cyrilzakka/clinical-trials huggingface dataset:
WEB-Based Physiotherapy for People With Multiple Sclerosis

The study will be a pragmatic, single blind, randomised, controlled feasibility study, comparing 6 months of web-based physiotherapy plus usual care with usual care alone in pwMS. The study will recruit 90 pwMS from three UK Centres (30 from each centre); NHS Ayrshire and Arran, NHS Lothian, and Plymouth Hospitals NHS Trust.

The aim of this study is to assess the feasibility of a randomised controlled trial examining the effectiveness of a six-month web-based physiotherapy programme and usual care compared to usual care alone, in people moderately affected by MS and to gather essential information for the planning of a definitive trial, which would evaluate both clinical and cost effectiveness of the intervention.

Following baseline assessments, both groups will be given an appointment with the physiotherapist to agree shared goals and to devise an individualised exercise programme based upon their needs and treatment goals. Participants will then be randomised to one of two groups.

Participants randomised to the intervention group will receive their individualised exercise programme delivered via the web-based physio website. Participants will be asked to complete their exercise programme at least twice weekly. They will receive weekly standardised phone calls from the physiotherapist for the first two weeks of the programme. Every two weeks thereafter for the remainder of the 6 month intervention period the physiotherapist will review the exercise diary of each participant and remotely alter the participant's exercise programme as appropriate, by changing any combination of exercises, level of difficulty or number of repetitions. The number and type of exercises within the programme and duration to complete the exercise programme will be documented. Participants will be informed of any changes by standardised email.

Participants randomised to the control group will receive a print out exercise sheet of their individualised exercise programme. Participants will be asked to complete their exercise programme at least twice weekly. Compliance will be captured using a home exercise diary. Participants will also receive a weekly phone call from the physiotherapist for the first two weeks to check on progress.

Eligibility Criteria:
Inclusion Criteria:

* A confirmed diagnosis of MS
* Known to a MS consultant in NHS Ayrshire and Arran, Lothian or Plymouth Hospitals NHS Trust
* EDSS of 4 - 6.5
* Access to a personal computer/tablet or smart television with an email address and internet connection

Exclusion Criteria:

* Currently taking part in regular exercise (two or more times per week) and/or a regular physiotherapy programme
* Poor cognitive function as assessed by a Mini Mental State Examination Score (MMSE) \<24
* Any significant change in medication (within the last 3 months)
* Relapse within 3 months requiring treatment
* Other significant co-morbidities for which exercise is contra-indicated
* Unwilling to be randomised to intervention/control group
* Currently participating in another clinical trial (rehabilitation or pharmacological)
Mineral Water Rich in Magnesium and Perceived Stress in Healthy Consumers

The goal of clinical trial is to evaluate the effect of one month of consumption of mineral water rich in magnesium or not on perceived stress, duration and quality of sleep in healthy consumers having magnesium daily intakes below the recommended dietary allowance (RDA).

This is a single-center, double-blind, controlled, randomized, 2 parallel-groups clinical trial.

256 healthy volunteers will be recruited for clinical trial if they meet the inclusion and no inclusion criteria.

50% of volunteers (Mg+ group) will drink daily 1,5 L of mineral water rich in magnesium during 30 days

50% of volunteers (Mg- group) will drink daily 1,5 L of water low in magnesium during 30 days

Volunteers in both groups will be equipped with a wristband-connected device allowing recording of duration and quality of sleep.

Eligibility Criteria:
Inclusion Criteria:

* a magnesium daily intakes lower than the recommended dietary allowance (RDA)
* a score at perceived stress scale (PPS) greater than or equal to 25
* BMI \> 18 et \< 25 kg/m2
* Describing himself as tired for reasons of stress or lack of sleep.
* Do not take any medication likely to act on stress and sleep as anxiolytics, hypnotics, antidepressants, etc.
* Knowing read and write French routinely,
* Possessing an internet connection at home,
* Possessing and knowing how to use a computer or tablet,
* Owning a smartphone,
* Affiliated with a social security scheme
* Not Trust
* Having signed the informed consent letter

Exclusion Criteria:

