cyrilzakka/clinical-trials huggingface dataset:
Study on the Treatment of Anal Fistulas Using Alofisel Versus Fat Autologous Stem Cells

One of the newest and most innovative medicinal approaches is cell therapy. Several clinical trials and experimental investigations have looked into the feasibility of treating CD-related fistulas with stem cells.

The current indication for ALOFISEL® (active ingredient: Darvadstrocel) is the treatment of difficult perianal Crohn's fistulas that have not responded well to at least one conventional therapy or biotherapy.

This brand-new cell therapy medication is created using amplified allogeneic human adult mesenchymal stem cells from adipose tissue (ADSC). The supplier mandates that two patients be booked for a single dose of ALOFISEL® due to the medication's expensive price-roughly €54,000 for a single dose of 120 million-which cannot be stored once thawed.

Only one of the two patients receives therapy; the other serves as the backup patient. By doing this, another "back-up" patient who might receive no care at all is avoided.

An developing alternate approach to allogeneic ADSC injection for the treatment of complicated anal fistulas in CD is autologous fat injection. In recent years, autologous fat grafts have been the subject of in-depth research. They are popular because it is simple to get clinical samples (lipoaspirate, adipose tissue), and because there are a lot of ADSCs in adipose tissue. Additionally, ADSCs show strong immunomodulatory and regenerative capacities.

We would wish to compare the effectiveness of these two injection kinds on perianal fistulas as part of our care of CD.

The trial will be made available to patients who are scheduled for perianal surgery with ALOFISEL® or backup (fat injection). The history and signs of perianal fistula will be noted if the patient doesn't object.

Two visits that correspond to typical follow-up visits for patients will be noted:

Visit following surgery: fistula clinical evaluation, analgesic use, etc. and six months after : clinical assessment, MRI

Eligibility Criteria:
Inclusion Criteria:

* Complex anal fistula with the following criteria: - Inactive/slightly active luminal Crohn's disease under conventional treatment or biotherapy MRI has demonstrated effective drainage. Maximum of two internal orifices and three external orifices; persists despite internal orifice(s) closing.

Exclusion Criteria:

* Pregnant or breast-feeding women
* Patients hypersensitive to the product, bovine serum or any of the excipients of Alofisel
* Vulnerable persons: deprived of liberty, under guardianship, under curatorship, etc.
Mesenchymal Stem Cell Transplantation for Osteoarthritis

The purpose of this study is to explore the efficacy and safety of autologous bone marrow-derived mesenchymal stem cells (BMSCs) plus autologous platelet rich plasma (PRP) in the treatment of severe knee osteoarthritis.

This is a single centered, randomized, single blind phase II clinical study. Patients will be divided into two groups of case and control. Patients of case group will receive intra-articular injection of autologous BMSCs suspended in 3 ml autologous PRP for 3 times, patients of control group will receive intra-articular injection of 3 ml of autologous PRP for 3 times. The investigators designed this clinical study to evaluate therapeutic effects of BM-MSCs in patients with severe knee osteoarthritis.

Eligibility Criteria:
Inclusion Criteria:

1. Subject has Kellgren and Lawrence grade II-IV primary osteoarthritis as determined by X-ray.
2. Subject's pain score is 8-13 points (Lequesne's index).
3. Ages between 40-70 years.
4. Signed informed consent from the subject.-

Exclusion Criteria:

1. Subject infected with hepatitis B, hepatitis C, HIV, syphilis or HTLV
2. Subject not suitable for bone marrow suction surgery.
3. Subject with hypersensitivity/allergy to anesthetic.
4. Subject's creatinine values higher than 1.6mg/dl.
5. Subject with body mass index, BMI over 30.
6. Subject's studied knee treated with intra-articular injection therapy within 6 months prior to screen.
7. Subject has undergone surgery on studied knee, including fracture surgery, arthroscopic surgery, meniscus repair surgery, or cruciate ligament reconstruction surgery.
8. Subject enrolled in any other cell therapy studies within the past 30 days.
9. Subject who the investigator considers inappropriate for the clinical trial due to any other reasons than those listed above.
10. Subject has a history of gouty arthritis, septic arthritis, rheumatoid arthritis and any other autoimmune arthritis of the knee joint.
11. Subject has had major medical problems in vital organs, such as; heart, liver, kidney, or lung.-
Replacing Canes With an Elasticated Orthosis in Chronic Stroke Patients: The Influence on Gait and Balance. A Series of N-of-1 Trials

This study aims to investigate the effect of an elasticated orthotic garment "Thera Togs" on walking ability and balance in currently cane using chronic stroke subjects (minimum 6 months post stroke) using a series of N-of-1 Trials.

