cyrilzakka/clinical-trials huggingface dataset:
Repairing the Defect of Intervertebral Disc With Autologous BMSC and Gelatin Sponge After Microendoscopic Discectomy for Lumbar Disc Herniation

In this prospective study the investigators seek to evaluate clinical outcomes after repairing the defect of intervertebral disc with autologous BMSC/gelatin sponge during microendoscopic discectomy for participants of lumbar disc herniation.

The participants with lumbar disc herniation diseases are treated by Microendoscopic discectomy, and they are divided into four groups depend on whether the defect is repaired with Autologous Bone Marrow Stem Cell (BMSC)/gelatin sponge or not and whether the defect is sutured or not. In the first group,the defect of intervertebral disc is repaired with Autologous Bone Marrow Stem Cell (BMSC)/gelatin sponge and sutured. In the second group, the defect of intervertebral disc is repaired with autologous Bone Marrow Stem Cell (BMSC)/gelatin sponge but not sutured after discectomy. In the third group, the defect of intervertebral disc is sutured but not repaired with autologous Bone Marrow Stem Cell (BMSC)/gelatin sponge after discectomy. In the four group, the defect of intervertebral disc is neither sutured nor repaired with autologous Bone Marrow Stem Cell (BMSC)/gelatin sponge after discectomy.

Eligibility Criteria:
Inclusion Criteria:

1. Participants with signs and symptoms of lumbar disc herniation requiring surgical treatment after conservative management;
2. Radiological data on CT/MRI obtained within a period prior to enrollment;
3. Participants give written informed consent before enrollment.

Exclusion Criteria:

1. If participants had an incomplete medical record;
2. Participants had spine tumor, spine infection, previous underwent lumbar surgery, or revision surgery.
3. Participants are taking uninterruptible anticoagulation therapy.
4. Dementia and/or inability to give informed consent.
5. MRI contraindication (e.g. cerebral aneurysm clips, cochlear implants, pacemaker, implanted biostimulators);
6. Pregnancy;
7. Participation in other clinical trial within the last 30 days.
An Efficacy and Safety Study of Mitiperstat (AZD4831) (MPO Inhibitor) vs Placebo in the Treatment of Moderate to Severe COPD.

This is a research study to evaluate the efficacy and safety of the investigational drug Mitiperstat (AZD4831) in adult patients with chronic obstructive pulmonary disease.

Study D6582C00001 is a phase IIa randomised, double blind, placebo controlled, parallel arm study to evaluate the efficacy and safety of Mitiperstat (AZD4831) in adult participants with moderate to severe chronic obstructive pulmonary disease.

Approximately 100 sites globally will participate in this study. Approximately 406 participants will be randomised to two treatment groups; Mitiperstat (AZD4831) vs placebo in a 1:1 ratio.

Eligibility Criteria:
Inclusion Criteria:

* Provision of informed consent.
* Participants must be deemed as high risk of exacerbations as defined by: \>= 1 moderate or severe exacerbation in the previous 24 months; or frequent productive cough; or post-bronchodilator (BD) forced expiratory volume in the first second (FEV1) \< 50% predicted.
* Participants must be 40-80 years of age inclusive, at the time of signing informed consent form (ICF).
* Participants who have a confirmed primary diagnosis of moderate to severe COPD.
* Participants who are current or ex-smokers with a tobacco history of ≥ 10 pack-years.
* Participants who have a documented stable regimen of triple therapy or dual therapy for

  ≥ 3 months prior to enrolment.
* Body mass index within the range 18 to 40 kg/m2 (inclusive).

