cyrilzakka/clinical-trials huggingface dataset:
A 52-Week Study to Learn About the Safety and Effects of Ritlecitinib in Participants With Nonsegmental Vitiligo

This study is to evaluate how safe and effective ritlecitinib is in participants with non-segmental vitiligo (NSV).

Ritlecitinib is studied in patients with non-segmental vitiligo. Vitiligo is a chronic acquired depigmentation disorder characterized by well-defined pale white patches of skin.

Non-segmental vitiligo is an autoimmune disorder and is the focus of this study. The study will show:

* if the repigmentation (the recovery of pigmentation) achieved in study B7981040 (also called the "parent study") will stay the same or will further increase if you keep receiving the same study medicine (ritlecitinib 50 milligrams or placebo)
* Or if more repigmentation can be achieved if you start receiving ritlecitinib 100 milligrams in this study
* Or how long the repigmentation achieved during the parent study lasts if you start receiving placebo in this study.

This study is seeking for participants who:

* have non-segmental vitiligo (either active or stable) and
* received ritlecitinib or placebo for 52 weeks in the parent study. A placebo looks exactly like the study capsule but does not contain any medicine in it.

All participants in this study will receive the study medicine or placebo. The study medicine (ritlecitinib 50 milligrams or 100 milligrams) or placebo are capsules that are taken by mouth at home every day. At week 4 (or if it cannot be done then, at week 8) study visit, you must take the medication at the study site, and not at home.

Participants may receive the study medicine or placebo for up to 52 weeks.

The study will look at the experiences of people receiving the study medicine. This will help see if ritlecitinib is better for treating vitiligo.

Participants will be involved in this study for a maximum of 60 weeks. During this time, they will have 9 study visits during the study.

Ritlecitinib 50 mg is an approved drug for the treatment of severe Alopecia Areata (a disease with similar abnormal changes in the body functions like vitiligo) in the US, EU and Japan. China, Great Britain and other market applications are pending.


Eligibility Criteria:
Inclusion Criteria:

* Participants ≥18 years of age at Screening in Study B7981040. Adolescents (12 to \<18 years of age at Screening in the parent study) are also eligible for this study if approved by the local IRB/EC and regulatory health authority.
* Participants who met the eligibility criteria and completed 52 weeks of study intervention for stable or active nonsegmental vitiligo in Study B7981040
* The BL visit/first dose in Study B7981041 must be within 30 days after the week 52 visit in Study B7981040

Exclusion Criteria:

* Participant met the parent study (Study 7981040) discontinuation criteria or discontinued the parent study for any safety-related event
* Any active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation
Recovery Therapy Trial

This project will systematically apply a specialist version of Cognitive Behaviour Therapy (CBT), known as Recovery Therapy, to a random sample of patients with psychotic disorders. Previously, the therapy has been developed and efficacy established, but the extent of applicability to (unselected) mental health service patients is unknown. The main aim is to establish the extent to which this therapy is acceptable and effective for mental health service clients. A secondary aim is to develop guidelines for the conduct of such therapy in public mental health settings.


Eligibility Criteria:
Inclusion Criteria:

* acceptance by the participating Community Mental Health Services for case management
* a preliminary DSM-IV diagnosis of schizophrenia, schizoaffective disorder, mood disorder with psychotic features, or delusional disorder
* a recovery "need" in one of the areas addressed by the therapy

Exclusion Criteria:

* a preliminary DSM-IV diagnosis of brief psychotic disorder, drug-induced psychosis, mood disorder without hallucinations or delusions, or any other disorder (eg. personality disorder, PTSD) even where psychotic features are/have been present
* non-English speaking
* comorbid intellectual disability
Chemoradiotherapy With Targeted Immunotherapy in Pediatric Lymphoma

The addition of targeted immunotherapy will be safe and well tolerated and facilitate the reduction of anthracycline exposure while preserving lymphoma disease control in children, adolescents and young adults (CAYA) with mature B-cell non-Hodgkin lymphoma (MB-NHL) and classical Hodgkin lymphoma (cHL).

