cyrilzakka/clinical-trials huggingface dataset:
Pharmacodynamic Study of BIIB095 and BIIB074 in Healthy Participants and Participants With Painful Diabetic Polyneuropathy

Part A: Primary objective is to determine the effects of BIIB095 on nerve excitability in healthy participants. Secondary and exploratory objectives include determining the effects of BIIB095 on nerve excitability in diabetic polyneuropathy (DPN) and assessing the safety, tolerability and pharmacokinetics of BIIB095.

Part B (optional): Equivalent objectives are pursued for BIIB074.


Eligibility Criteria:
Key Inclusion Criteria:

* Healthy participants must be in good health, as determined based on medical history and screening evaluations
* Participants with DPN

  * Must have a documented diagnosis of type 2 diabetes mellitus (DM)
  * Must have stable glycemic control
  * Must have at least clinical evidence of painful DPN
  * Pain related to DPN must be present for at least 6 months prior to screening
  * Average daily pain intensity over 7 consecutive days recorded during screening must be ≥ 4 on an 11-point numerical rating scale ranging from 0 (no pain) to 10 (worst pain imaginable)

Key Exclusion Criteria:

* Any neurologic or painful condition that could confound the interpretation of study results
* History of any clinically significant cardiac, hematologic, hepatic, immunologic, urologic, pulmonary, dermatologic, psychiatric, renal, or other major disease. This includes any clinically significant endocrinologic or neurologic disease other than DM or DPN.
* Use of local anesthetics or capsaicin for topical or regional treatment within 3 months prior to Screening.
* Systemic use of sodium channel inhibitors

Note: Other protocol-specific inclusion/exclusion criteria may apply.
Spinal Cord Gray Matter Imaging in Post Polio Syndrome

This is a longitudinal, observational study with the aims of comparing spinal cord gray matter areas in patients with Post-Polio Syndrome to age and sex matched healthy control subjects and to correlate atrophy with metrics of clinical disability.

Post-Polio syndrome (PPS) is characterised by new muscle weakness, pain, and fatigue several years to decades after the acute polio infection. Pathomechanisms are not yet fully understood.

This is a longitudinal, observational study. The aims are (a) to detect spinal cord gray (and possibly) white matter atrophy in patients with Post Polio Syndrome in comparison to healthy age and sex matched control subjects both cross-sectionally and longitudinally and (b) to correlate spinal cord gray and white matter atrophy to metrics of clinical disability.

Investigators will assess 20 patients with Post-Polio syndrome and 20 control subjects at baseline and 48 weeks by MRI and clinically including quantitative muscle strength assessments.

Eligibility Criteria:
Inclusion Criteria:

* Prior paralytic poliomyelitis with evidence of motor neuron loss. This is confirmed by history of the acute paralytic illness, signs of residual weakness and atrophy of muscles on neuromuscular examination, and signs of motor neuron loss.
* a period of partial or complete functional recovery after acute paralytic poliomyelitis, followed by an interval (usually 15 years or more) of stable neuromuscular function.
* slowly progressive and persistent new muscle weakness or decreased endurance, with or without generalized fatigue, muscle atrophy, or muscle and joint pain. Symptoms that persist for at least a year.
* Exclusion of other neuromuscular, medical, and skeletal abnormalities as causes of symptoms.
* Patients older than 18 years at time of screening
* Ambulant
* Ability to walk 150 m in the 6 min walking distance (6MWT) with or without one or two walking sticks.

Exclusion Criteria:

* Previous (3 months or less) or concomitant participation in any other therapeutic trial
* known or suspected malignancy
* Other chronic disease or clinical relevant limitation of renal, liver, heart function according to discretion of investigator
A Long-Term Study to Evaluate the Safety of Asoprisnil and Estrogen Administration to Postmenopausal Women

The objective of this study is to determine the long-term safety of asoprisnil 10 mg when administered to postmenopausal women with Premarin® 0.625 mg

The objective of this study is to determine the long-term safety of asoprisnil 10 mg (2-5mg tablets) when taken with Premarin® 0.625 mg, by postmenopausal women, for 6 months after an initial 12 weeks in Study M00-198. Pharmacodynamic effects to be assessed include uterine bleeding pattern, endometrial biopsy results, and endometrial thickness. Safety assessments will include clinical laboratory results, physical examination with vital signs, pelvic and breast examinations, ultrasound results, and adverse events.