Exclusion Criteria:

* As judged by the investigator, any evidence of any active medical or psychiatric condition or other reason (at SV1 \[screening\] and SV3 \[pre-dose\]) which in the investigator's opinion makes it undesirable for the participant to participate in the study.
* Current diagnosis of asthma or past diagnosis of asthma which persisted beyond the age of 25 years.
* Clinically important pulmonary disease other than COPD.
* Any other clinically relevant abnormal findings on physical examination, laboratory testing including haematology, coagulation, serum chemistry, or urinalysis; or chest CT scan at screening or randomisation, which in the opinion of the investigator or medical monitor may compromise the safety of the participant in the study or interfere with evaluation of the study intervention or reduce the participant's ability to participate in the study.
* History of a clinically significant infection (viral, bacterial, or fungal; defined as requiring systemic antibiotics, antiviral, or antifungal medication for \> 7 days) within 4 weeks prior to SV3 (Day 1) (including unexplained diarrhoea) or clinical suspicion of infection at time of dosing.
MT10109L in the Long-term, Open-label Treatment of Glabellar Lines (GL) and Lateral Canthal Lines (LCL)

To evaluate the long-term safety of MT10109L in the treatment of GL and/or LCL in participants with moderate to severe GL and/or LCL.

Study MT10109L-004 is an open-label extension involving participants from studies MT10109L-001 (NCT03795922), -002 (NCT03785145), -005 (NCT03721016), and -006 (NCT03732833) (referred to as Lead-In studies). The objective is to evaluate long term safety of MT10109L. Participants will include those who completed the global lead-in studies and meet the eligibility criteria for entering this open-label extension study.

Participants who meet retreatment criteria will receive MT10109L administered in the same treatment area(s) with the same number of injections and injection sites as in their lead-in studies.

The safety and efficacy data from the lead-in and this open-label extension will be summarized.

Eligibility Criteria:
Inclusion Criteria:

* Completion of lead-in Phase 3 study;
* Female participants must not be pregnant or planning to get pregnant and willing to minimize the risk of inducing pregnancy for the duration of the clinical study and follow-up period.

Exclusion Criteria:

* Known immunization or hypersensitivity to any botulinum toxin serotype;
* Any medical condition that may put the participant at increased risk with exposure to MT10109L including diagnosed myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis, or any other condition that might interfere with neuromuscular function;
* Known allergy or sensitivity to any of the components of the study interventions, or any materials used in the study procedures;
* Females who are pregnant, nursing, or planning a pregnancy during the study;
* Participants who plan for an extended absence away from the immediate area of the study site that would preclude them from returning for all protocol-specified study visits.
Serum Citrate in Diagnosis and Follow-up for Glaucoma

Glaucoma might be a mitochondria associated disease. Since citrate is a major component in mitochondrial metabolism its determination in blood might serve as a biomarker.


Eligibility Criteria:
Inclusion Criteria:

* age\> 18 years
* glaucoma

Exclusion Criteria:

* Active ocular inflammation
* Ocular Hypertension
* Nephropathy
* Alcohol-, Drug abuse
* Mitochondriopathy
Tocotrienol as a Nutritional Supplement in Patients With Advanced Ovarian Cancer

The purpose of this study is to to investigate the effect of tocotrienol as a nutritional supplement in combination with bevacizumab in patients with advanced ovarian cancer.


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed epithelial, primary fallopian or primary peritoneal cancer.
* Prior treatment with at least two different cytostatic regimens including platinum.
* Progression on previous treatment.
* Measurable disease by RECIST 1.1 or evaluable by GCIG CA-125 criteria.
* Age ≥ 18 years.
* Performance stage 0-2.
* Adequate bone marrow function, liver function, and renal function (within 7 days prior to inclusion):

  * WBC ≥ 3.0 \* 10\^9/l or neutrophils (ANC) ≥ 1.5 \* 109/l
  * Platelet count ≥ 100 \* 10\^9/l
  * Hemoglobin ≥ 6 mmol/l
  * Serum bilirubin \< 2.0 \* ULN
  * Serum transaminase ≤ 2.5 \* ULN
  * Serum creatinine ≤ 1.5 ULN
* Urine dipstick for protein \<2+. If the dipstick shows protein ≥2+ 24 hour urine testing must be made with protein contents \< 1 g.
* Written informed consent.