The primary objective is 1) to determine feasibility and safety, as defined by dose limiting toxicities (DLTs), of adding polatuzumab vedotin (Pv) in combination with rituximab (RTX) containing French-American-British (FAB) chemoimmunotherapy, with reduced dose anthracycline, in CAYA with intermediate and high risk newly diagnosed MB-NHL; 2) To define the feasibility and safety, as defined by DLTs, of the addition of nivolumab to the backbone of reduced toxicity chemoimmunotherapy with brentuximab vedotin (Bv), vinblastine, dacarbazine and rituximab, with reduced dose anthracycline, in CAYA with newly diagnosed intermediate and high risk cHL.

Eligibility Criteria:
Inclusion Criteria:

* Newly diagnosed patients with histologically or cytologically proven newly diagnosed MB-NHL or cHL according to WHO Classification who meet the following criteria are eligible:

COHORT I:

Burkitt lymphoma (ICD-O 9687/3) Burkitt-like lymphoma with 11q aberration (ICD-O 9687/3) Diffuse large B-cell lymphoma, NOS (ICD-O 9680/3) High grade B-cell lymphoma (ICD-O 9680/3)

COHORT Ia: stage III with LDH ≥ 2 ULN OR stage IV (5-24% bone marrow lymphoma infiltration) (GROUP B)61

COHORT Ib: any CNS involvement and/or BM involvement (≥ 25% lymphoma cells) (GROUP C)61 OR patients with less than 20% tumor size reduction post chemotherapy with cyclophosphamide, dexamethasone, vincristine (DOC Reduction for Cohort Ia).

COHORT II Classical Hodgkin lymphoma (ICD-O 9650/3, 9663/3, 9651/3, 9652/3, 9653/3)

COHORT IIa: stage I-IIA with bulky ± E, I-IIB no bulky ± E, IIIA ± E (INTERMEDIATE RISK)

COHORT IIb: stage IIB with bulky ± E, IIIA with bulky ± E, IIIB, IV (HIGH RISK)

* Adequate organ function

Exclusion Criteria:

* Primary mediastinal B-cell lymphoma (PMBL)
* T-cell/histiocyte-rich large B-cell lymphoma
* Gray zone lymphoma
* Follicular lymphoma
* Nodular lymphocyte-predominant Hodgkin lymphoma (NLPHL)
* Posttransplant lymphoproliferative lymphoma (PTLD)
Docetaxel+Oxaliplatin+S-1 (DOS) Regimen as Neoadjuvant Chemotherapy in Advanced Gastric Cancer

Primary Objective:

- To compare the 3-year progression free survival (PFS) in the two treatment arms.

Secondary Objectives:

* Overall survival (OS).
* Postoperative pathological stage and R0 (complete) resection rate.
* Safety: Toxicities associated with neoadjuvant chemotherapy, surgery, morbidity/mortality, toxicity of adjuvant chemotherapy.

Participants in the neoadjuvant chemotherapy arm were treated for 3 cycles (1 cycle is 21 days) before surgery and treated for a year with S-1. Participants in the adjuvant chemotherapy arm underwent surgery and were treated for a year with S-1. All participants were followed during and after the study treatment until death or disease progression, whichever comes first.

Eligibility Criteria:
Inclusion criteria :

* Participants with new histologically confirmed, newly diagnosed, localized gastric or gastro-oesophageal adenocarcinoma, that is considered resectable.
* Participants with clinical stage (T2-3/N(+), T4/N(+/-):N positive means greater than or equal to \[\>=\] 8 in hour axis).
* Signed informed consent.

Exclusion criteria:

* Aged less than (\<) 20 years or \>= 76 years. Performance status \>=2 in Eastern Cooperative Oncology Group (ECOG) scale
* The participants who had the history of other malignancy within the last five years except cured basal cell carcinoma of skin and carcinoma in situ of uterine cervix which had been already successfully treated.
* Previous surgery on neoplasm of stomach.
* Participants who did not completely recovered from surgery.
* Distant metastases (M1) to other organs including distant nodal groups (retropancreatic, para-aortic, portal, retroperitoneal, mesenteric node). severe/unstable angina, coronary artery bypass graft, congestive heart failure, transient ischemic attack within 6 months prior to enrollment in the study.
* Any previous palliative, adjuvant or neoadjuvant chemotherapy and/or radiotherapy and/or immunotherapy, for the currently treated gastric cancer.
* Participants with active infection or sepsis.
* Intolerance of oral taking or malabsorption: lack of physical integrity of the upper gastrointestinal tract or those who have malabsorption syndrome likely to influence absorption of S-1. Ileus, chronic inflammatory intestinal disease or extensive resection of the small intestine and other disorders which limit drug resorption. This includes gastric dumping syndrome, indications of accelerated passage through the small intestine and indications of resorption disorders after intestinal surgery.
* Greater than or equal to grade 2 severe tumour haemorrhage.
* Simultaneous participation in another study, or participation in another study within 4 weeks of commencement of this study.
* Pregnant or lactating participants.

