cyrilzakka/clinical-trials huggingface dataset:
Depression Treatment and Economic Empowerment

This pilot study randomized 48 depressed rural Bangladeshi housewives to either intervention or control groups. The intervention groups received depression treatment and a financial empowerment intervention.

This study was conducted in the rural Sirajganj region of Bangladesh. Working with the International Centre for Diarrhoeal Disease Research, Bangladesh and a local NGO, we recruited 48 depressed rural housewives for the study. Participants were randomized into intervention in control groups. The intervention groups (n=24) received 12 sessions of evidence based depression treatment, financial literacy education, agricultural training and skill building. They opened bank accounts and saved for six months. At the end of the six month period, participants who had met savings and attendance requirements received a cash transfer of approximately $186, which was used to purchase a productive asset. 22 participants purchased an agricultural animal, usually a goat; 1 financed a small retail business, and 1 leased land to grow crops for sale. Depression scores on the PHD-9 were sharply reduced. The study had 100% retention.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-40
* PHQ greater than 10
* Able to save
* Able to read and write

Exclusion Criteria:

* Not in age range PhQ below 10 Unable to contribute to savings account Illiterate
A Study of Ocrelizumab in Participants With Primary Progressive Multiple Sclerosis

This randomized, parallel group, double-blind, placebo controlled study will evaluate the efficacy and safety of ocrelizumab in participants with primary progressive multiple sclerosis. Eligible participants will be randomized 2 : 1 to receive either ocrelizumab or placebo.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of primary progressive multiple sclerosis (according to revised McDonald criteria)
* EDSS at screening from 3 to 6.5 points
* Disease duration from onset of MS symptoms less than (\<) 15 years if EDSS greater than (\>) 5.0; \<10 years if EDSS greater than or equal to (\>/=) 5.0
* Sexually active male and female participants of reproductive potential must use two methods of contraception throughout the study treatment phase and for 48 weeks after the last dose

Exclusion Criteria:

* History of relapsing remitting MS, secondary progressive, or progressive relapsing MS at screening
* Inability to complete an MRI (contraindications for MRI)
* Known presence of other neurologic disorders
* Known active infection or history of or presence of recurrent or chronic infection
* History of cancer, including solid tumors and hematological malignancies (except for basal cell, in situ squamous cell carcinomas of the skin and in situ carcinoma of the cervix that have been excised and resolved)
* Previous treatment with B-cell targeted therapies (e.g. rituximab, ocrelizumab, atacicept, belimumab, or ofatumumab)
* Any previous treatment with lymphocyte trafficking blockers, with alemtuzumab, anti-cluster of differentiation 4 (CD4), cladribine, cyclophosphamide, mitoxantrone, azathioprine, mycophenolate mofetil, cyclosporine, methotrexate, total body irradiation, or bone marrow transplantation
* Any concomitant disease that may require chronic treatment with systemic corticosteroids or immunosuppressants during the course of the study
Relevance of Biomarkers in the Process of Weaning

The purpose of the study is to examine the relevance of biochemical markers (specific pulmonary and cardiac markers and markers of endogenous stress) in the process of weaning in patients with artificial ventilation.

Artificially ventilated patients on our intensive care unit will be monitored if specific biomarkers have a relevance in risk stratification, optimizing therapy, outcome and success in the process of weaning. Therefore, consecutively, specific blood parameters will be taken at time of intubation,day 1 of weaning and extubation.

Eligibility Criteria:
Inclusion Criteria:

* Written informed consent
* Able and willing to understand the protocol
* At least 18 years or older

Exclusion Criteria:

* Not fulfilling inclusion criteria
A Phase I-Ib/II Study to Determine the Maximum Tolerated Dose (MTD) of AUY922 Alone and in Combination With Bortezomib, With or Without Dexamethasone, in Patients With Relapsed or Refractory Multiple Myeloma.

This is a Phase I-Ib/II, open-label, multicenter study of AUY922 administered intravenously in patients with multiple myeloma to determine the maximum tolerated dose. The Phase II part will investigate the efficacy of AUY922 in patients with multiple myeloma. Additionally, the study includes a Phase Ib combination part of AUY922 administered in combination with bortezomib, to determine the maximum tolerated dose of the combination drugs in patients with multiple myeloma.


