cyrilzakka/clinical-trials huggingface dataset:
Chronic GVHD Response Measures Validation

The purpose of this study is to develop and validate endpoint measures that can accurately determine whether patients are responding to treatment for chronic Graft-versus-Host Disease (GVHD). Hopefully, this will also lead to being better able to predict which patients will respond to what therapies.


Eligibility Criteria:
Inclusion Criteria:

* Age 7 years or older
* Prior first allogeneic stem cell transplant, with any graft source, donor type, and GVHD prophylaxis.
* Diagnosis of chronic GVHD according to the criteria of the diagnosis and scoring group of the NIH consensus conference (Patient must have at least one diagnostic manifestation of chronic GVHD or one distinctive manifestation with pathological confirmation of the diagnosis. Concurrent acute GVHD manifestations will be allowed as long as at least one classic chronic manifestation is present.)
* Initiation of a new systemic treatment for chronic GVHD in the past 4 weeks or anticipated within the next 4 weeks. Systemic treatment is defined as any medication or intervention that has intended systemic effects, including extracorporeal photopheresis, regardless of prior lines of therapy or prior treatment with the agent(s). If a patient is restarting a treatment to which they were previously exposed, they must have been off of it for at least 4 weeks before restarting.
* No evidence of persistent or progressive malignancy at the time of enrollment
* Evaluation at the transplant center at the time of study enrollment, and agreement to be re-evaluated at the transplant center up to four subsequent times: at 3 months, 6 months, and 18 months after enrollment and once if another treatment is added for chronic GVHD.
* Signed, informed consent

Exclusion Criteria:

* Inability to comply with study procedures
* Complete resolution of chronic GVHD at the time of enrollment (patient must have some measurable chronic GVHD activity)
Influence of Age, Weight and Ethnic Background on Blood Pressure

Hypertension, also known as high blood pressure, is a chronic medical condition, in which the blood pressure is elevated. This is a common condition, which can lead to severe complications such as cardiovascular disease, heart attack, stroke and kidney disease, if not detected and treated early.

Accumulating evidence suggests that the incidence of hypertension varies according to age, ethnicity and obesity. In order to obtain an in-depth knowledge of the pathophysiological mechanisms of hypertension, we aim to investigate the haemodynamic and biochemical correlates of elevated blood pressure across the adult age-span, and determine the extent to which body size and ethnicity impact on these associations. We also wish to investigate the impact of hypertension on key target organs (end-organ damage). The primary objective of this study is to compare the mechanisms regulating blood pressure in hypertensive and non-hypertensive participants across the adult age span, and to assess the influence of body mass index and ethnic background on these mechanisms. Secondary objectives are to investigate the association between blood pressure and cardiovascular physiology across the adult age span at rest and during sub-maximal exercise and to investigate the impact of blood pressure haemodynamics on key organs including the arteries and heart by assessing end-organ damage such as endothelial function, arterial structure and left ventricular mass/function.

This study will be a combined case-control and cross-sectional study describing the procedures and time commitment required to investigate our scientific aims. This is a single centre study that will be conducted in a secondary care environment. Both male and females aged 18 and over and that are able provide informed consent will be considered for this study. People who are pregnant, currently receiving dialysis, illness with a life expectancy \<1 year, current active malignancy and cannot provide informed consent are ineligible for this study. The study will be open for five years and each patient will complete a maximum of four visits in a 12 month period. Participants will complete a variety of non-invasive physiological assessments of their cardiovascular system and lung function. There will be some minimally invasive procedures completed, including a blood test and assessment of small artery endothelial function which involves insertion of a small needle under local anesthetic.


Eligibility Criteria:
Inclusion Criteria:

* Male or Female, aged 18 or above
* Able to give informed consent and willing to participate

Exclusion Criteria:

* Pregnancy
* Current active malignancy
* Currently receiving dialysis
* Any illness with a life expectancy \< 1 year
* Lack of written informed consent
Oxytocin and Alcohol Withdrawal and Dependence

This study evaluates the effect of oxytocin nasal spray on alcohol withdrawal and dependence in adults admitted for detoxification of alcohol, and during the following 4 weeks in an outpatient setting. Half of the participants will receive oxytocin nasal spray, the other half placebo nasal spray.