The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
A Phase II, Open-Label Study Evaluating the Effect Of GW786034 In Subjects With Ovarian Cancer

This study was designed to find out how effective and safe GW786034, is in the treatment of epithelial ovarian, fallopian tube, or primary peritoneal cancer that has not responded to standard treatment.


Eligibility Criteria:
Inclusion criteria:

* Confirmed diagnosis of epithelial ovarian, fallopian tube or primary peritoneal carcinoma.
* Has received one prior platinum-based chemotherapy regimen(cisplatin,carboplatin, or oxaliplatin).
* Has psychological, familial, sociological or geographical condition that does not permit compliance with the protocol.
* Is on a specifically prohibited medication or requires these medications during treatment with GW786034.

Exclusion criteria:

* Has had any surgery, chemotherapy, hormonal therapy, biologic, immunotherapy, or radiotherapy with in the last 28 days and has not recovered from such prior therapy.
* Poorly controlled hypertension(systolic 140mmHg or higher or Diastolic 90mmHg or higher).
* Currently taking warfarin.
* Low molecular weight heparin and low-dose warfarin(1mg per day)is permitted.
Low Stable Pressure Pneumoperitoneum in Colorectal Surgery (CROSS STUDY)

The objective of this prospective, international cohort is to incorporate the low stable pressure (using Airseal Insufflator) approach and its associated parameters into the early rehabilitation program after colorectal surgery so as to shorten hospitalization up to the ambulatory care and reduce postoperative pain and opioid consumption.

Laparoscopy is currently the gold standard for the vast majority of abdominal surgeries, and especially for colectomy for cancer or benign diseases. There are many data showing the benefits of the laparoscopic approach to colectomy in terms of morbidity, post-operative pain and analgesic consumption, length of hospital stay, cosmetic results, and improved patient satisfaction. In 2002, consensus European guidelines recommended insufflating at the lowest pressure that still provides sufficient exposure. Considering these results, low-pressure laparoscopy is one of the alternatives that have been developed to do away with the complications of the pneumoperitoneum while retaining its advantages.

However, other factors may influence the outcomes of the low-pressure pneumoperitoneum such as the use of humidification and warming gaz, robotic or microsurgical instrumentation, neuromuscular blockade, patient positioning, pre-stretching of the abdominal wall, ventilation-induced changes, and probably individual patient factors like obesity. These parameters could not be separately tested in randomized trial. We should consider all these parameters in a prospective international registry in order to optimize the benefit of low-pressure pneumoperitoneum in post-operative recovery.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years old
* Colonic resection (right or left) performed for benign or malignant pathology
* Partial or Total mesorectal Excision (PME or TME) with or without stoma for benign or malignant pathology
* Laparoscopic or robotic procedure
* Surgery under low stable pressure pneumoperitoneum with AirSeal
* Patient who benefits by medicare system
* Oral agreement after reading information letter

Exclusion Criteria:

* Laparotomy procedure
* Associated resection (except appendectomy or liver biopsy)
* Transverse colectomy
* Emergency procedure
* Pelvic sepsis
* Pregnancy or breast feeding period
* Legal incapacity or physical, psychological social or geographical status interfering with the patient's ability to agree to participate in the study
* Persons deprived of liberty or under guardianship
Sequential and Mixture Injection of Opioids and Hyperbaric Bupivacaine

Neuraxial anesthesia, especially the subarachnoid block, is the preferred method for LSCS. The intrathecal spread of local anesthetic drugs is unpredictable. However, Baricity, which is the relative density of local anesthetics to that of CSF, is a key determinant of the local anesthetic spread within the subarachnoid space. Alterations in the baricity of a solution to the extent of 0.0006 g/ml-1 can alter the spread of local anesthetic solution in CSF. Patients features such as position, weight, height, and age, and local anaesthetic characteristics such as density, PH, and temperature may play a role as well.

Bupivacaine is the main local anaesthetic used frequently for the subarachnoid block. Hyperbaric bupivacaine has dextrose added at a concentration of 80 g/ml to increase its density to 1.0262 which is higher than that of cerebrospinal fluid (CSF), leading to a more predictable spread after intrathecal injection.