Eligibility Criteria:
Inclusion Criteria:

* Successful completion of study M00-198
* Continued good general health
* Negative urine pregnancy test

Exclusion Criteria:

* History of known or suspected cancer other than basal cell carcinoma in last 5 years
* History of reproductive endocrine disorder
* Submucous or other symptomatic fibroid which would confound efficacy
* Ovarian mass
* Ongoing treatment with an excluded medication
* Stenosis of the cervix
* Any abnormal lab result the study-doctor considers significant.
Safety and Efficacy of Low-volume Preparation in the Elderly: Oral Sulfate Solution

The investigators will investigate the safety and efficacy of low-volume preparation (Oral Sulfate solution) compared to 4L PEG solution in bowel preparation before colonoscopy.

One aim of this study was to investigate the efficacy of low-volume preparation (Oral Sulfate solution) on bowel preparation before colonoscopy.

Traditionally, polyethylene glycol (PEG) solution, which requires ingestion of a large volume of liquid, has been used and now to a low-volume preparations because of its clear advantages in tolerability. The tolerability of bowel preparations is related to their volume, taste, and side effects, with this being a particular problem in the elderly. Meanwhile, a new oral sulfate solution (OSS, SUPREP, Braintree Laboratories, Braintree, Mass) formulation as an effective low-volume bowel cleansing agent, with a split-dose regimen was recently developed in 2009.

Concerned about being able to better complete ingestion of bowel cleansing agent, OSS with lower volume and improved taste features, as long as it does not sacrifice safety, shuld be a better choice than PEG. Many studies have already looked at the efficacy and safety of OSS compared to PEG in average risk population, but there are no data available in solely at the elderly population. In this context, we hypothesized that OSS could be a good alternative to a standard 4L-PEG solution in elderly patients.

In this report, we describe a multicenter, prospective, investigator-blind, randomized, controlled trial investigating OSS with 4L PEG for efficacy and safety in the elderly.

Eligibility Criteria:
Inclusion Criteria:

All participants from 65 to 75 age

Exclusion Criteria:

1. Underwent Colorectal surgery
2. CHF, Acute MI \<6 months
3. ASA class III =\<
4. LC, CRF, Ascite, IBD, or Severe inflammatory state
5. Severe constipation (Bowel movement 3/wk \> or Taking stool softener)
6. Disabled person physically or mentally
7. Refuse consent
DETECT-IP: a Clinical Decision Support System and Intelligent Procedures to Counter Some Adverse Drug Events in Older Hospital Patients

Current evidence shows that computerized decision support systems (CDSS) have shown to be insufficiently effective to prevent adverse drug reactions (ADRs) at large scale (e.g. whole hospital). Several barriers for successful implementation of CDSS have been identified: over-alerting, lack of specificity of rules, and physician interruption during prescription. The effectiveness of CDSS could be increased in two ways. Firstly, by creating rules that are more specific to a given adverse drug reaction: the current study focuses on acute renal failure and hyperkalemia (two serious and frequent ADR in older hospitalized patients). Secondly, by involving the pharmacist in the review of the alerts so that he/she can transmit, if deemed necessary, a pharmaceutical recommendation to the clinician. This procedure will reduce over-alerting and prevent task interruption.

The hypothesis is that the use of specific rules created by a multidisciplinary team and implemented in a CDSS, combined with a strategy for managing and transmitting alerts, can reduce specific ADRs such as hyperkalemia and acute renal failure.


Eligibility Criteria:
Inclusion Criteria:

* Hospitalized for 3 days or more in an MCO (medicine surgery obstetrics) department participating in the study
* Patient who gave oral consent to participate in the study
* Socially insured patient

Exclusion Criteria:

* Patient discharged or died before D3 of hospitalization
* Patient in palliative care or end of life on entry to the service
* Person under legal protection (curatorship)
* Lack of coverage by the social security system, Failure to obtain oral consent to participate in the study
Conversation With Family Doctor to Increase COVID-19 Vaccine Uptake

The investigators will randomise individuals from family doctors' lists of patients that are at risk of severe Coronavirus Disease 2019 (COVID-19), and that are not registered as having taken the vaccine against the disease. The patients will be randomised to receiving a phone call from their family physician where the participants are given the opportunity to raise questions they might have around vaccination. The investigators will assess whether this has an impact on vaccine uptake.