* Pregnant or breast-feeding or planning an early pregnancy during the study
* Severe chronic condition or type of acute disease: vascular cardio - pulmonary - renal - Hematologic - Liver - endocrine (thyroid) - allergic
* Inability to understand information about the protocol and / or to sign the informed consent
Long Term Follow-Up Study of Human Immunodeficiency Virus Type 1 (HIV-1) Positive Patients Who Have Received OZ1 Gene Therapy as Part of a Clinical Trial

The purpose of this Observational Study is long term follow-up of the Human Immunodeficiency Virus -1 (HIV-1) infected patients who have received a gene therapy product (anti-HIV-1 Ribozyme \[OZ1\]) as part of an earlier phase 2 trial. Patients are seen twice yearly until 5 years from initial infusion of study drug has elapsed and then yearly until withdrawal or study completion. The study will monitor for and record any ill effects from the gene therapy product to provide long term safety information.

During an earlier phase 2 base trial (study # NCT00074997), HIV-1 infected patients received a gene therapy product (anti-HIV-1 Ribozyme \[OZ1\]). Gene therapy is an investigational treatment where genes are inserted into an individual's cells and tissues to treat a disease. The gene therapy OZ1 is thought to have anti-HIV-1 actions. This is an Observational Study to provide long term follow-up of those HIV-1 infected patients who received the gene therapy product (anti-HIV-1 Ribozyme \[OZ1\]) as part of the earlier study. Patients are seen twice yearly until 5 years from initial infusion of study drug has elapsed and then yearly until withdrawal or study completion. The study will monitor for and record any ill effects from the gene therapy product to provide long term safety information. Observational study - no investigational drug administered.

Eligibility Criteria:
Inclusion Criteria:

* All patients who were enrolled (between 18 and 45 years of age) in the base study "OTH/OZ1-INT-1" (NCT00074997) will be invited to participate in this long term follow-up study
* Patients must have received the Final Cell Product infusion in base study "OTH/OZ1-INT-1"
* Have signed Informed Consent Form

Exclusion Criteria:

* All patients who were enrolled in the OTH/OZ1-INT-1 study and received the final cell product will be invited to participate in this long term follow-up study. After unblinding of the OTH/OZ1-INT-1 study, any patients in the placebo arm will be withdrawn from this protocol
FArial NErf MRI in the Preoperative Assessment of PArotide Tumors

1. st visit: Inclusion, 3Tesla injected parotid MRI performed as part of routine care for characterization, to which two specific high resolution sequences will be added. Evaluation of the exact position of the parotid tumor relative to the trunk of the facial nerve and its first branches, classification into two categories: on contact (≤ 5 mm) or at a distance (\> 5 mm).
2. nd visit: Surgical intervention of the parotid tumor. The surgeon will specify the same data as that collected by the radiologists after the MRI.
3. rd visit: Post-operative consultation in the week following the intervention. The surgeon will look for the occurrence of post-operative facial paralysis.


Eligibility Criteria:
Inclusion Criteria:

* Patient over 18 years old
* Patient candidate for first line surgery for a parotid tumor
* Parotid tumor located near the trunk of the facial nerve and or its first branches of division according to the clinical examination of the ENT surgeon and the imaging data
* Affiliate or beneficiary of a social security scheme
* Written consent to participate in the study

Exclusion Criteria:

* Personal history of parotid homolateral surgery
* Absolute or relative contraindication to MRI
* Known hypersensitivity to gadolinic contrast media
* Pre or post operative period of a liver transplant
* Patient benefiting from a legal protection measure
* Pregnant or lactating woman
* Patient who has already benefited from a preoperative MRI to characterize a complete, well conducted and interpretable parotid lesion
Epidemiologic Analysis of Change in Eyelash Characteristics With Age in Healthy Women

This study will asses epidemiologic changes in eyelash characteristics with increasing age.


Eligibility Criteria:
Inclusion Criteria:

* Willing to have photographs taken of the face/eye regions

Exclusion Criteria:

* No visible eyelashes
* Permanent eyeliner or eyelash implants
* Semi-permanent eyelash tint, dye, or extensions within the last 3 months
* Use of prescription eyelash growth products in the last 6 months
SHP2 Inhibitor BBP-398 in Combination With Nivolumab in Patients With Advanced Non-Small Cell Lung Cancer With a KRAS Mutation

This is a Phase 1 study of BBP-398, a SHP2 inhibitor, in combination with nivolumab, a PD-1 antibody, in patients with NSCLC with a KRAS mutation. The study involves 2 parts: Phase 1a Dose Escalation and Phase 1b Dose Expansion.

