cyrilzakka/clinical-trials huggingface dataset:
Validation Study of Posturology Platforms for Evaluating Postural Control of Hemiparetic and Neuro-muscular Patients

The instrumental evaluation of standing postural control by posturographic analysis supplements the clinical evaluation and, as such, is recommended by the French National Authority for Health (HAS 2007). The quantitative data obtained after a standardized postural examination appear relevant for the longitudinal follow-up of neuromuscular patients and hemiparetic patients. Neuro muscular (NM) diseases are progressive, these instrumental evaluations can highlight a deterioration or stabilization of postural control possibly not observable with the scores on clinical scales.

The K-Force Plates, recently developed appear to be an interesting alternative to the stabilometry platforms currently used. Static and dynamic conditions in upright position are tested. Moreover, posturologic, kinematics data and clinical scores are correlated to increase understanding of strategies during postural control tasks in patients with stroke and in patients with NM disorders.

To date, no clinical validation study of these K-Force Plates force platforms has been proposed. The investigator hypothesize that the data obtained by the Plates are comparable to the measurements made by the reference tool, the AMTI platforms during a static and dynamic posturographic examination in MNM, hemiparetic and healthy subjects. The strategies of the patients (stroke and NM) during the dynamic task are also explored with kinematic analysis in correlation with data from force platforms and clinical scores.

Eligibility Criteria:
"Eligible couples must present all the following criteria :

* Signing of the informed consent form
* Men and women aged from 18
* Single stroke hemiparetic patient, or patient with neuro-muscular disease, or healthy subject free of neurological disorder and other disease
* Patient able to stand alone at least 30 seconds without technical assistance (multiple repetitions)

To be included, patient should not present any of the following criteria :

* Bilateral brain injury, cerebellar syndrome
* Other disease or defect that may interfere with the study such as visual, vestibular or other related uncontrolled medical condition
* Major cognitive impairment that does not allow evaluation
* Pregnant women, breastfeeding
* Non affiliated to a social security scheme"
Botswana Tenofovir Oral HIV Prophylaxis Trial

This study will test whether taking a pill of tenofovir (an antiretroviral medicine) is safe for sexually-active young adults in Botswana without HIV infection and whether it will reduce their risk of getting an HIV infection.

Twelve hundred healthy, sexually active women and men, 18-29 years old, without HIV infection will be enrolled in Francistown and Gaborone, Botswana. They will be provided with free male and female condoms, repeated individualized risk-reduction counseling, diagnosis and treatment of sexually transmitted diseases, and women will be provided with a choice of effective family planning methods. In addition, volunteers will be randomized to receive either Tenofovir or a placebo pill to take once a day. Volunteers will be seen monthly for at least 12 months to monitor for side effects and toxicities and to test their HIV status. Persons who become HIV infected during the trial will receive ongoing supportive counseling, CD4 and viral load monitoring, education about HIV infection/disease, and access to HIV care including free antiretrovirals when clinically indicated. Volunteer safety will be monitored by a local ethics committee, Centers for Disease Control Institutional Review Board (CDC IRB) and an independent data safety and monitoring board.

Eligibility Criteria:
Inclusion Criteria:

* citizen of Botswana 18-29 years old
* sexually active
* HIV uninfected
* Hepatitis B and C uninfected
* Calculated creatinine clearance \>= 60 mL/min
* hemoglobin \>= 8 gm/dL
* ALT and AST \<= 2x ULN
* total bilirubin \<= 1.5 mg/dL
* total serum amylase \<= 1.5x ULN
* Serum phosphorus \>= 2.2 mg/dL
* willing to use effective contraception
* living within 1 hours travel of study clinic
* pass comprehension test
* willing and able to give informed consent

Exclusion Criteria:

* history of significant renal or bone disease
* any chronic illness requiring ongoing prescription medication
* pregnant or breastfeeding
* planning to move away from site in the next year
* participating in another HIV prevention or vaccine safety trial
* any other clinical condition or prior therapy that, in the opinion of the study physician, would make the volunteer unsuitable for the study or unable to comply with the dosing requirements
Immunologic Response to Secukinumab in Plaque Psoriasis

This is a single-arm, open-label study, which will examine the effect of secukinumab on the immunologic and genetic environment within psoriatic lesions.