Exclusion Criteria:

* Other malignant diseases within 5 years prior to inclusion in the study, except curatively treated basal cell or squamous cell carcinoma of the skin and other types of cancer with minimal risk of recurrence.
* Other experimental therapy or participation in another clinical trial within 28 days prior to treatment initiation.
* Underlying medical disease not adequately treated (diabetes, cardiac disease).
* Uncontrolled hypertension (BT \>150/100 despite antihypertensive treatment).
* Surgery, incl. open biopsy, within 4 weeks prior to first dose of bevacizumab.
* Non-healing wounds or fractures.
* Cerebral vascular attack, transient ischemic attack or subarachnoidal hemorhage within 6 months before start of treatment.
* Clinically significant cardiovascular disease, including:

  * Myocardial infarction or unstable angina within 6 months before start of treatment
  * New York heart Association (NYHA) class ≥ 2
  * Poorly controlled cardiac arrhythmia despite medication
  * Periferal vascular disease grade ≥ 3
* Allergy to the active substance or any of the auxiliary agents
* Bleeding tumor
* Pregnant or breast-feeding patients. For fertile women a negative pregnancy test at screening is mandatory.
* Fertile patients not willing to use effective methods of contraception during treatment and for 6 months after the end of treatment
A Reliability and Validity Study: Urdu Version of Rivermead Extended Activities of Daily Life

The goal of this study is to translate and culturally adapt Rivermead Extended Activities of Daily Life into the Urdu language and to evaluate its reliability and validity in the Pakistani neurological rehabilitation population. Also assess its correlation with Memory and Concentration Test, The Barthel Index, and The index of French activities.

As per the preceding commendation, Rivermead Extended Activities of Daily Life will be deciphered into the Urdu dialect from its English adaptation and adjusted socially in Pakistan. Among the neurological rehabilitation population, Rivermead Extended Activities of Daily Life will be distributed in 100 patients enrolled by comfort inspecting strategy beneath the pre-defined incorporation and avoidance criteria after marking assent shapes. For testing inter-observer unwavering quality and intra-observer unwavering quality of Rivermead Extended Activities of Daily Life, Memory and Concentration Test, index of French activities, and Barthel Index surveys will be managed by spectator, on the same day, with a time interval of 2 hours between 1st and 2nd readings. As for the 3rd readings, it will be carried out after seven days by the first observer, for intra-observer appraisal. Statistical Package of Social Sciences computer program has been utilized for information passage and examination. Inner consistency will be analyzed with Cronbach alpha esteem. Test-retest unwavering quality will be surveyed by utilizing an intra-class relationship coefficient. The Rivermead Extended Activities of Daily Life will be assessed for content validity, construct validity, criterion validity, and responsiveness.

Eligibility Criteria:
Inclusion Criteria:

* Patients from Rehabilitation centers mainly outpatients; with more or severe impairments due to neurological /neuro-muscular diseases.
* Patient should be in a stable state unlikely to change over 2- weeks.
* Patient should score 18/28 short orientation-memory-concentration test; indicating a reasonable cognitive and communicative ability.

Exclusion Criteria:

* People not suffering from any neurological impairment.
* Scorning less than 18/28 on short orientation-memory-concentration test.
Women's Health Research Registry

Women have been disproportionately underrepresented in clinical research. Few of the many drugs approved by the FDA have been adequately tested in women. Most common health conditions experienced by both women and men are managed by treatments that have been developed and tested most in men.

A new barrier to enrolling women in clinical trials is in effect: HIPAA (the Health Insurance Portability and Accountability Act). The positive benefit of HIPAA-protecting a person's health information from abuse-is laudable, but it comes at a cost: it will deny investigators the benefit of access to chart (medical record) review in order to gather data to answer clinical questions. In the past, investigators were allowed access to patient's charts because the hospital consent form included a clause indicating that the patient's information may be used for research.

The investigators propose to overcome this crisis and challenge with a proven method of identifying individuals who would be willing to consider participating in a clinical trial: The Women's Guild Health Research Registry. In keeping with the focus of the Women's Health Program, we would propose to enroll only women. The registry will allow qualified investigators to identify potential study participants. This idea has been effective at improving the quantity and quality of women able and willing to participate in trials.