Eligibility Criteria:
Inclusion criteria:

* Patients must have a diagnosis of active multiple myeloma.
* Phase I and Phase II part: Patients must have received at least 2 but not more than 4 prior line of therapy and their disease has progressed during or after last therapy.
* Phase Ib part: Patients must have received no more than 2 prior lines of therapy (excluding dexamethasone as single agent).
* ECOG Performance Status of ≤ 2.
* Patients must have acceptable neutrophil and platelet counts as well as adequate kidney and liver function.
* Patients must have magnesium levels above lower limit of normal or correctable with supplements.
* Patients must be willing and able to undergo bone marrow biopsy/aspirate.
* Able to sign informed consent.

Exclusion criteria:

* Prior treatment with any HSP90 or HDAC inhibitor for the treatment of multiple myeloma.
* Patients with unresolved diarrhea ≥ CTCAE grade 2.
* Patients with acute or chronic liver disease.
* Patients using medications that have a relative risk of prolonging the QT interval.
* Clinically significant cardiac diseases.
* Patients with known disorders due to a deficiency in bilirubin glucuronidation (e.g. Gilbert's syndrome).
* Pregnant or lactating women.
* Fertile women of childbearing potential (WCBP) not using adequate contraception.
* Male patients whose partners are WCBP, not using adequate contraception.
* Patients who unwilling or unable to comply with the protocol.
* Phase Ib part: Peripheral neuropathy ≥ CTCAE grade 1.
* Phase Ib part: Prior treatment with bortezomib.

Other protocol-defined inclusion/exclusion criteria may apply
Effects of Urocortins on Forearm Arterial Blood Flow in Healthy Volunteers

Impairment of the heart's pumping capacity (heart failure) remains a major clinical problem with a poor prognosis and the search for novel treatments remains an important area of research.

Urocortins are proteins that appear to increase blood flow and heart pumping activity. There has been particular interest in the role of Urocortins 2 \& 3 (subtypes of Urocortins) in heart failure.

In this study, we will examine the effects and mechanisms of Urocortins 2 \& 3 and the Corticotrophin Releasing Hormone Receptor Type 2 (CRH-R2) receptor (through which urocortins act) on forearm blood flow and release of natural blood clot dissolving factors in the forearm circulation of healthy volunteers.

In this study, we will look at the role of the lining of the blood vessel (endothelium) in response to urocortin types 2 and 3. We hypothesise that urocortins 2 \& 3 act via the endothelium to cause dilatation of the blood vessels and release of tissue-plasminogen activating factor (blood clot dissolving factor). We also hypothesise that urocortins have a role in maintaining the normal baseline level of blood flow in forearm arteries. In addition to the above, we will also look at the effect of temporarily blocking the effect of urocortins, using a specially designed blocker drug (Astressin 2B).

Utilising the well-established technique of 'forearm venous occlusion plethysmography', we will be able to focus on the local effects of urocortins on arterial blood flow in forearm vessels, without affecting this system in the body as a whole.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male volunteers between 18 - 65 years (inclusive)

Exclusion Criteria:

* Lack of informed consent
* Age \<18 years \> 65 years
* Current involvement in a clinical trial
* Severe or significant co-morbidity including bleeding diathesis, renal or hepatic failure
* Smoker
* History of anaemia
* Recent infective/inflammatory condition
* Recent blood donation (prior 3 months)
* Positive baseline urine test for drugs of abuse (including cannabinoids, benzodiazepines, opiates, cocaine and amphetamines)
Ga-68-FAPI-46 PET for CRC Recurrence Detection in Elevated CEA

This single-center, phase II clinical trial investigates the diagnostic efficacy of Ga-68-FAPI-46 PET scans in detecting colorectal cancer (CRC) recurrence during post-treatment surveillance, particularly in patients with elevated serum carcinoembryonic antigen (CEA). The study compares the sensitivity, specificity, and accuracy of Ga-68-FAPI-46 PET with the conventional F-18-FDG PET scans, aiming to enhance recurrence detection in CRC patients who underwent curative surgery. Thirty participants will be enrolled and monitored through imaging studies and clinical follow-up.