Quantitative analysis of the immunologic changes in immune cell populations will be performed after secukinumab treatment in 15 patients at weeks 2, 4, and 12 compared to baseline week 0. The immunologic profiles in psoriasis patients will also be compared to healthy control skin surgical discard specimens (n=10). The number of differentially expressed genes in each cell population will be quantified by RNA-seq at weeks 2, 4, 12 after secukinumab compared to baseline.

Eligibility Criteria:
Inclusion Criteria:

1. Ability to provide written informed consent and comply with the protocol.
2. At least 18 years of age.
3. Diagnosis of predominately plaque psoriasis for at least 6 months prior to enrollment.
4. Subject is considered a candidate for phototherapy or systemic therapy
5. PASI ≥ 12
6. PGA ≥ 3
7. Subject has a negative Quantiferon Gold, or if positive undergoes CXR. If CXR negative, subject initiated prophylactic therapy with isoniazid for a course of 9 months with one month of therapy completed prior to first dose of secukinumab.
8. Subject is unlikely to conceive (male, post-menopausal, or using adequate oral contraceptive therapy or IUD).
9. Physical exam within clinically acceptable limits.

Exclusion Criteria:

1. Subject is unable to provide written informed consent or comply with the protocol.
2. Subject is younger than 18 years of age.
3. Subject has predominately non-plaque form of psoriasis.
4. Subject with mild psoriasis (PASI\<12 and PGA\<3) or is not a candidate for phototherapy or systemic treatments.
5. Subject has drug-induced psoriasis.
6. Subject with current, or a history of, severe psoriatic arthritis well controlled on current therapy.
7. Subjects with a serum creatinine level exceeding 176.8 μmol/L (2.0 mg/dl).
8. Screening total white blood cell (WBC count) \< 2,500/μl, platelets \< 100,000/μl, neutrophils \< 1,500/μl, or hemoglobin \<8.5 g/dl.
9. Evidence of active tuberculosis infection as defined by a positive QuantiFERON TB-Gold test (QFT) with a positive chest X-ray at screening, or untreated latent tuberculosis defined by positive QFT with a negative chest X-ray without prophylactic therapy with isoniazid for a course of 9 months with one month of therapy completed prior to first dose of secukinumab.
10. History of an ongoing, chronic or recurrent infectious disease including past medical history record of HIV, hepatitis B or hepatitis C.
11. Subjects possess other diagnoses that, in the investigator's opinion, preclude him/her from safely participating in this study or interfere with the evaluation of the subject's psoriasis.
12. History of known or suspected intolerance to any of the ingredients of the investigational study product.
Evaluation of Choroidal Thickness During Pregnancy Using Enhanced Depth Imaging Optical Coherence Tomography

The purpose of this study is to evaluate choroidal thickness and volume during the third trimester of pregnancy by comparison with a group of age-matched non-pregnant healthy group of women

Pregnant women in the last trimester and age-matched healthy controls have an Optical Coherence Tomography (OCT) image taken on the OCT Spectralis® device.

A map of the choroid in the macular area is constructed automatically. Choroidal thickness and volume are calculated for the 9 subfields defined by the Early Treatment Diabetic Retinopathy Study (ETDRS).

A comparative analysis between the two groups will be performed. As a secondary outcome measure, the change in choroidal thickness of the pregnant group of women will be assessed at 6 months postpartum by comparison to the 3rd trimester of pregnancy.

The OCT is a non-invasive examination that poses no risk to the mother or the fetus.

Eligibility Criteria:
Inclusion Criteria:

Pregnant women:

* uncomplicated pregnancy in the third trimester (from 28 weeks of gestation)

For both groups:

* no systemic or ocular disease
* absence of systemic medication other than prenatal vitamins
* no smoking habits
* emmetropia or a small refractive error (spherical equivalent \<1.5 diopters)

Exclusion Criteria:

* any of the above
Maggot Debridement Therapy Versus Conventional Dressing Therapy to Treat Diabetic Foot Ulcers

This is a prospective study of participants with diabetic foot ulcers who will receive either maggot debridement therapy (MDT) or conventional dressing therapy (CDT). Wound healing time is the main outcome measure to compare the clinical efficacy of these two therapies. The investigators developed a hypothesis that MDT could achieve remarkable shorter time and better healing rate for wound closure when compared with CDT.