Aim: To investigate the effect of replacing canes with an elasticated orthotic-garment on gait and balance in chronic stroke subjects.

Design Experimental, multiple baseline N-of-1 series with an ABC design with randomised period duration.

Participants Four cane using chronic stroke subjects. Interventions Phase A (9-12 weeks) usual cane-walking to establish baseline values; Phase B (9-19 weeks) intervention: orthotic-garment worn throughout the day with maximal cane reduction; Phase C (9-10 weeks) individually determined follow-up: either no walking-aid, orthotic-garment or cane.

Weekly measurement of Outcome Measures for gait and balance function

Eligibility Criteria:
Inclusion Criteria:

* Chronic stroke (\> six months since last stroke)
* Independent cane walkers. Subjects usually use canes to walk inside (this could be intermittent changing from cane to holding furniture etc.) and always when outside
* A Mini Mental Score of 22 or above.

Exclusion Criteria:

* Patients at risk of falling identified as a Berg Balance Score ≤42/56
Mucosal-Associated Invariant T Cells in Cases of Miscarriage

Miscarriage is the most frequently encountered complication of pregnancy ranging from 10% to 30%. The etiology of recurrent spontaneous miscarriage (RSM) in 40%-50% of cases cannot be identified. Immunological disturbances have been suggested to play an important role.

Previous studies have focused that women with miscarriage have elevated NK cell numbers and activity both in the periphery and in the endometrium. Also, NK cells in women with RSM displayed an imbalance of Killer cell Ig-like receptors (KIRs) in favor of activating KIR leading to an unbalanced activation of dNK cytotoxicity and higher risk of miscarriage.


Eligibility Criteria:
Inclusion Criteria:

* Regular marital life with the same partner.
* Regularly menstruating before current pregnancy.
* Spontaneous conception.

Exclusion Criteria:

* Women with Polycystic ovarian syndrome or any endocrinal abnormalities like DM, thyroid disorders.
* History of abnormal uterine cavity proved by sonohysterography or hysteroscopy before pregnancy.
* Women with positive consanguinity.
Study Targeting Affect Regulation

This Phase Ib pilot RCT will examine the safety, feasibility, and acceptability of a multi-component intervention to address traumatic stress symptoms among HIV-positive, methamphetamine-using men who have sex with men (MSM). Following a baseline assessment, 56 participants will be randomized to receive either: 1) a 7-session intervention to address traumatic stress related to living with HIV/AIDS; or 2) a 7-session, attention-control condition. Follow-up assessments will be administered at 1 and 3 months post-randomization.

In the multi-component intervention protocol, participants will complete expressive writing exercises where they will be asked to write about difficult life experiences. Following expressive writing, participants will receive stress management skills training to assist them with managing any acute increases in distress that arise from the writing experience. Participants in the attention-control condition will write about neutral topics and complete psychological measures. The overarching goals of this Phase Ib RCT will be to: 1) examine the feasibility and acceptability of the intervention and attention-control; and 2) determine whether intervention participants report reductions in traumatic stress symptoms over the 3 months following randomization. Findings from this Phase Ib trial will inform our efforts to implement a more definitive RCT of this intervention with HIV-positive, methamphetamine-using MSM.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* Speak English
* Self-identify as a man who has sex with men
* Have been diagnosed with HIV for at least 3 months
* Provide evidence of HIV-positive serostatus
* Report using methamphetamine during the past 30 days

Exclusion Criteria:

* Do not have the capacity to provide informed consent
Probiotics to Promote Intestinal Health

The purpose of this study is to evaluate the effectiveness of bacteria called Lactobacillus GG, a Probiotic, in preventing the growth of resistant bacteria in the digestive tract in patients on broad spectrum antimicrobials.