Opioids such as morphine and fentanyl are commonly injected as adjuvants to hyperbaric bupivacaine. Their synergistic role leads to satisfactory block at smaller subtherapeutic doses of bupivacaine which minimizes the associated side effects. The combination of fentanyl which is lipophilic opioid and morphine which is hydrophilic opioid results in rapid onset and prolonged course of perioperative analgesia. In an in vitro study, the mean densities of fentanyl and morphine were found to be 0.9957 and 1.0013 respectively while the mean density of CSF in term pregnant woman is 1.000306. Thus, opioids spread freely within the CSF interacting on the spinal and supraspinal opioid receptors. They have a synergistic effect to bupivacaine leading to adequate sensory blockade with lesser hemodynamic adverse effects.

Nevertheless, opioids are commonly mixed with hyperbaric bupivacaine in a single syringe before intrathecal injection. This practice alters the density and PH of the mixture which may impact the pharmacokinetics of each individual drug. Therefore, we hypothesize in this study that separate injection of opioids and hyperbaric bupivacaine may improve their intrathecal spread. This will not only improve the quality of anesthesia, but it will also decrease the associated hemodynamic adverse events and the incidence of undesired high sensory block levels, which all will increase the perioperative patient satisfaction.


Eligibility Criteria:
Inclusion Criteria:

* LSCS
* ASA I or II
* Single baby pregnancy of more than 32 weeks
* Elective or semi-elective surgery (category 3 and 4 Caesarean sections)

Exclusion Criteria:

* Abnormal Placentation
* PET
* Disordered coagulation
* Allergy to opioids or local anesthetic.
* BMI \> 35
* Spine surgery
* Cardiac disease
* Extremes of height; height more than 180 or less than 140
* Multiple pregnancy or polyhydramnios
Exploratory Study of the Effects of Vortioxetine (Lu AA21004) on Cognition and Blood Oxygen Level Dependent (BOLD) Functional Magnetic Resonance Imaging (fMRI) Signals in Subjects Remitted From Depression and in Controls

The purpose of this study is to determine if Vortioxetine 20 mg/day will lead to changes in neural activity (BOLD signal), as measured using fMRI, in brain areas associated with executive functioning and memory during cognitive task performances compared to placebo in subjects remitted from depression and in controls, and to explore if Vortioxetine will lead to improved cognitive performance in the absence of depression.


Eligibility Criteria:
Inclusion Criteria:

All subjects must have:

* a Hamilton Depression Rating Scale (HAM-D17) total score ≤ 7

Subjects remitted from depression must:

* be in remission from recurrent depression having suffered from at least two previous Major Depressive Episodes (MDEs)
* have received prescribed treatment with an antidepressant or a recognised psychotherapy for depression for a previous MDE
* report present subjective cognitive dysfunction
* not have been treated with antidepressants or received other psychotherapy for depression for at least six weeks prior to screening visit

Control group subjects must:

* have no history of MDEs
* have no history of MDEs in a biological parent or other first degree relative as reported by the subject
* not report present subjective cognitive dysfunction
* never have been treated with antidepressants or psychotherapy

Exclusion Criteria:

* The subject is, in the opinion of the investigator, unlikely to comply with the clinical study protocol or is unsuitable for any other reason

Other inclusion and exclusion criteria may apply.
Phase I/II Study of Escalating Doses of Idarubicin Orally Given With Oral Cyclophosphamide, Etoposide, Prednisolone and Intravenous Rituximab in Elderly Patient With Disseminated High Grade Non Hodgkin Lymphoma

R-CHOP with doxorubicin is the standard first line treatment of high grade non-Hodgkin's lymphoma. In order to avoid central venous system insertion and reduce hospitalization time in elderly patients, we developed an oral chemotherapy treatment: " OROCIEP"trial.

Nineteen patients were enrolled and 127 chemotherapy cycles were available for toxicities. The estimated two-years overall survival was 74%. The main haematological toxicity was neutropenia.

This study is still ongoing to confirm recommended dose of oral anthracycline.