The primary objective for Phase 1a Dose Escalation is to evaluate the safety, tolerability, and RP2D of BBP-398, a SHP2 inhibitor, when used in combination with nivolumab in patients with advanced NSCLC with a KRAS mutation who have failed standard of care treatment.

The primary objective for Phase 1b Dose Expansion is to evaluate the antitumor activity of BBP-398, as defined by the ORR (per investigator) according to RECIST v1.1, when used in combination with nivolumab in patients with advanced NSCLC with a KRAS mutation who have failed standard of care treatment.

Eligibility Criteria:
Key Inclusion Criteria:

* Patients must have histologically documented, locally advanced and unresectable, or metastatic NSCLC with documentation of a KRAS mutation within the 1 year prior to screening.
* Patients must have measurable disease by RECIST v1.1.
* Patients must have a minimum life expectancy of \>12 weeks after start of study treatment.
* Patients must have progression or disease recurrence on or after at least one prior line of systemic therapy, which must include platinum-based doublet chemotherapy and anti-PD-(L)1 therapy.
* Patients must have experienced progressive or recurrent disease occurring either during treatment or within 90 days after discontinuing anti-PD-(L)1 therapy.
* Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1.
* Patients must have adequate organ function.

Key Exclusion Criteria:

* Patients that have participated in an interventional clinical study within the last 4 weeks.
* Patients that have received radiotherapy or proton therapy with a limited field of radiation for palliation within 1 week of the start of study treatment, OR radiation to more than 30% of the bone marrow or with a wide field of radiation within 4 weeks of the start of study treatment.
* Patients with known central nervous system (CNS) tumors or active CNS metastases.
* Patients that have experienced progressive disease (PD) within the first 120 days of initiating treatment with an anti- PD-(L)1 agent (e.g., primary refractory).
* Patients that have a history of allogenic bone marrow transplant.
* Patients that have select known or suspected autoimmune disease.
* Patients that have a condition requiring systemic treatment with either corticosteroids (\>10 mg prednisone equivalent) or other immunosuppressive medication within 14 days of study start.
* Patients that have received any live/attenuated vaccine within 30 days of first study treatment.
Effects of Flutamide on Insulin and Glucose Metabolism in Women With Polycystic Ovary Syndrome

Polycystic Ovary Syndrome (PCOS) is the major cause of infertility in the United States. Many women with PCOS demonstrate insulin resistance and a compensatory hyperinsulinemia.This is due to both an intrinsic form of insulin resistance unique to PCOS and, in many cases, acquired insulin resistance due to obesity. The importance of this observation lies in the fact that hyperinsulinemia appears to play an important pathogenetic role in the hyperandrogenism and anovulation of both obese and lean women with PCOS.

Hyperinsulinemia stimulates ovarian production of androgens, especially testosterone, in PCOS. Therefore, it is theoretically possible that testosterone increases urinary clearance of D-chiro-inositol (uCl(DCI) in PCOS, and that this serves as the explanation for the correlation between uClDCI and insulin sensitivity. While we regard this possibility as unlikely, it is important that it be tested. To accomplish this, we will assess obese (Body Mass Index (BMI) \>30 kg/m2) women with and without PCOS at baseline, and again after 4 weeks of androgen action blockade with the drug flutamide. Flutamide is an antiandrogen that works by blocking the binding of androgens to the androgen receptor.

We will determine if this pharmacologic blockade i) decreases the renal clearance of DCI, ii) increases the circulating concentration of DCi, and iii) enhances the insulin-stimulated release of the D-chiro-inositol-containing inositolphosphoglycan (DCI-IPG) mediator during an OGTT.