Colorectal cancer (CRC) is one of the leading causes of cancer-related mortality, with a significant recurrence rate following curative surgery, particularly in stages II and III. Early detection of asymptomatic recurrence is critical for initiating salvage treatment. Serum CEA elevation is a marker for recurrence, necessitating advanced imaging tools for precise localization.

This study evaluates the use of Ga-68-FAPI-46, a novel imaging agent targeting fibroblast activation protein (FAP), which is overexpressed in the tumor stroma. Ga-68-FAPI-46 demonstrates higher tumor uptake and faster clearance from normal tissues compared to F-18-FDG, offering a potential diagnostic advantage. Participants will undergo both F-18-FDG PET and Ga-68-FAPI-46 PET scans, with lesion detection validated through pathology or clinical follow-up.

The trial aims to determine the diagnostic performance of Ga-68-FAPI-46 PET in terms of sensitivity, specificity, positive predictive value, and negative predictive value, using the McNemar test for statistical comparison. The study also emphasizes participant safety and data protection, adhering to Good Clinical Practice (GCP) guidelines.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 20 years old
* The surgical intervention for colorectal cancer aims for curative resection, with the goal of achieving a disease-free status that persists for six months or more, as assessed clinically and through imaging studies.
* Elevated serum CEA levels:

Exceeding the laboratory's normal range (5 ng/ml) or, but not surpassing 13 ng/ml; using the individual's post-surgery +/- adjuvant chemotherapy or targeted therapy minimum value as a baseline, a consecutive increase of more than 10% for two times or as determined by the attending physician suggests suspicion of recurrence.

* Already performed or scheduled for FDG PET scanning examination. (5) Able to lie flat for at least 30 minutes.
* Signing the subject consent form.
* ECOG grade 0-2.
* The timing of F-18-FDG usage in this trial follows the " 2023 - Colorectal Cancer Treatment Principles" of our institution.

Exclusion Criteria:

* pregnant woman and breastfeeding women
* severe renal impairment (eGRF\< 30ml/min)
* Known or suspected allergy to radiopharmaceuticals
* Simultaneously or previously diagnosed with malignant tumors other than colorectal cancer.
* Inability to undergo the necessary PET scan procedure
* Refusal or unwillingness to sign the informed consent form
* Severe medical conditions (severe disabilities, mental disorders)
Tight Hemodynamic Control in Patients Who Are Chronically on Metoprolol

This study proposes to assess the effect of the standard of care, which is continuation of the pre op beta blocker dose into the post operative period compared to the administration of esmolol titrated to a pre determined target HR. The primary outcome will compare postoperative plasma levels of metoprolol in 2 cohorts in a group who has been continued on metoprolol (administrated via a nasogastric tube in NPO patients) to a group who has been withdrawn from metoprolol but given an esmolol infusion titrated to HR. Secondary outcomes will compare a) the hemodynamic responses, documenting the incidence of unplanned hypotension and bradycardia and b) to compare the effects of Heart rate to the incidence of myocardial ischemia, arrhythmias, delirium and infarction.

The number of high-risk patients undergoing non-cardiac surgery has increased continuously over the last two decades. There is a paucity of data exist about the bioavailability of postoperative administrated beta-blockers. One study reported adequate plasma levels of Propanolol after administration via nasogastric tube but not after oral administration in patient undergoing thyroid surgery.Thus it is possible that patients maintained on oral beta blockers may in fact be experiencing a withdrawal syndrome. Because of the importance of avoiding withdrawal of beta blockers, intravenous administration may be the only alternative in cases where oral administration fails to achieve adequate plasma levels perioperatively. Furthermore, due to changes in pharmacodynamics, intravenous dosage may be the optimal way to achieve tight hemodynamic control. There is, however, no data on the post-operative hemodynamic effects of orally administered beta blockers in patients on chronic beta blockers.