Eligibility Criteria:
Inclusion Criteria:

* Adults ≥ 18 years old
* Admission to the non-ICU medical and surgical wards
* On broad spectrum antimicrobials with an anticipated length of stay of \>48 hours

Exclusion Criteria:

* Pregnancy
* Non English speaking
* Expected to die within 7 days
* Unable or unwilling to consent
* HIV infection with a CD4 count \<200
* Neutropenia with an absolute neutrophil count less than 500 cells/ml (or expected to drop to less than 500)
* Clinically significant diarrhea or history of C. difficile infection in the last 3 months
* History of VRE colonization and/or infection in the last year
* Transplant recipients
Pharmacokinetics of Fevipiprant (QAW039) in Patients With Hepatic Impairment Compared to Matched Healthy Subjects

This study will characterize the pharmacokinetics (PK) of QAW039 after a single oral dose of QAW039 in patients with hepatic impairment compared to healthy matched control subjects.

The purpose of this study is to determine if the pharmacokinetic profile of Fevipiprant is different in patients with hepatic impairment compared to healthy matched volunteers to an extent that would require an adjustment of the dosage. Data from this study will be used to guide enrollment criteria in future clinical trials and to support regulatory submission and labeling information.

Eligibility Criteria:
Inclusion Criteria:

All subjects

- Weight of at least 50 kg and no more than 120 kg and have a body mass index in the range 18.0-36.0 kg/m2

Patients with hepatic impairment

* Moderate hepatic impairment (Group 1): Child-Pugh Class B (7-9 points),
* Severe hepatic impairment (Group 2): Child-Pugh Class C (10-15 points
* Mild hepatic impairment (Group 4): Child-Pugh Class A (5-6 points)

Healthy subjects

* Match in age (±5 years), gender, smoking status, and weight (± 15%) to an individual patient.
* In good health as determined by past medical history, physical examination, electrocardiogram, laboratory tests and urinalysis at screening.

Exclusion Criteria:

All subjects

* History of hypersensitivity and/or idiosyncracies to QAW039 or to drugs of similar classes (CRTh2 antagonists).
* Use of co-medications that may impact QAW039 exposure such as broad range UGT inhibitors or strong inhibitors of OAT3, OATP1B3, and P-gp, including but not limited to probenecid, ritonavir, valproic acid, and rifampin
* Surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of drugs, or which may jeopardize the subject in case of participation in the study.
* History of malignancy of any organ system (other than localized basal cell carcinoma of the skin), treated or untreated, within the past 5 years, regardless of whether there is evidence of local recurrence or metastases.
* Pregnant or nursing (lactating) women.
* Women of child-bearing potential

Patients with hepatic impairment

* Hepatic impairment due to non-liver disease (e.g., right heart failure)
* Current symptoms or history of encephalopathy Grade III or IV within the past 6 months
* Primary biliary liver cirrhosis and biliary obstruction
* Emergency room visit or hospitalization due to liver disease within the preceding 3 months.
* Severe complications of liver disease within the preceding 3 months.

Healthy subjects

* Liver disease or liver injury as indicated by abnormal liver function tests.
* Any single parameter of ALT, AST, γ-GT, alkaline phosphatase or serum bilirubin must not exceed 1.5 x upper limit of normal (ULN)
* Any elevation above ULN of more than one parameter of ALT, AST, γ GT, alkaline phosphatase or serum bilirubin will exclude a subject from participation in the study
* A positive Hepatitis B surface antigen or Hepatitis C test result.
A Pilot Study of Rapid Haplotyping Procedure for Personalized Dosing of Dichloroacetate (DCA) in Healthy Volunteers

The purpose of this study is to identify and analyze the frequency of GSTZ1 haplotypes in a healthy adult population and determine the pharmacokinetics of Dichloroacetate (DCA) metabolism based on haplotype analysis.

The DCA drug is the first targeted treatment for Pyruvate Dehydrogenase Complex Deficiency (PDCD).

This pilot study, focuses on developing a high throughput, sensitive and accurate screening test for determining glutathione transferase zeta 1 (GSTZ1) haplotype status in individuals who would be treated with DCA.

Pyruvate dehydrogenase complex (PDC) deficiency (PDCD) is a rare disease of mitochondrial energy failure with the life of expectancy of affected children severely truncated. Treatment of PDCD remains a serious, unmet challenge. Dichloroacetate (DCA) represents the first targeted therapy for PDCD by stimulating residual PDC activity. Cumulative experience with DCA has revealed dose accumulation in a subset of the population. This can be abated through personalized dosing of DCA, assigned by haplotype variation in the gene encoding glutathione transferase zeta 1 (GSTZ1), which biotransforms DCA to glyoxylate. Haplotype variations in GSTZ1 influence the kinetics and dynamics of chronically administered DCA. A single dose of DCA has a bioavailability approaching unity and is widely distributed throughout the body. The plasma half-life (t ½) is \~1 hr in drug-naïve subjects. Gender does not influence DCA kinetics or metabolism. The major route of biotransformation is via dehalogenation to glyoxylate by glutathione transferase zeta 1 (GSTZ1). DCA is a mechanism-based inhibitor of GSTZ1, so repeated administration results in increased plasma t ½ and decreased clearance.