Eligibility Criteria:
Inclusion Criteria:

1. At least one prior episode 2 days or longer in duration during which the subject experienced withdrawal symptoms that caused significant incapacitation (e.g., inability to work or do normal activities) OR at least one prior inpatient or outpatient medical detoxification during which the subject exhibited withdrawal symptoms of sufficient magnitude that sedative-hypnotic or anticonvulsant medication was required at least once on 2 consecutive days after cessation of or reduction in the use of alcohol following 2 weeks or more of heavy daily consumption
2. average consumption of 8-30 standard drinks per day for at least 2 weeks prior to enrollment in the study;
3. consenting to participate in the study;
4. have residency in Trøndelag County after discharge

Exclusion Criteria:

1. chronic treatment with sedative-hypnotic medications such as benzodiazepines or z-hypnotics;
2. dependence on substances other than alcohol, nicotine or caffeine;
3. inadequately treated, unstable and/or compromising medical or psychiatric conditions;
4. low body weight (BMI \< 17) or history of anorexia nervosa or bulimia in the past 2 years;
5. pregnancy; parturition or breast-feeding in the past 6 months;
6. inability to read well enough to complete study questionnaires determined by whether the prospective subject can read the consent form without help and correctly answer basic questions about information in the consent form;
7. no alcohol in the blood and \> 15 h since last intake of alcohol;
8. prior inclusion and participation in the same study.
Hyperinsulinemic Normoglycemic Clamp for Pancreas and Simultaneous Pancreas/Kidney Transplant Recipients

This study proposes a simple and safe way of lowering this complicate rate, while improving graft recovering and protecting the graft as it recovers from the transplant. The investigators hypothesize that by maintaining a tight glucose control via a glucose-insulin clamp during surgery and 72 hours post-operatively the investigators will be able to lower the complication rate by 50%.


Eligibility Criteria:
Inclusion Criteria:

* Male or female patient over 18 years of age
* Patient is about to receive a pancreas or a simultaneous pancreas/kidney transplant
* Able to give written informed consent prior to any study specific procedure

Exclusion Criteria:

* Multi-organ transplant other than kidney transplant
* No central venous access available to deliver the D20W solution
Brentuximab Vedotin Combined With AVD Chemotherapy in Patients With Newly Diagnosed Early Stage, Unfavorable Risk Hodgkin Lymphoma

The purpose of this study is to compare the outcomes across the 4 different treatment groups. The investigators hope that this treatment will improve the ability to cure more patients with HL and also limit the long-term side effects from the treatment. Although eliminating radiation in cohort 4 will eliminate the risk for long-term side effects from radiation, it is also possible that with BV+AVD chemotherapy alone there may be an increased risk of the Hodgkin lymphoma coming back after initial treatment.


Eligibility Criteria:
Inclusion Criteria:

* Histologic diagnosis of classical, CD30 positive Hodgkin lymphoma confirmed at enrolling institution
* FDG-avid disease by FDG-PET/CT and measurable disease of at least 1.5 cm by CT
* Ann Arbor Stage I or II disease
* Disease bulk defined as any lymph node mass with transverse maximal diameter \> 7.0 cm OR coronal maximal diameter \> 7.0 cm on CT imaging
* Females of childbearing age must be on an acceptable form of birth control per institutional standards
* Ages 18 and over

Exclusion Criteria:

* Cardiac ejection fraction ≤ 50%
* Hemoglobin-adjusted diffusing capacity for carbon monoxide \< 40%
* ANC≤1000/μl and Platelets≤75,000/μl
* Total bilirubin ≥ 2.0 mg/dl in the absence of a history of Gilbert's disease
* Serum creatinine clearance of \<30 mL/min as estimated by the Cockcroft-Gault Method
* Known pregnancy or breast-feeding
* Known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS)
* Medical illness unrelated to Hodgkin Lymphoma, which, in the opinion of the attending physician and/or MSKCC principal investigator, makes participation in this study inappropriate.
* Peripheral neuropathy \> grade 1
* Patients receiving chronic treatment with systemic steroids. However, patients can receive up to 10 days of steroid therapy prior to starting treatment with BV+AVD.
Evaluation of the SpyGlass DS for Detection of Residual Pancreatic Calculations

The purpose of the study is to assess the efficacy of the SpyGlass DS for the detection of residual pancreatic calculations after endoscopic treatment.