Eligibility Criteria:
Patient inclusion criteria:

* Elective vascular surgery
* Any of the following co morbidities

  * Diabetes
  * Angina
  * Congestive heart failure
  * A serum creatinine above 176 mmol/l
* All patients must be on stable dose of oral metoprolol (≥ 30 days)
* Age ≥ 20 years and ≤ 80 years
* Written informed consent to participate to the study

Patient exclusion criteria:

* Inability to understand the study protocol
* Prior gastric surgery or small bowel resection
* Pacemaker ( since it precludes the measurement of ST changes)
* Malabsorption syndromes
* Body Mass Index \< 18 and \> 35
* Any patient with suspected of diagnosed Cerebral vascular disease. (We chose to exclude CVA patients due to the ongoing controversy about the increased incidence of stroke in patients have surgery and who are taking beta-blockers.)
Development and Evaluation of an Artificial Intelligence Model for the Diagnosis of Aeroallergies

To improve accuracy and take out human error, Hippo Dx previously developed S.P.A.T., an automated skin prick test. Now, Hippo Dx will develop and evaluate a S.P.A.T. artificial intelligence (AI) medical software to support physicians in the read out of the test results from an automated skin prick test.

In this study 700 images will be collected to develop the AI model, an additional 200 images will be collected to evaluate performance of the AI model. In a last independent cohort of 100 patients, performance of read-out by the physician will be compared with read out by the physician supported by the S.P.A.T. AI medical software.

The primary endpoint is the accuracy of the maximal wheal size measurement by S.P.A.T. AI versus the maximal wheal size measurement by the physician.

It is a prospective multicentric study that will include 1000 study participants from different countries.


Eligibility Criteria:
Inclusion Criteria:

- Adults aged 18 years or above, consulting the outpatient clinic for an allergy diagnosis to aeroallergens will be included.

Exclusion Criteria:

* Skin pathology like chronic or exuberant urticaria, dermographism, chronic dermatitis that needs daily treatment
* Use of antihistaminic medication \< 7 days before the start of the study
* Use of tricyclic antidepressants (antihistamine activity) \< 7 days before the start of the study
* Use of topical corticoids on the forearm \< 7 days before the start of the study
* Use of Omalizumab \< 6 months before the start of the study
* Pregnancy: there is a remote possibility of inducing a systemic allergic reaction that could induce uterine contractions or necessitate the use of epinephrine (thought to cause constriction of the umbilical artery)
* Incapacitated individuals
* Individuals who do not speak the local language (Dutch - French)
* Individuals who cannot read or write
Reduction of Low-Density Lipoprotein Cholesterol (LDL-C) With PCSK9 Inhibition in Heterozygous Familial Hypercholesterolemia Disorder Study

The primary objective of this study was to evaluate the effect of 12 weeks of subcutaneous evolocumab (AMG 145), compared with placebo, on percent change from baseline in LDL-C in adults with heterozygous familial hypercholesterolemia (HeFH).


Eligibility Criteria:
Inclusion Criteria:

* Male or female ≥ 18 to ≤ 75 years of age
* Diagnosis of heterozygous familial hypercholesterolemia by having met the diagnostic criteria outlined by the Simon Broome Register Group (Scientific Steering Committee 1991)
* On an approved statin, with or without ezetimibe, with stable dose(s) for at least 4 weeks
* Fasting Low-Density Lipoprotein Cholesterol (LDL-C) ≥ 100 mg/dL
* Fasting triglycerides ≤ 400 mg/dL

Exclusion Criteria:

* Homozygous familial hypercholesterolemia
* Low-Density Lipoprotein (LDL) or plasma apheresis within 12 months prior to randomization
* New York Heart Association (NYHA) III or IV heart failure, or known left ventricular ejection fraction \< 30%
* Uncontrolled cardiac arrhythmia
* Myocardial infarction, unstable angina, percutaneous coronary intervention (PCI), coronary artery bypass graft (CABG) or stroke within 3 months prior to randomization
* Type 1 diabetes; newly diagnosed or poorly controlled type 2 diabetes (HbA1c \> 8.5%)
* Uncontrolled hypertension
Stepped Care for Depression and Musculoskeletal Pain

This study will evaluate the effectiveness of a stepped care approach in treating depression and reducing pain.