The investigators designed a prospective randomized study to compare the clinical safety and efficacy of maggot debridement therapy (MDT) and conventional dressing therapy (CDT). This study is scheduled from July 2016 to February 2017. Patients, aged from 18-80, who suffered from type 2 diabetic mellitus foot ulcers with Grade 1 or Grade 2 according to the Wagner classification could be the participants of this study. A sample of 138 participants was calculated based on the morbidity of diabetic foot ulcers, accounting for estimated 10% attrition rate. The glycemic control is important for the validity of study results. A specific team of endocrine doctors will manage the blood glucose of participants of two groups within the range of 7-10 mmol/L.

Participants will be allocated into MDT group and CDT group randomly according to the random number table. For MDT-participants, bio-bags containing sterilized, live, medicinal Lucilia sericata larvae will be placed on the wound of ulcers. For CDT-participants, conventional dressing (disinfected by iodophor, dressed by gauze ) will be performed ordinally. Every 3 days the procedures of two groups will be performed and wounds assessment will be done until the wounds closure is achieved. The wounds assessment, including measurement of the area of wound surface and bacterial culture, will be performed by a specific team of microsurgical doctors. The outcome measures include wound healing time (days) and the time negative bacterial culture occurs (days). The secondary outcome measures include the area of wound surface (cm2), treatment related pain, comfort of the dressing and adverse events.

Eligibility Criteria:
Inclusion Criteria:

1. Participants aged from 18-80 years old.
2. Participants with type 2 diabetes mellitus longer than one year, foot ulcer longer than three weeks and with ischemic symptoms of lower limb.
3. The ulcer erosion depth is not reached and muscle layer.
4. The Wagner classification of ulcers should be Grade 1 or Grade 2.
5. Blood glucose control: Fasting blood glucose ≤ 8mmol / L; Postprandial blood glucose two hours ≤ 11.1 mmol / L.
6. Participants do not receive ulcer wound management in the past three days when recruited.
7. Participants with neuropathy symptoms, such as limb numbness, tingling or pain, especially pain at night.

Exclusion Criteria:

1. Participants with acute thrombosis that required thrombolysis or thrombectomy.
2. Participants with severe systemic infection.
3. Participants who are sensitive to pain.
4. Participants with bone/joint deformities of foot (eagle claw toes, hammer toes)
Fast Food Photo Study

The investigators aim to discover if people of different demographic levels are more or less attentive to changes in calorie information vs. changes in price information on a restaurant menu. The investigators will record whether the calorie/price change was noticed or not, as well as how quickly the calorie/price change was noticed, depending on condition and individual differences.

Participants complete a short study regarding their ability to detect "mistakes" in a printed version of a fast food restaurant menu. We ask participants to identify the differences between the menu board and a typical menu board at that location. Individuals list the differences that they find and have a chance to win a prize if they identify the most mistakes among participants recruited that day. The differences created will remain constant (e.g., featuring Pepsi products instead of the typical Coca-Cola offerings, including items from other restaurants on the menu), including changes to calorie labels and price labels. Additionally, we recruit participants in a variety of locations to test for differences between demographics (e.g., income groups, education levels, and BMI levels).

Eligibility Criteria:
Inclusion Criteria:

* Age 18 or older
* Speaks English
* Willing to complete both task and follow-up survey

Exclusion Criteria:

* N/A
TCD Followed by autoSCT for Newly Diagnosed MM Patients

Multiple Myeloma is a incurable disease. Thalidomide in combination with other agents are currently in trials for the newly diagnosed patients, we designed treatment of TCD, followed by high dose chemotherapy with autologous stem cell transplantation and TD maintenance therapy for the patients with newly diagnosed multiple myeloma.

Phase II clinical trial for the patients with newly diagnosed. TCD (thalidomide, cyclophosphamide and dexamethasone) will be applied for the patients as an induction chemotherapy, followed by high dose chemotherpy and autologous stem cell transplantation. Afterthen, they will receive TD (thalidomide and dexamethasone) maintenance therapy for one year.