Eligibility Criteria:
Inclusion Criteria:

(1) Obese (BMI≥30 kg/m2) women with PCOS between 18-40 years of age: i) oligomenorrhea (8 menstrual periods annually), ii) biochemical hyperandrogenemia (elevated total or free testosterone), iii) normal thyroid function tests and serum prolactin, and iv) exclusion of 21α-hydroxylase deficiency by a fasting 17α-hydroxyprogesterone \<200 ng/dl.48, (2) acceptable health on the basis of interview, medical history, physical examination, and laboratory tests (complete blood chemistry (CBC), complete metabolic panel (CMP), urinalysis, serum Beta-Human Chorionic Gonadotropin (BhCG)). (3) Signed, witnessed informed consent. (4) Ability to comply with study requirements.

Exclusion Criteria:

(1) Diabetes mellitus by fasting glucose or oral glucose tolerance test (OGTT), or clinically significant pulmonary, cardiac, renal, hepatic, neurologic, psychiatric, infectious, neoplastic and malignant disease (other than non-melanoma skin cancer). (2) Current use of oral contraceptives. (3) Documented or suspected recent (within one year) history of drug abuse or alcoholism. (4) Ingestion of any investigational drug within two months prior to study onset.

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Before-after Comparison of Pharmacist Drug Therapy Management in Pediatric Hypertension

This study will measure the effect of a novel pharmacy practice model on pediatric patients with hypertension. In North Louisiana, many patients have to travel to see subspecialists for treatment for hypertension and elevated blood pressure, which has many costs including direct medical costs, direct nonmedical costs, and indirect costs like missed time from work, school, or social obligations. Also, many patients who have to travel to get to their appointments have a high rate of missed appointments, which can be bad for overall health.

This study will use a pharmacist to perform collaborative drug therapy management with pediatric cardiologists to manage therapy for patients with hypertension or elevated blood pressure. Patients will monitor blood pressure at home and follow up with the pharmacist by telecommunications. Pharmacist drug therapy management and telemedicine have been studied separately, but this is the first study with pharmacist drug therapy management by telemedicine for pediatric patients. If this model is successful, it could be replicated in other rural areas to improve patient care and reduce healthcare costs.


Eligibility Criteria:
Inclusion criteria:

* Diagnosis of elevated blood pressure or hypertension.
* Physician decision to treat with drug therapy or lifestyle modifications and physician referral to pharmacist.
* Consent both to therapy with pharmacist and participation in study (Note: in the state of Louisiana, patients must provide consent to be treated in a collaborative drug therapy management program).
* For patients younger than 18, informed assent and parental permission to participate in the study. For patients who turn 18 during the study, informed consent will be obtained on the first visit after they turn 18.
* Males and females; age 4-20 at enrollment
* Willingness to adhere to study regimen

The same inclusion criteria will apply to control patients except that:

* They will have been treated at the clinic for hypertension or elevated blood pressure during the control period.
* A waiver of consent has been obtained for historical data.

Exclusion Criteria:

* Physical preclusion to taking blood pressure, such as lack of limbs or any congenital or acquired anatomical defect preventing routine measurement of blood pressure
* Participation in another treatment or intervention study for hypertension during the study period
* Inability to speak English
* For patients under 18 years old, not having at least one parent or guardian able to speak English
* Patients who are pregnant
Stem Cell Migratory Activity: Prognostic Marker in Myocardial Ischemia

The present project aims to determine whether a deficit in migration of stem cells could be implicated in the failure to mount an adequate collateralization after Myocardial Infarction (MI) and thereby facilitate the development of post-ischemic heart failure (HF) and to dissect underlying molecular mechanisms. Furthermore, the investigators wish to determine the predictive value of stem cell migration assay in patients with MI.

MAIN OBJECTIVES OF THE STUDY:

Characterization of circulating CD133+ stem cells in a group of 170 patients with MI (mean post-MI follow up, 6 months):

* Counting total mononuclear cells and FACS analysis of CD133 stem cells.
* Characterization of CD133+ stem cell biology: Migratory assay, imaging of cytoskeleton, angiogenesis tests in vitro.
* Evaluation of migratory signalling, with specific focus on the PI3K/Akt/eNOS system.

Assessment of the prognostic value of the stem cell migration assay.

* Relationship between cell biology tests on CD133+ cells and changes in circulating cytokines and pro-angiogenic factors after MI.
* Assessment of area at risk by ECG-synchronized Single Photon Emission Computed Tomography (gated-SPECT) in subgroups with different patterns of stem cell migratory tests.
* Assessment of ventricular remodelling (echocardiography, NMR) in relation with patterns of stem cell migratory test.

