health that the mother starts breastfeeding her baby as early as possible and that the baby is fed only breast milk for the first six months. The perception of insufficient milk is defined as the mother thinking that she cannot produce milk or believing that there is too little milk in her breasts. The main reasons are; The mother's stay in the hospital longer than normal during the postpartum period, the mother's separation from her baby, and therefore the late establishment of the emotional bond between the mother and the baby may trigger the perception of insufficient milk. Cortisol is a glucocorticoid steroid hormone that is released in the human body during stress and whose release is regulated through the hypothalamic-pituitary adrenal (HPA) system. Stress and fear of birth cause insufficient milk secretion. Stress and fear in the mother can prevent early skin-to-skin contact between the mother and the baby by affecting the oxytocin hormone.

Eligibility Criteria:
Inclusion Criteria:

* Those aged 18 and over
* Those who feed their babies only with breast milk
* Do you believe that you produce enough milk to feed your baby?" in the Insufficient Milk Perception Scale. Those who answered "No" to the question
* Having given birth at 37\>gestational weeks
* Having a baby weighing at least 2500 grams
* Giving birth vaginally
* Primiparous

Exclusion Criteria:

* Cannot speak Turkish
* Mothers who did not agree to participate in the research