Eligibility Criteria:
Inclusion Criteria:

* CD20-positive diffuse large B-cell lymphoma.WHO classification (55)
* Written informed consent
* Age \> 65 and \< 80 years
* Performance status (ECOG) \<3
* measurable disease
* Serology HIV negative, Hepatites B, Hepatites C negative

Exclusion Criteria:

* Serology HIV positive, Hepatite B positive, Hepatite C positive
* Cardiac failure.
Study on the Predictive Value of the Natural Calcium Isotope Ratio in Urine and Serum for the Diagnosis of Osteoporosis

The study aims at investigating whether the natural calcium isotope ratio (δ44/40Ca) in urine and serum differs between postmenopausal women aged 50 to 75 years suffering from osteoporosis and a healthy control group and whether δ44/40Ca in urine and serum can be used for the diagnosis of osteoporosis or whether further parameters have to be included.

According to the operational definition of WHO in the year 1994 osteoporosis is present if bone mineral content as assessed by DXA densitometry of the lumbar spine and/or proximal femur (total area or femoral neck) deviates from the mean of a 20 to 29 years old women by at least -2.5 standard deviations (DXA T-Score ≤ -2.5). This definition of osteoporosis is only valid after exclusion of other disorders, which may be associated with a reduction of bone mineral content and exclusion of osteomalacia.

By an individual screening 100 women will be included in the study who are characterized concerning existing or non-existing osteoporosis according to the guidelines of DVO 2014 and ISCD 2015, respectively.

According to the EPOS study results the prevalence of osteoporosis in Germany in postmenopausal women aged 50 to 60 years is about 15% and at the age of more than 70 years about 45%. In case of risk factors, such as hip fracture of father and/or mother, smoking, lactose intolerance, vegan nutrition, underweight (BMI \< 20), diabetes, intake of loop diuretics, glucocorticoids, aromatase inhibitors and proton pump inhibitors a higher prevalence can be assumed. Thus by electing women with at least one risk factor of osteoporosis a higher proportion may meet the criteria of osteoporosis.

Since some women are expected to present with low vitamin D levels and so far are expected to present with osteomalacia, and since other exclusion criteria may occur, N = 100 women will be investigated, in order to obtain data from N = 80 women who may meet the criteria of the target group (about N = 40 with osteoporosis and about N = 40 without osteoporosis (normal control).

Eligibility Criteria:
Inclusion Criteria:

* Postmenopausal women
* Age 50 - 75 years
* Fullfilling the criteria for diagnostic examination for osteoporosis incl. DXA according to DVO/ZÄS list 2015
* Written informed consent

Exclusion Criteria:

* known fracture within the last 3 months
* DXA within the last 12 month before inclusion
* Substitution with sex hormones
* Substitution with non-identified calcium supplements
* Vitamin D deficiency (post-hoc stratifying and exclusion from primary analysis, respectively)
* Hyperparathyreoidism (by history and based on calcium, phosphate and chloride in serum
* known renal failure
* known cancer disease
* Current enrollement in a clinical intervention trial
* Enrollement in a clinical intervention trial within the last 4 weeks
* Severe cognitive or psychiatric disorder
* Scheduled hospitalisation before the radiological examination (DXA)
* Legal incapacity
Tissue Engineering Conjunctiva for the Treatment of Pterygium and Atretoblepharia

The purpose of this study is to determine whether tissue engineering conjunctiva is effective in the treatment of pterygium and atretoblepharia.

The most important area for research on the pterygium are the recurrence occurred after operation. Now the best way to prevent the recurrence is autologous conjunctival stem cell transplantation, but this way of operation can cause lack of conjunctiva and conjunctival scar, even may effect the later glaucoma surgery. For the atretoblepharia patients, amniotic membrane transplantation and autologous oral mucosa transplantation can not make effect to alleviate it. In this pilot project, investigators would like to study the effect of tissue engineering conjunctiva transplantation in the treatment of pterygium and tissue engineering conjunctiva transplantation combined with conjunctiva sac formation for the treatment of atretoblepharia. This will allow us to determine if useful data can be obtained, and if so, lead to further studies in various conjunctiva loss caused by trauma, infections, and so on.

Eligibility Criteria:
Inclusion Criteria:

1. Primary and recurrent pterygium patients,atretoblepharia patients
2. Voluntarily signed informed consent
3. No surgery and anesthesia contraindications.

Exclusion Criteria:

1. The patients combined systemic diseases
2. Reject study and follow visit
3. Patients don't accept the tissue engineering conjunctiva
4. Cannot tolerate surgery or anesthesia