EXPECTED RESULTS:

Clarification of the implication of stem cell migratory deficit in post-ischemic HF.

* Identification of underlying mechanisms
* Identification of a cellular marker for prediction of patients at risk of HF.

RELEVANCE TO PUBLIC HEALTH:

* Introduction of a biological test for the early diagnosis of post-MI HF
* Recognition of therapeutic targets for the rescue of stem cell migratory liabilities

Eligibility Criteria:
Inclusion Criteria:

* Age \>= 18 years
* Thoracic pain lasting at least 20 min and ST changes or left B block, not present in previous ECG.
* MI confirmed by elevation of troponin I and CK-MB.
* Patients with Killip II e III LV dysfunction will be included.

Exclusion Criteria:

* Patients reporting thoracic pain 24 hours prior to hospitalization
* HF symptoms resistant to therapy
* Haemoglobin\< 10 gr/dl
* Haemodynamic instability (systolic pressure \<90 mmHg after treatment)
* Alterations in haematopoiesys
* Concurrent neoplastic disease
* No written informed consent or other conditions that affect patient's compliance to protocol.
Prospective Study on a Novel Port-site Closure Device (EZ Close): Effectiveness and Comparison With Carter-Thomason

This study aims to evaluate the efficacy and safety of a novel port-site closure device (EZ Close) by comparing it with the Carter-Thomason device.

Port-site closure is a critical procedure after every laparoscopic surgery. Complications such as visceral organ injury, port-site hernia, infection, ascitic fluid leakage may occur during and after the procedure. Many devices were developed and utilized for the procedure and Carter-Thomason is one of the most commonly used device and validated with several studies. This study aims to evaluate the efficacy and safety of a novel port-site closure device (EZ Close) by comparing it with the Carter-Thomason device.

Eligibility Criteria:
Inclusion Criteria:

* All patients with laparoscopic ports over 10mm

Exclusion Criteria:

* Patients with laparoscopic ports under 10mm
* Patients who refused the study
* Patients who received concurrent surgery for other reason
Assessment of Intrahepatic Hepatitis C Virus (HCV) RNA Levels at the Time of Liver Transplantation

The purpose of this study is to measure intrahepatic HCV RNA levels at the time of liver transplantation in patients receiving antiviral therapy while on the liver transplant waiting list. This will eventually be correlated with the degree of hepatic fibrosis present within different geographic sites in the cirrhotic liver. Tissue samples will be obtained from the patient's liver explant as well as hilar lymph nodes. Upon the removal of the cirrhotic liver at the time of transplantation, the explant will be biopsied multiple times in different segments of the liver and preserved for viral detection studies as well as analysis of the degree of fibrosis. Peripheral blood mononuclear cells (PBMCs) will be obtained for viral detection at the time of transplantation. Serum HCV RNA levels will also be obtained at 1 month, 3 months and 6 months post liver transplantation.

Study Hypotheses:

* Virological relapse or non-response is higher is patients with cirrhosis due to failure of antiviral medication to concentrate adequately in a fibrotic liver having an altered sinusoidal micro-architecture
* HCV may persist in different geographic regions of the fibrotic liver in part predicated on blood supply to that area and this may have an effect on overall virological response. These differences in viral persistence and detection may exist in different lobes of the liver or even within a few centimeters within the same portion of the liver parenchyma.
* PBMC and hilar lymph nodes may be extrahepatic reservoirs of HCV viral persistence in patients receiving antiviral therapy and may account for virological relapse post-therapy
* There may be varying degrees of fibrosis within the same cirrhotic liver which may impact on hepatic synthetic function and antiviral response to treatment.


Eligibility Criteria:
Inclusion Criteria:

* Patients age 18-80 with chronic HCV on the liver transplant waiting list may be eligible for participation
* The following subjects will be enrolled:

  * Patients undergoing liver transplantation who are documented HCV viral load undetectable while on antiviral therapy
  * Patients receiving anti-viral therapy and who have a detectable HCV viral load
  * Patients not currently receiving antiviral therapy and are HCV PCR (+) will be included and serve as a comparison group

Exclusion Criteria:

* Patients who are co-infected with HIV and/or HBV will not be included