Eligibility Criteria:
Inclusion Criteria:Newly diagnosed multiple myeloma in aged between 18 and 75 years old with following mesurable leisons: (serum M-protein ≥ 1 g/dL or urine M-protein ≥ 400 mg/day) -

Exclusion Criteria:

- 1. Smoldering or indolent myeloma 2. ECOG performance status \> 3 point 3. Known hypersensitivity to cyclphosphamide, thalidomide or dexamethasone 4. Peripheral neuropathy or neuropathic pain Grade 2 or higher as defined by NCI CTCAE version 3 5. Uncontrolled or severe cardiovascular disease, including MI within 6 months of enrolment, New York Heart Association (NYHA) Class III or IV heart failure, uncontrolled angina, clinically significant pericardial disease, or cardiac amyloidosis, cardiac ejection fraction \<0.5 : Severe conduction disorder : Hypotension (sitting systolic BP ≤ 100 mmHg and/or sitting diastolic BP ≤ 60 mmHg 6. Impaired hepatic function (AST or ALT ≥ x 3 upper normal, T-bilirubin ≥ x 2 upper normal) 7. Creatinine cliearance \< 20 ml/min 8. Corrected serum calcium ≥ 14 mg/dL 9. Sepsis or current active infection 10. Pregnancy or breast feeding 11. Uncontrolled Diabetes Mellitus 12. Previous history of Recurrent DVT or pulmonary embolism 13. Active ulcers detected by gastroscopy 14. Serious medical or psychiatric illness likely to interfere with participation in this clinical study.

15. Receipt of extensive radiation therapy within 4 weeks
Effectiveness of a Socio-Community Health Intervention on Pre-Frailty in Older Adults

The objective of this study is: To evaluate the effectiveness of a health intervention with a socio-community approach on frailty in older adults with pre-frailty.

Specific Objectives:

To characterize the study population according to sociodemographic and clinical variables.

To evaluate the effect of the intervention on the functionality domain at 3 and 6 months.

To evaluate the effect of the intervention on the cognitive-emotional domain at 3 and 6 months.

To evaluate the effect of the intervention on the socio-community domain at 3 and 6 months.

To evaluate the effect of the intervention on frailty in older adults. To determine the proportion of participants hospitalized during the study period.

To determine the proportion of participants who visited the emergency room during the study period.

To determine the proportion of participants in long-term care facilities. To determine the proportion of adverse events associated with the intervention.

Study Hypothesis

The mean frailty score pre-intervention is equal to the mean frailty score post-intervention.

The mean frailty score pre-intervention is different from the mean frailty score post-intervention.


Eligibility Criteria:
Inclusion Criteria:

* Individuals ≥ 60 years old classified as pre-frail in the last 3 months and documented in their medical history.
* Individuals who meet the requirements and provide voluntary informed consent for their participation.
* Individuals available to remain in Bogotá D.C. during the study period.

Exclusion Criteria:

* Individuals receiving care at community-focused medical centers.
* Individuals attending community dining programs, physical activity programs, community groups, care blocks, volunteering, or other related activities.
* Individuals who have experienced falls in the last 6 months with clinical consequences (hospitalization, fractures, traumatic brain injury).
* Individuals with a clinical history of moderate cognitive impairment, neurodegenerative diseases (e.g., Parkinson's disease), and/or neuro-musculoskeletal disorders, active cancer, end-stage renal disease, unstable ischemic heart disease, uncontrolled arrhythmias, severe aortic stenosis, uncontrolled hypertension (\>180/100 mmHg), or advanced heart failure, exacerbation of chronic diseases (COPD, heart failure), unrehabilitated severe hearing loss, deafness, or blindness with communication limitations.
* Acute conditions requiring hospitalization, such as acute myocardial infarction or urinary tract infections.
* Bone fractures in the last 3 months.
* Individuals unable to follow instructions or with behavioral changes that hinder their participation in the study.
* Individuals with severe psychiatric illness that, in the physician's judgment, prevents proper adherence to the study intervention.
* Institutionalized individuals in long-term care facilities.
Comparison of the Effects of Core Stabilization and Resistance Exercises in Latin Dancers

With our study, we aim to contribute to the literature by determining the effects of core stabilization and resistance exercise applications on muscle strength, endurance, balance, flexibility and performance in latin dancers. It is also aimed to raise awareness of the necessity of an exercise program in order to improve physical fitness parameters in addition to dance training in dancers. Considering the physiological demands of dance and dancer, it is necessary to develop a dance-specific approach by blending physical condition and art. Our study aims to contribute in this context.