Eligibility Criteria:
Inclusion Criteria:

* Healthy as outline in the physical exam and blood tests
* Non smoker

Exclusion Criteria:

* Cannot comprehend or refuse to sign the informed consent form;
* Febrile or have other clinical signs of infection;
* Pregnant or are nursing;
* In females, cannot or refuse to use contraception or avoid unprotected intercourse during the study;
* Uncontrolled hypertension (BPs \> 160 mmHg or BPd \> 100 mmHg) on conventional medication;
* Anemic (hematocrit \< 35% in males; \< 35% in females;
* Serum creatinine ≥ 1.3 mg/dl, TSH \> 4.5 mIU/ml; a transaminase (ALT or AST) \> 2 x ULN, total bilirubin \> 1.2 mg/dl or fasting glucose ≥ 110 mg/dl.
* History of psychosis, seizures or diabetes mellitus or be receiving anti-psychotic, anti-epileptic or blood glucose-lowering medication.
Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy in Peritoneal Carcinomatosis From Gastric Cancer

Gastric cancer associated peritoneal carcinomatosis has a poor prognosis with a median survival of less than one year. Systemic chemotherapy including targeted agents has not been found to significantly increase the survival in Gastric cancer associated peritoneal carcinomatosis. Since recurrent gastric cancer remains confined to the abdominal cavity in many patients, regional therapies like aggressive cytoreductive surgery and hyperthermic intraperitoneal chemotherapy have been investigated for Gastric cancer associated peritoneal carcinomatosis. Hyperthermic intraperitoneal chemotherapy has been used for three indications in Gastric Cancer- as an adjuvant therapy after a curative surgery, hyperthermic intraperitoneal chemotherapy has been shown to improve survival and reduce peritoneal recurrences in many randomised trials in Asian countries; as a definitive treatment in established PC, hyperthermic intraperitoneal chemotherapy along with cytoreductive surgery is the only therapeutic modality that has resulted in long-term survival in select groups of patients. While the results of randomised trials of adjuvant hyperthermic intraperitoneal chemotherapy from western centres are awaited, the role of hyperthermic intraperitoneal chemotherapy in the treatment of Gastric cancer associated peritoneal carcinomatosis is still evolving and needs larger studies before it is accepted as a standard of care.


Eligibility Criteria:
Inclusion Criteria:

* Confirmed peritoneal carcinomatosis from gastric cancer
* Metachronous/synchronous peritoneal carcinomatosis

Exclusion Criteria:

- Gastric origin of peritoneal carcinomatosis unconfirmed
506U78 In Relapsed Or Refractory Acute Lymphoblastic Leukemia (T-ALL)

The purpose of this study is to determine whether Nelarabine is effective in the treatment of patients with T-ALL/NHL in order to achieve a complete remission followed by an early stem cell transplantation.


Eligibility Criteria:
Inclusion Criteria:

* T-ALL; T-NHL
* age \>= 18 years
* cytological treatment failure / relapse
* molecular treatment failure / relapse
* no promising therapy alternatives with approved medication available
* no CNS-manifestation, requiring intrathecal therapy or CNS-radiation
* no convulsive disease or neurotoxicity \> grade III in patients history
* written informed consent
* no cytostatic therapy in the last 10 days
* no pregnancy or breastfeeding
* effective contraception
* recovery of toxicities of previous chemotherapy - except leukemia- related changes like bone marrow suppression or pathological transaminases in liver manifestation

Exclusion Criteria:

* Severe psychiatric illness
* uncontrolled or severe cardiac disease or infection
* active secondary neoplasms - except skin cancer (no melanoma)
Risk Factors and Biomarkers for Post-tuberculosis Lung Damage

This prospective study aims to determine the incidence of Post-tuberculosis lung damage (PTLD), examine trends in the changes in lung function, and investigate the impact of smoking and other factors on respiratory symptoms, lung function, and chest CT findings, which will aid in the development of prognostic and therapeutic strategies for PTLD.