The investigators will also allow other approved sites to utilize the Registry via the approved procedure of submitting an IRB approved protocol which will be reviewed by our Internal Review Committee. This protocol's inclusion/exclusion criteria will be used to query the database for eligible participants. The participants will be contacted by the Registry staff to ascertain their interest in this research protocol and their agreement to release their contact data to the investigator will be obtained.

Investigators will be charged at the time they approach the registry for assistance. The charge is intended to cover the cost of maintaining the registry now that initial funding has been exhausted.

See Brief Summary above

Eligibility Criteria:
Inclusion Criteria:

* Adult women
* English speaking

Exclusion Criteria:

* We do not include children.
* We do not include non-English speaking subjects at this time.
Role and Mechanisms of Obesity Surgery

The purpose of this study is to examine how physical activity and lifestyle factors influence postoperative recovery and postoperative complications after bariatric surgery.

The hypothesis is that physically active people, with a healthy alcohol consumption and non smokers have shorter lengths of hospital stay, shorter sick-leave, fewer re-hospitalizations and fewer re-operations, fewer complications as well as a faster recovery after a surgical procedure.

The investigators also hypothesize that possible risk factors for non-surgical postoperative complications e g abdominal discomfort are also life-style related factors such as smoking, high alcohol consumption, low level of physical activity, as well as other risk factors such as prior frequent abdominal pains (e g irritable bowel syndrome symptoms), high levels of anxiety and/or depression, difficulties with coping with the changed food intake regimen after obesity surgery, and generally high sensitivity for painful-sensations and nausea.

First aim of this study is to investigate how life style factors prior to obesity surgery are related to hospital stay, sick-leave, immediate postoperative complication rates and the rate of resumption of QoL and normal physical function.

The second aim of the study is to identify risk factors for the development of chronic abdominal discomfort and dumping symptoms after obesity surgery.


Eligibility Criteria:
Inclusion Criteria:

* \>18 y of age
* BMI \>35

Exclusion Criteria:

* non-knowledgeable in Swedish language
Association of Mean Platelet Volume and Cardiovascular Disease in Children With End Stage Renal Disease.

Cardiovascular disease (CVD) is the major risk factor for death in end stage renal diseases (ESRD). Approximately 80% of ESRD patients have some degrees of left ventricular abnormalities at initiation of dialysis. Carotid intima media thickness (CIMT) has been widely accepted as an useful marker to assess CVD in ESRD children. In addition, cardiac mechanics parameters are used to evaluate cardiac function more precisely. However, measuring CIMT and cardiac mechanics parameters are expensive and difficult to perform as a routine method. Mean platelet volume (MPV) is a hematological index which shows the size of platelets. Uremic state causes inflammatory condition that affects MPV. Previous studies on people with normal renal function have shown that this parameter can also have association with CVD. However the data in children with ESRD is scarce. The aim of this study is to find a simple hematologic marker to use regularly in ESRD children finding patients at risk of CVD. Therefore, we will investigate the relationship between mean platelet volume and CIMT and cardiac mechanic parameters in children with ESRD.


Eligibility Criteria:
Inclusion Criteria:

* Children under 18 years who have being dialyzed (hemodialysis or peritoneal dialysis) regularly more than 6 months, as case group.
* Age and gender matched healthy children who have been referred for routine medical examination.

Exclusion Criteria:

* Patients with uncontrolled hypertension (until being stabled)
* Patients on any kind of antithrombotic agents or NSAIDs
* Severe obesity
* Diabetes patients
* Patients with a past history of CVD or stroke in the last 6 months
* Passive smokers who contacted daily with high smokers in their houses
* Patients with known hematologic diseases or malignancies (such as Fanconi Anemia)
* Uncontrolled hypothyroid or hyperthyroid patients
* Patients with recent (in the last 4 weeks) catheter or exit -site infection.
Reduced-Intensity Allogeneic Hematopoietic Stem Cell Transplantation for Malignant Hematological Diseases