Eligibility Criteria:
Inclusion Criteria:

* aged 18 and over;
* with chronic calcifying pancreatitis;
* having already received endoscopic treatment for pancreatic pain related to stenosis and / or pancreatic stones;
* having given free, informed and written consent;
* being affiliated to a social security scheme or beneficiary of such a scheme.

Exclusion Criteria:

* contraindications to performing an upper digestive endoscopy;
* haemorrhagic disease, haemostasis and coagulation disorder (PR \<60%, PTT\> 40 s and platelets \<60,000 / mm3;
* pregnant or breastfeeding woman;
* adult patient protected (guardianship or curatorship), or deprived of liberty by a judicial or administrative decision;
* person subject to a safeguard measure.
Guided Self-help for Binge Eating

Guided self-help (GSH) is a recommended first-step treatment for bulimia nervosa, binge eating disorder, and atypical variants of these disorders. The current study proposes to investigate the effectiveness of providing GSH either face-to-face or via e-mail, also using a delayed treatment control condition. Symptom outcomes will be assessed, and an estimate of cost-effectiveness made. Results are proposed to be disseminated locally and internationally (through submission to conferences and peer-reviewed journals), and will hopefully inform local service provision.

Please note that we are only able to offer the intervention to individuals who are currently registered with a General Practitioner that is covered by Oxford Health NHS Foundation Trust - this is typically restricted to practices in Oxfordshire, Buckinghamshire, and parts of Wiltshire.


Eligibility Criteria:
Inclusion Criteria:

* Registration with a General Practitioner covered by Oxford Health NHS Foundation Trust (typically: Oxfordshire, Buckinghamshire, parts of Wiltshire)
* Primary diagnosis of an eating disorder with recurrent binge eating (BN, EDNOS \[BN-type\] or BED)
* Age above 17.5 years (box below requires whole numbers)

Exclusion Criteria:

* A severe eating disorder (e.g., one complicated by medical issues that would not be best managed by a self-help intervention)
* BMI \<18.5
* Rapid weight loss (regardless of BMI)
* current excessive drug use
* active and untreated psychosis (the latter two are usually exclusion criteria to the EDS)
To Compare the Safety and Pharmacokinetics of PT105 With PT105R in Healthy Postmenopausal Female Volunteers

The purpose of study is to compare the safety and pharmacokinetics of PT105 with PT105R in healthy postmenopausal female volunteers

The purpose of study is to confirm the safety and pharmacokinetics of PT105 in healthy postmenopausal female volunteers

Eligibility Criteria:
Inclusion Criteria:

* A healthy woman who is over 19 years of age and has been certified obstetrically with menopause, at the time of screening.
* Subjects weighing over 50 kg with BMI between 18 and 30 kg/m2 (inclusive) at screening visit.

Exclusion Criteria:

* Those who have clinical significant liver, kidney, nervous system, respiratory, endocrine, hematology and oncology, cardiovascular, urinary, and mental diseases or past history
* Those whose plasma AST and ALT exceed 2 times to the upper limit of the normal range in screening including additional examinations prior to randomization
* Subjects who have participated and taken investigational drug in any other clinical trial (including bioequivalence study) within six months prior to study drug administration
* Subjects who have donated a unit of whole blood within two months or blood components within one month prior to study drug administration
Cerebral Oxygen Saturation Monitoring During Optimum Cord Management in Preterm Infants

This study will assess the feasibilty measuring cerebral oxygen saturations using a Near Infrared Spectroscopy (NIRS) monitor immediately after delivery of preterm infants. The investigators aim to evaluate the effects of optimum cord management on cerebral oxygenation in this cohort

Optimal cord management is defined by delaying clamping of the umbilical cord for 1 minute after delivery and is recommend in all neonates, regardless of gestational age. Transfusion of blood from placenta to baby in this minute enables smooth cardiovascular transition and stable cerebral perfusion. Preterm infants are at increased risk of haemodynamic instability and brain injury if the cord is clamped too early. It remains unclear what the optimum time is to clamp the cord in preterm infants, and it is likely different for each baby. Current monitoring of heart rate and peripheral oxygen saturations does not correlate well with oxygen delivery to the brain. Near infrared spectroscopy (NIRS) is a non-invasive method of measuring regional cerebral oxygenation saturations. NIRS may be a helpful monitoring tool to guide optimum timing of cord clamping in preterm infants.