Introduction: Post-tuberculosis lung damage (PTLD) refers to residual pulmonary impairment following the completion of tuberculosis (TB) treatment, characterized by persistent respiratory symptoms and abnormal pulmonary function. The risk factors and biomarkers for PTLD have been scarcely investigated. Additionally, it remains unclear whether and to what extent cigarette smoking affects PTLD in patients with TB.

Methods and analysis: This prospective observational study will enroll 400 adult male ever-smoker or never-smoker patients aged 25-60 years, with newly confirmed active TB between 2022 and 2024 from the Department of Respiratory and Critical Care Medicine at Peking University Third Hospital and the Tuberculosis Department at Beijing Geriatric Hospital. Baseline data (age, smoking history, and smoking pack-years), clinical symptoms, lung functions, and chest CT (computed tomography) findings will be prospectively collected. Respiratory questionnaires, lung function measurements, and chest CT examinations will be completed during follow-up visits at 6 months after the initiation of TB treatment, immediately at the completion of TB treatment, and at 1 year, 2 years, and 3 years after the completion of TB treatment. Peripheral blood samples will be obtained at baseline to measure inflammatory mediators and cytokines in serum. The collected data will be analyzed to determine the incidence of and factors/biomarkers for PTLD after TB treatment.

Eligibility Criteria:
Inclusion Criteria:

Male patients aged 25-60 years newly diagnosed with active pulmonary TB.

Exclusion Criteria:

1. patients with positive sputum smear or TB culture results;
2. human immunodeficiency virus-positive patients;
3. patients infected with multidrug-resistant TB;
4. patients with malignant neoplasms (e.g., lung cancer) or severe cardiovascular and cerebrovascular diseases;
5. non-compliant patients who were unable to complete the lung function tests;
6. patients without lung parenchymal destruction (such as tuberculous pleurisy). -
Digital Health Program With Participants Using an Autoinjector

This is a prospective, single-arm, feasibility study. Up to thirty (30) participants meeting study eligibility criteria will use the SK-M11/3A1 digital health program for 12 weeks. The program will be delivered via the Sidekick mobile application (app).

The study objective is to evaluate the performance and safety of the SK-M11/3A1 digital health program when added to routine medical treatment of patients with Immune-Mediated Inflammatory Disease (IMID). All participants are using a prescribed medication for regular subcutaneous injection provided in a prefilled autoinjector.

Numerous therapies are formulated for subcutaneous injections, enabling patients and caregivers to administer them at home instead of intravenously in-clinic. Despite the notable benefit and decrease in the treatment burden, the act of self-injecting and at-home administration inevitably imposes a substantial responsibility and burden on the patient.

To support the efforts to improve medication adherence and make the process of self-injecting more user friendly and easy, Sidekick Health (SKH) has developed a digital health program designed specifically for this purpose (SK-M11). SKH has paired this with disease-specific content that is indicated for patients with an Immune-Mediated Inflammatory Disease (IMID) (SK-3A1), addressing some of the most common challenges these patients encounter, as well as general assistance with making healthy lifestyle choices.

The aim of this study is primarily to assess the acceptability and feasibility of combining the SK-M11 and SK-3A1 and adding the digital health program to the Standard of Care (SoC) by measuring participants engagement, retention and satisfaction. Up to 30 IMID patients using a prescribed medication for regular subcutaneous injection provided in a prefilled autoinjector for self-injection in the home environment will be included. The participants will use SK-M11/3A1 for the study period of 12 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Adults 18 years or older
* Patients diagnosed with IMID and already using or initiating an IMID therapy with a medicine for regular subcutaneous injection provided in a prefilled autoinjector for self-injection in the home environment, as prescribed by their doctor.
* Owns a smartphone compatible with the SK-M11/3A1 digital health program and is willing and able to use it
* Participant has been informed of the nature of the study and has been provided with electronic informed consent approved by the appropriate Independent Ethics Committee (IEC)
* Willing and able to comply with all protocol-specified items (app use, all scheduled visits, and completing questionnaires/surveys)

Exclusion Criteria:

* The patient has other concurrent conditions that in the opinion of the Investigator may compromise patient safety or study objectives
* Pregnant and/or breastfeeding females (self-reported) at baseline or during the course of the study (12 weeks)
* Enrollment in a concurrent study in which the study treatment may confound the evaluation of the investigational program.