Within the scope of our study, the voluntary participation of 36 Latin dancers was planned. Dancers will be randomly divided into two groups, core stabilization exercises in one group and resistance exercises in the other group. An evaluation form developed by the researchers will be used as a data collection tool in the research. Before starting the study, a form containing demographic data (gender, age, height, weight, educational status) and medical history (chronic illness, previous injury, eating disorder) of the participants will be filled. Before starting the training, sit and stand test will be applied to evaluate the lower extremity muscle strength to evaluate the physical fitness parameters of the dancers, the plank test to evaluate the endurance, the Y balance test to evaluate the balance, the sit and reach test to evaluate the flexibility and the squat jump test to evaluate the performance. After the evaluation process, an exercise program for 6 weeks, 2 days a week and approximately 30-45 minutes (including warm-up and cool-down) will be applied for both groups. Core exercises will be applied to the 1st group, and resistance exercises will be applied to the 2nd group. Progress during the program will be achieved by increasing the intensity of the exercises. After 6 weeks of work, physical fitness parameters and performance will be evaluated again.

Eligibility Criteria:
Inclusion Criteria:

* • Being 18 years or older

  * Volunteering to participate in the study
  * Being actively attending latin dance lessons

Exclusion Criteria:

* • Being under the age of 18

  * Presence of upper or lower extremity musculoskeletal injuries or any cardiovascular, metabolic, neurological or pulmonary complications in the last 3 months
  * Being involved in any physiotherapy program in the last 3 months
  * Involvement in any exercise program other than dance
Study to Evaluate the Efficacy and Safety of Oxabact (OC5) in Primary Hyperoxaluria Patients Who Are on Dialysis

The purpose of this study is to determine if Oxalobacter formigenes is effective at lowering plasma oxalate levels in patients with primary hyperoxaluria who are on dialysis.


Eligibility Criteria:
Inclusion Criteria:

1. Signed informed consent (as applicable for the age of the subject). An appendix to the informed consent will be signed by patients continuing on treatment after week 14.
2. Male or female subjects ≥ 2 years of age. Subjects have to be able to swallow size 4 capsules twice daily for 6 weeks, or use a gastric tube that allows for administration of size 4 capsules.
3. A diagnosis of PH (as determined by standard diagnostic methods).
4. Patient should be on a stable dialysis regimen for at least two weeks before baseline.
5. Pre-dialysis plasma oxalate ≥40 micromole/L.
6. Patients receiving vitamin B6 must be receiving a stable dose for at least 3 months prior to screening and must remain on the stable dose during the study. Patients not receiving vitamin B6 at study entry must be willing to refrain from initiating vitamin B6 during study participation.

   Exclusion Criteria:
7. Inability to swallow size 4 capsules twice daily for 6 weeks or using a gastric tube not suited for administration of size 4 capsules via the tube.
8. Ongoing treatment with immunosuppressive medication.
9. The existence of secondary hyperoxaluria, e.g. hyperoxaluria due to bariatric surgery or chronic gastrointestinal diseases such as cystic fibrosis, chronic inflammatory bowel disease and short-bowel syndrome.
10. Use of antibiotics to which O. formigenes is sensitive, including current antibiotic use, or antibiotics use within 14 days of initiating study medication.
11. Current treatment with a separate ascorbic acid preparation. Standard of care vitamin supplement for patients on dialysis is allowed.
12. Pregnancy.
13. Women of childbearing potential who are not using adequate contraceptive precautions. Sexually active females, unless surgically sterile or at least 2 years post-menopausal, must be using a highly effective contraception (including oral, transdermal, injectable, or implanted contraceptives, IUD, abstinence, use of a condom by the sexual partner or sterile sexual partner) for 30 days prior to the first dose of OC5 and must agree to continue using such precautions during the clinical study.
14. Presence of a medical condition that the Investigator considers likely to make the subject susceptible to adverse effect of study treatment or unable to follow study procedures.
15. Participation in any study of an investigational product, biologic, device, or other agent within 30 days prior to the first dose of OC5 or not willing to forego other forms of investigational treatment during this study.