This study aims to assess the feasibility of using the INVOS 5100 NIRS monitor immediately after delivery in preterm infants born before 34 weeks gestational age. The investigators aim to assess if they can generate meaningful data on brain oxygen levels in the first few minutes of life. The secondary objectives are to use this data to describe the changes in heart rate, peripheral oxygen and cerebral oxygen saturations during placental transfusion and cord clamping.

The investigators will use the INVOS device to measure cerebral oxygenation immediately after delivery, during placental transfusion and cord clamping. We will assess the feasibility of the INVOS device for this purpose. We will use the INVOS data and routinely collected data at delivery to evaluate the effect of optimum cord management on cerebral perfusion, heart rate and peripheral oxygen saturations.

Eligibility Criteria:
Inclusion Criteria:

* All babies eligible for optimum cord management born before 34 completed weeks gestational age
* Parental consent

Exclusion Criteria:

* Multiple pregnancies
* Infants for whom resuscitation at birth is not appropriate
* Antenatal or immediate postnatal diagnosis of severe congenital anomaly
* Infants with complex congenital cardiac disease
Comparison of HF10 Therapy Combined With CMM to CMM Alone in the Treatment of Non-Surgical Refractory Back Pain

This study is being conducted to document the safety, clinical effectiveness and cost-effectiveness of high-frequency SCS at 10 kHz (HF10™ Therapy) delivered through the Senza system in subjects with chronic refractory back pain (with or without leg pain) who are not considered candidates for spine surgery. This study is a multi-center, prospective, randomized study to compare the two treatment groups.


Eligibility Criteria:
Key Inclusion Criteria:

1. Have been diagnosed with chronic, refractory axial low back pain with a neuropathic component and are not eligible for spine surgery
2. Have not had any surgery for back or leg pain, or any surgery resulting in back or leg pain
3. Qualifying pain score
4. Be on stable pain medications, as determined by the Investigator
5. Be willing and capable of giving informed consent
6. Be willing and able to comply with study-related requirements, procedures, and visits
7. Be capable of subjective evaluation, able to read and understand written questionnaires in the local language and are able to read, understand and sign the written inform consent

Key Exclusion Criteria:

1. Have a diagnosed back condition with inflammatory causes of back pain, serious spinal pathology and/or neurological disorders
2. Have a medical condition or pain in other area(s), not intended to be treated in this study
3. Any diagnosis or known condition that can impact reporting of study outcomes as determined by the Investigator
4. Be benefitting within 30 days prior to enrollment from an interventional procedure to treat back and/or leg pain
5. Have any addictions as determined by the Investigator
6. Have an existing drug pump and/or SCS system or another active implantable device such as a pacemaker
7. Have prior experience with neuromodulation devices
8. Other general exclusions applicable for SCS devices
9. Be involved in an injury claim under current litigation
10. Have a pending or approved worker's compensation claim
S. Endotoxin, Inflammatory Mediators and MRS Before and After Treatment in MHE

The purpose of this study is to examine S.endotoxins , inflammatory mediators and Magnetic Resonance Spectroscopy (MRS) before and after treatment in patients of cirrhosis and minimal hepatic encephalopathy.

60 patients of cirrhosis with Minimal Hepatic Encephalopathy (MHE) who fulfills the inclusion \& exclusion criteria will be the part of study. Study patients will be divided in to two groups ( n=30 in each group).

Group L patients will receive lactulose therapy while Group NL will receive placebo. After 3 months , S.endotoxins , inflammatory mediators and MRS will be repeated in each group.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of Cirrhosis (Age 15 yr -70 yr )

Exclusion Criteria:

* Recent history of gastrointestinal bleed in last 6 weeks
* Active ongoing infection
* Creatinine \>1.5mg%
* Electrolyte impairment. (S. Sodium \< 130 meq/L, S. Potassium 3.5 meq/L or \>5.0meq/L)
* H/O use of psychotropic drugs in last 6 weeks
* Recent alcohol use (\< 6 week )
* H/O TIPS or shunt surgery.
* Hepatocellular Carcinoma
* Severe comorbidity as Congestive Heart Failure, Pulmonary disease, Neurological and Psychiatric problems impairing quality of life
* Poor vision precluding neuropsychological assessment
A Trial of Two Electrosurgical Conizations: Histopathological Analysis of Excision Margins

The purpose of this trial is to evaluate if Straight Wire Excision of the Transformation Zone (SWETZ) is superior to (Large Loop Excision of the Transformation Zone) LLETZ cone in reducing the incomplete excision of disease.