To evaluate engraftment and toxicity of a reduced intensity preparative regimen for patients who receive a matched related or unrelated donor allogeneic stem cell transplant (ASCT) for malignant hematological diseases

Primary Endpoints:

1. Engraftment of donor cells
2. Regimen related toxicities

Secondary Endpoints:

1. Disease-free survival
2. Overall survival

Eligibility Criteria:
Inclusion Criteria:

* Performance status 0-2
* Ejection fraction \> 30%
* AST/ALT and bilirubin not \> 4 times normal
* Creatinine clearance greater than 70 ml/min.
* FEV1 greater than 1.0 and diffusion capacity greater than 40%
* Age 18-75 years
* Patients must be at high risk for conventional regimen related toxicity
* Malignant hematologic disease that would otherwise be considered treatable with ASCT

Exclusion Criteria:

* Does not meet the above Inclusion criteria
Effectiveness of Podiatry on Plantar Pain

MAIN OBJECTIVE: To value the effectiveness of the different quiropody interventions in the heel pain.

SECONDARY OBJECTIVES: To evaluate the effectiveness of lasw different technologies in front of each one of the other experimental technologies. To analyze the state of general health and of quality of the patients' life in all the treatment groups. To analyze the study cost-effectiveness of each one of the experimental interventions. DESIGN: randomized controled trial, prospective.

SUBJECT OF STUDY: Patient that go to the Assistance Educational Unit of Podología of the E.U. Sciences of the Health with footpain like consultation reason.

INTERVENTION: Establishment of four experimental groups with intervention varied podológica. He/she will be carried out a complete pursuit with valuations at the 1,2, 6, 12 and 24 months, by means of pain scales and function of the foot (FHSQ), the index postural of the foot (FPI), the study of pressures by means of biofoot/IBV and of the state of general health (SF-12) and quality of life (Euroqol).

VARIABLES: Of intervention; treatment basic orthopodiatry, treatment advanced orthopodiatry, of treatment quiropody. Of result: pain and function of the foot (FHSQ), of the state of general health (SF12) and quality of life (Euroqol). Variables of characterization of the sample.

ANALYSIS DATA: Descriptive statistic, with measures of central tendency and dispersion of the study variables. They will be carried out statistical inferenciales between the main variables of intervention and result (square chi, t Student, ANOVA, Mann-Whitney, Wilcoxon, according to types and normality of variables). Likewise, measures of the size of the effect will settle down in the main variables of result, by means of the relative reduction of the risk, absolute risk and odds ratio, with their respective intervals of trust.


Eligibility Criteria:
Inclusion Criteria:

* Heel and plantar pain

Exclusion Criteria:

* Inflammatory infections and specific organic disease of foot
Educational Program Associated With a Conventional Spa Therapy of Knee Osteoarthritis Patients

The main objective of this work is to measure the efficiency of 18 days SPA Therapy in orientation rheumatology associated with an educational intervention in patients with knee osteoarthritis on a priority objective, personalized and determined by the patient, chosen in the list of 5 objectives determined during the educational assessment.

This program begin with a shared educational balance assessment allowing to set up the individual program adapted to the objectives personalized by the patients. The objectives to achieve are to allow the patients to acquire knowledge and skills (attitudes, behavior) concerning their pathology and the existing treatment. A multidisciplinary team trained in the therapeutic education of the patient assure the educational interventions. The proposed educational activities (7 educational workshops) concern major axes of the care of the knee osteoarthritis: knowledge of the pathology, the adapted physical exercise, the dietetics, the management of the pain, the articular hygiene and the technical helps.

Eligibility Criteria:
Inclusion Criteria:

* Patients, male or female, aged 50 to 75 years
* Patients with knee osteoarthritis clinical criteria of the American College of Rheumatology (ACR)
* Patient affiliated to a social security scheme (beneficiary entitled)
* Patient registered spa
* Pain intensity equal or more than "3" at the Visual Analogical Scale
* Patient has given its consent in writing to

Exclusion Criteria:

* Contraindication to the spa therapy
* Trouble behavior or understanding making it impossible to assess