In the United States, pain accounts for nearly 20% of all primary health care visits. In the majority of cases, the pain is musculoskeletal and primarily affects the lower back, hips, and knees. Studies have shown that at least one-third of patients with pain also suffer from depression. It has not been determined whether treatments for depression are effective in patients with comorbid pain and depression. The "Stepped Care for Affective Disorders and Musculoskeletal Pain" (SCAMP) study will determine the most effective treatment for patients with pain and depression.

This study will last 12 months and will comprise depressed and nondepressed participants. Nondepressed participants will receive no treatment. Depressed patients will be randomly assigned to receive standard of care or stepped care for 12 weeks. Standard of care may include cognitive therapy, antidepressant treatment, or other treatments. The stepped care group will receive 12 weeks of antidepressant treatment. Participants who respond to antidepressant treatment will continue their treatment for the duration of the study. Participants who do not respond to the treatment after 12 weeks will receive 6 weekly pain self-management sessions. During these sessions, an educator will teach participants how to manage their pain through exercise and relaxation techniques. Self-report scales and questionnaires will be used to assess participants' pain, depressive symptoms, health care usage and costs, and quality of life. Depressed participants will undergo assessments at study start and at Months 1, 3, 6, and 12. Nondepressed participants will undergo assessments at study start and at Months 3 and 12.

Study hypotheses: 1) Stepped care is more effective than usual care in improving depression and pain. 2) Stepped care is more effective than usual care in improving health-related quality of life, negative pain beliefs and behaviors, reduced opiate use, and health care costs. 3) Patients with musculoskeletal pain who are not depressed at baseline will have an incidence of depression less than 20% over 12 months of follow-up, characteristics that can be identified as risk factors for incident depression, baseline characteristics distinguishing them from depressed patients, and better pain and health status outcomes, compared to depressed patients.

Eligibility Criteria:
Inclusion Criteria:

* Moderate or severe pain in the back, hips, or knees for at least 3 months prior to study entry
* History of or current use of at least one medication for pain
* English-speaking

Exclusion Criteria:

* Moderate to severe cognitive impairment
* Schizophrenia or other psychotic disorders
* Receiving disability benefits for pain
* Anticipated life expectancy less than 12 months
* Pregnancy
Health Status and Cardiovascular Stress of Veteran Soccer Players

This study shall provide missing descriptive data on health status of veteran players and potential preventive effects of soccer at an age of 40 to 60 years. The investigation represents a cross-sectional examination of cardiovascular parameters and metabolic stress induced by training and competition. Additionally, orthopedic and other medical risks are to be revealed, and options should be developed to minimize these risks, e.g. by preventive measures included in training or rule modifications.

Facing the demographic trends in Western societies there is an expected increase in interest in soccer for males between 40 and 60 years. Positive effects of such an activity on health can be suspected based on some studies and analogous conclusions. However, no sufficient database is available yet. Moreover, the range of cardiovascular risk factors or pre-existing diseases for this specific population is not known.

This study shall provide missing descriptive data on health status of veteran players and potential preventive effects of soccer at an age of 40 to 60 years. The investigation represents a cross-sectional examination of cardiovascular parameters and metabolic stress induced by training and competition. Additionally, orthopedic and other medical risks are to be revealed, and options should be developed to minimize these risks, e.g. by preventive measures included in training or rule modifications.

Eligibility Criteria:
Inclusion Criteria:

* Male veteran soccer players aged 40 years and older, who are member of a club veteran team

Exclusion Criteria:

* Diseases or injuries which are contraindications for physical exercise
An Observational Study Validating a Score That Quantifies the Therapeutic Response to Treatment With Norditropin®

This observational study is conducted in Europe. The aim of this observational study is to investigate the changes in a score (GET-score) which includes quality of life, body composition and cholesterol metabolism in patients on growth hormone treatment. The GET score stands for: Growth hormone deficiency and Efficacy of Treatment, and is a quantitative measurement of the efficacy of the treatment with growth hormone in adults.


Eligibility Criteria:
Inclusion Criteria:

* Severe acquired growth hormone deficiency
* No treatment with somatropin in the last 24 months before study participation
* Written informed consent

Exclusion Criteria:

* Contraindications for the treatment with somatropin