Eligibility Criteria:
Inclusion Criteria:

* Belonging to group at risk of severe COVID-19

Exclusion Criteria:

-
Hand Exercises in Psoriatic Arthritis

This study is a randomized controlled study examining the effects of 8-week hand home exercises on grip strength, functionality, disease activity and quality of life in patients with PsA. Individuals participating in the study will be randomly divided into 2 groups. Individuals in the intervention group will perform home exercises consisting of stretching, mobility and strengthening, 4 days a week for 8 weeks, and the patients' compliance with the exercise will be monitored by phone call once a week. Individuals in the control group are on the waiting list and the same home exercise program will be taught to the patients at the end of the study.

Psoriatic arthritis (PsA) is a chronic inflammatory musculoskeletal disease that is in the spondyloarthritis group and is frequently accompanied by peripheral arthritis, dactylitis, enthesitis, spondylitis and accompanied by psoriasis. Although hand effects in patients with PsA are known, there is no exercise study performed only on the hand and no study examining the effect of this study on the grip strength and functionality of the hand. This study is a randomized controlled study examining the effects of 8-week hand home exercises on grip strength, functionality, disease activity and quality of life in patients with PsA. 34 individuals with PsA who meet the inclusion criteria will be included in the study. Individuals participating in the study will be randomly divided into 2 groups. Individuals in the intervention group will perform 30-45 minutes of home exercises consisting of stretching, mobility and strengthening, 4 days a week for 8 weeks, and the patients' compliance with the exercise will be monitored by phone call once a week. Individuals in the control group are on the waiting list and the same home exercise program will be taught to the patients at the end of the study. Evaluations will be made twice, at the beginning and at the end of the 8-week program. In the evaluation, the demographic form, Psoriatic Arthritis Disease Activity Score (DAPSA), Grip Strength, Nine-Hole Peg Test, Duruöz Hand Index, Michigan Hand Outcome Questionnaire (MHQ) Functional Hand Index, Psoriatic Arthritis Quality of Life Questionnaire (PsAQoL) will be applied. This study will be one of the first studies to show the effects of hand exercises on PsA disease activity, grip strength, functionality and quality of life.

Eligibility Criteria:
Inclusion Criteria:

* Being diagnosed with PsA by a physician according to CASPAR criteria
* Being 18 years or older
* Involvement in hand joints (pain, swelling, tenderness)
* Being on stable drug treatment for the last 6 months
* Having sufficient cooperation to participate in the study
* Volunteering to participate in the study

Exclusion Criteria:

* Having difficulty cooperating at work
* Having additional orthopedic and/or neurological disease that will affect hand functions
An Efficacy and Safety Study of ABT-SLV176 for the Treatment of Hypogonadal Men

This is an open-study with a 26 week open label treatment period followed by an optional 26 week open label extension. The total treatment period will be 52 weeks.


Eligibility Criteria:
Inclusion Criteria:

Low testosterone

Exclusion Criteria:

* Normal testosterone levels
* Elevated Prostatic Specific Antigen (PSA)
* History of breast or prostate cancer
Evaluation of High-Frequency Chest Wall Oscillation

To compare the outcomes of patients treated with the Vest and conventional chest physiotherapy to determine if the Vest provides equivalent therapy


Eligibility Criteria:
Inclusion Criteria:

* Acute or chronic disease requiring secretion mobilization as per hospital protocol

Exclusion Criteria:

* Absolute contraindications for positional changes
* Absolute contraindications for chest percussion
* Women visibly pregnant
* Previous enrollment in study
* Previous CPT or Vest treatment
Edessy ICSI Outcome Embryo Score (EIOS) Efficacy

Purpose of this study is to detect outcome of intracytoplasmic sperm injection (ICSI) according to EIOS

A total of 243 infertile couples underwent long GnRH agonist protocol in the ART unit, International Islamic Center for Population Studies and Research (IICPSR), Al-Azhar University.

Embryos which reached the two cell stage at 25-27 hr were classified as EC, and the remaining as Non Early Cleavage embryos (NEC). Embryos were assessed again at 64-68 hours post-ICSI for day three embryo morphology score (Loi et al.,2008). The best two or three embryos, according to day 3 embryo morphology were transferred. Each patient was given a score according to EIOS (female age, number of retrieved oocytes, number of EC embryos, number of good quality embryos and number of embryos transferred).