Cone biopsy is a surgical procedure which objectives the excision of endocervical pre-invasive disease located at transformation zone or glandular epithelium. Although cone biopsy is considered adequate for the treatment of endocervical dysplastic epithelium , using electrosurgery as opposed to the cold knife technique of cone biopsy has been criticized because of the perceived potential for incomplete excision of disease, thermal damage and surgical specimen fragmentation, which might increase the risk of missing early invasive cancer. Also, incomplete excision margin of disease exposes women to an increased risk of residual post-treatment disease.

The standard procedure, Large Loop Excision of the Transformation Zone (LLETZ-cone), is performed with a large loop electrode of 20-25 mm depth.

The experimental intervention is Straight Wire Excision of the Transformation Zone (SWETZ), a method of excision using a 1cm straight disposal of 0.20 wire to remove the endocervical transformation zone or glandular disease.

Both procedures were previously studied in another clinical trial(NCT00995020), but the histological analysis were inconclusive for many outcomes. SWETZ were superior to LLETZ cone to acquire complete excision of disease, with no statistical significance, probably due to the small sample size.

This study objectives a better histological analyses of the surgical specimens related to incomplete excision, thermal damage and fragmentation.

Eligibility Criteria:
Inclusion Criteria:

* Patients were eligible if the colposcopist decided that a cone biopsy was indicated.
* Common indications for a cone biopsy included:

  * High-grade Squamous Intraepithelial Lesion in a type 3 transformation zone,
  * suspicion of micro-invasive or invasive carcinoma and
  * suspicion of glandular disease.

Exclusion Criteria:

* Patients were excluded if pregnancy, coagulation disorders and cervicitis were present or if they refused to participate in the study.
Endometrial Compaction and Its Influence on Pregnancy Rate in Frozen Embryo Cycle Regimes

For a pregnancy to occur, an euploid embryo at blastocyst developmental stage, a receptive endometrium and the synchrony of both is crucial. Many studies lately investigated the influence of the endometrial thickness and pattern on the artificial reproductive technology (ART) outcome, however, with conflicting results.

Further on, the measurement of the endometrial thickness was mostly performed either on the day of final oocyte maturation in stimulated cycles with fresh embryo transfer or on the day of progesterone administration in FET cycles.

Progesterone is essential for the secretory transformation and compaction of the endometrium, prior to implantation. A recently published paper (Haas et al., 2019) however, evaluated the degree of endometrial compaction under the influence of progesterone in FET cycles and described, that a lack of certain endometrial compaction has a negative impact on the ongoing pregnancy rate. As in this study embryos of unknown ploidy status were transferred, the role of embryo ploidy on the outcome may bias the study results.

In the herein presented study protocol we aim to investigate the influence of endometrial compaction in FET cycles in which euploid embryos are transferred.

HYPOTHESIS: Lack of endometrial compaction after the start of progesterone leads to an impaired reproductive outcome.

Eligibility Criteria:
Inclusion Criteria:

* Women aged 18 years to 40 years with regular menses (26-34 days)
* Having 1 or 2 chromosomally normal cryopreserved blastocysts available for transfer after IVF / ICSI treatment
* First frozen-thawed transfer cycle
* Progesterone level \< 1.5 ng/mL day of trigger injection in stimulation cycle from which embryos to be transferred were created.

Exclusion Criteria:

* Polycystic ovarian syndrome
* Poor ovarian responder in accordance with Bologna criteria
* Uterine abnormality US / saline infusion sonohysterogram
* Previous dilatation \& curettage (D\&C)
* Hydrosalpinx
* Asherman syndrome
* History of endometriosis AFS ≥ 2
* ICSI due to severe male factor with testicular sperm
* Any known contraindications or allergy to oral estradiol or progesterone.
* Discontinuation of HRT medication ( medication error in research HRT cycle )
* Failure to detect ovulation in the research natural cycle
* Ovulation after day 20 in a natural cycle
* Duration of estradiol exposure ≥ 17 days and endometrium \< 6mm
* Spontaneous ovulation in HRT artificial cycle