Eligibility Criteria:
Inclusion Criteria:

* Age ≤ 40 years old. BMI \>25 - 30 kg/m2. Have two ovaries. Regular cycles. 1st ICSI cycle. Long midluteal GnRH protocol

Exclusion Criteria:

uterine factor as a cause of female factor infertility. pelvic masses or diseases (e.g: endometriosis, fibroids, hydro- salpnix, ...). history of medical disorders (e.g: hypertension, D.M, thyroid dysfunction, liver diseases, renal diseases,...).

azoospermia as a cause of male factor infertility.
Dose-range Finding Treosulfan-based Conditioning

Evaluation of the safety and efficacy of 3 x 10, 3 x 12 or 3 x 14 g/m² Treosulfan resp., combined with 5 x 30 mg/m² fludarabine prior to allogeneic, hematopoietic stem cell transplantation of patients with hematological malignancies, but non-eligible to standard conditioning treatment.


Eligibility Criteria:
Inclusion Criteria:

1. Patients with a haematological chemosensitive malignancy indicated for an allogeneic transplantation, but presenting an increased toxicity risk for classical (high-dose busulfan or standard-dose total body irradiation) conditioning therapies (remission criteria ref. to Appendix L):

   * CML in first or subsequent chronic phase
   * NHL in 2nd CR/PR, chemosensitive PR after autologous transplantation ; CLL in 2nd or subsequent CR/PR
   * Relapsed Morbus Hodgkin (MH) after autologous transplantation
   * Multiple Myeloma (MM) stage II and III according to Durie and Salmon
   * AML in 2nd CR/PR or high-risk AML in 1st CR/PR

   High-risk defined for example by the following:
   * Cytogenetics: -5/5q, -7/7q, del(5q), abnormalities of 3q, complex karyotype (\> 3 abnormalities), or
   * PR after 1 cycle of induction therapy
   * ALL in 2nd CR/PR or high-risk ALL in 1st CR/PR

   High-risk defined as follows:
   * Leukocytes \> 3000/µl (B-Linage) or \> 100000/µl (T-Linage);
   * Pro-B-ALL, pre-T-ALL
   * Cytogenetics: t(9;22)/BCR-ABL; t(4;11)/ALL1-AF
   * MDS (patients without prior chemotherapy may be included)
2. Availability of an HLA-identical sibling donor (MRD) or HLA-identical unrelated donor (MUD) or one mismatch (out of the 6 standard markers) sibling donor (1 misMRD):

   • HLA-identity defined by the following markers: A, B, DRB1. DQB1 must be recorded.
3. Age \> 18 years
4. Karnofsky Index \> 80 %
5. Adequate contraception in female patients of child-bearing potential
6. Co-operative behavior of individual patients
7. Written informed consent

Exclusion Criteria:

1. Completely chemotherapy-resistant disease
2. Severe cardiac insufficiency, severe cardio-vascular or other severe concomitant diseases
3. Symptomatic malignant involvement of the CNS
4. Active infectious disease
5. HIV-positive or active hepatitis infection
6. Impaired liver function (Bilirubin \> 1.5 x upper normal limit; Transaminases \> 3.0 x upper normal limit)
7. Impaired renal function (Creatinine-clearance \< 60 ml/min; Serum Creatinine \> 1.5 x upper normal limit).
8. Pleural effusion or ascites \> 1.0 L
9. Pregnancy or lactation
10. Known hypersensitivity to fludarabine and/or treosulfan
11. Parallel participation in another experimental drug trial
CLaret Embolic Protection ANd TAVI - Trial

This prospective, randomized study was designed to investigate the benefit of using a Filter-Protection-Device (Claret MontageTM Dual Filter System) during transcatheter aortic valve implantation (TAVI) with a Medtronic CoreValve®.


Eligibility Criteria:
Inclusion Criteria:

* Subject must be scheduled to undergo an endovascular aortic valve prosthesis (Medtronic CoreValve®) implant procedure with the femoral artery as the intended access site for the valve delivery system.

Exclusion Criteria:

* Patient is unsuitable for TAVI
* Prior Stroke or TIA in the last 12 month
* Carotic stenosis \>70%
* Relevant stenosis of the brachiocephalic trunc or the right subclavian artery
* Expected Non-compliance for follow-ups
* Pregnancy
* Patient is already recruited for another study
A Prospective Study: Sintilimab and R-CHOP in PMBCL Treatment

The purpose of this multi-center, single arm, phase Ⅱ clinical trail is to evaluate the efficacy and toxicity of sintilimab combined with R-CHOP regimen as first-line treatment for primary mediastinal large B-cell Lymphoma (PMBCL)


Eligibility Criteria:
Inclusion Criteria:

* Pathological diagnosis of PMBCL , and did not receive any previous treatment for PMBCL ;
* Predicted survival time ≥ 6 months ;
* 18-75 years ;
* IPI score 0-3；
* ECOG performance status 0-2 ;
* Clinicians judge that the patient is suitable for the treatment of primary mediastinal large B-cell lymphoma ;
* After the patient was enrolled in the trial, other drugs that may have therapeutic effects on primary mediastinal large B-cell lymphoma were not acceptable ;
* WBC ≥ 3 × 109 / L, NE ≥ 1.5 × 109 / L, PLT ≥ 100 × 109 / L ;
* Serum creatinine ≤ 1.5mg / dL, creatinine clearance rate ≥ 50mL / min ;
* ALT, AST ≤ 3 × ULN ( normal upper limit ) ; total bilirubin ≤ 2 × ULN ;
* Sign the informed consent.

Exclusion Criteria:

* Other malignant diseases except PMBCL were diagnosed within 5 years；·Participating in other interventional clinical studies, or has received chemotherapy, radiotherapy, immunotherapy or biotherapy for lymphoma；
* Known allergies to test drugs or any excipient component of these products；·Allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation has been performed；
* Women in pregnancy or lactation；
* Severe infectious diseases, such as HIV infection, untreated active hepatitis B, active hepatitis C；
* The researchers believe that there are other potential risks that are not suitable for participation in this study.
Efficacy of a Depigmented Extract of Phleum in Local Allergic Rhinitis

The purpose of this study is evaluate the efficacy of a depigmented grass extract in the treatment of local allergic rhinitis.


Eligibility Criteria:
Inclusion Criteria:

* Local allergic rhinitis with sensitization to grass pollen
* Skin prick test and serum specific IgE negative to grass pollen.
* Positive Nasal allergen provocation test (NAPT) to grass pollen and/or positive nasal specific IgE to grass pollen.
* Written informed consent

Exclusion Criteria:

* Immunological diseases
* Heart diseases that limit the use of adrenaline. For example, severe hypertension or treatment with beta-blockers.
* Treatment with beta-blockers
* Severe psychological disorders
* Severe atopic dermatitis
* FEV1 \< 70% of reference value after treatment
* Hypersensitivity or intolerance to excipients and / or medication trial.
* Failure to adequately perform diagnostic tests or treatment.
* Sensitization to other allergens (perennial or seasonal) with clinical relevance for the subject and that may interfere in the evaluation of the response.
* Immunotherapy in the 5 years prior to their inclusion in the study.
* Pregnant women or at risk of pregnancy and lactating women.
A Study of Tadalafil in Men With Benign Prostatic Hyperplasia (BPH) and Erectile Dysfunction (ED)

The purpose of this study is to see whether tadalafil can reduce the signs and symptoms in men with Erectile Dysfunction (ED) and Benign Prostatic Hyperplasia-Lower Urinary Tract Symptoms (BPH-LUTS) and improve their quality of life.


Eligibility Criteria:
Main Inclusion Criteria:

* Present with a history of ED and signs and symptoms of BPH.
* Are sexually active with an adult female partner, and expect to remain sexually active with the same adult female partner for the duration of the study.

Main Exclusion Criteria:

* Current treatment with nitrates.
* Prostate-specific antigen (PSA) greater than 10.0 nanogram (ng)/mL at 1st screening.
* PSA greater than or equal to 4.0 to less than or equal to 10.0 ng/mL at 1st screening if prostate malignancy has not been ruled out to the satisfaction of a urologist
* Suffering from other urinary disease like cancer, or infection
* Serious cardiovascular disease
* History of significant renal insufficiency